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Sample records for blind randomized clinical

  1. Topical corticosteroids in the treatment of acute sunburn - A randomized, double-blind clinical trial

    DEFF Research Database (Denmark)

    Faurschou, A.; Wulf, Hans Chr.

    2008-01-01

    Objective: To examine the effect of topical corticosteroid treatment on acute sunburn. Design: Randomized, double-blind clinical trial. Setting: University dermatology department. Patients: Twenty healthy volunteers with Fitzpatrick skin types I (highly sensitive, always burns easily, tans...... in the acute sunburn reaction when applied 6 or 23 hours after UV exposure. Clinical Trial Registry: clinicaltrials. gov Identifier: NCT00206882 Udgivelsesdato: 2008/5...

  2. A prospective, randomized, double-blind clinical trial of one nano ...

    African Journals Online (AJOL)

    A prospective, randomized, double-blind clinical trial of one nano-hybrid and one high-viscosity bulk-fill composite restorative systems in class II cavities: 12 ... composites (RCs) perform just as well as nano‑hybrid RCs with the 2 mm RC layering technique, therefore could be alternative to conventional nano‑hybrid RCs.

  3. The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial.

    Science.gov (United States)

    Thelen, Mark D; Dauber, James A; Stoneman, Paul D

    2008-07-01

    Prospective, randomized, double-blinded, clinical trial using a repeated-measures design. To determine the short-term clinical efficacy of Kinesio Tape (KT) when applied to college students with shoulder pain, as compared to a sham tape application. Tape is commonly used as an adjunct for treatment and prevention of musculoskeletal injuries. A majority of tape applications that are reported in the literature involve nonstretch tape. The KT method has gained significant popularity in recent years, but there is a paucity of evidence on its use. Forty-two subjects clinically diagnosed with rotator cuff tendonitis/impingement were randomly assigned to 1 of 2 groups: therapeutic KT group or sham KT group. Subjects wore the tape for 2 consecutive 3-day intervals. Self-reported pain and disability and pain-free active ranges of motion (ROM) were measured at multiple intervals to assess for differences between groups. The therapeutic KT group showed immediate improvement in pain-free shoulder abduction (mean +/- SD increase, 16.9 degrees +/- 23.2 degrees ; P = .005) after tape application. No other differences between groups regarding ROM, pain, or disability scores at any time interval were found. KT may be of some assistance to clinicians in improving pain-free active ROM immediately after tape application for patients with shoulder pain. Utilization of KT for decreasing pain intensity or disability for young patients with suspected shoulder tendonitis/impingement is not supported. Therapy, level 1b-.

  4. Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial

    OpenAIRE

    Carbonell, Josep Lluis; Garcia, Ramon; Gonzalez, Adriana; Breto, Andres; Sanchez, Carlos

    2015-01-01

    Josep Lluis Carbonell,1 Ramon Garcia,2 Adriana Gonzalez,2 Andres Breto,2 Carlos Sanchez2 1Mediterranea Medica Clinic, Valencia, Spain; 2Eusebio Hernandez Gynecology and Obstetrics Teaching Hospital, Havana, Cuba Purpose: To estimate the efficacy and safety of 5 mg and 10 mg mifepristone for emergency contraception up to 144 hours after unprotected coitus. Methods: This double-blind randomized clinical trial was carried out at Eusebio Hernandez Hospital (Havana, Cuba). A total of 2,418 women ...

  5. The Effect of Footbath on Sleep Quality of the Elderly: A Blinded Randomized Clinical Trial

    OpenAIRE

    Seyyedrasooli, Allehe; Valizadeh, Leila; Zamanzadeh, Vahid; Nasiri, Khadijeh; Kalantri, Hossein

    2013-01-01

    Introduction: The progressive increase in the elderly population of developing countries has drawn attention to their health. Sleep Pattern and quality can affect life quality in old people. We need more documents about footbath (a non-invasive method). The purpose of this research was to examine footbath on sleep quality of the elderly. Methods: This study is a blinded, randomized, clinical trial on 46 old men that had health documents in health center, 2013. Participants in the research wer...

  6. Green banana reduces clinical severity of childhood shigellosis: a double-blind, randomized, controlled clinical trial.

    Science.gov (United States)

    Rabbani, Golam H; Ahmed, Shamsir; Hossain, Iqbal; Islam, Rafiqul; Marni, Farzana; Akhtar, Mastura; Majid, Nashiha

    2009-05-01

    Mature green banana (GB) fruit is rich in amylase-resistant starch that stimulates colonic production of short-chain fatty acids (referred to as fatty acid) and is useful in treating diarrheal diseases. We studied therapeutic effects of GB in childhood shigellosis by determining colonic fatty acid production in a double-blind, randomized, controlled, clinical trial. Seventy-three children aged 6 to 60 months with severe bloody dysentery caused by Shigella infection were either given a rice-based diet (54 kcal/dL), with cooked GB (250 g/L) (n = 34) or without GB (n = 39) for 5 days; all given ciprofloxacin (15 mg/kg, q12 hours). Stool volume, frequency, excretion of blood/mucus, and relevant clinical and laboratory indices were determined. On day 5 (post-treatment), 59% children in GB group had no mucus compared with 36% in controls, fecal blood was completely cleared from 96% in GB group compared with 60% without GB (P < 0.05). GB treatment significantly reduced (P < 0.01) numbers of stools/day compared with controls (70% vs. 50%, P < 0.05). GB-specific reductions of mean fecal volumes (mL/kg) ranged from 25% to 40%; (P < 0.05) during the 5-day observations. Clinical success rates were 85% in GB group compared with 67% in controls (P < 0.05). GB significantly (P < 0.01) reduced fecal myeloperoxidase activity and increased fecal fatty acid concentrations (P < 0.01). GB diet improves clinical severity in childhood shigellosis and could be a simple and useful adjunct for dietary management of this illness.

  7. Olsalazine is contraindicated during pelvic radiation therapy: results of a double-blind, randomized clinical trial

    International Nuclear Information System (INIS)

    Martenson, James A.; Hyland, Glenn; Moertel, Charles G.; Mailliard, James A.; O'Fallon, Judith R.; Collins, Roger T.; Morton, Roscoe F.; Tewfik, Hamed H.; Moore, Randy L.; Frank, Albert R.; Urias, Rodolfo E.; Deming, Richard L.

    1996-01-01

    Purpose: A randomized clinical trial from Great Britain suggested a possible beneficial effect of acetylsalicylate in the prevention of radiation-induced bowel toxicity. Olsalazine is an orally administered drug designed to deliver 5-aminosalicylate to the large bowel with minimal systemic absorption. A randomized clinical trial was undertaken to assess the effectiveness of olsalazine in preventing acute diarrhea in patients receiving pelvic radiation therapy. Methods and Materials: Patients receiving pelvic radiation therapy were randomized, in double-blind fashion, to olsalazine 250 mg, two capsules twice daily, or an identical appearing placebo, two capsules twice daily. Patients were then evaluated weekly during radiation therapy for the primary study endpoint, diarrhea, as well as rectal bleeding, abdominal cramping, and tenesmus. Results: The study was closed early, after entry of 58 evaluable patients, when a preliminary analysis showed excessive diarrhea in patients randomized to olsalazine. The incidence and severity of diarrhea were worse in patients randomized to olsalazine (p 0.0036). Sixty percent of the patients randomized to olsalazine experienced Grade 3 or 4 diarrhea compared to only 14% randomized to placebo. There was also a trend toward higher incidence and greater severity of abdominal cramping in patients who were randomized to olsalazine (p = 0.084). Conclusion: Administration of olsalazine during pelvic radiation therapy resulted in an increased incidence and severity of diarrhea. Olsalazine is contraindicated in patients receiving pelvic radiation therapy

  8. Efficacy of oral cholecalciferol on rhododendrol-induced vitiligo: A blinded randomized clinical trial.

    Science.gov (United States)

    Watabe, Akiko; Yamasaki, Kenshi; Asano, Masayuki; Kanbayashi, Yumi; Nasu-Tamabuchi, Mei; Terui, Hitoshi; Furudate, Sadanori; Kakizaki, Aya; Tsuchiyama, Kenichiro; Kimura, Yutaka; Ito, Yumiko; Kikuchi, Katsuko; Aiba, Setsuya

    2018-02-05

    Rhododendrol (RD), 4-(4-hydroxyphenyl)-2-butanol, inhibits melanin synthesis and has been used for skin-whitening cosmetic products. RD has been very effective in lightening skin pigmentation, but some persons have developed so-called RD vitiligo, in which vitiligo starts on the face, neck and hands where topical RD has been applied and even extended over skin areas where RD has not been applied. RD vitiligo lesions in some patients have lasted for years and have been resistant to conventional vitiligo treatments. We examined the effects of cholecalciferol on RD vitiligo in a blinded randomized clinical trial. Forty-eight female RD vitiligo patients were recruited for the trial and were randomized into two groups: the vitamin D (VD)-intervention group that received daily 5000 IU cholecalciferol for 5 months and the control group. Three blinded investigators scored vitiligo improvement by comparing photographic images of baseline and at 5-month observation. Serum 25(OH)D3 of RD vitiligo patients was not significantly different from age-matched healthy volunteers. Twenty-two in the VD-intervention group and 23 in the control group completed the 5-month observation. Serum 25(OH)D3 levels were significantly increased after the 5-month VD intervention, while the control group did not change. The improvement scores were significantly higher in the VD-intervention group than the control group. The improvement scores were positively correlated with the serum 25(OH)D3 levels after the 5-month intervention period but not before the treatment. This blinded randomized clinical trial showed favor in administrating 5000 IU cholecalciferol daily to RD vitiligo patients. © 2018 Japanese Dermatological Association.

  9. Preoperative Use of Dexamethasone in Rhinoplasty: A Randomized, Double-blind, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Valente, Denis S; Steffen, Niveo; Carvalho, Lauro A; Borille, Giuliano B; Zanella, Rafaela K; Padoin, Alexandre V

    2015-01-01

    Postoperative edema and ecchymosis following rhinoplasty are a cause of anxiety for both patients and physicians and can affect the cosmetic results. Corticosteroids have been used to reduce these events. To determine whether preoperative use of dexamethasone sodium phosphate alters the occurrence of edema and ecchymosis following rhinoplasty. Randomized, double-blind, placebo-controlled clinical trial at an institutional referral center among a sample of individuals with rhinomegaly. Patients were randomized into 2 groups. In group 1, dexamethasone was intravenously injected before surgery. In group 2, normal saline solution was intravenously injected before surgery. When patients returned at 1 week after surgery, standardized photographs were obtained. The photographs were analyzed by 5 plastic surgeons who were blinded as to whether dexamethasone or normal saline solution had been injected. The plastic surgeons rated the degree of edema and ecchymosis. Forty-two patients participated in the study. Randomization by lottery resulted in 20 patients in group 1 and 22 patients in group 2. Group 1 showed lower rates of postoperative ecchymosis than group 2; the difference of 0.62 (P = .02) reflects less perceived ecchymosis when dexamethasone was administered. Group 1 also showed lower rates of postoperative edema than group 2; the difference of 0.68 (P = .01) reflects less perceived edema when dexamethasone was administered. Preoperative use of dexamethasone reduced edema and ecchymosis at 7 days after rhinoplasty. Rigorous methods in this trial demonstrate the beneficial effect of preoperative corticosteroid administration in this surgical procedure. 1.

  10. Progressive learning in endoscopy simulation training improves clinical performance: a blinded randomized trial.

    Science.gov (United States)

    Grover, Samir C; Scaffidi, Michael A; Khan, Rishad; Garg, Ankit; Al-Mazroui, Ahmed; Alomani, Tareq; Yu, Jeffrey J; Plener, Ian S; Al-Awamy, Mohamed; Yong, Elaine L; Cino, Maria; Ravindran, Nikila C; Zasowski, Mark; Grantcharov, Teodor P; Walsh, Catharine M

    2017-11-01

    A structured comprehensive curriculum (SCC) that uses simulation-based training (SBT) can improve clinical colonoscopy performance. This curriculum may be enhanced through the application of progressive learning, a training strategy centered on incrementally challenging learners. We aimed to determine whether a progressive learning-based curriculum (PLC) would lead to superior clinical performance compared with an SCC. This was a single-blinded randomized controlled trial conducted at a single academic center. Thirty-seven novice endoscopists were recruited and randomized to either a PLC (n = 18) or to an SCC (n = 19). The PLC comprised 6 hours of SBT, which progressed in complexity and difficulty. The SCC included 6 hours of SBT, with cases of random order of difficulty. Both groups received expert feedback and 4 hours of didactic teaching. Participants were assessed at baseline, immediately after training, and 4 to 6 weeks after training. The primary outcome was participants' performance during their first 2 clinical colonoscopies, as assessed by using the Joint Advisory Group Direct Observation of Procedural Skills assessment tool (JAG DOPS). Secondary outcomes were differences in endoscopic knowledge, technical and communication skills, and global performance in the simulated setting. The PLC group outperformed the SCC group during first and second clinical colonoscopies, measured by JAG DOPS (P technical and communication skills and global performance in the simulated setting (P  .05). Our findings demonstrate the superiority of a PLC for endoscopic simulation, compared with an SCC. Challenging trainees progressively is a simple, theory-based approach to simulation whereby the performance of clinical colonoscopies can be improved. (Clinical trial registration number: NCT02000180.). Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  11. Pimpinella anisum in the treatment of functional dyspepsia: A double-blind, randomized clinical trial

    Directory of Open Access Journals (Sweden)

    S Ashraffodin Ghoshegir

    2015-01-01

    Full Text Available Background: We aimed to evaluate the effects of Pimpinella anisum (anise from Apiaceae family on relieving the symptoms of postprandial distress syndrome (PDS in this double-blind randomized clinical trial. Materials and Methods: Totally, 107 patients attending the gastroenterology clinic, aged 18-65 years, diagnosed with PDS according to ROME III criteria and signed a written consent form were enrolled. They were randomized to receive either anise or placebo, blindly, for 4 weeks. Anise group included 47 patients and received anise powders, 3 g after each meal (3 times/day. Control group involved 60 patients and received placebo powders (corn starch, 3 gafter each meal (3 times/day. The severity of Functional dyspepsia (FD symptoms was assessed by FD severity scale. Assessments were done at baseline and by the end of weeks 2, 4 and 12. Mean scores of severity of FD symptoms and the frequency distribution of patients across the study period were compared. Results: The age, sex, body mass index, smoking history, and coffee drinking pattern of the intervention and control groups were not significantly different. Mean (standard deviation total scores of FD severity scale before intervention in the anise and control groups were 10.6 (4.1 and 10.96 (4.1, respectively (P = 0.6. They were 7.04 (4.1 and 12.30 (4.3 by week 2, respectively (P = 0.0001, 2.44 (4.2 and 13.05 (5.2 by week 4, respectively (P = 0.0001, and 1.08 (3.8 and 13.30 (6.2 by week 12, respectively (P = 0.0001. Conclusion: This study showed the effectiveness of anise in relieving the symptoms of postpartum depression. The findings were consistent across the study period at weeks 2, 4 and 12.

  12. Magnesium Sulfate in Acute Stroke: A Randomized Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    S A Mousavi

    2004-08-01

    Full Text Available Background: Administration of magnesium sulfate has neuroprotective effects and reduces infarct volume in animal models of stroke. Previous small clinical trials have reported beneficial effect of magnesium on the outcome in patients with stroke. This study was a randomized, placebo-controlled, double-blind study , investigated the benefit of magnesium sulfate the administration given intravenously as a neuroprotective. Methods: Patients who had cortical infarction in the middle cerebral artery territory (superior or inferior division with moderate neurologic deficits (Orgogozo scale score greater than 30 and less than 70 and onset less than 24 hours were included. The patients were treated with magnesium sulfate (4gr stat and 1gr/hr or placebo for 4 days and examined by a blind investigator. NIH Stroke Scale was obtained on admission and fifth day after stroke. Results: Eighteen patients were given treatment and nineteen patients were given placebo who demonstrated significant beneficial effects on the difference between NIH Stroke Scales on the day of admission and day 5 (3.16 ± 0.98 vs. 1.84 ± 1.06; p = 0.000 respectively. Conclusion: Intravenous magnesium sulfate had significant beneficial effect on acute phase of stroke patients and, as a result, may reduce duration of admission. Keywords: Stroke, Magnesium sulfate, Neuroprotective.

  13. Repetitive transcranial magnetic stimulation for rehabilitation of poststroke dysphagia: A randomized, double-blind clinical trial.

    Science.gov (United States)

    Du, Juan; Yang, Fang; Liu, Ling; Hu, Jingze; Cai, Biyang; Liu, Wenhua; Xu, Gelin; Liu, Xinfeng

    2016-03-01

    This randomized, sham-controlled, double-blind study was conducted to investigate the effects of high-frequency versus low-frequency repetitive transcranial magnetic stimulation (rTMS) on patients with poststroke dysphagia during early rehabilitation. Forty patients with poststroke dysphagia were randomized to receive five daily sessions of sham, 3-Hz ipsilesional, or 1-Hz contralesional rTMS. Swallowing function, the severity of stroke and functional disability, and cortical excitability were examined before, immediately after five daily sessions, as well as the first, second, and third month after the last session. At baseline, no significant differences between groups were observed in terms of demographic and clinical rating scales. However, a significantly greater improvement in swallowing function as well as functional disability was observed after real rTMS when compared with sham rTMS, which remained 3 months after the end of the treatment sessions. In addition, 1-Hz rTMS increased cortical excitability of the affected hemisphere and decreased that of the non-affected hemisphere; however, 3-Hz rTMS only increased cortical excitability of the affected hemisphere. rTMS (both high and low frequency) improved swallowing recovery in patients with poststroke dysphagia, and the effects lasted for at least 3 months. rTMS appears to be a beneficial therapeutic modality for patients with dysphagia during the early phase of stroke. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

  14. Corticosteroids and vestibular exercises in vestibular neuritis. Single-blind randomized clinical trial.

    Science.gov (United States)

    Goudakos, John K; Markou, Konstantinos D; Psillas, George; Vital, Victor; Tsaligopoulos, Miltiadis

    2014-05-01

    IMPORTANCE The management of patients with unilateral acute vestibular neuritis (VN) has not been established to date. OBJECTIVE To compare the use of vestibular exercises vs corticosteroid therapy in the recovery of patients with acute VN. DESIGN, SETTING, AND PARTICIPANTS Prospective, single-blind, randomized clinical trial at a primary referral center. Among all patients with acute vertigo, those having VN were eligible for inclusion in the study. INTERVENTIONS Forty patients with acute VN were randomly assigned to perform vestibular exercises or to receive corticosteroid therapy. After a baseline examination, follow-up evaluations were performed at 1, 6, and 12 months. MAIN OUTCOMES AND MEASURES Efficacy outcomes included clinical, canal, and otolith recovery. Scores on the European Evaluation of Vertigo Scale and the Dizziness Handicap Inventory were used for the evaluation of clinical recovery. Findings of caloric irrigation and vestibular evoked myogenic potentials indicated canal and otolith improvement, respectively. RESULTS Comparing the 2 treatment groups, no statistically significant differences were found in clinical, canal, or otolith recovery. At the 6-month examination, the number of patients with complete disease resolution in the corticosteroids group was significantly higher than that in the vestibular exercises group. However, at the end of the follow-up period, 45%(9 of 20) of patients in the vestibular exercises group and 50% (10 of 20) of patients in the corticosteroids group had complete disease resolution (P > .05). CONCLUSIONS AND RELEVANCE Treating patients who have acute VN with vestibular exercises seems equivalently effective as treating them with corticosteroid therapy in clinical, caloric, and otolith recovery. Corticosteroid therapy seems to enhance earlier complete acute VN resolution, with no added benefit in the long-term prognosis.

  15. VITAMINE E IN THE MANAGEMENT OF DRUG INDUCED TARDIVE DYSKINESIA: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    M KAR AHMADI

    2002-12-01

    Full Text Available Introduction. Expresssion of tardive dyskinesia as one of the side effects of antipsychotic drugs causes various problems in psychotic patients. It is the main cause of patient"s drug incompliance.Vitamine E with it"s antioxidants properties might be an effective treatment for tardive dyskinesia. Methods. In a randomized double blind clinical trial, thirty inpatients of the psychiatric hospital in Isfahan were studied. Patients were stratified according to their age, psychiatric disorder and duration, intensity of tardive dyskinesia and antipsychotic dosage. Then they were asssigned randomly into two groups. Vitamine E (600 mg/day was administered to interventional group (15 patients. Another group received placebo (15 patients. Treatment durated for 6 weeks. Abnormal Involuntary Movment Scale (AIMS was used to measure tardive dyskinesia intensity. Results. Average of disorder intensity in those who received vit. E, dropped down from 8.33/10 (befor treatment to 6.13/10 (after treatment. It means 26.3 percent reduction of tardive dyskinesia intensity. This difference was only 7.3 percent in control group. There were no statistical diffrence between two groups after treatment (P>0.05. Discussion. There is no statistical efficacy for vitamine E in the management of tardive dyskinesia. But it is recommended to make another study with more samples.

  16. Transversus abdominis plane blockade in laparoscopic colorectal surgery: a double-blind randomized clinical trial.

    Science.gov (United States)

    Smith, Stephen Ridley; Draganic, Brian; Pockney, Peter; Holz, Phillip; Holmes, Ryan; Mcmanus, Brendan; Carroll, Rosemary

    2015-09-01

    Adequate postoperative analgesia is essential for recovery following colorectal surgery. Transversus abdominis plane (TAP) blocks have been found to be beneficial in improving pain following a variety of abdominal operations. The objective of this study was to determine if TAP blocks are useful in improving postoperative recovery following laparoscopic colorectal surgery. A prospective double-blind randomized clinical trial, involving 226 consecutive patients having laparoscopic colorectal surgery, was performed by a university colorectal surgical department. Patients were randomized to either TAP blockade using ultrasound guidance, or control, with the primary outcome being postoperative pain, as measured by analgesic consumption. Secondary outcomes assessed were pain visual analogue score (VAS), respiratory function, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. A total of 142 patients were followed up to trial completion (74 controls, 68 interventions). Patients were well matched with regard to demographics. No complications occurred as a result of the intervention of TAP blockade. There was no difference between groups with regards to analgesic consumption (161 mEq morphine control vs 175 mEq morphine TAP; p = 0.596). There was no difference between the two groups with regards to the secondary outcomes of daily VAS, respiratory outcome, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. We conclude that TAP blockade appears to be a safe intervention but confers no specific advantage following laparoscopic colorectal surgery.

  17. Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.

    Science.gov (United States)

    Fatheree, Nicole Y; Liu, Yuying; Taylor, Christopher M; Hoang, Thomas K; Cai, Chunyan; Rahbar, Mohammad H; Hessabi, Manouchehr; Ferris, Michael; McMurtry, Valarie; Wong, Christine; Vu, Ta; Dancsak, Theresa; Wang, Ting; Gleason, Wallace; Bandla, Vinay; Navarro, Fernando; Tran, Dat Q; Rhoads, J Marc

    2017-12-01

    To assess the safety of probiotic Lactobacillus reuteri strain Deutsche Sammlung von Mikroorganismen (DSM) 17938 with daily administration to healthy infants with colic and to determine the effect of L reuteri strain DSM 17938 on crying, fussing, inflammatory, immune, and microbiome variables. We performed a controlled, double-blinded, phase 1 safety and tolerability trial in healthy breast-fed infants with colic, aged 3 weeks to 3 months, randomly assigned to L reuteri strain DSM 17938 (5 × 10 8 colony-forming units daily) or placebo for 42 days and followed for 134 days. Of 117 screened infants, 20 were randomized to L reuteri strain DSM 17938 or placebo (sunflower oil) (in a 2:1 ratio) with 80% retention. Eleven of the 20 (55%) presented with low absolute neutrophil counts (L reuteri strain DSM 17938 produced no severe adverse events and did not significantly change crying time, plasma bicarbonate, or inflammatory biomarkers. Fecal calprotectin decreased rapidly in both groups. In the infants with dominant fecal gram negatives (Klebsiella, Proteus, and Veillonella), resolution of colic was associated with marked decreases in these organisms. Daily administration of L reuteri strain DSM 17938 appears to be safe in newborn infants with colic, including those with neutropenia, which frequently coexists. A placebo response of 66% suggests that many infants with colic will have resolution within 3 weeks. ClinicalTrials.gov: NCT01849991. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Dali, Christine í; Hansen, Flemming Juul; Pedersen, Søren Anker

    2002-01-01

    A randomized double-blind placebo-controlled clinical trial was carried out to determine whether a group of stable children with cerebral palsy (36 males, 21 females; mean age 10 years 11 months, range 5 to 18 years) would improve their motor skills after 12 months of threshold electrical...

  19. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

    NARCIS (Netherlands)

    Versyck, B.; Geffen, G.J. van; Houwe, P. Van

    2017-01-01

    STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

  20. Using instrumental variables to disentangle treatment and placebo effects in blinded and unblinded randomized clinical trials influenced by unmeasured confounders

    Science.gov (United States)

    Chaibub Neto, Elias

    2016-11-01

    Clinical trials traditionally employ blinding as a design mechanism to reduce the influence of placebo effects. In practice, however, it can be difficult or impossible to blind study participants and unblinded trials are common in medical research. Here we show how instrumental variables can be used to quantify and disentangle treatment and placebo effects in randomized clinical trials comparing control and active treatments in the presence of confounders. The key idea is to use randomization to separately manipulate treatment assignment and psychological encouragement conversations/interactions that increase the participants’ desire for improved symptoms. The proposed approach is able to improve the estimation of treatment effects in blinded studies and, most importantly, opens the doors to account for placebo effects in unblinded trials.

  1. Purse-string suture vs second intention healing: results of a randomized, blind clinical trial.

    Science.gov (United States)

    Joo, Jayne; Custis, Trenton; Armstrong, April W; King, Thomas H; Omlin, Kenny; Kappel, Stefani T; Eisen, Daniel B

    2015-03-01

    Purse-string suture is a closure method that purportedly reduces the scar area compared with second intention healing. Randomized clinical trials comparing these 2 methods appear to be limited or absent. To determine if purse-string suture improves cosmetic outcome, healing time, and scar to defect area compared with second intention healing for circular defects on the trunk and extremities. Prospective, 2-arm, randomized, evaluator-blinded clinical trial in a single-center outpatient academic dermatology center. Patients were eligible if they were older than 18 years, able to give informed consent, and had circular or oval postoperative defects larger than 8 mm on the trunk or extremities. For the purse-string treatment arm, wounds were sewn in circumferential fashion using polydiaxanone suture. Patients in the other treatment arm were allowed to heal by second intent. The primary outcome measures were the mean total Patient and Observer Scar Assessment Scale (POSAS) scores ascertained from the patient and 2 blinded observers. Secondary outcomes included the ratio of scar to initial defect size, healing time, pain scores, and complication rates. Fifty-two patients were screened, and a total of 44 patients with 50 surgical sites were enrolled. Forty-two patients with 48 surgical sites completed the study. The mean total observer POSAS score was 18.38 for the purse-string group vs 19.91 for the secondary intention group, a nonsignificant difference (P = .41). Similarly, there were no significant differences for any of the following secondary outcome measures: mean total patient POSAS score (P = .96), mean scar-to-defect area (P = .61), and mean pain level at week 1 (P = .19). Statistical trends toward significance were seen in the mean healing time in favor of purse-string suture (P = .10) and scar relief, which favored second intention healing (P = .07). The purse-string suture results in similar cosmetic outcomes, scar sizes, and pain

  2. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial.

    Science.gov (United States)

    Bagnato, Gian Luca; Miceli, Giovanni; Marino, Natale; Sciortino, Davide; Bagnato, Gian Filippo

    2016-04-01

    This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA and persistent pain higher than 40 mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. The primary outcome measure was the reduction in pain intensity, assessed through VAS and WOMAC scores. Secondary outcomes included quality of life assessment through the 36-item Medical Outcomes Study Short-Form version 2 (SF-36 v2), pressure pain threshold (PPT) and changes in intake of NSAIDs/analgesics. Sixty-six patients were included, and 60 completed the study. After 1 month, PEMF induced a significant reduction in VAS pain and WOMAC scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of -0.73 (95% CI - 1.24 to - 0.19) was seen in VAS score, while the effect size was -0.34 (95% CI - 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected. These results suggest that PEMF therapy is effective for pain management in knee OA patients and also affects pain threshold and physical functioning. Future larger studies, including head-to-head studies comparing PEMF therapy with standard pharmacological approaches in OA, are warranted. ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01877278. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology.

  3. Chocolate flavanols and skin photoprotection: a parallel, double-blind, randomized clinical trial.

    Science.gov (United States)

    Mogollon, Jaime Andres; Boivin, Catherine; Lemieux, Simone; Blanchet, Claudine; Claveau, Joël; Dodin, Sylvie

    2014-06-27

    Solar ultraviolet (UV) radiation has deleterious effects on the skin, including sunburn, photoaging and cancer. Chocolate flavanols are naturally-occurring antioxidant and anti-inflammatory molecules that could play a role in preventing cutaneous UV damage. We investigated the influence of 12-week high-flavanol chocolate (HFC) consumption on skin sensitivity to UV radiation, measured by minimal erythema dose (MED). We also evaluated skin elasticity and hydration. In this 2-group, parallel, double-blind, randomized controlled trial, 74 women aged 20-65 years and Fitzpatrick skin phototypes I or II were recruited from the general community in Quebec City, for randomization to either HFC (n = 33) or low-flavanol chocolate (LFC) (n = 41). A blocked randomisation (4), considering date of entry, skin type and age as factors, generated a sequentially-numbered allocation list. Study participants and research assistants were blinded. Totally, 30 g of chocolate were consumed daily for 12 weeks, followed by a 3-week washout period. MED was assessed at baseline and at 6, 9, 12 and 15 weeks. Main outcome was changes in MED at week 12. 33 participants in the HFC group and 41 in the LFC group were analyzed with 15 weeks of follow-up. Both groups showed similarly-increased MED at 12 weeks (HFC: 0.0252 ± 0.1099 J/cm2 [mean ± standard deviation (SD)]; LFC: 0.0151 ± 0.1118; mean difference (MD): 0.0100 J/cm2; 95% confidence interval (CI): -0.0417 to 0.0618). However, after 3-week washout, the HFC group presented decreased MED (-0.0248 ± 0.1145) whereas no effect was seen in the LFC group (0.0168 ± 0.1698) (MD: -0.0417; 95% CI: -0.1106 to 0.0272). Net temple elasticity increased slightly but significantly by 0.09 ± 0.12 mm in the HFC group at 12 weeks compared to 0.02 ± 0.12 mm in the LFC group (MD: 0.06; 95% CI: 0.01 to 0.12 ). No significant adverse events were reported. Our study failed to demonstrate a statistically

  4. The effect of footbath on sleep quality of the elderly: a blinded randomized clinical trial.

    Science.gov (United States)

    Seyyedrasooli, Allehe; Valizadeh, Leila; Zamanzadeh, Vahid; Nasiri, Khadijeh; Kalantri, Hossein

    2013-12-01

    The progressive increase in the elderly population of developing countries has drawn attention to their health. Sleep Pattern and quality can affect life quality in old people. We need more documents about footbath (a non-invasive method). The purpose of this research was to examine footbath on sleep quality of the elderly. This study is a blinded, randomized, clinical trial on 46 old men that had health documents in health center, 2013. Participants in the research were divided into two groups. One group had footbath (experimental group) and another group did not have footbath (control group). The experimental group participants were asked to put their feet in warm water (41-42 ºC) for 20 minutes before sleeping for 6 weeks. The co-researcher completed the Pittsburgh Sleep Quality Index (PSQI) before and after the intervention by individual interview. Data were analyzed by SPSS software. The comparison of changes in sleep quality score the old men showed the sleep duration and total sleep quality has significantly improved in the experimental group. According to the study results, the maximum effect of footbath was on sleep latency and sleep duration disturbances. In this study, the researchers had limited access to the elderly in Tabriz; therefore, it is recommended that future research be conducted in a higher number of health centers.

  5. Dapsone Gel in the Treatment of Papulopustular Rosacea: A Double-Blind Randomized Clinical Trial.

    Science.gov (United States)

    Faghihi, Gita; Khosravani, Parastoo; Nilforoushzadeh, Mohammad Ali; Hosseini, Sayyed Mohsen; Assaf, Fatemeh; Zeinali, Naser; Smiley, Abbas

    2015-06-01

    We aimed to evaluate the effects of 5% dapsone gel compared with 0.75% metronidazole gel in the treatment of papulopustular rosacea. In a double-blind randomized clinical trial, 56 adult patients with papulopustular rosacea were enrolled. The severity of disorder was determined by the patient according to visual analogue score (VAS). Investigator's global assessment (IGA) scores and number of inflammatory lesions were recorded. 5% dapsone gel was administered for group D and 0.75% metronidazole gel was administered for group M. Systemic doxycycline was administered for all patients. Follow-up assessments were done at 4, 8, and 12 weeks. Changes in VAS, IGA scores and number of lesions were evaluated. Intention to treat analysis was carried out using SPSS version 17 (Chicago, IL). There was no significant difference in sex and age distribution between the two groups. Mean (SD) IGA score before and after intervention in group D was 3.9 (0.9) and 3.3 (0.9), respectively (PDapsone gel was as effective as metronidazole gel in the treatment of papulopustular rosacea.

  6. The Effect of Footbath on Sleep Quality of the Elderly: A Blinded Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Allehe Seyyedrasooli

    2013-11-01

    Full Text Available Introduction: The progressive increase in the elderly population of developing countries has drawn attention to their health. Sleep Pattern and quality can affect life quality in old people. We need more documents about footbath (a non-invasive method. The purpose of this research was to examine footbath on sleep quality of the elderly. Methods: This study is a blinded, randomized, clinical trial on 46 old men that had health documents in health center, 2013. Participants in the research were divided into two groups. One group had footbath (experimental group and another group did not have footbath (control group. The experimental group participants were asked to put their feet in warm water (41-42 ºC for 20 minutes before sleeping for 6 weeks. The co-researcher completed the Pittsburgh Sleep Quality Index (PSQI before and after the intervention by individual interview. Data were analyzed by SPSS software. Results: The comparison of changes in sleep quality score the old men showed the sleep duration and total sleep quality has significantly improved in the experimental group. Conclusion: According to the study results, the maximum effect of footbath was on sleep latency and sleep duration disturbances. In this study, the researchers had limited access to the elderly in Tabriz; therefore, it is recommended that future research be conducted in a higher number of health centers.

  7. Correction: PAIS: paracetamol (acetaminophen in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480

    Directory of Open Access Journals (Sweden)

    Kappelle L Jaap

    2008-11-01

    Full Text Available Abstract Background The Paracetamol (Acetaminophen In Stroke (PAIS study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever. The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis. Methods Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial. Conclusion The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power. Trial Registration Current Controlled Trials [ISCRTN74418480

  8. Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Carbonell JL

    2015-01-01

    Full Text Available Josep Lluis Carbonell,1 Ramon Garcia,2 Adriana Gonzalez,2 Andres Breto,2 Carlos Sanchez2 1Mediterranea Medica Clinic, Valencia, Spain; 2Eusebio Hernandez Gynecology and Obstetrics Teaching Hospital, Havana, Cuba Purpose: To estimate the efficacy and safety of 5 mg and 10 mg mifepristone for emergency contraception up to 144 hours after unprotected coitus. Methods: This double-blind randomized clinical trial was carried out at Eusebio Hernandez Hospital (Havana, Cuba. A total of 2,418 women who requested emergency contraception after unprotected coitus received either 5 mg or 10 mg mifepristone. The variables for assessing efficacy were the pregnancies that occurred and the fraction of pregnancies that were prevented. Other variables assessed were the side effects of mifepristone, vaginal bleeding, and changes in the date of the following menstruation. Results: There were 15/1,206 (1.2% and 9/1,212 (0.7% pregnancies in the 5 mg and 10 mg group, respectively (P=0.107. There were 88% and 93% prevented pregnancies in the 5 mg and 10 mg group, respectively. The side effect profiles were similar in both groups. Delayed menstruation ≥7 days was experienced by 4.9% and 11.0% of subjects in the 5 mg and 10 mg group, respectively (P=0.001. There was a significant high failure rate for women weighing >75 kg in the 5 mg group. Conclusion: It would be advisable to use the 10 mg dose of mifepristone for emergency contraception as there was a trend suggesting that the failure rate of the larger dose was lower. Keywords: mifepristone, emergency contraception

  9. Randomized single-blind clinical evaluation of Safoof-e-Pathar phori in urolithiasis patients

    Directory of Open Access Journals (Sweden)

    S M Arif Zaidi

    2016-01-01

    Full Text Available Objective: Safoof-e-Pathar phori (SPP, a unani polyherbomineral formulation, used for antilithiatic activity since long time. This study was aimed to evaluate the clinical efficacy of SPP in adult human patients with urolithiasis. The study was a randomized, placebo-controlled, and single-blind, clinical trial. Materials and Methods: Forty-five patients who have stone size below 15 mm in the age group of 15-55 years with diagnosis of calcium oxalate renal calculi were taken in the study. Out of which, only 30 patients fulfilled the criteria and completed the study. Twenty patients received SPP (Group I and ten patients were given placebo (Group II for 2 months. The patients were investigated for routine, hemogram, blood urea, serum creatinine, calcium, phosphorus, serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, and uric acid levels at definite time intervals. Similarly, routine and microscopic urine examination was done with radio-imaging KUB and ultrasound KUB examination, etc., which were repeated on completion of the study. Results: All patients received the same dosage of SPP or placebo for a 2-month period. On starting SPP, symptomatic relief was reported by patients. The disappearance of stones was noted in patients as confirmed by X-ray KUB and Ultrasound KUB examination. Totally, 56.67% of patients showed reduction in size of stone and 49.31% showed litho expulsive effect. Conclusion: The use of SPP in the treatment of calcium oxalate stone as noninvasive remedy for the urolithiatic patients is validated and proved. Since the dose of formulation is too high, further study on dose reduction followed by preclinical evaluation may be attempted for development of scientific data.

  10. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Dali, Christine í; Hansen, Flemming Juul; Pedersen, Søren Anker

    2002-01-01

    A randomized double-blind placebo-controlled clinical trial was carried out to determine whether a group of stable children with cerebral palsy (36 males, 21 females; mean age 10 years 11 months, range 5 to 18 years) would improve their motor skills after 12 months of threshold electrical...... stimulation (TES). Two thirds received active and one third received inactive stimulators. For the primary outcome we constructed a set of plausible motor function tests and studied the change in summary indices of the performance measurements. Tests were videotaped and assessed blindly to record qualitative...

  11. Efficacy of Zinc Sulfate in Peptic Ulcer Disease: A Randomized Double-Blind Clinical Trial Study.

    Science.gov (United States)

    Yazdanpanah, Kambiz; Parhizkar, Baran; Sheikhesmaeili, Farshad; Roshani, Mohammad; Nayebi, Morteza; Gharibi, Fardin

    2016-08-01

    Peptic ulcer is a common disease that affects millions of people worldwide. Considering its global prevalence finding new approach for treating is important. The aim of this study was to investigate the effect of zinc sulfate on gastric and duodenal ulcer treatment. This double-blind clinical trial study was done on 90 patients who were admitted to the gastrointestinal endoscopy clinic of Tohid hospital in Sanandaj, Iran. All patients were diagnosed with gastric and duodenal ulcers. They were randomly divided into two-intervention and control groups, using block randomization with block sizes of 4. Patients and researcher were unaware of the grouping. To assess the level of zinc, blood samples were taken. In case of positive Rapid Urease Test (RUT), triple therapy regimen including amoxicillin, clarithromycin and omeprazole was administered for two weeks. For intervention group in addition to "triple therapy", an oral dose of Zinc Sulfate 220mg capsules were administered daily, while the control group received placebo capsules. A total of 54.5% and 57% of the patients in the intervention and control groups had gastric ulcer respectively. The Rapid Urease Test (RUT) result of 72.7% of intervention group and 83.3% of control group was positive (p = 0.24). Serum zinc level of 20.9% of intervention group and 35.7% of control group was lower than the normal level (p = 0.13). The mean of serum zinc level of intervention group and control group were 81.9 and 78.9 mg dL respectively (p = 0.4). After intervention, peptic ulcer in 81.8% of the intervention group and 83.3% of the control groups were improved (p= 0.85). Response to treatment were higher in patients with normal zinc levels compared to patients with abnormal levels (77.5% vs. 22.5%, p=0.019). A daily dose of 220mg zinc sulfate was not significantly effective on peptic ulcer. However, patients with normal zinc levels had better ulcer treatment.

  12. Effect of Nepeta bracteata Benth. on allergic rhinitis symptoms: A randomized double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Hajiheydari

    2017-01-01

    Full Text Available Background: Allergic rhinitis (AR is one of the health problems in the world. It is necessary to develop new treatment procedure for control of this disease. The aim of this study was to assess the effect of Zofa (Nepeta bracteata Benth on AR patients. Materials and Methods: In this double-blind randomized clinical trial study, 71 patients (37 patients in treatment and 34 in placebo group participated. In treatment group, N. bracteata syrup (NBS was used for 4 weeks as three times a day. The efficacy of the drug regarding AR symptoms (rhinorrhea, sneezing, nasal obstruction, itchy nose, and ocular symptoms were evaluated through a visual analog scale (VAS by 0–10 before administration and at the end of the whole treatment period. The collected information was entered in the SPSS software (version 18 and was analyzed using the Fisher's exact test, Chi-square test, independent sample t-test, and paired sample test. Results: The improvement of AR symptoms in the group receiving NBS was significantly higher compared to control group (4.73 ± 1.84 vs. 0.38 ± 2.06; P < 0.0001. Furthermore, the mean of total VAS before and after the treatment (in case group was 7.10 ± 1.92 and 2.37 ± 1.76, respectively (P < 0.001. Conclusion: The results of this study indicate that N. bracteata has significant effects on improving the symptoms of AR. Hence, it can be a good alternative to AR symptoms relief.

  13. Gabapentin May Relieve Post-Coronary Artery Bypass Graft Pain: A Double Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    MSoltanzadeh

    2011-09-01

    Full Text Available Background: One of the most common complaints after coronary artery bypass graft (CABG is post-operative pain. Gabapentin is an anticonvulsant and antineuralgic agent. Objective: To evaluate the analgesic effect of preemptive gabapentin on post-operative pain and morphine consumption after cardiac surgery. Methods: A double-blind randomized clinical trial was conducted on 60 male candidates for CABG. The patients were divided into two groups—the gabapentin (n=30 and the control group (n=30. The test group received 800 mg gabapentin orally two hours before the surgery followed by 400 mg of the drug two hours post-extubation. The control group received placebo instead. Then severity of pain was recorded according to an 11-point visual analog pain scale. The amount of morphine consumed, its side effects and hemodynamic changes were also recorded during and at 2, 6, 12, 18 and 24 hours after extubation. Results: The mean±SD cumulative morphine consumption at the first 24 hours after extubation in gabapentin group was 0.9±1.5 mg while it was 1.5±4 mg for the control group. Therefore, gabapentin group consumed 38% less than the control group (P=0.01. The pain scores during rest and coughing at 2, 6, and 12 hours after extubation were also significantly lower in the gabapentin group compared with the control group (P=0.02. The mean±SD mechanical ventilation time was 5.4±1.7 hours for gabapentin group and 1.6±4.4 hours for the control group (P=0.035. The other variables including hemodynamic changes (HR, SBP and DBP, and incidence of nausea, vomiting and respiratory depression showed no significant difference between the studied groups within 24 hours after extubation. Conclusion: Oral pre-medication with gabapentin before CABG significantly reduces post-operative pain and morphine consumption in adult cardiac surgery.

  14. Topical symphytum herb concentrate cream against myalgia: a randomized controlled double-blind clinical study.

    Science.gov (United States)

    Kucera, Miroslav; Barna, Milos; Horàcek, Ondrej; Kàlal, Jan; Kucera, Alexander; Hladìkova, Marie

    2005-01-01

    The effectiveness and tolerability of the topical Symphytum product Traumaplant (Harras Pharma Curarina, München, Germany) (10% active ingredient of a 2.5:1 aqueous-ethanolic pressed concentrate of freshly harvested, cultivated comfrey herb [Symphytum uplandicum Nyman], corresponding to 25 g of fresh herb per 100 g of cream) in the treatment of patients with myalgia (n=104) were tested against a 1% reference product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n=111). The primary efficacy parameter in this double-blind, reference- controlled, randomized, multicenter study of 215 patients with pain in the lower and upper back was pain in motion, assessed with the aid of a visual analogue scale. Secondary efficacy parameters included pain at rest, pain on palpation, and functional impairment. With high concentrations of the treatment product, amelioration of pain on active motion (P<5 x 10 -9 ), pain at rest (P<.001), and pain on palpation (P=5 x 10 -5 ) was significantly more pronounced than that attained with the reference product and was clinically highly relevant. A number needed to treat of 3.2 was calculated from the study results. Global efficacy was significantly better (P=1 x 10 -8 ) and onset of effects was faster (P=4 x 10 -7 ) with the high-concentration product. Tolerability of the highly concentrated study product was good to excellent in all patients. Study results confirm the known anti-inflammatory and analgesic effects of topical (Symphytum cream. As a new finding, applicability in certain forms of back pain can be concluded.

  15. Impact of using a local protocol in preoperative testing: blind randomized clinical trial.

    Science.gov (United States)

    Santos, Mônica Loureiro; Iglesias, Antônio Carlos

    2017-01-01

    to evaluate the impact of the use of a local protocol of preoperative test requests in reducing the number of exams requested and in the occurrence of changes in surgical anesthetic management and perioperative complications. we conducted a randomized, blinded clinical trial at the Gaffrée and Guinle University Hospital with 405 patients candidates for elective surgery randomly divided into two groups, according to the practice of requesting preoperative exams: a group with non-selectively requested exams and a protocol group with exams requested according to the study protocol. Studied exams: complete blood count, coagulogram, glycemia, electrolytes, urea and creatinine, ECG and chest X-ray. Primary outcomes: changes in surgical anesthetic management caused by abnormal exams, reduction of the number of exams requested after the use of the protocol and perioperative complications. there was a significant difference (pprotocolo local de solicitações de exames pré-operatórios na redução do número de exames solicitados e na ocorrência de alterações na conduta anestésico-cirúrgica e de complicações perioperatórias. ensaio clínico randomizado, cego, realizado no Hospital Universitário Gaffrée e Guinle com 405 pacientes candidatos à operação eletiva divididos randomicamente em dois grupos segundo a prática de solicitação de exames pré-operatórios: grupo Rotina com exames solicitados de maneira não seletiva e grupo Protocolo com exames solicitados de acordo com o protocolo em estudo. Exames em estudo: hemograma, coagulograma, glicemia, eletrólitos, ureia e creatinina, ECG e radiografia de tórax. Desfechos primários: alterações na conduta anestésico-cirúrgica motivadas por exames anormais, redução do número de exames solicitados após o uso do protocolo e complicações perioperatórias. foi observada diferença significativa (pprotocolo proposto foi efetivo em eliminar um quantitativo significativo de exames complementares sem indica

  16. Sclerotherapy for Reticular Veins in the Lower Limbs: A Triple-Blind Randomized Clinical Trial.

    Science.gov (United States)

    Bertanha, Matheus; Jaldin, Rodrigo Gibin; Moura, Regina; Pimenta, Rafael Elias Farres; Mariúba, Jamil Victor de Oliveira; Lúcio Filho, Carlos Eduardo Pinheiro; Alcantara, Giovana Piteri; Padovani, Carlos Roberto; Yoshida, Winston Bonetti; Sobreira, Marcone Lima

    2017-12-01

    Reticular veins are subdermal veins located in the lower limbs and are mainly associated with aesthetic complaints. Although sclerotherapy is the treatment of choice for reticular veins in the lower limbs, no consensus has been reached regarding to the optimal sclerosant. To compare the efficacy and safety of 2 sclerosants used to treat reticular veins: 0.2% polidocanol diluted in 70% hypertonic glucose (HG) (group 1) vs 75% HG alone (group 2). Prospective, randomized, triple-blind, controlled, parallel-group clinical trial with patients randomly assigned in a 1:1 ratio between the 2 treatment groups from March through December 2014, with 2 months' follow-up. The study was conducted in a single academic medical center. Eligible participants were all women, aged 18 to 69 years, who had at least 1 reticular vein with a minimum length of 10 cm in 1 of their lower limbs. The patients underwent sclerotherapy in a single intervention with either 0.2% polidocanol plus 70% HG or 75% HG alone to eliminate reticular veins. The primary efficacy end point was the disappearance of the reticular veins within 60 days after treatment with sclerotherapy. The reticular veins were measured on images obtained before treatment and after treatment using ImageJ software. Safety outcomes were analyzed immediately after treatment and 7 days and 60 days after treatment and included serious adverse events (eg, deep vein thrombosis and systemic complications) and minor adverse events (eg, pigmentation, edema, telangiectatic matting, and hematomas). Ninety-three women completed the study, median (interquartile range) age 43.0 (24.0-61.0) years for group 1 and 41.0 (27.0-62.0) years for group 2. Sclerotherapy with 0.2% polidocanol plus 70% HG was significantly more effective than with 75% HG alone in eliminating reticular veins from the treated area (95.17% vs 85.40%; P vein pigmentation length for group 1 and 7.09% for group 2, with no significant difference between the groups (P = .09

  17. A multicenter, longitudinal, interventional, double blind randomized clinical trial in hematopoietic cell transplant recipients residing in remote areas: Lessons learned from the late cytomegalovirus prevention trial

    Directory of Open Access Journals (Sweden)

    Louise E. Kimball

    2016-12-01

    Conclusion: Complex randomized, double-blind, multicenter interventional trials with treatment decisions made at a central coordinating site can be conducted safely and effectively according to Good Clinical Practice (GCP guidelines over a large geographic area.

  18. The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials

    Science.gov (United States)

    Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco

    2017-12-01

    The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain

  19. The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials.

    Science.gov (United States)

    Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco

    2017-12-01

    The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain

  20. Single-blind randomized clinical trial to evaluate clinical and radiological outcomes after one year of immediate versus delayed implant placement supporting full-arch prostheses

    OpenAIRE

    Pellicer-Chover, Hilario; Peñarrocha-Oltra, David; Bagán, Leticia; Fichy-Fernandez, Antonio J.; Canullo, Luigi; Peñarrocha-Diago, Miguel

    2013-01-01

    Purpose: To evaluate and compare peri-implant health, marginal bone loss and success of immediate and delayed implant placement for rehabilitation with full-arch fixed prostheses. Material and Methods: The present study was a prospective, randomized, single-blind, clinical preliminary trial. Patients were randomized into two treatment groups. In Group A implants were placed immediately post-extraction and in Group B six months after extraction. The following control time-points were establish...

  1. E-learning as a complement to presential teaching of blindness prevention: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Rodrigo Pessoa Cavalcanti Lira

    2013-02-01

    Full Text Available OBJECTIVE: To investigate if E-learning material improves the basal student knowledge level before attending the presential class of blindness prevention (BP and if helps to fix this information one-month after the class. METHODS: Fourth-year medical students were randomly assigned to have a presential class of BP (Traditional group = TG or to have a presential class of BP plus an additional E-learning material (E-learning group = ELG. This material was e-mailed one week before the presential class. The students were submitted to a multiple-choice test (with three options each with seven questions immediately before the presential class, immediately after the class, and one-month later. The three tests had the same questions; however, the answers options were distributed in different sequences. The primary outcome was immediate pretest score. The secondary outcomes were immediate posttest score and one-month posttest score. RESULTS: Among the 120 fourth-year medical students, a random sample of 34 students was assigned to the TG and 34 students was assigned to the ELG. The two groups showed similar immediate posttest score (TG=6.8 and ELG=6.9; P<.754, but the differences at the immediate pretest score (TG=3.6 and ELG=4.7; P<.001, and at the one-month posttest score, were significant (TG=6.1 and ELG=6.8; P<.001. CONCLUSIONS: The pretest and the one-month posttest results suggested that the E-learning material acts as an effective complementary tool of the presential class of blindness prevention.

  2. Interferential and horizontal therapies in chronic low back pain: a randomized, double blind, clinical study.

    Science.gov (United States)

    Zambito, A; Bianchini, D; Gatti, D; Viapiana, O; Rossini, M; Adami, S

    2006-01-01

    Chronic Low Back Pain (CLBP) is one of the most frequent medical problems. Electrical nerve stimulation is frequently used but its efficacy remains controversial. Twenty-six men and 94 women with CLBP associated with either degenerative disk disease or previous multiple vertebral osteoporotic fractures were randomly assigned to either interferential currents (IFT), horizontal therapy (HT) or sham HT administered for 10, 40 and 40 minutes, respectively, daily for 5 days per week for two weeks together with a standard flexion-extension stretching exercise program, Blind efficacy assessment were obtained at baseline and at week 2, 6 and 14 and included a functional questionnaire (Backill), the standard visual analog scale (VAS) and the mean analgesic consumption. At week 2 a significant and similar improvement in both the VAS and Backill score was observed in all three groups. The Backill score continued to improve only in the two active groups with changes significantly greater than those observed in control patients at week 14. The pain VAS score returned to baseline values at week 6 and 14 in the control group while in the IFT and HT groups it continued to improve (p< 0.01 vs controls). The use of analgesic medications significantly improved at week 14 versus pretreatment assessment and over control patients only in the HT group. This randomized double-blind controlled study provides the first evidence that IFT and HT therapy are significantly effective in alleviating both pain and disability in patients with CLBP. The placebo effect is remarkable at the beginning of the treatment but it tends to vanish within a couple of weeks.

  3. The efficacy of chiropractic manipulation for back pain : Blinded review of relevant randomized clinical trials

    NARCIS (Netherlands)

    Assendelft, W. J J; Koes, B. W.; Van der Heijden, G. J M G; Bouter, L. M.

    1992-01-01

    Objective: To assess the efficacy of chiropractic for patients with back pain. Data Sources: Randomized clinical trials (RCTs) on spinal manipulation were identified with a Medline search (1966-1990), by citation tracking, and by manual examination of the relevant chiropractic reference systems

  4. Unreported formal assessment of unblinding occurred in 4 of 10 randomized clinical trials, unreported loss of blinding in 1 of 10 trials

    DEFF Research Database (Denmark)

    Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

    2017-01-01

    Objectives Randomized clinical trials often involve blinding as a methodological procedure to avoid bias. Unfortunately, blinding procedures may be unsuccessful, but the risk of unblinding is rarely reported in trial publications. Our primary aim was to assess the occurrence of unreported assessm...

  5. Clonidine versus tramadol for post spinal shivering during caesarean section: A randomized double blind clinical study

    Directory of Open Access Journals (Sweden)

    Velayudha S Reddy

    2011-01-01

    Full Text Available Background : Control of post spinal shivering is essential for optimal perioperative care, which can be achieved either by oral or parental medications. The present study is designed to evaluate the efficacy and safety of intravenous low-dose clonidine and tramadol in the treatment of post spinal shivering. Materials and Methods : In this prospective, a double blind, randomized study, 90 ASA grade I or II, parturients aged 18 - 35 years, undergoing caesarean section under spinal anaesthesia, who subsequently developed shivering grade 3 or 4, were randomized into two groups, to receive either clonidine or tramadol. The efficacy and response rate of the study drugs were evaluated and recorded. Side effects like, nausea, vomiting, hypotension, bradycardia, dry mouth, sedation, skin rash and headache, if present, were recorded. All data were analyzed by using the Chi square test and the Z-test. Results : There were significant differences in the response rate between the drugs (P < 0.05. Time taken from the starting of treatment to cessation of shivering was significantly less with the tramadol group (P < 0.05, however, the frequency of nausea, vomiting, sedation and headache were also significantly more in the tramadol group Conclusion : In our study we concluded that both clonidine and tramadol control shivering. However, the response rate was higher and time taken to control shivering was lesser with tramadol, but the response rate and the side effects were lesser with clonidine.

  6. Effect of a Prebiotic Formulation on Frailty Syndrome: A Randomized, Double-Blind Clinical Trial.

    Science.gov (United States)

    Buigues, Cristina; Fernández-Garrido, Julio; Pruimboom, Leo; Hoogland, Aldert J; Navarro-Martínez, Rut; Martínez-Martínez, Mary; Verdejo, Yolanda; Mascarós, Mari Carmen; Peris, Carlos; Cauli, Omar

    2016-06-14

    Aging can result in major changes in the composition and metabolic activities of bacterial populations in the gastrointestinal system and result in impaired function of the immune system. We assessed the efficacy of prebiotic Darmocare Pre(®) (Bonusan Besloten Vennootschap (BV), Numansdorp, The Netherlands) to evaluate whether the regular intake of this product can improve frailty criteria, functional status and response of the immune system in elderly people affected by the frailty syndrome. The study was a placebo-controlled, randomized, double blind design in sixty older participants aged 65 and over. The prebiotic product was composed of a mixture of inulin plus fructooligosaccharides and was compared with placebo (maltodextrin). Participants were randomized to a parallel group intervention of 13 weeks' duration with a daily intake of Darmocare Pre(®) or placebo. Either prebiotic or placebo were administered after breakfast (between 9-10 a.m.) dissolved in a glass of water carefully stirred just before drinking. The primary outcome was to study the effect on frailty syndrome. The secondary outcomes were effect on functional and cognitive behavior and sleep quality. Moreover, we evaluated whether prebiotic administration alters blood parameters (haemogram and biochemical analysis). The overall rate of frailty was not significantly modified by Darmocare Pre(®) administration. Nevertheless, prebiotic administration compared with placebo significantly improved two frailty criteria, e.g., exhaustion and handgrip strength (p sleep quality. The use of novel therapeutic approaches influencing the gut microbiota-muscle-brain axis could be considered for treatment of the frailty syndrome.

  7. Pentoxifylline as a rescue treatment for DMD: a randomized double-blind clinical trial.

    Science.gov (United States)

    Escolar, D M; Zimmerman, A; Bertorini, T; Clemens, P R; Connolly, A M; Mesa, L; Gorni, K; Kornberg, A; Kolski, H; Kuntz, N; Nevo, Y; Tesi-Rocha, C; Nagaraju, K; Rayavarapu, S; Hache, L P; Mayhew, J E; Florence, J; Hu, F; Arrieta, A; Henricson, E; Leshner, R T; Mah, J K

    2012-03-20

    To determine whether pentoxifylline (PTX) slows the decline of muscle strength and function in ambulatory boys with Duchenne muscular dystrophy (DMD). This was a multicenter, randomized, double-blinded, controlled trial comparing 12 months of daily treatment with PTX or placebo in corticosteroid-treated boys with DMD using a slow-release PTX formulation (~20 mg/kg/day). The primary outcome was the change in mean total quantitative muscle testing (QMT) score. Secondary outcomes included changes in QMT subscales, manual muscle strength, pulmonary function, and timed function tests. Outcomes were compared using Student t tests and a linear mixed-effects model. Adverse events (AEs) were compared using the Fisher exact test. A total of 64 boys with DMD with a mean age of 9.9 ± 2.9 years were randomly assigned to PTX or placebo in 11 participating Cooperative International Neuromuscular Research Group centers. There was no significant difference between PTX and the placebo group in total QMT scores (p = 0.14) or in most of the secondary outcomes after a 12-month treatment. The use of PTX was associated with mild to moderate gastrointestinal or hematologic AEs. The addition of PTX to corticosteroid-treated boys with DMD at a moderate to late ambulatory stage of disease did not improve or halt the deterioration of muscle strength and function over a 12-month study period. This study provides Class I evidence that treatment with PTX does not prevent deterioration in muscle function or strength in corticosteroid-treated boys with DMD.

  8. Effect of a Prebiotic Formulation on Frailty Syndrome: A Randomized, Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Cristina Buigues

    2016-06-01

    Full Text Available Aging can result in major changes in the composition and metabolic activities of bacterial populations in the gastrointestinal system and result in impaired function of the immune system. We assessed the efficacy of prebiotic Darmocare Pre® (Bonusan Besloten Vennootschap (BV, Numansdorp, The Netherlands to evaluate whether the regular intake of this product can improve frailty criteria, functional status and response of the immune system in elderly people affected by the frailty syndrome. The study was a placebo-controlled, randomized, double blind design in sixty older participants aged 65 and over. The prebiotic product was composed of a mixture of inulin plus fructooligosaccharides and was compared with placebo (maltodextrin. Participants were randomized to a parallel group intervention of 13 weeks’ duration with a daily intake of Darmocare Pre® or placebo. Either prebiotic or placebo were administered after breakfast (between 9–10 a.m. dissolved in a glass of water carefully stirred just before drinking. The primary outcome was to study the effect on frailty syndrome. The secondary outcomes were effect on functional and cognitive behavior and sleep quality. Moreover, we evaluated whether prebiotic administration alters blood parameters (haemogram and biochemical analysis. The overall rate of frailty was not significantly modified by Darmocare Pre® administration. Nevertheless, prebiotic administration compared with placebo significantly improved two frailty criteria, e.g., exhaustion and handgrip strength (p < 0.01 and p < 0.05, respectively. No significant effects were observed in functional and cognitive behavior or sleep quality. The use of novel therapeutic approaches influencing the gut microbiota–muscle–brain axis could be considered for treatment of the frailty syndrome.

  9. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial.

    Directory of Open Access Journals (Sweden)

    Chun-Shin Chang

    Full Text Available Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds.In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30 or vehicle (normal saline; n = 30 injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS, Visual Analogue Scale (VAS and photographic plus ultrasound measurements of scar widths.58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group.Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing.ClinicalTrials.gov NCT01429402.

  10. Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trial

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    Legemate Dink A

    2009-07-01

    Full Text Available Abstract Background Intravenous (IV fluid administration is an essential part of postoperative care. Some studies suggest that a restricted post-operative fluid regime reduces complications and postoperative hospital stay after surgery. We investigated the effects of postoperative fluid restriction in surgical patients undergoing major abdominal surgery. Methods In a blinded randomized trial, 62 patients (ASA I-III undergoing elective major abdominal surgical procedures in a university hospital were allocated either to a restricted (1.5 L/24 h or a standard postoperative IV fluid regime (2.5 L/24 h. Primary endpoint was length of postoperative hospital stay (PHS. Secondary endpoints included postoperative complications and time to restore gastric functions. Results After a 1-year inclusion period, an unplanned interim analysis was made because of many protocol violations due to patient deterioration. In the group with the restricted regime we found a significantly increased PHS (12.3 vs. 8.3 days; p = 0.049 and significantly more major complications: 12 in 30 (40% vs. 5 in 32 (16% patients (Absolute Risk Increase: 0.24 [95%CI: 0.03 to 0.46], i.e. a number needed to harm of 4 [95%CI: 2–33]. Therefore, the trial was stopped prematurely. Intention to treat analysis showed no differences in time to restore gastric functions between the groups. Conclusion Restricted postoperative IV fluid management, as performed in this trial, in patients undergoing major abdominal surgery appears harmful as it is accompanied by an increased risk of major postoperative complications and a prolonged postoperative hospital stay. Trial registration Current Controlled Trials ISRCTN16719551

  11. Intravenous lidocaine for postmastectomy pain treatment: randomized, blind, placebo controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Tania Cursino de Menezes Couceiro

    2015-06-01

    Full Text Available BACKGROUND AND OBJECTIVE: Postoperative pain treatment in mastectomy remains a major challenge despite the multimodal approach. The aim of this study was to investigate the analgesic effect of intravenous lidocaine in patients undergoing mastectomy, as well as the postoperative consumption of opioids. METHODS: After approval by the Human Research Ethics Committee of the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, a randomized, blind, controlled trial was conducted with intravenous lidocaine at a dose of 3 mg/kg infused over 1 h in 45 women undergoing mastectomy under general anesthesia. One patient from placebo group was. RESULTS: Groups were similar in age, body mass index, type of surgery, and postoperative need for opioids. Two of 22 patients in lidocaine group and three of 22 patients in placebo group requested opioid (p = 0.50. Pain on awakening was identified in 4/22 of lidocaine group and 5/22 of placebo group (p = 0.50; in the post-anesthetic recovery room in 14/22 and 12/22 (p = 0.37 of lidocaine and placebo groups, respectively. Pain evaluation 24 h after surgery showed that 2/22 and 3/22 patients (p = 0.50 of lidocaine and placebo groups, respectively, complained of pain. CONCLUSION: Intravenous lidocaine at a dose of 3 mg/kg administered over a period of an hour during mastectomy did not promote additional analgesia compared to placebo in the first 24 h, and has not decreased opioid consumption. However, a beneficial effect of intravenous lidocaine in selected and/or other therapeutic regimens patients cannot be ruled out.

  12. Transcutaneous vagus nerve stimulation for the treatment of depression: a study protocol for a double blinded randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Rong Pei-Jing

    2012-12-01

    Full Text Available Abstract Background Depressive disorders are the most common form of mental disorders in community and health care settings. Unfortunately, the treatment of Major Depressive Disorder (MDD is far from satisfactory. Vagus nerve stimulation (VNS is a relatively new and promising physical treatment for depressive disorders. One particularly appealing element of VNS is the long-term benefit in mood regulation. However, because this intervention involves surgery, perioperative risks, and potentially significant side effects, this treatment has been limited to those patients with treatment-resistant depression who have failed medication trials and exhausted established somatic treatments for major depression, due to intolerance or lack of response. This double-blinded randomized clinical trial aims to overcome these limitations by introducing a novel method of stimulating superficial branches of the vagus nerve on the ear to treat MDD. The rationale is that direct stimulation of the afferent nerve fibers on the ear area with afferent vagus nerve distribution should produce a similar effect as classic VNS in reducing depressive symptoms without the burden of surgical intervention. Design One hundred twenty cases (60 males of volunteer patients with mild and moderate depression will be randomly divided into transcutaneous vagus nerve stimulation group (tVNS and sham tVNS group. The treatment period lasts 4 months and all clinical and physiological measurements are acquired at the beginning and the end of the treatment period. Discussion This study has the potential to significantly extend the application of VNS treatment for MDD and other disorders (including epilepsy, bipolar disorder, and morbid obesity, resulting in direct benefit to the patients suffering from these highly prevalent disorders. In addition, the results of this double-blinded clinical trial will shed new light on our understanding of acupuncture point specificity, and development of

  13. Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial

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    Franciane Schneider

    2015-04-01

    Full Text Available OBJECTIVE To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. METHOD This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27 and experimental (24. RESULTS There is statistically significant evidence (p-value = 0.0120 that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402. CONCLUSION Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

  14. [Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial].

    Science.gov (United States)

    Schneider, Franciane; Danski, Mitzy Tannia Reichembach; Vayego, Stela Adami

    2015-04-01

    To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27) and experimental (24). There is statistically significant evidence (p-value = 0.0120) that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402). Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

  15. Randomized, Double-Blind, and Placebo-Controlled Clinic Report of Intranasal Low-Intensity Laser Therapy on Vascular Diseases

    Directory of Open Access Journals (Sweden)

    Timon Cheng-Yi Liu

    2012-01-01

    Full Text Available The intranasal low intensity GaInP/AlGaInP diode 650 nm laser therapy (ILGLT might improve blood lipid and hemorheologic behavior of patients in view of its previous research, but it should be further supported by a randomized, double-blind, and placebo-controlled clinical study. In this paper, 90 patients with coronary heart disease or cerebral infarction were randomly divided into two groups, 60 in the treatment group and 30 in the control group, and were blindly treated with ILGLT at 8.38 and 0 mW/cm2 for 30 min each time once a day ten days each session for two sessions between which there were three days for rest, respectively. Fasting blood lipid such as total cholesterol and low/high-density lipoprotein cholesterol and hemorheologic behavior such as blood viscosity, plasma viscosity, redox viscosity and red blood cell aggregation were assessed before the first treatment and after the two sessions and were found to be significantly improved by ILGLT. It was concluded that ILGLT may improve blood lipid and hemorheologic behavior of patients with coronary heart disease or cerebral infarction.

  16. The effect of thyme honey nasal spray on chronic rhinosinusitis: a double-blind randomized controlled clinical trial.

    Science.gov (United States)

    Hashemian, Farnaz; Baghbanian, Neda; Majd, Zahra; Rouini, Mohammad-Reza; Jahanshahi, Javaneh; Hashemian, Farshad

    2015-06-01

    Chronic rhinosinusitis is a common disease which causes persisting inflammatory conditions of one or more sinuses. This study was designed to evaluate the effect of thyme honey nasal spray as an adjunctive medication on chronic rhinosinusitis after functional endoscopic sinus surgery. This was a randomized, placebo controlled, double-blind clinical study. 64 patients with chronic rhinosinusitis undergoing functional endoscopic sinus surgery were enrolled in this study. Patients were randomized and blinded to receive either placebo or thyme honey nasal spray in addition to the standard regimen postoperatively. Patients were visited on postoperative days 7, 30 and 60. The sino-nasal outcome test, endoscopic grading system and sinus CT-scan were scored before operation and on the day 60 after surgery. 54 patients completed the study. Significant improvement was observed in both treatment groups. There were no significant changes in SNOT-22, endoscopy and CT-scan scores between the two study groups. However, a greater reduction in endoscopic scores was shown in thyme honey group. The incidence of adverse effects was not significantly different between the groups, but synechiae formation and epistaxis were lower in treatment group. Thyme honey nasal spray seems to be a low-priced potential adjuvant remedy with excellent safety profile, to reduce inflammation and polyp formation and also fostering mucosal healing for patients suffering from chronic rhinosinusitis. However, further studies are recommended.

  17. Metoclopramide improves the quality of tramadol PCA indistinguishable to morphine PCA: a prospective, randomized, double blind clinical comparison.

    Science.gov (United States)

    Pang, Weiwu; Liu, Yu-Cheng; Maboudou, Edgard; Chen, Tom Xianxiu; Chois, John M; Liao, Cheng-Chun; Wu, Rick Sai-Chuen

    2013-09-01

    Multimodal analgesia has been effectively used in postoperative pain control. Tramadol can be considered "multimodal" because it has two main mechanisms of action, an opioid agonist and a reuptake inhibitor of norepinephrine and serotonin. Tramadol is not as commonly used as morphine due to the increased incidence of postoperative nausea and vomiting (PONV). As metoclopramide is an antiemetic and an analgesic, it was hypothesized that when added to reduce PONV, metoclopromide may enhance the multimodal feature of tramadol by the analgesic property of metoclopramide. Therefore, the effectiveness of postoperative patient-controlled analgesia (PCA) with morphine was compared against PCA with combination of tramadol and metoclopramide. A prospective, randomized, double blind clinical trial. Academic pain service of a university hospital. Sixty patients undergoing elective total knee arthroplasty with general anesthesia. Sixty patients were randomly divided into Group M and Group T. In a double-blinded fashion, Group M received intraoperative 0.2 mg/kg morphine and postoperative PCA with 1 mg morphine per bolus, whereas Group T received intraoperative tramadol 2.5 mg/kg and postoperative PCA with 20 mg tramadol plus 1 mg metoclopramide per bolus. Lockout interval was 5 minutes in both groups. Pain scale, satisfaction rate, analgesic consumption, PCA demand, and side effects were recorded by a blind investigator. These two groups displayed no statistically significant difference between the items and variables evaluated. This combination provides analgesia equivalent to that of morphine and can be used as an alternative to morphine PCA. Wiley Periodicals, Inc.

  18. Double-Blind Randomized Clinical Trial: Gluten versus Placebo Rechallenge in Patients with Lymphocytic Enteritis and Suspected Celiac Disease.

    Directory of Open Access Journals (Sweden)

    Mercè Rosinach

    Full Text Available The role of gluten as a trigger of symptoms in non-coeliac gluten sensitivity has been questioned.To demonstrate that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for non-coeliac gluten sensitivity (NCGS, which presented with lymphocytic enteritis, positive celiac genetics and negative celiac serology.Double-blind randomized clinical trial of gluten vs placebo rechallenge.>18 years of age, HLA-DQ2/8+, negative coeliac serology and gluten-dependent lymphocytic enteritis, and GI symptoms, with clinical and histological remission at inclusion. Eighteen patients were randomised: 11 gluten (20 g/day and 7 placebo. Clinical symptoms, quality of life (GIQLI, and presence of gamma/delta+ cells and transglutaminase deposits were evaluated.91% of patients had clinical relapse during gluten challenge versus 28.5% after placebo (p = 0.01. Clinical scores and GIQLI worsened after gluten but not after placebo (p<0.01. The presence of coeliac tissue markers at baseline biopsy on a gluten-free diet allowed classifying 9 out of the 18 (50% patients as having probable 'coeliac lite' disease.This proof-of-concept study indicates that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for NCGS. They were characterized by positive celiac genetics, lymphocytic enteritis, and clinical and histological remission after a gluten-free diet.ClinicalTrials.gov NCT02472704.

  19. Double-Blind Randomized Clinical Trial: Gluten versus Placebo Rechallenge in Patients with Lymphocytic Enteritis and Suspected Celiac Disease.

    Science.gov (United States)

    Rosinach, Mercè; Fernández-Bañares, Fernando; Carrasco, Anna; Ibarra, Montserrat; Temiño, Rocío; Salas, Antonio; Esteve, Maria

    2016-01-01

    The role of gluten as a trigger of symptoms in non-coeliac gluten sensitivity has been questioned. To demonstrate that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for non-coeliac gluten sensitivity (NCGS), which presented with lymphocytic enteritis, positive celiac genetics and negative celiac serology. Double-blind randomized clinical trial of gluten vs placebo rechallenge. >18 years of age, HLA-DQ2/8+, negative coeliac serology and gluten-dependent lymphocytic enteritis, and GI symptoms, with clinical and histological remission at inclusion. Eighteen patients were randomised: 11 gluten (20 g/day) and 7 placebo. Clinical symptoms, quality of life (GIQLI), and presence of gamma/delta+ cells and transglutaminase deposits were evaluated. 91% of patients had clinical relapse during gluten challenge versus 28.5% after placebo (p = 0.01). Clinical scores and GIQLI worsened after gluten but not after placebo (pgluten-free diet allowed classifying 9 out of the 18 (50%) patients as having probable 'coeliac lite' disease. This proof-of-concept study indicates that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for NCGS. They were characterized by positive celiac genetics, lymphocytic enteritis, and clinical and histological remission after a gluten-free diet. ClinicalTrials.gov NCT02472704.

  20. CHLOROQUINE VS STEROID INJECTION IN MANAGEMENT OF PRIMARY KNEE OSTEOARTHRITIS: A DOUBLE BLINDED RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    H KARIMZADEH

    2002-03-01

    Full Text Available Introduction. Osteoarthritis (OA is one of the most common forms of articular disease and one of the major causes of pain and disability especially in old age. The purpose of this study is to assay therapeutic effect of oral chloroquine in comparison with intraarticular injection of corticosteroid in management of osteoarthritis. Methods. A controlled randomized clinical trial study was done in Isfahan Alzahra hospital from October 2000 to September 2001 (11 months. The eligible patients were randomized in one of the therapeutic modalities (oral chloroquine: 15 patients; Intraarticular steroid injection: 15 patient. The patient initially were classified as their intensity of jont pain on the base of (visual analog scale 0-100, their (global status 0-100 and Lequesne"s functional index (0 - 25. Data was obtioned in 4th, 8th, 12th weeks follow up. Results. In the first group the intensity of pain in 4th, 8th, 12th weeks became significantly attenutated in Comparison to initiation of study (P < 0.05. In contrast second group the intensity of pain in 4th week became attenuated in comparison to the bigining of the study but this effect was not significant in 8th and 12th weeks (P > 0.05. Discussion. The most clinical responsiveness including attenuation of pain improvment of global status and lequesne"s functional index in first group was observed in 12th week but this responsiveness in second group (corticosteroid decreased significantly after 4th week. Oral chloroquine in comparison with intra articular corticosteroid injection in patients with knee OA cause therapeutic benefit effect for longer time. It can be as a useful, treatment method without a serious side effects on these patients.

  1. Steroid/Antiviral for the treatment of Bell's palsy: Double blind randomized clinical trial.

    Science.gov (United States)

    Khedr, Eman Mohamed; Badry, Reda; Ali, Anwer Mohamed; Abo El-Fetoh, Noha; El-Hammady, Dina Hatem; Ghandour, Abeer Mohamed; Abdel-Haleem, Ahmed

    2016-11-22

    A large number of patients with Bell's palsy fail to recover facial function completely after steroid therapy. Only a few small trials have been conducted to test whether outcomes can be improved by the addition of antiviral therapy. To evaluate the efficacy of treatment with steroid alone versus steroid + antiviral in a group of patients with moderately severe to severe acute Bell's palsy. Fifty eligible patients out of a total of 65 with acute onset Bell's palsy were randomized to receive the two treatments. Evaluation was performed before starting treatment, after 2 weeks of treatment and 3 months after onset, using the House and Brackmann facial nerve grading system (HB) and the Sunnybrook grading system.This study was registered with ClinicalTrials.gov, number NCT02328079. Both treatments had comparable demographics and clinical scores at baseline. There was greater improvement in the mean HB and Sunnybrook scores of the steroid + antiviral group in comparison to steroid group at 3 months. At the end of the 3rd month, 17 patients (68%) had good recovery and 8 patients (32%) had poor recovery in the steroid group compared with 23 patients (92%) and 2 (8%) respectively in the steroid and antiviral group (p = 0.034). The combination of steroid and antiviral treatment increases the possibility of recovery in moderately severe to complete acute Bell's palsy.

  2. Efficacy of L-arginine for preventing preeclampsia in high-risk pregnancies: A double-blind, randomized, clinical trial.

    Science.gov (United States)

    Camarena Pulido, E E; García Benavides, L; Panduro Barón, J G; Pascoe Gonzalez, S; Madrigal Saray, A J; García Padilla, F E; Totsuka Sutto, S E

    2016-05-01

    This study aimed to estimate the effectiveness of L-arginine for preventing preeclampsia in high-risk pregnancy. We performed a randomized, double-blind, placebo-controlled, clinical trial in patients with high-risk factors for preeclampsia. Fifty subjects received L-arginine, beginning from the 20th week of gestation. An additional 50 patients received homologated placebo. The placebo group had a higher number of cases of preeclampsia (11/47) compared with the L-arginine group (3/49, P = 0.01). Birth weight was higher in the L-arginine group and there was a smaller number of preterm births (P = 0.03). L-arginine is effective for preventing preeclampsia.

  3. The deception and fallacies of sponsored randomized prospective double-blinded clinical trials: the bisphosphonate research example.

