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Sample records for blind randomized trial

  1. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  2. 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.

  3. Blinding in randomized control trials: the enigma unraveled.

    Directory of Open Access Journals (Sweden)

    Vartika Saxena

    2016-03-01

    Full Text Available The search for new treatments and testing of new ideas begins in the laboratory and then established in clinical research settings. Studies addressing the same therapeutic problem may produce conflicting results hence Randomised Clinical Trial is regarded as the most valid method for assessing the benefits and harms of healthcare interventions. The next challenge face by the medical community is the validity of such trials as theses tend to deviate from the truth because of various biases. For the avoidance of the same it has been suggested that the validity or quality of primary trials should be assessed under blind conditions. Thus blinding, is a crucial method for reducing bias in randomized clinical trials. Blinding can be defined as withholding information about the assigned interventions from people involved in the trial who may potentially be prejudiced by this knowledge. In this article we make an effort to define blinding, explain its chronology, hierarchy and discuss methods of blinding, its assessment, its possibility, un-blinding and finally the latest guidelines.

  4. Coblation versus traditional tonsillectomy: A double blind randomized ontrolled trial

    Directory of Open Access Journals (Sweden)

    Mohammadreza Omrani

    2012-01-01

    Full Text Available Background: Coblation tonsillectomy is a new surgical technique and demands further research to be proven as a suitable and standard method of tonsillectomy. This study compares coblation and traditional tonsillectomy techniques in view of their advantages and complications. Methods: In a prospective double-blind randomized controlled trial information on operation time, intraoperative blood loss, postoperative pain, time needed to regain the normal diet and activity and post-operative hemorrhage were gathered and compared between two groups containing 47 patients in each group. Results: We found statistically significant differences in operation time (p 0.5 was not significantly different between two groups. Conclusions: This study revealed a significantly less intraoperative or postoperative complications and morbidity in coblation tonsillectomy in comparison with traditional method. Coblation was associated with less pain and quick return to normal diet and daily activity. These findings addressed coblation tonsillectomy as an advanced method.

  5. 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...

  6. Blinding Techniques in Randomized Controlled Trials of Laser Therapy: An Overview and Possible Solution

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    Ian Relf

    2008-01-01

    Full Text Available Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection.

  7. Position of the physician's nametag--a randomized, blinded trial.

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    Samuel Luca Schmid

    Full Text Available The patient-physician relation begins when the physician introduces himself with name and function. Most institutions request a nametag with name and function to be worn. Although nametags are consequently worn, the optimal position for the nametag is unknown. It was the purpose of this study to identify whether positioning the nametag on the right or the left chest side provides better visibility to the patient.One hundred volunteers, blinded to the experimental setup, presented for an orthopedic consultation in a standardized manner. The nametag of the physician was randomly positioned on the left chest side and presented to 50 individuals (age 35 years (range 17 to 83 or the right chest side and then presented to 50 other individuals (35 years (range 16 to 59. The time of the participant noticing the nametag was documented. Subsequently, the participant was questioned concerning the relevance of a nametag and verbal self-introduction of the physician.38% of the participants noticed the nametag on the right as opposed to 20% who noticed it if placed on the left upper chest (p = 0.0473. The mean time to detection was 9 (range 1-40 seconds for nametags on the right and 25.2 seconds (range 3 to 49, p = 0.006 on the left. For 87% of the participants, a nametag is expected and important and nearly all participants (96% expected the physician to introduce himself verbally.It is expected that a physician wears a nametag and introduce himself verbally at the first encounter. Positioning the nametag on the right chest side results in better and faster visibility.

  8. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    Science.gov (United States)

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  9. Klapp method effect on idiopathic scoliosis in adolescents: blind randomized controlled clinical trial

    OpenAIRE

    Dantas, Diego de Sousa; Assis, Sanderson José Costa de; Baroni, Marina Pegoraro; Lopes, Johnnatas Mikael; Cacho, Enio Walker Azevedo; Cacho,Roberta de Oliveira; Pereira, Silvana Alves

    2017-01-01

    [Purpose] To estimate the effect of Klapp method on idiopathic scoliosis in school students. [Subjects and Methods] A single-blind randomized clinical trial with 22 students randomly divided into intervention group (n=12) and inactive control group (n=10). Exercise protocol consisted of Klapp method, 20 sessions, three times a week for intervention group, and inactivity for control group. Dorsal muscle strength was measured by dynamometer; body asymmetries and gibbosity angles were measured b...

  10. Upper Limb Robot-Assisted Therapy in Cerebral Palsy: A Single-Blind Randomized Controlled Trial

    OpenAIRE

    Gilliaux, Maxime; Renders, Anne; Dispa, Delphine; Holvoet, Dominique; Sapin, Julien; Dehez, Bruno; Detrembleur, Christine; LEJEUNE, Thierry; Stoquart, Gaëtan

    2015-01-01

    Background. Several pilot studies have evoked interest in robot-assisted therapy (RAT) in children with cerebral palsy (CP). Objective. To assess the effectiveness of RAT in children with CP through a single-blind randomized controlled trial. Patients and Methods. Sixteen children with CP were randomized into 2 groups. Eight children performed 5 conventional therapy sessions per week over 8 weeks (control group). Eight children completed 3 conventional therapy sessions and 2 robot-assisted se...

  11. Acupuncture for Functional Dyspepsia: A Single Blinded, Randomized, Controlled Trial

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    Yulian Jin

    2015-01-01

    Full Text Available In order to investigate the therapeutic potential of acupuncture on patients with functional dyspepsia (FD, patients were randomized to receive acupuncture at classic acupoints with manipulations (treatment group versus acupuncture at nonacupoints without manipulation (control group once every other day, three times a week, for one month and were followed up for three months. The primary outcomes included dyspeptic symptoms, quality of life, and mental status. The secondary outcomes included the fasting serum gastrin concentration, and frequency and propagation velocity of gastric slow waves. Sixty patients with FD were included, among whom, four dropped out. After one month's treatment, patients with FD showed significant improvements in primary (in both groups and secondary (in the eight patients of the treatment group outcomes as compared with baseline (P=0.0078 to <0.0001; treatment group has better outcomes in all primary outcome measures (P<0.0001 except for SDS (P=0.0005. Improvements on dyspeptic symptoms persist during follow-up (better in the treatment group. Acupuncture with manual manipulation had better effects on improving dyspeptic symptoms, mental status, and quality of life in patients with FD. These effects may be related to the increased frequency and propagation speed of gastric slow waves and serum gastrin secretion.

  12. Antidepressants for bipolar disorder A meta-analysis of randomized, double-blind, controlled trials

    Institute of Scientific and Technical Information of China (English)

    Yingli Zhang; Huan Yang; Shichang Yang; Wei Liang; Ping Dai; Changhong Wang; Yalin Zhang

    2013-01-01

    OBJECTIVE: To examine the efficacy and safety of short-term and long-term use of antidepres-sants in the treatment of bipolar disorder. DATA SOURCES:A literature search of randomized, double-blind, control ed trials published until December 2012 was performed using the PubMed, ISI Web of Science, Medline and Cochrane Central Register of Control ed Trials databases. The keywords“bipolar disorder, bipolar I disorder, bipolar II disorder, bipolar mania, bipolar depression, cyclothymia, mixed mania and depression, rapid cycling and bipolar disorder”, AND “antidepressant agent, antidepressive agents second-generation, antidepressive agents tricyclic, monoamine oxidase inhibitor, noradrenaline uptake in-hibitor, serotonin uptake inhibitor, and tricyclic antidepressant agent” were used. The studies that were listed in the reference list of the published papers but were not retrieved in the above-mentioned databases were supplemented. STUDY SELECTION: Studies selected were double-blind randomized control ed trials assessing the efficacy and safety of antidepressants in patients with bipolar disorder. Al participants were aged 18 years or older, and were diagnosed as having primary bipolar disorder. Antidepressants or antidepressants combined with mood stabilizers were used in experimental interventions. Placebos, mood stabilizers, antipsychotics and other antide pressants were used in the control interventions. Studies that were quasi-randomized studies, or used antidepressants in combination with antipsy-chotics in the experimental group were excluded. Al analyses were conducted using Review Man-ager 5.1 provided by the Cochrane Col aboration. MAIN OUTCOME MEASURES:The primary outcome was the response and switching to mania. The secondary outcomes included remission, discontinuation rate, and suicidality. RESULTS: Among 5 001 treatment studies published, 14 double-blind randomized control ed trials involving 1 244 patients were included in the meta

  13. Femicomfort in the Treatment of Premenstrual Syndromes: A Double-Blind, Randomized and Placebo Controlled Trial

    Directory of Open Access Journals (Sweden)

    Shahin Akhondzadeh

    2010-06-01

    Full Text Available "nObjective:Premenstrual syndromes (PMS affecting 20-40% of women of reproductive age. The aim of this double blind and placebo controlled trial was to investigate whether femicofort a supplement contains Vitamin B6, Vitamin E and evening primrose oil could relieve symptoms of PMS. "nMethod: This was a randomized and double blind clinical trial. The trial was conducted between November 2009 and April March 2010. Women aged 20 to 45 years with regular menstrual cycles and experience of PMS symptoms (According to the current diagnostic criteria proposed by the American College of Obstetrics and Gynecology for at least 6 months were eligible for the study. Patients were randomized to receive femicomfort or placebo in a 1: ratio using a computer-generated code. The assignments were kept in sealed, opaque envelopes until the point of analysis of data. In this double-blind, patients were randomly assigned to receive capsule of femicomfort (Group A or capsule placebo for two menstrual cycles (cycles 3 and 4. The primary outcome measure was the Daily Symptom Report, a checklist of 17 premenstrual symptoms rated from 0 to 4 according to their severity throughout the menstrual cycle. Secondary outcome measure was Hamilton Depression Rating Scale (17-item. "nResults:Femicomfort at this dose was found to be effective in relieving symptoms of PMS. The difference between the femicomfort and placebo in the frequency of side effects was not significant. Conclusion: The results of this study indicate the efficacy of femicomfort in the treatment of PMS.

  14. A randomized double-blind trial on perioperative administration of probiotics in colorectal cancer patients

    Institute of Scientific and Technical Information of China (English)

    Luca; Gianotti; Lorenzo; Morelli; Francesca; Galbiati; Simona; Rocchetti; Sara; Coppola; Aldo; Beneduce; Cristina; Gilardini; Daniela; Zonenschain; Angelo; Nespoli; Marco; Braga

    2010-01-01

    AIM:To investigate whether probiotic bacteria,given perioperatively,might adhere to the colonic mucosa, reduce concentration of pathogens in stools,and modulate the local immune function. METHODS:A randomized,double-blind clinical trial was carried out in 31 subjects undergoing elective colorectal resection for cancer.Patients were allocated to receive either a placebo(group A,n=10),or a dose of 10 7 of a mixture of Bifidobacterium longum(BB536) and Lactobacillus johnsonii(La1)(group B,n=11),or the same mix...

  15. Effects of Piracetam on Pediatric Breath Holding Spells: A Randomized Double Blind Controlled Trial

    OpenAIRE

    2012-01-01

    How to cite this article:Abbaskhanian A, Ehteshami S, Sajjadi S, Rezai MS. Effects of Piracetam on Pediatric Breath Holding Spells: A Randomized Double Blind Controlled Trial. Iran J Child Neurol Autumn 2012; 6(4): 9-15. Abstarct:Objective Breath holding spells (BHS) are common paroxysmal non-epileptic eventsin the pediatric population which are very stressfull despite their harmlessnature. There has been no specific treatment found for the spells yet. The aimof this study was to evaluate the...

  16. 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

  17. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

    OpenAIRE

    amrutesh, sunita; Malini, J; Tandur, Prakash S; Pralhad S. Patki

    2010-01-01

    Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hyg...

  18. Blinded trials taken to the test

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Forfang, E; Haahr, M T

    2007-01-01

    Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

  19. Intravenous Vitamin C administration reduces fatigue in office workers: a double-blind randomized controlled trial

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    Suh Sang-Yeon

    2012-01-01

    Full Text Available Abstract Background Studies of the efficacy of vitamin C treatment for fatigue have yielded inconsistent results. One of the reasons for this inconsistency could be the difference in delivery routes. Therefore, we planned a clinical trial with intravenous vitamin C administration. Methods We evaluated the effect of intravenous vitamin C on fatigue in office workers. A group of 141 healthy volunteers, aged 20 to 49 years participated in this randomized, double-blind, controlled clinical trial. The trial group received 10 grams of vitamin C with normal saline intravenously, while the placebo group received normal saline only. Since vitamin C is a well-known antioxidant, oxidative stress was measured. Fatigue score, oxidative stress, and plasma vitamin C levels were measured before intervention, and again two hours and one day after intervention. Adverse events were monitored. Results The fatigue scores measured at two hours after intervention and one day after intervention were significantly different between the two groups (p = 0.004; fatigue scores decreased in the vitamin C group after two hours and remained lower for one day. Trial also led to higher plasma vitamin C levels and lower oxidative stress compared to the placebo group (p Conclusion Thus, intravenous vitamin C reduced fatigue at two hours, and the effect persisted for one day. There were no significant differences in adverse events between two groups. High dose intravenous vitamin C proved to be safe and effective against fatigue in this study. Trial Registration The clinical trial registration of this trial is http://ClinicalTrials.govNCT00633581.

  20. 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...... of authors to trial publications which did not report risk of unblinding. Respondents were corresponding authors to a random sample of PubMed indexed articles on blinded randomized clinical trials published in 2010. We initially sampled 300 publications of which 24 reported on risk of unblinding. RESULTS......: Of the 276 contacted trial authors, 129 (47%) responded. Assessment of the risk of unblinding was conducted in 56 trials (43%), often based on a pretrial evaluation involving a group of healthy assessors trying to identify differences between experimental and control interventions. When we included informal...

  1. 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.

  2. A Double Blind Randomized Clinical Trial of Remote Ischemic Conditioning in Live Donor Renal Transplantation.

    Science.gov (United States)

    Nicholson, Michael L; Pattenden, Clare J; Barlow, Adam D; Hunter, James P; Lee, Gwyn; Hosgood, Sarah A

    2015-08-01

    Ischemic conditioning involves the delivery of short cycles of reversible ischemic injury in order to induce protection against subsequent more prolonged ischemia. This randomized controlled trial was designed to determine the safety and efficacy of remote ischemic conditioning (RC) in live donor kidney transplantation.This prospective randomized clinical trial, 80 patients undergoing live donor kidney transplantation were randomly assigned in a 1:1 ratio to either RC or to a control group. RC consisted of cycles of lower limb ischemia induced by an arterial tourniquet cuff placed around the patient's thigh. In the RC treatment group, the cuff was inflated to 200 mm Hg or systolic pressure +25 mm Hg for 4 cycles of 5 min ischemia followed by 5 min reperfusion. In the control group, the blood pressure cuff was inflated to 25 mm Hg. Patients and medical staff were blinded to treatment allocation. The primary end-point was renal function measured by estimated glomerular filtration rate (eGFR) at 1 and 3 months posttransplant.Donor and recipient demographics were similar in both groups (P protocol described here, did not improve renal function after live donor kidney transplantation.

  3. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial

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    Usman Anju

    2009-03-01

    Full Text Available Abstract Background Several uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism. Methods 62 children with autism recruited from 6 centers, ages 2–7 years (mean 4.92 ± 1.21, were randomly assigned to 40 hourly treatments of either hyperbaric treatment at 1.3 atmosphere (atm and 24% oxygen ("treatment group", n = 33 or slightly pressurized room air at 1.03 atm and 21% oxygen ("control group", n = 29. Outcome measures included Clinical Global Impression (CGI scale, Aberrant Behavior Checklist (ABC, and Autism Treatment Evaluation Checklist (ATEC. Results After 40 sessions, mean physician CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0008, receptive language (p Conclusion Children with autism who received hyperbaric treatment at 1.3 atm and 24% oxygen for 40 hourly sessions had significant improvements in overall functioning, receptive language, social interaction, eye contact, and sensory/cognitive awareness compared to children who received slightly pressurized room air. Trial Registration clinicaltrials.gov NCT00335790

  4. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Berry-Kravis, Elizabeth; Des Portes, Vincent; Hagerman, Randi; Jacquemont, Sébastien; Charles, Perrine; Visootsak, Jeannie; Brinkman, Marc; Rerat, Karin; Koumaras, Barbara; Zhu, Liansheng; Barth, Gottfried Maria; Jaecklin, Thomas; Apostol, George; von Raison, Florian

    2016-01-13

    Fragile X syndrome (FXS), the most common cause of inherited intellectual disability and autistic spectrum disorder, is typically caused by transcriptional silencing of the X-linked FMR1 gene. Work in animal models has described altered synaptic plasticity, a result of the up-regulation of metabotropic glutamate receptor 5 (mGluR5)-mediated signaling, as a putative downstream effect. Post hoc analysis of a randomized, placebo-controlled, crossover phase 2 trial suggested that the selective mGluR5 antagonist mavoglurant improved behavioral symptoms in FXS patients with completely methylated FMR1 genes. We present the results of two phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of mavoglurant in FXS, designed to confirm this result in adults (n = 175, aged 18 to 45 years) and adolescents (n = 139, aged 12 to 17 years). In both trials, participants were stratified by methylation status and randomized to receive mavoglurant (25, 50, or 100 mg twice daily) or placebo over 12 weeks. Neither of the studies achieved the primary efficacy end point of improvement on behavioral symptoms measured by the Aberrant Behavior Checklist-Community Edition using the FXS-specific algorithm (ABC-C(FX)) after 12 weeks of treatment with mavoglurant. The safety and tolerability profile of mavoglurant was as previously described, with few adverse events. Therefore, under the conditions of our study, we could not confirm the mGluR theory of FXS nor the ability of the methylation state of the FMR1 promoter to predict mavoglurant efficacy. Preclinical results suggest that future clinical trials might profitably explore initiating treatment in a younger population with longer treatment duration and longer placebo run-ins and identifying new markers to better assess behavioral and cognitive benefits.

  5. Zinc and copper supplementation in acute diarrhea in children: a double-blind randomized controlled trial

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    Mamtani Manju

    2009-05-01

    Full Text Available Abstract Background Diarrhea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhea. Zinc and copper stores in the body are known to be depleted during acute diarrhea. Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with standard treatment to children with acute watery or bloody diarrhea. Methods We conducted a double-blind randomized controlled clinical trial in the Department of Pediatrics at Indira Gandhi Government Medical College Nagpur, India. Eight hundred and eight children aged 6 months to 59 months with acute diarrhea were individually randomized to placebo (Pl, zinc (Zn only, and zinc and copper (Zn+Cu together with standard treatment for acute diarrhea. Results The mean duration of diarrhea from enrolment and the mean stool weight during hospital stay were 63.7 hours and 940 grams, respectively, and there were no significant differences in the adjusted means across treatment groups. Similarly, the adjusted means of the amount of oral rehydration solution or intravenous fluids used, the proportion of participants with diarrhea more than 7 days from onset, and the severity of diarrhea indicated by more than three episodes of some dehydration or any episode of severe dehydration after enrolment, did not differ across the three groups. Conclusion The expected beneficial effects of zinc supplementation for acute diarrhea were not observed. Therapeutic Zn or Zn and Cu supplementation may not have a universal beneficial impact on the duration of acute diarrhea in children. Trial registration The study was registered as an International Standard Randomized Controlled Trial (ISRCTN85071383.

  6. T cell vaccination benefits relapsing progressive multiple sclerosis patients: a randomized, double-blind clinical trial.

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    Dimitrios Karussis

    Full Text Available BACKGROUND: T-cell vaccination (TCV for multiple sclerosis (MS refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled. AIM: To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial. METHODOLOGY: Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7. T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10-30×10(6 T-cells, attenuated by irradiation, on days 1, 30, 90 and 180 and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo were eligible for per-protocol analysis. RESULTS: At one year following the inclusion, an increase in the EDSS (+0.50 and an increase in 10-meter walking time (+0.18 sec, were observed in the placebo group; in the TCV group there was a decrease in the EDSS (-0.44; p<0.01 and in the 10-meter walking time (0.84 sec; p<0.005. Sixteen of the 17 patients (94.1% in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment. The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly. CONCLUSIONS: This is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT01448252.

  7. Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial

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    Higurashi Takuma

    2012-03-01

    Full Text Available Abstract Background Colorectal cancer is one of the major neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggestive to have a suppressive effect on tumorigenesis and cancer cell growth. In a previous study conducted in non-diabetic subjects, we showed that oral short-term low-dose metformin suppressed the development of colorectal aberrant crypt foci (ACF. ACF have been considered as a useful surrogate biomarker of CRC, although the biological significance of these lesions remains controversial. We devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against metachronous colorectal polyps and the safety of this drug in non-diabetic post-polypectomy patients. Methods/Design This study is a multi-center, double-blind, placebo-controlled, randomized controlled trial to be conducted in non-diabetic patients with a recent history of undergoing colorectal polypectomy. All adult patients visiting the Yokohama City University hospital or affiliated hospitals for polypectomy shall be recruited for the study. Eligible patients will then be allocated randomly into either one of two groups: the metformin group and the placebo group. Patients in the metformin group shall receive oral metformin at 250 mg per day, and those in the placebo group shall receive an oral placebo tablet. At the end of 1 year of administration of metformin/placebo, colonoscopy will be performed to evaluate the polyp formation. Discussion This is the first study proposed to explore the effect of metformin against colorectal polyp formation. Metformin activates AMPK, which inhibits the mammalian target of rapamycin (mTOR pathway. The mTOR pathway plays an important role in the cellular protein translational machinery and cell proliferation. Patients with

  8. Implant decontamination during surgical peri-implantitis treatment : a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    de Waal, Yvonne C. M.; Raghoebar, Gerry M.; Huddleston Slater, James J. R.; Meijer, Henny J. A.; Winkel, Edwin G.; van Winkelhoff, Arie Jan

    2013-01-01

    Aim The objective of this randomized, double-blind, placebo-controlled trial was to study the effect of implant surface decontamination with chlorhexidine (CHX)/cetylpyridinium chloride (CPC) on microbiological and clinical parameters. Material & Methods Thirty patients (79 implants) with peri-impla

  9. Implant decontamination during surgical peri-implantitis treatment : a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    de Waal, Yvonne C.M.; Raghoebar, Gerry M; Huddleston Slater, James J R; Meijer, Hendrikus; Winkel, Edwin G; van Winkelhoff, Arie Jan

    2013-01-01

    AIM: The objective of this randomized, double-blind, placebo-controlled trial was to study the effect of implant surface decontamination with chlorhexidine (CHX)/cetylpyridinium chloride (CPC) on microbiological and clinical parameters. MATERIAL & METHODS: Thirty patients (79 implants) with peri-imp

  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 stimula...

  11. Relay model for recruiting alcohol dependent patients in general hospitals--a single-blind pragmatic randomized trial

    DEFF Research Database (Denmark)

    Schwarz, Anne-Sophie; Bilberg, Randi; Bjerregaard, Lene Berit Skov;

    2016-01-01

    - The Relay Model. METHOD/DESIGN: The study is a single-blind pragmatic randomized controlled trial including patients admitted to the hospital. The study group (n = 500) will receive an intervention, and the control group (n = 500) will be referred to treatment by usual procedures. All patients complete...

  12. Raloxifene and body composition and muscle strength in postmenopausal women: a randomized, double-blind, placebo-controlled trial.

    NARCIS (Netherlands)

    Jacobsen, D.E.; Samson, M.M.; Emmelot-Vonk, M.H.; Verhaar, H.J.

    2010-01-01

    OBJECTIVE: To compare the effects of raloxifene and placebo on body composition and muscle strength. DESIGN: Randomized, double-blind, placebo-controlled trial involving 198 healthy women aged 70 years or older conducted between July 2003 and January 2008 at the University Medical Centre, Utrecht, T

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

    Science.gov (United States)

    2014-01-01

    Background 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. Methods 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. Results 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. Conclusion Our study failed to

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

    Science.gov (United States)

    Ghoshegir, S. Ashraffodin; Mazaheri, Mohammad; Ghannadi, Alireza; Feizi, Awat; Babaeian, Mahmoud; Tanhaee, Maryam; Karimi, Mehrdad; Adibi, Peyman

    2015-01-01

    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. PMID:25767516

  15. 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.

  16. Effect of allopurinol in chronic nonbacterial prostatitis: a double blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Amir M. Ziaee

    2006-04-01

    Full Text Available INTRODUCTION: The exact mechanism of chronic nonbacterial prostatitis has not been yet elucidated and the outcome with the current management is dismal. In this trial, we studied the effect of allopurinol in the treatment of this disease. MATERIALS AND METHODS: In this randomized double blind controlled trial, a calculated sample size of 56 were grouped into "intervention group" who received allopurinol (100 mg tds for 3 months with ofloxacin (200 mg tds for 3 weeks (n = 29 and "control group" who received placebo tablets with ofloxacin (n = 27. Patients’ scores based on the National Institute of Health Chronic Prostatitis Symptom Score were recorded before therapy and then every month during the study. A four-glass study was performed before intervention and after 3 months. RESULTS: The 2 groups were similar regarding outcome variables. In the first month of study, a significant but similar improvement in symptom scores was observed in both groups. Microscopic examination of prostate massage and post-massage samples were also similar in both groups. No side effects due to allopurinol were observed in patients. CONCLUSION: We did not find any advantage for allopurinol in the management of chronic prostatitis versus placebo in patients receiving routine antibacterial treatment.

  17. Pterostilbene on metabolic parameters: a randomized, double-blind, and placebo-controlled trial.

    Science.gov (United States)

    Riche, Daniel M; Riche, Krista D; Blackshear, Chad T; McEwen, Corey L; Sherman, Justin J; Wofford, Marion R; Griswold, Michael E

    2014-01-01

    Introduction. The purpose of this trial was to evaluate the effect of pterostilbene on metabolic parameters. Methods. A prospective, randomized, double-blind, and placebo-controlled study that enrolled 80 patients with a total cholesterol ≥200 mg/dL and/or LDL ≥ 100 mg/dL. Subjects were divided into four groups: (1) pterostilbene 125 mg twice daily; (2) pterostilbene 50 mg twice daily; (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily; (4) matching placebo twice daily for 6-8 weeks. Endpoints included lipids, blood pressure, and weight. Linear mixed models were used to examine and compare changes in parameters over time. Models were adjusted for age, gender, and race. Results. LDL increased with pterostilbene monotherapy (17.1 mg/dL; P = 0.001) which was not seen with GE combination (P = 0.47). Presence of a baseline cholesterol medication appeared to attenuate LDL effects. Both systolic (-7.8 mmHg; P < 0.01) and diastolic blood pressure (-7.3 mmHg; P < 0.001) were reduced with high dose pterostilbene. Patients not on cholesterol medication (n = 51) exhibited minor weight loss with pterostilbene (-0.62 kg/m(2); P = 0.012). Conclusion. Pterostilbene increases LDL and reduces blood pressure in adults. This trial is registered with Clinicaltrials.gov NCT01267227.

  18. Pterostilbene on Metabolic Parameters: A Randomized, Double-Blind, and Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Daniel M. Riche

    2014-01-01

    Full Text Available Introduction. The purpose of this trial was to evaluate the effect of pterostilbene on metabolic parameters. Methods. A prospective, randomized, double-blind, and placebo-controlled study that enrolled 80 patients with a total cholesterol ≥200 mg/dL and/or LDL≥100 mg/dL. Subjects were divided into four groups: (1 pterostilbene 125 mg twice daily; (2 pterostilbene 50 mg twice daily; (3 pterostilbene 50 mg + grape extract (GE 100 mg twice daily; (4 matching placebo twice daily for 6–8 weeks. Endpoints included lipids, blood pressure, and weight. Linear mixed models were used to examine and compare changes in parameters over time. Models were adjusted for age, gender, and race. Results. LDL increased with pterostilbene monotherapy (17.1 mg/dL; P=0.001 which was not seen with GE combination (P=0.47. Presence of a baseline cholesterol medication appeared to attenuate LDL effects. Both systolic (−7.8 mmHg; P<0.01 and diastolic blood pressure (−7.3 mmHg; P<0.001 were reduced with high dose pterostilbene. Patients not on cholesterol medication (n=51 exhibited minor weight loss with pterostilbene (−0.62 kg/m2; P=0.012. Conclusion. Pterostilbene increases LDL and reduces blood pressure in adults. This trial is registered with Clinicaltrials.gov NCT01267227.

  19. Ranitidine and placebo in the treatment of reflux oesophagitis. A double-blind randomized trial.

    Science.gov (United States)

    Goy, J A; Maynard, J H; McNaughton, W M; O'Shea, A

    1983-11-26

    A study was carried out to assess the effectiveness of ranitidine in the short-term treatment of reflux oesophagitis. In a double-blind randomized trial of 37 outpatients with symptomatic, endoscopically proven, moderate or severe reflux oesophagitis, 18 patients received ranitidine (150 mg twice a day) and 19 patients received identical-looking placebo tablets for a period of six weeks. Clinical, laboratory, and endoscopic assessments were made initially, and at the end of six weeks. Two patients withdrew during the trial. Endoscopic evidence of improvement was found in 15 of 17 ranitidine-treated and in five of 18 placebo-treated patients. This difference was significant (P less than 0.01). Antacid consumption was significantly lower in the ranitidine-treated group (P less than 0.01). Improvement in histological findings, and the relief of retrosternal pain, regurgitation, dysphagia, and epigastric pain did not achieve levels of statistical significance. No adverse clinical or laboratory changes occurred in patients in either group. It is concluded that, as judged by endoscopic evidence, ranitidine is an effective drug for the short-term treatment of reflux oesophagitis.

  20. Klapp method effect on idiopathic scoliosis in adolescents: blind randomized controlled clinical trial.

    Science.gov (United States)

    Dantas, Diego De Sousa; De Assis, Sanderson José Costa; Baroni, Marina Pegoraro; Lopes, Johnnatas Mikael; Cacho, Enio Walker Azevedo; Cacho, Roberta De Oliveira; Pereira, Silvana Alves

    2017-01-01

    [Purpose] To estimate the effect of Klapp method on idiopathic scoliosis in school students. [Subjects and Methods] A single-blind randomized clinical trial with 22 students randomly divided into intervention group (n=12) and inactive control group (n=10). Exercise protocol consisted of Klapp method, 20 sessions, three times a week for intervention group, and inactivity for control group. Dorsal muscle strength was measured by dynamometer; body asymmetries and gibbosity angles were measured by biophotogrammetry. Data were obtained by Generalized Estimated Equation, with 5% significance level. Clinical impact for dependent variables was estimated by "d" Cohen. [Results] There was no change in intragroup analysis and intergroup for all postural symmetry variables. However, it was detected intergroup difference in extensor muscle strength and intergroup difference with marginal significance of gibbosity angles. Regarding extensor muscle strength, intervention group produced average improvement of 7.0 kgf compared to control group. Gibbosity angles progressed less in intervention group, with 5.71° average delay compared to control group. [Conclusion] Klapp method was effective for gibbosity stabilization and it improves spine extensor muscle strength.

  1. The Effect of Eicosapentaenoic Acid Supplementation on Depression Remission: a Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Karamati

    2011-12-01

    Full Text Available Introduction: There is some evidence that omega-3 fatty acids are associated with depression. The aim of this study was to compare the effects of eicosapentaenoic acid(EPA and placebo on mild to moderate depression. Methods: This double-blind randomized clinical trial was conducted on 54 outpatients with mild to moderate depression. Patients were randomly assigned to two groups: receiving EPA supplement or placebo. EPA and placebo groups received two identical capsules per day for 12 weeks. Each capsule contained 500 mg EPA or coconut oil. Hamilton Rating Scale for Depression(HRSD was used to determine the severity of depression at baseline, sixth and twelfth weeks after intervention. Results: Forty two patients(77.8% completed the 12-week intervention. A statistically significant difference was observed in mean scores of HRSD between EPA and placebo groups at the end of the study (P=0.001. Mean scores of HRSD decreased over time in both groups so that the analysis of variance for repeated measurements showed a statistically significant time effect(F=50.55, df=1.32, P<0.0001. Also, a statistically significant treatment effect of EPA compared to placebo was observed over time (treatment*time interaction, F=12.67, df=1.32, P=0.0001. Conclusion: The results of this study showed the efficacy of EPA in treatment of depression, so its use is recommended as an add-on to antidepressant medications in treatment of mild to moderate depression.

  2. 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.

  3. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial.

    Science.gov (United States)

    Cerezo-Téllez, Ester; Torres-Lacomba, María; Fuentes-Gallardo, Isabel; Perez-Muñoz, Milagros; Mayoral-Del-Moral, Orlando; Lluch-Girbés, Enrique; Prieto-Valiente, Luis; Falla, Deborah

    2016-09-01

    Chronic neck pain attributed to a myofascial pain syndrome is characterized by the presence of muscle contractures referred to as myofascial trigger points. In this randomized, parallel-group, blinded, controlled clinical trial, we examined the effectiveness of deep dry needling (DDN) of myofascial trigger points in people with chronic nonspecific neck pain. The study was conducted at a public Primary Health Care Centre in Madrid, Spain, from January 2010 to December 2014. A total of 130 participants with nonspecific neck pain presenting with active myofascial trigger points in their cervical muscles were included. These participants were randomly allocated to receive: DDN plus stretching (n = 65) or stretching only (control group [n = 65]). Four sessions of treatment were applied over 2 weeks with a 6-month follow-up after treatment. Pain intensity, mechanical hyperalgesia, neck active range of motion, neck muscle strength, and perceived neck disability were measured at baseline, after 2 sessions of intervention, after the intervention period, and 15, 30, 90, and 180 days after the intervention. Significant and clinically relevant differences were found in favour of dry needling in all the outcomes (all P neck pain. The results support the use of DDN in the management of myofascial pain syndrome in people with chronic nonspecific neck pain.

  4. Klapp method effect on idiopathic scoliosis in adolescents: blind randomized controlled clinical trial

    Science.gov (United States)

    Dantas, Diego De Sousa; De Assis, Sanderson José Costa; Baroni, Marina Pegoraro; Lopes, Johnnatas Mikael; Cacho, Enio Walker Azevedo; Cacho, Roberta De Oliveira; Pereira, Silvana Alves

    2017-01-01

    [Purpose] To estimate the effect of Klapp method on idiopathic scoliosis in school students. [Subjects and Methods] A single-blind randomized clinical trial with 22 students randomly divided into intervention group (n=12) and inactive control group (n=10). Exercise protocol consisted of Klapp method, 20 sessions, three times a week for intervention group, and inactivity for control group. Dorsal muscle strength was measured by dynamometer; body asymmetries and gibbosity angles were measured by biophotogrammetry. Data were obtained by Generalized Estimated Equation, with 5% significance level. Clinical impact for dependent variables was estimated by “d” Cohen. [Results] There was no change in intragroup analysis and intergroup for all postural symmetry variables. However, it was detected intergroup difference in extensor muscle strength and intergroup difference with marginal significance of gibbosity angles. Regarding extensor muscle strength, intervention group produced average improvement of 7.0 kgf compared to control group. Gibbosity angles progressed less in intervention group, with 5.71° average delay compared to control group. [Conclusion] Klapp method was effective for gibbosity stabilization and it improves spine extensor muscle strength.

  5. Lidocaine for systemic sclerosis: a double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Trevisani Virgínia FM

    2011-02-01

    Full Text Available Abstract Background Systemic sclerosis (scleroderma; SSc is an orphan disease with the highest case-specific mortality of any connective-tissue disease. Excessive collagen deposit in affected tissues is a key for the disease's pathogenesis and comprises most of the clinical manifestations. Lidocaine seems to be an alternative treatment for scleroderma considering that: a the patient's having excessive collagen deposits in tissues affected by scleroderma; b the patient's demonstrating increased activity of the enzyme prolyl hydroxylase, an essential enzyme for the biosynthesis of collagen; and c lidocaine's reducing the activity of prolyl hydroxylase. The aim of this study was to evaluate the efficacy and safety of lidocaine in treating scleroderma. Methods A randomized double-blind clinical trial included 24 patients with scleroderma randomized to receive lidocaine or placebo intravenously in three cycles of ten days each, with a one-month interval between them. Outcomes: cutaneous (modified Rodnan skin score, oesophageal (manometry and microvascular improvement (nailfold capillaroscopy; improvement in subjective self-assessment and in quality of life (HAQ. Results There was no statistically significant difference between the groups for any outcome after the treatment and after 6-months follow-up. Improvement in modified Rodnan skin score occurred in 66.7% and 50% of placebo and lidocaine group, respectively (p = 0.408. Both groups showed an improvement in subjective self-assessment, with no difference between them. Conclusions Despite the findings of a previous cohort study favouring the use of lidocaine, this study demonstrated that lidocaine at this dosage and means of administration showed a lack of efficacy for treating scleroderma despite the absence of significant adverse effects. However, further similar clinical trials are needed to evaluate the efficacy of lidocaine when administered in different dosages and by other means.

  6. Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation

    Directory of Open Access Journals (Sweden)

    Nilsson Robert

    2011-09-01

    Full Text Available Abstract Background Epidemiological studies suggest that smokeless tobacco in the form of Swedish snus has been used by many smokers in Scandinavia to quit smoking, but the efficacy of snus has so far not been evaluated in controlled clinical trials. Methods We conducted a randomized, double-blind, placebo-controlled, clinical trial aimed at assessing the efficacy of snus to help adult cigarette smokers in Serbia to substantially reduce, and, eventually, completely stop smoking. The study enrolled 319 healthy smokers aged 20-65 years at two occupational health centers in Belgrade, Serbia. Most of them (81% expressed an interest to quit rather than just reduce their smoking. Study products were used ad libitum throughout the 48-week study period. The main study objective during the first 24 weeks was smoking reduction. The primary end-point was defined as a biologically verified reduction of ≥ 50% in the average number of smoked cigarettes per day during week 21-24 compared to baseline. During week 25-48 participants were actively instructed to stop smoking completely. Outcome measures of biologically verified, complete smoking cessation included 1-week point prevalence rates at clinical visits after 12, 24, 36, and 48 weeks, as well as 4-, 12- and 24-week continued cessation rates at the week 36 and 48 visits. Results At the week 24 visit, the proportion of participants who achieved the protocol definition of a ≥ 50% smoking reduction was similar in the two treatment groups. However, the proportion that reported more extreme reductions (≥ 75% was statistically significantly higher in the snus group than in the placebo group (p Conclusions Swedish snus could promote smoking cessation among smokers in Serbia, that is, in a cultural setting without traditional use of oral, smokeless tobacco. Trial registration www.clinicaltrials.gov, identifier: NCT00601042

  7. 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.

  8. A Randomized, Controlled, Single-Blind Trial of Leflunomide in the Treatment of Rheumatoid Arthritis

    Institute of Scientific and Technical Information of China (English)

    胡永红; 涂胜豪; 刘沛霖

    2001-01-01

    The efficacy and safety of leflunomide (LEF) in the treatment of rheumatoid arthritis (RA) were evaluated and the comparison with methotrexate's (MTX's) was performed in a 12-week, single-blind, randomized, parallel trial for treating 81 patients with RA. There were 56 cases in LEF group and 25 cases in MTX group. The dose of LEF was 20 mg per day and MTX 15 mg per week. All patients took oxaproxin simultaneously at the 4th to 6th week after the trail. The results showed that the general effective rate and notable effective rate were 94.64 % and 73.21 % in LEF group, 72 % and 44 % in MTX group, respectively, with the differences being statistically significant between the two groups (P<0.05). LEF and oxaprozin could obviously improve the symptoms, signs and joint functions. The incidence of side reactions was lower in LEF group (17.86 %) than in MTX group (40.00 %, P<0.05). LEF had a good therapeutic effect for RA, especially for refractory RA and had slight side reactions, and could be regarded as a superior immunosuppressive agent used in the treatment of RA and other connective tissue diseases.

  9. Randomized double-blind trial of prednisone versus radiotherapy in Graves' ophthalmopathy

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    Prummel, M.F.; Mourits, M.; Blank, L.; Berghout, A.; Koornneef, L.; Wiersinga, W.M. (Univ. of Amsterdam (Netherlands))

    1993-10-16

    Corticosteriods are usually given for management of Graves' ophthalmopathy, but they have many and serious side-effects. By comparison, retrobulbar irradiation is well tolerated, although its efficacy has been evaluated only in uncontrolled studies. Therefore, the authors did a double-blind randomized trial, in which 28 patients with moderately severe Graves' ophthalmopathy were treated with a 3-month course of oral prednisone and sham irradiation, and 28 received retrobulbar irradiation (20 Gy) and placebo capsules. Therapeutic outcome, assessed twenty-four weeks after the start of treatment, was determined by the change in the highest NOSPECS class. A successful outcome was observed in 14 prednisone-treated and in 13 irradiated patients. Responders to treatment (but not nonresponders) in both groups showed improvements in total and subjective eye score and a decrease in eye-muscle volume. Response to either treatment was due largely to changes in soft-tissue involvement and eye-muscle motility. Radiotherapy and oral prednisone appear to be equally effective as initial treatment in patients with moderately severe Graves' ophthalmopathy. In view of its better tolerability, radiotherapy should be considered the treatment of first choice.

  10. Combined conventional/antioxidant "Astaxanthin" treatment for male infertility: a double blind, randomized trial

    Institute of Scientific and Technical Information of China (English)

    F. H. Comhaire; Y. El Garem; A. Mahmoud; F. Eertmans; F. Schoonjans

    2005-01-01

    Aim: To evaluate the treatment of male infertility with a strong natural antioxidant, in addition to conventional treatment.Methods: Using a double blind, randomized trial design, 30 men with infertility of ≥12 months and female partners with no demonstrable cause of infertility received conventional treatment according to the guidelines of the World Health Organization (WHO), and either a strong antioxidant Astaxanthin 16 mg/day (AstaCarox(R), AstaReal AB,Gustavsberg, Sweden) or placebo for 3 months. The effects of treatment on semen parameters, reactive oxygen species (ROS), zona-free hamster oocyte test, serum hormones including testosterone, luteinizing hormone (LH),follicle stimulating hormone (FSH) and Inhibin B, and spontaneous or intrauterine insemination (IUI)-induced pregnancies were evaluated. Results: ROS and Inhibin B decreased significantly and sperm linear velocity increased in the Astaxanthin group (n = 11), but not in the placebo group (n = 19). The results of the zona-free hamster oocyte test tended to improve in the Astaxanthin group in contrast with the placebo group, though not reaching statistical significance.The total and per cycle pregnancy rates among the placebo cases (10.5 % and 3.6 %) were lower compared with 54.5 % and 23.1% respectively in the Astaxanthin group (P = 0.028; P = 0.036). Conclusion: Although the present study suggests a positive effect of Astaxanthin on sperm parameters and fertility, the results need to be confirmed in a larger trial before recommending Astaxanthin for the complementary treatment of infertile men.

  11. A Double Blind Randomized Clinical Trial of Remote Ischemic Conditioning in Live Donor Renal Transplantation

    OpenAIRE

    Nicholson, Michael L; Pattenden, Clare J.; Barlow, Adam D.; Hunter, James P.; Lee, Gwyn; Hosgood, Sarah A.

    2015-01-01

    Abstract Ischemic conditioning involves the delivery of short cycles of reversible ischemic injury in order to induce protection against subsequent more prolonged ischemia. This randomized controlled trial was designed to determine the safety and efficacy of remote ischemic conditioning (RC) in live donor kidney transplantation. This prospective randomized clinical trial, 80 patients undergoing live donor kidney transplantation were randomly assigned in a 1:1 ratio to either RC or to a contro...

  12. Efficacy of Two Streptokinase Formulations in Acute Myocardial Infarction: A Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Navid Paydari

    2009-03-01

    Full Text Available Background: We sought to evaluate the efficacy and safety of the different trade forms of streptokinase available in our country, namely Heberkinasa (Heberbiotec, Havana, Cuba and Streptase (Aventis Behring GmbH, Marburg, Germany. Methods: We conducted a double-blind randomized clinical trial to compare the two streptokinase formulations, i.e. Heberkinasa (HBK or Streptase (STP, in patients with acute myocardial infarction who needed thrombolysis. Thrombolysis success was evaluated angiographically and/or clinically. Clinical follow-up was done 30 days after thrombolysis. Results: We randomly allocated 221 patients with a mean age of 56.9±10.8 years (males: 88.2% to HBK (n=119 and STP (n=102 groups. Baseline clinical and demographic characteristics were similar between the two groups, and the two groups were not significantly different in terms of door-to-needle and pain-to-needle intervals. The rate of complications was not significantly different between the groups (44.1% [HBK] vs. 42% [STP]. Angiography was done for 158 (71.5 % patients in the first 24 hours (9% and in the first 72 hours (38.8% after thrombolysis. Lesion morphology and lesion/patient ratio were not significantly different between the two groups (1.87[HBK] vs. 1.67[STP]. The two groups were similar with respect to angiographic patency rate (67.5% [HBK] vs. 67.6% [STP]. The study groups were also similar as regards clinical outcome and complications of both streptokinase formulations. Conclusion: The present study demonstrated that Heberkinasa is as effective and as safe as a standard streptokinase, namely Streptase, in a clinical setting.

  13. Effects of Piracetam on Pediatric Breath Holding Spells: A Randomized Double Blind Controlled Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Sadegh REZAI

    2012-10-01

    Full Text Available ObjectiveBreath holding spells (BHS are common paroxysmal non-epileptic events in the pediatric population which are very stressful despite their harmless nature. There has been no specific treatment found for the spells yet. The aim of this study was to evaluate the efficacy of piracetam (2-oxo-l-pyrrolidineon these children.Materials & MethodsIn this randomized double blind clinical trial study, 150 children with severe BHS referred to our pediatric outpatient service were enrolled from August 2011 to July 2012. The patients were randomized into two equal groups.One received 40mg/kg/day piracetam and the other group received placebo,twice daily. Patients were followed monthly for three months. The number of attacks/month before and after treatment were documented.Results Of the enrolled patients, 86 were boys. The mean age of the patients was 17 months (range, 6 to 24 months. In the piracetam group, 1 month after treatment an 81% response to treatment was found. In the placebo group,none of the patients had complete remission and 7% of the cases had partial remission. Overall, control of breath-holding spells was observed in 91%of the patients in the group taking piracetam as compared with 16% in the group taking placebo at the end of the study. There was nosignificant difference detected between the groups regarding the prevalence of drug side effects.ConclusionA significant difference was detected between piracetam and placebo in prevention and controlling BHS. Piracetam (40mg/kg/day had a good effect on our patients.

  14. 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...

  15. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R;

    2002-01-01

    BACKGROUND: Downsizing the port incisions may reduce pain after laparoscopic cholecystectomy. METHODS: In a double-blind controlled study, 60 patients were randomized to undergo either microlaparoscopic cholecystectomy using one 10-mm and three 3.5-mm trocars (3.5-mm LC) or traditional laparoscopic...

  16. Tic Reduction with Risperidone Versus Pimozide in a Randomized, Double-Blind, Crossover Trial

    Science.gov (United States)

    Gilbert, Donald L.; Batterson, J. Robert; Sethuraman, Gopalan; Sallee, Floyd R.

    2004-01-01

    Objective: To compare the tic suppression, electrocardiogram (ECG) changes, weight gain, and side effect profiles of pimozide versus risperidone in children and adolescents with tic disorders. Method: This was a randomized, double-blind, crossover (evaluable patient analysis) study. Nineteen children aged 7 to 17 years with Tourette's or chronic…

  17. Mucolytic Effectiveness of Tyloxapol in Chronic Obstructive Pulmonary Disease - A Double-Blind, Randomized Controlled Trial.

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    Martin Koppitz

    Full Text Available Mucoactive drugs should increase the ability to expectorate sputum and, ideally, have anti-inflammatory properties. The aim of the study was to evaluate the mucolytic activity of Tyloxapol compared to saline (0.9% in COPD.A randomized, placebo-controlled, double-blinded crossover, clinical trial was carried out. Patients were randomly assigned to either inhale 5 ml Tyloxapol 1% or saline 0.9% solution three times daily for 3 weeks and vice versa for another 3 weeks. 28 patients (18 male, 10 female, 47 to 73 years old, median age 63.50 were screened, 21 were treated and 19 patients completed the study per protocol.A comparison of the two treatment phases showed that the primary endpoint sputum weight was statistically significant higher when patients inhaled Tyloxapol (mean 4.03 g, 95% CI: 2.34-5.73 g at week 3 compared to saline (mean 2.63 g, 95% CI: 1.73-3.53 g at week 3. The p-value at three weeks of treatment was 0.041 between treatment arms. Sputum cells decreased during the Tyloxapol treatment after 3 weeks, indicating that Tyloxapol might have some anti-neutrophilic properties. Lung function parameters (FVC, FEV1, RV, and RV/TLC remained stable during the study, and no treatment effect was shown. Interestingly, there was a mean increase in all inflammatory cytokines (IL-1β, IL-6, and IL-8 during the saline treatment from day 1 to week 3, whereas during the Tyloxapol treatment, all cytokines decreased. Due to the small sample size and the large individual variation in sputum cytokines, these differences were not significant. However, analyses confirmed that Tyloxapol has significant anti-inflammatory properties in vitro. Despite the high number of inhalations (more than 1000, only 27 adverse events (20 during the Tyloxapol and seven during saline were recorded. Eleven patients experienced AEs under Tyloxapol and six under saline treatment, which indicates that inhalation of saline or Tyloxapol is a very safe procedure.Our study

  18. A Double-Blind Randomized Placebo-Controlled Clinical Trial of Squalamine Ointment for tinea capitis Treatment

    OpenAIRE

    2015-01-01

    International audience; Background Novel treatments against for tinea capitis are needed, and the natural aminosterol squal-amine is a potential topical antidermatophyte drug candidate. Objectives This phase II randomized double-blind placebo-controlled clinical trial aimed at testing the efficacy and safety of a three-week squalamine ointment regimen for the treatment of tinea capitis. Patients Males aged 6–15 years presenting with tinea capitis were treated with either topical squal-amine o...

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

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    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.

  20. Comparison of two doses of ketoprofen to treat pain: a double-blind, randomized, noninferiority trial.

    Science.gov (United States)

    Riou, Bruno; Plaisance, Patrick; Lecomte, François; Soulat, Louis; Orcel, Philippe; Mazoit, Jean-Xavier

    2014-02-01

    The aim of our study was to compare the efficacy and safety of two doses of ketoprofen (200 mg vs. 300 mg/day) in ambulatory emergency patients with pain related to traumatic and nontraumatic bone and joint diseases. We tested the hypothesis that the efficacy of the lower dose was not lower than that of the higher dose in a double-blind, randomized, noninferiority trial. Patients included in the study were aged 18-65 years with closed benign trauma of the motor system or acute noninfectious rheumatologic conditions, with a resting pain intensity ≥3/10 on a numeric pain scale (NPS), requiring ketoprofen for 5 days. The main end-point was based on two efficacy co-criteria: (i) mean change from baseline of resting pain intensity at the end of the day over 5 days and (ii) total intake of concomitant analgesics. We included 409 patients: 200 in the 200-mg group and 209 in the 300-mg group. The mean change in pain intensity at rest (difference between groups: 0.0, 95% CI -0.4 to 0.4; P = 1.00) and in analgesic consumption (difference between groups: -0.6, 95% CI -1.9 to 0.6; P = 0.33) was not significantly different between the two groups, and the differences were lower than the predefined inferiority margins (0.5 and 1.5, respectively), thus demonstrating noninferiority. No significant difference was noted in the incidence of adverse events (21% vs. 20%, P = 0.71). The efficacy of the 200-mg daily dose of ketoprofen in relieving pain in emergency cases was not inferior to that of the 300-mg dose.

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

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    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

  2. EXTRADURAL ANESTHESIA WITH AND WITHOUT KETAMIN: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

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    R TALA KOUB

    2001-09-01

    Full Text Available Introduction. Extradural anesthesia is a successfull procedure in many operations.This is also a suitable and elective anesthetic procedure in many operations have particular hemodynamic conditions. Hence the onset time on this of anesthesia is slow and the degree of sensory and motor block is relatively variable in many cases, this procedure is not accepted by anesthesiologists and surgeons. So, inspite of its priority in many cases, it is less used. Thegoal of this study is to achieve a practical and effective solution to shorten the onset of analgesia and increasing analgesic duration which studies adding ketamin to bupivacain in extradural anesthesia. Methods. This study is a double blinded randomized clinical trial. Forty adult patients in class 1 and 2 of ASA who have been candidate for elective lower limb or lower abdominal surgery in Al-zahra and Kashani medical center in 1998 were selected. Without receiving any premedications, all of the patients received 500 CC ringer lactated solution before onset of anesthesia and they were divided into 2 groups. Group 1 received 20 cc of 0.5 percent bupivacain+0.5cc of 0.9 percent normal saline. Group 2 (interventional received 20 cc of 0.5 percent bupivacain + 0.5 cc of Ketamin (25mg. The onset of sensory block and the duration of sensory and motor block were measured and compared in both groups. Results. The onset of sensory block in interventional group was shorter than in controlled group. The duration of sensory block in interventional group was longer than in controlled group. The duration of the motor block was longer in controlled group than interventional group (P < 0.05. Discussion. Adding ketamin to bupivacain results in earlier onset and longer duration of analgesia in extradural anesthesia. This effect may be due to the inhibitory effect of the ketamin on posterior nerve root activity in spinal cord which can be an effective mechanism of ketamin in making analgesia.

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

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    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.

  4. 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...

  5. Effect of fish oil supplementation on quality of life in a general population of older Dutch subjects: a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Rest, van de O.; Geleijnse, J.M.; Kok, F.; Staveren, van W.A.; Olderikkert, M.G.M.; Beekman, A.T.F.; Groot, de L.C.P.G.M.

    2009-01-01

    OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:

  6. Increased calcium absorption from synthetic stable amorphous calcium carbonate: Double-blind randomized crossover clinical trial in post-menopausal women

    Science.gov (United States)

    Calcium supplementation is a widely recognized strategy for achieving adequate calcium intake. We designed this blinded, randomized, crossover interventional trial to compare the bioavailability of a new stable synthetic amorphous calcium carbonate (ACC) with that of crystalline calcium carbonate (C...

  7. Effect of Fish Oil Supplementation on Quality of Life in a General Population of Older Dutch Subjects: A Randomized, Double-Blind, Placebo-Controlled Trial.

    NARCIS (Netherlands)

    Rest, van de O.; Geleijnse, J.M.; Kok, F.J.; Staveren, van W.A.; OldeRikkert, M.G.M.; Beekman, A.T.F.; Groot, de C.P.G.M.

    2009-01-01

    OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:

  8. Effect of fish oil supplementation on quality of life in a general population of older Dutch subjects: a randomized, double-blind, placebo-controlled trial.

    NARCIS (Netherlands)

    Rest, O. van de; Geleijnse, J.M.; Kok, F.J.; Staveren, W.A. van; Olde Rikkert, M.G.M.; Beekman, A.T.; Groot, L.C. de

    2009-01-01

    OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:

  9. A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

    DEFF Research Database (Denmark)

    Miller, I; Lynggaard, C D; Lophaven, S;

    2011-01-01

    BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo...... the outcomes were blinded to group assignment. The primary efficacy endpoints were changes in the HS scores (Sartorius and Hurley scoring systems). Secondary efficacy endpoints included changes in pain (visual analogue scale), days with lesions and Dermatology Life Quality Index, and evaluation of scarring......-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg...

  10. The brain signature of paracetamol in healthy volunteers: a double-blind randomized trial

    Directory of Open Access Journals (Sweden)

    Pickering G

    2015-07-01

    Full Text Available Gisèle Pickering,1–3 Adrian Kastler,4 Nicolas Macian,1,2 Bruno Pereira,5 Romain Valabrègue,6 Stéphane Lehericy,6 Louis Boyer,4,7 Claude Dubray,1–3 Betty Jean4 1CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, 2Centre d’Investigation Clinique – Inserm 1405, 3Clermont Université, Laboratoire de Pharmacologie, Faculté de médecine, 4CHU Gabriel Montpied, Clermont-Ferrand, Service d’Imagerie Ostéo-articulaire thoracique et neurologique, 5CHU Clermont-Ferrand, Délégation Recherche Clinique et à l’Innovation, Clermont-Ferrand, France; 6Institut du Cerveau et de la Moelle epiniere – ICM, Centre de NeuroImagerie de Recherche CENIR, Inserm U1127, CNRS UMR 7225, Sorbonne Universités, UPMC University Paris, Paris, France, Department of Neuroradiology, Groupe Hospitalier Pitié-Salpêtrière, Paris, France; 7UMR CNRS UdA 6284, Clemont-Ferrand, France Background: Paracetamol’s (APAP mechanism of action suggests the implication of supraspinal structures but no neuroimaging study has been performed in humans.Methods and results: This randomized, double-blind, crossover, placebo-controlled trial in 17 healthy volunteers (NCT01562704 aimed to evaluate how APAP modulates pain-evoked functional magnetic resonance imaging signals. We used behavioral measures and functional magnetic resonance imaging to investigate the response to experimental thermal stimuli with APAP or placebo administration. Region-of-interest analysis revealed that activity in response to noxious stimulation diminished with APAP compared to placebo in prefrontal cortices, insula, thalami, anterior cingulate cortex, and periaqueductal gray matter.Conclusion: These findings suggest an inhibitory effect of APAP on spinothalamic tracts leading to a decreased activation of higher structures, and a top-down influence on descending inhibition. Further binding and connectivity studies are needed to evaluate how APAP modulates pain, especially in the context of repeated

  11. Paracetamol as a prophylactic analgesic for hysterosalpingography: A double blind randomized controlled trial

    Energy Technology Data Exchange (ETDEWEB)

    Elson, E.M.; Ridley, N.T.F

    2000-09-01

    AIM: To evaluate the effectiveness of paracetamol as a prophylactic analgesic for hysterosalpingography (HSG). DESIGN: A prospective double blind randomized controlled trial comparing one 1 g of paracetamol (SmithKline Beecham, Brentford, U.K.) to placebo taken 30 min before HSG. One hundred consecutive out-patients were studied prospectively. The analgesic effectiveness during the procedure and at 24 h and 1 week post procedure was analysed by a postal pain score questionnaire. Additional data on the ethnicity of the patient, sex and level of experience of the radiologist performing the hysterosalpingogram, the parity of the patient, the ease of the procedure, and whether pathology was identified were also recorded. RESULTS: Eighty-eight patients (88%) replied, 39 (44%) received paracetamol and 49 placebo (56%). During the procedure 3/39 (7%) of women in the paracetamol group were pain-free compared to 9/49 (18%) in the placebo group, which was not significant (P = 0.11). At 24 h, 15/39 (38%) of women in the paracetamol group were pain-free compared to 20/49 (41%) in the placebo group, which was not significant (P = 0.82). At 1 week, 27/39 (69%) of women in the paracetamol group were pain-free compared to 29/49 (59%) in the placebo group, which was not significant (P = 0.33). No significant difference in mean pain scores was determined during the procedure (P 0.91), or at 24 h post procedure (P = 0.94). Similarly, no difference in mean pain scores was identified with regard to the ethnicity of the patient, the sex of the radiologist performing the procedure, the level of experience of the radiologist performing the procedure, or whether pathology was present or not. Difficult cannulations were associated with higher mean pain scores, however, there was no difference in mean pain scores between the paracetamol or placebo groups for both easy and difficult cannulations. CONCLUSION: Paracetamol is not effective as a prophylactic analgesic for HSG. If a prophylactic

  12. Effects of Piracetam on Pediatric Breath Holding Spells: A Randomized Double Blind Controlled Trial

    Directory of Open Access Journals (Sweden)

    Ali ABBASKHANIAN

    2013-01-01

    Full Text Available How to cite this article:Abbaskhanian A, Ehteshami S, Sajjadi S, Rezai MS. Effects of Piracetam on Pediatric Breath Holding Spells: A Randomized Double Blind Controlled Trial. Iran J Child Neurol Autumn 2012; 6(4: 9-15. Abstarct:Objective Breath holding spells (BHS are common paroxysmal non-epileptic eventsin the pediatric population which are very stressfull despite their harmlessnature. There has been no specific treatment found for the spells yet. The aimof this study was to evaluate the efficacy of piracetam (2-oxo-l-pyrrolidineon these children.Materials & MethodsIn this randomized double blind clinical trial study, 150 children with severe BHS referred to our pediatric outpatient service were enrolled from August2011 to July 2012. The patients were randomized into two equal groups.One received 40mg/kg/day piracetam and the other group received placebo,twice daily. Patients were followed monthly for three months. The numberof attacks/month before and after treatment were documented.ResultsOf the enrolled patients, 86 were boys. The mean age of the patients was17 months (range, 6 to 24 months. In the piracetam group, 1 month after treatment an 81% response to treatment was found. In the placebo group,none of the patients had complete remission and 7% of the cases had partialremission. Overall, control of breath-holding spells was observed in 91%of the patients in the group taking piracetam as compared with 16% in the group taking placebo at the end of the study. There wasd nosignificant difference detected between the groups regarding the prevalenceof drug side effects.ConclusionA significant difference was detected between piracetam and placebo in prevention and controlling BHS. Piracetam (40mg/kg/day had a good effecton our patients. ReferencesDi Mario FJ Jr. Prospective study of children with cyanotic and pallid breath-holding spells. Pediatrics. 2001 Feb;107(2:265-9.Kotagal P, Costa M, Wyllie E, Wolgamuth B. Paroxysmal non epileptic

  13. 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 BACKGROUND: 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. METHODS: 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. RESULTS: 58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01429402.

