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Sample records for blinded controlled trial

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

    OpenAIRE

    Marie Pirotta; Roberta Chow; Ian Relf

    2008-01-01

    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 b...

  2. The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

    DEFF Research Database (Denmark)

    Bello, Segun; Wei, Maoling; Hilden, Jørgen;

    2016-01-01

    BACKGROUND: Blinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often matching procedures are inadequate, so we decided to sys...

  3. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

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

    Directory of Open Access Journals (Sweden)

    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.

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

    OpenAIRE

    Nilsson Robert; Antić Ruza; Spasojević-Tišma Vera; Joksić Gordana; Rutqvist Lars E

    2011-01-01

    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 enr...

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

    OpenAIRE

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

    2013-01-01

    OBJECTIVE: To examine the efficacy and safety of short-term and long-term use of antidepressants in the treatment of bipolar disorder. DATA SOURCES: A literature search of randomized, double-blind, controlled trials published until December 2012 was performed using the PubMed, ISI Web of Science, Medline and Cochrane Central Register of Controlled Trials databases. The keywords “bipolar disorder, bipolar I disorder, bipolar II disorder, bipolar mania, bipolar depression, cyclothymia, mixed ma...

  7. 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…

  8. SMALL INCISION CATARACT SURGERY VERSUS PHACOEMULSIFICATION FOR IMMATURE CATARACT: A SINGLE BLIND RANDOMIZED CONTROLLED TRIAL

    OpenAIRE

    Md. Jawed; Himadri; De, Abhijit; Rathindra; Deshmukh Md Saudmiya

    2014-01-01

    BACKGROUND: Manual small incision cataract surgery (SICS) has given visual results almost equivalent to Phacoemulsification but limited studies are available regarding the efficacy of small incision cataract surgery in phaco suitable immature cataracts. OBJECTIVE: To compare manual small incision cataract surgery and Phacoemulsification in immature cataracts. MATERIALS AND METHODS: A single blind randomized controlled trial was conducted with 105 eyes each for small incisi...

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

    OpenAIRE

    Usman Anju; Logerquist Sally; Schneider Cindy; Smith Scott; Rossignol Lanier W; Rossignol Daniel A; Neubrander Jim; Madren Eric M; Hintz Gregg; Grushkin Barry; Mumper Elizabeth A

    2009-01-01

    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 ...

  10. Randomized, Double-Blind, and Placebo-Controlled Trial of Clenbuterol in Denervated Muscle Atrophy

    OpenAIRE

    Jiang, Guang-Liang; Gu, Yu-Dong; Zhang, Li-Yin; Shen, Li-Ying; Yu, Cong; Xu, Jian-Guang

    2011-01-01

    Objectives. 2 -adrenergic agonists, such as clenbuterol, have been shown to promote the hypertrophy of healthy skeletal muscles and to ameliorate muscle wasting in a few pathological conditions in both animals and humans. We intended to investigate the clinical efficacy of clenbuterol on attenuating denervation-induced muscle atrophy. Methods. A double-blind, placebo-controlled, parallel, and randomized trial was employed. 71 patients, suffering from brachial plexus injuries, were given eit...

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

    OpenAIRE

    2015-01-01

    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 cond...

  12. Effects of adjunctive daily phototherapy on chronic periodontitis: a randomized single-blind controlled trial

    OpenAIRE

    Jung, Gyu-Un; Kim, Jin-Woo; Kim, Sun-Jong; Pang, Eun-Kyoung

    2014-01-01

    Purpose The purpose of this randomized single-blind controlled trial was to elucidate the clinical and antimicrobial effects of daily phototherapy (PT) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis. Methods The study was conducted from December 2013 to May 2014 at Ewha Womans University Mokdong Hospital, Seoul, Korea. Forty-one patients with mild to moderate chronic periodontitis were randomly divided into two therapeutic groups in a 1:1 ratio: SRP+PT ...

  13. Oral Doxycycline Reduces Pterygium Lesions; Results from a Double Blind, Randomized, Placebo Controlled Clinical Trial

    OpenAIRE

    Oscar Rúa; Larráyoz, Ignacio M; Barajas, María T.; Sara Velilla; Alfredo Martínez

    2012-01-01

    PURPOSE: To determine whether oral doxycycline treatment reduces pterygium lesions. DESIGN: Double blind, randomized, placebo controlled clinical trial. PARTICIPANTS: 98 adult patients with primary pterygium. METHODS: Patients were randomly assigned to receive 100 mg oral doxycycline twice a day (49 subjects), or placebo (49 subjects), for 30 days. Photographs of the lesion were taken at the time of recruitment and at the end of the treatment. Follow-up sessions were performed 6 and 12 months...

  14. Homoeopathy for delayed onset muscle soreness: a randomised double blind placebo controlled trial.

    OpenAIRE

    Vickers, A J; Fisher, P.; Smith, C.; Wyllie, S E; Lewith, G T

    1997-01-01

    OBJECTIVE: To pilot a model for determining whether a homoeopathic medicine is superior to placebo for delayed onset muscle soreness (DOMS). DESIGN: Randomised double blind placebo controlled trial. SETTING: Physiotherapy department of a homoeopathic hospital. SUBJECTS: Sixty eight healthy volunteers (average age 30; 41% men) undertook a 10 minute period of bench stepping carrying a small weight and were randomised to a homoeopathic medicine or placebo. OUTCOME MEASURES: Mean muscle soreness ...

  15. Testing for Placebo Effects Using Data from Blinded, Randomized Controlled Trials

    OpenAIRE

    Anup Malani

    2004-01-01

    This paper proposes a test for the existence of placebo effects, as described by the so-called expectancy theory. This theory, which is the dominant medical theory of how placebo effects operate, posits that health outcomes rise in individuals' beliefs about the probability that they are getting a beneficial treatment and their beliefs about the efficacy of that treatment. Blinded, randomized, controlled trials provide near-perfect environments in which to test this theory because they offer ...

  16. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial

    OpenAIRE

    Enander, Jesper; Andersson, Erik; Mataix-Cols, David; Lichtenstein, Linn; Alstroem, Katarina; Andersson, Gerhard; Ljotsson, Brjann; Rueck, Christian

    2016-01-01

    Objectives To evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy. Design A 12 week single blind parallel group randomised controlled trial. Setting Academic medical centre. Participants 94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥20. Concurrent psychotrop...

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

    Directory of Open Access Journals (Sweden)

    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.

  18. 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

  19. A randomised, double-blind, placebo-controlled trial of tropisetron in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Shiraishi Tetsuya

    2010-06-01

    Full Text Available Abstract Background Cognitive deficits in schizophrenia are associated with psychosocial deficits that are primarily responsible for the poor long-term outcome of this disease. Auditory sensory gating P50 deficits are correlated with neuropsychological deficits in attention, one of the principal cognitive disturbances in schizophrenia. Our studies suggest that the α7 nicotinic acetylcholine receptor (α7 nAChR agonist tropisetron might be a potential therapeutic drug for cognitive deficits in schizophrenia. Therefore, it is of particular interest to investigate the effects of tropisetron on the cognitive deficits in patients with schizophrenia. Methods A randomised, placebo-controlled trial of tropisetron in patients with schizophrenia was performed. A total of 40 patients with chronic schizophrenia who had taken risperidone (2 to 6 mg/day were enrolled. Subjects were randomly assigned to a fixed titration of tropisetron (n = 20, 10 mg/day or placebo (n = 20 in an 8-week double-blind trial. Auditory sensory gating P50 deficits and Quality of Life Scale (QLS, Cambridge Neuropsychological Test Automated Battery (CANTAB, and Positive and Negative Syndrome Scale (PANSS scores were measured. Results In all, 33 patients completed the trial. Tropisetron was well tolerated. Administration of tropisetron, but not placebo, significantly improved auditory sensory gating P50 deficits in non-smoking patients with schizophrenia. The score on the rapid visual information processing (sustained visual attention task of CANTAB was significantly improved by tropisetron treatment. Total and subscale scores of PANSS were not changed by this trial. QLS scores in the all patients, but not non-smoking patients, were significantly improved by tropisetron trial. Conclusions This first randomised, double-blind, placebo-controlled trial supports the safety and efficacy of adjunctive tropisetron for treatment of cognitive deficits in schizophrenia.

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

    OpenAIRE

    ABBASKHANIAN, Ali; Sara EHTESHAMI; Sadegh SAJJADI; Mohammad Sadegh REZAI

    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...

  1. A blinded, controlled trial of an ultrasound device as mosquito repellent.

    Science.gov (United States)

    Sylla el-H, K; Lell, B; Kremsner, P G

    2000-05-19

    Ultrasound emitting devices are used to repel mosquitoes. We tested the repelling properties of a commercially available ultrasound device in a domestic setting in Gabon. Devices emitting three different block frequencies ranging from 3 to 11 kHz were tested in a paired, cross-over blinded and placebo controlled trial during eighteen nights in nine pairs of houses. A total of 7485 mosquitoes (10% Anopheles, 62% Culex, 27% Mansonia and 1% Aedes) were caught, 23 per house per night. There was no significant difference in landing rate between the houses with ultrasound device and the houses with placebo for any species of mosquito. Thus the ultrasound device used was not effective against mosquitoes in this strictly controlled trial. PMID:10890136

  2. Treatment of chronic idiopathic urticaria with levamisole: a multicentre, randomized, double-blind, controlled trial.

    Science.gov (United States)

    Zhang, H; Shan, C; Hua, Z; Zhao, P; Zhang, H

    2009-01-01

    The objective of this study was to evaluate the efficacy of treating chronic idiopathic urticaria (CIU) with levamisole in combination with levocetirizine. This was a multicentre, randomized, double-blind, controlled trial that included 132 patients with active CIU who were treated for 6 weeks with either levocetirizine alone (control group; n = 65) or levamisole plus levocetirizine (treatment group; n = 67). Response to therapy was evaluated by measuring the efficacy rate. After 2 weeks of treatment, there was no significant difference in the efficacy rate between the treatment and control groups (54.84% and 42.37%, respectively). After 6 weeks of treatment, a statistically significant difference in the efficacy rate was observed between the groups (76.27% and 54.39% for the treatment and control groups, respectively). This study demonstrated that a combination of levamisole plus levocetirizine is more effective than levocetirizine alone and potentially provides a new, promising approach to the treatment of CIU. PMID:19761700

  3. 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...

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

    Directory of Open Access Journals (Sweden)

    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

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

    OpenAIRE

    Wahner-Roedler, Dietlind L; Thompson, Jeffrey M; Luedtke, Connie A; King, Susan M.; Cha, Stephen s; Elkin, Peter L.; Barbara K. Bruce; Townsend, Cynthia O.; Bergeson, Jody R.; Eickhoff, Andrea L.; Laura L. Loehrer; Amit Sood; Bauer, Brent A.

    2011-01-01

    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 Epidemio...

  6. Trimethoprim as adjuvant treatment in schizophrenia: a double-blind, randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Shibre, Teshome; Alem, Atalay; Abdulahi, Abdulreshid; Araya, Mesfin; Beyero, Teferra; Medhin, Girmay; Deyassa, Negusse; Negash, Alemayehu; Nigatu, Alemayehu; Kebede, Derege; Fekadu, Abebaw

    2010-07-01

    Various infectious agents, such as Toxoplasma gondii, have been hypothesized to be potentially relevant etiological factors in the onset of some cases of schizophrenia. We conducted a randomized, double-blind, placebo-controlled treatment trial in an attempt to explore the hypothesis that the symptoms of schizophrenia may be related to infection of the central nervous system with toxoplasma gondii. Systematically selected patients with ongoing and at least moderately severe schizophrenia from Butajira, in rural Ethiopia, were randomly allocated to trimethoprim or placebo, which were added on to participants' regular antipsychotic treatments. Trial treatments were given for 6 months. The Positive and Negative Syndrome Scale (PANSS) was used to assess outcome. Ninety-one patients were included in the study, with 80 cases (87.9%) positive for T. gondii immunoglobulin G antibody. Seventy-nine subjects (87.0%) completed the trial. The mean age of subjects was 35.3 (SD = 8.0) years, with a mean duration of illness of 13.2 (SD = 6.7) years. Both treatment groups showed significant reduction in the overall PANSS score with no significant between-group difference. In this sample of patients with chronic schizophrenia, trimethoprim used as adjuvant treatment is not superior to placebo. However, it is not possible to draw firm conclusion regarding the etiological role of toxoplasmosis on schizophrenia based on this study because the timing and the postulated mechanisms through which toxoplasmosis produces schizophrenia are variable. PMID:19193743

  7. The Effect of Intravenous Lidocaine on Trigeminal Neuralgia: A Randomized Double Blind Placebo Controlled Trial

    Science.gov (United States)

    Argyra, Erifili

    2014-01-01

    Trigeminal neuralgia is the most common neuralgia. Its therapeutic approach is challenging as the first line treatment often does not help, or even causes intolerable side effects. The aim of our randomized double blind, placebo controlled, crossover study was to investigate in a prospective way the effect of lidocaine in patients with trigeminal neuralgia. Twenty patients met our inclusion criteria and completed the study. Each patient underwent four weekly sessions, two of which were with lidocaine (5 mgs/kg) and two with placebo infusions administered over 60 minutes. Intravenous lidocaine was superior regarding the reduction of the intensity of pain, the allodynia, and the hyperalgesia compared to placebo. Moreover, contrary to placebo, lidocaine managed to maintain its therapeutic results for the first 24 hours after intravenous infusion. Although, intravenous lidocaine is not a first line treatment, when first line medications fail to help, pain specialists may try it as an add-on treatment. This trial is registered with NCT01955967.