    Science.gov (United States)

    Marx, Robert E

    2014-01-01

    The randomized prospective double-blinded clinical trial (RCT) is accepted as Level I evidence and is highly regarded. However, RCTs that gained FDA approval of drugs such as Vioxx, Fen-Phen, and oral and intravenous bisphosphonates have proven to generate misleading results and have not adequately identified serious adverse reactions. The development, research, and clinical marketing of the oral and intravenous bisphosphonates can serve as a representative example for the deteriorated value of many of today's RCTs. The expected high value of RCTs is jeopardized by: (1) sponsorship that incorporates bias; (2) randomization that can select out an expected improved result or eliminate higher-risk individuals; (3) experimental design that can avoid recognition of serious adverse reactions; (4) blinding that can easily become unblinded by the color, shape, odor, or administration requirements of a drug; (5) definitions that can define an observation as something other than what it actually represents, or fail to define it as an adverse reaction; (6) labeling of retrospective data as a prospective trial by using adjudicators prospectively to look at retrospective data; (7) change of the length of study to avoid the longer-term adverse reaction from accumulation of drug or treatment effects; (8) ghost writing, as when drug company physicians or a hired corporation either edit or write the entire protocol and/or manuscript for publication. Such corruption of the well-intended properly conducted RCT should be viewed with a sense of outrage by practitioners and requires a restructuring of the levels of evidence accepted today.

  4. The Effect of Peers Support on Postpartum Depression: A Single-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mahin Kamalifard

    2013-08-01

    Full Text Available Introduction: Postpartum depression and its consequences not only involve mothers and their children but it will also affect their families. Therefore, this study aimed to investigate the effect of mothers receiving peer support on postpartum depression. Methods: 100 eligible primiparous women participated in a randomized clinical trial. The intervention group received phone calls by their peers from the last three months of pregnancy until two months after delivery. The control group only had access to routine care. Both groups in the second month after delivery were checked regarding depression using Edinburgh Postnatal Depression Scale. Data analysis was performed using independent t-test, chi-square test and covariance analysis. Results: Mean depression score before intervention was 13.92 (3.23 in the control group and 14.06 (3.12 in the intervention group. In week 8 after delivery, mean score of depression in control group was 13.29 (4.08 but in the intervention group it was reduced to 10.25 (4.18. Difference in the reduction of mean postpartum depression score between the two groups showed statistically significant difference (p < 0.001. Conclusion: This study showed that peer support was effective in the prevention of postpartum depression, therefore, it is recommended to be used in the reduction of postpartum depression.

  5. Hydrogen peroxide release kinetics into saliva from different whitening products: a double-blind, randomized clinical trial.

    Science.gov (United States)

    Marques, Duarte Nuno da Silva; da Mata, António Duarte Sola Pereira; Silveira, João Miguel Lourenço; Marques, Joana Rita Oliveira Faria; Amaral, João Pedro de Almeida Rato; Guilherme, Nuno Filipe Rito Parada Marques

    2012-02-01

    The objective of this study is to compare salivary hydrogen peroxide (HP) release kinetics and potential toxicity of systemic exposure of four different whitening products. A double-blind, randomized controlled trial was conducted in a Portuguese dental faculty clinic. Two hundred forty volunteers were randomized to eight intervention groups. Participants were randomly assigned to receive active or placebo applications of one of four different products: Opalescence 10% PF™ (OPL), Vivastyle® 10%™ (VS10%), Vivadent Paint On Plus™ (PO+), and Trés White Supreme™ (TWS). Saliva collection was obtained by established methods at different times. The HP salivary content was determined by a photometric method. Salivary HP variations, total amount of salivary HP, and counts of subjects above the safe daily HP dose were the main outcome measures. All whitening systems significantly released HP to the saliva when compared to placebo, and all showed different release kinetics. The adaptable tray system (TWS) presented a risk increase of 37% [20-54%, 95% confidence interval] when compared to the other systems. The use of an adaptable tray whitening system with higher concentration of HP increases the toxicity potential.

  6. Interferential and horizontal therapies in chronic low back pain due to multiple vertebral fractures: a randomized, double blind, clinical study.

    Science.gov (United States)

    Zambito, A; Bianchini, D; Gatti, D; Rossini, M; Adami, S; Viapiana, O

    2007-11-01

    Chronic low back pain due to multiple vertebral fractures is of difficult management. Electrical nerve stimulation is frequently used, but its efficacy has never been properly evaluated. In a randomized placebo-controlled clinical trial, we have shown that both interferential currents and horizontal therapy are more effective than placebo for functional. Multiple vertebral fractures almost invariably ensue in chronic low back pain that remains of difficult management. Electrical nerve stimulation is frequently used but its efficacy has never been properly evaluated. One hundred and fifteen women with chronic back pain due to previous multiple vertebral osteoporotic fractures (CBPMF) were randomly assigned to either interferential currents (IFT), horizontal therapy (HT) or sham HT administered for 30 minutes daily for 5 days per week for two weeks together with a standard exercise program. Efficacy assessment was obtained at baseline and at week 2, 6 and 14 and included a functional questionnaire (Backill), the standard visual analog scale (VAS) and the mean analgesic consumption. At week 2 a significant and similar improvement in both the VAS and Backill score was observed in the three groups. The two scores continued to improve in the two active groups with changes significantly (p < 0.001) greater than those observed in control patients at week 6 and 14. The use of analgesic medications improved only in the HT group. This randomized double-blind controlled study provides the first evidence that IFT and HT therapy are significantly effective in alleviating both pain and disability in patients with CBPMF.

  7. Randomized, Double-Blind Clinical Trial to Assess the Acute Diuretic Effect of Equisetum arvense (Field Horsetail in Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    Danilo Maciel Carneiro

    2014-01-01

    Full Text Available In this double-blind, randomized clinical trial, 36 healthy male volunteers were randomly distributed into three groups (n=12 that underwent a three-step treatment. For four consecutive days, we alternately administered a standardized dried extract of Equisetum arvense (EADE, 900 mg/day, placebo (corn starch, 900 mg/day, or hydrochlorothiazide (25 mg/day, separated by a 10-day washout period. Each volunteer served as his own control, and the groups’ results were compared. We repeated the same evaluation after each stage of treatment to evaluate the safety of the drug. The diuretic effect of EADE was assessed by monitoring the volunteers’ water balance over a 24 h period. The E. arvense extract produced a diuretic effect that was stronger than that of the negative control and was equivalent to that of hydrochlorothiazide without causing significant changes in the elimination of electrolytes. There was no significant increase in the urinary elimination of catabolites. Rare minor adverse events were reported. The clinical examinations and laboratory tests showed no changes before or after the experiment, suggesting that the drug is safe for acute use. Further research is needed to better clarify the mechanism of diuretic action and the other possible pharmacological actions of this phytomedicine.

  8. Effect of Methylphenidate and Folic Acid on ADHD Symptoms and Quality of Life and Aggression: A Randomized Double Blind Placebo Controlled Clinical Trial

    OpenAIRE

    Ghanizadeh, Ahmad; Sayyari, Zohreh; Mohammadi, Mohammad Reza

    2013-01-01

    Objective This clinical trial examines the effect of augmentation of methylphenidate (MPH) with folic acid to improve quality of life, and to treat aggression and ADHD symptoms. Method Participants of this eight week randomized double blind placebo controlled clinical trial were 49 children with ADHD. They were randomly assigned into one of the two groups: the first group receiving methylphenidate (10 to 20mg/day) plus folic (5mg/day), and the second group receiving methylphenidate plus place...

  9. Efficacy of sodium butyrate adjunct therapy in shigellosis: a randomized, double-blind, placebo-controlled clinical trial

    Science.gov (United States)

    2012-01-01

    Background Treatment of shigellosis in rabbits with butyrate reduces clinical severity and counteracts the downregulation of cathelicidin (CAP-18) in the large intestinal epithelia. Here, we aimed to evaluate whether butyrate can be used as an adjunct to antibiotics in the treatment of shigellosis in patients. Methods A randomized, double-blind, placebo-controlled, parallel-group designed clinical trial was conducted. Eighty adult patients with shigellosis were randomized to either the Intervention group (butyrate, n = 40) or the Placebo group (normal saline, n = 40). The Intervention group was given an enema containing sodium butyrate (80 mM), twice daily for 3 days, while the Placebo group received the same dose of normal saline. The primary endpoint of the trial was to assess the efficacy of butyrate in improving clinical, endoscopic and histological features of shigellosis. The secondary endpoint was to study the effect of butyrate on the induction of antimicrobial peptides in the rectum. Clinical outcomes were assessed and concentrations of antimicrobial peptides (LL-37, human beta defensin1 [HBD-1] and human beta defensin 3 [HBD-3]) and pro-inflammatory cytokines (interleukin-1β [IL-1β] and interleukin-8 [IL-8]) were measured in the stool. Sigmoidoscopic and histopathological analyses, and immunostaining of LL-37 in the rectal mucosa were performed in a subgroup of patients. Results Compared with placebo, butyrate therapy led to the early reduction of macrophages, pus cells, IL-8 and IL-1β in the stool and improvement in rectal histopathology. Butyrate treatment induced LL-37 expression in the rectal epithelia. Stool concentration of LL-37 remained significantly higher in the Intervention group on days 4 and 7. Conclusion Adjunct therapy with butyrate during shigellosis led to early reduction of inflammation and enhanced LL-37 expression in the rectal epithelia with prolonged release of LL-37 in the stool. Trial Registration Clinical

  10. The Effect of Melatonin on Pediatric Drug-Resistant Epilepsy; a Randomized Double Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Javad Akhondian

    2016-11-01

    Full Text Available BackgroundAbout 15 to 40% of children with seizures are refractory to standard anti-epileptic drugs and for such patients, other treatments such as surgery and the ketogenic diet can reduce seizure frequency. Melatonin is a natural pineal gland hormone. The use of melatonin for controlling pediatric seizures is still controversial. This study aimed to evaluate the effect of melatonin on seizures, parent's satisfaction, sleep, and behavior in children with drug-resistant epilepsy.Materials and Methods: In a pilot crossover study, children with drug-resistant epilepsy, who referred to the epileptic clinic of Ghaem Hospital, were randomly assigned to receive treatment with melatonin or a placebo for 4 weeks followed by a one-day washout period. Then patients who started with melatonin were switched to the placebo. Melatonin was administered 30 minutes before bedtime at a dose of 10 mg /m2 in 3mg tablets.ResultsTwenty patients, of which 11 (55% were male, were enrolled into the study. The range and mean age of patients were 2 to 13 years and 7.28 ± 3.46 years, respectively. The mean number of diurnal seizures in the study group during placebo treatment was 11.05 and during melatonin treatment was 6.25, which was statistically significant (P=0.021. However, the reduction of the mean duration of diurnal seizures in the study groups was not statistically significant (P=0.386. There was no correlation between decreasing in number or duration of seizures with melatonin plasma levels. Drowsiness was the only side effect of melatonin, which occurred in three patients. ConclusionMelatonin has probable beneficial effects on some epileptic patients with unclear mechanisms. Physicians can use it in selected epileptic children to improve seizures.

  11. Topical terbinafine in the treatment of cutaneous leishmaniasis: triple blind randomized clinical trial.

    Science.gov (United States)

    Farajzadeh, Saeedeh; Heshmatkhah, Amireh; Vares, Behrooz; Mohebbi, Elham; Mohebbi, Azadeh; Aflatoonian, Mahin; Eybpoosh, Sana; Sharifi, Iraj; Aflatoonian, Mohammad Reza; Shamsi Meymandi, Simin; Fekri, Ali Reza; Mostafavi, Mahshid

    2016-12-01

    Leishmaniasis is a spectrum of disease condition with considerable health impacts, caused by different species of Leishmania . This disease is currently endemic in 98 countries and territories in the world. There are many treatment modalities for cutaneous leishmaniasis. The use of topical terbinafine in the treatment of cutaneous leishmaniasis has recently been considered. Eighty-eight participants more than two years old with proven acute CL by a positive direct smear were randomly allocated to one of the two study arms: first group received meglumine antimoniate (Glucantime) 20 mg/kg/day intramuscular injection (IM) plus a placebo ointment (Mahan Vaseline) for 20 days. The second group received meglumine antimoniate (Glucantime) 20 mg/kg/day IM plus topical terbinafine, for 20 days and were monitored closely by dermatologist during the course of the study. Crude regression analysis showed that there was no significant difference between placebo and intervention group regarding partial or complete treatment (partial treatment: HR crude  = 1.1, CI 95 % = 0.7-1.7; complete treatment: HR crude  = 1.1, CI 95 % = 0.8-1.7). Although, there was no statistically significant different between the two treatment groups, but clinically it seems that the treatment rate in those who receive glucantime plus terbinafine was more effective than the other group. However this rate depended on the type of lesions. As data indicated ulcerated nodules, papules and plaque in experimental group have been completely improved two times faster than placebo group. Ulcerated nodules, nodules and plaque were partially improved faster in those used tebinafine than placebo ointment.

  12. [Effects of a neuropsychology program based on mindfulness on Alzheimer's disease: randomized double-blind clinical study].

    Science.gov (United States)

    Quintana Hernández, Domingo Jesús; Miró Barrachina, María Teresa; Ibáñez Fernández, Ignacio; del Pino, Angelo Santana; García Rodríguez, Javie r; Hernández, Jaime Rojas

    2014-01-01

    The purpose of this research was to assess effects of a mindfulness based neuropsychological intervention on the clinical course of Alzheimer's disease. A two year randomized and double blind clinical trial was conducted on 127 probable Alzheimer's disease patients, according to NINCDS-ADRDA scale. Patients were grouped into three experimental groups (cognitive stimulation, progressive muscular relaxation, and mindfulness) plus a control group. All participants were receiving donepezil. Cognitive skills were assessed with CAMCOG and MMSE, functional area with RDRS-2, and NPI was used for psychopathology screening. Three treatment sessions per week were carried out for two years, and follow up measurements were taken every six months. The global cognitive function, functionality and behavioral disorders measurements indicated that patients from the experimental group based on mindfulness were stable during the two years, while patients from the control group, as well as the other experimental groups, showed a mild but significant worsening of their mental capacities. The mindfulness based neuropsychological program showed better cognitive and functional stability, as well as significant improvement in the psychopathological condition of mild to moderate Alzheimer' patients. These results support the idea that a mindfulness based intervention can produce a clinically relevant improvement in the treatment of dementia. More research is needed to confirm these data. Copyright © 2013 SEGG. Published by Elsevier Espana. All rights reserved.

  13. Triage by cervical length sonographic measurements for targeted therapy in threatened preterm labor: A double blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Homeira Vafaei

    2017-11-01

    Full Text Available Background: Preterm labor and birth are associated with several neonatal complications including respiratory distress syndrome and intraventricular hemorrhage. Differentiating true and false labor pain is a dilemma to obstetricians. Objective: To elucidate the role of cervical length measurement in prediction of birth in pregnant women with threatened preterm labor. Materials and Methods: In this double blind randomized clinical trial, 120 women with gestational age <34 wk who presented painful uterine contractions randomly assigned to undergo measurement of cervical length. Patients were registered in the hospital and a unit number was given. Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator. All participants were managed accordingly (n=65 or to receive tocolysis as planned (n=55. Tocolysis was prescribed when cervical length was <15 mm while those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of the presentation was the primary outcome. Results: This RCT showed in case group, 78.9% of patient with cervical length <15 mm were delivered within 7 days and only 21.1% of them maintained their pregnancy. Of those with cervical length ≥15 mm, only 15.2% were delivered within the study period and the rest (84.8% maintained their pregnancy (p<0.001. Conclusion: “Our results indicate that in women who presented preterm labor symptoms, cervical length measurement will result in decreased unnecessary tocolytic treatment. Women with cervical length ≥15mm should not receive tocolysis, however, withholding corticosteroid therapy in these patients needs further evidence.

  14. Aripiprazole versus risperidone for treating children and adolescents with tic disorder: a randomized double blind clinical trial.

    Science.gov (United States)

    Ghanizadeh, Ahmad; Haghighi, Alireza

    2014-10-01

    There are some uncontrolled studies about the efficacy and safety of both aripiprazole and risperidone for treating tic disorder. Moreover, the efficacy of these medications has never been compared. This is the first double blind randomized clinical trial comparing the safety and efficacy of aripiprazole and risperidone for treating patients with tic disorder. Sixty children and adolescents with tic disorder were randomly allocated into one of the two groups to receive either aripiprazole or risperidone for 2 months. The primary outcome measure was the score of Yale Global Tic Severity Scale. In addition, health related quality of life and adverse events were assessed. Both aripiprazole and risperidone decreased the Yale Global Tic Severity Scale score during this trial. Moreover, both medications increased the health related quality of life score. Both aripiprazole and risperidone were tolerated well. Aripiprazole [3.22 (1.9) mg/day] decreased tic score as much as risperidone [0.6 (0.2) mg/day]. Their adverse effects and their effects on health related quality of life were comparable. However, risperidone increased the patients' social functioning more than aripiprazole in short term.

  15. Efficacy of 1.23% APF gel applications on incipient carious lesions: a double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Maria Laura Menezes Bonow

    2013-06-01

    Full Text Available The aim of this double-blind randomized clinical trial was to evaluate the efficacy of 1.23% APF gel application on the arrest of active incipient carious lesions in children. Sixty 7- to 12-year-old children, with active incipient lesions were included in the study. Children were divided randomly into 2 groups: 1.23% APF gel and placebo gel applications. Each group received 8 weekly applications of treatment. The lesions were re-evaluated at the 4th and 8th appointments. Poisson regression analysis was used to estimate relative risks of the presence of active white spot lesions. Groups showed similar results (PR = 1.67; CI 95% 0.69–3.98. The persistence of at least 1 active lesion was associated with a higher number of lesions in the baseline (PR = 2.67; CI 95% 1.19–6.03, but not with sugar intake (PR = 1.06; CI 95% 0.56–2.86 and previous exposure to fluoride dentifrice (PR = 1.26; CI 95% 0.49–2.29. The trial demonstrates the equivalence of the treatments. The use of the APF gel showed no additional benefits in this sample of children exposed to fluoridated water and dentifrice. The professional dental plaque removal in both groups may also account for the resulting equivalence of the treatments.

  16. Modafinil improves real driving performance in patients with hypersomnia: a randomized double-blind placebo-controlled crossover clinical trial.

    Science.gov (United States)

    Philip, Pierre; Chaufton, Cyril; Taillard, Jacques; Capelli, Aurore; Coste, Olivier; Léger, Damien; Moore, Nicholas; Sagaspe, Patricia

    2014-03-01

    Patients with excessive daytime sleepiness (EDS) are at high risk for driving accidents, and physicians are concerned by the effect of alerting drugs on driving skills of sleepy patients. No study has up to now investigated the effect of modafinil (a reference drug to treat EDS in patients with hypersomnia) on on-road driving performance of patients suffering from central hypersomnia. The objective is to evaluate in patients with central hypersomnia the effect of a wake-promoting drug on real driving performance and to assess the relationship between objective sleepiness and driving performance. Randomized, crossover, double-blind placebo-controlled trial conducted among 13 patients with narcolepsy and 14 patients with idiopathic hypersomnia. Patients were randomly assigned to receive modafinil (400 mg) or placebo for 5 days prior to the driving test. Each condition was separated by at least 3 weeks of washout. Mean number of Inappropriate Line Crossings, Standard Deviation of Lateral Position of the vehicle and mean sleep latency in the Maintenance of Wakefulness Test were assessed. Modafinil reduced the mean number of Inappropriate Line Crossings and Standard Deviation of Lateral Position of the vehicle compared to placebo (F(1,25) = 4.88, P Modafinil improves driving performance in patients with narcolepsy and idiopathic hypersomnia. The Maintenance of Wakefulness Test is a suitable clinical tool to assess fitness to drive in this population.

  17. Kinesio taping effect on quadriceps strength and lower limb function of healthy individuals: A blinded, controlled, randomized, clinical trial.

    Science.gov (United States)

    Fernandes de Jesus, Julio; de Almeida Novello, Aline; Bezerra Nakaoka, Gustavo; Curcio Dos Reis, Amir; Fukuda, Thiago Yukio; Fernandes Bryk, Flavio

    2016-03-01

    To analyze kinesio taping (KT) effect on quadriceps strength and lower limb function over a 7-day period. Blind randomized clinical trial. Hospital's Physical Therapy Department. Sixty healthy individuals (30 men and 30 women) were randomly distributed into three groups: Control--without KT application; Placebo--placebo KT application and Experimental--A KT application designed to stimulate quadriceps femoris activity. The quadriceps strength was measured using a manual dynamometer whereas lower limb function was assessed using the Single Hop Test for Distance. Evaluations occurred at five time-points: baseline; immediately, 3 and 5 days after KT application; and 72 h post KT withdrawal. There was no significant interaction between time-points and groups for muscle strength: dominant (P = 0.13) and non-dominant (P = 0.41) and lower limb function: dominant (P = 0.09) and non-dominant (P = 0.53); but lower limb function within-group comparisons showed improvements in all groups at the evolution of all time-points analyzed for both limbs (P = 0.001). This is possibly due to a learning effect as the participants became more familiar with executing the assessment tests. KT did not improve quadriceps strength and lower limb function of healthy individuals and its application with these objectives should be reconsidered. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. Immediate pain relief effect of low level laser therapy for sports injuries: Randomized, double-blind placebo clinical trial.

    Science.gov (United States)

    Takenori, A; Ikuhiro, M; Shogo, U; Hiroe, K; Junji, S; Yasutaka, T; Hiroya, K; Miki, N

    2016-12-01

    To determine the immediate pain relief effect of low-level laser therapy on sports injuries in athletes and degree of pain relief by the therapy. Double-blind, randomized, comparative clinical study. Participants were 32 college athletes with motion pain at a defined site. Participants were randomized into two groups in which the tested or placebo laser therapy was administered to determine pain intensity from painful action before and after laser irradiation, using the Modified Numerical Rating Scale. The post-therapeutic Modified Numerical Rating Scale score was subtracted from the pre-therapeutic Modified Numerical Rating Scale score to determine pain intensity difference, and the rate of pain intensity difference to pre-therapeutic Modified Numerical Rating Scale was calculated as pain relief rate. Low-level laser therapy was effective in 75% of the laser group, whereas it was not effective in the placebo group, indicating a significant difference in favor of the laser group (pPain relief rate was significantly higher in the laser group than in the placebo group (36.94% vs. 8.20%, respectively, ppain relief rate being 28.74%. Low-level laser therapy provided an immediate pain relief effect, reducing pain by 28.74%. It was effective for pain relief in 75% of participants. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  19. Efficacy and complications associated with a modified inferior alveolar nerve block technique. A randomized, triple-blind clinical trial

    Science.gov (United States)

    Montserrat-Bosch, Marta; Nogueira-Magalhães, Pedro; Arnabat-Dominguez, Josep; Valmaseda-Castellón, Eduard; Gay-Escoda, Cosme

    2014-01-01

    Objectives: To compare the efficacy and complication rates of two different techniques for inferior alveolar nerve blocks (IANB). Study Design: A randomized, triple-blind clinical trial comprising 109 patients who required lower third molar removal was performed. In the control group, all patients received an IANB using the conventional Halsted technique, whereas in the experimental group, a modified technique using a more inferior injection point was performed. Results: A total of 100 patients were randomized. The modified technique group showed a significantly higher onset time in the lower lip and chin area, and was frequently associated to a lingual electric discharge sensation. Three failures were recorded, 2 of them in the experimental group. No relevant local or systemic complications were registered. Conclusions: Both IANB techniques used in this trial are suitable for lower third molar removal. However, performing an inferior alveolar nerve block in a more inferior position (modified technique) extends the onset time, does not seem to reduce the risk of intravascular injections and might increase the risk of lingual nerve injuries. Key words:Dental anesthesia, inferior alveolar nerve block, lidocaine, third molar, intravascular injection. PMID:24608204

  20. The Effect of Honey Gel on Abdominal Wound Healing in Cesarean Section: A Triple Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Maryam Nikpour

    2014-07-01

    Full Text Available Objective: To assess whether honey can accelerate the wound healing in women undergoing cesarean section. Methods: This was a triple blinded randomized prospective clinical trial. Women with cesarean section were randomly designated as drug (37 cases and placebo (38 cases groups. The drug group received local honey gel 25% while the placebo group received similar free-honey gel on abdominal cesarean incision twice a day for 14 days. REEDA scale (Redness, Edema, Ecchymosis, Discharge and Approximation of wound edges was used to assess wound healing. Results: The mean REEDA was 2.27 ± 2.46 and 3.91 ± 2.74 (p=0.008 on the 7th day and 0.47 ± 0.84 and 1.59± 1.95 (p=0.002 on the 14th day for the drug and placebo groups, respectively. Redness, edema and hematoma in the drug group were significantly lower on the 7th and 14th days. Conclusion: Honey was effective in healing the cesarean section incision. Using topical honey is suggested as a natural product with rare side effects in order to reduce the complications of cesarean wounds.

  1. Effect of Ketofol on Pain and Complication after Caesarean Delivery under Spinal Anaesthesia: A Randomized Double-blind Clinical Trial.

    Science.gov (United States)

    Jaafarpour, Molouk; Vasigh, Aminolah; Khajavikhan, Javaher; Khani, Ali

    2017-03-01

    Pain is the key concern of women after caesarean delivery that may interfere with breastfeeding. The aim of this study was to assess effect of ketofol (ketamine/propofol combination) on pain and complication after caesarean delivery under spinal anaesthesia. In this randomized double-blind clinical trial, 92 parturient scheduled for elective caesarean delivery under spinal anaesthesia were included. The simple random sampling method was used to place subjects in four groups of ketamine (0.25 mg/kg), propofol (0.25 mg/kg), ketofol (25 mg ketamine plus 25 mg propofol) and placebo (saline). The drugs were administered intravenously immediately after clamping the umbilical cord. Visual Analog Scale (VAS) was used to determine the intensity of pain. Complications after surgery including shivering, nausea and vomiting as well as onset of breastfeeding were recorded. The mean score of pain, morphine consumption and time of breastfeeding in the ketofol group were significantly lower than other groups at various intervals (ppain and complication after caesarean delivery indicated that it can be considered as a safe and alternative drug in these patients.

  2. Effect of curettage after segmental phenolization in the treatment of onychocryptosis: a randomized double-blind clinical trial.

    Science.gov (United States)

    Álvarez-Jiménez, Jesús; Córdoba-Fernández, Antonio; Munuera, Pedro V

    2012-03-01

    Segmental phenolization for the treatment of onychocryptosis has a number of disadvantages, resulting from the cauterization of the tissue, including delayed healing and prolonged drainage. Although one may expect excision or curettage of the cauterized tissue after phenolization to benefit the healing process, these simple procedures have not been suitably studied. To examine the effect of curettage primarily on cicatrization or healing time and secondarily on postoperative bleeding. Fifty-one patients (80 feet) with stage I or IIa onychocryptosis according to the classification of Mozena were enrolled in this randomized, double-blind, parallel-group, controlled clinical trial. A total of 137 phenolizations were performed on affected folds of ingrowing hallux nails. Each hallux was randomly assigned to one of two groups (experimental [phenolization with curettage]; control [phenolization alone]). Curettage reduced healing time (7.49 ± 1.76 days vs 12.38 ± 3.01 days; p = .001), increased postoperative bleeding (p Surgery, Inc. Published by Wiley Periodicals, Inc.

  3. Comparative Evaluation of Commercially Available Freeze Dried Powdered Probiotics on Mutans Streptococci Count: A Randomized, Double Blind, Clinical Study

    Directory of Open Access Journals (Sweden)

    Asif Yousuf

    2016-03-01

    Full Text Available Objectives: Probiotic approaches are being considered to eliminate pathogenic microorganisms and are an alternative and promising way to combat infections by using harmless bacteria to displace pathogenic microorganisms. The aim of this study was to evaluate the effectiveness of commercially available freeze dried powdered probiotics on mutans streptococci count among 12-15 year-old Indian schoolchildren. Materials and Methods: The study was conducted in two phases of in-vitro (phase I and in-vivo (phase II study, which was a double blind, randomized and placebo controlled clinical trial. A total of 33 schoolchildren between 12-15 years were included in the study. They were randomly allocated to three groups. Group A included 11 children using freeze dried Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium bifidum and Bifidobacterium lactis. Group B included 11 children using freeze dried lactic acid bacillus only. Group C included 11 children using placebo powder. The study was conducted over a period of three weeks and examination and sampling of the subjects were done on days 0 (baseline, seven, 14 and 21. Results: For both the intervention groups A and B, statistically significant reduction (P<0.05 in salivary mutans streptococci counts was recorded up to the second week.Conclusion: Oral administration of probiotics showed a short-term effect on reduction of mutans streptococci count and showed a preventive role in caries development.Key words: Probiotics; Viridans Streptococci; Dental Caries.

  4. Reiki therapy for postoperative oral pain in pediatric patients: pilot data from a double-blind, randomized clinical trial.

    Science.gov (United States)

    Kundu, Anjana; Lin, Yuting; Oron, Assaf P; Doorenbos, Ardith Z

    2014-02-01

    To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

  5. Memantine for prophylaxis of chronic tension-type headache--a double-blind, randomized, crossover clinical trial

    DEFF Research Database (Denmark)

    Lindelof, K; Bendtsen, L; Lindelof, K

    2009-01-01

    Treatment for chronic tension-type headache (CTTH) is unsatisfactory. Our aim was to investigate the efficacy of the N-methyl D-aspartate (NMDA) antagonist memantine in the prophylactic treatment of CTTH. We included 40 patients in a randomized, double-blind, placebo-controlled, crossover trial...

  6. Efficacy of Dragon's blood cream on wound healing: A randomized, double-blind, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Foroogh Namjoyan

    2016-01-01

    Full Text Available The blood-red sap of Dragon's blood has been used in folk medicine for fractures, wounds, inflammation, gastrointestinal disorders, rheumatism, blood circulation dysfunctions, and cancer. Existing in vitro and in vivo bioactivity of this herb on different mechanisms of healing shows strong potential of this sap in wound healing. This clinical trial study was designated to evaluate the wound healing effect of Dragon's blood on human wounds. Sixty patients, between the ages of 14–65 years, who were referred to remove their skin tag, were assigned to this double-blind, placebo-controlled, randomized clinical trial and received either Dragon's blood or a placebo cream. They were visited on the 3rd, 5th, 7th, 10th, 14th, and 20th day of the trial to check the process of healing and to measure the wound's surface. At the end of trial, there was a significant difference in the mean duration of wound healing between the two groups (p = 0.0001. The phenolic compounds and the alkaloid taspine, which exist in Dragon's-blood resin, are probably the main reasons for the wound healing property of this plant. Being natural accessible, safe, and affordable makes Dragon's blood cream, a good choice for addition to the wound healing armamentarium. Further studies on wounds with different causes and among larger populations are suggested to ensure the effectiveness and safety of Dragon's blood.

  7. A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia

    Directory of Open Access Journals (Sweden)

    Amy S Chappell

    2008-12-01

    Full Text Available Amy S Chappell1, Laurence A Bradley2, Curtis Wiltse1, Michael J Detke1,3,4, Deborah N D’Souza1, Michael Spaeth51Lilly Research Laboratories, Indianapolis, IN, USA; 2University of Alabama at Birmingham, Birmingham, Alabama, USA; 3Indiana University School of Medicine, Indianapolis, IN, USA; 4Harvard Medical School, Boston, MA, USA; 5Practice for Internal Medicine/Rheumatology, Graefelfing, GermanyObjective: Assess the efficacy of duloxetine 60/120 mg (N = 162 once daily compared with placebo (N = 168 in the treatment of patients with fibromyalgia, during six months of treatment.Methods: This was a phase-III, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of duloxetine.Results: There were no significant differences between treatment groups on the co-primary efficacy outcome measures, change in the Brief Pain Inventory (BPI average pain severity from baseline to endpoint (P = 0.053 and the Patient’s Global Impressions of Improvement (PGI-I at endpoint (P = 0.073. Duloxetine-treated patients improved significantly more than placebo-treated patients on the Fibromyalgia Impact Questionnaire pain score, BPI least pain score and average interference score, Clinical Global Impressions of Severity scale, area under the curve of pain relief, Multidimensional Fatigue Inventory mental fatigue dimension, Beck Depression Inventory-II total score, and 36-item Short Form Health Survey mental component summary and mental health score. Nausea was the most common treatment-emergent adverse event in the duloxetine group. Overall discontinuation rates were similar between groups.Conclusions: Although duloxetine 60/120 mg/day failed to demonstrate significant improvement over placebo on the co-primary outcome measures, in this supportive study, duloxetine demonstrated significant improvement compared with placebo on numerous secondary measures.Keywords: fibromyalgia, duloxetine, placebo, double-blind, trial

  8. The effect of pheniramine on fentanyl-induced cough: a randomized, double blinded, placebo controlled clinical study

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    Zakir Arslan

    Full Text Available Abstract Background and objectives: There are many studies conducted on reducing the frequency and severity of fentayl-induced cough during anesthesia induction. We propose that pheniramine maleate, an antihistaminic, may suppress this cough. We aim to observe the effect of pheniramine on fentanyl-induced cough during anesthesia induction. Methods: This is a double-blinded, prospective, three-arm parallel, randomized clinical trial of 120 patients with ASA (American Society of Anesthesiologists physical status III and IV who aged ≥18 and scheduled for elective open heart surgery during general anesthesia. Patients were randomly assigned to three groups of 40 patients, using computer-generated random numbers: placebo group, pheniramine group, and lidocaine group. Results: Cough incidence differed significantly between groups. In the placebo group, 37.5% of patients had cough, whereas the frequency was significantly decreased in pheniramine group (5% and lidocaine group (15% (Fischer exact test, p = 0.0007 and p = 0.0188, respectively. There was no significant change in cough incidence between pheniramine group (5% and lidocaine group (15% (Fischer exact test, p = 0.4325. Cough severity did also change between groups. Post Hoc tests with Bonferroni showed that mean cough severity in placebo differed significantly than that of pheniramine group and lidocaine group (p < 0.0001 and p = 0.009, respectively. There was no significant change in cough severity between pheniramine group and lidocaine group (p = 0.856. Conclusion: Intravenous pheniramine is as effective as lidocaine in preventing fentayl-induced cough. Our results emphasize that pheniramine is a convenient drug to decrease this cough.

  9. The effect of pheniramine on fentanyl-induced cough: a randomized, double blinded, placebo controlled clinical study.

    Science.gov (United States)

    Arslan, Zakir; Çalık, Eyup Serhat; Kaplan, Bekir; Ahiskalioglu, Elif Oral

    2016-01-01

    There are many studies conducted on reducing the frequency and severity of fentayl-induced cough during anesthesia induction. We propose that pheniramine maleate, an antihistaminic, may suppress this cough. We aim to observe the effect of pheniramine on fentanyl-induced cough during anesthesia induction. This is a double-blinded, prospective, three-arm parallel, randomized clinical trial of 120 patients with ASA (American Society of Anesthesiologists) physical status III and IV who aged ≥18 and scheduled for elective open heart surgery during general anesthesia. Patients were randomly assigned to three groups of 40 patients, using computer-generated random numbers: placebo group, pheniramine group, and lidocaine group. Cough incidence differed significantly between groups. In the placebo group, 37.5% of patients had cough, whereas the frequency was significantly decreased in pheniramine group (5%) and lidocaine group (15%) (Fischer exact test, p=0.0007 and p=0.0188, respectively). There was no significant change in cough incidence between pheniramine group (5%) and lidocaine group (15%) (Fischer exact test, p=0.4325). Cough severity did also change between groups. Post Hoc tests with Bonferroni showed that mean cough severity in placebo differed significantly than that of pheniramine group and lidocaine group (ppheniramine group and lidocaine group (p=0.856). Intravenous pheniramine is as effective as lidocaine in preventing fentayl-induced cough. Our results emphasize that pheniramine is a convenient drug to decrease this cough. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  10. [The effect of pheniramine on fentanyl-induced cough: a randomized, double blinded, placebo controlled clinical study].

    Science.gov (United States)

    Arslan, Zakir; Çalık, Eyup Serhat; Kaplan, Bekir; Ahiskalioglu, Elif Oral

    2016-01-01

    There are many studies conducted on reducing the frequency and severity of fentayl-induced cough during anesthesia induction. We propose that pheniramine maleate, an antihistaminic, may suppress this cough. We aim to observe the effect of pheniramine on fentanyl-induced cough during anesthesia induction. This is a double-blinded, prospective, three-arm parallel, randomized clinical trial of 120 patients with ASA (American Society of Anesthesiologists) physical status III and IV who aged ≥18 and scheduled for elective open heart surgery during general anesthesia. Patients were randomly assigned to three groups of 40 patients, using computer-generated random numbers: placebo group, pheniramine group, and lidocaine group. Cough incidence differed significantly between groups. In the placebo group, 37.5% of patients had cough, whereas the frequency was significantly decreased in pheniramine group (5%) and lidocaine group (15%) (Fischer exact test, p=0.0007 and p=0.0188, respectively). There was no significant change in cough incidence between pheniramine group (5%) and lidocaine group (15%) (Fischer exact test, p=0.4325). Cough severity did also change between groups. Post Hoc tests with Bonferroni showed that mean cough severity in placebo differed significantly than that of pheniramine group and lidocaine group (ppheniramine group and lidocaine group (p=0.856). Intravenous pheniramine is as effective as lidocaine in preventing fentayl-induced cough. Our results emphasize that pheniramine is a convenient drug to decrease this cough. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  11. Efficacy of mouth rinses on dental plaque and gingivitis: A randomized, double-blind, placebo-controlled clinical trial

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    Arun Shyam

    2014-01-01

    Full Text Available Introduction: Over the years chlorhexidine (CHX, triclosan and sodium fluoride (NaF mouth rinses are used alone or combined in the prevention of dental diseases. However, at present little is known about the combined effects of NaF + triclosan and CHX + NaF + triclosan mouth rinses on reducing dental plaque and gingivitis. Aim: The aim was to determine the efficacy of mouth rinses used as adjuncts to regular oral hygiene measures on reducing dental plaque and gingivitis. Materials and Methods: A randomized, placebo-controlled, double-blind, parallel-group study was conducted for 6-month, among 12-15 years old school children in Nellore, India. Eligible subjects (n = 210 with consent were randomly allocated to four groups and were provided with a mouth rinse (Group A = 0.2% CHX; Group B = 0.05% sodium fluoride + 0.03% triclosan; Group C = 0.2% CHX + 0.05% sodium fluoride + 0.03% triclosan; Group D = Placebo. All subjects used 10 ml of mouth rinse, once daily for 60 s. The clinical parameters evaluated were plaque index (PlI and gingival Index (GI. Statistical significance within and between four groups was tested using one-way analysis of variance (ANOVA, repeated measures ANOVA with post-hoc and paired t-test. Results: At the end of clinical trial, the three test groups showed statistically significant (P < 0.001 reduction in PlI and GI scores compared with placebo group. Conclusion: The active agents demonstrated highly potent antiplaque and antigingivitis properties when compared to placebo.

  12. Effects of Intrathecal Clonidine on Spinal Analgesia during Elective Cesarean Delivery: A Randomized Double Blind Clinical Trial

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    Houshang Talebi

    2016-05-01

    Full Text Available In order To investigate the effect of addition of clonidine to lidocaine on duration of spinal analgesia and need for postoperative analgesics after Caesarean section delivery, this randomized case-controlled double-blind clinical trial was designed and conducted. 166 eligible women were randomly allocated to either case or control group (n=83, Spinal anesthesia was done by 75-100 mg lidocaine 0.5% in control group and by 75-100 mg lidocaine 0.5% plus 75µg clonidine in case group. Onset of analgesia, Blood pressure, Hypotension, Bradycardia, and Neonates Apgar scores were recorded during surgery. After surgery, duration of sensory and motor functions, Intensity of post-operative nausea and vomiting, Total analgesic consumption and time to first analgesic request were assessed. Data were analyzed by SPSS and an alpha level < 0.05 was considered to be statistically significant. Onset of analgesia, Duration of Motor and sensory block, mothers’ systolic blood pressure and pulse rate in different recorded times, and Total Analgesic consumption in case group showed a statically significant difference in comparison to the control group. Analgesia demanding, Time of first request for analgesics, Intensity of Nauseas and vomiting, Apgar score showed no significant difference. We have demonstrated that addition of 75 µg clonidine to lidocaine extends spinal analgesia along with sensory and motor block after Caesarean section and improves early analgesia without clinically significant maternal or neonatal side-effects. This single 75 µg intrathecal clonidine dose also reduced the amount of subsequent analgesic consumption during the first 12 hours after delivery.

  13. A Prospective, Randomized, Double-blind Clinical Trial of One Nano ...

    African Journals Online (AJOL)

    2015-12-16

    Dec 16, 2015 ... American Dental Association guidelines for submitted dentin and enamel adhesive materials specify provisional acceptance, means that no more than 5% of the restorations should have been lost at the 6 months recall and, to obtain full acceptance, the cumulative incidence of clinical failures in each of the ...

  14. Melissa officinalis effect on female sexual dysfunction: a double blind, randomized clinical trial

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    Z. Darvish-Mofrad-Kashani

    2017-11-01

    Full Text Available Background and objectives: Female sexual dysfunction is a very common health problem that affects 25-65% of women. Melissa officinalis or lemon balm (Lamiaceae has been reported in folk medicine for treatment of nervous debility, so this study was designed to evaluate the efficacy of M. officinalis to improve female libido. Methods: Eighty nine eligible women with decreased sexual desire were randomly divided into two groups and consumed four 500 mg capsules of M. officinalis or placebo for 4 weeks. Medication was prepared from dried aqueous extract of M. officinalis (standardized as 3.32±0.02 mg gallic acid/g and 1.8±0.003 mg rutin/g. Changes in female sexual function index (FSFI questionnaire scores were evaluated for the two groups. Results: Patients in M. officinalis group experienced significant improvement in lubrication (p

  15. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial

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    Eftekharsadat, Bina; Babaei-Ghazani, Arash; Zeinolabedinzadeh, Vahideh

    2016-01-01

    Background: This study examined the effects of dry needling on chronic heel pain due to plantar fasciitis. Methods: During this single-blinded clinical trial, 20 eligible patients were randomized into two groups: A case group treated with dry needling and a control group. Patients’ plantar pain severity, (using modified visual analog scale [VAS] scoring system), range of motion of ankle joint in dorsiflexion [ROMDF] and plantar extension[ROMPE] and foot function index (using standard questionnaires of SEM5 and MDC7) were assessed at baseline, four weeks after intervention and four weeks after withdrawing treatment. Independent sample t-test, Mann-Whitney U test, paired t-test, Wilcoxon signed rank tests, and chi square test were used for data analysis. Results: The mean VAS scores in the case group was significantly lower than the control group after four weeks of intervention (pdry needling, by improving the severity of heel pain, can be used as a good alternative option before proceeding to more invasive therapies of plantar fasciitis. PMID:27683642

  16. Effects of Probiotic Supplementation on Oxidative Stress Indices in Women with Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial.

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    Vaghef-Mehrabany, Elnaz; Homayouni-Rad, Aziz; Alipour, Beitullah; Sharif, Sakineh-Khatoun; Vaghef-Mehrabany, Leila; Alipour-Ajiry, Serour

    2016-01-01

    Rheumatoid arthritis (RA) is an autoimmune inflammatory disease that causes great pain and disability and increasing oxidative stress in patients. The objective of the present study was to evaluate the effects of probiotics-live microorganisms with many health benefits, including antioxidant properties-on oxidative stress indices of patients with RA. This study is a secondary analysis from a previously published study Methods: In a randomized double-blind placebo-controlled clinical trial, 46 patients with RA were assigned to one of two groups; patients in the probiotic group received a daily capsule containing 10(8) colony forming units (CFUs) of Lactobacillus casei 01 (L. casei 01), while those in the placebo group took identical capsules containing maltodextrin, for 8 weeks. In the baseline and at the end of the study, anxiety, physical activity levels, and dietary intakes were assessed. Anthropometric parameters, serum malondialdehyde (MDA), total antioxidant capacity (TAC), erythrocyte superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase (CAT) activities were measured. There was no significant difference between the two groups for demographic characteristics, anthropometric parameters, physical activity, anxiety levels, or dietary intakes, throughout the course of the study. No significant within- and between-group differences were observed for MDA, TAC, or CAT. SOD activity decreased only in the probiotic group and GPx activity decreased in both study groups (p 0.05). No significant effect of L. casei 01 supplementation was observed on the oxidative status of patients with RA, compared to placebo.

  17. A randomized double-blind clinical trial of posterior composite restorations with or without bevel: 1-year follow-up

    Science.gov (United States)

    COELHO-DE-SOUZA, Fábio Herrmann; CAMARGO, Junara Cristina; BESKOW, Tiago; BALESTRIN, Matheus Dalmolin; KLEIN-JÚNIOR, Celso Afonso; DEMARCO, Flávio Fernando

    2012-01-01

    Objective This randomized double-blind clinical trial compared the performance of posterior composite restorations with or without bevel, after 1-year follow-up. Material and Methods Thirteen volunteers requiring at least two posterior composite restorations were selected. Twenty-nine cavities were performed, comprising 14 without bevel (butt joint) and 15 with bevel preparation of the enamel cavosurface angle. All cavities were restored with simplified adhesive system (Adper Single Bond) and composite resin (Filtek P60). A halogen light curing unit was used through the study. Restorations were polished immediately. Analysis was carried out at baseline, after 6 months and after 1 year by a calibrated evaluator (Kappa), according to the FDI criteria. Data were statistically analyzed by Mann-Whitney test (p<0.05). Results Beveled and non-beveled cavities performed similarly after 1 year follow-up, regarding to fractures and retention, marginal adaptation, postoperative hypersensitivity, recurrence of caries, surface luster and anatomic form. However, for surface and marginal staining, beveled cavities showed significantly better performance (p<0.05) than butt joint restorations. Conclusions It was concluded that the restorations were acceptable after 1 year, but restorations placed in cavities with marginal beveling showed less marginal staining than those placed in non-beveled cavities. PMID:22666833

  18. A randomized double-blind clinical trial of posterior composite restorations with or without bevel: 1-year follow-up

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    Fábio Herrmann Coelho-De-Souza

    2012-04-01

    Full Text Available OBJECTIVE: This randomized double-blind clinical trial compared the performance of posterior composite restorations with or without bevel, after 1-year follow-up. MATERIAL AND METHODS: Thirteen volunteers requiring at least two posterior composite restorations were selected. Twenty-nine cavities were performed, comprising 14 without bevel (butt joint and 15 with bevel preparation of the enamel cavosurface angle. All cavities were restored with simplified adhesive system (Adper Single Bond and composite resin (Filtek P60. A halogen light curing unit was used through the study. Restorations were polished immediately. Analysis was carried out at baseline, after 6 months and after 1 year by a calibrated evaluator (Kappa, according to the FDI criteria. Data were statistically analyzed by Mann-Whitney test (p <0.05. RESULTS: Beveled and non-beveled cavities performed similarly after 1 year follow-up, regarding to fractures and retention, marginal adaptation, postoperative hypersensitivity, recurrence of caries, surface luster and anatomic form. However, for surface and marginal staining, beveled cavities showed significantly better performance (p<0.05 than butt joint restorations. CONCLUSIONS: It was concluded that the restorations were acceptable after 1 year, but restorations placed in cavities with marginal beveling showed less marginal staining than those placed in non-beveled cavities.

  19. High-Dose Intravenous Methylprednisolone for Hantavirus Cardiopulmonary Syndrome in Chile: A Double-Blind, Randomized Controlled Clinical Trial

    Science.gov (United States)

    Vial, Pablo A.; Valdivieso, Francisca; Ferres, Marcela; Riquelme, Raul; Rioseco, M. Luisa; Calvo, Mario; Castillo, Constanza; Díaz, Ricardo; Scholz, Luis; Cuiza, Analia; Belmar, Edith; Hernandez, Carla; Martinez, Jessica; Lee, Sang-Joon; Mertz, Gregory J.; Abarca, Juan; Tomicic, Vinko; Aracena, M. Eugenia; Rehbein, Ana Maria; Velásquez, Soledad; Lavin, Victoria; Garrido, Felipe; Godoy, Paula; Martinez, Constanza; Chamorro, Juan Carlos; Contreras, Jorge; Hernandez, Jury; Pino, Marcelo; Villegas, Paola; Zapata, Viviana; León, Marisol; Vega, Ivonne; Otarola, Irisol; Ortega, Carlos; Daube, Elizabeth; Huecha, Doris; Neira, Alda; Ruiz, Ines; Nuñez, M. Antonieta; Monsalve, Luz; Chabouty, Henriette; Riquelme, Lorena; Palma, Samia; Bustos, Raul; Miranda, Ruben; Mardones, Jovita; Hernandez, Nora; Betancur, Yasna; Sanhueza, Ligia; Inostroza, Jaime; Donoso, Solange; Navarrete, Maritza; Acuña, Lily; Manriquez, Paulina; Castillo, Fabiola; Unzueta, Paola; Aguilera, Teresa; Osorio, Carola; Yobanolo, Veronica; Mardones, Jorge; Aranda, Sandra; Carvajal, Soledad; Sandoval, Moisés; Daza, Soraya; Vargas, Felipe; Diaz, Violeta; Riquelme, Mauricio; Muñoz, Miriam; Carriel, Andrea; Lanino, Paola; Hernandez, Susana; Schumacher, Patricia; Yañez, Lia; Marco, Claudia; Ehrenfeld, Mildred; Delgado, Iris; Rios, Susana; Vial, Cecilia; Bedrick, Edward

    2013-01-01

    Background. Andes virus (ANDV)–related hantavirus cardiopulmonary syndrome (HCPS) has a 35% case fatality rate in Chile and no specific treatment. In an immunomodulatory approach, we evaluated the efficacy of intravenous methylprednisolone for HCPS treatment, through a parallel-group, placebo-controlled clinical trial. Methods. Patients aged >2 years, with confirmed or suspected HCPS in cardiopulmonary stage, admitted to any of 13 study sites in Chile, were randomized by study center in blocks of 4 with a 1:1 allocation and assigned through sequentially numbered envelopes to receive placebo or methylprednisolone 16 mg/kg/day (≤1000 mg) for 3 days. All personnel remained blinded except the local pharmacist. Infection was confirmed by immunoglobulin M antibodies or ANDV RNA in blood. The composite primary endpoint was death, partial pressure of arterial oxygen/fraction of inspired oxygen ratio ≤55, cardiac index ≤2.2, or ventricular tachycardia or fibrillation within 28 days. Safety endpoints included the number of serious adverse events (SAEs) and quantification of viral RNA in blood. Analysis was by intention to treat. Results. Infection was confirmed in 60 of 66 (91%) enrollees. Fifteen of 30 placebo-treated patients and 11 of 30 methylprednisolone-treated patients progressed to the primary endpoint (P = .43). We observed no significant difference in mortality between treatment groups (P = .41). There was a trend toward more severe disease in placebo recipients at entry. More subjects in the placebo group experienced SAEs (P = .02). There were no SAEs clearly related to methylprednisolone administration, and methylprednisolone did not increase viral load. Conclusions. Although methylprednisolone appears to be safe, it did not provide significant clinical benefit to patients. Our results do not support the use of methylprednisolone for HCPS. Clinical Trials Registration. NCT00128180. PMID:23784924

  20. A Double-Blind, Randomized, Placebo-Controlled Clinical Study of Trofinetide in the Treatment of Rett Syndrome.

    Science.gov (United States)

    Glaze, Daniel G; Neul, Jeffrey L; Percy, Alan; Feyma, Tim; Beisang, Arthur; Yaroshinsky, Alex; Stoms, George; Zuchero, David; Horrigan, Joseph; Glass, Larry; Jones, Nancy E

    2017-11-01

    This study aimed to determine the safety and tolerability of trofinetide and to evaluate efficacy measures in adolescent and adult females with Rett syndrome, a serious and debilitating neurodevelopmental condition for which no therapies are available for its core features. This was an exploratory, phase 2, multicenter, double-blind, placebo-controlled, dose-escalation study of the safety and tolerability of trofinetide in 56 adolescent and adult females with Rett syndrome. Subjects were randomly assigned in a 2:1 ratio to 35 mg/kg twice daily of trofinetide or placebo for 14 days; 35 mg/kg twice daily or placebo for 28 days; or 70 mg/kg twice daily or placebo for 28 days. Safety assessments included adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and concomitant medications. Efficacy measurements were categorized into four efficacy domains, which related to clinically relevant, phenotypic dimensions of impairment associated with Rett syndrome. Both 35 mg/kg and 70 mg/kg dose levels of trofinetide were well tolerated and generally safe. Trofinetide at 70 mg/kg demonstrated efficacy compared with placebo based on prespecified criteria. Trofinetide was well tolerated in adolescent and adult females with Rett syndrome. Although this study had a relatively short duration in a small number of subjects with an advanced stage of disease, consistent efficacy trends at the higher dose were observed in several outcome measures that assess important dimensions of Rett syndrome. These results represented clinically meaningful improvement from the perspective of the clinicians as well as the caregivers. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. TOPICAL ESTROGEN IN WOUND HEALING: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL ON YOUNG HEALTHY PEOPLE

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    A ASILIAN

    2001-03-01

    Full Text Available Introduction: Acceleration of wounf healing is intrested because of decreasing the risk of wound complication and infections as well as reducing the cost of treatment. In animal models, it has been proved that estrogen can accelerate wound healing. It has been also suggested that topical estrogen can eliminate effect of aging on wound healing and can increase the speed of wound healing in old people. Methods: We selected 16 young healthy people who developed symmetrical and ulcers (regarding size and depths after dermabrasion, shave and electrocoagulouzon and CO2 laser. Primary lesions of patients were benign and noninfective. Identical and symmetrical lesions of each patient were randomly divided into two groups (A and B. Topical estrogen with concentration of 0.625 mg/g in the base of silver sulfadiazine cream was applied to A ulcers and silver sulfadiazine cream alone was applied on B ulcers. Ulcers were dressed by Telfa gauzes. The A ulcers of each patients were compared to counterpart B ulcers in regard of redness, size, depth, general appearance of ulcers and wound healing duration at three days intervals by a physician. Results: Average time of healing was 10.8 days and 8.5 days for B (n=29 and A (n=29 ulcers, respectively (P < 0.001. In 78 percent of cases, the A ulcers were judged better than B ulcers by physician (P < 0.01. Discussion: It seems that estrogen not only accelerate healing of acute ulcers but also it is efficient in young healthy people who don"t have any hormonal or wound healing problems.

  2. Comparison of the analgesic effects of dexketoprofen and diclofenac during shockwave lithotripsy: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Tokgoz, Husnu; Yurtlu, Serhan; Hanci, Volkan; Turksoy, Ozlem; Erol, Bulent; Akduman, Bulent; Mungan, Aydin

    2010-06-01

    This prospective, randomized, and double-blind clinical study aimed to assess the analgesic efficacy of single-dose intramuscular (IM) injection of dexketoprofen (group DE) compared with single-dose IM injection of diclofenac (group DI) in patients who were undergoing shockwave lithotripsy (SWL). A total of 70 men with single renal or ureteral stones were randomly separated into two groups. The 40 men in group DI received 75 mg IM diclofenac sodium and 30 men in Group DE received 50 mg IM dexketoprofen trometamol 30 minutes before SWL. A 10-point visual analog scale was used to evaluate pain. The age, body mass index, and mean stone burden were comparable between the two groups (P > 0.05). The mean visual analog scale score for group DE was statistically lower compared with the score for group DI (P = 0.02). In 34 (85%) of the 40 men in group DI, the SWL procedure was performed with no, minor, or tolerable pain. In group DE, however, 28 (93.3%) of 30 patients evaluated the pain severity as no, minor, or tolerable (p = 0.01). No major/minor adverse effects were observed in group DI, whereas in one patient in group DE, dyspepsia after injection was noticed (P = 0.423). The severity of SWL-related pain was significantly better tolerated with dexketoprofen trometamol. During an SWL procedure, the analgesic efficacy of dexketoprofen was greater than that of diclofenac sodium. Although statistically insignificant, a little increased risk for gastric irritation was noticed with dexketoprofen.

  3. Effect of Low-dose Atracurium on Laryngeal Mask Airway Insertion Conditions: A Randomized Double-blind Clinical Trial

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    Karim Nasseri

    2017-01-01

    Full Text Available Background: The amount of sedation and muscle relaxation of the jaw may have an impact on complications caused by laryngeal mask airway (LMA. The aim of this study is to evaluate the effect of low-dose Atracurium on conditions of insertion, complications, and hemodynamic responses to LMA insertion following induction of anesthesia with propofol, in patients undergoing cataract surgery. Patients and Methods: In this double-blind randomized clinical trial study, 60 patients were randomly divided into two groups. Initially, the patients in the study group received 0.15 mg/kg intravenous injection of atracurium, and the patients in the control group received 2 ml of intravenous injection of normal saline, after which anesthesia in both groups were induced with midazolam, fentanyl, lidocaine, and propofol. The amount of jaw relaxation, ease of insertion, and the time needed for insertion, hemodynamic responses and complications of LMA insertion were evaluated. Results: Jaw relaxation and ease of LMA insertion in the study group was significantly better than that of the control group (P = 0.02. Average time needed for LMA placement in the study group (5/06 ± 0.52 second was significantly lower than the control group (5/76 ± 0.67 second (P = 0.001. Hemodynamic response to LMA insertion was similar in both groups. Sore throat at recovery and 24 h after surgery in the control group was significantly higher than that of the study group (3/30 vs. 10/30 (P = 0.01. Conclusions: Using low doses of atracurium decreases the time needed for LMA insertion and sore throat after the operation. Atracurium also increases jaw relaxation and facilitates the placement of LMA.

  4. The Efficacy of Postoperative Wound Infusion with Bupivacaine for Pain Control after Cesarean Delivery: Randomized Double Blind Clinical Trial

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    Azin Alavi

    2007-06-01

    Full Text Available Objective: This study investigated the efficacy of bupivacaine wound infusion for pain control and opioid sparing effect after cesarean delivery.Materials and methods: We conducted a randomized double blind, placebo controlled clinical trial on 60 parturients undergoing cesarean section at a university hospital in Tehran. Patients were randomized to receive a pump infusion system that was filled with either 0.25% bupivacaine or equal volume of distilled water. A catheter was placed above the fascia and connected to electronic pump for 24 hours. Postoperative analog pain scores and morphine consumption were assessed at 6, 12 and 24 hours. Also time interval to first ambulation, length of hospitalization, complications and patient satisfaction were recorded. Data were analyzed using the SPSS software and P < 0.05 was considered statistically significant. Mann-Whitney u-test, student t-test and chi-square were used. Results: There were no differences in patient demographics and length of hospitalization and patient-generated resting pain scores between the two groups. Pain scores after coughing and leg raise during the first 6 postoperative hours were significantly less in the Bupivacaine group (P<0.001. The total dose of morphine consumption during the 24 hours study period was 2.5 ± 2.5 mg vs. 7.3 ± 2.7 mg for the bupivacaine and control groups, respectively (P<0.001. Compared with the control group, time to first ambulation was shorter in the bupivacaine group (11± 5h vs. 16 ± 4h (P< 0.01. Conclusion: Bupivacaine wound infusion was a simple and safe technique that provides effective analgesia and reduces morphine requirements after cesarean delivery.

  5. Pain relief assessment by aromatic essential oil massage on outpatients with primary dysmenorrhea: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Ou, Ming-Chiu; Hsu, Tsung-Fu; Lai, Andrew C; Lin, Yu-Ting; Lin, Chia-Ching

    2012-05-01

    This study assessed the effectiveness of blended essential oils on menstrual cramps for outpatients with primary dysmenorrhea and explored the analgesic ingredients in the essential oils. A randomized, double-blind clinical trial was conducted. Forty-eight outpatients were diagnosed with primary dysmenorrhea by a gynecologist and had 10-point numeric rating scales that were more than 5. The patients were randomly assigned to an essential oil group (n = 24) and a synthetic fragrance group (n = 24). Essential oils blended with lavender (Lavandula officinalis), clary sage (Salvia sclarea) and marjoram (Origanum majorana) in a 2:1:1 ratio was diluted in unscented cream at 3% concentration for the essential oil group. All outpatients used the cream daily to massage their lower abdomen from the end of the last menstruation continuing to the beginning of the next menstruation. Both the numeric rating scale and the verbal rating scale significantly decreased (P < 0.001) after one menstrual cycle intervention in the two groups. The duration of pain was significantly reduced from 2.4 to 1.8 days after aromatherapy intervention in the essential oil group. Aromatic oil massage provided relief for outpatients with primary dysmenorrhea and reduced the duration of menstrual pain in the essential oil group. The blended essential oils contain four key analgesic components that amount to as much as 79.29%; these analgesic constitutes are linalyl acetate, linalool, eucalyptol, and β-caryophyllene. This study suggests that this blended formula can serve as a reference for alternative and complementary medicine on primary dysmenorrhea. © 2012 The Authors. Journal of Obstetrics and Gynaecology Research © 2012 Japan Society of Obstetrics and Gynecology.

  6. Glucose Oral Solution as A Pain-Relieving Agent In Infantile Colic: A Double Blinded Randomized Clinical Trial

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    Iraj Shahramian

    2017-12-01

    Full Text Available Background Infantile colic (IC is a common painful disorder within early months of life. There is no definitive therapeutics for IC. In present study aimed to assess pain-relieving potential of glucose administration in infantile colic. Materials and Methods This was a double blinded randomized clinical trial performed during May 2015-June 2017 in pediatric ward of Amir-Al-Momenin Hospital, Zabol city, Iran. Overall, 72 infants were randomly assigned to either glucose or simethicone groups (36 infants per group. Treatments were continued for 28 days with either 25% or 30% glucose solution and 2.5 mg/kg simethicone. Outcomes were assessed at the end of the intervention (28 days. Statistical analysis was done in SPSS version 22.0. Results Males and females constituted 20 (55.5%, and 16 (45.5% in glucose administrated, and 23 (63.8% and 13 (36.2%, P=0.4 in simethicone group respectively. The mean age (days was 19.1±3.8 and 20.2±4.9 for glucose and simethicone administrated groups, respectively (P=0.2. The crying times per day significantly reduced in both groups (mean reduction in crying times of 3.7±2.1, and 6.3±2.1 hours in glucose and simethicone groups, respectively. Moreover, 25% and 44.4% of infants in glucose and simethicone groups achieved ≥ 50% reduction in crying time, respectively (P=0.06. According to the glucose dose, infants who received 30% glucose solution significantly revealed higher ratio of ≥ 50% reduction in crying time (47.3% than those received 25% glucose solution in which no cases fulfilled this outcome (P

  7. Effect of Chlorhexidine with Fluoride Mouthrinse on Plaque Accumulation, Plaque pH - A Double Blind Parallel Randomized Clinical Trial.

    Science.gov (United States)

    Shukla, Neha; Saha, Sabyasachi; Singh, Sanjay

    2016-07-01

    Mouthwashes are important means used in chemical control of dental plaque. There is strong evidence suggestive of better effectiveness, when fluoride is added to chlorhexidine mouthwash. To assess the anti-plaque efficacy of Chlorhexidine combined with Fluoride mouthwash and to measure its impact on plaque accumulation and on plaque pH. Initially 100 subjects were screened. A double blind, parallel randomized clinical trial was conducted on 30 subjects after applying inclusion and exclusion criteria. Other independent variables were matched before randomly allocating them in three groups: Group A-Chlorhexidine as positive control, Group B-Chlorhexidine + Fluoride as test group and Group C- Distilled water as negative control. Oral prophylaxis of participants was done before onset of the study. Plaque pH was assessed before and immediately after rinsing at 0, 5 and 10 minutes interval and after 7 days with digital pH electrode (pHepR pH meter, Hanna Instruments R10285) and accumulation of plaque was recorded by Turesky et al., modification of Quigley Hein Plaque Index (1970). ANOVA test was used for statistical analysis. Although there was a statistically significant reduction in mean plaque scores from baseline to seven days in both Groups A and B, Group B showed better anti-plaque efficacy . Almost equal drop in plaque pH was seen for both the groups at 5 and 10 minutes. Better anti-plaque efficacy was observed in Group B (Chlorhexidine and Fluoride combination) with minimum variation of plaque pH.

  8. Efficacy of Aloe vera/ Plantago major gel in Diabetic Foot Ulcer: a randomized double-blind clinical trial.

    Science.gov (United States)

    Najafian, Younes; Mazloum, Zahra; Najaf Najafi, Mona; Hamedi, Shokouhsadat; Mahjour, Marjan; Feyzabadi, Zohre

    2018-01-14

    Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFU. Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software. At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (Pulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group. Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  9. Effect of Zolpidem on Sleep Quality of Professional Firefighters; a Double Blind, Randomized, Placebo-Controlled Crossover Clinical Trial

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    Ramin Mehrdad

    2015-10-01

    Full Text Available Professional firefighting is among the most demanding jobs. Prior studies have showed the notable prevalence of poor sleep quality among professional firefighters that may result in catastrophes. The aim of this study was in field confirmation of zolpidem usage (10 mg/PO/bed time for short term management of poor sleeps quality among professional firefighters. In a double-blind, randomized, placebo-controlled crossover clinical trial among professional firefighters, 27 poor sleepers were assigned randomly to one of the two groups. Two 14 days experimental periods were separated by a 14-day washout phase. Sleep quality was assessed using the Persian version of Pittsburgh Sleep Quality Index (PSQI. Six of the 27 enrolled voluntaries dropped out. Two rare side effects of zolpidem occurred in the study. A significant improvement of the PSQI score was detected in zolpidem period versus placebo in both groups (7.14 ± 3.02 vs 12.38 ± 2.51, PP=0.89. Zolpidem significantly improved all components of PSQI (Subjective sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbances and Daytime dysfunction in the current study except the use of sleep medication. Sleep onset latency was the component of PSQI with the greatest degree of abnormality among firefighters in a previous study. Interestingly, sleep latency was the component of PSQI with the most treatment effect of zolpidem in the current study. Zolpidem can be used as a part of treatment regimens in short time management of poor sleep quality among professional firefighters.

  10. Oral Zinc Sulfate as Adjuvant Treatment in Children With Nephrolithiasis: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Yousefichaijan, Parsa; Cyrus, Ali; Dorreh, Fatemeh; Rafeie, Mohammad; Sharafkhah, Mojtaba; Frohar, Faryar; Safi, Fatemeh

    2015-12-01

    Nephrolithiasis in children is associated with a high rate of complications and recurrence. Since some evidences reported that zinc has an important place amongst inhibitors of crystallization and crystal growth, we decided to assess the effectiveness of oral zinc sulfate as adjuvant treatment in children with nephrolithiasis. This was a randomized, double-blind, placebo-controlled clinical trial. 102 children in the age range 1 month to 11 years with first nephrolithiasis were recruited. Patients were randomly divided into two equal groups (intervention and control groups). Intervention group received conservative measures for stones and 1 mg/kg/day (maximum 20 mg/day) oral zinc sulfate syrup for 3 months. Control group received placebo in addition to conservative measures, also for 3 months. Patients were followed up by ultrasonography for 9 months, in 5 steps (at the end of 1st, 2nd, 3rd, 6th and 9th month after treatment) assessing size and number of stones in the kidneys. Only at the end of the first month, the average number (intervention: 1.15 ± 3.78, control: 1.3 ± 2.84) (P = 0.001) and size (cm) (intervention: 0.51 ± 1.76, control: 0.62 ± 1.39) (P = 0.001) of stones was significantly lower in the intervention group, and in other points there was no significant therapeutic efficacy in oral zinc adjuvant treatment compared to conservative treatment alone. Also, during the 9-month follow-up, the number and size of stones in both groups decreased significantly (both: P field.

  11. Clinical effects of Portulaca oleracea seeds on dyslipidemia in obese adolescents: a triple-blinded randomized controlled trial.

    Science.gov (United States)

    Sabzghabaee, Ali Mohammad; Kelishadi, Roya; Jelokhanian, Hadi; Asgary, Sedigheh; Ghannadi, Alireza; Badri, Shirinsadat

    2014-01-01

    Childhood obesity is a major public health concern worldwide while the current epidemic may be secondary to over consumption of high-fat, energy-rich foods. Purslane (Portulaca oleracea L.) has been traditionally used in medicine for several antioxidant and anti-atherogenic activities. In this study the anti-dyslipidemic effects of Poleracea was evaluated in obese adolescents. In this triple-blinded randomized placebo-controlled clinical trial which was done from July 2011 to June 2012, obese adolescent patients whom were referred to the Isfahan Cardiovascular Research Institute (Iran) were randomly allocated to the two arms of cases and controls. The cases group was asked to take one capsule containing powdered P. oleracea seeds (500 milligrams) two times a day for one month, and the controls group were asked to take identical but placebo (lactose) capsules in the same way. Biochemical parameters including 12-hours fasting serum levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) were measured before the initiation and after the completion of the study protocol. Total cholesterol, LDL-C, and TG showed statistically significant changes over time (one month) in the P. oleracea group (p < 0.05). However, between-group analysis using general linear model (multivariate) test revealed that the differences in the mentioned parameters between two study groups were statistically significant just for LDL-C and TG, while others did not differ significantly. P. oleracea L. may have positive effects on serum lipids profile which may be attributed to its polyphenolic and antioxidant compounds. This herbal drug seems to be well-tolerated in adolescent population as well. Further studies are recommended.

  12. Reducing wound pain in venous leg ulcers with Biatain Ibu: A randomized, controlled double-blind clinical investigation on the performance and safety

    DEFF Research Database (Denmark)

    Gottrup, F.; Jorgensen, B.; Karlsmark, T.

    2008-01-01

    Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu...... without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 (double blind) and days 43-47 (single blind). The primary response variable, persistent pain relief, was significantly......-47, the patients in the ibuprofen-foam group had a significant (p Wound healing was similar in the ibuprofen foam and comparator group. No difference in adverse events between...

  13. Reducing wound pain in venous leg ulcers with Biatain Ibu: A randomized, controlled double-blind clinical investigation on the performance and safety

    DEFF Research Database (Denmark)

    Gottrup, F.; Jorgensen, B.; Karlsmark, T.

    2008-01-01

    Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu...... without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 (double blind) and days 43-47 (single blind). The primary response variable, persistent pain relief, was significantly...... higher in the ibuprofen-foam group, as compared with the comparator on day 1-5, with a quick onset of action (p Wound pain intensity was significantly reduced with the ibuprofen foam during day 1-5 with 40% from baseline, compared with 30% with the comparator (p

  14. Outcome of Er,Cr:YSGG laser-assisted treatment of teeth with apical periodontitis: a blind randomized clinical trial.

    Science.gov (United States)

    Martins, Miguel R; Carvalho, Manuel F; Pina-Vaz, Irene; Capelas, Jose A; Martins, Miguel A; Gutknecht, Norbert

    2014-01-01

    As clinical studies conducted to explore the safety and efficacy of new procedures are considered an important focus in endodontic research, the aim of this controlled clinical study was to compare a laser-assisted endodontic treatment using an erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) laser and radial firing tips (RFT) versus the conventional use of 3% sodium hypochlorite and interim calcium hydroxide paste, in teeth with chronic apical periodontitis. Forty-three single-rooted and premolar teeth were randomly assigned. In group 1, teeth were prepared and irrigated with 3% sodium hypochlorite and calcium hydroxide inter-appointment dressing was applied; in group 2 teeth were prepared with saline solution and irradiated with Er,Cr:YSGG laser using RFT2 (140 μs, 37.5 mJ, 20 Hz) and RFT3 (140 μs, 62.5 mJ, 20 Hz) at the first and second appointments, respectively, four times each, moving at 2 mm/sec(-1) from apical to coronal. The primary outcome measure was change in apical bone density at 12 months, using the periapical index (PAI) for blind radiographic assessment. Thirty teeth were examined and subjected to statistical analysis, 12 in the control group and 18 in the test group. There were two treatment failures in the control group that were not included for analysis; both groups exhibited statistically significant decreases in PAI scores. The present findings suggest that for single-rooted and premolar teeth, this laser-assisted protocol can achieve predictable endodontic outcomes, comparable to conventional strategies in 1 year of follow-up.

  15. Natural products for the management of xerostomia: a randomized, double-blinded, placebo-controlled clinical trial.

    Science.gov (United States)

    Navarro Morante, Anabel; Wolff, Andy; Bautista Mendoza, Gloria Rocio; López-Jornet, Pia

    2017-02-01

    The aim of this study was to evaluate the clinical performance of lycopene-enriched virgin olive oil in spray form used to treat patients with drug-induced xerostomia, comparing this with a placebo spray. This double-blind, randomized clinical trial included elderly subjects with drug-induced xerostomia (n = 60). Resting salivary flow was measured using the draining technique. The Xerostomia Inventory (XI) was used to assess symptoms and the Oral Health Impact Profile 14 (OHIP-14) to assess patient quality of life. Evaluations were made before and after 12 weeks of product/placebo application. Sixty patients took part in the study. Symptoms improved among the treatment group (n = 30) after 12 weeks in the following XI domains: 'Rate the difficulty you experience in speaking because of dryness' (P = 0.03); 'Rate how much saliva is in your mouth' (P = 0.03); and 'Rate the dryness of your lips' (P = 0.04). The placebo group (n = 30) underwent improvements in: 'Rate how much saliva is in your mouth' (P = 0.02) and 'Rate the dryness of your mouth' (P = 0.01). A significant improvement (P = 0.001) in oral-related quality of life (OHIP-14) was identified in the treatment group, while no significant differences were observed in the placebo group (P > 0.05). The topical application of lycopene-enriched virgin olive oil and its placebo counterpart improved xerostomia-related symptoms significantly (but not salivary flow rate) in patients with drug-induced xerostomia. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  16. Intracorporeal pneumatic shock application for the treatment of chronic plantar fasciitis: a randomized, double blind prospective clinical trial.

    Science.gov (United States)

    Dogramaci, Yunus; Kalaci, Aydiner; Emir, Anil; Yanat, Ahmet Nedim; Gökçe, Ahmet

    2010-04-01

    Plantar fasciitis (PF) is a common clinical condition that usually resolves with non-operative treatments. Extracorporeal shock wave therapy (ESWT) has been used in the treatment of chronic PF not responding to other conservative measures; however, ESWT devices are expensive and available for daily practice in only few centers (In developing countries). A pneumatic lithotripter is a cheap and readily available device which uses pneumatic shock application for the intracorporeal lithotripsy. The aim of this study was to investigate the clinical efficacy of intracorporeal pneumatic shock therapy (IPST) application for the treatment of chronic PF using a cheap and readily available pneumatic lithotripter. A randomized, double-blind, placebo-controlled study was conducted. A total of 50 patients with clinically and radiologically confirmed PF were randomly allocated to either an active- (treatment) (n = 25) or inactive (placebo) (n = 25) group. Under local anesthesia and posterior tibial nerve block, a rigid probe was directly introduced into the calcaneal spur under fluoroscopic control; a standard protocol of 1,000 shock was applied during a single session into the calcaneal spur. The main outcome measure was the patients' subjective assessment of pain by means of a Visual Analog Scale (VAS) and the Roles and Maudsley Score before the treatment and 6 months later. At the 6 months, the rate of successful outcomes (excellent + good results) in the treatment group (92%) were significantly higher comparing to the control group (24%) (P < 0.001). Heel pain measured 6 months after using the VAS were 2.04 +/- 1.67 in treatment group and 7.16 +/- 1.57 in control group as compared to 8.92 +/- 1.22 and 9.12 +/- 1.23 before the commencement of the treatment. No complications attributable to the procedure such as rupture of the planter fascia, hematoma, or infection were observed during the study. This pilot study showed that IPST is an effective and safe method of treatment of

  17. The effectiveness of moxibustion for the treatment of functional constipation: a randomized, sham-controlled, patient blinded, pilot clinical trial

    Directory of Open Access Journals (Sweden)

    Park Ji-Eun

    2011-12-01

    Full Text Available Abstract Background Moxibustion is an ancient traditional medicine using burning mugworts to stimulate acupuncture points. The aim of this study was to investigate the safety and efficacy of moxibustion for the treatment of constipation using a randomized, sham-controlled, participant-blinded, pilot trial. Methods Twenty-six participants (identified with either qi (vital energy deficiency or qi excess syndrome were randomly divided into either a moxibustion or sham group. Participants were treated with real or sham moxibustion at 4 acupuncture points, ST23 and ST27, bilaterally, 3 times per week for four weeks. The primary outcome was the frequency of defecations; secondary outcomes were the Bristol stool form scale (BSS and the constipation assessment scale (CAS. Results Of the 26 participants that were randomized, 24 completed the study. Defecation frequency, BSS, and CAS showed no difference between the moxibustion and sham groups. The differences were -0.25 (95% CI: -2.08, 1.58, p = 0.78, -1.22 (95% CI: -2.7, 0.26, p = 0.1, 0.91 (95% CI: -1.46, 3.28, p = 0.44 in defecation frequency, BSS, CAS, respectively. The defecation frequency increased from an average of 3.3 to 4.6 times per week in the moxibustion group (1.5[-0.5, 2], p = 0.06 and from 2.7 to 3.7 stools per week in the sham group (1[-1, 2], p = 0.15 after four weeks of treatment. The difference between participants with a deficiency or an excess syndrome, determined based on assessment of sweat, facial features, pain, body energy, and pulse type, was significant in only defecation frequency. The difference was 3.3 (95% CI: 0.41, 6.19, p = 0.03. Conclusion Moxibustion treatment appears safe, but showed no positive effect on constipation. The effectiveness of moxibustion treatment may depend on the syndrome pattern, and further long-term studies with a larger number of subjects are warranted. Trial registration Clinical Research Information Service, KCT0000168

  18. Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation.