  14. Botulinum toxin versus trihexyphenidyl in cervical dystoni - A prospective, randomized, double-blind controlled trial

    NARCIS (Netherlands)

    Brans, JWM; Lindeboom, R; Snoek, JW; Zwarts, MJ; vanWeerden, TW; Brunt, ERP; vanHilten, JJ; vanderKamp, W; Prins, MH; Speelman, J.D.

    1996-01-01

    Background: Botulinum toxin type A (BTA) is replacing trihexyphenidyl as the treatment of choice for idiopathic cervical dystonia (ICD), but there has never been a direct comparative study. Methods: This trial compares the effectiveness of BTA with that of trihexyphenidyl in a prospective, randomize

  15. Trachyspermum ammi 10 % topical cream versus placebo on neuropathic pain, a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Petramfar, Peyman; Moein, Mahmoodreza; Samani, Soliman Mohammadi; Tabatabaei, Sayed Hamidreza; Zarshenas, Mohammad M

    2016-09-01

    A four-week, double-blind, randomized, placebo-controlled trial was conducted to assay the effectiveness of Ajwain 10 % (Trachyspermum ammi Sprague) topical cream on neuropathic pain. Intervention encompassed Ajwain 10 % and placebo creams. Ninety-two patients who specifically mentioned daily and nocturnal burning feet were randomly assigned to receive one of those interventions. Presence and decline in patients' numbness, tingling and allodynia were also evaluated. Major outcome measure was alteration in feet burning intensity (final week versus baseline week) regarding to a visual analog scale on a 0-10 cm scale (0 being "no pain", 10 being "worst pain"). Significant reduction in feet burning scores as well as numbness, tingling and allodynia were found in Ajwain group compared to placebo. This trial examining a cream of Ajwain essential oil versus placebo revealed the significance difference between two groups. This medicament can be a good candidate for the alleviation of feet burning, a neuropathic complication.

  16. Bacterial vaginosis: a double-blind randomized trial of the effect of treatment of the sexual partner

    DEFF Research Database (Denmark)

    Vejtorp, M; Bollerup, A C; Vejtorp, L

    1988-01-01

    In a double-blind randomized controlled trial we assessed the effect of metronidazole treatment of the male partner on the recurrence rate of bacterial vaginosis. Women who fulfilled the diagnostic criteria for bacterial vaginosis were treated with metronidazole given in single doses of 2 g on days...... for bacterial vaginosis. At assessment 5 weeks after the treatment, 75% reported that they were cured or improved and the diagnostic criteria were not present in 73%. Treatment of the male partner did not affect subjective symptoms, clinical signs and isolation rates of Gardnerella vaginalis at 1 and 5 weeks...

  17. Erratum to: Effects of oxcarbazepine versus carbamazepine on tinnitus: A randomized double-blind placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Hooshang Gerami

    2015-10-01

    Full Text Available Erratum:Affiliation of authors of the article "Effects of oxcarbazepine versus carbamazepine on tinnitus: A randomized double-blind placebo-controlled clinical trial. Ir J neurol 2012; 11(3: 106-110' was changed as:Hooshang Gerami 1, Alia Saberi2, Shadman Nemati1, Ehsan Kazemnejad1, Mohammad Aghajanpour1.1.Department of Otolaryngology , Nose and Sinus Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.2. Department of Neurology, Guilan University of Medical Sciences, Rasht, Iran

  18. Infant skin-cleansing product versus water: A pilot randomized, assessor-blinded controlled trial

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    Cork Michael J

    2011-05-01

    Full Text Available Abstract Background The vulnerability of newborn babies' skin creates the potential for a number of skin problems. Despite this, there remains a dearth of good quality evidence to inform practice. Published studies comparing water with a skin-cleansing product have not provided adequate data to inform an adequately powered trial. Nor have they distinguished between babies with and without a predisposition to atopic eczema. We conducted a pilot study as a prequel to designing an optimum trial to investigate whether bathing with a specific cleansing product is superior to bathing with water alone. The aims were to produce baseline data which would inform decisions for the main trial design (i.e. population, primary outcome, sample size calculation and to optimize the robustness of trial processes within the study setting. Methods 100 healthy, full term neonates aged Results Forty nine babies were randomized to cleansing product, 51 to water. The 95% confidence intervals (CI for the average TEWL measurement at each time point were: whole sample at baseline: 10.8 g/m2/h to 11.7 g/m2/h; CP group 4 weeks: 10.9 g/m2/h to 13.3 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h; W group 4 weeks:10.9 g/m2/h to 12.2 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h. Conclusion This pilot study provided valuable baseline data and important information on trial processes. The decision to proceed with a superiority trial, for example, was inconsistent with our data; therefore a non-inferiority trial is recommended. Trial registration ISRCTN72285670

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

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    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.

  20. The Lipid lowering and Onset of Renal Disease (LORD Trial: A randomized double blind placebo controlled trial assessing the effect of atorvastatin on the progression of kidney disease

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    Geraghty Dominic P

    2008-03-01

    Full Text Available Abstract Background There is evidence that dyslipidemia is associated with chronic kidney disease (CKD. Experimental studies have established that lipids are damaging to the kidney and animal intervention studies show statins attenuate this damage. Small clinical trials, meta-analyses, observational studies and post-hoc analyses of cardiovascular intervention studies all support the concept that statins can reduce kidney damage in humans. Based on this background, a double blind randomized placebo controlled trial was designed to assess the effectiveness of atorvastatin 10 mg on slowing the progression of kidney disease in a population of patients with CKD. Method/Design The Lipid lowering and Onset of Renal Disease (LORD trial is a three-year, single center, multi-site, double blind, randomized, placebo controlled trial. The primary outcome measure is kidney function measured by eGFR calculated by both Modification of Diet in Renal Disease (MDRD and Cockcroft and Gault equations. Secondary outcome measures include kidney function measured by 24-hour urine creatinine clearance and also 24-hour urinary protein excretion, markers of oxidative stress, inflammation and drug safety and tolerability. Discussion The results of this study will help determine the effectiveness and safety of atorvastatin and establish its effects on oxidative stress and inflammation in patients with CKD. Trial Registration ANZCTRN012605000693628

  1. The therapeutic effects of acupuncture on patients with chronic neck myofascial pain syndrome: a single-blind randomized controlled trial.

    Science.gov (United States)

    Sun, Mei-Yuan; Hsieh, Ching-Liang; Cheng, Yung-Yen; Hung, Hung-Chang; Li, Tsai-Chung; Yen, Sch-May; Huang, I-Shin

    2010-01-01

    Chronic neck myofascial pain syndrome (MPS) is a common disorder seen in clinics. There is no gold standard method to treat myofascial pain. We investigated the effects of acupuncture on patients with chronic neck MPS by a single-blind randomized controlled trial. A total of 35 patients were randomly allocated to an acupuncture group (AG) or a sham acupuncture group (SG). Each subject received acupuncture treatment twice per week for three consecutive weeks. The primary outcome measure was quality of life as assessed with Short Form-36, and secondary outcome measures were neck range of motion (ROM), motion-related pain, and Short-Form McGill Pain Questionnaire (SF-MPQ), as determined by a blinded investigator. The clinical assessments were made before treatment (BT) and after six acupuncture treatments (AT), as well as four weeks (F1) and 12 weeks (F2) after the end of the treatment. A total of 34 patients completed the trial. The results indicated that there is no significant difference in the ROM, motion-related pain, and SF-MPQ scores between AG and SG at AT, F1 and F2 (all p > 0.05). However, AG has greater improvement in physical functioning and role emotional of Short Form-36 quality of life at F2. The results indicate that acupuncture may be used to improve the quality of life in patients with chronic neck MPS.

  2. 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.

  3. Comparison of Saffron versus Fluoxetine in Treatment of Mild to Moderate Postpartum Depression: A Double-Blind, Randomized Clinical Trial.

    Science.gov (United States)

    Kashani, L; Eslatmanesh, S; Saedi, N; Niroomand, N; Ebrahimi, M; Hosseinian, M; Foroughifar, T; Salimi, S; Akhondzadeh, S

    2017-03-01

    Introduction: Postpartum depression is a common mental health problem that is associated with maternal suffering. The aim of this double-blind clinical trial was to compare safety and efficacy of saffron and fluoxetine in treatment of mild to moderate postpartum depression. Methods: This was a 6-week, double-blind, randomized clinical trial. Subjects were women aged 18-45 years with mild to moderate postpartum depression who had Hamilton Depression Rating Scale (HDRS 17-item) score≤18. Eligible participants were randomized to receive either a capsule of saffron (15 mg capsule) or fluoxetine (20 mg capsule) twice daily for 6 weeks. The primary outcome measure was to evaluate efficacy of saffron compared to fluoxetine in improving depressive symptoms (HDRS score). Results: There was no significant effect for time×treatment interaction on HDRS score [F (4.90, 292.50)=1.04, p=0.37] between the 2 groups. 13 (40.60%) patients in the saffron group experienced complete response (≥50% reduction in HDRS score) compared with 16 (50%) in the fluoxetine group and the difference between the 2 groups was not significant in this regard (p=0.61). Frequency of adverse events was not significantly different between the treatment groups. Discussion: The results of this study may suggest that saffron is a safe alternative medication for improving depressive symptoms of postpartum depression. Nevertheless, it should be mentioned that the trial is not well powered and should be considered a preliminary study. Therefore, large clinical trials with longer treatment periods and comparison with placebo group would be appropriate for future studies.

  4. Early report of randomized double blind clinical trial of hormonal therapy of carcinoma of prostate (CAP stage D2

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    Jagdeesh N Kulkarni

    2003-01-01

    Full Text Available Objectives: We herein report our experience of double blind randomized clinical trial comparing combined an-drogen blockade vs monotherapy in stage D2 CaP. Patients and Methods: Through June 1999 and May 2001, 100 patients of stage D2 CaP were randomized into placebo (44 and flutamide (42 group after orchiectomy in double blind fashion using the strictest criteria. All men and histological proof of CaP with bone metastasis dem-onstrated on imaging: bone scan and skeletal survey. These patients were further substratified according to number o f bony metastases into high volume disease (HVD>5 sites and low volume disease (LVD< 5 sites. The follow-up was at 3 month intervals. Criteria for decoding were clinical or serological progression and serious adverse effects. Results: Of the 100 patients recruited in the trial, 48 had HVD and 52 LVD. Treatmentwise they were almost equally distributed in flutamide group and placebo group. In the follow-up ranging front 6 to 24 months, 30 out of 100 patients (30% required decoding, reasons for decod-ing were progression of disease in 25 and serious adverse effects in remaining 5. These 25 patients were further analyzed according to treatment group, volume of metas-tasis pre -orchiectomy PSA and Gleason score. We observed that number of bony metastases had impact over the dura-tion of response to hormonal therapy. Discussion: We initiated this simple trial to address the issue of benefit of total androgen blockade over monotherapy in Indian population. In the initial analysis, we observed that treatment group did not make any impact over the response. While subset of prostate cancer with large number of bony metastases has higher propensity to convert into hormone refractory cancer Conclusions: Addition of flutamide did not provide ben-efit. We observed that large number of bony metastases had poor response to hormonal therapy, hence it requires large trial to substantiate this initial observation.

  5. The effect of vitamin D on primary dysmenorrhea with vitamin D deficiency: a randomized double-blind controlled clinical trial.

    Science.gov (United States)

    Moini, Ashraf; Ebrahimi, Tabandeh; Shirzad, Nooshin; Hosseini, Reihaneh; Radfar, Mania; Bandarian, Fatemeh; Jafari-Adli, Shahrzad; Qorbani, Mostafa; Hemmatabadi, Mahboobeh

    2016-06-01

    Dysmenorrhea is common among women of reproductive age. This study aim was to investigate the effect of vitamin D (vit D) supplementation in treatment of primary dysmenorrhea with vit D deficiency. A randomized double-blind placebo-controlled clinical trial was conducted on 60 women with primary dysmenorrhea and vit D deficiency referred to our clinic at Arash Women's Hospital from September 2013 to December 2014. Eligible women were randomly assigned into treatment and control groups (30 in each group). Individuals in the treatment group received 50 000 IU oral vit D and the control group received placebo weekly for eight weeks. After two months of treatment, there was a significant difference in serum vit D concentration between the two groups (p D supplementation for eight weeks in patients with primary dysmenorrhea and vit D deficiency could improve pain intensity.

  6. Effects of sertindole on cognition in clozapine-treated schizophrenia patients - a double-blinded, randomized, placebo-controlled trial

    DEFF Research Database (Denmark)

    Nielsen, R E; Levander, S; Nielsen, Jimmi

    Nielsen RE, Levander S, Thode D, Nielsen J. Effects of sertindole on cognition in clozapine-treated schizophrenia patients. Objective:  To assess the cognitive effects of sertindole augmentation in clozapine-treated patients diagnosed with schizophrenia. Cognition is secondary outcome of the trial....... Method:  A 12-week, double-blinded, randomized, placebo-controlled, augmentation study of patients treated with clozapine. Participants were randomized 1:1 to receive 16 mg of sertindole or placebo as adjunctive treatment to clozapine. Results:  Participants displayed substantial cognitive deficits...... changes in cognitive test performance, and found no significant correlations. Conclusion:  The clozapine-treated patients displayed marked cognitive deficits at baseline. Adding sertindole did not improve or worsen cognitive functioning, which is in line with previous negative studies of the effect...

  7. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia

    DEFF Research Database (Denmark)

    Branco, Jaime C; Zachrisson, Olof; Perrot, Serge

    2010-01-01

    This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....

  8. Effects of Oxcarbazepine Versus Carbamazepine on Tinnitus: A Randomized Double-Blind Placebo-Controlled Clinical Trial

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    Ehsan Kazemnejad

    2012-07-01

    Full Text Available Background: It is still a challenge to find an effective treatment for tinnitus. The aim of this study was the evaluation of carbamazepine and oxcarbazepine effects on tinnitus.Methods: In a randomized double–blind clinical trial, 57 patients who were visited in a university hospital due to chronic non-pulsatile tinnitus, were randomized in three groups and treated with carbamazepine (300-600 mg/day, oxcarbazepine (450-900 mg/day and placebo for 12 weeks. Visual analogue scale (VAS and tinnitus severity index (TSI were measured in all subjects in the beginning and at the end of the 8th and 12th weeks of the trial. Data was analyzed by repeated measure analysis, paired and independent t-test.Results: Among 51 participants who completed the trial course (28 men, 23 women, carbamazepine, oxcarbazepine and placebo decreased tinnitus severity in 56.6%, 46.2% and 38.5% of patients according to VAS, and in 61.1%, 58.8% and 50% of patients according to TSI, respectively. The effects of carbamazepine and oxcarbazepine were better in the first 8 weeks of treatment. However, their effect on tinnitus did not show any statistical difference in comparison with placebo (P = 0.34, P = 0.28.Conclusion: Carbamazepine and oxcarbazepine are not more effective than placebo in decreasing tinnitus severity.

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

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    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.

  10. High dose Senna or Poly Ethylene Glycol (PEG for elective colonoscopy preparation: a prospective randomized investigator-blinded clinical trial

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    Ahmad Shavakhi

    2011-01-01

    Full Text Available Background: The aim of this study was to determine the efficacy of two methods of colon preparation for colon cleansing in a randomized controlled trial. Methods: In this prospective randomized investigator-blinded trial, consecutive outpatients indicated for elective colonoscopy were randomized into two groups. Patients in Senna group took 24 tablets of 11 mg Senna in two divided doses 24 hour before colonoscopy. In Poly Ethylene Glycol (PEG group they solved 4 sachets in 4 liters of water the day before the procedure and were asked to drink 250 ml every 15 minutes. The overall quality of colon cleansing was evaluated using the Aronchick scoring scale. Difficulty of the procedure, patients′ tolerance and compliance and adverse events were also evaluated. Results: 322 patients were enrolled in the study. There was no significant difference in the quality of colon cleansing, patients′ tolerance, compliance and the difficulty of the procedure between two groups (p > 0.05. The incidence of adverse effects was similar between two groups except for abdominal pain that was more severe in Senna group (p < 0.05 and nausea and vomiting that was more common in PEG group (p < 0.05 Conclusions: In conclusion we deduce that Senna has the same efficacy and patient′s acceptance as Polyethylene glycol-electrolyte solution (PEG-ES and it could be prescribed as an alternative method for bowel preparation.

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

    Science.gov (United States)

    Namjoyan, Foroogh; Kiashi, Fatemeh; Moosavi, Zahra Beigom; Saffari, Fatemeh; Makhmalzadeh, Behzad Sharif

    2016-01-01

    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.

  12. Eicosapentaenoic acid (EPA efficacy for colorectal aberrant crypt foci (ACF: a double-blind randomized controlled trial

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    Higurashi Takuma

    2012-09-01

    Full Text Available Abstract Background Colorectal cancer (CRC is one of the most commonly occurring neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Eicosapentaenoic acid (EPA, the omega-3 polyunsaturated fatty acid that is widely used in the treatment of hyperlipidemia and prevention of cardiovascular disease, has recently been suggested to have a suppressive effect on tumorigenesis and cancer cell growth. In CRC chemoprevention trials, in general, the incidence of polyps or of the cancer itself is set as the study endpoint. Although the incidence rate of CRC would be the most reliable endpoint, use of this endpoint would be unsuitable for chemoprevention trials, because of the relatively low occurrence rate of CRC in the general population and the long-term observation period that it would necessitate. Moreover, there is an ethical problem in conducting long-term trials to determine whether a test drug might be effective or harmful. Aberrant crypt foci (ACF, defined as lesions containing crypts that are larger in diameter and stain more darkly with methylene blue than normal crypts, are considered as a reliable surrogate biomarker of CRC. Thus, we devised a prospective randomized controlled trial as a preliminary study prior to a CRC chemoprevention trial to evaluate the chemopreventive effect of EPA against colorectal ACF formation and the safety of this drug, in patients scheduled for polypectomy. Methods This study is a multicenter, double-blind, placebo-controlled, randomized controlled trial to be conducted in patients with both colorectal ACF and colorectal polyps scheduled for polypectomy. Eligible patients shall be recruited for the study and the number of ACF in the rectum counted at the baseline colonoscopy. Then, the participants shall be allocated randomly to either one of two groups, the EPA group and the placebo group. Patients in the EPA group shall receive oral

  13. EFFICACY OF CITALOPRAM IN TREATMENT OF PATHOLOGICAL SKIN PICKING, A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED TRIAL

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    M Arbabi

    2008-11-01

    Full Text Available "nVarious studies suggest that selective serotonin reuptake inhibitors (SSRIs may be useful in treating pathological skin picking (PSP. This study sought to assess effectiveness of citalopram in comparison with placebo in treating PSP. Forty five individuals with PSP were recruited in a four-week, randomized clinical trial of citalopram (20 mg/day in comparison with placebo. Study measures assessing skin picking severity, mental health status, obsessive compulsive disorder and quality of life were given at baseline, weeks 2 and 4. PSP severity, general health status, obsession-compulsion severity and quality of life level were similar between two groups at baseline (P > 0.05. Treatment analyses revealed significant improvements in quality of life, general health status and obsession-compulsion severity in citalopram group compared to placebo group (P < 0.05. Mean PSP severity reduction in citalopram group was more than placebo group but this difference was not significant. Citalopram can improve general health status and quality of life in individuals with PSP but its effect on skin picking behavior doesn't differ significantly with placebo. Other trials with longer time are needed to determine the exact efficacy of citalopram on PSP

  14. Pregabalin for the treatment of abdominal adhesion pain: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Silverman, Ann; Samuels, Qiana; Gikas, Helen; Nawras, Ali

    2012-11-01

    Chronic pain related to postoperative abdominal adhesions is a common problem with no standard analgesic regimen currently established. In a double-blind, placebo-controlled trial, we examined the effects of pregabalin on pain modulation in patients with prior abdominal surgery and documented adhesion. The primary outcome measure was pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption. A total of 18 women were randomized to receive either the drug (n = 11) or placebo (n = 7). Thirteen patients (eight pregabalin, five placebo) completed the blinded phase and 10 patients (seven pregabalin, three placebo) completed the open-label phase. Statistical analysis was performed in two settings: 1) Week 0 (as the baseline) through the end of Week 7 of the blinded fixed-dose phase; and 2) Week 7 (as the baseline) along With weeks 8 through 11 of the open-label phase. The pain score result from the blinded phase setting indicated that the amount of decrease was significantly greater in the drug group (P = 0.024), whereas the pain score result from the open-label setting indicated that the amount of decrease was significantly greater in the placebo group (P = 0.043). Only the sleep score result in the open-label setting was significantly greater in the placebo group (P = 0.024). We conclude that pregabalin significantly reduced patient-documented pain scores compared with placebo in our small cohort of patients with abdominal adhesion pain.

  15. A single blind randomized control trial on support groups for Chinese persons with mild dementia

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    Young DKW

    2014-12-01

    Full Text Available Daniel KW Young,1 Timothy CY Kwok,2 Petrus YN Ng1 1Department of Social Work, Hong Kong Baptist University, Kowloon Tong, Hong Kong; 2Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong Purpose: Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Research methods: Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. Results: At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59% of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48 to 7.35 (standard deviation =2.18, which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05, while the control group’s participants did not show any significant change. Conclusion: This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants. Keywords: support group, mild dementia, Chinese, depression

  16. Mentha longifolia syrup in secondary amenorrhea: a double-blind, placebo-controlled, randomized trials

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    Mokaberinejad Roshanak

    2012-12-01

    Full Text Available Abstract Background Amenorrhea is defined as the cessation of menses. Hormone therapy is the most common treatment. Due to the contraindications and side effects of it and the increasing demand for alternative medicine substitutes, Mentha longifolia L. was used in this study. Mentha longifolia L. is a known medication in Iranian traditional medicine to induce menstrual bleeding in women with secondary amenorrhea and oligomenorrhea. Methods A double-blind, randomized, placebo-controlled, multicenter study was conducted in 120 women with secondary amenorrhea and oligomenorrhea. Treatment consisted of sequential oral syrup, 45 ml (15 ml three times a day for 2 weeks. If the patients did not have menstruation after 2 weeks of taking the medication, we would wait for two more weeks. If the patients had menstruation at each stage of using the drug, we started it one week after the end of menstruation. But if the patients had not menstruate after four weeks (two-week using of drug and waiting for two more weeks, the previous steps were repeated. The drug and placebo were repeated in three cycles of menstruation. Bleeding was documented by the patient on diary cards. The primary outcome variable was the occurrence (yes/no of bleeding during the first treatment cycle. The secondary efficacy outcome was the regularity of bleeding pattern during the three cycles of the study. Results The number of women with bleeding during the first cycle were higher in the drug group as in the placebo group (68.3% vs. 13.6%; p Mentha longifolia L. syrup. Conclusion In conclusion, Mentha longifolia L. syrup is a safe, well-tolerated, and effective choice in inducing bleeding and maintaining regular bleeding in women with secondary amenorrhea and oligomenorrhea.

  17. Cardiovascular benefits from ancient grain bread consumption: findings from a double-blinded randomized crossover intervention trial.

    Science.gov (United States)

    Sereni, Alice; Cesari, Francesca; Gori, Anna Maria; Maggini, Niccolò; Marcucci, Rossella; Casini, Alessandro; Sofi, Francesco

    2017-02-01

    Ancient grain varieties have been shown to have some beneficial effects on health. Forty-five clinically healthy subjects were included in a randomized, double-blinded crossover trial aimed at evaluating the effect of a replacement diet with bread derived from ancient grain varieties versus modern grain variety on cardiovascular risk profile. After 8 weeks of intervention, consumption of bread obtained by the ancient varieties showed a significant amelioration of various cardiovascular parameters. Indeed, the ancient varieties were shown to result in a significant reduction of total cholesterol, low-density lipoprotein (LDL)-cholesterol and blood glucose, whereas no significant differences during the phase with the modern variety were reported. Moreover, a significant increase in circulating endothelial progenitor cells were reported after the consumption of products made from the ancient "Verna" variety. The present results suggest that a dietary consumption of bread obtained from ancient grain varieties was effective in reducing cardiovascular risk factors.

  18. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

    Directory of Open Access Journals (Sweden)

    Poeze Martijn

    2011-05-01

    Full Text Available Abstract Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%, non-union (5-21% and early osteo-arthritis (up to 32% which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning. Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation

  19. Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial

    Directory of Open Access Journals (Sweden)

    Jae-Young Shin

    2015-01-01

    Full Text Available Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n=28 or the sham laser acupuncture group (n=28. Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.

  20. Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial.

    Science.gov (United States)

    Shin, Jae-Young; Ku, Boncho; Kim, Jaeuk U; Lee, Yu Jung; Kang, Jae Hui; Heo, Hyun; Choi, Hyo-Joon; Lee, Jun-Hwan

    2015-01-01

    Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n = 28) or the sham laser acupuncture group (n = 28). Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version) were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.

  1. 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

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

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    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.

  3. 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.

  4. Mangiferin supplementation improves serum lipid profiles in overweight patients with hyperlipidemia: a double-blind randomized controlled trial.

    Science.gov (United States)

    Na, Lixin; Zhang, Qiao; Jiang, Shuo; Du, Shanshan; Zhang, Wei; Li, Ying; Sun, Changhao; Niu, Yucun

    2015-05-19

    Our previous studies have shown that mangiferin decreased serum triglycerides and free fatty acids (FFAs) by increasing FFAs oxidation in both animal and cell experiments. This study sought to evaluate the effects of mangiferin on serum lipid profiles in overweight patients with hyperlipidemia. Overweight patients with hyperlipidemia (serum triglyceride ≥ 1.70 mmol/L, and total cholesterol ≥ 5.2 mmol/L) were included in this double-blind randomized controlled trial. Participants were randomly allocated to groups, either receiving mangiferin (150 mg/day) or identical placebo for 12 weeks. The lipid profile and serum levels of mangiferin, glucose, L-carnitine, β-hydroxybutyrate, and acetoacetate were determined at baseline and 12 weeks. A total of 97 participants completed the trial. Compared with the placebo control, mangiferin supplementation significantly decreased the serum levels of triglycerides and FFAs, and insulin resistance index. Mangiferin supplementation also significantly increased the serum levels of mangiferin, high-density lipoprotein cholesterol, L-carnitine, β-hydroxybutyrate, and acetoacetate, and increased lipoprotein lipase activity. However, there were no differences in the serum levels of total cholesterol, low-density lipoprotein cholesterol, serum glucose, and insulin between groups. Mangiferin supplementation could improve serum lipid profiles by reducing serum triglycerides and FFAs in overweight patients with hyperlipidemia, partly due to the promotion of FFAs oxidation.

  5. The Effect of Milnacipran on Pain in Rheumatoid Arthritis Patients with Widespread Pain: A Randomized Blinded Crossover Trial

    Science.gov (United States)

    Lee, Yvonne C.; Massarotti, Elena; Edwards, Robert R.; Lu, Bing; Liu, ChihChin; Lo, Yuanyu; Wohlfahrt, Alyssa; Kim, Nancy D.; Clauw, Daniel J.; Solomon, Daniel H.

    2015-01-01

    Objective Clinical trials have shown that serotonin norepinephrine reuptake inhibitors, such as milnacipran, decrease pain in non-inflammatory pain conditions like fibromyalgia and osteoarthritis. We examined the effect of milnacipran on self-reported pain intensity and experimental pain sensitivity among rheumatoid arthritis (RA) patients with widespread pain and stable RA disease activity. Methods In this double-blind, crossover study, RA patients with widespread pain, on a stable treatment regimen, were randomized (via a random number generator) to receive milnacipran 50 mg twice daily or placebo for 6 weeks, followed by a 3-week washout and crossed over to the other arm for the remaining 6 weeks. The primary outcome was change in average pain intensity, assessed by the Brief Pain Inventory short form. The sample size was calculated to detect a 30% improvement in pain with power = 0.80 and alpha = 0.05. Results Of the 43 randomized subjects, 41 received study drug, and 32 completed the 15-week study per protocol. On a 0–10 scale, average pain intensity decreased by 0.39 (95% CI −1.27, 0.49; P = 0.37) more points during 6 weeks of milnacipran treatment compared to placebo. In the subgroup of subjects with swollen joint count ≤ 1, average pain intensity decreased by 1.14 (95% CI −2.26, −0.01; P= 0.04) more points during 6 weeks of milnacipran compared to placebo. Common adverse events included nausea (26.8%) and loss of appetite (9.7%). Conclusion Compared to placebo, milnacipran did not improve overall, self-reported pain intensity among subjects with widespread pain taking stable RA medications. Trial registration: ClinicalTrials.gov NCT01207453 PMID:26628607

  6. A randomized, double blind, placebo-controlled trial of pioglitazone in combination with riluzole in amyotrophic lateral sclerosis.

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    Luc Dupuis

    Full Text Available BACKGROUND: Pioglitazone, an oral anti-diabetic that stimulates the PPAR-gamma transcription factor, increased survival of mice with amyotrophic lateral sclerosis (ALS. METHODS/PRINCIPAL FINDINGS: We performed a phase II, double blind, multicentre, placebo controlled trial of pioglitazone in ALS patients under riluzole. 219 patients were randomly assigned to receive 45 mg/day of pioglitazone or placebo (one: one allocation ratio. The primary endpoint was survival. Secondary endpoints included incidence of non-invasive ventilation and tracheotomy, and slopes of ALS-FRS, slow vital capacity, and quality of life as assessed using EUROQoL EQ-5D. The study was conducted under a two-stage group sequential test, allowing to stop for futility or superiority after interim analysis. Shortly after interim analysis, 30 patients under pioglitazone and 24 patients under placebo had died. The trial was stopped for futility; the hazard ratio for primary endpoint was 1.21 (95% CI: 0.71-2.07, p = 0.48. Secondary endpoints were not modified by pioglitazone treatment. Pioglitazone was well tolerated. CONCLUSION/SIGNIFICANCE: Pioglitazone has no beneficial effects on the survival of ALS patients as add-on therapy to riluzole. TRIAL REGISTRATION: Clinicaltrials.gov NCT00690118.

  7. Pimecrolimus versus Placebo in Minor, Recurrent Aphthous Stomatitis: A Randomized Double-blind Controlled Trial

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    Ayda Moghaddas

    2015-10-01

    Full Text Available Background: Oral aphthous is one of the most common oral mucosal inflammatory disorders which are very painful. There is no definite medical strategy up to now for aphthous treatment. Recently, some researchers have focused on immunomodulatory drugs such as tacrolimus and pimecrolimus in preventing aphthus recurrences. The aim of this study is to assess the effect of pimecrolimus cream against placebo in management of oral minor aphthous.Methods: The study is a randomized clinical trial, was done in “Shariati” hospital and Isfahan Skin Research Center. 62 patients with minor aphthuos were included and divided randomly to two groups (31 in each. In experimental group, pimecrolimus cream was applied for two weeks and cold cream for the same duration in control group. Patients were followed for 3 and one week; results were assessed in recovery after drug administration. Compared variables between two groups were including: the size of lesions, the time to recovery and pain intensity.Results: Results showed that mean size lesion in experimental and placebo group after complete recovery reduced (23.6 ±15.3 and 24.8 ±15 mm respectively but it was not significant (P: 0.1. Mean time for recovery in both groups was 8±2.2 and 9.5±2.5 respectively which was significant in pimecrolimus treated patients (P: 0.014. Also mean degree for pain intensity measured by pain scale method was reduced significantly in test group (6 ± 1.2 before treatment and 5.3 ± 1.1 after treatment, P<0.001.Conclusion: This study stated that pimecrolimus cream has an appropriate effect in reduction of recovery time and pain in minor aphthous compared to placebo but more clinical studies are needed to better conclusion.

  8. Cinnarizine versus Topiramate in Prophylaxis of Migraines among Children and Adolescents: A Randomized, Double-Blind Clinical Trial

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    Mahmoud Reza ASHRAFI

    2014-12-01

    Full Text Available How to Cite This Article: Ashrafi MR, Najafi Z, Shafiei M, Heidari K, Togha M. Cinnarizinev ersus Topiramate in Prophylaxis of Migraines among Children and Adolescents: A Randomized, Double-Blind Clinical Trial. Iran J Child Neurol. 2014 Autumn;8(4: 18-27. AbstractObjectiveMigraines, a common health problem in children and adolescents, still do not have an FDA approved preventive treatment for patients under the age of 18 years. This study compares and contrasts the efficacy and safety of cinnarizine and topiramate in preventing pediatric migraines.Materials & MethodsIn this randomized, double-blind clinical trial 44 migrainous (from 4–15 years of age were equally allocated to receive cinnarizine or topiramate. The primary efficacy measure was monthly migraine frequency. Secondary efficacy measures were monthly migraine intensity and ≥ 50% responder rate. Efficacy measures were recorded at the baseline and at 4, 8, and 12 weeks of treatment.ResultsDuring the double-blind phase of the study, monthly migraine frequency and intensity were significantly decreased in both the cinnarizine and topiramate groups when compared to the baseline. However, at the end of the study, the cinnarizine group exhibits a significant decrease from the baseline in the mean monthly migraine intensity when compared to the topiramate group (4.7 vs. 3, respectively; 95% CI = -0.8 to -3.2.ConclusionNo significant difference between cinnarizine and topiramate was found for the prevention of pediatric migraines. Both treatments were well tolerated.ReferencesHershey AD, Winner PK. Pediatric Migraine: Recognition and Treatment. J Am Osteopath Assoc. 2005;105:2S-8.Lewis DW, Yonker M, Winner P, Sowell M. The treatment of pediatric migraine. Pediatric Annals. 2005;34:448-460.Abu-Arefeh I, Russell G. Prevalence of headache and migraine in schoolchildren. BMJ. 1994;309:765-769.Linet MS, Stewart WF, Celentano DD, Ziegler D, Sprecher M. An Epidemiologic Study of Headache among

  9. Effect of Auricular Acupress Therapy on Insomnia of Cancer Patients : Randomized, Single Blinded, Placebo Controlled Trial

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    In-Sook Jung

    2010-06-01

    Full Text Available Background: Auricular acupressure is one of the traditional health care treatments in oriental medicine. Approximately, 30~40% of the cancer patients have said to be suffering from insomnia and half of them having chronic and severe insomnia at the same time. Insomnia caused cancer patients feel more pain, fatigue, depression and anxiety and it sometimes let the power to have the best of cancer pull down. Objective: To investigate how effective the auricular acupressure treatment to cancer patients suffering from insomnia. Methods: We recruited participants from East-West Cancer Center of Daejeon University. Finally, of the people whose age range from 20 to 75, 12 patients who got less than 40 points from the score of Oh's sleeping score (OSS were recruited. Single-blind, randomized pilot study was performed. The treatment group received auricular acupressure treatment (AAT on active points and the control group had received sham acupressure treatment (SAT for five times. Sleep parameters were checked by using OSS and numeric rating scale (NRS. We checked the scale everytime, both before and after treatment. We analyzed the data statistically by using independent T-test, paired T-test and analysis of variance (ANOVA test. (p<0.05 Results: Twelve cancer patients participated in this pilot study and there was no significant difference between control and treatment group. Only 7 of them had completed the whole treatment process, 4 patients of AAT group and 3 participants of SAT. The OSS of AAT group had increased from 34.0± 4.3 to 39.5±3.1 and that of SAT group had increased from 38.3±3.5 to 40.0±0.0. There was no significant difference between them. The NRS of AAT group had increased from 6.3±2.9 to 4.8±2.1 and that of SAT group had increased from 7.0±1.0 to 5.0±2.6. No significant difference was observed between them. Conclusion: Although both groups did not show significant differences, most of the experimental participants showed

  10. Mentha Longifolia Syrup in Secondary Amenorrhea: a Double-blind, Placebo-Controlled, Randomized Trials

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    Roshanak Mokaberinejad

    2012-12-01

    Full Text Available Amenorrhea is defined as the cessation of menses. Hormone therapy is the most common treatment. Due to the contraindications and side effects of it and the increasing demand for alternative medicine substitutes, Mentha longifolia L. was used in this study. Mentha longifolia L. is a known medication in Iranian traditional medicine to induce menstrual bleeding in women with secondary amenorrhea and oligomenorrhea.Methods A double-blind, randomized, placebo-controlled, multicenter study was conducted in 120 women with secondary amenorrhea and oligomenorrhea. Treatment consisted of sequential oral syrup, 45 ml (15 ml three times a day for 2 weeks. If the patients did not have menstruation after 2 weeks of taking the medication, we would wait for two more weeks. If the patients had menstruation at each stage of using the drug, we started it one week after the end of menstruation. But if the patients had not menstruate after four weeks (two-week using of drug and waiting for two more weeks, the previous steps were repeated. The drug and placebo were repeated in three cycles of menstruation. Bleeding was documented by the patient on diary cards. The primary outcome variable was the occurrence (yes/no of bleeding during the first treatment cycle. The secondary efficacy outcome was the regularity of bleeding pattern during the three cycles of the study.Results The number of women with bleeding during the first cycle were higher in the drug group as in the placebo group (68.3% vs. 13.6%; p < 0.001. The regularity of bleeding throughout the study was markedly better in the drug group compared with those given placebo (33.3% vs. 3.3%; p < 0.001. No notable complication or side effect was reported in relation to Mentha longifolia L. syrup.ConclusionIn conclusion, Mentha longifolia L. syrup is a safe, well-tolerated, and effective choice in inducing bleeding and maintaining regular bleeding in women with secondary amenorrhea and oligomenorrhea.

  11. Mentha longifolia syrup in secondary amenorrhea: a double-blind, placebo-controlled, randomized trials

    Science.gov (United States)

    2012-01-01

    Background Amenorrhea is defined as the cessation of menses. Hormone therapy is the most common treatment. Due to the contraindications and side effects of it and the increasing demand for alternative medicine substitutes, Mentha longifolia L. was used in this study. Mentha longifolia L. is a known medication in Iranian traditional medicine to induce menstrual bleeding in women with secondary amenorrhea and oligomenorrhea. Methods A double-blind, randomized, placebo-controlled, multicenter study was conducted in 120 women with secondary amenorrhea and oligomenorrhea. Treatment consisted of sequential oral syrup, 45 ml (15 ml three times a day) for 2 weeks. If the patients did not have menstruation after 2 weeks of taking the medication, we would wait for two more weeks. If the patients had menstruation at each stage of using the drug, we started it one week after the end of menstruation. But if the patients had not menstruate after four weeks (two-week using of drug and waiting for two more weeks), the previous steps were repeated. The drug and placebo were repeated in three cycles of menstruation. Bleeding was documented by the patient on diary cards. The primary outcome variable was the occurrence (yes/no) of bleeding during the first treatment cycle. The secondary efficacy outcome was the regularity of bleeding pattern during the three cycles of the study. Results The number of women with bleeding during the first cycle were higher in the drug group as in the placebo group (68.3% vs. 13.6%; p < 0.001). The regularity of bleeding throughout the study was markedly better in the drug group compared with those given placebo (33.3% vs. 3.3%; p < 0.001). No notable complication or side effect was reported in relation to Mentha longifolia L. syrup. Conclusion In conclusion, Mentha longifolia L. syrup is a safe, well-tolerated, and effective choice in inducing bleeding and maintaining regular bleeding in women with secondary amenorrhea and oligomenorrhea. PMID

  12. A randomized, placebo-controlled, double-blind trial on sulfadoxine-pyrimethamine alone or combined with artesunate or amodiaquine in uncomplicated malaria.

    NARCIS (Netherlands)

    Mockenhaupt, F.P.; Ehrhardt, S.; Dzisi, S.Y.; Bousema, T.; Wassilew, N.; Schreiber, J.; Anemana, S.D.; Cramer, J.P.; Otchwemah, R.N.; Sauerwein, R.W.; Eggelte, T.A.; Bienzle, U.

    2005-01-01

    The therapeutic efficacy of sulfadoxine-pyrimethamine (SP) alone, SP plus amodiaquine (AQ), and SP plus artesunate (AS) was assessed in a randomized, placebo-controlled, and double-blind trial among 438 children with uncomplicated Plasmodium falciparum malaria in northern Ghana. Clinical and parasit

  13. Effects of influenza plus pneumococcal conjugate vaccination versus influenza vaccination alone in preventing respiratory tract infections in children : a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Jansen, Angelique G S C; Sanders, Elisabeth A M; Hoes, Arno W; van Loon, Anton M; Hak, Eelko

    2008-01-01

    OBJECTIVE: To evaluate the effects of influenza vaccination with or without heptavalent pneumococcal conjugate vaccination on respiratory tract infections (RTIs) in children. STUDY DESIGN: This was a randomized, double-blind, placebo-controlled trial comprising 579 children age 18 to 72 months with

  14. Omega 3/6 Fatty Acids for Reading in Children: A Randomized, Double-Blind, Placebo-Controlled Trial in 9-Year-Old Mainstream Schoolchildren in Sweden

    Science.gov (United States)

    Johnson, Mats; Fransson, Gunnar; Östlund, Sven; Areskoug, Björn; Gillberg, Christopher

    2017-01-01

    Background: Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties. We aimed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren. Methods: We performed a 3-month parallel, randomized, double-blind, placebo-controlled trial followed by 3-month active…

  15. Dietary Soy Supplement on Fibromyalgia Symptoms: A Randomized, Double-Blind, Placebo-Controlled, Early Phase Trial

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    Dietlind L. Wahner-Roedler

    2011-01-01

    Full Text Available Most patients with fibromyalgia use complementary and alternative medicine (CAM. Properly designed controlled trials are necessary to assess the effectiveness of these practices. This study was a randomized, double-blind, placebo-controlled, early phase trial. Fifty patients seen at a fibromyalgia outpatient treatment program were randomly assigned to a daily soy or placebo (casein shake. Outcome measures were scores of the Fibromyalgia Impact Questionnaire (FIQ and the Center for Epidemiologic Studies Depression Scale (CES-D at baseline and after 6 weeks of intervention. Analysis was with standard statistics based on the null hypothesis, and separation test for early phase CAM comparative trials. Twenty-eight patients completed the study. Use of standard statistics with intent-to-treat analysis showed that total FIQ scores decreased by 14% in the soy group (P = .02 and by 18% in the placebo group (P < .001. The difference in change in scores between the groups was not significant (P = .16. With the same analysis, CES-D scores decreased in the soy group by 16% (P = .004 and in the placebo group by 15% (P = .05. The change in scores was similar in the groups (P = .83. Results of statistical analysis using the separation test and intent-to-treat analysis revealed no benefit of soy compared with placebo. Shakes that contain soy and shakes that contain casein, when combined with a multidisciplinary fibromyalgia treatment program, provide a decrease in fibromyalgia symptoms. Separation between the effects of soy and casein (control shakes did not favor the intervention. Therefore, large-sample studies using soy for patients with fibromyalgia are probably not indicated.

  16. Carbon Dioxide Insufflation in Routine Colonoscopy Is Safe and More Comfortable: Results of a Randomized Controlled Double-Blinded Trial

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    M. Geyer

    2011-01-01

    Full Text Available Many patients experience pain and discomfort after colonoscopy. Carbon dioxide (CO2 can reduce periprocedural pain although air insufflation remained the standard procedure. The objective of this double-blinded, randomized controlled trial was to evaluate whether CO2 insufflation does decrease pain and bloating during and after colonoscopy compared to room air. Methods. 219 consecutive patients undergoing colonoscopy were randomized to either CO2 or air insufflation. Propofol was used in all patients for sedation. Transcutaneous CO2 was continuously measured with a capnograph as a safety parameter. Pain, bloating, and overall satisfaction were assessed at regular intervals before and after the procedure. Results(data are mean ±SD. 110 patients were randomized to CO2 and 109 to room air. The baseline characteristics were similar in both groups. The mean propofol dose was not different between the treatments, as were the time to reach the ileum and the withdrawal time. pCO2 at the end of the procedure was 35.2±4.3 mmHg (CO2 group versus 35.6±6.0 mmHg in the room air group (>.05. No relevant complication occurred in either group. There was significantly less bloating for the CO2 group during the postprocedural recovery period (<.001 and over the 24-hour period (<.001. Also, patients with CO2 insufflation experienced significantly less pain (=.014. Finally, a higher overall satisfaction (=.04 was found in the CO2 group. Conclusions. This trial provides compelling evidence that CO2 insufflation significantly reduces bloating and pain after routine colonoscopy in propofol-sedated patients. The procedure is safe with no significant differences in CO2 between the two groups.

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

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    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

  18. Open-label trial and randomized, double-blind, placebo-controlled, crossover trial of hydrogen-enriched water for mitochondrial and inflammatory myopathies

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    Ito Mikako

    2011-10-01

    Full Text Available Abstract Background Molecular hydrogen has prominent effects on more than 30 animal models especially of oxidative stress-mediated diseases and inflammatory diseases. In addition, hydrogen effects on humans have been reported in diabetes mellitus type 2, hemodialysis, metabolic syndrome, radiotherapy for liver cancer, and brain stem infarction. Hydrogen effects are ascribed to specific radical-scavenging activities that eliminate hydroxyl radical and peroxynitrite, and also to signal-modulating activities, but the detailed molecular mechanisms still remain elusive. Hydrogen is a safe molecule that is largely produced by intestinal bacteria in rodents and humans, and no adverse effects have been documented. Methods We performed open-label trial of drinking 1.0 liter per day of hydrogen-enriched water for 12 weeks in five patients with progressive muscular dystrophy (PMD, four patients with polymyositis/dermatomyositis (PM/DM, and five patients with mitochondrial myopathies (MM, and measured 18 serum parameters as well as urinary 8-isoprostane every 4 weeks. We next conducted randomized, double-blind, placebo-controlled, crossover trial of 0.5 liter per day of hydrogen-enriched water or placebo water for 8 weeks in 10 patients with DM and 12 patients with MM, and measured 18 serum parameters every 4 weeks. Results In the open-label trial, no objective improvement or worsening of clinical symptoms was observed. We, however, observed significant effects in lactate-to-pyruvate ratios in PMD and MM, fasting blood glucose in PMD, serum matrix metalloproteinase-3 (MMP3 in PM/DM, and serum triglycerides in PM/DM. In the double-blind trial, no objective clinical effects were observed, but a significant improvement was detected in lactate in MM. Lactate-to-pyruvate ratios in MM and MMP3 in DM also exhibited favorable responses but without statistical significance. No adverse effect was observed in either trial except for hypoglycemic episodes in an insulin

  19. Comparison of Iohexol-380 and Iohexol-350 for coronary CT angiography: A multicenter, randomized, double-blind phase 3 trial

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    Park, Eun Ah; Lee, Whal [Dept. of Radiology, Seoul National University Hospital, Seoul (Korea, Republic of); Kang, Doo Kyoung [Dept. of Radiology, Ajou University School of Medicine, Suwon (Korea, Republic of); and others

    2016-06-15

    This multi-center, randomized, double-blind, phase 3 trial was conducted to compare the safety and efficacy of contrast agents iohexol-380 and iohexol-350 for coronary CT angiography in healthy subjects. Volunteers were randomized to receive 420 mgI/kg of either iohexol-350 or iohexol-380 using a flow rate of 4 mL/sec. All adverse events were recorded. Two blinded readers independently reviewed the CT images and conflicting results were resolved by a third reader. Luminal attenuations (ascending aorta, left main coronary artery, and left ventricle) in Hounsfield units (HUs) and image quality on a 4-point scale were calculated. A total of 225 subjects were given contrast media (115 with iohexol-380 and 110 with iohexol-350). There was no difference in number of adverse drug reactions between groups: 75 events in 56 (48.7%) of 115 subjects in the iohexol-380 group vs. 74 events in 51 (46.4%) of 110 subjects in the iohexol-350 group (p = 0.690). No severe adverse drug reactions were recorded. Neither group showed an increase in serum creatinine. Significant differences in mean density between the groups was found in the ascending aorta: 375.8 ± 71.4 HU with iohexol-380 vs. 356.3 ± 61.5 HU with iohexol-350 (p = 0.030). No significant differences in image quality scores between both groups were observed for all three anatomic evaluations (all, p > 0.05). Iohexol-380 provides improved enhancement of the ascending aorta and similar attenuation of the coronary arteries without any increase in adverse drug reactions, as compared with iohexol-350 using an identical amount of total iodine.

  20. Transcutaneous pulsed radiofrequency treatment for patients with shoulder pain booked for surgery: a double-blind, randomized controlled trial.

    Science.gov (United States)

    Taverner, Murray; Loughnan, Terence

    2014-02-01

    Shoulder pain is the third most common musculoskeletal problem and accounts for 5% of general practitioner consultations. Although many treatments are described, there is no consensus on optimal treatment and up to 40% of patients still have pain 12 months after initially seeking help for pain. Previously, the effect of transcutaneous pulsed radiofrequency treatment (TCPRFT) was evaluated in a retrospective audit that showed good pain relief for a mean 395 days and justified this randomized sham controlled trial. In this study, 51 patients entered into a randomized double-blinded, placebo controlled study of TCPRFT. Patients were assessed at 4 and 12 weeks by a blinded observer and compared with baseline. We observed sustained reductions in pain at night, pain with activity, and functional improvement at 4 and 12 weeks with active but not sham TCPRFT. The 25 subjects who received active treatment showed statistically significant reductions of 24/100 in pain at night and 20/100 of pain with activity at 4 weeks and 18/100 and 19/100, respectively, at 12 weeks from baseline. Statistically significant lower Brief Pain Inventory pain and function scores (4 and 12 weeks), improved pain self-efficacy (4 weeks), Oxford Shoulder scores (12 weeks), and internal rotation (12 weeks) were seen. Pain at both rest and shoulder elevation were not improved by active treatment. No complications were seen. This study of a simple, low risk, outpatient treatment confirms the findings of our earlier study of TCPRFT for knee pain and shoulder pain audit that transcutaneous pulsed radiofrequency treatment may help some people with painful shoulders.

  1. A 20-week program of resistance or concurrent exercise improves symptoms of schizophrenia: results of a blind, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bruna Andrade e Silva

    2015-01-01

    Full Text Available Objective:To evaluate the effects of 20 weeks of resistance and concurrent training on psychotic and depressive symptoms, quality of life outcomes, and serum IGF-1, IGFBP-3, and brain-derived neurotrophic factor (BDNF concentrations in patients with schizophrenia.Methods:In this blind, randomized controlled clinical trial, 34 patients with schizophrenia were assigned to one of three groups: control (CTRL, n=13, resistance exercise (RESEX, n=12, or concurrent exercise (CONCEX, n=9. Symptoms, quality of life, strength, and other variables were assessed.Results:A significant time-by-group interaction was found for the RESEX and CONCEX groups on the Positive and Negative Syndrome Scale (PANSS total score for disease symptoms (p = 0.007, positive symptoms (p = 0.003, and on the arm extension one-repetition maximum (1RM test (p = 0.016. In addition, significant improvements on negative symptoms (p = 0.027, on the role-physical domain of the Short Form-36 Health Survey (p = 0.019, and on the chest press 1RM test (p = 0.040 were observed in the RESEX group. No changes were observed for the other variables investigated.Conclusions:In this sample of patients with schizophrenia, 20 weeks of resistance or concurrent exercise program improved disease symptoms, strength, and quality of life. ClinicalTrials.gov: NCT01674543.

  2. Efficacy and safety of ecabet sodium on functional dyspepsia :A prospective, double-blinded, randomized, multi-center controlled trial

    Institute of Scientific and Technical Information of China (English)

    Jun Haeng Lee; Soo Teik Lee; Eun Hyun Lee; Jong Chul Rhee; Jae J Kim; Ki-Baik Hahm; Dong Ho Lee; Nayoung Kim; Sung Kook Kim; Jong Jae Park; Seok Reyol Choi; Jong Hun Lee

    2006-01-01

    AIM: To compare ecabet sodium and cimetidine in relieving symptoms of functional dyspepsia.METHODS: We performed a multi-center, prospective,randomized, double-blinded controlled trial to compare the clinical efficacy of ecabet sodium and cimetidine in patients with functional dyspepsia. Two-hundred and seventy-two patients with dyspeptic symptoms fulfilling the Rome-Ⅱ criteria were enrolled from 7 centers. In the study group (115 patients), 1.5 g ecabet sodium was given twice a day. In the control group (121 patients),400 mg cimetidine was given twice a day. Symptoms and parameters of quality of life were analyzed at baseline, 3,14, and 28 d after initiating the treatment.RESULTS: Two-hundred and thirty-six patients completed the clinical trial. After 4 wk of treatment,the rates of improvement in patients with dyspeptic symptoms were not different between two groups (77.4% in the ecabet group and 79.3% in the cimetidine group, respectively, P > 0.05). Likewise, the rates of symptomatic improvement were not different at 3 d and 14 d. The parameters of quality of life did not change significantly during the study period in both groups.There was no clinically significant adverse event in both groups.CONCLUSION: In patients with functional dyspepsia,ecabet sodium has similar clinical efficacy with cimetidine.

  3. Results of a Double-Blind, Randomized Trial of Ceftobiprole Treatment of Complicated Skin and Skin Structure Infections Caused by Gram-Positive Bacteria▿

    OpenAIRE

    2007-01-01

    Ceftobiprole is the first broad-spectrum cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA) to be assessed in late-stage clinical trials. As a pivotal step in the clinical development of ceftobiprole, a multicenter, global, randomized, double-blind trial was conducted to compare the efficacy of ceftobiprole to that of vancomycin in patients with complicated skin and skin structure infections (cSSSIs) caused by gram-positive bacteria. The primary objective w...

  4. Efficacy of chlorophyll c2 for seasonal allergic rhinitis: single-center double-blind randomized control trial.

    Science.gov (United States)

    Fujiwara, Takashi; Nishida, Naoya; Nota, Jumpei; Kitani, Takashi; Aoishi, Kunihide; Takahashi, Hirotaka; Sugahara, Takuya; Hato, Naohito

    2016-12-01

    Chlorophyll c2 extracted from Sargassum horneri improved allergic symptoms in an animal model of allergic rhinitis. In the present study, we explored the efficacy of chlorophyll c2 in patients with seasonal allergic rhinitis. This was a single-center, randomized, double-blind placebo-controlled trial. Sixty-six patients aged 20-43 years, each with a 2-year history of seasonal allergic rhinitis, were randomly assigned to receive either a single daily dose (0.7 mg) of chlorophyll c2 or placebo for 12 weeks. The use of medications including H1-antihistamines and topical nasal steroids was recorded by rescue medication scores (RMSs) noted after 4, 8, and 12 weeks of treatment. Disease-specific quality of life was measured using the Japan Rhinitis Quality of Life Questionnaire (JRQLQ) both before and after 4, 8, and 12 weeks of treatment. The RMS at 8 weeks was significantly better in the chlorophyll c2 than the placebo group (mean RMS difference = -3.09; 95 % confidence interval = -5.96 to -0.22); the mean RMS at 4 weeks was only slightly better in the chlorophyll c2 group. The JRQLQ scores did not differ significantly between the two groups. Chlorophyll c2 would have a potential to be an alternative treatment for allergic rhinitis.

  5. 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.

  6. Effects of ketoconazole on ovarian response in patients with polycystic ovarian syndrome: A double blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Niloofar Memarpour

    2007-03-01

    Full Text Available Objective: The study assessed the efficacy of low dose ketoconazole in addition to clomiphene citrate (CC and hMG on ovulation induction.Materials and methods:A double blind, randomized, clinical trial was performed on fifty infertile patients with PCOS who had failed to respond to a daily dose of hMG and 100 mg CC for controlled ovarian hyperstimulation in Vali-e-Asr Reproductive Health Research Center.These patients were randomly divided into two equal groups receiving ketoconazole or placebo.All patients received CC and hMG for controlled ovarian hyperstimulation.Number of mature follicles, estradiol and progesterone levels at the time of hCG adminstration, endometrial thickness, ovarian hyperstimulation syndrome(OHSS, pregnancy rate, abortion, multiple pregnancies were measured. SPSS 11 software was used for statistical analysis. Statistical significance was defined as P < 0.05.Results: No significant statistical differences existed in the number of mature follicles,   estradiol and progesterone levels prior to hCG administration ,endometrial thickness, OHSS and pregnancy rate between two groups. Estradiol level was lower among those receiving ketoconazole. No abortion and multiple pregnancy were found.Conclusion: Ketoconazole may suppress steroid production in resistant PCOS patients undergoing CC and hMG induction. But it has no effects on follicular maturation and OHSS prevention.

  7. Clonazepam for the Management of Anxiety Associated with Oral Surgery: A Randomized Double-blind Controlled Trial

    Directory of Open Access Journals (Sweden)

    Zamiri B.

    2012-06-01

    Full Text Available Statement of Problem: Anxiety is one of the most common challenges which affect both the patient and the surgeon throughout dental procedures. Thus, there has been growing interest in the application of sedatives in dentistry. Purpose: This study evaluated the efficacy of clonazepam in reducing anxiety prior to oral surgery. Materials and Method: The participants of this, randomized controlled trial, study included 60 patients who referred to the Department of Oral and Maxillof-acial Surgery, Shiraz University of Medical Sciences. They were randomly allocated to either a single 2 mg dose of Clonazepam or a placebo one hour prior to the surgery. The participants and the outcome assessors were blind to the inter-vention. Levels of anxiety were recorded using Visual Analogue Scale (VAS and measuring blood pressure (BP, pulse rate and arterial oxygen saturation percentage. After collecting the data, the Chi-square test was run and then the data was analyzed.Results: The participants in the treatment and control groups were matched for age, sex, education, marital status and employment status ( p >0.05. All anxiety determinants (VAS, BP, pulse, and oxygen saturation rates changed significan-tly one hour after the administration of clonazepam ( p <0.05.Conclusion: Clonazepam is an effective anxiolytic drug with minimal side effects which can be used to reduce anxiety in dental patients.

  8. Efficacy of intravenous ondansetron to prevent vomiting episodes in acute gastroenteritis: a randomized, double blind, and controlled trial

    Directory of Open Access Journals (Sweden)

    Sanguansak Rerksuppaphol

    2010-09-01

    Full Text Available Acute gastroenteritis is one of the most common infectious diseases of childhood. Its symptoms are vomiting, diarrhea, and dehydration. In the emergency ward, intravenous rather than oral rehydration is usually preferred because of the high likelihood of emesis. Treatments to reduce emesis are of value in improving the rehydration procedure. Our study is a double-blind randomized trial and proposes the use of ondansetron as an anti-emetic drug to treat children with acute gastroenteritis. Seventy-four in-patients, aged 3 months to 15 years, were enrolled and randomly assigned to an ondansetron or placebo group. Inclusion criteria were the diagnosis of acute gastroenteritis and the absence of other diseases or allergies to drugs. A single bolus (0.15 mg/kg of ondansetron was injected intravenously; normal 0.9% saline solution was used as a placebo. This treatment induced vomiting cessation in the ondansetron group significantly in comparison to the placebo group. The length of the hospital stay and the oral rehydration fluid volume were similar in the two groups and no adverse effects were noticed. Thus, safety, low cost, and overall bene­fit of ondansetron treatment suggests that this drug can be administered successfully to children with acute gastroenteritis.

  9. Single-dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: A double-blind randomized controlled trial.

    Science.gov (United States)

    Dehghan, Mohammad; Akbari, Negin; Alborzi, Nazila; Sadani, Somayeh; Keshtkar, Abas A

    2010-08-01

    This study was designed to compare the therapeutic effects of topical clotrimazole and systemic fluconazole in pityriasis versicolor. A double-blind randomized controlled trial was carried out in the dermatological clinic of Gorgan, northern Iran, between April 2006 and May 2007. All consecutive patients with pityriasis versicolor were included and randomly divided into two groups. In the first group (G1), patients underwent treatment with a single dose of fluconazole capsule (400 mg) and placebo cream. In the second group (G2), patients underwent treatment with clotrimazole cream (twice daily) and placebo capsule. The course of treatment was 2 weeks. All subjects were re-evaluated 2, 4 and 12 weeks after the end of the therapeutic course. After 2 weeks, the rate of complete resolution of disease was significantly higher in G2 than G1 (49.1% vs 30%). After 4 weeks, 41 patients (81.2%) of G1 and 52 patients (94.9%) of G2 showed complete resolution. After 12 weeks, 46 patients (92%) in G1 and 45 patients (81.8%) in G2 showed complete resolution. Recurrence rate in G1 and G2 were 6% and 18.2%, respectively. No complications were seen in either group. In this study, clinical response at week 4 was greater in the clotrimazole group than the fluconazole group. Recurrence at week 12 after treatment was less with oral fluconazole than clotrimazole cream. So, for better evaluation, more studies need to be done.

  10. 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.

  11. A multicentric, double-blind randomized, homoeopathic pathogenetic trial of Allium sativum

    Directory of Open Access Journals (Sweden)

    Raj K Manchanda

    2016-01-01

    Conclusion: The pathogenetic response elicited during the proving trial expands the scope of use of the drug A. sativum and will benefit the research scholars and clinicians. The generated symptoms of this drug will carry more value when verified clinically.