  8. Safety and efficacy of rivastigmine in children with Down syndrome: A double blind placebo controlled trial.

    Science.gov (United States)

    Spiridigliozzi, Gail A; Hart, Sarah J; Heller, James H; Schneider, Heather E; Baker, Jane Ann; Weadon, Cathleen; Capone, George T; Kishnani, Priya S

    2016-06-01

    Individuals with Down syndrome (DS) have decreased cholinergic function and an uneven profile of cognitive abilities, with more pronounced deficits in learning, memory, and expressive language. Cholinesterase inhibitors may improve cognitive function in adults and adolescents with DS, but studies in children with DS have been limited. This study aimed to: (i) investigate the safety and efficacy of rivastigmine treatment; (ii) build upon our open-label studies in children with DS in a double-blind, placebo-controlled clinical trial; and (iii) investigate specific cognitive domains that may respond to rivastigmine treatment. We conducted a 20-week double-blind, placebo-controlled trial to investigate the safety and efficacy of rivastigmine in 22 children and adolescents with DS aged 10-17 years. Safety measures included reports of adverse events, laboratory parameters, and electrocardiograms. Efficacy measures included parental assessments of adaptive behavior and executive function, and direct measures of language and memory. No group differences were found on safety measures and 22 of 24 participants that passed study screening completed the study. The results did not demonstrate evidence for significant improvement in aspects of cognition, language, or overall function in the children receiving rivastigmine. Our results suggest that rivastigmine is safe and well-tolerated for children and adolescents with DS, but may not be effective for improving performance on the selected measures in this study. However, larger samples and/or alternate measures could possibly reveal improvements in cognitive function with rivastigmine treatment. Further research is needed to define a battery of cognitive measures that is sensitive to treatment effects in DS. © 2016 Wiley Periodicals, Inc. PMID:27061338

  9. Use of Low-Cost Videomicroscopy versus Standard Videodermatoscopy in Trichoscopy: A Controlled, Blinded Noninferiority Trial.

    Science.gov (United States)

    Verzì, Anna Elisa; Lacarrubba, Francesco; Micali, Giuseppe

    2016-05-01

    Affordable (USD ∼30) handheld USB digital microscopes, or videomicroscopes (VMs), that provide ×10-200 magnification are available on the web for nonmedical uses such as in botany, entomology, microelectronics or, recently, for hair/scalp evaluation. The aim of this study was to compare the reliability of low-cost VMs versus standard, medically marketed videodermatoscopes (VDs) in trichoscopy. Twenty-five patients affected by different types of hair loss were enrolled in a controlled, blinded noninferiority trial. All patients underwent examination by two low-cost VMs as well as by standard VD in order to evaluate any variability in the detection of common trichoscopic features. At the end of the study, the two low-cost VMs enabled a correct identification of all hair shaft alterations; as regards follicular and/or perifollicular examination, black dots were easily recognized by both equipments, but other follicular features, such as yellow dots, white dots and perifollicular scales, were not always adequately visualized because of low color quality and/or reduced brightness and/or resolution. In conclusion, our study suggests that the potential accuracy of low-cost VMs in the evaluation of hair loss may have some pitfalls. Therefore, a low-cost VM should not be routinely used for reliable scalp trichoscopy, unless supported by individual controlled noninferiority trials. PMID:27386460

  10. Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment : a randomized, double-blind, controlled trial

    NARCIS (Netherlands)

    de Waal, Y. C. M.; Raghoebar, G. M.; Meijer, H. J. A.; Winkel, E. G.; van Winkelhoff, A. J.

    2015-01-01

    ObjectiveThe objective of this randomized, double-blind, controlled trial was to evaluate the clinical, radiographic, and microbiological effects of implant surface decontamination with a 2% chlorhexidine (CHX) solution in comparison with a 0.12% chlorhexidine+0.05% cetylpyridinium chloride (CPC) so

  11. 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

  12. 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

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

    Directory of Open Access Journals (Sweden)

    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.

  14. Targeted physiotherapy for patellofemoral joint osteoarthritis: A protocol for a randomised, single-blind controlled trial

    Directory of Open Access Journals (Sweden)

    Schache Anthony G

    2008-09-01

    Full Text Available Abstract Background The patellofemoral joint (PFJ is one compartment of the knee that is frequently affected by osteoarthritis (OA and is a potent source of OA symptoms. However, there is a dearth of evidence for compartment-specific treatments for PFJ OA. Therefore, this project aims to evaluate whether a physiotherapy treatment, targeted to the PFJ, results in greater improvements in pain and physical function than a physiotherapy education intervention in people with symptomatic and radiographic PFJ OA. Methods 90 people with PFJ OA (PFJ-specific history, signs and symptoms and radiographic evidence of PFJ OA will be recruited from the community and randomly allocated into one of two treatments. A randomised controlled trial adhering to CONSORT guidelines will evaluate the efficacy of physiotherapy (8 individual sessions over 12 weeks, as well as a home exercise program 4 times/week compared to a physiotherapist-delivered OA education control treatment (8 individual sessions over 12 weeks. Physiotherapy treatment will consist of (i quadriceps muscle retraining; (ii quadriceps and hip muscle strengthening; (iii patellar taping; (iv manual PFJ and soft tissue mobilisation; and (v OA education. Resistance and dosage of exercises will be tailored to the participant's functional level and clinical state. Primary outcomes will be evaluated by a blinded examiner at baseline, 12 weeks and 9 months using validated and reliable pain, physical function and perceived global effect scales. All analyses will be conducted on an intention-to-treat basis using linear mixed regression models, including respective baseline scores as a covariate, subjects as a random effect, treatment condition as a fixed factor and the covariate by treatment interaction. Conclusion This RCT is targeting PFJ OA, an important sub-group of knee OA patients, with a specifically designed conservative intervention. The project's outcome will influence PFJ OA rehabilitation, with the

  15. 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. PMID:26764156

  16. 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

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

    International Nuclear Information System (INIS)

    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. 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. 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 type 2 diabetes taking under treatment with metformin have been

  18. Perioperative Continuous Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy: A Randomized Controlled Double-blind Trial.

    Science.gov (United States)

    Fassoulaki, Argyro; Vassi, Emilia; Korkolis, Dimitrios; Zotou, Marianna

    2016-02-01

    Wound infusion with local anesthetics has been used for postoperative pain relief with variable results. This randomized, controlled, double-blind clinical trial examines the effect of ropivacaine infusion on pain after laparoscopic cholecystectomy. A total of 110 patients were randomly assigned to 2 groups. After induction of anesthesia a 75-mm catheter was inserted subcutaneously and connected to an elastomeric pump containing either 0.75% ropivacaine (ropivacaine group) or normal saline (control group) for 24 hours postoperatively. Before skin closure, each hole was infiltrated with 2 mL of 0.75% ropivacaine or normal saline according to randomization. Pain at rest, pain during cough, and analgesic consumption were recorded in the postanesthesia care unit and at 2, 4, 8, 24, and 48 hours postoperatively. Analgesic requirements and pain scores were recorded 1 and 3 months after surgery. The ropivacaine group reported less pain during cough (P=0.044) in the postanesthesia care unit (P=0.017) and 4 hours postoperatively (P=0.038). Ropivacaine wound infusion had no effect on late and chronic pain. PMID:26679680

  19. Carbetocin vs. Syntometrine in Prevention of Postpartum Hemorrhage: a Double Blind Randomized Control Trial

    OpenAIRE

    Samimi, Mansoureh; Imani-Harsini, Azam; Abedzadeh-Kalahroudi, Masoumeh

    2013-01-01

    Background Postpartum hemorrhage is a significant cause of maternal mortality and morbidity, worldwide. Objectives The aim of this study was to compare the efficacy between carbetocin and syntometrine in prevention of postpartum hemorrhage. Materials and Methods This study was a double blind randomized clinical trial that carried out on 200 pregnant women referred to Shabiehkhani maternity center of Kashan, during 2011. The first group received intramuscular syntometrine and the second group r...

  20. Double-blind, randomized, controlled clinical trial of norfloxacin for cholera.

    OpenAIRE

    Bhattacharya, S K; Bhattacharya, M. K.; P Dutta; Dutta, D.; De, S. P.; Sikdar, S. N.; Maitra, A.; Dutta, A; Pal, S C

    1990-01-01

    In a double-blind, randomized clinical trial with 78 adults with acute watery diarrhea and severe dehydration, 37 subjects were positive for Vibrio cholerae. In conjunction with rehydration therapy, 13 patients received norfloxacin, 12 received trimethoprim-sulfamethoxazole (TMP-SMX), and 12 received a placebo. Norfloxacin was superior to TMP-SMX and to the placebo in reducing stool output, duration of diarrhea, fluid requirements, and vibrio excretion. TMP-SMX was no better than the placebo.

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

    OpenAIRE

    Franciane Schneider; Mitzy Tannia Reichembach Danski; Stela Adami Vayego

    2015-01-01

    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 i...

  2. Randomised, Double Blind, Placebo-Controlled Trial of Echinacea Supplementation in Air Travellers

    Directory of Open Access Journals (Sweden)

    E. Tiralongo

    2012-01-01

    Full Text Available Objective. To identify whether a standardised Echinacea formulation is effective in the prevention of respiratory and other symptoms associated with long-haul flights. Methods. 175 adults participated in a randomised, double-blind placebo-controlled trial travelling back from Australia to America, Europe, or Africa for a period of 1–5 weeks on commercial flights via economy class. Participants took Echinacea (root extract, standardised to 4.4 mg alkylamides or placebo tablets. Participants were surveyed before, immediately after travel, and at 4 weeks after travel regarding upper respiratory symptoms and travel-related quality of life. Results. Respiratory symptoms for both groups increased significantly during travel (P<0.0005. However, the Echinacea group had borderline significantly lower respiratory symptom scores compared to placebo (P=0.05 during travel. Conclusions. Supplementation with standardised Echinacea tablets, if taken before and during travel, may have preventive effects against the development of respiratory symptoms during travel involving long-haul flights.

  3. SMALL INCISION CATARACT SURGERY VERSUS PHACOEMULSIFICATION FOR IMMATURE CATARACT: A SINGLE BLIND RANDOMIZED CONTROLLED TRIAL

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    Md. Jawed

    2014-08-01

    Full Text Available BACKGROUND: Manual small incision cataract surgery (SICS has given visual results almost equivalent to Phacoemulsification but limited studies are available regarding the efficacy of small incision cataract surgery in phaco suitable immature cataracts. OBJECTIVE: To compare manual small incision cataract surgery and Phacoemulsification in immature cataracts. MATERIALS AND METHODS: A single blind randomized controlled trial was conducted with 105 eyes each for small incision cataract surgery and Phacoemulsification. RESULT: Mean IOL power was similar in both Phacoemulsifications as well as SICS. Four cases of posterior capsular rupture occurred in Phacoemulsification while one case of zonular dialysis occurred in SICS. Uncorrected visual acuity was good (6/6-6/18 in 80.0 % of the phaco and 93.33 % of the SICS group. CONCLUSION: SICS surgical technique resulted in significantly better visual acuity on the 1st postoperative day in comparison with phaco. Hence, SICS with rigid PMMA IOL implantation being a cheaper, faster and easier technique, may be recommended for immature cataract surgery in the developing countries

  4. Efficacy of Bosentan in patients after Fontan procedures: a double-blind, randomized controlled trial.

    Science.gov (United States)

    Shang, Xiao-Ke; Lu, Rong; Zhang, Xi; Zhang, Chang-Dong; Xiao, Shu-Na; Liu, Mei; Wang, Bin; Dong, Nian-Guo

    2016-08-01

    Fontan surgery is a widely used palliative procedure that significantly improves the survival period of patients with complex congenital heart disease (CHD). However, it does not decrease postoperative complication rate. Previous studies suggested that elevated mean pulmonary artery pressure (mPAP) and vascular resistance lead to decreased exercise tolerance and myocardial dysfunction. Therapy with endothelial receptor antagonists (Bosentan) has been demonstrated to improve the patients' prognosis. A double-blind, randomized controlled trial was performed to explore the efficacy of Bosentan in treating patients who underwent the Fontan procedure. Eligible participants were randomly divided into Bosentan group and control group. Liver function was tested at a local hospital and the results were reported to the phone inspector every month. If the results suggested abnormal liver function, treatment would be adjusted or terminated. All the participants finished the follow-up study, with no patients lost to follow-up. Unblinding after 2-year follow-up, no mortality was observed in either group. However, secondary end-points were found to be significantly different in the comparable groups. The cardiac function and 6-min walking distance in the Bosentan group were significantly superior to those in the control group (P=0.018 and P=0.027). Bosentan could improve New York Heart Association (NYHA) functional status and improve the results of the 6-min walking test (6MWT) in Fontan patients post-surgery, and no other benefits were observed. Furthermore, a primary meta-analysis study systematically reviewed all the similar clinical trails worldwide and concluded an overall NYHA class improvement in Fontan patients who received Bosentan treatments. PMID:27465329

  5. Prospective, double blind, randomized, controlled trial of simvastatin in human fracture healing.

    Science.gov (United States)

    Patil, Sanjeev; Holt, Graeme; Raby, Nigel; McLellan, Alastair R; Smith, Karen; O'Kane, Sarah; Beastall, Graham; Crossan, James F

    2009-03-01

    Although statins are widely prescribed as cholesterol-lowering drugs, a number of studies suggest that these compounds may have anabolic effects on bone. Our aim was to assess whether simvastatin affects the rate of fracture healing in humans. A prospective, double-blind, randomized controlled trial was performed. Individuals who had sustained an undisplaced, extra-articular fracture of the distal radial metaphysis were recruited from a trauma clinic. Patients were randomized to receive simvastatin 20 mg once daily or a placebo. Regular clinical and radiological follow-up was undertaken for a 12 week period. Dual-energy X-ray absorptiometry assessment of bone mineral density was conducted at 2 and 12 weeks postinjury. Biochemical markers of bone turnover were assayed during the study period. Time to fracture union was defined as the time to cortical bridging in four cortices on plain radiographs. In addition, the rate of trabecular union was assessed. Eighty patients were recruited, of which 62 completed the study (31 in each group). Study cohorts were matched for age and gender. For patients receiving simvastatin therapy, the mean time to fracture union was 71.6 days (SD 22.2 days, SEM 3.8 days). This compared to 71.3 days (SD 21.3, SEM 4.1 days) for the control cohort (p = 0.6481). There was no significant difference between bone mineral density or bone biochemical markers between groups (p > 0.05). Despite promising results from in vivo and in vitro animal studies, simvastatin at a treatment dose of 20 mg once daily does not affect the rate of fracture healing in humans. PMID:18853428

  6. Effect of Kaempferia parviflora Extract on Physical Fitness of Soccer Players: A Randomized Double-Blind Placebo-Controlled Trial

    OpenAIRE

    Promthep, Kreeta; Eungpinichpong, Wichai; Sripanidkulchai, Bungorn; Chatchawan, Uraiwan

    2015-01-01

    Background Physical fitness is a fundamental prerequisite for soccer players. Kaempferia parviflora is an herbal plant that has been used in some Asian athletes with the belief that it might prevent fatigue and improve physical fitness. This study aimed to determine the effects of Kaempferia parviflora on the physical fitness of soccer players. Material/Methods Sixty soccer players who routinely trained at a sports school participated in a double-blind placebo-controlled trial and were random...