    Science.gov (United States)

    Pokhis, Karina; Bitterlich, Norman; Cornelli, Umberto; Cassano, Giuseppina

    2015-01-01

    The purpose of this clinical study was to ascertain whether low molecular weight chitosan polyglucosamine is able to produce significantly better weight loss than placebo. 115 participants were included in the study. We used a two-center randomized, double blind, placebo-controlled design. The participants followed a standard treatment (ST), which included the combination of a low-calorie diet achieved through creating a daily calorie deficit (500 cal) and an increased daily physical activity (7 MET-h/week). They were randomized to receive standard treatment plus placebo (ST + PL) or standard treatment plus polyglucosamine (ST + PG), respectively. Participants were instructed to take 2 × 2 tablets before the two meals containing the highest fat content for at least 24 weeks. Body weight, BMI, waist circumference and the time needed for a 5 % body weight reduction (5R) were taken as main variables. The average weight loss over a period of 25 weeks in the ITT population was 5.8 ± 4.09 kg in the ST + PG group versus 4.0 ± 2.94 kg in the ST + PL (pU = 0.023; pt = 0.010). After 25 weeks, 34 participants achieved 5R in the ST + PG group (64.1 %) compared to only 23 participants in the ST + PL group (42.6 %) (ITT) (p Fisher = 0.033). Weight loss through hypo-caloric diets have been found to be effective. The additional effect of PG in combination with standard treatment is able to produce significantly better weight loss than placebo. Participants treated with ST + PG showed a significant amount of weight loss, an additional 1.8 kg, compared to controls treated with ST + PL. Trial Registration at ClinicalTrials.gov: NCT02410785 Registered 07 April 2015.

  19. Low and high-frequency TENS in post-episiotomy pain relief: a randomized, double-blind clinical trial

    Science.gov (United States)

    Pitangui, Ana C. R.; Araújo, Rodrigo C.; Bezerra, Michelle J. S.; Ribeiro, Camila O.; Nakano, Ana M. S.

    2014-01-01

    Objective To evaluate the effectiveness of low-frequency TENS (LFT) and high-frequency TENS (HFT) in post-episiotomy pain relief. Method A randomized, controlled, double-blind clinical trial with placebo composed of 33 puerperae with post-episiotomy pain. TENS was applied for 30 minutes to groups: HFT(100 Hz; 100 µs), LFT (5 Hz; 100 µs), and placebo (PT). Four electrodes were placed in parallel near the episiotomy and four pain evaluations were performed with the numeric rating scale. The first and the second evaluation took place before TENS application and immediately after its removal and were done in the resting position and in the activities of sitting and ambulating. The third and fourth evaluation took place 30 and 60 minutes after TENS removal, only in the resting position. Intragroup differences were verified using the Friedman and Wilcoxon tests, and the intergroup analysis employed the Kruskal-Wallis test. Results In the intragroup analysis, there was no significant difference in the PT during rest, sitting, and ambulation (P>0.05). In the HFT and LFT, a significant difference was observed in all activities (P<0.001). In the intergroup analysis, there was a significant difference in the resting position in the HFT and LFT (P<0.001). In the sitting activity, a significant difference was verified in the second evaluation in the HFT and LFT (P<0.008). No significant difference was verified among the groups in ambulation (P<0.20). Conclusions LFT and HFT are an effective resource that may be included in the routine of maternity wards. PMID:24675915

  20. Curcumin as an add-on to antidepressive treatment: a randomized, double-blind, placebo-controlled, pilot clinical study.

    Science.gov (United States)

    Bergman, Joseph; Miodownik, Chanoch; Bersudsky, Yuly; Sokolik, Shmuel; Lerner, Paul P; Kreinin, Anatoly; Polakiewicz, Jacob; Lerner, Vladimir

    2013-01-01

    Depression is a widespread mental disorder in which nearly half of the affected people have recurrent symptoms. Drug combinations may produce cumulative adverse effects, especially in elderly and physically ill patients. It was demonstrated that curcumin possesses antidepressive activity in various animal models of depression, and a combination of curcumin with some antidepressants potentiates the antidepressive effect of these agents. We sought to evaluate the efficacy of curcumin as an antidepressive agent in a combination with other antidepressants in patients with major depression. Forty patients with a first episode of depression participated in a 5-week, double-blind, randomized, placebo-controlled study. The subjects were treated with either 500-mg/d curcumin or placebo together with antidepressants (escitalopram or venlafaxine) during August 2010 until June 2011. The outcome measures were Clinical Global Impression-Severity Scale, Hamilton Depression Rating Scale, and Montgomery-Asberg Depression Rating Scale. Analysis of variance showed significant positive changes in both groups from baseline to the end of the study in all scales of measurement. These changes became significant from the first visit after 7 days of treatment. There was no difference between curcumin and placebo, which means negative results. However, the patients in the curcumin group demonstrated a trend to a more rapid relief of depressive symptoms in comparison to those in the placebo group. None of the patients complained of any adverse effect during the study. Although there is no definitive proof that curcumin can induce an earlier beneficial effect of antidepressive agents, it seems like an extended study is needed to prove it, using higher therapeutic doses of curcumin.

  1. Intra-articular morphine versus bupivacaine for knee motion among patients with osteoarthritis: randomized double-blind clinical trial

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    Miriam Bellini Gazi

    Full Text Available CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of elderly people. The aim of the present study was to assess the efficacy of intra-articular morphine and bupivacaine on the joint flexion and extension angles of patients with knee osteoarthritis. DESIGN AND SETTING: A randomized double-blind study was performed at a pain clinic of Universidade Federal de São Paulo. METHODS: Thirty-nine patients with pain for more than three months, of intensity greater than three on a numerical scale (zero to 10, were included. G1 patients received 1 mg (1 ml of morphine diluted in 9 ml of saline, intra-articularly, and G2 patients received 25 mg (10 ml of 0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee flexion and extension angles were measured after administration of the drugs at rest and during movement. The total amount of analgesic supplementation using 500 mg doses of paracetamol was also determined. RESULTS: No significant difference in pain intensity was observed between G1 and G2. Significant decreases in pain at rest and during movement and significant increases in mean flexion and extension angles were observed in both groups, with no significant difference between the two groups. The mean total amount of paracetamol used over a seven-day period was 3578 mg in G1 and 5333 mg in G2 (P = 0.2355; Mann-Whitney test. CONCLUSION: The analgesic effects of 1 mg of morphine and 25 mg of 0.25% bupivacaine were similar among patients with osteoarthritis of the knee.

  2. Homeopathy for mental fatigue: lessons from a randomized, triple blind, placebo-controlled cross-over clinical trial

    Directory of Open Access Journals (Sweden)

    Dean Michael

    2012-10-01

    Full Text Available Abstract Background Difficulty in controlling attention can lead to mental fatigue in the healthy population. We identified one trial reporting a benefit in patients’ attention using a homeopathic formula preparation. One component of the preparation was potassium phosphate, widely available off the shelf as Kali phos 6x for cognitive problems. The aim of this exploratory trial was to assess the effectiveness of Kali phos 6x for attention problems associated with mental fatigue. Methods We recruited student and staff volunteers (University of York with self-reported mental fatigue, excluding any using homeopathy or prescribed stimulants, or with a diagnosis of chronic fatigue syndrome. In a triple blind, cross-over, placebo-controlled clinical trial, 86 volunteers were randomized to receive Kali phos 6x or identical placebo 10 minutes before taking a psychological test of attention (Stroop Colour-Word Test. One week later they were crossed over and took the other preparation before repeating the test. Results We found no evidence of a treatment effect in a comparison of Kali phos 6x with placebo (Kali phos minus placebo = −1.1 (95% CI −3.0 to 0.9, P = 0.3 Stroop score units, Cohen effect size = −0.17 even when allowing for a weak period effect with accuracy scores in the second period being higher than those in the first (P = 0.05. We observed a ceiling effect in the Stroop test which undermined our ability to interpret this result. Conclusions Kali phos 6x was not found to be effective in reducing mental fatigue. A ceiling effect in our primary outcome measure meant that we could not rule out a type II error. Thorough piloting of an adequate outcome measure could have led to an unequivocal result. Current Controlled Trials ISRCTN16521161

  3. Low and high-frequency TENS in post-episiotomy pain relief: a randomized, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Ana C. R. Pitangui

    2014-01-01

    Full Text Available Objective: To evaluate the effectiveness of low-frequency TENS (LFT and high-frequency TENS (HFT in post-episiotomy pain relief. Method: A randomized, controlled, double-blind clinical trial with placebo composed of 33 puerperae with post-episiotomy pain. TENS was applied for 30 minutes to groups: HFT(100 Hz; 100 µs, LFT (5 Hz; 100 µs, and placebo (PT. Four electrodes were placed in parallel near the episiotomy and four pain evaluations were performed with the numeric rating scale. The first and the second evaluation took place before TENS application and immediately after its removal and were done in the resting position and in the activities of sitting and ambulating. The third and fourth evaluation took place 30 and 60 minutes after TENS removal, only in the resting position. Intragroup differences were verified using the Friedman and Wilcoxon tests, and the intergroup analysis employed the Kruskal-Wallis test. Results: In the intragroup analysis, there was no significant difference in the PT during rest, sitting, and ambulation (P>0.05. In the HFT and LFT, a significant difference was observed in all activities (P<0.001. In the intergroup analysis, there was a significant difference in the resting position in the HFT and LFT (P<0.001. In the sitting activity, a significant difference was verified in the second evaluation in the HFT and LFT (P<0.008. No significant difference was verified among the groups in ambulation (P<0.20. Conclusions: LFT and HFT are an effective resource that may be included in the routine of maternity wards.

  4. Randomized, double-blind, placebo-controled clinical trial of sublingual immunotherapy in natural rubber latex allergic patients

    Directory of Open Access Journals (Sweden)

    Audicana Maria T

    2011-08-01

    Full Text Available Abstract Background Natural rubber latex allergy is a common and unsolved health problem. Since the avoidance of exposure is very difficult, immunotherapy is strongly recommended, but before its use in patients, it is essential to prove the efficacy and safety of extracts. The aim of the present randomised, double-blind, placebo-controlled clinical trial was to assess the efficacy and tolerability of latex sublingual immunotherapy in adult patients undergoing permanent latex avoidance. Methods Twenty-eight adult latex-allergic patients (5 males and 23 females, with mean age of 39 years (range 24-57 were randomized to receive a commercial latex-sublingual immunotherapy or placebo during one year, followed by another year of open, active therapy. The following outcomes were measured at baseline and at the end of first and second year of follow-up: skin prick test, gloves-use score, conjunctival challenge test, total and specific IgE, basophil activation test, and adverse reactions monitoring. Results No significant difference in any of the efficacy in vivo variables was observed between active and placebo groups at the end of the placebo-controlled phase, nor when each group was compared with their baseline values at the end of the two year-study. An improvement in the average percentage of basophils activated was observed. During the induction phase, 4 reactions in the active group and 5 in the placebo group were recorded. During the maintenance phase, two patients dropped out due to pruritus and to acute dermatitis respectively. Conclusion Further studies are needed to evaluate latex-sublingual immunotherapy, since efficacy could not be demonstrated in adult patients with avoidance of the allergen. Trial registration number ACTRN12611000543987

  5. Effect of tomato consumption on high-density lipoprotein cholesterol level: a randomized, single-blinded, controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Cuevas-Ramos D

    2013-07-01

    Full Text Available Daniel Cuevas-Ramos,1 Paloma Almeda-Valdés,1 Emma Chávez-Manzanera,1 Clara Elena Meza-Arana,2 Griselda Brito-Córdova,1 Roopa Mehta,1 Oscar Pérez-Méndez,3 Francisco J Gómez-Pérez1 1Department of Endocrinology and Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; 2Department of Internal Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; 3Department of Molecular Biology, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico Introduction: Epidemiologic evidence suggests that tomato-based products could reduce the risk of cardiovascular diseases. One of the main cardiovascular risk factors is low levels of high-density lipoprotein cholesterol (HDL-C. This study aimed to prospectively evaluate the effect of tomato consumption on HDL-C levels. Subject and methods: We conducted a randomized, single-blinded, controlled clinical trial. We screened 432 subjects with a complete lipid profile. Those individuals with low HDL-C (men 40 mg/dL. A linear regression model that adjusted for those parameters that impact HDL-C levels (age, gender, waist-to-hip ratio, body mass index, fasting triglyceride concentration, simple sugars, alcohol, physical activity, and omega-3 consumption showed an independent association between tomato consumption and the increase in HDL-C (r2 = 0.69; P > 0.0001. Conclusion: Raw tomato consumption produced a favorable effect on HDL-C levels in overweight women. Keywords: lycopene, hypoalphalipoproteinemia, dyslipidemia, overweight, cardiovascular diseases

  6. Treatment of Palmar Hyperhidrosis with Tap Water Iontophoresis: A Randomized, Sham-Controlled, Single-Blind, and Parallel-Designed Clinical Trial

    OpenAIRE

    Kim, Do Hun; Kim, Tae Han; Lee, Seung Ho; Lee, Ai Young

    2017-01-01

    Background Palmar hyperhidrosis is a common disorder of excessive sweating. A number of studies have demonstrated the effectiveness of iontophoresis in the treatment of palmar hyperhidrosis. However, controlled clinical studies on iontophoresis for palmar hyperhidrosis have been limited. Objective To determine the efficacy and safety of iontophoresis in the treatment of palmar hyperhidrosis with a randomized, sham-controlled, single-blind, and parallel-designed study. Methods Twenty nine pati...

  7. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Using a Low-Frequency Magnetic Field in the Treatment of Musculoskeletal Chronic Pain

    OpenAIRE

    Alex W Thomas; Karissa Graham; Frank S Prato; Julia McKay; Patricia Morley Forster; Dwight E Moulin; Sesh Chari

    2007-01-01

    Exposure to a specific pulsed electromagnetic field (PEMF) has been shown to produce analgesic (antinociceptive) effects in many organisms. In a randomized, double-blind, sham-controlled clinical trial, patients with either chronic generalized pain from fibromyalgia (FM) or chronic localized musculoskeletal or inflammatory pain were exposed to a PEMF (400 μT) through a portable device fitted to their head during twice-daily 40 min treatments over seven days. The effect of this PEMF on pain re...

  8. A prospective, randomized, double blind controlled trial

    African Journals Online (AJOL)

    Effects of intravenous diclofenac on postoperative sore throat in patients undergoing laparoscopic surgery at Aga Khan University Hospital, Nairobi: A prospective, randomized, double blind controlled trial.

  9. Chlorhexidine alcohol base mouthrinse versus Chlorhexidine formaldehyde base mouthrinse efficacy on plaque control: Double blind, randomized clinical trials

    OpenAIRE

    Ennibi, Oumkeltoum; Lakhdar, Leila; Bouziane, Amal; Bensouda, Yahia; Abouqal, Redouane

    2012-01-01

    Background: Chlorhexidine is well known for its antiplaque effect. However, the mouthrinse based chlorhexidine antiplaque efficiency may vary according to the formulation of the final product. The aim of the present study was to compare anti-plaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F). Material and Methods: the study was a seven day randomized, double-blind,...

  10. Professional brushing study comparing the effectiveness of sonic brush heads with manual toothbrushes: a single blinded, randomized clinical trial.

    Science.gov (United States)

    Pelka, Anna-Kristina; Nagler, Tonia; Hopp, Imke; Petschelt, Anselm; Pelka, Matthias Anton

    2011-08-01

    The aim of this study was to evaluate the plaque removal efficacy of four toothbrushes: the Philips Sonicare Elite with medium and mini brush heads, the Elmex Sensitive, and the American Dental Association (ADA) reference toothbrush. This study was a randomized, controlled, investigator-blinded, four-brush crossover design study, which examined plaque removal following a consecutive repeated use. All brushes were used on each participant in a randomly assigned quadrant of the mouth. A total of 90 subjects participated in the study. Prior to the experiment, they received a professional prophylaxis and were requested to refrain from toothbrushing for 48 h. Teeth were professionally brushed consecutively for 10 to 90 s per quadrant. A Turesky-modified Quigley Hein Index score was assessed at baseline and after each brushing interval by one blinded investigator. Results showed reduction of mean plaque scores for all brushes with time from 10 to 90 s. After 30 s (2-min whole mouth equivalent) of brushing, the Sonicare brushes cleaned 19, the ADA brush 16, and the Elmex Sensitive 10 of in average 28 tooth surfaces. With time, the number of additional cleaned surfaces decreased. Time is an important variable in the evaluation of plaque-removing efficacy since absolute efficacy increases with time and differs per toothbrush. No differences could be found between the two brush heads of the Sonicare.

  11. Randomized double-blind clinical trial comparing two anesthetic techniques for ultrasound-guided transvaginal follicular puncture.

    Science.gov (United States)

    Oliveira, Gilvandro Lins de; Serralheiro, Fernando Cesar; Fonseca, Fernando Luiz Affonso; Ribeiro, Onésimo Duarte; Adami, Fernando; Christofolini, Denise Maria; Bianco, Bianca; Barbosa, Caio Parente

    2016-01-01

    To compare the anesthetic techniques using propofol and fentanyl versus midazolam and remifentanil associated with a paracervical block with lidocaine in performing ultrasound-guided transvaginal oocyte aspiration. A randomized double-blind clinical trial (#RBR-8kqqxh) performed in 61 women submitted to assisted reproductive treatment. The patients were divided into two groups: anesthetic induction with 1mcg/kg of fentanyl associated with 1.5mg/kg of propofol (FP Group, n=32), in comparison with anesthetic induction using 0.075mg/kg of midazolam associated with 0.25mcg/kg/min of remifentanil, and paracervical block with 3mL of 2% lidocaine (MRPB Group, n=29). Main outcome measures: human reproduction outcomes, modified Aldrete-Kroulik index, hemodynamic parameters, and salivary cortisol. The results revealed a higher number of embryos formed in the FP Group (p50=2 versus 1; p=0.025), gestation rate two times higher in the FP Group (44.4% versus 22.2%; p=0.127), less time to reach AK=10 in the MRPB Group (p50=10 versus 2; panestesia com 1mcg/kg de fentanil associada com 1,5mg/kg de propofol (Grupo FP, n=32), em comparação com ao grupo submetido à indução da anestesia utilizando 0,075mg/kg de midazolam associada com 0,25mcg/kg/min de remifentanil, e bloqueio paracervical com 3mL de lidocaína a 2% (Grupo MRBP, n=29). Foram avaliados os resultados reprodutivos, índice modificado de Aldrete e Kroulik, parâmetros hemodinâmicos e cortisol salivar. Foi encontrado um número mais elevado de embriões formados no Grupo FP (p50=2 versus 1; p=0,025), taxa de gestação duas vezes mais elevada no Grupo FP (44,4% versus 22,2%; p=0,127), menos tempo para alcançar AK=10 no Grupo MRBP (p50=10 versus 2; panestesias (com fentanil e propofol, e com midazolam, remifentanil e bloqueio paracervical) ofereceram condições anestésicas satisfatórias na realização de procedimentos realizados em reprodução assistida, proporcionando conforto para o paciente e médico.

  12. Clinical application of probiotics in type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Tonucci, Livia Bordalo; Olbrich Dos Santos, Karina Maria; Licursi de Oliveira, Leandro; Rocha Ribeiro, Sonia Machado; Duarte Martino, Hercia Stampini

    2017-02-01

    Type 2 diabetes has been associated with dysbiosis and one of the possible routes to restore a healthy gut microbiota is by the regular ingestion of probiotics. We aimed to investigate the effects of probiotics on glycemic control, lipid profile, inflammation, oxidative stress and short chain fatty acids in T2D. In a double-blind, randomized, placebo-controlled trial, 50 volunteers consumed daily 120 g/d of fermented milk for 6 wk. Participants were assigned into two groups: probiotic group, consuming fermented milk containing Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp lactis BB-12 (10 9  colony-forming units/d, each) and control group, consuming conventional fermented milk. Anthropometric measurements, body composition, fasting blood and faecal samples were taken at baseline and after 6 wk. 45 subjects out of 50 (90%) completed follow-up. After 6 wk, there was a significant decrease in fructosamine levels (-9.91 mmol/L; p = 0.04) and hemoglobin A 1 c tended to be lower (-0.67%; p=0.06) in probiotic group. TNF-α and resistin were significantly reduced in probiotic and control groups (-1.5 and -1.3 pg/mL, -.1 and -2.8 ng/mL, respectively), while IL-10 was significantly reduced (- 0.65 pg/mL; p probiotic and control groups, respectively; p probiotic group; p=0.02), total cholesterol (+0.55 for control group vs -0.15 for probiotic group; p=0.04) and LDL-cholesterol (+0.36 for control group vs -0.20 for probiotic group p=0.03). Probiotic consumption improved the glycemic control in T2D subjects, however, the intake of fermented milk seems to be involved with others metabolic changes, such as decrease in inflammatory cytokines (TNF-α and resistin) and increase in the acetic acid. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  13. Complementary feeding with cowpea reduces growth faltering in rural Malawian infants: a blind, randomized controlled clinical trial.

    Science.gov (United States)

    Stephenson, Kevin B; Agapova, Sophia E; Divala, Oscar; Kaimila, Yankho; Maleta, Kenneth M; Thakwalakwa, Chrissie; Ordiz, M Isabel; Trehan, Indi; Manary, Mark J

    2017-12-01

    Background: Growth faltering is common in rural African children and is attributed to inadequate dietary intake and environmental enteric dysfunction (EED). Objective: We tested the hypothesis that complementary feeding with cowpea or common bean flour would reduce growth faltering and EED in 6-mo-old rural Malawians compared with the control group receiving a corn-soy blend. Design: A prospective, double-blind, randomized controlled clinical trial was conducted in which children received daily feeding for 6 mo (200 kcal/d when 6-9 mo old and 300 kcal/d when 10-12 mo old). The primary outcomes were change in length-for-age z score (LAZ) and improvements in EED, as measured by percentage of lactulose excretion (%L). %L group and the control group with Student's t test. Results: Of the 355 infants enrolled, 291 infants completed the trial, and 288 were breastfed throughout the duration of the study. Cowpea and common bean added 4.6-5.2 g protein/d and 4-5 g indigestible carbohydrate/d to the diet. LAZ and weight-for-height z score were reduced in all 3 groups from 6 to 12 mo of age. The changes in LAZ [mean (95% CI)] for the cowpea, common bean, and control groups from 6 to 9 mo were -0.14 (-0.24, -0.04), -0.27 (-0.38, -0.16), and -0.27 (-0.35, -0.19), respectively. LAZ was reduced less in infants receiving cowpea than in those receiving control food from 6 to 9 mo ( P = 0.048). The absolute value of %L did not differ between the dietary groups at 9 mo of age (mean ± SD: 0.30 ± 0.43, 0.23 ± 0.21, and 0.26 ± 0.31 for cowpea, common bean, and control, respectively), nor did the change in %L from 6 to 9 mo. Conclusion: Addition of cowpea to complementary feeding in Malawian infants resulted in less linear growth faltering. This trial was registered at clinicaltrials.gov as NCT02472262. © 2017 American Society for Nutrition.

  14. Clinical and microbiological evaluation of the effect of Lactobacillus reuteri in the treatment of mucositis and peri-implantitis: A triple-blind randomized clinical trial.

    Science.gov (United States)

    Galofré, M; Palao, D; Vicario, M; Nart, J; Violant, D

    2018-01-19

    Oral probiotics appear to improve the treatment of periodontal diseases but there is limited evidence on their efficacy in the treatment of peri-implant diseases. The objective of the present study was to evaluate, clinically and microbiologically, the effect of the oral probiotic, Lactobacillus reuteri Prodentis, as adjuvant to non-surgical mechanical therapy in implants with mucositis or peri-implantitis, placed in patients with a history of periodontal disease. A randomized, controlled, parallel-design, triple-blind prospective clinical study was designed. Patients included in the study were partially edentulous and had implants with mucositis or peri-implantitis. Implants with radiographic bone loss of ≥5 mm and/or ≥50% of the implant length were excluded, and only one implant per patient was included. After non-surgical mechanical therapy, subjects were randomly assigned to take either 1 probiotic lozenge or 1 placebo lozenge every day for 30 days. Clinical measurements were taken in the whole mouth (general plaque index and general bleeding on probing) and at the implant site (probing pocket depth, plaque index and bleeding on probing) at baseline and 30 and 90 days Microbiological examination (to identify Aggregatibacter actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Treponema denticola, Prevotella intermedia, Peptostreptococcus micros, Fusobacterium nucleatum, Campylobacter rectus and Eikenella corrodens) was performed at the same study time points that clinical measurements were made. A total of 44 patients - 22 with mucositis and 22 with peri-implantitis - randomly received treatment with either probiotic or placebo. The probiotic L. reuteri, together with mechanical therapy, produced an additional improvement over treatment with mechanical therapy alone, both in the general clinical parameters of patients with mucositis (bleeding on probing) and at the level of implants with mucositis (probing pocket depth) or peri

  15. Symptoms after ingestion of pig whipworm Trichuris suis eggs in a randomized placebo-controlled double-blind clinical trial

    DEFF Research Database (Denmark)

    Bager, Peter; Kapel, Christian Moliin Outzen; Roepstorff, Allan Knud

    2011-01-01

    21 days for 168 days (total 8 doses) in a double-blind clinical trial. In a previous publication, we reported a lack of efficacy and a high prevalence of adverse gastrointestinal reactions. The aim of the present study was to present a detailed description of the adverse event data and post...... reactions lasting up to 14 days, whereas 4 months further treatment mainly provoked a subclinical stimulation. TRIAL REGISTRATION: University hospital Medical Information Network trial registry Reg. no. R000001298, Trial ID UMIN000001070....

  16. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Dali, Christine í; Hansen, Flemming Juul; Pedersen, Søren Anker

    2002-01-01

    stimulation (TES). Two thirds received active and one third received inactive stimulators. For the primary outcome we constructed a set of plausible motor function tests and studied the change in summary indices of the performance measurements. Tests were videotaped and assessed blindly to record qualitative......). There was no significant difference between active and placebo treatment in any of the tested groups, nor combined. Visual and subjective assessments favoured TES (ns), whereas objective indices showed the opposite trend. We conclude that TES in these patients did not have any significant clinical effect during the test...

  17. Effects of Transcranial Direct Current Stimulation Block Remifentanil-Induced Hyperalgesia: A Randomized, Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Gilberto Braulio

    2018-02-01

    Full Text Available Background: Remifentanil-induced hyperalgesia (r-IH involves an imbalance in the inhibitory and excitatory systems. As the transcranial Direct Current Stimulation (tDCS modulates the thalamocortical synapses in a top-down manner, we hypothesized that the active (a-t-DCS would be more effective than sham(s-tDCS to prevent r-IH. We used an experimental paradigm to induce temporal summation of pain utilizing a repetitive cold test (rCOLDT assessed by the Numerical Pain Score (NPS 0-10 and we evaluated the function of the descending pain modulatory system (DPMS by the change on the NPS (0–10 during the conditioned pain modulation (CPM-task (primary outcomes. We tested whether a-tDCS would be more effective than s-tDCS to improve pain perception assessed by the heat pain threshold (HPT and the reaction time during the ice-water pain test (IPT (secondary outcomes.Methods: This double-blinded, factorial randomized trial included 48 healthy males, ages ranging 19–40 years. They were randomized into four equal groups: a-tDCS/saline, s-tDCS/saline, a-tDCS/remifentanil and s-tDCS/remifentanil. tDCS was applied over the primary motor cortex, during 20 min at 2 mA, which was introduced 10 min after starting remifentanil infusion at 0.06 μg⋅kg-1⋅min-1 or saline.Results: An ANCOVA mixed model revealed that during the rCOLDT, there was a significant main effect on the NPS scores (F = 3.81; P = 0.01. The s-tDCS/remifentanil group presented larger pain scores during rCOLDT, [mean (SD 5.49 (1.04] and a-tDCS/remifentanil group had relative lower pain scores [4.15 (1.62]; showing its blocking effect on r-IH. a-tDCS/saline and s-tDCS/saline groups showed lowest pain scores during rCOLDT, [3.11 (1.2] and [3.15 (1.62], respectively. The effect of sedation induced by remifentanil during the rCOLDT was not significant (F = 0.76; P = 0.38. Remifentanil groups showed positive scores in the NPS (0–10 during the CPM-task, that is, it produced a disengagement of

  18. A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy

    Science.gov (United States)

    Kerson, Cynthia

    2013-01-01

    Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large…

  19. A randomized, double‑blind clinical study to assess the antiplaque and antigingivitis efficacy of Aloe vera mouth rinse

    Directory of Open Access Journals (Sweden)

    Bathini Chandrahas

    2012-01-01

    Full Text Available Aims: To evaluate the efficacy of Aloe Vera mouth rinse on experimental plaque accumulation and gingivitis. Materials and Methods: In this randomized, controlled, and double-blind study, a total of 148 systemically healthy subjects were screened in the age group of 18-25 years. Finally, 120 subjects were requested to abstain from oral hygiene (tooth brushing for 14 days and used a specially fabricated plaque guard. Following cessation of tooth brushing in the specified area, the subjects were randomly divided into Group A (test group who received 100% Aloe vera, Group B (negative control group who received placebo (distilled water, and Group C (positive control group who received 0.2% chlorhexidine. The rinse regimen began on the 15 th day and continued for 7 days. Plaque accumulation was assessed by Plaque Index (PI and gingivitis was assessed by Modified Gingival Index (MGI and Bleeding Index (BI at baseline (0, 7 th , 14 th , and 22 nd days. Results: There was statistically significant decrease in PI, MGI, and BI scores after the rinse regimen began in both Group A (test group and Group C (chlorhexidine compared with Group B. Mouth wash containing Aloe vera showed significant reduction of plaque and gingivitis but when compared with chlorhexidine the effect was less significant. Conclusion: Aloe vera mouthwash can be an effective antiplaque agent and with appropriate refinements in taste and shelf life can be an affordable herbal substitute for chlorhexidine.

  20. Double-blind placebo-controlled randomized clinical trial on the use of paracetamol for performing mammography.

    Science.gov (United States)

    Freitas-Junior, Ruffo; Martins, Edesio; Metran-Nascente, Cristiane; Carvalho, Angela Assis; Silva, Marilceia Ferreira da; Soares, Leonardo Ribeiro; Ximenes, Carlos Alberto

    2018-03-01

    This study was conducted within the Goias Mastology Research Network. To verify the possibility of diminishing pain, and discomfort during the mammography using analgesic administration. Randomized, double-blinded, placebo controlled trial, testing paracetamol to diminish the pain, and discomfort during mammography. Three hundred patients who came for screening mammography were randomized for this study. A questionnaire with 2 parts was used: the first had questions that concerned the patient identification, and factors related to the pain during mammography; and the second asked about the scale of discomfort (no discomfort; uncomfortable; very uncomfortable; intolerable), and the pain (analogical linear scale) during the mammography. Each patient received 1000 mg of paracetamol, or placebo. Afterwards each patient filled out the second part of the questionnaire. Six patients were excluded from the analysis; this resulted in 149 in the paracetamol group, and 145 in the placebo group. The 2 groups were homogenous concerning the mean of the ages, weight, height, and breast size. The mean of the pain was 3.5 in the paracetamol, and 2.8 in the placebo group (P = .12). There were fewer women experiencing mild pain in the paracetamol group when compared with those in placebo group (relative risk [RR] 0.76, confidence interval [CI] 95% 0.52-0.98). There was no significant difference between the 2 groups, according to the degrees of discomfort (P =  .69). The use of paracetamol can reduces the mild pain for women undergoing mammography.

  1. The effect of counseling on anxiety after traumatic childbirth in nulliparous women; a single blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mahnaz Azizi

    2010-09-01

    Full Text Available Background: Traumatic birthing mothers may expose more susceptible to experiences posttraumatic mental disorder such as anxiety. This study aimed to determine the effect of midwifery counseling intervention on the anxiety level after traumatic childbirth of primiparous women.Methods: In a randomized control trial 180 woman who had experienced traumatic childbirth based on DSM-IV criteria have been selected. The subjects were randomly divided into an intervention (n=90 and control (n=90 groups. The intervention group received midwifery counseling during two sessions and control group just received routin health care after childbirth. Both groups were followed up with partial – blind technique and compared 4-6 weeks and 3 months post partum. The data were analyzed using descriptive statistics by SPSS software. Results: Demographic characteristics, pregnancy complications and social support level were the same in both groups. In addition, there was no significant difference between two groups according to stress, depression and anxiety level before intervention (P>0.05. There was significant difference between two groups in anxiety level after 4-6 weeks and 3 months followup (P<0.001.Conclusion: Findings of this research shows that performing midwifery-counseling program may have significant effect on decreasing of anxiety level after traumatic childbirth.

  2. Evaluation of a Crataegus-Based Multiherb Formula for Dyslipidemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Miao Hu

    2014-01-01

    Full Text Available Background. We for the first time examined the effects of a multiherb formula containing Crataegus pinnatifida (1 g daily, Alisma orientalis, Stigma maydis, Ganoderma lucidum, Polygonum multiflorum, and Morus alba on plasma lipid and glucose levels in Chinese patients with dyslipidemia. Methods. In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c, and laboratory safety parameters were performed before and after treatment. Results. The difference in the changes in low-density lipoprotein cholesterol (LDL-C levels between placebo and active treatment (−9% was significantly (P<0.05 better with active treatment. HbA1c levels significantly decreased by −3.9% in the active treatment group, but the change was not significantly different from that with placebo (−1.1% (P=0.098. There were no apparent adverse effects or changes in laboratory safety parameters with either treatment. Conclusions. The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects.

  3. Single-blind randomized clinical trial to evaluate clinical and radiological outcomes after one year of immediate versus delayed implant placement supporting full-arch prostheses

    Science.gov (United States)

    Pellicer-Chover, Hilario; Peñarrocha-Oltra, David; Bagán, Leticia; Fichy-Fernandez, Antonio J.; Canullo, Luigi

    2014-01-01

    Purpose: To evaluate and compare peri-implant health, marginal bone loss and success of immediate and delayed implant placement for rehabilitation with full-arch fixed prostheses. Material and Methods: The present study was a prospective, randomized, single-blind, clinical preliminary trial. Patients were randomized into two treatment groups. In Group A implants were placed immediately post-extraction and in Group B six months after extraction. The following control time-points were established: one week, six months and twelve months after loading. Measurements were taken of peri-implant crevicular fluid volume, plaque index, gingival retraction, keratinized mucosa, probing depth, modified gingival index and presence of mucositis. Implant success rates were evaluated for the two groups. The study sample included fifteen patients (nine women and six men) with a mean average age of 63.7 years. One hundred and forty-four implants were placed: 76 placed in healed sites and 68 placed immediately. Results: At the moment of prosthetic loading, keratinized mucosa width and probing depth were higher in immediate implants than delayed implants, with statistically significant differences. However, after six and twelve months, differences between groups had disappeared. Bone loss was 0.54 ± 0.39 mm for immediate implants and 0.66 ± 0.25 mm for delayed implants (p=0.201). No implants failed in either group. Conclusions: The present study with a short follow-up and a small sample yielded no statistically significant differences in implant success and peri-implant marginal bone loss between immediate and delayed implants with fixed full-arch prostheses. Peri-implant health showed no statistically significant differences for any of the studied parameters (crevicular fluid volume, plaque index, gingival retraction, keratinized mucosa, probing depth, modified gingival index and presence of mucositis) at the twelve-month follow-up. Key words:Immediate implants, delayed implants

  4. Efficacy of Er,Cr:YSGG laser with endodontical radial firing tips on the outcome of endodontic treatment: blind randomized controlled clinical trial with six-month evaluation.

    Science.gov (United States)

    Martins, M R; Carvalho, M F; Vaz, I P; Capelas, J A; Martins, M A; Gutknecht, N

    2013-07-01

    Clinical reports stating the efficacy of novel root canal disinfection protocols are an important focus in endodontic research. This blind randomized clinical trial assessed the clinical efficacy of the erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) laser radial firing tips (RFT) versus the concomitant use of 3 % sodium hypochlorite and interim calcium hydroxide paste in necrotic teeth with chronic apical periodontitis. We hypothesized to find similar or improved bone healing in the laser-assisted endodontic treatment. Thirty-six anterior and premolar teeth were randomly assigned. In group 1, teeth were prepared with 3 % sodium hypochlorite for irrigation and calcium hydroxide as inter-appointment dressing; in group 2, teeth were prepared with saline solution and irradiated with Er,Cr:YSGG laser using RFT2 (140 μs, 37.5 mJ, 20 Hz) and RFT3 (140 μs, 62.5 mJ, 20 Hz) in the first and second appointment, respectively, four times each, moving at 2 mm s(-1) from apical to coronal. The primary outcome measure was changed in apical bone density at 6 months, using the periapical index (PAI) for blind radiographic evaluation. Twenty-nine patients were examined and subjected to statistical analysis, 12 in group 1 and 17 in group 2. There was one treatment failure in group 1. Both groups gave similar outcomes exhibiting statistically significant decreases in PAI scores.

  5. Azithromycin vs. Placebo for the Clinical Outcome in Campylobacter concisus Diarrhoea in Adults: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Nielsen, Hans Linde; Kirk, Karina Frahm; Bodilsen, Jacob; Ejlertsen, Tove; Nielsen, Henrik

    2016-01-01

    Campylobacter concisus has been associated with prolonged mild diarrhoea, but investigations regarding the efficacy of antimicrobial treatment have not been reported previously. We initiated a phase 3, single-centre, randomized, double-blinded, placebo-controlled study comparing the efficacy of 500 mg once-daily dose of azithromycin with a 500 mg once-daily dose of placebo for three days, for the treatment of C. concisus diarrhoea in adult patients with a follow-up period of ten days. If symptoms persisted at day ten, the patient was offered cross-over study treatment of three days and another ten-day follow-up period. The primary efficacy endpoint was the clinical response, defined as time to cessation of diarrhoea (azithromycin (n = 12) or placebo (n = 12). Both groups presented symptoms of mild, prolonged diarrhoea with a mean duration of 18 days (95% CI: 16-19). One person in the azithromycin group and four from the placebo group chose to continue with crossover medication after the initial ten-day period. In the azithromycin group, there was a mean of seven days (95% CI: 5-9) to clinical cure and for the placebo group it was ten days (95% CI: 6-14) (OR-3 (95% CI: -7-1). We observed no differences in all examined outcomes between azithromycin treatment and placebo. However, due to unforeseen recruitment difficulties we did not reach our estimated sample size of 100 patients and statistical power to conclude on an effect of azithromycin treatment was not obtained. Clinicaltrials.gov identifier: NCT01531218.

  6. Randomized single-blind clinical trial of intradermal methylene blue on pain reduction after open diathermy haemorrhoidectomy.

    Science.gov (United States)

    Sim, H-L; Tan, K-Y

    2014-08-01

    Open haemorrhoidectomy has been associated with considerable postoperative pain and discomfort. Perianal intradermal injection of methylene blue has been shown to ablate perianal nerve endings and may bring about temporary pain relief after haemorrhoidectomy. We hypothesized that the administration of intradermal methylene blue would reduce postoperative pain during the initial period after surgery. A randomized, prospective, single-blind placebo-controlled trial was conducted. Patients were randomized to intradermal injection at haemorrhoidectomy of either 4 ml 1% methylene blue and 16 ml 0.5% marcaine or of 16 ml 0.5% marcaine and 4 ml saline prior to surgical dissection. Patients were asked to fill in a pain diary with a visual analogue scale. The primary outcome measure was pain score and analgesic use. Secondary outcomes were complications. There were 37 patients in the methylene blue arm and 30 patients in the placebo arm. There were no statistically significant differences in the sex, type of haemorrhoid, number of haemorrhoids excised, duration of surgery or hospital stay. The mean pain scores were significantly lower and the use of paracetamol was also significantly less in the methylene blue group during the first three postoperative days. The risk ratio of acute urinary retention occurring when methylene blue was not used was 2.320 (95% CI 1.754-3.067). Other complication rates were not significantly different. Perianal intradermal injection of methylene blue was useful in reducing the initial postoperative pain of open haemorrhoidectomy. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  7. The influence of ginger (Zingiber officinale on human sperm quality and DNA fragmentation: A double-blind randomized clinical trial

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    Jalil Hosseini

    2016-08-01

    Full Text Available Background: Although the effectiveness of ginger as an antioxidant agent has been exploited, little human research has been conducted on its activity on male reproductive functions. Objective: This study was designed to investigate the effects of ginger (Zingiber officinale on sperm DNA fragmentation (SDF in infertile men. Materials and Methods: This randomized double-blind, placebo-controlled trial with a 1:1 allocation was performed on 100 infertility treatment candidates who were admitted to Royan Institute for Reproductive Biomedicine, Tehran, Iran. Patients were randomly assigned to receive one of two treatments: ginger and placebo. Patients were given a 3-month oral treatment (members received capsules containing 250 mg of ginger powder twice a day in ginger and a placebo in other group. Before and after treatment, standardized semen samples were obtained to determine sperm concentration, motility, and SDF according to World Health Organization. Results: There was no significant difference between two groups regarding SDF at baseline (53.48. 95%CI: 37.95-69.02 in cases and (56.75, 95%CI: 40.01-73.5 in controls. The average positive percentage of SDF in patients receiving ginger (17.77, 95%CI: 6.16-29.39 was lower compared with placebo (40.54, 95%CI: 23.94-57.13 after three month of treatment (p=0.02. In multivariate analysis, SDF was significantly lower in patients receiving ginger compared with placebo (mean difference: 3.21, 95%CI: 0.78-5.63, p=0.009. There were no significant differences between two groups regarding to semen parameters. Conclusion: The present study has demonstrated that ginger in a controlled study of efficacy was effective in decreasing SDF in infertile men.

  8. [A clinical study on a randomized, double-blind control of Chinese medicine granules in treatment of vascular dementia].

    Science.gov (United States)

    Zhu, Ai-Hua; Tian, Jin-Zhou; Zhong, Jian; Yang, Cheng-Zhi; Shi, Jing; Yin, Jun-Xiang

    2006-10-01

    To evaluate the effectiveness of Chinese medicine granules (Compound Chinese extract from herbs) in the treatment on senile vascular dementia. One hundred and twenty patients meeting criteria for vascular dementia were selected from patients in Dongzhimen Hospital and were randomly assigned into a treatment group (n = 70 cases), given 1 package of Chinese medicine granules with 1 placebo tablets, and a positive control group (n = 50 cases), given 1 tablets of Duxil with 1 package of placebo. All subjects took this medication 3 times a day for 2 months. Double-blind and double-moulding control were used in this study. At a baseline and end (two months later), all subjects were assessed using a battery consisting of MMSE and Blessed behavior measuring scale. Both Chinese medicine granules and Duxil could remarkably increase the score of cognition and activity (P increasing memory scores. Chinese medicine granules was better than Duxil in increasing the scores of behavior (P < 0.05). Chinese medicine granules has certain effects on vascular dementia. And it has remarkable effectiveness in ameliorating the status of total body. And it can relieve the symptoms in vascular dementia.

  9. Triple combination as adjuvant to cryotherapy in the treatment of solar lentigines: investigator-blinded, randomized clinical trial.

    Science.gov (United States)

    Hexsel, D; Hexsel, C; Porto, M D; Siega, C

    2015-01-01

    Post-inflammatory hyperpigmentation is a frequent concern when treating solar lentigines. To assess the safety and efficacy of a triple combination cream with fluocinolone acetonide 0.01%, hydroquinone 4% and tretinoin 0.05% as adjuvant to cryotherapy in the treatment of solar lentigines in hands dorsum, and in the prevention of post-inflammatory hyperpigmentation after cryotherapy. This prospective, randomized, controlled, investigator-blinded, single-centre study enrolled 50 patients. Twenty-five patients received a 2-week daily triple combination cream plus sunscreen pre-treatment and 25 received sunscreen alone. After that, cryotherapy was performed in all patients followed by a 3-week recovery period. After this period, patients received the same initial treatment and were followed up for 8 weeks. Melanin and erythema levels of a target and a control lentigo were objectively measured using a narrowband reflectance spectrophotometer. Lentigines count, colour homogeneity and global improvement were also assessed. The number of solar lentigines reduced in the first 2 weeks only in patients who used the triple combination 25 ± 7 vs. 22 ± 8 (P cryotherapy were the reported adverse reactions. Triple combination cream can be used to enhance the resolution of solar lentigines, and to significantly reduce melanin levels and lentigines count, improving treatment results. It was well-tolerated and did not increase the occurrence of neither erythema nor other side-effects after the cryotherapy. © 2014 European Academy of Dermatology and Venereology.

  10. Neuroprotective impact of a vitamin trace element composition - a randomized, double blind, placebo controlled clinical trial with healthy volunteers.

    Science.gov (United States)

    Muss, Claus; Mosgoeller, Wilhelm; Endler, Thomas

    2015-01-01

    Neurotoxic metabolites and oxidative and nitrosative stress reactions play a crucial role in the pathways leading to neuronal cell death and neurodegeneration. The bioavailability of the many antioxidant ingredients a vitamin and trace element composition was investigated, to reveal the neuroprotective (preventive) potential of the composition. We recruited 159 healthy volunteers, assigned them randomly and double blind to a placebo and verum group. Physicians excluded volunteers with severe chronic diseases or interfeering medications. 142 participants finished the six month trial. Laboratory parameters were determined 1) before participation, and 2) after three and 3) six months. We confirmed the bioavailability of ingredients, and determined metabolic parameters associated with the integrity of the blood brain barrier, mitochondrial deficiency (Q 10), neurodegeneration (homocystein), and antioxidative capacity (e.g. lipidperoxidation), and superoxiddismutase activity. Starting from baseleine, after three months neuroprotective ingredients increased within their physiological borders, folic acid (p<0.003), pyridoxin (p<0.001), cobalamin (p=0.001), and the fat soluble vitamin tocopherol (p<0.001). In parallel, homocytein decreased after 3 and 6 months (p<0.001, and p<0.025, respectively). Other paramters like zinc reacted slower, significant changes were observed only after 6 months. The observed metabolic changes and alteration of the oxidative status after 3 and six month of regular intake underlines the compositions' potential to ameliorate neurodegenerative processes. We conclude that the subsitution of vitamins and trace-elements with natural source in a proper manner may be effective for neuroprotection in healthy population.

  11. Effects of intrathecal dexmedetomidine on shivering after spinal anesthesia for cesarean section: a double-blind randomized clinical trial.

    Science.gov (United States)

    Nasseri, Karim; Ghadami, Negin; Nouri, Bijan

    2017-01-01

    Shivering is among the common troublesome complications of spinal anesthesia (SA), and causes discomfort and discontentment in parturients undergoing cesarean sections (CSs). The aim of this study was to investigate the effects of intrathecal dexmedetomidine in the prevention of shivering in those who underwent CS under SA. Fifty parturients planned for elective CSs under SA were enrolled in this prospective, double-blinded, controlled study and randomly divided into two equal groups. Spinal block was achieved with 12.5 mg 0.5% heavy bupivacaine plus 5 μg dexmedetomidine (BD group) or 0.5 mL 0.9% normal saline (BN group). The incidence and intensity of shivering, peripheral and core body temperature, hemodynamic parameters, and adverse events was recorded. The incidence of shivering was significantly higher in the BN group (52%) than the BD group (24%) ( P =0.04). Likewise, the intensity of shivering was significantly higher in the BN group than the BD group ( P =0.04). The incidence of adverse events, such as hypotension, nausea/vomiting, and bradycardia, was not significantly different between the two groups, although the grade of sedation was higher in the BD group than the BN group ( P =0.004). We conclude that intrathecal dexmedetomidine is effective in lowering the incidence and intensity of shivering in parturients undergoing CSs under SA without major adverse effects.

  12. Baclofen for maintenance treatment of opioid dependence: A randomized double-blind placebo-controlled clinical trial [ISRCTN32121581

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    Ahmadi-Abhari Seyed Ali

    2003-11-01

    Full Text Available Abstract Background Results of preclinical studies suggest that the GABAB receptor agonist baclofen may be useful in treatment of opioid dependence. This study was aimed at assessing the possible efficacy of baclofen for maintenance treatment of opioid dependence. Methods A total of 40 opioid-dependent patients were detoxified and randomly assigned to receive baclofen (60 mg/day or placebo in a 12-week, double blind, parallel-group trial. Primary outcome measure was retention in treatment. Secondary outcome measures included opioids and alcohol use according to urinalysis and self-report ratings, intensity of opioid craving assessed with a visual analogue scale, opioid withdrawal symptoms as measured by the Short Opiate Withdrawal Scale and depression scores on the Hamilton inventory. Results Treatment retention was significantly higher in the baclofen group. Baclofen also showed a significant superiority over placebo in terms of opiate withdrawal syndrome and depressive symptoms. Non-significant, but generally favorable responses were seen in the baclofen group with other outcome measures including intensity of opioid craving and self-reported opioid and alcohol use. However, no significant difference was seen in the rates of opioid-positive urine tests. Additionally, the drug side effects of the two groups were not significantly different. Conclusion The results support further study of baclofen in the maintenance treatment of opioid dependence.

  13. Effect of Nebulized Morphine on Dyspnea of Mustard Gas-Exposed Patients: A Double-Blind Randomized Clinical Trial Study

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    Majid Shohrati

    2012-01-01

    Full Text Available Background. Dyspnea is one of the main complaints in a group of COPD patients due to exposure to sulfur mustard (SM and is refractory to conventional therapies. We designed this study to evaluate effectiveness of nebulized morphine in such patients. Materials and Methods. In a double-blind clinical trial study, 40 patients with documented history of exposure to SM were allocated to two groups: group 1 who received 1 mg morphine sulfate diluted by 4 cc normal saline 0.5% using nebulizer once daily for 5 days and group 2 serving as control who received normal saline as placebo. They were visited by pulmonologist 7 times per day to check symptoms and signs and adverse events. Different parameters including patient-scored peak expiratory flow using pick flow meter, visual analogue scale (VAS for dyspnea, global quality of life and cough, and number of respiratory rate, night time awaking for dyspnea and cough have been assessed. Results. The scores of VAS for dyspnea, cough and quality of life and also respiratory rate, heart rate, and night time awaking due to dyspnea and night time awaking due to cough improved significantly after morphine nebulization without any major adverse events. Also pick expiratory flow has been improved significantly after nebulization in each day. Conclusion. Our results showed the clinical benefit of nebulized morphine on respiratory complaints of patients due to exposure to SM without significant side effects.

  14. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Using a Low-Frequency Magnetic Field in the Treatment of Musculoskeletal Chronic Pain

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    Alex W Thomas

    2007-01-01

    Full Text Available Exposure to a specific pulsed electromagnetic field (PEMF has been shown to produce analgesic (antinociceptive effects in many organisms. In a randomized, double-blind, sham-controlled clinical trial, patients with either chronic generalized pain from fibromyalgia (FM or chronic localized musculoskeletal or inflammatory pain were exposed to a PEMF (400 μT through a portable device fitted to their head during twice-daily 40 min treatments over seven days. The effect of this PEMF on pain reduction was recorded using a visual analogue scale. A differential effect of PEMF over sham treatment was noticed in patients with FM, which approached statistical significance (P=0.06 despite low numbers (n=17; this effect was not evident in those without FM (P=0.93; n=15. PEMF may be a novel, safe and effective therapeutic tool for use in at least certain subsets of patients with chronic, nonmalignant pain. Clearly, however, a larger randomized, double-blind clinical trial with just FM patients is warranted.

  15. A randomized, double-blind, placebo-controlled clinical trial using a low-frequency magnetic field in the treatment of musculoskeletal chronic pain

    Science.gov (United States)

    Thomas, Alex W; Graham, Karissa; Prato, Frank S; McKay, Julia; Forster, Patricia Morley; Moulin, Dwight E; Chari, Sesh

    2007-01-01

    Exposure to a specific pulsed electromagnetic field (PEMF) has been shown to produce analgesic (antinociceptive) effects in many organisms. In a randomized, double-blind, sham-controlled clinical trial, patients with either chronic generalized pain from fibromyalgia (FM) or chronic localized musculoskeletal or inflammatory pain were exposed to a PEMF (400 μT) through a portable device fitted to their head during twice-daily 40 min treatments over seven days. The effect of this PEMF on pain reduction was recorded using a visual analogue scale. A differential effect of PEMF over sham treatment was noticed in patients with FM, which approached statistical significance (P=0.06) despite low numbers (n=17); this effect was not evident in those without FM (P=0.93; n=15). PEMF may be a novel, safe and effective therapeutic tool for use in at least certain subsets of patients with chronic, nonmalignant pain. Clearly, however, a larger randomized, double-blind clinical trial with just FM patients is warranted. PMID:18080043

  16. Effects of Semelil (ANGIPARSTM on diabetic peripheral neuropathy: A randomized, double-blind Placebo-controlled clinical trial

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    S Bakhshayeshi

    2011-03-01

    Full Text Available "n Background and the purpose of the study: Diabetic neuropathy is the most common diabetic complication that often is accompanied by significant morbidity, mortality and economic burden. The purpose of this study was evaluation of effect of Semelil (ANGIPARSTM, a new herbal drug for treatment of diabetic foot ulcers or diabetic peripheral neuropathy. "nMethods: In this double blind clinical trial, 49 type 2 diabetes patients with different degrees of neuropathy were evaluated in two groups (ANGIPARSTM and placebo groups. All patients were assessed at the start and 12 weeks after treatment, with laboratory tests, United Kingdom screening test, Michigan neuropathy screening score, Michigan diabetic neuropathy score, vibration perception thresholds, nerve conduction study, monofilament test and visual analog scale. "nResults: Michigan diabetic neuropathy score was decreased notably in ANGIPARSTM group. In the nerve conduction study, appropriate meaningful changes were observed in the distal latency and amplitude in the motor Ulnar nerve in ANGIPARSTM group. Conclusion: The results showed limited evidence of efficacy of ANGIPARSTM in diabetic neuropathy treatment and more studies with a larger sample size and longer duration are required.

  17. Combined effects of repeated oral hygiene motivation and type of toothbrush on orthodontic patients: a blind randomized clinical trial.

    Science.gov (United States)

    Marini, Ida; Bortolotti, Francesco; Parenti, Serena Incerti; Gatto, Maria Rosaria; Bonetti, Giulio Alessandri

    2014-09-01

    To investigate the effects on plaque index (PI) scores of manual or electric toothbrush with or without repeated oral hygiene instructions (OHI) and motivation on patients wearing fixed orthodontic appliances. One month after the orthodontic fixed appliance bonding on both arches, 60 patients were randomly assigned to four groups; groups E1 (n  =  15) and E2 (n  =  15) received a powered rotating-oscillating toothbrush, and groups M1 (n  =  15) and M2 (n  =  15) received a manual toothbrush. Groups E1 and M1 received OHI and motivation at baseline (T0) and after 4, 8, 12, 16, and 20 weeks (T4, T8, T12, T16, and T20, respectively) by a Registered Dental Hygienist; groups E2 and M2 received OHI and motivation only at baseline. At each time point a blinded examiner scored plaque of all teeth using the modified Quigley-Hein PI. In all groups the PI score decreased significantly over time, and there were differences among groups at T8, T12, T16, and T20. At T8, PI scores of group E1 were lower than those of group E2, and at T12, T16, and T20, PI scores of groups M1 and E1 were lower compared to those of groups M2 and E2. A linear mixed model showed that the effect of repeated OHI and motivation during time was statistically significant, independently from the use of manual or electric toothbrush. The present results showed that repeated OHI and motivation are crucial in reducing PI score in orthodontic patients, independent of the type of toothbrush used.

  18. Chlorhexidine alcohol base mouthrinse versus Chlorhexidine formaldehyde base mouthrinse efficacy on plaque control: Double blind, randomized clinical trials

    Science.gov (United States)

    Lakhdar, Leila; Bouziane, Amal; Bensouda, Yahia; Abouqal, Redouane

    2013-01-01

    Background: Chlorhexidine is well known for its antiplaque effect. However, the mouthrinse based chlorhexidine antiplaque efficiency may vary according to the formulation of the final product. The aim of the present study was to compare anti-plaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F). Material and Methods: the study was a seven day randomized, double-blind, placebo-controlled trial including 30 volunteers. At the start, all participants received a dental prophylaxis. Over 7 days experimental non-brushing period, during which subjects abstained from all forms of mechanical oral hygiene, one group test rinsed twice daily with 15ml of an alcohol base 0.12% Chlorhexidine mouthrinse. The second group test used 15ml of alcohol free 0.1% Chlorhexidine mouthrinse base 0.1% formaldehyde twice daily. The negative control group used a placebo. Plaque indexes were recorded in all volunteers prior to treatment at Day 0, 1 and 7. Results: After 7 days, the mean plaque index for the first group was 0.76±0.38 compared with a mean plaque index of 1.43±0.56 for the second group. The difference in plaque scores between the groups was statistically significant. Conclusion: the results of this study showed that rinsing with an alcohol base 0.12% Chlorhexidine mouthrinse is significantly different from rinsing with an alcohol free 0.1% Chlorhexidine mouthrinse on plaque inhibition. Key words:Chlorhexidine, dental plaque, mouthrinse, alcohol, formaldehyde. PMID:23229237

  19. Chlorhexidine alcohol base mouthrinse versus Chlorhexidine formaldehyde base mouthrinse efficacy on plaque control: double blind, randomized clinical trials.

    Science.gov (United States)

    Ennibi, Oumkeltoum; Lakhdar, Leila; Bouziane, Amal; Bensouda, Yahia; Abouqal, Redouane

    2013-01-01

    Chlorhexidine is well known for its antiplaque effect. However, the mouthrinse based chlorhexidine antiplaque efficiency may vary according to the formulation of the final product. The aim of the present study was to compare anti-plaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F). the study was a seven day randomized, double-blind, placebo-controlled trial including 30 volunteers. At the start, all participants received a dental prophylaxis. Over 7 days experimental non-brushing period, during which subjects abstained from all forms of mechanical oral hygiene, one group test rinsed twice daily with 15 ml of an alcohol base 0.12% Chlorhexidine mouthrinse. The second group test used 15 ml of alcohol free 0.1% Chlorhexidine mouthrinse base 0.1% formaldehyde twice daily. The negative control group used a placebo. Plaque indexes were recorded in all volunteers prior to treatment at Day 0, 1 and 7. After 7 days, the mean plaque index for the first group was 0.76 ± 0.38 compared with a mean plaque index of 1.43 ± 0.56 for the second group. The difference in plaque scores between the groups was statistically significant. the results of this study showed that rinsing with an alcohol base 0.12% Chlorhexidine mouthrinse is significantly different from rinsing with an alcohol free 0.1% Chlorhexidine mouthrinse on plaque inhibition.

  20. Cutaneous anaesthesia of the lower leg can improve sensibility in the diabetic foot. A double-blind, randomized clinical trial.

    Science.gov (United States)

    Lundborg, G N; Björkman, A C G; Rosén, B N; Nilsson, J-A; Dahlin, L B

    2010-07-01

    Impaired sensory function in the sole of the foot in diabetic patients is a substantial problem caused by unknown mechanisms. Hand or foot sensibility can be improved by cutaneous anaesthesia of the forearm or lower leg, respectively, in healthy subjects. Hypothetically, cutaneous anaesthesia induces a silent area in the primary somatosensory cortex, allowing adjacent cortical areas to expand; thus, resulting in enhanced sensory processing. Our aim was to improve sensory function in the foot in Type 1 and Type 2 diabetic patients by application of an anaesthetic cream to the lower leg. In a double-blind study, 37 patients with Type 1 or Type 2 diabetes were randomly assigned to cutaneous application of either an anaesthetic cream (EMLA) or a placebo cream to the skin of the lower leg for 1.5 h. Sensibility at five points of the sole of the foot was assessed before and after 1.5 and 24 h. Vibrotactile sense was also assessed. Primary outcome was change of touch threshold at the first metatarsal head from pretreatment to 1.5 h assessment. Anaesthetic cream on the lower leg resulted in a significant improvement of touch threshold at the first metatarsal head after 1.5 and 24 h. In addition, improvement of touch thresholds was also observed at the other four assessment sites, together with a decreased vibration threshold at 125 Hz. The findings of improved touch thresholds open up new possibilities in treatment of sensibility disturbances in the diabetic foot, using a simple and non-invasive method.

  1. Salivary Streptococcus mutans and Lactobacilli levels following probiotic cheese consumption in adults: A double blind randomized clinical trial

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    Shiva Mortazavi

    2012-01-01

    Full Text Available Background: The beneficial effects of Lactobacillus species have been reported but the role of these species including Lactobacillus casei (L. casei on oral health is not well documented. The purpose of this study was to evaluate the ef-fects of conventional or probiotic cheese containing L.casei on salivary Streptococcus mutans (SM and Lactobacilli levels. Methods: In this double-blind controlled trial (IRCT201009144745N1, 60 adults were randomly allocated in 2 paral-lel blocks. SM and Lactobacilli count assessment were performed three times. Subjects consumed either cheese contain-ing L. casei (110[6] Cfu /g (probiotic block, n=29 or cheese without any probiotic (control block, n=31 twice daily for two weeks. Bacterial levels changes were compared using Wilcoxon and Mann-Whitney Tests. Logistic regression compared changes in number of subjects with lowest and highest SM or Lactobacilli levels. Results: Statistically significant (p = 0.001 reduction of salivary SM was found in probiotic group. SM levels reduc-tion was not significant between placebo and trial groups (p = 0.46, 62% in probiotic vs. 32% in placebo group. Lacto-bacilli count changes during trial were not statistically significant inter and intra blocks (p = 0.12. Probiotic interven-tion was significantly effective in high levels (> 10[5] cfu/ml of SM (Odds Ratio 11.6, 95% CI 1.56-86.17, p = 0.017. Conclusions: Probiotic cheese containing L. casei was not effective in salivary SM levels reduction comparing to conventional cheese. Adding L. casei to cheese could be useful in decreasing SM counts in adults 18-37 years old with highest level of SM.

  2. Randomized, double-blind, placebo-controlled trial of probiotics for primary prevention: no clinical effects of Lactobacillus GG supplementation.

    Science.gov (United States)

    Kopp, Matthias Volkmar; Hennemuth, Isabell; Heinzmann, Andrea; Urbanek, Radvan

    2008-04-01

    The value of probiotics for primary prevention is controversial. Published trials vary considerably in study design and the applied probiotics, thereby limiting comparability of the results. The purpose of this trial was to study the preventive effect of the probiotic Lactobacillus GG on the development of atopic dermatitis. In a double-blind, placebo-controlled prospective trial, 105 pregnant women from families with > or = 1 member (mother, father, or child) with an atopic disease were randomly assigned to receive either the probiotic Lactobacillus GG (American Type Culture Collection 53103; 5 x 10(9) colony-forming units of Lactobacillus GG twice daily) or placebo. Ninety-four families (89.5%) completed the trial. The supplementation period started 4 to 6 weeks before expected delivery, followed by a postnatal period of 6 months. The primary end point was the occurrence of atopic dermatitis at the age of 2 years. Secondary outcomes were severity of atopic dermatitis, recurrent episodes of wheezing bronchitis, and allergic sensitization at the age of 2 years. Atopic dermatitis was diagnosed in 14 (28%) of 50 in the Lactobacillus GG group and in 12 (27.3%) of 44 in the placebo group. The risk of atopic dermatitis in children on probiotics relative to placebo was 0.96 (confidence interval 0.38-2.33). Severity of atopic dermatitis was comparable between the 2 groups. Notably, children with recurrent (> or = 5) episodes of wheezing bronchitis were more frequent in the Lactobacillus GG group (26%; n = 13), as compared with the placebo group (9.1%; n = 4). No difference was observed between both groups in total immunoglobulin E concentrations or numbers of specific sensitization to inhalant allergens. Supplementation with Lactobacillus GG during pregnancy and early infancy neither reduced the incidence of atopic dermatitis nor altered the severity of atopic dermatitis in affected children but was associated with an increased rate of recurrent episodes of wheezing

  3. Effects of intrathecal dexmedetomidine on shivering after spinal anesthesia for cesarean section: a double-blind randomized clinical trial

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    Nasseri K

    2017-04-01

    Full Text Available Karim Nasseri,1,2 Negin Ghadami,1 Bijan Nouri2 1Department of Anesthesiology, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran; 2Social Determinants of Health Research Center, Kurdistan University of Medical Sciences, Sanandaj, Iran Background: Shivering is among the common troublesome complications of spinal anesthesia (SA, and causes discomfort and discontentment in parturients undergoing cesarean sections (CSs. The aim of this study was to investigate the effects of intrathecal dexmedetomidine in the prevention of shivering in those who underwent CS under SA.Subjects and methods: Fifty parturients planned for elective CSs under SA were enrolled in this prospective, double-blinded, controlled study and randomly divided into two equal groups. Spinal block was achieved with 12.5 mg 0.5% heavy bupivacaine plus 5 µg dexmedetomidine (BD group or 0.5 mL 0.9% normal saline (BN group. The incidence and intensity of shivering, peripheral and core body temperature, hemodynamic parameters, and adverse events was recorded.Results: The incidence of shivering was significantly higher in the BN group (52% than the BD group (24% (P=0.04. Likewise, the intensity of shivering was significantly higher in the BN group than the BD group (P=0.04. The incidence of adverse events, such as hypotension, nausea/vomiting, and bradycardia, was not significantly different between the two groups, although the grade of sedation was higher in the BD group than the BN group (P=0.004.Conclusion: We conclude that intrathecal dexmedetomidine is effective in lowering the incidence and intensity of shivering in parturients undergoing CSs under SA without major adverse effects. Keywords: dexmedetomidine, shivering, spinal anesthesia, cesarean sections, bupivacaine

  4. Clinical efficacy and safety of a pharmacopial polyherbal Unani formulation in pityriasis versicolor: a comparative randomized single-blind study.

    Science.gov (United States)

    Lone, Azad Hussain; Ahmad, Tanzeel; Anwar, Mohd; Sofi, G

    2012-10-01

    Pityriasis versicolor (PV) is a common superficial fungal infection of skin caused by the fungus, Malassezia furfur. It can occur at any age but occurs mainly during adolescence and typically presents with hypopigmented or hyperpigmented scaling plaques, generally on the trunk and upper arms. It often poses a therapeutic challenge. In the Unani system of medicine, many herbal drugs are used empirically for its treatment. The objective of this study was to evaluate safety and efficacy of a topical Polyherbal Unani formulation in the management of PV on scientific parameters. This was a randomized, single-blind, standard controlled study. This study was performed in the Dermatology Outpatient Department, National Institute of Unani Medicine, Bangalore, India. Forty-six (46) patients with PV were included in the study after taking informed consents and were randomly allocated to test and control groups. In the test group, a polyherbal formulation was advised for topical application while in the control group, sodium thiosulphate lotion (20%) was advised locally for a duration of 1 month. The assessment of the severity of PV and efficacy of treatment in both groups was carried out using the Total Sign and Symptom Score (TSSS) scale. Data were analyzed with the Instat Graph pad. The mean±standard error of the mean (SEM) scores of TSSS in the test group were 7.7±1.174 and 0.9±0.7881 before and after treatment, respectively, while it was 6.9±0.8756 and 1.2±0.7888 in the control group before and after treatment, respectively. Mean±SEM of TSSS of both groups was found to be significantly lowered (p<0.001) after treatment when compared with mean±SEM of TSSS before treatment. However, the polyherbal formulation showed precedence over the standard drug by exhibiting comparatively quicker response. Furthermore, no unpleasant side-effects were observed in the test group during and after the study. This study concluded that polyherbal Unani formulation is safe, effective

  5. Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial.

    Science.gov (United States)

    Posser, Simone Regina; Callegaro, Carine Cristina; Beltrami-Moreira, Marina; Moreira, Leila Beltrami

    2016-08-02

    Hypertension is a complex chronic condition characterized by elevated arterial blood pressure. Management of hypertension includes non-pharmacologic strategies, which may include techniques that effectively reduce autonomic sympathetic activity. Respiratory exercises improve autonomic control over cardiovascular system and attenuate muscle metaboreflex. Because of these effects, respiratory exercises may be useful to lower blood pressure in subjects with hypertension. This randomized, double-blind clinical trial will test the efficacy of inspiratory muscle training in reducing blood pressure in adults with essential hypertension. Subjects are randomly allocated to intervention or control groups. Intervention consists of inspiratory muscle training loaded with 40 % of maximum inspiratory pressure, readjusted weekly. Control sham intervention consists of unloaded exercises. Systolic and diastolic blood pressures are co-primary endpoint measures assessed with 24 h ambulatory blood pressure monitoring. Secondary outcome measures include cardiovascular autonomic control, inspiratory muscle metaboreflex, cardiopulmonary capacity, and inspiratory muscle strength and endurance. Previously published work suggests that inspiratory muscle training reduces blood pressure in persons with hypertension, but the effectiveness of this intervention is yet to be established. We propose an adequately sized randomized clinical trial to test this hypothesis rigorously. If an effect is found, this study will allow for the investigation of putative mechanisms to mediate this effect, including autonomic cardiovascular control and metaboreflex. ClinicalTrials.gov NCT02275377 . Registered on 30 September 2014.

  6. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments.

    Directory of Open Access Journals (Sweden)

    Isabelle Boutron

    2007-02-01

    Full Text Available BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment, or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography, or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.

  7. Clinical effects produced by a standardized herbal medicinal product of Hibiscus sabdariffa on patients with hypertension. A randomized, double-blind, lisinopril-controlled clinical trial.

    Science.gov (United States)

    Herrera-Arellano, Armando; Miranda-Sánchez, Judith; Avila-Castro, Pedro; Herrera-Alvarez, Sara; Jiménez-Ferrer, Jesús Enrique; Zamilpa, Alejandro; Román-Ramos, Rubén; Ponce-Monter, Héctor; Tortoriello, Jaime

    2007-01-01

    Hibiscus sabdariffa L. (Malvaceae) has been used in different countries as an antihypertensive. Pharmacological work has demonstrated that this effect is probably produced by a diuretic activity and inhibition of the angiotensin-converting enzyme (ACE). Two clinical trials have confirmed the antihypertensive effect using watery infusions, in which a natriuretic effect was also detected. To compare therapeutic effectiveness, tolerability, and safety, as well as the effect on serum electrolytes and the ACE inhibitory effect of a herbal medicinal product prepared from the dried extract of H. sabdariffa calyxes (HsHMP) with those of lisinopril on patients with hypertension (HT), a randomized, controlled, and double-blind clinical trial was conducted. Patients of either sex, 25 - 61 years of age, with hypertension stage I or II, were daily treated for 4 weeks with the HsHMP, 250 mg of total anthocyanins per dose (experimental group), or 10 mg of lisinopril (control group). Outcome variables included effectiveness (diastolic blood pressure [DBP] reduction, >or= 10 mmHg), safety (absence of pathological modifications in the biochemical tests of hepatic and renal function), tolerability (absence of intense side effects), effect on serum electrolytes, and effect on ACE activity. Basal analysis included 193 subjects (100 in the experimental group), while outcome variable analysis integrated 171. Results showed that the experimental treatment decreased blood pressure (BP) from 146.48/97.77 to 129.89/85.96 mmHg, reaching an absolute reduction of 17.14/11.97 mmHg (11.58/12.21%, p < 0.05). The experimental treatment showed therapeutic effectiveness of 65.12 % as well as tolerability and safety of 100 %. BP reductions and therapeutic effectiveness were lower than those obtained with lisinopril (p < 0.05). Under the experimental treatment, the serum chlorine level increased from 91.71 to 95.13 mmol/L (p = 0.0001), the sodium level showed a tendency to decrease (from 139.09 to 137

  8. Effects of Kinesio® Tape in low back muscle fatigue: randomized, controlled, doubled-blinded clinical trial on healthy subjects.

    Science.gov (United States)

    Álvarez-Álvarez, S; José, F García-Muro San; Rodríguez-Fernández, A L; Güeita-Rodríguez, J; Waller, B J

    2014-01-01

    Muscle fatigue of the trunk extensor musculature plays a considerable role in chronic low back pain (LBP). The underlying physiology of fatigue is complex and not fully understood. The Kinesio® Taping (KT) supports damaged structures while allowing mobility and at the same time may influence some of the mechanisms associated with muscle fatigue such as blood flow and proprioception. The aim of this study is to determine the influence of KT on the resistance to fatigue of the lumbar extensor musculature in a sample of young healthy subjects. A randomized, controlled, doubled-blinded clinical trial was conducted. Ninety nine healthy subjects were randomized in to the three arms of the study Kinesio® Tape (KT), placebo (P) and control (C). Directly after application of KT we measured lumbar extensor musculature endurance with the Biering-Sorensen test. Subjects and researchers were blinded to the intervention. Time achieved (seconds) was compared between groups with one-way ANOVA with confidence intervals of 95%. There were significant differences between the time achieved in the KT group versus the control group (p < 0.05). The placebo group performed better than the control group but worse than the KT group, these were not significant in either case. KT appears to improve the time to failure of the extensor muscle of the trunk obtained using the Biering-Sorensen test. These findings suggest that KT influences processes that lead to muscle fatigue and that KT could be effective in the management of LBP.

  9. Visual field protective effect of Erigeron breviscapus (vant.) Hand. Mazz. extract on glaucoma with controlled intraocular pressure: a randomized, double-blind, clinical trial.

    Science.gov (United States)

    Zhong, Yisheng; Xiang, Minhong; Ye, Wen; Cheng, Yu; Jiang, Youqin

    2010-01-01

    To evaluate the visual field protective effect of Erigeron breviscapus (vant.) Hand. Mazz. (EBHM) extract on glaucoma with controlled intraocular pressure (IOP). Forty patients (40 eyes) with primary open-angle glaucoma, visual field defects and a postsurgical IOP of <18 mmHg were enrolled. The EBHM and placebo tablets were given orally according to the randomized and double-blind principle. Two tablets (of either EBHM or placebo) were taken three times a day for a period of 6 months. Patients were examined every 2 months after treatment commenced. At the end of the study, the results were given to the drug manufacturer. All patients completed the prospective, randomized, double-blind, clinical trial. No obvious adverse effects were found in patients during the treatment period. In the placebo group, no significant difference was found in mean defect (MD) or mean sensitivity (MS) between the values at pre-treatment and after 2, 4, and 6 months of treatment. After 6 months of EBHM treatment, the MD was significantly decreased and the MS was significantly increased compared with pre-treatment (p < 0.05). In the patients with moderate and late glaucoma, the MD was significantly decreased and the MS was significantly increased after 2, 4, and 6 months of EBHM treatment compared with pre-treatment. EBHM extract may have a partial protective effect on the visual field of glaucoma patients with controlled IOP. Further studies are needed to determine the safety and effectiveness of long-term EBHM treatment.

  10. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Emanuelsson, Frida; Skou Thomsen, Ann Sofia

    2014-01-01

    . There was a larger effect size difference in 10 acupuncture trials [-0.63 (-0.77 to -0.49)], than in the two non-acupuncture trials [-0.17 (-0.41 to 0.07)]. Lack of patient blinding also increased attrition and use of co-interventions: ratio of control group attrition risk 1.79 (1.18 to 2.70), and ratio of control...

  11. A randomized, double-blind, multicenter, controlled clinical trial of chicken type II collagen in patients with rheumatoid arthritis.

    Science.gov (United States)

    Zhang, Ling-Ling; Wei, Wei; Xiao, Feng; Xu, Jian-Hua; Bao, Chun-De; Ni, Li-Qing; Li, Xing-Fu

    2008-07-15

    To assess the efficacy and safety of chicken type II collagen (CCII) in rheumatoid arthritis (RA) compared with methotrexate (MTX). We conducted a prospective, 24-week, followup, multicenter, double-blind, controlled study of CCII (0.1 mg/day) versus MTX (10 mg/week) in patients with active RA. Clinical assessments were performed at screening and at 12, 18, and 24 weeks of treatment. A total of 236 RA patients were included; 211 patients (89.4%) completed the 24-week followup. In both groups there was a decrease in pain, morning stiffness, tender joint count, swollen joint count, Health Assessment Questionnaire score, and investigator and patient assessment of function; all differences were statistically significant. In the MTX group, erythrocyte sedimentation rate and C-reactive protein level decreased. Rheumatoid factor did not change in either group. At 24 weeks, 68.57% of patients in the CCII group and 83.02% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR20), and 40.95% and 57.54%, respectively, met the ACR50 criteria. The ACR20 and ACR50 response rates in the CCII group were lower than those in the MTX group, and this difference was statistically significant (P < 0.05). Gastrointestinal symptoms were common in both groups. There were fewer and milder side effects in the CCII group than the MTX group. The difference in incidence of adverse events between the 2 groups was statistically significant (P < 0.05). CCII is effective in the treatment of RA. CCII is well tolerated, and the incidence of adverse events of CCII is lower than that of MTX.

  12. Effect of Agaricus sylvaticus supplementation on nutritional status and adverse events of chemotherapy of breast cancer: a randomized, placebo-controlled, double-blind clinical trial.

    Science.gov (United States)

    Valadares, Fabiana; Garbi Novaes, Maria Rita Carvalho; Cañete, Roberto

    2013-01-01

    Breast cancer (BC) represents the highest incidence of malignancy in women throughout the world. Medicinal fungi can stimulate the body, reduce side-effects associated with chemotherapy and improve the quality of life in patients with cancer. To evaluate the effects of dietary supplementation of Agaricus sylvaticus on clinical and nutritional parameters in BC patients undergoing chemotherapy. A randomized, placebo-controlled, double-blind, clinical trial was carried out at the Oncology Clinic, Hospital of the Federal District-Brazil from September 2007 to July 2009. Forty six patients with BC, Stage II and III, were randomly assigned to receive either nutritional supplement with A. sylvaticus (2.1 g/day) or placebo. Patients were evaluated during treatment period. Patient supplemented with A. sylvaticus improved in clinical parameters and gastrointestinal functions. Poor appetite decreased by 20% with no changes in bowel functions (92.8%), nausea and vomiting (80%). Dietary supplementation with A. sylvaticus improved nutritional status and reduced abnormal bowel functions, nausea, vomiting, and anorexia in patients with BC receiving chemotherapy.

  13. A multicenter, double-blind, randomized, controlled phase III clinical trial of chicken type II collagen in rheumatoid arthritis.