  12. Alendronate prevents postmenopausal bone loss in women without osteoporosis. A double-blind, randomized, controlled trial. Alendronate Osteoporosis Prevention Study Group

    DEFF Research Database (Denmark)

    McClung, M; Clemmesen, B; Daifotis, A

    1998-01-01

    BACKGROUND: Preventing bone loss associated with menopause and aging and maintaining the normal micro-architecture of bone provide important opportunities for the prevention of osteoporosis and fractures. OBJECTIVE: To determine the safety and efficacy of alendronate, an aminobisphosphonate......, for preventing postmenopausal bone loss. DESIGN: 3-year double-blind, randomized, placebo-controlled trial. SETTING: 15 osteoporosis centers throughout the world. PARTICIPANTS: 447 women who had recently experienced menopause (6 to 36 months before study entry). INTERVENTION: Participants were randomly assigned...

  13. A double-blind, randomized trial of IV immunoglobulin treatment in acute optic neuritis

    DEFF Research Database (Denmark)

    Roed, H.G; Langkilde, Annika Reynberg; Sellebjerg, F;

    2005-01-01

    -four patients were randomized to IVIG 0.4 g/kg body wt, and 34 patients were randomized to placebo. Infusions were given at days 0, 1, 2, 30, and 60. Contrast sensitivity, visual acuity, and color vision were measured at baseline and after 1 week, 1 month, and 6 months. Pattern reversal visual evoked potential...

  14. A Randomized, Double-Blind, Sham-Controlled Trial of Transcranial Direct Current Stimulation in Attention-Deficit/Hyperactivity Disorder.

    Directory of Open Access Journals (Sweden)

    Camila Cosmo

    Full Text Available Current standardized treatments for cognitive impairment in attention-deficit/hyperactivity disorder remain limited and their efficacy restricted. Transcranial direct current stimulation (tDCS is a promising tool for enhancing cognitive performance in several neuropsychiatric disorders. Nevertheless, the effects of tDCS in reducing cognitive impairment in patients with attention-deficit/hyperactivity disorder (ADHD have not yet been investigated.A parallel, randomized, double-blind, sham-controlled trial was conducted to examine the efficacy of tDCS on the modulation of inhibitory control in adults with ADHD. Thirty patients were randomly allocated to each group and performed a go/no-go task before and after a single session of either anodal stimulation (1 mA over the left dorsolateral prefrontal cortex or sham stimulation.A nonparametric two-sample Wilcoxon rank-sum (Mann-Whitney test revealed no significant differences between the two groups of individuals with ADHD (tDCS vs. sham in regard to behavioral performance in the go/no go tasks. Furthermore, the effect sizes of group differences after treatment for the primary outcome measures-correct responses, impulsivity and omission errors--were small. No adverse events resulting from stimulation were reported.According to these findings, there is no evidence in support of the use of anodal stimulation over the left dorsolateral prefrontal cortex as an approach for improving inhibitory control in ADHD patients. To the best of our knowledge, this is the first clinical study to assess the cognitive effects of tDCS in individuals with ADHD. Further research is needed to assess the clinical efficacy of tDCS in this population.ClinicalTrials.gov NCT01968512.

  15. Efficacy and Safety of "URSA Complex" in Subjects with Physical Fatigue: A Multicenter, Randomized, Double-blind,Placebo-controlled Trial

    Institute of Scientific and Technical Information of China (English)

    Kwang-Min Kim; Moon-Jong Kim; Sang-Wook Song; Doo-Yeoun Cho; Kyung-Chae Park; Sung-Won Yang; Young-Sang Kim

    2016-01-01

    Background:Fatigue is a common symptom both in diseases status and in healthy subjects.Various supplements and nutraceuticals for relieving of fatigue have been used.However,there are a few studies to evaluate the efficacy and the safety of the drug for fatigue alleviation,we conducted using URSA Complex to evaluate the efficacy on physical fatigue via score changes in the checklist individual strength (CIS).Methods:The study was designed as a multicenter,randomized,double-blind,placebo-controlled trial,with subjects randomized to one of the two arms,receiving either placebo or URSA Complex administered as identical capsules.The primary efficacy endpoints of this clinical trials are the ratio of improving CIS scores < 76 points in patients at the end (4 weeks).Secondary efficacy variables are as follows one is an improvement of fatigue and the other is an improvement of the liver enzyme.Results:The fatigue recovery rate in who had improved CIS scores of< 76 points were 70.0%,50.9% in the therapy group and placebo group,respectively (P =0.019).The fatigue recovery rate in CIS score was higher in URSA Complex therapy group than placebo group.The difference between therapy group and placebo group was statistically significant at 4 weeks later,but not 2 weeks.Conclusions:Our results provided that the URSA Complex was effective in alleviating physical fatigue.The adverse event frequency in the therapy groups was similar to that in the placebo group.

  16. Prospective double-blind randomized controlled trial of terazosin, finasteride and allylestrenol in the management of benign prostatic hyperplasia

    Directory of Open Access Journals (Sweden)

    Madhu S Agrawal

    2001-01-01

    Full Text Available Medical management is rapidly becoming a very im-portant part of the armamentarium of the urologist in-volved in the treatment of benign prostatic hyperplasia. The commonest options for medical management include alpha-blockers, 5-alpha reductase inhibitors, and pro-gestational anti-androgens. We present a double-blind randomized controlled trial evaluating the safety and efficacy of terazosin, finasteride and allylestrenol, the prototype drugs in each of these respective categories. A total of 140 patients who satisfied the inclusion and exclusion criteria were inducted into the trial after an informed consent. They were randomized into 4 groups, which received placebo, terazosin, finasteride and allylestrenol respectively for 6 months. Since 29 patients did not complete 6 months of therapy, there were 111 evaluable patients at the end of the study. We found that these 3 drugs produce comparable improvement in symp-tom score (-40%, flow rates (-60% and PVR (-50% which is significantly better than that in the placebo group. Both allylestrenol and finasteride bring about a comparable reduction in prostate volume (-23%, which is statistically significant as compared to the placebo and terazosin groups. Terazosin in doses of I and 2 mg/ day was, found to be effiective and well-tolerated in the vast majority of our cases. No adverse effects were seen in the placebo and finasteride groups, while 9.6% in the terazosin group had postural hypotension and 10.7% in the allylestrenol group had some loss of libido, prob-lems which were reversible upon cessation of therapy.

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

    Directory of Open Access Journals (Sweden)

    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.

  18. A preliminary randomized double blind placebo-controlled trial of intravenous immunoglobulin for Japanese encephalitis in Nepal.

    Directory of Open Access Journals (Sweden)

    Ajit Rayamajhi

    Full Text Available Japanese encephalitis (JE virus (JEV is a mosquito-borne flavivirus found across Asia that is closely related to West Nile virus. There is no known antiviral treatment for any flavivirus. Results from in vitro studies and animal models suggest intravenous immunoglobulin (IVIG containing virus-specific neutralizing antibody may be effective in improving outcome in viral encephalitis. IVIG's anti-inflammatory properties may also be beneficial.We performed a pilot feasibility randomized double-blind placebo-controlled trial of IVIG containing anti-JEV neutralizing antibody (ImmunoRel, 400mg/kg/day for 5 days in children with suspected JE at two sites in Nepal; we also examined the effect on serum neutralizing antibody titre and cytokine profiles. 22 children were recruited, 13 of whom had confirmed JE; 11 received IVIG and 11 placebo, with no protocol violations. One child (IVIG group died during treatment and two (placebo subsequently following hospital discharge. Overall, there was no difference in outcome between treatment groups at discharge or follow up. Passive transfer of anti-JEV antibody was seen in JEV negative children. JEV positive children treated with IVIG had JEV-specific neutralizing antibody titres approximately 16 times higher than those treated with placebo (p=0.2, which was more than could be explained by passive transfer alone. IL-4 and IL-6 were higher in the IVIG group.A trial of IVIG for JE in Nepal is feasible. IVIG may augment the development of neutralizing antibodies in JEV positive patients. IVIG appears an appealing option for JE treatment that warrants further study.ClinicalTrials.gov NCT01856205.

  19. Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

    Directory of Open Access Journals (Sweden)

    U. C. Adler

    2011-01-01

    Full Text Available Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1 in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654 and 8th weeks (P = .965 of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine were −3.04 (95% CI −6.95, 0.86 and −2.4 (95% CI −6.05, 0.77 at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of

  20. Origanum vulgar inhaler in the treatment of chronic rhinosinositis, a double blind placebo controlled randomized clinical trial

    Directory of Open Access Journals (Sweden)

    K. Rabie

    2007-01-01

    Full Text Available AbstractBackground and purpose: Symptoms of chronic rhinisinositis (CRS are cumbersome and refractory to most systemic medications and even after surgical intervention, the recurrence of symptoms are frequent. In order to study the beneficial effects of Origanum vulgar inhaler in relaxing the symptoms, this study was conducted in Boo Ali Sina Hospital, Sari, Iran.Materials and Methods: The study was a randomized double blind placebo controlled clinical trial carried out from April to December 2005. The diagnosis of CRS was made by an ENT specialist upon clinical and CT scan findings and or signs during functional endoscopy sinuses surgery (FESS. Patients younger than 15 years old, with a history of allergic eye disease and symptoms of infections were excluded. Patients were randomized in case and control groups (32 in each according to age, sex and disease chronicity. After verbal explanation of the trial, an informed consent form was signed by each patient. The study was approved by the medical ethics committee of the Mazandaran University of Medical Sciences, Iran. Origanum vulgar was gathered from local mountains (Kojor area, Nour, Mazandaran, Iran, and identified by an experienced botanist. The airial organs of the herb were dried, macerated followed by 75% hydroalcoholic extraction and standardized by Emerson method. The active ingredient and placebo in the same bottles were administered to the patients and they were asked to add 5 ml of the liquid to boiling water and inhale it for 15 minutes, three times a day for two weeks. A telephone contact was made to the patients, to increase the compliance to treatment. A questionnaire was filled in for each patient before and after the intervention by a doctor blind to groups. Chi square test was used for comparing the differences in symptoms and P< 0.05 was considered statistically significant.Results: Sixty four patients were recruited and allocated equally in case and control groups matched for

  1. 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....

  2. The starting dose of Levothyroxine in primary hypothyroidism treatment - A prospective, randomized, double-blind trial

    NARCIS (Netherlands)

    Roos, A; Linn-Rasker, SP; van Domburg, RT; Tijssen, JP; Berghout, A

    2005-01-01

    Background: The treatment of hypothyroidism with levothyroxine is effective and simple; however, recommendations for the starting dose vary considerably. To our knowledge, the levothyroxine starting dose has never been studied prospectively. Methods: We conducted a prospective, randomized, double-bl

  3. 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

  4. Consumption of Sutherlandia frutescens by HIV-Seropositive South African Adults: An Adaptive Double-Blind Randomized Placebo Controlled Trial.

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    Douglas Wilson

    Full Text Available Sutherlandia frutescens (L. R. Br. is widely used as an over the counter complementary medicine and in traditional medications by HIV seropositive adults living in South Africa; however the plant's safety has not been objectively studied. An adaptive two-stage randomized double-blind placebo controlled study was used to evaluate the safety of consuming dried S. frutescens by HIV seropositive adults with CD4 T-lymphocyte count of >350 cells/μL.In Stage 1 56 participants were randomized to S. frutescens 400, 800 or 1,200 mg twice daily or matching placebo for 24 weeks. In Stage 2 77 additional participants were randomized to either 1,200 mg S. frutescens or placebo. In the final analysis data from Stage 1 and Stage 2 were combined such that 107 participants were analysed (54 in the S. frutescens 1,200 mg arm and 53 in the placebo arm.S. frutescens did not change HIV viral load, and CD4 T-lymphocyte count was similar in the two arms at 24 weeks; however, mean and total burden of infection (BOI; defined as days of infection-related events in each participant was greater in the S. frutescens arm: mean (SD 5.0 (5.5 vs. 9.0 (12.7 days (p = 0.045, attributed to two tuberculosis cases in subjects taking isoniazid preventive therapy (IPT.A possible interaction between S. frutescens and IPT needs further evaluation, and may presage antagonistic interactions with other herbs having similar biochemical (antioxidant properties. No other safety issues relating to consumption of S. frutescens in this cohort were identified.ClinicalTrials.gov NCT00549523.

  5. Risperidone Improves Behavioral Symptoms in Children with Autism in a Randomized, Double-Blind, Placebo-Controlled Trial

    Science.gov (United States)

    Pandina, Gahan J.; Bossie, Cynthia A.; Youssef, Eriene; Zhu, Young; Dunbar, Fiona

    2007-01-01

    Subgroup analysis of children (5-12 years) with autism enrolled in an 8-week, double-blind, placebo-controlled trial of risperidone for pervasive developmental disorders. The primary efficacy measure was the Aberrant Behavior Checklist-Irritability (ABC-I) subscale. Data were available for 55 children given risperidone (n = 27) or placebo (n =…

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

    OpenAIRE

    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.

    2013-01-01

    We conducted a double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous methylprednisolone for hantavirus cardiopulmonary syndrome in Chile between 2003 and 2010. Sixty of 66 enrollees had hantavirus confirmed. We observed no significant difference in primary efficacy or safety outcomes between the groups.

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

    Science.gov (United States)

    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

  8. Symptomatic treatment of neurolathyrism with tolperisone HCL (Mydocalm): a randomized double blind and placebo controlled drug trial.

    Science.gov (United States)

    Melka, A; Tekle-Haimanot, R; Lambien, F

    1997-04-01

    The efficacy and safety of oral Tolperisone HCL was evaluated in double blind, placebo-controlled, randomized trial in 72 patients with neurolathyrism in stages I, II, and III of the disease at Kolla Duba Health Centre of Dembia District of North Gondar between January and April 1995. Taken orally daily for 12 weeks, tolperisone HCL (Mydocalm) in a dose of 150 milligrams (mgs) twice daily significantly improved subjective complaints such as muscle cramps, heaviness of the legs, startle attacks, flexor spasms and repeated falls. An overall subjective improvement was observed in 75% of the patients on tolperisone HCL and 39% of the placebo group (P = 0.002). When objectively assessed spastic muscle tone in the abductors, stiffness of Achilles and spontaneous ankle clonus were significantly reduced in tolperisone HCL group (P values = 0.001, 0.04, and 0.0001, respectively). Walking ability and speed of walking was also significantly improved. The drug is most effective in relieving symptoms of stage I and stage II disease. Some adverse effects like muscle pain, generalized body weakness and dizziness were recorded in patients taking the drug but all were minor and self limited, none requiring discontinuation of treatment. It is concluded that tolperisone is a well tolerated and efficacious drug for symptomatic treatment of neurolathyrism.

  9. Administration of ascorbic acid to prevent bleaching-induced tooth sensitivity: a randomized triple-blind clinical trial.

    Science.gov (United States)

    de Paula, E A; Kossatz, S; Fernandes, D; Loguercio, A D; Reis, A

    2014-01-01

    This study evaluated the effect of ascorbic acid, 500 mg every eight hours, on bleaching-induced tooth sensitivity. A triple-blind, parallel design, and placebo-controlled randomized clinical trial was conducted on 39 adults. The pills (placebo or ascorbic acid) were administered three times per day for 48 hours; the first dose was given one hour prior to each bleaching session. Two bleaching sessions with 35% hydrogen peroxide gel were performed with a one-week interval. Tooth sensitivity was recorded up to 48 hours after bleaching. The color evaluation was performed before and 30 days after bleaching. The absolute risk and intensity of tooth sensitivity were evaluated by Fisher exact and Mann-Whitney U-tests, respectively. Color changes were evaluated by unpaired t-test (α=0.05). There were no significant differences in the absolute risk and intensity of tooth sensitivity and color change between the groups. Both groups showed a similar risk of tooth sensitivity (p>0.05). The perioperative use of an antioxidant, such as ascorbic acid (500 mg, three times daily) perorally, was not able to prevent bleaching-induced tooth sensitivity or reduce its intensity.

  10. Is Gabapentin Effective on Pain Management after Arthroscopic Anterior Cruciate Ligament Reconstruc tion? A Triple Blinded Randomized Controlled Trial

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    Mohsen Mrdani Kivi

    2013-09-01

    Full Text Available Background: Acute pain is common after arthroscopic surgeries and it is one of the most important causes of patient dissatisfaction, admission time and increased morbidity . Gabapentin with anti-hyperalgesic effects can play a critical role in pre-emptive analgesia methods. The aim of this study was to assess the efficacy of gabapentin in pain management after surgery and the rate of drug consumption in patients who are candidate for anterior cruciate ligament (ACL reconstruction arthroscopic surgery. Methods: In this randomized, triple blind clinical trial, 114 patients who were candidate for arthroscopic ACL reconstruction were divided into two groups of gabapentin (G and placebo (p, with 57 patients in each group. The intervention group received gabapentin 600 mg and a placebo was administered in control group. Patients received on-demand pethedine for pain management. The primary outcome was pain intensity according to the visual analogue scale (VAS and the secondary outcome was the amount of opioid consumption and incidence of side effects (including: dizziness, sedation, nausea and vomiting at 6 and 24 h visits. Results: The mean pain intensity in G group at both the 6 and 24 hour visits was significantly lower than the control group (Both p

  11. Orange Pomace Improves Postprandial Glycemic Responses: An Acute, Randomized, Placebo-Controlled, Double-Blind, Crossover Trial in Overweight Men

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    C.-Y. Oliver Chen

    2017-02-01

    Full Text Available Orange pomace (OP, a fiber-rich byproduct of juice production, has the potential for being formulated into a variety of food products. We hypothesized that OP would diminish postprandial glycemic responses to a high carbohydrate/fat breakfast and lunch. We conducted an acute, randomized, placebo-controlled, double blind, crossover trial with 34 overweight men who consumed either a 255 g placebo (PLA, a low (35% OP (LOP, or a high (77% (HOP dose OP beverage with breakfast. Blood was collected at 0, 10, 20, 30, and 45 min and at 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 8 h. Lunch was consumed after the 5.5-h blood draw. OP delayed the time (Tmax1 to the maximum concentration (Cmax1 of serum glucose during the 2-h period post breakfast by ≥36% from 33 (PLA to 45 (HOP and 47 (LOP min (p = 0.055 and 0.013, respectively. OP decreased post-breakfast insulin Cmax1 by ≥10% and LOP delayed the Tmax1 by 14 min, compared to PLA at 46 min (p ≤ 0.05. HOP reduced the first 2-h insulin area under concentration time curve (AUC by 23% compared to PLA. Thus, OP diminishes postprandial glycemic responses to a high carbohydrate/fat breakfast and the second meal in overweight men.

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

    Science.gov (United States)

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

    2016-01-01

    ABSTRACT Objective: 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. Methods: 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. Results: 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; p<0.001), and lower mean of hemodynamic parameters in the MRPB Group (p<0.05). Conclusion: Anesthesia with fentanyl and propofol as well as with midazolam, remifentanil, and paracervical block offered satisfactory anesthetic conditions when performing assisted reproduction procedures, providing comfort for the patient and physician. PMID:27759816

  13. 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.

  14. Aspirin desensitization for patients with aspirin-exacerbated respiratory disease: A randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Esmaeilzadeh, Hossein; Nabavi, Mohammad; Aryan, Zahra; Arshi, Saba; Bemanian, Mohammad Hassan; Fallahpour, Morteza; Mortazavi, Negar

    2015-10-01

    The effect of aspirin desensitization (AD) on immunologic profile of patients with AERD has been poorly understood. This study is aimed at investigating the effect of AD on clinical and immunological markers of patients with AERD. This randomized double-blind placebo-controlled trial comprised 34 adult patients (67.6% female) with chronic rhinosinusitis, nasal polyps, and aspirin-intolerant asthma. The active group underwent AD over a 2-day period with increasing doses of aspirin (60, 125, 325, and 625 mg), followed by receiving aspirin 625 mg twice daily for 6 months. Symptom scores and medication needs of patients with AERD who have undergone AD were significantly lower compared to the placebo group after 6 months (7.5 ± 3.5 vs. 10.6 ± 3.8 and 9.3 ± 2.0 vs. 11.0 ± 3.1, respectively, all p < 0.05). However, no significant difference was observed in serum concentration of IL-10, IFN-γ, and TGF-β between two groups neither at baseline nor at the end of study.

  15. Effects of Panax ginseng extract in patients with fibromyalgia: a 12-week, randomized, double-blind, placebo-controlled trial

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    Alessandra S. Braz

    2013-03-01

    Full Text Available The purpose of the study was to evaluate the efficacy of an extract of Panax ginseng in patients with fibromyalgia. A randomized, double-blind, controlled clinical trial was carried out over 12 weeks to compare the effects of P. ginseng (100 mg/d with amitriptyline (25 mg/d and placebo in 38 patients with fibromyalgia: 13 in Group I (amitriptyline, 13 in Group II (placebo, and 12 in Group III (P. ginseng. Ratings on the Visual Analogue Scale (VAS revealed a reduction in pain in the P. ginseng group (p < .0001, an improvement in fatigue (p < .0001 and an improvement in sleep (p < .001, with respect to baseline characteristics, but there were no differences between the three groups. With respect to anxiety, improvements occurred in the P. ginseng group compared to baseline (p < .0001; however, amitriptyline treatment resulted in significantly greater improvements (p < .05. P. ginseng reduced the number of tender points and improved patients' quality of life (using the Fibromyalgia Impact Questionnaire - FIQ; however, there were no differences between groups. The beneficial effects experienced by patients for all parameters suggest a need for further studies to be performed on the tolerability and efficacy of this phytotherapic as a complementary therapy for fibromyalgia.

  16. Laser Assisted Non-surgical Periodontal Therapy: A Double Blind, Randomized Clinical Trial

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    Everett, Joseph D.; Rossmann, Jeffrey A.; Kerns, David G.; Al-Hashimi, Ibtisam

    2017-01-01

    The objective of this study was to examine potential benefits of using laser therapy for secular decontamination in conjunction with scaling and root planing in the treatment of chronic periodontitis. The study was performed on 173 teeth in 14 patients in a split-mouth design, one side received scaling and root planing followed by laser therapy using a carbon dioxide (CO2) laser with an ablative handpiece (test group); the contralateral side received scaling and root planing without laser (control group). Clinical and laboratory parameters were evaluated prior to treatment and at 3 and 6 months following therapy; clinical measurements were performed by two blinded examiners. The clinical parameters included measurement of gingival recession (REC), bleeding on probing (BOP), clinical attachment level (CAL), pocket depth (PD), furcation involvement (FUR), and tooth mobility (MOB). Laboratory testing to determine the levels of periodontal pathogens was performed using PCR techniques. The results of the study revealed statistically significant differences in clinical and laboratory parameters at 3 and 6 months after therapy for both test and control groups, but no significant difference was observed between the two groups. However, sites receiving laser therapy tended to show a greater decrease in probing depths, gain in clinical attachment level, and reduced bacterial levels. In conclusion, the overall results of the study suggest a potential benefit of using laser therapy in conjunction with scaling and root planing for the treatment of chronic periodontitis. PMID:28357001

  17. Ghrelin treatment of cachectic patients with chronic obstructive pulmonary disease: a multicenter, randomized, double-blind, placebo-controlled trial.

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    Keisuke Miki

    Full Text Available BACKGROUND: Pulmonary cachexia is common in advanced chronic obstructive pulmonary disease (COPD, culminating in exercise intolerance and a poor prognosis. Ghrelin is a novel growth hormone (GH-releasing peptide with GH-independent effects. The efficacy and safety of adding ghrelin to pulmonary rehabilitation (PR in cachectic COPD patients were investigated. METHODOLOGY/PRINCIPAL FINDINGS: In a multicenter, randomized, double-blind, placebo-controlled trial, 33 cachectic COPD patients were randomly assigned PR with intravenous ghrelin (2 µg/kg or placebo twice daily for 3 weeks in hospital. The primary outcomes were changes in 6-min walk distance (6-MWD and the St. George Respiratory Questionnaire (SGRQ score. Secondary outcomes included changes in the Medical Research Council (MRC scale, and respiratory muscle strength. At pre-treatment, serum GH levels were increased from baseline levels by a single dose of ghrelin (mean change, +46.5 ng/ml; between-group p<0.0001, the effect of which continued during the 3-week treatment. In the ghrelin group, the mean change from pre-treatment in 6-MWD was improved at Week 3 (+40 m, within-group p = 0.033 and was maintained at Week 7 (+47 m, within-group p = 0.017, although the difference between ghrelin and placebo was not significant. At Week 7, the mean changes in SGRQ symptoms (between-group p = 0.026, in MRC (between-group p = 0.030, and in maximal expiratory pressure (MEP; between-group p = 0.015 were better in the ghrelin group than in the placebo group. Additionally, repeated-measures analysis of variance (ANOVA indicated significant time course effects of ghrelin versus placebo in SGRQ symptoms (p = 0.049 and MEP (p = 0.021. Ghrelin treatment was well tolerated. CONCLUSIONS/SIGNIFICANCE: In cachectic COPD patients, with the safety profile, ghrelin administration provided improvements in symptoms and respiratory strength, despite the lack of a significant between

  18. Vitamin D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial

    Science.gov (United States)

    Steenhoff, Andrew P.; Schall, Joan I.; Samuel, Julia; Seme, Boitshepo; Marape, Marape; Ratshaa, Bakgaki; Goercke, Irene; Tolle, Michael; Nnyepi, Maria S.; Mazhani, Loeto; Zemel, Babette S.; Rutstein, Richard M.; Stallings, Virginia A.

    2015-01-01

    Objectives Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D). Design Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years. Methods Sixty subjects randomized within five age groups to either 4000 or 7000IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ≥32ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores. Results Subjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of 1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9ng/ml to 56±18ng/ml (p<0.0001) and 68% and 90% had 25D ≥32ng/ml, respectively (p = 0.02). Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04). HAZ and CD4% increased and VL decreased in the 7000IU/d group (p<0.04). Younger (5–13y) and older (30–50y) subjects had greater Δ25D than those 14–29y (26±17 and 28±12 vs. 11±11ng/ml, respectively, p≤0.001). Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03). Conclusions In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers. Trial Registration ClinicalTrials.gov NCT02189902 PMID:25706751

  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. The analgesic efficacy of intravenous lidocaine infusion after laparoscopic fundoplication: a prospective, randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Dale GJ

    2016-12-01

    Full Text Available Gregory J Dale,1 Stephanie Phillips,2 Gregory L Falk3 1Westmead Hospital Clinical School, The University of Sydney, 2Sydney Adventist Hospital Clinical School, The University of Sydney, 3Concord Clinical School, The University of Sydney, Sydney, Australia Abstract: This study aimed to determine if intravenous lidocaine infusion reduces postoperative pain intensity following laparoscopic fundoplication surgery and to also validate the safety of intravenous lidocaine at the dose tested. This was an equally randomized, double-blind, placebo-controlled, parallel-group, single center trial. Adult patients undergoing laparoscopic fundoplication were recruited. The intervention group received 1 mg/kg intravenous lidocaine bolus prior to induction of anesthesia, then an intravenous infusion at 2 mg/kg/h for 24 hours. The primary outcome was pain, measured using a numeric rating scale for 30 hours postoperatively. Secondary outcomes were nausea and vomiting, opioid requirements, adverse events, serum lidocaine concentration, and length of hospital stay. The study was terminated after an interim analysis of 24 patients showed evidence of futility. There was no difference in postoperative pain scores (lidocaine versus control, mean ± standard deviation at rest (2.0 ± 2.7 vs 2.1 ± 2.4, P=0.286 or with movement (2.0 ± 2.6 vs 2.6 ± 2.7, P=0.487. Three adverse events occurred in the lidocaine group (25% of patients. Intravenous lidocaine did not provide clinically significant analgesia to patients undergoing laparoscopic fundoplication. The serum lidocaine concentration of patients who experienced adverse events were within the therapeutic range. This trial cannot confirm the safety of intravenous lidocaine at the dose tested. Keywords: analgesia, local anesthetics, intravenous infusions, pharmacokinetics

  1. Resistive Exercise for Arthritic Cartilage Health (REACH: A randomized double-blind, sham-exercise controlled trial

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    Smith Richard M

    2009-01-01

    Full Text Available Abstract Background This article provides the rationale and methodology, of the first randomised controlled trial to our knowledge designed to assess the efficacy of progressive resistance training on cartilage morphology in women with knee osteoarthritis. Development and progression of osteoarthritis is multifactorial, with obesity, quadriceps weakness, joint malalignment, and abnormal mechanical joint forces particularly relevant to this study. Progressive resistance training has been reported to improve pain and disability in osteoarthritic cohorts. However, the disease-modifying potential of progressive resistance training for the articular cartilage degeneration characteristic of osteoarthritis is unknown. Our aim was to investigate the effect of high intensity progressive resistance training on articular cartilage degeneration in women with knee osteoarthritis. Methods Our cohort consisted of women over 40 years of age with primary knee osteoarthritis, according to the American College of Rheumatology clinical criteria. Primary outcome was blinded measurement of cartilage morphology via magnetic resonance imaging scan of the tibiofemoral joint. Secondary outcomes included walking endurance, balance, muscle strength, endurance, power, and velocity, body composition, pain, disability, depressive symptoms, and quality of life. Participants were randomized into a supervised progressive resistance training or sham-exercise group. The progressive resistance training group trained muscles around the hip and knee at 80% of their peak strength and progressed 3% per session, 3 days per week for 6 months. The sham-exercise group completed all exercises except hip adduction, but without added resistance or progression. Outcomes were repeated at 3 and 6 months, except for the magnetic resonance imaging scan, which was only repeated at 6 months. Discussion Our results will provide an evaluation of the disease-modifying potential of progressive

  2. Polyethylene glycol 3350 in occasional constipation: A one-week, randomized, placebo-controlled, double-blind trial

    Institute of Scientific and Technical Information of China (English)

    Thomas Mc Graw

    2016-01-01

    AIM:to evaluate the efficacy and safety of polyethylene glycol(PEG)3350 in subjects with self-reported occasional constipation.METHODS:Eligible subjects≥17 years of age were randomized to receive either placebo or PEG 335017 g once daily in this multicenter,double-blind trial.Evaluations were conducted before(baseline)and after a 7-d treatment period.The primary efficacy variable was the proportion of subjects reporting complete resolution of straining and hard or lumpy stools.Secondary efficacy variables assessed the severity of the subjects’daily bowel movement(BM)symptoms,and preference of laxatives based on diary entries,visual analog scale scores,and questionnaires.RESULTS:Of the 203 subjects enrolled in the study,11had major protocol violations.Complete resolution was noted by 36/98(36.7%)subjects in the PEG 3350 group and 23/94(24.5%)in the placebo group(P=0.0595).The number of complete BMs without straining or lumpy stools was similar between both groups.Subjects receiving PEG 3350 experienced significant relief in straining and reduction in hardness of stools over a7-d period(P<0.0001).Subjects reported that PEG3350 had a better effect on their daily lives,provided better control over a BM,better relief from constipation,cramping,and bloating,and was their preferred laxative.Adverse events(AEs)were balanced between the PEG3350 and the placebo groups.No deaths,serious AEs,or discontinuations due to AEs were reported.This trial is registered at clinicaltrials.gov as NCT00770432.CONCLUSION:Oral administration of 17 g PEG3350 once daily for a week is effective,safe,and well tolerated in subjects with occasional constipation.

  3. A randomized, double-blind, parallel group trial of iomeprol, iohexol and iopamidol in intravenous urography.

    Science.gov (United States)

    Harding, J R; Bertazzoli, M; Spinazzi, A

    1995-07-01

    The aim of this study was to compare the safety, tolerance, and diagnostic efficacy of iomeprol 350 mg I ml-1, iohexol 350 mg I ml-1, and iopamidol 370 mg I ml-1 in 90 adult patients undergoing intravenous urography. Radiographs obtained 5, 10 and 15 min after contrast injection were blindly graded for quality on a four point scale as: 0, non-diagnostic; 1, diagnostic but of limited quality; 2, diagnostic and of good quality; 3, fully diagnostic and of very good quality. The sum of these scores indicated the overall diagnostic quality (0-4, non-diagnostic; 4-8, diagnostic; 9-12, good or excellent). Contrast tolerability was evaluated by discomfort (heat or pain) associated with injection of the test compounds, and patients were monitored and questioned for adverse experiences. The quality of the individual radiographs was assessed as diagnostic and good or fully diagnostic and very good in most cases, with no significant differences between the three study groups, and overall scores were predominantly good or excellent (p = 0.55). All adverse reactions were transient and non-serious, and most of them were reported as mild in intensity. There were no significant differences between the three groups for heat sensation (p = 0.29). Pain at the injection site was reported only in the iohexol group (p = 0.104). It is concluded that iomeprol 350 mg I ml-1 is at least as safe and effective as iohexol 350 mg I ml-1 or iopamidol 370 mg I ml-1 when used for intravenous urography.

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

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    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

  5. A double-blind, randomized trial of IV immunoglobulin treatment in acute optic neuritis

    DEFF Research Database (Denmark)

    Roed, H.G; Langkilde, Annika Reynberg; Sellebjerg, F;

    2005-01-01

    OBJECTIVE: To investigate if IV immunoglobulin (IVIG) treatment in the acute phase of optic neuritis (ON) could improve visual outcome and reduce MRI disease activity 6 months after onset of ON. METHODS: Sixty-eight patients with ON were randomized within 4 weeks from onset of symptoms. Thirty...... during follow-up. CONCLUSIONS: There was no effect of IV immunoglobulin (IVIG) on long-term visual function following acute optic neuritis, nor was there an effect of IVIG treatment in reducing latency on visual evoked potentials and thus preserving function of axons of the optic nerve...

  6. The effect of Frankincense in the treatment of moderate plaque-induced gingivitis: a double blinded randomized clinical trial

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    M Chitsazan

    2011-10-01

    Full Text Available "n  Background and the purpose of the Study: Extract of Boswellia Serrata species has been used in the Indian traditional medicine in the treatment of various inflammatory diseases. The present study was designed to evaluate anti-inflammatory effects of Frankincense in the treatment of gingivitis, which is a periodontal tissue inflammatory disease. "n  Methods: This double blind randomized placebo controlled trial was carried out among high school female students with moderate plaque-induced gingivitis. Based on either administration of 0.1 gram of Frankincense extract or 0.2 gram of its powder or placebo and whether the patients undergone scaling and root planning (SRP or not, they were randomly assigned to 6 groups. The primary efficacy outcome was changes in Gingival Index (Loe & Sillness and the secondary outcomes were alteration in plaque index (Sillness & Loe, bleeding index (Cowell and probing pocket depth (WHO probe. All indices were measured in the 0, 7th and 14th days of the study. "n  Results: Seventy five patients ranged of 15-18 years old were enrolled. At the end of the study, the indices in all groups showed significant decreases in comparison to the first day (p< 0.05, except for the bleeding index in the group without SRP and drug therapy (p=0.111. More precise analysis of data revealed that SRP in association with Frankincense application (either extract or powder can lead to remarkable decrease in inflammatory indices in comparison to the groups without SRP and drug therapy (p<0.001. In addition, no significant difference was observed between powder or extract therapy (p >0.05 and between patients received either SRP or treatment alone (p=0.169. "n  Conclusion: Frankincense, a safe and low-cost herbal medicine, may be feasibly applied to improve inflammation based disease of gingival as an adjunct to the conventional mechanical therapy.

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

    Science.gov (United States)

    Hosseini, Jalil; Mardi Mamaghani, Azar; Hosseinifar, Hani; Sadighi Gilani, Mohammad Ali; Dadkhah, Farid; Sepidarkish, Mahdi

    2016-01-01

    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. PMID:27679829

  8. The Effect of Melatonin on Climacteric Symptoms in Menopausal Women; A Double-Blind, Randomized Controlled, Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Nehleh Parandavar

    2014-10-01

    Full Text Available Menopause is one of the most critical periods of woman's life. With reducing of ovarian estrogen; women are more prone to psychological and physical symptoms. The present study aimed to investigate the effect of melatonin on the climacteric symptoms.The present double blind, placebo randomized controlled clinical trial was conducted on 240 menopausal women (40 - 60 years old referring to the gynecology clinics of Shiraz University of Medical Sciences (January - November 2012. The participants were randomly divided into two groups through sortition. Demographic characteristics, Goldberg's general health questionnaire (GHQ, Greene Climacteric Scale and level of Follicle Stimulating Hormone (FSH were determined for both groups before the intervention. The intervention group received one 3mg melatonin tablet each night for 3 months and the control group received the placebo in the same period. Changes of climacteric symptoms and drug complications were measured 1, 2 and 3 months after the intervention.We analyzed the data of 99 postmenopausal women in the intervention group and 101 postmenopausal women in the control group. In the melatonin group, the climacteric symptoms score decreased from 35.73+11.6 to 17.09+10.22 during the 3-month study period and regardless of time, a significant difference was observed between the two groups (P<0.001. In addition, a significant difference was found between the two groups regarding various dimensions of the climacteric symptoms over time (P<0.001. No significant difference was found regarding side effects between the two groups (P= 0.135.The study findings showed that using melatonin improved the climacteric symptoms.

  9. Cardiopulmonary Benefits of Reducing Indoor Particles of Outdoor Origin: a Randomized Double-Blind Crossover Trial of Air Purifiers

    Science.gov (United States)

    Chen, Renjie; Zhao, Ang; Chen, Honglei; Zhao, Zhuohui; Cai, Jing; Wang, Cuicui; Yang, Changyuan; Li, Huichu; Xu, Xiaohui; Ha, Sandie; Li, Tiantian; Kan, Haidong

    2017-01-01

    Background Indoor exposure to fine particulate matter (PM2.5) from outdoor sources is a major health concern, especially in highly polluted developing countries, such as China. Few studies have evaluated the effectiveness of indoor air purification on the improvement of cardiopulmonary health in these areas. Objectives To evaluate whether a short-term indoor air purifier intervention improves cardiopulmonary health. Methods We conducted a randomized double-blind crossover trial among 35 healthy college students in Shanghai, China in 2014. These students lived in dormitories that were randomized into 2 groups and alternated the use of true or sham air purifiers for 48 h with a 2-week washout interval. We measured 14 circulating biomarkers of inflammation, coagulation and vasoconstriction, lung function, blood pressure (BP), and fractional exhaled nitric oxide (FeNO). We applied linear mixed-effect models to evaluate the effect of the intervention on health outcome variables. Results On average, air purification resulted in a 57% reduction in PM2.5 concentration from 96.2 to 41.3 μg/m3 within hours of operation. Air purification was significantly associated with decreases in geometric means of several circulating inflammatory and thrombogenic biomarkers, including 17.5% in monocyte chemoattractant protein-1, 68.1% in interleukin-1β, 32.8% in myeloperoxidase and 64.9% in soluble CD40 ligand. Further, systolic BP, diastolic BP, and FeNO were significantly decreased by 2.7%, 4.8%, and 17.0% in geometric mean, respectively. The impacts on lung function and vasoconstriction biomarkers were beneficial, but not statistically significant. Conclusion This intervention study demonstrated clear cardiopulmonary benefits of indoor air purification among young, healthy adults in a Chinese city with severe ambient particulate air pollution. (Intervention Study on the Health Impact of Air Filters in Chinese Adults; NCT02239744) PMID:26022815

  10. Pimpinella anisum in modifying the quality of life in patients with functional dyspepsia: A double-blind randomized clinical trial

    Science.gov (United States)

    Ghoshegir, S. Ashraffodin; Mazaheri, Mohammad; Ghannadi, Alireza; Feizi, Awat; Babaeian, Mahmoud; Tanhaee, Maryam; Karimi, Mehrdad; Adibi, Peyman

    2014-01-01

    Background: We aimed to assess the effects of anise on quality of life (QOL) of patients with functional dyspepsia (FD) in a double-blind randomized clinical trial. Materials and Methods: Of 180 patients attending the gastroenterology clinic, 107 ones with the diagnosis of postprandial distress syndrome according to Rome III criteria were enrolled. They were randomized into two groups, anise and placebo. Anise group involved 47 patients and received anise powders, 3 g after each meal (3 times/day) for 4 weeks. Control group had 60 patients who received placebo powders (cornstarch), 3 g after each meal (3 times/day) for 4 weeks. The QOL was assessed by short-form (SF)-36 questionnaire. Mean scores of eight health domains of the two groups were compared at baseline and at the end of study. Results: The age, sex, body mass index, smoking history, tea and coffee drinking patterns of the two groups were not significantly different. All domains of SF-36 were similar between the two groups at baseline but were significantly different at week 12. At baseline, mean score of physical component summary was 159 in placebo group and 167 in anise group (P = 0.1). At week 12, the score was 141 in placebo group and 251 in anise group (P = 0.0001). Mean baseline score of mental component summary was 172 and 165 in placebo and anise groups, respectively (P = 0.1). At week 12, the score was 135 in placebo group and 233 in anise group (P = 0.0001). Conclusion: The current study revealed the effectiveness of anise in improvement of QOL in patients with FD. PMID:25709650

  11. Pimpinella anisum in modifying the quality of life in patients with functional dyspepsia: A double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    S Ashraffodin Ghoshegir

    2014-01-01

    Full Text Available Background: We aimed to assess the effects of anise on quality of life (QOL of patients with functional dyspepsia (FD in a double-blind randomized clinical trial. Materials and Methods: Of 180 patients attending the gastroenterology clinic, 107 ones with the diagnosis of postprandial distress syndrome according to Rome III criteria were enrolled. They were randomized into two groups, anise and placebo. Anise group involved 47 patients and received anise powders, 3 g after each meal (3 times/day for 4 weeks. Control group had 60 patients who received placebo powders (cornstarch, 3 g after each meal (3 times/day for 4 weeks. The QOL was assessed by short-form (SF-36 questionnaire. Mean scores of eight health domains of the two groups were compared at baseline and at the end of study. Results: The age, sex, body mass index, smoking history, tea and coffee drinking patterns of the two groups were not significantly different. All domains of SF-36 were similar between the two groups at baseline but were significantly different at week 12. At baseline, mean score of physical component summary was 159 in placebo group and 167 in anise group (P = 0.1. At week 12, the score was 141 in placebo group and 251 in anise group (P = 0.0001. Mean baseline score of mental component summary was 172 and 165 in placebo and anise groups, respectively (P = 0.1. At week 12, the score was 135 in placebo group and 233 in anise group (P = 0.0001. Conclusion: The current study revealed the effectiveness of anise in improvement of QOL in patients with FD.

  12. Telephone-delivered psychoeducational intervention for Hong Kong Chinese dementia caregivers: a single-blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kwok T

    2013-09-01

    Full Text Available Timothy Kwok,1,2 Bel Wong,2 Isaac Ip,2 Kenny Chui,2 Daniel Young,2 Florence Ho2 1Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region; 2Jockey Club Centre for Positive Ageing, Hong Kong, Special Administrative Region Purpose: Many family caregivers of persons with dementia (PWD are unable to participate in community center-based caregiver support services because of logistical constraints. This study evaluated the effectiveness of a telephone-delivered psychoeducational intervention for family caregivers of PWD in alleviating caregiver burden and enhancing caregiving self-efficacy. Subjects and methods: In a single-blinded randomized controlled trial, 38 family caregivers of PWD were randomly allocated into an intervention group or a control group. The intervention group received psychoeducation from a registered social worker over the phone for 12 sessions. Caregivers in the control group were given a DVD containing educational information about dementia caregiving. Outcomes of the intervention were measured by the Chinese versions of the Zarit Burden Interview and the Revised Scale for Caregiving Self-efficacy. Mann–Whitney U tests were used to compare the differences between the intervention and control groups. Results: The level of burden of caregivers in the intervention group reduced significantly compared with caregivers in the control group. Caregivers in the intervention group also reported significantly more gain in self-efficacy in obtaining respite than the control group. Conclusion: A structured telephone intervention can benefit dementia caregivers in terms of self-efficacy and caregiving burden. The limitations of the research and recommendations for intervention are discussed. Keywords: telephone intervention, psychoeducation, dementia caregivers

  13. Indigenous recombinant streptokinase Vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial

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    Diwedi S

    2005-05-01

    Full Text Available Background : Streptokinase is the most widely used thrombolytic agent and can now be made using recombinant DNA technology. The present trial was initiated to assess an indigenous recombinant streptokinase (Shankinase, r-SK. Aim: To compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK and natural streptokinase (Streptase, n-SK. Settings and Design: Double blind, randomized, non-inferiority, multicentric, parallel study. Materials and Methods: Patients of AMI < 6 hours of chest pain and 2 mm ST elevation in 2 contiguous chest leads V1- V6 or 1 mm in limb leads were randomized to receive 1.5 miu of either r-SK or n-SK. CK Peaking and decrease of > 50% ST segment were used to assess reperfusion. Statistical analysis: Difference in the groups was assessed by chi-square or paired t test as required. Probability value Results: Overall 150 patients were recruited (96 r-SK group and 54 in n-SK group and demographic and clinical profile of the groups was comparable. Reperfusion was seen in 68.2% (58 and 69.4% (34 patients in r-SK and n-SK groups respectively. Commonly seen adverse events were fever in 7 (8.5%, hypotension in 3 (3.6%, nausea in 2 (2.4% patients. Minor bleeding were seen in 4 (4.8% of patients. Conclusion: Indigenous recombinant Streptokinase (r-SK is as efficacious as natural streptokinase (n-SK in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile..

  14. Maintenance Therapy by Vaginal Progesterone after Threatened Idiopathic Preterm Labor: A Randomized Placebo-Controlled Double-blind Trial

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    Seyede Hajar Sharami

    2010-01-01

    Full Text Available Background: Patients with arrested preterm labor (PTL are at increased risk for recurrence ofpreterm birth (PTB. Maintenance tocolysis after arrest of acute PTL is of questionable value. Theobjective of this study was to evaluate the efficacy of 200 mg vaginal progesterone in order toprevent PTB in women with episodes of threatened PTL.Materials and Methods: This is a randomized double blind clinical trial study.Women with singletonpregnancies between 28-36 weeks of gestation, who were hospitalized for PTL were included. Atotal of 173 pregnant patients were randomly allocated to receive 200 mg vaginal progesteronesuppositories (n=86 or placebo (n=87 daily until the 36th gestational week. The two groups werecompared relative to demographic characteristics, incidence of PTB before 34 and 37 weeks, andmaternal and neonatal complications. Data were analyzed by chi-square and Fisher’s exact tests.Results: Mean latency until delivery in the cases was longer than the control group (23.88 ± 18.01vs. 16.67 ± 12.9; p=0.004.Treatment with progesterone was not associated with a reduction inthe rate of PTB before 34 weeks [cases: 9 (10.8% vs. controls: 8 (10%] and 37 weeks [cases: 45(54.2% vs. controls: 33 (41.2%]. Log rank analysis revealed a significant difference for mean timeto delivery between the two groups (p=0.028. There were no significant differences for neonataland maternal complications in the two groups.Conclusion: Prophylactic administration of 200 mg vaginal progesterone suppositories aftersuccessful tocolysis in patients with threatened idiopathic PTL is associated with a longer latencyto delivery, but failed to reduce the rate of PTB (Registeration Number: IRCT138706051096N1.

  15. Tranexamic acid reduces blood loss during and after cesarean section:A double blinded, randomized, controlled trial

    Institute of Scientific and Technical Information of China (English)

    Amr H Yehia; Magdy H Koleib; Ibrahim A Abdelazim; Ahmed Atik

    2014-01-01

    Objective:To evaluate the efficacy of tranexamic acid in reduction of blood loss during and after cesarean section.Methods:Women included in the current double blinded, randomized, controlled trial were recruited from women attending for elective cesarean section and randomized into two groups; study group: received tranexamic acid with induction of anesthesia plus10IU of oxytocin injection after delivery of the baby.Control group: received only oxytocin 10IU injection after delivery of the baby.Results:Twenty four hours post-operative hemoglobin level was significantly higher in study group(11.2±1.5 mg/dL) compared to control(9.6±1.2 mg/dL), also24 hours post-operative hematocrit was significantly higher in study group(30.2±6.6) compared to control(29.2±2.8).Calculated total blood loss from placental delivery till end of cesarean section was significantly less in study group compared to control(369.5±198.0 versus606.8±193.0 mL; respectively), also, calculated vaginal bleeding during first6 hours post-operative was significantly less in study group compared to control(85.0±30.7 mL versus130.8±49.3 mL, respectively).The incidence of post-partum hemorrhage was significantly less in study group compared to control(31.1% versus63.2%; respectively), also the need for iron replacement therapy was significantly less frequent in study group compared to control(0.9% versus6.6%, respectively). Conclusions:Tranexamic acid can be used safely to reduce blood loss during cesarean section. Reduced blood loss after tranexamic acid was associated with improvement of post-operative hemoglobin, hematocrit and with reduction of post-partum need for iron replacement.

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

    Directory of Open Access Journals (Sweden)

    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.

  17. 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.

  18. Ebrotidine versus ranitidine in the treatment of acute duodenal ulcer. A multicentre, randomized, double-blind, controlled clinical trial.

    Science.gov (United States)

    Matov, V; Metchkov, G; Krastev, Z; Tchernev, K; Mitova, R; Márquez, M; Torres, J; Herrero, E; Fillat, O; Ortiz, J A

    1997-04-01

    A total of 478 patients with endoscopically confirmed duodenal ulcer entered this randomized, parallel, double-blind trial. Patients were randomly assigned to receive ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]- 4-thiazolyl]methyl]thio]ethyl]amino]methylene]-4-bromo-benzenesulfona mid e, CAS 100981-43-9, FI-3542) 400 mg or ranitidine 300 mg tablets (4:1) respectively, administered in single evening doses. Endoscopy, clinical examination and symptom assessment were performed at baseline and at weeks 4 and 8. Safety evaluations including laboratory tests, treatment compliance and antacid consumption checks were conducted at the beginning and/or at the 4 and 8 week visits. Patients whose ulcer showed endoscopic healing at the 4-week control left the study. Both groups were matched in all parameters studied. The healing rates at 4 weeks were 76.4% and 75.3% for ebrotidine and ranitidine respectively, while at 8 weeks the final rates were 95% and 91.8% respectively. Accompanying symptoms disappeared rapidly and the patients returned to normal. Smoking proved to be a highly significant negative risk factor, since healing rates were 83.4% and 71.2% at 4 weeks and 97.4% and 92.3% at 8 weeks in non-smokers and smokers respectively (p = 0.0046). Smokers treated with ranitidine showed significantly lower final healing rates than non-smokers (86% vs 100%; p = 0.0358), while the healing rates among patients treated with ebrotidine were similar regardless of whether they were smokers or not (93.9% and 96.7% N.S.). Ebrotidine (94%) proved to be more effective than ranitidine (86%) in smokers with higher healing rates (p < 0.05). Alcohol intake showed no significant relationship with the healing rates. Both drugs demonstrated an excellent safety. There were no changes in blood parameters, and no significant adverse events were reported.

  19. Myofascial Pain Syndrome in the Elderly and Self-Exercise: A Single-Blind, Randomized, Controlled Trial

    Science.gov (United States)

    Kim, Minhee; Lee, Minyoung; Kim, Yushin; Oh, Sejun; Lee, Dongshin

    2016-01-01

    Abstract Objective: This study aimed to demonstrate the effect of self-exercise with a therapeutic inflatable ball (SEIB) in elderly patients with myofascial pain syndrome. Design: Single-blind, randomized, controlled noninferiority trial. Setting: University campus. Participants: Forty elderly patients with myofascial pain syndrome completed the study. They were randomly allocated to SEIB (n = 22; mean age, 70.23 ± 6.11 years) or ultrasound (US) therapy (n = 18; mean age, 67.99 ± 5.64 years). Intervention: SEIB and US therapy (twice weekly for 4 consecutive weeks). Outcome measures: Visual analog scale (VAS), pressure pain threshold (PPT), and cervical lateral flexion (CLF) were measured at baseline and at 1, 2, 3, and 4 weeks. Results: The noninferiority test indicated that SEIB was not inferior to US for VAS, PPT, and CLF. Between-group comparisons showed no significant differences in the VAS (F = 2.579; p = 0.117), the PPT (F = 0.245; p = 0.624), and the CLF (F = 2.072; p = 0.159). In within-group comparisons, both groups presented significant differences in VAS (SEIB after 1 week and US after 1 week), PPT (SEIB after 3 weeks and US after 4 weeks), and CLF (SEIB after 4 weeks and US after 4 weeks) compared with baseline values. Conclusions: SEIB for 4 weeks has an effect similar to that of US for desensitizing myofascial pain and increasing joint flexibility. High accessibility and low cost would make SEIB a practical self-treatment method in elderly patients with myofascial pain syndrome. PMID:26910293

  20. Effects of Dextromethorphan on reducing methadone dosage in opium addicts undergoing methadone maintenance therapy: A double blind randomized clinical trial

    Science.gov (United States)

    Salehi, Mehrdad; Zargar, Ali; Ramezani, Mohammad Arash

    2011-01-01

    BACKGROUND: Dextromethorphan (DM) is an N-methyl-D-aspartate (NMDA) receptor antagonist that may be useful during opiate addiction process, especially in reducing methadone consumption in methadone maintenance therapy (MMT). The goal of the current study was to evaluate the effects of oral administration of DM on reducing methadone dose in MMT used to treat illicit opioid drug abuse. METHODS: A double-blinded randomized clinical trial was designed. Seventy two opiate abusers undergoing MMT were randomly divided into two groups. Participants in the intervention group were medicated by DM while those in the control group received placebo. After a 6-week follow-up, methadone consumption dosage, quality of life (QOL) and withdrawal symptoms were assessed and compared between the two groups by repeated measure ANOVA statistical test. RESULTS: The mean of methadone consumption in the DM and control groups were 62.7 mg/day (52.7-72.7) and 70.4 mg/day (60.4-80.4), respectively. No statistically significant difference was found between the two groups among the four evaluations made (F = 1.192, P = 0.279). There were not any significant differences in withdrawal symptoms between the two groups (P > 0.05). Total mean scores of QOL in the intervention and control groups were 84.8 (78.7-90.8) and 77.8 (71.8-83.7) (P > 0.05), respectively. CONCLUSIONS: Although DM might be useful for opioid dependence treatment, results of the current study did not reveal any statistically significant differences. Therefore, further studies exploring this possibility are needed. PMID:22973331

  1. Topical Finasteride in Hirsutism: A Double Blind Randomized Clinical Trial on Adult Women

    Directory of Open Access Journals (Sweden)

    F Iraji

    2005-11-01

    Full Text Available Background: Finasteride partially blocks the conversion of testosterone to dihydrotestosterone through inhibition of 5 α- reductase in hair follicles. Finasteride cream can penetrate to dermis to arrive at hair follicle due to its solubility. Therefore, it is expected to be used in treatment of hirsutism with less systemic adverse effects. This study was designed to determine the efficacy of finasteride cream 0.5% in management of idiopathic hirsutism. Methods: Finasteride (0.5% and placebo creams were administered to 35 women with hirsutism on the face. Medication and placebo creams, each one was used on one side of the face in an area of excessive hair growth, which were not necessarily symmetrical. The side for the finasteride and placebo creams were chosen randomizly and blindly in 1cm2 areas on each side of the face. Hair numbers were counted and the thickness of all hairs was also measured by micrometer and their mean was calculated, at the start of therapy and after 6 months. Statistical analysis was done in SPSS software using Paired and Student t-tests. P-values less than 0.05 were considered significant. Results: The mean of hair numbers decreased at placebo-applied side from 12.20 ± 6.15 to 10.50 ± 4.90 (P<0.0001 and at finasteride- treated side from 11.37 ± 6.15 to 8.47 ± 4.62 (p<0.0001. Mean of hair thickness at placebo side decreased from 2.92 ± 0.84µm to 2.72 ± 0.79 µm (p<0.0001 and at finasteride side from 3.17 ± 0.90µm to 2.37 ± 0.79 µm (p<0.0001. Comparison of hair number and thickness showed no statistically significant changes in finasteride versus placebo treated sides. But, according to patients' view points, hair growth rate was diminished and hair was looser on finasteride treated side. Conclusion: Six months of topically applied finasteride (0.5% does not affect on number and thickness of facial hirsutism significantly. Despite lack of objective changes, on questioning, most patients in finastride group

  2. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial

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    Shiv Akshat

    2014-01-01

    Full Text Available Introduction. Pain is the commonest morbidity after open surgical procedures. The most effective treatment of postoperative pain is opioid therapy. Morphine, the commonly used opioid, is associated with many side effects including respiratory depression, sedation, postoperative nausea vomiting, and pruritus. Nalbuphine, on the other hand, is known to cause less respiratory depression. Thus this study was undertaken to compare the intraoperative and postoperative analgesic efficacy and side effect profile of the two drugs. Methodology. 60 patients undergoing open gynaecological surgery were randomized to receive either morphine (Group M or nalbuphine (Group N in the intraoperative and postoperative period. Intraoperative analgesic efficacy (measured by need for rescue analgesics, postoperative pain by visual analogue scale, and side effects like postoperative nausea, vomiting, sedation, respiratory depression, and pruritus were compared in both groups. Intraoperative and postoperative heart rate and blood pressure were also compared between the groups. Results. Need for intraoperative analgesia was significantly more in Group N (P=0.023. Postoperative VAS scores were significantly different between the groups at various time points; however, none of the patients required any rescue analgesia. The incidence of various side effects was not significantly different between the groups. The haemodynamic profile of patients was comparable between the groups in both intraoperative and postoperative period. Conclusion. Nalbuphine provides less effective intraoperative analgesia than morphine in patients undergoing open gynaecological surgery under general anaesthesia. Both drugs, however, provided similar postoperative analgesia and had similar haemodynamic and side effect profile.

  3. Remifentanil at induction of general anesthesia for cesarean section: Double blind, randomized clinical trial

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    Shokoufeh Behdad

    2013-05-01

    Full Text Available Introduction: Remifentanil, with its rapid activity onset and short duration of action, may be more effective than other opioids for providing hemodynamic stability during obstetric anesthesia. However, there is some evidence of adverse effects on neonatal respiratory function. We investigated maternal and fetal effects of remifentanil during cesarean section surgery. Methods: Eighteen women with singleton term pregnancies, and physical class status of I or II as defined by the American Society of Anesthesia (ASA, who were undergoing general anesthesia for semi-elective cesarean section were randomized into two groups (40 in each group that received either and intravenous bolus of 0.5 µg/kg remifentanil or the same dose of saline as a placebo. Maternal hemodynamic variables and neonatal umbilical artery pH and Apgar score at first and fifth min were evaluated in both groups. Results: Systolic and diastolic blood pressure were significantly lower after tracheal intubation and skin incision in the remifentanil group as compared with the control group (p<0.05. There were no significant differences regarding heart rate between groups at any time (p>0.05. Apgar scores at first and fifth min were not significantly different among groups (p>0.05. No neonate required assisted ventilation or naloxan administration. Conclusion: Remifentanil may be a safe and effective drug for the induction of general anesthesia and surgical stimulation without subsequent neonatal depression. 

  4. A Randomized Double-Blind Placebo Controlled Trial of Oral Acyclovir in Renal Allograft Recipients

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    Walter F Schlech

    1993-01-01

    Full Text Available Fifty renal transplant patients were randomized to receive either 800 mg acyclovir by mouth four times daily or identical placebo tablets for prophylaxis of herpes simplex infection. Patients were followed weekly to assess reactivation of herpes simplex, varicella zoster virus, Epstein-Barr virus or cytomegalovirus (CMV infections. The patients received standard immunosuppressive regimens including cyclosporine A. Acyclovir suppressed secretion of herpes simplex virus in treated patients (P=0.001. Three episodes of mucocutaneous herpes simplex virus occurred in placebo recipients and one in a noncompliant acyclovir recipient. A clinically important difference in graft survival was demonstrated, but because of sample size failed to reach statistical significance (P=0.11. No reactivation of varicella zoster virus, Epstein-Barr virus or CMV infection was detected in either group. Toxicity was limited to central nervous irritability. The authors conclude that high dose oral acyclovir provides effective prophylaxis for prevention of herpes simplex virus infections in renal transplantation and may be associated with increased graft survival, perhaps from suppression of CMV infection.

  5. Vitamin D₃supplementation in Batswana children and adults with HIV: a pilot double blind randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Andrew P Steenhoff

    Full Text Available Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃ in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D.Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0-50.9 years.Sixty subjects randomized within five age groups to either 4000 or 7000 IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D ≥32 ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL, CD4%, anti-retroviral therapy (ART regime, and height-adjusted (HAZ, weight-adjusted (WAZ and Body Mass Index (BMIZ Z scores.Subjects were 50% male, age (mean±SD 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of 1.4 in 22%. From baseline to 12 weeks, 25D increased from 36±9 ng/ml to 56±18 ng/ml (p<0.0001 and 68% and 90% had 25D ≥32 ng/ml, respectively (p = 0.02. Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04. HAZ and CD4% increased and VL decreased in the 7000 IU/d group (p<0.04. Younger (5-13y and older (30-50y subjects had greater Δ25D than those 14-29y (26±17 and 28±12 vs. 11±11 ng/ml, respectively, p≤0.001. Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03.In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers.ClinicalTrials.gov NCT02189902.