  7. Captopril for prevention of Contrast Induced Nephropathy in patients undergoing Coronary Angioplasty: A double blind placebo controlled clinical trial

    OpenAIRE

    Hashemi, M.; Kharazi, A; Shahidi, S.

    2005-01-01

    Background: Contrast induced nephropathy is a potential cause of mortality and morbidity in patients undergoing angiography–angioplasty. Except for hydrating and probably low – isoosmolar contrast agents in high risk groups, other modalities have not provided benefit. We investigated preventive effects of captopril for contrast induced nephropathy during angiography–angioplasty. Methods: In a double blind placebo controlled clinical trial, 88 patients were randomized to two groups: 42 pa...

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

    OpenAIRE

    Coulibaly, Oumar; thera, mahamadou,; Koné, Abdoulaye; siaka, goita; Traoré, Pierre; Djimde, Abdoulaye; Brunel, Jean-Michel; Gaudart, Jean; Piarroux, Renaud; Doumbo, Ogobara; Ranque, Stéphane

    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...

  9. Safety and radiosensitizing efficacy of sanazole (AK 2123) in oropharyngeal cancers: Randomized controlled double blind clinical trial

    OpenAIRE

    MRSM Pai; Chowta M; Adiga SMN; Dinesh M; Shenoy K; Kamath A; Ullal S; Kotian M; Pai D

    2006-01-01

    Oropharynx is an important site of cancer in India. Global comparison indicates higher incidences in India. Radiotherapy remains an important treatment modality. Efforts to improve loco-regional treatment and prolong survival are areas of focus. Radiosensitizers in hypoxic tumors have shown promise. Aim:0 To study the safety and radiosensitizing efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage T2-4, N0-3, M0) as phase-II double blind controlled trial in patients treated ...

  10. Citalopram, Methylphenidate, or Their Combination in Geriatric Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

    OpenAIRE

    Lavretsky, H.; Reinlieb, M; St. Cyr, N.; Siddarth, P.; Ercoli, LM; Senturk, D

    2015-01-01

    OBJECTIVE: The authors evaluated the potential of methylphenidate to improve antidepressant response to citalopram, as assessed by clinical and cognitive outcomes, in elderly depressed patients. METHOD: The authors conducted a 16-week randomized double-blind placebo-controlled trial for geriatric depression in 143 older outpatients diagnosed with major depression comparing treatment response in three treatment groups: methylphenidate plus placebo (N=48), citalopram plus placebo (N=48), and ci...

  11. Triple-blind, placebo-controlled trial of Ginkgo biloba extract on sexual desire in postmenopausal women in Tehran

    OpenAIRE

    Pebdani, Mina Amiri; Taavoni, Simin; Seyedfatemi, Naima; Haghani, Hamid

    2014-01-01

    Background: During the menopausal period, sexual desire may decrease. Therefore, restoring the sexual desire may help to improve sexual functioning in this group of women. The aim of this study was to examine the effect of Ginkgo biloba extract (GBE) on sexual desire in postmenopausal women. Materials and Methods: In this triple-blind, randomized, placebo-controlled trial, 80 healthy female volunteers attending three healthcare centers of Tehran University of Medical Sciences (TUMS) were enro...

  12. Measurable prediction for the single patient and the results of large double blind controlled randomized trials.

    Directory of Open Access Journals (Sweden)

    Cathy M Helgason

    Full Text Available BACKGROUND: It has been shown that the clinical state of one patient can be represented by known measured variables of interest, each of which then form the element of a fuzzy set as point in the unit hypercube. We hypothesized that precise comparison of a single patient with the average patient of a large double blind controlled randomized study is possible using fuzzy theory. METHODS/PRINCIPLE FINDINGS: The sets as points unit hypercube geometry allows fuzzy subsethood to define in measures of fuzzy cardinality different conditions, similarity and comparison between fuzzy sets. A fuzzy measure of prediction is defined from fuzzy measures of similarity and comparison. It is a measure of the degree to which fuzzy set A is similar to fuzzy set B when different conditions are taken into account and removed from the comparison. When represented as a fuzzy set as point in the unit hypercube, a clinical patient can be compared to an average patient of a large group study in a precise manner. This comparison is expressed by the fuzzy prediction measure. This measure in itself is not a probability. Once thus precisely matched to the average patient of a large group study, risk reduction is calculated by multiplying the measured similarity of the clinical patient to the risk of the average trial patient. CONCLUSION/SIGNIFICANCE: Otherwise not precisely translatable to the single case, the result of group statistics can be applied to the single case through the use of fuzzy subsethood and measured in fuzzy cardinality. This measure is an alternative to a Bayesian or other probability based statistical approach.

  13. A double-blind randomized controlled trial of oxytocin nasal spray in Prader Willi syndrome.

    Science.gov (United States)

    Einfeld, Stewart L; Smith, Ellie; McGregor, Iain S; Steinbeck, Kate; Taffe, John; Rice, Lauren J; Horstead, Siân K; Rogers, Naomi; Hodge, M Antoinette; Guastella, Adam J

    2014-09-01

    Individuals with Prader-Willi syndrome (PWS) have a significant reduction in the number of oxytocin-producing neurons (42%) in the hypothalamic paraventricular nucleus. A number of animal studies and observations of humans show that lesions in this region can produce PWS-like symptoms. Given the evidence for potential oxytocin deficiency, we tested the effects of a course of intranasal oxytocin on PWS symptoms. Thirty individuals with PWS aged 12-30 years participated in an 18-week randomized double-blind placebo-controlled crossover trial. Participants received 8 weeks of oxytocin and 8 weeks of placebo with a minimum 2-week washout period. The first 11 participants received the following oxytocin doses: 24 IU (twice daily) B.I.D for participants 16 years and over and 18 IU B.I.D for participants 13-15 years. The dose was increased for the remaining 18 participants to 40 IU B.I.D for participants 16 years and over and 32 IU B.I.D for 13-15 years. Measures used to assess changes were standardized well-accepted measures, including the Developmental Behavior Checklist-Monitor, Parent, Teacher, and Adult; The Yale-Brown Obsessive Compulsive Scale; The Dykens Hyperphagia questionnaire; Reading The Mind in the Eyes Test; Epworth Sleepiness Scale and the Movie Stills. Oxytocin had little impact on any measure. The only significant difference found between the baseline, oxytocin, and placebo measures was an increase in temper outbursts (P = 0.023) with higher dose oxytocin. The lack of effect of oxytocin nasal spray may reflect the importance of endogenous release of oxytocin in response to exogenous oxytocin. PMID:24980612

  14. Double-Blind, Randomized, Placebo-Controlled Trial of Metoclopramide for Hypersalivation Associated With Clozapine.

    Science.gov (United States)

    Kreinin, Anatoly; Miodownik, Chanoch; Mirkin, Vitaly; Gaiduk, Yulia; Yankovsky, Yan; Bersudsky, Yuly; Lerner, Paul P; Bergman, Joseph; Lerner, Vladimir

    2016-06-01

    Hypersalivation is a frequent, disturbing, and uncomfortable adverse effect of clozapine therapy that frequently leads to noncompliance. The aim of this study was to examine the efficacy of metoclopramide (dopamine D2 antagonist, antiemetic medication) as an option for management of hypersalivation associated with clozapine (HAC). A 3-week, double-blind, placebo-controlled trial was conducted in university-based research clinics from January 2012 to May 2014, on 58 inpatients treated with clozapine who were experiencing hypersalivation. The subjects were randomly divided into placebo and metoclopramide groups. The starting dose was 10 mg/d. Participants who did not respond were up-titrated 10 mg/d weekly to a total of 30 mg/d during the third week. The number of placebo capsules was increased accordingly up to 3 capsules per day. Primary outcome was the change from baseline to the end of study in the severity of hypersalivation as measured with the Nocturnal Hypersalivation Rating Scale and the Drooling Severity Scale. Secondary outcomes included Clinical Global Impression of Improvement scale and adverse effect scales. Significant improvement on the Nocturnal Hypersalivation Rating Scale was demonstrated in the metoclopramide group from the end of the second week (P Impression-Improvement scale scores revealed major improvement. Twenty subjects (66.7%) treated with metoclopramide reported significant decline or total disappearance of HAC in comparison to 8 patients (28.6%) who received placebo (P = 0.031). No adverse effects to metoclopramide were reported. Metoclopramide was found to be safe and effective for the treatment of HAC. PMID:27028980

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

    Directory of Open Access Journals (Sweden)

    Tania Cursino de Menezes Couceiro

    2015-06-01

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

  16. Double blind, placebo-controlled trial of Tranexamic acid on recent internal hemorrhoid bleeding

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    Abdul A. Rani

    2002-12-01

    Full Text Available Double blind randomized placebo controlled trial was conducted to evaluate the efficacy of Tranexamic acid in 54 patients with recent hemorrhoid bleeding. Age, gender, body weight, height, grade of hemorrhoid, time of onset of recent bleeding were comparable between two groups. Analysis of haemostatic effect or stop bleeding as an immediate outcome of this study revealed that in the grade 2 patients, 23/23 (100% of tranexamic group and 18/23(78.26% of placebo group the bleeding stop. After 3 days of observation, there was statistically significant different for the rate of stop bleeding as well as at the end of observation. Bleeding stop earlier in the Tranexamic group with median 4 days (3-5 days, compare to placebo, median 11(9.55-12.45. Analysis of recurrent bleeding as an outcome of this study revealed that in the placebo group 9/18(50% of grade 2 patients and all grade 3 (100%patients suffered from recurrent bleeding. Since the days 4, both group have significant different time for recurrent bleeding and at the end of observation, cumulative probability of free of bleeding between two groups significantly different. Median still stop bleeding in the placebo group was 36 days, and the tranexamic group never reaches the median until the end of observation. Conclusion: tranexamic acid was an effective drug to stop recent hemorrhoid bleeding and prevent further recurrent bleeding, significantly better than placebo. (Med J Indones 2002;11: 215-21Keywords: Tranexamic acid, hemorrhoid bleeding, haemostatic effect, recurrent bleeding.

  17. Baclofen for stroke patients with persistent hiccups: a randomized, double-blind, placebo-controlled trial

    OpenAIRE

    Zhang, Cuie; Zhang, Ruifen; Zhang, Shuangyan; Xu, Meiling; Zhang, Shuyan

    2014-01-01

    Background The results of preclinical studies suggest that baclofen may be useful in the treatment of stroke patients with persistent hiccups. This study was aimed to assess the possible efficacy of baclofen for the treatment of persistent hiccups after stroke. Methods In total, 30 stroke patients with persistent hiccups were randomly assigned to receive baclofen (n = 15) or a placebo (n = 15) in a double-blind, parallel-group trial. Participants in the baclofen group received 10 mg baclofen ...

  18. 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:

  19. 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:

  20. 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....

  1. 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.

  2. Stratification, Blinding and Placebo Effect in a Randomized, Double Blind Placebo-controlled Clinical Trial of Gold Bead Implantation in Dogs with Hip Dysplasia

    Directory of Open Access Journals (Sweden)

    Moe L

    2005-06-01

    Full Text Available The purpose of this study was to investigate the need for and choice of stratification factors, and the effects of blinding and placebo in a clinical experiment. Eighty dogs with canine hip dysplasia (CHD were included in a randomized, placebo-controlled and double blind clinical trial with stratified parallel group design, in which body weight and degree of CHD were used as stratification factors. Thirty-eight dogs were allocated to gold bead implantation and 42 to placebo. After six months, 33 of the 42 placebo-treated dogs received gold bead implantation in an open study lasting a further 18 months. The main outcome variable in the study was change in pain signs of CHD as assessed by the owner. No significant difference in the main outcome variable, regardless of the treatment given, could be detected in the two chosen stratification factors. The only factor to influence the main outcome variable significantly was age. The blinding procedure used in the study, in which 60% of the owners correctly guessed the treatment given, was found sufficient. Of those who guessed the treatment erroneously, 88% believed the treatment given was gold bead implantation. The treatment efficacy after six months in the blinded treatment group was found to be significantly larger compared to the efficacy obtained in the open study. A significant placebo effect was therefore detected. Conclusion and Clinical Relevance: The age of the dogs influenced the outcome of the CHD treatment, and is recommended as a stratification factor. A significant placebo effect has to be expected and an optimal blinding procedure is necessary in similar clinical studies.