    Science.gov (United States)

    Wei, Wei; Zhang, Ling-Ling; Xu, Jian-Hua; Xiao, Feng; Bao, Chun-De; Ni, Li-Qing; Li, Xing-Fu; Wu, Yu-Qing; Sun, Ling-Yun; Zhang, Rong-Hua; Sun, Bao-Liang; Xu, Sheng-Qian; Liu, Shang; Zhang, Wei; Shen, Jie; Liu, Hua-Xiang; Wang, Ren-Cheng

    2009-01-01

    Chicken type II collagen (CCII) is a protein extracted from the cartilage of chicken breast and exhibits intriguing possibilities for the treatment of autoimmune diseases by inducing oral tolerance. A 24-week, double-blind, double-dummy, randomized, methotrexate (MTX)-controlled study was conducted to evaluate the efficacy and safety of CCII in the treatment of rheumatoid arthritis (RA). Five hundred three RA patients were included in the study. Patients received either 0.1 mg daily of CCII (n = 326) or 10 mg once a week of MTX (n = 177) for 24 weeks. Each patient was evaluated for pain, morning stiffness, tender joint count, swollen joint count, health assessment questionnaire (HAQ), assessments by investigator and patient, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) by using the standard tools at baseline (week 0) and at weeks 12 and 24. Additionally, rheumatoid factor (RF) was evaluated at weeks 0 and 24. Measurement of a battery of biochemical parameters in serum, hematological parameters, and urine analysis was performed to evaluate the safety of CCII. Four hundred fifty-four patients (94.43%) completed the 24-week follow-up. In both groups, there were decreases in pain, morning stiffness, tender joint count, swollen joint count, HAQ, and assessments by investigator and patient, and all differences were statistically significant. In the MTX group, ESR and CRP decreased. RF did not change in either group. At 24 weeks, 41.55% of patients in the CCII group and 57.86% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR-20) and 16.89% and 30.82%, respectively, met the ACR 50% improvement criteria (ACR-50). Both response rates for ACR-20 and ACR-50 in the CCII group were lower than those of the MTX group, and this difference was statistically significant (P < 0.05). The DAS28 (disease activity score using 28 joint counts) values of the two treatment groups were calculated, and there was a statistically

  14. L-arginine supplementation and risk factors of cardiovascular diseases in healthy men: a double-blind randomized clinical trial.

    Science.gov (United States)

    Pahlavani, Naseh; Jafari, Mostafa; Sadeghi, Omid; Rezaei, Masoud; Rasad, Hamid; Rahdar, Hossein Ali; Entezari, Mohammad Hasan

    2014-01-01

    Context: The effect of L-arginine on risk factors of cardiovascular diseases (CVD) has mostly focused on western countries. Since cardiovascular diseases is the second cause of death in Iran and, as far as we are aware, there have been no studies about the effect of L-arginine on CVD risk factors, the aim of this trial was to assess the effects of L-arginine supplementation on CVD risk factors in healthy men. Objective:  The purpose of this study was to evaluate the effect of low-dose L-arginine supplementation on CVD risk factors (lipid profile, blood sugar and blood pressure) in Iranian healthy men. Design, setting, participants:  We conducted a double-blind randomized controlled trial in 56 patients selected from sport clubs at the Isfahan University of Medical Science between November 2013 and December 2013. Interventions: Healthy men received L-arginine supplementation (2000 mg daily) in the intervention group or placebo (2000 mg maltodextrin daily) in the control group for 45 days. Main outcome measure:  The primary outcome measures were we measured the levels of fasting blood sugar, blood pressure and lipid profile including triglyceride (TG), cholesterol, LDL and HDL in healthy subjects. It was hypothesized that these measures would be significantly improved in those receiving L-arginine supplementation. at the beginning and end of the study. Results:  In this trial, we had complete data for 52 healthy participants with mean age of 20.85±4.29 years. At the end of study, fasting blood sugar (P=0.001) and lipid profile (triglycerideTG (PL-arginine group but we found no significant change in the placebo group. In addition, the reduction of fasting blood sugar and lipid profile in L-arginine was significant compared with placebo group. No significant changes were found about systolic (P=0.81) and diastolic blood pressure either in L-arginine or placebo group. (P=0.532). Conclusion : The use of L-arginine significantly improved outcomes compared to placebo.

  15. L-arginine supplementation and risk factors of cardiovascular diseases in healthy men: a double-blind randomized clinical trial

    Science.gov (United States)

    Pahlavani, Naseh; Jafari, Mostafa; Sadeghi, Omid; Rezaei, Masoud; Rasad, Hamid; Rahdar, Hossein Ali; Entezari, Mohammad Hasan

    2017-01-01

    Context: The effect of L-arginine on risk factors of cardiovascular diseases (CVD) has mostly focused on western countries. Since cardiovascular diseases is the second cause of death in Iran and, as far as we are aware, there have been no studies about the effect of L-arginine on CVD risk factors, the aim of this trial was to assess the effects of L-arginine supplementation on CVD risk factors in healthy men. Objective: The purpose of this study was to evaluate the effect of low-dose L-arginine supplementation on CVD risk factors (lipid profile, blood sugar and blood pressure) in Iranian healthy men. Design, setting, participants: We conducted a double-blind randomized controlled trial in 56 patients selected from sport clubs at the Isfahan University of Medical Science between November 2013 and December 2013. Interventions: Healthy men received L-arginine supplementation (2000 mg daily) in the intervention group or placebo (2000 mg maltodextrin daily) in the control group for 45 days. Main outcome measure: The primary outcome measures were we measured the levels of fasting blood sugar, blood pressure and lipid profile including triglyceride (TG), cholesterol, LDL and HDL in healthy subjects. It was hypothesized that these measures would be significantly improved in those receiving L–arginine supplementation. at the beginning and end of the study. Results: In this trial, we had complete data for 52 healthy participants with mean age of 20.85±4.29 years. At the end of study, fasting blood sugar (P=0.001) and lipid profile (triglycerideTG (PL-arginine group but we found no significant change in the placebo group. In addition, the reduction of fasting blood sugar and lipid profile in L-arginine was significant compared with placebo group. No significant changes were found about systolic (P=0.81) and diastolic blood pressure either in L-arginine or placebo group. (P=0.532). Conclusion: The use of L-arginine significantly improved outcomes compared to placebo

  16. A randomized, double-blind clinical study of the effects of Ankascin 568 plus on blood lipid regulation

    Directory of Open Access Journals (Sweden)

    Sheng-Fu Liu

    2018-01-01

    Full Text Available Hyperlipidemia and inflammation play important roles in the development and progression of atherosclerosis. Atherosclerosis is regarded as an inflammatory response of blood vessels to injury at the start of atherosclerotic plaque formation, which then leads to cardiovascular events. Edible fungi of the Monascus species have been used as traditional Chinese medicines in East Asia for several centuries. The fermented products of Monascus purpureus NTU 568 possess a number of functional secondary metabolites including the anti-inflammatory pigments monascin and ankaflavin. Compounds derived from M. purpureus have been shown to have hypolipidemic effects. We aimed to evaluate the effects of M. purpureus NTU 568 fermentation product an extract (Ankascin 568 plus containing monascin and ankaflavin on blood lipids in volunteers with borderline high levels of total cholesterol (TC and low-density lipoprotein cholesterol (LDL-C by conducting a 12-week randomized, double-blind, placebo-controlled, adaptive-design study. This study enrolled 40 subjects aged 18–65 years from a population of patients with TC and LDL-C levels of ≥180 mg/dL and 130–190 mg/dL, respectively. Measured endpoints included lipid profile, liver, kidney and thyroid function, electrolyte balance, creatinine phosphokinase, and fasting blood glucose. After 4 weeks of treatment (500 mg Ankascin 568 plus/day, the changes in the lipid levels showed that the active products had a more favorable effect than the placebo. Compared to the baseline, statistically significant decreases of 11.9% and 19.0% were observed in TC and LDL-C levels, respectively (p < 0.05 for all pairs. This study demonstrated that subjects administered one 500 mg capsule of Ankascin 568 plus for more than 4 weeks exhibited a significant reduction in serum TC and LDL-C levels. Therefore, Ankascin 568 plus may be a potentially useful agent for the regulation of blood lipids and the treatment of coronary artery

  17. Evolutionary cognitive therapy versus standard cognitive therapy for depression: a protocol for a blinded, randomized, superiority clinical trial.

    Science.gov (United States)

    Giosan, Cezar; Cobeanu, Oana; Mogoase, Cristina; Muresan, Vlad; Malta, Loretta S; Wyka, Katarzyna; Szentagotai, Aurora

    2014-03-19

    Depression is estimated to become the leading cause of disease burden globally by 2030. Despite existing efficacious treatments (both medical and psychotherapeutic), a large proportion of patients do not respond to therapy. Recent insights from evolutionary psychology suggest that, in addition to targeting the proximal causes of depression (for example, targeting dysfunctional beliefs by cognitive behavioral therapy), the distal or evolutionary causes (for example, inclusive fitness) should also be addressed. A randomized superiority trial is conducted to develop and test an evolutionary-driven cognitive therapy protocol for depression, and to compare its efficacy against standard cognitive therapy for depression. Romanian-speaking adults (18 years or older) with elevated Beck Depression Inventory (BDI) scores (>13), current diagnosis of major depressive disorder or major depressive episode (MDD or MDE), and MDD with comorbid dysthymia, as evaluated by the Structured Clinical Interview for DSM-IV (SCID), are included in the study. Participants are randomized to one of two conditions: 1) evolutionary-driven cognitive therapy (ED-CT) or 2) cognitive therapy (CT). Both groups undergo 12 psychotherapy sessions, and data are collected at baseline, mid-treatment, post-treatment, and the 3-month follow-up. Primary outcomes are depressive symptomatology and a categorical diagnosis of depression post-treatment. This randomized trial compares the newly proposed ED-CT with a classic CT protocol for depression. To our knowledge, this is the first attempt to integrate insights from evolutionary theories of depression into the treatment of this condition in a controlled manner. This study can thus add substantially to the body of knowledge on validated treatments for depression. Current Controlled Trials ISRCTN64664414The trial was registered in June 2013. The first participant was enrolled on October 3, 2012.

  18. Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    ALINE TABORDA FLESCH

    Full Text Available ABSTRACT Objective: to evaluate the effect of perioperative administration of symbiotics on the incidence of surgical wound infection in patients undergoing surgery for colorectal cancer. Methods: We conducted a randomized clinical trial with colorectal cancer patients undergoing elective surgery, randomly assigned to receive symbiotics or placebo for five days prior to the surgical procedure and for 14 days after surgery. We studied 91 patients, 49 in the symbiotics group (Lactobacillus acidophilus 108 to 109 CFU, Lactobacillus rhamnosus 108 to 109 CFU, Lactobacillus casei 108 to 109 CFU, Bifi dobacterium 108 to 109 CFU and fructo-oligosaccharide (FOS 6g and 42 in the placebo group. Results: surgical site infection occurred in one (2% patient in the symbiotics group and in nine (21.4% patients in the control group (p=0.002. There were three cases of intraabdominal abscess and four cases of pneumonia in the control group, whereas we observed no infections in patients receiving symbiotics (p=0.001. Conclusion: the perioperative administration of symbiotics significantly reduced postoperative infection rates in patients with colorectal cancer. Additional studies are needed to confirm the role of symbiotics in the surgical treatment of colorectal cancer.

  19. Metformin versus chromium picolinate in clomiphene citrate-resistant patients with PCOs: A double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Sedigheh Amooee

    2013-01-01

    Full Text Available Background: Chromium picolinate could be effective in clomiphen citrate resistant PCOS patients. Objective: To compare the effects of chromium picolinate vs. metformin in clomiphen citrate resistant PCOS patients. Materials and Methods: The present randomized clinical trial was performed on 92 women with clomiphen citrate-resistant PCOS at the clinics which were affiliated to Shiraz University of Medical Sciences, Shiraz, Iran. The subjects were randomly assigned to two groups receiving either chromium picolinate (200μg daily or metformin (1500mg daily for 3 months. Anthropometric and hormonal profile were measured and compared both before and after the treatment. Ovulation and pregnancy rate was measured in the two study groups, as well. Results: Chromium picolinate significantly decreased fasting blood sugar (FBS after 3 months of treatment (p=0.042. In the same way, the serum levels of fasting insulin had significantly decreased leading to an increase in insulin sensitivity as measured by QUICKI index (p=0.014. In comparison to the patients who received chromium picolinate, those who received metformin had significantly lower levels of testosterone (p=0.001 and free testosterone (p=0.001 after 3 months of treatment. Nevertheless, no significant difference was found between the two study groups regarding ovulation (p=0.417 and pregnancy rates (p=0.500. Conclusion: Chromium picolinate decreased FBS and insulin levels and, thus, increased insulin sensitivity in clomiphene citrate-resistance PCOS women. These effects were comparable with metformin; however, metformin treatment was associated with decreased hyperandrogenism. Overall, chromium picolinate was better tolerated compared to metformin; nonetheless, the two study groups were not significantly different regarding ovulation and pregnancy rates.

  20. Double-blind, randomized evaluation of clinical efficacy and tolerability of an apple pectin-chamomile extract in children with unspecific diarrhea.

    Science.gov (United States)

    Becker, Brigitta; Kuhn, Ulrike; Hardewig-Budny, Bettina

    2006-01-01

    Acute diarrhea is one of the most common childhood diseases. The main aim of therapy is oral rehydration, mostly using a glucose-electrolyte solution. Results from a previous study (DIALOG I) investigating adjuvant treatment with a medicinal preparation containing an apple pectin-chamomile extract (Diarrhoesan) indicated a significantly reduced duration of diarrhea in children. The objective of the present clinical placebo-controlled, double-blind study (DIALOG II) was to assess the clinical efficacy and tolerability of the apple pectin-chamomile extract on a larger number of patients. The investigation was designed as a multicenter, randomized, double-blind, placebo-controlled parallel study enrolling 255 patients presenting with acute diarrhea. Patients were aged between 6 months and 6 years and treated on an outpatient basis with either an apple pectin-chamomile preparation or placebo. As a basic medication, each child received a glucose-electrolyte solution on the first day of treatment. The primary outcome (primary efficacy parameter) included a combined analysis of stool frequency, stool The statistical analysis revealed a superior efficacy of the tested preparation over placebo with a significantly reduced stool frequency in the treatment group compared to the control group. The results were corroborated by efficacy assessment performed by investigators and patients. Treatment was well tolerated, with an incidence of adverse effects similar to placebo. These findings support the concept of a beneficial influence of the investigated vegetable extract in shortening the course of the disease and relieving associated symptoms.

  1. The Efficacy of Treatment of Different Intervention Programs for Patellofemoral Pain Syndrome–A Single Blinded Randomized Clinical Trial. Pilot Study

    Directory of Open Access Journals (Sweden)

    Feazadeh Avraham

    2007-01-01

    Full Text Available Patello-femoral pain syndrome (PFPS is a common knee joint disability. The integration of hip soft tissue regimens are not always emphasized, although current literature implies that there is a significant relationship between the two and there is a lack of randomized clinical trials to substantiate this relationship in clinical practice. A randomized controlled assessor blinded trial was designed to explore different rehabilitation programs related to PFPS. The study was conducted at RAZIEL institute of physical therapy, Netania, Israel with a total of 30 consecutive patients (mean age 35y, diagnosed with PFPS. All patients were randomly allocated into 3 groups. Group I conventional knee rehabilitation program. Included quadriceps strengthening and Trans Electric Neuromuscular Stimulation (TENS. Group II hip oriented rehabilitation program. included stretching, Hip external rotators strengthening and TENS. Group III a combination of the two above programs. Pain and function were documented on initial of the program and again 3 weeks later, on the completion. Pain was assessed by a numeric visual analogue scale (VAS; function was assessed by Patello-femoral joint evaluation scale (PFJES (0-100 points. At end of trial, all groups showed significant improvements in VAS and PFJES (p<0.0001; these improvements did not vary significantly between the 3 groups. The conclusions were that the explored different rehabilitation programs showed a similar beneficial effect.

  2. Effect of indacaterol on lung deflation improves cardiac performance in hyperinflated COPD patients: an interventional, randomized, double-blind clinical trial.

    Science.gov (United States)

    Santus, Pierachille; Radovanovic, Dejan; Di Marco, Silvia; Valenti, Vincenzo; Raccanelli, Rita; Blasi, Francesco; Centanni, Stefano; Bussotti, Maurizio

    2015-01-01

    COPD is often associated with cardiovascular comorbidity. Treatment guidelines recommend therapy with bronchodilators as first choice. We investigated the acute effect of single-dose indacaterol on lung hyperinflation in COPD subjects, for the first time evaluating the potential effects on right heart performance. In this Phase IV, randomized, interventional, double-blind, crossover clinical study, we recruited 40 patients (50-85 years of age) with stable COPD. Patients were treated with 150 μg indacaterol or placebo and after 60 minutes (T60) and 180 minutes (T180) the following tests were performed: trans-thoracic echocardiography (TTE), plethysmography, diffusing capacity of the lung for carbon monoxide, saturation of peripheral oxygen, and visual analog scale dyspnea score. Patients underwent a crossover re-challenge after a further 72 hours of pharmacological washout. All TTE measurements were conducted blindly by the same operator and further interpreted by two different blinded operators. Consensus decisions were taken on every value and parameter. The primary outcome was the effect of the reduction of residual volume and functional residual capacity on right heart systolic and diastolic function indexes evaluated by TTE in patients treated with indacaterol, as compared to placebo. Vital capacity, inspiratory capacity, and forced expiratory volume in 1 second were significantly increased by indacaterol, when compared with placebo, while residual volume, intrathoracic gas volume, and specific airway resistance were significantly reduced in patients treated with indacaterol. Tricuspid annular plane systolic excursion was significantly increased versus placebo, paralleled by an increase of tricuspid E-wave deceleration time. The cardiac frequency was also significantly reduced in indacaterol-treated patients. Indacaterol significantly reduces lung hyperinflation in acute conditions, with a clinically relevant improvement of dyspnea. These modifications are

  3. A Double-Blind Placebo-Controlled Randomized Clinical Trial With Magnesium Oxide to Reduce Intrafraction Prostate Motion for Prostate Cancer Radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Lips, Irene M., E-mail: i.m.lips@umcutrecht.nl [Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands); Gils, Carla H. van [Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht (Netherlands); Kotte, Alexis N.T.J. [Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands); Leerdam, Monique E. van [Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam (Netherlands); Franken, Stefan P.G.; Heide, Uulke A. van der; Vulpen, Marco van [Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands)

    2012-06-01

    Purpose: To investigate whether magnesium oxide during external-beam radiotherapy for prostate cancer reduces intrafraction prostate motion in a double-blind, placebo-controlled randomized trial. Methods and Materials: At the Department of Radiotherapy, prostate cancer patients scheduled for intensity-modulated radiotherapy (77 Gy in 35 fractions) using fiducial marker-based position verification were randomly assigned to receive magnesium oxide (500 mg twice a day) or placebo during radiotherapy. The primary outcome was the proportion of patients with clinically relevant intrafraction prostate motion, defined as the proportion of patients who demonstrated in {>=}50% of the fractions an intrafraction motion outside a range of 2 mm. Secondary outcome measures included quality of life and acute toxicity. Results: In total, 46 patients per treatment arm were enrolled. The primary endpoint did not show a statistically significant difference between the treatment arms with a percentage of patients with clinically relevant intrafraction motion of 83% in the magnesium oxide arm as compared with 80% in the placebo arm (p = 1.00). Concerning the secondary endpoints, exploratory analyses demonstrated a trend towards worsened quality of life and slightly more toxicity in the magnesium oxide arm than in the placebo arm; however, these differences were not statistically significant. Conclusions: Magnesium oxide is not effective in reducing the intrafraction prostate motion during external-beam radiotherapy, and therefore there is no indication to use it in clinical practice for this purpose.

  4. Local anesthetic wound infiltration for pain management after periacetabular osteotomy. A randomized, placebo-controlled, double-blind clinical trial with 53 patients

    DEFF Research Database (Denmark)

    Bech, Rune D; Ovesen, Ole; Lindholm, Peter

    2014-01-01

    BACKGROUND AND PURPOSE: To our knowledge, there is no evidence to support the use of local infiltration analgesia (LIA) for postoperative pain relief after periacetabular osteotomy (PAO). We investigated the effect of wound infiltration with a long-acting local anesthetic (ropivacaine......) for postoperative analgesia after PAO. PATIENTS AND METHODS: We performed a randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov: NCT00815503) in 53 patients undergoing PAO to evaluate the effect of local anesthetic infiltration on postoperative pain and on postoperative opioid consumption. All...... subjects received intraoperative infiltration followed by 5 postoperative injections in 10-hour intervals through a multi-holed catheter placed at the surgical site. 26 patients received ropivacaine and 27 received saline. The intervention period was 2 days and the observational period was 4 days. All...

  5. A Traditional Mouthwash (Punica granatum var pleniflora) for Controlling Gingivitis of Diabetic Patients: A Double-Blind Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Sedigh-Rahimabadi, Massih; Fani, Mohammadmehdi; Rostami-Chijan, Mahsa; Zarshenas, Mohammad M; Shams, Mesbah

    2017-01-01

    This study evaluates the safety and efficacy of Punica granatum var pleniflora mouthwash in treatment of diabetic gingivitis. In a double-blind randomized clinical trial 80 patients with diabetes mellitus and gingivitis were assigned to Golnaar and chlorhexidine 0.2% groups. After using mouthwashes for 2 weeks; participants underwent tooth scaling and the last visit was 2 weeks after scaling. The primary outcome measures were plaque, modified gingival and gingival bleeding indices, and pocket depth. Both interventions had significant improvement on all of the gingival and plaque indices (P < .001 for all indices). There were no significant differences between Golnaar and chlorhexidine in primary outcome measures except for modified gingival index for which Golnaar mouthwash had a superiority after 2 weeks when comparing with chlorhexidine (P = .039). Meanwhile, Golnaar mouthwash had no staining effect. Golnaar mouthwash is safe and effective in treatment of gingivitis in diabetic patients although further studies are recommended. © The Author(s) 2016.

  6. A Double-Blind Randomized Trial Comparing Implants with Laser-Microtextured and Machined Collar Surfaces: Microbiologic and Clinical Results.

    Science.gov (United States)

    Guarnieri, Renzo; Rappelli, Giorgio; Piemontese, Matteo; Procaccini, Maurizio; Quaranta, Alessandro

    2016-01-01

    The purpose of this study was to compare the clinical outcome of and determine the differences in periodonto-pathogenic microbiota around two types of implant collar surfaces: laser-microtextured (test) vs machined (control). Seventeen patients (11 periodontally healthy, and 6 periodontally compromised) were selected to receive the two different implants, placed randomly, in two edentulous sites. Six months following the surgical placement of the dental implants, subgingival plaque samples were collected using paper points from the peri-implant sulcus and from the sulcus of an adjacent tooth. The presence of five putative periodontal pathogens, namely, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, and Tannerella forsythensis, was assessed using real-time polymerized chain reaction (RT-PCR). Peri-implant parameters and intraoral radiographs were recorded up to 1 year after abutment connection. In the main population, and in the periodontally compromised subgroup, the total number of periodontal pathogens around test implant sites was lower than control implant sites and adjacent tooth sites, with a statistically significant difference (P < .05). In periodontally healthy patients, the mean probing pocket depth for the test implant was 1.31 ± 0.51 mm, compared with 2.66 ± 0.83 mm for the control implant, while in periodontally compromised patients, it was 1.61 ± 0.58 mm for the test implant, compared with a mean value of 2.84 ± 1.0 mm for the control implant. Implants with a laser-microtextured collar surface are not more vulnerable to pathogenic microflora colonization than implants with a machined collar surface. In both of the subgroups of patients (periodontally healthy and periodontally compromised), implants with a laser-microtextured collar surface have a better clinical outcome at 1 year of loading, compared with implants with a machined collar surface.

  7. Low-dose ketamine infusion for labor analgesia: A double-blind, randomized, placebo controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Sam Joel

    2014-01-01

    Full Text Available Background: Most primary and secondary level hospitals in developing countries provide inadequate labor analgesia due to various medical, technical and economic reasons. This clinical trial was an effort to study the efficacy, safety and feasibility of intravenous (IV ketamine to provide labor analgesia. Materials and Methods: A total of 70 parturients were consented and randomly assigned to receive either IV ketamine or 0.9% saline. A loading dose of ketamine (0.2 mg/kg was followed-by an infusion (0.2 mg/kg/h until the delivery of the neonate. Similar volume of saline was infused in the placebo-group. Intramuscular meperidine was the rescue analgesic in both groups. The pain score, hemodynamic parameters of mother and fetus and the anticipated side-effects of ketamine were observed for. The newborn was assessed by the Neonatologist. Results: The pain score showed a decreasing trend in the ketamine group and after the 1 st h more than 60% of women in the ketamine group had pain relief, which was statistically significant. There was no significant clinical change in the maternal hemodynamics and fetal heart rate. However, 17 (48.5% of them had transient light headedness in the ketamine group. All the neonates were breast fed and the umbilical cord blood pH was between 7.1 and 7.2. The overall satisfaction was significantly high in the intervention group (P = 0.028. Conclusion: A low-dose ketamine infusion (loading dose of 0.2 mg/kg delivered over 30 min, followed-by an infusion at 0.2 mg/kg/h could provide acceptable analgesia during labor and delivery.

  8. Effects of Benazepril on Survival of Dogs with Chronic Kidney Disease: A Multicenter, Randomized, Blinded, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    King, J N; Font, A; Rousselot, J-F; Ash, R A; Bonfanti, U; Brovida, C; Crowe, I D; Lanore, D; Pechereau, D; Seewald, W; Strehlau, G

    2017-07-01

    Chronic kidney disease (CKD) is an important cause of morbidity and mortality in dogs. To evaluate the efficacy in prolonging survival and safety of benazepril administration to dogs with CKD. Forty-nine client-owned dogs with CKD. Dogs were randomized to benazepril (0.25 to benefit of benazepril versus placebo was detected for renal survival time in all dogs; median (95% confidence interval (CI)) survival times were 305 (53-575) days in the benazepril group and 287 (152-not available) in the placebo group (P = .53). Renal survival times were not significantly longer with benazepril compared to placebo for subgroups: hazard ratios (95% CI) were 0.50 (0.21-1.22) with P = .12 for initial urine protein-to-creatinine ratio (UPC) >0.5, and 0.38 (0.12-1.19) with P = .080 for initial UPC >0.5 plus plasma creatinine ≤440 μmol/L. Proteinuria, assessed from the UPC, was significantly (P = .0032) lower after treatment with benazepril compared to placebo. There were no significant differences between groups for clinical signs or frequencies of adverse events. Benazepril significantly reduced proteinuria in dogs with CKD. Insufficient numbers of dogs were recruited to allow conclusions on survival time. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  9. Comparison of the analgesic efficacy of oral ketorolac versus intramuscular tramadol after third molar surgery: A parallel, double-blind, randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Isiordia-Espinoza, M-A; Pozos-Guillen, A; Martinez-Rider, R; Perez-Urizar, J

    2016-09-01

    Preemptive analgesia is considered an alternative for treating the postsurgical pain of third molar removal. The aim of this study was to evaluate the preemptive analgesic efficacy of oral ketorolac versus intramuscular tramadol after a mandibular third molar surgery. A parallel, double-blind, randomized, placebo-controlled clinical trial was carried out. Thirty patients were randomized into two treatment groups using a series of random numbers: Group A, oral ketorolac 10 mg plus intramuscular placebo (1 mL saline solution); or Group B, oral placebo (similar tablet to oral ketorolac) plus intramuscular tramadol 50 mg diluted in 1 mL saline solution. These treatments were given 30 min before the surgery. We evaluated the time of first analgesic rescue medication, pain intensity, total analgesic consumption and adverse effects. Patients taking oral ketorolac had longer time of analgesic covering and less postoperative pain when compared with patients receiving intramuscular tramadol. According to the VAS and UAC results, this study suggests that 10 mg of oral ketorolac had superior analgesic effect than 50 mg of tramadol when administered before a mandibular third molar surgery.

  10. Mirroring everyday clinical practice in clinical trial design: a new concept to improve the external validity of randomized double-blind placebo-controlled trials in the pharmacological treatment of major depression

    Directory of Open Access Journals (Sweden)

    Severus Emanuel

    2012-07-01

    Full Text Available Abstract Background Randomized, double-blind, placebo-controlled trials constitute the gold standard in clinical research when testing the efficacy of new psychopharmacological interventions in the treatment of major depression. However, the blinded use of placebo has been found to influence clinical trial outcomes and may bias patient selection. Discussion To improve clinical trial design in major depression so as to reflect clinical practice more closely we propose to present patients with a balanced view of the benefits of study participation irrespective of their assignment to placebo or active treatment. In addition every participant should be given the option to finally receive the active medication. A research agenda is outlined to evaluate the impact of the proposed changes on the efficacy of the drug to be evaluated and on the demographic and clinical characteristics of the enrollment fraction with regard to its representativeness of the eligible population. Summary We propose a list of measures to be taken to improve the external validity of double-blind, placebo-controlled trials in major depression. The recommended changes to clinical trial design may also be relevant for other psychiatric as well as medical disorders in which expectations regarding treatment outcome may affect the outcome itself.

  11. Treatment of Multiple-Resistant and/or Recurrent Cutaneous Warts With Squaric Acid Dibutylester: A Randomized, Double-blind, Vehicle-controlled Clinical Trial.

    Science.gov (United States)

    DallʼOglio, Federica; Luca, Maria; Barresi, Sebastiano; Micali, Giuseppe

    Contact immunotherapy with squaric acid dibutylester (SADBE) for cutaneous warts has been reported to be effective, although no controlled studies are available so far. The aim of this study was to evaluate the efficacy of SADBE on cutaneous warts by a randomized, double-blind, vehicle-controlled, clinical trial. Thirty-six patients were randomly assigned to SADBE (18 cases) or vehicle (18 cases) group. At 8 weeks, subjects were clinically evaluated for number/size reduction rate and for Investigator Global Assessment. Those who showed improvement extended therapy up to 40 weeks, whereas those who showed unresponsiveness were either switched to SADBE application for up to 48 weeks (if in the vehicle group) or withdrawn from the study (if under SADBE). At 8 weeks, a significant reduction in wart number (P = 0.020) and size (P = 0.010) in the SADBE group, with clearing rates of 41.2% versus 12.5% in the SADBE and vehicle groups, respectively, was observed. Nine remaining SADBE responders who underwent treatment extension up to 40 weeks achieved clearing versus 2 patients of the vehicle group who remained unresponsive. Clearing was obtained in 81.8% of patients who underwent previous ineffective vehicle treatment and had been switched to SADBE. Squaric acid dibutylester is an effective therapeutic option and is significantly more effective than vehicle.

  12. Impact of selected magnetic fields on the therapeutic effect in patients with lumbar discopathy: A prospective, randomized, single-blinded, and placebo-controlled clinical trial.

    Science.gov (United States)

    Taradaj, Jakub; Ozon, Marcin; Dymarek, Robert; Bolach, Bartosz; Walewicz, Karolina; Rosińczuk, Joanna

    2018-03-23

    Interdisciplinary physical therapy together with pharmacological treatment constitute conservative treatment strategies related to low back pain (LBP). There is still a lack of high quality studies aimed at an objective evaluation of physiotherapeutic procedures according to their effectiveness in LBP. The aim of this study is to carry out a prospective, randomized, single-blinded, and placebocontrolled clinical trial to evaluate the effectiveness of magnetic fields in discopathy-related LBP. A group of 177 patients was assessed for eligibility based on inclusion and exclusion criteria. In the end, 106 patients were randomly assigned into 5 comparative groups: A (n = 23; magnetic therapy: 10 mT, 50 Hz); B (n = 23; magnetic therapy: 5 mT, 50 Hz); C (n = 20; placebo magnetic therapy); D (n = 20; magnetic stimulation: 49.2 μT, 195 Hz); and E (n = 20; placebo magnetic stimulation). All patients were assessed using tests for pain intensity, degree of disability and range of motion. Also, postural stability was assessed using a stabilographic platform. In this study, positive changes in all clinical outcomes were demonstrated in group A (p 0.05). It was determined that the application of magnetic therapy (10 mT, 50 Hz, 20 min) significantly reduces pain symptoms and leads to an improvement of functional ability in patients with LBP.

  13. Comparison of topical tacrolimus and clobetasol in the management of symptomatic oral lichen planus: A double-blinded, randomized clinical trial in Sri Lanka.

    Science.gov (United States)

    Hettiarachchi, Pilana Vithanage Kalani Shihanika; Hettiarachchi, Ruvini Manjula; Jayasinghe, Ruwan Duminda; Sitheeque, Mohaideen

    2017-11-01

    Oral lichen planus (OLP) is a common, chronic inflammatory disease of the oral mucosa. Although several studies have shown the efficacy of different treatment modalities, a definitive cure has not yet been established. The present trial compares the effectiveness of topically-applied clobetasol and tacrolimus in the symptomatic management of OLP. A randomized, comparative, double-blind study with 68 patients (43 females, 25 males; mean age: 46.76 years) was undertaken. Patients were randomly divided into two groups of 34 patients each to receive topical tacrolimus 0.1% cream or clobetasol propionate 0.05% cream for 3 weeks. After 3 weeks of treatment, the mean pain score dropped by 1.59 (right) and 1.53 (left) in the tacrolimus group, while in clobetasol group these values were 0.94 and 0.85, respectively. The mean scores for clinical appearance reduced by 1.18 (right) and 1.0 (left) in the tacrolimus group compared with a reduction of 0.5 and 0.26, respectively, in the clobetasol group. These reductions were statistically significant (P < .05). The results suggest that tacrolimus 0.1% cream is an effective alternative to topical steroid and can be considered a first-line therapy in OLP. However, further studies are needed to confirm the effectiveness of this treatment before it is recommended for use in clinical practice. © 2016 John Wiley & Sons Australia, Ltd.

  14. The efficacy of zinc supplementation on outcome of children with severe pneumonia. A randomized double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Valavi, Ehsan; Hakimzadeh, Mehran; Shamsizadeh, Ahmad; Aminzadeh, Majid; Alghasi, Arash

    2011-09-01

    To compare the clinical outcome of children having severe pneumonia, with and without zinc supplementation by a randomized double-blind placebo controlled trial. In this study, 128 children (3-60 months old) admitted to the hospital with severe pneumonia were randomly divided into 2 groups (64 in each) that received either zinc sulfate (2 mg/kg/d, maximum 20 mg in 2 divided doses, for 5 days) or a placebo, along with the standard antimicrobial therapy. Primary outcome measurements included the time taken for clinical symptoms of severe pneumonia such as fever and respiratory distress symptoms to resolve, and the secondary outcome included the duration of hospital stay. The time taken for all the symptoms to resolve in the zinc-supplemented group was significantly lesser then that in the placebo group (42.26 [6.66] vs. 47.52 [7.15] h respectively, p children. The results suggest that adjuvant treatment with zinc accelerates recovery from severe pneumonia in young children and significantly reduces the duration of hospital stay. Further studies are required to develop appropriate recommendations for the use of zinc in the treatment of severe pneumonia in other populations.

  15. The influence of smear layer removal on primary tooth pulpectomy outcome: a 24-month, double-blind, randomized, and controlled clinical trial evaluation.

    Science.gov (United States)

    Barcelos, Roberta; Tannure, Patricia Nivoloni; Gleiser, Rogerio; Luiz, Ronir Raggio; Primo, Laura Guimarães

    2012-09-01

    The effect of smear layer (SL) removal on primary tooth pulpectomy outcome has not been well elucidated. To determine the effect of SL removal on primary tooth pulpectomy outcome. This is a double-blind, randomized, and controlled clinical trial. Forty-eight patients were randomly divided into SL removal (G1 = 40 teeth) or smear layer nonremoval (G2 = 42 teeth) groups. Following the chemomechanical preparation with K-files and 2.5% sodium hypochlorite (NaOCl), teeth were irrigated with either 6% citric acid and 0.9% physiologic solution (G1) or only 0.9% physiologic solution (G2). Camphorated paramonochlorophenol was used as intracanal medication. At the second appointment, 1 week after, root canals were filled with zinc oxide-eugenol paste. Clinical and radiographical baseline criteria were stipulated equally for both groups. The success rate (G1 = 91.2%; G2 = 70.0%) was statistically different (P = 0.04) between the groups. In G2, the outcome was affected significantly by pulpal necrosis (P = 0.02), pre-operatory symptoms (P = 0.02), and periapical/inter-radicular radiolucency (P = 0.04). The pulpectomy outcome was improved by smear layer removal. The outcome for teeth with pulpal necrosis, pre-operatory symptoms, or periapical/inter-radicular radiolucency was significantly improved by removal of the smear layer. © 2011 The Authors. International Journal of Paediatric Dentistry © 2011 BSPD, IAPD and Blackwell Publishing Ltd.

  16. Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (III) Clinical responses of early-postmenopausal women to Maca in double blind, randomized, Placebo-controlled, crossover configuration, outpatient study

    OpenAIRE

    Meissner, H. O.; Mscisz, A.; Reich-Bilinska, H.; Mrozikiewicz, P.; Bobkiewicz-Kozlowska, T.; Kedzia, B.; Lowicka, A.; Barchia, I.

    2006-01-01

    This is the second, conclusive part of the clinical study on clinical responses of early-postmenopausal women to standardized doses of pre-Gelatinized Organic Maca (Maca-GO). Total of 34 Caucasian women volunteers participated in a double-blind, randomized, four months outpatient crossover configuration Trial. After fulfilling the criteria of being early-postmenopausal: blood Estrogen (E230 IU/ml) at admission, they were randomly allocated to Placebo (P) and Maca-GO (M) treatments (2 groups o...

  17. Evaluation of S-adenosyl l-methionine in a double-blinded, randomized, placebo-controlled, clinical trial for treatment of presumptive osteoarthritis in the dog.

    Science.gov (United States)

    Imhoff, Darren J; Gordon-Evans, Wanda J; Evans, Richard B; Johnson, Ann L; Griffon, Dominique J; Swanson, Kelly S

    2011-02-01

    To evaluate the efficacy of S-adenosyl l-methionine (SAMe) in the treatment of clinically inferred canine osteoarthritis (OA). Six weeks, double-blinded, placebo-controlled, clinical trial. Dogs (n=33) with clinical signs, history, and orthopedic exams consistent with OA. Dogs were block randomized by body condition score (goniometry, and the Canine Brief Pain Inventory (CBPI) at the time of study entrance and at 3 and 6 weeks after entry. Groups were compared using parametric and nonparametric paired tests as appropriate, and numbers needed to treat (NNT) were calculated for the CBPI and peak vertical force (PVF). Both groups (n=15 placebo, n=18 SAMe) had a reduction in mean PVF (P=.02) and vertical impulse (VI; P=.06) from the 1st to 3rd visit. There was no significant difference between the placebo group and SAMe group for PVF, VI, or either part of the CBPI (Severity or Impact). The NNT at 6 weeks for the Severity score was 3, Impact score was 25, and PVF was 45. These data do not support the use of SAMe as an effective stand alone treatment for reducing clinical signs of OA, as measured by PVF, VI, goniometry, CBPI (both Severity and Impact), and examination score within 6 weeks of treatment. © Copyright 2011 by The American College of Veterinary Surgeons.

  18. The Therapeutic Efficacy of Botulinum Toxin in Treating Scleroderma-Associated Raynaud's Phenomenon: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Bello, Ricardo J; Cooney, Carisa M; Melamed, Eitan; Follmar, Keith; Yenokyan, Gayane; Leatherman, Gwendolyn; Shah, Ami A; Wigley, Fredrick M; Hummers, Laura K; Lifchez, Scott D

    2017-08-01

    To assess the therapeutic efficacy of local injections of botulinum toxin type A (Btx-A) in improving blood flow to the hands of patients with Raynaud's phenomenon (RP) secondary to scleroderma. In this randomized, double-blind, placebo-controlled clinical trial, patients with scleroderma-associated RP received Btx-A (50 units in 2.5 ml sterile saline) in one randomly selected hand and sterile saline (2.5 ml) in the opposite hand. Follow-up at 1 and 4 months postinjection included laser Doppler imaging of hands, patient-reported outcomes, and physical examination. We compared outcomes using paired t-tests and population-average generalized models with generalized estimating equations. Of 40 patients enrolled, 25 had limited scleroderma and 15 had diffuse scleroderma. From baseline to 1-month follow-up, there was a greater reduction in average blood flow in Btx-A-treated hands compared to placebo-treated hands. The model estimated that this difference was statistically significant (average difference -30.08 flux units [95% confidence interval -56.19, -3.98], P for interaction = 0.024). This difference was mainly influenced by patients with longstanding RP and diffuse scleroderma. Change in blood flow at 4-month follow-up was not significantly different between groups. Clinical measures (QuickDASH, McCabe Cold Sensitivity Score, pain on a visual analog scale, and Raynaud's Condition Score) improved slightly for Btx-A-treated hands. Our laboratory-based laser Doppler imaging flow data do not support using Btx-A to treat RP in all scleroderma patients. The secondary clinical outcomes suggest some positive effect, but its clinical meaningfulness is questionable. The role of Btx-A in treating RP should be further studied with more homogeneous patient populations and in unique clinical situations such as acute digital ischemia. © 2017, American College of Rheumatology.

  19. Analgesic efficacy of diazepam and placebo in patients with temporomandibular disorders: A double blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    G V Pramod

    2011-01-01

    Full Text Available Aim: The aim of the study was to evaluate and compare the analgesic efficacy of placebo and diazepam in patients with temporomandibular disorder. Materials and Methods: Thirty-five patients were recruited with a diagnosis of temporomandibular disorder based on standard clinical diagnostic criteria for temporomandibular disorder. The patients were put in to one of the two groups: placebo or diazepam at random. The average pain intensity was recorded with visual analog scale (VAS at pretreatment, at weekly interval till the completion of a three-week trial and at post-treatment visit on the eighth week from baseline. The secondary outcome measures were changes in masticatory muscle tenderness, viz. massater muscle, lateral pterygoid muscle, medial pterygoid muscle and temporalis muscle and changes in mouth opening. Statistical Analysis: Intra-group comparison for analgesic efficacy and mouth opening was carried out by Wilcoxon′s signed ranked test. Inter-group comparison for analgesic efficacy was also carried out using Mann-Whitney′s test. Results: A statistically significant (P<0.01 decrease in temporomandibular disorder pain in the placebo group (65% and statistically highly significant (P<0.001 decrease in the diazepam group (72% were observed on VAS after three weeks of treatment. The inter-group comparison demonstrated no statistically significant difference between the groups. Conclusion: This study suggests that the placebo can give near similar results as diazepam can. So the role of placebo should also be considered as one of the important management strategies. In the short term, reduction in the masticatory muscle tenderness and significant improvement in the mouth opening in both the groups were observed.

  20. Preoperative low level laser therapy in dogs undergoing tibial plateau levelling osteotomy: A blinded, prospective, randomized clinical trial.

    Science.gov (United States)

    Rogatko, Cleo P; Baltzer, Wendy I; Tennant, Rachel

    2017-01-16

    To evaluate the influence of preoperative low-level laser therapy (LLLT) on therapeutic outcomes of dogs undergoing tibial plateau levelling osteotomy (TPLO). Healthy dogs undergoing TPLO were randomly assigned to receive either a single preoperative LLLT treatment (800-900 nm dual wavelength, 6 W, 3.5 J/cm 2 , 100 cm 2 area) or a sham treatment. Lameness assessment and response to manipulation, as well as force plate analysis, were performed preoperatively, then again at 24 hours, two weeks, and eight weeks postoperatively. Radiographic signs of healing of the osteo-tomy were assessed at eight weeks postoperatively. Twenty-seven dogs (27 stifles) were included and no major complications occurred. At eight weeks postoperatively, a significant difference in peak vertical force analysis was noted between the LLLT (39.6% ± 4.7%) and sham groups (28.9% ± 2.6%), (p dogs in the LLLT group (6.6 ± 1.6 years) was greater than that for the sham group (4.5 ± 2.0, p dogs (5/8) had healed at the eight-week time point than in the sham group (3/12) despite the age difference (p = 0.11) Clinical significance: The results of this study demonstrate that improved peak vertical force could be related to the preoperative use of LLLT for dogs undergoing TPLO at eight weeks postoperatively. The use of LLLT may improve postoperative return to function following canine osteotomies and its use is recommended.

  1. IMPROVEMENT OF INTESTINAL PERMEABILITY WITH ALANYL-GLUTAMINE IN HIV PATIENTS: a randomized, double blinded, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Robério Dias LEITE

    2013-03-01

    Full Text Available Context Glutamine is the main source of energy of the enterocyte and diarrhea and weight loss are frequent in HIV infected patients. Objective To determine the effect of alanyl-glutamine supplementation on intestinal permeability and absorption in these patients. Methods Randomized double-blinded, placebo-controlled study using isonitrogenous doses of alanyl-glutamine (24 g/day and placebo (glycine, 25 g/day during 10 days. Before and after this nutritional supplementation lactulose and mannitol urinary excretion were determined by high performance liquid chromatography. Results Forty six patients with HIV/AIDS, 36 of whom were male, with 37.28 ± 3 (mean ± standard error years were enrolled. Twenty two and 24 subjects were treated with alanyl-glutamine and with glycine respectively. In nine patients among all in the study protocol that reported diarrhea in the 14 days preceding the beginning of the study, mannitol urinary excretion was significantly lower than patients who did not report this symptom [median (range: 10.51 (3.01–19.75 vs. 15.37 (3.93–46.73; P = 0.0281] and lactulose/mannitol ratio was significantly higher [median (range: 0.04 (0.00–2.89 vs. 0.02 (0.00–0.19; P = 0.0317]. There was also a significant increase in mannitol urinary excretion in the group treated with alanyl-glutamine [median (range: 14.38 (8.25–23.98 before vs 21.24 (6.27–32.99 after treatment; n = 14, P = 0.0382]. Conclusion Our results suggest that the integrity and intestinal absorption are more intensely affected in patients with HIV/AIDS who recently have had diarrhea. Additionally, nutritional supplementation with alanyl-glutamine was associated with an improvement in intestinal absorption. Contexto A glutamina é a principal fonte de energia do enterócito e diarreia e perda de peso são frequentes em pacientes infectados pelo HIV. Objetivo Determinar o efeito da alanil-glutamina sobre a permeabilidade e a absorção intestinais nesses

  2. Comparison of Acupuncture with Ibuprofen for Pain Management in Patients with Symptomatic Irreversible Pulpitis: A Randomized Double-Blind Clinical Trial

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    Haneesh Murugesan

    2017-12-01

    Full Text Available Emergency pain management in symptomatic irreversible pulpitis commonly includes use of nonnarcotic analgesics. Acupuncture has been used in dentistry to alleviate pain after tooth extraction. The aim of this randomized, double-blind, placebo controlled clinical trial was to evaluate and compare the efficacy of acupuncture therapy and ibuprofen for pain management in such patients. A total of 157 patients participated in this study and were randomly assigned to three groups, Group I—classical acupuncture with placebo tablet, Group II—sham acupuncture with placebo tablet, and Group III—sham acupuncture with ibuprofen. Before commencement of the experiment, initial pain assessment was done using a HP-VAS scale. Treatment was done by first operator, while pain assessment was done by the second operator who was blinded to the procedure performed. Acupuncture needles were inserted for 15–20 minutes at acupoints for classical acupuncture and at nonacupoints for sham acupuncture. Posttreatment pain assessment was carried out at 15, 30, 45, and 60 minutes intervals. Follow-up analysis was recorded at 12, 24, and 48 hours using VAS verbal scale. The mean final HP VAS values for Group I showed statistically significant lower pain values when compared with groups II and III (p < 0.05, with no significant difference between groups II and III. Follow-up analysis showed Group I with higher percentage of no pain, which was statistically significant when compared with other two groups. It can be concluded that classical acupuncture is more effective in pain relief (faster and prolonged than analgesics.

  3. Efficacy of topical resin lacquer, amorolfine and oral terbinafine for treating toenail onychomycosis: a prospective, randomized, controlled, investigator-blinded, parallel-group clinical trial.

    Science.gov (United States)

    Auvinen, T; Tiihonen, R; Soini, M; Wangel, M; Sipponen, A; Jokinen, J J

    2015-10-01

    Norway spruce (Picea abies) produces resin to protect against decomposition by microbial pathogens. In vitro tests have shown that spruce resin has antifungal properties against dermatophytes known to cause nearly 90% of onychomycosis in humans. To confirm previous in vivo observations that a topical resin lacquer provides mycological and clinical efficacy, and to compare this lacquer with topical amorolfine hydrochloride lacquer and systemic terbinafine for treating dermatophyte toenail onychomycosis. In this prospective, randomized, controlled, investigator-blinded study, 73 patients with onychomycosis were randomized to receive topical 30% resin lacquer once daily for 9 months, topical 5% amorolfine lacquer once weekly for 9 months, or 250 mg oral terbinafine once daily for 3 months. The primary outcome measure was complete mycological cure at 10 months. Secondary outcomes were clinical efficacy, cost-effectiveness and patient compliance. At 10 months, complete mycological cure rates with the resin, amorolfine and terbinafine treatments were 13% [95% confidence interval (CI) 0-28], 8% (95% CI 0-19) and 56% (95% CI 35-77), respectively (P ≤ 0·002). At 10 months, clinical responses were complete in four patients (16%) treated with terbinafine, and partial in seven (30%), seven (28%) and nine (36%) patients treated with resin, amorolfine and terbinafine, respectively (P Resin, amorolfine and terbinafine treatments cost €41·6, €56·3 and €52·1, respectively, per patient (P resin lacquer and topical 5% amorolfine lacquer provided similar efficacy for treating dermatophyte toenail onychomycosis. However, orally administered terbinafine was significantly more effective in terms of mycological cure and clinical outcome than either topical therapy at the 10-month follow-up. © 2015 British Association of Dermatologists.

  4. Eccentric versus conventional exercise therapy in patients with rotator cuff tendinopathy: a randomized, single blinded, clinical trial

    NARCIS (Netherlands)

    Dejaco, B.; Habets, B.; Loon, C.J.M. van; Grinsven, S. van; Cingel, R.E. van

    2017-01-01

    PURPOSE: To investigate the effectiveness of isolated eccentric versus conventional exercise therapy in patients with rotator cuff tendinopathy. METHODS: Thirty-six patients with rotator cuff tendinopathy, diagnosed by an orthopaedic surgeon, were included and randomly allocated to an isolated

  5. Comparison of paroxetine and agomelatine in depressed type 2 diabetes mellitus patients: a double-blind, randomized, clinical trial

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    Kang RY

    2015-05-01

    Full Text Available Ruiying Kang,1 Yan He,1 Yuxiang Yan,1 Zhiwu Li,2 Yeqing Wu,3 Xiaojuan Guo,4 Zhigang Liang,5 Jun Jiang2 1Department of Epidemiology and Biostatics, School of Public Health, Capital Medical University, Beijing, People’s Republic of China; 2Fengtai Nanyuan Hospital of Beijing, Beijing, People’s Republic of China; 3Fengtai District Community Health Center, Beijing, People’s Republic of China; 4Department of Preventive Medicine, School of Environmental and Public Health, Wenzhou Medical University, Wenzhou, People’s Republic of China; 5Xuanwu Hospital, Capital Medical University, Beijing, People’s Republic of China Background: Comorbid depression/anxiety in type 2 diabetes mellitus (DM patients is highly prevalent, affecting both diabetes control and quality of life. However, the best treating method for depression/anxiety in type 2 DM patients is still unclear. This study was conducted to compare the efficacy of paroxetine and agomelatine on depression/anxiety and metabolic control of type 2 DM patients.Methods: A total of 116 depressed, type 2 DM patients were recruited for 12 weeks treatment. Patients were randomly assigned to receive either paroxetine or agomelatine. Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale were used to assess depression and anxiety, respectively. Hemoglobin A1c, fasting plasma glucose, and body mass index were assessed at baseline and at the end of the trial.Results: At the end of the trial, there were 34 (60.7% responders and 22 (39.3% remissions in paroxetine group; and 38 (63.3% responders and 26 (43.3% remissions in agomelatine group. Compared to paroxetine group, lower depression scores were observed in agomelatine group. Fasting plasma glucose and body mass index were not significantly different after 12 weeks treatment between the two groups, but agomelatine group had a significantly lower final hemoglobin A1c level compared to paroxetine group. The two antidepressants had comparable

  6. Intravenous Ibuprofen for Treatment of Post-Operative Pain: A Multicenter, Double Blind, Placebo-Controlled, Randomized Clinical Trial

    Science.gov (United States)

    Escontrela Rodriguez, Blanca; Planas Roca, Antonio; Martínez Ruiz, Alberto

    2016-01-01

    Background Non-steroidal anti-inflammatory drugs are often used as components of multimodal therapy for postoperative pain management, but their use is currently limited by its side effects. The specific objective of this study was to evaluate the efficacy and safety of a new formulation of intravenous (IV) ibuprofen for the management of postoperative pain in a European population. Methods and Findings A total of 206 patients from both abdominal and orthopedic surgery, were randomly assigned in 1:1 ratio to receive 800 mg IV-ibuprofen or placebo every 6 hours; all patients had morphine access through a patient controlled analgesia pump. The primary outcome measure was median morphine consumption within the first 24 hours following surgery. The mean±SEM of morphine requirements was reduced from 29,8±5,25 mg to 14,22±3,23 mg (p = 0,015) and resulted in a decrease in pain at rest (p = 0,02) measured by Visual Analog Scale (VAS) from mean±SEM 3.34±0,35 to 0.86±0.24, and also in pain during movement (p = 0,02) from 4.32±0,36 to 1.90±0,30 in the ibuprofen treatment arm; while in the placebo group VAS score at rest ranged from 4.68±0,40 to 2.12±0,42 and during movement from 5.66±0,42 to 3.38±0,44. Similar treatment-emergent adverse events occurred across both study groups and there was no difference in the overall incidence of these events. Conclusions Perioperative administration of IV-Ibuprofen 800 mg every 6 hours in abdominal surgery patient’s decreases morphine requirements and pain score. Furthermore IV-Ibuprofen was safe and well tolerate. Consequently we consider appropriate that protocols for management of postoperative pain include IV-Ibuprofen 800 mg every 6 hours as an option to offer patients an analgesic benefit while reducing the potentially risks associated with morphine consumption. Trial Registration EU Clinical Trials Register 2011-005007-33 PMID:27152748

  7. Evaluation of the efficacy of a topical sialogogue spray containing malic acid 1% in elderly people with xerostomia: a double-blind, randomized clinical trial.

    Science.gov (United States)

    Gómez-Moreno, Gerardo; Cabrera-Ayala, Maribel; Aguilar-Salvatierra, Antonio; Guardia, Javier; Ramírez-Fernández, María Piedad; González-Jaranay, Maximino; Calvo-Guirado, José Luis

    2014-12-01

    The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid for elderly people affected by xerostomia. This research took the form of a double-blind, randomized clinical trial. Forty-one individuals (mean age: 78.7 years) with xerostomia were divided into two groups: for the first 'intervention group' (21 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second 'control group' (20 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The Xerostomia Inventory (XI) was used to evaluate xerostomia levels before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after spray application, were measured. XI scores decreased significantly (clinically meaningful) from 36.4 ± 7.3 points to 29.1 ± 7.1 (p xerostomia in an elderly population and increased unstimulated and stimulated salivary flows rates. © 2013 The Gerodontology Society and John Wiley & Sons A/S.

  8. Efficacy and safety of premedication with single dose of oral pregabalin in children with dental anxiety: A randomized double-blind placebo-controlled crossover clinical trial

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    Tahereh Eskandarian

    2015-01-01

    Full Text Available Background: Dental anxiety is a relatively frequent problem that can lead to more serious problems such as a child entering a vicious cycle as he/she becomes reluctant to accept the required dental treatments. The aim of this randomized double-blind clinical trial study was to evaluate the anxiolytic and sedative effect of pregabalin in children. Materials and Methods: Twenty-five children were randomized to a double-blind placebo-controlled crossover clinical trial. Two visits were scheduled for each patient. At the first visit, 75 mg pregabalin or placebo was given randomly, and the alternative was administered at the next visit. Anxiolytic and sedative effects were measured using the visual analogue scale. The child′s behavior was rated with the Frankl behavioral rating scale and the sedation level during the dental procedure was scored using the Ramsay sedation scale. The unpaired, two-tailed Student′s t-test was used to compare the mean changes of visual analog scale (VAS for anxiety in the pregabalin group with that of the placebo group. A repeated measures MANOVA model was used to detect differences in sedation level in the pregabalin and placebo groups regarding the interaction of 3-time measurements; sub-group analysis was performed using Student′s t-test. The Mann-Whitney U-test was used to analyze the nonparametric data of the Frankl and Ramsay scales. A P < 0.05 was considered significant. Results: The reduction of the VAS-anxiety score from 2 h post-dose was statistically significant in the pregabalin group. From 2 h to 4 h post-dose, the VAS-sedation score increased significantly in the pregabalin group. The child′s behavior rating was not significantly different between the groups. The number of "successful" treatment visits was higher in the pregabalin group compared to the placebo group. Conclusion: Significant anxiolytic and sedative effects can be anticipated 2 h after oral administration of pregabalin without serious

  9. Multisite, randomized, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.

    Science.gov (United States)

    Winhusen, Theresa M; Kropp, Frankie; Lindblad, Robert; Douaihy, Antoine; Haynes, Louise; Hodgkins, Candace; Chartier, Karen; Kampman, Kyle M; Sharma, Gaurav; Lewis, Daniel F; VanVeldhuisen, Paul; Theobald, Jeff; May, Jeanine; Brigham, Gregory S

    2014-07-01

    To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence. A randomized, double-blind, placebo-controlled, 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013. Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to 60 mg/d (n = 35) or placebo (n = 27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days to first cocaine use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens. There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. In the female participants (n = 23), there was a significant treatment-by-time interaction effect (χ²₁ = 15.26, P P = .70). The results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may worsen their cocaine use outcomes. ClinicalTrials.gov identifier: NCT01641159. © Copyright 2014 Physicians Postgraduate Press, Inc.

  10. 17-Hydroxyprogesterone caproate to prolong pregnancy after preterm rupture of the membranes: early termination of a double-blind, randomized clinical trial

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    Combs C Andrew

    2011-12-01

    Full Text Available Abstract Background Progestational agents may reduce the risk of preterm birth in women with various risk factors. We sought to test the hypothesis that a weekly dose of 17-hydroxyprogesterone caproate (17P given to women with preterm rupture of the membranes (PROM will prolong pregnancy and thereby reduce neonatal morbidity. Methods Double-blind, placebo-controlled randomized clinical trial. Women with PROM at 23.0 to 31.9 weeks of gestation were randomly assigned to receive a weekly intramuscular injection of 17P (250 mg in 1 mL castor oil or placebo (1 mL castor oil. The primary outcome was the rate of continuing the pregnancy until 34.0 weeks of gestation or until documentation of fetal lung maturity at 32.0 to 33.9 weeks of gestation. Planned secondary outcomes were duration of latency period and rate of composite neonatal morbidity. Enrollment of 111 participants per group, 222 total, was planned to yield 80% power to detect an increase in the primary outcome from 30% with placebo to 50% with 17P. Results Twelve women were enrolled of whom 4 were randomly assigned to receive 17P and 8 to receive placebo. The trial was terminated prematurely because of two separate issues related to the supply of 17P. No adverse events attributable to 17P were identified. Conclusion Because of premature termination, the trial does not have adequate statistical power to evaluate efficacy or safety of 17P in women with PROM. Nonetheless, ethical principles dictate that we report the results, which may contribute to possible future metaanalyses and systematic reviews. Trial Registration ClinicalTrials.gov: NCT01119963 Supported by a research grant from the Center for Research, Education, and Quality, Pediatrix Medical Group, Sunrise, FL

  11. A randomized, placebo-controlled double-blinded comparative clinical study of five over-the-counter non-pharmacological topical analgesics for myofascial pain: single session findings

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    Avrahami Daniel

    2012-03-01

    Full Text Available Abstract Objectives To investigate the effects of topical agents for the treatment of Myofascial Pain Syndrome (MPS and Myofascial Trigger Point (MTRP. Methods Subjects with an identifiable trigger point in the trapezius muscle, age 18-80 were recruited for a single-session randomized, placebo-blinded clinical study. Baseline measurements of trapezius muscle pressure pain threshold (PPT: by pressure algometer along with right and left cervical lateral flexion (rangiometer were obtained by a blinded examiner. An assessor blinded to the outcomes assessments applied one of 6 topical formulations which had been placed in identical plastic containers. Five of these topicals were proposed active formulations; the control group was given a non-active formulation (PLA. Five minutes after the application of the formula the outcome measures were re-tested. Data were analyzed with a 5-way ANOVA and Holms-adjusted t-tests with an alpha level of 0.05. Results 120 subjects were entered into the study (63 females; ages 16-82; 20 subjects randomly allocated into each group. The pre- and post-treatment results for pressure threshold did show significant intra-group increases for the Ben-Gay Ultra Strength Muscle Pain Ointment (BG, the Professional Therapy MuscleCare Roll-on (PTMC roll-on and Motion Medicine Cream (MM with an increased threshold of 0.5 kg/cm2 (+/-0.15, 0.72 kg/cm2 (+/-0.17 and 0.47 Kg/cm2 (+/-0.19 respectively. With respect to the inter-group comparisons, PTMC roll-on showed significant increases in pressure threshold compared with Placebo (PLA (p = 0.002 and Icy Hot Extra Strength Cream (IH (p = 0.006. In addition, BG demonstrated significant increases in pressure threshold compared with PLA (p = 0.0003. Conclusions With regards to pressure threshold, PTMC roll-on, BG and MM showed significant increases in pain threshold tolerance after a short-term application on a trigger points located in the trapezius muscle. PTMC roll-on and BG were both

  12. Effect of an experimental desensitizing agent on reduction of bleaching-induced tooth sensitivity: A triple-blind randomized clinical trial.

    Science.gov (United States)

    Parreiras, Sibelli Olivieri; Szesz, Anna Luiza; Coppla, Fabiana Madalozzo; Martini, Eveline Claudia; Farago, Paulo Vitor; Loguercio, Alessandro D; Reis, Alessandra

    2018-04-01

    In this randomized study, split-mouth, triple-blind clinical trial, the authors evaluated the efficacy of a desensitizing gel that contained 5% potassium nitrate and 5% glutaraldehyde applied before in-office bleaching with 35% hydrogen peroxide (HP). Treatment with the desensitizing or placebo control gels was randomly assigned to one-half of the maxillary teeth of 42 patients in a split-mouth design. The desensitizing gels were applied and maintained in contact with the tooth enamel for 10 minutes, followed by 2 HP bleaching sessions separated by 1 week. The primary outcome variable was pain intensity assessed with a numeric rating scale and a visual analog scale. Color was evaluated by means of a digital spectrophotometer and a value-oriented shade guide. The difference in risk of developing tooth sensitivity between the desensitizing gel group (31.7%, 95% confidence interval [CI], 19.6 to 46.9) and the control group (70.7%; 95% CI, 55.5 to 82.3%) was statistically significant (P whitening reduced the risk and severity of dental sensitivity, without altering the effectiveness of whitening. A single application of desensitizing gel that contained 5% potassium nitrate and 5% glutaraldehyde can reduce tooth sensitivity after dental bleaching systems. Copyright © 2018 American Dental Association. Published by Elsevier Inc. All rights reserved.

  13. Randomized double-blind controlled clinical trial of the blood pressure-lowering effect of fermented milk with Lactococcus lactis: A pilot study.

    Science.gov (United States)

    Beltrán-Barrientos, Lilia M; González-Córdova, Aarón F; Hernández-Mendoza, Adrián; Torres-Inguanzo, Eduardo H; Astiazarán-García, Humberto; Esparza-Romero, Julián; Vallejo-Cordoba, Belinda

    2018-04-01

    The blood pressure-lowering effect of fermented milk with Lactococcus lactis NRRL B-50571 was evaluated in a double-blind randomized controlled clinical trial with prehypertensive subjects. Participants were randomized into 2 groups (n = 18 each group): one group treated with fermented milk with Lactococcus lactis NRRL B-50571 and a control group treated with artificially acidified milk. Results revealed that during daily consumption of fermented milk for 5 wk, systolic [(116.55 ± 12.26 mmHg vs. 124.77 ± 11.04 mmHg) and diastolic blood pressure (80.7 ± 9 vs. 84.5 ± 8.5 mmHg)] from the fermented milk group was lower than the control group. Additionally, triglyceride, total cholesterol, and low-density lipoprotein in blood serum were lower in the fermented milk group than in the control group. Results demonstrated that daily consumption of fermented milk with Lactococcus lactis (NRRL B-50571) had a blood pressure-lowering effect on prehypertensive subjects. Regular consumption of this product may be used as a potential functional food. Copyright © 2018 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  14. Effects of co-administered dexamethasone and nimesulide on pain, swelling, and trismus following third molar surgery: a randomized, triple-blind, controlled clinical trial.

    Science.gov (United States)

    Barbalho, J C; Vasconcellos, R J H; de Morais, H H; Santos, L A M; Almeida, R de A C; Rêbelo, H L; Lucena, E E; de Araújo, S Q

    2017-02-01

    This study aimed to determine the effect of the co-administration of dexamethasone 8mg and nimesulide 100mg given 1h before mandibular third molar surgery. A prospective, randomized, triple-blind, split-mouth clinical trial was developed at the study institution in Pernambuco, Brazil. A pilot study was first performed (95% confidence interval, 80% test power, and 5% error), and a sample of 40 patients aged between 18 and 40 years was selected. The patients were randomized and divided into two groups: dexamethasone+placebo and dexamethasone+nimesulide. The following parameters were evaluated: pain (visual analogue scale), total number of rescue analgesics taken, time taken to first rescue analgesic consumption, oedema, trismus, and patient satisfaction. The paired t-test and the Wilcoxon test were used to compare means. Statistically significant differences were found between the groups in pain values at 2, 4, and 12h postoperative, and in the total number of rescue analgesics and time taken to first rescue analgesic ingestion (Pthird molar surgery. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  15. Effective low dosage of mepivacaine in ultrasound-guided axillary nerve block: a double-blinded, randomized clinical trial of efficacy in patients undergoing distal upper extremity surgery.

    Science.gov (United States)

    Perov, Samuel; Patel, Pranav; Kumar, Sanjeev; McKelvey, George M; Chidiac, Elie; Motlani, Faisal

    2014-05-01

    To evaluate two low-dose volumes (20 mL or 30 mL) of 1.5% mepivacaine solution used for ultrasound-guided axillary blockade for outpatients undergoing distal upper limb surgery. Prospective, double-blinded randomized study. Outpatient surgical setting of a university-affiliated hospital. 64 adult, ASA physical status 1, 2, and 3 patients, aged 28-46 years, scheduled for upper limb surgery. Patients were randomized to two groups to receive either 20 mL of 1.5% mepivacaine solution (n=31) or 30 mL of 1.5% mepivacaine solution (n=33) for ultrasound-guided axillary plexus blockade. Block duration, proportion of surgical and functional successful blocks, onset of sensory and motor blockade measured from 0 to 30 minutes following final needle extraction, total amount of preoperative sedative (midazolam), and intraoperative propofol administered were recorded. Following axillary plexus blockade, neither patient group showed any statistically significant difference in the percentage of functionally successful blockade (30 mL, 100%: 20 mL, 97%; P = 0.48), surgically successful blockade (30 mL, 100%; 20 mL, 94%; P = 0.23), cumulative sensory or motor blockade surgical time, block performance time, preoperative midazolam use, or intraoperative propofol use. Low volumes (30 mL or 20 mL) of 1.5% mepivacaine provides satisfactory anesthesia for ambulatory distal upper limb surgery with no significant difference in clinical outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. Evaluation of pretreatment with gelofen and novafen on pain relief after endodontic treatment; A double-blind randomized clinical trial study

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    Seyed Mehdi Dejkam

    2015-03-01

    Full Text Available Introduction: Feeling pain after root canal therapy has always been a major problem for patients and dentists. One of the suggested methods to manage the pain is using the prophylactic medication before treatment process. This study aimed at investigating the comparison of pretreatment with novafen versus gelofen on reducing the pain after root canal therapy. Materials &Methods: This double-blind randomized clinical trial study was conducted on 60 patients aged 18-65 who were indicated for root canal therapy. Patients were randomly assigned to receive gelofen capsules (400mg, novafen capsules (200mg and placebo two capsules by every patient of these groups one hour prior to sampling. Pre/post-treatment pain was measured using Visual Analog Scale (VAS before treatment and 4, 8, 12, 24 and 48 hours after treatment. Results: Both novafen and gelofen indicated significant analgesic effect during the study period (p<0.001. Pain severity within 8 hours after treatment was significantly lower in novafen group than two other groups (p=0.03. The difference between the severity of pain did not show any association to their place of life and gender in any groups. Conclusion: Our findings revealed that the prophylactic novafen in comparison to gelofen had a better analgesic effect in short-term and could be a good candidate for the management of post-endodontic treatment pain.

  17. Impact comparison of ketamine and sodium thiopental on anesthesia during electroconvulsive therapy in major depression patients with drug-resistant; a double-blind randomized clinical trial

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    B Salehi

    2015-01-01

    Full Text Available Background: Electroconvulsive therapy (ECT is one of the available and the most effective therapies for the treatment of resistant depression. Considering the crucial role of seizure duration on therapeutic response in patients treated with ECT, this study aimed to compare the effect of ketamine and sodium thiopental anesthesia during ECT for treatment of patients with drug-resistant major depression (DRMD. Materials and Methods: In a double-blind randomized clinical trial, 160 patients with DRMD were selected consequently and were assigned randomly into two groups including ketamine 0.8 mg/kg and sodium thiopental 1.5 mg/kg. The seizure duration, recovery time, and the side effects of anesthesia were evaluated after 1-h after anesthesia. Data of recovery time and complication collected in 2 nd , 4 th , 6 th , and 8 th ECT. Depression was assessed by Hamilton depression scale. Results: The results indicated that ketamine and sodium thiopental had a significant effect on the reduction of depression scores in patients with DRMD (P 0.05. But ketamine was more effective in improvement of depression score and increasing systolic and diastolic blood pressure (P < 0.05. The mean of seizure duration showed a decreasing trend and was significant between two study groups (P < 0.05. Conclusion: Anesthesia induced by ketamine during ECT therapy increased blood pressure and seizure duration. Therefore, due to lower medical complication and attack rate of seizure, ketamine is an appropriate option for anesthesia with ECT in patients with DRMD.

  18. Brief motivational interview and educational brochure in emergency room settings for adolescents and young adults with alcohol-related problems: a randomized single-blind clinical trial.

    Science.gov (United States)

    Segatto, Maria Luiza; Andreoni, Solange; de Souza e Silva, Rebeca; Diehl, Alessandra; Pinsky, Ilana

    2011-09-01

    To evaluate the effectiveness of brief motivational interviewing and an educational brochure when delivered in emergency room to reduce alcohol abuse and related problems among adolescents and young adults. A randomized single-blind clinical trial with a three-month follow-up was carried out at three emergency rooms from October 2004 to November 2005; subjects assessed were 16-25 years old treated for alcohol related events up to 6 hours after consumption. Socio-demographic data, quantity, frequency and negative consequences of alcohol consumption, motivation to change habits and future risk perception were evaluated. Statistical analysis was performed on subjects who completed follow-up (completers). ANCOVA model was used to analyze the difference between the intervention groups with statistical significance level α = 5% and confidence interval (CI) of 95%. 186 subjects formed the initial sample, being 175 included and randomized to the educational brochure group (n = 88) or motivational interviewing group (n = 87). Follow-up assessment was performed in 85.2% of the sample. No significant difference between groups was observed. However, significant reductions (p motivational interviewing, educational brochure and nonintervention should be of future interest among Brazilian adolescent populations.

  19. Protein Supplementation Has Minimal Effects on Muscle Adaptations during Resistance Exercise Training in Young Men: A Double-Blind Randomized Clinical Trial.

    Science.gov (United States)

    Reidy, Paul T; Borack, Michael S; Markofski, Melissa M; Dickinson, Jared M; Deer, Rachel R; Husaini, Syed H; Walker, Dillon K; Igbinigie, Sherry; Robertson, Shay M; Cope, Mark B; Mukherjea, Ratna; Hall-Porter, Janine M; Jennings, Kristofer; Volpi, Elena; Rasmussen, Blake B

    2016-09-01

    To our knowledge the efficacy of soy-dairy protein blend (PB) supplementation with resistance exercise training (RET) has not been evaluated in a longitudinal study. Our aim was to determine the effect of PB supplementation during RET on muscle adaptation. In this double-blind randomized clinical trial, healthy young men [18-30 y; BMI (in kg/m(2)): 25 ± 0.5] participated in supervised whole-body RET at 60-80% 1-repetition maximum (1-RM) for 3 d/wk for 12 wk with random assignment to daily receive 22 g PB (n = 23), whey protein (WP) isolate (n = 22), or an isocaloric maltodextrin (carbohydrate) placebo [(MDP) n = 23]. Serum testosterone, muscle strength, thigh muscle thickness (MT), myofiber cross-sectional area (mCSA), and lean body mass (LBM) were assessed before and after 6 and 12 wk of RET. All treatments increased LBM (P 0.10) between treatments. Testosterone was not altered. PB supplementation during 3 mo of RET tended to slightly enhance gains in whole-body and arm LBM, but not leg muscle mass, compared with RET without protein supplementation. Although protein supplementation minimally enhanced gains in LBM of healthy young men, there was no enhancement of gains in strength. This trial was registered at clinicaltrials.gov as NCT01749189. © 2016 American Society for Nutrition.

  20. Effects of Fresh Yellow Onion Consumption on CEA, CA125 and Hepatic Enzymes in Breast Cancer Patients: A Double- Blind Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Jafarpour-Sadegh, Farnaz; Montazeri, Vahid; Adili, Ali; Esfehani, Ali; Rashidi, Mohammad-Reza; Mesgari, Mehran; Pirouzpanah, Saeed

    2015-01-01

    Onion (Allium cepa) consumption has been remarked in folk medicine which has not been noted to be administered so far as an adjunct to conventional doxorubicin-based chemotherapy in breast cancer patients. To our knowledge, this is the first study aimed to investigate the effects of consuming fresh yellow onions on hepatic enzymes and cancer specific antigens compared with a low-onion containing diet among breast cancer (BC) participants treated with doxorubicin. This parallel design randomized controlled clinical trial was conducted on 56 BC patients whose malignancy was confirmed with histopathological examination. Subjects were assigned in a stratified-random allocation into either group received body mass index dependent 100-160 g/d of onion as high onion group (HO; n=28) or 30-40 g/d small onion in low onion group (LO; n=28) for eight weeks intervention. Participants, care givers and laboratory assessor were blinded to the assignments (IRCT registry no: IRCT2012103111335N1). The compliance of participants in the analysis was appropriate (87.9%). Comparing changes throughout pre- and post-dose treatments indicated significant controls on carcinoembryonic antigen, cancer antigen-125 and alkaline phosphatase levels in the HO group (Ponion administration could be effective for hepatic enzyme conveying adjuvant chemotherapy relevant toxicity and reducing the tumor markers in BC during doxorubicin-based chemotherapy.

  1. The Effect of L-arginine Supplementation on Blood Pressure in Patients with Type 2 Diabetes: A Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Sara Asadi

    2016-10-01

    Full Text Available Background: The prevalence of hypertension in patients with type 2 diabetes (T2D is approximately twice as much as healthy people. This study was designed to determine the effect of L-arginine supplementation on blood pressure in patients with T2D. Methods: In a double-blind randomized clinical trial, 75 T2D were randomly divided into three groups (3 g/d and 6g/d of L-arginine and placebo for 3 months. Height, weight, waist circumference, dietary intake, and blood pressure (BP were measured before and after intervention. Results: In patients who received 3g/d L-arginine, no significant difference was observed between BP before and after the intervention, however, subgroup analysis among patients with high BP showed significant reduction in systolic (P = 0.036 and diastolic BP (P = 0.027 after L-arginine supplementation. After 3 months of intervention, systolic and diastolic BP were significantly different compared to the baseline values and also with placebo value in patients receiving 6g/d of L-arginine (P < 0.05. Conclusions: The daily intake of 6g of L-arginine for 3 months in T2D may improve BP. Taking 3g/d of this supplement may help to improve BP only in patients with hypertension.

  2. Measure Of Frequency Of Alveolar Osteitis Using Two Different Methods Of Osteotomy In Mandibular Third Molar Impactions: A Double-Blind Randomized Clinical Trial.

    Science.gov (United States)

    Rashid, Hina; Hussain, Azmina; Sheikh, Abdul Hafeez; Azam, Kehkishan; Malik, Sofia; Amin, Muhammad

    2018-01-01

    Dento-alveolar surgical procedures involving third molar teeth are the most common surgical procedure in the field of surgery. The objective of this research was to analyse the impact of surgery on the incidence of alveolar osteitis after surgical removal of mandibular third molar and to compare two different bone cutting methods following impacted mandibular third molar surgery.. This double blinded randomized clinical trial was executed at the OPD of Department of Oral and Maxillofacial Surgery, Dow University of Health Sciences, Karachi. The study duration was four months. It was conducted on 60 patients needing unilateral mandibular third molar impaction removal. Patients were randomized to two groups (i.e., physio dispenser group and slow speed handpiece group) before surgery. The surgical procedure was performed under local anaesthesia by using standardized cross infection protocol. The frequency of alveolar osteitis was evaluated on thirdday postoperatively. Alveolar osteitis was diagnosed and confirmed by patient's history and clinical evaluation. Post-operative sequelae were observed and recorded objectively. Out of 60 patients', five patients experienced alveolar osteitis, and the incidence rate was 8.3%. A significant pvalue of 0.000 was calculated using binomial test for comparison of alveolar osteitis among both groups. Inter-examiner reliability was assessed by kappa and good (62%) agreement, which was found among the examiners, who diagnosed alveolar osteitis clinically. Post-operative sequelae were insignificant in slow speed hand piece group. It was observed that alveolar osteitis was reported in physio-dispenser group; similarly, post-operative complications were also more in this group as compared with slow speed-hand piece group. No surgical complications were observed in slow speed-hand piece group suggesting slow speed hand piece mode of osteotomy to be safer for third molar extraction as compared with physio-dispenser.

  3. Clinical benefit of midodrine hydrochloride in symptomatic orthostatic hypotension: a phase 4, double-blind, placebo-controlled, randomized, tilt-table study.