  6. 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.

  7. Effectiveness of physical activity in reducing pain in patients with fibromyalgia: a blinded randomized clinical trial.

    Science.gov (United States)

    Kayo, Andrea Harumi; Peccin, Maria Stella; Sanches, Carla Munhoz; Trevisani, Virgínia Fernandes Moça

    2012-08-01

    The purpose of this study was to evaluate and compare the effectiveness of muscle-strengthening exercises (MS) and a walking program (WA) in reducing pain in patients with fibromyalgia. Ninety women, 30-55 years of age, diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria, were randomized into 3 groups: WA Group, MS Group, and control group. Pain (visual analog scale) was evaluated as the primary outcome. Physical functioning (Fibromyalgia Impact Questionnaire, FIQ), health-related quality of life (Short-Form 36 Health Survey, SF-36), and use of medication were evaluated as secondary outcomes. Assessments were performed at baseline, 8, 16, and 28 weeks. Intention-to-treat and efficacy analyses were conducted. Sixty-eight patients completed the treatment protocol. All 3 groups showed improvement after the 16-week treatment compared to baseline. At the 28-week follow-up, pain reduction was similar for the WA and MS groups (P = 0.39), but different from the control group (P = 0.01). At the end of the treatment, 80% of subjects in the control group took pain medication, but only 46.7% in the WA and 41.4% in the MS groups. Mean FIQ total scores were lower for the WA and MS groups (P = 0.96) compared with the control group (P < 0.01). Patients in the WA and MS groups reported higher scores (better health status) than controls in almost all SF-36 subscales. MS was as effective as WA in reducing pain regarding all study variables; however, symptoms management during the follow-up period was more efficient in the WA group.

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

    OpenAIRE

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

    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 ...

  9. Effect of an Echinacea-Based Hot Drink Versus Oseltamivir in Influenza Treatment: A Randomized, Double-Blind, Double-Dummy, Multicenter, Noninferiority Clinical Trial

    OpenAIRE

    Karel Rauš; Stephan Pleschka; Peter Klein, MSc; Roland Schoop, MSc; Peter Fisher

    2015-01-01

    Background: Echinacea has antiviral activity against influenza viruses in vitro and has traditionally been used for treatment of colds and flu. Objectives: This randomized, double-blind, double-dummy, multicenter, controlled clinical trial compared a new echinacea formulation with the neuraminidase inhibitor oseltamivir, the gold standard treatment for influenza. Methods: Following informed consent, 473 patients with early influenza symptoms (≤48 hours) were recruited in primary care in...

  10. Pyronaridine-Artesunate versus Chloroquine in Patients with Acute Plasmodium vivax Malaria: A Randomized, Double-Blind, Non-Inferiority Trial

    OpenAIRE

    Yi Poravuth; Duong Socheat; Ronnatrai Rueangweerayut; Chirapong Uthaisin; Aung Pyae Phyo; Neena Valecha; B. H. Krishnamoorthy Rao; Emiliana Tjitra; Asep Purnama; Isabelle Borghini-Fuhrer; Stephan Duparc; Chang-Sik Shin; Lawrence Fleckenstein

    2011-01-01

    BACKGROUND: New antimalarials are needed for P. vivax and P. falciparum malaria. This study compared the efficacy and safety of pyronaridine-artesunate with that of chloroquine for the treatment of uncomplicated P. vivax malaria. METHODS AND FINDINGS: This phase III randomized, double-blind, non-inferiority trial included five centers across Cambodia, Thailand, India, and Indonesia. In a double-dummy design, patients (aged >3-≤ 60 years) with microscopically confirmed P. vivax mono-infection ...

  11. Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial

    OpenAIRE

    2013-01-01

    Background Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave® Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chro...

  12. History of early abuse as a predictor of treatment response in patients with fibromyalgia : A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release

    NARCIS (Netherlands)

    Pae, Chi-Un; Masand, Prakash S.; Marks, David M.; Krulewicz, Stan; Han, Changsu; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A.

    2009-01-01

    Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind, placeb

  13. Fractional nonablative 1,540-nm laser resurfacing of atrophic acne scars. A randomized controlled trial with blinded response evaluation

    DEFF Research Database (Denmark)

    Hedelund, Lene; Moreau, Karen Estell R; Beyer, Ditte M

    2010-01-01

    The efficacy of nonablative fractional laser resurfacing of acne scars has been described in case reports and uncontrolled trials. The present study is the first randomized controlled trial in this field. The aim of this study was to examine the efficacy and adverse effects of 1,540-nm nonablativ...

  14. Selegiline in Comparison with Methylphenidate in Treatment of Adults with Attention Deficit yperactivity Disorder: A Double-blind, Randomized Trial

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    Farbod Fadai

    2009-12-01

    Full Text Available  Objective: "n "nAttention-Deficit/Hyperactivity Disorder (ADHD is one of the most common mental disorders in childhood and it continues to adulthood without proper treatment. Stimulants have been used in treatment of ADHD for many years and the efficacy of methylphenidate (MPH in the treatment of adults with ADHD has been proven to be acceptable according to meta-analysis studies. However, there are some concerns about stimulants. Finding other effective medications for the treatment of adult ADHD seems necessary. We tried a monoamine oxidase inhibitor, Selegiline, as there are some theoretical and experimental evidences for the efficacy of this medication . "nMethod: Forty patients were randomized to receive Selegiline or methylphenidate in an equal ratio for an 8-week double-blind clinical trial. Each patient filled the CAARS self report screening form before starting to take the medication and in weeks 2-4-6 and 8. Patients were also assessed by a psychiatrist at the baseline and on each 14 days up to the 8 weeks period. "nResults: The mean score of the two groups- receiving Selegiline or methylphenidate- decreased over the 8 weeks. There was not a significant difference between the two groups. The most prevalent side-effect of methylphenidate was decrease of appetite and for Selegiline change in sleep pattern . "nConclusion: Selegiline is as effective as methylphenidate in the treatment of adults with Attention-Deficit/Hyperactivity Disorder. Selegiline can be an alternative medication for the treatment of adult ADHD If its clinical efficacy is proven by other larger studies .

  15. Effect of Hypericum perforatum L. compared with metronidazole in bacterial vaginosis:a double-blind randomized trial

    Institute of Scientific and Technical Information of China (English)

    Sakineh; Mohammad-Alizadeh-Charandabi; Zahra; Mohammadzadeh; Azizeh; Farshbaf-Khalili; Yousef; Javadzadeh

    2014-01-01

    Objective:To compare effect of Hypericum perforatum(H.perforatum) vaginal gel with metronidazole on bacterial vaginosis(BV) in terms of initial response to treatment and preventing recurrence(primary outcomes) and also patient complaints(secondary outcomes).Methods:In this double-blind,double dummy trial,married women aged 18-49 with BV were randomized into two groups and administered 5 g of 3%H.perforatum and placebo of metronidazole(n=82),or 5 g of 0.75%metronidazole and placebo of H.peiforatum(n=80)vaginally for 5 d.Amsel criteria were used for diagnosis and assessing cure and recurrence of BV.The comparisons was done using Chi-square,Fisher’s exact and logistic regression.Results:At 10-12 d.cure rate was 82%in the H.perforatum and 85%in metronidazole group(risk ratio 0.9.95%confidence interval 0.6 to 1.3).Among the cured women,recurrence rate was 9%in the H.perforatum and 13%in the metronidazole group at the 30-35 d visit(risk ratio 0.8,95%confidence interval 0.4 to 1.3),There was no statistically significant difference between the groups regarding any patient complaints,except itching which was less in H.perforatum group(5%vs.16%,P=0.018 at the first and 13%vs.43%,P<0.001 at the second follow-up).No significant adverse event was reported at any groups.Conclusions:H.peiforatum could be a good option for treatment of BV.However,further studies arc needed for its public use.

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

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    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

  17. Creatine supplementation and resistance training in vulnerable older women: a randomized double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Gualano, Bruno; Macedo, André Regis; Alves, Christiano Robles Rodrigues; Roschel, Hamilton; Benatti, Fabiana Braga; Takayama, Liliam; de Sá Pinto, Ana Lucia; Lima, Fernanda Rodrigues; Pereira, Rosa Maria Rodrigues

    2014-05-01

    This study aimed to examine the efficacy of creatine supplementation, associated or not with resistance training, in vulnerable older women. A 24-week, double-blind, randomized, placebo-controlled trial was performed. Sixty subjects were assigned to compose the following groups: placebo (PL), creatine supplementation (CR), placebo with resistance training (PL+RT), and creatine supplementation with resistance training (CR+RT). The subjects were assessed at baseline and after 24weeks. The primary outcome was muscle strength, as assessed by one-repetition maximum (1-RM) tests. Secondary outcomes included appendicular lean mass, bone mass, biochemical bone markers, and physical function tests. The changes in 1-RM leg press were significantly greater in the CR+RT group (+19.9%) than in the PL (+2.4%) and the CR groups (+3.7%), but not than in the PL+RT group (+15%) (p=0.002, p=0.002, and p=0.357, respectively). The CR+RT group showed superior gains in 1-RM bench press (+10%) when compared with all the other groups (p≤0.05). The CR+RT group (+1.31%) showed greater appendicular lean mass accrual than the PL (-1.2%), the CR (+0.3%), and the PL+RT groups (-0.2%) (p≤0.05). The CR and the PL+RT groups experienced comparable gains in appendicular lean mass (p=0.62), but superior to those seen in the PL group. Changes in fat mass, bone mass and serum bone markers did not significantly differ between the groups (p>0.05). In conclusion, creatine supplementation combined with resistance training improved appendicular lean mass and muscle function, but not bone mass, in older vulnerable women. Clinicaltrials.gov: NCT01472393.

  18. The Deferasirox–AmBisome Therapy for Mucormycosis (DEFEAT Mucor) study: a randomized, double-blinded, placebo-controlled trial

    Science.gov (United States)

    Spellberg, Brad; Ibrahim, Ashraf S.; Chin-Hong, Peter V.; Kontoyiannis, Dimitrios P.; Morris, Michele I.; Perfect, John R.; Fredricks, David; Brass, Eric P.

    2012-01-01

    Objectives Host iron availability is fundamental to mucormycosis pathogenesis. The combination of liposomal amphotericin B (LAmB) and deferasirox iron chelation therapy synergistically improved survival in diabetic mice with mucormycosis. To determine the safety of combination deferasirox plus LAmB therapy for mucormycosis, a multicentred, placebo-controlled, double-blinded clinical trial was conducted. Methods Twenty patients with proven or probable mucormycosis were randomized to receive treatment with LAmB plus deferasirox (20 mg/kg/day for 14 days) or LAmB plus placebo (NCT00419770, clinicaltrials.gov). The primary analyses were for safety and exploratory efficacy. Results Patients in the deferasirox arm (n = 11) were more likely than those in the placebo arm (n = 9) to have active malignancy, neutropenia and corticosteroid therapy, and were less likely to receive concurrent non-study antifungal therapy. Reported adverse events and serious adverse events were similar between the groups. However, death was more frequent in the deferasirox than in the placebo arm at 30 days (45% versus 11%, P = 0.1) and 90 days (82% versus 22%, P = 0.01). Global success (alive, clinically stable, radiographically improved) for the deferasirox arm versus the placebo arm at 30 and 90 days, respectively, was 18% (2/11) versus 67% (6/9) (P = 0.06) and 18% (2/11) versus 56% (5/9) (P = 0.2). Conclusions Patients with mucormycosis treated with deferasirox had a higher mortality rate at 90 days. Population imbalances in this small Phase II study make generalizable conclusions difficult. Nevertheless, these data do not support a role for initial, adjunctive deferasirox therapy for mucormycosis. PMID:21937481

  19. 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.

  20. Oxytocin to modulate emotional processing in schizophrenia: A randomized, double-blind, cross-over clinical trial.

    Science.gov (United States)

    Brambilla, Michela; Cotelli, Maria; Manenti, Rosa; Dagani, Jessica; Sisti, Davide; Rocchi, Marco; Balestrieri, Matteo; Pini, Stefano; Raimondi, Sara; Saviotti, Francesco Maria; Scocco, Paolo; de Girolamo, Giovanni

    2016-10-01

    Deficits in social cognition, including emotional processing, are hallmarks of schizophrenia and antipsychotic agents seem to be ineffectual to improve these symptoms. However, oxytocin does seem to have beneficial effects on social cognition. The aim of this study was to examine the effects of four months of treatment with intranasal oxytocin, in 31 patients with schizophrenia, on distinct aspects of social cognition. This was assessed using standardized and experimental tests in a randomized, double-blind, placebo-controlled, cross-over trial. All patients underwent clinical and experimental assessment before treatment, four months after treatment and at the end of treatment. Social cognition abilities were assessed with the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) and the Reading the Mind in the Eyes task (RMET). Furthermore, an Emotional Priming Paradigm (EPP) was developed to examine the effects of oxytocin on implicit perceptual sensitivity to affective information and explicit facial affect recognition. We found that oxytocin improved performance on MSCEIT compared to placebo in Branch 3-Understanding Emotion (p-value=0.004; Cohen׳s d=1.12). In the EPP task, we observed a significant reduction of reaction times for facial affect recognition (p-value=0.021; Cohen׳s d=0.88). No effects were found for implicit priming or for theory of mind abilities. Further study is required in order to highlight the potential for possible integration of oxytocin with antipsychotic agents as well as to evaluate psycho-social treatment as a multi-dimensional approach to increase explicit emotional processing abilities and compensate social cognition deficits related to schizophrenia.

  1. High oleic ready-to-use therapeutic food maintains docosahexaenoic acid status in severe malnutrition: a randomized, blinded trial

    Science.gov (United States)

    Hsieh, Ji-Cheng; Liu, Lei; Zeilani, Mamane; Ickes, Scott; Trehan, Indi; Maleta, Ken; Craig, Christina; Thakwalakwa, Chrissie; Singh, Lauren; Brenna, J. Thomas; Manary, Mark J.

    2015-01-01

    Objective Ready-to-use therapeutic food (RUTF) is the preferred treatment for uncomplicated severe acute malnutrition. RUTF contains large amounts of linoleic acid and very little α-linolenic acid, which may reduce the availability of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) to the recovering child. A novel high oleic RUTF (HO-RUTF) was developed with less linoleic acid to determine its effect on DHA and EPA status. Methods We conducted a prospective, randomized, double-blinded, clinical effectiveness trial treating rural Malawian children with severe acute malnutrition. Children were treated with either HO-RUTF or standard RUTF. Plasma phospholipid (PL) fatty acid status was measured upon enrollment and after 4 weeks and compared between the two intervention groups. Results Among the 141 children enrolled, 48/71 receiving HO-RUTF and 50/70 receiving RUTF recovered. Plasma PL samples were analyzed from 43 children consuming HO-RUTF and 35 children consuming RUTF. The change in DHA content during the first 4 weeks was +4% and −25% in the HO-RUTF and RUTF groups, respectively (P = 0.04). For EPA, the change in content was 63% and −24% in the HO-RUTF and RUTF groups (P < 0.001). For arachidonic acid, the change in content was −3% and 13% in the HO-RUTF and RUTF groups (P < 0.009). Conclusions The changes in DHA and EPA seen in the children treated with HO-RUTF warrant further investigation as they suggest HO-RUTF support improved PUFA status, necessary for neural development and recovery. PMID:25633498

  2. The effect of intravenous aminophylline on stone free status after transureteral lithotripsy (TUL: a randomized double blind clinical trial study

    Directory of Open Access Journals (Sweden)

    A barzegarnezhad

    2015-10-01

    Full Text Available Background: The third common urinary tract disease was renal stone, after the UTI and pathologic states of kidney. TUL is most useful and effective for removing the stones of inferior ureter. In other hand aminophylline can decrease urinary tract spasm. Then, combination of TUL and aminophylline help us to reduce the complication of TUL. Methods and materials: We have study on 87 case of renal colic who referred to Imam Khomeini hospital of sari and Tooba clinic. This study was a double blind systematic randomized clinical trial that patients were divided to two group as 1 and 2: group one includes patients who received aminophylline and group 2 were selected as our control samples. Our sample size was calculated by statistic analysis according to recent studies. Result: The average of TUL time was 5.12± 1.77 min in group 1 and 6.59± 3.47 min in group 2(p0.05. ESWL was used in one patient of group 1 because of remaining of stone, but 7 patients of group 2 did not response to Transureter lithotripsy, then they needed ESWL. Complication were not seen in patient who received Aminophylline and mean arterial pressure and heart rate was equal in two group. Conclusion: The difference of TUL Time between two groups was meaningful. As you know, aminophylline has an antispasmotic effect on urinary tract and tract with smooth muscle, and according to our finding, usage of aminophylline can reduce the complication of TUL and increase success rate of Lithotripsy in this patient. In other hand, it complications was few.

  3. Effect of Hypericum perforatum L. compared with metronidazole in bacterial vaginosis:a double-blind randomized trial

    Institute of Scientific and Technical Information of China (English)

    Zahra Mohammadzadeh; Azizeh Farshbaf-Khalili; Yousef Javadzadeh

    2014-01-01

    Objective: To compare effect of Hypericum perforatum (H. perforatum) vaginal gel with metronidazole on bacterial vaginosis (BV) in terms of initial response to treatment and preventing recurrence (primary outcomes) and also patient complaints (secondary outcomes). Methods: In this double-blind, double dummy trial, married women aged 18-49 with BV were randomized into two groups and administered 5 g of 3% H. perforatum and placebo of metronidazole (n=82), or 5 g of 0.75% metronidazole and placebo of H. perforatum (n=80) vaginally for 5 d. Amsel criteria were used for diagnosis and assessing cure and recurrence of BV. The comparisons was done using Chi-square, Fisher's exact and logistic regression.Results:At 10-12 d, cure rate was 82% in the H. perforatum and 85% in metronidazole group (risk ratio 0.9, 95% confidence interval 0.6 to 1.3). Among the cured women, recurrence rate was 9%in the H. perforatum and 13% in the metronidazole group at the 30-35 d visit (risk ratio 0.8, 95%confidence interval 0.4 to 1.3). There was no statistically significant difference between the groups regarding any patient complaints, except itching which was less in H. perforatum group (5% vs. 16%, P=0.018 at the first and 13% vs. 43%, P<0.001 at the second follow-up). No significant adverse event was reported at any groups. Conclusions: H. perforatum could be a good option for treatment of BV. However, further studies are needed for its public use.

  4. A randomized triple blind trial to assess the effect of an anthelmintic programme for working equids in Morocco

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    Christley Robert M

    2011-01-01

    Full Text Available Abstract Background Gastro-intestinal parasitism has been identified as a significant cause of disease in working equids in many countries. This randomized triple-blind trial was designed to assess the impact of an anthelmintic treatment programme (using oral ivermectin and fenbendazole comparing treated and placebo control populations of working donkeys, mules and horses in field conditions in Morocco. In particular, we assessed animal body weight and condition score, together with a questionnaire-based owner evaluation of number of subjective animal health parameters. Faecal worm egg count was also measured. Results 239 animals completed the full study, 130 in the treatment group and 109 in the control group. Although the average animal weight increased during the study, this change was not significantly different between the two groups. Animals in the treatment group had a significantly lower strongyle worm egg count and increased in body condition score compared to animals in the control group at each examination during the study period. Owners of animals in the treatment group reported improvement in health and work ability and a beneficial effect on pruritus during the early period of the study. These differences in owner perception between treatment groups had disappeared in the latter stages of the study. Conclusion This study demonstrated that a routine anthelmintic treatment programme of three treatments annually can have a significant effect on faecal worm egg count. There may be beneficial consequences for the animal health and productivity. Further research on other populations of working equids in different environments would facilitate the objective planning of effective parasite control strategies for specific situations and provide better understanding of the likely clinical benefits of such programmes.

  5. The recolonization hypothesis in a full-mouth or multiple-session treatment protocol : a blinded, randomized clinical trial

    NARCIS (Netherlands)

    Zijnge, Vincent; Meijer, Henriette F.; Lie, Mady-Ann; Tromp, Jan A. H.; Degener, John E.; Harmsen, Hermie J. M.; Abbas, Frank

    2010-01-01

    P>Aim To test recolonization of periodontal lesions after full-mouth scaling and root planing (FM-SRP) or multiple session-SRP (MS-SRP) in a randomized clinical trial and whether FM-SRP and MS-SRP result in different clinical outcomes. Materials and Methods Thirty-nine subjects were randomly assigne

  6. Bispectral index monitoring prevent awareness during total intravenous anesthesia: a prospective, randomized,double-blinded, multi-center controlled trial

    Institute of Scientific and Technical Information of China (English)

    ZHANG Chen; GUO Jian-rong; JIN Yao-jun; WU Gang; YUAN Wei; YUAN Zhi-guo; YUE Yun; XU Liang; MA Ya-qun; SUN Yan-xia; LI Yan-hong; ZHANG Liang; FENG Chun-sheng; LUO Bing; ZHAO Zhen-long

    2011-01-01

    Background Awareness is a serious complication of general anesthesia.In China,the incidence of intraoperative awareness was 1% in patients undergoing total intravenous anesthesia (TIVA).In this study,we compared the incidence of awareness between Bispectral index (BIS)-guided and routine TIVA protocol and evaluated the effect of BIS on preventing awareness.Methods A prospective,randomized,double-blinded,multicenter controlled trial was performed.Patients (≥18 years of age) undergoing TIVA were randomly divided into BIS-guided group (Group A,BIS was monitored and recommended to maintain between 40-60) and control group (Group B,BIS was monitored but the screen was covered).The intraoperative BIS values were downloaded and the BIS trends of confirmed awareness cases were analyzed to determine whether light anesthesia existed.Results Of the total 5228 patients,2919 patients were assigned to Group A and 2309 to Group B.Four cases of confirmed awareness (0.14%) were reported in the BIS-guided group and 15 (0.65%) in the control group (P=0.002,OR=0.21,95% confidence intervals:0.07-0.63).The incidence of possible awareness (0.14% vs.0.26%,P=0.485) and dreaming (3.1% vs.3.1%,P=0.986) was comparable between BIS-guided group and the control group.Among the 19 confirmed awareness cases,intraoperative BIS trends of six cases were downloaded and identified.Five of them showed signs of light anesthesia as BIS >60 and lasted 19-106 minutes,whereas one case had a stable BIS trend and the values were within 60 during the operation.Another five awareness cases were reviewed for anesthesia procedures,of which improper light anesthesia were confirmed.Conclusions BIS-guided TIVA (BIS was recommended to maintain between 40-60) decreased the risk of awareness compared with routine TIVA.The main reason for awareness was light anesthesia.

  7. Sono-electro-magnetic therapy for treating chronic pelvic pain syndrome in men: A randomized, placebo-controlled, double-blind trial

    OpenAIRE

    2014-01-01

    OBJECTIVE: To assess the efficacy and safety of sono-electro-magnetic therapy compared to placebo in men with refractory CPPS. PATIENTS AND METHODS: In a randomized, placebo-controlled, double-blind single center trial, we assessed the effect of sono-electro-magnetic therapy in men with treatment refractory CPPS. Sixty male patients were randomly assigned to treatment with either sono-electro-magnetic (n = 30) or placebo therapy (n = 30) for 12 weeks. The primary outcome was a change in the N...

  8. Efficacy and safety of Myofascial-meridian Release Acupuncture (MMRA) for chronic neck pain: a study protocol for randomized, patient- and assessor-blinded, sham controlled trial

    OpenAIRE

    Lee, Seunghoon; Nam, Dongwoo; Leem, Jungtae; Han, Gajin; Lee, Seungmin; Lee,Junhee

    2016-01-01

    Background The purpose of this study is to evaluate the efficacy and safety of myofascial-meridian release acupuncture (MMRA) in the treatment of chronic neck pain compared with sham acupuncture. Methods/design A protocol for a randomized, patient- and assessor-blinded, sham controlled parallel trial is presented. Seventy-four participants with a ≥3 month history of neck pain and a score of ≥4 on the 11-point pain intensity numerical rating scale (PI-NRS) will be randomly assigned to the MMRA...

  9. Zinc adjunct therapy reduces case fatality in severe childhood pneumonia: a randomized double blind placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Srinivasan Maheswari G

    2012-02-01

    Full Text Available Abstract Background Pneumonia is a leading cause of children's deaths in developing countries and hinders achievement of the fourth Millennium Development Goal. This goal aims to reduce the under-five mortality rate, by two thirds, between 1990 and 2015. Few studies have examined the impact of zinc adjunct therapy on the outcome of childhood pneumonia. We determined the effect of zinc as adjunct therapy on time to normalization of respiratory rate, temperature and oxygen saturation. We also studied the effect of zinc adjunct therapy on case fatality of severe childhood pneumonia (as a secondary outcome in Mulago Hospital, Uganda. Methods In this double blind, randomized, placebo-controlled clinical trial, 352 children aged 6 to 59 months, with severe pneumonia were randomized to zinc (20 mg for children ≥12 months, and 10 mg for those Results Time to normalization of the respiratory rate, temperature and oxygen saturation was not significantly different between the two arms. Case fatality was 7/176 (4.0% in the zinc group and 21/176 (11.9% in the placebo group: Relative Risk 0.33 (95% CI 0.15 to 0.76. Relative Risk Reduction was 0.67 (95% CI 0.24 to 0.85, while the number needed to treat was 13. Among HIV infected children, case fatality was higher in the placebo (7/27 than in the zinc (0/28 group; RR 0.1 (95% CI 0.0, 1.0. Among 127 HIV uninfected children receiving the placebo, case fatality was 7/127 (5.5%; versus 5/129 (3.9% among HIV uninfected group receiving zinc: RR 0.7 (95% CI 0.2, 2.2. The excess risk of death attributable to the placebo arm (Absolute Risk Reduction or ARR was 8/100 (95% CI: 2/100, 14/100 children. This excess risk was substantially greater among HIV positive children than in HIV negative children (ARR: 26 (95% CI: 9, 42 per 100 versus 2 (95% CI: -4, 7 per 100; P-value for homogeneity of risk differences = 0.006. Conclusion Zinc adjunct therapy for severe pneumonia had no significant effect on time to normalization of

  10. Valsartan improves adipose tissue function in humans with impaired glucose metabolism: a randomized placebo-controlled double-blind trial.

    Directory of Open Access Journals (Sweden)

    Gijs H Goossens

    Full Text Available BACKGROUND: Blockade of the renin-angiotensin system (RAS reduces the incidence of type 2 diabetes mellitus. In rodents, it has been demonstrated that RAS blockade improved adipose tissue (AT function and glucose homeostasis. However, the effects of long-term RAS blockade on AT function have not been investigated in humans. Therefore, we examined whether 26-wks treatment with the angiotensin II type 1 receptor blocker valsartan affects AT function in humans with impaired glucose metabolism (IGM. METHODOLOGY/PRINCIPAL FINDINGS: We performed a randomized, double-blind, placebo-controlled parallel-group study, in which 38 subjects with IGM were treated with valsartan (VAL, 320 mg/d or placebo (PLB for 26 weeks. Before and after treatment, an abdominal subcutaneous AT biopsy was collected for measurement of adipocyte size and AT gene/protein expression of angiogenesis/capillarization, adipogenesis, lipolytic and inflammatory cell markers. Furthermore, we evaluated fasting and postprandial AT blood flow (ATBF ((133Xe wash-out, systemic inflammation and insulin sensitivity (hyperinsulinemic-euglycemic clamp. VAL treatment markedly reduced adipocyte size (P<0.001, with a shift toward a higher proportion of small adipocytes. In addition, fasting (P = 0.043 and postprandial ATBF (P = 0.049 were increased, whereas gene expression of angiogenesis/capillarization, adipogenesis and macrophage infiltration markers in AT was significantly decreased after VAL compared with PLB treatment. Interestingly, the change in adipocyte size was associated with alterations in insulin sensitivity and reduced AT gene expression of macrophage infiltration markers. VAL did not alter plasma monocyte-chemoattractant protein (MCP-1, TNF-α, adiponectin and leptin concentrations. CONCLUSIONS/SIGNIFICANCE: 26-wks VAL treatment markedly reduced abdominal subcutaneous adipocyte size and AT macrophage infiltration markers, and increased ATBF in IGM subjects. The VAL

  11. Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind,placebo-controlled multicenter trial

    Institute of Scientific and Technical Information of China (English)

    YANG Hai-zhen; LIU Xiao-ming; TU Cai-xia; JI Su-zhen; SHEN Yang; ZHU Xue-jun; WANG Ke; JIN Hong-zhong; GAO Tian-wen; XIAO Sheng-xiang; XU Jin-hua; WANG Bao-xi; ZHANG Fu-ren; LI Chun-yang

    2012-01-01

    Background Tumor necrosis factor-α is a key mediator in the pathogenesis of psoriasis.Infliximab is a monoclonal antibody that specifically binds to tumor necrosis factor-a.The purpose of this study was to validate the efficacy and safety of 5 mg/kg infiiximab therapy in Chinese patients with moderate to severe plaque psoriasis.Methods In this multicenter,double-blind,placebo-controlled trial,129 patients with moderate-to-severe psoriasis were randomized to the induction therapy (weeks 0,2 and 6) with infliximab 5 mg/kg (n=84) or placebo (n=45),followed with infliximab 5 mg/kg scheduled at week 14 and week 22 in the infliximab group,and infliximab 5 mg/kg scheduled at weeks 10,12 and 16 in the placebo group,The primary end point was the proportion of patients who achieved at least 75%improvement in Psoriasis Area and Severity Index (PASI 75 response rate) from baseline at week 10.Results At week 10,B1.0% of patients treated with infliximab (5 mg/kg) achieved a 75% or greater improvement compared with 2.2% of patients treated with placebo (P <0.001).A significant improvement in PASI,Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI),was seen from week 6 through week 14 in the infliximab group compared with the placebo group.Through week 22,PASI,PGA,DLQI were well maintained.The incidence of adverse events for the infliximab treatment group was slightly higher in comparison to the placebo treatment group during the first 10 weeks without statistical significance.However,there were 3 cases of tuberculosis that developed during the 26 weeks treatment with infliximal.Conclusions Infliximab treatment was effective as induction and maintenance treatments for Chinese patients with moderate to severe plaque psoriasis.Most drug-induced adverse events were mild to moderate,and well tolerated.Screening for tuberculosis is essential and prophylactic treatment should be given if necessary.

  12. SMA CARNI-VAL trial part I: double-blind, randomized, placebo-controlled trial of L-carnitine and valproic acid in spinal muscular atrophy.

    Directory of Open Access Journals (Sweden)

    Kathryn J Swoboda

    Full Text Available BACKGROUND: Valproic acid (VPA has demonstrated potential as a therapeutic candidate for spinal muscular atrophy (SMA in vitro and in vivo. METHODS: Two cohorts of subjects were enrolled in the SMA CARNIVAL TRIAL, a non-ambulatory group of "sitters" (cohort 1 and an ambulatory group of "walkers" (cohort 2. Here, we present results for cohort 1: a multicenter phase II randomized double-blind intention-to-treat protocol in non-ambulatory SMA subjects 2-8 years of age. Sixty-one subjects were randomized 1:1 to placebo or treatment for the first six months; all received active treatment the subsequent six months. The primary outcome was change in the modified Hammersmith Functional Motor Scale (MHFMS score following six months of treatment. Secondary outcomes included safety and adverse event data, and change in MHFMS score for twelve versus six months of active treatment, body composition, quantitative SMN mRNA levels, maximum ulnar CMAP amplitudes, myometry and PFT measures. RESULTS: At 6 months, there was no difference in change from the baseline MHFMS score between treatment and placebo groups (difference = 0.643, 95% CI = -1.22-2.51. Adverse events occurred in >80% of subjects and were more common in the treatment group. Excessive weight gain was the most frequent drug-related adverse event, and increased fat mass was negatively related to change in MHFMS values (p = 0.0409. Post-hoc analysis found that children ages two to three years that received 12 months treatment, when adjusted for baseline weight, had significantly improved MHFMS scores (p = 0.03 compared to those who received placebo the first six months. A linear regression analysis limited to the influence of age demonstrates young age as a significant factor in improved MHFMS scores (p = 0.007. CONCLUSIONS: This study demonstrated no benefit from six months treatment with VPA and L-carnitine in a young non-ambulatory cohort of subjects with SMA. Weight gain, age and treatment

  13. REASSESSMENT OF DEFIBRASE IN TREATMENT OF ACUTE CEREBRAL INFARCTION: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED TRIAL

    Institute of Scientific and Technical Information of China (English)

    The Cooperative Group for Reassessment of Defibras

    2005-01-01

    Objective To evaluate the efficacy and safety of defibrase in patients with acute cerebral infarction by a large sample,multicenter, randomized, double-blind, placebo-controlled clinical trial.Methods Patients with acute cerebral infarction within 12 hours of stroke onset were randomly assigned to receive either an initial intravenous infusion of defibrase 15 U plus normal saline 250 Ml or 250 Ml of normal saline only.Subsequent infusions of defibrase 15 U or placebo (normal saline) were given on the 3rd, 5th, 7th, and 9th day, respectively.Both groups received standard care of acute cerebral infarction. The primary efficacy outcome was functional status(Barthel Index) at 3 months after treatment. Safety outcome were bleeding events and mortality rate. Secondary outcome included Chinese Stroke Scale (CSS) score at 14 days and recurrence rate of stroke at 1 year. Results A total of 1053 patients were enrolled at 46 centers from September 2001 to July 2003, and 527 patients were randomly assigned to receive defibrase and 526 to receive placebo. A similar proportion of patients in both groups completed a full course of treatment. There was a significantly greater proportion of favorable functional status (Barthel Index ≥95) in defibrase group than in placebo group at 3 months (52.2% vs. 42.8%, P < 0.01), and the proportion of dependent functional status (Barthel Index ≤60) was a little lower in defibrase group compared with placebo group(27.7%vs. 32.4%). These differences were more obvious among patients who were treated within 6 hours of stroke onset.Patients in defibrase group had better improvement with respect to CSS score than those in placebo group at 14 days (P <0.05). Recurrence rate of stroke at 1 year was lower in the defibrase group compared with placebo group (6.2% vs. 10.1%,P = 0.053). Patients in defibrase group had higher risk of extracranial bleeding events (4.7%vs. 1.5%, P< 0.01) and a tendency of higher risk of symptomatic intracranial hemorrhage

  14. Management of ocular trauma in emergency (MOTE trial: A pilot randomized double-blinded trial comparing topical amethocaine with saline in the outpatient management of corneal trauma

    Directory of Open Access Journals (Sweden)

    Ting Joseph

    2009-01-01

    Full Text Available Background: It is unclear whether local anesthetic eye drops can be safely used for the topical anesthesia of patients with minor corneal injury who are discharged from the emergency department (ED. Objectives: To assess whether topical 0.4% amethocaine self-administered to a maximum recommended frequency of once every hour for 36-48 h is safe in the management of uncomplicated corneal injury in patients discharged from the ED. Patients and Methods: A pilot randomized double-blinded trial comparing topical 0.4% amethocaine with topical normal saline. Results: Forty-seven subjects were recruited, with 22 randomized to receive amethocaine and 25 to receive placebo (normal saline . Baseline characteristics, including corneal injury type, were similar in both groups. There were no significant functional or clinical adverse sequelae in the majority of enrolled patients who could be contacted at 2 weeks (17/22 for amethocaine and 21/25 for placebo. Follow-up for the primary study outcome was suboptimal, with only 7/22 from the amethocaine group and 9/25 from the saline group presenting for 36-48 h review; there was a statistically nonsignificant trend for persistence of the corneal defect in the amethocaine group as compared with the saline group (2/7 and 1/9, respectively. Conclusion: Compared with saline drops, amethocaine eye drops are not definitely safe but they are effective for topical analgesia in minor corneal injury. Until further definitive studies, topical nonsteroidal agents or long-lasting artificial tears may be preferred for the topical analgesia of minor corneal injury. Return for corneal re-evaluation will necessarily remain suboptimal in an otherwise self-limiting condition, leading to a bias even if study recruitment is good.

  15. Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial

    DEFF Research Database (Denmark)

    Fätkenheuer, G; Duvivier, C; Rieger, A;

    2012-01-01

    Etravirine is approved for use in treatment-experienced patients at a dose of 200 mg twice daily. Efavirenz has been associated with greater increases in serum lipids compared with other non-nucleosides in randomized trials of first-line treatment....

  16. Effects of a Web-Based Decision Aid Regarding Diagnostic Self-Testing. A Single-Blind Randomized Controlled Trial

    Science.gov (United States)

    Ickenroth, Martine H. P.; Grispen, J. E. J.; de Vries, N. K.; Dinant, G. J.; Ronda, G.; van der Weijden, T.

    2016-01-01

    Currently, there are many diagnostic self-tests on body materials available to consumers. The aim of this study was to assess the effect of an online decision aid on diagnostic self-testing for cholesterol and diabetes on knowledge among consumers with an intention to take these tests. A randomized controlled trial was designed. A total of 1259…

  17. The Effect of Psychosocial Support Intervention on Depression in Patients with Dementia and Their Family Caregivers: An Assessor-Blinded Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Froydis Kristine Bruvik

    2013-10-01

    Full Text Available Background/Aim: A three-component tailored psychosocial 12-month assessor-blinded randomized controlled trial to reduce depression in people with dementia (PWD and carers was conducted. Methods: A total of 230 home-dwelling dyads of PWD and their carers were randomized to usual care or intervention consisting of three components over 12 months. Primary outcomes were the difference between the baseline and 12-month score on the Cornell Scale of Depression in Dementia (CSDD in the PWD and on the Geriatric Depression Scale (GDS in the carers. Results: The intent-to-treat difference between the baseline and 12- month change score was not significant between the intervention and control groups for the CSDD (p = 0.95 or GDS (p = 0.82. Conclusions: The trial did not show a significant difference between usual care and the intervention on depressive symptoms in PWD or their family caregivers.

  18. A randomized, double-blind, placebo-controlled multicenter trial evaluating topical zinc oxide for acute open wounds following pilonidal disease excision

    DEFF Research Database (Denmark)

    Agren, Magnus S; Ostenfeld, Ulla; Kallehave, Finn;

    2006-01-01

    The purpose of this randomized, double-blind, placebo-controlled multicenter trial was to compare topical zinc oxide with placebo mesh on secondary healing pilonidal wounds. Sixty-four (53 men) consecutive patients, aged 17-60 years, were centrally randomized to either treatment with 3% zinc oxide...... range 42-71 days) for the zinc and 62 days (55-82 days) for the placebo group (p = 0.32). Topical zinc oxide increased (p wound fluid zinc levels to 1,540 (1,035-2,265) microM and decreased (p wounds. Fewer zinc oxide (n = 3) than placebo...... abnormalities by histopathological examination of wound biopsies, or other harmful effects. Larger clinical trials will be required to show definitive effects of topical zinc oxide on wound healing and infection....

  19. Bioavailability is improved by enzymatic modification of the citrus flavonoid hesperidin in humans: A randomized, double-blind, crossover trial

    DEFF Research Database (Denmark)

    Nielsen, I.L.F.; Chee, W.S.S.; Bredsdorff, Lea

    2006-01-01

    Hesperidin is the predominant polyphenol consumed from citrus fruits and juices. However, hesperidin is proposed to have limited bioavailability due to the rutinoside moiety attached to the flavonoid. The aim of this study was to demonstrate in human subjects that the removal of the rhamnose group...... to yield the corresponding flavonoid glucoside (i.e., hesperetin-7-glucoside) will improve the bioavailability of the aglycone hesperetin. Healthy volunteers (n = 16) completed the double-blind, randomized, crossover study. Subjects randomly consumed hesperetin equivalents supplied as orange juice...... with natural hesperidin ("low dose"), orange juice treated with hesperidinase enzyme to yield hesperetin-7-glucoside, and orange juice fortified to obtain 3 times more hesperidin than naturally present ("high dose"). The area under the curve (AUC) for total plasma hesperetin of subjects consuming hesperetin-7...

  20. The Effect of the Educational Program on Iranian Premature Infants’ Parental Stress in a Neonatal Intensive Care Unit: A Double-Blind Randomized Controlled Trial

    OpenAIRE

    Beheshtipour, Noushin; Baharlu, Seyedeh Marzieh; Montaseri, Sedigheh; Razavinezhad Ardakani, Seyed Mostajab

    2014-01-01

    Background: Hospitalization in neonatal intensive care unit (NICU) leads to a lot of stress and shock to the parents. Nurses, as the primary sources of information, could play an important role in reducing their stress. The aim of this study was to determine the effect of educational program on the premature infants’ parental stress in NICU. Methods: This double-blind randomized controlled trial study with a pre-and post-test and follow up design was conducted from February 2013 to March 2014...

  1. Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety of Ginkgo biloba Extract EGb 761 and Betahistine

    OpenAIRE

    Larysa Sokolova; Robert Hoerr; Tamara Mishchenko

    2014-01-01

    A multicenter clinical trial was performed to compare the efficacy and safety of Ginkgo biloba extract EGb 761 and betahistine at recommended doses in patients with vertigo. One hundred and sixty patients (mean age 58 years) were randomly assigned to double-blind treatment with EGb 761 (240 mg per day) or betahistine (32 mg per day) for 12 weeks. An 11-point numeric analogue scale, the Vertigo Symptom Scale—short form, the Clinical Global Impression Scales and the Sheehan Disability Scale wer...

  2. Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: A pilot double-blind randomized trial [ISRCTN45683816

    Directory of Open Access Journals (Sweden)

    Jamshidi Amir-Hossein

    2004-09-01

    Full Text Available Abstract Background The morbidity and mortality associated with depression are considerable and continue to increase. Depression currently ranks fourth among the major causes of disability worldwide, after lower respiratory infections, prenatal conditions, and HIV/AIDS. Crocus sativus L. is used to treat depression. Many medicinal plants textbooks refer to this indication whereas there is no evidence-based document. Our objective was to compare the efficacy of stigmas of Crocus sativus (saffron with imipramine in the treatment of mild to moderate depression in a 6-week pilot double-blind randomized trial. Methods Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition for major depression based on the structured clinical interview for DSM IV participated in the trial. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18. In this double-blind, single-center trial, patients were randomly assigned to receive capsule of saffron 30 mg/day (TDS (Group 1 and capsule of imipramine 100 mg/day (TDS (Group 2 for a 6-week study. Results Saffron at this dose was found to be effective similar to imipramine in the treatment of mild to moderate depression (F = 2.91, d.f. = 1, P = 0.09. In the imipramine group anticholinergic effects such as dry mouth and also sedation were observed more often that was predictable. Conclusion The main overall finding from this study is that saffron may be of therapeutic benefit in the treatment of mild to moderate depression. To the best of our knowledge this is the first clinical trial that supports this indication for saffron. A large-scale trial with placebo control is warranted.

  3. Exploring the Effect of Lactium™ and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Andrew Scholey

    2017-02-01

    Full Text Available Acute, non-clinical insomnia is not uncommon. Sufferers commonly turn to short-term use of herbal supplements to alleviate the symptoms. This placebo-controlled, double-blind study investigated the efficacy of LZComplex3 (lactium™, Zizyphus, Humulus lupulus, magnesium and vitamin B6, in otherwise healthy adults with mild insomnia. After a 7-day single-blind placebo run-in, eligible volunteers (n = 171 were randomized (1:1 to receive daily treatment for 2 weeks with LZComplex3 or placebo. Results revealed that sleep quality measured by change in Pittsburgh Sleep Quality Index (PSQI score improved in both the LZComplex3 and placebo groups. There were no significant between group differences between baseline and endpoint on the primary outcome. The majority of secondary outcomes, which included daytime functioning and physical fatigue, mood and anxiety, cognitive performance, and stress reactivity, showed similar improvements in the LZComplex3 and placebo groups. A similar proportion of participants reported adverse events (AEs in both groups, with two of four treatment-related AEs in the LZComplex3 group resulting in permanent discontinuation. It currently cannot be concluded that administration of LZComplex3 for 2 weeks improves sleep quality, however, a marked placebo response (despite placebo run-in and/or short duration of treatment may have masked a potential beneficial effect on sleep quality.

  4. Exploring the Effect of Lactium™ and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial

    Science.gov (United States)

    Scholey, Andrew; Benson, Sarah; Gibbs, Amy; Perry, Naomi; Sarris, Jerome; Murray, Greg

    2017-01-01

    Acute, non-clinical insomnia is not uncommon. Sufferers commonly turn to short-term use of herbal supplements to alleviate the symptoms. This placebo-controlled, double-blind study investigated the efficacy of LZComplex3 (lactium™, Zizyphus, Humulus lupulus, magnesium and vitamin B6), in otherwise healthy adults with mild insomnia. After a 7-day single-blind placebo run-in, eligible volunteers (n = 171) were randomized (1:1) to receive daily treatment for 2 weeks with LZComplex3 or placebo. Results revealed that sleep quality measured by change in Pittsburgh Sleep Quality Index (PSQI) score improved in both the LZComplex3 and placebo groups. There were no significant between group differences between baseline and endpoint on the primary outcome. The majority of secondary outcomes, which included daytime functioning and physical fatigue, mood and anxiety, cognitive performance, and stress reactivity, showed similar improvements in the LZComplex3 and placebo groups. A similar proportion of participants reported adverse events (AEs) in both groups, with two of four treatment-related AEs in the LZComplex3 group resulting in permanent discontinuation. It currently cannot be concluded that administration of LZComplex3 for 2 weeks improves sleep quality, however, a marked placebo response (despite placebo run-in) and/or short duration of treatment may have masked a potential beneficial effect on sleep quality. PMID:28218661

  5. Efficacy of trans abdominis plane block for post cesarean delivery analgesia: A double-blind, randomized trial

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    Uma Srivastava

    2015-01-01

    Full Text Available Background: The transverse abdominis plane (TAP block, a regional block provides effective analgesia after lower abdominal surgeries if used as part of multimodal analgesia. In this prospective, randomized double-blind study, we determined the efficacy of TAP block in patients undergoing cesarean section. Materials and Methods: Totally, 62 parturients undergoing cesarean section were randomized in a double-blind manner to receive either bilateral TAP block at the end of surgery with 20 ml of 0.25% bupivacaine or no TAP block, in addition to standard analgesic comprising 75 mg diclofenac 8 hourly and intravenous patient-controlled analgesia (PCA tramadol. Each patient was assessed at 0, 4, 8, 12, 24, 36, and 48 h after surgery by an independent observer for pain at rest and on movement using numeric rating scale of 0-10, time of 1 st demand for tramadol, total consumption of PCA tramadol, satisfaction with pain management and side effects. Results: Use of tramadol was reduced in patients given TAP block by 50% compared to patients given no block during 48 h after surgery (P < 0.001. Pain scores were lower both on rest and activity at each time point for 24 h in study group (P < 0.001, time of first analgesia was significantly longer, satisfaction was higher, and side effects were less in study group compared to control group. Conclusion: Transverse abdominis plane block was effective in providing analgesia with a substantial reduction in tramadol use during 48 h after cesarean section when used as adjunctive to standard analgesia.

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

    Directory of Open Access Journals (Sweden)

    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.

  7. Effectiveness of intramuscular corticosteroid injection versus placebo injection in patients with hip osteoarthritis: design of a randomized double-blinded controlled trial

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    Dorleijn Desirée MJ

    2011-12-01

    Full Text Available Abstract Background Recent international guidelines recommend intra-articular corticosteroid injections for patients with hip osteoarthritis who have moderate to severe pain and do not respond satisfactorily to oral analgesic/anti-inflammatory agents. Of the five available randomized controlled trials, four showed positive effects with respect to pain reduction. However, intra-articular injection in the hip is complex because the joint is adjacent to important neurovascular structures and cannot be palpated. Therefore fluoroscopic or ultrasound guidance is needed. The systemic effect of corticosteroids has been studied in patients with impingement shoulder pain. Gluteal corticosteroid injection was almost as effective as ultrasound-guided subacromial corticosteroid injection. Such a clinically relevant effect of a systemic corticosteroid injection offers a less complex alternative for treatment of patients with hip osteoarthritis not responsive to oral pain medication. Methods/Design This is a double-blinded, randomized controlled trial. A total of 135 patients (aged > 40 years with hip osteoarthritis and persistent pain despite oral analgesics visiting a general practitioner or orthopaedic surgeon will be included. They will be randomized to a gluteal intramuscular corticosteroid injection or a gluteal intramuscular placebo (saline injection. The randomization will be stratified for setting (general practitioner and outpatient clinics of department of orthopaedics. Treatment effect will be evaluated by questionnaires at 2, 4, 6, and 12 weeks follow-up and a physical examination at 12 weeks. Primary outcome is severity of hip pain reported by the patients at 2-week follow-up. Statistical analyses will be based on the intention-to-treat principle. Discussion This study will evaluate the effectiveness of an intramuscular corticosteroid injection on pain in patients with hip osteoarthritis. Patient recruitment has started. Trial Registration This

  8. Duloxetine versus placebo for the treatment of women with stress predominant urinary incontinence in Taiwan: a double-blind, randomized, placebo-controlled trial

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    Beyrer Julie

    2008-01-01

    Full Text Available Abstract Background This manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with SUI. Methods Taiwanese women with SUI were were randomly assigned to placebo (n = 61 or duloxetine 80 mg/day (n = 60 in this double-blind, 8-week, placebo-controlled study. Outcome variables included: incontinence episode frequency (IEF, Incontinence Quality of Life questionnaire (I-QOL scores, and Patient Global Impression of Improvement rating (PGI-I. Results Decrease in IEF was significantly greater in duloxetine-treated than placebo-treated women (69.98% vs 42.56%, P Conclusion Data provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI. Trial Registration ClinicalTrials.gov Identifier: NCT00475358

  9. Stem cell mobilization induced by subcutaneous granulocyte-colony stimulating factor to improve cardiac regeneration after acute ST-elevation myocardial infarction: result of the double-blind, randomized, placebo-controlled stem cells in myocardial infarction (STEMMI) trial

    DEFF Research Database (Denmark)

    Ripa, Rasmus Sejersten; Jørgensen, Erik; Wang, Yongzhong;

    2006-01-01

    BACKGROUND: Phase 1 clinical trials of granulocyte-colony stimulating factor (G-CSF) treatment after myocardial infarction have indicated that G-CSF treatment is safe and may improve left ventricular function. This randomized, double-blind, placebo-controlled trial aimed to assess the efficacy...

  10. Lovastatin as an Adjuvant to Lithium for Treating Manic Phase of Bipolar Disorder: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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    Ahmad Ghanizadeh

    2014-01-01

    Full Text Available Objectives. Many patients with bipolar disorder suffer from metabolic disorder. Lovastatin is effective for treating major depression. This double-blind randomized placebo controlled clinical trial investigates whether lovastatin is a useful adjuvant to lithium for treating mania. Methods. Fifty-four patients with bipolar disorder-manic phase were randomly allocated into lovastatin or placebo group. The clinical symptoms were assessed at baseline, week 2, and week 4 using Young Mania Rating Scale. Adverse effects were checked. Results. Forty-six out of 54 patients completed this trial. The mania score in the lovastatin group decreased from 40.6 (11.1 at baseline to 12.9 (8.7 and 4.1 (5.4 at weeks 2 and 4, respectively. The score in the placebo group decreased from 41.0 (11.2 at baseline to 12.8 (8.07 and 5.8 (4.6 at weeks 2 and 4, respectively. However, there was no significant difference between groups at week 2 and week 4. The adverse effects rates were comparable between the two groups. No serious adverse effect was found. Tremor and nausea were the most common adverse effects. Conclusions. Lovastatin neither exacerbated nor decreased the symptoms of mania in patients with bipolar disorder. Current results support that the combination of lovastatin with lithium is tolerated well in bipolar disorder. The trial was registered with the Iranian Clinical Trials Registry (IRCT201302203930N18.

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

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    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.

  12. The efficacy of treatment of different intervention programs for patellofemoral pain syndrome--a single blinded randomized clinical trial. Pilot study.

    Science.gov (United States)

    Avraham, Feazadeh; Aviv, Saposhnik; Ya'akobi, Pnina; Faran, Hava; Fisher, Zilla; Goldman, Yael; Neeman, Guy; Carmeli, Eli

    2007-08-24

    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.

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

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    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.

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

    Science.gov (United States)

    Zeng, Weiwei; Tomlinson, Brian

    2014-01-01

    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. PMID:24834096

  15. Galantamine efficacy and tolerability as an augmentative therapy in autistic children: A randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Ghaleiha, Ali; Ghyasvand, Mohammad; Mohammadi, Mohammad-Reza; Farokhnia, Mehdi; Yadegari, Noorollah; Tabrizi, Mina; Hajiaghaee, Reza; Yekehtaz, Habibeh; Akhondzadeh, Shahin

    2014-07-01

    The role of cholinergic abnormalities in autism was recently evidenced and there is a growing interest in cholinergic modulation, emerging for targeting autistic symptoms. Galantamine is an acetylcholinesterase inhibitor and an allosteric potentiator of nicotinic receptors. This study aimed to evaluate the possible effects of galantamine as an augmentative therapy to risperidone, in autistic children. In this randomized, double-blind, placebo-controlled, parallel-group study, 40 outpatients aged 4-12 years whom had a diagnosis of autism (DSM IV-TR) and a score of 12 or higher on the Aberrant Behavior Checklist-Community (ABC-C) Irritability subscale were equally randomized to receive either galantamine (up to 24 mg/day) or placebo, in addition to risperidone (up to 2 mg/day), for 10 weeks. We rated participants by ABC-C and a side effects checklist, at baseline and at weeks 5 and 10. By the study endpoint, the galantamine-treated patients showed significantly greater improvement in the Irritability (P = 0.017) and Lethargy/Social Withdrawal (P = 0.005) subscales than the placebo group. The difference between the two groups in the frequency of side effects was not significant. In conclusion, galantamine augmentation was shown to be a relatively effective and safe augmentative strategy for alleviating some of the autism-related symptoms.

  16. A randomized, double-blind, placebo-controlled trial of paracetamol and ketoprofren lysine salt for pain control in children with pharyngotonsillitis cared by family pediatricians

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    Della Casa Alberighi Ornella

    2011-09-01

    Full Text Available Abstract Background To evaluate the analgesic effect and tolerability of paracetamol syrup compared to placebo and ketoprofen lysine salt in children with pharyngotonsillitis cared by family pediatricians. Methods A double-blind, randomized, placebo-controlled trial of a 12 mg/kg single dose of paracetamol paralleled by open-label ketoprofren lysine salt sachet 40 mg. Six to 12 years old children with diagnosis of pharyngo-tonsillitis and a Children's Sore Throat Pain (CSTP Thermometer score > 120 mm were enrolled. Primary endpoint was the Sum of Pain Intensity Differences (SPID of the CSTP Intensity scale by the child. Results 97 children were equally randomized to paracetamol, placebo or ketoprofen. Paracetamol was significantly more effective than placebo in the SPID of children and parents (P Conclusions A single oral dose of paracetamol or ketoprofen lysine salt are safe and effective analgesic treatments for children with sore throat in daily pediatric ambulatory care.

  17. The Effect of Recorded Mum's Lullaby and Brahm’s Lullaby on Oxygen Saturation in Preterm Infants: a Randomized Double-Blind Clinical Trial

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    Mahnaz Jabraeili

    2016-03-01

    Full Text Available Introduction: Music stimulation has been shown to provide significant benefits to preterm infants. Thus the aim of this study was determine the effect of recorded mum's lullaby and Brahm’s lullaby on oxygen saturation in preterm infants. Methods: This double-blind randomized controlled trial was carried out on 66 premature newborns with the postnatal age of ≥3 days and weight ≤ 2800 grams at Taleghani Hospital. Infants were randomly divided into three groups: control, Brahm’s lullaby and Mum's lullaby groups. Infants were continuously monitored for primary outcome of percutaneous oxygen saturation, for three consecutive sessions. Results: There were significant difference in neonate oxygen saturation between the Brahm’s lullaby and Mum's lullaby as compared with control groups in the 15 minutes after intervention. Conclusion: This study showed beneficial effects of Brahm’s lullaby and Mum's lullaby sound. Therefore; it may be used for improving short term outcomes in premature infants.

  18. A randomized, double-blind, placebo-controlled multicenter trial evaluating topical zinc oxide for acute open wounds following pilonidal disease excision

    DEFF Research Database (Denmark)

    Friis-Møller, Alice; Agren, MS; Ostenfeld, U;

    2006-01-01

    The purpose of this randomized, double-blind, placebo-controlled multicenter trial was to compare topical zinc oxide with placebo mesh on secondary healing pilonidal wounds. Sixty-four (53 men) consecutive patients, aged 17-60 years, were centrally randomized to either treatment with 3% zinc oxide...... range 42-71 days) for the zinc and 62 days (55-82 days) for the placebo group (p = 0.32). Topical zinc oxide increased (p zinc levels to 1,540 (1,035-2,265) microM and decreased (p zinc oxide (n = 3) than placebo......-treated patients (n = 12) were prescribed postoperative antibiotics (p = 0.005). Serum-zinc levels increased (p Zinc oxide was not associated with increased pain by the visual analog scale, cellular...

  19. The Effect of Recorded Mum's Lullaby and Brahm’s Lullaby on Oxygen Saturation in Preterm Infants: a Randomized Double-Blind Clinical Trial

    Science.gov (United States)

    Jabraeili, Mahnaz; Sabet, Tahmineh; MustafaGharebaghi, Manijeh; Asghari Jafarabadi, Mohammad; Arshadi, Mohammad

    2016-01-01

    Introduction: Music stimulation has been shown to provide significant benefits to preterm infants. Thus the aim of this study was determine the effect of recorded mum's lullaby and Brahm’s lullaby on oxygen saturation in preterm infants. Methods: This double-blind randomized controlled trial was carried out on 66 premature newborns with the postnatal age of ≥3 days and weight ≤ 2800 grams at Taleghani Hospital. Infants were randomly divided into three groups: control, Brahm’s lullaby and Mum's lullaby groups. Infants were continuously monitored for primary outcome of percutaneous oxygen saturation, for three consecutive sessions. Results: There were significant difference in neonate oxygen saturation between the Brahm’s lullaby and Mum's lullaby as compared with control groups in the 15 minutes after intervention. Conclusion: This study showed beneficial effects of Brahm’s lullaby and Mum's lullaby sound. Therefore; it may be used for improving short term outcomes in premature infants. PMID:26989669

  20. Effects of a Topical Saffron (Crocus sativus L) Gel on Erectile Dysfunction in Diabetics: A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Mohammadzadeh-Moghadam, Hossein; Nazari, Seyed Mohammad; Shamsa, Ali; Kamalinejad, Mohammad; Esmaeeli, Habibollah; Asadpour, Amir Abbas; Khajavi, Abdoljavad

    2015-10-01

    Erectile dysfunction is a man's persistent or recurrent inability to achieve and maintain erection for a satisfactory sexual relationship. As diabetes is a major risk factor for erectile dysfunction, the prevalence of erectile dysfunction among diabetic men has been reported as 35% to 90%. This randomized, parallel-group, double-blind, placebo-controlled trial investigated the effects of a topical saffron (Crocus sativus L) gel on erectile dysfunction in diabetic men. Patients were randomly allocated to 2 equal groups (with 25 patients each). The intervention group was treated with topical saffron, and the control received a similar treatment with placebo. The 2 groups were assessed using the International Index of Erectile Function Questionnaire before the intervention and 1 month after the intervention. Compared to placebo, the prepared saffron gel could significantly improve erectile dysfunction in diabetic patients (P saffron can be considered as a treatment option for diabetic men with erectile dysfunction.

  1. The Treatment of Idiopathic Sudden Sensorineural Hearing Loss Using Phle-botomy: A Prospective, Randomized, Double-Blind Clinical Trial

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    Mohammad Taghi Goodarzi

    2009-12-01

    Full Text Available This randomized clinical trial aimed to assess the efficacy of phlebotomy on improvement of hearing loss. 71 patients with sudden sensorineural hearing loss were enrolled in this randomized clinical trial study. They were divided into two groups: group A received steroid and hydration therapy plus phlebotomy, while group B received the same regimen without phlebotomy. They were matched according to sex, age, Hb, and Htc. Pure tone audiometries were administered to examine the hearing levels before and after treatment. Statistical analysis showed higher improvement in 250-1000 Hz in patients whit phlebotomy (P<0.001. However, there was noticed no significant difference in hearing improvement in 2000-8000 Hz between two methods. The number (% of patients who had improvement was 29(85.3% in phlebotomy group and 21(56.8% in non-phlebotomy group. On the other hand, the number (% of patients who showed no improvement in A and B group was 5(14.7% and 16(43.2%, respectively (P=0.008. Using phlebotomy accompanied by steroid and hydration therapy leads to higher improvement in hearing loss especially in 250-1000 Hz. We think that this method has the ability to achieve better result in the management of patients with SSNHL.

  2. 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

  3. 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.