  3. Maintenance N-acetyl cysteine treatment for bipolar disorder: A double-blind randomized placebo controlled trial

    Directory of Open Access Journals (Sweden)

    Berk Michael

    2012-08-01

    Full Text Available Abstract Background N-acetyl cysteine (NAC is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder. Method The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149 had a Montgomery Asberg Depression Rating Score of ≥12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes. Results There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures. Conclusions There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations. Trial Registration The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493.

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

    International Nuclear Information System (INIS)

    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

  5. 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

  6. Safety and radiosensitizing efficacy of sanazole (AK 2123 in oropharyngeal cancers: Randomized controlled double blind clinical trial

    Directory of Open Access Journals (Sweden)

    Pai MRSM

    2006-01-01

    Full Text Available Oropharynx is an important site of cancer in India. Global comparison indicates higher incidences in India. Radiotherapy remains an important treatment modality. Efforts to improve loco-regional treatment and prolong survival are areas of focus. Radiosensitizers in hypoxic tumors have shown promise. Aim:0 To study the safety and radiosensitizing efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage T2-4, N0-3, M0 as phase-II double blind controlled trial in patients treated with conventional radiotherapy. SETTINGS AND DESIGN: Single institutional, randomized, double-blind, placebo-controlled trial. MATERIALS AND METHODS: Group 1 (control; n =23 received normal saline infusion, group 2 (test; n =23 received sanazole biweekly 1.25 g intravenous infusion 15 minutes before radiotherapy. Surrogate end points of efficacy were tumor and nodal size; safety parameters were mucositis, salivary and skin reactions, dysphagia, vomiting, dysgeusia and neurological deficit. Investigators blinded to the trial evaluated patients, weekly during treatment for six weeks and thereafter monthly for three months. STATISTICAL METHODS: Non-parametric, Friedman′s, Chi square, Mann-Whitney U tests. RESULTS: In the test, 15 (65% patients had complete response, five (22% partial/no response, two (9% died, one (4% lost to follow up. In the control, five (22% patients had complete response, 16 (70% partial/no response, one (4% died, one (4% lost to follow up. Short-term loco-regional response was better in the test ( DF = 3 , 95% Confidence Interval 0.418, 0.452, P=0.0048 . In the test group significant vomiting and one case of grade 3 neurological deficit was observed. CONCLUSION: The study validates the usefulness of sanazole for initial loco-regional control in oropharyngeal cancers.

  7. 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

  8. 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...... changes that might not be reflected in performance measurements. We also judged range of motion, degree of spasticity, and muscle growth measured by CT. Fifty seven of 82 outpatients who were able to walk at least with a walker, completed all 12 months of treatment (hemiplegia n=25, diplegia n=32). There...

  9. Treatment of adult asthma: controlled double-blind clinical trial of oxitropium bromide.

    Science.gov (United States)

    Taytard, A; Auzerie, J; Vergeret, J; Tozon, N; Freour, P

    1984-01-01

    Sixteen young adult sufferers from extrinsic paroxysmal asthma with pollen hypersensitivity took part in a therapeutic trial of the synthetic anticholinergic agent oxitropium bromide administered by a metered dose inhaler. The study comprised three 3-week periods. The first, run-in period was carried out to confirm the ability of the patients to maintain a daily record of symptoms. During the second and third periods, the patient received 3 X 2 inhalations of drug or placebo in a cross-over design. The medical staff was blind to the nature of the aerosol (drug or placebo), which was given in random order. The run-in clinical score was high. Asymptomatic days were relatively infrequent and daily drug consumption was high. Functional studies between the cross-over periods showed flow-rate values close to normal, with an increase in residual volume and functional residual capacity. During treatment either with placebo or oxitropium, there was a statistically significant decrease in clinical scores. Results for oxitropium bromide treatment were significantly better than the run-in values (p less than 0.005) and the placebo period (p less than 0.02). There was no significant change in non-trial drug consumption. Functional values showed no difference in terms of flow rate, although oxitropium did cause a significant improvement in the RV/TLC ratio (p less than 0.05). No adverse reactions were reported. PMID:6376144

  10. Lactobacillus GG (LGG) and smectite versus LGG alone for acute gastroenteritis: a double-blind, randomized controlled trial

    OpenAIRE

    Pieścik-Lech, Małgorzata; Urbańska, Magdalena; Szajewska, Hania (gyermekgyógyász)

    2012-01-01

    Diarrhea treatment with either Lactobacillus GG (LGG) or smectite as an adjuvant to standard rehydration therapy has proven efficacy. In countries where both LGG and smectite are available, concomitant use is frequently practiced. We investigated whether LGG plus smectite is superior to LGG alone in the management of children with acute gastroenteritis (AGE). A double-blind, placebo-controlled, randomized trial was performed. Children aged 4 to 60 months with AGE received LGG 6 × 109 colony f...

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

    OpenAIRE

    Alessandra S. Braz; Liana Clébia S. Morais; Ana Patríca Paula; Margareth de F.F.M. Diniz; Reinaldo N. Almeida

    2013-01-01

    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. g...

  12. 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......). There was no significant difference between active and placebo treatment in any of the tested groups, nor combined. Visual and subjective assessments favoured TES (ns), whereas objective indices showed the opposite trend. We conclude that TES in these patients did not have any significant clinical effect during the test...

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

    Directory of Open Access Journals (Sweden)

    Franciane Schneider

    2015-04-01

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

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

    Science.gov (United States)

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

    2015-01-01

    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. PMID:25992820

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    postoperative analgesia after PAO. PATIENTS AND METHODS: We performed a randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov: NCT00815503) in 53 patients undergoing PAO to evaluate the effect of local anesthetic infiltration on postoperative pain and on postoperative opioid consumption. All...

  16. 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 nonablative...... fractional laser treatment of acne scars. Ten patients with acne scars were included. Two intraindividual areas of similar size and appearance within contralateral anatomical regions were randomized to (1) 3-monthly laser treatments with a StarLux 1,540-nm fractional handpiece, and (2) no treatment. Blinded...... possible), and patient satisfaction (from score 0, no satisfaction, to 10, best imaginable satisfaction). Before treatment, scars were moderately atrophic and uneven in texture on both treated and untreated sides (median score 6.5, interquartile range 4.5-8; P=1). After treatment, laser-treated scars...

  17. Anti-hemorrhagic effect of prophylactic tranexamic acid in benign hysterectomy - a double-blinded randomized placebo-controlled trial

    DEFF Research Database (Denmark)

    Fink Topsøe, Märte; Bergholt, Thomas; Ravn, Pernille;

    2016-01-01

    to benign hysterectomy is still missing. OBJECTIVE: To investigate the anti-hemorrhagic effect of prophylactic tranexamic acid in elective benign hysterectomy. STUDY DESIGN: A double-blinded randomized placebo-controlled trial was conducted at four Gynecological departments in Denmark from April 2013...... in 2004, 8% of all women in Denmark undergoing benign hysterectomy experienced a bleeding complication. Tranexamic acid is an anti-fibrinolytic agent that has shown to effectively reduce bleeding complications within other surgical and medical areas. However, knowledge on the drugs effect in relation...... to October 2014. A total of 332 women undergoing benign abdominal, laparoscopic or vaginal hysterectomy were included in the trial, and randomized to either 1 g of intravenous tranexamic acid or placebo at start of surgery. Chi-test and Student T-test statistical analyses were applied. RESULTS: The...

  18. 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 and...

  19. 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...

  20. 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.

  1. Sublingual buprenorphine for acute renal colic pain management: a double-blind, randomized controlled trial

    OpenAIRE

    Payandemehr, Pooya; Jalili, Mohammad; Mostafazadeh Davani, Babak; Dehpour, Ahmad Reza

    2014-01-01

    Background The aim of this study was to compare the efficacy and safety of sublingual buprenorphine with intravenous morphine sulfate for acute renal colic in the emergency department. Methods In this double-dummy, randomized controlled trial, we enrolled patients aged 18 to 55 years who had a clinical diagnosis of acute renal colic. Patients received either 2 mg sublingual buprenorphine with an IV placebo, or 0.1 mg/kg IV morphine sulfate with a sublingual placebo. Subjects graded their pain...

  2. Oral contraceptives induce lamotrigine metabolism: evidence from a double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Christensen, Jakob; Petrenaite, Vaiva; Attermann, Jørn;

    2007-01-01

    PURPOSE: This study evaluates the effect of oral contraceptives on lamotrigine (LTG) plasma concentrations and urine excretion of LTG metabolites in a double-blind, placebo-controlled, crossover study in patients with epilepsy. METHODS: Women with epilepsy, treated with LTG in monotherapy and...... taking combination-type oral contraceptives, were randomized to treatment with placebo or a standard combination-type contraceptive pill. The dose-corrected trough plasma concentration of LTG and the ratio of N-2-glucuronide/unchanged LTG on urine after 21 days of concomitant placebo treatment was...... analyzed versus those after 21 days of concomitant treatment with the oral contraceptive pill. RESULTS: The mean dose-corrected LTG concentration after placebo treatment was 84%[95% confidence interval (CI), 45-134%] higher than after oral contraceptives, signifying an almost doubling of the concentration...

  3. 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 dysmenorrhea and vit D deficiency could improve pain intensity. PMID:27147120

  4. Azithromycin therapy of papillomatosis in dogs: a prospective, randomized, double-blinded, placebo-controlled clinical trial.

    Science.gov (United States)

    Yağci, Buğrahan Bekir; Ural, Kerem; Ocal, Naci; Haydardedeoğlu, Ali Evren

    2008-08-01

    Azithromycin, an azalide subclass macrolide antibiotic, is an effective, well-tolerated and safe therapeutic option for treatment of papillomatosis in humans. This study reports the clinical and histopathological results from a prospective, randomized, double-blinded, placebo-controlled trial of 17 dogs of various breeds with diagnosis of oral (n = 12) and cutaneous papillomatosis (n = 5) treated with azithromycin. Papillomas appeared as whitish, verrucous, hyperkeratotic papules 1-2.7 mm in size. The cases were randomly assigned to azithromycin (n = 10) and placebo treatment groups (n = 7). Both owners and investigators were blinded to the allocation to the groups. Azithromycin (10 mg/kg) was administered per os every 24 h for 10 days. Clinical evaluations were done by the same investigator throughout the trial. Azithromycin treatment significantly decreased clinical scores (P azithromycin treatment group, skin lesions disappeared in 10-15 days. One case in the placebo had spontaneous regression of its papillomas by day 41, but lesions were still evident at day 50 in the remaining six cases. There was no recurrence of papillomatosis in the azithromycin treated dogs (follow up 8 months). No adverse effects were seen in either group. In conclusion, azithromycin appears to be a safe and effective treatment for canine papillomatosis. PMID:18494759

  5. A blinded randomised controlled trial to determine the effect of enteric coating on enzyme treatment for canine exocrine pancreatic efficiency

    Directory of Open Access Journals (Sweden)

    Mas Aran

    2012-07-01

    Full Text Available Abstract Background Enzyme treatment is the mainstay for management of exocrine pancreatic insufficiency (EPI in dogs. ‘Enteric-coated’ preparations have been developed to protect the enzyme from degradation in the stomach, but their efficacy has not been critically evaluated. The hypothesis of the current study was that enteric coating would have no effect on the efficacy of pancreatic enzyme treatment for dogs with EPI. Thirty-eight client-owned dogs with naturally occurring EPI were included in this multicentre, blinded, randomised controlled trial. Dogs received either an enteric-coated enzyme preparation (test treatment or an identical preparation without the enteric coating (control treatment over a period of 56 days. Results There were no significant differences in either signalment or cobalamin status (where cobalamin deficient or not between the dogs on the test and control treatments. Body weight and body condition score increased in both groups during the trial (PPPP=0.225. Clinical disease severity score decreased over time for both groups (P=0.011 and no difference was noted between groups (P=0.869. No significant adverse effects were reported, for either treatment, for the duration of the trial. Conclusions Enteric coating a pancreatic enzyme treatment improves response in canine EPI.