    Science.gov (United States)

    Smith, William; Wan, Hong; Much, David; Robinson, Antoine G; Martin, Patrick

    2016-08-01

    Midodrine hydrochloride is a short-acting pressor agent that raises blood pressure in the upright position in patients with orthostatic hypotension. The US Food and Drug Administration's Subpart H approval, under which midodrine was initially approved, requires post-marketing studies to confirm midodrine's clinical benefit in this indication. The purpose of this study was to evaluate the clinical benefit of midodrine with regard to symptom response. This was a double-blind, placebo-controlled, randomized, crossover, multicenter study (NCT01518946). Following screening, patients aged ≥18 years with severe symptomatic orthostatic hypotension and on a stable dose of midodrine for at least 3 months were randomized to treatment with either their previous midodrine dose or placebo on day 1 and the respective alternate treatment on day 2. The primary endpoint measured time to syncopal symptoms or near-syncope using a 45-min tilt-table test at 1 h post-dose. Thirty-three patients were screened for inclusion: 19 received at least one dose of midodrine and had at least one post-dose measurement of the primary endpoint. The least-squares mean time to syncopal symptoms or near-syncope after tilt-table initiation (mean ± standard error) was 1626.6 ± 186.8 s for midodrine and 1105.6 ± 186.8 s for placebo (difference, 521.0 s; 95 % confidence interval 124.2-971.7 s; p = 0.0131). There were 15 adverse events in 10 patients; all of these were mild or moderate in severity, with none considered by the investigators to be related to midodrine. Midodrine is a well-tolerated and clinically effective treatment for symptomatic orthostatic hypotension.

  4. Evaluation of the efficacy and safety of Tribulus terrestris in male sexual dysfunction-A prospective, randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Kamenov, Zdravko; Fileva, Svetlana; Kalinov, Krassimir; Jannini, Emmanuele A

    2017-05-01

    The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of men with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to monitor the safety profile of the drug. The secondary objective was to evaluate the level of lipids in blood during treatment. Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 180 males aged between 18 and 65 years with mild or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Patients with ED and hypertension, diabetes mellitus, and metabolic syndrome were included in the study. In the trial, an herbal medicine intervention of Bulgarian origin was used (Tribestan ® , Sopharma AD). Each Tribestan film-coated tablet contains the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112.5mg). Each patient received orally 3×2 film-coated tablets daily after meals, during the 12-week treatment period. At the end of each month, participants' sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Global Efficacy Question (GEQ). Several biochemical parameters were also determined. The primary outcome measure was the change in IIEF score after 12 weeks of treatment. Complete randomization (random sorting using maximum allowable% deviation) with an equal number of patients in each sequence was used. This randomization algorithm has the restriction that unequal treatment allocation is not allowed; that is, all groups must have the same target sample size. Patients, investigational staff, and data collectors were blinded to treatment. All outcome assessors were also blinded to group allocation. 86 patients in each group completed the study. The IIEF

  5. Deep heating therapy via microwave diathermy relieves pain and improves physical function in patients with knee osteoarthritis: a double-blind randomized clinical trial.

    Science.gov (United States)

    Rabini, A; Piazzini, D B; Tancredi, G; Foti, C; Milano, G; Ronconi, G; Specchia, A; Ferrara, P E; Maggi, L; Amabile, E; Galli, M; Bernabei, R; Bertolini, C; Marzetti, E

    2012-12-01

    Deep heating therapy (DHT) has shown to improve pain and function in patients with knee osteoarthritis (OA) in the short term. Benefits of superficial heating therapy (SHT) are controversial. Long-term effects of both heating modalities have not yet been investigated. To compare the effects of DHT and SHT in patients with symptomatic knee OA, and to determine the long-term effects of heat therapy. Double-blind randomized clinical trial. Outpatient clinic of Geriatrics and Physiatrics, University Hospital. Fifty-four patients with radiologically established diagnosis of moderate knee OA (Kellgren-Lawrence grade II or III) and pain lasting for at least three weeks. DHT: local microwave diathermy (three 30-min sessions a week for four weeks); SHT: application of hot packs (three 30-min sessions a week for four weeks). Western Ontario and McMaster Universities (WOMAC) index for the assessment of joint pain, stiffness and physical function limitations. British Medical Research Council (BMRC) rating scale for the evaluation of muscle strength, and a visual analogue scale (VAS) for pain assessment. Follow up: 24 weeks for all outcome measures; 12 months for the primary outcome. Intention-to-treat analyses showed a treatment effect in favor of DHT for all outcome measures. No clinically relevant changes were observed in the SHT group. Benefits of DHT were maintained over 12 months of follow-up. DHT via localized microwave diathermy improves pain, muscle strength and physical function in patients affected by knee OA, with benefits maintained over the long term. No clinically relevant improvements were observed in patients who underwent SHT. DHT via microwave diathermy delivered three times a week for four weeks significantly improves pain and function in patients affected by moderate knee OA, with benefits retained for at least 12 months. No clinically relevant changes are observed in knee OA patients treated with SHT.

  6. Structured cues or modafinil for fatigue amelioration in clinicians? A double-blind, randomized controlled trial of critical clinical information recall in fatigued clinicians.

    Science.gov (United States)

    Flindall, Ian; Leff, Daniel Richard; Goodship, Jonathan; Sugden, Colin; Darzi, Ara

    2016-04-01

    To evaluate the impact of modafinil on "free" and "cued" recall of clinical information in fatigued but nonsleep-deprived clinicians. Despite attempts to minimize sleep deprivation through redesign of the roster of residents and staff surgeons, evidence suggests that fatigue remains prevalent. The wake-promoting agent modafinil improves cognition in the sleep-deprived fatigued state and may improve information recall in fatigued nonsleep-deprived clinicians. Twenty-four medical undergraduates participated in a double-blind, parallel, randomized controlled trial (modafinil-200 mg:placebo). Medication was allocated 2 hours before a 90-minute fatigue-inducing, continuous performance task (dual 2-back task). A case history memorization task was then performed. Clinical information recall was assessed as "free"(no cognitive aids) and "cued"(using aid memoirs). Open and closed cues represent information of increasing specificity to aid the recall of clinical information. Fatigue was measured objectively using the psychomotor vigilance task at induction, before and after the dual 2-back task. Modafinil decreased false starts and lapses (modafinil = 0.50, placebo = 9.83, P modafinil = 0.006, placebo = 0.098, P Modafinil improved free information recall (modafinil = 137.8, placebo = 106.0, P modafinil = 62.3, placebo = 52.8, P = .1) and closed cues (modafinil = 80.1, placebo = 75.9, P = .3). Modafinil attenuated fatigue and improved free recall of clinical information without improving cue-based recall under the design of our experimental conditions. Memory cues to aid retrieval of clinical information are convenient interventions that could decrease fatigue-related error without adverse effects of the neuropharmacology. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Combined therapy with levothyroxine and liothyronine in two ratios, compared with levothyroxine monotherapy in primary hypothyroidism: a double-blind, randomized, controlled clinical trial

    NARCIS (Netherlands)

    Appelhof, Bente C.; Fliers, Eric; Wekking, Ellie M.; Schene, Aart H.; Huyser, Jochanan; Tijssen, Jan G. P.; Endert, Erik; van Weert, Henk C. P. M.; Wiersinga, Wilmar M.

    2005-01-01

    Controversy remains about the value of combined treatment with levothyroxine (LT4) and liothyronine (LT3), compared with LT4 alone in primary hypothyroidism. We compared combined treatment with LT4 and LT3 in a ratio of 5: 1 or 10: 1 with LT4 monotherapy. We conducted a double-blind, randomized,

  8. Depressive symptoms in patients with subclinical hypothyroidism--the effect of treatment with levothyroxine: a double-blind randomized clinical trial.

    Science.gov (United States)

    Najafi, Laily; Malek, Mojtaba; Hadian, Ali; Ebrahim Valojerdi, Ameneh; Khamseh, Mohammad E; Aghili, Rokhsareh

    2015-01-01

    Despite the increasing evidence for relationships between thyroid dysfunction and neuropsychiatric alterations, the effect of treatment of thyroid disease on various clinical psychiatric outcomes is controversial. The purpose of this study was to investigate the effect of levothyroxine treatment on depressive symptoms in subjects with subclinical hypothyroidism. A randomized double-blind placebo-controlled clinical trial was performed. Sixty subjects (51 females and 9 males) with subclinical hypothyroidism were enrolled. Beck Depression Inventory was completed for all participants at the beginning of the study and 12 weeks after enrollment. The intervention and control groups received levothyroxine and placebo, respectively, for 12 weeks. There were no statistical differences in the total depression score and its subscales between the two groups at the beginning of the study. The Beck Depression Inventory score decreased from 16.79 ± 13.25 to 12.37 ± 10.01 (p value = 0.04) in the intervention group. The change in score was not significant for the control group (13.77 ± 11.71 to 11.86 ± 10.71; p value= 0.16). The affective subscale of Beck Depression Inventory did not change after 12 weeks of treatment with levothyroxine, while somatic subscale remarkably improved in the intervention group (p value = 0.02). This study showed the efficacy of treatment of subclinical hypothyroidism in people with levothyroxine in relation to depressive symptoms.

  9. Local anesthetic wound infiltration for pain management after periacetabular osteotomy. A randomized, placebo-controlled, double-blind clinical trial with 53 patients.

    Science.gov (United States)

    Bech, Rune D; Ovesen, Ole; Lindholm, Peter; Overgaard, Søren

    2014-04-01

    To our knowledge, there is no evidence to support the use of local infiltration analgesia (LIA) for postoperative pain relief after periacetabular osteotomy (PAO). We investigated the effect of wound infiltration with a long-acting local anesthetic (ropivacaine) for postoperative analgesia after PAO. We performed a randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov: NCT00815503) in 53 patients undergoing PAO to evaluate the effect of local anesthetic infiltration on postoperative pain and on postoperative opioid consumption. All subjects received intraoperative infiltration followed by 5 postoperative injections in 10-hour intervals through a multi-holed catheter placed at the surgical site. 26 patients received ropivacaine and 27 received saline. The intervention period was 2 days and the observational period was 4 days. All subjects received patient-controlled opioid analgesia without any restrictions on the total daily dose. Pain was assessed at specific postoperative time points and the daily opioid usage was registered. Infiltration with 75 mL (150 mg) of ropivacaine did not reduce postoperative pain or opioid requirements during the first 4 days. The clinical importance of ropivacaine as single component in postoperative treatment of pain is questionable, and we are planning further studies to explore the potential of LIA in larger volume-and also a multimodal regimen-to treat pain in this category of patients.

  10. Sporozoite immunization of human volunteers under mefloquine prophylaxis is safe, immunogenic and protective: a double-blind randomized controlled clinical trial.

    Science.gov (United States)

    Bijker, Else M; Schats, Remko; Obiero, Joshua M; Behet, Marije C; van Gemert, Geert-Jan; van de Vegte-Bolmer, Marga; Graumans, Wouter; van Lieshout, Lisette; Bastiaens, Guido J H; Teelen, Karina; Hermsen, Cornelus C; Scholzen, Anja; Visser, Leo G; Sauerwein, Robert W

    2014-01-01

    Immunization of healthy volunteers with chloroquine ChemoProphylaxis and Sporozoites (CPS-CQ) efficiently and reproducibly induces dose-dependent and long-lasting protection against homologous Plasmodium falciparum challenge. Here, we studied whether chloroquine can be replaced by mefloquine, which is the only other licensed anti-malarial chemoprophylactic drug that does not affect pre-erythrocytic stages, exposure to which is considered essential for induction of protection by CPS immunization. In a double blind randomized controlled clinical trial, volunteers under either chloroquine prophylaxis (CPS-CQ, n = 5) or mefloquine prophylaxis (CPS-MQ, n = 10) received three sub-optimal CPS immunizations by bites from eight P. falciparum infected mosquitoes each, at monthly intervals. Four control volunteers received mefloquine prophylaxis and bites from uninfected mosquitoes. CPS-MQ immunization is safe and equally potent compared to CPS-CQ inducing protection in 7/10 (70%) versus 3/5 (60%) volunteers, respectively. Furthermore, specific antibody levels and cellular immune memory responses were comparable between both groups. We therefore conclude that mefloquine and chloroquine are equally effective in CPS-induced immune responses and protection. Trial registration: ClinicalTrials.gov NCT01422954.

  11. COMPARATIVE ANALYSIS OF EFFECTIVENESS AND SAFETY OF PHYTO- AND ANTIBIOTIC THERAPY OF ACUTE BRONCHITIS IN CHILDREN: RESULTS OF A MULTICENTER DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    L. S. Namazova-Baranova

    2014-01-01

    Full Text Available Although viruses cause most cases of acute bronchitis, antibacterial drugs are still widely used to treat children with such diseases; this results in development of antibiotic resistance. Therefore, one of the key objectives of clinical medicine is now an effort to reduce unreasonable use of antibacterial agents. A multicenter double blind randomized clinical trial (E-BRO-PCT involved 182 2-6-years-old children and was aimed at assessing effectiveness and safety of phytotherapy (the syrup characterized by a fixed combination of thyme herb and ivy leaf extracts of acute bronchitis. Patients were divided into groups according to the type of therapy: phyto-, antibacterial or multimodal therapy. The level of procalcitonin (PCT – a bacterial inflammation marker – was measured retrospectively in the blood samples of all the children obtained at inclusion to the study. Therapy effectiveness was assessed by means of overall assessment of response to treatment on day 7. The share of children with low PCT and positive response to phytotherapy was comparable to the share of children subjected to antibiotic therapy. This is also true for all the patients included in the study regardless of the PCT level. Phyto- and antibacterial therapy featured a comparable safety profile; however, according to the researchers, the former one came out slightly better. Results of this study convincingly demonstrate that phytotherapy is an effective and well-tolerated type of treatment of acute bronchitis in children. 

  12. Topiramate Combined with Cognitive Restructuring for the Treatment of Gambling Disorder: A Two-Center, Randomized, Double-Blind Clinical Trial.

    Science.gov (United States)

    de Brito, Antonio Marcelo Cabrita; de Almeida Pinto, Moema Galindo; Bronstein, Gabriel; Carneiro, Elizabeth; Faertes, Daniela; Fukugawa, Viviane; Duque, Angela; Vasconcellos, Fatima; Tavares, Hermano

    2017-03-01

    Gambling disorder (GD) is a prevalent condition for which no pharmacological treatment has yet been approved, although there is evidence that topiramate can reduce impulsivity in GD and craving in various addictive behaviors. The goal of this study was to investigate the effectiveness of topiramate combined with cognitive restructuring for GD in a two-center, randomized, double-blind clinical trial. Participants were individuals seeking outpatient treatment for GD (n = 30), treated with either topiramate or placebo combined with a brief cognitive intervention, over a 12-week period, the dose of topiramate being tapered up during the first 8 weeks. The main outcome measures were gambling craving, behavior, and cognitive distortions; impulsivity; depression and social adjustment. Topiramate proved superior to placebo in reducing gambling craving (P = 0.017); time and money spent gambling (P = 0.007 and P = 0.047, respectively); cognitive distortions related to gambling (P = 0.003); and social adjustment (P = 0.040). We found no significant effects on impulsivity or depression. These findings are in contrast with data from a previous clinical trial with topiramate for GD. In the current study, we found that topiramate affects features specifically related to gambling addiction and had no significant effect on associated phenomena such as impulsiveness and depression. We believe that this response could be due to synergistic interaction between topiramate and the cognitive intervention.

  13. Minimally invasive video-assisted thyroidectomy versus conventional thyroidectomy: A single-blinded, randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    El-Labban Gouda

    2009-01-01

    Full Text Available We aimed to test the hypothesis that Minimally Invasive Video-assisted Thyroidectomy (MIVAT affords comparable safety and efficacy as to the open conventional surgery, when dealing with patients with unilateral thyroid nodules or follicular lesions, in terms of cosmetic results, intraoperative and postoperative complications, postoperative pain and hospital stay. Materials And Methods: This was a single-blinded randomised controlled trial comparing the MIVAT with conventional thyroidectomy. The primary endpoints of the study were measurement of postoperative pain after 24 and 48 hours from operation and self-rated patient satisfaction with cosmetic outcome three months postoperatively. The secondary outcome measures were operative time, incidence of temporary and permanent recurrent laryngeal nerve injury, postoperative haematoma formation, length of incision, and duration of hospital stay. Results: Operative time was significantly less with open thyroidectomy than with MIVAT, while MIVAT was associated with less pain 24 hours postoperatively. Blood loss did not reach significance between procedures. Comparisons between the two procedures with regard to pain scores after 24 and 48 hours, respectively, depicted statistically significant differences in favour of the MIVAT after 24 hours. MIVAT was associated with less scarring and more satisfactory cosmetic results. There were statistically no significant differences between both procedures for the presence of transient recurrent laryngeal nerve palsy and hypoparathyroidism. Conclusions: MIVAT is a safe procedure that produces outcomes, in view of short-term adverse events, similar to those of open thyroidectomy, and is superior in terms of immediate postoperative pain and cosmetic results.

  14. A Double-Blind, Randomized Clinical Trial of Niacinamide 4% versus Hydroquinone 4% in the Treatment of Melasma

    OpenAIRE

    Josefina Navarrete-Solís; Juan Pablo Castanedo-Cázares; Bertha Torres-µlvarez; Cuauhtemoc Oros-Ovalle; Cornelia Fuentes-Ahumada; Francisco Javier González; Juan David Martínez-Ramírez; Benjamin Moncada

    2011-01-01

    Background. Multiple modalities have been used in the treatment of melasma with variable success. Niacinamide has anti-inflammatory properties and is able to decrease the transfer of melanosomes. Objective. To evaluate the therapeutic effect of topical niacinamide versus hydroquinone (HQ) in melasma patients. Patients and Methods. Twenty-seven melasma patients were randomized to receive for eight weeks 4% niacinamide cream on one side of the face, and 4% HQ cream on the other. Sunscreen was a...

  15. Randomized, Single-Blind, Parallel Clinical Trial on Efficacy of Oral Prednisolone Versus Intramuscular Corticotropin on Immediate and Continued Spasm Control in West Syndrome.

    Science.gov (United States)

    Wanigasinghe, Jithangi; Arambepola, Carukshi; Sri Ranganathan, Shalini; Sumanasena, Samanmalie; Attanapola, Gangani

    2015-09-01

    A single-center, single-blind, parallel-group, randomized clinical trial was performed to test the null hypothesis that adrenocorticotropic hormone is not superior to high-dose prednisolone for treatment of newly diagnosed West syndrome. Newly diagnosed infants with West syndrome were randomized to receive 14 days of oral prednisolone (40-60 mg/day) or a synthetically prepared intramuscular long-acting adrenocorticotropic hormone (40-60 IU/every other day [0.5-0.75 mg]) according to the United Kingdom Infantile Spasm Study protocol. They were blindly evaluated for infantile spasm remission by day 14, electroclinical remission (spasm cessation + resolution of hypsarrhythmia on a 30-minute electroencephalograph) by day 14 and continued spasm freedom for 28 days. Ninety-seven patients were enrolled in the study, with 48 of them receiving prednisolone and 49 receiving ACTH. There was no significant difference in the baseline characteristics or risk factors for the two treatment groups. By day 14, cessation of infantile spasms occurred in 28/48 (58.3%) infants on prednisolone compared with only 18/49 (36.7%) infants given adrenocorticotropic hormone (P = 0.03) and electroclinical remission in 21 on prednisolone compared with nine on adrenocorticotropic hormone (P = 0.007). Sustained spasm control for 28 consecutive days following electroclinical remission occurred in 15 children on prednisolone compared with six on adrenocorticotropic hormone (P = 0.008). The total number of days required for spasm cessation was significantly less in those treated with prednisolone (3.85 days ± 2.4) compared with adrenocorticotropic hormone (8.65 days ± 3.7) (P = 0.001). Among patients who did not achieve remission, there was a non-significant trend toward greater quantitative reduction of spasms with prednisolone than with adrenocorticotropic hormone (P = 0.079). Synthetic adrenocorticotropic hormone of 40-60 IU/every other day did not yield superior rates of electroencephalographic

  16. Effect of topical application of dipyrone on dental sensitivity reduction after in-office dental bleaching: A randomized, triple-blind multicenter clinical trial.

    Science.gov (United States)

    Rezende, Márcia; Chemin, Kaprice; Vaez, Savil Costa; Peixoto, Aline Carvalho; Rabelo, Jéssica de Freitas; Braga, Stella Sueli Lourenço; Faria-E-Silva, André Luis; Silva, Gisele Rodrigues da; Soares, Carlos José; Loguercio, Alessandro D; Reis, Alessandra

    2018-03-14

    Tooth sensitivity commonly occurs during and immediately after dental bleaching. The authors conducted a trial to compare tooth sensitivity after in-office bleaching after the use of either a topical dipyrone or placebo gel. A split-mouth, triple-blind, randomized, multicenter clinical trial was conducted among 120 healthy adults having teeth that were shade A2 or darker. The facial tooth surfaces of the right or left sides of the maxillary arch of each patient were randomly assigned to receive either topical dipyrone or placebo gel before 2 in-office bleaching sessions (35% hydrogen peroxide) separated by 2 weeks. Visual analog and numerical rating scales were used to record tooth sensitivity during and up to 48 hours after bleaching. Tooth color change from baseline to 1 month after bleaching was measured with shade guide and spectrophotometer measures. The primary outcome variable was absolute risk of tooth sensitivity. An intention-to-treat analysis was used to analyze data from all patients who were randomly assigned to receive the dipyrone and placebo gels. No statically significant difference was found in the absolute risk of tooth sensitivity between the dipyrone and placebo gels (83% and 90%, respectively, P = .09; relative risk, 0.92; 95% confidence interval, 0.8 to 1.0). A whitening effect was observed in both groups with no statistically significant difference (P > .05) between them. No adverse effects were observed. Topical use of dipyrone gel before tooth bleaching, at the levels used in this study, did not reduce the risk or intensity of bleaching-induced tooth sensitivity. Topical application of dipyrone gel does not reduce bleaching-induced tooth sensitivity. Copyright © 2018 American Dental Association. Published by Elsevier Inc. All rights reserved.

  17. The Impact of Methylphenidate on Motor Performance in Children with both Attention Deficit Hyperactivity Disorder and Developmental Coordination Disorder: A Randomized Double-Blind Crossover Clinical Trial.

    Science.gov (United States)

    Soleimani, Robabeh; Kousha, Maryam; Zarrabi, Homa; Tavafzadeh-Haghi, Seyede Mahnaz; Jalali, Mir Mohammad

    2017-07-01

    Children with attention deficit hyperactivity disorder/developmental coordination disorder (ADHD/DCD) suffer from problems associated with gross and fine motor skills. There is no effective pharmacological therapy for such patients. We aimed to assess the impact of methylphenidate (MPH) on motor performance of children with ADHD/DCD. In this double-blind placebo-controlled, 17 children (12 boys) with ADHD/DCD with a mean age of 7 years 6 months were recruited in Shafa Hospital, Rasht, Iran. The response was defined as ≥25% reduction in the total score of ADHD rating scale-IV from the baseline. Sixteen boys entered phase 2 of the study in which the impact of MPH on motor function was determined through a crossover randomized clinical trial. Eligible individuals were scheduled for baseline and two assessment visits after a one-week period of intervention. We used the short form of Bruininks-Oseretsky test (BOT-2) to identify the disability of motor function. Children were randomly assigned to receive MPH or inert ingredients (placebo). In the second period, medication (MPH/placebo) was crossed over. The effects of MPH were analyzed using χ 2 test for related samples to compare the performance during baseline, placebo, and MPH trials. The results were analyzed using the SPSS software version 16.0. The mean minimal effective dose of MPH per day was 17.3 mg (0.85 mg/kg). Children with higher ADHD rating scale had a significantly lower standard score in BOT-2 (P=0.03). Following MPH intake, 26.6% of the children showed clinically significant improvement in motor function. However, the improvement was not statistically different between the MPH and placebo. Although MPH improved ADHD symptoms, problems with motor performance still remained. Further work is required to determine the probable effects of MPH in a higher dosage or in different subtypes of ADHD. IRCT201107071483N2.

  18. Does high-dose metformin cause lactic acidosis in type 2 diabetic patients after CABG surgery? A double blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Rahman Ghafari

    2011-06-01

    Full Text Available Metformin is a dimethyl biguanide oral anti-hyperglycemic agent. Lactic acidosis due to metformin is a fatal metabolic condition that limits its use in patients in poor clinical condition, consequently reducing the number of patients who benefit from this medication. In a double blind randomized clinical trial, we investigated 200 type 2 diabetic patients after coronary artery bypass surgery in the open heart ICU of the Mazandaran Heart Center, and randomly assigned them to equal intervention and control groups. The intervention group received regular insulin infusion along with 2 metformin 500 mg tablets every twelve hours, while the control group received only intravenous insulin with 2 placebo tablets every twelve hours. Lactate level, pH, base excess, blood glucose and serum creatinine were measured over five 12 h periods, with data averaged for each period. The primary outcome in this study was high lactate levels. Comparison between the 2 groups was made by independent Student’s t-test. To compare changes in multiple measures in each group and analysis of group interaction, a repeated measurement ANOVA test was used. There was no significant difference between the 2 groups regarding pH, base excess, or bicarbonate intake (P>0.05. No patient showed lactic acidosis in either group. Lactate levels were 23.0 vs 23.4 in the insulin-metformin and insulin only groups when the study was started, respectively. At the end of the study, those levels were 18.7 vs 18.9, respectively. In addition, the ANOVA repeated measurement test did not show a significant difference in terms of changes in the amount of lactate level between the 2 groups during the five measurement tests of the study period (P>0.05. High-dose metformin (1,000 mg twice daily with insulin does not cause lactic acidosis in type 2 diabetic patients after coronary artery

  19. The effects of co-administration of probiotics with herbal medicine on obesity, metabolic endotoxemia and dysbiosis: a randomized double-blind controlled clinical trial.

    Science.gov (United States)

    Lee, Sin Ji; Bose, Shambhunath; Seo, Jae-Gu; Chung, Won-Seok; Lim, Chi-Yeon; Kim, Hojun

    2014-12-01

    Probiotics help maintain balance in composition of the gut microbiota, and have been considered as a potential treatment for obesity. This study was conducted in order to assess the effects of probiotics when combined with herbal medicine in treatment of obesity. Probiotics were tested for the ability to modulate gut microbiota, gut permeability, and endotoxin level, which may have correlation with factors involved in obesity. A randomized, double-blind, placebo controlled study was conducted, in which patients with higher BMI (>25 kg/m(2)) and waist circumference (>85 cm) were enrolled and randomly assigned to receive Bofutsushosan with either probiotics or placebo capsules for a period of eight weeks. Assessment of body composition parameters, metabolic biomarkers, endotoxin level, gut permeability, and fecal bacteria in stool was performed at baseline and at week 8. The study was registered at the Clinical Research Information Service, approved by the Korea National Institute of Health (KCT0000386). Although both groups showed a significant reduction in weight and waist circumference (p = 0.000), no significant differences in body composition and metabolic markers were observed. In correlation analysis, change in body composition showed positive correlation with endotoxin level (r = 0.441, p metabolism in obesity. Correlation between endotoxin level and weight reduction indicates that probiotics may play an important role in prevention of endotoxin production, which can lead to gut microbiota dysbiosis associated with obesity. Copyright © 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  20. Effect of Roy’s Adaptation Model-Guided Education on Coping Strategies of the Veterans with Lower Extremities Amputation: A Double-Blind Randomized Controlled Clinical Trial

    Science.gov (United States)

    Farsi, Zahra; Azarmi, Somayeh

    2016-01-01

    Background: Any defect in the extremities of the body can affect different life aspects. The purpose of this study was to investigate the effect of Roy’s adaptation model-guided education on coping strategies of the veterans with lower extremities amputation. Methods: In a double-blind randomized controlled clinical trial, 60 veterans with lower extremities amputation referring to Kowsar Orthotics and Prosthetics Center of Veterans Clinic in Tehran, Iran were recruited using convenience method and randomly assigned to intervention and control groups in 2013-2014. Lazarus and Folkman coping strategies questionnaire was used to collect the data. After completing the questionnaires in both groups, maladaptive behaviours were determined in the intervention group and an education program based on Roy’s adaptation model was implemented. After 2 months, both groups completed the questionnaires again. Data were analyzed using SPSS software. Results: Independent T-test showed that the score of the dimensions of coping strategies did not have a statistically significant difference between the intervention and control groups in the pre-intervention stage (P>0.05). This test showed a statistically significant difference between the two groups in the post-intervention stage in terms of the scores of different dimensions of coping strategies (P>0.05), except in dimensions of social support seeking and positive appraisal (P>0.05). Conclusion: The findings of this research indicated that the Roy’s adaptation model-guided education improved the majority of coping strategies in veterans with lower extremities amputation. It is recommended that further interventions based on Roy’s adaptation model should be performed to improve the coping of the veterans with lower extremities amputation. Trial Registration Number: IRCT2014081118763N1 PMID:27218110

  1. Effect of Roy’s Adaptation Model-Guided Education on Coping Strategies of the Veterans with Lower Extremities Amputation: A Double-Blind Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Zahra Farsi

    2016-04-01

    Full Text Available Background: Any defect in the extremities of the body can affect different life aspects. The purpose of this study was to investigate the effect of Roy’s adaptation model-guided education on coping strategies of the veterans with lower extremities amputation. Methods: In a double-blind randomized controlled clinical trial, 60 veterans with lower extremities amputation referring to Kowsar Orthotics and Prosthetics Center of Veterans Clinic in Tehran, Iran were recruited using convenience method and randomly assigned to intervention and control groups in 2013-2014. Lazarus and Folkman coping strategies questionnaire was used to collect the data. After completing the questionnaires in both groups, maladaptive behaviours were determined in the intervention group and an education program based on Roy’s adaptation model was implemented. After 2 months, both groups completed the questionnaires again. Data were analyzed using SPSS software. Results: Independent T-test showed that the score of the dimensions of coping strategies did not have a statistically significant difference between the intervention and control groups in the pre-intervention stage (P>0.05. This test showed a statistically significant difference between the two groups in the post-intervention stage in terms of the scores of different dimensions of coping strategies (P>0.05, except in dimensions of social support seeking and positive appraisal (P>0.05. Conclusion: The findings of this research indicated that the Roy’s adaptation model-guided education improved the majority of coping strategies in veterans with lower extremities amputation. It is recommended that further interventions based on Roy’s adaptation model should be performed to improve the coping of the veterans with lower extremities amputation.

  2. Effect of Roy's Adaptation Model-Guided Education on Coping Strategies of the Veterans with Lower Extremities Amputation: A Double-Blind Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Farsi, Zahra; Azarmi, Somayeh

    2016-04-01

    Any defect in the extremities of the body can affect different life aspects. The purpose of this study was to investigate the effect of Roy's adaptation model-guided education on coping strategies of the veterans with lower extremities amputation. In a double-blind randomized controlled clinical trial, 60 veterans with lower extremities amputation referring to Kowsar Orthotics and Prosthetics Center of Veterans Clinic in Tehran, Iran were recruited using convenience method and randomly assigned to intervention and control groups in 2013-2014. Lazarus and Folkman coping strategies questionnaire was used to collect the data. After completing the questionnaires in both groups, maladaptive behaviours were determined in the intervention group and an education program based on Roy's adaptation model was implemented. After 2 months, both groups completed the questionnaires again. Data were analyzed using SPSS software. Independent T-test showed that the score of the dimensions of coping strategies did not have a statistically significant difference between the intervention and control groups in the pre-intervention stage (P>0.05). This test showed a statistically significant difference between the two groups in the post-intervention stage in terms of the scores of different dimensions of coping strategies (P>0.05), except in dimensions of social support seeking and positive appraisal (P>0.05). The findings of this research indicated that the Roy's adaptation model-guided education improved the majority of coping strategies in veterans with lower extremities amputation. It is recommended that further interventions based on Roy's adaptation model should be performed to improve the coping of the veterans with lower extremities amputation. IRCT2014081118763N1.

  3. Rectal versus intravenous quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Achan, Jane; Byarugaba, Justus; Barennes, Hubert; Tumwine, James K

    2007-12-01

    Although artemesinin derivatives are promising for the treatment of severe Plasmodium falciparum malaria, intravenous quinine remains the most affordable treatment. However, administration of intravenous quinine is often not feasible in rural areas in Africa because of the lack of simple equipment or trained staff. We compared the efficacy and safety of intrarectal quinine with those of intravenous quinine in the treatment of childhood cerebral malaria. In a randomized, double-blind clinical trial at Mulago Hospital (Kampala, Uganda), Uganda's national referral hospital, we studied 110 children aged 6 months to 5 years who had cerebral malaria. Patients were randomized to receive either intrarectal or intravenous quinine. Main outcome measures included parasite clearance time, fever clearance time, coma recovery time, time to sit unsupported, time to begin oral intake, time until oral quinine was tolerated, and death. Overall, there was no difference in the clinical and parasitological outcomes between the 2 groups (data are mean+/-standard deviation, intrarectal quinine group vs. intravenous quinine group): coma recovery time, 19.4+/-18.1 h versus 17.0+/-12.1 h; fever clearance time, 26.7+/-16.1 h versus 29.9+/-18.1 h; and parasite clearance time, 43.2+/-14.2 h versus 41.9+/-15.2 h. Mortality was similar in both groups; 4 of 56 patients in the intrarectal quinine group died, and 5 of 54 patients in the intravenous quinine group died (odds ratio, 1.3; 95% confidence interval, 0.3-5.2). Intrarectal quinine was well tolerated, and no major immediate adverse events occurred. Intrarectal quinine is efficacious and could be used as an alternative in the treatment of childhood cerebral malaria, especially in situations in which intravenous therapy is not feasible.

  4. Evaluation of pulsing magnetic field effects on paresthesia in multiple sclerosis patients, a randomized, double-blind, parallel-group clinical trial.

    Science.gov (United States)

    Afshari, Daryoush; Moradian, Nasrin; Khalili, Majid; Razazian, Nazanin; Bostani, Arash; Hoseini, Jamal; Moradian, Mohamad; Ghiasian, Masoud

    2016-10-01

    Evidence is mounting that magnet therapy could alleviate the symptoms of multiple sclerosis (MS). This study was performed to test the effects of the pulsing magnetic fields on the paresthesia in MS patients. This study has been conducted as a randomized, double-blind, parallel-group clinical trial during the April 2012 to October 2013. The subjects were selected among patients referred to MS clinic of Imam Reza Hospital; affiliated to Kermanshah University of Medical Sciences, Iran. Sixty three patients with MS were included in the study and randomly were divided into two groups, 35 patients were exposed to a magnetic pulsing field of 4mT intensity and 15-Hz frequency sinusoidal wave for 20min per session 2 times per week over a period of 2 months involving 16 sessions and 28 patients was exposed to a magnetically inactive field (placebo) for 20min per session 2 times per week over a period of 2 months involving 16 sessions. The severity of paresthesia was measured by the numerical rating scale (NRS) at 30, 60days. The study primary end point was NRS change between baseline and 60days. The secondary outcome was NRS change between baseline and 30days. Patients exposing to magnetic field showed significant paresthesia improvement compared with the group of patients exposing to placebo. According to our results pulsed magnetic therapy could alleviate paresthesia in MS patients .But trials with more patients and longer duration are mandatory to describe long-term effects. Copyright © 2016 Elsevier B.V. All rights reserved.

  5. Daily blueberry consumption improves blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension: a randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Johnson, Sarah A; Figueroa, Arturo; Navaei, Negin; Wong, Alexei; Kalfon, Roy; Ormsbee, Lauren T; Feresin, Rafaela G; Elam, Marcus L; Hooshmand, Shirin; Payton, Mark E; Arjmandi, Bahram H

    2015-03-01

    Postmenopausal women have a high prevalence of hypertension and often develop arterial stiffness thereby increasing cardiovascular disease risk. Although antihypertensive drug therapies exist, increasing numbers of people prefer natural therapies. In vivo studies and a limited number of clinical studies have demonstrated the antihypertensive and vascular-protective effects of blueberries. To examine the effects of daily blueberry consumption for 8 weeks on blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension. This was an 8-week, randomized, double-blind, placebo-controlled clinical trial. Forty-eight postmenopausal women with pre- and stage 1-hypertension recruited from the greater Tallahassee, FL, area participated. Participants were randomly assigned to receive either 22 g freeze-dried blueberry powder or 22 g control powder. Resting brachial systolic and diastolic blood pressures were evaluated and arterial stiffness was assessed using carotid-femoral pulse wave velocity and brachial-ankle pulse wave velocity. C-reactive protein, nitric oxide, and superoxide dismutase were measured at baseline, 4 weeks, and 8 weeks. Statistical analysis was performed using a split plot model of repeated measures analysis of variance. After 8 weeks, systolic blood pressure and diastolic blood pressure (131±17 mm Hg [Pblueberry powder group, whereas there were no changes in the group receiving the control powder. Nitric oxide levels were greater (15.35±11.16 μmol/L; Pblueberry powder group at 8 weeks compared with baseline values (9.11±7.95 μmol/L), whereas there were no changes in the control group. Daily blueberry consumption may reduce blood pressure and arterial stiffness, which may be due, in part, to increased nitric oxide production. Copyright © 2015 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  6. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

    Science.gov (United States)

    Saha, Suparna Ganguly; Dubey, Sandeep; Kala, Shubham; Misuriya, Abhinav; Kataria, Devendra

    2016-01-01

    Introduction It is generally accepted that achieving complete anaesthesia with an Inferior Alveolar Nerve Block (IANB) in mandibular molars with symptomatic irreversible pulpitis is more challenging than for other teeth. Therefore, administration of Non-Steroidal Anti-Inflammatory Agents (NSAIDs) 1 hour prior to anaesthetic administration has been proposed as a means to increase the efficacy of the IANB in such patients. Aim The purpose of this prospective, double-blind, randomized clinical trial was to determine the effect of administration of oral premedication with ketorolac (KETO) and diclofenac potassium (DP) on the efficacy of IANB in patients with irreversible pulpitis. Materials and Methods One hundred and fifty patients with irreversible pulpitis were evaluated preoperatively for pain using Heft Parker visual analogue scale, after which they were randomly divided into three groups. The subjects received identical tablets of ketorolac, diclofenac pottasium or cellulose powder (placebo), 1 hour prior to administration of IANB with 2% lidocaine containing 1:200 000 epinephrine. Lip numbness as well as positive and negative responses to cold test were ascertained. Additionally pain score of each patient was recorded during cavity preparation and root canal instrumentation. Success was defined as the absence of pain or mild pain based on the visual analog scale readings. The data was analysed using One-Way Anova, Post-Hoc Tukey pair wise, Paired T – Test and chi-square test. Trial Registery Number is 4722/2015 for this clinical trial study. Results There were no significant differences with respect to age (p =0.098), gender (p = 0.801) and pre-VAS score (DP-KETO p=0.645, PLAC-KETO p =0.964, PLAC-DP p = 0.801) between the three groups. All patients had subjective lip anaesthesia with the IAN blocks. Patients of all the three groups reported a significant decrease in active pain after local anaesthesia (ppulpitis than pre-medication with 50 mg DP & PLAC. PMID

  7. D-cycloserine for treatment of numbing and avoidance in chronic post traumatic stress disorder: A randomized, double blind, clinical trial

    Directory of Open Access Journals (Sweden)

    Abbas Attari

    2014-01-01

    Full Text Available Background: Posttraumatic stress disorder (PTSD tends to follow a chronic and treatment resistant course. Avoidance and numbing are symptoms associated with chronicity and impaired life quality. As D-cycloserine (DCS can facilitate extinction of conditioned fear, we aimed to investigate the efficacy and tolerability of DCS for the treatment of numbing and avoidance in chronic PTSD. Materials and Methods: This was an 11-week, double-blind, cross-over trial conducted in 2012 and 2013, in out-patient University psychiatry clinics. The studied population was selected randomly among outpatients with chronic combat-related PTSD (based on DSM-IV-TR criteria for chronic PTSD, who were males over 18 and <65 years of age (n = 319. Seventy six eligible patients were randomly assigned to two groups. Patients entered a 1-week run-in period. The groups received either an add-on treatment of DCS (50 mg daily, or placebo (4-week. After a 2-week washout, the groups received cross-over treatments (4-week. Clinical, paraclinical assessments, and clinician administered PTSD scale (CAPS were performed at baseline, and at the end of the 1 st , 5 th , and 11 th week. Side-effects were also evaluated. The overall number of avoidance and numbing symptoms, symptom frequency, and symptom intensity were measured separately. Results: Neither frequency nor number of symptoms was significantly influenced. However, DCS treatment demonstrates a significant decrease in intensity of avoidance/numbing symptoms, and improvement in function (mean [standard error] = −4.2 [1.5], P = 0.008. Side-effects were not statistically remarkable. Conclusion: D-cycloserine can help as an adjunctive treatment to alleviate numbing and avoidance in combat-related chronic PTSD.

  8. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Saha, Suparna Ganguly; Jain, Sohini; Dubey, Sandeep; Kala, Shubham; Misuriya, Abhinav; Kataria, Devendra

    2016-02-01

    It is generally accepted that achieving complete anaesthesia with an Inferior Alveolar Nerve Block (IANB) in mandibular molars with symptomatic irreversible pulpitis is more challenging than for other teeth. Therefore, administration of Non-Steroidal Anti-Inflammatory Agents (NSAIDs) 1 hour prior to anaesthetic administration has been proposed as a means to increase the efficacy of the IANB in such patients. The purpose of this prospective, double-blind, randomized clinical trial was to determine the effect of administration of oral premedication with ketorolac (KETO) and diclofenac potassium (DP) on the efficacy of IANB in patients with irreversible pulpitis. One hundred and fifty patients with irreversible pulpitis were evaluated preoperatively for pain using Heft Parker visual analogue scale, after which they were randomly divided into three groups. The subjects received identical tablets of ketorolac, diclofenac pottasium or cellulose powder (placebo), 1 hour prior to administration of IANB with 2% lidocaine containing 1:200 000 epinephrine. Lip numbness as well as positive and negative responses to cold test were ascertained. Additionally pain score of each patient was recorded during cavity preparation and root canal instrumentation. Success was defined as the absence of pain or mild pain based on the visual analog scale readings. The data was analysed using One-Way Anova, Post-Hoc Tukey pair wise, Paired T - Test and chi-square test. Trial Registery Number is 4722/2015 for this clinical trial study. There were no significant differences with respect to age (p =0.098), gender (p = 0.801) and pre-VAS score (DP-KETO p=0.645, PLAC-KETO p =0.964, PLAC-DP p = 0.801) between the three groups. All patients had subjective lip anaesthesia with the IAN blocks. Patients of all the three groups reported a significant decrease in active pain after local anaesthesia (pblock in patients with irreversible pulpitis than pre-medication with 50 mg DP & PLAC.

  9. A blinded, randomized clinical trial comparing the efficacy and safety of oclacitinib and ciclosporin for the control of atopic dermatitis in client-owned dogs

    Science.gov (United States)

    Little, Peter R; King, Vickie L; Davis, Kylie R; Cosgrove, Sallie B; Stegemann, Michael R

    2015-01-01

    Background Ciclosporin is approved for the treatment of atopic dermatitis (AD) in dogs and has been shown to be safe and effective. Placebo-controlled studies suggest that oclacitinib is a safe and effective alternative therapy. Hypothesis/Objectives To evaluate the efficacy and safety of oclacitinib, in comparison to ciclosporin, for the control of AD in a blinded, randomized clinical trial, incorporating a noninferiority test at day 28. Animals A total of 226 client-owned dogs with a history of AD from eight sites were enrolled. Methods Enrolled animals were randomized to receive oral oclacitinib (0.4–0.6 mg/kg twice daily for 14 days, then once daily) or oral ciclosporin (3.2–6.6 mg/kg once daily) for 12 weeks. Owners assessed pruritus using an enhanced visual analog scale (VAS), and veterinarians assessed dermatitis using the Canine Atopic Dermatitis Extent and Severity Index (CADESI)-02. Results On days 1, 2, 7, 14, 28, 56 and 84, the percentage reduction from baseline for owner-assessed pruritus changed from 25.6 to 61.0% in the oclacitinib group compared with 6.5 to 61.5% in the ciclosporin group; differences were significant at all time points up to day 28. On day 56, ciclosporin-treated dogs showed a similar decrease in pruritus to oclacitinib-treated dogs. On day 14, the percentage reduction from baseline CADESI-02 was significantly greater in the oclacitinib group (58.7%) than in the ciclosporin group (43.0%). Three times as many adverse events attributed to gastrointestinal signs were reported in the ciclosporin group compared with the oclacitinib group. Conclusions and clinical importance In this study of treatment for canine AD, oclacitinib had a faster onset of action and a lower frequency of gastrointestinal side effects compared with ciclosporin. PMID:25496303

  10. Effect of Methylphenidate and Folic Acid on ADHD Symptoms and Quality of Life and Aggression: A Randomized Double Blind Placebo Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ahmad Ghanizadeh

    2013-09-01

    Full Text Available bjective: This clinical trial examines the effect of augmentation of methylphenidate (MPH with folic acid to improve quality of life, and to treat aggression and ADHD symptoms .Method:Participants of this eight week randomized double blind placebo controlled clinical trial were 49 children with ADHD. They were randomly assigned into one of the two groups: the first group receiving methylphenidate (10 to 20mg/day plus folic (5mg/day, and the second group receiving methylphenidate plus placebo. Parent-reported ADHD symptoms and Overt Aggression Scale score were the outcome measures. Quality of life was assessed as well. Assessments were performed at pre-intervention, and at one month and two months after starting the interventions using repeated measure analysis Results:The mean age of children was 9.6(2.7 years. Age and gender were not associated with the groups. ADHD symptoms significantly decreased in both groups during the trial. However, no difference was observed between the groups. Moreover, aggression non-significantly decreased in both groups. Meanwhile, there was no difference between the two groups in efficacy for treating different types of aggressive behaviors including: verbal aggression, physical aggression against people, physical aggression against properties or objects, and aggression against self (self-injurious behavior. While methylphenidate improved quality of life of children with ADHD, folic acid did not improve it more than placebo. Both medications were well tolerated.Conclusion:considering the marked limitations of this trial, this primarily report suggests that methylphenidate may improve ADHD symptoms and the quality of life of children with ADHD. Current evidence does not support that folic acid as an adjuvant is effective for treating ADHD symptoms or aggression, or the improving quality of life of children with ADHD.

  11. The effects of scapular mobilization in patients with subacromial impingement syndrome: a randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Aytar, Aydan; Baltaci, Gul; Uhl, Tim L; Tuzun, Handan; Oztop, Pinar; Karatas, Metin

    2015-05-01

    To determine the effects of scapular mobilization on function, pain, range of motion, and satisfaction in patients with subacromial impingement syndrome (SAIS). Randomized, double-blind, placebo-controlled clinical trial. University hospital clinics in Turkey. 66 participants (mean ± SD age 52.06 ± 3.71 y) with SAIS. Participants were randomized into 3 groups: scapular mobilization, sham scapular mobilization, and supervised exercise. Before the interventions transcutaneous electrical stimulation and hot pack were applied to all groups. Total intervention duration for all groups was 3 wk with a total of 9 treatment sessions. Shoulder function and pain intensity were primary outcome measures; range of motion and participant satisfaction were secondary outcome measures. Shoulder function was assessed with the short form of the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). A visual analog scale was used to evaluate pain severity. Active range of motion was measured with a universal goniometer. A 7-point Likert scale was used to evaluate satisfaction. Outcome measurements were performed at baseline, before visits 5 and 10, 4 wk after visit 9, and 8 wk after visit 9. There was no group difference for DASH score (P = .75), pain at rest (P = .41), pain with activity (P = .45), pain at night (P = .74), and shoulder flexion (P = .65), external rotation (P = .63), and internal rotation (P = .19). There was a significant increase in shoulder motion and function and a significant decrease in pain across time when all groups were combined (P .05). There was not a significant advantage of scapular mobilization for shoulder function, pain, range of motion, and satisfaction compared with sham or supervised-exercise groups in patients with SAIS.

  12. Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial.

    Science.gov (United States)

    Han, Seung Beom; Rhim, Jung-Woo; Shin, Hye Jo; Lee, Soo Young; Kim, Hyun-Hee; Kim, Jong-Hyun; Lee, Kyung-Yil; Ma, Sang Hyuk; Park, Joon Soo; Kim, Hwang Min; Kim, Chun Soo; Kim, Dong Ho; Choi, Young Youn; Cha, Sung-Ho; Hong, Young Jin; Kang, Jin Han

    2015-01-01

    A multicenter, double-blind, randomized, active-control phase III clinical trial was performed to assess the immunogenicity and safety of a trivalent, inactivated split influenza vaccine. Korean children between the ages of 6 months and 18 y were enrolled and randomized into a study (study vaccine) or a control vaccine group (commercially available trivalent, inactivated split influenza vaccine) in a 5:1 ratio. Antibody responses were determined using hemagglutination inhibition assay, and post-vaccination immunogenicity was assessed based on seroconversion and seroprotection rates. For safety assessment, solicited local and systemic adverse events up to 28 d after vaccination and unsolicited adverse events up to 6 months after vaccination were evaluated. Immunogenicity was assessed in 337 and 68 children of the study and control groups. In the study vaccine group, seroconversion rates against influenza A/H1N1, A/H3N2, and B strains were 62.0% (95% CI: 56.8-67.2), 53.4% (95% CI: 48.1-58.7), and 54.9% (95% CI: 48.1-60.2), respectively. The corresponding seroprotection rates were 95.0% (95% CI: 92.6-97.3), 93.8% (95% CI: 91.2-96.4), and 95.3% (95% CI: 93.0-97.5). The lower 95% CI limits of the seroconversion and seroprotection rates were over 40% and 70%, respectively, against all strains. Seroconversion and seroprotection rates were not significantly different between the study and control vaccine groups. Furthermore, the frequencies of adverse events were not significantly different between the 2 vaccine groups, and no serious vaccination-related adverse events were noted. In conclusion, the study vaccine exhibited substantial immunogenicity and safety in Korean children and is expected to be clinically effective.

  13. Effects of Folic Acid on Appetite in Children with Attention Deficit Hyperactivity Disorder (ADHD Treated with Methylphenidate: A Randomized Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Forough Riahi

    2018-01-01

    Full Text Available Background: The highly effective medications in treating attention deficit hyperactivity disorder (ADHD symptoms are stimulants like methylphenidate. However, they have adverse effects like reduced appetite. We investigated the effects of folic acid on reduced appetite caused by the use of methylphenidate in children with ADHD. Methods: This randomized double-blind clinical trial evaluated 70 outpatients, aged between 6 and 12 years, with a diagnosis of ADHD. The children were recruited from the Outpatient Child and Adolescent Psychiatric Clinic of Golestan Hospital (Ahwaz, Iran between 2016 and 2017. The study subjects were randomly assigned to 2 groups: Group 1 received an average dose of methylphenidate (1 mg/kg plus folic acid (5 mg/d and Group 2 received an average dose of methylphenidate (1 mg/kg plus a placebo (5 mg of sucrose for 8 weeks. Assessments, comprising the Conners Parent Questionnaire, anthropometric measurements, and appetite questionnaire, were conducted by a psychiatrist at baseline and then at 2, 4, 6, and 8 weeks after the medication was started using repeated measure analysis. The data were analyzed with the Mann–Whitney U and ANOVA tests using the SPSS statistical software (v. 18.0. Results: Age and gender were not associated with the groups. Weight, height, and the body mass index were not changed during the study in both groups. ADHD symptoms significantly decreased in both groups during the trial; however, no difference was observed between the groups. Moreover, appetite was significantly improved in Group 1. Both medications were well tolerated. Conclusion: It seems that folic acid improved the reduced appetite caused by the use of methylphenidate in our children with ADHD. Trial Registration Number: IRCT2016040927304N1

  14. Improving Balance in Older People: A Double-Blind Randomized Clinical Trial of Three Modes of Balance Training.

    Science.gov (United States)

    Nematollahi, Ahmadreza; Kamali, Fahimeh; Ghanbari, Ali; Etminan, Zahra; Sobhani, Sobhan

    2016-04-01

    The aim of this study was to examine and compare the effects of conventional, multisensory, and dual-task exercises on balance ability in a group of older community dwellers over a four-week period. Forty-four older people were randomly assigned to one of the three training groups. The score on the Fullerton Advanced Balance (FAB) scale, gait stability ratio, and walking speed were evaluated at baseline and after four weeks of training. All three groups showed significant (p balance of older adults, with no significant superiority of one mode of training over another.

  15. Efficacy and safety of Ginkgo biloba standardized extract in the treatment of vascular cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial

    Science.gov (United States)

    Demarin, Vida; Bašić Kes, Vanja; Trkanjec, Zlatko; Budišić, Mislav; Bošnjak Pašić, Marija; Črnac, Petra; Budinčević, Hrvoje

    2017-01-01

    Objectives The aim of this randomized, double-blind, placebo-controlled trial was to determine the efficacy and safety of Ginkgo biloba extract in patients diagnosed with vascular cognitive impairment (VCI). Methods A total of 90 patients (aged 67.1±8.0 years; 59 women) were randomly allocated (1:1:1) to receive G. biloba 120 mg, G. biloba 60 mg, or placebo during a 6-month period. Assessment was made for efficacy indicators, including neuropsychological tests scores (Sandoz Clinical Assessment Geriatric Scale, Folstein Mini-Mental State Examination, Mattis Dementia Rating Scale, and Clinical Global Impression) and transcranial Doppler ultrasound findings. Safety indicators included laboratory findings, reported adverse reactions, and clinical examination. Results At the end of 6-month study period, G. biloba 120 and 60 mg showed a statistically significant positive effect in comparison with placebo only on the Clinical Global Impression score (2.6±0.8 vs 3.1±0.7 vs 2.8±0.7, respectively; P=0.038). The Clinical Global Impression score showed a significant deterioration from the baseline values in the placebo group (−0.3±0.5; P=0.021) as opposed to G. biloba groups. No significant differences were found in the transcranial Doppler ultrasound findings. Adverse reactions were significantly more common and serious in the placebo group (16 subjects) than in either of the two G. biloba extract groups (eight and nine subjects, respectively), whereas laboratory findings and clinical examinations revealed no differences between the groups receiving G. biloba extract and placebo. Conclusion According to our results, G. biloba seemed to slow down the cognitive deterioration in patients with VCI, but the effect was shown in only one of the four neuropsychological tests administered. However, because of this mild effect in combination with a few adverse reactions, we cannot say that it is ineffective or unsafe either. Further studies are still needed to provide

  16. Trichuris suis ova therapy for allergic rhinitis: a randomized, double-blind, placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Bager, Peter; Arnved, John; Rønborg, Steen

    2010-01-01

    Parasitic helminth infections can protect against allergic airway inflammation in experimental models and have been associated with a reduced risk of atopy and a reduced course of asthma in some observational studies. Although no clinical evidence exists to support the use of helminth therapy...... for allergic disease, the helminth Trichuris suis has demonstrated efficacy in treatment of inflammatory bowel disease....

  17. Trichuris suis ova therapy for allergic rhinitis: a randomized, double-blind, placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Bager, Peter; Arnved, John; Rønborg, Steen

    2010-01-01

    Parasitic helminth infections can protect against allergic airway inflammation in experimental models and have been associated with a reduced risk of atopy and a reduced course of asthma in some observational studies. Although no clinical evidence exists to support the use of helminth therapy for...

  18. Effects of Pioglitazone on Asymmetric Dimethylarginine and Components of the Metabolic Syndrome in Nondiabetic Patients (EPICAMP Study: A Double-Blind, Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Pedram Shokouh

    2013-01-01

    Full Text Available The present trial aimed to investigate the effects of pioglitazone on the serum level of asymmetric dimethylarginine (ADMA, a marker of endothelial function, and some indices of inflammation and glucose and lipid metabolism in nondiabetic metabolic syndrome patients. 104 eligible participants (57% female; age between 20 and 70 were enrolled in a double-blind placebo-controlled trial and were randomized to receive either pioglitazone (uptitrated to 30 mg/day or matching placebo for 24 weeks. Participants were clinically examined and a blood sample was obtained at baseline and at the end of the trial. Pioglitazone significantly improved C-reactive protein level irrespective of changes in insulin sensitivity. Compared with the placebo group, alanine and aspartate transaminases were decreased and high-density lipoprotein cholesterol was increased after treatment with pioglitazone. A considerably greater weight gain was also recorded in the intervention group. We failed to observe any significant changes in serum ADMA in either group and between groups with and without adjustment for age, sex, and components of the metabolic syndrome. In a nutshell, pioglitazone seems to have positive effects on lipid profile, liver transaminases, and systemic inflammation. However, its previously demonstrated endothelial function-improving properties do not seem to be mediated by ADMA.

  19. Improved glycemic control in patients with advanced type 2 diabetes mellitus taking Urtica dioica leaf extract: a randomized double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Kianbakht, Saeed; Khalighi-Sigaroodi, Farahnaz; Dabaghian, Fataneh Hashem

    2013-01-01

    Advanced type 2 diabetes mellitus (T2DM) needing insulin therapy is common. Most conventional anti-hyperglycemic drugs have limited efficacies and significant side effects, so that better anti-hyperglycemic agents are needed. Urtica dioica L. (nettle) leaves have insulin secretagogue, PPARgamma agonistic, and alpha-glucosidase inhibitory effects. Moreover, nettle leaves are used in traditional medicine as an anti-hyperglycemic agent to treat diabetes mellitus. Thus, efficacy and safety of nettle in the treatment of patients with advanced type 2 diabetes mellitus needing insulin were studied. In this randomized double-blind placebo-controlled clinical trial, we evaluated the effects of taking nettle leaf extract (one 500 mg capsule every 8 hours for 3 months) combined with the conventional oral anti-hyperglycemic drugs on the blood levels of fasting glucose, postprandial glucose, glycosylated hemoglobin (HbA1c), creatinine and liver enzymes SGOT and SGPT, and systolic and diastolic blood pressures in 46 patients and compared with the placebo group (n = 46). At the endpoint, the extract lowered the blood levels of fasting glucose, 2 hours postprandial glucose, and HbA1c significantly (p 0.05) compared with placebo. Nettle may safely improve glycemic control in type 2 diabetic patients needing insulin therapy.

  20. [Investigation of the use of triclosan in patients with indwelling catheters: a randomized, double blind, multicenter, placebo-controlled clinical study].

    Science.gov (United States)

    Sperling, H; Eisenhardt, A; Mumperow, E; Gralla, O; Lümmen, G; Seidali, K; Hinke, A; Jäger, T

    2014-10-01

    This article presents the first randomized, double blind, multicenter, placebo-controlled, non-interventional trial with a medical product after approval by the ethical committee of the medical council of North-Rhine. The study investigated the use of the antimicrobial agent triclosan (Farco-fill® Protect) as a liquid for inflation of catheter balloons in patients with chronic indwelling catheters. In this study 84 patients were investigated (43 in the treatment group and 41 in the placebo group) all with a suprapubic catheter and a positive history of catheter incrustation. The catheters were changed after 6 weeks and endpoints were the quantitative analysis of the incrustation, weight of the catheter, pain during catheter change and the number of urinary tract infections. The maintenance of the catheter was a secondary endpoint. The primary endpoint could not be reached because the study, which was initially planned with 70 patients in each arm, had to be terminated due to logistical and technical problems with the catheter weighing. The maintenance of the catheter as the most important clinical parameter showed statistically significant differences with a longer indwelling time in the triclosan group. Adverse events with respect to the product were not recorded. Using the antimicrobial solution triclosan as a fluid for inflation of catheter balloons led to a statistically significant extension in the catheter indwelling time. The reduction of pain during changing the catheter and the reduction of incrustation, although not statistically significant, led to an improvement in the quality of life of these patients.

  1. Immediate effect of nonspecific mandibular mobilization on postural control in subjects with temporomandibular disorder: a single-blind, randomized, controlled clinical trial.

    Science.gov (United States)

    Amaral, Ana P; Politti, Fabiano; Hage, Yasmin E; Arruda, Eric E C; Amorin, Cesar F; Biasotto-Gonzalez, Daniela A

    2013-01-01

    Temporomandibular disorder (TMD) is considered multifactorial and is defined as a group of pain conditions characterized by functional stomatognathic system alterations, which may be affected by or related disrupted postural control. Assess the immediate effect of nonspecific mandibular mobilization (NMM) on the postural control of subjects diagnosed or not with TMD. A simple-blind, randomized, controlled clinical trial was performed involving 50 subjects of both genders assigned to two groups: the TMD group and the control group. TMD was diagnosed according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). A stabilometric assessment was performed by testing subjects in a quiet stance on a dual force platform under two visual conditions (eyes open and eyes closed). The Center of Pressure (CoP)-related variables analyzed were displacement, amplitude, speed of anterior-posterior (AP) and medial-lateral (ML) displacements and CoP sway area. The mean values of each variable were compared, considering the accepted significance value of ppostural control in patients with TMD.

  2. Assessing the therapeutic use of Lafoensia pacari St. Hil. extract (mangava-brava) in the eradication of Helicobacter pylori: double-blind randomized clinical trial.

    Science.gov (United States)

    da Mota Menezes, Valfredo; Atallah, Alvaro Nagib; Lapa, Antonio José; Catapani, Wilson R

    2006-06-01

    The eradication of Helicobacter pylori is easily achieved by combining antisecretory agents and antibiotics; however, the cost of these associations is very high for the population of Third World countries, where the prevalence of the infection is even higher and leads to markedly reduced treatment effectiveness. We tested a plant (Lafoensia pacari) that is used in the central region of Brazil. According to previous studies, this plant has high concentrations of ellagic acid, which presents gastric antisecretory and antibacterial actions. One hundred dyspeptic, urease-positive patients were randomized to receive 500 mg of methanolic extract of L. pacari (n = 55) or placebo (n = 45), for 14 days, in a double-blind clinical trial. The main variables assessed were the eradication of H. pylori 8 weeks after the intervention and complete symptom relief at the end of the treatment. The examinations (urease and histology) showed persistence of H. pylori in 100% of participants. Complete symptom relief was experienced by 42.5% of patients (95% CI: 29.4-55.8) in the intervention group and by 21% (95% CI: 8.8-33.1) in the control group, p = .020. The side-effects were minimal and similar in both groups. The extract of L. pacari as a single agent was not effective to eradicate H. pylori. However, it was well tolerated and many participants reported relief of symptoms. Future studies may test the agent using larger doses and longer periods, in monotherapy or in combination with antibiotics.

  3. Efficacy and safety of 1% ropivacaine for postoperative analgesia after lower third molar surgery: a prospective, randomized, double-blinded clinical study.

    Science.gov (United States)

    Brković, Božidar; Andrić, Miroslav; Ćalasan, Dejan; Milić, Marija; Stepić, Jelena; Vučetić, Milan; Brajković, Denis; Todorović, Ljubomir

    2017-04-01

    The purpose of this study was to investigate postoperative analgesic effect of ropivacaine administered as main or supplemental injection for the inferior alveolar nerve block (IANB) in patients undergoing lower third molar surgery. The double-blind randomized study comprised 72 healthy patients. All patients received two blocks, the IANB for surgical procedure + IANB after surgery for postoperative pain control, and were divided into three groups: (1) 2 % lidocaine/epinephrine + 1 % ropivacaine, (2) 2 % lidocaine/epinephrine + saline, and (3) 1 % ropivacaine + saline. The occurrence of postoperative pain, pain intensity and analgesic requirements were recorded. Data were statistically analyzed using chi-square, Fisher, and Kruskal-Wallis tests and analysis of variance (ANOVA) with Bonferroni and Tukey correction. Ropivacaine was more successful than lidocaine/epinephrine in obtaining duration of postoperative analgesia, reduction of pain, and analgesic requirements whether ropivacaine was used for surgical block or administered as a supplemental injection after surgery. Ropivacaine (1 %, 2 ml) resulted in effective postoperative analgesia after lower third molar surgery. Since pain control related to third molar surgery requires the effective surgical anesthesia and postoperative analgesia, the use of 1 % ropivacaine could be clinically relevant in a selection of appropriate pain control regimen for both surgical procedure and early postsurgical treatment.

  4. Does lipoic acid consumption affect the cytokine profile in multiple sclerosis patients: a double-blind, placebo-controlled, randomized clinical trial.

    Science.gov (United States)

    Khalili, Mohammad; Azimi, Amirreza; Izadi, Vajihe; Eghtesadi, Shahryar; Mirshafiey, Abbas; Sahraian, Mohamad Ali; Motevalian, Abbas; Norouzi, Abbas; Sanoobar, Meisam; Eskandari, Ghazaleh; Farhoudi, Mehdi; Amani, Firouz

    2014-01-01

    A limited amount of data exists regarding the effect of lipoic acid (LA), an oral antioxidant supplement, on cytokine profiles among multiple sclerosis (MS) patients. We aimed to assess the effect of daily consumption of LA on the cytokine profiles in MS patients. In this double-blind, placebo-controlled, randomized clinical trial, 52 relapsing-remitting MS patients with an age range of 18-50 years were recruited into 2 groups: LA consumption (1,200 mg/day) or placebo. Patients followed their prescribed supplements for 12 weeks. Fasting blood samples for cytokine profile measurement were collected at baseline and after the intervention. Anthropometric parameters were measured based on the standard guidelines. INF-γ, ICAM-1, TGF-β and IL-4 were significantly reduced in the LA group compared to the placebo group [(INF-γ: 0.82 ± 0.2 vs. 0.2 ± 0.2 pg/ml, p consumption of 1,200 mg LA per day beneficially affects several inflammatory cytokines including INF-γ, ICAM-1 TGF-β and IL-4. Further investigations are needed to verify the beneficial role of LA on other cytokine profiles among MS patients.

  5. Efficacy of topical chamomile oil for mild and moderate carpal tunnel syndrome: A randomized double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Hashempur, Mohammad Hashem; Ghasemi, Mohammad Sadegh; Daneshfard, Babak; Ghoreishi, Parissa Sadat; Lari, Zeinab Nasiri; Homayouni, Kaynoosh; Zargaran, Arman

    2017-02-01

    To evaluate the efficacy of topical chamomile oil in patients with mild and moderate carpal tunnel syndrome (CTS). Eighty six patients with electrodiagnostic criteria of mild and moderate CTS were enrolled in this randomized double-blind placebo-controlled clinical trial and received wrist splint plus topical chamomile oil or placebo for 4 weeks. They were evaluated at the baseline and end of the study regarding functional and symptomatic scores, dynamometry, and electrodiagnostic indexes. Dynamometry, functionality, and symptom severity scores of the patients were significantly improved in the chamomile oil group compared with the placebo group (P = 0.040, P = 0.0001, P = 0.017, respectively). Additionally, compound latency of the median nerve in the chamomile oil group significantly decreased (P = 0.035) compared to the placebo group. Other electerodiagnostic measurements did not change significantly. Complementary treatment with topical chamomile oil may have some benefits for patients with mild and moderate CTS, both subjectively and objectively. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. The Effect of Acupuncture on the Success of Inferior Alveolar Nerve Block for Teeth with Symptomatic Irreversible Pulpitis: A Triple-blind Randomized Clinical Trial.

    Science.gov (United States)

    Jalali, Shahrzad; Moradi Majd, Nima; Torabi, Samane; Habibi, Mohammad; Homayouni, Hamed; Mohammadi, Navid

    2015-09-01

    An inferior alveolar nerve block (IANB) does not always provide satisfactory anesthesia for patients with irreversible pulpitis. The aim of this study was to assess the effect of preoperative acupuncture on the success rate of IANBs for teeth with symptomatic irreversible pulpitis. In a randomized triple-blinded clinical trial, 40 patients with symptomatic irreversible pulpitis were divided into 2 groups: the acupuncture and control groups. In the acupuncture group, a disposable needle was inserted at LI4 (Hegu) acupoint, and after 15 minutes, for patients who had reported the De qi sensation, an IANB was administered. In the control group, 15 minutes before the administration of an IANB, the practitioner simply imitated the acupuncture procedure but did not actually insert the needle. Endodontic treatments were conducted for the patients who reported lip numbness 15 minutes after the injection of the IANB. If the patients felt intolerable pain (>20 mm on a visual analog scale of 100 mm) during the procedure, a supplementary injection was administered. In those situations, the IANB was considered an unsuccessful injection. Data were evaluated by the chi-square, Wilcoxon, Mann-Whitney, and t tests. The level of significance was set at 0.05. The overall success rates of IANB for the acupuncture and control groups were 60% and 20%, respectively (P pulpitis. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  7. Comparison between Nintendo Wii Fit and conventional rehabilitation on functional performance outcomes after hamstring anterior cruciate ligament reconstruction: prospective, randomized, controlled, double-blind clinical trial.

    Science.gov (United States)

    Baltaci, Gul; Harput, Gulcan; Haksever, Bunyamin; Ulusoy, Burak; Ozer, Hamza

    2013-04-01

    The aim of this prospective, randomized, controlled, double-blind clinical trial was to compare the outcomes, including knee strength, balance, coordination, proprioception and response time, of Nintendo Wii Fit with those of conventional rehabilitation on the subjects with anterior cruciate ligament reconstruction. Thirty volunteer subjects were enrolled in either Wii Fit (n = 15; mean age, 29 ± 7 years) or conventional rehabilitation (n = 15; mean age, 29 ± 6 years) programmes from the first week up to 12th weeks of the operation. Endoscopic reconstruction of a completely ruptured ACL was performed by using graft harvested from hamstrings. Each subject underwent an individual therapeutic programme. Functional examinations included the measurements of the balance using modified star excursion balance test, coordination, proprioception and response time using functional squat system and strength of flexor and extensor muscles of the involved and uninvolved leg using an isokinetic machine. There was no significant difference between Wii Fit and conventional group in terms of isokinetic knee strength at 12th week, and dynamic balance, and functional squat tests including coordination, proprioception and response time at first, 8th and 12th weeks of the rehabilitation. Two different 12-week-physiotherapy programmes following ACL reconstruction have the same affect on muscle strength, dynamic balance and functional performance values in both groups. We considered that the practice of Wii Fit activities like conventional rehabilitation could also address physical therapy goals, which included improving visual-perceptual processing, coordination, proprioception and functional mobility.

  8. Results of a phase II double-blinded randomized clinical trial of difluoromethylornithine for cervical intraepithelial neoplasia grades 2 to 3.

    Science.gov (United States)

    Vlastos, Anne-Thérèse; West, Loyd A; Atkinson, E Neely; Boiko, Iouri; Malpica, Anais; Hong, Waun K; Follen, Michele

    2005-01-01

    Our purpose was to conduct a double-blinded randomized trial of difluoromethylornithine (DFMO) at 0.125, 0.5 gm/m2, versus placebo in the treatment of cervical intraepithelial neoplasia (CIN) grades 2 to 3. A promising phase I study has shown histopathologic responses at these dose levels. Patients with histopathologically confirmed CIN 2-3 lesions were recruited from a colposcopy clinic and underwent Papanicolaou testing, human papillomavirus testing, and colpophotography. They took oral contraception and DFMO or placebo elixir for 28 days and filled out the National Cancer Institute common toxicity calendars. They returned for follow-up and a repeat Papanicolaou smear, colpophotograph, and loop excision of the cervix. There were no statistically significant differences among the arms in histopathologic response. This could no be explained by any biases in risk factors. The prominent toxicities were diarrhea, dizziness, nausea, and headaches. There were no differences in the toxicities among arms. The Papanicolaou smear was a poor biomarker of response and correlated poorly with the histopathology. DFMO is no active at 0.125 and 0.5 gm/m2 for 28 days when given orally in CIN 2-3. Higher oral doses or longer administration is necessary, supporting data from breast trials. Alternatively, a trial of topical DFMO might merit attention as activity has been noted in trials of actinic keratoses.

  9. Efficacy and safety of topically applied Symphytum herb extract cream in the treatment of ankle distortion: results of a randomized controlled clinical double blind study.

    Science.gov (United States)

    Kucera, Miroslav; Barna, Milos; Horácek, Ondrej; Kováriková, Jaroslava; Kucera, Alexander

    2004-11-01

    In a controlled, double blind, randomized multicentre study, the efficacy and safety of the topical comfrey product Traumaplant (10% active ingredient of a 2.5:1 aqueous ethanolic pressed juice of freshly harvested, cultivated comfrey herb (Symphytum x uplandicum NYMAN), corresponding to 25 g of fresh herb per 100 g of cream; n = 104) was tested against a 1% product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n = 99) in 203 patients with acute ankle distortion. With the high concentration, decrease of the scores for pain on active motion, pain at rest and functional impairment was highly significant and clinically relevant on days T3-4 as well as T7 (p < 0.001). Amelioration of swellings as compared to reference was also significant on day 3-4 (p < 0.01). Efficacy was judged good to excellent in 85.6% of cases with verum and in 65.7% of cases with reference on day 3-4. Overall tolerability was excellent.

  10. Benefits of Semelil (ANGIPARSTM on oxidant-antioxidant balance in diabetic patients; A randomized, double-blind placebo controlled clinical trial

    Directory of Open Access Journals (Sweden)

    M Hemmatabadi

    2010-01-01

    Full Text Available "n "nBackground and the purpose of the study: Diabetes mellitus is one of the most common chronic diseases in the world with dreadful complications which not only is debilating for the patients but also puts a big burden on the health system.One of the mechanisms by which the complications of diabetes occur is imbalance in the oxidant-antioxidant equilibrium in the body and therefore many studies have been performed to either correct this equilibrium or delay the occurrence of the complications. "nMethods:In this randomized, double-blind placebo-controlled clinical trial, a total number of 61 subjects were divided into two groups and the antioxidant effects of a novel herbal drug, Semelil,was compared with placebo. Baseline laboratory tests including a complete blood count, fasting blood sugar,lipid profile,fasting plasma insulin, liver and renal function tests plus tumor necrotizing factor α (TNFα and C-reactive protein (CRP and homocystein were performed. Total antioxidant power assay, cellular lipid peroxidation assay, and nuclear damage (deoxyguanosine and carbonly molecules were also measured to help determination of state of antioxidants- oxidants equilibrium in serum. "nResult:Apart from deoxyguanosine, no significant change was found in TNFα or CRP levels in the studied group who received Semelil.Conclusion: Mechanisms other than antioxidant effects are involved for Semelil in the treatment of diabetic foot ulcers.

  11. Pre-emptive analgesic effect of lornoxicam in mandibular third molar surgery: a prospective, randomized, double-blind clinical trial.

    Science.gov (United States)

    Mojsa, I M; Stypulkowska, J; Novak, P; Lipczynski, K; Szczeklik, K; Zaleska, M

    2017-05-01

    The aim of this study was to establish whether the pre-emptive use of lornoxicam (16mg) in third molar surgery ensures successful postoperative analgesia and reduces rescue analgesic intake when compared to postoperative application, and in comparison with placebo. Ninety patients were split randomly into three groups: group A received lornoxicam 60min before surgery and placebo 60min after surgery; group B received placebo 60min before surgery and lornoxicam 60min after surgery; group C received placebo 60min before surgery and placebo 60min after surgery. Postoperative pain was recorded on a visual analogue scale and on a numerical rating scale at 1, 2, 4, 6, 8, 12, and 24h after surgery. The patients recorded total dose of paracetamol intake during the 24h after the procedure. The efficacy of postoperative analgesia was greater in lornoxicam groups when compared to the placebo group; there was no difference between the two lornoxicam groups (A and B). Patients in group C took their first rescue analgesic dose earlier after surgery than patients in the two lornoxicam groups. The average dose of paracetamol taken in group C was 1000mg, while it was500 mg in the lornoxicam groups. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  12. Balance training improves postural balance, gait, and functional strength in adolescents with intellectual disabilities: Single-blinded, randomized clinical trial.

    Science.gov (United States)

    Lee, Kyeongjin; Lee, Myungmo; Song, Changho

    2016-07-01

    Adolescents with intellectual disabilities often present with problems of balance and mobility. Balance training is an important component of physical activity interventions, with growing evidence that it can be beneficial for people with intellectual disabilities. The aim of this study was to investigate the effect of balance training on postural balance, gait, and functional strength in adolescents with intellectual disabilities. Thirty-two adolescents with intellectual disabilities aged 14-19 years were randomly assigned either to a balance training group (n = 15) or a control group (n = 16). Subjects in the balance training group underwent balance training for 40 min per day, two times a week, for 8 weeks. All subjects were assessed with posture sway and the one-leg stance test for postural balance; the timed up-and-go test and 10-m walk test for gait; and sit to stand test for functional strength. Postural balance and functional strength showed significant improvements in the balance training group (p functional strength significantly improved in the balance training group compared with those in the control group. Balance training for adolescents with intellectual disabilities might be beneficial for improving postural balance and functional strength. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Melatonin Effects in Methylphenidate Treated Children with Attention Deficit Hyperactivity Disorder: A Randomized Double Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Mohammadi

    2012-06-01

    Full Text Available Objective: The aim of this study was to determine melatonin effects on sleep patterns, symptoms of hyperactivity and attention deficiency in children with attention-deficit hyperactivity disorder (ADHD.Methods: Children with age range of 7-12 years who had a combined form of ADHD were randomly divided in to 2 groups according to gender blocks. One group took melatonin (3 or 6mg combined with methylphenidate (Ritalin (1mg/kg, and the other group took placebo combined with methylphenidate (1mg/kg. ADHD rating scale and sleep patterns questionnaires were completed. Research hypotheses were assessed at the baseline, the second, fourth and eighth weeks after the treatment.Results: The mean sleep latency and total sleep disturbance scores were reduced in melatonin group, while the scores increased in the placebo group (p≥0.05. Data analysis, using ANOVA with repeated measures, did not show any statistically significant differences between the two groups in ADHD scores.Conclusion: Administration of melatonin along with methylphenidate can partially improve symptoms of sleep disturbance. However, it does not seem to reduce attention deficiency and hyperactivity behavior of children with ADHD.

  14. A Double-Blind, Randomized Clinical Trial of Niacinamide 4% versus Hydroquinone 4% in the Treatment of Melasma.

    Science.gov (United States)

    Navarrete-Solís, Josefina; Castanedo-Cázares, Juan Pablo; Torres-Álvarez, Bertha; Oros-Ovalle, Cuauhtemoc; Fuentes-Ahumada, Cornelia; González, Francisco Javier; Martínez-Ramírez, Juan David; Moncada, Benjamin

    2011-01-01

    Background. Multiple modalities have been used in the treatment of melasma with variable success. Niacinamide has anti-inflammatory properties and is able to decrease the transfer of melanosomes. Objective. To evaluate the therapeutic effect of topical niacinamide versus hydroquinone (HQ) in melasma patients. Patients and Methods. Twenty-seven melasma patients were randomized to receive for eight weeks 4% niacinamide cream on one side of the face, and 4% HQ cream on the other. Sunscreen was applied along the observation period. They were assessed by noninvasive techniques for the evaluation of skin color, as well as subjective scales and histological sections initially and after the treatment with niacinamide. Results. All patients showed pigment improvement with both treatments. Colorimetric measures did not show statistical differences between both sides. However, good to excellent improvement was observed with niacinamide in 44% of patients, compared to 55% with HQ. Niacinamide reduced importantly the mast cell infiltrate and showed improvement of solar elastosis in melasma skin. Side effects were present in 18% with niacinamide versus 29% with HQ. Conclusion. Niacinamide induces a decrease in pigmentation, inflammatory infiltrate, and solar elastosis. Niacinamide is a safe and effective therapeutic agent for this condition.