  4. Correction of vitamin D deficiency in critically ill patients - VITdAL@ICU study protocol of a double-blind, placebo-controlled randomized clinical trial

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    Amrein Karin

    2012-11-01

    Full Text Available Abstract Background Vitamin D deficiency is associated with multiple adverse health outcomes including increased morbidity and mortality in the general population and in critically ill patients. However, no randomized controlled trial has evaluated so far whether treatment with sufficiently large doses of vitamin D can improve clinical outcome of patients in an intensive care setting. Methods/design The VITdAL@ICU trial is an investigator-initiated, non-commercial, double-blind, placebo-controlled randomized clinical trial. This study compares high-dose oral cholecalciferol (vitamin D3 versus placebo treatment in a mixed population of 480 critically ill patients with low 25-hydroxyvitamin-D levels at study enrollment (≤ 20ng/ml. Following an initial loading dose of 540,000 IU of vitamin D3, patients receive 90,000 IU of vitamin D3 on a monthly basis for 5 months. The study is designed to compare clinical outcome in the two study arms with the primary endpoint being length of hospital stay. Secondary endpoints include among others length of ICU stay, the percentage of patients with 25(OHD levels > 30 ng/ml at day 7, ICU and hospital mortality and duration of mechanical ventilation. We describe here the VITdAL@ICU study protocol for the primary report. Discussion This trial is designed to evaluate whether high-dose vitamin D3 is able to improve morbidity and mortality in a mixed population of adult critically ill patients and correct vitamin D deficiency safely. Trial registration ClinicalTrials: NCT01130181

  5. Effectiveness of Moxibustion Treatment in Quality of Life in Patients with Knee Osteoarthritis: A Randomized, Double-Blinded, Placebo-Controlled Trial

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    Xiumei Ren

    2015-01-01

    Full Text Available Objective. To observe the effects of traditional Chinese moxibustion, compared with sham moxibustion, on the quality of life (QOL in patients with chronic knee osteoarthritis (KOA. Methods. This is a randomized double-blinded, placebo-controlled trial. 150 patients with KOA were randomly allocated to either a true moxibustion treatment (n = 77 or a sham moxibustion treatment (n = 73 three times a week for six weeks. The QOL of patients was evaluated with SF-36 at baseline and 3, 6, and 12 weeks after baseline. Results. 136 patients were available for analysis. Participants in the true moxibustion group experienced statistically significantly greater improvement in GH (general health scores than the sham group at week 6 (P = 0.015 and week 12 (P = 0.029. Participants in the true moxibustion group experienced statistically significantly greater improvement in VT (vitality scores than the sham group at week 12 (P = 0.042. No significant adverse effects were found during the trial. Conclusion. A 6-week moxibustion treatment seems to improve general health and vitality, which are associated with physical and mental quality of life, in patients with KOA up to 12 weeks, relative to credible sham moxibustion. This trial is registered with Clinicaltrials.gov ISRCTN68475405.

  6. A comparative randomized double-blind clinical trial of isoaminile citrate and chlophedianol hydrochloride as antitussive agents.

    Science.gov (United States)

    Diwan, J; Dhand, R; Jindal, S K; Malik, S K; Sharma, P L

    1982-08-01

    The efficacy and safety of a new centrally acting antitussive agent, isoaminile citrate, was compared with that of chlophedianol hydrochloride in a double-blind, randomized interpatient study. A total of 66 patients participated, two and four patients were lost to follow-up with isoaminile and chlophedianol, respectively. In the experimentally induced cough in 12 normal human subjects, isoaminile (40 mg) was as effective as chlophedianol (20 mg), but its duration of action was somewhat longer. One subject developed allergic skin rash with chlophedianol and was withdrawn from the study. In 60 patients with cough associated with chest diseases, isoaminile (40 mg, 3 x daily) was as effective as chlophedianol (20 mg, 3 x daily) in suppressing cough as judged from the 3-h and 24-h cough counts. The increase in PEFR at day 7 of treatment was somewhat more marked with chlophedianol as compared with isoaminile. None of the drugs interfered with the expectoration process. The side effects observed were few, mild in nature, and did not require a decrease in dose or withdrawal of treatment in any of the patients. Isoaminile citrate was concluded to be an effective and relatively safe antitussive agent. Isoaminile citrate, alpha(isopropyl)-alpha-(beta-dimethylaminoproyl) phenylacetonitrile citrate, is a centrally acting antitussive agent. In animal experiments this drug was as efficacious as codeine but was devoid of any respiratory depressant effect [Krause 1958, Kuroda et al. 1971]. This controlled double-randomized interpatient study was designed to test the comparative efficacy and safety of isoaminile and chlophedianol, another centrally acting antitussive, in humans.

  7. Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Tsuyoshi Miyaoka

    2015-01-01

    Full Text Available Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted. Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS. Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS and intention-to-treat (ITT. However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54: −0.23±0.08; placebo: −0.03±0.08, P<0.018, tension (TJ-54: −0.42±0.09; placebo: −0.18±0.09, P<0.045, and poor impulse control (TJ-54: −0.39±0.10; placebo: −0.07±0.10, P<0.037. Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

  8. Rapid and reliable smooth extubation – Comparison of fentanyl with dexmedetomidine: A randomized, double-blind clinical trial

    Science.gov (United States)

    Rani, P.; Hemanth Kumar, V. R.; Ravishankar, M.; Sivashanmugam, T.; Sripriya, R.; Trilogasundary, M.

    2016-01-01

    Background: Fentanyl and dexmedetomidine have been tried to attenuate airway and circulatory reflexes during emergence and extubation individually but have not been compared with respect to the level of sedation to evolve a reliable technique for rapid and smooth extubation. Aim: To compare the effects of fentanyl and dexmedetomidine in attenuating airway and circulatory reflexes during emergence and extubation of the endotracheal tube. Setting and Design: This double-blind, randomized, controlled study was done in patients undergoing surgery under general anesthesia belonging to the American Society of Anesthesiologists physical status 1 or 2. Methodology: All patients received a standardized anesthetic protocol. Patients were randomized to receive either fentanyl 1 μg/kg or dexmedetomidine 0.75 μg/kg. Fifteen minutes before expected last surgical suture, isoflurane was cutoff and equal amount of test solution was given when train-of-four ratio was 0.3. The degree of sedation, airway, and circulatory responses at the time of suction and extubation were analyzed. Statistical Analysis Used: Chi-square test for nonparametric data and t-test for parametric data. Results: Heart rate (HR) was comparable in both the groups until endotracheal extubation. Later, there was rise in HR in fentanyl group. There was stastisticaly significant drop in blood pressure at 5 min after test drug administration in both the groups. Airway response for suctioning and extubation was better in dexmedetomidine group and it was associated with better sedation score than fentanyl group. Conclusion: Single dose of 0.75 μg/kg dexmedetomidine given 15 min before extubation provides smooth extubation when compared to fentanyl. PMID:27746558

  9. Effect of a mangosteen dietary supplement on human immune function: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Tang, Yu-Ping; Li, Peng-Gao; Kondo, Miwako; Ji, Hong-Ping; Kou, Yan; Ou, Boxin

    2009-08-01

    The effect of a mangosteen product containing multivitamins and essential minerals was tested on immune function and well-being in healthy adults. A randomized, double blinded, placebo-controlled study was conducted in 59 healthy human subjects (40-60 years old). Changes from baseline immune function were measured after a 30-day consumption of the mangosteen product and the placebo. The subjects' self-appraisal of their health status was also surveyed. A xanthone-rich mangosteen product intake increased mean values for peripheral T-helper cell frequency (P = .020) and reduced the serum C-reactive protein concentration (P = .014). Increases in peripheral CD4/CD8 double-positive (DP) T-cell frequency and serum complement C3, C4, and interleukin (IL)-1alpha concentrations were significantly higher in the experimental group than in the placebo group (DP, P = .038; C3, P = .017; C4, P = .031; IL-1alpha, P = .006). At the end of study, serum IL-1alpha and IL-1beta concentrations in the study group were significantly higher than that in the placebo group (IL-1alpha, P = .033; IL-1beta, P = .04). Furthermore, more participants in the experimental group reported greatly improved overall health status compared with participants receiving placebo (P = .001). The results indicated that the intake of an antioxidant-rich product significantly enhanced immune responses and improved the subject's self-appraisal on his or her overall health status.

  10. 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...

  11. 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......: 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....... or psychiatrists and were eligible if they fulfilled the International Classification of Diseases, Tenth Revision, criteria for unipolar depression and were aged between 18 and 55 years. Patients (N = 165) were allocated to supervised strength, aerobic, or relaxation training during a 4-month period. The primary...

  12. Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial

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    Seo Byung-Kwan

    2013-01-01

    Full Text Available Abstract Background Chronic non-specific low back pain is the most common medical problem for which patients seek complementary and alternative medical treatment, including bee venom acupuncture. However, the effectiveness and safety of such treatments have not been fully established by randomized clinical trials. The aim of this study is to determine whether bee venom acupuncture is effective for improving pain intensity, functional status and quality of life of patients with chronic non-specific low back pain. Methods/design This study is a randomized, double-blinded, sham-controlled clinical trial with two parallel arms. Fifty-four patients between 18 and 65 years of age with non-radicular chronic low back pain experiencing low back pain lasting for at least the previous three months and ≥4 points on a 10-cm visual analog scale for bothersomeness at the time of screening will be included in the study. Participants will be randomly allocated into the real or sham bee venom acupuncture groups and treated by the same protocol to minimize non-specific and placebo effects. Patients, assessors, acupuncturists and researchers who prepare the real or sham bee venom acupuncture experiments will be blinded to group allocation. All procedures, including the bee venom acupuncture increment protocol administered into predefined acupoints, are designed by a process of consensus with experts and previous researchers according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Bothersomeness measured using a visual analogue scale will be the primary outcome. Back pain-related dysfunction, pain, quality of life, depressive symptoms and adverse experiences will be measured using the visual analogue scale for pain intensity, the Oswestry Disability Index, the EuroQol 5-Dimension, and the Beck’s Depression Inventory. These measures will be recorded at baseline and 1, 2, 3, 4, 8 and 12 weeks. Discussion The results from this study

  13. A phase IIa randomized, double-blind trial of erlotinib in inhibiting epidermal growth factor receptor signaling in aberrant crypt foci of the colorectum.

    Science.gov (United States)

    Gillen, Daniel L; Meyskens, Frank L; Morgan, Timothy R; Zell, Jason A; Carroll, Robert; Benya, Richard; Chen, Wen-Pin; Mo, Allen; Tucker, Chris; Bhattacharya, Asmita; Huang, Zhiliang; Arcilla, Myra; Wong, Vanessa; Chung, Jinah; Gonzalez, Rachel; Rodriguez, Luz Maria; Szabo, Eva; Rosenberg, Daniel W; Lipkin, Steven M

    2015-03-01

    Colorectal cancer progresses through multiple distinct stages that are potentially amenable to chemopreventative intervention. Epidermal growth factor receptor (EGFR) inhibitors are efficacious in advanced tumors including colorectal cancer. There is significant evidence that EGFR also plays important roles in colorectal cancer initiation, and that EGFR inhibitors block tumorigenesis. We performed a double-blind randomized clinical trial to test whether the EGFR inhibitor erlotinib given for up to 30 days had an acceptable safety and efficacy profile to reduce EGFR signaling biomarkers in colorectal aberrant crypt foci (ACF), a subset of which progress to colorectal cancer, and normal rectal tissue. A total of 45 patients were randomized to one of three erlotinib doses (25, 50, and 100 mg) with randomization stratified by nonsteroidal anti-inflammatory drug (NSAID) use. There were no unanticipated adverse events with erlotinib therapy. Erlotinib was detected in both normal rectal mucosa and ACFs. Colorectal ACF phosphorylated ERK (pERK), phosphorylated EGFR (pEGFR), and total EGFR signaling changes from baseline were modest and there was no dose response. Overall, this trial did not meet is primary efficacy endpoint. Colorectal EGFR signaling inhibition by erlotinib is therefore likely insufficient to merit further studies without additional prescreening stratification or potentially longer duration of use.

  14. Pain relief by applying transcutaneous electrical nerve stimulation (TENS) during unsedated colonoscopy: a randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Amer-Cuenca, J J; Goicoechea, C; Girona-López, A; Andreu-Plaza, J L; Palao-Román, R; Martínez-Santa, G; Lisón, J F

    2011-01-01

    Transcutaneous electrical nerve stimulation (TENS) is a noninvasive alternative to traditional pain treatments. TENS has been studied in the past as a pain reduction modality in colonoscopy with limited success. Reviews and meta-analysis have shown that the inconclusive results of TENS may be due to the lack of randomized controlled trials and the difficulty in defining precise output parameters. The objective of this double-blind randomized placebo-controlled trial was to investigate the pain-relieving effect of a new application of TENS in unsedated screening colonoscopy. Ninety patients undergoing unsedated screening colonoscopy were randomly allocated to one of three groups: a control group (n=30), a group to receive active TENS (n=30), or a group to receive placebo TENS (n=30). A visual analogue scale (VAS) and a five-point Likert scale were used to assess pain 5 min into the procedure and at the end of the procedure. The patient's bloating sensation during colonoscopy and the effect on the duration of the procedure were also evaluated. Throughout the procedure, the active TENS group experienced a VAS pain score reduction ≥50% compared to the placebo TENS group (PTENS group compared to the placebo TENS and control groups (P=0.009). No significant differences were found between the study groups as to the bloating sensation and the duration of the procedure. We conclude that TENS can be used as a pain relief therapy in unsedated screening colonoscopy.

  15. Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (StAR): A Single-Blind, Randomized Trial

    Science.gov (United States)

    Bobrow, Kirsten; Farmer, Andrew J; Springer, David; Shanyinde, Milensu; Yu, Ly-Mee; Brennan, Thomas; Rayner, Brian; Namane, Mosedi; Steyn, Krisela; Tarassenko, Lionel; Levitt, Naomi

    2016-01-01

    Background We assessed the effect of automated treatment adherence support delivered via mobile-phone short message system (SMS) text-messages on blood pressure. Methods and Results In this pragmatic single-blind, three-arm randomized trial (StAR), undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information-only or interactive SMS text-messaging, or usual care. The primary outcome was change in systolic blood pressure at 12-months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012 and November 23, 2012, 1372 participants were randomized to receive information-only SMS text-messages (n=457), interactive SMS text-messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 (92%) participants. At 12-months, the mean adjusted change (95% CI) in systolic blood pressure compared to usual care was −2.2 mm Hg (−4.4 to −0.04) with information-only SMS and −1.6 mm Hg (−3.7 to 0.6) with interactive SMS. Odds ratios (95% CI) for the proportion of participants with a blood pressure <140/90mm Hg were for information-only messaging 1.42 (1.03 to 1.95) and for interactive messaging 1.41 (1.02 to 1.95) compared to usual care. Conclusions In this randomized trial of an automated adherence support program delivered by SMS text-message in a general outpatient population of adults with high blood pressure, we found a small, reduction in systolic blood pressure control compared to usual care at 12-months. There was no evidence that an interactive intervention increased this effect. Clinical Trial Registration Information ClinicalTrials.gov. Identifier: South African National Clinical Trials Register number (SANCTR DOH-27-1212-386); Pan Africa Trial Register (PACTR201411000724141). PMID:26769742

  16. Botulinum toxin type A for cephalic cutaneous allodynia in chronic migraine: a randomized, double-blinded, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Luciano Hollanda

    2014-12-01

    Full Text Available Cephalic allodynia (CA can be observed in 50-70% of patients with chronic migraine (CM. The aim of this trial was to assess the efficacy of botulinum toxin type A (Botx-A in the treatment of CA associated with CM. In this placebo-controlled trial, patients were randomized either into Botx-A or 0.9% saline injections and efficacy measures were assessed every 4 weeks for 3 months. Efficacy endpoints were number of migraine episodes associated with CA, changes from baseline in visual analogical scale scores for pain (VAS and frequency of common analgesics use for migraine. A total of 38 subjects were randomized to saline (n=18 or Botx-A (n=20. There were no significant differences in baseline between active intervention or placebo groups regarding mean age, number of headache episodes [mean 12.1 (9.22 and 17.00 (9.69 respectively; P=0.12], pain severity as measured by the VAS or frequency of analgesic use for headache episodes. Efficacy analysis showed that Botx-A injections led to an important decrease from baseline in the mean migraine episodes associated with CA after 12 weeks (5.20 versus 11.17; P=0.01. Also, VAS scores and frequency of analgesics use for headache were significantly reduced in the Botx-A group. This study suggests that Botx-A injections are superior to saline in the treatment of CA associated with CM, with mild self limited side effects.

  17. Oxymatrine therapy for chronic hepatitis B: A randomized double-blind and placebo- controlled multi- center trial

    Institute of Scientific and Technical Information of China (English)

    Lun-Gen Lu; Wei-Min She; Xiong Cai; Jun Ye; Xia-Qiu Zhou; Hui Wang; Sham-Ming Wu; Mei-Fang Tang; Jin-Shui Zhu; Wei-Xiong Chen; Hui-Quan Zhang; Min-De Zeng; Yi-Min Mao; Ji-Qiang Li; Mo-Bin Wan; Cheng-Zhong Li; Cheng-Wei Chen; Qing-Chun Fu; Ji-Yao Wang

    2003-01-01

    AIM: To evaluate the efficacy and safety of capsule oxymatrine in the treatment of chronic hepatitis B.METHODS: A randomised double-blind and placebocontrolled multicenter trial was conducted. Injection of oxymatrine was used as positive-control drug. A total of 216 patients with chronic hepatitis B entered the study for 24 weeks, of them 108 received capsule oxymatrine, 36 received injection of oxymatrine, and 72 received placebo.After and before the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reaction were observed.RESULTS: Among the 216 patients, six were dropped off,and 11 inconsistent with the standard were excluded.Therefore, the efficacy and safety of oxymatrine in patients were analysed. In the capsule treated patients, 76.47 % became normal in ALT level, 38.61% and 31.91% became negative both in HBV DNA and in HBeAg. In the injection treated patients, 83.33 % became normal in ALT level,43.33 % and 39.29 % became negative both in HBV DNA and in HBeAg. In the placebo treated patients, 40.00 % became normal in ALT level, 7.46 % and 6.45 % became negative both in HBV DNA and in HBeAg. The rates of complete response and partial response were 24.51% and 57.84 % in the capsule treated patients, and 33.33 % and 50.00 % in the injection treated patients, and 2.99 % and 41.79 % in the placebo treated patients, respectively.There was no significance between the two groups of patients, but both were significantly higher than the placebo. The adverse drug reaction rates of the capsule,injection and placebo were 7.77 %, 6.67 % and 8.82 %,respectively. There was no statistically significant difference among them.CONCLUSION: Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.

  18. Does sensory relearning improve tactile function after carpal tunnel decompression? A pragmatic, assessor-blinded, randomized clinical trial

    Science.gov (United States)

    Jerosch-Herold, C.; Houghton, J.; Miller, L.; Shepstone, L.

    2016-01-01

    Despite surgery for carpal tunnel syndrome being effective in 80%–90% of cases, chronic numbness and hand disability can occur. The aim of this study was to investigate whether sensory relearning improves tactile discrimination and hand function after decompression. In a multi-centre, pragmatic, randomized, controlled trial, 104 patients were randomized to a sensory relearning (n = 52) or control (n = 52) group. A total of 93 patients completed a 12-week follow-up. Primary outcome was the shape-texture identification test at 6 weeks. Secondary outcomes were touch threshold, touch localization, dexterity and self-reported hand function. No significant group differences were seen for the primary outcome (Shape-Texture Identification) at 6 weeks or 12 weeks. Similarly, no significant group differences were observed on secondary outcomes, with the exception of self-reported hand function. A secondary complier-averaged-causal-effects analysis showed no statistically significant treatment effect on the primary outcome. Sensory relearning for tactile sensory and functional deficits after carpal tunnel decompression is not effective. Level of Evidence: II PMID:27402282

  19. Memantine versus Methylphenidate in Children and Adolescents with Attention Deficit Hyperactivity Disorder: A Double-Blind, Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    MohammadReza Mohammadi

    2015-10-01

    Full Text Available Objectives: The aim of this randomized clinical trial was to assess the efficacy of memantine versus methylphenidate in the treatment of children with attention deficit hyperactivity disorder.Method: Forty participants (34 boys and 6 girls aged 6-11 who were diagnosed with attention deficit hyperactivity disorder based on (DSM-IV-TR criteria were selected for this study. The participants were randomly assigned to two groups: group one (n = 22 received memantine and the other group (n = 18 received methylphenidate for six weeks. Treatment outcomes were assessed using the Attention Deficit Hyperactivity Rating Scale and Clinical Global Impression- Severity Scale administered at baseline and at weeks 3 and 6 following the treatment. Also, a two-way repeated measures analysis of variance (time- treatment interaction was used.Results: At 6 weeks, methylphenidate produced a significantly better outcome on the Parent Rating Scale scores and Clinical Global Impression- Severity than memantine. Side effects were observed more often in the memantine group. However, with respect to the frequency of side effects, the difference between the memantine and methylphenidate groups was not significant. The most common side effects associated with memantine are appetite suppression, headache, vomiting, nausea and fatigue.Conclusion: The results of this study revealed that although memantine was less effective than methylphenidate in the treatment of attention deficit hyperactivity disorder, it may be considered as an alternative treatment.

  20. Double-blinded, randomized controlled trial comparing real versus placebo acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy without sedation: a study protocol

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    Plaschke K

    2011-02-01

    Full Text Available Abstract Background Sedation prior to performance of diagnostic esophagogastroduodenoscopy (EGDE is widespread and increases patient comfort. But 98% of all serious adverse events during EGDEs are ascribed to sedation. The S3 guideline for sedation procedures in gastrointestinal endoscopy published in 2008 in Germany increases patient safety by standardization. These new regulations increase costs because of the need for more personnel and a prolonged discharge procedure after examinations with sedation. Many patients have difficulties to meet the discharge criteria regulated by the S3 guideline, e.g. the call for a second person to escort them home, to resign from driving and working for the rest of the day, resulting in a refusal of sedation. Therefore, we would like to examine if an acupuncture during elective, diagnostic EGDEs could increase the comfort of patients refusing systemic sedation. Methods/Design A single-center, double blinded, placebo controlled superiority trial to compare the success rates of elective, diagnostic EGDEs with real and placebo acupuncture. All patients aged 18 years or older scheduled for elective, diagnostic EGDE who refuse a systemic sedation are eligible. 354 patients will be randomized. The primary endpoint is the rate of successful EGDEs with the randomized technique. Intervention: Real or placebo acupuncture before and during EGDE. Duration of study: Approximately 24 months. Discussion Organisation/Responsibility The ACUPEND - Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989 and Good Clinical Practice (GCP. The Interdisciplinary Endoscopy Center (IEZ of the University Hospital Heidelberg is responsible for design and conduct of the trial, including randomization and documentation of patients' data. Data management and statistical analysis will be performed

  1. Effects of killing Helicobacter pylori quadruple therapy on peptic ulcer: A randomized double-blind clinical trial

    Institute of Scientific and Technical Information of China (English)

    Li-Ying Feng; Xi-Xian Yao; Shu-Lin Jiang

    2005-01-01

    AIM: To study the therapeutic efficacy of a Chinese and Western integrated regimen, killing Helicobacter pylori quadruple therapy on H pylori-associated peptic ulcers(PU).METHODS: With prospective and double-blind controlled method, seventy-five active PU patients with H pylori infection were randomized to receive one of the following three regimens: (1) new triple therapy (group A:lansoprazole 30 mg qd, plus clarithromycin 250 mg bid,plus amoxycillin 500 mg tid, each for 10 d); (2) killing Hp quadruple therapy(group B: the three above drugs plus killing H pylori capsule 6 capsules bid for 4 wk) and (3)placebo(group C: gastropine 3 tablets bid for 4 wk).H pylori eradication and ulcer healing quality were evaluated under an endoscope 4 wk after treatment. The patients were followed up for 5 years.RESULTS: Both the healing rate of PU and H pylori eradication rate in group B were significantly higher than those in group C (100% and 96.4% vs 20% and 0%,respectively, P<0.005), but there was no significant difference compared to those in group A (88% and92%, P>0.05). The healing quality of ulcer in group B was superior to that in groups C and A (P<0.05). The recurrence rate of PU in group B (4%) was lower than that in group A (10%) and group C (100%, P<0.01).CONCLUSION: Killing Helicobacter pylori quadruple therapy can not only promote the eradication of H pylori and healing quality of ulcer but also reduce recurrence rate of ulcer.

  2. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    Science.gov (United States)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-11-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls ( p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  3. Role of Synbiotics in the Treatment of Childhood Constipation: A Double-Blind Randomized Placebo Controlled Trial

    Directory of Open Access Journals (Sweden)

    Mozhgan Sabbaghian

    2010-12-01

    Full Text Available Objective:Constipation is a common problem in children. There is some clinical evidence for the role of probiotics and prebiotics in the treatment of constipated children. This is the first study on the therapeutic effect of synbiotics (combination of probiotics and prebiotic in treatment of childhood constipation. Methods:In a double-blind randomized placebo controlled study 102 children aged 4-12 years with functional constipation were assessed according to Rome III criteria for 4 weeks. They were divided into 3 groups: Group A, received 1.5 ml/kg/day oral liquid paraffin plus placebo, group B, 1 sachet synbiotic per day plus placebo and group C, 1.5 ml/kg/day oral liquid paraffin plus 1 sachet synbiotic per day. Frequency of bowel movements (BMs, stool consistency, number of fecal incontinence episodes, abdominal pain, painful defecation per week, success of treatment and side effects were determined in each group before and after treatment. Findings:The frequency of BMs per week increased in all groups (P<0.001, but it differed between groups and was higher in group C (P=0.03. Stool consistency increased and number of fecal incontinence episodes, abdominal pain and painful defecation per week decreased in all groups similarly and there was statistically no difference between them. No side effects were reported in group B; the main side effect in group A and C was seepage of oil (P<0.001. Treatment success was similar in all groups without any significant difference between them (P=0.6.   Conclusion:This study showed that synbiotics have positive effects on symptoms of childhood constipation without any side effects.

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

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    Roberio 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  6. Randomized, double-blind, placebo-controlled trial of spironolactone for hypokalemia in continuous ambulatory peritoneal dialysis patients.

    Science.gov (United States)

    Yongsiri, Somchai; Thammakumpee, Jiranuch; Prongnamchai, Suriya; Tengpraettanakorn, Pechngam; Chueansuwan, Rachaneeporn; Tangjaturonrasme, Siriporn; Dinchuthai, Pakaphan

    2015-02-01

    The incidence of hypokalemia in continuous ambulatory peritoneal dialysis (CAPD) patients is about 15-60%, leading to significant complications. There is no standard treatment other than potassium supplement in this setting. The aim of this study was to evaluate effect of spironolactone 25 mg/day in CAPD patients who have a history of hypokalemia. This is a randomized, double-blind, placebo-controlled, cross-over study in CAPD patients who had a history of hypokalemia. Study intervention is 4 weeks of oral spironolactone 25 mg/day or placebo, cross-over after a 2-week wash-out period. The primary outcome was the difference of serum potassium before and after 4 weeks of spironolactone treatment. Serum potassium was measured every 2 weeks, serum magnesium, urine and peritoneal fluid potassium measured before and after each treatment period. We enrolled 24 patients, and 20 completed the cross-over study. Ten patients were anuric. The total doses of potassium supplement were the same during the study period. Serum potassium levels before and after study intervention were not significantly different in both groups (4.23 ± 0.64 vs. 3.90 ± 0.59 mEq/L for spironolactone P = 0.077 and 3.84 ± 0.62 vs. 3.91 ± 0.52 for placebo P = 0.551). Total 24-h potassium, magnesium, sodium excretion, urine volume and ultrafiltration volume were not affected by spironolactone or placebo. There was one episode of hyperkalemia (5.6 mEq/L) during the spironolactone treatment period. Spironolactone 25 mg/day does not have a significant effect on serum potassium or urine and peritoneal excretion rate in CAPD patients who have a history of hypokalemia.

  7. RANDOMIZED DOUBLE BLIND CLINICAL TRIAL OF INTRAMUSCULAR DEXMEDETOMIDINE V/S MIDAZOLAM AS PREMEDICATION IN PAEDIATRIC SURGICAL PATIENTS

    Directory of Open Access Journals (Sweden)

    Anmol

    2016-05-01

    Full Text Available OBJECTIVE A genuine attempt was made to find ideal drug for premedication in paediatric surgical patients. Dexmedetomidine a newer, highly selective alpha-2 agonist was compared to midazolam via intramuscular route. Setting: Institute-Department of Anaesthesiology, Krishna Institute of Medical Sciences. METHODS Dexmedetomidine group (Group D with the conventional Midazolam group (Group M was compared for premedication in cases of paediatric surgical patients. A total of sixty patients, scheduled for elective surgery of duration 15 to 90 minutes, were enrolled and randomly assigned in a double blind manner to Group D and Group M. Intramuscular Dexmedetomidine (1.5 mcg/kg in Group D or midazolam (0.05 mg/kg in Group M, as a premedication in preoperative room was given and sedation score with Ramsay sedation scale and parent separation anxiety score were recorded. After 45 mins, patient was shifted in the operation room and a standard technique of anaesthesia was applied to all patients. Mask acceptance score, wake up score, demand of post-op analgesia, time for first analgesia requirement were recorded. RESULTS Our study comparing dexmedetomidine with midazolam premedication found a stable heart rate and blood pressure with comparable sedative effects, (90% vs 56%, P value 0.0074 concluded that dexmedetomidine group had better sedative effect. Parent separation anxiety score was better with dexmedetomidine group compared to midazolam group with p value 0.0419 (93% vs 70%. Mask acceptance was better with dexmedetomidine group compared to midazolam group with p value 0.0153 (90% vs 60%. Wake up score were compared and dexmedetomidine was better than midazolam with p value 0.0001 (93% vs 46%. CONCLUSION Premedication with low-dose intramuscular dexmedetomidine resulted in better sedation, lower anxiety levels during parent separation, better mask acceptance and wake up behaviour as compared with low-dose intramuscular midazolam.

  8. The effect of ranitidine on postoperative infectious complications following emergency colorectal surgery: a randomized, placebo-controlled, double-blind trial

    DEFF Research Database (Denmark)

    Moesgaard, F; Jensen, L S; Christiansen, P M

    1998-01-01

    OBJECTIVE AND DESIGN: To study the potential effect of ranitidine on postoperative infectious complications following emergency colorectal surgery. A randomized, placebo-controlled, double-blind trial was carried out in three university clinics and two county hospitals in Denmark. PATIENTS...... patients were withdrawn from the study (for reasons such as other diagnosis, refused to continue, medication not given as prescribed). MAIN OUTCOME MEASURES: Patients were observed for signs of infectious complications; such as wound infection, intra-abdominal abscess, septicemia, and pneumonia. RESULTS...... pneumonia were 12.9%, 5.2%, 3.8% and 14%, respectively in group I. In group II, the infectious complications were 16.1%, 6.8%, 6.9% and 22%, respectively. Twelve patients (13.8%) in the placebo group developed more than one complication...

  9. Milk-based cornstarch porridge fortified with iron is effective in reducing anemia: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Arcanjo, Francisco Plácido Nogueira; Arcanjo, Cecília Costa; Arcanjo, Francisco Carlos Nogueira; Campos, Lício de Albuquerque; Amancio, Olga Maria Silverio; Braga, Josefina Aparecida Pellegrini

    2012-10-01

    This study evaluates the impact of a milk-based cornstarch porridge fortified with iron, in 4-year olds, compared with control on hemoglobin levels and anemia prevalence. This trial was a cluster-randomized, double-blind one, and used milk-based cornstarch porridge fortified with 10 mg elemental iron (FeSO(4)), daily, during 14 weeks, compared with control. The study population comprised 4-year-old preschoolers (n = 131). Mean hemoglobin values at baseline were found to be 10.6 ± 0.61 g dl(-1) for intervention group, and after intervention 11.5 ± 0.80 g/dl, p porridge fortified with ferrous sulfate increased hemoglobin levels and reduced anemia prevalence in 4-year-old preschoolers.

  10. Pulsed dye laser vs. intense pulsed light for port-wine stains: a randomized side-by-side trial with blinded response evaluation

    DEFF Research Database (Denmark)

    Faurschou, A; Togsverd-Bo, K; Zachariae, C

    2009-01-01

    : To compare efficacy and adverse events of PDL and IPL in an intraindividual randomized clinical trial. METHODS: Twenty patients with PWS (face, trunk, extremities; pink, red and purple colours; skin types I-III) received one side-by-side treatment with PDL (V-beam Perfecta, 595 nm, 0.45-1.5 ms; Candela Laser...... Corporation, Wayland, MA, U.S.A.) and IPL (StarLux, Lux G prototype handpiece, 500-670 and 870-1400 nm, 5-10 ms; Palomar Medical Technologies, Burlington, MA, U.S.A.). Settings depended on the preoperative lesional colour. Treatment outcome was evaluated by blinded, clinical evaluations and by skin...... reflectance measurements. RESULTS: Both PDL and IPL lightened PWS. Median clinical improvements were significantly better for PDL (65%) than IPL (30%) (P = 0.0004). A higher proportion of patients obtained good or excellent clearance rates with the PDL (75%) compared with IPL (30%) (P = 0.0104). Skin...

  11. Randomized, Double-Blind, Crossover Trial of Amitriptyline for Analgesia in Painful HIV-Associated Sensory Neuropathy.

    Directory of Open Access Journals (Sweden)

    Natalya Dinat

    Full Text Available We conducted a randomized, double-blind, placebo-controlled, crossover study at a single center in South Africa, to ascertain whether amitriptyline is an effective analgesic for painful HIV-associated sensory neuropathy of moderate to severe intensity in: i antiretroviral drug naive individuals, and ii antiretroviral drug users. 124 HIV-infected participants (antiretroviral drug naive = 62, antiretroviral drug users = 62 who met the study criteria for painful HIV-associated sensory neuropathy were randomized to once-daily oral amitriptyline (titrated to a median: interquartile range of 50: 25-50 mg or placebo for six weeks, followed by a three-week washout period and subsequent treatment crossover. The primary outcome measure was change from baseline in worst pain intensity of the feet (measured by participant self-report using an 11-point numerical pain rating scale after six weeks of treatment. 122 of 124 participants completed all study visits and were included in the analysis of the primary outcome. In the antiretroviral drug-naive group (n = 61 there was no significant difference in the mean change in pain score from baseline after six weeks of treatment with placebo or amitriptyline [amitriptyline: 2.8 (SD 3.3 vs. placebo: 2.8 (3.4]. Similarly, there was no significant difference in the change in pain score after six weeks of treatment with placebo or amitriptyline in the antiretroviral drug-user group (n = 61 [amitriptyline: 2.7 (3.3 vs. placebo: 2.1 (2.8]. Controlling for period effects and treatment order effects did not alter the outcome of the analyses. Nor did analyzing the intention-to-treat cohort (missing data interpolated using baseline observation carried forward alter the outcome of the analyses. In summary, amitriptyline, at the doses used here, was no more effective than an inactive placebo at reducing pain intensity in individuals with painful HIV-associated sensory neuropathy of moderate to severe intensity, irrespective of

  12. Low-Dose Daily Intake of Vitamin K(2) (Menaquinone-7) Improves Osteocalcin γ-Carboxylation: A Double-Blind, Randomized Controlled Trials.

    Science.gov (United States)

    Inaba, Naoko; Sato, Toshiro; Yamashita, Takatoshi

    2015-01-01

    Vitamin K is essential for bone health, but the effects of low-dose vitamin K intake in Japanese subjects remain unclear. We investigated the effective minimum daily menaquinone-7 dose for improving osteocalcin γ-carboxylation. Study 1 was a double-blind, randomized controlled dose-finding trial; 60 postmenopausal women aged 50-69 y were allocated to one of four dosage group and consumed 0, 50, 100, or 200 μg menaquinone-7 daily for 4 wk, respectively, with a controlled diet in accordance with recommended daily intakes for 2010 in Japan. Study 2 was a double-blind, randomized placebo-controlled trial based on the results of Study 1; 120 subjects aged 20-69 y were allocated to the placebo or MK-7 group and consumed 0 or 100 μg menaquinone-7 daily for 12 wk, respectively. In both studies, circulating carboxylated osteocalcin and undercarboxylated osteocalcin were measured. The carboxylated osteocalcin/undercarboxylated osteocalcin ratio decreased significantly from baseline in the 0 μg menaquinone-7 group, in which subjects consumed the recommended daily intake of vitamin K with vitamin K1 and menaquinone-4 (Study 1). Menaquinone-7 increased the carboxylated osteocalcin/undercarboxylated osteocalcin ratio dose dependently, and significant effects were observed in both the 100 and 200 μg groups compared with the 0 μg group. Undercarboxylated osteocalcin concentrations decreased significantly, and the carboxylated osteocalcin/undercarboxylated osteocalcin ratio increased significantly in the 100 μg menaquinone-7 group compared with the placebo group (Study 2). Daily menaquinone-7 intake ≥100 μg was suggested to improve osteocalcin γ-carboxylation.

  13. Lithium trial in Alzheimer's disease: a randomized, single-blind, placebo-controlled, multicenter 10-week study.

    LENUS (Irish Health Repository)

    Hampel, Harald

    2012-02-01

    OBJECTIVE: Lithium, a first-line drug for the treatment of bipolar depression, has recently been shown to regulate glycogen synthase kinase-3 (GSK-3), a kinase that is involved in the phosphorylation of the tau protein. Since hyperphosphorylation of tau is a core pathological feature in Alzheimer\\'s disease, lithium-induced inhibition of GSK-3 activity may have therapeutic effects in Alzheimer\\'s disease. In the current study, we tested the effect of short-term lithium treatment in patients with Alzheimer\\'s disease. METHOD: A total of 71 patients with mild Alzheimer\\'s disease (Mini-Mental State Examination score > or = 21 and < or = 26) were successfully randomly assigned to placebo (N = 38) or lithium treatment (N = 33) at 6 academic expert memory clinics. The 10-week treatment included a 6-week titration phase to reach the target serum level of lithium (0.5-0.8 mmol\\/L). The primary outcome measures were cerebrospinal fluid (CSF) levels of phosphorylated tau (p-tau) and GSK-3 activity in lymphocytes. Secondary outcome measures were CSF concentration of total tau and beta-amyloid(1-42) (Abeta(1-42)), plasma levels of Abeta(1-42), Alzheimer\\'s Disease Assessment Scale (ADAS)-Cognitive summary scores, MMSE, and Neuropsychiatric Inventory (NPI). Patients were enrolled in the study from November 2004 to July 2005. RESULTS: No treatment effect on GSK-3 activity or CSF-based biomarker concentrations (P > .05) was observed. Lithium treatment did not lead to change in global cognitive performance as measured by the ADAS-Cog subscale (P = .11) or in depressive symptoms. CONCLUSIONS: The current results do not support the notion that lithium treatment may lead to reduced hyperphosphorylation of tau protein after a short 10-week treatment in the Alzheimer\\'s disease target population. TRIAL REGISTRATION: (Controlled-Trials.com) Identifier: ISRCTN72046462.

  14. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial

    Science.gov (United States)

    2013-01-01

    Background Lateral epicondylitis is the most frequent cause of pain around the elbow joint. It causes pain in the region of the elbow joint and results in dysfunction of the elbow and deterioration of the quality of life. The purpose of this study is to compare the effects of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis. Methods/design Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. The inclusion criteria will be as follows: (1) age between 19 and 65 years with pain due to one-sided lateral epicondylitis that persisted for at least four weeks, (2) with tenderness on pressure limited to regions around the elbow joint, (3) complaining of pain during resistive extension of the middle finger or the wrist, (4) with average pain of NRS 4 or higher during the last one week at a screening visit and (5) voluntarily agree to this study and sign a written consent. Acupuncture treatment will be given 10 times in total for 4 weeks to all groups. Follow up observations will be conducted after the completion of the treatment, 8 weeks and 12 weeks after the random assignment. Ipsilateral acupuncture group and contralateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points. The sham acupuncture group will receive treatment on acupuncture points not related to the lateral epicondylitis using a non-invasive method. The needles will be maintained for 20 minutes. The primary outcome will be differences in the visual analogue scale (VAS) for elbow pain between the groups. The secondary outcome will be differences in patient-rated tennis elbow evaluation (PRTEE), pain-free/maximum grip strength (Dynamometer), pressure pain threshold, clinically relevant improvement, patient global assessment, and the EQ-5D. The data will be analyzed with the paired t

  15. Long-pulsed dye laser versus intense pulsed light for photodamaged skin: A randomized split-face trial with blinded response evaluation

    DEFF Research Database (Denmark)

    Jorgensen, G.F.; Hedelund, L.; Haedersdal, M.

    2008-01-01

    Objective: In a randomized controlled split-face trial to evaluate efficacy and adverse effects from rejuvenation with long-pulsed dye laser (LPDL) versus intense pulsed light (IPL). Materials and Methods: Twenty female volunteers with Fitzpatrick skin types I-III, classes I-II rhytids, and symme......Objective: In a randomized controlled split-face trial to evaluate efficacy and adverse effects from rejuvenation with long-pulsed dye laser (LPDL) versus intense pulsed light (IPL). Materials and Methods: Twenty female volunteers with Fitzpatrick skin types I-III, classes I-II rhytids...... assigned to left and right sides. Primary end-points were telangiectasias, irregular pigmentation and preferred treatment. Secondary end-points were skin texture, rhytids, pain, and adverse effects. Efficacy was evaluated by patient self-assessments and by blinded clinical on-site and photographic.......031, 3, 6 months). Irregular pigmentation and skin texture improved from both treatments with no significant side-to-side differences. No reduction was seen of rhytides on LPDL- or IPL-treated sides. Treatment-related pain scores were significantly higher after IPL (medians 7-8) than LPDL (4...

  16. A 12-week double-blind randomized clinical trial of vitamin D3 supplementation on body fat mass in healthy overweight and obese women

    Directory of Open Access Journals (Sweden)

    Salehpour Amin

    2012-09-01

    Full Text Available Abstract Background 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. Methods 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. Results Serum 25(OHD 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; P Conclusion Among healthy overweight and obese women, increasing 25(OH D concentrations by vitamin D3 supplementation led to body fat mass reduction. This trial is registered at clinicaltrials.gov as NCT01344161.

  17. A double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of Cerebrolysin in patients with acute ischaemic stroke in Asia--CASTA.

    Science.gov (United States)

    Hong, Z; Moessler, H; Bornstein, N; Brainin, M; Heiss, W-D

    2009-10-01

    Cerebrolysin has exhibited neuroprotective as well as neurotrophic properties in various animal models of cerebral ischaemia and has shown clinical efficacy and good safety in several small controlled clinical studies in ischaemic stroke. Therefore, a large double-blind placebo-controlled randomized clinical trial was launched in Asia to prove the validity of this treatment strategy. In the more than 50 participating centres patients with acute ischemic hemispheric stroke are randomized within 12 hours of symptoms onset to treatment (30 ml Cerebrolysin diluted in physiologic saline) or placebo (saline) given as intravenous infusion once daily added to standard care for 10 days. The patients are followed with regular visits for 90 days. Efficacy is evaluated on day 90 by three outcome scales - modified Rankin Scale, Barthel Index and NIH Stroke Scale - combined to single global directional test. Additionally, adverse events are documented to prove safety. In this study a total of 1060 patients will be included and analysis of data will be completed in 2010. If positive, this trial will add an effective strategy to the treatment of acute ischaemic stroke.

  18. Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial.

    Science.gov (United States)

    Ala, Shahram; Saeedi, Majid; Janbabai, Ghasem; Ganji, Reza; Azhdari, Elham; Shiva, Afshin

    2016-01-01

    Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapy-induced stomatitis and mucositis in a number of studies, but the results are contradictory. To answer such discrepancies, the present study was designed to evaluate the efficacy of sucralfate mouthwash in prevention of 5-fluorouracil (5-FU)-induced oral mucositis in patients with gastrointestinal malignancies. Patients with gastrointestinal cancers receiving 5-FU-based chemotherapy regimens were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate mouthwash (every 6 h) or placebo. The patients were visited at fifth and tenth day of trial; the presence and severity of oral mucositis and the intensity of pain were assessed. The patients receiving sucralfate experienced lower frequency and severity of mucositis (76% vs. 38.5%, P = 0.005 and 84 vs. 38.5%, P oral mucositis in patients with gastrointestinal malignancies compared with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis.

  19. Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial

    Directory of Open Access Journals (Sweden)

    Guwatudde David

    2012-11-01

    Full Text Available Abstract Background Use of multivitamin supplements during the pre-HAART era has been found to reduce viral load, enhance immune response, and generally improve clinical outcomes among HIV-infected adults. However, immune reconstitution is incomplete and significant mortality and opportunistic infections occur in spite of HAART. There is insufficient research information on whether multivitamin supplementation may be beneficial as adjunct therapy for HIV-infected individuals taking HAART. We propose to evaluate the efficacy of a single recommended daily allowance (RDA of micronutrients (including vitamins B-complex, C, and E in slowing disease progression among HIV-infected adults receiving HAART in Uganda. Methods/Design We are using a randomized, double-blind, placebo-controlled trial study design. Eligible patients are HIV-positive adults aged at least 18 years, and are randomized to receive either a placebo; or multivitamins that include a single RDA of the following vitamins: 1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 2.6 mcg B12, 18 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid. Participants are followed for up to 18 months with evaluations at baseline, 6, 12 and 18 months. The study is primarily powered to examine the effects on immune reconstitution, weight gain, and quality of life. In addition, we will examine the effects on other secondary outcomes including the risks of development of new or recurrent disease progression event, including all-cause mortality; ARV regimen change from first- to second-line therapy; and other adverse events as indicated by incident peripheral neuropathy, severe anemia, or diarrhea. Discussions The conduct of this trial provides an opportunity to evaluate the potential benefits of this affordable adjunct therapy (multivitamin supplementation among HIV-infected adults receiving HAART in a developing country setting. Trial registration Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique

  20. Randomized, double-blind, placebo-controlled superiority trial of the Yiqigubiao pill for the treatment of patients with chronic obstructive pulmonary disease at a stable stage

    Science.gov (United States)

    Li, Feng-Sen; Zhang, Yan-Li; Li, Zheng; Xu, Dan; Liao, Chun-Yan; Ma, Huan; Gong, Li; Su, Jun; Sun, Qi; Xu, Qian; Gao, Zhen; Wang, Ling; Jing, Jing; Wang, Jing; Jiang, Min; Tian, Ge; Hasan, Bilal

    2016-01-01

    In traditional Chinese medicine (TCM), the Yiqigubiao pill is commonly used to enhance physical fitness. The current clinical trial was designed to evaluate the efficacy and safety of the Yiqigubiao pill as an adjuvant therapy for patients with stable chronic obstructive pulmonary disease (COPD). The current trial was a randomized, double-blind, placebo-controlled superiority trial. The participants were recruited from outpatients at the Traditional Chinese Medicine Hospital affiliated with Xinjiang Medical University (Ürümqi, China) between February and September 2012. All participants were patients with stable COPD that were randomized to the Yiqigubiao pill (YQGB; n=84) or placebo (Pb; n=87) groups. The occurrences of acute exacerbation (AE) of COPD during the trial were recorded. Lung function value assessments, scoring of life quality and exercise endurance, arterial blood gas analysis and serum inflammatory cytokines level determination were performed prior to and throughout the study. A total of 139 participants completed the intervention and 132 participants completed the study. The interval between the initial intervention and the first AECOPD was greater in the YQGB group compared with the Pb group (P<0.01). The incidence rate of AECOPD was lower in the YQGB group than in the Pb group (P<0.01). Subsequent to the intervention or at the end of the study, the 6-min walking distance difference was longer in the YQGB group compared with the Pb group (P<0.01). The scores reflecting life quality decline became lower in the YQGB group (P<0.01). The serum levels of proinflammatory factors were downregulated to a greater extent in the YQGB group compared with the Pb group. Thus, the Yiqigubiao pill is an efficient and safe adjuvant therapy for the treatment of stable patients with COPD. PMID:27698749

  1. Effectiveness of low-level laser therapy for patients with carpal tunnel syndrome: design of a randomized single-blinded controlled trial

    Directory of Open Access Journals (Sweden)

    Barbosa Rafael Inácio

    2012-12-01

    Full Text Available Abstract Background Carpal tunnel syndrome is the most common neuropathy in the upper extremity, resulting from the compression of the median nerve at wrist level. Clinical studies are essentials to present evidence on therapeutic resources use at early restoration on peripheral nerve functionality. Low-level laser therapy has been widely investigated in researches related to nerve regeneration. Therefore, it is suggested that the effect of low-level laser therapy associated with other conservative rehabilitation techniques may positively affect symptoms and overall hand function in compressive neuropathies such as carpal tunnel syndrome. The aim of this study is to evaluate the effectiveness of low-level laser therapy in addition to orthoses therapy and home orientations in patients with carpal tunnel syndrome. Methods/Design Patients older than 18 years old will be included, with clinical diagnosis of carpal tunnel syndrome, excluding comorbidies. A physiotherapist will conduct intervention, with a blinding evaluator. Randomization will be applied to allocate the patients in each group: with association or not to low-level laser therapy. All of them will be submitted to orthoses therapy and home orientations. Outcome will be assessed through: pain visual analogic scale, Semmes Weinstein monofilaments™ threshold sensibility test, Pinch Gauge™, Boston Carpal Tunnel Questionnaire and two point discrimination test. Discussion This paper describes the design of a randomized controlled trial, which aim to assess the effectiveness of conservative treatment added to low-level laser therapy for patients with carpal tunnel syndrome. Trial registration Brazilian Clinical Trials Registry (ReBec - 75ddtf / Universal Trial Number: U1111-1121-5184

  2. Efficacy of praziquantel against Schistosoma mekongi and Opisthorchis viverrini: a randomized, single-blinded dose-comparison trial.

    Directory of Open Access Journals (Sweden)

    Leonore Lovis

    Full Text Available BACKGROUND: Schistosomiasis and opisthorchiasis are of public health importance in Southeast Asia. Praziquantel (PZQ is the drug of choice for morbidity control but few dose comparisons have been made. METHODOLOGY: Ninety-three schoolchildren were enrolled in an area of Lao PDR where Schistosoma mekongi and Opisthorchis viverrini coexist for a PZQ dose-comparison trial. Prevalence and intensity of infections were determined by a rigorous diagnostic effort (3 stool specimens, each examined with triplicate Kato-Katz before and 28-30 days after treatment. Ninety children with full baseline data were randomized to receive PZQ: the 40 mg/kg standard single dose (n = 45 or a 75 mg/kg total dose (50 mg/kg+25 mg/kg, 4 hours apart; n = 45. Adverse events were assessed at 3 and 24 hours posttreatment. PRINCIPAL FINDINGS: Baseline infection prevalence of S. mekongi and O. viverrini were 87.8% and 98.9%, respectively. S. mekongi cure rates were 75.0% (95% confidence interval (CI: 56.6-88.5% and 80.8% (95% CI: 60.6-93.4% for 40 mg/kg and 75 mg/kg PZQ, respectively (P = 0.60. O. viverrini cure rates were significantly different at 71.4% (95% CI: 53.4-84.4% and 96.6% (95% CI: not defined, respectively (P = 0.009. Egg reduction rates (ERRs against O. viverrini were very high for both doses (>99%, but slightly lower for S. mekongi at 40 mg/kg (96.4% vs. 98.1% and not influenced by increasing diagnostic effort. O. viverrini cure rates would have been overestimated and no statistical difference between doses found if efficacy was based on a minimum sampling effort (single Kato-Katz before and after treatment. Adverse events were common (96%, mainly mild with no significant differences between the two treatment groups. CONCLUSIONS/SIGNIFICANCE: Cure rate from the 75 mg/kg PZQ dose was more efficacious than 40 mg/kg against O. viverrini but not against S. mekongi infections, while ERRs were similar for both doses. TRIAL REGISTRATION: Controlled-Trials

  3. A Double-Blind Randomized Controlled Trial of Maternal Postpartum Deworming to Improve Infant Weight Gain in the Peruvian Amazon

    Science.gov (United States)

    Casapía, Martín; Aguilar, Eder; Silva, Hermánn; Montresor, Antonio; Rahme, Elham; Fraser, William D.; Marquis, Grace S.; Vercruysse, Jozef; Allen, Lindsay H.; Blouin, Brittany; Razuri, Hugo; Pezo, Lidsky

    2017-01-01

    Background Nutritional interventions targeting the critical growth and development period before two years of age can have the greatest impact on health trajectories over the life course. Compelling evidence has demonstrated that interventions investing in maternal health in the first 1000 days of life are beneficial for both mothers and their children. One such potential intervention is deworming integrated into maternal postpartum care in areas where soil-transmitted helminth (STH) infections are endemic. Methodology/Principal Findings From February to August 2014, 1010 mother-infant pairs were recruited into a trial aimed at assessing the effectiveness of maternal postpartum deworming on infant and maternal health outcomes. Following delivery, mothers were randomly assigned to receive either single-dose 400 mg albendazole or placebo. Participants were followed-up at 1 and 6 months postpartum. There was no statistically significant difference in mean weight gain between infants in the experimental and control groups (mean difference: -0.02; 95% CI: -0.1, 0.08) at 6 months of age. Further, deworming had no effect on measured infant morbidity indicators. However, ad hoc analyses restricted to mothers who tested positive for STHs at baseline suggest that infants of mothers in the experimental group had greater mean length gain in cm (mean difference: 0.8; 95% CI: 0.1, 1.4) and length-for-age z-score (mean difference: 0.5; 95% CI: 0.2, 0.8) at 6 months of age. Conclusions/Significance In a study population composed of both STH-infected and uninfected mothers, maternal postpartum deworming was insufficient to impact infant growth and morbidity indicators up to 6 months postpartum. Among STH-infected mothers, however, important improvements in infant length gain and length-for-age were observed. The benefits of maternal postpartum deworming should be further investigated in study populations having higher overall prevalences and intensities of STH infections and, in

  4. 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.

  5. Bronchodilatory effect of inhaled budesonide/formoterol and budesonide/salbutamol in acute asthma: a double-blind, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Arun Jenish J

    2012-03-01

    Full Text Available Abstract Background There are no published studies that have compared bronchodilatory effect of inhaled budesonide/formoterol combination with budesonide/salbutamol delivered by metered dose inhaler with a spacer in acute exacerbation of asthma in children. We, therefore, compared the bronchodilatory effects of inhaled budesonide/formoterol (dose: 200 μg and 12 μg respectively combination with budesonide (200 μg/salbutamol (200 μg administered by metered dose inhaler and spacer in children of 5-15 years with mild acute exacerbation of asthma [Modified Pulmonary Index Score (MPIS between 6-8] in this double-blind, randomized controlled trial. The primary outcome was FEV1 (% predicted in the two groups at 1, 5, 15, 30, 60 min after administration of the study drug. Results We did not observe any significant differences in the % predicted FEV1 and MPIS between formoterol and salbutamol at various time points from 1 min to 60 min post drug administration. There was significant improvement in FEV1 (% predicted from baseline in both the groups as early as 1 min after drug administration. Conclusions Salbutamol or formoterol delivered along with inhaled corticosteroid by metered dose inhaler with spacer in children between 5-15 years of age with mild acute exacerbation of asthma had similar bronchodilatory effects. Trial Registration ClinicalTrials.gov: NCT00900874

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

    Directory of Open Access Journals (Sweden)

    Else M Bijker

    Full Text Available 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.

  7. Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety of Ginkgo biloba Extract EGb 761 and Betahistine

    Directory of Open Access Journals (Sweden)

    Larysa Sokolova

    2014-01-01

    Full Text Available A multicenter clinical trial was performed to compare the efficacy and safety of Ginkgo biloba extract EGb 761 and betahistine at recommended doses in patients with vertigo. One hundred and sixty patients (mean age 58 years were randomly assigned to double-blind treatment with EGb 761 (240 mg per day or betahistine (32 mg per day for 12 weeks. An 11-point numeric analogue scale, the Vertigo Symptom Scale—short form, the Clinical Global Impression Scales and the Sheehan Disability Scale were used as outcome measures. Both treatment groups were comparable at baseline and improved in all outcome measures during the course of treatment. There was no significant intergroup difference with regard to changes in any outcome measure. Numerically, improvements of patients receiving EGb 761 were slightly more pronounced on all scales. Clinical global impression was rated “very much improved” or “much improved” in 79% of patients treated with EGb 761 and in 70% receiving betahistine. With 27 adverse events in 19 patients, EGb 761 showed better tolerability than betahistine with 39 adverse events in 31 patients. In conclusion, the two drugs were similarly effective in the treatment of vertigo, but EGb 761 was better tolerated. This trial is registered with controlled-trials.com ISRCTN02262139.

  8. Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety of Ginkgo biloba Extract EGb 761 and Betahistine.

    Science.gov (United States)

    Sokolova, Larysa; Hoerr, Robert; Mishchenko, Tamara

    2014-01-01

    A multicenter clinical trial was performed to compare the efficacy and safety of Ginkgo biloba extract EGb 761 and betahistine at recommended doses in patients with vertigo. One hundred and sixty patients (mean age 58 years) were randomly assigned to double-blind treatment with EGb 761 (240 mg per day) or betahistine (32 mg per day) for 12 weeks. An 11-point numeric analogue scale, the Vertigo Symptom Scale-short form, the Clinical Global Impression Scales and the Sheehan Disability Scale were used as outcome measures. Both treatment groups were comparable at baseline and improved in all outcome measures during the course of treatment. There was no significant intergroup difference with regard to changes in any outcome measure. Numerically, improvements of patients receiving EGb 761 were slightly more pronounced on all scales. Clinical global impression was rated "very much improved" or "much improved" in 79% of patients treated with EGb 761 and in 70% receiving betahistine. With 27 adverse events in 19 patients, EGb 761 showed better tolerability than betahistine with 39 adverse events in 31 patients. In conclusion, the two drugs were similarly effective in the treatment of vertigo, but EGb 761 was better tolerated. This trial is registered with controlled-trials.com ISRCTN02262139.

  9. Platelet-Rich Plasma Injections for Advanced Knee Osteoarthritis: A Prospective, Randomized, Double-Blinded Clinical Trial

    Science.gov (United States)

    Joshi Jubert, Nayana; Rodríguez, Luciano; Reverté-Vinaixa, Maria Mercedes; Navarro, Aurora

    2017-01-01

    Background: Intra-articular injections of platelet-rich plasma (PRP) to treat symptoms of knee osteoarthritis (OA) have been successfully used in young patients and in the early stages of disease. No previous studies have analyzed outcomes of PRP injections during the late stages. Hypothesis: PRP reduces pain and leads to a more effective and lasting functional recovery than corticosteroid with local anesthetic. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A total of 75 patients with symptomatic knee OA (Kellgren-Lawrence grade 3 to 4) were enrolled in this study between August 2013 and July 2014. Patients were randomized to treatment either with a single leukocyte-reduced PRP or corticosteroid intra-articular injection. The primary variable was visual analog scale assessment at 1 month. Secondary outcomes were the Knee injury and Osteoarthritis Outcome Score (KOOS) and Short Form–36 (SF-36) at 1, 3, and 6 months after treatment. Patient satisfaction at final follow-up was assessed. Both groups were homogeneous and comparable in baseline characteristics. Results: All variables improved in both groups. Statistical differences between groups were not found for the majority of the outcome variables, although the magnitude of improvements tended to be greater in the PRP group. Quality-of-life differences between values at 3 and 6 months versus baseline increased significantly more in the study group (P = .05 and .03, respectively), and so did general health perception differences at 6 months (P = .018). Conclusion: A single PRP intra-articular injection is effective for relieving pain and improving activities of daily living and quality of life in late-stage knee OA. For patients with late-stage knee OA who are 67 years or older, 1 intra-articular injection of PRP has similar results to 1 shot of corticosteroid. PMID:28255569

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

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    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.

  11. Open and Closed Endotracheal Suctioning and Arterial Blood Gas Values: A Single-Blind Crossover Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Azam Faraji

    2015-01-01

    Full Text Available Aim. This study was aimed at comparing the effects of the open and closed suctioning techniques on the arterial blood gas values in patients undergoing open-heart surgery. Methods. In a clinical trial, we recruited 42 patients after open-heart surgery in an educational hospital. Each patient randomly underwent both open and closed suctioning. ABGs, PaO2, SaO2, PaCO2, were analyzed before and one, five, and fifteen minutes after each suctioning episode. Results. At first the pressure of oxygen in arterial blood increased; however, this increase in the open technique was greater than that of the closed system (P<0.001. The pressure of oxygen decreased five and fifteen minutes after both suctioning techniques (P<0.05. The trends of carbon dioxide variations after the open and closed techniques were upward and downward, respectively. Moreover, the decrease in the level of oxygen saturation five and fifteen minutes after the open suctioning was greater than that of the closed suctioning technique (P<0.05.  Conclusion. Arterial blood gas disturbances in the closed suctioning technique were less than those of the open technique. Therefore, to eliminate the unwanted effects of endotracheal suctioning on the arterial blood gases, the closed suctioning technique is recommended.