  6. Prolonged release melatonin for improving sleep in totally blind subjects: a pilot placebo-controlled multicenter trial

    Directory of Open Access Journals (Sweden)

    Roth T

    2015-01-01

    Full Text Available Thomas Roth,1 Tali Nir,2 Nava Zisapel2,3 1Henry Ford Sleep Disorders Center, Detroit, MI, USA; 2Neurim Pharmaceuticals Ltd, Tel Aviv, Israel; 3Department of Neurobiology Faculty of Life Sciences, Tel Aviv University, Tel Aviv, Israel Introduction: Melatonin, secreted by the pineal gland during the night phase, is a regulator of the biological clock and sleep tendency. Totally blind subjects frequently report severe, periodic sleep problems, with 50%–75% of cases displaying non-24-hour sleep–wake disorder (N24HSWD due to inability to synchronize with the environmental day–night cycle. Melatonin immediate-release preparations are reportedly effective in N24HSWD. Here, we studied the efficacy and safety of prolonged-release melatonin (PRM, a registered drug for insomnia, for sleep disorders in totally blind subjects living in normal social environments. The primary endpoint was demonstration of clinically meaningful effects on sleep duration (upper confidence interval [CI] limit >20 minutes whether significant or not to allow early decision-making on further drug development in this indication. Trial registration: ClinicalTrials.gov registry – NCT00972075. Methods: In a randomized, double-blind, placebo-controlled proof-of-principle study, 13 totally blind subjects had 2 weeks' placebo run-in, 6 weeks' randomized (1:1 PRM (Circadin® or placebo nightly, and 2 weeks' placebo run-out. Outcome measures included daily voice recorded sleep diary, Clinical Global Impression of Change (CGIC, WHO-Five Well-being Index (WHO-5, and safety. Results: Mean nightly sleep duration improved by 43 minutes in the PRM and 16 minutes in the placebo group (mean difference: 27 minutes, 95% CI: -14.4 to 69 minutes; P=0.18; effect size: 0.82 meeting the primary endpoint. Mean sleep latency decreased by 29 minutes with PRM over placebo (P=0.13; effect size: 0.92 and nap duration decreased in the PRM but not placebo group. The variability in sleep onset/offset and

  7. The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique

    Directory of Open Access Journals (Sweden)

    Gerritsen Pieter G

    2009-09-01

    Full Text Available Abstract Background Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain. Methods The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work and recurrence. Both groups will be evaluated. Success rate of hernia repair and complications will be measured as safeguard for quality. To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP technique reduces postoperative pain to Discussion The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP technique, compared to Lichtenstein. In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein. Trial registration ISRCTN 93798494

  8. Pediatric functional constipation treatment with Bifidobacterium-containing yogurt: A crossover, double-blind, controlled trial

    Institute of Scientific and Technical Information of China (English)

    Paula VP Guerra; Luiza N Lima; Tassia C Souza; Vanessa Mazochi; Francisco J Penna; Andreia M Silva; Jacques R Nicoli; Elizabet V Guimaraes

    2011-01-01

    AIM: To evaluate the treatment off pediatric ffunctional chronic intestinal constipation (FCIC) with a probiotic goat yogurt. METHODS: A crossover double-blind fformula-con- trolled trial was carried out on 59 students (age range: 5-15 years) off a public school in Belo Horizonte, MG, Brazil, presenting a FCIC diagnostic, according to Roma Ⅲ criteria. The students were randomized in two groups to receive a goat yogurt supplemented with 109 colony fforming unit/mL Biffidobacterium longum (B. longum) (probiotic) daily or only the yogurt ffor a period off 5 wk (fformula). Affterwards, the groups were intercrossed another 5 wk. DDeffecation ffrequency, stool consistency and abdominal and deffecation pain were assessed. RESULTS: Both treatment groups demonstrated improvement in deffecation ffrequency compared to baseline. However, the group treated with probiotic showed most significant improvement in the first phase of the study. An inversion was observed affter crossing over, resulting in a reduction in stool when this group was treated by fformula. Probiotic and fformula improved stool consistency in the first phase of treatment, but the improvement obtained with probiotic was signifficantly higher (P = 0.03). In the second phase off treatment, the group initially treated with probiotic showed worseningstool consistency when using fformula. However, the difference was not significant. A significant improvement in abdominal pain and deffecation pain was observed with both probiotic and fformula in the ffirst phase off treatment, but again the improvement was more significant ffor the group treated with B. longum during phase I (P < 0.05). When all data off the crossover study were analyzed, signifficant difffferences were observed between probiotic yogurt and yogurt only ffor deffecation ffrequency (P = 0.012), deffecation pain (P = 0.046) and abdominal pain (P = 0.015). CONCLUSION: An improvement in deffecation ffrequen- cy and abdominal pain was observed using

  9. Combination of Citalopram and Nortriptyline in Treatment of Moderate to Severe Major Depression: A Double-blind, Placebo- controlled Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Mohammadi

    2006-04-01

    Full Text Available Objective: Depression is a major health problem, which is not only underrecognized and undertreated, but is also associated with significant morbidity and mortality. It has been suggested that combination therapy rapidly reduces depressive symptoms in patients with moderate to severe depression and is more effective than monotherapy; but this suggestion remains controversial. Serotonergic and noradrenergic enhancement may be synergistic and more effective than serotonergic enhancement alone in the management of depression. The objective of this double blind, placebo-controlled study was to investigate the efficacy and tolerability of the combination of citalopram and nortriptyline for the treatment of moderate to severe major depression. Method: 45 patients, who met the DSM-IV criteria for major depressive disorder based on the clinical interview, were included in the study. Patients had a baseline Hamilton Depression Rating Scale score of at least 20. In this trial, patients were randomly assigned to receive nortriptyline 50 mg/day plus citalopram 40 mg/day (group1 or placebo plus citalopram 40 mg/day (group2, for an 8 week, double-blind, placebo-controlled trial. Results: Both protocols significantly decreased the score of Hamilton Depression Rating Scale over the trial period, but the combination of nortriptyline and citalopram showed a significant superiority over citalopram alone in the treatment of moderate to severe major depressive disorder (t = 3.34, d.f. = 36, P = 0.001. The difference between the two groups in the frequency of side effects was not significant. Conclusion: The results of this study suggest that combination of nortriptyline and citalopram is more effective than citalopram alone in the treatment of depression. This advantage is probably the result of reuptake inhibition of both serotonin and norepinephrine

  10. INTRAPERITONEAL INSTILLATION OF BUPIVACAINE AND GLYCEMIC LEVELS IN LAPROSCOPIC SURGERIES: A DOUBLE BLIND, PLACEBO - CONTROLLED TRIAL

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    Suresh Chander

    2015-09-01

    Full Text Available BACKGROUND: Surgical stress is associated with hormonal changes. Hyperglycemia is an easily measurable factor to quantify stress. Intraoperative stress can be due to pain or surgical manipulation. We made an attempt to see the glycemic response in laparoscopic patients by intraperitoneal instillation of bupivacaine vs placebo. OBJECT IVES: To observe the response of intraperitoneal instillation of Bupivacaine vs placebo on glycemic levels. PATIENTS AND METHODS : A prospective randomized double blind, placebo - controlled study was conducted in the department of Anaesthesiology, Gandhi Hos pital, Secunderabad. Fifty patients were randomly selected to be enrolled in this study who were scheduled for laproscopic surgery. All patients were of ASA I - II physical status. Study group consisted of 25 patients receiving intraperitoneal bupivacaine 2 mg/kg (Group B and the control group consisted of 25 patients receiving 20 ml of normal saline as placebo (Group C. Blood sugar levels were measured at baseline and at interval of 30 min and 90 min after incision. Mean blood pressure and pulse rate were recorded at baseline and and every 15 min from incision to 90 min. RESULT S : There is no significant difference in the glycemic levels in both groups. CONCLUSION: Stress during laproscopic cholecystectomy and appendicectomy may not be high enough to cause glycemic derangement. However, the study group is small and needs further studies to substantiate this

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

    International Nuclear Information System (INIS)

    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. 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 900-mg EPA capsules thrice daily (total daily

  12. The IDvIP Trial: A two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia

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    Thomas Peter

    2011-07-01

    Full Text Available Abstract Background Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. Methods The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score Discussion If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour. Trial Registration ISRCTN14898678 Eudra No: 2006-003250-18, REC Reference No: 06/Q1702/95, MHRA Authorisation No: 1443/0001/001-0001, NIHR UKCRN reference 6895, RfPB grant

  13. Efficacy of minocycline in acute ischemic stroke: A single-blinded, placebo-controlled trial

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    M V Padma Srivastava

    2012-01-01

    Full Text Available Background: Minocycline is a semisynthetic derivative of the tetracycline group of antibiotics, which have neuroprotective effects. In animal stroke models, minocycline had shown promising evidence to improve clinical and functional outcomes. Objective: To analyze the effect of oral minocycline in acute ischemic stroke patients. Materials and Methods: This was a randomized single-blinded open-label study. The study group received oral minocycline 200 mg/day for 5 days and the control group received oral vitamin B capsules. Baseline assessment included the following: National Institute of Health Stroke Scale (NIHSS score, modified Barthel Index (mBI, modified Rankin Scale (mRS score, Magnetic Resonance Imaging (MRI of brain including Diffusion Weighted Imaging (DWI, chest X-ray, and routine laboratory investigations. The clinical scales were repeated at days 1, 7, and 30. The end point was outcomes at 3 months (90 days. Statistical analysis was done with SPSS 11.5 (P<0.05. Paired t-test and multiple-measures Analysis Of Variance (ANOVA were used. Results: Fifty patients with acute ischemic stroke were included in the study. Of these, 23 patients received minocycline and 27 patients received placebo i.e., vitamin B capsules. NIHSS score in patients receiving minocycline had shown statistically significant improvement at day 30 and 90 as compared with the controls. Similarly, mRS scores and BI showed significant improvement in patients receiving minocycline at three months as compared to the control group. No mortality, myocardial infarctions, recurrent strokes, and hemorrhagic transformations were noted in both groups. Conclusions: Patients with acute ischemic stroke had significantly better outcome with minocycline treatment as compared with those administered placebo. The above findings suggest that minocycline can be helpful in reducing the clinical deficits after acute ischemic stroke.

  14. Neurofeedback intervention in fibromyalgia syndrome; a randomized, controlled, rater blind clinical trial.

    Science.gov (United States)

    Kayiran, Sadi; Dursun, Erbil; Dursun, Nigar; Ermutlu, Numan; Karamürsel, Sacit

    2010-12-01

    We designed a randomized, rater blind study to assess the efficacy of EEG Biofeedback (Neurofeedback-NFB) in patients with fibromyalgia syndrome (FMS). Eighteen patients received twenty sessions of NFB-sensory motor rhythm (SMR) treatment (NFB group) during 4 weeks, and eighteen patients were given 10 mg per day escitalopram treatment (control group) for 8 weeks. Visual Analog Scales for pain and fatigue, Hamilton and Beck Depression and Anxiety Inventory Scales, Fibromyalgia Impact Questionnaire and Short Form 36 were used as outcome measures which were applied at baseline and 2nd, 4th, 8th, 16th, 24th weeks. Mean amplitudes of EEG rhythms (delta, theta, alpha, SMR, beta1 and beta2) and theta/SMR ratio were also measured in NFB group. All post-treatment measurements showed significant improvements in both of the groups (for all parameters p 0.05 for all). However, theta/SMR ratio showed a significant decrease at 4th week compared to baseline in the NFB group (p < 0.05). These data support the efficacy of NFB as a treatment for pain, psychological symptoms and impaired quality of life associated with fibromyalgia. PMID:20614235

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

    Directory of Open Access Journals (Sweden)

    Dean Michael

    2012-10-01

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

  16. Antipyretic effect of ibuprofen in Gabonese children with uncomplicated falciparum malaria: a randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Necek Magdalena

    2008-05-01

    Full Text Available Abstract Background Antipyretic drugs are widely used in children with fever, though there is a controversy about the benefit of reducing fever in children with malaria. In order to assess the effect of ibuprofen on fever compared to placebo in children with uncomplicated Plasmodium falciparum malaria in Gabon, a randomized double blind placebo controlled trial, was designed. Methods Fifty children between two and seven years of age with uncomplicated malaria were included in the study. For the treatment of fever, all patients "received" mechanical treatment when the temperature rose above 37.5°C. In addition to the mechanical treatment, continuous fanning and cooling blanket, patients were assigned randomly to receive ibuprofen (7 mg/kg body weight, every eight hours or placebo. Results The fever clearance time using a fever threshold of 37.5°C was similar in children receiving ibuprofen compared to those receiving placebo. The difference was also not statistically significant using a fever threshold of 37.8°C or 38.0°C. However, the fever time and the area under the fever curve were significantly smaller in the ibuprofen group compared to the placebo group. Conclusion Ibuprofen is effective in reducing the time with fever. The effect on fever clearance is less obvious and depends on definition of the fever threshold. Trial registration The trial registration number is: NCT00167713

  17. A double-blind placebo-controlled trial of omeprazole on urinary pH in healthy subjects

    DEFF Research Database (Denmark)

    Osther, P J; Rasmussen, L; Pedersen, S A

    1992-01-01

    Urinary pH is related to urinary calculus formation as well as urinary infection. Omeprazole is an effective inhibitor of gastric acid secretion through inhibition of the parietal cell H+K+ATPase. In this study we have evaluated a possible effect of omeprazole on urine acidification. Ten healthy...... male subjects took placebo and omeprazole, 40 mg o.m., for 10 days in a double-blind placebo-controlled trial. Morning fasting urinary pH was measured on day 10 of each treatment course using a pH meter. No effect of omeprazole on urinary pH could be demonstrated. It is thus unlikely that it is...... necessary to take omeprazole treatment into consideration in stone screening. As omeprazole did not affect urinary pH, no urological side effects related to changes in urinary pH can be expected....