  15. A Double-Blind, Randomized Clinical Trial of Niacinamide 4% versus Hydroquinone 4% in the Treatment of Melasma

    Directory of Open Access Journals (Sweden)

    Josefina Navarrete-Solís

    2011-01-01

    Full Text Available Background. Multiple modalities have been used in the treatment of melasma with variable success. Niacinamide has anti-inflammatory properties and is able to decrease the transfer of melanosomes. Objective. To evaluate the therapeutic effect of topical niacinamide versus hydroquinone (HQ in melasma patients. Patients and Methods. Twenty-seven melasma patients were randomized to receive for eight weeks 4% niacinamide cream on one side of the face, and 4% HQ cream on the other. Sunscreen was applied along the observation period. They were assessed by noninvasive techniques for the evaluation of skin color, as well as subjective scales and histological sections initially and after the treatment with niacinamide. Results. All patients showed pigment improvement with both treatments. Colorimetric measures did not show statistical differences between both sides. However, good to excellent improvement was observed with niacinamide in 44% of patients, compared to 55% with HQ. Niacinamide reduced importantly the mast cell infiltrate and showed improvement of solar elastosis in melasma skin. Side effects were present in 18% with niacinamide versus 29% with HQ. Conclusion. Niacinamide induces a decrease in pigmentation, inflammatory infiltrate, and solar elastosis. Niacinamide is a safe and effective therapeutic agent for this condition.

  16. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Dali, Christine í; Hansen, Flemming Juul; Pedersen, Søren Anker

    2002-01-01

    changes that might not be reflected in performance measurements. We also judged range of motion, degree of spasticity, and muscle growth measured by CT. Fifty seven of 82 outpatients who were able to walk at least with a walker, completed all 12 months of treatment (hemiplegia n=25, diplegia n=32......). There was no significant difference between active and placebo treatment in any of the tested groups, nor combined. Visual and subjective assessments favoured TES (ns), whereas objective indices showed the opposite trend. We conclude that TES in these patients did not have any significant clinical effect during the test...

  17. A randomized, double-blind clinical study to determine the effect of ANKASCIN 568 plus on blood glucose regulation

    Directory of Open Access Journals (Sweden)

    Yin-Ruei Wang

    2017-04-01

    Full Text Available Diabetes is the fourth major cause of death in Taiwan. High blood glucose can lead to macrovascular diseases, small vessel diseases (retinopathy, kidney disease, and neuropathy. This study aimed to investigate whether Monascus-fermented products (ANKASCIN 568 plus can regulate blood glucose and blood lipids. This study enrolled 39 patients with a fasting blood glucose level between 100 mg/dL and 180 mg/dL, and a glycated hemoglobin (HbA1c level of <9%. All patients were randomly divided into placebo (n=20 and experimental (n=19 groups. Each patient received two placebo capsules (maltodextrin or ANKASCIN 568 plus capsules daily for 12 weeks. The patients were screened during follow-up 4 weeks after the administration of sample or placebo had been discontinued. Blood and urine samples were collected at the initial, 6th week, 12th week, and 16th week. The anthropometric indicators of blood pressure, fasting plasma glucose level, postprandial plasma glucose level, insulin level, insulin resistance, blood lipid changes, and liver, kidney, and thyroid function indices were measured. After 6 weeks, changes in fasting blood glucose, low-density lipoprotein cholesterol (LDL-C, and total cholesterol (TC levels showed that ANKASCIN 568 plus had a more favorable effect than the placebo. Compared to baseline, a statistically significant decrease of 8.5%, 10.3%, and 7.5% was observed in fasting blood glucose, LDL-C and, TC levels, respectively (p<0.05 for all pairs. Therefore, ANKASCIN 568 plus produced by Monascus purpureus NTU 568 fermentation may be a potentially useful agent for the regulation of blood glucose and blood lipids and for treatment of coronary artery diseases.

  18. Eccentric versus conventional exercise therapy in patients with rotator cuff tendinopathy: a randomized, single blinded, clinical trial.

    Science.gov (United States)

    Dejaco, Beate; Habets, Bas; van Loon, Corné; van Grinsven, Susan; van Cingel, Robert

    2017-07-01

    To investigate the effectiveness of isolated eccentric versus conventional exercise therapy in patients with rotator cuff tendinopathy. Thirty-six patients with rotator cuff tendinopathy, diagnosed by an orthopaedic surgeon, were included and randomly allocated to an isolated eccentric exercise (EE) group (n = 20, mean age = 50.2 ± 10.8 years) or a conventional exercise (CG) group (n = 16, mean age = 48.6 ± 12.3 years). Both groups fulfilled a 12-week daily home-based exercise programme and received a total amount of nine treatment sessions. The Constant Murley score was used to evaluate both objective (e.g. range of motion and strength) and subjective measures (e.g. pain and activities of daily living). A visual analogue scale (VAS) was used to evaluate pain during daily activities. As secondary outcomes, shoulder range of motion and isometric abduction strength in 45° in the scapular plane were evaluated. All measurements were taken at baseline, at 6, 12 and 26 weeks. After 26 weeks, both groups showed a significant increase in the Constant Murley score and a significant decrease in VAS scores. No difference was found between the groups, for any of the evaluated outcome measures. A 12-week-isolated eccentric training programme of the rotator cuff is beneficial for shoulder function and pain after 26 weeks in patients with rotator cuff tendinopathy. However, it is no more beneficial than a conventional exercise programme for the rotator cuff and scapular muscles. Based on the results, clinicians should take into account that performing two eccentric exercises twice a day is as effective as performing six concentric/eccentric exercises once a day in patients with rotator cuff tendinopathy.

  19. Randomized double blinded placebo controlled trial comparing diclofenac and piroxicam in management of acute renal colic and its clinical implications.

    Science.gov (United States)

    KandaSwamy, Gokul Vignesh; Dhanasekaran, Ananda Kumar; Elangovan, Aravindhan; John, Bobby; Viswaroop, Bobby; Vedanayagam, Kandasami Sangam

    2015-04-29

    To compare the efficacy of sublingual piroxicam 40 mg with intramuscular diclofenac 75 mg in treatment of acute renal colic. The secondary objective was to look for factors that can affect the severity of the pain and pain relief in acute renal colic. One hundred patients with acute renal colic were randomized into two groups. Group A (n = 50) received intramuscular diclofenac and sublingual methylcobalamin. Group B (n = 50) received sublingual piroxicam 40 mg and intramuscular distilled water. Pain severity was measured using Visual Analog Scale (VAS) and verbal and facial response scales. They were followed up for 3 h. Intramuscular injection of pentazocine 30 mg with promethazine 25 mg were used as rescue drugs. Both groups were comparable for age, sex distribution, body mass index (BMI), and pain duration before presentation. Significant pain relief was noticed in both groups. Sixteen percent in group A and 18% in group B had complete pain relief within 30 min (P = .75). Fifteen patients in group A and 13 patients in group B needed rescue drugs, 84% of group A and 76% of group B had complete pain relief at the end of 3 hours (P = .25). Decrease in pain by each scoring method was also comparable (P = .75). In multiple regression analysis, increasing age, positively affects the severity of pain and pain relief while increasing BMI negatively affect the initial pain relief. Acute renal colic seems to affect men more commonly than women, 81% of the study population were men. Patients with low initial pain score did not require any additional pain relief. Average pain duration before presenting to hospital is 260 min. Sixty percent of renal colics are due to stones below pelvic brim. The results show that sublingual piroxicam is as effective as intramuscular diclofenac. It can be easily self-administered and it overcomes the morbidity and time delay in getting intramuscular diclofenac.

  20. Clinical trial: transcutaneous interferential electrical stimulation in individuals with irritable bowel syndrome - a prospective double-blind randomized study.

    Science.gov (United States)

    Coban, Şahin; Akbal, Erdem; Köklü, Seyfettin; Köklü, Gülşah; Ulaşlı, Murat Alper; Erkeç, Serap; Aktaş, Bora; Yüksel, Osman; Koçak, Erdem; Erdem, Hatice Rana

    2012-01-01

    The exact etiology of irritable bowel syndrome (IBS) remains unclear. Curative treatment is not available and current treatment modalities are mainly directed against the predominant symptoms. There are a few studies reporting the beneficial effects of transcutaneous electrical stimulation in patients with chronic constipation, gastroparesis, and functional dyspepsia. To investigate whether transcutaneous electrical stimulation is an effective procedure in IBS patients. IBS patients were randomly placed in vacuum interferential current (IFC) and placebo groups. Both treatments consisted of 12 sessions administered over 4 weeks. Symptoms due to IBS were documented via questionnaires, including the IBS Global Assessment of Improvement Scale, numeric rating scales, visual analogue scale, and IBS Quality of Life Scale at the beginning of, end of, and 1 month after the treatment. Patients in the therapy (29 cases) and placebo (29 cases) groups were homogeneous with respect to demographic data and gastrointestinal system symptoms. When compared to the beginning scores, severity of abdominal discomfort, bloating, and abdominal distension and rumbling improved significantly in either interference or placebo groups at both the end of treatment and 1 month after treatment. In the IFC group, severity of symptoms continued to decrease significantly at 1 month after treatment when compared to scores at just the end of treatment, whereas in the placebo group severity of these symptoms did not change significantly on numeric severity scales. Also, the visual analogue scale of the first month after treatment continued to decrease significantly when compared to the level at the end of treatment in the IFC group. Total quality score increased significantly in the IFC group. Vacuum IFC therapy can significantly improve symptoms and quality of life in patients with IBS. It may represent a novel treatment modality for drug-refractory IBS patients. Copyright © 2012 S. Karger AG, Basel.

  1. Effect of dexamethasone in low volume supraclavicular brachial plexus block: A double-blinded randomized clinical study

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    Arun Kumar Alarasan

    2016-01-01

    Full Text Available Background and Aims: With the use of ultrasound, a minimal effective volume of 20 ml has been described for supraclavicular brachial plexus block. However achieving a long duration of analgesia with this minimal volume remains a challenge. We aimed to determine the effect of dexamethasone on onset and duration of analgesia in low volume supraclavicular brachial plexus block. Material and Methods: Sixty patients were randomly divided into two groups of 30 each. Group C received saline (2 ml + 20 ml of 0.5% bupivacaine and Group D received dexamethasone (8 mg + 20 ml of 0.5% bupivacaine in supraclavicular brachial plexus block. Hemodynamic variables and visual analog scale (VAS score were noted at regular intervals until 450 min. The onset and duration of sensory and motor block were measured. The incidence of "Halo" around brachial plexus was observed. Student′s t-test and Chi-square test were used for statistical analysis. Results: The onset of sensory and motor block was significantly earlier in dexamethasone group (10.36 ± 1.99 and 12 ± 1.64 minutes compared to control group (12.9 ± 2.23 and 18.03 ± 2.41 minutes. The duration of sensory and motor block was significantly prolonged in dexamethasone group (366 ± 28.11 and 337.33 ± 28.75 minutes compared to control group (242.66 ± 26.38 and 213 ± 26.80 minutes. The VAS score was significantly lower in dexamethasone group after 210 min. "Halo" was present around the brachial plexus in all patients in both the groups. Conclusion: Dexamethasone addition significantly increases the duration of analgesia in patients receiving low volume supraclavicular brachial plexus block. No significant side-effects were seen in patients receiving dexamethasone as an adjunct.

  2. The Clinical Efficacy and Safety of the Sahastara Remedy versus Diclofenac in the Treatment of Osteoarthritis of the Knee: A Double-Blind, Randomized, and Controlled Trial

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    Piya Pinsornsak

    2015-01-01

    Full Text Available Introduction. The Sahastara (SHT remedy is a Thai traditional medicine that has been acknowledged in the Thai National List of Essential Medicine and has been used as an alternative medicine to treat knee osteoarthritis. Although SHT remedies have been used in Thai traditional medical practices for a long period of time, there are few reports on their clinical trials. Aim of the Study. To investigate the clinical efficacy and safety of the SHT remedy in treating OA of the knee when compared to diclofenac. Methods. A phase 2, double-blind, randomized, and controlled trial study with a purpose to determine the clinical efficacy and safety of SHT in comparison with diclofenac for the treatment of knee osteoarthritis. Sixty-six patients, ages between 45 and 80 years of age, were randomly allocated into 2 groups. The SHT group received 1,000 mg of SHT powdered capsules 3 times per day, orally before meals, while another group received 25 mg of diclofenac sodium capsules 3 times a day, orally after meals for 28 days. All patients were followed up at 14 and 28 days for the evaluation of the efficacy and safety by using clinical examinations, blood tests, a visual analogue scale (VAS for pain, and the 100-meter walktime test. Improvement on the quality of life was also assessed by the WOMAC index. Results. There were 31 and 30 patients in SHT and diclofenac groups, respectively, who had completed the study. Both medications have shown to significantly reduce the VAS for pain, and significantly improve the 100-meter walktime test and the WOMAC index score. However, there were no differences in the efficacy between the two groups. The blood chemistry showed no toxicity on renal and/or liver functions after taking SHT for 28 days but the patients who took diclofenac showed significant increases in their AST, ALT, and ALP. Systolic and diastolic blood pressure slightly increased in the diclofenac group but the SHT group did not effect on blood pressure

  3. Effect of probiotic fermented milk (kefir) on glycemic control and lipid profile in type 2 diabetic patients: a randomized double-blind placebo-controlled clinical trial.

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    Ostadrahimi, Alireza; Taghizadeh, Akbar; Mobasseri, Majid; Farrin, Nazila; Payahoo, Laleh; Beyramalipoor Gheshlaghi, Zahra; Vahedjabbari, Morteza

    2015-02-01

    Diabetes is a global health problem in the world. Probiotic food has anti-diabetic property. The aim of this trial was to determine the effect of probiotic fermented milk (kefir) on glucose and lipid profile control in patients with type 2 diabetes mellitus. This randomized double-blind placebo-controlled clinical trial was conducted on 60 diabetic patients aged 35 to 65 years.Patients were randomly and equally (n=30) assigned to consume either probiotic fermented milk (kefir) or conventional fermented milk (dough) for 8 weeks. Probiotic group consumed 600 ml/day probiotic fermented milk containing Lactobacillus casei, Lactobacillus acidophilus and Bifidobacteria and control group consumed 600 ml/day conventional fermented milk.Blood samples tested for fasting blood glucose, HbA1C, triglyceride (TG), total cholesterol, HDL-C and LDL-C at the baseline and end of the study. The comparison of fasting blood glucose between two groups after intervention was statistically significant (P=0.01). After intervention, reduced HbA1C compared with the baseline value in probiotic fermented milk group was statistically significant (P=0.001), also the HbA1C level significantly decreased in probiotic group in comparison with control group (P=0.02) adjusting for serum levels of glucose, baseline values of HbA1c and energy intake according to ANCOVA model. Serum triglyceride, total cholesterol, LDL-cholesterol and HDL- cholesterol levels were not shown significant differences between and within the groups after intervention. Probiotic fermented milk can be useful as a complementary or adjuvant therapy in the treatment of diabetes.

  4. Pre-operative rectal indomethacin for reduction of postoperative nausea and vomiting after laparoscopic cholecystectomy: a double-blind randomized clinical trial

    International Nuclear Information System (INIS)

    Pazouki, A.; Cheraghali, R.; Saeedimotahhar, H.; Jesmi, F.

    2015-01-01

    To evaluate the effect of pre-operative indomethacin suppository on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Study Design: A double blind placebo-controlled randomized clinical trial. Place and Duration of Study: Hazrat Rasoul Akram Hospital, Tehran, Iran, from February 2010 to September 2012. Methodology: One hundred and thirty patients, scheduled for laparoscopic cholecystectomy, were randomly divided into case and control groups. Sixty-five patients received indomethacin suppository and 70 patients received rectal placebo in the case and control groups respectively. All patients underwent the same protocol in laparoscopic surgery and anesthesia, then nausea and vomiting was recorded after 1, 6, 12 and 24 hours postoperatively and compared between the two groups. Independent-sample t-test or Mann-Whitney tests were used for statistical analysis. Level of statistical significance was set at P = 0.05. Results: Patients' nausea was statistically lower in the case group at the 1st hour (43.1 vs. 92.9%), 6th hour (20.0 vs. 68.6%) and 12th hour (7.7 vs. 24.3%) after surgery (for all periods, P < 0.001). Fewer patients in the case group experienced vomiting at the first (13.8 vs. 51.4%) and 6th hour (0 vs. 20%) after surgery (for both P < 0.001). The use of pethidine was also statistically less in the case group in the same hours after surgery (for all of them, P < 0.001). Conclusion: Rectal indomethacin before laparoscopic cholecystectomy led to lower postoperative nausea and vomiting. (author)

  5. Comparison of captopril (0.5%) cream with diltiazem (2%) cream for chronic anal fissure: a prospective randomized double-blind two-centre clinical trial.

    Science.gov (United States)

    Ala, S; Enayatifard, R; Alvandipour, M; Qobadighadikolaei, R

    2016-05-01

    This study compared the efficacy of topical captopril with topical diltiazem in the treatment of chronic anal fissure (CAF). Fifty patients aged between 15 and 75 years with CAF were included in a prospective randomized, double-blind clinical trial. They were randomly allocated to either captopril (0.5%) cream or diltiazem (2%) cream in a dose of 2 cm of cream on the perianal skin every 12 h for 8 weeks. The intensity of pain upon defaecation was evaluated every 10 days using a visual analogue scale. Bleeding on defaecation, pruritus and the presence of perianal irritation were also recorded before and during the trial. The average pain scores were lower in the diltiazem group on the 20th and 30th days. From day 40 to the end of the trial the average pain scores of the two groups did not differ significantly. There were no significant differences in bleeding or perianal irritation between the groups, but the incidence of pruritus was considerably higher in the captopril group, and at the end of the trial 45.8% of the patients in this group still suffered from pruritus. Topical captopril and diltiazem were found to be equally effective in the management of pain, bleeding and perianal irritation due to CAF, but due to the high incidence of pruritus observed with topical captopril this medication is not recommended for the treatment of CAF. Colorectal Disease © 2015 The Association of Coloproctology of Great Britain and Ireland.

  6. Topical diclofenac versus dexamethasone after strabismus surgery: A double-blind randomized clinical trial of anti-inflammatory effect and ocular hypertensive response

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    Khan Hayat

    2007-01-01

    Full Text Available Background: Compared to steroids non-steroidal anti-inflammatory drugs offer comparable anti-inflammatory action without ocular side-effects. Aim: To compare the anti-inflammatory effect and effect on IOP (Goldmann of topical diclofenac 0.1% with dexamethasone 0.1% after strabismus surgery. Design: Prospective, randomized, double-blind, single-center, clinical trial. Materials and Methods: Forty-three cases of constant horizontal strabismus, qualifying for standard uniocular recession-resection surgery on two horizontal rectus muscles were randomized to either the dexamethasone or diclofenac group. They were excluded if they had previous ocular surgery, recently used anti-inflammatory drugs and had a neurological, systemic or an ocular inflammatory condition. In addition all received ciprofloxacin 0.3% four times daily. Assessment was done on the first postoperative day and at two and four weeks. The inflammatory characteristics graded from nil (0 to severe (3 were: discomfort, chemosis, injection, discharge and drop-intolerance. Their sum provided the total inflammatory score (TIS. Results: Dexamethasone group (n=21 was comparable in age, gender, preoperative IOP, strabismus, anesthesia administered and baseline IOP, to diclofenac (n=22. There were no significant differences in the inflammatory characteristics and TIS. The dexamethasone group had IOP significantly higher at two weeks (95% CI 0.17 to 3.25 and four weeks (95% CI 1.09 to 4.24 compared to diclofenac group and the net change of IOP at four weeks (95% CI 0.60 to 3.14. Compared to the baseline IOP. Conclusion: Topical diclofenac is comparable to dexamethasone in providing anti-inflammatory and analgesic effect with the advantage of significantly lesser IOP rise and should be preferred after strabismus surgery.

  7. Does quercetin improve cardiovascular risk factors and inflammatory biomarkers in women with type 2 diabetes: A double-blind randomized controlled clinical trial

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    Maryam Zahedi

    2013-01-01

    Full Text Available Background: Quercetin has been distributed in a wide range of foods, but some of its known effects in vitro, are not proven in human studies. Therefore, the aim of this study was evaluation of the effects of quercetin intake on cardiovascular risk factors and inflammatory biomarkers in women with type 2 diabetes. Methods: This double-blind randomized clinical trial was carried out on 72 women for 10 weeks. Subjects were assigned to quercetin and placebo groups using a permutated block randomization of size two. Quercetin was given to participants as a 500 mg capsule daily. Biochemical variables were measured at baseline and at the end of the study, and changes were compared using appropriate statistical methods. Results: Compared with placebo, quercetin intake decreased systolic blood pressure significantly (−8.8 ± 9.3 vs. −3.5 ± 11.7, P = 0.04. Although changes in diastolic blood pressure between the groups was not significant ( P = 0.19, high-density lipoprotein cholesterol (HDL-C was significantly decreased in both groups while changes in total cholesterol, low-density lipoprotein cholesterol (LDL-C, triglycerides (TG and ratio of TG/HDL-C and LDL-C/HDL-C were not significant between and within groups. Quercetin supplementation significantly reduced the serum concentration of tumor necrosis factor-α (TNF-α and interleukin-6 (IL-6 ( P = 0.01 and P < 0.0001, respectively; however, the mean changes in serum levels of IL-6, TNF-α, and high-sensitivity C-reactive protein were not significant between the groups. Conclusions: Quercetin supplementation reduced systolic blood pressure significantly but had no effect on other cardiovascular risk factors and inflammatory biomarkers. Considering the biological effects of quercetin in vitro, we need more studies with a stronger design and sample size with different doses of quercetin.

  8. Intravenous sufentanil and morphine for post-cardiac surgery pain relief using patient-controlled analgesia (pca) device: a randomized double-blind clinical trial

    International Nuclear Information System (INIS)

    Alavi, S.M.; Kish, R.F.; Farsad, F.; Imani, F.; Sheikhvatan, M.

    2010-01-01

    Selection of the best analgesic technique in patients undergoing major surgeries can result in lower morbidity and satisfactory postoperative pain relief. In the present study, we tried to compare the effect of morphine and sufentanil on postoperative pain severity and hemodynamic changes by using patient-controlled analgesia (PCA) device in patients who were candidate for coronary artery bypass surgery (CABG). It was a randomized double-blinded clinical trial in which 120 patients aged 30-65 years, ASA physical status I-III, candidate for CABG in Shahid Rajaee hospital in Tehran were included. Before anesthesia, patients were randomly assigned to one of three groups to receive sufentanil (n=40), morphine (n=40) or normal saline (n=40). After tracheal extubation at intensive care unit, PCA was started by, sufentanil 4mg for the first group, morphine 2mg for the second group and normal saline, at same volume for the third group, intravenously with 10 minute lockout interval. Postoperative pain was evaluated by VAS scale, 1, 6, 12, 18 and 24 hours after extubation and systolic blood pressure, arterial oxygen saturation, PCO2 and PO2 were recorded 24 hours after extubation. VAS scores at rest revealed significantly less pain for patients in sufentanil and morphine groups than normal saline group, throughout the twenty-four hours after operation (P<0.001). However, there were no significant differences in the means of VAS scores between sufentanil and morphine groups. Among studied hemodynamic parameters, only systolic blood pressure was reduced more in morphine than sufentanil group (P<0.001). After CABG surgery, administration of intravenous sufentanil and morphine using PCA can lead to similar reduction of postoperative pain severity. (author)

  9. Effects of Taping on Pain and Functional Outcome of Patients with Knee Osteoarthritis: A Pilot Randomized Single-blind Clinical Trial

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    Parisa Taheri

    2017-01-01

    Full Text Available Background: To determine the effects of knee taping in combination with exercise and medical treatment on functional outcome and pain of patients with knee osteoarthritis (OA. Materials and Methods: In a randomized single-blinded clinical trial, 36 patients with knee OA were randomly assigned to two study groups. Both groups received exercise and medical therapy for 6 weeks. In addition, the first group (20 patients received taping in the first 3 weeks. Pain severity (assessed by visual analog scaling, weekly amount of analgesics consumption, timed get up and go test (TUG, and step tests were recorded at baseline, 3 and 6 weeks after the treatment and were further compared between two study groups. Results: There was no significant difference between two groups in pain severity score (P = 0.228, step test score (P = 0.771, TUG test score (P = 0.821 and weekly amount of analgesics consumption (P = 0.873 at baseline. After 3 weeks, weekly amount of analgesics consumption (P = 0.006, pain severity (P < 0.001 was significantly lower in taping group whereas step test score (P = 0.006 was significantly higher in the taping group. After 6 weeks, patients in taping group had significantly lower pain severity (P = 0.011 and higher step test score (P = 0.042. However, there was no significant difference in TUG test score (P = 0.443 and weekly amount of analgesics consumption (P = 0.270 between two groups. Conclusion: Therapeutic knee taping may be an effective method for short-term management of pain and disability in patients with knee OA.

  10. Mindfulness-based stress reduction for chronic insomnia in adults older than 75 years: a randomized, controlled, single-blind clinical trial.

    Science.gov (United States)

    Zhang, Jia-Xu; Liu, Xiao-Hui; Xie, Xin-Hui; Zhao, Dan; Shan, Mo-Shui; Zhang, Xi-Liang; Kong, Xiao-Ming; Cui, Hong

    2015-01-01

    To assess the effectiveness of mindfulness-based stress reduction (MBSR) for chronic insomnia and combined depressive or anxiety symptoms of older adults aged 75 years and over. A randomized, controlled, single-blind clinical trial. Participants included 60 adults aged 75 years and over with chronic insomnia. Participants were randomly assigned to the eight-week MBSR group or the wait-list control group. Assessments using the Pittsburgh Sleep Quality Index (PSQI), Self-rating Anxiety Sale (SAS), and Geriatric Depression Scale (GDS) were taken at baseline and post-treatment. For each outcome measure, a repeated measures analysis of variance was used to detect changes across assessments. There was a significant time × group interaction for the PSQI global score (P = .006); the MBSR group had a decrease in the PSQI global score (Cohen׳s d = 1.12), while the control group did not (Cohen׳s d = -0.06). Among the PSQI components, there was a significant time × group interaction for daytime dysfunction (P = .048); Cohen׳s d of the MBSR group was 0.76, while Cohen׳s d of control group was -0.04. There was no significant time × group interaction for the SAS score (P = .116), while for the GDS there was a significant time × group interaction (P = .039); the Cohen׳s d value for the MBSR group was 1.20, and it was 0.12 for the control group. This study demonstrated that the MBSR program could be a beneficial treatment for chronic insomnia in adults aged 75 years and older. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. Effects of Ascorbic Acid on Serum Level of Unconjugated Estriol and Its Relationship with Preterm Premature Rupture of Membrane: A Double-Blind Randomized Controlled Clinical Trial

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    Mehrangiz Zamani

    2013-09-01

    Full Text Available Background: Vitamin C is a water-soluble antioxidant that not only stimulates and protects collagen synthesis but also plays an important role in maintaining cellular integrity in a normal pregnancy. This study surveyed the effects of ascorbic acid on the serum level of unconjugated estriol and the relationship between unconjugated estriol and preterm premature rupture of membrane (PPROM. Methods: This double-blind, randomized clinical trial recruited 60 patients with predisposing factors to PPROM. The women were randomly divided into two groups of intervention and control and received vitamin C and placebo, respectively. The intervention group received 250 mg vitamin C twice a day and the controls received the placebo only. Unconjugated estriol was measured using the ELISA. All data were extracted and recorded in a checklist and compared using descriptive statistics as well as the x2, Fisher exact, and t tests. Results: The demographic data showed no difference between the two groups. The mean level of serum unconjugated estriol was significantly lower in the intervention group than in the control group (P=0.044. Also, the frequency of PPROM was lower in the intervention group, but the difference was not significant (P>0.05. Unconjugated estriol levels were not significantly different between the healthy women and the PPROM patients. Conclusion: This study demonstrated that vitamin C administration decreased unconjugated estriol levels in the patients with PPROM. The findings of this study also indicated that administration of ascorbic acid was a safe and effective method to reduce the incidence of PPROM. Alteration in unconjugated estriol is an active mediator for this effect. Trial Registration Number: IRCT201012083580N3

  12. Dexamethasone versus ondansetron in combination with dexamethasone for the prophylaxis of postoperative vomiting in pediatric outpatients: a double-blind, randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    de Orange, Flávia A; Marques, Jaime; Flores, Marília; Borges, Paulo S G N

    2012-09-01

    To determine the frequency of postoperative vomiting (POV) in children submitted to outpatient surgery and to compare the efficacy of antiemetic drugs in preventing this complication. Nausea and vomiting are common in the immediate postoperative period following anesthetic and surgical procedures. Compared to adults, pediatric patients are more likely to develop postoperative nausea and vomiting, the incidence of which ranges from 8.9% to 42%. This double-blind, randomized, placebo-controlled clinical trial included 129 children. The participants were randomized into three prophylactic treatment groups: dexamethasone (n = 43), ondansetron in combination with dexamethasone (n = 44), and placebo (n = 42). The variables studied were the frequency of POV and the incidence of vomiting after the patient had been discharged from hospital, the need for antiemetic rescue therapy in the postanesthesia care unit (PACU), need for hospitalization, and the time the patient remained in the PACU. A significance level of 5% was adopted. Postoperative vomiting occurred in 12.4% of the children, with no statistically significant difference between the groups: 6.8% in the group receiving ondansetron combined with dexamethasone, 14.3% in the placebo group, and 14% in the group that received dexamethasone alone (P = 0.47). Furthermore, no significant difference was found between the groups with respect to the time the children remained in the PACU, and only five patients reported having vomited following discharge from hospital. The prophylactic use of antiemetic drugs failed to reduce the incidence of POV in pediatric outpatient surgery with a low emetic potential; therefore, routine prophylaxis may be unnecessary. © 2012 Blackwell Publishing Ltd.

  13. Facilitation of motor and balance recovery by thermal intervention for the paretic lower limb of acute stroke: a single-blind randomized clinical trial.

    Science.gov (United States)

    Chen, Jia-Ching; Lin, Chun-Hsiang; Wei, Yu-Chun; Hsiao, Jung; Liang, Chung-Chao

    2011-09-01

    To evaluate the effectiveness of thermal stimulation accompanied by either active or passive movement added to standard rehabilitation in facilitating motor and balance function of the paretic leg of acute stroke. Pilot, observer-blinded, randomized clinical trial. Department of rehabilitation medicine in a general hospital. Thirty-six patients were enrolled within four weeks of the onset of a stroke causing moderate to severe leg paresis (Brunnstrom stage ≤III). Patients were randomly assigned to thermal (standard rehabilitation plus approximately 30-40 minutes of thermal stimulation therapy daily for six weeks) and control (standard rehabilitation only) groups. Fugl-Meyer lower extremity score, Medical Research Council scale for lower extremity, Modified Motor Assessment Scale, Postural Assessment Scale for Stroke Patients Trunk Control, Berg Balance Scale, Functional Ambulation Classification and Modified Ashworth Scale. Patients in the thermal group experienced significantly better median scores for Fugl-Meyer lower extremity (14.0; interquartile range, 10.5-15.5), Medical Research Council scale for lower extremity (6.0; 4.0-7.0), Modified Motor Assessment Scale (16.0; 12.5-18.5), Berg Balance Scale (28.0; 20.5-33.5), and Functional Ambulation Classification (2.0; 2.0-2.0) (all P < 0.05). The thermal group also had more independent walkers (15/17; 88.2%) than the control group (9/16; 56.3%) after six weeks (P = 0.06). No adverse effect occurred. Thermal stimulation accompanied by either manual facilitation or encouragement for active participation of the paretic lower limb may be an effective promising supplementary treatment for the early-phase rehabilitation of moderate to severe stroke that warrants additional study.

  14. Is there a dose response of dexamethasone as adjuvant for supraclavicular brachial plexus nerve block? A prospective randomized double-blinded clinical study.

    Science.gov (United States)

    Liu, Jiabin; Richman, Kenneth A; Grodofsky, Samuel R; Bhatt, Siya; Huffman, George Russell; Kelly, John D; Glaser, David L; Elkassabany, Nabil

    2015-05-01

    The study objective is to examine the analgesic effect of 3 doses of dexamethasone in combination with low concentration local anesthetics to determine the lowest effective dose of dexamethasone for use as an adjuvant in supraclavicular brachial plexus nerve block. The design is a prospective randomized double-blinded clinical study. The setting is an academic medical center. The patients are 89 adult patients scheduled for shoulder arthroscopy. All patients were randomly assigned into 1 of 4 treatment groups: (i) bupivacaine, 0.25% 30 mL; (ii) bupivacaine, 0.25% 30 mL with 1-mg preservative-free dexamethasone; (iii) bupivacaine, 0.25% 30 mL with 2-mg preservative-free dexamethasone; and (iv) bupivacaine, 0.25% 30 mL with 4-mg preservative-free dexamethasone. All patients received ultrasound-guided supraclavicular brachial plexus nerve blocks and general anesthesia. The measurements are the duration of analgesia and motor block. The median analgesia duration of supraclavicular brachial plexus nerve block with 0.25% bupivacaine was 12.1 hours; and 1-, 2-, or 4-mg dexamethasone significantly prolonged the analgesia duration to 22.3, 23.3, and 21.2 hours, respectively (P = .0105). Dexamethasone also significantly extended the duration of motor nerve block in a similar trend (P = .0247). Low-dose dexamethasone (1-2 mg) prolongs analgesia duration and motor blockade to the similar extent as 4-mg dexamethasone when added to 0.25% bupivacaine for supraclavicular brachial plexus nerve block. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. Clinical and biochemical effects of a combination botanical product (ClearGuard™ for allergy: a pilot randomized double-blind placebo-controlled trial

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    Lin Yumei

    2008-07-01

    Full Text Available Abstract Background Botanical products are frequently used for treatment of nasal allergy. Three of these substances, Cinnamomum zeylanicum, Malpighia glabra, and Bidens pilosa, have been shown to have a number of anti-allergic properties in-vitro. The current study was conducted to determine the effects of these combined ingredients upon the nasal response to allergen challenge in patients with seasonal allergic rhinitis. Methods Twenty subjects were randomized to receive the combination botanical product, (CBP 2 tablets three times a day, loratadine, 10 mg once a day in the morning, or placebo, using a randomized, double-blinded crossover design. Following 2 days of each treatment and during the third day of treatment, subjects underwent a nasal allergen challenge (NAC, in which nasal symptoms were assessed after each challenge dose and every 2 hours for 8 hours. Nasal lavage fluid was assessed for tryptase, prostaglandin D2, and leukotriene E4 concentrations and inflammatory cells. Results Loratadine significantly reduced the total nasal symptom score during the NAC compared with placebo (P = 0.04 while the CBP did not. During the 8 hour period following NAC, loratadine and the CBP both reduced NSS compared with placebo (P = 0.034 and P = 0.029, respectively. Analysis of nasal lavage fluid demonstrated that the CBP prevented the increase in prostaglandin D2 release following NAC, while neither loratadine nor placebo had this effect. None of the treatments significantly affected tryptase or leukotriene E4 release or inflammatory cell infiltration. Conclusion The CBP significantly reduced NSS during the 8 hours following NAC and marginally inhibited the release of prostaglandin D2 into nasal lavage fluid, suggesting potential clinical utility in patients with allergic rhinitis.

  16. Effects of protein-carbohydrate supplementation on immunity and resistance training outcomes: a double-blind, randomized, controlled clinical trial.

    Science.gov (United States)

    Naclerio, Fernando; Larumbe-Zabala, Eneko; Ashrafi, Nadia; Seijo, Marco; Nielsen, Birthe; Allgrove, Judith; Earnest, Conrad P

    2017-02-01

    To examine the impact of ingesting hydrolyzed beef protein, whey protein, and carbohydrate on resistance training outcomes, body composition, muscle thickness, blood indices of health and salivary human neutrophil peptides (HNP1-3), as reference of humoral immunity followed an 8-week resistance training program in college athletes. Twenty-seven recreationally physically active males and females (n = 9 per treatment) were randomly assigned to one of the three groups: hydrolyzed beef protein, whey protein, or non-protein isoenergetic carbohydrate. Treatment consisted of ingesting 20 g of supplement, mixed with orange juice, once a day immediately post-workout or before breakfast on non-training days. Measurements were performed pre- and post-intervention on total load (kg) lifted at the first and last workout, body composition (via plethysmography) vastus medialis thickness (mm) (via ultrasonography), and blood indices of health. Salivary HNP1-3 were determined before and after performing the first and last workout. Salivary concentration and secretion rates of the HNP1-3 decreased in the beef condition only from pre-first-workout (1.90 ± 0.83 μg/mL; 2.95 ± 2.83 μg/min, respectively) to pre-last-workout (0.92 ± 0.63 μg/mL, p = 0.025, d = 1.03; 0.76 ± 0.74 μg/min, p = 0.049, d = 0.95), and post-last-workout (0.95 ± 0.60 μg/mL, p = 0.032, d = 1.00; 0.59 ± 0.52 μg/min, p = 0.027, d = 1.02). No other significant differences between groups were observed. Supplementation with a carbohydrate-protein beverage may support resistance training outcomes in a comparable way as the ingestion of only carbohydrate. Furthermore, the ingestion of 20 g of hydrolyzed beef protein resulted in a decreased level and secretion rates of the HNP1-3 from baseline with no negative effect on blood indices of health.

  17. Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Fu Dong-Jing

    2011-05-01

    Full Text Available Abstract Background Paliperidone palmitate is a long-acting injectable atypical antipsychotic for the acute and maintenance treatment of adults with schizophrenia. The recommended initiation dosing regimen is 234 mg on Day 1 and 156 mg on Day 8 via intramuscular (deltoid injection; followed by 39 to 234 mg once-monthly thereafter (deltoid or gluteal. These post-hoc analyses addressed two commonly encountered clinical issues regarding the initiation dosing: the time to onset of efficacy and the associated tolerability. Methods In a 13-week double-blind trial, 652 subjects with schizophrenia were randomized to paliperidone palmitate 39, 156, or 234 mg (corresponding to 25, 100, or 150 mg equivalents of paliperidone, respectively or placebo (NCT#00590577. Subjects randomized to paliperidone palmitate received 234 mg on Day 1, followed by their randomized fixed dose on Day 8, and monthly thereafter, with no oral antipsychotic supplementation. The onset of efficacy was defined as the first timepoint where the paliperidone palmitate group showed significant improvement in the Positive and Negative Syndrome Scale (PANSS score compared to placebo (Analysis of Covariance [ANCOVA] models and Last Observation Carried Forward [LOCF] methodology without adjusting for multiplicity using data from the Days 4, 8, 22, and 36 assessments. Adverse event (AE rates and relative risks (RR with 95% confidence intervals (CI versus placebo were determined. Results Paliperidone palmitate 234 mg on Day 1 was associated with greater improvement than placebo on Least Squares (LS mean PANSS total score at Day 8 (p = 0.037. After the Day 8 injection of 156 mg, there was continued PANSS improvement at Day 22 (p ≤ 0.007 vs. placebo and Day 36 (p Conclusions Significantly greater symptom improvement was observed by Day 8 with paliperidone palmitate (234 mg on Day 1 compared to placebo; this effect was maintained after the 156 mg Day 8 injection, with a trend towards a dose

  18. Clinical Efficacy of Traditional Chinese Medicine, Suan Zao Ren Tang, for Sleep Disturbance during Methadone Maintenance: A Randomized, Double-Blind, Placebo-Controlled Trial

    OpenAIRE

    Chan, Yuan-Yu; Chen, Yi-Hung; Yang, Szu-Nian; Lo, Wan-Yu; Lin, Jaung-Geng

    2015-01-01

    Methadone maintenance therapy is an effective treatment for opiate dependence, but more than three-quarters of persons receiving the treatment report sleep quality disturbances. In this double-blind, randomized, controlled trial, we recruited 90 individuals receiving methadone for at least one month who reported sleep disturbances and had Pittsburgh Sleep Quality Index (PSQI) scores > 5. The purpose of this study was to determine whether Suan Zao Ren Tang, one of the most commonly prescribed ...

  19. Randomized, controlled, assessor-blind clinical trial to assess the efficacy of single- versus repeated-dose albendazole to treat ascaris lumbricoides, trichuris trichiura, and hookworm infection.

    Science.gov (United States)

    Adegnika, Ayola A; Zinsou, Jeannot F; Issifou, Saadou; Ateba-Ngoa, Ulysse; Kassa, Roland F; Feugap, Eliane N; Honkpehedji, Yabo J; Dejon Agobe, Jean-Claude; Kenguele, Hilaire M; Massinga-Loembe, Marguerite; Agnandji, Selidji T; Mordmüller, Benjamin; Ramharter, Michael; Yazdanbakhsh, Maria; Kremsner, Peter G; Lell, Bertrand

    2014-05-01

    In many regions where soil-transmitted helminth infections are endemic, single-dose albendazole is used in mass drug administration programs to control infections. There are little data on the efficacy of the standard single-dose administration compared to that of alternative regimens. We conducted a randomized, controlled, assessor-blinded clinical trial to determine the efficacies of standard and extended albendazole treatment against soil-transmitted helminth infection in Gabon. A total of 175 children were included. Adequate cure rates and egg reduction rates above 85% were found with a single dose of albendazole for Ascaris infection, 85% (95% confidence interval [CI], 73, 96) and 93.8% (CI, 87.6, 100), respectively, while two doses were necessary for hookworm infestation (92% [CI, 78, 100] and 92% [CI, 78, 100], respectively). However, while a 3-day regimen was not sufficient to cure Trichuris (cure rate, 83% [CI, 73, 93]), this regimen reduced the number of eggs up to 90.6% (CI, 83.1, 100). The rate ratios of two- and three-dose regimens compared to a single-dose treatment were 1.7 (CI, 1.1, 2.5) and 2.1 (CI, 1.5, 2.9) for Trichuris and 1.7 (CI, 1.0, 2.9) and 1.7 (CI, 1.0, 2.9) for hookworm. Albendazole was safe and well tolerated in all regimens. A single-dose albendazole treatment considerably reduces Ascaris infection but has only a moderate effect on hookworm and Trichuris infections. The single-dose option may still be the preferred regimen because it balances efficacy, safety, and compliance during mass drug administration, keeping in mind that asymptomatic low-level helminth carriage may also have beneficial effects. (This study has been registered at ClinicalTrials.gov under registration number NCT01192802.).

  20. Treatment of Palmar Hyperhidrosis with Tap Water Iontophoresis: A Randomized, Sham-Controlled, Single-Blind, and Parallel-Designed Clinical Trial.

    Science.gov (United States)

    Kim, Do Hun; Kim, Tae Han; Lee, Seung Ho; Lee, Ai Young

    2017-12-01

    Palmar hyperhidrosis is a common disorder of excessive sweating. A number of studies have demonstrated the effectiveness of iontophoresis in the treatment of palmar hyperhidrosis. However, controlled clinical studies on iontophoresis for palmar hyperhidrosis have been limited. To determine the efficacy and safety of iontophoresis in the treatment of palmar hyperhidrosis with a randomized, sham-controlled, single-blind, and parallel-designed study. Twenty nine patients with significant palmar hyperhidrosis were enrolled in this study. They received active iontophoresis treatment (group A) or sham treatment (group B). Iontophoresis was performed 20 minutes each time, five times per week, for 2 weeks. Its efficacy was assessed with starch-iodine test, mean sweat secretion rate, and hyperhidrosis disease severity scale. Twenty-seven of the 29 patients completed the 2-week treatment. After completion of 10 times of treatment, results of the starch-iodine test showed clinical improvement in 92.9% of patients in group A and 38.5% of patients in group B ( p =0.001). The mean sweat secretion rate was reduced by 91.8% of patients in group A and by 39.1% of patients in group B ( p <0.001). Improvement in quality of life was reported by 78.6% of patients in group A and by 30.8% of patients in group B ( p =0.028). In group A, one case of localized adverse event was noted, although no adverse event was encountered in group B. Tap water iontophoresis could be used as an effective and safe treatment modality for palmar hyperhidrosis.

  1. Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Gustavo F. Wandalsen

    Full Text Available Abstract Introduction: A combination of antihistamines and oral corticosteroids is often used to treat acute symptoms of allergic rhinitis. Objective: To evaluate safety and efficacy of desloratadine plus prednisolone in the treatment of acute symptoms of children (2-12 years with allergic rhinitis, and to compare it to dexchlorpheniramine plus betamethasone. Methods: Children with moderate/severe persistent allergic rhinitis and symptomatic (nasal symptoms score [0-12] ≥ 6 were allocated in a double-blind, randomized fashion to receive dexchlorpheniramine plus betamethasone (n = 105; three daily doses or desloratadine plus prednisolone (n = 105; single dose followed by two of placebo for 7 days. At the beginning and end of the evaluation, the following were obtained: nasal symptoms score, extra nasal symptoms score, peak nasal inspiratory flow, blood biochemistry, and electrocardiogram. Ninety-six children of the dexchlorpheniramine plus betamethasone group and 98 of the desloratadine plus prednisolone group completed the protocol. Results: The two groups were similar regarding initial and final nasal symptoms scores, extra nasal symptoms scores and peak nasal inspiratory flow. A drop of 76.4% and 79.1% for nasal symptoms score, 86.0% and 79.2% for extra nasal symptoms score, as well as an increase of 25.2% and 24.3% for peak nasal inspiratory flow occurred for those treated with desloratadine plus prednisolone and dexchlorpheniramine plus betamethasone, respectively. There were no significant changes in blood chemistry. Sinus tachycardia was the most frequent electrocardiogram change, but with no clinical significance. Drowsiness was reported significantly more often among those of dexchlorpheniramine plus betamethasone group (17.14% × 8.57%, respectively. Conclusion: The desloratadine plus prednisolone combination was able to effectively control acute symptoms of rhinitis in children, improving symptoms and nasal function. Compared to the

  2. Nutraceutical Effects on Glucose and Lipid Metabolism in Patients with Impaired Fasting Glucose: A Pilot, Double-Blind, Placebo-Controlled, Randomized Clinical Trial on a Combined Product.

    Science.gov (United States)

    Cicero, Arrigo Francesco Giuseppe; Fogacci, Federica; Morbini, Martino; Colletti, Alessandro; Bove, Marilisa; Veronesi, Maddalena; Giovannini, Marina; Borghi, Claudio

    2017-09-01

    A number of natural compounds have individually demonstrated to improve glucose and lipid levels in humans. To  evaluate the short-term glucose and lipid-lowering activity in subjects with impaired fasting glucose. To assess the effects of a combination of nutraceuticals based on Lagerstroemia speciosa, Berberis aristata, Curcuma longa, Alpha-lipoic acid, Chrome picolinate and Folic acid, we performed a double-blind, parallel group, placebo-controlled, randomized clinical trial in 40 adults affected by impaired fasting glucose (FPG = 100-125 mg/dL) in primary prevention of cardiovascular disease. After a period of 2 weeks of dietary habits correction only, patients continued the diet and began a period of 8 weeks of treatment with nutraceutical or placebo. Data related to lipid pattern, insulin resistance, liver function and hsCRP were obtained at the baseline and at the end of the study. No side effects were detected in both groups of subjects. After the nutraceutical treatment, and compared to the placebo-treated group, the enrolled patients experienced a significant improvement in TG (-34.7%), HDL-C (+13.7), FPI (-13.4%), and HOMA-Index (-25%) versus the baseline values. No significant changes were observed in the other investigated parameters in both groups (Body Mass Index, LDL-C, hsCRP). The tested combination of nutraceuticals showed clinical efficacy in the improvement of TG, HDL-C, FPI and HOMA-Index, with an optimal tolerability profile. Further confirmation is needed to verify these observations on the middle and long term with a larger number of subjects.

  3. A new method for treating fecal incontinence by implanting stem cells derived from human adipose tissue: preliminary findings of a randomized double-blind clinical trial.

    Science.gov (United States)

    Sarveazad, Arash; Newstead, Graham L; Mirzaei, Rezvan; Joghataei, Mohammad Taghi; Bakhtiari, Mehrdad; Babahajian, Asrin; Mahjoubi, Bahar

    2017-02-21

    Anal sphincter defects are a major cause of fecal incontinence causing negative effects on daily life, social interactions, and mental health. Because human adipose-derived stromal/stem cells (hADSCs) are easier and safer to access, secrete high levels of growth factor, and have the potential to differentiate into muscle cells, we investigated the ability of hADSCs to improve anal sphincter incontinence. The present randomized double-blind clinical trial was performed on patients with sphincter defects. They were categorized into a cell group (n = 9) and a control group (n = 9). Either 6 × 10 6 hADSCs per 3 ml suspended in phosphate buffer saline (treatment) or 3 ml phosphate buffer saline (placebo) was injected. Two months after surgery, the Wexner score, endorectal sonography, and electromyography (EMG) results were recorded. Comparing Wexner scores in the cell group and the control group showed no significant difference. In our EMG and endorectal sonography analysis using ImageJ/Fiji 1.46 software, the ratio of the area occupied by the muscle to total area of the lesion showed a 7.91% increase in the cell group compared with the control group. The results of the current study show that injection of hADSCs during repair surgery for fecal incontinence may cause replacement of fibrous tissue, which acts as a mechanical support to muscle tissue with contractile function. This is a key point in treatment of fecal incontinence especially in the long term and may be a major step forward. Iranian Registry of Clinical Trials IRCT2016022826316N2 . Retrospectively registered 7 May 2016.

  4. Influence of vitamin D status and vitamin D3 supplementation on genome wide expression of white blood cells: a randomized double-blind clinical trial.

    Directory of Open Access Journals (Sweden)

    Arash Hossein-nezhad

    Full Text Available Although there have been numerous observations of vitamin D deficiency and its links to chronic diseases, no studies have reported on how vitamin D status and vitamin D3 supplementation affects broad gene expression in humans. The objective of this study was to determine the effect of vitamin D status and subsequent vitamin D supplementation on broad gene expression in healthy adults. (Trial registration: ClinicalTrials.gov NCT01696409.A randomized, double-blind, single center pilot trial was conducted for comparing vitamin D supplementation with either 400 IUs (n = 3 or 2000 IUs (n = 5 vitamin D3 daily for 2 months on broad gene expression in the white blood cells collected from 8 healthy adults in the winter. Microarrays of the 16 buffy coats from eight subjects passed the quality control filters and normalized with the RMA method. Vitamin D3 supplementation that improved serum 25-hydroxyvitamin D concentrations was associated with at least a 1.5 fold alteration in the expression of 291 genes. There was a significant difference in the expression of 66 genes between subjects at baseline with vitamin D deficiency (25(OHD20 ng/ml. After vitamin D3 supplementation gene expression of these 66 genes was similar for both groups. Seventeen vitamin D-regulated genes with new candidate vitamin D response elements including TRIM27, CD83, COPB2, YRNA and CETN3 which have been shown to be important for transcriptional regulation, immune function, response to stress and DNA repair were identified.Our data suggest that any improvement in vitamin D status will significantly affect expression of genes that have a wide variety of biologic functions of more than 160 pathways linked to cancer, autoimmune disorders and cardiovascular disease with have been associated with vitamin D deficiency. This study reveals for the first time molecular finger prints that help explain the nonskeletal health benefits of vitamin D.ClinicalTrials.gov NCT01696409.

  5. Porous silicon nitride spacers versus PEEK cages for anterior cervical discectomy and fusion: clinical and radiological results of a single-blinded randomized controlled trial.

    Science.gov (United States)

    Arts, Mark P; Wolfs, Jasper F C; Corbin, Terry P

    2017-04-05

    Anterior cervical discectomy with fusion is a common procedure for treating radicular arm pain. Polyetheretherketone (PEEK) plastic is a frequently used material in cages for interbody fusion. Silicon nitride is a new alternative with desirable bone compatibility and imaging characteristics. The aim of the present study is to compare silicon nitride implants with PEEK cages filled with autograft harvested from osteophytes. The study is a prospective, randomized, blinded study of 100 patients with 2 years follow-up. The primary outcome measure was improvement in the Neck Disability Index. Other outcome measures included SF-36, VAS arm pain, VAS neck pain, assessment of recovery, operative characteristics, complications, fusion and subsidence based on dynamic X-ray and CT scan. There was no significant difference in NDI scores between the groups at 24 months follow-up. At 3 and 12 months the NDI scores were in favor of PEEK although the differences were not clinically relevant. On most follow-up moments there was no difference in VAS neck and VAS arm between both groups, and there was no statistically significant difference in patients' perceived recovery during follow-up. Fusion rate and subsidence were similar for the two study arms and about 90% of the implants were fused at 24 months. Patients treated with silicon nitride and PEEK reported similar recovery rates during follow-up. There was no significant difference in clinical outcome at 24 months. Fusion rates improved over time and are comparable between both groups.

  6. Efficacy of Healing meditation in reducing anxiety of individuals at the phase of weight loss maintenance: A randomized blinded clinical trial.

    Science.gov (United States)

    Sampaio, Cynthia Vieira Sanches; Lima, Manuela Garcia; Ladeia, Ana Marice

    2016-12-01

    To verify the efficacy of Healing Meditation in reducing anxiety levels in individuals on a weight loss maintenance program. A randomized, controlled, evaluator-blinded clinical trial, conducted between January and October 2014, with a follow-up of 12 weeks. A weight loss secondary care facility in Salvador, Brazil., of 41 patients at the weight maintenance phase (Mean initial BMI 33.6±4.7kg/m 2 , who had attained a mean BMI of 24.5±1.6kg/m 2 in a median period of 7 months). An 8-week Healing Meditation program (n=20), consisting of a 1h weekly meeting, or for a control group on the waiting list (n=21), in addition to the standard clinical program. Total anxiety was measured by the Hamilton Anxiety Scale (HAM-A), before and after the intervention. Secondary analyses included comparison of the effect of meditation on the somatic and psychic components of the scale. Through an intention to treat analysis, we detected a difference in the mean variation between the intervention and control groups in the total anxiety scores of 7.7 (95% CI 6.3-9.2; Cohen's d=3.41). Means and standard deviations for pre and post intervention anxiety scores were 15.5 (3.4) and 7.8 (2.0) for the intervention group and 14.8 (3.4) and 14.9 (3.4) for the control. Healing meditation significantly reduced the anxiety of obese individuals, in the phase of weight maintenance, suggesting this to be an effective auxiliary resource for weight loss maintenance. Copyright © 2016 Elsevier Ltd. All rights reserved.

  7. Active tactile sensibility of single-tooth implants versus natural dentition: a split-mouth double-blind randomized clinical trial.

    Science.gov (United States)

    Kazemi, Mahmoud; Geramipanah, Farideh; Negahdari, Ramin; Rakhshan, Vahid

    2014-12-01

    Unlike passive sensitivity of implants/teeth that is assessed more, only three controversial studies have compared active tactile sensibility (ATS) of implants and teeth. We aimed to explore the difference between the ATS of teeth and single-tooth implants. The ATS of single-tooth implants and contralateral teeth was measured in 25 patients after they bit on gold and placebo foils 0- to 70-μm thick, each for five times, in a random order blinded to patients and assessor, carried out at two sessions. Based on the experimental range of 0 μm (mock trials) to 70 μm, the sigmoid shape of psychometric curve was estimated to locate the 50% values as the ATS thresholds for each tooth or implant. ATS Data were analyzed using paired and unpaired t-tests and multiple linear regression (α = 0.05, β ≤ 0.1). Also, equivalence testing approach was used to assess semi-objectively the clinical significance. Average ATS values for teeth and implants were 21.4 ± 6.55 μm and 30.0 ± 7.55 μm, respectively (p = .0001 [paired t-test]). None of the geometric characteristics of implants nor duration of implant in function were correlated with the ATS (p > .4 [regression]). Age was positively associated with the ATS of both implants and teeth (p ≤ .019 [regression]). Tooth ATS (but not implant ATS) was significantly higher in males compared with females (p = .050 [unpaired t-test]), which contributed to a generalizable tooth-implant difference higher than 8-μm clinical equivalence margin in females. The ATS was not significantly different between arches or between anterior/posterior regions (p > .6). There was a slight but statistically significant difference between implant and tooth tactile sensitivities. © 2013 Wiley Periodicals, Inc.

  8. Long-wave infrared radiation reflected by compression stockings in the treatment of cellulite: a clinical double-blind, randomized and controlled study.

    Science.gov (United States)

    Bagatin, E; Miot, H A; Soares, J L M; Sanudo, A; Afonso, J P J M; de Barros Junior, N; Talarico, S

    2013-10-01

    Cellulite refers to changes in skin relief on the thighs and buttocks of women, with a prevalence of 80-90%, causing dissatisfaction and search for treatment. Etiopathogenesis is multifactorial, as follows: herniation of the hypodermis towards the dermis, facilitated by perpendicular fibrous septa, changes in the dermal extracellular matrix, decreased adiponectin, genetic polymorphism, microcirculation alterations and inflammatory process. There are numerous therapeutic approaches, with little evidence of effectiveness. The long-wave infrared (LWIR) radiation interacts with water, improves microcirculation and stimulates metabolic processes. To date, the use of tissues with potential reflection of LWIR radiation has not been systematically investigated as adjuvant treatment for cellulite. To investigate the efficacy and safety of the treatment of cellulite through the use of compression stockings made with thread reflecting LWIR radiation. Clinical study of therapeutic intervention, controlled and double-blind, including 30 women, aging from 25 to 40 years, with cellulite of grades II and III on the thighs and buttocks who used compression stockings, "pantyhose" model, made with reflector thread of LWIR radiation, on only one randomized side. Women under other treatments for cellulite and with venous and/or blood insufficiencies were excluded. Evaluation of efficacy by clinical parameters, photographs, Dermatology Life Quality Index (DLQI), cutometry and high frequency ultrasonography and security by observation of adverse events and venous EcoDoppler recordings. DLQI scores showed significant reduction; the two-dimensional high-frequency ultrasonography showed an insignificant increase in dermal echogenicity as well as other efficacy parameters demonstrated no or slight improvement, with no differences between the sides exposed or not to LWIR; and there were no severe adverse events. Compression stockings, with or without thread reflector of LWIR, showed slight

  9. Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia.

    Science.gov (United States)

    Ascher-Svanum, Haya; Zhao, Fangyi; Detke, Holland C; Nyhuis, Allen W; Lawson, Anthony H; Stauffer, Virginia L; Montgomery, William; Witte, Michael M; McDonnell, David P

    2011-09-23

    In patients with schizophrenia, early non-response to oral antipsychotic therapy robustly predicts subsequent non-response to continued treatment with the same medication. This study assessed whether early response predicted later response when using a long-acting injection (LAI) antipsychotic. Data were taken from an 8-week, randomized, double-blind, placebo-controlled study of olanzapine LAI in acutely ill patients with schizophrenia (n = 233). Early response was defined as ≥ 30% improvement from baseline to Week 4 in Positive and Negative Syndrome Scale (PANSS0-6) Total score. Subsequent response was defined as ≥ 40% baseline-to-endpoint improvement in PANSS0-6 Total score. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and predictive accuracy were calculated. Clinical and functional outcomes were compared between Early Responders and Early Non-responders. Early response/non-response to olanzapine LAI predicted later response/non-response with high sensitivity (85%), specificity (72%), PPV (78%), NPV (80%), and overall accuracy (79%). Compared to Early Non-responders, Early Responders had significantly greater improvement in PANSS0-6 Total scores at all time points and greater baseline-to-endpoint improvement in PANSS subscale scores, Quality of Life Scale scores, and Short Form-36 Health Survey scores (all p ≤ .01). Among Early Non-responders, 20% demonstrated response by Week 8. Patients who lacked early improvement (at Week 4) in Negative Symptoms and Disorganized Thoughts were more likely to continue being non-responders at Week 8. Among acutely ill patients with schizophrenia, early response predicted subsequent response to olanzapine LAI. Early Responders experienced significantly better clinical and functional outcomes than Early Non-responders. Findings are consistent with previous research on oral antipsychotics. F1D-MC-HGJZ: Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of

  10. Adjunctive moxifloxacin in the treatment of generalized aggressive periodontitis patients: clinical and microbiological results of a randomized, triple-blind and placebo-controlled clinical trial.

    Science.gov (United States)

    Ardila, Carlos Martín; Martelo-Cadavid, Juan Felipe; Boderth-Acosta, Gina; Ariza-Garcés, Astrid Adriana; Guzmán, Isabel C

    2015-02-01

    The aim of the present study was to evaluate the clinical and microbiological efficacy of moxifloxacin (MOX) in one-stage scaling and root planing (SRP) in treating generalized aggressive periodontitis (GAgP). Forty subjects were randomly allocated to two treatment groups. The two treatment groups consisted of SRP combined with systemically administered MOX at the dosage of 400 mg once daily for 7 days or SRP + placebo once daily for 7 days. Subgingival plaque samples were analysed for cultivable bacteria. Both groups resulted in significant reduction of probing depth (PD) and clinical attachment level (CAL) compared with baseline (p < 0.0001), and this difference was maintained at 6 months from baseline in both groups. However, subjects receiving MOX showed the greatest improvements CAL, and PD. Subjects in both groups at 6 months displayed the greatest reduction from baseline in frequency of sites with PD ≥ 6 mm (p < 0.001), favouring the MOX group. Adjunctive antibiotic protocol reduced subgingival Aggregatibacter actinomycetemcomitans to undetectable levels, after 3 and 6 months, and there was a significant reduction in the levels of Porphyromonas gingivalis and Tannerella forsythia in the MOX group compared to the placebo group. The results from this study suggest that moxifloxacin as and adjunct to one-stage full-mouth SRP leads to a better clinical and microbiological advantages compared to mechanical treatment. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  11. Clinical benefit of midodrine hydrochloride in symptomatic orthostatic hypotension: a phase 4, double-blind, placebo-controlled, randomized, tilt-table study

    OpenAIRE

    Smith, William; Wan, Hong; Much, David; Robinson, Antoine G.; Martin, Patrick

    2016-01-01

    Objective Midodrine hydrochloride is a short-acting pressor agent that raises blood pressure in the upright position in patients with orthostatic hypotension. The US Food and Drug Administration?s Subpart H approval, under which midodrine was initially approved, requires post-marketing studies to confirm midodrine?s clinical benefit in this indication. The purpose of this study was to evaluate the clinical benefit of midodrine with regard to symptom response. Methods This was a double-blind, ...

  12. Effect of indacaterol on lung deflation improves cardiac performance in hyperinflated COPD patients: an interventional, randomized, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Santus P

    2015-09-01

    Full Text Available Pierachille Santus,1,2 Dejan Radovanovic,1,2 Silvia Di Marco,3 Vincenzo Valenti,4,5 Rita Raccanelli,1,2 Francesco Blasi,6,7 Stefano Centanni,8,9 Maurizio Bussotti31Department of Health Sciences, University of Milan, 2Pulmonary Rehabilitation Unit, Fondazione Salvatore Maugeri Scientific Institute of Milan-IRCCS, 3Cardiological Rehabilitation Unit, Fondazione Salvatore Maugeri Rehabilitation Institute of Milan-IRCCS, 4Department of Biomedical Sciences for Health, University of Milan, 5Respiratory Unit, Policlinico San Donato-IRCCS, San Donato Milanese, 6Department of Pathophysiology and Transplantation, University of Milan, 7IRCCS Fondazione Ospedale Maggiore Policlinico Cà Granda Milan, 8Department of Health Sciences, University of Milan, 9Respiratory Unit, Ospedale San Paolo, Milan, ItalyBackground: COPD is often associated with cardiovascular comorbidity. Treatment guidelines recommend therapy with bronchodilators as first choice. We investigated the acute effect of single-dose indacaterol on lung hyperinflation in COPD subjects, for the first time evaluating the potential effects on right heart performance.Methods: In this Phase IV, randomized, interventional, double-blind, crossover clinical study, we recruited 40 patients (50–85 years of age with stable COPD. Patients were treated with 150 µg indacaterol or placebo and after 60 minutes (T60 and 180 minutes (T180 the following tests were performed: trans-thoracic echocardiography (TTE, plethysmography, diffusing capacity of the lung for carbon monoxide, saturation of peripheral oxygen, and visual analog scale dyspnea score. Patients underwent a crossover re-challenge after a further 72 hours of pharmacological washout. All TTE measurements were conducted blindly by the same operator and further interpreted by two different blinded operators. Consensus decisions were taken on every value and parameter. The primary outcome was the effect of the reduction of residual volume and functional

  13. Effectiveness evaluation of two volumizing hyaluronic acid dermal fillers in a controlled, randomized, double-blind, split-face clinical study

    Directory of Open Access Journals (Sweden)

    Kerscher M

    2017-06-01

    Full Text Available Martina Kerscher,1 Karla Agsten,2 Maria Kravtsov,3 Welf Prager4 1Department of Cosmetic Science, University of Hamburg, 2SCIderm GmbH, Hamburg, Germany; 3Anteis S.A., Geneva, Switzerland; 4Prager & Partner Dermatologische Praxis, Hamburg, Germany Background: Enhancement of the midface can be achieved with volumizing hyaluronic acid (HA fillers.Objective: The objective of this study was to compare the safety and effectiveness of Cohesive Polydensified Matrix® 26 mg/mL HA gel (CPM-26 and Vycross® 20 mg/ml HA gel (VYC-20 in a controlled, randomized, evaluator-blind, split-face clinical study.Patients and methods: Subjects with moderate-to-severe malar volume loss on the Merz Aesthetics Scale (MAS received CPM-26 on one side and VYC-20 on the contralateral side of the face. Effectiveness assessments were performed by blinded evaluators including photographic and live MAS ratings and live Global Aesthetic Improvement Scale (GAIS ratings. Calculations of anatomical volume variations at month 3 (M3, month 6 (M6, month 12 (M12 and month 18 (M18 were also performed.Results: Non-inferiority of CPM-26 versus VYC-20 was demonstrated at M3 (primary end point based on MAS. GAIS rating showed that significantly more subjects had better improvement with CPM-26 than with VYC-20 at month 1, M3, M12 and M18 (p=0.0032, p=0.0074, p=0.0384 and p=0.0110, respectively. Standardized evaluation of volume variations from baseline to M3, M12 and M18 showed that CPM-26 created more volume augmentation at all time points, and the difference was significant at M3.Conclusion: CPM-26 was non-inferior to VYC-20 based on MAS ratings at M3 and demonstrated a favorable safety and effectiveness profile for midfacial volume enhancement with results lasting up to M18. Keywords: cohesive polydensified matrix, hyaluronic acid fillers, Belotero® Volume, Modélis® SHAPE, Juvéderm® VOLUMA®, volumizing

  14. The Impact of Methylphenidate on Motor Performance in Children with both Attention Deficit Hyperactivity Disorder and Developmental Coordination Disorder: A Randomized Double-Blind Crossover Clinical Trial

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    Robabeh Soleimani

    2017-07-01

    Full Text Available Background: Children with attention deficit hyperactivity disorder/developmental coordination disorder (ADHD/DCD suffer from problems associated with gross and fine motor skills. There is no effective pharmacological therapy for such patients. We aimed to assess the impact of methylphenidate (MPH on motor performance of children with ADHD/DCD. Methods: In this double-blind placebo-controlled, 17 children (12 boys with ADHD/DCD with a mean age of 7 years 6 months were recruited in Shafa Hospital, Rasht, Iran. The response was defined as ≥25% reduction in the total score of ADHD rating scale-IV from the baseline. Sixteen boys entered phase 2 of the study in which the impact of MPH on motor function was determined through a crossover randomized clinical trial. Eligible individuals were scheduled for baseline and two assessment visits after a one-week period of intervention. We used the short form of Bruininks-Oseretsky test (BOT-2 to identify the disability of motor function. Children were randomly assigned to receive MPH or inert ingredients (placebo. In the second period, medication (MPH/placebo was crossed over. The effects of MPH were analyzed using χ2 test for related samples to compare the performance during baseline, placebo, and MPH trials. The results were analyzed using the SPSS software version 16.0. Results: The mean minimal effective dose of MPH per day was 17.3 mg (0.85 mg/kg. Children with higher ADHD rating scale had a significantly lower standard score in BOT-2 (P=0.03. Following MPH intake, 26.6% of the children showed clinically significant improvement in motor function. However, the improvement was not statistically different between the MPH and placebo. Conclusion: Although MPH improved ADHD symptoms, problems with motor performance still remained. Further work is required to determine the probable effects of MPH in a higher dosage or in different subtypes of ADHD. Trial Registration Number: IRCT201107071483N2

  15. Neurocognitive therapeutic exercise improves pain and function in patients with shoulder impingement syndrome: a single-blind randomized controlled clinical trial.

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    Marzetti, E; Rabini, A; Piccinini, G; Piazzini, D B; Vulpiani, M C; Vetrano, M; Specchia, A; Ferriero, G; Bertolini, C; Saraceni, V M

    2014-06-01

    Traditional rehabilitation improves pain and function in patients with shoulder impingement syndrome. Neurocognitive rehabilitation has shown to be highly effective after surgical reconstruction of the anterior cruciate ligament. However, its effects in patients with shoulder impingement syndrome have not yet been established. The aim of the study was to compare the effects of neurocognitive therapeutic exercise, based on proprioception and neuromuscular control, on pain and function in comparison to traditional therapeutic exercise in patients with shoulder impingement syndrome. Single-blind randomized, non-inferiority clinical trial. Outpatient clinic of Geriatrics and Physiatrics, University Hospital. Forty-eight patients with shoulder impingement syndrome (Neer stage I) and pain lasting for at least three months. Participants were randomly allocated (1:1) to either neurocognitive therapeutic exercise or traditional therapeutic exercise. Both treatments were provided one-hour session, three times a week for five weeks. The primary outcome measure was the short form of the Disability of the Arm, Shoulder and Hand Questionnaire (Quick-DASH questionnaire) for the assessment of physical ability and symptoms of the upper extremity. Constant-Murley shoulder outcome score for the determination of range of motion, pain and strength; American Shoulder and Elbow Surgeons Society standardized shoulder assessment form for the evaluation of physical ability in daily-living tasks; a visual analogue scale for pain assessment at rest and during movements; Likert score for the estimation of participant satisfaction. before treatment, end of treatment, 12 and 24 weeks after the completion of each intervention for all outcome measures, except for the Likert score that was evaluated only at the end of treatment. 24 weeks. At the end of treatment and at follow-up, both treatment groups experienced improvements in all outcomes measures relative to baseline values, except for the

  16. A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor

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    Yokoyama Sayaka

    2008-12-01

    Full Text Available Abstract Background Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2, however, its clinical efficacies on oral malodor have been evaluated only with organoleptic measurements (OM or sulphide monitors. No clinical studies have investigated the inhibitory effects of ClO2 on volatile sulfur compounds (VSCs using gas chromatography (GC. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor using OM and GC. Methods A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups. In the first test phase, the group 1 subjects (N = 8 were instructed to rinse with the experimental mouthwash containing ClO2, and those in group 2 (N = 7 to rinse with the placebo mouthwash without ClO2. In the second test, phase after a one week washout period, each group used the opposite mouthwash. Oral malodor was evaluated before rinsing, right after rinsing and every 30 minutes up to 4 hours with OM, and concentrations of hydrogen sulfide (H2S, methyl mercaptan (CH3SH and dimethyl sulfide ((CH32S, the main VSCs of human oral malodor, were evaluated with GC. Results The baseline oral condition in the subjects in the 2 groups did not differ significantly. The mouthwash containing ClO2 improved morning bad breath according to OM and reduced concentrations of H2S, CH3SH and (CH32S according to GC up to 4 hours after rinsing. OM scores with ClO2 were significantly lower than those without ClO2 at all examination times. Significant reductions in the concentrations of the three kinds of VSCs measured by GC were also evident at all examination times. The concentrations of the three gases with ClO2 were significantly lower than those without ClO2 at most examination times. Conclusion In this explorative study, ClO2 mouthwash was effective at reducing morning malodor for 4

  17. An experimental study and a randomized, double-blind, placebo-controlled clinical trial to evaluate the antisecretory activity of Lactobacillus acidophilus strain LB against nonrotavirus diarrhea.

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    Liévin-Le Moal, Vanessa; Sarrazin-Davila, Luis E; Servin, Alain L

    2007-10-01

    Previous studies have shown that selected strains of Lactobacillus have the capacity to antagonize rotavirus-induced diarrhea. However, only a few reports have documented their efficacy against nonrotavirus diarrhea. This study involved an experimental investigation and a clinical trial of the antisecretory activity of Lactobacillus acidophilus strain LB in the context of nonrotavirus diarrhea. The activity of a culture of L. acidophilus LB or of the lyophilized, heat-killed L. acidophilus LB bacteria plus their spent culture medium was tested in inhibiting the formation of fluid-formed domes in cultured human intestinal Caco-2/TC7 cell monolayers infected with diarrheagenic, diffusely adhering Afa/Dr Escherichia coli C1845 bacteria. A randomized, double-blind, placebo-controlled clinical trial of male or female children who were 10 months of age and presented with nonrotavirus, well-established diarrhea was conducted to evaluate the therapeutic efficacy of a pharmaceutical preparation that contains 10 billion heat-killed L. acidophilus LB plus 160 mg of spent culture medium. Infection of the cells with C1845 bacteria that were treated with L. acidophilus LB culture or the lyophilized, heat-killed L. acidophilus LB bacteria plus their culture medium produced a dosage-dependent decrease in the number of fluid-formed domes as compared with cells that were infected with untreated C1845 bacteria. The clinical results show that in selected and controlled homogeneous groups of children with well-established, nonrotavirus diarrhea, adding lyophilized, heat-killed L. acidophilus LB bacteria plus their culture medium to a solution of oral rehydration solution shortened by 1 day the recovery time (ie, the time until the first normal stool was passed) as compared with children who received placebo oral rehydration solution. Heat-killed L. acidophilus LB plus its culture medium antagonizes the C1845-induced increase in paracellular permeability in intestinal Caco-2/TC7 cells

  18. Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial

    Science.gov (United States)

    2013-01-01

    Background Lactose intolerance (LI) is a common medical problem with limited treatment options. The primary symptoms are abdominal pain, diarrhea, bloating, flatulence, and cramping. Limiting dairy foods to reduce symptoms contributes to low calcium intake and the risk for chronic disease. Adaptation of the colon bacteria to effectively metabolize lactose is a novel and potentially useful approach to improve lactose digestion and tolerance. RP-G28 is novel galacto-oligosaccharide (GOS) being investigated to improve lactose digestion and the symptoms of lactose intolerance in affected patients. Methods A randomized, double-blind, parallel group, placebo-controlled study was conducted at 2 sites in the United States. RP-G28 or placebo was administered to 85 patients with LI for 35 days. Post-treatment, subjects reintroduced dairy into their daily diets and were followed for 30 additional days to evaluate lactose digestion as measured by hydrogen production and symptom improvements via a patient-reported symptom assessment instrument. Results Lactose digestion and symptoms of LI trended toward improvement on RP-G28 at the end of treatment and 30 days post-treatment. A reduction in abdominal pain was also demonstrated in the study results. Fifty percent of RP-G28 subjects with abdominal pain at baseline reported no abdominal pain at the end of treatment and 30 days post treatment (p = 0.0190). RP-G28 subjects were also six times more likely to claim lactose tolerance post-treatment once dairy foods had been re-introduced into their diets (p = 0.0389). Conclusions Efficacy trends and favorable safety/tolerability findings suggest that RP-G28 appears to be a potentially useful approach for improving lactose digestion and LI symptoms. The concurrent reduction in abdominal pain and improved overall tolerance could be a meaningful benefit to lactose intolerant individuals. Study registration ClinicalTrials.gov NCT01113619. PMID:24330605

  19. Effect of a traditional syrup from Citrus medica L. fruit juice on migraine headache: A randomized double blind placebo controlled clinical trial.

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    Jafarpour, Mehrnaz; Yousefi, Gholamhossein; Hamedi, Azadeh; Shariat, Abdolhamid; Salehi, Alireza; Heydari, Mojtaba

    2016-02-17

    In Persian ethnomedicine several herbal remedies and functional foods have been used to treat migraine headache which are mostly summarized in Qarabadin-e-kabir (Aghili-Shirazi MH, 1773). One of them is Citron syrup (Sharbat-e-Balang) containing edible Citrus medica L. fruit juice and sugar. The present study was designed to assess the efficacy and safety of Citron syrup on patients with migraine headache. Citron syrup was prepared as described in Qarabadin-e-kabir. In this double blind randomized placebo-controlled clinical trial, ninety patients with migraine headache were allocated to three parallel groups (Citron syrup, propranolol or placebo). Patients received 15ml of Citron syrup, placebo syrup or 20mg of propranolol tablet three times daily after a meal for 4 weeks. Primary outcomes were obtained from three measures: the frequency (per month), mean duration (hour) and mean intensity (visual analogue scale "VAS" 0-10 score) of headache attacks evaluated prior to and following 4 weeks of the intervention. Citron syrup was superior to placebo in reduction of headache attacks intensity (P0.05). However, unlike propranolol, Citron syrup could not significantly reduce the frequency of attacks compared to placebo. No indication of any serious side effects from Citron syrup was observed. According to obtained results, Citron syrup as a traditional Persian remedy can be suggested as an effective treatment for decreasing pain intensity and duration of attacks in migraine headache and the effectiveness is comparable to propranolol. However, the syrup did not show significant effect on frequency of attacks. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  20. Comparison of ischemic compression and lumbopelvic manipulation as trigger point therapy for patellofemoral pain syndrome in young adults: A double-blind randomized clinical trial.