  12. Boosting of HIV envelope CD4 binding site antibodies with long variable heavy third complementarity determining region in the randomized double blind RV305 HIV-1 vaccine trial

    Science.gov (United States)

    Ackerman, Margaret; Saunders, Kevin O.; Pollara, Justin; Vandergrift, Nathan; Parks, Rob; Michael, Nelson L.; O’Connell, Robert J.; Vasan, Sandhya; Rerks-Ngarm, Supachai; Kaewkungwal, Jaranit; Pitisuttithum, Punnee; Nitayaphan, Sorachai; Sinangil, Faruk; Phogat, Sanjay; Alam, S. Munir; Liao, Hua-Xin; Ferrari, Guido; Seaman, Michael S.; Montefiori, David C.; Harrison, Stephen C.; Haynes, Barton F.

    2017-01-01

    The canary pox vector and gp120 vaccine (ALVAC-HIV and AIDSVAX B/E gp120) in the RV144 HIV-1 vaccine trial conferred an estimated 31% vaccine efficacy. Although the vaccine Env AE.A244 gp120 is antigenic for the unmutated common ancestor of V1V2 broadly neutralizing antibody (bnAbs), no plasma bnAb activity was induced. The RV305 (NCT01435135) HIV-1 clinical trial was a placebo-controlled randomized double-blinded study that assessed the safety and efficacy of vaccine boosting on B cell repertoires. HIV-1-uninfected RV144 vaccine recipients were reimmunized 6–8 years later with AIDSVAX B/E gp120 alone, ALVAC-HIV alone, or a combination of ALVAC-HIV and AIDSVAX B/E gp120 in the RV305 trial. Env-specific post-RV144 and RV305 boost memory B cell VH mutation frequencies increased from 2.9% post-RV144 to 6.7% post-RV305. The vaccine was well tolerated with no adverse events reports. While post-boost plasma did not have bnAb activity, the vaccine boosts expanded a pool of envelope CD4 binding site (bs)-reactive memory B cells with long third heavy chain complementarity determining regions (HCDR3) whose germline precursors and affinity matured B cell clonal lineage members neutralized the HIV-1 CRF01 AE tier 2 (difficult to neutralize) primary isolate, CNE8. Electron microscopy of two of these antibodies bound with near-native gp140 trimers showed that they recognized an open conformation of the Env trimer. Although late boosting of RV144 vaccinees expanded a novel pool of neutralizing B cell clonal lineages, we hypothesize that boosts with stably closed trimers would be necessary to elicit antibodies with greater breadth of tier 2 HIV-1 strains. Trial Registration: ClinicalTrials.gov NCT01435135 PMID:28235027

  13. Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial

    Institute of Scientific and Technical Information of China (English)

    LI Ting; CHEN Shun-le; DAI Qing; HAN Xing-hai; LI Zhan-guo; WU Dong-hai; ZHANG Xiao

    2013-01-01

    Background Acute gout is an intensely painful,inflammatory arthritis.Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition,the efficacy is based on only a few studies,particularly in China.We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.Methods A randomized,double-blind,active comparator study was conducted at 10 sites in China.Patients (n=178; ≥18 years of age) with acute gouty attack (<48 hours) were treated for 5 days with etoricoxib (120 mg/d; n=89) or indometacin (75 mg twice daily; n=89).The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2-5.Secondary end points included investigator assessments of tenderness and swelling,patient/ investigator global assessments of response to therapy,and patients discontinuing treatment.Safety was assessed by adverse events (AEs).Results Etoricoxib and indometacin had comparable primary and secondary end points.Mean change difference from baseline from days 2-5 was 0.03 (95% confidence interval (Cl)-0.19 to 0.25; P=0.6364),which fell within the prespecified comparative bounds of-0.5 to 0.5.No severe AEs were associated with etoricoxib use.Non-severe AEs were mainly digestive and general,and most (73.7%) were mild,although they caused withdrawal of two subjects in the etoricoxib group,due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related).Overall,AEs were similar,although the absolute number of AEs in the etoricoxib group (n=31) was less than the indometacin group (n=34).Conclusions Etoricoxib (120 mg once daily) is effective in treating acute gout,is generally safe and well-tolerated,and is comparable in efficacy to indometacin (75 mg twice daily).

  14. Role of intravenously administered hyoscine butyl bromide in retrograde terminal ileoscopy: A randomized, double-blinded, placebo-controlled trial

    Institute of Scientific and Technical Information of China (English)

    SP Misra; M Dwivedi

    2007-01-01

    AIM:To evaluated the role of hyoscine butyl bromide in facilitating retrograde ileoscopy.METHODS:Retrograde terminal ileoscopy was attempted in 200 consecutive patients undergoing colonoscopy. After intubation of the cecum and visualization of the ileocecal valve,butyl bromide injection or normal saline was given intravenously to the patients in a double blind random fashion. The pulse rate and oxygen saturation were measured continuously. After completion of the procedure,endoscopists were then asked to score the ease of intubation and the ease of visualization of the terminal ileum on a visual scale of 1 to 10. The patients were also asked to score the pain after receiving hyoscine butyl bromide injection on a score of 1 to 10.RESULTS:Terminal ileoscopy could be performed in 188 patients. The mean (SD) visual analogue score for the ease of intubation of the cecum was 7.4 (0.65) in the injection group and 5.9 (0.8) in the placebo group (P<0.001). The mean (SD) length of ileum visualized in the injection group was 14.4 (3.3) cm and 10.4 (2.7) cm in the placebo group (P<0.001). The mean (SD) visual analogue score for ease of visualization of the terminal ileum was 7.5 (0.69) in the injection group and 5.9 (0.7) in the placebo group (P<0.001). The pain score experienced by the patients was 6.5 (0.7) in the injection group and 6.7 (0.69) in the placebo group (P<0.008). Although the pulse rate increased significantly in patients receiving the drug,no statistically significant difference was noted in the oxygen saturation between the two groups either before or after administration of the drug. No complications were observed in either of the groups.CONCLUSION:Hyoscine butyl bromide injection is a useful adjunct in helping the intubation and visualizationof terminal ileum during colonoscopy.

  15. Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial

    Energy Technology Data Exchange (ETDEWEB)

    Michel, Patrik [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Neurology Service, Lausanne (Switzerland); Centre Hospitalier Universitaire Vaudois and University of Lausanne, Neurology Service, Lausanne (Switzerland); Ntaios, George; Reichhart, Marc [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Neurology Service, Lausanne (Switzerland); Schindler, Christian [Center Hospitalier Universitaire Vaudois and University of Lausanne, Pharmacy Department, Lausanne (Switzerland); Bogousslavsky, Julien [Genolier Swiss Medical Network, Glion (Switzerland); Maeder, Philip; Meuli, Reto [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Radiology, Lausanne (Switzerland); Wintermark, Max [University of Virginia, Department of Radiology, Division of Neuroradiology, Charlottesville, VA (United States)

    2012-06-15

    Patients with unknown stroke onset are generally excluded from acute recanalisation treatments. We designed a pilot study to assess feasibility of a trial of perfusion computed tomography (PCT)-guided thrombolysis in patients with ischemic tissue at risk of infarction and unknown stroke onset. Patients with a supratentorial stroke of unknown onset in the middle cerebral artery territory and significant volume of at-risk tissue on PCT were randomized to intravenous thrombolysis with alteplase (0.9 mg/kg) or placebo. Feasibility endpoints were randomization and blinded treatment of patients within 2 h after hospital arrival, and the correct application (estimation) of the perfusion imaging criteria. At baseline, there was a trend towards older age [69.5 (57-78) vs. 49 (44-78) years] in the thrombolysis group (n = 6) compared to placebo (n = 6). Regarding feasibility, hospital arrival to treatment delay was above the allowed 2 h in three patients (25%). There were two protocol violations (17%) regarding PCT, both underestimating the predicted infarct in patients randomized in the placebo group. No symptomatic hemorrhage or death occurred during the first 7 days. Three of the four (75%) and one of the five (20%) patients were recanalized in the thrombolysis and placebo group respectively. The volume of non-infarcted at-risk tissue was 84 (44-206) cm{sup 3} in the treatment arm and 29 (8-105) cm{sup 3} in the placebo arm. This pilot study shows that a randomized PCT-guided thrombolysis trial in patients with stroke of unknown onset may be feasible if issues such as treatment delays and reliable identification of tissue at risk of infarction tissue are resolved. Safety and efficiency of such an approach need to be established. (orig.)

  16. Oral Administration of Lactobacillus plantarum 299v Reduces Cortisol Levels in Human Saliva during Examination Induced Stress: A Randomized, Double-Blind Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hannah Andersson

    2016-01-01

    Full Text Available Objective. To clarify the effect of Lactobacillus plantarum 299v on the salivary cortisol and salivary IgA levels in young adults under examination stress. Design. Forty-one students with an upcoming academic exam were included in a randomized double-blind, placebo-controlled study. The probiotic bacteria or the placebo product was administered in capsules once a day during 14 days. Saliva was collected and a perceived stress test was filled out at each sampling occasion. Saliva was collected for cortisol analysis by Electrochemiluminescence Immunoassay (ECLI and salivary IgA was analysed by Enzyme-Linked Immunosorbent Assay (ELISA. Abundance of lactobacilli was evaluated by cultivation of saliva on selective medium and identification of L. plantarum 299v was done on randomly selected colonies by a random amplification of polymorphic DNA (RAPD typing. Results. A significant difference in cortisol levels was found between the treatment group and the placebo group (P<0.05, together with a significant increase in levels of lactobacilli in the treatment group compared with the placebo group (P<0.001. No significant changes were found for salivary IgA. Conclusion. A probiotic bacterium with ability to reduce symptoms of irritable bowel syndrome (IBS prohibited increased levels of the stress marker cortisol during the examination period. The registration number of the study is NCT02974894, and the study is registered at ClinicalTrials.gov.

  17. Oral Administration of Lactobacillus plantarum 299v Reduces Cortisol Levels in Human Saliva during Examination Induced Stress: A Randomized, Double-Blind Controlled Trial

    Science.gov (United States)

    Andersson, Hannah; Tullberg, Cecilia; Ahrné, Siv; Hamberg, Kristina; Lazou Ahrén, Irini; Molin, Göran; Sonesson, Mikael

    2016-01-01

    Objective. To clarify the effect of Lactobacillus plantarum 299v on the salivary cortisol and salivary IgA levels in young adults under examination stress. Design. Forty-one students with an upcoming academic exam were included in a randomized double-blind, placebo-controlled study. The probiotic bacteria or the placebo product was administered in capsules once a day during 14 days. Saliva was collected and a perceived stress test was filled out at each sampling occasion. Saliva was collected for cortisol analysis by Electrochemiluminescence Immunoassay (ECLI) and salivary IgA was analysed by Enzyme-Linked Immunosorbent Assay (ELISA). Abundance of lactobacilli was evaluated by cultivation of saliva on selective medium and identification of L. plantarum 299v was done on randomly selected colonies by a random amplification of polymorphic DNA (RAPD) typing. Results. A significant difference in cortisol levels was found between the treatment group and the placebo group (P < 0.05), together with a significant increase in levels of lactobacilli in the treatment group compared with the placebo group (P < 0.001). No significant changes were found for salivary IgA. Conclusion. A probiotic bacterium with ability to reduce symptoms of irritable bowel syndrome (IBS) prohibited increased levels of the stress marker cortisol during the examination period. The registration number of the study is NCT02974894, and the study is registered at ClinicalTrials.gov. PMID:28101105

  18. 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, Mario-Alberto; Martinez-Rider, Ricardo; Perez-Urizar, Jose

    2016-01-01

    Background 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. Material and Methods 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. Results Patients taking oral ketorolac had longer time of analgesic covering and less postoperative pain when compared with patients receiving intramuscular tramadol. Conclusions According to the VAS and AUC 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. Key words:Ketorolac, tramadol, third molar surgery, pain, preemptive analgesia. PMID:27475688

  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. Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Michelle L Dossett

    Full Text Available It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1 either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2 either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41, however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01. Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this

  1. Beneficial effects of dark chocolate on exercise capacity in sedentary subjects: underlying mechanisms. A double blind, randomized, placebo controlled trial.

    Science.gov (United States)

    Taub, Pam R; Ramirez-Sanchez, Israel; Patel, Minal; Higginbotham, Erin; Moreno-Ulloa, Aldo; Román-Pintos, Luis Miguel; Phillips, Paul; Perkins, Guy; Ceballos, Guillermo; Villarreal, Francisco

    2016-09-14

    In heart failure patients the consumption of (-)-epicatechin ((-)-Epi)-rich cocoa can restore skeletal muscle (SkM) mitochondrial structure and decrease biomarkers of oxidative stress. However, nothing is known about its effects on exercise capacity and underlying mechanisms in normal, sedentary subjects. Twenty normal, sedentary subjects (∼50 years old) were randomized to placebo or dark chocolate (DC) groups and consumed 20 g of the products for 3 months. Subjects underwent before and after treatment, bicycle ergometry to assess VO2 max and work, SkM biopsy to assess changes in mitochondrial density, function and oxidative stress and blood sampling to assess metabolic endpoints. Seventeen subjects completed the trial. In the DC group (n = 9), VO2 max increased (17% increase, p = 0.056) as well as maximum work (watts) achieved (p = 0.026) with no changes with placebo (n = 8). The DC group evidenced increases in HDL levels (p = 0.005) and decreased triglycerides (p = 0.07). With DC, SkM evidenced significant increases in protein levels for LKB1, AMPK and PGC1α and in their active forms (phosphorylated AMPK and LKB1) as well as in citrate synthase activity while no changes were observed in mitochondrial density. With DC, significant increases in SkM reduced glutathione levels and decreases in protein carbonylation were observed. Improvements in maximum work achieved and VO2 max may be due to DC activation of upstream control systems and enhancement of SkM mitochondria efficiency. Larger clinical studies are warranted to confirm these observations.

  2. Effects of Terazosin and Tolterodine on Ureteral Stent Related Symptoms: A Double-Blind Placebo-Controlled Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ali Tehranchi

    2013-12-01

    Full Text Available Objective To evaluate the effects of terazosin and tolterodine on ureteral stent discomfort. Materials and Methods Of 163 patients assessed for eligibility, 104 patients were randomly assigned to receive placebo, 2 mg of terazosin twice daily, 2 mg of tolterodine daily, or both terazosin plus tolterodine during the stenting period. Prior to stenting and at stent removal, the International Prostate Symptom Score (IPSS, the IPSS quality of life (QoL subscore and the Visual Analog Scale for Pain were determined. The patients also reported their analgesic use during the stenting period. Results Ninety-four patients completed the study. We noted significant decreases in the total IPSS scores (p = 0.002, irritative subscore (p = 0.039, QoL (p = 0.001, flank pain (p = 0.013, voiding pain (p = 0.01 and amount of analgesics used (p = 0.02 in the groups. However, neither the obstructive subscore nor the suprapubic pain improved significantly (p = 0.251 and p = 0.522, respectively. The patients receiving terazosin plus tolterodine experienced significant reductions in the total IPSS, irritative symptoms, QoL, flank pain, voiding pain and decreased analgesics use compared with those patients receiving placebo. However, compared with placebo, terazosin monotherapy did not affect pain levels, and tolterodine monotherapy did not improve QoL, flank pain or analgesics use. Conclusions Terazosin plus tolterodine improves ureteral stent-related complications, including irritative symptoms, the amount of analgesics used, QoL, flank pain and voiding pain but does not decrease obstructive symptoms or suprapubic pain. This trial was registered at www.clinicaltrials.gov as NCT01530243.

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

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    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.

  4. Efficacy of simple integrated group rehabilitation program for patients with knee osteoarthritis: Single-blind randomized controlled trial

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    Flávio S. da Silva, MS

    2015-06-01

    Full Text Available We investigated the role of an evidence-based integrated group rehabilitation program on the treatment of patients with knee osteoarthritis (KOA. This was a two-group, randomized controlled, 8 wk trial with 41 patients with moderate to very severe KOA. Patients were assigned to an intervention group (IG or control group (CG. After both groups had received a self-management education program, IG participants underwent a rehabilitation program, including educational aspects about KOA followed by exercises. CG participants received only general health orientation about KOA during this period. The outcome measures were the Lequesne algofunctional index; 36-Item Short Form Health Survey (SF-36; and chair-stand, sit-and-reach, timed up-and-go, and 6-minute walk tests. Analysis of covariance revealed significant postintervention improvements of IG participants compared with CG participants (p < 0.05 on Lequesne total score and pain and function subdomains; SF-36 physical function, role physical, bodily pain, general health, vitality, and role emotional subdomains; and performance assessed by chair-stand, timed up-and-go, and 6-minute walk tests. Focusing on the primary outcome (Lequesne total score, the mean +/– standard deviation after 8 wk was 5.50 +/– 2.98 for the IG and 7.87 +/– 3.48 for the CG (p = 0.009. The corresponding effect size (partial eta squared with 90% confidence interval was 0.23 (0.04–0.42, indicating a large effect. The presented rehabilitation program reduced pain and improved quality of life and function in patients with KOA.

  5. Does the new angiotensin converting enzyme inhibitor cilazapril prevent restenosis after percutaneous transluminal coronary angioplasty? Results of the MERCATOR study: a multicenter, randomized, double-blind placebo-controlled trial

    NARCIS (Netherlands)

    P.W.J.C. Serruys (Patrick); W.R. Rutsch (Wolfgang); N. Danchin (Nicolas); W. Wijns (William); H.U. Emanuelsson (Hakan); F. Chappuis; W.R.M. Hermans (Walter)

    1992-01-01

    textabstractBACKGROUND. Cilazapril is a novel angiotensin converting enzyme inhibitor with antiproliferative effects in the rat model after balloon injury. METHODS AND RESULTS. We conducted a randomized, double-blind placebo-controlled trial to assess the effect of cilazapril in angiographic resteno

  6. Supplementation with 1000 IU vitamin D/d leads to parathyroid hormone suppression, but not increased fractional calcium absorption, in 4-8-y-old children: A double-blind randomized controlled trial

    Science.gov (United States)

    The effects of vitamin D supplementation in healthy prepubertal children on physiologic outcomes have not been investigated. The objective was to evaluate the effects of supplementation with 1000 IU vitamin D(3)/d on calcium absorption. In a double-blind, placebo-controlled trial, we randomly assign...

  7. Evaluation of the Efficacy of Topical Ethyl Vanillate in Enhancing the Effect of Narrow Band Ultraviolet B against Vitiligo: A Double Blind Randomized, Placebo-Controlled Clinical Trial

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    Mohammad Reza Namazi

    2015-11-01

    Full Text Available Background: Vitiligo is an acquired disease of skin that presents with depigmented patches due to lack of melanocytes in the epidermis. Accumulation of toxic free radicals like hydrogen peroxide in the epidermis may be responsible for melanocytes death. Since ethyl vanillate (vanillic acid ethyl ester is a strong hydrogen peroxide scavenger, it may be effective against vitiligo. This study was carried out to evaluate the effect of ethyl vanillate cream on vitiligo patients receiving phototherapy. Methods: A double-blind placebo-controlled clinical trial using ethyl vanillate cream 20% was performed on 30 cases of generalized stable vitiligo (randomly selected who were receiving phototherapy in the outpatient clinic of Faghihi Hospital (Shiraz, Iran. The patients randomly applied ethyl vanillate on an assigned lesion (left or right side of the body and placebo on the opposite side lesion (almost the same size and location twice a day for 3 months, while receiving a narrow band ultraviolet B (NB-UVB 2-3 times weekly. Photos were taken at the beginning of the trial and at the end of 4th, 8th, and 12th weeks. Then, images were compared with the photos from the beginning of the trial based on VASI score. Results: There was a significant change in pigmentation after applying ethyl vanillate compared with baseline in medication side (P=0.002, but no significant change in placebo side (P=0.066. Additionally, there was a significant difference between medication and placebo sides in pigmentation (P=0.005. Conclusion: Ethyl vanillate may serve as an adjunct therapy for the treatment of vitiligo, although changes in pigmentation are mild clinically.

  8. Tolerability and efficacy of paliperidone ER compared to olanzapine in the treatment of schizophrenia: A randomized, double-blind, multicentric trial

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    Sandip Shah

    2011-01-01

    Full Text Available Background: Paliperidone is an active metabolite of risperidone and actss through a combination of central dopamine Type 2 (D2 and serotonin Type 2 (5HT2A receptor antagonism. Aim: The present randomized, double-blind, multicentric trial was designed to determine the safety and efficacy of paliperidone extended release (ER compared to olanzapine in the treatment of acute schizophrenia. Materials and Methods: A total of 214 patients with diagnosis of schizophrenia were randomized to paliperidone ER (n=109 and olanzapine (n=106 treatment groups. Totally 206 patients were evaluated for efficacy parameters using Positive and negative syndrome scale (PANSS score and Clinical Global Impression-severity of illness (CGI-S and Clinical Global Impression-improvement of illness (CGI-I scales. Safety was assessed by treatment-emergent adverse events and movement disorders. Results: All patients showed significant reduction in PANSS scores at the end of treatment. However, the results were comparable and there was no significant difference at the end of the trial between paliperidone ER group and olanzapine group. Both the treatment groups showed decrease in the severity of illness and improvement in symptomatology. The most common adverse events reported in paliperidone ER versus olanzapine group were Extra Pyramidal Syndrome (EPS (13.7% vs. 15.6%, headache (12.7% vs. 8.9%, increased appetite (8.8% vs. 10.0% and drowsiness (4.9% vs. 303%. There was no clinically relevant difference in change from baseline to the end of the trial in abnormal involuntary movement scale (AIMS and barnes akathisia rating scale (BARS total scores between both the groups. Conclusion: Paliperidone ER is effective in controlling schizophrenic symptoms as well as exhibits comparable tolerability profile. Thus, paliperidone ER has the potential to be a useful new treatment option for patients with schizophrenia.

  9. Results of a double-blind, randomized trial of ceftobiprole treatment of complicated skin and skin structure infections caused by gram-positive bacteria.

    Science.gov (United States)

    Noel, Gary J; Strauss, Richard S; Amsler, Karen; Heep, Markus; Pypstra, Rienk; Solomkin, Joseph S

    2008-01-01

    Ceftobiprole is the first broad-spectrum cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA) to be assessed in late-stage clinical trials. As a pivotal step in the clinical development of ceftobiprole, a multicenter, global, randomized, double-blind trial was conducted to compare the efficacy of ceftobiprole to that of vancomycin in patients with complicated skin and skin structure infections (cSSSIs) caused by gram-positive bacteria. The primary objective was to assess noninferiority on the basis of the cure rates 7 to 14 days after the completion of therapy in patients administered ceftobiprole 500 mg every 12 h or vancomycin 1 g every 12 h. Of 784 patients randomized, 282 receiving ceftobiprole and 277 receiving vancomycin were clinically evaluable. Of these patients, 93.3% treated with ceftobiprole and 93.5% treated with vancomycin were cured (95% confidence interval of difference, -4.4%, 3.9%). The cure rates for patients with MRSA infections were 91.8% (56/61) with ceftobiprole treatment and 90.0% (54/60) with vancomycin treatment (95% confidence interval of difference, -8.4%, 12.1%). At least one adverse event (AE) was reported by 52% of the ceftobiprole-treated patients and 51% of the vancomycin-treated patients. The most common AEs reported by the ceftobiprole-treated patients were nausea (14%) and taste disturbance (8%). Discontinuation of the study drug because of treatment-emergent AEs occurred in 4% (n = 17) of the ceftobiprole-treated patients and 6% (n = 22) of the vancomycin-treated patients. The results of this trial support the use of ceftobiprole as an effective and well-tolerated treatment option for patients with cSSSIs caused by a spectrum of gram-positive bacteria.

  10. Using a low-sodium, high-potassium salt substitute to reduce blood pressure among Tibetans with high blood pressure: a patient-blinded randomized controlled trial.

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    Xingshan Zhao

    Full Text Available OBJECTIVES: To evaluate the effects of a low-sodium and high-potassium salt-substitute on lowering blood pressure (BP among Tibetans living at high altitude (4300 meters. METHOD: The study was a patient-blinded randomized controlled trial conducted between February and May 2009 in Dangxiong County, Tibetan Autonomous Region, China. A total of 282 Tibetans aged 40 or older with known hypertension (systolic BP≥140 mmHg were recruited and randomized to intervention (salt-substitute, 65% sodium chloride, 25% potassium chloride and 10% magnesium sulfate or control (100% sodium chloride in a 1: 1 allocation ratio with three months' supply. Primary outcome was defined as the change in BP levels measured from baseline to followed-up with an automated sphygmomanometer. Per protocol (PP and intention to treat (ITT analyses were conducted. RESULTS: After the three months' intervention period, the net reduction in SBP/DBP in the intervention group in comparison to the control group was -8.2/-3.4 mmHg (all p<0.05 in PP analysis, after adjusting for baseline BP and other variables. ITT analysis showed the net reduction in SBP/DBP at -7.6/-3.5 mmHg with multiple imputations (all p<0.05. Furthermore, the whole distribution of blood pressure showed an overall decline in SBP/DBP and the proportion of patients with BP under control (SBP/DBP<140 mmHg was significantly higher in salt-substitute group in comparison to the regular salt group (19.2% vs. 8.8%, p = 0.027. CONCLUSION: Low sodium high potassium salt-substitute is effective in lowering both systolic and diastolic blood pressure and offers a simple, low-cost approach for hypertension control among Tibetans in China. TRIAL REGISTRATION: ClinicalTrials.gov NCT01429246.

  11. The effect of 12 weeks Anethum graveolens (dill on metabolic markers in patients with metabolic syndrome; a randomized double blind controlled trial

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    Mansouri Masoume

    2012-10-01

    Full Text Available Abstract Background The clustering of metabolic abnormalities defined as metabolic syndrome is now both a public health and a clinical problem .While interest in herbal medicine has greatly increased, lack of human evidence to support efficacies shown in animals does exist. This clinical trial study designed to investigate whether herbal medicine, Anethum graveolens (dill extract, could improve metabolic components in patients with metabolic syndrome. Methods A double-blind, randomized, placebo-controlled trial using a parallel design was conducted. 24 subjects who had metabolic syndrome diagnostic criteria (update of ATP III were randomly assigned to either dill extract (n = 12 or placebo (n = 12 for 3 months. Results Across lipid component of metabolic syndrome, no significant differences in triglyceride (TG concentration and high density lipoprotein cholesterol were seen between the two groups. However TG improved significantly from baseline (257.0 vs. 201.5p = 0.01 with dill treatment but such a significant effect was not observed in placebo group. Moreover, no significant differences in waist circumference, blood pressure and fasting blood sugar were seen between two groups after 3 months follow up period. Conclusion In this small clinical trial in patients with metabolic syndrome, 12 weeks of dill extract treatment had a beneficial effect in terms of reducing TG from baseline. However dill treatment was not associated with a significant improvement in metabolic syndrome related markers compared to control group. Larger studies might be required to prove the efficacy and safety of long-term administration of dill to resolve metabolic syndrome components.

  12. The effect of 12 weeks Anethum graveolens (dill on metabolic markers in patients with metabolic syndrome; a randomized double blind controlled trial

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    Bagher Larijani

    2012-10-01

    Full Text Available The clustering of metabolic abnormalities defined as metabolic syndrome is now both a public health and a clinical problem .While interest in herbal medicine has greatly increased, lack of human evidence to support efficacies shown in animals does exist. This clinical trial study designed to investigate whether herbal medicine, Anethum graveolens (dill extract, could improve metabolic components in patients with metabolic syndrome.MethodsA double-blind, randomized, placebo-controlled trial using a parallel design was conducted. 24 subjects who had metabolic syndrome diagnostic criteria (update of ATP III were randomly assigned to either dill extract (n = 12 or placebo (n = 12 for 3 months.ResultsAcross lipid component of metabolic syndrome, no significant differences in triglyceride (TG concentration and high density lipoprotein cholesterol were seen between the two groups. However TG improved significantly from baseline (257.0 vs. 201.5p = 0.01 with dill treatment but such a significant effect was not observed in placebo group. Moreover, no significant differences in waist circumference, blood pressure and fasting blood sugar were seen between two groups after 3 months follow up period.ConclusionIn this small clinical trial in patients with metabolic syndrome, 12 weeks of dill extract treatment had a beneficial effect in terms of reducing TG from baseline. However dill treatment was not associated with a significant improvement in metabolic syndrome related markers compared to control group. Larger studies might be required to prove the efficacy and safety of long-term administration of dill to resolve metabolic syndrome components.

  13. Preoperative dexamethasone improves surgical outcome after laparoscopic cholecystectomy: a randomized double-blind placebo-controlled trial

    DEFF Research Database (Denmark)

    Bisgaard, Thue; Klarskov, Birthe; Kehlet, Henrik

    2003-01-01

    OBJECTIVE: To determine the effects of preoperative dexamethasone on surgical outcome after laparoscopic cholecystectomy (LC). SUMMARY BACKGROUND DATA: Pain and fatigue are dominating symptoms after LC and may prolong convalescence. METHODS: In a double-blind, placebo-controlled study, 88 patient...

  14. Effects of folic acid and zinc sulfate on male factor subfertility: a double-blind, randomized, placebo-controlled trial.

    NARCIS (Netherlands)

    Wong, W.Y.; Merkus, J.M.W.M.; Thomas, C.M.G.; Menkveld, R.; Zielhuis, G.A.; Steegers-Theunissen, R.P.M.

    2002-01-01

    OBJECTIVE: To study the effects of folic acid and zinc sulfate treatment on semen variables in fertile and subfertile men. DESIGN: Double-blind, placebo-controlled interventional study. SETTING: Two outpatient fertility clinics and nine midwifery practices in The Netherlands. PARTICIPANT(S): One hun

  15. A double-blind randomized controlled trial to assess the effect of bright light therapy on depression in patients with Parkinson’s disease

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    Sonja Rutten

    2016-10-01

    Full Text Available Abstract Background A disturbed circadian rhythm seems to be a causal factor in the occurrence of depressive disorders in patients with Parkinson’s disease (PD. The circadian rhythm can be restored with light. Therefore, Bright Light Therapy (BLT might be a new treatment option for depression in PD patients. Methods/design In this double-blind controlled trial, 84 subjects with idiopathic PD are randomized to either BLT or a control light condition. The BLT condition emits white light with an intensity of 10,000 Lux, while the control device emits dim white light of 200 Lux, which is presumed to be too low to influence the circadian rhythm. Subjects receive 30 min of home treatment twice daily for three months. Timing of treatment is based on the individual chronotype. After finishing treatment, subjects enter a follow-up period of six months. The primary outcome of the study is the severity of depressive symptoms, as measured with the Hamilton Depression Rating Scale. Secondary outcomes are alternative depression measures, objective and subjective sleep measures, and salivary melatonin and cortisol concentrations. For exploratory purposes, we also assess the effects on motor symptoms, global cognitive function, comorbid psychiatric disorders, quality of life and caregiver burden. Data will be analyzed using a linear mixed models analysis. Discussion Performing a placebo-controlled trial on the effects of BLT in PD patients is challenging, as the appearance of the light may provide clues on the treatment condition. Moreover, fixed treatment times lead to an improved sleep-wake rhythm, which also influences the circadian system. With our study design, we do not compare BLT to placebo treatment, i.e. an ineffective control treatment. Rather, we compare structuring of the sleep-wake cycle in both conditions with additional BLT in the experimental condition, and additional dim light in the control condition. Participants are not informed about

  16. A Double-Blind Randomized Clinical Trial Comparing the Effect of Neostigmine and Metoclopramide on Gastric Residual Volume of Mechanically Ventilated ICU Patients

    Science.gov (United States)

    Gholipour Baradari, Afshin; Alipour, Abbas; Firouzian, Abolfazl; Moarab, Laleh; Emami Zeydi, Amir

    2016-01-01

    Background: In critically ill patients, enteral feeding through the nasogastric tube is the method of choice for nutritional support. Gastrointestinal feeding intolerance and disturbed gastric emptying are common challenges in these patients. The aim of this study was to compare the effect of Neostigmine and Metoclopramide on gastric residual volume (GRV) in mechanically ventilated ICU patients. Methods: In a double blind, randomized clinical trial, a total of 60 mechanically ventilated ICU patients with GRV >120 mL (3 hours after the last gavage), were randomly assigned into two groups A and B. At baseline and 6 hours later, patients in group A and B received intravenous infusion of neostigmine in a dose of 2.5 mg and metoclopramide in a dose of 10 mg in 100 ml of normal saline, within 30 minutes. Patients’ gastric residual volumes were evaluated before the beginning of the intervention, and 3, 6, 9 and 12 hours after the intervention. Results: After adjusting of other variables (Sex, BMI and ICU stay period) generalized estimating equation (GEE) model revealed that neostigmine treatment increased odds of GRV improvement compare to metoclopramide group (Estimate 1.291, OR= 0.3.64, 95% CI 1.07-12.34). However there is a statistically significant time trend (within-subject differences or time effect) regardless of treatment groups (P<0.001). The median time from intervention to GRV improvement was 6 hours (95% CI 3.75-8.25) and 9 hours (95% CI 7.38-10.17) in neostigmine and metoclopramide groups, respectively. This difference was statistically significant (P<0.05). Conclusion: It seems that neostigmine is more effective than metoclopramide in reducing GRV and improving gastric emptying in mechanically ventilated ICU patients without significant complication and this protocol may be effective on the tolerance of enteral feeding in ICU patients. Further well-designed randomized clinical trials are needed. PMID:28077899

  17. Influence of the Chungkookjang on histamine-induced wheal and flare skin response: a randomized, double-blind, placebo controlled trial

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    Kwon Dae-Young

    2011-12-01

    Full Text Available Abstracts Background Allergic disease is a consequence of exposure to normally innocuous substances that elicit the activation of mast cells. Mast-cell-mediated allergic response is involved in many diseases such as anaphylaxis, urticaria, allergic rhinitis, asthma and allergic dermatitis. The development of food products for the prevention of allergic disease is an important subject in human health. The chungkookjang (CKJ has been reported to exhibit antiallergic inflammatory activity. Therefore, the aim of the study is to examine the effects of the CKJ to reduce histamine-induced wheal and flare skin responses. Methods/Design A randomized, double-blind, placebo-controlled study in 60 healthy subjects will be carried out. Sixty volunteers (aged 20-80 who gave a written consent before entering the study will be randomized in two groups of thirty subjects each. The skin prick test with histamine solution of 10 mg/ml will be performed on the ventral forearm, 10 cm from the elbow. The subjects will be instructed to take 35 g per day of either the CKJ pills or a placebo pills for a period of 3 months. Diameters of wheal and flare will be assessing 15 minutes after performing the above-mentioned skin prick test. The primary outcome is change in wheal and flare responses. Secondary outcomes will be include change in serum histamine, immunoglobulin E, cytokines (interferon-gamma, interleukin-4, -10, and tumor necrosis factor-alpha, and eosinophil cationic protein. Discussion This study will show the potential anti-inflammatory properties of the CKJ in their skin activity when histamine is the challenging agent as occurs in the clinical situation. And the present protocol will confirm the efficacy and safety of the CKJ for allergy symptoms, suggesting more basic knowledge to conduct further randomized controlled trials (RCT. If this study will be successfully performed, the CKJ will be an alternative dietary supplemental remedy for allergy patients

  18. The efficacy of Shugan Jianpi Zhixie therapy for diarrhea-predominant irritable bowel syndrome: a meta-analysis of randomized, double-blind, placebo-controlled trials.

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    Ya Xiao

    Full Text Available Shugan Jianpi Zhixie therapy (SJZT has been widely used to treat diarrhea-predominant irritable bowel syndrome (IBS-D, but the results are still controversial. A meta-analysis of randomized, double-blind, placebo-controlled trials was performed to assess the efficacy and tolerability of SJZT for IBS-D.The MEDLINE, EMBASE, Cochrane Library, the China National Knowledge Infrastructure database, the Chinese Biomedical Literature database and the Wanfang database were searched up to June 2014 with no language restrictions. Summary estimates, including 95% confidence intervals (CI, were calculated for global symptom improvement, abdominal pain improvement, and Symptom Severity Scale (BSS score.Seven trials (N=954 were included. The overall risk of bias assessment was low. SJZT showed significant improvement for global symptom compared to placebo (RR 1.61; 95% CI 1.24, 2.10; P =0.0004; therapeutic gain = 33.0%; number needed to treat (NNT = 3.0. SJZT was significantly more likely to reduce overall BSS score (SMD -0.67; 95% CI -0.94, -0.40; P < 0.00001 and improve abdominal pain (RR 4.34; 95% CI 2.64, 7.14; P < 0.00001 than placebo. The adverse events of SJZT were no different from those of placebo.This meta-analysis suggests that SJZT is an effective and safe therapy option for patients with IBS-D. However, due to the high clinical heterogeneity and small sample size of the included trials, further standardized preparation, large-scale and rigorously designed trials are needed.

  19. Randomized Double-blind Placebo-controlled Trial of Celecoxib for Oral Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

    Science.gov (United States)

    Lalla, Rajesh V.; Choquette, Linda E.; Curley, Kathleen F.; Dowsett, Robert J.; Feinn, Richard S.; Hegde, Upendra P.; Pilbeam, Carol C.; Salner, Andrew L.; Sonis, Stephen T.; Peterson, Douglas E.

    2016-01-01

    Objectives Oral mucositis (OM) is a painful complication of radiation therapy (RT) for head and neck cancer (H&NC). OM can compromise nutrition, require opioid analgesics and hospitalization for pain control, and lead to treatment interruptions. Based on the role of inflammatory pathways in OM pathogenesis, we investigated effect of cyclooxygenase-2 (COX-2) inhibition on severity and morbidity of OM. Methods In this double-blind placebo-controlled trial, 40 H&NC patients were randomized to daily use of 200 mg celecoxib or placebo, for the duration of RT. Clinical OM, normalcy of diet, pain scores, and analgesic use were assessed 2–3 times/week by blinded investigators during the 6–7 week RT period, using validated scales. Results Twenty subjects were randomized to each arm, which were similar with respect to tumor location, radiation dose, and concomitant chemotherapy. In both arms, mucositis and pain scores increased over course of RT. Intention-to-treat analyses demonstrated no significant difference in mean Oral Mucositis Assessment Scale (OMAS) scores at 5000 cGy (primary endpoint). There was also no difference between the two arms in mean OMAS scores over the period of RT, mean worst pain scores, mean normalcy of diet scores, or mean daily opioid medication use in IV morphine equivalents. There were no adverse events attributed to celecoxib use. Conclusions Daily use of a selective COX-2 inhibitor, during period of RT for H&NC, did not reduce the severity of clinical OM, pain, dietary compromise or use of opioid analgesics. These findings also have implications for celecoxib use in H&NC treatment regimens (NCT00698204). PMID:25151488

  20. Effect of transcranial direct-current stimulation combined with treadmill training on balance and functional performance in children with cerebral palsy: a double-blind randomized controlled trial.

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    Natália de Almeida Carvalho Duarte

    Full Text Available BACKGROUND: Cerebral palsy refers to permanent, mutable motor development disorders stemming from a primary brain lesion, causing secondary musculoskeletal problems and limitations in activities of daily living. The aim of the present study was to determine the effects of gait training combined with transcranial direct-current stimulation over the primary motor cortex on balance and functional performance in children with cerebral palsy. METHODS: A double-blind randomized controlled study was carried out with 24 children aged five to 12 years with cerebral palsy randomly allocated to two intervention groups (blocks of six and stratified based on GMFCS level (levels I-II or level III.The experimental group (12 children was submitted to treadmill training and anodal stimulation of the primary motor cortex. The control group (12 children was submitted to treadmill training and placebo transcranial direct-current stimulation. Training was performed in five weekly sessions for 2 weeks. Evaluations consisted of stabilometric analysis as well as the administration of the Pediatric Balance Scale and Pediatric Evaluation of Disability Inventory one week before the intervention, one week after the completion of the intervention and one month after the completion of the intervention. All patients and two examiners were blinded to the allocation of the children to the different groups. RESULTS: The experimental group exhibited better results in comparison to the control group with regard to anteroposterior sway (eyes open and closed; p<0.05, mediolateral sway (eyes closed; p<0.05 and the Pediatric Balance Scale both one week and one month after the completion of the protocol. CONCLUSION: Gait training on a treadmill combined with anodal stimulation of the primary motor cortex led to improvements in static balance and functional performance in children with cerebral palsy. TRIAL REGISTRATION: Ensaiosclinicos.gov.br/RBR-9B5DH7.

  1. 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

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    Gluud Christian

    2008-07-01

    Full Text Available Abstract Background A number of studies indicate a link between cannabis-use and psychosis as well as more severe psychosis in those with existing psychotic disorders. There is currently insufficient evidence to decide the optimal way to treat cannabis abuse among patients with psychosis. Objectives 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 of cannabis consumption over time. Other outcome measures will be psychosis symptoms, cognitive functioning, quality of life, social functioning, and cost-benefit analyses. Trial registration ClinicalTrials.gov NCT00484302.

  2. Efficacy of diazepam as an anti-anxiety agent: meta-analysis of double-blind, randomized controlled trials carried out in Japan.

    Science.gov (United States)

    Inada, Toshiya; Nozaki, Shoko; Inagaki, Ataru; Furukawa, Toshiaki A

    2003-08-01

    Diazepam is one of the most widely used, broad-spectrum anti-anxiety agents. The aim of this study was to evaluate the efficacy of diazepam, and to establish whether it is more effective than a placebo in improving the various neurotic anxiety states seen in patients with neurosis or psychosomatic disease. Of the recently established comprehensive register of psychotropic drug trials carried out in Japan, a total of 17 double-blind, randomized controlled trials were identified on the treatment of neurosis using anti-anxiety compounds, in which both diazepam and placebos were used. Meta-analysis of these 17 studies demonstrated that diazepam is significantly more effective than a placebo (relative risk 1.35, 95% confidence interval 1.21-1.51, number needed to treat 9). The maximal effective dose of diazepam seems to be 12 or 18 mg/day with a treatment duration of 2 or more weeks. There was no significant difference between the effects of placebo and a diazepam dose of 6 mg/day. Caution should be exercised in assessing these results, however, since this is the first meta-analysis showing the significant effectiveness of diazepam in the treatment of neurosis or psychosomatic disease.

  3. A moderate dose of caffeine ingestion does not change energy expenditure but decreases sleep time in physically active males: a double-blind randomized controlled trial.

    Science.gov (United States)

    Júdice, Pedro B; Magalhães, João P; Santos, Diana A; Matias, Catarina N; Carita, Ana Isabel; Armada-Da-Silva, Paulo A S; Sardinha, Luís B; Silva, Analiza M

    2013-01-01

    Research on the effect of caffeine on energy expenditure (EE), physical activity (PA), and total sleep time (TST) during free-living conditions using objective measures is scarce. We aimed to determine the impact of a moderate dose of caffeine on TST, resting EE (REE), physical activity EE (PAEE), total EE (TEE), and daily time spent in sedentary, light, moderate, and vigorous intensity activities in a 4-day period and the acute effects on heart rate (HR) and EE in physically active males. Using a double-blind crossover trial (ClinicalTrials.gov ID: NCT01477294) with two conditions (4 days each with 3-day washout) randomly ordered as caffeine (5 mg/kg of body mass/day) and placebo (maltodextrin) administered twice per day (2.5 mg/kg), 30 nonsmoker males, low-caffeine users (caffeine intake, while no differences were found between conditions for REE, PAEE, TEE, and PA patterns. Also, no acute effects on HR and EE were found between conditions. Though a large individual variability was observed, our findings revealed no acute or long-term effects of caffeine on EE and PA but decreased TST during free-living conditions in healthy males.

  4. Effects of Ezetimibe/Simvastatin and Rosuvastatin on Oxidative Stress in Diabetic Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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    Geannyne Villegas-Rivera

    2015-01-01

    Full Text Available Objective. To evaluate the effects of ezetimibe/simvastatin (EZE/SIMV and rosuvastatin (ROSUV on oxidative stress (OS markers in patients with diabetic polyneuropathy (DPN. Methods. We performed a randomized, double-blind, placebo-controlled phase III clinical trial in adult patients with Type 2 Diabetes Mellitus (T2DM and DPN, as evaluated by composite scores and nerve conduction studies (NCS. Seventy-four subjects with T2DM were allocated 1 : 1 : 1 to placebo, EZE/SIMV 10/20 mg, or ROSUV 20 mg for 16 weeks. All patients were assessed before and after treatment: primary outcomes were lipid peroxidation (LPO, and nitric oxide (NO surrogate levels in plasma; secondary outcomes included NCS, neuropathic symptom scores, and metabolic parameters. Data were expressed as mean ± SD or SEM, frequencies, and percentages; we used nonparametric analysis. Results. LPO levels were reduced in both statin arms after 16 weeks of treatment (p<0.05 versus baseline, without changes in the placebo group. NO levels were not significantly affected by statin treatment, although a trend towards significance concerning increased NO levels was noted in both statin arms. No significant changes were observed for the NCS or composite scores. Discussion. EZE/SIMV and ROSUV are superior to placebo in reducing LPO in subjects with T2DM suffering from polyneuropathy. This trial is registered with NCT02129231.

  5. A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia.

    Science.gov (United States)

    Kane, John M; Skuban, Aleksandar; Ouyang, John; Hobart, Mary; Pfister, Stephanie; McQuade, Robert D; Nyilas, Margaretta; Carson, William H; Sanchez, Raymond; Eriksson, Hans

    2015-05-01

    The objective of this study was to evaluate the efficacy, safety and tolerability of brexpiprazole versus placebo in adults with acute schizophrenia. This was a 6-week, multicenter, placebo-controlled double-blind phase 3 study. Patients with acute schizophrenia were randomized to brexpiprazole 1, 2 or 4 mg, or placebo (2:3:3:3) once daily. The primary endpoint was changed from baseline at week 6 in Positive and Negative Syndrome Scale (PANSS) total score; the key secondary endpoint was Clinical Global Impressions-Severity (CGI-S) at week 6. Brexpiprazole 4 mg showed statistically significant improvement versus placebo (treatment difference: -6.47, p=0.0022) for the primary endpoint. Improvement compared with placebo was also seen for the key secondary endpoint (treatment difference: -0.38, p=0.0015), and on multiple secondary efficacy outcomes. Brexpiprazole 1 and 2mg also showed numerical improvements versus placebo, although p>0.05. The most common treatment-emergent adverse events were headache, insomnia and agitation; incidences of akathisia were lower in the brexpiprazole treatment groups (4.2%-6.5%) versus placebo (7.1%). Brexpiprazole treatment was associated with moderate weight gain at week 6 (1.23-1.89 kg versus 0.35 kg for placebo); there were no clinically relevant changes in laboratory parameters and vital signs. In conclusion, brexpiprazole 4 mg is an efficacious and well-tolerated treatment for acute schizophrenia in adults. Clinical Trials.gov NCT01393613; BEACON trial.

  6. 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

  7. Study Protocol- Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS: a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults

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    Friedly Janna L

    2012-03-01

    Full Text Available Abstract Background Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis. Methods We will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone. Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention. Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization

  8. Evaluation of the efficacy and safety of olanzapine as an adjunctive treatment for anorexia nervosa in adolescent females: a randomized, double-blind, placebo-controlled trial

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    Moher David

    2008-01-01

    Full Text Available Abstract Background Anorexia Nervosa (AN is a serious, debilitating condition that causes significant physical, emotional, and functional impairment. The condition is characterized by destructive weight loss behaviours and a refusal to maintain body weight at or above a minimally normal weight for age and height. AN often develops in adolescence and is a predominantly female disorder. Treatment for AN typically involves medical, nutritional and psychological interventions. Pharmacotherapy is also often used; however, the literature on the effectiveness of these drugs in a pediatric population is very limited. Olanzapine, which is an 'atypical' antipsychotic, is becoming more widespread in the treatment of AN. Olanzapine is hypothesized to facilitate weight gain, while decreasing levels of agitation and decreasing resistance to treatment in young women with AN. This randomized, double-blind placebo-controlled trial seeks to examine the effectiveness and safety of olanzapine in female youth with AN. Methods/Design Adolescent females between the ages of 12 and 17 diagnosed with AN (either restricting or binge/purge type or Eating Disorder Not Otherwise Specified with a Body Mass Index of less than or equal to 17.5, will be offered inclusion in the study. Patients will be randomly assigned to receive either olanzapine or placebo. Patients assigned to receive olanzapine will start at a low dose of 1.25 mg/day for three days, followed by 2.5 mg/day for four days, 5 mg/day for one week, then 7.5 mg/day (the target dose chosen for 10 weeks. After 10 weeks at 7.5 mg the medication will be tapered and discontinued over a period of two weeks. The effectiveness of olanzapine versus placebo will be determined by investigating the change from baseline on measures of eating attitudes and behaviors, depression and anxiety, and change in Body Mass Index at week 12, and after a follow-up period at week 40. It is anticipated that 67 participants will be recruited

  9. A randomized double-blind placebo-controlled trial to evaluate the value of a single bolus intravenous alfentanil in CT colonography

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    Boellaard Thierry N

    2011-11-01

    Full Text Available Abstract Background Although CT colonography is a less invasive alternative for colonoscopy for the detection of colorectal polyps and cancer, procedural pain is common. In several studies, CT colonography pain and burden is higher than in colonoscopy. Apart from discomfort, anxiety and its related stress-induced peri- procedural side effects, this may influence the adherence for CT colonography as a possible screening tool for colorectal cancer. We hypothesize that a single bolus intravenous alfentanil will give a clinically relevant reduction in maximum pain defined as at least 1.3 point reduction on an 11-point numeric rating scale (NRS. Methods/Design A randomized double-blind placebo-controlled trial in which patients scheduled for elective CT colonography in a single tertiary centre are eligible for inclusion. The first 90 consenting patient will be block-randomized to either the alfentanil group or the placebo group. Before bowel insufflation, the alfentanil group receives a single bolus intravenous alfentanil 7.5 μg/kg dissolved in 0.9% NaCl, while the placebo group receives an intravenous bolus injection of pure 0.9% NaCl. For both groups an equal amount of fluid per kilogram (75 μL/kg is injected. The primary outcome is the difference in maximum pain on an 11-point NRS. Secondary outcomes include: pain and burden of different CT colonography aspects, side effects, procedural time and recovery time. For the primary outcome an independent samples t-test is performed and a P value Discussion This study will provide evidence whether a single bolus intravenous alfentanil gives a clinically relevant reduction in maximum pain during CT colonography. Trial registration Netherlands Trial Register (NTR: NTR2902 This trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989 and Good Clinical Practice

  10. Immediate Effect of Postural Insoles on Gait Performance of Children with Cerebral Palsy: Preliminary Randomized Controlled Double-blind Clinical Trial.

    Science.gov (United States)

    Neto, Hugo Pasini; Grecco, Luanda André Collange; Duarte, Natália Almeida Carvalho; Christovão, Thaluanna Calil Lourenço; Franco de Oliveira, Luis Vicente; Dumont, Arislander Jonathan Lopes; Galli, Manuela; Oliveira, Claudia Santos

    2014-07-01

    [Purpose] Improved gait efficiency is one of the goals of therapy for children with cerebral palsy (CP). Postural insoles can allow more efficient gait by improving biomechanical alignment. The aim of the present study was to assess the effect of postural insoles on gait performance of children with CP classified as levels I or II of the Gross Motor Function Classification System (GMFCS). [Subjects and Methods] the study was a randomized controlled double-blind clinical trial. After meeting the legal aspects and the eligibility criteria, 10 children between four and 12 years old were randomly divided into a two groups: a control group (n=5), and an experimental group (n=5). Children in the control group used a placebo insoles, and children in the experimental group used postural insoles. Evaluation consisted of three-dimensional gait analysis under three conditions: barefoot, shoes without insoles and shoes with postural insoles or shoes with placebo insoles. [Results] Regarding the immediate effects of insole use, significant improvements in gait velocity and cadence were observed in the experimental group in comparison to the control group. [Conclusion] The use of postural insoles led to improvements in gait velocity and cadence of the children with cerebral palsy classified as levels I or II of the GMFCS.

  11. Safety and Efficacy of Rice Bran Supercritical CO2 Extract for Hair Growth in Androgenic Alopecia: A 16-Week Double-Blind Randomized Controlled Trial.

    Science.gov (United States)

    Choi, Jae-Suk; Park, Jae Beom; Moon, Woi-Sook; Moon, Jin-Nam; Son, Sang Wook; Kim, Mi-Ryung

    2015-01-01

    We conducted a 16-week double-blind randomized controlled single-center trial to evaluate the safety and efficacy of dermal rice bran supercritical CO2 extract (RB-SCE) in the treatment of androgenic alopecia. Fifty alopecia patients were randomly assigned to the experimental and placebo groups. The experimental group received a dermal application of 0.5% RB-SCE (8 mL/d) to the head skin for 16 weeks while the control group received a dermal application of placebo. Changes in hair count, diameter, and density were evaluated with a Folliscope(®). Patient satisfaction was evaluated via questionnaire and clinical photographs were rated by dermatologists. The results showed that RB-SCE significantly increased hair density and hair diameter in male subjects. Patient satisfaction and the evaluation of photographs by dermatologists also confirmed the effectiveness of RB-SCE in the treatment of alopecia. No adverse reactions related to RB-SCE were reported. Therefore, RB-SCE shows promise for use in functional cosmetics and pharmaceuticals.

  12. Myrtus communis L. Freeze-Dried Aqueous Extract Versus Omeprazol in Gastrointestinal Reflux Disease: A Double-Blind Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Zohalinezhad, Mohammad E; Hosseini-Asl, Mohammad Kazem; Akrami, Rahimeh; Nimrouzi, Majid; Salehi, Alireza; Zarshenas, Mohammad M

    2016-01-01

    The current work assessed a pharmaceutical dosage form of Myrtus communis L. (myrtle) in reflux disease compared with omeprazol via a 6-week double-blind randomized controlled clinical trial. Forty-five participants were assigned randomly to 3 groups as A (myrtle berries freeze-dried aqueous extract, 1000 mg/d), B (omeprazol capsules, 20 mg/d), and C (A and B). The assessment at the beginning and the end of the study was done by using a standardized questionnaire of frequency scale for the symptoms of gastroesophageal reflux disease (FSSG). In all groups, both reflux and dyspeptic scores significantly decreased in comparison with the respective baselines. Concerning each group, significant changes were found in FSSG, dysmotility-like symptoms and acid reflux related scores. No significant differences were observed between all groups in final FSSG total scores (FSSG2). Further studies with more precise design and larger sample size may lead to a better outcome to suggest the preparation as an alternative intervention.

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

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    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.

  14. 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.

  15. Evaluation of the Effects of Cucumis sativus Seed Extract on Serum Lipids in Adult Hyperlipidemic Patients: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Soltani, Rasool; Hashemi, Mohammad; Farazmand, Alimohammad; Asghari, Gholamreza; Heshmat-Ghahdarijani, Kiyan; Kharazmkia, Ali; Ghanadian, Syed Mustafa

    2017-01-01

    Hyperlipidemia is associated with increased risk of atherosclerosis; therefore, control of this risk factor is very important in preventing atherosclerosis. Cucumber (Cucumis sativus) seed is used traditionally as a lipid-lowering nutritional supplement. The aim of this study was to evaluate the effect of cucumber seed extract on serum lipid profile in adult patients with mild hyperlipidemia. In a randomized double-blind placebo-controlled clinical trial, hyperlipidemic patients with inclusion criteria were randomly and equally assigned to either Cucumis or placebo groups and used one medicinal or placebo capsule, respectively, once daily with food for 6 wk. Body mass index (BMI) as well as fasting serum levels of total cholesterol, triglycerides (TG), low-density lipoprotein (LDL-C), and high-density lipoprotein (HDL-C) were measured for all patients pre- and post-intervention and finally the changes were compared between the groups. Twenty-four patients in Cucumis group and 23 patients in placebo group completed the study. Cucumis seed extract resulted in significant reduction of total cholesterol (P = 0.016), LDL-C (P < 0.001), TG (P < 0.001), and BMI (P < 0.001) as well as significant increase of HDL-C (P = 0.012) compared to placebo. In conclusion, the consumption of C. sativus seed extract with daily dose of 500 mg results in desirable effects on serum lipid profile in adult hyperlipidemic patients. Therefore, cucumber seed could be considered as a food supplement for treatment of dyslipidemia.

  16. Effects of Zinc Supplementation on Endocrine Outcomes in Women with Polycystic Ovary Syndrome: a Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Jamilian, Mehri; Foroozanfard, Fatemeh; Bahmani, Fereshteh; Talaee, Rezvan; Monavari, Mahshid; Asemi, Zatollah

    2016-04-01

    The current study was conducted to evaluate the effects of zinc supplementation on endocrine outcomes, biomarkers of inflammation, and oxidative stress in patients with polycystic ovary syndrome (PCOS). This study was a randomized double-blind, placebo-controlled trial. Forty-eight women (18-40 years) with PCOS diagnosed according to Rotterdam criteria were randomly assigned to receive either 220 mg zinc sulfate (containing 50 mg zinc) (group 1; n = 24) and/or placebo (group 2; n = 24) for 8 weeks. Hormonal profiles, biomarkers of inflammation, and oxidative stress were measured at study baseline and after 8-week intervention. After 8 weeks of intervention, alopecia (41.7 vs. 12.5%, P = 0.02) decreased compared with the placebo. Additionally, patients who received zinc supplements had significantly decreased hirsutism (modified Ferriman-Gallwey scores) (-1.71 ± 0.99 vs. -0.29 ± 0.95, P zinc intake on reducing high-sensitivity C-reactive protein (hs-CRP) levels (P = 0.06) was also observed. We did observe no significant changes of zinc supplementation on hormonal profiles, inflammatory cytokines, and other biomarkers of oxidative stress. In conclusion, using 50 mg/day elemental zinc for 8 weeks among PCOS women had beneficial effects on alopecia, hirsutism, and plasma MDA levels; however, it did not affect hormonal profiles, inflammatory cytokines, and other biomarkers of oxidative stress.

  17. Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers: A Triple-Blind, Randomized, Placebo-Controlled Trial

    Science.gov (United States)

    Javadzadeh Bolouri, Abbas; Pakfetrat, Atessa; Tonkaboni, Arghavan; Aledavood, Seyed Amir; Fathi Najafi, Mohsen; Delavarian, Zahra; Shakeri, Mohammad Taghi; Mohtashami, Azade

    2015-01-01

    Background: Mucositis is one of the acute complications of radiotherapy which can ulcerate oral mucosa and cause severe pain and discomfort which can affect oral normal function. Propolis is a natural source of flavenoid which has antiulcer, antibacterial, antifungal, healing and anti-inflammatory effects. Using such an affordable compound without any bad smell or taste that has reasonable price can help the radiotherapy undergoing patients. Objectives: Our goal is assessing the preventing and therapeutic effect of propolis in radiotherapy induced mucositis in patients with head and neck cancer. Patients and Methods: In a randomized triple blind clinical trial, 20 patient were selected randomly to swish and swallow 15 ml of water based extract of propolis mouth wash 3 times a day in the case group (n = 10) and 15 ml placebo mouth wash in control group (n = 10). we use NIC-CTC scale for determining mucositis grading. Results: We use T-test, Man-Whitney, Chi-square, and Friedman as analyzing tests. Case group had significantly (P 0.05). Conclusions: This is a pilot study which shows water based extract of propolis efficiently prevents and heals radiotherapy induced mucositis. PMID:26634113

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

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    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.

  19. 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

    Science.gov (United States)

    Salehi, B.; Mohammadbeigi, A.; Kamali, A. R.; Taheri-Nejad, M. R.; Moshiri, I.

    2015-01-01

    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 2nd, 4th, 6th, and 8th 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 ketamine group (P > 0.05). But ketamine was more effective in improvement of depression score and increasing systolic and diastolic blood pressure (P 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. PMID:26440233

  20. Evaluation of efficacy of a commercially available herbal mouthwash on dental plaque and gingivitis: A double-blinded parallel randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sanjukta Bagchi

    2015-01-01

    Full Text Available Aim: To evaluate if a commercially available herbal mouthwash, can be a better choice as an anti-plaque and antigingivitis agent when compared with chlorhexidine. Materials and Methods: In a double-blind, parallel group randomized clinical trial 90 nursing students aged 18-25 years were randomly divided into three groups: A (chlorhexidine, B (HiOra and C (distilled water. These groups were asked to rinse with their respective mouthwash two times daily for 21 days. Plaque and gingivitis were evaluated by using Turesky et al. modification of Quigley Hein Plaque Index (1970 and Modified Gingival Index by Lobene et al. (1986 respectively. Statistical analysis was done using ANOVA test. Results: There was statistically significant reduction in plaque and gingival scores from baseline to 21 days in both the groups A and B. Conclusions: Although chlorhexidine group proved to be the best anti-plaque and antigingivitis agent, it was found that HiOra group also showed gradual improvement from baseline to 21 days. Whereas no improvement was seen in the Group C using distilled water over 21 days.

  1. Antibiotic prophylaxis in third molar surgery: A randomized double-blind placebo-controlled clinical trial using split-mouth technique.