  18. The Effect of Adjuvant Zinc Therapy on Recovery from Pneumonia in Hospitalized Children: A Double-Blind Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Javad Qasemzadeh

    2014-01-01

    Full Text Available Objectives. Pneumonia is one of the common mortality causes in young children. Some studies have shown beneficial effect of zinc supplements on treatment of pneumonia. The present study aimed to investigate the effects of short courses of zinc administration on recovery from this disease in hospitalized children. Methods. In a parallel Double-Blind Randomized Controlled Trial at Ayatollah Golpaygani Hospital in Qom, 120 children aged 3–60 months with pneumonia were randomly assigned 1 : 1 to receive zinc or placebo (5 mL every 12 hours along with the common antibiotic treatments until discharge. Primary outcome was recovery from pneumonia which included the incidence and resolving clinical symptoms and duration of hospitalization. Results. The difference between two groups in all clinical symptoms at admittance and the variables affecting the disease such as age and sex were not statistically significant (P<0.05 at baseline. Compared to the placebo group, the treatment group showed a statistically significant decrease in duration of clinical symptoms (P=0.044 and hospitalization (P=0.004. Conclusions. Supplemental administration of zinc can expedite the healing process and results in faster resolution of clinical symptoms in children with pneumonia. In general, zinc administration, along with common antibiotic treatments, is recommended in this group of children. It can also reduce the drug resistance caused by multiple antibiotic therapies. This trial is approved by Medical Ethic Committee of Islamic Azad University in Iran (ID Number: 8579622-Q. This study is also registered in AEARCTR (The American Economic Association's Registry for Randomized Controlled Trials. This trial is registered with RCT ID: AEARCTR-0000187.

  19. Metabolic and hormonal effects of caffeine: randomized, double-blind, placebo-controlled crossover trial.

    Science.gov (United States)

    MacKenzie, Todd; Comi, Richard; Sluss, Patrick; Keisari, Ronit; Manwar, Simone; Kim, Janice; Larson, Robin; Baron, John A

    2007-12-01

    In short-term studies, caffeine has been shown to increase insulin levels, reduce insulin sensitivity, and increase cortisol levels. However, epidemiological studies have indicated that long-term consumption of beverages containing caffeine such as coffee and green tea is associated with a reduced risk of type 2 diabetes mellitus. There is a paucity of randomized studies addressing the metabolic and hormonal effects of consuming caffeine over periods of more than 1 day. We evaluated the effect of oral intake of 200 mg of caffeine taken twice a day for 7 days on glucose metabolism, as well as on serum cortisol, dehydroepiandrosterone (DHEA), and androstenedione, and on nighttime salivary melatonin. A double-blind, randomized, placebo-controlled crossover study with periods of 7 days and washouts of 5 days comparing caffeine with placebo capsules was conducted. Participants were 16 healthy adults aged 18 to 22 years with a history of caffeine consumption. Blood samples from each subject were assayed for glucose, insulin, serum cortisol, DHEA, and androstenedione on the eighth day of each period after an overnight fast. Nighttime salivary melatonin was also measured. Insulin levels were significantly higher (by 1.80 microU/mL; 95% confidence interval, 0.33-3.28) after caffeine intake than after placebo. The homeostasis model assessment index of insulin sensitivity was reduced by 35% (95% confidence interval, 7%-62%) by caffeine. There were no differences in glucose, DHEA, androstenedione, and melatonin between treatment periods. This study provides evidence that daily caffeine intake reduces insulin sensitivity; the effect persists for at least a week and is evident up to 12 hours after administration. PMID:17998023

  20. 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....

  1. 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

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

    Science.gov (United States)

    2011-01-01

    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, radiological consolidation

  3. 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

  4. 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.

  5. 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 nonablative...... fractional laser treatment of acne scars. Ten patients with acne scars were included. Two intraindividual areas of similar size and appearance within contralateral anatomical regions were randomized to (1) 3-monthly laser treatments with a StarLux 1,540-nm fractional handpiece, and (2) no treatment. Blinded...... appeared more even and smooth than untreated control areas (4.5, 2-6.5, versus 6.5, 4.5-8, P=0.0156, at 4 weeks; 4.5, 2.5-6.5, versus 6.5, 4.5-8, at 12 weeks; P=0.0313). Patients were satisfied with the treatment (5.5, 1-7, after 12 weeks) and five of the ten patients evaluated their acne scars as...

  6. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  8. 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.

  9. Pulsed electromagnetic fields after arthroscopic treatment for osteochondral defects of the talus: double-blind randomized controlled multicenter trial

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    Krips Rover

    2009-07-01

    Full Text Available Abstract Background Osteochondral talar defects usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracturing. Although this is mostly successful, early sport resumption is difficult to achieve, and it can take up to one year to obtain clinical improvement. Pulsed electromagnetic fields (PEMFs may be effective for talar defects after arthroscopic treatment by promoting tissue healing, suppressing inflammation, and relieving pain. We hypothesize that PEMF-treatment compared to sham-treatment after arthroscopy will lead to earlier resumption of sports, and aim at 25% increase in patients that resume sports. Methods/Design A prospective, double-blind, randomized, placebo-controlled trial (RCT will be conducted in five centers throughout the Netherlands and Belgium. 68 patients will be randomized to either active PEMF-treatment or sham-treatment for 60 days, four hours daily. They will be followed-up for one year. The combined primary outcome measures are (a the percentage of patients that resume and maintain sports, and (b the time to resumption of sports, defined by the Ankle Activity Score. Secondary outcome measures include resumption of work, subjective and objective scoring systems (American Orthopaedic Foot and Ankle Society – Ankle-Hindfoot Scale, Foot Ankle Outcome Score, Numeric Rating Scales of pain and satisfaction, EuroQol-5D, and computed tomography. Time to resumption of sports will be analyzed using Kaplan-Meier curves and log-rank tests. Discussion This trial will provide level-1 evidence on the effectiveness of PEMFs in the management of osteochondral ankle lesions after arthroscopy. Trial registration Netherlands Trial Register (NTR1636

  10. 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

  11. Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: Randomised, Investigator Blinded, Controlled Trial

    Science.gov (United States)

    To investigate the effect of two different food supplements on body mass index (BMI) in wasted Malawian adults with HIV who were starting antiretroviral therapy. A randomised, investigator blinded, controlled trial was used in a large, public clinic associated with a referral hospital in Blantyre, M...

  12. Randomized double-blind controlled Phase I/IIa trial to assess the efficacy of malaria vaccine PfCS102 to protect against challenge with P. falciparum.

    NARCIS (Netherlands)

    Genton, B.; D'Acremont, V.; Lurati-Ruiz, F.; Verhage, D.F.; Audran, R.; Hermsen, C.C.; Wolters, L.; Reymond, C.; Spertini, F.; Sauerwein, R.W.

    2010-01-01

    The aim of this Phase I/IIa double-blind controlled trial was to test the efficacy of the sporozoite-based malaria vaccine PfCS 282-383 (PfCS102) to protect against Plasmodium falciparum parasitaemia. 16 volunteers were randomized to receive twice 30 mug of PfCS102 formulated in Montanide ISA 720 or

  13. Lack of effect of doxycycline on disease activity and joint damage in patients with rheumatoid arthritis. A double blind, placebo controlled trial

    NARCIS (Netherlands)

    Laan, W. van der; Molenaar, E.; Ronday, K.; Verheijen, J.; Breedveld, F.; Greenwald, R.; Dijkmans, B.; Tekoppele, J.

    2001-01-01

    Objective. To investigate the effects of doxycycline on disease activity and joint destruction in patients with rheumatoid arthritis (RA). Methods. A 36 week double blind, placebo controlled crossover trial was conducted. Patients (n = 66) received 50 mg doxycycline or placebo twice a day during 12,

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

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    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.

  15. Lithium in patients with amyotrophic lateral sclerosis (LiCALS): a phase 3 multicentre, randomised, double-blind, placebo-controlled trial

    OpenAIRE

    [...

    2013-01-01

    Summary Background Lithium has neuroprotective effects in cell and animal models of amyotrophic lateral sclerosis (ALS), and a small pilot study in patients with ALS showed a significant effect of lithium on survival. We aimed to assess whether lithium improves survival in patients with ALS. Methods The lithium carbonate in amyotrophic lateral sclerosis (LiCALS) trial is a randomised, double-blind, placebo-controlled trial of oral lithium taken daily for 18 months in patients with ALS. Patien...

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

    OpenAIRE

    Ahmad Ghanizadeh; Zohreh Sayyari; Mohammad Reza Mohammadi

    2013-01-01

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

  17. 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; Kallehave, F; Gong, Y; Raffn, K; Crawford, ME; Kiss, K; Gluud, Christian; Jørgensen, LN

    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...... 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....

  18. Published and not fully published double-blind, randomised, controlled trials with oral naratriptan in the treatment of migraine

    DEFF Research Database (Denmark)

    Tfelt-Hansen, Peer Carsten

    2011-01-01

    Naratriptan 2.5 mg is now an over-the-counter drug in Germany. This should increase the interest in drug. The GSK Trial Register was searched for published and unpublished double-blind, randomised, controlled trials (RCTs) concerning the use of naratriptan in migraine. Only 7 of 17 RCTs are...... published in full. Naratriptan 2.5 mg is superior to placebo for acute migraine treatment in 6 RCTs, but inferior to sumatriptan 100 mg and rizatriptan 10 mg in one RCT each. This dose of naratriptan has no more adverse events than placebo. Naratriptan 1 mg b.i.d. has some effect in the short......-term prophylactic treatment of menstruation-associated migraine in 3 RCTs. In 2 RCTs, naratriptan 2.5 mg was equivalent to naproxen sodium 375 mg for migraine-related quality of life. Naratriptan 2.5 mg (34% preference) was superior to naproxen sodium 500 mg (25% preference). Naratriptan 2.5 mg is better than...

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

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

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    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. 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

  2. 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.

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

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    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.

  4. Topiramate for the management of methamphetamine dependence: a pilot randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Rezaei, Farzin; Ghaderi, Ebrahim; Mardani, Roya; Hamidi, Seiran; Hassanzadeh, Kambiz

    2016-06-01

    To date, no medication has been approved as an effective treatment for methamphetamine dependence. Topiramate has attracted considerable attention as a treatment for the dependence on alcohol and stimulants. Therefore, this study aimed to evaluate the effect of topiramate for methamphetamine dependence. This study was a double-blind, randomized, placebo-controlled trial. In the present investigation, 62 methamphetamine-dependent adults were enrolled and randomized into two groups, and received topiramate or a placebo for 10 weeks in escalating doses from 50 mg/day to the target maintenance dose of 200 mg/day. Addiction severity index (ASI) and craving scores were registered every week. The Beck questionnaire was also given to each participant at baseline and every 2 weeks during the treatment. Urine samples were collected at baseline and every 2 weeks during the treatment. Fifty-seven patients completed 10 weeks of the trial. There was no significant difference between both groups in the mean percentage of prescribed capsules taken by the participants. At week six, the topiramate group showed a significantly lower proportion of methamphetamine-positive urine tests in comparison with the placebo group (P = 0.01). In addition, there were significantly lower scores in the topiramate group in comparison with the placebo group in two domains of ASI: drug use severity (P < 0.001) and drug need (P < 0.001). Furthermore, the craving score (duration) significantly declined in the topiramate patients compared to those receiving the placebo. In conclusion, the results of this trial suggest that topiramate may be beneficial for the treatment of methamphetamine dependence. PMID:26751259

  5. Substrate Utilization and Cycling Performance Following Palatinose™ Ingestion: A Randomized, Double-Blind, Controlled Trial

    Science.gov (United States)

    König, Daniel; Zdzieblik, Denise; Holz, Anja; Theis, Stephan; Gollhofer, Albert

    2016-01-01

    (1) Objective: To compare the effects of isomaltulose (Palatinose™, PSE) vs. maltodextrin (MDX) ingestion on substrate utilization during endurance exercise and subsequent time trial performance; (2) Methods: 20 male athletes performed two experimental trials with ingestion of either 75 g PSE or MDX 45 min before the start of exercise. The exercise protocol consisted of 90 min cycling (60% VO2max) followed by a time trial; (3) Results: Time trial finishing time (−2.7%, 90% CI: ±3.0%, 89% likely beneficial; p = 0.147) and power output during the final 5 min (+4.6%, 90% CI: ±4.0%, 93% likely beneficial; p = 0.053) were improved with PSE compared with MDX. The blood glucose profile differed between trials (p = 0.013) with PSE resulting in lower glycemia during rest (95%–99% likelihood) and higher blood glucose concentrations during exercise (63%–86% likelihood). In comparison to MDX, fat oxidation was higher (88%–99% likelihood; p = 0.005) and carbohydrate oxidation was lower following PSE intake (85%–96% likelihood; p = 0.002). (4) Conclusion: PSE maintained a more stable blood glucose profile and higher fat oxidation during exercise which resulted in improved cycling performance compared with MDX. These results could be explained by the slower availability and the low-glycemic properties of Palatinose™ allowing a greater reliance on fat oxidation and sparing of glycogen during the initial endurance exercise. PMID:27347996

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

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    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.

  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. A randomised controlled single-blind trial of the efficacy of reiki at benefitting mood and well-being.

    Science.gov (United States)

    Bowden, Deborah; Goddard, Lorna; Gruzelier, John

    2011-01-01

    This is a constructive replication of a previous trial conducted by Bowden et al. (2010), where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students-half with high depression and/or anxiety and half with low depression and/or anxiety-were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions over a period of two to eight weeks, where they were blind to whether noncontact Reiki was administered as their attention was absorbed in a guided relaxation. The efficacy of the intervention was assessed pre-post intervention and at five-week follow-up by self-report measures of mood, illness symptoms, and sleep. The participants with high anxiety and/or depression who received Reiki showed a progressive improvement in overall mood, which was significantly better at five-week follow-up, while no change was seen in the controls. While the Reiki group did not demonstrate the comparatively greater reduction in symptoms of illness seen in our earlier study, the findings of both studies suggest that Reiki may benefit mood. PMID:21584234

  9. A Randomised Controlled Single-Blind Trial of the Efficacy of Reiki at Benefitting Mood and Well-Being

    Directory of Open Access Journals (Sweden)

    Deborah Bowden

    2011-01-01

    Full Text Available This is a constructive replication of a previous trial conducted by Bowden et al. (2010, where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students—half with high depression and/or anxiety and half with low depression and/or anxiety—were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions over a period of two to eight weeks, where they were blind to whether noncontact Reiki was administered as their attention was absorbed in a guided relaxation. The efficacy of the intervention was assessed pre-post intervention and at five-week follow-up by self-report measures of mood, illness symptoms, and sleep. The participants with high anxiety and/or depression who received Reiki showed a progressive improvement in overall mood, which was significantly better at five-week follow-up, while no change was seen in the controls. While the Reiki group did not demonstrate the comparatively greater reduction in symptoms of illness seen in our earlier study, the findings of both studies suggest that Reiki may benefit mood.