    Science.gov (United States)

    Behrangrad, Shabnam; Kamali, Fahimeh

    2017-07-01

    To compare the effectiveness of ischemic compression (IC) directly to the vastus medialis obliquus (VMO) versus lumbopelvic manipulation (LPM) in improving pain, functional status and sensitivity to mechanical stimulation of the VMO trigger point in patients with patellofemoral pain syndrome (PFPS). 40 patients with unilateral PFPS aged 20-30 years were selected randomly among patients with unilateral PFPS referred to physical therapy clinics of Shiraz University of Medical Sciences in Shiraz, Iran, between March 2014 and July 2014. 30 young adults participated. Participants were blinded to treatment allocation, and 15 patients were allocated to either IC or LPM. Patients in both groups were treated in three sessions per week. IC consisted of three sets of continuous pressure applied for on the myofascial trigger point (MTrP) of VMO. LPM consisted of supine rotational glide manipulation of the ipsilateral lumbopelvic region of the involved knee. Numeric pain rating scale (VAS) for pain intensity, Kujala questionnaire for functional status, and pressure pain threshold (PPT) for sensitivity to mechanical stimulation. All three were recorded before treatment, 1 week, 1 month and 3 months after the last session. Both groups showed significant improvement (p < 0.05, 95% confidence interval) in pain, functional status and PPT values. However, the IC group showed greater improvements, and outcome measures remained significantly better than in the LPM group during post-intervention follow-up. Both groups showed improvements throughout the study and follow-up period. However, the IC showed better short-term and long-term effectiveness than LPM for treating PFPS. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Efficacy of mefloquine intermittent preventive treatment in pregnancy against Schistosoma haematobium infection in Gabon: a nested randomized controlled assessor-blinded clinical trial.

    Science.gov (United States)

    Basra, Arti; Mombo-Ngoma, Ghyslain; Melser, Meskure Capan; Diop, Daisy Akerey; Würbel, Heike; Mackanga, Jean-Rodolphe; Fürstenau, Moritz; Zoleko, Rella Manego; Adegnika, Ayola A; Gonzalez, Raquel; Menendez, Clara; Kremsner, Peter G; Ramharter, Michael

    2013-03-01

    Urogenital schistosomiasis is a major public health problem in sub-Saharan Africa, and routine programs for screening and treatment of pregnant women are not established. Mefloquine-currently evaluated as a potential alternative to sulfadoxine-pyrimethamine as intermittent preventive treatment against malaria in pregnancy (IPTp)-is known to exhibit activity against Schistosoma haematobium. In this study we evaluated the efficacy of mefloquine IPTp against S. haematobium infection in pregnant women. Pregnant women with S. haematobium infection presenting at 2 antenatal health care centers in rural Gabon were invited to participate in this nested randomized controlled, assessor-blinded clinical trial comparing sulfadoxine-pyrimethamine with mefloquine IPTp. Study drugs were administered twice during pregnancy with a 1- month interval after completion of the first trimester. Sixty-five pregnant women were included in this study. Schistosoma haematobium egg excretion rates showed a median reduction of 98% (interquartile range [IQR], 70%-100%) in the mefloquine group compared to an increase of 20% (IQR, -186% to 75%) in the comparator group. More than 80% of patients showed at least 50% reduction of egg excretion and overall cure rate was 47% (IQR, 36%-70%) 6 weeks after the second administration of mefloquine IPTp. When used as IPTp for the prevention of malaria, mefloquine shows promising activity against concomitant S. haematobium infection leading to an important reduction of egg excretion in pregnant women. Provided that further studies confirm these findings, the use of mefloquine may transform future IPTp programs into a 2-pronged intervention addressing 2 of the most virulent parasitic infections in pregnant women in sub-Saharan Africa. NCT01132248; ATMR2010020001429343.

  2. Effect of Melatonin on the Outcome of Assisted Reproductive Technique Cycles in Women with Diminished Ovarian Reserve: A Double-Blinded Randomized Clinical Trial

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    Bahia Namavar Jahromi

    2017-01-01

    Full Text Available Diminished ovarian reserve (DOR significantly decreases the success rate of the assisted reproductive technique (ART. In this study, we assessed the effect of melatonin on the ART outcomes in women with DOR. A double-blinded, randomized, clinical trial was performed on 80 women with DOR as a pilot study in Shiraz, between 2014 and 2015. DOR was defined as the presence of 2 of the following 3 criteria: 1 anti-Müllerian hormone ≤1, 2 folliclestimulating hormone ≥10, and 3 bilateral antral follicle count ≤6. The women received 3 mg/d melatonin or a placebo since the fifth day of one cycle prior to gonadotropin stimulation and continued the treatment up to the time of ovum pickup. The ART outcomes were compared between the groups using SPSS software. Finally, there were 32 women in the case and 34 in the placebo groups. The mean age and basal ovarian reserve test were the same between the groups. The serum estradiol level on the triggering day was significantly higher in the case group (P=0.005. The mean number of MII oocytes was higher in the case group, but the difference did not reach statistical significance. Number of the patients who had mature MII oocytes (P=0.014, top-quality embryos with grade 1 (P=0.049, and embryos with grades 1 and 2 (P=0.014 was higher among the women who received melatonin. However, the other ART outcomes were not different between the groups. The serum estradiol level was higher and more women with DOR had good-quality oocytes and embryos after receiving melatonin; however, no other outcome was different between the case and control groups. Trial Registration Number: IRCT2014041417264N1

  3. Atomoxetine treatment of attention-deficit/hyperactivity disorder in young adults with assessment of functional outcomes: a randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Durell, Todd M; Adler, Lenard A; Williams, Dave W; Deldar, Ahmed; McGough, James J; Glaser, Paul E; Rubin, Richard L; Pigott, Teresa A; Sarkis, Elias H; Fox, Bethany K

    2013-02-01

    Attention-deficit/hyperactivity disorder (ADHD) is associated with significant impairment in multiple functional domains. This trial evaluated efficacy in ADHD symptoms and functional outcomes in young adults treated with atomoxetine. Young adults (18-30 years old) with ADHD were randomized to 12 weeks of double-blind treatment with atomoxetine (n = 220) or placebo (n = 225). The primary efficacy measure of ADHD symptom change was Conners' Adult ADHD Rating Scale (CAARS): Investigator-Rated: Screening Version Total ADHD Symptoms score with adult prompts. Secondary outcomes scales included the Adult ADHD Quality of Life-29, Clinical Global Impression-ADHD-Severity, Patient Global Impression-Improvement, CAARS Self-Report, Behavior Rating Inventory of Executive Function-Adult Version Self-Report, and assessments of depression, anxiety, sleepiness, driving behaviors, social adaptation, and substance use. Atomoxetine was superior to placebo on CAARS: Investigator-Rated: Screening Version (atomoxetine [least-squares mean ± SE, -13.6 ± 0.8] vs placebo [-9.3 ± 0.8], 95% confidence interval [-6.35 to -2.37], P ADHD-Severity (atomoxetine [-1.1 ± 0.1] vs placebo [-0.7 ± 0.1], 95% confidence interval [-0.63 to -0.24], P ADHD Quality of Life-29 and Behavior Rating Inventory of Executive Function-Adult Version Self-Report. Additional assessments failed to detect significant differences (P ≥ 0.05) between atomoxetine and placebo. The adverse event profile was similar to that observed in other atomoxetine studies. Nausea, decreased appetite, insomnia, dry mouth, irritability, dizziness, and dyspepsia were reported significantly more often with atomoxetine than with placebo. Atomoxetine reduced ADHD symptoms and improved quality of life and executive functioning deficits in young adults compared with placebo. Atomoxetine was also generally well tolerated.

  4. Efficacy and safety of honey based formulation of Nigella sativa seed oil in functional dyspepsia: A double blind randomized controlled clinical trial.

    Science.gov (United States)

    Mohtashami, Reza; Huseini, Hasan Fallah; Heydari, Mojtaba; Amini, Mohsen; Sadeqhi, Zainab; Ghaznavi, Habib; Mehrzadi, Saeed

    2015-12-04

    A honey based formulation from Nigella sativa L. (N. sativa) has been used in Traditional Persian Medicine for upper gastrointestinal symptoms. Considering the traditional use of this formulation and its ingredients known pharmacologic effects, this study aimed to evaluate the efficacy and safety of N. sativa seed oil mixed with honey in treatment of patients with functional dyspepsia. Seventy patients diagnosed with functional dyspepsia according to ROME III criteria and confirmed by upper gastrointestinal endoscopy were selected to receive a traditional honey based formulation of N. sativa (5 ml N. sativa oil orally daily) or placebo for 8 weeks in a double-blind randomized placebo-controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 8 weeks of the intervention in terms of the Hong Kong index of dyspepsia severity, presence of Helicobacter pylori infection based on urease test, scores in different domains of short form (SF-36) health survey, and any observed adverse events. The mean scores of Hong Kong index of dyspepsia severity sores and the rate of H. pylori infection were significantly lower in the N. sativa group comparing the placebo group after the intervention (P<0.001). No serious adverse event was reported. This study showed that adjuvant supplementation of honey based formulation of N. sativa can cause significant symptomatic improvement of patients with functional dyspepsia whom received the standard anti-secretory therapy. The results should be investigated further in studies with longer duration and larger sample size. Published by Elsevier Ireland Ltd.

  5. Safety and efficacy of letibotulinumtoxinA(BOTULAX®) in treatment of post stroke upper limb spasticity: a randomized, double blind, multi-center, phase III clinical trial.

    Science.gov (United States)

    Do, Kyung Hee; Chun, Min Ho; Paik, Nam-Jong; Park, Yoon Ghil; Lee, Shi-Uk; Kim, Min-Wook; Kim, Don-Kyu

    2017-09-01

    To investigate a new botulinum neurotoxin type A, termed letibotulinumtoxinA(Botulax ® ) and compare its efficacy and safety for post-stroke upper limb spasticity with that of onabotulinumtoxinA(Botox ® ). A prospective, double-blinded, multicenter, randomized controlled clinical study. Six university hospitals in Korea. A total of 187 stroke participants with upper limb spasticity. Two kinds of botulinum neurotoxin type A were used. One set of injection was performed and total injected doses were 309.21±62.48U(Botulax) and 312.64±49.99U(Botox)( P>0.05). Primary outcome was measured using the modified Ashworth scale for wrist flexors at week 4 and secondary outcome was measured using modified Ashworth scale for wrist flexors, elbow flexors, finger flexors, and thumb flexors as well as Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale. Safety measures including adverse events, vital signs and physical examination, and laboratory tests were also monitored. The mean ages for the Botulax group were 56.81±9.49 and which for the Botox group were 56.93±11.93( P>0.05). In primary outcome, the change in modified Ashworth scale for wrist flexors was -1.45±0.61 in the Botulax group and -1.40±0.57 in the Botox group, and the difference between the two groups was -0.06(95% CI:-0.23-0.12, P>0.05). In secondary outcome, both groups demonstrated significant improvements with respect to modified Ashworth scale, Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale ( P0.05). In addition, safety measures showed no significant differences between the two groups ( P>0.05). The efficacy and safety of Botulax were comparable with those of Botox in treatment of post-stoke upper limb spasticity.

  6. The clinical anti-aging effects of topical kinetin and niacinamide in Asians: a randomized, double-blind, placebo-controlled, split-face comparative trial.

    Science.gov (United States)

    Chiu, Pin-Chi; Chan, Chih-Chieh; Lin, Hui-Min; Chiu, Hsien-Ching

    2007-12-01

    Kinetin and niacinamide are used in the cosmetic industry as anti-aging agents. Neither the interactive/additive effects of these compounds nor the anti-aging efficacy on Asian skin has been studied. Objective To assess the clinical anti-aging effects and efficacy differences between kinetin plus niacinamide and niacinamide alone vs. vehicle placebo in an Asian cohort. Fifty-two Taiwanese subjects were enrolled in a randomized, double-blind, placebo-controlled, split-face comparative study. Group 1 subjects were treated with kinetin 0.03% plus niacinamide 4%, whereas group 2 subjects received niacinamide 4%. The treatment formulation was applied on one side of the face, whereas a placebo was applied on the other for a period of 12 weeks. We used noninvasive biometrological instruments to evaluate a variety of skin parameters at baseline and at weeks 4, 8, and 12. Persistent and significant reductions in spot, pore, wrinkle, and evenness counts were found at weeks 8 and 12 in group 1. A significant increase in corneal hydration status was also evident at week 12, whereas persistent decreases in erythema index were apparent at 8 and 12 weeks. In group 2, significant reductions in pore and evenness counts at week 8 and wrinkle counts at week 12 were noted. We found kinetin and niacinamide exert a synergistic anti-aging effect. Our data suggest that these compounds have multiactive, multifunctional, and pluripotent effects on skin. They are also both promising to be included in the cutaneous anti-aging cosmeceuticals in the future.

  7. Mid-Face Volumization With Hyaluronic Acid: Injection Technique and Safety Aspects from a Controlled, Randomized, Double-Blind Clinical Study.

    Science.gov (United States)

    Prager, Welf; Agsten, Karla; Kravtsov, Maria; Kerscher, Prof Martina

    2017-04-01

    BACKGROUND: Injection of hyaluronic acid (HA) volumizing fillers in the malar area is intended for rejuvenation of the mid-face. The choice of products, depth, and technique of injection depends on the desired level of volume enhancement and practitioners' preferences. OBJECTIVE: To describe a volumizing injection technique in the scope of a controlled, randomized, double-blind, single-center, split-face clinical study. A total of 45 subjects with bilateral symmetrical moderate to severe volume loss in the malar area received a single 2 mL injection of CPM®-26 (Cohesive Polydensified Matrix®) on one side and VYC®-20 (VYCROSS®) on the contralateral side of the face. The same injection technique was applied for both sides of the face. Use of anesthetics, overcorrection, and touch-ups were not permitted. The investigator completed a product satisfaction questionnaire. Adverse events (AE) and injection-site reactions (ISRs) were reported during the study. RESULTS: The products were placed at the epiperiosteal depth in 88.9% (n=40), at the subdermal depth in 8.9% (n=4) and at both levels in 2.2% (n=1) of subjects. Fanning technique using cannulae was applied in most cases (97.8%, n=44). Results of the investigator satisfaction questionnaire allowed to characterize CPM-26 in comparison to other volumizing gels. Both study products were generally well tolerated. Local reactions were transient and of mild to moderate intensity, with the most frequent ones being redness, pain, and swelling. CONCLUSION: Adequate injection technique in volumizing treatments is essential to create a natural aesthetic rejuvenation while respecting the safety aspect of the procedures. A 22G blunt cannula used with CPM-26 was preferred due to an easier and a more homogeneous distribution of the product. The investigator also appreciated CPM-26 for its ease of injection, positioning, lifting, and volumizing capacity. J Drugs Dermatol. 2017;16(4):351-357..

  8. Intravenous acetaminophen is superior to ketamine for postoperative pain after abdominal hysterectomy: results of a prospective, randomized, double-blind, multicenter clinical trial

    Directory of Open Access Journals (Sweden)

    Faiz HR

    2014-01-01

    Full Text Available Hamid Reza Faiz,1 Poupak Rahimzadeh,1 Ognjen Visnjevac,2 Behzad Behzadi,1 Mohammad Reza Ghodraty,1 Nader D Nader2 1Iran University of Medical Sciences, Tehran, Iran; 2VA Western NY Healthcare System, University at Buffalo, Buffalo, NY, USA Background: In recent years, intravenously (IV administered acetaminophen has become one of the most common perioperative analgesics. Despite its now-routine use, IV acetaminophen's analgesic comparative efficacy has never been compared with that of ketamine, a decades-old analgesic familiar to obstetricians, gynecologists, and anesthesiologists alike. This double-blind clinical trial aimed to evaluate the analgesic effects of ketamine and IV acetaminophen on postoperative pain after abdominal hysterectomy. Methods: Eighty women aged 25–70 years old and meeting inclusion and exclusion criteria were randomly allocated into two groups of 40 to receive either IV acetaminophen or ketamine intraoperatively. Postoperatively, each patient had patient-controlled analgesia. Pain and sedation (Ramsay Sedation Scale were documented based on the visual analog scale in the recovery room and at 4 hours, 6 hours, 12 hours, and 24 hours after the surgery. Hemodynamic changes, adverse medication effects, and the need for breakthrough meperidine were also recorded for both groups. Data were analyzed by repeated-measures analysis of variance. Results: Visual analog scale scores were significantly lower in the IV acetaminophen group at each time point (P<0.05, and this group required significantly fewer doses of breakthrough analgesics compared with the ketamine group (P=0.039. The two groups had no significant differences in terms of adverse effects. Conclusion: Compared with ketamine, IV acetaminophen significantly improved postoperative pain after abdominal hysterectomy. Keywords: intravenous acetaminophen, abdominal hysterectomy, ketamine, analgesia, postoperative pain

  9. A Randomized, Controlled, Double-Blinded Clinical Trial of Gabapentin 300mg versus 900mg versus Placebo for Anxiety Symptoms in Breast Cancer Survivors

    Science.gov (United States)

    Lavigne, Jill E.; Mustian, Karen; Mathews, Jennifer L; Heckler, Charles; Palesh, Oxana; Amos, Eric; Morrow, Gary R

    2015-01-01

    BACKGROUND Gabapentin is used for the treatment of hot flashes and neuropathic pain in breast cancer survivors, and is commonly used off-label for the treatment of anxiety. Yet, clinical trial evidence to support the use of gabapentin for anxiety symptoms is lacking. METHODS In a randomized, double-blinded controlled trial we compared 300mg gabapentin versus 900mg gabapentin versus placebo. Subjects were 420 breast cancer patients who had completed all chemotherapy cycles. Anxiety traits and current (state) anxiety were measured using the Speilberger Strait-Trait Anxiety Inventory at baseline, 4 weeks and 8 weeks. Pain was measured at baseline using a 10-point scale. Analyses included analysis of covariance (ANCOVA) and ordinary least squares regression. RESULTS At 4 weeks, state anxiety change scores were significantly better for gabapentin 300mg and 900mg (p=0.005) compared to placebo. The magnitude of improvement was proportional to baseline state anxiety. At 8 weeks, the anxiolytic effects of gabapentin compared to placebo persisted (p cancer survivors presenting in primary care practices with anxiety symptoms. Gabapentin is effective for hot flashes, and therefore may provide therapeutic benefit for both anxiety and hot flashes at a generic drug price. For patients reluctant to take a controlled substance, such as a benzodiazepine, gabapentin may offer an alternative therapy. Similarly, patients with a history of substance use may benefit from gabapentin without risk of addiction or abuse. For cancer survivors experiencing both hot flashes and anxiety, gabapentin may provide a single effective treatment for both and is an alternative therapy for anxiety for patients unwilling to take a benzodiazepine or those with a history of substance use. PMID:23053645

  10. The effect of Ginkgo biloba on functional outcome of patients with acute ischemic stroke: a double-blind, placebo-controlled, randomized clinical trial.

    Science.gov (United States)

    Oskouei, Darioush Savadi; Rikhtegar, Reza; Hashemilar, Mazyar; Sadeghi-Bazargani, Homayoun; Sharifi-Bonab, Mohsen; Sadeghi-Hokmabadi, Elyar; Zarrintan, Sina; Sharifipour, Ehsan

    2013-11-01

    Acute ischemic stroke is a major cerebrovascular disease with potential morbidity and mortality. Despite the availability of thrombolytic therapy in some centers, risk factor modification and rehabilitation therapy are the mainstays of stroke management. There is supporting evidence that Ginkgo biloba may afford neuroprotection and improve the outcomes of patients with acute ischemic stroke. In a double-blind, placebo-controlled, randomized controlled trial, we assessed the efficacy of G biloba on functional outcome in patients with acute stroke. The National Institutes of Heath Stroke Scale (NIHSS) was used to measure functional outcome. A total of 102 patients with acute ischemic stroke were studied. All patients received either G biloba or placebo tablets for 4 months. This trial was registered to the Iranian Registry of Clinical Trials (www.irct.ir; trial IRCT138804212150N1). There were 52 patients who received G biloba and 50 patients who were in the placebo group. Age, sex distribution, previous medical condition, and laboratory data did not have any significant difference between the 2 groups (P>.05). The mean difference of 4-month follow-up NIHSS scores and NIHSS scores at admission was 4.7±2.7 and 4.1±3.0 in the G biloba and placebo groups, respectively (P>.05). The primary outcome-a 50% reduction in the 4-month follow-up NIHSS score compared to the baseline NIHSS score-was reached in 17 patients (58.6%) and 5 patients (18.5%) in the G biloba and placebo groups, respectively (Pbiloba group compared to the placebo group (Pbiloba may have protective effects in ischemic stroke. Therefore, the administration of G biloba is recommended after acute ischemic stroke. Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  11. Clinical Outcomes of Knee Osteoarthritis Treated With an Autologous Protein Solution Injection: A 1-Year Pilot Double-Blinded Randomized Controlled Trial.

    Science.gov (United States)

    Kon, Elizaveta; Engebretsen, Lars; Verdonk, Peter; Nehrer, Stefan; Filardo, Giuseppe

    2018-01-01

    Osteoarthritis (OA) is a debilitating disease resulting in substantial pain and functional limitations. A novel blood derivative has been developed to concentrate both growth factors and antagonists of inflammatory cytokines, with promising preliminary findings in terms of safety profile and clinical improvement. To investigate if one intra-articular injection of autologous protein solution (APS) can reduce pain and improve function in patients affected by knee OA in a multicenter, randomized, double-blind, saline-controlled study. Randomized controlled trial; Level of evidence, 2. Forty-six patients with unilateral knee OA (Kellgren-Lawrence 2 or 3) were randomized into the APS group (n = 31), which received a single ultrasound-guided injection of APS, and the saline (control) group (n = 15), which received a single saline injection. Patient-reported outcomes and adverse events were collected at 2 weeks and at 1, 3, 6, and 12 months through visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), Short Form-36 (SF-36), Clinical Global Impression of Severity/Change (CGI-S/C), Patient Global Impression of Severity/Change (PGI-S/C), and Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder rate. Imaging evaluation was also performed with radiograph and magnetic resonance imaging (MRI) before and after treatment (12 months and 3 and 12 months, respectively). The safety profile was positive, with no significant differences in frequency and severity of adverse events between groups. The improvement from baseline to 2 weeks and to 1, 3, and 6 months was similar between treatments. At 12 months, improvement in WOMAC pain score was 65% in the APS group and 41% in the saline group ( P = .02). There were no significant differences in VAS pain improvement between groups. At 12 months, APS group showed improved SF-36 Bodily Pain

  12. Efficacy and safety of Ginkgo biloba standardized extract in the treatment of vascular cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Demarin V

    2017-02-01

    Full Text Available Vida Demarin,1,2 Vanja Bašić Kes,1 Zlatko Trkanjec,1 Mislav Budišić,1 Marija Bošnjak Pašić,3,4 Petra Črnac,5 Hrvoje Budinčević4,5 1Department of Neurology, University Hospital Center “Sestre Milosrdnice”, 2International Institute for Brain Health, 3Department of Neurology, University Hospital Center Zagreb, Zagreb, 4Department of Neurology, School of Medicine, University Josip Juraj Strossmayer, Osijek, 5Department of Neurology, Stroke and Intensive Care Unit, University Hospital “Sveti Duh”, Zagreb, Croatia Objectives: The aim of this randomized, double-blind, placebo-controlled trial was to determine the efficacy and safety of Ginkgo biloba extract in patients diagnosed with vascular cognitive impairment (VCI. Methods: A total of 90 patients (aged 67.1±8.0 years; 59 women were randomly allocated (1:1:1 to receive G. biloba 120 mg, G. biloba 60 mg, or placebo during a 6-month period. Assessment was made for efficacy indicators, including neuropsychological tests scores (Sandoz Clinical Assessment Geriatric Scale, Folstein Mini-Mental State Examination, Mattis Dementia Rating Scale, and Clinical Global Impression and transcranial Doppler ultrasound findings. Safety indicators included laboratory findings, reported adverse reactions, and clinical examination. Results: At the end of 6-month study period, G. biloba 120 and 60 mg showed a statistically significant positive effect in comparison with placebo only on the Clinical Global Impression score (2.6±0.8 vs 3.1±0.7 vs 2.8±0.7, respectively; P=0.038. The Clinical Global Impression score showed a significant deterioration from the baseline values in the placebo group (-0.3±0.5; P=0.021 as opposed to G. biloba groups. No significant differences were found in the transcranial Doppler ultrasound findings. Adverse reactions were significantly more common and serious in the placebo group (16 subjects than in either of the two G. biloba extract groups (eight and nine subjects

  13. Clinical evaluation of XaraColl®, a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies

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    Cusack SL

    2012-06-01

    Full Text Available Susan L Cusack,1 Mark Jaros,2 Michael Kuss,3 Harold S Minkowitz,4 Peter Winkle,5 Lisa Hemsen61Cusack Pharmaceutical Consulting, Burlington, NJ, 2Summit Analytical, Denver, CO, USA; 3Premier Research Group, Austin, TX, USA; 4Memorial Hermann Memorial City Medical Center, Houston, TX, USA; 5Advanced Clinical Research Institute, Anaheim, CA, USA; 6Innocoll Technologies, Athlone, IrelandBackground: XaraColl®, a collagen-based implant that delivers bupivacaine to the site of surgical trauma, is under development for postoperative analgesia. Because of differing patient attitudes to postoperative pain control and the inability to assess baseline pain, standard clinical methods for evaluating analgesic efficacy are compromised and justify application of novel integrated approaches.Methods: We conducted two independent, multicenter, double-blind, placebo-controlled studies in men undergoing unilateral inguinal hernioplasty by open laparotomy to evaluate the safety and efficacy of XaraColl at different doses (100 mg and 200 mg of bupivacaine hydrochloride; study 1 and 2, respectively. Enrolled patients (50 in study 1 and 53 in study 2 were randomized to receive active or placebo implants in a 1:1 ratio. Postoperative pain intensity and use of supplementary opioid medication were recorded through 72 hours. Safety was assessed through 30 days. The principal efficacy variables were the summed pain intensity (SPI, total use of opioid analgesia (TOpA, and an integrated endpoint (I-SPI-TOpA. Each variable was analyzed at 24, 48, and 72 hours after implantation. A pooled analysis of both studies was also performed retrospectively.Results: Through 24 and 48 hours, XaraColl-treated patients experienced significantly less pain in study 1 (P < 0.001 and P = 0.012, respectively whereas they took significantly less opioid analgesia in study 2 (P = 0.004 and P = 0.042, respectively. Over the same time intervals in the pooled analysis, treated patients experienced

  14. Identification of a botanical inhibitor of intestinal diacylglyceride acyltransferase 1 activity via in vitro screening and a parallel, randomized, blinded, placebo-controlled clinical trial.

    Science.gov (United States)

    Velliquette, Rodney A; Grann, Kerry; Missler, Stephen R; Patterson, Jennifer; Hu, Chun; Gellenbeck, Kevin W; Scholten, Jeffrey D; Randolph, R Keith

    2015-01-01

    Diacylglyceride acyltransferase 1 (DGAT1) is the enzyme that adds the final fatty acid on to a diacylglyceride during triglyceride (TG) synthesis. DGAT1 plays a key role in the repackaging of dietary TG into circulating TG rich chylomicrons. A growing amount of research has indicated that an exaggerated postprandial circulating TG level is a risk indicator for cardiovascular and metabolic disorders. The aim of this research was to identify a botanical extract that inhibits intestinal DGAT1 activity and attenuates postprandial hypertriglyceridemia in overweight and obese humans. Twenty individual phytochemicals and an internal proprietary botanical extract library were screened with a primary cell-free DGAT1 enzyme assay that contained dioleoyl glycerol and palmitoleoyl Coenzyme A as substrates plus human intestinal microsomes as the DGAT1 enzyme source. Botanical extracts with IC50 values botanical extracts were then evaluated in a parallel, double-blind, placebo-controlled clinical trial. Ninety healthy, overweight and obese participants were randomized to receive 2 g daily of placebo or individual botanical extracts (the investigational product) for seven days. Serum TG levels were measured before and after consuming a high fat meal (HFM) challenge (0.354 L drink/shake; 77 g fat, 25 g carbohydrate and 9 g protein) as a marker of intestinal DGAT1 enzyme activity. Phenolic acids (i.e., gallic acid) and polyphenols (i.e., cyanidin) abundantly found in nature appeared to inhibit DGAT1 enzyme activity in vitro. Four polyphenolic rich botanical extracts were identified from in vitro evaluation in both cell-free and cellular model systems: apple peel extract (APE), grape extract (GE), red raspberry leaf extract (RLE) and apricot/nectarine extract (ANE) (IC50 = 1.4, 5.6, and 10.4 and 3.4 μg/mL, respectively). In the seven day clinical trial, compared to placebo, only GE significantly reduced the baseline subtracted change in serum TG AUC following

  15. Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia

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    Stauffer Virginia L

    2011-09-01

    Full Text Available Abstract Background In patients with schizophrenia, early non-response to oral antipsychotic therapy robustly predicts subsequent non-response to continued treatment with the same medication. This study assessed whether early response predicted later response when using a long-acting injection (LAI antipsychotic. Methods Data were taken from an 8-week, randomized, double-blind, placebo-controlled study of olanzapine LAI in acutely ill patients with schizophrenia (n = 233. Early response was defined as ≥30% improvement from baseline to Week 4 in Positive and Negative Syndrome Scale (PANSS0-6 Total score. Subsequent response was defined as ≥40% baseline-to-endpoint improvement in PANSS0-6 Total score. Sensitivity, specificity, positive predictive value (PPV, negative predictive value (NPV, and predictive accuracy were calculated. Clinical and functional outcomes were compared between Early Responders and Early Non-responders. Results Early response/non-response to olanzapine LAI predicted later response/non-response with high sensitivity (85%, specificity (72%, PPV (78%, NPV (80%, and overall accuracy (79%. Compared to Early Non-responders, Early Responders had significantly greater improvement in PANSS0-6 Total scores at all time points and greater baseline-to-endpoint improvement in PANSS subscale scores, Quality of Life Scale scores, and Short Form-36 Health Survey scores (all p ≤ .01. Among Early Non-responders, 20% demonstrated response by Week 8. Patients who lacked early improvement (at Week 4 in Negative Symptoms and Disorganized Thoughts were more likely to continue being non-responders at Week 8. Conclusions Among acutely ill patients with schizophrenia, early response predicted subsequent response to olanzapine LAI. Early Responders experienced significantly better clinical and functional outcomes than Early Non-responders. Findings are consistent with previous research on oral antipsychotics. Clinical Trials Registry F1D

  16. Use of a fermented dairy probiotic drink containing Lactobacillus casei (DN-114 001) to decrease the rate of illness in kids: the DRINK study A patient-oriented, double-blind, cluster-randomized, placebo-controlled, clinical trial

    OpenAIRE

    Merenstein, D; Murphy, M; Fokar, A; Hernandez, R K; Park, H; Nsouli, H; Sanders, M E; Davis, B A; Niborski, V; Tondu, F; Shara, N M

    2010-01-01

    Background: To evaluate whether a fermented dairy drink containing the probiotic strain Lactobacillus casei DN-114 001 could reduce the incidence of common infectious diseases (CIDs) and the change of behavior because of illness in children. Subjects/Methods: We conducted a double-blinded, randomized, placebo-controlled allocation concealment clinical trial in the Washington, DC metropolitan area. Participants were 638 children 3?6 years old in daycare/schools. The intervention was a fermente...

  17. Reduction of alcohol drinking in young adults by naltrexone: a double-blind, placebo-controlled, randomized clinical trial of efficacy and safety.

    Science.gov (United States)

    O'Malley, Stephanie S; Corbin, William R; Leeman, Robert F; DeMartini, Kelly S; Fucito, Lisa M; Ikomi, Jolomi; Romano, Denise M; Wu, Ran; Toll, Benjamin A; Sher, Kenneth J; Gueorguieva, Ralitza; Kranzler, Henry R

    2015-02-01

    Naltrexone, an opioid antagonist, may facilitate reduction in drinking among young adults. We compared the efficacy and safety of naltrexone administered daily plus targeted dosing with placebo to reduce drinking in young adults who engage in heavy drinking. A randomized, double-blind, placebo-controlled study was conducted in an outpatient research center in March 2008-January 2012. Participants were aged 18-25 years and reported ≥ 4 heavy drinking days in the prior 4 weeks. Interventions included naltrexone 25 mg daily plus 25 mg targeted (at most daily) in anticipation of drinking (n = 61) or daily/targeted placebo (n = 67). All participants received a personalized feedback session and brief counseling every other week. Primary outcomes were percent heavy drinking days and percent days abstinent over the 8-week treatment period. Secondary outcomes included number of drinks per drinking day and percentage of days with estimated blood alcohol concentration (BAC) levels ≥ 0.08 g/dL. Of 140 randomized patients, 128 began treatment, comprising the evaluable sample. During treatment, percent heavy drinking days (naltrexone: mean = 21.60, SD = 16.05; placebo: mean = 22.90, SD = 13.20) (P = .58) and percent days abstinent (naltrexone: mean = 56.60, SD = 22.52; placebo: mean = 62.50, SD = 15.75) (P = .39) did not differ by group. Naltrexone significantly reduced the number of drinks per drinking day (naltrexone: mean = 4.90, SD = 2.28; placebo: mean = 5.90, SD = 2.51) (P = .009) and percentage of drinking days with estimated BAC ≥ 0.08 g/dL (naltrexone: mean = 35.4, SD = 28.40; placebo: mean = 45.7, SD = 26.80) (P = .042). There were no serious adverse events. Sleepiness was more common with naltrexone. Naltrexone did not reduce frequency of drinking or heavy drinking days, but reduced secondary measures of drinking intensity. While effects were modest, the risk-benefit ratio favors offering naltrexone to help young adult heavy drinkers reduce the amount of alcohol

  18. Effect of herbal Ephedra sinica and Evodia rutaecarpa on body composition and resting metabolic rate: a randomized, double-blind clinical trial in Korean premenopausal women.

    Science.gov (United States)

    Kim, Ho-Jun; Park, Jung-Mi; Kim, Jin-Ah; Ko, Byeong-Pyo

    2008-12-01

    As obesity is becoming an epidemic, diet programs, including low-calorie diets, are continuously being developed. It is generally believed that a low-calorie diet is commonly followed by a resting metabolic rate decrease and ultimate weight regain. Ephedra sinica and evodia rutaecarpa are known to have sympathomimetic and anti-obesity effects. This study was a prospective; double-blinded, randomized and placebo-controlled clinical trial to evaluate the effects of ephedra sinica and evodia rutaecarpa on resting metabolic rate (RMR), body composition and short-term safety in obese Korean premenopausal women on a low-calorie diet. One hundred and twenty-five otherwise healthy obese women (body mass index > or =25 kg/m(2)) were recruited and randomly assigned to three groups: ephedra group (n = 41), evodia group (n = 45) and placebo group (n = 39). Subjects were administered ephedra extract in capsules (pseudo-ephedrine 31.52 mg) or evodia extract in capsules (evodiamine 6.75 mg, rutaecarpine 0.66 mg) or placebo capsules as well as participating in a low-calorie diet for 8 weeks. Resting metabolic rate and body composition were measured at baseline, 4 and 8 weeks. Basic serum tests were performed to evaluate the short-term safety and lipid-lowering effects of the herbs. All three groups showed significant body mass index (BMI) decreases, probably due to the low-calorie diet. Among the groups, the most prominent BMI-reducing effect was seen in the ephedra group. In RMR, no significant change in any group or significant difference among the groups was found. No significant adverse effects were observed in serum tests or in the self-questionnaire. Ephedra combined with a low-calorie diet was effective in reducing BMI. RMR change was not compensated for by the herbal medicines tried. RMR change seemed to be affected by constitution and body composition rather than by medicine. Ephedra and evodia were proven to be safe for short-term use in the herbal form.

  19. Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial.

    Science.gov (United States)

    Bruna, Jordi; Videla, Sebastián; Argyriou, Andreas A; Velasco, Roser; Villoria, Jesús; Santos, Cristina; Nadal, Cristina; Cavaletti, Guido; Alberti, Paola; Briani, Chiara; Kalofonos, Haralabos P; Cortinovis, Diego; Sust, Mariano; Vaqué, Anna; Klein, Thomas; Plata-Salamán, Carlos

    2018-01-01

    This trial assessed the efficacy of MR309 (a novel selective sigma-1 receptor ligand previously developed as E-52862) in ameliorating oxaliplatin-induced peripheral neuropathy (oxaipn). A discontinuous regimen of MR309 (400 mg/day, 5 days per cycle) was tested in patients with colorectal cancer receiving FOLFOX in a phase II, randomized, double-blind, placebo-controlled, multicenter clinical trial. Outcome measures included changes in 24-week quantitative measures of thermal sensitivity and total neuropathy score. In total, 124 patients were randomized (1:1) to MR309 or placebo. Sixty-three (50.8%) patients withdrew prematurely before completing 12 planned oxaliplatin cycles. Premature withdrawal because of cancer progression was less frequent in the MR309 group (7.4% vs 25.0% with placebo; p = 0.054). MR309 significantly reduced cold pain threshold temperature [mean treatment effect difference (SE) vs placebo: 5.29 (1.60)°C; p = 0.001] and suprathreshold cold stimulus-evoked pain intensity [mean treatment effect difference: 1.24 (0.57) points; p = 0.032]. Total neuropathy score, health-related quality-of-life measures, and nerve-conduction parameters changed similarly in both arms, whereas the proportion of patients with severe chronic neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events ≥ 3) was significantly lower in the MR309 group (3.0% vs 18.2% with placebo; p = 0.046). The total amount of oxaliplatin delivered was greater in the active arm (1618.9 mg vs 1453.8 mg with placebo; p = 0.049). Overall, 19.0% of patients experienced at least 1 treatment-related adverse event (25.8% and 11.9% with MR309 and placebo, respectively). Intermittent treatment with MR309 was associated with reduced acute oxaipn and higher oxaliplatin exposure, and showed a potential neuroprotective role for chronic cumulative oxaipn. Furthermore, MR309 showed an acceptable safety profile.

  20. A Randomized, Double-Blinded, Clinical Trial on Effects of a Vitis vinifera Extract on Cognitive Function in Healthy Older Adults

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    Gioacchino Calapai

    2017-10-01

    Full Text Available Introduction: Gradual population aging is creating a new set of needs in the general population. Memory capacity decreases with age, and memory deficits are considered an early symptom of Alzheimer’s Disease (AD, one of the most prevalent cognitive disorders in older people. Numerous studies have shown that grape polyphenolic compounds (GPs are able to attenuate cognitive impairment and reduce brain lesions in experimental AD animal models. These GP effects are associated with improvement in brain antioxidant status and prevention of free radical-induced neuronal damage. We designed a randomized, double-blind, placebo-controlled clinical trial to investigate the potential beneficial effects of a Vitis vinifera-based dietary supplement on cognitive function and neuropsychological status in healthy older adults.Methods: One-hundred eleven subjects were recruited and randomly divided in two groups: one group received the V. vinifera-based dietary supplement Cognigrape® for 12 weeks (250 mg/day and the second group received placebo over the same period of time. Before and after the end of the supplementation period, cognitive function and neuropsychological status were evaluated using the Mini-Mental State Examination (MMSE, Beck Depression Inventory (BDI, Hamilton Anxiety Rating Scale (HARS, and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS evaluations.Results: MMSE scores were significantly improved after supplementation with Cognigrape® in comparison with baseline levels (p < 0.0001 and placebo (r = 0.59, 0.95% CI 0.11, 1.22; p < 0.0001. Cognigrape® supplementation produced a significant reduction in BDI (-15.8% and HARS (-24.9% scores with respect to baseline levels (p < 0.0001 and placebo (p < 0.0001 for BDI and p < 0.05 for HARS. RBANS total score was significantly improved by Cognigrape® with respect to baseline levels and placebo (r = 0.55, 0.95% CI 0.48, 6.07; p < 0.0001. The comparison with the placebo

  1. Randomized, Single-Blind, Parallel Clinical Trial on Efficacy of Oral Prednisolone Versus Intramuscular Corticotropin: A 12-Month Assessment of Spasm Control in West Syndrome.

    Science.gov (United States)

    Wanigasinghe, Jithangi; Arambepola, Carukshi; Ranganathan, Shalini Sri; Sumanasena, Samanmali

    2017-11-01

    We earlier completed a single-blind, parallel-group, randomized clinical trial to test the null hypothesis that adrenocorticotropic hormone (ACTH) is not superior to high-dose prednisolone for short-term control of West syndrome. We now present long-term follow-up data for spasm control for individuals who completed this earlier trial. Infants with untreated West syndrome were randomized to receive 14 days of prednisolone (40 to 60 mg/day) or intramuscular long-acting ACTH (40 to 60 IU every other day). They were evaluated at three, six, and 12 months to evaluate long-term spasm control. The total number of infants treated was 97 (48 prednisolone; 49 ACTH). All completed the treatment course. Eighty-five, 82, and 76 children were available for follow-up at three, six, and 12 months. The number lost to follow-up at each interval was not statistically different. Likelihood of spasm freedom at three months was significantly higher for prednisolone (64.6%) than for ACTH (38.8%) (P = 0.01; odds ratio = 2.9; 95% confidence interval = 1.3 to 6.6). At six months (P = 0.19) and twelve months (P = 0.13), the control of spasms was not statistically different, although a trend in favor of prednisolone was documented at both of these time points (58.3% versus 44.9% for ACTH at six months and 56.2% versus 40.8% with ACTH at 12 months). After initial remission by day 14 (n = 46), the likelihood of a relapse within the next 12 months was not statistically different between the two treatment groups (P = 0.1). Control of spasms at three months was significantly better if initially treated with prednisolone. Control of spasms at six and 12 months was not significantly different despite a trend favoring prednisolone. Risk of relapse following initial remission was similar in the two groups. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Effects of Prednisolone on Disease Progression in Antiretroviral-Untreated HIV Infection: A 2-Year Randomized, Double-Blind Placebo-Controlled Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Christa Kasang

    Full Text Available HIV-disease progression correlates with immune activation. Here we investigated whether corticosteroid treatment can attenuate HIV disease progression in antiretroviral-untreated patients.Double-blind, placebo-controlled randomized clinical trial including 326 HIV-patients in a resource-limited setting in Tanzania (clinicaltrials.gov NCT01299948. Inclusion criteria were a CD4 count above 300 cells/μl, the absence of AIDS-defining symptoms and an ART-naïve therapy status. Study participants received 5 mg prednisolone per day or placebo for 2 years. Primary endpoint was time to progression to an AIDS-defining condition or to a CD4-count below 200 cells/μl.No significant change in progression towards the primary endpoint was observed in the intent-to-treat (ITT analysis (19 cases with prednisolone versus 28 cases with placebo, p = 0.1407. In a per-protocol (PP-analysis, 13 versus 24 study participants progressed to the primary study endpoint (p = 0.0741. Secondary endpoints: Prednisolone-treatment decreased immune activation (sCD14, suPAR, CD38/HLA-DR/CD8+ and increased CD4-counts (+77.42 ± 5.70 cells/μl compared to -37.42 ± 10.77 cells/μl under placebo, p < 0.0001. Treatment with prednisolone was associated with a 3.2-fold increase in HIV viral load (p < 0.0001. In a post-hoc analysis stratifying for sex, females treated with prednisolone progressed significantly slower to the primary study endpoint than females treated with placebo (ITT-analysis: 11 versus 21 cases, p = 0.0567; PP-analysis: 5 versus 18 cases, p = 0.0051: No changes in disease progression were observed in men.This study could not detect any significant effects of prednisolone on disease progression in antiretroviral-untreated HIV infection within the intent-to-treat population. However, significant effects were observed on CD4 counts, immune activation and HIV viral load. This study contributes to a better understanding of the role of immune activation in the pathogenesis

  3. The efficacy of whey associated with dodder seed extract on moderate-to-severe atopic dermatitis in adults: A randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Mehrbani, Mehrzad; Choopani, Rasool; Fekri, Alireza; Mehrabani, Mitra; Mosaddegh, Mahmoud; Mehrabani, Mehrnaz

    2015-08-22

    Atopic dermatitis is a common chronic inflammatory skin condition that is on the rise and adversely affects quality of life of the affected individual. Dry skin and pruritus, major characteristics of this disease, are associated with the dysfunction of the skin barrier. Though mild cases of the disease can be controlled with antihistamines and topical corticosteroids, moderate-to-severe cases often require treatment with immunomodulatory drugs, which have many side effects. It is now more common to use complementary and alternative medicines in the treatment of atopic dermatitis. In traditional Iranian medicine, the use of whey with the aqueous extract of field dodder (Cuscuta campestris Yunck.) seeds in severe and refractory cases of atopic dermatitis is common and has no side effects. The aim of this study was to assess the efficacy and safety of whey associated with dodder seed extract in the treatment of moderate-to-severe atopic dermatitis in adults. The study was a randomized, double-blind placebo control trial that was conducted on 52 patients with moderate-to-severe atopic dermatitis for 30 days. In this study patients received freeze dried whey powder with spray dried water extract of field dodder or the placebo for 15 days. At baseline (week zero), after the end of the 15 day treatment period (week three) and 15 days after stopping the drug or placebo (follow-up/week five), patients were evaluated in terms of skin moisture, elasticity, pigmentation, surface pH and sebum content on the forearm with Multi Skin Test Center® MC1000 (Courage & Khazaka, Germany) and the degree of pruritus and sleep disturbance in patients were also recorded. 42 patients completed 30 days of treatment with the medicine and the follow-up period. At the end of the follow-up period a significant increase in skin moisture and elasticity in the group receiving whey with dodder was observed compared with the placebo group (pwhey associated with dodder seed extract over time (pwhey

  4. The effect of IV dexamethasone versus local anesthetic infiltration technique in postoperative nausea and vomiting after tonsillectomy in children: A randomized double-blind clinical trial.

    Science.gov (United States)

    Naja, Zoher; Kanawati, Saleh; Al Khatib, Rania; Ziade, Fouad; Naja, Zeina Z; Naja, Ahmad Salah; Rajab, Mariam

    2017-01-01

    Local anesthetic infiltration and corticosteroids had shown effectiveness in reducing post tonsillectomy nausea, vomiting and pain. To compare the effect of intravenous dexamethasone versus pre-incision infiltration of local anesthesia in pediatric tonsillectomy on postoperative nausea and vomiting (PONV). The secondary objective was postoperative pain. A randomized double-blind clinical trial was conducted at a tertiary care teaching hospital. Children admitted to undergo tonsillectomy aged between 4 and 13 years from January 2015 to August 2015 were enrolled and divided into two groups. Both groups had general anesthesia. Group I received intravenous dexamethasone 0.5 mg/kg (maximum dose 16 mg) with placebo pre-incision infiltration. Group II received pre-incision infiltration a total of 2-4 ml local anesthesia mixture with saline and an equivalent volume of intravenous saline. Group I consisted of 64 patients while group II had 65 patients. In the PACU, 15.6% of patients in group I experienced vomiting compared to 3.1% in group II (p-value = 0.032). After 24 h, the incidence of PONV was significantly higher in group I compared to group II (26.6% vs. 9.2% respectively, p-value = 0.019). At 48 h postoperatively, PONV was significantly higher in group I (p-value = 0.013). The incidence was similar in both groups after three, four and five postoperative days. Baseline pain and pain during swallowing were significantly different at 6, 12 and 24 h as well as days 1 through 5. Pain upon jaw opening was significantly different at 6, 12 and 24 h between the two groups. Pain while eating soft food was significantly different at 24 h and days 2 through 5. In the PACU, 20.3% of patients in group I received diclofenac compared to 3.1% in group II (p-value = 0.005). From day 1 till day 5, analgesic consumption was significantly higher in group I. Local anesthetic infiltration in addition to NSAIDS and paracetamol could serve as a multimodal analgesia and

  5. Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch: PATHON

    Directory of Open Access Journals (Sweden)

    Silva Federico A

    2007-09-01

    Full Text Available Abstract Background Diabetes Mellitus constitutes one of the most important public health problems due to its high prevalence and enormous social and economic consequences. Diabetic foot ulcers are one of the chronic complications of diabetes mellitus and constitute the most important cause of non-traumatic amputation of inferior limbs. It is estimated that 15% of the diabetic population will develop an ulcer sometime in their lives. Although novel therapies have been proposed, there is no effective treatment for this pathology. Naturally produced nitric oxide participates in the wound healing process by stimulating the synthesis of collagen, triggering the release of chemotactic cytokines, increasing blood vessels permeability, promoting angiogenic activity, stimulating the release of epidermical growth factors, and by interfering with the bacterial mitochondrial respiratory chain. Topically administered nitric oxide has demonstrated to be effective and safe for the treatment of chronic ulcers secondary to cutaneous leishmaniasis. However, due to their unstable nitric oxide release, the topical donors needed to be applied frequently, diminishing the adherence to the treatment. This difficulty has led to the development of a multilayer polymeric transdermal patch produced by electrospinning technique that guarantees a constant nitric oxide release. The main objective of this study is to evaluate the effectiveness and safety of this novel nitric oxide releasing wound dressing for the treatment of diabetic foot ulcers. Methods and design A double-blind, placebo-controlled clinical trial, including 100 diabetic patients was designed. At the time of enrollment, a complete medical evaluation and laboratory tests will be performed, and those patients who meet the inclusion criteria randomly assigned to one of two groups. Over the course of 90 days group 1 will receive active patches and group 2 placebo patches. The patients will be seen by the

  6. Clinical and metabolic response to probiotic supplementation in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Zamani, Batol; Golkar, Hamid R; Farshbaf, Shima; Emadi-Baygi, Modjtaba; Tajabadi-Ebrahimi, Maryam; Jafari, Parvaneh; Akhavan, Reyhaneh; Taghizadeh, Mohsen; Memarzadeh, Mohammad R; Asemi, Zatollah

    2016-09-01

    This study was performed to determine the effects of probiotic supplementation on clinical and metabolic status of patients with rheumatoid arthritis (RA). Sixty patients with RA aged 25-70 years were assigned into two groups to receive either probiotic capsules (n = 30) or placebo (n = 30) in this randomized, double-blind, placebo-controlled trial. The patients in the probiotic group received a daily capsule that contained three viable and freeze-dried strains: Lactobacillus acidophilus (2 × 10(9) colony-forming units [CFU]/g), Lactobacillus casei (2 × 10(9) CFU/g) and Bifidobacterium bifidum (2 × 10(9) CFU/g) for 8 weeks. The placebo group took capsules filled with cellulose for the same time period. Fasting blood samples were taken at the beginning and the end of the study to quantify related markers. After 8 weeks of intervention, compared with the placebo, probiotic supplementation resulted in improved Disease Activity Score of 28 joints (DAS-28) (-0.3 ± 0.4 vs. -0.1 ± 0.4, P = 0.01). In addition, a significant decrease in serum insulin levels (-2.0 ± 4.3 vs. +0.5 ± 4.9 μIU/mL, P = 0.03), homeostatic model assessment-B cell function (HOMA-B) (-7.5 ± 18.0 vs. +4.3 ± 25.0, P = 0.03) and serum high-sensitivity C-reactive protein (hs-CRP) concentrations (-6.66 ± 2.56 vs. +3.07 ± 5.53 mg/L, P probiotics compared with the placebo. Subjects who received probiotic capsules experienced borderline statistically significant improvement in total- (P = 0.09) and low-density lipoprotein-cholesterol levels (P = 0.07) compared with the placebo. Overall, the results of this study indicated that taking probiotic supplements for 8 weeks among patients with RA had beneficial effects on DAS-28, insulin levels, HOMA-B and hs-CRP levels. © 2016 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

  7. Effect of chromium supplementation on the glucose homeostasis and anthropometry of type 2 diabetic patients: Double blind, randomized clinical trial: Chromium, glucose homeostasis and anthropometry.

    Science.gov (United States)

    Guimarães, Marília Mendonça; Carvalho, Ana Clara Martins Silva; Silva, Maria Sebastiana

    2016-07-01

    To evaluate the effect of chromium supplementation on the glucose homeostasis and anthropometry of type 2 diabetic patients. Fifty-six individuals with type 2 Diabetes were randomized on a double blind clinical trial into three groups: placebo (NC0), 50μg (NC50) and 200μg (NC200) of chromium nicotinate. Glucose homeostasis, anthropometry and physical activity intensity were evaluated at the beginning, at day 45 and at day 90. Energy intake was evaluated at the beginning, between the beginning and 45 days, and between days 45 and 90 of the study. There were no differences within or between groups for HOMA-IR, waist circumference, body fat percentage, lean body mass percentage and total energy intake during the trial. There was an increase of the HOMA-β in group NC0 (p=0.0349) and a decrease of 1.08kg in group NC50 (p=0.0048) at 90 days. The relation between body mass index, body fat percentage and insulin sensitivity did not change in the placebo and supplemented groups (p>0.05). In the effect of the intervention, for each 1cm increase in waist circumference there was an increase of 1.90±0.63 in HOMA-IR (p=0.0087) and 16.31±5.27% in HOMA-β (p=0.0073) in group NC200. No difference was seen in the intensity of physical activity within the groups and in the comparison between the supplemented groups (NC50 and NC200) and placebo (NC0) at 90 days. There was an increase in energy expenditure in physical activity at 90days (p=0.0371) of intervention in the group subjects NC50. As for total energy intake, there were no differences within or between the groups during the study. 50μg and 200μg supplementation with chromium nicotinate for 90days did not promote improvements in glucose homeostasis and anthropometry in individuals with type 2 diabetes mellitus. Copyright © 2016 Elsevier GmbH. All rights reserved.

  8. Design of a randomized controlled double-blind crossover clinical trial to assess the effects of saliva substitutes on bovine enamel and dentin in situ

    Directory of Open Access Journals (Sweden)

    Kielbassa Andrej M

    2011-04-01

    Full Text Available Abstract Background Hyposalivation is caused by various syndromes, diabetes, drugs, inflammation, infection, or radiotherapy of the salivary glands. Patients with hyposalivation often show an increased caries incidence. Moreover, hyposalivation is frequently accompanied by oral discomfort and impaired oral functions, and saliva substitutes are widely used to alleviate oral symptoms. However, preference of saliva substitutes due to taste, handling, and relief of oral symptoms has been discussed controversially. Some of the marketed products have shown demineralizing effects on dental hard tissues in vitro. This demineralizing potential is attributed to the undersaturation with respect to calcium phosphates. Therefore, it is important to modify the mineralizing potential of saliva substitutes to prevent carious lesions. Thus, the aim of the present study was to evaluate the effects of a possible remineralizing saliva substitute (SN; modified Saliva natura compared to a demineralizing one (G; Glandosane on mineral parameters of sound bovine dentin and enamel as well as on artificially demineralized enamel specimens in situ. Moreover, oral well-being after use of each saliva substitute was recorded. Methods/Design Using a randomized, double-blind, crossover, phase II/III in situ trial, volunteers with hyposalivation utilize removable dentures containing bovine specimens during the experimental period. The volunteers are divided into two groups, and are required to apply both saliva substitutes for seven weeks each. After both test periods, differences in mineral loss and lesion depth between values before and after exposure are evaluated based on microradiographs. The oral well-being of the volunteers before and after therapy is determined using questionnaires. With respect to the microradiographic analysis, equal mineral losses and lesion depths of enamel and dentin specimens during treatment with SN and G, and no differences in patients

  9. Repetitive Intermittent Hypoxia and Locomotor Training Enhances Walking Function in Incomplete Spinal Cord Injury Subjects: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Navarrete-Opazo, Angela; Alcayaga, Julio; Sepúlveda, Oscar; Rojas, Enrique; Astudillo, Carolina

    2017-05-01

    Incomplete spinal cord injuries (iSCI) leave spared synaptic pathways below the level of injury. Intermittent hypoxia (IH) elicits plasticity in the spinal cord and strengthens spared synaptic pathways, expressed as respiratory and somatic functional recovery in experimental animals and humans with iSCI. This study is a randomized, triple-blind, two-arm parallel clinical trial performed in Santiago, Chile. We compared the effects of a 4-week protocol of IH combined with body weight-supported treadmill training (BWSTT), with continuous normoxia (Nx) and BWSTT on 10-meter walk test (10MWT), 6-minute walk test (6MWT), and timed up and go (TUG) test in American Spinal Injury Association C and D individuals with iSCI. Subjects received daily IH (cycling 9%/21% O 2 every 1.5 min, 15 cycles/day) or continuous Nx (21% O 2 ) combined with 45 min BWSTT for 5 consecutive days, followed by IH/Nx 3 × per week (3 × wIH/Nx) for 3 additional weeks. Subjects were assessed at day 5, weekly from weeks 2-4, and at a 2-week follow-up. Daily IH plus BWSTT enhanced walking speed, expressed as decreased 10MWT time at day 5 versus baseline (IH: -10.2 ± 3.0 vs. Nx: -1.7 ± 1.7 sec, p = 0.006), and walking endurance expressed as increased 6MWT distance at day 5 versus baseline (IH: 43.0 ± 10.7 vs. Nx: 6.1 ± 3.4 m, p = 0.012), but not TUG time. Further, 3 × wIH maintained the daily IH-induced walking speed, and enhanced the daily IH-induced walking endurance, which is maintained up to the 2-week follow-up. We conclude that daily IH enhances walking recovery in subjects with iSCI, confirming previous findings. Moreover, 3 × wIH prolonged or enhanced daily IH-induced walking speed and endurance improvements, respectively, up to 5 weeks post-daily IH. Repetitive IH may be a safe and effective therapeutic alternative for persons with iSCI.

  10. The effects of the DDS-1 strain of lactobacillus on symptomatic relief for lactose intolerance - a randomized, double-blind, placebo-controlled, crossover clinical trial.

    Science.gov (United States)

    Pakdaman, Michael N; Udani, Jay K; Molina, Jhanna Pamela; Shahani, Michael

    2016-05-20

    Lactose intolerance is a form of lactose maldigestion where individuals experience symptoms such as diarrhea, abdominal cramping, flatulence, vomiting and bowel sounds following lactose consumption. Lactobacillus acidophilus is a species of bacteria known for its sugar fermenting properties. Preclinical studies have found that Lactobacillus acidophilus supplementation may assist in breaking down lactose; however, no human clinical trials exist evaluating its efficacy in alleviating symptoms related to lactose intolerance. The aim of this randomized, double-blind, placebo-controlled, crossover study was to evaluate the effect of a proprietary strain of Lactobacillus acidophilus on relieving discomfort related to lactose intolerance. The study enrolled healthy volunteers between 18 and 75 years of age who complained of lactose intolerance. Screening visits included a lactose challenge visit to confirm eligibility based on a score of 10 or higher on subjective assessment of the following symptoms after lactose challenge: diarrhea, abdominal cramping, vomiting, audible bowel sounds, flatulence, and overall symptoms. Qualified subjects participated in a 2-arm crossover design, with each arm consisting of 4 weeks of intervention of either active or placebo product, with a 2-week washout period during crossover. The study product consisted of the DDS-1 strain of Lactobacillus acidophilus (Nebraska Cultures, Walnut Creek, California). The placebo was formulated from maltodextrin. Study participants were instructed to take the product once daily for 4 weeks. Data collected included subjective symptom scores related to lactose intolerance. Longitudinal comparison between the DDS-1 group and placebo group demonstrated statistically significant reductions in abdominal symptom scores during the 6-h Lactose Challenge at week 4 for diarrhea (p = 0.033), abdominal cramping (p = 0.012), vomiting (p = 0.0002), and overall symptom score (p = 0.037). No adverse

  11. Effects of synbiotic food consumption on metabolic status of diabetic patients: a double-blind randomized cross-over controlled clinical trial.

    Science.gov (United States)

    Asemi, Zatollah; Khorrami-Rad, Ashraf; Alizadeh, Sabihe-Alsadat; Shakeri, Hossein; Esmaillzadeh, Ahmad

    2014-04-01

    We are aware of no study indicating the effects of synbiotic food consumption on metabolic profiles, inflammation and oxidative stress among diabetic patients. The aim of the current study was to investigate the effects of synbiotic food consumption on metabolic profiles, hs-CRP and biomarkers of oxidative stress in diabetic patients. This randomized double-blinded cross-over controlled clinical trial was performed among 62 diabetic patients aged 35-70 y. After a 2-wk run-in period, subjects were randomly assigned to consume either a synbiotic (n = 62) or control food (n = 62) for 6 weeks. A 3-week washout period was applied following which subjects were crossed over to the alternate treatment arm for an additional 6 weeks. The synbiotic food consisted of a probiotic viable and heat-resistant Lactobacillus sporogenes (1 × 10(7) CFU), 0.04 g inulin (HPX) as prebiotic with 0.38 g isomalt, 0.36 g sorbitol and 0.05 g stevia as sweetener per 1 g. Control food (the same substance without probiotic bacteria and prebiotic inulin) was packed in identical 9-gram packages. Patients were asked to consume the synbiotic and control foods three times a day. Fasting blood samples were taken at baseline and after a 6-wk intervention to measure metabolic profiles, hs-CRP and biomarkers of oxidative stress. Consumption of a synbiotic food, compared to the control, resulted in a significant decrease in serum insulin levels (changes from baseline: -1.75 ± 0.60 vs. +0.95 ± 1.09 μIU/mL, P = 0.03). Although we failed to find a significant effect of synbiotic food consumption on total- and LDL-cholesterol levels and HOMA-IR, the effects on FPG (22.3 vs. 4.2 mg/dL, P = 0.09), serum triglycerides (45.9 vs. 20.6 mg/dL, P = 0.08) and HDL-cholesterol levels (3.1 vs. -2 mg/dL, P = 0.06) tended to be significant. A significant reduction in serum hs-CRP levels (-1057.86 ± 283.74 vs. 95.40 ± 385.38 ng/mL, P = 0.01) was found following the consumption of synbiotic food compared with the

  12. [Simulation-based training and OR apprenticeship for medical students : A prospective, randomized, single-blind study of clinical skills].

    Science.gov (United States)

    Ott, T; Schmidtmann, I; Limbach, T; Gottschling, P F; Buggenhagen, H; Kurz, S; Pestel, G

    2016-11-01

    Simulation-based training (SBT) has developed into an established method of medical training. Studies focusing on the education of medical students have used simulation as an evaluation tool for defined skills. A small number of studies provide evidence that SBT improves medical students' skills in the clinical setting. Moreover, they were strictly limited to a few areas, such as the diagnosis of heart murmurs or the correct application of cricoid pressure. Other studies could not prove adequate transferability from the skills gained in SBT to the patient site. Whether SBT has an effect on medical students' skills in anesthesiology in the clinical setting is controversial. To explore this issue, we designed a prospective, randomized, single-blind trial that was integrated into the undergraduate anesthesiology curriculum of our department during the second year of the clinical phase of medical school. This study intended to explore the effect of SBT on medical students within the mandatory undergraduate anesthesiology curriculum of our department in the operating room with respect to basic skills in anesthesiology. After obtaining ethical approval, the participating students of the third clinical semester were randomized into two groups: the SIM-OR group was trained by a 225 min long SBT in basic skills in anesthesiology before attending the operating room (OR) apprenticeship. The OR-SIM group was trained after the operating room apprenticeship by SBT. During SBT the students were trained in five clinical skills detailed below. Further, two clinical scenarios were simulated using a full-scale simulator. The students had to prepare the patient and perform induction of anesthesia, including bag-mask ventilation after induction in scenario 1 and rapid sequence induction in scenario 2. Using the five-point Likert scale, five defined skills were evaluated at defined time points during the study period. 1) application of the safety checklist, 2) application of

  13. Clinical and metabolic response to probiotic administration in patients with major depressive disorder: A randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Akkasheh, Ghodarz; Kashani-Poor, Zahra; Tajabadi-Ebrahimi, Maryam; Jafari, Parvaneh; Akbari, Hossein; Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Asemi, Zatollah; Esmaillzadeh, Ahmad

    2016-03-01

    We are aware of no study examining the effects of probiotic supplementation on symptoms of depression, metabolic profiles, serum high-sensitivity C-reactive protein (hs-CRP), and biomarkers of oxidative stress in patients with major depressive disorder (MDD). The present study was designed to determine the effects of probiotic intake on symptoms of depression and metabolic status in patients with MDD. This randomized, double-blind, placebo-controlled clinical trial included 40 patients with a diagnosis of MDD based on DSM-IV criteria whose age ranged between 20 and 55 y. Patients were randomly allocated into two groups to receive either probiotic supplements (n = 20) or placebo (n = 20) for 8 wk. Probiotic capsule consisted of three viable and freeze-dried strains: Lactobacillus acidophilus (2 × 10(9) CFU/g), Lactobacillus casei (2 × 10(9) CFU/g), and Bifidobacterium bifidum (2 × 10(9) CFU/g). Fasting blood samples were taken at the beginning and end of the trial to quantify the relevant variables. All participants provided three dietary records (two weekdays and one weekend) and three physical activity records during the intervention. Dietary intake of study participants was not significantly different between the two groups. After 8 wk of intervention, patients who received probiotic supplements had significantly decreased Beck Depression Inventory total scores (-5.7 ± 6.4 vs. -1.5 ± 4.8, P = 0.001) compared with the placebo. In addition, significant decreases in serum insulin levels (-2.3 ± 4.1 vs. 2.6 ± 9.3 μIU/mL, P = 0.03), homeostasis model assessment of insulin resistance (-0.6 ± 1.2 vs. 0.6 ± 2.1, P = 0.03), and serum hs-CRP concentrations (-1138.7 ± 2274.9 vs. 188.4 ± 1455.5 ng/mL, P = 0.03) were observed after the probiotic supplementation compared with the placebo. Additionally, taking probiotics resulted in a significant rise in plasma total glutathione levels (1.8 ± 83.1 vs. -106.8 ± 190.7 μmol/L, P = 0.02) compared with the placebo. We

  14. Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Jiang Y

    2014-01-01

    Full Text Available Yan Jiang,1,* Zhen-Lin Zhang,2,* Zhong-Lan Zhang,3 Han-Min Zhu,4 Yi-Yong Wu,5 Qun Cheng,4 Feng-Li Wu,5 Xiao-Ping Xing,1 Jian-Li Liu,3 Wei Yu,6 Xun-Wu Meng11Department of Endocrinology, Key Laboratory of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 2Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Disease, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 3Department of Gynecology and Obstetrics, General Hospital of the People's Liberation Army, Beijing, 4Department of Geriatrics, Shanghai Huadong Hospital, Shanghai, 5Department of Gynecology and Obstetrics, Beijing Hospital, Ministry of Public Health, Beijing, 6Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China*These authors contributed equally to this workObjective: To evaluate whether the efficacy and safety of menatetrenone for the treatment of osteoporosis is noninferior to alfacalcidol in Chinese postmenopausal women.Method: This multicenter, randomized, double-blinded, double-dummy, noninferiority, positive drug-controlled clinical trial was conducted in five Chinese sites. Eligible Chinese women with postmenopausal osteoporosis (N=236 were randomized to Group M or Group A and received menatetrenone 45 mg/day or alfacalcidol 0.5 µg/day, respectively, for 1 year. Additionally, all patients received calcium 500 mg/day. Posttreatment bone mineral density (BMD, new fracture onsets, and serum osteocalcin (OC and undercarboxylated OC (ucOC levels were compared with the baseline value in patients of both groups.Results: A total of 213 patients (90.3% completed the study. After 1 year of treatment, BMD among patients in Group M significantly increased from baseline by 1.2% and 2.7% at the lumbar spine and trochanter, respectively (P<0.001; and the percentage increase of BMD in Group A was 2

  15. Effects of combination treatment with policosanol and omega-3 fatty acids on platelet aggregation: A randomized, double-blind clinical study.

    Science.gov (United States)

    Castaño, Gladys; Arruzazabala, Maria L; Fernández, Lilia; Mas, Rosa; Carbajal, Daisy; Molina, Vivian; Illnait, José; Mendoza, Sarahí; Gámez, Rafael; Mesa, Melbis; Fernández, Julio

    2006-05-01

    Policosanol is a mixture of long-chain primary aliphatic alcoholspurified from sugar cane wax that has cholesterol lowering and antiplatelet effects. Omega-3 fatty acids (FA) have triglyceride lowering and antiplatelet effects. Combination treatment with policosanol and omega-3 FA (Ω23FA) has been associated with significant inhibition of platelet aggregation in rabbits compared with either drug alone. The aim of this study was to investigate the effects of combination treatment with Ω3FA (1 g/d) and policosanol (Ω3FA+Poli) compared with Ω3FA (1 g/d) plus placebo (Ω3FA+Pla) on platelet aggregation in human patients with hypercholesterolemia. This randomized, double-blind, clinical study at the Surgical Medical Research Center (Havana City, Cuba) recruited outpatients from lipid clinics, with some atherosclerotic risk factors. Outpatients of both sexes aged 20 to 75 years with serum total cholesterol (TC) levels ≥5 and <6 mmol/L were eligible to enroll. They were included in the study at the end of a 4-week diet stabilization period if their platelet aggregation to arachidonic acid (AA) was ≥50% and serum TC level remained ≥5 mmol/L. Patients were then evenly randomized to receive Ω3FA (1 g/d) + placebo or Ω3FA (1 g/d) + policosanol (10 mg/d) to be taken PO with the evening meal for 21 days. Treatment was assigned according to a randomization code using balanced blocks and a 1:1 allocation ratio. Inhibition of platelet aggregation to AA was the primary efficacy variable, while effects on platelet aggregation to collagen and epinephrine and on lipid profile were secondary variables. Drug compliance and adverse events (AEs) were monitored. Tolerability was assessed using physical examinations and laboratory test results. Sixty-four subjects were initially enrolled. Fifty-four patients (30 women, 24 men; mean [SD] age, 58.4 [12] years, [range, 40-70 years]) met the inclusion criteria and were randomized to treatment; 2 groups of 27. After 21 days, platelet

  16. Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial

    Directory of Open Access Journals (Sweden)

    Hsien-Yin Liao

    2017-01-01

    Full Text Available Background and Purpose. The effect of acupuncture as treatment for poststroke complications is questionable. We performed a randomized, sham-controlled double-blind study to investigate it. Methods. Patients with first-time acute stroke were randomized to receive 24 sessions of either real or sham acupuncture during an eight-week period. The primary outcome measure was change in National Institute of Health Stroke Scale (NIHSS score. Secondary outcome measures included changes in Barthel Index (BI, Instrumental Activities of Daily Living (IADL, Hamilton Depression Rating Scale (HAM-D, and Visual Analogue Scale (VAS for pain scores. Results. Of the 52 patients who were randomized to receive acupuncture (n=28 or placebo (n=24, 10 patients in the acupuncture group and 9 patients in the placebo group failed to complete the treatment. In total, 18 patients in the acupuncture group and 15 patients in the control group completed the treatment course. Reduction in pain was significantly greater in the acupuncture group than in the control group (p value = 0.04. There were no significant differences in the other measures between the two groups. Conclusions. Acupuncture provided more effective poststroke pain relief than sham acupuncture treatment. However, acupuncture had no better effect on neurological, functional, and psychological improvement.

  17. Clinical study on the therapeutic role of midodrine in non azotemic cirrhotic patients with tense ascites: a double-blind, placebo-controlled, randomized trial.

    Science.gov (United States)

    Ali, Ahmed; Farid, Samar; Amin, Mona; Kassem, Mohamed; Al-Garem, Nouman

    2014-10-01

    Midodrine is an α-agonist prodrug of desglymidodrine used for the management of hypotension. Midodrine has demonstrated usefulness in hepatorenal syndrome. The objective of the present work was to study the role of midodrine in patients with non-azotemic cirrhosis with tense ascites. This prospective randomized double blind placebo-controlled study was conducted on 67 non azotemic inpatients with liver cirrhosis and tense ascites (52 men and 15 women; age range, 45-72). One patient declined to participate in the study, 33 patients were randomly assigned to take midodrine hydrochloride, and 33 patients were randomly assigned to take placebo. Out of 67 enrolled patients, 60 patients (30: in midodrine group; 30: in placebo group) completed the study and 6 patients lost to follow up. Patients were assessed for patients’ characteristics, history of tapping their ascetic fluid, laboratory values, and Doppler parameters before and after the study. Average 24-h urine volume was assessed before and after the start of the study. significant reduction in body weight and abdominal girth was observed after 2 weeks of midodrine therapy. Midodrine appeared to be effective in lowering body weights and abdominal girths of non azotemic cirrhotic patients with tense ascites.

  18. Intralesional immunotherapy with tuberculin purified protein derivative (PPD) in recalcitrant wart: A randomized, placebo-controlled, double-blind clinical trial including an extra group of candidates for cryotherapy.

    Science.gov (United States)

    Amirnia, Mehdi; Khodaeiani, Effat; Fouladi, Daniel F; Masoudnia, Sima

    2016-01-01

    Due to paucity of randomized clinical trials, intralesional immunotherapy has not been yet accepted as a standard therapeutic method. To examine the efficacy and safety of intralesional immunotherapy with tuberculin purified protein derivative (PPD) for treating recalcitrant wart. In this randomized, placebo-controlled, double-blind clinical trial, a total of 69 patients with recalcitrant warts received either intralesional PPD antigen (n = 35) or intralesional saline (n = 34) for six times at 2-week intervals. A third group of candidates for cryotherapy (n = 33) was also included. The decrease in lesion size (good: complete response, intermediate: 50-99% improvement, poor: cryotherapy patients, respectively (PPD versus placebo: p cryotherapy: p cryotherapy groups, respectively (p > 0.05). Intralesional immunotherapy with PPD antigen is highly effective and safe for treating recalcitrant warts. IRCT201407089844N3 in the Iranian Registry of Clinical Trials (IRCT).

  19. Flexible optical intubation via the Ambu Aura-i vs blind intubation via the single-use LMA Fastrach: a prospective randomized clinical trial.

    Science.gov (United States)

    Artime, Carlos A; Altamirano, Alfonso; Normand, Katherine C; Ferrario, Lara; Aijazi, Hassan; Cattano, Davide; Hagberg, Carin A

    2016-09-01

    This study was designed to compare the Ambu Aura-i to the single-use LMA Fastrach regarding time to intubation, success rate, and airway morbidity in patients undergoing elective surgery requiring general anesthesia. Prospective, randomized controlled trial. Academic medical center. Sixty-five adult patients scheduled for elective surgery requiring general anesthesia. Patients were randomized into 2 groups. Group A (n=33) were intubated using Ambu Aura-i and the Ambu aScope 2, a disposable flexible intubating scope, whereas those in group B (n=33) were blindly intubated using the Intubating Laryngeal Mask Airway (ILMA). First-attempt intubation success rate, overall intubation success rate, time to intubation, incidence of airway morbidity. The data demonstrated that time for endotracheal intubation in the ILMA group was significantly shorter than in the Ambu Aura-i group (PAura-i=26/33, 78.8%; ILMA=27/33, 81.8%; P=.757) or the overall intubation success rate (Aura-i=29/33, 87.9%; ILMA=31/33, 93.9%; P=.392) between the groups. Four patients (12%) in the Ambu Aura-i group had a failed intubation; 1 was due to a failure of the aScope monitor, whereas 3 were due to inability to visualize the glottis. Two patients (7%) in the ILMA group had a failed intubation due to esophageal intubation. There was no statistically significant difference in airway morbidity between the 2 groups. The data suggest that intubation with the ILMA is faster but that first-attempt and overall intubation success rates were comparable in both groups. The results suggest that although the flexible intubating scope-guided Aura-i does not outperform blind intubation via the ILMA, the technique is comparable in terms of first-attempt and overall intubation success rate. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

    DEFF Research Database (Denmark)

    Krogh, Jesper; Saltin, Bengt; Gluud, Christian

    2009-01-01

    OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners or psych......: Our findings do not support a biologically mediated effect of exercise on symptom severity in depressed patients, but they do support a beneficial effect of strength training on work capacity. TRIAL REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00103415....

  1. Does acromioplasty result in favorable clinical and radiologic outcomes in the management of chronic subacromial pain syndrome? A double-blinded randomized clinical trial with 9 to 14 years' follow-up.

    Science.gov (United States)

    Kolk, Arjen; Thomassen, Bregje J W; Hund, Hajo; de Witte, Pieter Bas; Henkus, Hans-Erik; Wassenaar, Willem G; van Arkel, Ewoud R A; Nelissen, Rob G H H

    2017-08-01

    The treatment effect of acromioplasty for chronic subacromial pain syndrome (SAPS) on long-term shoulder function and rotator cuff deterioration has still to be determined. This study aimed to determine the long-term clinical and radiologic treatment effect of arthroscopic acromioplasty in patients with chronic SAPS. In this double-blind, randomized clinical trial, 56 patients with chronic SAPS (median age, 47 years; age range, 31-60 years) were randomly allocated to arthroscopic bursectomy alone or to bursectomy combined with acromioplasty and were followed up for a median of 12 years. The primary outcome was the Constant score. Secondary outcomes included the Simple Shoulder Test, visual analog scale (VAS) for pain, VAS for shoulder functionality, and rotator cuff integrity assessed with magnetic resonance imaging or ultrasound. A total of 43 patients (77%) were examined at a median of 12 years' follow-up. Intention-to-treat analysis at 12 years' follow-up did not show a significant additional treatment effect of acromioplasty on bursectomy alone in improvement in Constant score (5 points; 95% confidence interval, -5.1 to 15.6), Simple Shoulder Test score, VAS score for pain, or VAS score for shoulder function. The prevalence of rotator cuff tears was not significantly different between the bursectomy group (17%) and acromioplasty group (10%). There were no relevant additional effects of arthroscopic acromioplasty on bursectomy alone with respect to clinical outcomes and rotator cuff integrity at 12 years' follow-up. These findings bring the effectiveness of acromioplasty into question and may support the idea of a more conservative approach in the initial treatment of SAPS. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  2. Randomized, double-blind clinical trial of a lactose-free and a lactose-containing formula in dietary management of acute childhood diarrhea.