    Science.gov (United States)

    Siddiqi, A; Morkel, J A; Zafar, S

    2010-02-01

    The use of prophylactic antibiotics to reduce postoperative complications in third molar surgery remains controversial. The study was a prospective, randomized, double blind, placebo-controlled clinical trial. 100 patients were randomly assigned to two groups. Each patient acted as their own control using the split-mouth technique. Two unilateral impacted third molars were removed under antibiotic cover and the other two were removed without antibiotic cover. The first group received antibiotics on the first surgical visit. On the second surgical visit (after 3 weeks), placebo capsules were given or vice versa. The second group received antibiotics with continued therapy for 2 days on the first surgical visit and on the second surgical visit (after 3 weeks) placebo capsules were given or vice versa. Pain, swelling, infection, trismus and temperature were recorded on days 3, 7 and 14 after surgery. Of 380 impactions, 6 sockets (2%) became infected. There was no statistically significant difference in the infection rate, pain, swelling, trismus, and temperature between the two groups (p>0.05). Results of the study showed that prophylactic antibiotics did not have a statistically significant effect on postoperative infections in third molar surgery and should not be routinely administered when third molars are removed in non-immunocompromised patients.

  2. The Effect of Ginger (Zingiber Officinale Powder Supplement on Pain in Patients with Knee Osteoarthritis: a Double-Blind Randomized Clinical Trial

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    A Nadjarzadeh

    2013-01-01

    Full Text Available Introduction: There is limited evidence that ginger (Zingiber Officinale powder consumption is effective to relieve the pain and inflammation due to special phytichemicals. The aim of this study was to investigate the effect of ginger powder supplementation in pain improvement in patients with knee osteoarthritis. Methods: This double-blind randomized clinical trial was conducted on 120 outpatients with knee osteoarthritis of moderate pain. Patients were randomly assigned to two groups: receiving ginger powder supplement and placebo. Ginger and placebo groups received two identical capsules per day for 12 weeks. Each capsule contained 500 mg ginger powder or starch. Pain severity was measured by VAS (Visual Analog Scale at first and after 3 months. A responder was defined as a reduction in pain of > 1.5 cm on a visual analog scale (VAS. Results: Before intervention, there was no significant difference between the two groups in severity of pain. However, after ginger supplementation, pain score decreased in ginger group. After 12 weeks, Pain reduction was more significant in ginger group than placebo. Response to intervention was 88% and 14% in ginger and placebo groups, respectively. There was statistically significant difference between both groups in response to intervention (p<0.001. Conclusion: The results of this study showed that ginger powder supplementation was effective in reducing pain in patients with knee osteoarthritis, therefore it is recommended as a safe supplement for these patients

  3. Non-Celiac Gluten Sensitivity Has Narrowed the Spectrum of Irritable Bowel Syndrome: A Double-Blind Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Shahbazkhani, Bijan; Sadeghi, Amirsaeid; Malekzadeh, Reza; Khatavi, Fatima; Etemadi, Mehrnoosh; Kalantri, Ebrahim; Rostami-Nejad, Mohammad; Rostami, Kamran

    2015-06-05

    Several studies have shown that a large number of patients who are fulfilling the criteria for irritable bowel syndrome (IBS) are sensitive to gluten. The aim of this study was to evaluate the effect of a gluten-free diet on gastrointestinal symptoms in patients with IBS. In this double-blind randomized, placebo-controlled trial, 148 IBS patients fulfilling the Rome III criteria were enrolled between 2011 and 2013. However, only 72 out of the 148 commenced on a gluten-free diet for up to six weeks and completed the study; clinical symptoms were recorded biweekly using a standard visual analogue scale (VAS). In the second stage after six weeks, patients whose symptoms improved to an acceptable level were randomly divided into two groups; patients either received packages containing powdered gluten (35 cases) or patients received placebo (gluten free powder) (37 cases). Overall, the symptomatic improvement was statistically different in the gluten-containing group compared with placebo group in 9 (25.7%), and 31 (83.8%) patients respectively (p gluten. Using the term of IBS can therefore be misleading and may deviate and postpone the application of an effective and well-targeted treatment strategy in gluten sensitive patients.

  4. Safe intake of an oral supplement containing carbohydrates and whey protein shortly before sedation to gastroscopy: a double-blind, randomized trial

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    José Eduardo de Aguilar-Nascimento

    2014-03-01

    Full Text Available Objective: To investigate the gastric emptying of an oral supplement containing carbohydrate plus whey protein drunk before sedation for gastroscopy. Methods: This is a randomized double-blind trial including adult patients (ages 18-65 with a chief complaint of epigastric burning and who were candidates to elective gastroscopy. After overnight fast subjects were randomized to drink 200 mL of an oral nutritional supplement containing maltodextrine in addition to whey protein 150 to 210 min before the gastroscopy (intervention group, n = 12 or to undergo the endoscopic procedure with no supplement (control group, n = 12. The residual gastric volume (RGV suctioned and measured during the exam was the main endpoint of the study. Results: There were no complications during all exams. The median (range fasting time was greater (P < 0.001 in control group (770 min, ranging from 660-917 min than in the study group (175min ranging from 150 to 210 min. The median (range RGV was similar in between the two groups (control group: 25 (10-70 mL versus intervention group: 10 (0-100 mL; p = 0.32. Conclusion: Gastric emptying 150-210 min after the ingestion of an oral supplement containing carbohydrate plus whey protein is similar to an overnight fasting condition. Although limited by the number of cases, the sedation for endoscopic procedures is safe with this fasting protocol.

  5. Comparison of anti-inflammatory and analgesic effects of Ginger powder and Ibuprofen in postsurgical pain model: A randomized, double-blind, case–control clinical trial

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    Rayati, Farshid; Hajmanouchehri, Fatemeh; Najafi, Elnaz

    2017-01-01

    Background: Ginger has been used as an herbal drug for a long time for the treatment of chronic inflammatory conditions. Materials and Methods: This randomized, double-blind clinical trial was conducted on 67 healthy adults with at least one impacted lower third molar. Participants were randomly allocated into three groups: Ibuprofen, Ginger, and placebo. Evaluation of inflammation was done by measuring cheek swelling, mouth opening ability, serum C-reactive protein (CRP) levels, and visual analog scale (for pain scoring). The number and the time of using rescue medication were recorded too. Results: Sixty patients completed the study. In all three groups, there was a significant increase in the mean cheek swelling measures, compared with the baseline, until day 5. The reduction in mouth opening ability was significant in all three groups, compared with the baseline, until day 5. There was no significant difference between ibuprofenand ginger groups in pain scores in all follow-up days. Number of required rescue medication on the day of surgery was significantly more in the placebo group. No significant or strong correlations were found between CRP levels and clinical findings. Conclusion: Within the limitations of this study, it can ban be concluded that gingerpowder is as effective as ibuprofenin the management of postsurgical sequelae. Furthermore, CRP levels alone are not suggested for the assessment of anti-inflammatory effects of drugs.

  6. Efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy: a randomized double-blind controlled trial

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    Meteerattanapipat, Pontip; Phupong, Vorapong

    2017-01-01

    The aim of this study was to compare the therapeutic efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. A double-blinded, randomized, controlled trial was conducted. One hundred pregnant women at less than 36 weeks gestation with heartburn at least twice per week were randomized to either alginate-based reflux suppressant or to magnesium-aluminium antacid gel. Details of heartburn were recorded before beginning the treatment and the second week of study. Primary outcome measure was the improvement of heartburn frequency after treatment and secondary outcome were the improvement of heartburn intensity, quality of life, maternal satisfaction, maternal side effects, pregnancy and neonatal outcomes. There was no difference between treatment and control groups in improvement of heartburn frequency (80% vs 88%, p = 0.275), 50% reduction of frequency of heartburn (56% vs 52%, p = 0.688), improvement of heartburn intensity (92% vs 92%, p = 1.000) and 50% reduction of heartburn intensity (68% vs 80% cases, p = 0.075). There were also no significant differences in quality of life, maternal satisfaction, maternal side effects, pregnancy and neonatal outcomes. Alginate-based reflux suppressant was not different from magnesium-aluminium antacid gel in the treatment of heartburn in pregnancy. PMID:28317885

  7. Double blind randomized placebo-controlled trial on the effects of testosterone supplementation in elderly men with moderate to low testosterone levels: design and baseline characteristics [ISRCTN23688581

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    Verhaar Harald JJ

    2006-08-01

    Full Text Available Abstract In ageing men testosterone levels decline, while cognitive function, muscle and bone mass, sexual hair growth, libido and sexual activity decline and the risk of cardiovascular diseases increase. We set up a double-blind, randomized placebo-controlled trial to investigate the effects of testosterone supplementation on functional mobility, quality of life, body composition, cognitive function, vascular function and risk factors, and bone mineral density in older hypogonadal men. We recruited 237 men with serum testosterone levels below 13.7 nmol/L and ages 60–80 years. They were randomized to either four capsules of 40 mg testosterone undecanoate (TU or placebo daily for 26 weeks. Primary endpoints are functional mobility and quality of life. Secondary endpoints are body composition, cognitive function, aortic stiffness and cardiovascular risk factors and bone mineral density. Effects on prostate, liver and hematological parameters will be studied with respect to safety. Measure of effect will be the difference in change from baseline visit to final visit between TU and placebo. We will study whether the effect of TU differs across subgroups of baseline waist girth ( At baseline, mean age, BMI and testosterone levels were 67 years, 27 kg/m2 and 10.72 nmol/L, respectively.

  8. The Influence of Oral Ginger before Operation on Nausea and Vomiting after Cataract Surgery under General Anesthesia: A double-blind placebo-controlled randomized clinical trial

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    Seidi, Jamal; Ebnerasooli, Shahrokh; Shahsawari, Sirous; Nzarian, Simin

    2017-01-01

    Background According to Iranian traditional medicine, using safe ginger may contribute to taking less chemical medicines and result in fewer side effects. Objective To determine the influence of using ginger before operation on nausea and vomiting, after cataract surgery under general anesthesia. Methods This study was a double-blind placebo-controlled randomized clinical trial conducted at Kurdistan University of Medical Sciences in 2015. 122 candidates of cataract surgery were randomly allocated in three groups. The first group received a ginger capsule in a single 1 g dose, the second received two separate doses of ginger capsule each containing 500 mg and the third group received placebo capsule before operation. The patients were examined and studied for the level of nausea and occurrence of vomiting for 6 hours after the operation. The intensity of nausea was scored from zero to ten, based upon Visual Analog Scale. SPSS version 20 was used to analyze the data. We used Chi square and Kruskal-Wallis test for the analyses of outcomes. Results The frequency and intensity of nausea and the frequency of vomiting after operation among those who had taken the ginger capsule in 2 separate 500 mg doses was less than the other 2 groups. This difference was significant (pKurdistan University of Medical Sciences, Sanandaj, Iran. PMID:28243400

  9. Role of enteric supplementation of probiotics on late-onset sepsis by candida species in preterm low birth weight neonates: A randomized, double blind, placebo-controlled trial

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    Amrita Roy

    2014-01-01

    Full Text Available Background: The increase in invasive fungal infections (IFIs in neonatal intensive care unit (NICU is jeopardizing the survival of preterm neonates. Probiotics modulating the intestinal microflora of preterm neonates may minimize enteral fungal colonization. Aims: This study was to examine whether probiotic supplementation in neonates reduced fungal septicemia. Materials and Methods: This prospective, randomized, double blind trial investigating the supplementation of preterm infants with a probiotic was done from May 2012 to April 2013, with 112 subjects randomized into two groups. Primary outcome: Decreased fungal colonization in gastrointestinal tract. Others: Incidence of late onset septicemia; duration of the primary hospital admission; number of days until full enteral feeds established. Results: Full feed establishment was earlier in probiotics group compared to placebo group (P = 0.016. The duration of hospitalization was less in the probiotic group (P = 0.002. Stool fungal colonization, an important outcome parameter was 3.03 ± 2.33 × 10 5 colony formation units (CFU in the probiotics group compared to 3 ± 1.5 × 10 5 CFU in the placebo group (P = 0.03. Fungal infection is less in the study group (P = 0.001. Conclusion: The key features of our study were reduced enteral fungal colonization, reduce invasive fungal sepsis, earlier establishment of full enteral feeds, and reduced duration of hospital stay in the probiotics group.

  10. PARTICIPANT BLINDING AND GASTROINTESTINAL ILLNESS IN A RANDOMIZED, CONTROLLED TRIAL OF AN IN-HOME DRINKING WATER INTERVENTION

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    Background. There is no consensus about the level of risk of gastrointestinal illness posed by consumption of drinking water that meets all regulatory requirements. Earlier drinking water intervention trials from Canada suggested that 14% - 40% of such gastrointestinal il...

  11. Olanzapine versus Placebo in Adolescents with Schizophrenia; a 6-Week, Randomized Double-Blind, Placebo-Controlled Trial

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    Kryzhanovskaya, Ludmila; Schulz, Charles; McDougle, Christopher; Frazier, Jean; Dittman, Ralf; Robertson-Plouch, Carol; Bauer, Theresa; Xu, Wen; Wang, Wei; Carlson, Janice; Tohen, Mauricio

    2009-01-01

    The efficacy of olanzapine in treating schizophrenia was tested through a placebo-controlled trial involving one hundred seven inpatient and outpatients adolescents. Patients who took olanzapine experienced significant symptom improvement.

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

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    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

  13. A single dose of preoperative gabapentin for pain reduction and requirement of morphine after total mastectomy and axillary dissection: Randomized placebo-controlled double-blind trial

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    Grover V

    2009-01-01

    Full Text Available Background : Gabapentin has been recently found to be useful for reducing acute postoperative pain when administered preoperatively. Although various dose regimens have been tried in different surgical settings, the minimum effective dose is not established. Aims : We aimed to evaluate the analgesic efficacy of single low dose gabapentin in patients undergoing total mastectomy and axillary dissection. Settings and Design : Prospective randomized placebo-controlled double-blind trial in a tertiary care teaching hospital. Materials and Methods : Fifty women scheduled for total mastectomy and axillary dissection were randomized to receive either gabapentin 600 mg or placebo orally 1 h preoperatively. The intraoperative and postoperative management was standardized. Postoperative pain was assessed at rest and on movement for 12 h using the numerical rating scale (NRS. Morphine was administered if NRS exceeded 30. Primary outcome measure was total morphine consumption. Statistical Analysis : The morphine consumption was compared using independent t test while pain and sedation scores were analyzed using Mann-Whitney U test. Results : Forty-six patients completed the trial. The postoperative morphine consumption was significantly less (5.8 ± 4.2 vs. 11.0 ± 3.4 mg; P 〈 0.001 and the median [IQR] time to first analgesic was significantly longer (90 [37.5-120] vs. 0 [0-90] min; P 〈 0.001 in the gabapentin group than in the placebo group. The incidence of side effects was similar in the two groups. Conclusions : A single low dose of 600 mg gabapentin administered 1 h prior to surgery produced effective and significant postoperative analgesia after total mastectomy and axillary dissection without significant side effects.

  14. 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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    Alireza Ostadrahimi

    2015-02-01

    Full Text Available 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.

  15. Randomized, Double-Blind, Placebo-Controlled, Phase III Chemoprevention Trial of Selenium Supplementation in Patients With Resected Stage I Non–Small-Cell Lung Cancer: ECOG 5597

    Science.gov (United States)

    Karp, Daniel D.; Lee, Sandra J.; Keller, Steven M.; Wright, Gail Shaw; Aisner, Seena; Belinsky, Steven Alan; Johnson, David H.; Johnston, Michael R.; Goodman, Gary; Clamon, Gerald; Okawara, Gordon; Marks, Randolph; Frechette, Eric; McCaskill-Stevens, Worta; Lippman, Scott M.; Ruckdeschel, John; Khuri, Fadlo R.

    2013-01-01

    Purpose Selenium has been reported to have chemopreventive benefits in lung cancer. We conducted a double-blind, placebo-controlled trial to evaluate the incidence of second primary tumors (SPTs) in patients with resected non–small-cell lung cancer (NSCLC) receiving selenium supplementation. Patients and Methods Patients with completely resected stage I NSCLC were randomly assigned to take selenized yeast 200 μg versus placebo daily for 48 months. Participation was 6 to 36 months postoperatively and required a negative mediastinal node biopsy, no excessive vitamin intake, normal liver function, negative chest x-ray, and no other evidence of recurrence. Results The first interim analysis in October 2009, with 46% of the projected end points accumulated, showed a trend in favor of the placebo group with a low likelihood that the trial would become positive; thus, the study was stopped. One thousand seven hundred seventy-two participants were enrolled, with 1,561 patients randomly assigned. Analysis was updated in June 2011 with the maturation of 54% of the planned end points. Two hundred fifty-two SPTs (from 224 patients) developed, of which 98 (from 97 patients) were lung cancer (38.9%). Lung and overall SPT incidence were 1.62 and 3.54 per 100 person-years, respectively, for selenium versus 1.30 and 3.39 per 100 person-years, respectively, for placebo (P = .294). Five-year disease-free survival was 74.4% for selenium recipients versus 79.6% for placebo recipients. Grade 1 to 2 toxicity occurred in 31% of selenium recipients and 26% of placebo recipients, and grade ≥ 3 toxicity occurred in less than 2% of selenium recipients versus 3% of placebo recipients. Compliance was excellent. No increase in diabetes mellitus or skin cancer was detected. Conclusion Selenium was safe but conferred no benefit over placebo in the prevention of SPT in patients with resected NSCLC. PMID:24002495

  16. 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

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    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

  17. Effect of a high-intensity exercise program on physical function and mental health in nursing home residents with dementia: an assessor blinded randomized controlled trial.

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    Elisabeth Wiken Telenius

    Full Text Available Dementia is among the leading causes of functional loss and disability in older adults. Research has demonstrated that nursing home patients without dementia can improve their function in activities of daily living, strength, balance and mental well being by physical exercise. The evidence on effect of physical exercise among nursing home patients with dementia is scarce and ambiguous. Thus, the primary objective of this study was to investigate the effect of a high intensity functional exercise program on the performance of balance in nursing home residents with dementia. The secondary objective was to examine the effect of this exercise on muscle strength, mobility, activities of daily living, quality of life and neuropsychiatric symptoms.This single blinded randomized controlled trial was conducted among 170 persons with dementia living in nursing homes. Mean age was 86.7 years (SD = 7.4 and 74% were women. The participants were randomly allocated to an intervention (n = 87 or a control group (n = 83. The intervention consisted of intensive strengthening and balance exercises in small groups twice a week for 12 weeks. The control condition was leisure activities.The intervention group improved the score on Bergs Balance Scale by 2.9 points, which was significantly more than the control group who improved by 1.2 points (p = 0.02. Having exercised 12 times or more was significantly associated with improved strength after intervention (p<0.05. The level of apathy was lower in the exercise group after the intervention, compared to the control group (p = 0.048.The results from our study indicate that a high intensity functional exercise program improved balance and muscle strength as well as reduced apathy in nursing home patients with dementia.ClinicalTrials.gov NCT02262104.

  18. 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

  19. Adjacent, distal, or combination of point-selective effects of acupuncture on temporomandibular joint disorders: A randomized, single-blind, assessor-blind controlled trial

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    Kyung-Won Kang

    2012-12-01

    Conclusion: Our results suggest that point-selective effects among adjacent, distal, or a combination of acupoints are hardly associated with pain intensity or palpation index in participants with TMDs. Larger sample size trials are required to overcome the shortcomings of the study.

  20. Effects of oral L-carnitine administration in narcolepsy patients: a randomized, double-blind, cross-over and placebo-controlled trial.

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    Taku Miyagawa

    Full Text Available UNLABELLED: Narcolepsy is a sleep disorder characterized by excessive daytime sleepiness, cataplexy, and rapid eye movement (REM sleep abnormalities. A genome-wide association study (GWAS identified a novel narcolepsy-related single nucleotide polymorphism (SNP, which is located adjacent to the carnitine palmitoyltransferase 1B (CPT1B gene encoding an enzyme involved in β-oxidation of long-chain fatty acids. The mRNA expression levels of CPT1B were associated with this SNP. In addition, we recently reported that acylcarnitine levels were abnormally low in narcolepsy patients. To assess the efficacy of oral L-carnitine for the treatment of narcolepsy, we performed a clinical trial administering L-carnitine (510 mg/day to patients with the disease. The study design was a randomized, double-blind, cross-over and placebo-controlled trial. Thirty narcolepsy patients were enrolled in our study. Two patients were withdrawn and 28 patients were included in the statistical analysis (15 males and 13 females, all with HLA-DQB1*06:02. L-carnitine treatment significantly improved the total time for dozing off during the daytime, calculated from the sleep logs, compared with that of placebo-treated periods. L-carnitine efficiently increased serum acylcarnitine levels, and reduced serum triglycerides concentration. Differences in the Japanese version of the Epworth Sleepiness Scale (ESS and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36 vitality and mental health subscales did not reach statistical significance between L-carnitine and placebo. This study suggests that oral L-carnitine can be effective in reducing excessive daytime sleepiness in narcolepsy patients. TRIAL REGISTRATION: University hospital Medical Information Network (UMIN UMIN000003760.

  1. Randomized double-blind placebo-controlled trial of sublingual immunotherapy in children with house dust mite allergy in primary care: study design and recruitment

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    de Jongste Johan C

    2008-10-01

    Full Text Available Abstract Background For respiratory allergic disorders in children, sublingual immunotherapy has been developed as an alternative to subcutaneous immunotherapy. Sublingual immunotherapy is more convenient, has a good safety profile and might be an attractive option for use in primary care. A randomized double-blind placebo-controlled study was designed to establish the efficacy of sublingual immunotherapy with house dust mite allergen compared to placebo treatment in 6 to18-year-old children with allergic rhinitis and a proven house dust mite allergy in primary care. Described here are the methodology, recruitment phases, and main characteristics of the recruited children. Methods Recruitment took place in September to December of 2005 and 2006. General practitioners (in south-west Netherlands selected children who had ever been diagnosed with allergic rhinitis. Children and parents could respond to a postal invitation. Children who responded positively were screened by telephone using a nasal symptom score. After this screening, an inclusion visit took place during which a blood sample was taken for the RAST test. Results A total of 226 general practitioners invited almost 6000 children: of these, 51% was male and 40% Conclusion Our study was designed in accordance with recent recommendations for research on establishing the efficacy of sublingual immunotherapy; 98% of the target sample size was achieved. This study is expected to provide useful information on sublingual immunotherapy with house dust mite allergen in primary care. The results on efficacy and safety are expected to be available by 2010. Trial registration the trial is registered as ISRCTN91141483 (Dutch Trial Register

  2. Neuroplastic effects of transcranial direct current stimulation on painful symptoms reduction in chronic Hepatitis C: a phase II randomized, double blind, sham controlled trial

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    Aline Patricia Brietzke

    2016-01-01

    Full Text Available Introduction: Pegylated Interferon Alpha (Peg-IFN in combination with other drugs is the standard treatment for chronic hepatitis C infection (HCV and is related to severe painful symptoms. The aim of this study was access the efficacy of transcranial direct current stimulation (tDCS in controlling the painful symptoms related to Peg-IFN side effects. Material and Methods: In this phase II double-blind trial, twenty eight (n=28 HCV subjects were randomized to receive either five consecutive days of active tDCS (n=14 or sham (n=14 during five consecutive days with anodal stimulation over the primary motor cortex region using 2 mA for 20 minutes. The primary outcomes were visual analogue scale (VAS pain and brain-derived neurotrophic factor (BDNF serum levels. Secondary outcomes were the pressure-pain threshold (PPT, the Brazilian Profile of Chronic Pain: Screen (B-PCP:S and drug analgesics use. Results: tDCS reduced the VAS scores (P<0.003, with a mean pain drop of 56% (p<0.001. Furthermore, tDCS was able to enhance BDNF levels (p<0.01. The mean increase was 37.48% in the active group. Finally, tDCS raised PPT (p<0.001 and reduced the B-PCP:S scores and analgesic use (p<0.05. Conclusions: Five sessions of tDCS were effective in reducing the painful symptoms in HCV patients undergoing Peg-IFN treatment. These findings support the efficacy of tDCS as a promising therapeutic tool to improve the tolerance of the side effects related to the use of Peg-IFN. Future larger studies (phase III and IV trials are needed to confirm the clinical use of the therapeutic effects of tDCS in such condition. Trial registration: Brazilian Human Health Regulator for Research with the approval number CAAE 07802012.0.0000.5327

  3. A post hoc analysis of negative symptoms and psychosocial function in patients with schizophrenia: a 40-week randomized, double-blind study of ziprasidone versus haloperidol followed by a 3-year double-blind extension trial.

    Science.gov (United States)

    Stahl, Stephen M; Malla, Ashok; Newcomer, John W; Potkin, Steven G; Weiden, Peter J; Harvey, Philip D; Loebel, Antony; Watsky, Eric; Siu, Cynthia O; Romano, Steve

    2010-08-01

    Schizophrenia is a persistent, lifelong illness such that enduring functional improvements may only occur over the course of years [corrected].This post hoc analysis in stable outpatients with schizophrenia investigated the negative symptom efficacy and treatment outcomes of ziprasidone (80-160 mg/d given twice a day, mean modal dose of 112 mg/d; and 80-120 mg/d given every day, mean modal dose of 96 mg/d) versus haloperidol (5-20 mg/d, mean modal dose of 12 mg/d) in a randomized, 40-week, double-blind study, followed by a double-blind continuation trial that extended up to 156 additional weeks. Symptomatic and functional recovery criteria were met when subjects attained both negative symptom remission and adequate psychosocial functioning based on the 4 Quality-of-Life subscales (instrumental role, interpersonal relations, participation in community, and intrapsychic foundations). Negative symptom remission (P = 0.005), as well as sustained adequate functioning (6 months) in instrumental role (P = 0.04) and participation in community (P = 0.02), was associated with significantly shorter time to remission in the ziprasidone 80 to 160 mg group than in the haloperidol group, as was the combination of symptomatic and functional recovery during the 196-week double-blind study period. A similar pattern was observed for the ziprasidone 80 to 120 mg group, which showed significant differences versus haloperidol in negative symptom remission and instrumental role functioning (but not other Quality-of-Life subscale measures). The clinically relevant outcome differences detected in this post hoc exploratory analysis support the potential for both enhanced remission in negative symptoms and psychosocial recovery during long-term treatment with an atypical agent and add to our understanding regarding the degree to which negative symptom remission can be attained in the maintenance phase.

  4. Chlorproguanil-dapsone-artesunate versus artemether-lumefantrine: a randomized, double-blind phase III trial in African children and adolescents with uncomplicated Plasmodium falciparum malaria.

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    Zul Premji

    Full Text Available BACKGROUND: Chlorproguanil-dapsone-artesunate (CDA was developed as an affordable, simple, fixed-dose artemisinin-based combination therapy for use in Africa. This trial was a randomized parallel-group, double-blind, double-dummy study to compare CDA and artemether-lumefantrine (AL efficacy in uncomplicated Plasmodium falciparum malaria and further define the CDA safety profile, particularly its hematological safety in glucose-6-phosphate dehydrogenase (G6PD -deficient patients. METHODS AND FINDINGS: The trial was conducted at medical centers at 11 sites in five African countries between June 2006 and August 2007. 1372 patients (> or =1 to <15 years old, median age 3 years with acute uncomplicated P. falciparum malaria were randomized (2:1 to receive CDA 2/2.5/4 mg/kg once daily for three days (N = 914 or six-doses of AL over three days (N = 458. Non-inferiority of CDA versus AL for efficacy was evaluated in the Day 28 per-protocol (PP population using parasitological cure (polymerase chain reaction [PCR]-corrected. Cure rates were 94.1% (703/747 for CDA and 97.4% (369/379 for AL (treatment difference -3.3%, 95%CI -5.6, -0.9. CDA was non-inferior to AL, but there was simultaneous superiority of AL (upper 95%CI limit <0. Adequate clinical and parasitological response at Day 28 (uncorrected for reinfection was 79% (604/765 with CDA and 83% (315/381 with AL. In patients with a G6PD-deficient genotype (94/603 [16%] hemizygous males, 22/598 [4%] homozygous females, CDA had the propensity to cause severe and clinically concerning hemoglobin decreases: the mean hemoglobin nadir was 75 g/L (95%CI 71, 79 at Day 7 versus 97 g/L (95%CI 91, 102 for AL. There were three deaths, unrelated to study medication (two with CDA, one with AL. CONCLUSIONS: Although parasitologically effective at Day 28, the hemolytic potential of CDA in G6PD-deficient patients makes it unsuitable for use in a public health setting in Africa. TRIAL REGISTRATION: ClinicalTrials.Gov NCT

  5. Impact of morphine use in reducing the need for CT scan in patients with cervical spine trauma: a double blinded randomized clinical trial

    Science.gov (United States)

    Sharifi, Mohammad Davood; Doloo, Hamid Zamani Moghadam; Hashemian, Amir Masoud; Tourghabe, Javad Tootian; Kakhki, Behrang Rezvani; Teimoori, Sasan Johari; Chokan, Niaz Mohammad Jafari; Noroozi, Hamid Reza

    2016-01-01

    Background Cervical spine trauma occurs mostly among young males due to falls and car accidents. The CT scan technology is replacing radiography in many medical clinics as it is very capable in detecting subtle cervical spine injuries. However, the use of CT scan for routine screening in patients with cervical spine trauma remains controversial due to its radiation risks and relatively high cost. Objective The focus of this research was on using morphine in patients with cervical spine trauma. The objective was to determine the ability of morphine to reduce the number of patients in need of CT scans. Methods This double-blinded randomized clinical trial study was conducted from April 2014 to March 2015 in Hasheminejad Hospital in Mashhad, Iran. We enrolled 67 patients with cervical spine trauma and normal radiography in the study. They were divided randomly into two groups (groups A and B), where group A received intravenous morphine, and group B received a placebo. We measured the pain scores in both groups before giving the medication and 10 minutes afterwards using a visual analog scale (VAS). Results As a result of receiving morphine, the patients in group A had significantly lower pain than group B (p-value < 0.001). The average pain score in group A was reduced by 43% versus 23% in group B. However, the most pain reduction was in those in group A with a normal CT scan. The pain score of these patients dropped by 52%. Conclusions The findings of this study suggest that patients with a normal radiography may be discharged with a cervical collar without a need for a CT scan if morphine reduces their pain. This is because the pain in these patients stem from the muscles and non-bony structures in the cervical spine area. Clinical trial registration: The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the IRCT ID: IRCT2013100214872N1 Funding The authors received no financial support for the research or for the publication

  6. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double‐Blind, Placebo‐Controlled Trials

    Science.gov (United States)

    Wallace, Daniel J.; Furie, Richard A.; Petri, Michelle A.; Pike, Marilyn C.; Leszczyński, Piotr; Neuwelt, C. Michael; Hobbs, Kathryn; Keiserman, Mauro; Duca, Liliana; Kalunian, Kenneth C.; Galateanu, Catrinel; Bongardt, Sabine; Stach, Christian; Beaudot, Carolyn; Kilgallen, Brian; Gordon, Caroline; Batalov, A.; Bojinca, M.; Djerassi, R.; Duca, L.; Horak, P.; Kolarov, Z.; Milasiene, R.; Monova, D.; Otsa, K.; Pileckyte, M.; Popova, T.; Radulescu, F.; Rashkov, R.; Rednic, S.; Repin, M.; Stoilov, R.; Tegzova, D.; Vezikova, N.; Vitek, P.; Zainea, C.; East, Far; Baek, H.; Chen, Y.; Chiu, Y.; Cho, C.; Chou, C.; Choe, J.; Huang, C.; Kang, Y.; Kang, S.; Lai, N.; Lee, S.; Park, W.; Shim, S.; Suh, C.; Yoo, W.; Armengol, H. Avila; Zapata, F. Avila; Santiago, M. Barreto; Cavalcanti, F.; Chahade, W.; Costallat, L.; Keiserman, M.; Alcala, J. Orozco; Remus, C. Ramos; Roimicher, L.; Abu‐Shakra, M.; Agarwal, V.; Agmon‐Levin, N.; Kadel, J.; Levy, Y.; Mevorach, D.; Paran, D.; Reitblat, T.; Rosner, I.; Shobha, V.; Sthoeger, Z.; Zisman, D.; Ayesu, K.; Berney, S.; Box, J.; Busch, H.; Buyon, J.; Carter, J.; Chi, J.; Clowse, M.; Collins, R.; Dao, K.; Diab, I.; Dikranian, A.; El‐Shahawy, M.; Gaylis, N.; Grossman, J.; Halpert, E.; Huff, J.; Jarjour, W.; Kao, A.; Katz, R.; Kennedy, A.; Khan, M.; Kivitz, A.; Kohen, M.; Lawrence‐Ford, T.; Lawson, J.; Levesque, M.; Lowenstein, M.; Majjhoo, A.; Mcarthur, R.; McLain, D.; Merrill, J.; Murillo, A.; Neucks, S.; Niemer, G.; Noaiseh, G.; Parker, C.; Pantojas, C.; Pattanaik, D.; Petri, M.; Pickrell, P.; Reveille, J.; Roman‐Miranda, A.; Rothfield, N.; Sankoorikal, A.; Sayers, M.; Singhal, A.; Snyder, A.; Striebich, C.; Vo, Q.; von Feldt, J.; Wallace, D.; Wasko, M.; Young, C.; Adelstein, S.; Hall, S.; Littlejohn, G.; Nicholls, D.; Suranyi, M.; Amoura, Z.; Bannert, B.; Behrens, F.; Perez, L.Carreno; Chakravarty, K.; Gonzales, F. Diaz; Davies, K.; Doria, A.; Emery, P.; Fernández‐Nebro, A.; Govoni, M.; Hachulla, E.; Hellmich, B.; Houssiau, F.; Malaise, M.; Margaux, J.; Maugars, Y.; Muñoz‐Fernández, S.; Navarro, F.; Ordi‐Ros, J.; Pellerito, R.; Pena‐Sagredo, J.; Roussou, E.; Schmidt, R. E.; Ucar‐Angulo, E.; Viallard, J‐F.; Westhovens, R.; Worm, M.; Yee, C. S.; Nayiager, S.; Reuter, H.; Spargo, C.; Bazela, B.; Brzosko, M.; Chudzik, D.; Gasztonyi, B.; Geher, P.; Ionescu, R.; Jeka, S.; Kemeny, L.; Kiss, E.; Kotyla, P.; Kovacs, L.; Kovalenko, V.; Kucharz, E.; Kwiatkowska, B.; Leszczynski, P.; Levchenko, E.; Lysenko, G.; Majdan, M.; Mihailov, C.; Nalotov, S.; Nedelciu, M.; Pavel, M.; Raskina, T.; Rebrov, B.; Rezus, E.; Semen, T.; Smakotina, S.; Stanislavchuk, M.; Stanislav, M.; Szombati, I.; Szucs, G.; Udrea, G.; Zajdel, J.; Zon‐Giebel, A.; Bonfiglioli, R.; Bustamante, R.; Klumb, E.; Ramirez, G. Medrano; Neiva, C.; Olguin, M.; Gonzaga, J.Reyes; Scotton, A.; Ayala, S. Sicsik; Ximenes, A.; Sharma, R.; Srikantiah, C.; Aelion, J.; Aranow, C.; Baker, M.; Chadha, A.; Chao, J.; Chatham, W.; Chow, A.; Clay, C.; Cohen‐Gadol, S.; Conaway, D.; Denburg, J.; Escalante, A.; Espinoza, L.; Fiechtner, J.; Fortin, I.; Fraser, A.; Furie, R.; Gladman, D.; Goddard, D.; Goldberg, M.; Gonzalez‐Rivera, R.; Gorman, J.; Griffin, R.; Haaland, D.; Halter, D.; Hemaiden, A.; Hobbs, K.; Joshi, V.; Lim, S.; Kalunian, K.; Karpouzas, G.; Khraishi, M.; Lafyatis, R.; Lee, S.; Lidman, R.; Lue, C.; Mohan, M.; Mease, P.; Mehta, C.; Mizutani, W.; Nami, A.; Nascimento, J.; Neuwelt, C.; Pappas, J.; Pope, J.; Porges, A.; Roane, G.; Rosenberg, D.; Ross, S.; Saadeh, C.; Scoville, C.; Sherrer, Y.; Solomon, M.; Surbeck, W.; Valenzuela, G.; Waller, P.; Alten, R.; Baerwald, C.; Bienvenu, B.; Bombardieri, S.; Braun, J.; Dival, L.; Espinosa, G.; Fernandez, I. Figueroa; Gomez‐Reino, J.; Gordon, C.; Hiepe, F.; Hopkinson, N.; Isenberg, D.; Jacobi, A.; Jorgensen, C.; Guern, V. Le; Paul, C.; Pego‐Reigosa, J. M.; Heredia, J. Rodriguez; Rubbert‐Roth, A.; Sabbadini, M.; Schroeder, J.; Schwarting, A.; Spieler, W.; Valesini, G.; Wollenhaupt, J.; Mendoza, A. Zea; Zouboulis, C.

    2017-01-01

    Objective Epratuzumab, a monoclonal antibody that targets CD22, modulates B cell signaling without substantial reductions in the number of B cells. The aim of this study was to report the results of 2 phase III multicenter randomized, double‐blind, placebo‐controlled trials, the EMBODY 1 and EMBODY 2 trials, assessing the efficacy and safety of epratuzumab in patients with moderately to severely active systemic lupus erythematosus (SLE). Methods Patients met ≥4 of the American College of Rheumatology revised classification criteria for SLE, were positive for antinuclear antibodies and/or anti–double‐stranded DNA antibodies, had an SLE Disease Activity Index 2000 (SLEDAI‐2K) score of ≥6 (increased disease activity), had British Isles Lupus Assessment Group 2004 index (BILAG‐2004) scores of grade A (severe disease activity) in ≥1 body system or grade B (moderate disease activity) in ≥2 body systems (in the mucocutaneous, musculoskeletal, or cardiorespiratory domains), and were receiving standard therapy, including mandatory treatment with corticosteroids (5–60 mg/day). BILAG‐2004 grade A scores in the renal and central nervous system domains were excluded. Patients were randomized 1:1:1 to receive either placebo, epratuzumab 600 mg every week, or epratuzumab 1,200 mg every other week, with infusions delivered for the first 4 weeks of each 12‐week dosing cycle, for 4 cycles. Patients across all 3 treatment groups also continued with their standard therapy. The primary end point was the response rate at week 48 according to the BILAG‐based Combined Lupus Assessment (BICLA) definition, requiring improvement in the BILAG‐2004 score, no worsening in the BILAG‐2004 score, SLEDAI‐2K score, or physician's global assessment of disease activity, and no disallowed changes in concomitant medications. Patients who discontinued the study medication were classified as nonresponders. Results In the EMBODY 1 and EMBODY 2 trials of epratuzumab, 793

  7. 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

  8. Lactobacilli vs antibiotics to prevent urinary tract infections: A randomized, double-blind, noninferiority trial in postmenopausal women

    NARCIS (Netherlands)

    M.A.J. Beerepoot (Mariëlle); G. ter Riet; S. Nys (Sita); W. van der Wal (Willem); C.A. de Borgie (Corianne); T.M. de Reijke (Theo); J.M. Prins (Jan); J. Koeijers (Jeanne); A. Verbon (Annelies); E.E. Stobberingh (Ellen); S.E. Geerlings (Suzanne)

    2012-01-01

    textabstractBackground: Growing antibiotic resistance warrants studying nonantibiotic prophylaxis for recurrent urinary tract infections (UTIs). Use of lactobacilli appears to be promising. Methods: Between January 2005 and August 2007, we randomized 252 postmenopausal women with recurrent UTIs taki

  9. Effects on muscle performance of NSAID treatment with Piroxicam versus placebo in geriatric patients with acute infection-induced inflammation. a double blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Beyer Ingo

    2011-12-01

    Full Text Available Abstract Background Inflammation is the main cause of disease-associated muscle wasting. In a previous single blind study we have demonstrated improved recovery of muscle endurance following celecoxib treatment in hospitalized geriatric patients with acute infection. Here we further evaluate NSAID treatment with piroxicam in a double blind RCT and investigate the role of cytokines and heat shock proteins (Hsp with respect to muscle performance. We hypothesized that NSAID treatment would preserve muscle performance better than antibiotic treatment alone, by reducing infection-associated inflammation and by increasing expression of cytoprotective Hsp. Methods Consecutive admissions to the geriatric ward were screened. 30 Caucasian patients, median age 84.5 years, with acute infection-induced inflammation and serum levels of CRP > 10 mg/L were included and randomized to active treatment with 10 mg piroxicam daily or placebo. Assessment comprised general clinical and biochemical parameters, 25 cytokines in serum, intra-and extracellular Hsp27 and Hsp70, Elderly Mobility Scale (EMS scores, grip strength (GS, fatigue resistance (FR and lean body mass (LBM. Patients were evaluated until discharge with a maximum of 3 weeks after treatment allocation. Results EMS scores, FR and grip work (GW, a measure taking into account GS and FR, significantly improved with piroxicam, but not with placebo. Early decreases in IL-6 serum levels with piroxicam correlated with better muscle performance at week 2. Basal expression of Hsp27 in monocytes without heat challenge (WHC was positively correlated with FR at baseline and significantly increased by treatment with piroxicam compared to placebo. Profound modifications in the relationships between cytokines or Hsp and changes in muscle parameters were observed in the piroxicam group. Conclusions Piroxicam improves clinically relevant measures of muscle performance and mobility in geriatric patients hospitalized with

  10. Effectiveness of radiation synovectomy with samarium-{sup 153} particulate hydroxyapatite in rheumatoid arthritis patients with knee synovitis: a controlled randomized double-blind trial

    Energy Technology Data Exchange (ETDEWEB)

    Santos, Marla Francisca dos; Furtado, Rita Nely Vilar; Konai, Monique Sayuri; Natour, Jamil, E-mail: jnatour@unifesp.b [Universidade Federal de Sao Paulo (UNIFESP-EPM), Sao Paulo, SP (Brazil). Divisao de Reumatologia; Castiglioni, Mario Luiz Vieira; Marchetti, Renata Rosa [Universidade Federal de Sao Paulo (UNIFESP-EPM), Sao Paulo, SP (Brazil). Divisao de Medicina Nuclear

    2009-07-01

    Objectives: the aim of the present study was to investigate the effectiveness of Samarium{sup 153}-particulate hydroxyapatite radiation synovectomy in rheumatoid arthritis patients with chronic knee synovitis. Methods: fifty-eight rheumatoid arthritis patients (60 knees) with chronic knee synovitis participated in a controlled double-blinded trial. Patients were randomized to receive either an intra-articular injection with 40 mg triamcinolone hexacetonide alone (TH group) or 40 mg triamcinolone hexacetonide combined with 15 mCi Samarium{sup 153}-particulate hydroxyapatite (Sm/TH group). Blinded examination at baseline (T0) and at 1 (T1), 4 (T4), 12 (T12), 32 (T32), and 48 (T48) weeks post-intervention were performed on all patients and included a visual analog scale for joint pain and swelling as well as data on morning stiffness, flexion, extension, knee circumference, Likert scale of improvement, percentage of improvement, SF-36 generic quality of life questionnaire, Stanford Health Assessment Questionnaire (HAQ), Lequesne index, use of non-steroidal anti-inflammatory drugs or oral corticosteroids, events and adverse effects, calls to the physician, and hospital visits. Results: the sample was homogeneous at baseline, and there were no withdrawals. Improvement was observed in both groups in relation to T0, but no statistically significant differences between groups were observed regarding all variables at the time points studied. The Sm/TH group exhibited more adverse effects at T1 (p<0.05), but these were mild and transitory. No severe adverse effects were reported during follow-up. Conclusion: intra-articular injection of Samarium{sup 153}-particulate hydroxyapatite (15 mCi) with 40 mg of triamcinolone hexacetonide is not superior to triamcinolone hexacetonide alone for the treatment of knee synovitis in patients with rheumatoid arthritis at 1 y of follow-up. (author)

  11. 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.

  12. Impact of Multi-Micronutrient Fortified Rice on Hemoglobin, Iron and Vitamin A Status of Cambodian Schoolchildren: a Double-Blind Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Perignon, Marlène; Fiorentino, Marion; Kuong, Khov; Dijkhuizen, Marjoleine A; Burja, Kurt; Parker, Megan; Chamnan, Chhoun; Berger, Jacques; Wieringa, Frank T

    2016-01-07

    In Cambodia, micronutrient deficiencies remain a critical public health problem. Our objective was to evaluate the impact of multi-micronutrient fortified rice (MMFR) formulations, distributed through a World Food Program school-meals program (WFP-SMP), on the hemoglobin concentrations and iron and vitamin A (VA) status of Cambodian schoolchildren. The FORISCA-UltraRice+NutriRice study was a double-blind, cluster-randomized, placebo-controlled trial. Sixteen schools participating in WFP-SMP were randomly assigned to receive extrusion-fortified rice (UltraRice Original, UltraRice New (URN), or NutriRice) or unfortified rice (placebo) six days a week for six months. Four additional schools not participating in WFP-SMP were randomly selected as controls. A total of 2440 schoolchildren (6-16 years old) participated in the biochemical study. Hemoglobin, iron status, estimated using inflammation-adjusted ferritin and transferrin receptors concentrations, and VA status, assessed using inflammation-adjusted retinol-binding protein concentration, were measured at the baseline, as well as at three and six months. Baseline prevalence of anemia, depleted iron stores, tissue iron deficiency, marginal VA status and VA deficiency were 15.6%, 1.4%, 51.0%, 7.9%, and 0.7%, respectively. The strongest risk factors for anemia were hemoglobinopathy, VA deficiency, and depleted iron stores (all p status, respectively, in comparison to the placebo group. Hemoglobin significantly increased (+0.8 g/L) after three months for the URN group in comparison to the placebo group; however, this difference was no longer significant after six months, except for children without inflammation. MMFR containing VA effectively improved the VA status of schoolchildren. The impact on hemoglobin and iron status was limited, partly by sub-clinical inflammation. MMFR combined with non-nutritional approaches addressing anemia and inflammation should be further investigated.

  13. Randomized double blind trial of ciprofloxacin prophylaxis during induction treatment in childhood acute lymphoblastic leukemia in the WK-ALL protocol in Indonesia

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    Widjajanto PH

    2013-02-01

    Full Text Available Pudjo H Widjajanto,1 Sumadiono Sumadiono,1 Jacqueline Cloos,2,3 Ignatius Purwanto,1 Sutaryo Sutaryo,1 Anjo JP Veerman1,21Pediatric Hematology and Oncology Division, Department of Pediatrics, Dr Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia; 2Pediatric Oncology/Hematology Division, Department of Pediatrics, 3Department of Hematology, VU University Medical Center, Amsterdam, The NetherlandsObjectives: Toxic death is a big problem in the treatment of childhood acute lymphoblastic leukemia (ALL, especially in low-income countries. Studies of ciprofloxacin as single agent prophylaxis vary widely in success rate. We conducted a double-blind, randomized study to test the effects of ciprofloxacin monotherapy as prophylaxis for sepsis and death in induction treatment of the Indonesian childhood ALL protocol.Methods: Patients were randomized to the ciprofloxacin arm (n = 58 and to the placebo arm (n = 52. Oral ciprofloxacin monotherapy or oral placebo was administered twice a day. All events during induction were recorded: toxic death, abandonment, resistant disease, and complete remission rate.Results: Of 110 patients enrolled in this study, 79 (71.8% achieved CR. In comparison to the placebo arm, the ciprofloxacin arm had lower nadir of absolute neutrophil count during induction with median of 62 (range: 5–884 versus 270 (range: 14–25,480 × 109 cells/L (P > 0.01, greater risks for experiencing fever (50.0% versus 32.7%, P = 0.07, clinical sepsis (50.0% versus 38.5%, P = 0.22, and death (18.9% versus 5.8%, P = 0.05.Conclusion: In our setting, a reduced intensity protocol in a low-income situation, the data warn against using ciprofloxacin prophylaxis during induction treatment. A lower nadir of neutrophil count and higher mortality were found in the ciprofloxacin group.Keywords: ciprofloxacin, prophylaxis, childhood acute lymphoblastic leukemia, randomized trial, low-income country

  14. Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

    Science.gov (United States)

    Davison, Beth A.; Filippatos, Gerasimos S.; Radovanovic, Slavica; Beleslin, Branko; Merkely, Bela; Musialek, Piotr; Wojakowski, Wojciech; Andreka, Peter; Horvath, Ivan G.; Katz, Amos; Dolatabadi, Dariouch; El Nakadi, Badih; Arandjelovic, Aleksandra; Edes, Istvan; Seferovic, Petar M.; Obradovic, Slobodan; Vanderheyden, Marc; Jagic, Nikola; Petrov, Ivo; Atar, Shaul; Halabi, Majdi; Gelev, Valeri L.; Shochat, Michael K.; Kasprzak, Jaroslaw D.; Sanz-Ruiz, Ricardo; Heyndrickx, Guy R.; Nyolczas, Noémi; Legrand, Victor; Guédès, Antoine; Heyse, Alex; Moccetti, Tiziano; Fernandez-Aviles, Francisco; Jimenez-Quevedo, Pilar; Bayes-Genis, Antoni; Hernandez-Garcia, Jose Maria; Ribichini, Flavio; Gruchala, Marcin; Waldman, Scott A.; Teerlink, John R.; Gersh, Bernard J.; Povsic, Thomas J.; Henry, Timothy D.; Metra, Marco; Hajjar, Roger J.; Tendera, Michal; Behfar, Atta; Alexandre, Bertrand; Seron, Aymeric; Stough, Wendy Gattis; Sherman, Warren; Cotter, Gad; Wijns, William

    2017-01-01

    Aims Cardiopoietic cells, produced through cardiogenic conditioning of patients’ mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. Methods and results This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein–Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann–Whitney estimator 0.54, 95% confidence interval [CI] 0.47–0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200–370 mL (60% of patients) (Mann–Whitney estimator 0.61, 95% CI 0.52–0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. Conclusion The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted. PMID:28025189

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

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    Arash Hossein-nezhad

    Full Text Available BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSION/SIGNIFICANCE: 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

  16. Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial

    Science.gov (United States)

    Mulligan, Kathleen; Glidden, David V.; Anderson, Peter L.; Liu, Albert; McMahan, Vanessa; Gonzales, Pedro; Ramirez-Cardich, Maria Esther; Namwongprom, Sirianong; Chodacki, Piotr; de Mendonca, Laura Maria Carvalo; Wang, Furong; Lama, Javier R.; Chariyalertsak, Suwat; Guanira, Juan Vicente; Buchbinder, Susan; Bekker, Linda-Gail; Schechter, Mauro; Veloso, Valdilea G.; Grant, Robert M.; Vargas, Lorena; Sanchez, Jorge; Mai, Chiang; Saokhieo, Pongpun; Murphy, Kerry; Gilmore, Hailey; Holland, Sally; Faber, Elizabeth; Duda, John; Bewerunge, Linda; Batist, Elizabeth; Hoskin, Christine; Brown, Ben; de Janeiro, Rio; Beppu-Yoshida, Carina; da Costa, Marcellus Dias; Assis de Jesus, Sergio Carlos; Grangeiro da Silva, Jose Roberto; Millan, Roberta; de Siqueira Hoagland, Brenda Regina; Martinez Fernandes, Nilo; da Silva Freitas, Lucilene; Grinsztejn, Beatriz; Pilotto, Jose; Bushman, Lane; Zheng, Jia-Hua; Anthony Guida, Louis; Kline, Brandon; Goicochea, Pedro; Manzo, Jonathan; Hance, Robert; McConnell, Jeff; Defechereux, Patricia; Levy, Vivian; Robles, Malu; Postle, Brian; Burns, David; Rooney, James

    2015-01-01

    Background. Daily preexposure prophylaxis (PrEP) with oral emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) decreases the risk of human immunodeficiency virus (HIV) acquisition. Initiation of TDF decreases bone mineral density (BMD) in HIV-infected people. We report the effect of FTC/TDF on BMD in HIV-seronegative men who have sex with men and in transgender women. Methods. Dual-energy X-ray absorptiometry was performed at baseline and 24-week intervals in a substudy of iPrEx, a randomized, double-blind, placebo-controlled trial of FTC/TDF PrEP. Plasma and intracellular tenofovir concentrations were measured in participants randomized to FTC/TDF. Results. In 498 participants (247 FTC/TDF, 251 placebo), BMD in those randomized to FTC/TDF decreased modestly but statistically significantly by 24 weeks in the spine (net difference, −0.91% [95% confidence interval {CI}, −1.44% to −.38%]; P = .001) and hip (−0.61% [95% CI, −.96% to −.27%], P = .001). Changes within each subsequent 24-week interval were not statistically significant. Changes in BMD by week 24 correlated inversely with intracellular tenofovir diphosphate (TFV-DP), which was detected in 53% of those randomized to FTC/TDF. Net BMD loss by week 24 in participants with TFV-DP levels indicative of consistent dosing averaged −1.42% ± 29% and −0.85% ± 19% in the spine and hip, respectively (P < .001 vs placebo). Spine BMD tended to rebound following discontinuation of FTC/TDF. There were no differences in fractures (P = .62) or incidence of low BMD. Conclusions. In HIV-uninfected persons, FTC/TDF PrEP was associated with small but statistically significant decreases in BMD by week 24 that inversely correlated with TFV-DP, with more stable BMD thereafter. Clinical Trials Registration. NCT00458393. PMID:25908682

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

    OpenAIRE

    Namjoyan, Foroogh; Kiashi, Fatemeh; Moosavi, Zahra Beigom; Saffari, Fatemeh; Makhmalzadeh, Behzad Sharif

    2015-01-01

    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 ...

  18. Laser therapy for onychomycosis in patients with diabetes at risk for foot complications : study protocol for a randomized, double-blind, controlled trial (LASER-1)

    NARCIS (Netherlands)

    Nijenhuis-Rosien, Leonie; Kleefstra, Nanne; Wolfhagen, Maurice J.; Groenier, Klaas H.; Bilo, Henk J. G.; Landman, Gijs W. D.

    2015-01-01

    Background: In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in

  19. Ultramicronized palmitoylethanolamide in spinal cord injury neuropathic pain: A randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Andresen, Sven R; Bing, Jette; Hansen, Rikke Bod Middelhede

    2016-01-01

    Neuropathic pain and spasticity after spinal cord injury (SCI) represent significant problems. Palmitoylethanolamide (PEA), a fatty acid amide that is produced in many cells in the body, is thought to potentiate the action of endocannabinoids and to reduce pain and inflammation. This randomized, ......, insomnia, or psychological functioning. PEA was not associated with more adverse effects than placebo....

  20. Buspirone versus Methylphenidate in the Treatment of Attention Deficit Hyperactivity Disorder: A Double-Blind and Randomized Trial

    Science.gov (United States)

    Davari-Ashtiani, Rozita; Shahrbabaki, Mahin Eslami; Razjouyan, Katayoon; Amini, Homayoun; Mazhabdar, Homa

    2010-01-01

    The efficacy and side effects of buspirone compared with methylphenidate (MPH) in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). A total of 34 children with ADHD as defined by DSM-IV-TR were randomized to buspirone or methylphenidate dosed on weight-adjusted basis at buspirone (0.5 mg/kg/day) and methylphenidate…

  1. Clinical Research Methodology 3: Randomized Controlled Trials.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  2. Elderberry Supplementation Reduces Cold Duration and Symptoms in Air-Travellers: A Randomized, Double-Blind Placebo-Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Evelin Tiralongo

    2016-03-01

    Full Text Available Intercontinental air travel can be stressful, especially for respiratory health. Elderberries have been used traditionally, and in some observational and clinical studies, as supportive agents against the common cold and influenza. This randomized, double-blind placebo-controlled clinical trial of 312 economy class passengers travelling from Australia to an overseas destination aimed to investigate if a standardised membrane filtered elderberry (Sambucus nigra L. extract has beneficial effects on physical, especially respiratory, and mental health. Cold episodes, cold duration and symptoms were noted in a daily diary and assessed using the Jackson score. Participants also completed three surveys containing questions regarding upper respiratory symptoms (WURSS-21 and quality of life (SF-12 at baseline, just before travel and at 4-days after travel. Most cold episodes occurred in the placebo group (17 vs. 12, however the difference was not significant (p = 0.4. Placebo group participants had a significantly longer duration of cold episode days (117 vs. 57, p = 0.02 and the average symptom score over these days was also significantly higher (583 vs. 247, p = 0.05. These data suggest a significant reduction of cold duration and severity in air travelers. More research is warranted to confirm this effect and to evaluate elderberry’s physical and mental health benefits.

  3. Elderberry Supplementation Reduces Cold Duration and Symptoms in Air-Travellers: A Randomized, Double-Blind Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Tiralongo, Evelin; Wee, Shirley S; Lea, Rodney A

    2016-03-24

    Intercontinental air travel can be stressful, especially for respiratory health. Elderberries have been used traditionally, and in some observational and clinical studies, as supportive agents against the common cold and influenza. This randomized, double-blind placebo-controlled clinical trial of 312 economy class passengers travelling from Australia to an overseas destination aimed to investigate if a standardised membrane filtered elderberry (Sambucus nigra L.) extract has beneficial effects on physical, especially respiratory, and mental health. Cold episodes, cold duration and symptoms were noted in a daily diary and assessed using the Jackson score. Participants also completed three surveys containing questions regarding upper respiratory symptoms (WURSS-21) and quality of life (SF-12) at baseline, just before travel and at 4-days after travel. Most cold episodes occurred in the placebo group (17 vs. 12), however the difference was not significant (p = 0.4). Placebo group participants had a significantly longer duration of cold episode days (117 vs. 57, p = 0.02) and the average symptom score over these days was also significantly higher (583 vs. 247, p = 0.05). These data suggest a significant reduction of cold duration and severity in air travelers. More research is warranted to confirm this effect and to evaluate elderberry's physical and mental health benefits.

  4. Effects of gum Arabic ingestion on body mass index and body fat percentage in healthy adult females: two-arm randomized, placebo controlled, double-blind trial

    Directory of Open Access Journals (Sweden)

    Babiker Rasha

    2012-12-01

    Full Text Available Abstract Background Gum Arabic (acacia Senegal is a complex polysaccharide indigestible to both humans and animals. It has been considered as a safe dietary fiber by the United States, Food and Drug Administration (FDA since the 1970s. Although its effects were extensively studied in animals, there is paucity of data regarding its quantified use in humans. This study was conducted to determine effects of regular Gum Arabic (GA ingestion on body mass index and body fat percentage among healthy adult females. Methods A two-arm randomized, placebo controlled, double-blind trial was conducted in the Department of Physiology at the Khartoum University. A total of 120 healthy females completed the study. They were divided to two groups: A test group of 60 volunteers receiving GA (30 gm /day for 6 weeks and a placebo group of 60 volunteers receiving pectin (1 gm/day for the same period of time. Weight and height were measured before and after intervention using standardized height and weight scales. Skin fold thickness was measured using Harpenden Skin fold caliper. Fat percentage was calculated using Jackson and Pollock 7 caliper method and Siri equation. Results Pre and post analysis among the study group showed significant reduction in BMI by 0.32 (95% CI: 0.17 to 0.47; P Conclusions GA ingestion causes significant reduction in BMI and body fat percentage among healthy adult females. The effect could be exploited in the treatment of obesity.

  5. Effect of the local administration of betamethasone on pain, swelling and trismus after impacted lower third molar extraction. A randomized, triple blinded, controlled trial

    Science.gov (United States)

    Marques, José; Pié-Sánchez, Jordi; Valmaseda-Castellón, Eduard; Gay-Escoda, Cosme

    2014-01-01

    Objectives: The aim of this study is to compare the analgesic and anti-inflammatory effects of the local postoperative administration of a single 12-mg dose of betamethasone after the surgical removal of impacted lower third molars. Study Design: A split-mouth, triple-blind, randomized, placebo-controlled clinical trial of 25 patients requiring the surgical removal of symmetrical lower third molars was performed. In the experimental side, a 12-mg dose of betamethasone was administered submucosally after the surgical procedure, while in the control side a placebo (sterile saline solution) was injected in the same area. To assess postoperative pain, visual analogue scales and the consumption of rescue analgesic were used. The facial swelling and trismus were evaluated by measuring facial reference distances and maximum mouth opening. Results: There were no significant differences between the two study groups regarding postoperative pain, facial swelling and trismus. Conclusions: The injection of a single dose of betamethasone does not seem to reduce pain, facial swelling and trismus after impacted lower third molar removal when compared to placebo. Key words:Third molar extraction, corticosteroids, betamethasone. PMID:24121915

  6. Immunogenicity and safety of trivalent inactivated influenza vaccine: a randomized, double-blind, multi-center, phase 3 clinical trial in a vaccine-limited country.