  10. Ionization with diclofenac sodium in rheumatic disorders: a double-blind placebo-controlled trial.

    Science.gov (United States)

    Vecchini, L; Grossi, E

    1984-01-01

    A double-blind randomized study was performed to compare ionization with diclofenac sodium (150 mg) and ionization with saline solution in two groups of patients with scapulo-humeral periarthritis or elbow epicondylitis. The subjects of both groups were treated with 20 ionization sessions each lasting 30 minutes during a 1-month period. There was a significantly greater improvement in pain at rest, pain on pressure, pain on movement and joint swelling in the eleven patients treated with diclofenac compared with the thirteen placebo-treated patients, but no significant differences between the two treatments as regards functional impairment. However, placebo treatment produced a slight but significant improvement in pain on pressure, pain on movement and functional impairment. Further studies are needed to assess the relative role of the current and of autosuggestion in saline ionization response since both have well-known therapeutic effects on chronic rheumatic pain. PMID:6394405

  11. Effect of hookworm infection on wheat challenge in celiac disease--a randomised double-blinded placebo controlled trial.

    Directory of Open Access Journals (Sweden)

    A James Daveson

    Full Text Available BACKGROUND AND AIMS: The association between hygiene and prevalence of autoimmune disease has been attributed in part to enteric helminth infection. A pilot study of experimental infection with the hookworm Necator americanus was undertaken among a group of otherwise healthy people with celiac disease to test the potential of the helminth to suppress the immunopathology induced by gluten. METHODS: In a 21-week, double-blinded, placebo-controlled study, we explored the effects of N. americanus infection in 20 healthy, helminth-naïve adults with celiac disease well controlled by diet. Staged cutaneous inoculations with 10 and 5 infective 3(rd stage hookworm larvae or placebo were performed at week-0 and -12 respectively. At week-20, a five day oral wheat challenge equivalent to 16 grams of gluten per day was undertaken. Primary outcomes included duodenal Marsh score and quantification of the immunodominant α-gliadin peptide (QE65-specific systemic interferon-γ-producing cells by ELISpot pre- and post-wheat challenge. RESULTS: Enteric colonisation with hookworm established in all 10 cases, resulting in transiently painful enteritis in 5. Chronic infection was asymptomatic, with no effect on hemoglobin levels. Although some duodenal eosinophilia was apparent, hookworm-infected mucosa retained a healthy appearance. In both groups, wheat challenge caused deterioration in both primary and several secondary outcomes. CONCLUSIONS: Experimental N. americanus infection proved to be safe and enabled testing its effect on a range of measures of the human autoimmune response. Infection imposed no obvious benefit on pathology. TRIAL REGISTRATION: ClinicalTrials.gov NCT00671138.

  12. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Wu, Yung-Tsan; Ke, Ming-Jen; Chou, Yu-Ching; Chang, Chih-Ya; Lin, Ching-Yueh; Li, Tsung-Ying; Shih, Feng-Mei; Chen, Liang-Cheng

    2016-06-01

    Three recent studies demonstrated the positive effect of extracorporeal shock wave therapy (ESWT) for treating carpal tunnel syndrome (CTS). However, none have entirely proved the effects of ESWT on CTS because all studies had a small sample size and lacked a placebo-controlled design. Moreover, radial ESWT (rESWT) has not been used to treat CTS. We conducted a prospective randomized, controlled, double-blinded study to assess the effect of rESWT for treating CTS. Thirty-four enrolled patients (40 wrists) were randomized into intervention and control groups (20 wrists in each). Participants in the intervention group underwent three sessions of rESWT with nightly splinting, whereas those in the control group underwent sham rESWT with nightly splinting. The primary outcome was visual analog scale (VAS), whereas the secondary outcomes included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. Evaluations were performed before treatment and at 1, 4, 8, and 12 weeks after the third rESWT session. A significantly greater improvement in the VAS, BCTQ scores, and CSA of the median nerve was noted in the intervention group throughout the study as compared to the control group (except for BCTQ severity at week 12 and CSA at weeks 1 and 4) (p controlled trial and demonstrate that rESWT is a safe and effective method for relieving pain and disability in patients with CTS. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:977-984, 2016. PMID:26610183

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

    Directory of Open Access Journals (Sweden)

    Parsa Yousefichaijan

    2015-12-01

    Full Text Available Background: Nephrolithiasis in children is associated with a high rate of complications and recurrence. Objectives: Since some evidences reported that zinc has an important place amongst inhibitors of crystallization and crystal growth, we decided to assess the effectiveness of oral zinc sulfate as adjuvant treatment in children with nephrolithiasis. Patients and Methods: This was a randomized, double-blind, placebo-controlled clinical trial. 102 children in the age range 1 month to 11 years with first nephrolithiasis were recruited. Patients were randomly divided into two equal groups (intervention and control groups. Intervention group received conservative measures for stones and 1 mg/kg/day (maximum 20 mg/day oral zinc sulfate syrup for 3 months. Control group received placebo in addition to conservative measures, also for 3 months. Patients were followed up by ultrasonography for 9 months, in 5 steps (at the end of 1st, 2nd, 3rd, 6th and 9th month after treatment assessing size and number of stones in the kidneys. Results: Only at the end of the first month, the average number (intervention: 1.15 ± 3.78, control: 1.3 ± 2.84 (P = 0.001 and size (cm (intervention: 0.51 ± 1.76, control: 0.62 ± 1.39 (P = 0.001 of stones was significantly lower in the intervention group, and in other points there was no significant therapeutic efficacy in oral zinc adjuvant treatment compared to conservative treatment alone. Also, during the 9-month follow-up, the number and size of stones in both groups decreased significantly (both: P < 0.0001 in a way that the decrease in the intervention group showed no difference with the control group. Conclusions: Adjuvant treatment with zinc is not more effective than consecutive treatment in children with nephrolithiasis. However, further studies are recommended due to the lack of clinical evidence in this field.

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

    OpenAIRE

    Arbabi, M; V Farnia; K. Balighi; M.R. Mohammadi; A A Nejati-Safa; k Yazdchi; Golestan, B; F Darvish

    2008-01-01

    "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...

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

    OpenAIRE

    Ayda Moghaddas; Azadeh Moghaddas; AmirHossein Siadat; Giti Sadeghian

    2015-01-01

    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 ...

  16. Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP Trial

    Directory of Open Access Journals (Sweden)

    Hurley D

    2008-03-01

    Full Text Available Abstract Background Evidence supports the use of exercise for chronic low back pain (CLBP; however, adherence is often poor due to ongoing pain. Auricular acupuncture is a form of pain relief involving the stimulation of points on the outer ear corresponding with specific body parts. It may be a useful adjunct to exercise in managing CLBP; however, there is only limited evidence to support its use with this patient group. Methods/Design This study was designed to test the feasibility of an assessor-blind randomised controlled trial which assess the effects on clinical outcomes and exercise adherence of adding manual auricular acupuncture to a personalised and supervised exercise programme (PEP for CLBP. No sample size calculation has been carried out as this study aims to identify CLBP referral rates within the catchment area of the study site. The researchers aim to recruit four cohorts of n = 20 participants to facilitate a power analysis for a future randomised controlled trial. A computer generated random allocation sequence will be prepared centrally and used to allocate participants by cohort to one of the following interventions: 1 six weeks of PEP plus manual auricular acupuncture; 2 six weeks of PEP alone. Both groups will also complete a further six weeks of self-paced exercise with telephone follow-up support. In addition to a baseline and exit questionnaire at the beginning and end of the study, the following outcomes will be collected at baseline, and after 7, 13 and 25 weeks: pain frequency and bothersomeness, back-specific function, objective assessment and recall of physical activity, use of analgesia, perceived self-efficacy, fear avoidance beliefs, and beliefs about the consequences of back pain. Since this is a feasibility study, significance tests will not be presented, and treatment effects will be represented by point estimates and confidence intervals. For each outcome variable, analysis of covariance will be performed on

  17. Analgesic and antisympathetic effects of clonidine in burn patients, a randomized, double-blind, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Ostadalipour Abbas

    2007-01-01

    Full Text Available Objectives: Unlike most other Analgesic drugs, α2 adrenoceptor agonists are capable of producing analgesia. The aim of this study was to evaluate the Analgesic and antisympathetic effects of clonidine, an α2 adrenoceptor agonist in burn patients. Materials and Methods: This randomized, double-blind, placebo-controlled clinical trial performed on one hundred burn patients in Zarea Hospital, Mazandaran, Iran from august 2004 to July 2005. All patients divided in two groups. Case group (n=50 received oral clonidine, 3.3μg/kg TDS and controls (n=50 received placebo. Heart rate and systolic blood pressure and pain severity Visual analogue score (VAS, were recorded after clonidine administration. Statistical analysis was done by means of Mann Witney U test. Results: 50 patients (mean age 28.96±10 years in case group, and 50 patients (mean age 27.60±11.4 years in control group were studied. VAS pain scores and heart rate in the clonidine group were significantly lower than the control group (P< 0.0001, P< 0.02.there were no significant difference in systolic blood pressure between the two groups on the first and second day but on third day the systolic blood pressure in clonidine group, was lower than controls significantly (P=0.002. Conclusion: This study demonstrates that the use of oral clonidine affects the hemodynamic response to pain in burn patients. Our study demonstrated that clonidine can produce good analgesia and decreased in sympathetic over activity in burn patients, and also reduce opioid dose requirements.

  18. The Effect of Omega-3 Fatty Acid Supplementation on Maternal Depression during Pregnancy: A Double Blind Randomized Controlled Clinical Trial

    OpenAIRE

    Kaviani, Maasumeh; Saniee, Laleh; Azima, Sara; Sharif, Farkhondeh; Sayadi, Mehrab

    2014-01-01

    Background: Depression is one of the most debilitating disorders during pregnancy and its recovery and treatment are among the concerns of obstetrics and gynecology experts. The present study aimed to determine the effect of omega-3 supplement on mild depression during pregnancy among primiparous women. Method: In this double-blind clinical trial, 80 primiparous women were randomly divided into 2 groups of omega-3 and placebo. The experimental group received 1 g omega-3 capsules for 6 weeks. ...

  19. Symptoms after Ingestion of Pig Whipworm Trichuris suis Eggs in a Randomized Placebo-Controlled Double-Blind Clinical Trial

    OpenAIRE

    Bager, Peter; Kapel, Christian Moliin Outzen; Roepstorff, Allan Knud; Thamsborg, Stig Milan; Arnved, John; Rønborg, Steen; Kristensen, Bjarne; Poulsen, Lars K; Wohlfahrt, Jan; Melbye, Mads

    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 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 ...

  20. Effects of Semelil (ANGIPARS™) on diabetic peripheral neuropathy: A randomized, double-blind Placebo-controlled clinical trial

    OpenAIRE

    S Bakhshayeshi; Madani, SP.; M.Hemmatabadi; R Heshmat; Larijani, B.

    2011-01-01

    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 (ANGIPARS™), a new herbal drug for treatment of diabetic foot ulcers or diabetic peripheral neuropathy. Methods In this double blind clinical trial, 49 type 2 diabetes patients with different degrees of neuropathy were evaluated in two groups (ANGIPAR...

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

    OpenAIRE

    Ahmadi-Abhari Seyed Ali; Radgoodarzi Reza; Assadi Seyed Mohammad

    2003-01-01

    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. S...

  2. Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial

    OpenAIRE

    Pinnock, Hilary; Hanley, Janet; McCloughan, Lucy; Todd, Allison; Krishan, Ashma; Lewis, Stephanie; Stoddart, Andrew; van der Pol, Marjon; MacNee, William; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian

    2013-01-01

    Objective: To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design: Researcher blind, multicentre, randomised controlled trial. Setting: UK primary care (Lothian, Scotland). Participants: Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unab...

  3. Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial

    OpenAIRE

    Pinnock, Hilary; Hanley, Janet; McCloughan, Lucy; Todd, Allison; Krishan, Ashma; Lewis, Stephanie; Stoddart, Andrew; van der Pol, Marjon; MacNee, William; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian

    2013-01-01

    Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design Researcher blind, multicentre, randomised controlled trial. Setting UK primary care (Lothian, Scotland). Participants Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable t...

  4. Results of Double Blind Placebo Controlled Trial to Assess the Effect of Vitamin B6 on Managing of Nausea and Vomiting In Pediatrics with Acute Gastroenteritis

    OpenAIRE

    Hojjat Derakhshanfar; Arash Hadian Amree; Hossein Alimohammadi; Majid Shojahe; Ali Sharami

    2013-01-01

    Background: Gastroenteritis and respiratory tract infections are the most common childhood diseases. Despite the common use of vitamin B6 to control vomiting in children with gastroenteritis, no study has been performed in this field. This study aimed to assess the value of vitamin B6 in the prevention of vomiting in patients with mild to moderate gastroenteritis. Methodology: This study was a double blind controlled clinical trial on 96 children with mild to moderate gastroenteritis with age...