    Science.gov (United States)

    Simakachorn, Nipat; Tongpenyai, Yothi; Tongtan, Orapin; Varavithya, Wandee

    2004-06-01

    Refeeding of artificially fed infants with lactose-containing formula after oral rehydration therapy in the treatment of acute diarrhea was concluded to be indifferent to non-lactose formula by a meta-analysis. In Thai as well as Asian infants and children with low lactase level from genetically determinant and with rotavirus infection, lactose malabsorption is most likely to occur and cause delayed recovery. The aim of this study was to compare the effect of a lactose-free and a lactose-containing formula in dietary management of acute childhood diarrhea. A randomized, double-blind clinical trial of 80 male children, formula-fed, aged 3 to 24 months, admitted with acute watery diarrhea and mild or moderate dehydration, was carried out. All children received oral rehydration therapy for the first 4 hours. After appropriate rehydration, they were fed either a lactose-free formula (Dumex Lactose-Free Formula; treatment group, n = 40) or a lactose-containing formula (Dumex Infant Formula; control group, n = 40) in adjunction with oral rehydration solution. In addition, the infants were fed rice gruel as tolerated. Comparisons of duration of diarrhea, weight gain, vomiting, biochemical changes, stool frequency and weight and unscheduled intravenous fluid were made. Three children (2 treatment, and 1 control) dropped out from the study. The total number of unscheduled intravenous infusions were 6 of 80 children (7.5%), including 2 (5.0%) in the treatment group and 4 (10.0%) in the control group. Three children in the control group did not resolve from diarrhea within 7 days of treatment. Rotavirus was identified in approximately 50% of the children in each group. Using survival analysis, the median duration of diarrhea was significantly shortened by 20.5 hours in the treatment group compared to the control group (77.0 hours in the treatment group vs 97.5 hours in the control group; P = 0.002). Significantly decrease in stool frequency and increase in percent weight gain

  3. Evaluation of Clinical Effectiveness and Subjective Satisfaction of a New Toothbrush for Postsurgical Hygiene Care: A Randomized Split-Mouth Double-Blind Clinical Trial

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    Marco Montevecchi

    2015-01-01

    Full Text Available The aim of this RCT was to evaluate plaque control and gingival health promotion effectiveness of a new toothbrush with extra-soft filaments in postsurgical sets. Ten consecutive patients with at least two scheduled symmetrical periodontal surgeries were selected. Following the first periodontal surgery, a test (TB1 or control (TB2 toothbrush was randomly assigned. After the second surgery, the remaining toothbrush was given. Patients were asked to gently wipe the surgical area from days 3 to 7 postoperatively and to gently brush using a roll technique from day 7 till the end of the study. Baseline evaluation took place on the day of surgery and follow-ups were performed at days 7, 14, and 30 postoperatively. A more evident PI reduction was recorded for test toothbrush where a regular decrease was observed till day 14; then, this parameter tended to stabilize, remaining however lower than that recorded for the control toothbrush. There were no statistical differences in the GI between test and control toothbrushes. All patients introduced the test toothbrush at surgical site at third day; the control toothbrush was introduced within a mean of 9 days. The introduction of the test toothbrush 3 days after periodontal surgery may be recommended.

  4. Evaluation of clinical effectiveness and subjective satisfaction of a new toothbrush for postsurgical hygiene care: a randomized split-mouth double-blind clinical trial.

    Science.gov (United States)

    Montevecchi, Marco; Moreschi, Annalisa; Gatto, Maria Rosaria; Checchi, Luigi; Checchi, Vittorio

    2015-01-01

    The aim of this RCT was to evaluate plaque control and gingival health promotion effectiveness of a new toothbrush with extra-soft filaments in postsurgical sets. Ten consecutive patients with at least two scheduled symmetrical periodontal surgeries were selected. Following the first periodontal surgery, a test (TB1) or control (TB2) toothbrush was randomly assigned. After the second surgery, the remaining toothbrush was given. Patients were asked to gently wipe the surgical area from days 3 to 7 postoperatively and to gently brush using a roll technique from day 7 till the end of the study. Baseline evaluation took place on the day of surgery and follow-ups were performed at days 7, 14, and 30 postoperatively. A more evident PI reduction was recorded for test toothbrush where a regular decrease was observed till day 14; then, this parameter tended to stabilize, remaining however lower than that recorded for the control toothbrush. There were no statistical differences in the GI between test and control toothbrushes. All patients introduced the test toothbrush at surgical site at third day; the control toothbrush was introduced within a mean of 9 days. The introduction of the test toothbrush 3 days after periodontal surgery may be recommended.

  5. Effectiveness of low-dose doxycycline (LDD on clinical symptoms of Sjögren's Syndrome: a randomized, double-blind, placebo controlled cross-over study

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    Vuotila Tuija

    2007-12-01

    Full Text Available Abstract Background Matrix metalloproteinases (MMPs are proteolytic enzymes that may contribute to tissue destruction in Sjögren's syndrome (SS. Low-dose doxycycline (LDD inhibits MMPs. We evaluated the efficacy of LDD for the subjective symptoms in primary SS patients. This was a randomized, double blind, placebo controlled cross-over study. 22 patients were randomly assigned to receive either 20 mg LDD or matching placebo twice a day for 10 weeks. The first medication period was followed by 10-week washout period, after which the patient received either LDD or placebo, depending on the first drug received, followed by the second washout period. Stimulated saliva flow rates and pH were measured before and after one and ten weeks of each medication and after washout periods. VAS scale was used to assess the effect of LDD and placebo on following six subjective symptoms: xerostomia; xerophtalmia; difficulty of swallowing; myalgia; arthralgia; and fatigue. The effect was evaluated for each medication and washout period separately. Results Overall, the effects of medications on subjective symptoms were minor. Wilcoxon test demonstrated increased fatigue with LDD during medication (p Conclusion LDD may not be useful in reducing the primary SS symptoms.

  6. Perioperative bromelain reduces pain and swelling and improves quality of life measures after mandibular third molar surgery: a randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Majid, Omer Waleed; Al-Mashhadani, Bashar Adil

    2014-06-01

    The purpose of the present study was to compare the effect of oral bromelain (4 × 250 mg) versus oral diclofenac sodium (4 × 25 mg) on pain, swelling, trismus, and quality of life (QOL) after surgical removal of impacted lower third molars. A randomized, double-blind, placebo-controlled study was planned. The sample included patients requiring extraction under local anesthesia of a single partial bony impacted mandibular third molar. The patients were randomly distributed into 1 of 3 groups: bromelain, diclofenac, and placebo. Treatment started 1 day before surgery and continued for 4 days. The predictor variable was the type of the drug given to the patients. The outcome variables were pain, swelling, and trismus, which were measured at 1, 3, and 7 days postoperatively. The other study variables included QOL measures to assess the patients' perception regarding the effect of surgery on their well-being and daily activities. A validated questionnaire was used to measure QOL. The data were analyzed using analysis of variance, multiple measures analysis of variance, or Pearson's χ(2) test, as appropriate. P third molar under local anesthesia were included in the present study. The bromelain and diclofenac groups both showed a significant reduction in pain compared with the placebo group at all intervals (P third molars, with an effect on the postoperative sequelae comparable to that of preemptive diclofenac sodium. Copyright © 2014 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  7. Survey of Synergistic Effect of L-carnitine with Glutamine on Body Composition and Dietary Intake in Soccer Players: A Double-blind, Randomized Clinical Trial

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    Mohammad Hozoori

    2016-10-01

    Full Text Available Background: The present study was conducted to investigate the possible effects of L-carnitine and glutamine and their synergistic effects on male soccer athletes. Methods: 28 male soccer players (21.1 ± 0.7 y were enrolled in a randomized pre and post intervention, double-blind design. Before the intervention, their performances were assessed by Bruce protocol, and their body composition was measured with the body composition analyzer. Then, athletes were randomly allocated into four groups: 2 g L-glutamine, 2 g L-carnitine, 2 g L-carnitine + 2 g L-glutamine and placebo. Supplements were prescribed for 21 days and after three weeks, athletes' performances and body composition were re-evaluated. Results: The results showed that body weight, body fat percentage, lean muscle mass, and dietary intake made no significant changes in different groups of athletes. In between groups comparison, results did not significantly change in any performance indices. However, in L-carnitine supplement group, the results of pre and post intervention showed that the running distance and maximal oxygen uptake (VO2max increased significantly while the subjective sense of fatigue decreased significantly. Conclusions: Based on our findings, a three-week prescription of separateor combined glutamine and L-carnitine, had no effects on body composition or dietary intake in soccer players. But, the athletes' energy intake was more than the one reported in other studies. Although further studies are required to assess these effects on athletic performance.

  8. Clinical Efficacy of Traditional Chinese Medicine, Suan Zao Ren Tang, for Sleep Disturbance during Methadone Maintenance: A Randomized, Double-Blind, Placebo-Controlled Trial

    Science.gov (United States)

    Chan, Yuan-Yu; Chen, Yi-Hung; Yang, Szu-Nian; Lo, Wan-Yu; Lin, Jaung-Geng

    2015-01-01

    Methadone maintenance therapy is an effective treatment for opiate dependence, but more than three-quarters of persons receiving the treatment report sleep quality disturbances. In this double-blind, randomized, controlled trial, we recruited 90 individuals receiving methadone for at least one month who reported sleep disturbances and had Pittsburgh Sleep Quality Index (PSQI) scores > 5. The purpose of this study was to determine whether Suan Zao Ren Tang, one of the most commonly prescribed traditional Chinese medications for treatment of insomnia, improves subjective sleep among methadone-maintained persons with disturbed sleep quality. Ninety patients were randomly assigned to intervention group (n = 45) and placebo group (n = 45), and all participants were analyzed. Compared with placebo treatment, Suan Zao Ren Tang treatment for four weeks produced a statistically significant improvement in the mean total PSQI scores (P = 0.007) and average sleep efficiency (P = 0.017). All adverse events (e.g., lethargy, diarrhea, and dizziness) were mild in severity. Suan Zao Ren Tang is effective for improving sleep quality and sleep efficiency among methadone-maintained patients with sleep complaints. PMID:26346534

  9. Clinical Efficacy of Traditional Chinese Medicine, Suan Zao Ren Tang, for Sleep Disturbance during Methadone Maintenance: A Randomized, Double-Blind, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Yuan-Yu Chan

    2015-01-01

    Full Text Available Methadone maintenance therapy is an effective treatment for opiate dependence, but more than three-quarters of persons receiving the treatment report sleep quality disturbances. In this double-blind, randomized, controlled trial, we recruited 90 individuals receiving methadone for at least one month who reported sleep disturbances and had Pittsburgh Sleep Quality Index (PSQI scores > 5. The purpose of this study was to determine whether Suan Zao Ren Tang, one of the most commonly prescribed traditional Chinese medications for treatment of insomnia, improves subjective sleep among methadone-maintained persons with disturbed sleep quality. Ninety patients were randomly assigned to intervention group (n=45 and placebo group (n=45, and all participants were analyzed. Compared with placebo treatment, Suan Zao Ren Tang treatment for four weeks produced a statistically significant improvement in the mean total PSQI scores (P=0.007 and average sleep efficiency (P=0.017. All adverse events (e.g., lethargy, diarrhea, and dizziness were mild in severity. Suan Zao Ren Tang is effective for improving sleep quality and sleep efficiency among methadone-maintained patients with sleep complaints.

  10. Effectiveness of Topical Curcumin for Treatment of Mastitis in Breastfeeding Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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    Raha Afshariani

    2014-09-01

    Full Text Available Objective: To determine the efficacy of topical curcumin in reducing breast inflammation in women suffering from lactational mastitis. Methods: A randomized double-blind, placebo-controlled study including 63 breastfeeding women with lactational mastitis were randomly assigned to receive curcumin topical cream, one pump every 8 hours for 3 days (n=32 or topical moisturizer as placebo (n=31. Using an index for severity of breast inflammation, all of the patients had moderate breast inflammation before entering the study. The outcome of treatment was evaluated using the same index at 24, 48 and 72 hours of starting the treatment. Results: There was no significant difference between two study groups regarding the baseline characteristics such as age (p=0.361 and duration of lactation (p=0.551. After 72-hour of therapy, patients in curcumin groups had significantly lower rate of moderate (p=0.019 and mild (p=0.002 mastitis. Patients in curcumin group had significantly lower scores for tension (p<0.001, erythema (p<0.001 and pain (p<0.001, after 72-hour of treatment. Conclusion: The results of the current study indicate that topical preparation of curcumin successfully decrease the markers of lactational mastitis such as pain, breast tension and erythema within 72 hours of administration without side effects. Thus, topical preparation of curcumin could be safely administered for those suffering from lactational mastitis after excluding infectious etiologies.

  11. Korean traditional Chungkookjang improves body composition, lipid profiles and atherogenic indices in overweight/obese subjects: a double-blind, randomized, crossover, placebo-controlled clinical trial.

    Science.gov (United States)

    Byun, M-S; Yu, O-K; Cha, Y-S; Park, T-S

    2016-10-01

    Chungkookjang is a Korean representative fermented soybean food. In this study, we investigated the effect of Korean traditional Chungkookjang compared with placebo on body composition, dyslipidemia and risk factors for atherosclerosis in overweight/obese subjects. This double-blind, randomized, controlled crossover trial was conducted on 120 overweight/obese subjects, aged 19-29 years. Subjects were randomly divided into a Chungkookjang (n=60) or a placebo (n=60) group. After 12 weeks, the groups were crossed over for an additional 12 weeks. During the intervention period, subjects were asked to maintain their usual diet and activity and not to take any functional foods or dietary supplements. The anthropometric measures, lipid profiles and atherogenic indices were determined at baseline and at the end of each 12-week period. The anthropometry measurements, percentage body fat, lean body mass, waist circumference and waist-to-hip ratio of women in the Chungkookjang group were significantly improved compared with the placebo group. Lipid profiles and high-sensitivity C-reactive protein of women in Chungkookjang were significantly improved. The atherogenic indices of apolipoprotein B/apolipoprotein A1 decreased in both the placebo and the Chungkookjang group, and it also decreased below 0.55 for all the men and women in the Chungkookjang group. In conclusion, these results suggest that supplementation with Chungkookjang may improve body composition and risk factors for cardiovascular disease in overweight and obese adults.

  12. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial.

    Science.gov (United States)

    Murphy, Glenn S; Szokol, Joseph W; Avram, Michael J; Greenberg, Steven B; Shear, Torin D; Deshur, Mark A; Vender, Jeffery S; Benson, Jessica; Newmark, Rebecca L

    2017-05-01

    Patients undergoing spinal fusion surgery often experience severe pain during the first three postoperative days. The aim of this parallel-group randomized trial was to assess the effect of the long-duration opioid methadone on postoperative analgesic requirements, pain scores, and patient satisfaction after complex spine surgery. One hundred twenty patients were randomized to receive either methadone 0.2 mg/kg at the start of surgery or hydromorphone 2 mg at surgical closure. Anesthetic care was standardized, and clinicians were blinded to group assignment. The primary outcome was intravenous hydromorphone consumption on postoperative day 1. Pain scores and satisfaction with pain management were measured at postanesthesia care unit admission, 1 and 2 h postadmission, and on the mornings and afternoons of postoperative days 1 to 3. One hundred fifteen patients were included in the analysis. Median hydromorphone use was reduced in the methadone group not only on postoperative day 1 (4.56 vs. 9.90 mg) but also on postoperative days 2 (0.60 vs. 3.15 mg) and 3 (0 vs. 0.4 mg; all Pmethadone group at 21 of 27 assessments (all P = 0.001 to methadone group than in the hydromorphone group until the morning of postoperative day 3 (all P = 0.001 to methadone administration reduced postoperative opioid requirements, decreased pain scores, and improved patient satisfaction with pain management.

  13. Efficacy, Safety, and Preparation of Standardized Parenteral Nutrition Regimens: Three-Chamber Bags vs Compounded Monobags-A Prospective, Multicenter, Randomized, Single-Blind Clinical Trial.

    Science.gov (United States)

    Yu, Jianchun; Wu, Guohao; Tang, Yun; Ye, Yingjiang; Zhang, Zhongtao

    2017-08-01

    Parenteral nutrition (PN) covering the need for carbohydrates, amino acids, and lipids can either be compounded from single nutrients or purchased as an industrially manufactured ready-to-use regimen. This study compares a commercially available 3-chamber bag (study group) with a conventionally compounded monobag regarding nutrition efficacy, safety, and regimen preparation time. This prospective, randomized, single-blind study was conducted at 5 Chinese hospitals from October 2010-October 2011. Postsurgical patients requiring PN for at least 6 days were randomly assigned to receive the study or control regimen. Plasma concentrations of prealbumin and C-reactive protein (CRP), regimen preparation time, length of hospital stay (LOS), 30-day mortality, safety laboratory parameters, and adverse events (AEs) were recorded. In total, 240 patients (121 vs 119 in study and control groups) participated in this study. Changes in prealbumin concentrations during nutrition support (Δ Prealb(StudyGroup) = 2.65 mg/dL, P values were comparable. Regimen preparation time was significantly reduced in the study group by the use of 3-chamber bags (t (StudyGroup) = 4.90 ± 4.41 minutes vs t (ControlGroup) = 12.13 ± 5.62 minutes, P bag was comparable to the compounded regimen and safe in use. Time savings during regimen preparation indicates that use of 3-chamber bags simplifies the process of regimen preparation.

  14. Effect of single-dose low-level helium-neon laser irradiation on orthodontic pain: a split-mouth single-blind placebo-controlled randomized clinical trial.

    Science.gov (United States)

    Sobouti, Farhad; Khatami, Maziar; Chiniforush, Nasim; Rakhshan, Vahid; Shariati, Mahsa

    2015-01-01

    Pain is the most common complication of orthodontic treatment. Low-level laser therapy (LLLT) has been suggested as a new analgesic treatment free of the adverse effects of analgesic medications. However, it is not studied thoroughly, and the available studies are quite controversial. Moreover, helium neon (He-Ne) laser has not been assessed before. This split-mouth placebo-controlled randomized clinical trial was performed on 16 male and 14 female orthodontic patients requiring bilateral upper canine retraction. The study was performed at a private clinic in Sari, Iran, in 2014. It was single blind: patients, orthodontist, and personnel were blinded of the allocations, but the laser operator (periodontist) was not blinded. Once canine retractor was activated, a randomly selected maxillary quarter received a single dose of He-Ne laser irradiation (632.8 nm, 10 mw, 6 j/cm(2) density). The other quarter served as the placebo side, treated by the same device but powered off. In the first, second, fourth, and seventh days, blinded patients rated their pain sensed on each side at home using visual analog scale (VAS) questionnaires. There was no harm identified during or after the study. Pain changes were analyzed using two- and one-way repeated-measures ANOVA, Bonferroni, and t-test (α = 0.01, β > 0.99). This trial was not registered. It was self-funded by the authors. Sixteen males and 11 females remained in the study (aged 12-21). Average pain scores sensed in all 4 intervals on control and laser sides were 4.06 ± 2.85 and 2.35 ± 1.77, respectively (t-test P laser therapy might reduce orthodontic pain caused by retracting maxillary canines.

  15. Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis

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    Paulo D. Picon

    2014-08-01

    Full Text Available OBJECTIVES: Anemia is a common complication among chronic kidney disease patients on hemodialysis, occurring mostly due to erythropoietin deficiency. This randomized noninferiority trial sought to compare the efficacy and safety of a new epoetin formulation developed by Bio-Manguinhos, a biologics manufacturer affiliated with the Brazilian government, with those of a commercially available product currently used in Brazil (a biosimilar epoetin formulation. METHODS: The sample size needed to enable demonstration of noninferiority with a statistical power of 85% for a between-group difference in hemoglobin levels of no more than 1.5 g/dL was calculated. In total, 74 patients were randomly assigned to receive the epoetin formulation from Bio-Manguinhos (n = 36 or the biosimilar epoetin formulation (n = 38 in a double-blind fashion. The inclusion criteria were current epoetin therapy and stable hemoglobin levels for at least 3 months prior to the study. The primary and secondary outcomes were mean monthly hemoglobin levels and safety, respectively. The dose was calculated according to international criteria and adjusted monthly in both groups according to hemoglobin levels and at the assistant physicians' discretion. Iron storage was estimated at baseline and once monthly. Clinicaltrials.gov: NCT01184495. RESULTS: The study was conducted for 6 months after randomization. The mean baseline hemoglobin levels were 10.9±1.2 and 10.96±1.2 g/dL (p = 0.89 in the Bio-Manguinhos epoetin and biosimilar epoetin groups, respectively. During the study period, there was no significant change in hemoglobin levels in either group (p = 0.055, ANOVA. The epoetin from Bio-Manguinhos was slightly superior in the last 3 months of follow-up. The adverse event profiles of the two formulations were also similar. CONCLUSIONS: The epoetin formulations tested in this study are equivalent in efficacy and safety.

  16. A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research base study.

    Science.gov (United States)

    Jean-Pierre, Pascal; Morrow, Gary R; Roscoe, Joseph A; Heckler, Charles; Mohile, Supriya; Janelsins, Michelle; Peppone, Luke; Hemstad, Amy; Esparaz, Benjamin T; Hopkins, Judith O

    2010-07-15

    Cancer-related fatigue is a debilitating symptom affecting psychosocial functioning and quality of life in 70% to 100% of cancer patients during and after treatment. The authors examined the effect of 200 mg of modafinil daily on the severity of cancer-related fatigue. The authors conducted a multicenter, randomized, double-blind, placebo-controlled, phase 3, clinical trial to examine the effect of modafinil on patient-reported fatigue in cancer patients undergoing chemotherapy. A sample of 877 cancer patients beginning chemotherapy at 23 geographically separate University of Rochester Cancer Center (URCC) Community Clinical Oncology Program (CCOP) affiliates were assessed for fatigue. Patients who reported fatigue (N=867) were randomly assigned to receive either 200 mg of oral modafinil (Provigil) daily or a placebo. Treatment began on Day 5 of Cycle 2 and ended after Day 7 of Cycle 4. Fatigue and depression were assessed during Cycles 2 to 4 by using psychometrically valid measures. Group differences (treatment vs control) in the worst level of fatigue during the previous week at Cycle 4 were examined by using an analysis of covariance (ANCOVA) adjusting for baseline fatigue (Cycle 2). There were 631 patients (315 modafinil, 316 placebo) who provided evaluable data. ANCOVA showed a significant interaction between treatment condition and baseline fatigue (P=.017), where patients with severe baseline fatigue (n=458) benefited from modafinil, whereas patients with mild or moderate fatigue did not. Modafinil had no statistically significant effect on depression (P>.05). Modafinil may be useful in controlling cancer-related fatigue in patients who present with severe fatigue but is not useful in patients with mild or moderate fatigue. Copyright (c) 2010 American Cancer Society.

  17. Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study.

    Science.gov (United States)

    Majeed, Muhammed; Nagabhushanam, Kalyanam; Natarajan, Sankaran; Sivakumar, Arumugam; Ali, Furqan; Pande, Anurag; Majeed, Shaheen; Karri, Suresh Kumar

    2016-02-27

    Bacillus coagulans MTCC 5856 has been marketed as a dietary ingredient, but its efficacy in diarrhea predominant irritable bowel syndrome (IBS) condition has not been clinically elucidated till date. Thus, a double blind placebo controlled multi-centered trial was planned to evaluate the safety and efficacy of B. coagulans MTCC 5856 in diarrhea predominant IBS patients. Thirty six newly diagnosed diarrhea predominant IBS patients were enrolled in three clinical centres. Along with standard care of treatment, 18 patients in group one received placebo while in group two 18 patients received B. coagulans MTCC 5856 tablet containing 2 × 10(9) cfu/day as active for 90 days. Clinical symptoms of IBS were considered as primary end point measures and were evaluated through questionnaires. The visual analog scale (VAS) was used for abdominal pain. Physician's global assessment and IBS quality of life were considered as secondary efficacy measures and were monitored through questionnaires. Laboratory parameters, anthropometric and vital signs were within the normal clinical range during the 90 days of supplementation in placebo and B. coagulans MTCC 5856 group. There was a significant decrease in the clinical symptoms like bloating, vomiting, diarrhea, abdominal pain and stool frequency in a patient group receiving B. coagulans MTCC 5856 when compared to placebo group (p coagulans MTCC 5856 when compared to placebo group. The study concluded that the B. coagulans MTCC 5856 at a dose of 2 × 10(9) cfu/day along with standard care of treatment was found to be safe and effective in diarrhea predominant IBS patients for 90 days of supplementation. Hence, B. coagulans MTCC 5856 could be a potential agent in the management of diarrhea predominant IBS patients.

  18. Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model.

    Science.gov (United States)

    Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

    2017-01-01

    Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20-60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Our results suggest that RJ improves tear volume in patients with dry eye. Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446).

  19. Comparison of efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine in patients of allergic rhinitis: A randomized, double-blind clinical trial.

    Science.gov (United States)

    Mahatme, Mohini Sachin; Dakhale, Ganesh Natthuji; Tadke, Kanchan; Hiware, Sachin Keshaorao; Dudhgaonkar, S D; Wankhede, Sumit

    2016-01-01

    Allergic rhinitis (AR) is a global health problem. Almost 10%-25% of population worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor antagonists, and intranasal corticosteroids are the pillars in the management of AR. The combination therapy of montelukast with antihistaminic provides enhancing and complimentary effects, thereby reducing the symptoms effectively, but there are scanty data regarding the comparisons of combinations. Therefore, we aimed to compare the efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine combination in patients of AR. Seventy patients with AR participated in a prospective, randomized, double-blind, parallel, active-controlled, comparative 4-week trial. The patients between the age group of 18-65 years of either gender having moderate-severe intermittent or mild persistent AR were included in the study. The study inclusion criteria required the patients with total nasal symptom score (TNSS) of 5 or higher. The patients were randomly divided into two treatment groups with montelukast-levocetirizine (10 mg and 5 mg) in one group and montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main effectiveness parameter. Evaluation of TNSS revealed significant difference ( P < 0.05) when compared from baseline to 4 th week in both groups. The mean change of TNSS, i.e., 9.46 was significant ( P < 0.05) in montelukast-fexofenadine group. The cost-effectiveness ratio was less in montelukast-levocetirizine group than in montelukast-fexofenadine group. The decrease in TNSS was more in montelukast-fexofenadine group, but the cost-effectiveness is more with montelukast-levocetirizine combination.

  20. Efficacy of Ketorolac Buccal Infiltrations and Inferior Alveolar Nerve Blocks in Patients with Irreversible Pulpitis: A Prospective, Double-blind, Randomized Clinical Trial.

    Science.gov (United States)

    Akhlaghi, Nahid Mohammadzadeh; Hormozi, Behnoush; Abbott, Paul V; Khalilak, Zohreh

    2016-05-01

    The purpose of this prospective, randomized, double-blind, placebo-controlled study was to determine whether ketorolac buccal infiltrations (BIs) helped to improve the success of inferior alveolar nerve blocks (IANBs) in patients with acute irreversible pulpitis (AIP). Forty adult volunteers with AIP in a mandibular molar were included in this study. Patients were instructed to evaluate their pain by using a Heft-Parker visual analog scale. They were randomly divided into 2 groups (n = 20). All patients received standard IANB injection and after that a BI of 4% articaine with 1:100,000 epinephrine. After 5 minutes, 20 patients received a BI of 30 mg/mL ketorolac, and the other received a BI of normal saline (control group). Endodontic access cavity preparation (ACP) was initiated 15 minutes after the IANB when the patient reported lip numbness and had 2 electric pulp tests with no responses. The patient's pain during caries and dentin removal, ACP, and canal length measurements (CLM) was recorded by using Heft-Parker visual analog scale. Successful anesthesia was defined as no or mild pain during any of these steps, without the need for additional injection. Data were statistically analyzed by using Mann-Whitney U and χ(2) tests. Successful anesthesia after an IANB plus BI of articaine was obtained in 15% of patients in the control group at the end of CLM. Adding BI of ketorolac significantly increased the success rate to 40% (P < .05). Patient's pain during ACP and CLM was significantly lower in the ketorolac group (P < .05). Ketorolac BI can increase the success rate of anesthesia after IANB and BI with articaine in patients with AIP. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  1. Photobiomodulation therapy (PBMT) and/or cryotherapy in skeletal muscle restitution, what is better? A randomized, double-blinded, placebo-controlled clinical trial.

    Science.gov (United States)

    de Paiva, Paulo Roberto Vicente; Tomazoni, Shaiane Silva; Johnson, Douglas Scott; Vanin, Adriane Aver; Albuquerque-Pontes, Gianna Móes; Machado, Caroline Dos Santos Monteiro; Casalechi, Heliodora Leão; de Carvalho, Paulo de Tarso Camillo; Leal-Junior, Ernesto Cesar Pinto

    2016-12-01

    Cryotherapy for post-exercise recovery remains widely used despite the lack of quality evidence. Photobiomodulation therapy (PBMT) studies (with both low-level laser therapy and light-emitting diode therapy) have demonstrated positive scientific evidence to suggest its use. The study aims to evaluate PBMT and cryotherapy as a single or combined treatment on skeletal muscle recovery after eccentric contractions of knee extensors. Fifty healthy male volunteers were recruited and randomized into five groups (PBMT, cryotherapy, cryotherapy + PBMT, PMBT + cryotherapy, or placebo) for a randomized, double-blinded, placebo-controlled trial that evaluated exercise performance (maximum voluntary contraction (MVC)), delayed onset muscle soreness (DOMS), and muscle damage (creatine kinase (CK)). Assessments were performed at baseline; immediately after; and at 1, 24, 48, 72, and 96 h. Comparator treatments was performed 3 min after exercise and repeated at 24, 48, and 72 h. PBMT was applied employing a cordless, portable GameDay ™ device (combination of 905 nm super-pulsed laser and 875- and 640-nm light-emitting diodes (LEDs); manufactured by Multi Radiance Medical ™ , Solon - OH, USA), and cryotherapy by flexible rubber ice packs. PBMT alone was optimal for post-exercise recovery with improved MVC, decreased DOMS, and CK activity (p cryotherapy, and cryotherapy + PBMT. In the PBMT + cryotherapy group, the effect of PBMT was decreased (p > 0.05) but demonstrated significant improvement in MVC, decreased DOMS, and CK activity (p Cryotherapy as single treatment and cryotherapy + PBMT were similar to placebo (p > 0.05). We conclude that PBMT used as single treatment is the best modality for enhancement of post-exercise restitution, leading to complete recovery to baseline levels from 24 h after high-intensity eccentric contractions.

  2. Safety profile of incobotulinum toxin A [Xeomin(®)] in gastrocnemious muscles injections in children with cerebral palsy: Randomized double-blind clinical trial.

    Science.gov (United States)

    Carraro, Elena; Trevisi, Enrico; Martinuzzi, Andrea

    2016-07-01

    The only two preparations of botulinum toxin A for which there are published evidences of efficacy in children with cerebral palsy are onabotulinum toxin A (Botox(®)) and abobotulinum toxin A (Dyport(®)); these toxins should be considered generally safe and appropriate in the treatment for localized upper and lower limb spasticity. To establish the safety profile of incobotulinum toxin A (Xeomin(®)) in children with cerebral palsy and muscle spasticity. Randomized double-blind controlled trial that involved the recruitment of children of both sexes with spastic hemiplegia or diplegia in cerebral palsy, aged between 3 and 18 years. Children were randomized to either the study group (SG, incobotulinum toxin A) or the control group (CG, onabotulinum toxin A) both to be injected with 5units/kg on gastrocnemius (medialis and lateralis) muscles. The occurrence of adverse events at baseline, after 48 h, 10 days and 3 months was recorded by the caregivers in a checklist that listed both common and uncommon side effects. 35 patients were treated (CG = 18; SG = 17); the 2 groups were well balanced regarding demographics and anthropometry characteristics. At least 1 adverse event occurred in 49% of patients within first 2 days, 46% between 2 and 10 days, and 12% between 10 and 90 days. All the reported events were minor; no serious adverse event was recorded. Fatigue was the most frequent complaint. There was no significant difference in frequency and type of events between the 2 groups. Incobotulinum toxin A and onabotulinum toxin A share similar profile of safety in the treatment of lower limb spasticity in CP children. Copyright © 2016 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

  3. Effects of lactoferrin and lactoperoxidase-containing food on the oral hygiene status of older individuals: A randomized, double blinded, placebo-controlled clinical trial.

    Science.gov (United States)

    Morita, Yu; Ishikawa, Kentaro; Nakano, Manabu; Wakabayashi, Hiroyuki; Yamauchi, Koji; Abe, Fumiaki; Ooka, Takafumi; Hironaka, Shouji

    2017-05-01

    Lactoferrin and lactoperoxidase have antimicrobial effects against oral pathogens. This randomized, double-blinded, placebo-controlled parallel group study tested the efficacy of a lactoferrin and lactoperoxidase-containing tablet (LF + LPO tablet) in improving the oral hygiene status of older individuals. A total of 46 participants (31 nursing home residents and 15 healthy older individuals) were randomly assigned to receive either lactoferrin and lactoperoxidase-containing tablets or placebo tablets, and were asked to suck on a tablet after every meal for 8 weeks. Oral and bacteriological assessments were carried out at baseline, 4 weeks and 8 weeks. A total of 47 participants (test group n = 20; mean age 80.4 ± 6.4 years; placebo group n = 17; mean age 85.9 ± 6.7 years) were included in the efficacy analysis. In the test group, the total number of bacteria in the tongue coating was significantly reduced at 4 and 8 weeks compared with that at baseline, and the number of Porphyromonas gingivalis and Fusobacterium nucleatum was significantly reduced at 8 weeks. The total number of bacteria and the number of P. gingivalis in the supragingival plaque were significantly reduced at 8 weeks. Furthermore, there was a significant difference in the change in the number of P. gingivalis in supragingival plaque at 8 weeks between the two groups. Lactoferrin and lactoperoxidase-containing tablet ingestion showed antibacterial effects on periodontal bacteria present in the tongue coating and supragingival plaque, indicating that long-term ingestion could improve the oral hygiene of older individuals. Geriatr Gerontol Int 2017; 17: 714-721. © 2016 Japan Geriatrics Society.

  4. Effects of a soy-based dietary supplement compared with low-dose hormone therapy on the urogenital system: a randomized, double-blind, controlled clinical trial.

    Science.gov (United States)

    Carmignani, Lucio O; Pedro, Adriana Orcesi; Montemor, Eliana B; Arias, Victor A; Costa-Paiva, Lucia H; Pinto-Neto, Aarão M

    2015-07-01

    This study aims to compare the effects of a soy-based dietary supplement, low-dose hormone therapy (HT), and placebo on the urogenital system in postmenopausal women. In this double-blind, randomized, placebo-controlled trial, 60 healthy postmenopausal women aged 40 to 60 years (mean time since menopause, 4.1 y) were randomized into three groups: a soy dietary supplement group (90 mg of isoflavone), a low-dose HT group (1 mg of estradiol plus 0.5 mg of norethisterone), and a placebo group. Urinary, vaginal, and sexual complaints were evaluated using the urogenital subscale of the Menopause Rating Scale. Vaginal maturation value was calculated. Transvaginal sonography was performed to evaluate endometrial thickness. Genital bleeding pattern was assessed. Statistical analysis was performed using χ(2) test, Fisher's exact test, paired Student's t test, Kruskal-Wallis test, Kruskal-Wallis nonparametric test, and analysis of variance. For intergroup comparisons, Kruskal-Wallis nonparametric test (followed by Mann-Whitney U test) was used. Vaginal dryness improved significantly in the soy and HT groups (P = 0.04). Urinary and sexual symptoms did not change with treatment in the three groups. After 16 weeks of treatment, there was a significant increase in maturation value only in the HT group (P < 0.01). Vaginal pH decreased only in this group (P < 0.01). There were no statistically significant differences in endometrial thickness between the three groups, and the adverse effects evaluated were similar. This study shows that a soy-based dietary supplement used for 16 weeks fails to exert estrogenic action on the urogenital tract but improves vaginal dryness.

  5. Pulsed electromagnetic field and exercises in patients with shoulder impingement syndrome: a randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Galace de Freitas, Diego; Marcondes, Freddy Beretta; Monteiro, Renan Lima; Rosa, Sabrina Gonçalves; Maria de Moraes Barros Fucs, Patrícia; Fukuda, Thiago Yukio

    2014-02-01

    To evaluate the effects of pulsed electromagnetic field (PEMF) and exercises in reducing pain and improving function and muscle strength in patients with shoulder impingement syndrome (SIS). Double-blind, randomized controlled trial with a 3-month posttreatment follow-up. Outpatient rehabilitation of a public hospital. Patients (N=56) between 40 and 60 years of age, with a diagnosis of SIS, were randomly assigned to receive active PEMF (n=26; mean age, 50.1y) or placebo PEMF (n=30; mean age, 50.8y). After 3 weeks of active or placebo PEMF, both groups performed the same program of exercises that focused on shoulder strengthening. A visual analog scale, the University of California/Los Angeles shoulder rating scale, the Constant-Murley shoulder score, and handheld dynamometry for muscle strength were used as outcome measures at baseline (pretreatment), at 3 weeks (after active or placebo PEMF), at 9 weeks (postexercise), and at 3 months posttreatment. Patients in the active PEMF group had a higher level of function and less pain at all follow-up time frames compared with baseline (Pshoulder dynamometry, the active PEMF group had increased strength for lateral rotation at 9 weeks (Pshoulder strength in the placebo PEMF group (P>.05), as well as no significant differences (P>.05) for all outcome measures. The combination of PEMF and shoulder exercises is effective in improving function and muscle strength and decreasing pain in patients with SIS. However, these results should be carefully interpreted because of the lack of differences between groups. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  6. Vaginal misoprostol prior to intrauterine device insertion in women delivered only by elective cesarean section: a randomized double-blind clinical trial.

    Science.gov (United States)

    Abdellah, Mohamed S; Abbas, Ahmed M; Hegazy, Aml M; El-Nashar, Ihab M

    2017-06-01

    The current study aims to evaluate if vaginal misoprostol (400 mcg) administered prior to intrauterine device (IUD) insertion increases the ease and success of insertion among women who had delivered only by elective cesarean delivery (CD). The current study was a randomized, double-blind, placebo-controlled trial conducted in Assiut Women's Health Hospital, Egypt, between the 1st of April 2015 and the 31st of March 2016 and included women who delivered only by elective CD. One hundred forty women were randomized into two groups; misoprostol group received two misoprostol 400-mcg tablets vaginally, and placebo group received two placebo tablets 3 h before a copper T380A IUD insertion. The primary outcome measure was the difference in the ease of insertion score using a 10-cm visual analog scale between both groups with 0=very easy insertion, and 10=terribly difficult insertion. The ease of insertion score was lower in the misoprostol group (2.2±0.5 vs. 4.2±0.5, p=.0001) with higher number of successful IUD insertions than the placebo group (69 [98.6%] vs. 61 [87.1%], p=.009). The mean pain score reported by the women was lower in misoprostol group (2.7±0.6 vs. 4.3±0.8) with higher level of satisfaction from the whole procedure (8.9±0.4 vs. 7.9±0.2) with p=.001 for both. Misoprostol 400 mcg vaginally prior to IUD insertion eases and increase the success of insertion with reduction of pain among women who had delivered only by elective CD. The use of vaginal misoprostol before IUD insertion in women who had never delivered vaginally before may increase the ease and success of insertion. Moreover, it may reduce the pain felt by women during the procedure. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Comparison of Dill Seed Oil Mouth Rinse and Chlorhexidine Mouth Rinse on Plaque Levels and Gingivitis - A Double Blind Randomized Clinical Trial.

    Science.gov (United States)

    Eshwar, Shruthi; K, Rekha; Jain, Vipin; Manvi, Supriya; Kohli, Shivani; Bhatia, Shekhar

    2016-01-01

    Mouthrinses have been in use for centuries as breath fresheners, medicaments, and antiseptics. Dill is said to be a good source of calcium, manganese and iron. It contains flavonoids known for their antioxidant, anti-inflammatory, and antiviral properties. Dill can help with microbial infections in the mouth; and its anti-oxidants minimize damage caused by free radicals to the gums and teeth. Being a good source of calcium, dill also helps with bone and dental health. To compare the effectiveness of commercially available 0.2% chlorhexidine gluconate mouthrinse and dill seed oil mouthrinse on plaque levels and gingivitis. A randomized controlled, double blind parallel arm study was conducted over 90 days on 90 subjects. The subjects were randomly divided into 2 groups and baseline data was collected using Loe and Silness gingival index and Quigley Hein plaque index and oral prophylaxis was performed on all the subjects. The mouthrinses included in the present study were dill seed oil and Hexodent (0.2% chlorhexidine gluconate). Intervention regarding the mouthrinsing was given to the subjects and were followed up for 45 days and 90 days, after this post intervention changes were assessed using the respective indices. It was observed that there is no significant difference in gingival & plaque scores among two mouthrinses from baseline to 45 days and 90 days. It was observed that there is statistical difference in gingival and plaque scores when compared with baseline to 45 days (p<0.001), baseline to 90 days (p<0.001) and 45 days to 90 days (p<0.001) when intergroup comparisons were done. It was concluded that dill seed oil and Hexodent (0.2% chlorhexidine gluconate) mouthrinse have similar antiplaque and antigingival effectiveness.

  8. A 12-week double-blind randomized clinical trial of vitamin D₃ supplementation on body fat mass in healthy overweight and obese women.

    Science.gov (United States)

    Salehpour, Amin; Hosseinpanah, Farhad; Shidfar, Farzad; Vafa, Mohammadreza; Razaghi, Maryam; Dehghani, Sahar; Hoshiarrad, Anahita; Gohari, Mahmoodreza

    2012-09-22

    Vitamin D concentrations are linked to body composition indices, particularly body fat mass. Relationships between hypovitaminosis D and obesity, described by both BMI and waist circumference, have been mentioned. We have investigated the effect of a 12-week vitamin D3 supplementation on anthropometric indices in healthy overweight and obese women. In a double-blind, randomized, placebo-controlled, parallel-group trial, seventy-seven participants (age 38 ± 8.1 years, BMI 29.8 ± 4.1 kg/m²) were randomly allocated into two groups: vitamin D (25 μg per day as cholecalciferol) and placebo (25 μg per day as lactose) for 12 weeks. Body weight, height, waist, hip, fat mass, 25(OH) D, iPTH, and dietary intakes were measured before and after the intervention. Serum 25(OH)D significantly increased in the vitamin D group compared to the placebo group (38.2 ± 32.7 nmol/L vs. 4.6 ± 14.8 nmol/L; Psupplementation (-0.26 ± 0.57 pmol/L vs. 0.27 ± 0.56 pmol/L; PSupplementation with vitamin D3 caused a statistically significant decrease in body fat mass in the vitamin D group compared to the placebo group (-2.7 ± 2.1 kg vs. -0.47 ± 2.1 kg; Pbody weight and waist circumference did not change significantly in both groups. A significant reverse correlation between changes in serum 25(OH) D concentrations and body fat mass was observed (r = -0.319, P = 0.005). Among healthy overweight and obese women, increasing 25(OH) D concentrations by vitamin D3 supplementation led to body fat mass reduction.

  9. Single bolus low-dose of ketamine does not prevent postpartum depression: a randomized, double-blind, placebo-controlled, prospective clinical trial.

    Science.gov (United States)

    Xu, Yang; Li, Yuantao; Huang, Xiaolei; Chen, Daili; She, Baozuan; Ma, Daqing

    2017-05-01

    Postpartum depression is a common complication of childbirth. In the last decade, it has been suggested that subdissociative-dose ketamine is a fast-acting antidepressant. We aimed to investigate the efficacy of low-dose ketamine administered during caesarean section in preventing postpartum depression. Using a randomized, double-blind, placebo-controlled design, 330 parturients who were scheduled to undergo caesarean section were enrolled in this trial. The parturients were randomly assigned to receive intravenous ketamine (0.25 mg/kg diluted to 10 mL with 0.9% saline) or placebo (10 mL of 0.9% saline) within 5 min following clamping of the neonatal umbilical cord. The primary outcome was the degree of depression, which was evaluated using the Edinburgh Postnatal Depression Scale (EPDS) (a threshold of 9/10 was used) at 3 days and 6 weeks after delivery. The secondary outcome was the numeric rating scale score of pain at 3 day and 6 week postpartum. No significant differences were found in the prevalence of postpartum depression between the two groups at 3 days and 6 weeks after delivery. The pain scores measured at 3 days postoperatively were not significantly different between the groups, whereas the scores measured at 6 week postpartum were significantly reduced in the treatment group compared with the saline group (P = 0.014). Intra-operative low-dose ketamine (0.25 mg/kg) does not have a preventive effect on postpartum depression.

  10. The effect of l-arginine supplementation on body composition and performance in male athletes: a double-blinded randomized clinical trial.

    Science.gov (United States)

    Pahlavani, N; Entezari, M H; Nasiri, M; Miri, A; Rezaie, M; Bagheri-Bidakhavidi, M; Sadeghi, O

    2017-04-01

    Athletes used a lot of dietary supplements to achieve the more muscle mass and improve their athletic performance. The objective of this study was to investigate the effect of l-arginine supplementation on sport performance and body composition in male soccer players. This double-blinded, randomized and placebo-controlled trial was conducted on 56 male soccer players, with age range of 16-35, who referred to sport clubs in Isfahan, Iran. Subjects were randomly assigned to either l-arginine or placebo groups. Athletes received daily either 2 g per day l-arginine supplement or the same amount of placebo (maltodextrin) for 45 days. Sport performance and also body mass index (BMI), body fat mass (BFM) and lean body mass (LBM) were measured at the beginning and end of the study. Also, 3-day dietary records were collected at three different time points (before, in the middle of, and at the end of the study). The mean age of subjects was 20.85±4.29 years. Sport performance (VO 2 max) significantly increased in l-arginine supplementation group (4.12±6.07) compared with placebo group (1.23±3.36) (P=0.03). This increase remained significant even after adjustment of baseline values, physical activity and usual dietary intake of subjects throughout the study. No significant effect of l-arginine supplementation was found on weight, BMI, BFM and LBM. l-arginine supplementation (2 g per day) could increase the sport performance in male athletes, but had no effect on anthropometric measurements, including BMI, BFM and LBM. So, further studies are needed to shed light our findings.

  11. Effect of menstrual cycle on frequency of alveolar osteitis in women undergoing surgical removal of mandibular third molar: a single-blind randomized clinical trial.

    Science.gov (United States)

    Eshghpour, Majid; Rezaei, Naser Mohammadzadeh; Nejat, AmirHossein

    2013-09-01

    To measure the association between the menstrual cycle and the frequency of alveolar osteitis (AO). In a study with a single-blind design, patients with bilateral impacted third molar teeth underwent randomized surgical extraction: one tooth during the menstrual period and one during the middle of the cycle. The postoperative examiner was unaware of the menstrual cycle status of the patients. The predictor variable was the timing of the menstrual cycle and was grouped as mid-cycle and menstrual period. The outcome variable was AO, which was measured (without knowledge of the menstrual cycle timing) at 2 to 7 days postoperatively. Other study variables included oral contraceptive (OC) use, smoking status, irrigation used during surgery, extraction difficulty, surgeon experience, number of local anesthetic cartridges used, and patient age. Appropriate bi- and multivariate statistics were computed, and the level of statistical significance was set at P cycle than during the menstrual period inboth the OC users and nonusers (P menstrual period (P > .05). According to the results of the present study, the menstrual cycle could be a determinant risk factor in the frequency of AO. We recommend that elective procedures be performed during the menstrual period in both OC users and nonusers to eliminate the effect of cycle-related hormonal changes on the development of AO. Copyright © 2013 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  12. TORPEDO: Prospective, double blind, randomized clinical trial comparing the use of Ketorolac verse placebo during live donor nephrectomy for kidney transplant

    Directory of Open Access Journals (Sweden)

    Jeffrey Campsen

    2017-06-01

    Full Text Available The aim of this pilot study was to determine if the use of Ketorolac for donor nephrectomies could decrease the use of narcotics. Methods: This is a prospective, double blind, randomized trial involving patients undergoing nephrectomy for live donor kidney transplantation. Three arms: 1. Ketorolac 30 mg IV×1 in the OR, then ketorolac 15 mg IV every 6 h for 7 doses. 2. Ketorolac 30 mg IV×1 in the OR, then placebo IV every 6 h for 7 doses. 3. Placebo IV×1 in the OR, then placebo IV every 6 h for 7 doses. Outcomes: blood loss, mortality, renal function, cumulative narcotic use, length of hospital stay (LOS, and urinary retention. Results: There were no patient deaths, blood transfusions or renal dysfunction in any study arm. Arm 1 had less narcotic use, reduced length of stay, and reduced urinary retention than Arm 3. Conclusion: There was reduced LOS, less narcotic use and less urinary retention in the Ketorolac group (Arm 1 versus the placebo group (Arm 3. Based on these results we will proceed with a larger study to compare the use of non-opioid analgesics in donor nephrectomies.

  13. [Oral N-acetylcysteine in the treatment of Raynaud's phenomenon secondary to systemic sclerosis: a randomized, double-blind, placebo-controlled clinical trial].

    Science.gov (United States)

    Correa, Marcelo José Uchoa; Mariz, Henrique Ataíde; Andrade, Luís Eduardo Coelho; Kayser, Cristiane

    2014-01-01

    To evaluate the safety and efficacy of N-acetylcysteine (NAC) orally on digital microcirculation blood flow in patients with Raynaud's phenomenon (RP) secondary to systemic sclerosis (SSc). This was a randomized, double-blind, placebo-controlled trial in which 42 patients with SSc received oral NAC at a dose of 600mg tid (21 patients, mean age 45.6±9.5 years) or placebo (21 patients, mean age 45.0±12.7 years) for four weeks. The primary endpoint was the change in cutaneous microcirculation blood flow before and after cold stimulation measured by laser Doppler imaging (LDI) at weeks 0 and 4. The frequency and severity of RP and the number of digital ulcers were also measured at weeks 0 and 4. The adverse events were recorded in the fourth week. There was no significant change in digital blood flow assessed by LDI before or after cold stimulus after four weeks of NAC or placebo. Both groups showed significant improvement in the frequency and severity of RP attacks, with no difference between the two groups. At the end of the study, the placebo group had three digital ulcers, while the NAC group showed no ulcers. NAC was well tolerated and no patient discontinued the treatment. NAC orally at a dose of 1800mg/day showed no vasodilator effect on hands' microcirculation after four weeks of treatment in patients with RP secondary to SSc. Copyright © 2014 Elsevier Editora Ltda. All rights reserved.

  14. Effect of stretching with and without muscle strengthening exercises for the foot and hip in patients with plantar fasciitis: A randomized controlled single-blind clinical trial.

    Science.gov (United States)

    Kamonseki, Danilo H; Gonçalves, Geiseane A; Yi, Liu C; Júnior, Império Lombardi

    2016-06-01

    To compare the effect of stretching with and without muscle strengthening of the foot alone or foot and hip on pain and function in patients with plantar fasciitis. Single blind randomized controlled trial. Eighty-three patients with plantar fasciitis were allocated to one of three treatment options for an eight-week period: Foot Exercise Group (FEG - extrinsic and intrinsic foot muscles), Foot and Hip Exercise Group (FHEG - abductor and lateral rotator muscles) and Stretching Alone Exercise Group (SAEG). A visual analog scale for pain, the Foot and Ankle Outcome Score and the Star Excursion Balance Test. All evaluations were performed before treatment and after the last treatment session. Improvements were found in all groups regarding the visual analog scale, the pain, activities of daily living, sports and recreation, quality of life (p  0.05). All three exercise protocols analyzed led to improvements at eight-week follow-up in pain, function and dynamic lower limb stability in patients with plantar fasciitis. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. Effect of inhalation aromatherapy with lavender essential oil on stress and vital signs in patients undergoing coronary artery bypass surgery: A single-blinded randomized clinical trial.

    Science.gov (United States)

    Bikmoradi, Ali; Seifi, Zahra; Poorolajal, Jalal; Araghchian, Malihe; Safiaryan, Reza; Oshvandi, Khodayar

    2015-06-01

    At present, aromatherapy is used widely in medical research. This study aimed to investigate the effects of inhalation aromatherapy using lavender essential oil to reduce mental stress and improve the vital signs of patients after coronary artery bypass surgery (CABG). A single-blinded randomized controlled trial was conducted with 60 patients who had undergone CABG in a 2-day intervention that targeted stress reduction. Sixty subjects following coronary artery bypass surgery in two aromatherapy and control groups. The study was conducted in Ekbatan Therapeutic and Educational Center, Hamadan, Iran, in 2013. On the second and third days after surgery, the aromatherapy group patients received two drops of 2% lavender essential oil for 20min and the control group received two drops of distilled water as a placebo. The primary outcome was mental stress, which was measured before and after the intervention using the DASS-21 questionnaire. The secondary outcomes were vital signs, including the heart rate, respiratory rate, and systolic and diastolic blood pressure, which were measured before and after the intervention. The individual characteristics of the aromatherapy and control groups were the same. There were no significant difference in the mean mental stress scores and vital signs of the aromatherapy and control groups on the second or third days after surgery. Inhalation aromatherapy with lavender essential oil had no significant effects on mental stress and vital signs in patients following CABG, except the systolic blood pressure. Copyright © 2014 Elsevier Ltd. All rights reserved.

  16. Blueberries improve endothelial function, but not blood pressure, in adults with metabolic syndrome: a randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Stull, April J; Cash, Katherine C; Champagne, Catherine M; Gupta, Alok K; Boston, Raymond; Beyl, Robbie A; Johnson, William D; Cefalu, William T

    2015-05-27

    Blueberry consumption has been shown to have various health benefits in humans. However, little is known about the effect of blueberry consumption on blood pressure, endothelial function and insulin sensitivity in humans. The present study investigated the role of blueberry consumption on modifying blood pressure in subjects with metabolic syndrome. In addition, endothelial function and insulin sensitivity (secondary measurements) were also assessed. A double-blind and placebo-controlled study was conducted in 44 adults (blueberry, n = 23; and placebo, n = 21). They were randomized to receive a blueberry or placebo smoothie twice daily for six weeks. Twenty-four-hour ambulatory blood pressure, endothelial function and insulin sensitivity were assessed pre- and post-intervention. The blood pressure and insulin sensitivity did not differ between the blueberry and placebo groups. However, the mean change in resting endothelial function, expressed as reactive hyperemia index (RHI), was improved significantly more in the group consuming the blueberries versus the placebo group (p = 0.024). Even after adjusting for confounding factors, i.e., the percent body fat and gender, the blueberry group still had a greater improvement in endothelial function when compared to their counterpart (RHI; 0.32 ± 0.13 versus -0.33 ± 0.14; p = 0.0023). In conclusion, daily dietary consumption of blueberries did not improve blood pressure, but improved (i.e., increased) endothelial function over six weeks in subjects with metabolic syndrome.

  17. Comparison of photobiomodulation therapy and suprascapular nerve-pulsed radiofrequency in chronic shoulder pain: a randomized controlled, single-blind, clinical trial.

    Science.gov (United States)

    Ökmen, Burcu Metin; Ökmen, Korgün

    2017-11-01

    Shoulder pain can be difficult to treat due to its complex anatomic structure, and different treatment methods can be used. We aimed to examine the efficacy of photobiomodulation therapy (PBMT) and suprascapular nerve (SSN)-pulsed radiofrequency (RF) therapy. In this prospective, randomized, controlled, single-blind study, 59 patients with chronic shoulder pain due to impingement syndrome received PBMT (group H) or SSN-pulsed RF therapy (group P) in addition to exercise therapy for 14 sessions over 2 weeks. Records were taken using visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), and Nottingham Health Profile (NHP) scoring systems for pretreatment (PRT), posttreatment (PST), and PST follow-up at months 1, 3, and 6. There was no statistically significant difference in initial VAS score, SPADI, and NHP values between group H and group P (p > 0.05). Compared to the values of PRT, PST, and PST at months 1, 3, and 6, VAS, SPADI, and NHP values were statistically significantly lower in both groups (p shoulder pain. PBMT seems to be advantageous compared to SSN-pulsed RF therapy, as it is a noninvasive method.

  18. Hyaluronic acid concentration in postmenopausal facial skin after topical estradiol and genistein treatment: a double-blind, randomized clinical trial of efficacy.

    Science.gov (United States)

    Patriarca, Marisa Teresinha; Barbosa de Moraes, Andréa Regina; Nader, Helena B; Petri, Valeria; Martins, João Roberto Maciel; Gomes, Regina Célia Teixeira; Soares, José Maria

    2013-03-01

    The aim of this work was to compare the effects of estradiol and genistein treatment on hyaluronic acid (HA) concentration in postmenopausal facial skin. In this study, 30 postmenopausal women were evaluated in a prospective, randomized, double-blind trial. The volunteers were postmenopausal women treated in the Gynecology Department of the Federal University of São Paulo. The participants were divided into two groups: group E, treated with 0.01% 17β-estradiol gel (n = 15), and group G, treated with 4% genistein gel (isoflavones, n = 15). The treatment lasted for 24 consecutive weeks. Preauricular skin biopsies were performed for each participant at baseline (E1 and G1) and after treatment (E2 and G2) to evaluate HA concentration in tissue. The materials were processed using immunohistochemical and biochemical methods. After 24 weeks of treatment, HA concentration increased in both groups, but the effect was greater for estradiol treatment than for genistein treatment. Our data suggest that both treatments may enhance HA concentration in postmenopausal skin but that estrogen produces results that are greater than those produced by isoflavones.

  19. Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial

    Directory of Open Access Journals (Sweden)

    D. V. Tembe

    2011-01-01

    Full Text Available Aim. To compare the efficacy and safety of armodafinil, the R-enantiomer of modafinil, with modafinil in patients of shift work sleep disorder (SWSD. Material and Methods. This was a 12-week, randomized, comparative, double-blind, multicentric, parallel-group study in 211 patients of SWSD, receiving armodafinil (150 mg or modafinil (200 mg one hour prior to the night shift. Outcome Measures. Efficacy was assessed by change in stanford sleepiness score (SSS by at least 2 grades (responder and global assessment for efficacy. Safety was assessed by incidence of adverse events, change in laboratory parameters, ECG, and global assessment of tolerability. Results. Both modafinil and armodafinil significantly improved sleepiness mean grades as compared to baseline (<.0001. Responder rates with armodafinil (72.12% and modafinil (74.29% were comparable (=.76. Adverse event incidences were comparable. Conclusion. Armodafinil was found to be safe and effective in the treatment of SWSD in Indian patients. The study did not demonstrate any difference in efficacy and safety of armodafinil 150 mg and modafinil 200 mg.

  20. Comparison of the immunogenicity and reactogenicity of Cervarix and Gardasil human papillomavirus vaccines in HIV-infected adults: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Toft, Lars; Storgaard, Merete; Müller, Martin; Sehr, Peter; Bonde, Jesper; Tolstrup, Martin; Østergaard, Lars; Søgaard, Ole S

    2014-04-15

    We compared the immunogenicity and reactogenicity of Cervarix or Gardasil human papillomavirus (HPV) vaccines in adults infected with the human immunodeficiency virus (HIV). This was a double-blind, controlled trial randomizing HIV-positive adults to receive 3 doses of Cervarix or Gardasil at 0, 1.5, and 6 months. Immunogenicity was evaluated for up to 12 months. Neutralizing anti-HPV-16/18 antibodies were measured by pseudovirion-based neutralization assay. Laboratory tests and diary cards were used for safety assessment. The HPV-DNA status of the participants was determined before and after immunization. Ninety-two participants were included in the study. Anti-HPV-18 antibody titers were higher in the Cervarix group compared with the Gardasil group at 7 and 12 months. No significant differences in anti-HPV-16 antibody titers were found among vaccine groups. Among Cervarix vaccinees, women had higher anti-HPV-16/18 antibody titers compared to men. No sex-specific differences in antibody titers were found in the Gardasil group. Mild injection site reactions were more common in the Cervarix group than in the Gardasil group (91.1% vs 69.6%; P = .02). No serious adverse events occurred. Both vaccines were immunogenic and well tolerated. Compared with Gardasil, Cervarix induced superior vaccine responses among HIV-infected women, whereas in HIV-infected men the difference in immunogenicity was less pronounced.

  1. Lactitol, a second-generation disaccharide for treatment of chronic portal-systemic encephalopathy. A double-blind, crossover, randomized clinical trial.

    Science.gov (United States)

    Uribe, M; Toledo, H; Perez, F; Vargas, F; Gil, S; Garcia-Ramos, G; Ravelli, G P; Guevara, L

    1987-12-01

    A double-blind crossover trial was performed to test the therapeutic usefulness and safety of lactitol, a beta-galactoside sorbitol, against lactose in 18 patients with chronic portal-systemic encephalopathy (PSE). The study included four periods: two for washout and two for lactitol and lactose administration. During washout periods, which lasted two weeks each, patients were stabilized with neomycin plus milk of magnesia. Lactitol and lactose were administered during four weeks each. Ten patients were randomly assigned to receive lactose (group A) and eight patients to receive lactitol (group B) first. PSE parameters, ie, mental state, number connection test performance, asterixis and blood ammonia levels were assessed fortnightly. Electroencephalographic tracings and stool pHs were evaluated at the end of each study period. After the first administration of lactose and lactitol, no statistically significant differences in PSE parameters were found. At the same stage, a significant stool acidification (P less than 0.05) was detected. It is concluded that lactitol seems to be safe and efficacious in treating patients with chronic PSE.

  2. Effects of a dimeric vs a monomeric nonionic contrast medium on renal function in patients with mild to moderate renal insufficiency: a double-blind, randomized clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Carraro, M.; Malalan, F.; Antonione, R.; Faccini, L. [Institute of Medicina Clinica, Ospedale di Cattinara, University of Trieste, Strada di Fiume 447, I-34 149 Trieste (Italy); Stacul, F.; Cova, M.; Petz, S.; Assante, M.; Dalla Palma, L. [Institute of Radiology, Ospedale di Cattinara, University of Trieste, Strada di Fiume 447, I-34 149 Trieste (Italy); Grynne, B.; Haider, T. [Nycomed Imaging AS, Nycoveien 1-2, N-0401 Oslo (Norway)

    1998-02-01

    The efficacy and safety of nonionic dimeric contrast media in subjects with impaired renal function is largely unknown. The present study was aimed at determining the risk of tubular nephrotoxicity in patients with mild to moderate renal insufficiency who underwent intravenous urography (IVU) with the nonionic dimeric contrast agent iodixanol (Visipaque, Nycomed Imaging, Oslo, Norway). In a double-blind protocol 64 patients (55 males; mean age 68.3 years) with serum creatinine between 135 and 265 {mu}mol/l who were to undergo IVU were randomized to receive iodixanol (a nonionic dimer) or iopromide (a nonionic monomer), 600 mg I/kg b. w. Renal function was evaluated before and 1 h, 6 h, 24 h, 48 h and 7 days after IVU with analysis of serum creatinine, urinary enzymes alanylaminopeptidase and N-acetyl-{beta}-glucosaminidase, and urinary microproteins {alpha}-1-microglobulin and albumin. Renal function remained stable in both contrast medium groups during the follow-up period. No statistically significant differences were observed between the monomer and the dimer in terms of urinary enzyme and microprotein excretion or serum creatinine. Transient radiocontrast-induced nephropathy developed in 1 patient who had received iodixanol. The administration of the nonionic dimeric contrast medium iodixanol, or of the nonionic monomer iopromide, entailed a low nephrotoxic potential in patients with mild to moderate renal insufficiency undergoing excretory urography. (orig.) With 2 figs., 1 tab., 13 refs.

  3. Blueberries Improve Endothelial Function, but Not Blood Pressure, in Adults with Metabolic Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    April J. Stull

    2015-05-01

    Full Text Available Blueberry consumption has been shown to have various health benefits in humans. However, little is known about the effect of blueberry consumption on blood pressure, endothelial function and insulin sensitivity in humans. The present study investigated the role of blueberry consumption on modifying blood pressure in subjects with metabolic syndrome. In addition, endothelial function and insulin sensitivity (secondary measurements were also assessed. A double-blind and placebo-controlled study was conducted in 44 adults (blueberry, n = 23; and placebo, n = 21. They were randomized to receive a blueberry or placebo smoothie twice daily for six weeks. Twenty-four-hour ambulatory blood pressure, endothelial function and insulin sensitivity were assessed pre- and post-intervention. The blood pressure and insulin sensitivity did not differ between the blueberry and placebo groups. However, the mean change in resting endothelial function, expressed as reactive hyperemia index (RHI, was improved significantly more in the group consuming the blueberries versus the placebo group (p = 0.024. Even after adjusting for confounding factors, i.e., the percent body fat and gender, the blueberry group still had a greater improvement in endothelial function when compared to their counterpart (RHI; 0.32 ± 0.13 versus −0.33 ± 0.14; p = 0.0023. In conclusion, daily dietary consumption of blueberries did not improve blood pressure, but improved (i.e., increased endothelial function over six weeks in subjects with metabolic syndrome.

  4. A double-blind, randomized clinical study to determine the efficacy of benzocaine 10% on histamine-induced pruritus and UVB-light induced slight sunburn pain.

    Science.gov (United States)

    Bauer, Martin; Schwameis, Richard; Scherzer, Thomas; Lang-Zwosta, Isabelle; Nishino, Kanako; Zeitlinger, Markus

    2015-01-01

    This study aims to explore the efficacy of the topical application of 10% benzocaine for treating pruritus and pain as compared to vehicle ointment. Twenty male subjects were treated in a randomized double-blind fashion with the investigational medicinal product (IMPD) and vehicle. Immediately after the injection of 100 µg histamine on both arms, subjects received topical treatment and pruritus was subsequently assessed with visual analogue scale (VASpruritus) and Eppendorfer questionnaire. Ultraviolet B radiation (UVB) was administered on the back to induce slight sunburn. Twelve hours after UVB application again the IMPD was applied on the right or left upper back and vehicle on the other side and pain related to sunburn was measured with VASpain and pressure algometry. A trend towards better reduction of pruritus was shown for benzocaine in VASpruritus. For the VASpain significant differences in group comparison (p = 0.02) were observed. Algometer measurements showed onset of pain reduction in the verum group after 20 min whereas in the vehicle-treated area pain relief occurred only after 60 min after application. The topically administered ointment containing 10% benzocaine was found superior over vehicle for treating pain, but not pruritus.

  5. A prospective, randomized, double blind, placebo-controlled evaluation of the effects of eicosapentaenoic acid and docosahexaenoic acid on the clinical signs and erythrocyte membrane polyunsaturated fatty acid concentrations in dogs with osteoarthritis.

    Science.gov (United States)

    Mehler, Stephen J; May, Lauren R; King, Crystal; Harris, William S; Shah, Zubin

    2016-06-01

    Osteoarthritis (OA) in dogs is a prevalent and serious condition. The most common treatment for the clinical signs of OA in dogs is the administration of nonsteroidal antiiflammatory pharmaceuticals. Omega-3 (n-3) fatty acids have been shown to reduce the clinical signs of osteoarthritis in dogs. The primary goals of this study were 1) to determine the effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on the clinical signs of OA in dogs, 2) to evaluate the effects of supplementation on the arachadonic acid (ARA)/ (EPA+DHA) algorithm and 3) to correlate alterations in the ARA/(EPA+DHA) with changes in the clinical signs of canine OA. Seventy-eight client owned dogs were enrolled in a prospective, randomized, double-blind, placebo controlled clinical trial. Dogs were randomized to placebo oil or triglyceride n-3 oil (providing an average dose of 69mg EPA+DHA/kg/day). Orthopedic examinations and blood analyses were performed at baseline, day 42, and day 84. A single investigator confirmed a diagnosis of OA of the coxofemoral joints and/or stifle joints in all dogs. Seventy-four dogs completed the trial. All clinical outcomes for measuring discomfort, lameness, and joint severity at day 84 and all blood metrics at day 42 and day 84 significantly (pacid concentrations correlating to relief of clinical signs associated with OA in dogs. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  6. Effect of intra-alveolar placement of 0.2% chlorhexidine bioadhesive gel on the incidence of alveolar osteitis following the extraction of mandibular third molars. A double-blind randomized clinical trial

    Science.gov (United States)

    Garcia-Linares, Jordi; Hueto-Madrid, Juan-Antonio; González-Lagunas, Javier; Raspall-Martin, Guillermo; Mareque-Bueno, Javier

    2015-01-01

    Alveolar osteitis (AO) is a common complication after third molar surgery. One of the most studied agents in its prevention is chlorhexidine (CHX), which has proved to be effective. Objectives: The aim of this randomized double-blind clinical trial was to evaluate the efficacy of 0.2% bioadhesive chlorhexidine gel placed intra-alveolar in the prevention of AO after the extraction of mandibular third molars and to analyze the impact of risk factors such as smoking and oral contraceptives in the development of AO. Study Design: The study was a randomized, double-blind, clinical trial performed in the Ambulatory Surgery Unit of Hospital Vall d’Hebron and was approved by the Ethics Committee. A total of 160 patients randomly received 0.2% bioadhesive gel (80 patients) or bioadhesive placebo (80 patients). Results: 0.2% bioadhesive chlorhexidine gel applied in the alveolus after third molar extraction reduced the incidence of dry socket by 22% compared to placebo with differences that were not statistically significant. Smoking and the use of oral contraceptives were not related to higher incidence of dry socket. Female patients and the difficulty of the surgery were associated with a higher incidence of AO with statistically significant differences. 0.2% bioadhesive chlorhexidine gel did not produce any of the side effects related to chlorhexidine rinses. Conclusions: A 22% reduction of the incidence of alveolar osteitis with the application of 0.2% bioadhesive chlorhexidine gel compared to placebo with differences that were not statistically significant was found in this clinical trial. The lack of adverse reactions and complications related to chlorhexidine gel supports its clinical use specially in simple extractions and adds some advantages compared to the rinses in terms of duration of the treatment and reduction of staining and taste disturbance. Key words:Alveolar osteitis, dry socket, chlorhexidine bioadhesive gel, mandibular third molar surgery. PMID

  7. Increased vitamin D intake differentiated according to skin color is needed to meet requirements in young Swedish children during winter: a double-blind randomized clinical trial.

    Science.gov (United States)

    Öhlund, Inger; Lind, Torbjörn; Hernell, Olle; Silfverdal, Sven-Arne; Karlsland Åkeson, Pia

    2017-07-01

    Background: Dark skin and low exposure to sunlight increase the risk of vitamin D insufficiency in children. Objective: The aim of the study was to evaluate the amount of vitamin D needed to ascertain that most children >4 y of age attain sufficient serum 25-hydroxyvitamin D [S-25(OH)D; i.e., ≥50 nmol/L] during winter regardless of latitude and skin color. Design: In a longitudinal, double-blind, randomized, food-based intervention study, 5- to 7-y-old children from northern (63°N) and southern (55°N) Sweden with fair ( n = 108) and dark ( n = 98) skin were included. Children, stratified by skin color by using Fitzpatrick's definition, were randomly assigned to receive milk-based vitamin D 3 supplements that provided 2 (placebo), 10, or 25 μg/d during 3 winter months. Results: Mean daily vitamin D intake increased from 6 to 17 μg and 26 μg in the intervention groups supplemented with 10 and 25 μg, respectively. In the intention-to-treat analysis, 90.2% (95% CI: 81.1%, 99.3%) of fair-skinned children randomly assigned to supplementation of 10 μg/d attained sufficient concentrations, whereas 25 μg/d was needed in dark-skinned children to reach sufficiency in 95.1% (95% CI: 88.5%, 100%). In children adherent to the study product, 97% (95% CI: 91.3%, 100%) and 87.9% (95% CI: 76.8%, 99%) of fair- and dark-skinned children, respectively, achieved sufficient concentrations if supplemented with 10 μg/d. By using 95% prediction intervals for 30 and 50 nmol S-25(OH)D/L, intakes of 6 and 20 μg/d are required in fair-skinned children, whereas 14 and 28 μg/d are required in children with dark skin. Conclusion: Children with fair and dark skin require vitamin D intakes of 20 and 28 μg/d, respectively, to maintain S-25(OH)D ≥50 nmol/L, whereas intakes of 6 and 14 μg/d, respectively, are required to maintain concentrations ≥30 nmol/L during winter. This trial was registered at clinicaltrials.gov as NCT01741324. © 2017 American Society for Nutrition.

  8. Design paper: The CapOpus trial: a randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten; Fohlmann, Allan; Larsen, Anne-Mette

    2008-01-01

    : The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. DESIGN: The trial is designed as a randomized, parallel-group, observer-blinded clinical...... trial. Patients are primarily recruited through early-psychosis detection teams, community mental health centers, and assertive community treatment teams. Patients are randomized to one of two treatment arms, both lasting six months: 1) specialized addiction treatment plus treatment as usual or 2......) treatment as usual. The specialized addiction treatment is manualized and consists of both individual and group-based motivational interviewing and cognitive behavioral therapy, and incorporates both the family and the case manager of the patient.The primary outcome measure will be changes in amount...

  9. Effectiveness of tenoxicam and ibuprofen for pain prevention following endodontic therapy in comparison to placebo: a randomized double-blind clinical trial.

    Science.gov (United States)

    Arslan, Hakan; Topcuoglu, Huseyin S; Aladag, Halit

    2011-06-01

    Tenoxicam is an effective analgesic and anti-inflammatory agent for symptomatic treatment of various conditions. The purpose of this study was to evaluate clinically the effectiveness of prophylactic tenoxicam and prophylactic ibuprofen in reducing post-endodontic pain compared with placebo. A total of 48 patients consented to a double-blind, single dose, prophylactic oral administration of 20 mg of tenoxicam, 200 mg of ibuprofen, or a placebo before root canal treatment. The root canal treatment was performed in one visit. The patients registered their degree of discomfort on a 100-mm visual analog scale, immediately postoperative, and 6, 12, 24, 48 and 72 h after initiation of root canal treatment. The two-way ANOVA test and Tukey HSD post hoc test showed that in the 6-h period, both 20 mg of tenoxicam and 200 mg of ibuprofen provided significantly better pain relief than the placebo. Prophylactic administration of a single dose of 20 mg tenoxicam or 200 mg ibuprofen before RCT provides an effective reduction at 6 h (P < 0.05). Because of the advantages of tenoxicam, it may be useful as a prophylactic analgesic when post-endodontic pain is anticipated.

  10. IPARZINE-SKR study: randomized, double-blind clinical trial of a new topical product versus placebo to prevent pressure ulcers.

    Science.gov (United States)

    Verdú, José; Soldevilla, Javier

    2012-10-01

    This study compared the efficacy of a new topical agent (IPARZINE-4A-SKR) on preventing category I pressure ulcers (PUs) over a 2-week period, compared with a placebo. A double-blind, randomised, multi-centre, placebo-controlled clinical trial in two parallel groups was conducted. The primary objective was to compare PU incidence between groups. Hospital and socio-sanitary centre patients (n = 194) at risk of developing a PU (Braden scale) were randomised into two groups. The intervention group included 99 patients, and the placebo group comprised 95 patients. Patients were comparable in terms of age, sex and PU risk. In both groups, patients had a high risk of developing PUs. The product was applied on the sacrum, trochanters and heels. Six PUs (incidence = 6·1%) were detected in the intervention group versus seven (incidence = 7·4%) in the placebo group. Differences were not statistically significant (z = 0·08; P = 0·94), relative risk = 0·82 (95% confidence interval = 0·29–2·36). The main limitation of the study was the sample size and, therefore, the main difficulty encountered was in determining whether the product is ineffective or simply has not been used with sufficient patients. In conclusion, it is not possible to confirm that there are any differences between the studied and the placebo treatments in the prevention of PUs. The results obtained were similar to those obtained in studies of PU prevention using products based on topical fatty acids.

  11. Efficacy and tolerability of gastric-retentive gabapentin for the treatment of postherpetic neuralgia: results of a double-blind, randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Irving, Gordon; Jensen, Mark; Cramer, Marilou; Wu, Jacqueline; Chiang, Yu-Kun; Tark, Marvin; Wallace, Mark

    2009-01-01

    To determine the efficacy and safety of a gastric-retentive, extended-release gabapentin (gabapentin ER) taken once or twice daily for treatment of postherpetic neuralgia. Using an enrichment design, a randomized, double-blind, placebo-controlled study was conducted in 158 patients who had experienced pain for at least 3 months after healing of acute herpes zoster skin rash and who had a baseline average daily pain (ADP) score of > or =4 on a 0 to 10 Numerical Rating Scale. Patients received gabapentin ER either once daily (1800 mg PM) or twice daily (600 mg AM, 1200 mg PM) or placebo for 4 weeks. Efficacy measures included changes from baseline to end point in ADP score and average daily sleep interference score. Mean (SEM) changes for ADP score were -1.93 (0.28), -2.24 (0.29), and -1.29 (0.29) in the gabapentin ER once daily, twice daily, and placebo groups, respectively (P=0.089 and 0.014 for gabapentin ER once daily and twice daily, respectively, vs. placebo), with 25.5%, 28.8%, and 11.8% of patients, respectively, reporting > or =50% decrease from baseline in ADP score. Mean (SEM) changes in sleep interference scores were -1.94 (0.30), -2.28 (0.30), and -1.16 (0.30), respectively (P=0.048 and 0.006 for gabapentin ER once daily and twice daily, respectively, vs. placebo). Common adverse events in the gabapentin ER once daily, twice daily, and placebo groups, respectively, were dizziness (22.2%, 11.3%, and 9.8%) and somnolence (9.3%, 7.5%, and 7.8%). Gabapentin ER administered twice daily is effective and safe for the treatment of pain associated with postherpetic neuralgia.

  12. Comparison of the immunogenicity and safety of the purified chick embryo cell rabies vaccine manufactured in India and Germany: A randomized, single blind, multicentre, phase IV clinical study

    Science.gov (United States)

    Sampath, Gadey; Banzhoff, Angelika; Deshpande, Alaka; Malerczyk, Claudius; Arora, Ashwani Kumar; Vakil, Hoshang; Preiss, Scott

    2017-01-01

    ABSTRACT This phase IV, single blind study assessed the immunogenicity and safety of India-manufactured purified chick embryo cell rabies vaccine (PCECV), compared with a German-manufactured batch obtained by the same production process. A total of 340 participants enrolled at 2 study sites in India were randomized (1:1:1:1) in 4 groups to receive a 5-dose Essen regimen with either 1 of the 3 Indian batches (PCECV-I) or the German batch (PCECV-G), administered on Days (D) 0, 3, 7, 14 and 30. The lot-to-lot consistency of PCECV-I batches in terms of induced immune response at D14 was demonstrated. The immune response elicited by PCECV-I was shown to be non-inferior to that induced by PCECV-G, as the lower limit of the 95% confidence interval for the ratio (PCECV-I/PCECV-G) of rabies virus neutralising antibody (RVNA) geometric mean concentrations was higher than 0.5 at D14. At least 96% of participants developed adequate RVNA concentrations (≥ 0.5 IU/mL) by D14 and all achieved RVNA concentrations ≥ 0.5 IU/mL by D90. RVNA levels were comparable across all groups throughout the entire study. Solicited local and general symptoms had a similar incidence in all groups. Unsolicited adverse events (AEs) were reported by 11% of participants. Only 1 serious AE (leg fracture) was reported and was not related to vaccination. No deaths and no rabies cases were recorded during the 90 days of observation. The study showed that the 3 PCECV-I and the PCECV-G batches induced a similar immune response and had a comparable safety profile when administered according to a 5-dose schedule. PMID:28406752

  13. The Effects of a Standardized Herbal Remedy Made from a Subtype of Rosa canina in Patients with Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.