    Science.gov (United States)

    Song, Joon Young; Cheong, Hee Jin; Woo, Heung Jeong; Wie, Seong-Heon; Lee, Jin-Soo; Chung, Moon-Hyun; Kim, Yang Ree; Jung, Sook In; Park, Kyung-Hwa; Kim, Tae Hyong; Uh, Soo-Taek; Kim, Woo Joo

    2011-02-01

    Influenza vaccines are the primary method for controlling influenza and its complications. This study was conducted as a phase 3, randomized, double-blind, controlled, multi-center trial at seven university hospitals to evaluate the immunogenicity and safety of an inactivated, split, trivalent influenza vaccine (GC501, Green Cross Corporation, Yongin, Korea), which was newly manufactured in Korea in 2008. Between September 21 and 26, a total of 329 healthy subjects were recruited for the immunogenicity analysis, while 976 subjects were enrolled for the safety analysis. The GC501 vaccine met both FDA and EMEA criteria with ≥ 80% of subjects achieving post-vaccination titers ≥ 40 for all three subtypes, even in the elderly. The vaccine was well tolerated with only mild systemic and local adverse events. In summary, GC501 showed excellent immunogenicity and a good safety profile in both young adults and the elderly. The licensure of GC501 might be an important basis in preparation for the future influenza pandemic.

  7. Antihyperlipidemic effects of Salvia officinalis L. leaf extract in patients with hyperlipidemia: a randomized double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Kianbakht, S; Abasi, B; Perham, M; Hashem Dabaghian, F

    2011-12-01

    Hyperlipidemia is a common metabolic disorder contributing to morbidities and mortalities due to cardiovascular and cerebrovascular diseases. Conventional antihyperlipidemic drugs have limited efficacies and important side effects, so that alternative lipid lowering agents are needed. Salvia officinalis L. (sage) leaves have PPAR γ agonistic, pancreatic lipase and lipid absorption inhibitory, antioxidant, lipid peroxidation inhibitory and antiinflammatory effects. Thus, in this randomized double-blind placebo-controlled clinical trial with 67 hyperlipidemic (hypercholesterolemic and/or hypertriglyceridemic) patients aged 56.4 ± 30.3 years (mean ± SD), the effects of taking sage leaf extract (one 500 mg capsule every 8 h for 2 months) on fasting blood levels of lipids, creatinine and liver enzymes including SGOT and SGPT were evaluated in 34 patients and compared with the placebo group (n = 33). The extract lowered the blood levels of total cholesterol (p  0.05) compared with the placebo group at the endpoint. No adverse effects were reported. The results suggest that sage may be effective and safe in the treatment of hyperlipidemia.

  8. Randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of live oral cholera vaccine 638 in Cuban adults.

    Science.gov (United States)

    Valera, Rodrigo; García, Hilda María; Jidy, Manuel Díaz; Mirabal, Mayelin; Armesto, Marlene Isabel; Fando, Rafael; García, Luis; Fernández, Roberto; Año, Gemma; Cedré, Bárbara; Ramírez, Margarita; Bravo, Laura; Serrano, Teresita; Palma, Sara; González, Daniel; Miralles, Fernando; Medina, Vilma; Nuñez, Felicita; Plasencia, Yilian; Martínez, Juan Carlos; Mandarioti, Aleyda; Lugones, Juan; Rodríguez, Boris Luis; Moreno, Arlenis; González, Domingo; Baro, Morelia; Solis, Rosa Lidia; Sierra, Gustavo; Barbera, Ramón; Domínguez, Francisco; Gutiérrez, Carlos; Kouri, Gustavo; Campa, Concepción; Menéndez, Jorge

    2009-11-01

    A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the safety, reactogenicity and the immunogenicity of a 2 x 10(9)CFU dose of the 638 lyophilized live attenuated cholera vaccine for oral administration, formulated and produced at Finlay Institute, City of Havana, Cuba. Thirty-six healthy female and male adult volunteers from 18 to 40 years old were involved, clinically examined and laboratory tested after the informed consent signature. Adverse events were monitored and seroconversion rates and geometrical mean titer (GMT) of vibriocidal antibodies were tested in volunteer's sera samples. Neither serious adverse events nor other damages to the volunteers due to vaccine or placebo feeding were reported during the clinical follow-up period of this study; none of the adverse events registered within the first 72 h after inoculation were life-threatening for volunteers. Neither severe nor moderate adverse events were reported. Sixty-one percent of subjects showed mild expected adverse events in an interval lower than 24h up to the first 72 h, 75% of these in the vaccinated group and 18% in the placebo group. Fourteen days after inoculation the GMT of vibriocidal antibodies in the vaccine group significantly increased in comparison to the placebo group. All subjects in the vaccine group (24) seroconverted (100%). Results show that this vaccine is safe, well tolerated and immunogenic in healthy female and male volunteers.

  9. Effectiveness of Essence of Chicken in Improving Cognitive Function in Young People Under Work-Related Stress: A Randomized Double-Blind Trial.

    Science.gov (United States)

    Chan, Lung; Wang, Hsuan-Min; Chen, Kuan-Yu; Lin, Ying-Chin; Wu, Pei-Jung; Hsieh, Wan-Lin; Chen, Ying-Ru; Liu, Cheung-Pin; Tsai, Han-Yin; Chen, Yun-Ru; Chang, Hsiu-Hui; Hsieh, Yi-Chen; Hu, Chaur-Jong

    2016-05-01

    Work-related stress (WS) can result in considerable and extensive changes in physiological and psychological performance. WS beyond the optimal levels induces anxiety, confusion, exhaustion, and burnout. Chronic WS affects neurocognitive performance, particularly attention and visuospatial memory. Essence of chicken (EC) has been reported to improve neurocognitive function after mental stress.To investigate the beneficial effects of EC in improving neurocognitive performance under WS, we conducted a randomized, double blind trial. Total 102 young workers in New Taipei City with high WS, evaluated using the Individual Subjective Perception Job Stress Scale scores (>36 for job leaders and 33 for nonleaders) were recruited. Fifty-one participants received 70 mL of EC and 51 received a placebo daily for 2 weeks. Blood tests and neurocognitive assessment were performed before treatment, at the end of treatment, and 2 weeks after treatment.EC improved the performance of participants with high depression scores in the form-color associative memory test, used for assessing short-term memory. Although creatinine and glutamic-pyruvic transaminase (GPT) levels increased in week 2, but the levels returned to the baseline in week 4. Blood urea nitrogen (BUN) levels decreased in week 4.EC significantly improved short-term memory in participants with high WS and concomitant depressive mood, although it slightly increased GPT and creatinine levels and reduced BUN levels. The long-term treatment effects of EC warrant further investigation.

  10. Angelica keiskei Koidzumi extracts improve some markers of liver function in habitual alcohol drinkers: a randomized double-blind clinical trial.

    Science.gov (United States)

    Noh, Hye-Mi; Ahn, Eun-Mi; Yun, Jae-Moon; Cho, Be-Long; Paek, Yu-Jin

    2015-02-01

    Alcohol induces oxidative stress and inflammatory response, which can lead to hepatitis and cirrhosis. Previous studies reported that the extracts of Angelica keiskei Koidzumi (AKE) have antioxidant and anti-inflammatory properties, suggesting that AKE could improve abnormalities associated with alcoholic liver disease. In this study, the effectiveness of AKE supplementation was assessed in 82 habitual alcohol drinkers (male: more than 14 units per week, female: more than 7 units per week) with abnormal liver biochemistry in a placebo-controlled, randomized double-blind trial over 12 weeks. Among the subjects, 65% (n=43) were heavy drinkers consuming more than 35 units per week. Among heavy drinkers, gamma-glutamyl transferase levels of 19 subjects per AKE-treated group were significantly decreased (21.16±37.63, P=.016) with significant differences observed compared to the 24 subjects per placebo group (P=.046). However, no significant differences were observed in aspartate aminotransferase and alanine aminotransferase levels between the AKE- and placebo-treated groups. These results suggest that AKE supplementation might improve liver function in heavy drinkers.

  11. 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.

  12. A prospective double-blind randomized controlled trial comparing the suitability of KTP laser tonsillectomy with conventional dissection tonsillectomy for day case surgery.

    Science.gov (United States)

    Kothari, P; Patel, S; Brown, P; Obara, L; O'Malley, S

    2002-10-01

    Tonsillectomy using a KTP laser has been performed increasingly but is not a routinely practised technique in the UK. In the USA, tonsillectomy is often performed as a day case procedure but, here in the UK, it is still standard practice to admit patients for overnight stay. We present the largest prospective double-blind randomized controlled trial to date (151 patients) comparing KTP laser with standard dissection tonsillectomy and assess the suitability of both procedures for day case surgery. We found that there was significantly less peroperative haemorrhage if tonsillectomy was performed using the KTP laser, but it did cause more postoperative pain, more depression in mood and a higher rate of both reactionary and secondary haemorrhage, which was not significant when compared with conventional dissection. There was no difference in operating time, and over 40% of patients in each group needed overnight admission. We conclude that KTP laser tonsillectomy offers no benefit apart from less intraoperative bleeding over standard dissection tonsillectomy. Discharge from hospital after tonsillectomy was found to be unpredictable. Tonsillectomy is therefore an unsuitable procedure for planned surgery through a day unit, but approximately 58% of patients could be discharged on the same day from an extended day surgery unit, and the rest have one night in hospital.

  13. Effect of saffron on liver metastases in patients suffering from cancers with liver metastases: A randomized, double blind, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Azar Hosseini

    2015-08-01

    Full Text Available Objective: Cancer represents the second cause of mortality in the world. Saffron as a medicinal plant is known for its anti-cancer and anti-depressant properties. In this randomized double blind clinical trial, the effects of saffron on response to treatment in patients suffering from liver metastasis were evaluated. Materials and Methods: Thirteen patients suffering from liver metastases who referred to Ghaem and Imam Reza hospital, Mashhad, Iran were included in this study and then divided into two different groups. Both groups received chemotherapy regimen. Patients in group one were treated with saffron capsule (50 mg, twice daily during chemotherapy periods whereas patients in group two received placebo. A sum of the longest diameter were calculated and compared for all lesions in IV contrast CT scan before and after the treatment. Results: from 13 patients included in this study, six patients quit and seven continued until the end. In saffron-treated group, two patients showed partial and complete response (50% whereas in placebo group, no response was seen. Also, two deaths in placebo and one in saffron group occurred. Conclusion: This research suggests that saffron might be useful in patients suffering from liver metastasis. However, further investigations with larger sample size are required.

  14. A double-blind, randomized, controlled trial of amphotericin B colloidal dispersion versus amphotericin B for treatment of invasive aspergillosis in immunocompromised patients.

    Science.gov (United States)

    Bowden, Raleigh; Chandrasekar, Pranatharthi; White, Mary H; Li, Xin; Pietrelli, Larry; Gurwith, Marc; van Burik, Jo-Anne; Laverdiere, Michel; Safrin, Sharon; Wingard, John R

    2002-08-15

    We report a randomized, double-blind, multicenter trial in which amphotericin B colloidal dispersion (ABCD [Amphotec]; 6 mg/kg/day) was compared with amphotericin B (AmB; 1.0-1.5 mg/kg/day) for the treatment of invasive aspergillosis in 174 patients. For evaluable patients in the ABCD and AmB treatment groups, respective rates of therapeutic response (52% vs. 51%; P=1.0), mortality (36% vs. 45%; P=.4), and death due to fungal infection (32% vs. 26%; P=.7) were similar. Renal toxicity was lower (25% vs. 49%; P=.002) and the median time to onset of nephrotoxicity was longer (301 vs. 22 days; P<.001) in patients treated with ABCD. Rates of drug-related toxicity in patients receiving ABCD and AmB, respectively, were 53% versus 30% (chills), 27% versus 16% (fever), 1% versus 4% (hypoxia) and 22% versus 24% (toxicity requiring study drug discontinuation). ABCD appears to have equivalent efficacy and superior renal safety, compared with AmB, in the treatment of invasive aspergillosis. However, infusion-related chills and fever occurred more frequently in patients receiving ABCD than in those receiving AmB.

  15. Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial.

    Science.gov (United States)

    Guekht, Alla B; Moessler, Herbert; Novak, Philipp H; Gusev, Evgenyi I

    2011-01-01

    No drug to treat vascular dementia (VaD) has yet been approved by the American or European authorities, leaving a large population of patients without effective therapy. Cerebrolysin has a long record of safety and might be efficacious in this condition. We conducted a large, multicenter, double-blind, placebo-controlled study in 242 patients meeting the criteria for VaD. The primary endpoint was the combined outcome of cognition (based on Alzheimer's Disease Assessment Scale Cognitive Subpart, Extended Version [ADAS-cog+] score) and overall clinical functioning (based on Clinician's Interview-Based Impression of Change plus Caregiver Input [CIBIC+] score) assessed after 24 weeks of treatment. Intravenous Cerebrolysin 20 mL was administered once daily over the course of 2 treatment cycles as add-on therapy to basic treatment with acetylsalicylic acid. The addition of Cerebrolysin was associated with significant improvement in both primary parameters. At week 24, ADAS-cog+ score improved by 10.6 points in the Cerebrolysin group, compared with 4.4 points in the placebo group (least squares mean difference, -6.17; P Cerebrolysin group (ADAS-cog+ improvement of ≥4 points from baseline, 82.1% vs 52.2%; CIBIC+ score of Cerebrolysin, the odds ratio for achieving a favorable CIBIC+ response was 5.08 (P Cerebrolysin significantly improved clinical outcome, and that the benefits persisted for at least 24 weeks. Cerebrolysin was safe and well tolerated.

  16. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

    OpenAIRE

    Patki, Pralhad; Amruthesh ,Sunita; Tandur,Prakash; Tandur,AP; Malini

    2010-01-01

    Sunita Amrutesh1, J Malini2, Prakash S Tandur3, Pralhad S Patki41Department of Oral Medicine and Radiology, 2Department of Microbiology, 3Department of Oral and Maxillofacial Surgery, K.L.E. College of Dental Sciences and Hospital, Bangalore, India; 4Medical Services and Clinical Trials, R&D Center, The Himalaya Drug Company, Bangalore, IndiaBackground: The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream.Objective...

  17. 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 (p< 0.05). The post injection VAS Score was least in group

  18. Effect of JYTK on Antioxidant Status and Inflammation in Patients With Type 2 Diabetes: A Randomized Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Hu

    2016-01-01

    Full Text Available Background Diabetes is a metabolic disorder caused by oxidative stress and inflammation. JianYuTangKang (JYTK, as a potential Chinese integrative medicine, is an antioxidant used in Chinese medicine with potential anti-inflammatory properties. Objectives The present randomized clinical trial was carried out to evaluate the effects of JYTK on oxidative stress and inflammation in patients with type 2 diabetes mellitus (T2DM. Patients and Methods The parallel, randomized, double-blinded, placebo-controlled clinical trial included 150 newly diagnosed T2DM patients receiving metformin treatment (1.5 g/day, some of whom also received JYTK (4.5 g/day in tablet form. The control group received 4.5 g/day placebo plus 1.5 g/day metformin. Body mass index (BMI, fasting plasma glucose, urinary albumin-to-creatinine ratio, and complete blood count as well as antioxidant and inflammation indices such as tumor necrosis factor (TNF-α, interleukin (IL-6, superoxide dismutase (SOD, malonaldehyde (MDA, glutathione peroxidase (GPX, and high sensitivity C-reactive protein (hs-CRP levels were assessed at baseline and at different time points during the treatment. Results All 112 patients, including 59 in the treatment group (JYTK + metformin and 52 controls (metformin only completed the 26-week clinical trial. JYKT plus metformin treatment increased IL-6 (36.4 ± 11.5 ng/L; P < 0.05, TNF-α (17.5 ± 11.3 vs. 22.5 ± 12.9 ng/L; P < 0.05, and MDA (1.9 ± 0.9; P < 0.05 levels compared to the control (2.2 ± 0.6 mM/mL, whereas total SOD level decreased (98.1 ± 30.4 vs. 78.5 ± 29.3 U/mL; P < 0.05. There were no changes in GPX and hs-CRP levels. There were no adverse effects associated with JYTK treatment. Conclusions JYTK combined with metformin improves some antioxidant indices (SOD and MDA, and decreases inflammation in patients with T2DM, suggesting that it can reduce the risk of diabetic complications.

  19. Gabapentin Effect on Pain Associated with Heroin Withdrawal in Iranian Crack: a Randomized Double-blind Clinical Trial

    OpenAIRE

    Behnam, Behnaz; Semnani, Vahid; Saghafi, Nadia; Ghorbani, Raheb; Dianak Shori, Mina; Ghooshchian Choobmasjedi, Samaneh

    2012-01-01

    Gabapentin seems to be a safe and well tolerated medication for treating heroine dependence. This study examined the efficacy of gabapentin for relieving withdrawal-related pain due to heroin use. Sixty men were recruited from an inpatient psychiatric ward of Fatemieh hospital in Semnan and randomized to receive either placebo (n = 30) or gabapentin (1800 mg/day) (n = 30) for 7 days. Subjective Opioid Withdrawal Scale (SOWS) was measured as a self-administered scale for grading body pain at b...

  20. Lessons and implications from a mass immunization campaign in squatter settlements of Karachi, Pakistan: an experience from a cluster-randomized double-blinded vaccine trial [NCT00125047

    Directory of Open Access Journals (Sweden)

    Abu-Elyazeed Remon

    2006-05-01

    Full Text Available Abstract Objective To determine the safety and logistic feasibility of a mass immunization strategy outside the local immunization program in the pediatric population of urban squatter settlements in Karachi, Pakistan. Methods A cluster-randomized double blind preventive trial was launched in August 2003 in 60 geographic clusters covering 21,059 children ages 2 to 16 years. After consent was obtained from parents or guardians, eligible children were immunized parenterally at vaccination posts in each cluster with Vi polysaccharide or hepatitis A vaccine. Safety, logistics, and standards were monitored and documented. Results The vaccine coverage of the population was 74% and was higher in those under age 10 years. No life-threatening serious adverse events were reported. Adverse events occurred in less than 1% of all vaccine recipients and the main reactions reported were fever and local pain. The proportion of adverse events in Vi polysaccharide and hepatitis A recipients will not be known until the end of the trial when the code is broken. Throughout the vaccination campaign safe injection practices were maintained and the cold chain was not interrupted. Mass vaccination in slums had good acceptance. Because populations in such areas are highly mobile, settlement conditions could affect coverage. Systemic reactions were uncommon and local reactions were mild and transient. Close community involvement was pivotal for information dissemination and immunization coverage. Conclusion This vaccine strategy described together with other information that will soon be available in the area (cost/effectiveness, vaccine delivery costs, etc will make typhoid fever control become a reality in the near future.

  1. 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.).

  2. Effect of Melatonin on the Outcome of Assisted Reproductive Technique Cycles in Women with Diminished Ovarian Reserve: A Double-Blinded Randomized Clinical Trial

    Science.gov (United States)

    Jahromi, Bahia Namavar; Sadeghi, Sara; Alipour, Shohreh; Parsanezhad, Mohammad Ebrahim; Alamdarloo, Shaghayegh Moradi

    2017-01-01

    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) follicle-stimulating 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 PMID:28293053

  3. Randomized, Double Blind, Placebo-Controlled Trial of Disulfiram for the Treatment of Cocaine Dependence in Methadone-Stabilized Patients1

    Science.gov (United States)

    Oliveto, Alison; Poling, James; Mancino, Michael J.; Feldman, Zachary; Cubells, Joseph F.; Pruzinsky, Rhonda; Gonsai, Kishorchandra; Cargile, Christopher; Sofuoglu, Mehmet; Chopra, Mohit P.; Gonzalez-Haddad, Gerardo; Carroll, Kathleen M.; Kosten, Thomas R.

    2010-01-01

    This study examined the dose-related efficacy of disulfiram for treating cocaine dependence in methadone-stabilized cocaine dependent participants. Design One hundred sixty-one cocaine-and opioid-dependent volunteers were entered into a 14-week, double blind, randomized, placebo-controlled clinical trial at two sites. Methods Participants were stabilized on methadone during weeks 1–2 and received disulfiram at 0, 62.5, 125 or 250 mg/day during weeks 3–14. All participants also received weekly cognitive behavioral therapy. Thrice-weekly urine samples and weekly self-reported drug use assessments were obtained. Results Baseline subject characteristics, retention and drug use did not differ across groups. Outcome analyses were performed on those who participated beyond week 2. Opioid positive urine samples and self-reported opioid use did not differ by treatment group. The prevalence of alcohol use was low prior to and during the trial and did not differ by treatment group. Cocaine-positive urines increased over time in the 62.5 and 125 mg disulfiram groups and decreased over time in the 250 mg disulfiram and placebo groups (p<0.0001). Self-reported cocaine use increased in the 125 mg disulfiram group relative to the other three treatment groups (p=0.04). Conclusions Disulfiram may be contraindicated for cocaine dependence at doses less than 250 mg/day. Whether disulfiram at higher doses is efficacious in reducing cocaine use in dually cocaine and opioid dependent individuals needs to be determined. PMID:20828943

  4. Acute Effects of Caffeine on Heart Rate Variability, Blood Pressure and Tidal Volume in Paraplegic and Tetraplegic Compared to Able-Bodied Individuals: A Randomized, Blinded Trial

    Science.gov (United States)

    Flueck, Joelle Leonie; Schaufelberger, Fabienne; Lienert, Martina; Schäfer Olstad, Daniela; Wilhelm, Matthias; Perret, Claudio

    2016-01-01

    Caffeine increases sympathetic nerve activity in healthy individuals. Such modulation of nervous system activity can be tracked by assessing the heart rate variability. This study aimed to investigate the influence of caffeine on time- and frequency-domain heart rate variability parameters, blood pressure and tidal volume in paraplegic and tetraplegic compared to able-bodied participants. Heart rate variability was measured in supine and sitting position pre and post ingestion of either placebo or 6 mg caffeine in 12 able-bodied, 9 paraplegic and 7 tetraplegic participants in a placebo-controlled, randomized and double-blind study design. Metronomic breathing was applied (0.25 Hz) and tidal volume was recorded during heart rate variability assessment. Blood pressure, plasma caffeine and epinephrine concentrations were analyzed pre and post ingestion. Most parameters of heart rate variability did not significantly change post caffeine ingestion compared to placebo. Tidal volume significantly increased post caffeine ingestion in able-bodied (p = 0.021) and paraplegic (p = 0.036) but not in tetraplegic participants (p = 0.34). Systolic and diastolic blood pressure increased significantly post caffeine in able-bodied (systolic: p = 0.003; diastolic: p = 0.021) and tetraplegic (systolic: p = 0.043; diastolic: p = 0.042) but not in paraplegic participants (systolic: p = 0.09; diastolic: p = 0.33). Plasma caffeine concentrations were significantly increased post caffeine ingestion in all three groups of participants (p<0.05). Plasma epinephrine concentrations increased significantly in able-bodied (p = 0.002) and paraplegic (p = 0.032) but not in tetraplegic participants (p = 0.63). The influence of caffeine on the autonomic nervous system seems to depend on the level of lesion and the extent of the impairment. Therefore, tetraplegic participants may be less influenced by caffeine ingestion. Trial Registration ClinicalTrials.gov NCT02083328 PMID:27776149

  5. Sublingual versus Vaginal Misoprostol for the Induction of Labor at Term: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Bahia Namavar Jahromi

    2016-03-01

    Full Text Available Background: We sought to compare the effectiveness and safety of sublingual versus vaginal misoprostol for the termination of pregnancy with a live full-term fetus. Methods: This randomized, triple-blind, placebo-controlled clinical trial was performed on 200 primiparous women with normal, singleton, full-term pregnancies candidated for the induction of labor. Sublingual and vaginal tablets containing misoprostol (25 mcg or placebo in similar shapes were administered every 4 hours until the Bishop score reached above 8. Maternal and neonatal complications and outcomes were compared. Results: There were 100 parturient women in each group. The mean maternal age, gestational age, and Bishop score at the commencement of misoprostol had no statistical differences between the sublingual and vaginal groups. The mean time interval between misoprostol commencement and delivery was 497.10±291.49 and 511.67±08.46 minutes for the sublingual and vaginal groups, correspondingly. Twenty-two women had Cesarean deliveries in the sublingual group versus 14 in the vaginal group. Meconium-stained amniotic fluid was seen in 12 women in the sublingual group and 4 in the vaginal group (P=0.03. Late fetal heart rate deceleration was observed in 8 women in the sublingual group and 4 in the vaginal group (P=0.22. The mean neonatal birth weight, blood gas value at birth, Apgar score, and length of admission time in the neonatal intensive care unit were not different between the 2 groups. Conclusion: Sublingual and vaginal misoprostol had similar effectiveness; however, meconium-stained liquor was observed considerably more frequently with sublingual misoprostol than with vaginal misoprostol. Trial Registration Number: IRCT201402096541N3

  6. Sublingual versus Vaginal Misoprostol for the Induction of Labor at Term: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

    Science.gov (United States)

    Jahromi, Bahia Namavar; Poorgholam, Foroogh; Yousefi, Gholamhossein; Salarian, Leila

    2016-01-01

    Background: We sought to compare the effectiveness and safety of sublingual versus vaginal misoprostol for the termination of pregnancy with a live full-term fetus. Methods: This randomized, triple-blind, placebo-controlled clinical trial was performed on 200 primiparous women with normal, singleton, full-term pregnancies candidated for the induction of labor. Sublingual and vaginal tablets containing misoprostol (25 mcg) or placebo in similar shapes were administered every 4 hours until the Bishop score reached above 8. Maternal and neonatal complications and outcomes were compared. Results: There were 100 parturient women in each group. The mean maternal age, gestational age, and Bishop score at the commencement of misoprostol had no statistical differences between the sublingual and vaginal groups. The mean time interval between misoprostol commencement and delivery was 497.10±291.49 and 511.67±08.46 minutes for the sublingual and vaginal groups, correspondingly. Twenty-two women had Cesarean deliveries in the sublingual group versus 14 in the vaginal group. Meconium-stained amniotic fluid was seen in 12 women in the sublingual group and 4 in the vaginal group (P=0.03). Late fetal heart rate deceleration was observed in 8 women in the sublingual group and 4 in the vaginal group (P=0.22). The mean neonatal birth weight, blood gas value at birth, Apgar score, and length of admission time in the neonatal intensive care unit were not different between the 2 groups. Conclusion: Sublingual and vaginal misoprostol had similar effectiveness; however, meconium-stained liquor was observed considerably more frequently with sublingual misoprostol than with vaginal misoprostol. Trial Registration Number: IRCT201402096541N3 PMID:26989277

  7. Effect of Melatonin on the Outcome of Assisted Reproductive Technique Cycles in Women with Diminished Ovarian Reserve: A Double-Blinded Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    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

  8. Genetic determinants of cognitive responses to caffeine drinking identified from a double-blind, randomized, controlled trial.

    Science.gov (United States)

    Renda, Giulia; Committeri, Giorgia; Zimarino, Marco; Di Nicola, Marta; Tatasciore, Alfonso; Ruggieri, Benedetta; Ambrosini, Ettore; Viola, Vanda; Antonucci, Ivana; Stuppia, Liborio; De Caterina, Raffaele

    2015-06-01

    The widely observed between-subject variability in cognitive responses to coffee may have a genetic basis. We evaluated cognitive responses to caffeine throughout three complex cognitive tasks assessing different subdomains of attention, namely Alerting and Orienting (Categorical Search Task) and Executive Control (Stroop Task and Eriksen Flanker Task). We explored whether they are influenced by gene variants affecting adenosine metabolism or catecholamine receptors. We recruited 106 healthy male subjects who were administered, in a double-blind design, 40mL of either a decaffeinated coffee preparation plus 3mg/kg caffeine (caf) or the corresponding vehicle (decaf). The protocol was repeated 24h later with the alternative preparation. Cognitive tasks were performed between 30min and 2h after caf or decaf administration. Each subject underwent ambulatory blood pressure monitoring for 2h. Blood samples were collected for genetic evaluations and for plasma caffeine and catecholamines measures. We found a significant reduction of reaction times in two of the cognitive tasks (Categorical Search Task and Stroop Task) after caf compared with decaf, indicating that caffeine, on average, improved the attention level in the domains under investigation. We also found, however, a great inter-individual variability in the cognitive performance responses to caffeine. In exploring genetic sources for such variability, we found a relation between polymorphisms of adenosine A2A and the caffeine effects on the attentional domains of Orienting and Executive control. In conclusion, variability in the attentional response to coffee may be partly explained by genetic polymorphisms of adenosine and adrenergic receptors.

  9. Pyronaridine-artesunate versus chloroquine in patients with acute Plasmodium vivax malaria: a randomized, double-blind, non-inferiority trial.

    Directory of Open Access Journals (Sweden)

    Yi Poravuth

    Full Text Available BACKGROUND: New antimalarials are needed for P. vivax and P. falciparum malaria. This study compared the efficacy and safety of pyronaridine-artesunate with that of chloroquine for the treatment of uncomplicated P. vivax malaria. METHODS AND FINDINGS: This phase III randomized, double-blind, non-inferiority trial included five centers across Cambodia, Thailand, India, and Indonesia. In a double-dummy design, patients (aged >3-≤ 60 years with microscopically confirmed P. vivax mono-infection were randomized (1:1 to receive pyronaridine-artesunate (target dose 7.2:2.4 mg/kg to 13.8:4.6 mg/kg or chloroquine (standard dose once daily for three days. Each treatment group included 228 randomized patients. Outcomes for the primary endpoint, Day-14 cure rate in the per-protocol population, were 99.5%, (217/218; 95%CI 97.5, 100 with pyronaridine-artesunate and 100% (209/209; 95%CI 98.3, 100 with chloroquine. Pyronaridine was non-inferior to chloroquine: treatment difference -0.5% (95%CI -2.6, 1.4, i.e., the lower limit of the 2-sided 95%CI for the treatment difference was greater than -10%. Pyronaridine-artesunate cure rates were non-inferior to chloroquine for Days 21, 28, 35 and 42. Parasite clearance time was shorter with pyronaridine-artesunate (median 23.0 h versus chloroquine (32.0 h; p<0.0001, as was fever clearance time (median 15.9 h and 23.8 h, respectively; p = 0.0017. Kaplan-Meier estimates of post-baseline P. falciparum infection incidence until Day 42 were 2.5% with pyronaridine-artesunate, 6.1% with chloroquine (p = 0.048, log-rank test. Post-baseline P. vivax or P. falciparum infection incidence until Day 42 was 6.8% and 12.4%, respectively (p = 0.022, log rank test. There were no deaths. Adverse events occurred in 92/228 (40.4% patients with pyronaridine-artesunate and 72/228 (31.6% with chloroquine. Mild and transient increases in hepatic enzymes were observed for pyronaridine-artesunate. CONCLUSION: Pyronaridine-artesunate efficacy

  10. Pyronaridine-Artesunate versus Chloroquine in Patients with Acute Plasmodium vivax Malaria: A Randomized, Double-Blind, Non-Inferiority Trial

    Science.gov (United States)

    Poravuth, Yi; Socheat, Duong; Rueangweerayut, Ronnatrai; Uthaisin, Chirapong; Pyae Phyo, Aung; Valecha, Neena; Rao, B. H. Krishnamoorthy; Tjitra, Emiliana; Purnama, Asep; Borghini-Fuhrer, Isabelle; Duparc, Stephan; Shin, Chang-Sik; Fleckenstein, Lawrence

    2011-01-01

    Background New antimalarials are needed for P. vivax and P. falciparum malaria. This study compared the efficacy and safety of pyronaridine-artesunate with that of chloroquine for the treatment of uncomplicated P. vivax malaria. Methods and Findings This phase III randomized, double-blind, non-inferiority trial included five centers across Cambodia, Thailand, India, and Indonesia. In a double-dummy design, patients (aged >3–≤60 years) with microscopically confirmed P. vivax mono-infection were randomized (1∶1) to receive pyronaridine-artesunate (target dose 7.2∶2.4 mg/kg to 13.8∶4.6 mg/kg) or chloroquine (standard dose) once daily for three days. Each treatment group included 228 randomized patients. Outcomes for the primary endpoint, Day-14 cure rate in the per-protocol population, were 99.5%, (217/218; 95%CI 97.5, 100) with pyronaridine-artesunate and 100% (209/209; 95%CI 98.3, 100) with chloroquine. Pyronaridine was non-inferior to chloroquine: treatment difference −0.5% (95%CI −2.6, 1.4), i.e., the lower limit of the 2-sided 95%CI for the treatment difference was greater than −10%. Pyronaridine-artesunate cure rates were non-inferior to chloroquine for Days 21, 28, 35 and 42. Parasite clearance time was shorter with pyronaridine-artesunate (median 23.0 h) versus chloroquine (32.0 h; pestimates of post-baseline P. falciparum infection incidence until Day 42 were 2.5% with pyronaridine-artesunate, 6.1% with chloroquine (p = 0.048, log-rank test). Post-baseline P. vivax or P. falciparum infection incidence until Day 42 was 6.8% and 12.4%, respectively (p = 0.022, log rank test). There were no deaths. Adverse events occurred in 92/228 (40.4%) patients with pyronaridine-artesunate and 72/228 (31.6%) with chloroquine. Mild and transient increases in hepatic enzymes were observed for pyronaridine-artesunate. Conclusion Pyronaridine-artesunate efficacy in acute uncomplicated P. vivax malaria was at least that of chloroquine. As pyronaridine

  11. 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

  12. First phase 1 double-blind, placebo-controlled, randomized rectal microbicide trial using UC781 gel with a novel index of ex vivo efficacy.

    Directory of Open Access Journals (Sweden)

    Peter A Anton

    Full Text Available Successful control of the HIV/AIDS pandemic requires reduction of HIV-1 transmission at sexually-exposed mucosae. No prevention studies of the higher-risk rectal compartment exist. We report the first-in-field Phase 1 trial of a rectally-applied, vaginally-formulated microbicide gel with the RT-inhibitor UC781 measuring clinical and mucosal safety, acceptability and plasma drug levels. A first-in-Phase 1 assessment of preliminary pharmacodynamics was included by measuring changes in ex vivo HIV-1 suppression in rectal biopsy tissue after exposure to product in vivo.HIV-1 seronegative, sexually-abstinent men and women (N = 36 were randomized in a double-blind, placebo-controlled trial comparing UC781 gel at two concentrations (0.1%, 0.25% with placebo gel (1∶1∶1. Baseline, single-dose exposure and a separate, 7-day at-home dosing were assessed. Safety and acceptability were primary endpoints. Changes in colorectal mucosal markers and UC781 plasma drug levels were secondary endpoints; ex vivo biopsy infectibility was an ancillary endpoint.All 36 subjects enrolled completed the 7-14 week trial (100% retention including 3 flexible sigmoidoscopies, each with 28 biopsies (14 at 10 cm; 14 at 30 cm. There were 81 Grade 1 adverse events (AEs and 8 Grade 2; no Grade 3, 4 or procedure-related AEs were reported. Acceptability was high, including likelihood of future use. No changes in mucosal immunoinflammatory markers were identified. Plasma levels of UC781 were not detected. Ex vivo infection of biopsies using two titers of HIV-1(BaL showed marked suppression of p24 in tissues exposed in vivo to 0.25% UC781; strong trends of suppression were seen with the lower 0.1% UC781 concentration.Single and 7-day topical rectal exposure to both concentrations of UC781 were safe with no significant AEs, high acceptability, no detected plasma drug levels and no significant mucosal changes. Ex vivo biopsy infections demonstrated marked suppression of HIV

  13. High versus moderate energy use of bipolar fractional radiofrequency in the treatment of acne scars: a split-face double-blinded randomized control trial pilot study.

    Science.gov (United States)

    Phothong, Weeranut; Wanitphakdeedecha, Rungsima; Sathaworawong, Angkana; Manuskiatti, Woraphong

    2016-02-01

    Bipolar fractional radiofrequency (FRF) device was firstly FDA-approved for treating atrophic acne scar in 2008 through the process of dermal coagulation and minimal epidermal ablation. The average energy at 60 mJ/pin was widely used to treat atrophic acne scars. However, the higher energy was delivered, the deeper ablation and coagulation were found. At present, the new generation of a device with bipolar FRF technology with electrode-pin tip was developed to maximize ability to deliver energy up to 100 mJ/pin. The objective of the study was to explore and compare the efficacy of utilizing high energy (100 mJ/pin) and moderate energy (60 mJ/pin) of bipolar fractional radiofrequency in treatment of atrophic acne scar in Asians. This is a split-face, double-blinded, randomized control trial, pilot study by using parallel group design technique. Thirty healthy subjects with Fitzpatrick skin phototype III-IV diagnosed as atrophic acne scares were enrolled. All subjects received four monthly sessions of bipolar FRF treatment. Left and right facial sides of individual patients were randomly assigned for different energy (high energy at 100 mJ/pin versus moderate energy at 60 mJ/pin). Acne scars improvement was blinded graded by dermatologist using global acne scarring score (GASS) which was subjectively evaluated at baseline, 1-, 3-, and 6-month follow-up. Objective scar analysis was also done using UVA-light video camera to measure scar volume, skin smoothness, and wrinkle at baseline, 3-, and 6-month follow-up after the last treatment. Side effects including pain, erythema, swelling, and crusting were also recorded. Thirty subjects completed the study with full 4-treatment course. The mean GASS of high energy side and moderate energy side was significantly reduced at 1-, 3-, and 6-month follow-up visits. At 1 month follow-visit, high energy side demonstrated significant improvement compared with moderate energy side (p = 0.03). Postinflammatory hyperpigmentation

  14. 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

    Symptoms after human infection with the helminth Trichuris suis have not previously been described. Exposure to helminths has been suggested as immune therapy against allergy and autoimmune diseases. We randomized adults with allergic rhinitis to ingest a dose of 2500 T. suis eggs or placebo every...... by a fluoroenzymeimmunoassay (Phadia ApS). During 163 days complete follow-up, subjects ingesting T. suis eggs (N = 49) had a three to 19-fold higher rate of events (median duration, 2 days) with gastrointestinal reactions (moderate to severe flatulence, diarrhea, and upper abdominal pain) compared with placebo subjects (N...

  15. Linking vitamin D status, executive functioning and self-perceived mental health in adolescents through multivariate analysis: A randomized double-blind placebo control trial.

    Science.gov (United States)

    Grung, Bjørn; Sandvik, Asle M; Hjelle, Kay; Dahl, Lisbeth; Frøyland, Livar; Nygård, Irene; Hansen, Anita L

    2017-04-01

    The aim of the present randomized double-blind placebo control trial was to investigate if vitamin D supplementation had an effect on vitamin D status, executive functioning and self-perceived mental health in a group of Norwegian adolescents during winter time. Fifty adolescents were randomly assigned into an intervention group (vitamin D pearls) or a control group (placebo pearls). Before (pre-test in December/January) and after (post-test in April/May) the intervention period the participants were exposed to a test procedure, consisting of blood draw, completion of cognitive tests (Tower of Hanoi and Tower of London), and the Youth Self-report version of the Child Behavior Checklist. Multivariate data analysis showed that participants with low vitamin D status scored worse on the Tower of London tests and the more difficult sub-tasks on the Tower of Hanoi tests. They also had a tendency to report higher frequency of externalizing behavior problems and attention deficit. At pre-test, the overall mean vitamin D status measured as 25-hydroxy vitamin D was 42 nmol/L, defining deficiency (Intervention group = 44 nmol/L, Control group = 39 nmol/L). However, vitamin D supplementation caused a significant increase in vitamin D status resulting in a sufficient level in the Intervention group at post-test (mean 62 nmol/L). The results also revealed that the intervention group improved their performance on the most demanding sub-tasks on the ToH. Overall, the study indicates that vitamin D status in adolescents may be important for both executive functioning and mental health.

  16. Randomized Double-blinded and Controlled Clinical Trial on Treatment of HIV/AIDS by Zhongyan-4 (中研-4号)

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    Objective: To assess the efficacy and safety of Zhongyan-4 (中研-4号, ZY-4, a Chinese herbal preparation worked out according to the therapeutic principle of supplementing qi, nourishing Yin,clearing heat and detoxication) in treating HIV/AIDS patients in the early or middle stage. Methods: Adopted was randomized double-blinded and placebo-parallel-controlled method, with 72 HIV/AIDS patients randomly divided into the ZY-4 group (36 patients) treated with ZY-4 and the control group (36 patients) treated with placebo. The treatment course was six months. The index of CD4+ , CD8+ counts, body weight, clinical symptom scoring were estimated at 4 time points (0, 1, 3 and 6 month in the course), and also the viral load before and after treatment. The whole course of observation was completed in 63 patients, 30 in the ZY-4group and 33 in the control group. Results: CD4 + count in the ZY-4 group got elevated by 7.70 ± 150.96/mm3on average, while that in the control group lowered by 27.33±85.28 /mm3. Fifteen out of the 30 patients in the ZY-4 group had their CD4+ count increased, which was evidently much higher than that in the control group (8/33, P<0.05), suggesting that the efficacy of ZY-4 is superior to that of placebo in elevating CD4 +count. Moreover, ZY-4 showed actions in elevating CD45RA+ and CD8+ count, reducing HIV virus load, improving clinical symptom/sign and increasing body weight of patients. No obvious adverse reaction was found in the clinical trial. Conclusion: ZY-4 has an immunity-protective and/or rebuilding function in HIV/AIDS patients in the early and middle stage, and also shows effects in lowering viral load, increasing body weight and improving symptoms and signs to a certain degree.

  17. Analgesic Efficacy of Transverse Abdominal Plane Block after Elective Cesarean Delivery – Bupivacaine with Fentanyl versus Bupivacaine Alone: A Randomized, Double-blind Controlled Clinical Trial

    Science.gov (United States)

    John, Roshan; Ranjan, R. V.; Ramachandran, T. R.; George, Sagiev Koshy

    2017-01-01

    Background: The analgesic benefit of transversus abdominis plane (TAP) blocks for cesarean delivery remains controversial. In our study, we compared the analgesic efficacy of TAP block using local anesthetic bupivacaine and adjunct fentanyl with bupivacaine alone in patients undergoing elective cesarean section. Methods: Our study was a randomized, double-blind, controlled clinical trial where sixty patients undergoing elective cesarean delivery under subarachanoid block (2 ml of 0.5% bupivacaine) were randomized into two groups, A and B. At the end of the surgical procedure, bilateral TAP block was performed guided by the ultrasound. Group A received 38 ml of 0.25% bupivacaine and 2 ml of 50 μg of fentanyl, whereas Group B received 38 ml of 0.25% bupivacaine + 2 ml of normal saline. The total volume was divided equally and administered bilaterally. Each patient was assessed for 24 h after TAP block, for time to rescue analgesia, pain using visual analog scale (VAS) score at rest and on movement, hemodynamic parameters (heart rate and blood pressure), nausea, vomiting, and sedation. Diclofenac 75 mg was given as rescue analgesia when the patient complained of pain or when VAS score >4. Results: Prolonged postoperative analgesia was noticed with both the groups, with a mean time to rescue analgesia of approximately 6.5 h. There was no significant difference in time to rescue analgesia (6.49 ± 0.477 vs. 6.5 ± 0.480) when both the groups were compared among themselves. The pain scores among the two groups when compared did not show any added benefit. Incidence of nausea, vomiting, and sedation when compared between both the groups showed no difference. Conclusion: The TAP block as a part of a multimodal analgesic regimen definitely has a role in providing superior analgesia in the postoperative period. However, adjunct fentanyl to local anesthetic bupivacaine was found to have no added advantage when quality and duration of analgesia was compared.

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

    Directory of Open Access Journals (Sweden)

    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.

  19. Effect of Helicobacter pylori eradication on insulin resistance among prediabetic patients: A pilot study and single-blind randomized controlled clinical trial

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    Ali Kachuei

    2016-01-01

    Full Text Available Background: Type II diabetes mellitus (T2DM is the prevalent type of diabetes in the world. Prediabetic patients are the most probable group to get diabetes. Several studies have mentioned the role of inflammation in the incidence of diabetes. The origin of inflammation can be infection such as Helicobacter pylori (HP infection. This study was designed to explore the effect of HP eradication on insulin resistance. Materials and Methods: This single-blind randomized controlled clinical trial was conducted in 2014-2015. The sample size consisted of 49 individuals who were in prediabetes stage with HP infection. Patients with positive stool antigen were allocated randomly into two groups. The treatment group took medication to eradicate HP infection by the routine method of four-drug eradication. However, placebo capsules and tablets were given to the patients in the placebo group. Then fasting plasma glucose (FPG, fasting plasma insulin (FPI, and quantitative C-reactive protein (CRP levels were measured and homeostatic model assessment of insulin resistance (HOMA-IR, homeostatic model assessment of beta-cell function (HOMA-B, Matsuda index, insulinogenic index, and disposition index were calculated. Results: Results of this study showed that FPI and HOMA-IR increased significantly (P value of FPI = 0.023 and P value of HOMA-IR = 0.019 after HP eradication in the treatment group. On the other hand, comparison of differences at the baseline and after 6 weeks in FPG (P value = 0.045, FPI (P value = 0.013, and HOMA-B (P value = 0.038 revealed significant differences between the placebo group and treatment group. Conclusion: Results showed that HP eradication by a 2-week antibiotic medication did not decrease insulin resistance and even increased FPI and insulin resistance indices. So HP eradication among prediabetic patients is not recommended for the decrease of insulin resistance and postponement of the development of diabetes mellitus.

  20. Does Quercetin Improve Cardiovascular Risk factors and Inflammatory Biomarkers in Women with Type 2 Diabetes: A Double-blind Randomized Controlled Clinical Trial

    Science.gov (United States)

    Zahedi, Maryam; Ghiasvand, Reza; Feizi, Awat; Asgari, Gholamreza; Darvish, Leila

    2013-01-01

    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. PMID:24049596

  1. The effect of intravenous Dexamethasone on post-cesarean section pain and vital signs: A double-blind randomized clinical trial

    Science.gov (United States)

    Shahraki, Azar Danesh; Feizi, Awat; Jabalameli, Mitra; Nouri, Shadi

    2013-01-01

    Objective: Any operation leads to body stress and tissue injury that causes pain and its complications. Glucocorticoids such as Dexamethasone are strong anti-inflammatory agents, which can be used for a short time post-operative pain control in various surgeries. Main purpose of this study is to evaluate the effect of administration of intravenous (IV) Dexamethasone on reducing the pain after cesarean. Methods: A double-blind prospective randomized clinical trial was performed on 60 patients candidate for elective caesarean section. Patients were randomly assigned into two groups: A (treatment: 8 mg IV Dexamethasone) and B (control: 2 mL normal saline). In both groups, variables such as mean arterial blood pressure (MAP), heart rate (HR), respiratory rate (RR), pain and vomiting severity (based on visual analog scale) were recorded in different time points during first 24 h after operation. Statistical methods using repeated measure analysis of variances and t-test, Mann-Whitney and Chi-square tests were used for analyzing data. Findings: The results indicated that within-group comparisons including severity of pain, MAP, RR and HR have significant differences (P < 0.001 for all variables) during the study period. Between group comparisons indicated significant differences in terms of pain severity (P < 0.001), MAP (P = 0.048) and HR (P = 0.078; marginally significant), which in case group were lower than the control group. Conclusion: IV Dexamethasone could efficiently reduce post-operative pain severity and the need for analgesic consumption and improve vital signs after cesarean section. PMID:24991614

  2. Effect of Helicobacter pylori eradication on insulin resistance among prediabetic patients: A pilot study and single-blind randomized controlled clinical trial

    Science.gov (United States)

    Kachuei, Ali; Amini, Masoud; Sebghatollahi, Vahid; Feizi, Awat; Hamedani, Pooria; Iraj, Bijan

    2016-01-01

    Background: Type II diabetes mellitus (T2DM) is the prevalent type of diabetes in the world. Prediabetic patients are the most probable group to get diabetes. Several studies have mentioned the role of inflammation in the incidence of diabetes. The origin of inflammation can be infection such as Helicobacter pylori (HP) infection. This study was designed to explore the effect of HP eradication on insulin resistance. Materials and Methods: This single-blind randomized controlled clinical trial was conducted in 2014-2015. The sample size consisted of 49 individuals who were in prediabetes stage with HP infection. Patients with positive stool antigen were allocated randomly into two groups. The treatment group took medication to eradicate HP infection by the routine method of four-drug eradication. However, placebo capsules and tablets were given to the patients in the placebo group. Then fasting plasma glucose (FPG), fasting plasma insulin (FPI), and quantitative C-reactive protein (CRP) levels were measured and homeostatic model assessment of insulin resistance (HOMA-IR), homeostatic model assessment of beta-cell function (HOMA-B), Matsuda index, insulinogenic index, and disposition index were calculated. Results: Results of this study showed that FPI and HOMA-IR increased significantly (P value of FPI = 0.023 and P value of HOMA-IR = 0.019) after HP eradication in the treatment group. On the other hand, comparison of differences at the baseline and after 6 weeks in FPG (P value = 0.045), FPI (P value = 0.013), and HOMA-B (P value = 0.038) revealed significant differences between the placebo group and treatment group. Conclusion: Results showed that HP eradication by a 2-week antibiotic medication did not decrease insulin resistance and even increased FPI and insulin resistance indices. So HP eradication among prediabetic patients is not recommended for the decrease of insulin resistance and postponement of the development of diabetes mellitus. PMID:27904554

  3. Evaluation of the effect of Vaccinium arctostaphylos L. fruit extract on serum inflammatory biomarkers in adult hyperlipidemic patients: a randomized double-blind placebo-controlled clinical trial

    Science.gov (United States)

    Asgary, Sedigheh; Soltani, Rasool; Mirvakili, Saeide; Sarrafzadegan, Nizal

    2016-01-01

    Atherosclerosis is a chronic inflammatory condition. Many pro-inflammatory factors including interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and adhesion molecules including intercellular adhesion molecule (ICAM-1) and vascular cell adhesion molecule (VCAM-1) are expressed in atherosclerotic lesions. The plants of genus Vaccinium are rich in anthocyanins with anti-inflammatory effects. This study aimed to evaluate the effects of Vaccinium arctostaphylos fruit extract on the serum level of TNF-α, IL-6, ICAM-1, and VCAM-1 in adult patients with mild hyperlipidemia to detect its possible inhibitory effects on progression of atherosclerosis. In a randomized double-blind placebo-controlled clinical trial, eligible hyperlipidemic patients were randomly and equally divided in to two groups of study drug or placebo control to receive either the Vaccinium extract or placebo capsules, respectively, twice daily for four consecutive weeks. Each drug capsule contained 0.8 mg of anthocyanins. Serum levels of TNF-α, IL-6, ICAM-1, and VCAM-1 were measured before and after the interventions and finally were compared.A total of 8 men and 12 women in drug group as well as 11 men and 9 women in placebo group completed the study (P = 0.527). The use of Vaccinium extract significantly reduced only the IL-6 level (P = 0.037); however, this reduction was not significant compared to placebo (P = 0.062). Consumption of Vaccinium arctostaphylos fruit extract with the dose of 500 mg twice daily did not show any significant effect on serum levels of TNF-α, IL-6, ICAM-1, and VCAM-1 in adult hyperlipidemic patients. However, considering slight decrease in the level of IL-6, ICAM-1, and VCAM-1, the use of higher doses with longer duration might have significant effects on these factors. PMID:27651815

  4. Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica

    Science.gov (United States)

    Herrero, Rolando; Hildesheim, Allan; Rodríguez, Ana C; Wacholder, Sholom; Bratti, Concepción; Solomon, Diane; González, Paula; Porras, Carolina; Jiménez, Silvia; Guillen, Diego; Morales, Jorge; Alfaro, Mario; Cyr, Jean; Morrisey, Kerrygrace; Estrada, Yenory; Cortés, Bernal; Morera, Lidia Ana; Freer, Enrique; Schussler, John; Schiller, John; Lowy, Douglas; Schiffman, Mark

    2008-01-01

    We report the rationale, design, methods and details of participation of a community-based, double blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7,466 women (30% of those prescreened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A complex protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and Gonorrhea testing. Eighty percent of the women received 3 doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18. LSIL was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self-collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant. PMID:18640170

  5. The Effect of Vitamin B12 Infusion on Prevention of Nitrous Oxide-induced Homocysteine Increase: A Double-blind Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Alieh Zamani Kiasari

    2014-05-01

    Full Text Available Objective: Nitrous oxide is a common inhalation anesthetic agent in general anesthesia. While it is widely accepted as a safe anesthetic agent, evidence suggests exposure to this gas, leads to hyperhomocysteinemia. The present study aimed to evaluate the effects of single-dose intravenous infusions of vitamin B12, before and after the induction of nitrous oxide anesthesia on homocysteine levels after the surgery. Methods: This double-blind randomized controlled trial was conducted on 60 patients who were scheduled for elective surgery under general anesthesia, presumably lasting for more than two hours. The subjects were randomly allocated to three groups of 20. For the first group, vitamin B12 solution (1 mg/100 ml normal saline and 100 ml of normal saline (placebo, were infused before and after the induction of anesthesia, respectively. The second group received placebo and vitamin B12 infusion before and after the induction of anesthesia, respectively. The third group received placebo infusions at both times. Homocysteine levels were measured before and 24 hours after the surgery. Results: The mean homocysteine and vitamin B12 levels were significantly different within the three groups (p<0.001. In patients who had been infused with vitamin B12 before the surgery, homocysteine levels were significantly lower than the other two groups. In the placebo group, homocysteine levels significantly increased after the surgery. Conclusion: Nitrous oxide causes hyperhomocysteinemia after general anesthesia. Since vitamin B12 infusion is a safe and inexpensive method to decrease homocysteine levels in these patients, it may be recommended for patients undergoing nitrous oxide anesthesia to be used before induction of anesthesia.

  6. Effects of a Gentle, Self-Administered Stimulation of Perineal Skin for Nocturia in Elderly Women: A Randomized, Placebo-Controlled, Double-Blind Crossover Trial.

    Directory of Open Access Journals (Sweden)

    Kaori Iimura

    Full Text Available Somatic afferent nerve stimuli are used for treating an overactive bladder (OAB, a major cause of nocturia in the elderly. Clinical evidence for this treatment is insufficient because of the lack of appropriate control stimuli. Recent studies on anesthetized animals show that gentle stimuli applied to perineal skin with a roller could inhibit micturition contractions depending on the roller's surface material. We examined the efficacy of gentle skin stimuli for treating nocturia.The study was a cross-over, placebo-controlled, double-blind randomized clinical study using two rollers with different effects on micturition contractions. Participants were elderly women (79-89 years with nocturia. Active (soft elastomer roller or placebo (hard polystyrene roller stimuli were applied to perineal skin by participants for 1 min at bedtime. A 3-day baseline assessment period was followed by 3-day stimulation and 4-day resting periods, after which the participants were subjected to other stimuli for another 3 days. The primary outcome was change in the frequency of nighttime urination, for which charts were maintained during each 3-day period.Twenty-four participants were randomized, of which 22 completed all study protocols. One participant discontinued treatment because of an adverse event (abdominal discomfort. In participants with OAB (n = 9, change from baseline in the mean frequency of urination per night during the active stimuli period (mean ± standard deviation, -0.74 ± 0.7 times was significantly greater than that during placebo stimuli periods (-0.15 ± 0.8 times [p < 0.05]. In contrast, this difference was not observed in participants without OAB (n = 13.These results suggest that gentle perineal stimulation with an elastomer roller is effective for treating OAB-associated nocturia in elderly women. Here the limitation was a study period too short to assess changes in the quality of sleep and life.UMIN Clinical Trial Registry (CTR UMIN

  7. Mifepristone in Combination with Misoprostol vs. Low Dose Mifepristone Alone in Emergency Contraception: a Multi-center Double-blind Randomized Clinical Trial

    Institute of Scientific and Technical Information of China (English)

    2002-01-01

    Objective To compare the effectiveness and side effects of various low dose ofMi fepristone in combination with Misoprostol and low doses Mi fepristone alone in emer-gency contraceptionMaterials & Methods This is a multi-center double-blind randomized controlled clini-cal trial. A total of 899 healthy women were allocated into this study and were ran-domly divided into 3 groups. They were orally administrated with different emergen-cy contraceptives with 120 h after unprotected intercourse. Group Ⅰ (n = 300) was giv-en 25 mg Mifepristone plus 0. 2 mg Misoprostol after 24 h. Group Ⅱ (n = 299) wasgiven 10 mg Mifepristone plus 0. 2 mg Misoprostol after 24 h. Group Ⅲ (n = 300)was administrated with 10 mg Mifepristone alone. The effective rates in differentgroups were calculated with Dixon method.Results Altogether 11 pregnancies occurred, among which 2 cases were in Group Ⅰ, 2cases in Group Ⅱ, and 7 cases were in Grout Ⅲ. After correction with method fail-ure, there was only one case in Group Ⅰ, 0 case in Group Ⅱ, and 5 cases in Group Ⅲ.The contraceptive effectiveness in these groups was 95. 5%, 100% and 76. 9% respec-tively. The pregnancy rate was significantly lower in Group Ⅰ and Group Ⅱ than thatof Group Ⅲ (P< 0. 01). The side effects were slight and tolerable, and there was nosignificant difference between di fferent groups (P> 0. 05).Conclusion Use of low dose Mi fepristone (25 mg or 10 mg ) in combination with 0. 2mg Misoprostol was an effective, low side effects and safe treatment regimen foremergency contraception.

  8. Salvia Miltiorrhiza Root Water-Extract (Danshen Has No Beneficial Effect on Cardiovascular Risk Factors. A Randomized Double-Blind Cross-Over Trial.

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    Pleun C M van Poppel

    Full Text Available Danshen is the dried root extract of the plant Salvia Miltiorrhiza and it is used as traditional Chinese medicinal herbal product to prevent and treat atherosclerosis. However, its efficacy has not been thoroughly investigated. This study evaluates the effect of Danshen on hyperlipidemia and hypertension, two well known risk factors for the development of atherosclerosis.This was a randomized, placebo-controlled, double-blind crossover study performed at a tertiary referral center. Participants were recruited by newspaper advertisement and randomized to treatment with Danshen (water-extract of the Salvia Miltiorrhiza root or placebo for 4 consecutive weeks. There was a wash out period of 4 weeks. Of the 20 analysed participants, 11 received placebo first. Inclusion criteria were: age 40-70 years, hyperlipidemia and hypertension. At the end of each treatment period, plasma lipids were determined (primary outcome, 24 hours ambulant blood pressure measurement (ABPM was performed, and vasodilator endothelial function was assessed in the forearm.LDL cholesterol levels were 3.82±0.14 mmol/l after Danshen and 3.52±0.16 mmol/l after placebo treatment (mean±SE; p<0.05 for treatment effect corrected for baseline. Danshen treatment had no effect on blood pressure (ABPM 138/84 after Danshen and 136/87 after placebo treatment. These results were further substantiated by the observation that Danshen had neither an effect on endothelial function nor on markers of inflammation, oxidative stress, glucose metabolism, hemostasis and blood viscosity.Four weeks of treatment with Danshen (water-extract slightly increased LDL-cholesterol without affecting a wide variety of other risk markers. These observations do not support the use of Danshen to prevent or treat atherosclerosis.ClinicalTrials.gov NCT01563770.

  9. 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.

  10. Effects of low-level laser therapy applied before or after plyometric exercise on muscle damage markers: randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Fritsch, Carolina Gassen; Dornelles, Maurício Pinto; Severo-Silveira, Lucas; Marques, Vanessa Bernardes; Rosso, Isabele de Albuquerque; Baroni, Bruno Manfredini

    2016-12-01

    Promising effects of phototherapy on markers of exercise-induced muscle damage has been already demonstrated in constant load or isokinetic protocols. However, its effects on more functional situations, such as plyometric exercises, and when is the best moment to apply this treatment (pre- or post-exercise) remain unclear. Therefore, the purpose of this study was to investigate the effect of low-level laser therapy (LLLT) before or after plyometric exercise on quadriceps muscle damage markers. A randomized, double-blinded, placebo-controlled trial was conducted with 24 healthy men, 12 at pre-exercise treatment group and 12 at post-exercise treatment group. Placebo and LLLT (810 nm, 200 mW per diode, 6 J per diode, 240 J per leg) were randomly applied on right/left knee extensor muscles of each volunteer before/after a plyometric exercise protocol. Muscular echo intensity (ultrasonography images), soreness (visual analogue scale - VAS), and strength impairment (maximal voluntary contraction - MVC) were assessed at baseline, 24, 48, and 72 h post-exercise. Legs treated with LLLT before or after exercise presented significantly smaller increments of echo intensity (values up to 1 %) compared to placebo treatments (increased up to ∼7 %). No significant treatment effect was found for VAS and MVC, although a trend toward better results on LLLT legs have been found for VAS (mean values up to 30 % lesser than placebo leg). In conclusion, LLLT applied before or after plyometric exercise reduces the muscle echo intensity response and possibly attenuates the muscle soreness. However, these positive results were not observed on strength impairment.

  11. Effect of Dill (Anethum graveolens on the severity of primary dysmenorrhea in compared with mefenamic acid: A randomized, double-blind trial

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    Reza Heidarifar

    2014-01-01

    Full Text Available Background: Dysmenorrhea has negative effects on women′s life. Due to side-effects of chemical drugs, there is growing trend toward herbal medicine. The aim of this study was to assess the effect of Dill compared to mefenamic acid on primary dysmenorrhea. Materials and Methods: This double-blind, randomized, clinical trial study was conducted on 75 single female students between 18 and 28 years old educating in Nursing and Midwifery School and Paramedical Facul