  5. Study of Mental Activity and Regular Training (SMART in at risk individuals: A randomised double blind, sham controlled, longitudinal trial

    Directory of Open Access Journals (Sweden)

    Jain Nidhi

    2011-04-01

    Full Text Available Abstract Background The extent to which mental and physical exercise may slow cognitive decline in adults with early signs of cognitive impairment is unknown. This article provides the rationale and methodology of the first trial to investigate the isolated and combined effects of cognitive training (CT and progressive resistance training (PRT on general cognitive function and functional independence in older adults with early cognitive impairment: Study of Mental and Regular Training (SMART. Our secondary aim is to quantify the differential adaptations to these interventions in terms of brain morphology and function, cardiovascular and metabolic function, exercise capacity, psychological state and body composition, to identify the potential mechanisms of benefit and broader health status effects. Methods SMART is a double-blind randomized, double sham-controlled trial. One hundred and thirty-two community-dwelling volunteers will be recruited. Primary inclusion criteria are: at risk for cognitive decline as defined by neuropsychology assessment, low physical activity levels, stable disease, and age over 55 years. The two active interventions are computerized CT and whole body, high intensity PRT. The two sham interventions are educational videos and seated calisthenics. Participants are randomized into 1 of 4 supervised training groups (2 d/wk × 6 mo in a fully factorial design. Primary outcomes measured at baseline, 6, and 18 months are the Alzheimer's Disease Assessment Scale (ADAS-Cog, neuropsychological test scores, and Bayer Informant Instrumental Activities of Daily Living (B-IADLs. Secondary outcomes are psychological well-being, quality of life, cardiovascular and musculoskeletal function, body composition, insulin resistance, systemic inflammation and anabolic/neurotrophic hormones, and brain morphology and function via Magnetic Resonance Imaging (MRI and Spectroscopy (fMRS. Discussion SMART will provide a novel evaluation of the

  6. Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial

    DEFF Research Database (Denmark)

    Mathiassen, Ole N; Vase, Henrik; Bech, Jesper N;

    2016-01-01

    BACKGROUND: Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. METHOD: We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish.......5 (SHAM)].RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. CONCLUSION: Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM...... cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0....

  7. 5-HT3 antagonist for cognition improvement in schizophrenia: a double blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Neyousha Mohammadi

    2010-01-01

    Full Text Available   Abstract   Introduction: Patients with schizophrenia characteristically exhibit cognitive deficits. The level of cognitive impairment is found to predict the functional outcome of the illness more strongly than the severity of positive or negative symptoms. The purpose of this study was to assess the efficacy of ondansetron, a 5-HT3 receptor antagonist as an adjuvant agent in the treatment of chronic schizophrenia in particular for cognitive impairments.   Methods: This investigation was a 12-week, double blind study of parallel groups of patients with stable chronic schizophrenia. Thirty patients were recruited from inpatient and outpatient departments. All participants met Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR criteria for schizophrenia. To be eligible, patients were required to have been treated with a stable dose of risperidone as their primary antipsychotic treatment for a minimum period of 8 weeks. The subjects were randomized to receive ondansetron (8 mg/day or the placebo in addition to risperidone. Cognition was measured by a cognitive battery. Patients were assessed at baseline and after 8, and 12 weeks after the medication started.   Results: Administration of ondansetron significantly improved visual memory based on improvement on visual reproduction, visual paired associate and figural memory sub tests of Wechsler Memory Scale Revised.  Discussion: The present study indicates ondansetron as potential adjunctive treatment strategy for chronic schizophrenia particularly for cognitive impairments.

  8. Sativex successfully treats neuropathic pain characterised by allodynia: a randomised, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Nurmikko, Turo J; Serpell, Mick G; Hoggart, Barbara; Toomey, Peter J; Morlion, Bart J; Haines, Derek

    2007-12-15

    Cannabinoids are known to have analgesic properties. We evaluated the effect of oro-mucosal sativex, (THC: CBD), an endocannabinoid system modulator, on pain and allodynia, in 125 patients with neuropathic pain of peripheral origin in a five-week, randomised, double-blind, placebo-controlled, parallel design trial. Patients remained on their existing stable analgesia. A self-titrating regimen was used to optimise drug administration. Sixty-three patients were randomised to receive sativex and 62 placebo. The mean reduction in pain intensity scores (primary outcome measure) was greater in patients receiving sativex than placebo (mean adjusted scores -1.48 points vs. -0.52 points on a 0-10 Numerical Rating Scale (p=0.004; 95% CI: -1.59, -0.32). Improvements in Neuropathic Pain Scale composite score (p=0.007), sleep NRS (p=0.001), dynamic allodynia (p=0.042), punctate allodynia (p=0.021), Pain Disability Index (p=0.003) and Patient's Global Impression of Change (psativex vs. placebo. Sedative and gastrointestinal side effects were reported more commonly by patients on active medication. Of all participants, 18% on sativex and 3% on placebo withdrew during the study. An open-label extension study showed that the initial pain relief was maintained without dose escalation or toxicity for 52 weeks. PMID:17997224

  9. Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    A. A. Harandi

    2011-01-01

    Full Text Available Objective. To investigate the safety and efficacy of MLC601 (NeuroAid as a traditional Chinese medicine on motor recovery after ischemic stroke. Methods. This study was a double-blind, placebo-controlled clinical trial on 150 patients with a recent (less than 1 month ischemic stroke. All patients were given either MLC601 (100 patients or placebo (50 patients, 4 capsules 3 times a day, as an add-on to standard stroke treatment for 3 months. Results. Sex, age, elapsed time from stroke onset, and risk factors in the treatment group were not significantly different from placebo group at baseline (P>.05. Repeated measures analysis showed that Fugl-Meyer assessment was significantly higher in the treatment group during 12 weeks after stroke (P<.001. Good tolerability to treatment was shown, and adverse events were mild and transient. Conclusion. MLC601 showed better motor recovery than placebo and was safe on top of standard ischemic stroke medications especially in the severe and moderate cases.

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

    Directory of Open Access Journals (Sweden)

    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.

  11. Double-blind, randomized, controlled trial of zinc or vitamin A supplementation in young children with acute diarrhoea.

    Science.gov (United States)

    Faruque, A S; Mahalanabis, D; Haque, S S; Fuchs, G J; Habte, D

    1999-02-01

    In a double-blind, controlled trial with a factorial design, 684 patients (aged 6 months to 2 y; excludes 6 early dropouts) with acute watery diarrhoea of 3 d or less and some dehydration, who were attending a hospital, were randomly assigned to 4 groups to receive: (a) vitamin A 4500 microg retinol equivalent daily for 15 d; (b) 14.2 mg elemental zinc as acetate for the first 417 patients and 40 mg of the remaining 273 patients randomized to this group for 15 d; (c) both vitamin A 4500 microg retinol equivalent and zinc at the above doses daily for 15 d; or (d) placebo mixtures for 15 d. Patients were observed in the hospital for 24 h and followed up at home for 15 d. All received ascorbic acid 30 mg with each dose of medicine or placebo. Zinc supplementation was associated with a reduced duration of diarrhoea (13%, p = 0.03) and markedly reduced rate (43%, p = 0.017) of prolonged diarrhoea (>7 d). Vitamin A supplementation was associated with a nonsignificant trend for reduced rate of prolonged diarrhoea (p = 0.089). In conclusion, zinc supplementation as adjunct therapy had a substantial impact on the rate of prolonged diarrhoea and some impact on duration and may be beneficial in children with diarrhoea in developing countries. PMID:10102147

  12. A single-blinded, randomized, controlled clinical trial evaluating the effect of face washing on acne vulgaris.

    Science.gov (United States)

    Choi, Joanna Mimi; Lew, Vincent K; Kimball, Alexa B

    2006-01-01

    Despite the common recommendation to wash the face twice daily with a mild cleanser, there is little published evidence to support the practice. Indeed, while the general public believes that cleaner skin will result in fewer blemishes, dermatologists often warn that overwashing and scrubbing can exacerbate the condition. To clarify the effect of frequency of face washing on acne vulgaris, we designed a single-blinded, randomized, controlled clinical trial to be conducted on males with mild to moderate acne vulgaris. Subjects washed their faces twice daily for 2 weeks with a standard mild cleanser before being randomized to one of three study arms, in which face washing was to be done once, twice, or four times a day for 6 weeks. At the end of the study no statistically significant differences were noted between groups. However, significant improvements in both open comedones and total noninflammatory lesions were observed in the group washing twice a day. Worsening of acne condition was observed in the study group washing once a day, with significant increases in erythema, papules, and total inflammatory lesions. We concluded that slight support exists, both in terms of efficacy and convenience, for the recommendation to wash the face twice daily with a mild cleanser. However, excessive face washing may not be as culpable as previously thought. PMID:17014635

  13. A 6 week randomized double-blind placebo-controlled trial of ziprasidone for the acute depressive mixed state.

    Directory of Open Access Journals (Sweden)

    Ashwin Patkar

    Full Text Available OBJECTIVE: To examine the efficacy of ziprasidone vs. placebo for the depressive mixed state in patients with bipolar disorder type II or major depressive disorder (MDD. METHODS: 73 patients were randomized in a double-blinded, placebo-controlled study to ziprasidone (40-160 mg/d or placebo for 6 weeks. They met DSM-IV criteria for a major depressive episode (MDE, while also meeting 2 or 3 (but not more nor less DSM-IV manic criteria. They did not meet DSM-IV criteria for a mixed or manic episode. Baseline psychotropic drugs were continued unchanged. The primary endpoint measured was Montgomery-Åsberg Depression Rating Scale (MADRS scores over time. The mean dose of ziprasidone was 129.7±45.3 mg/day and 126.1±47.1 mg/day for placebo. RESULTS: The primary outcome analysis indicated efficacy of ziprasidone versus placebo (p = 0.0038. Efficacy was more pronounced in type II bipolar disorder than in MDD (p = 0.036. Overall ziprasidone was well tolerated, without notable worsening of weight or extrapyramidal symptoms. CONCLUSIONS: There was a statistically significant benefit with ziprasidone versus placebo in this first RCT of any medication for the provisional diagnostic concept of the depressive mixed state. TRIAL REGISTRATION: Clinicaltrials.gov NCT00490542.

  14. A double-blind, randomized, cross-over, placebo-controlled, pilot trial with Sativex in Huntington's disease.

    Science.gov (United States)

    López-Sendón Moreno, Jose Luis; García Caldentey, Juan; Trigo Cubillo, Patricia; Ruiz Romero, Carolina; García Ribas, Guillermo; Alonso Arias, M A Alonso; García de Yébenes, María Jesús; Tolón, Rosa María; Galve-Roperh, Ismael; Sagredo, Onintza; Valdeolivas, Sara; Resel, Eva; Ortega-Gutierrez, Silvia; García-Bermejo, María Laura; Fernández Ruiz, Javier; Guzmán, Manuel; García de Yébenes Prous, Justo

    2016-07-01

    Huntington's disease (HD) is a neurodegenerative disease for which there is no curative treatment available. Given that the endocannabinoid system is involved in the pathogenesis of HD mouse models, stimulation of specific targets within this signaling system has been investigated as a promising therapeutic agent in HD. We conducted a double-blind, randomized, placebo-controlled, cross-over pilot clinical trial with Sativex(®), a botanical extract with an equimolecular combination of delta-9-tetrahydrocannabinol and cannabidiol. Both Sativex(®) and placebo were dispensed as an oral spray, to be administered up to 12 sprays/day for 12 weeks. The primary objective was safety, assessed by the absence of more severe adverse events (SAE) and no greater deterioration of motor, cognitive, behavioral and functional scales during the phase of active treatment. Secondary objectives were clinical improvement of Unified Huntington Disease Rating Scale scores. Twenty-six patients were randomized and 24 completed the trial. After ruling-out period and sequence effects, safety and tolerability were confirmed. No differences on motor (p = 0.286), cognitive (p = 0.824), behavioral (p = 1.0) and functional (p = 0.581) scores were detected during treatment with Sativex(®) as compared to placebo. No significant molecular effects were detected on the biomarker analysis. Sativex(®) is safe and well tolerated in patients with HD, with no SAE or clinical worsening. No significant symptomatic effects were detected at the prescribed dosage and for a 12-week period. Also, no significant molecular changes were observed on the biomarkers. Future study designs should consider higher doses, longer treatment periods and/or alternative cannabinoid combinations.Clincaltrals.gov identifier: NCT01502046. PMID:27159993

  15. The effect of a diiodothyronine mimetic on insulin sensitivity in male cardiometabolic patients: a double-blind randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Fleur van der Valk

    Full Text Available BACKGROUND AND AIMS: Obesity and its associated cardiometabolic co-morbidities are increasing worldwide. Since thyroid hormone mimetics are capable of uncoupling the beneficial metabolic effects of thyroid hormones from their deleterious effects on heart, bone and muscle, this class of drug is considered as adjacent therapeutics to weight-lowering strategies. This study investigated the safety and efficacy of TRC150094, a thyroid hormone mimetic. MATERIALS AND METHODS: This 4-week, randomized, placebo-controlled, double-blind trial was conducted in India and The Netherlands. Forty subjects were randomized at a 1:1 ratio to receive either TRC150094 dosed at 50 mg or placebo once daily for 4 weeks. Hyperinsulinemic euglycemic clamp and (1H-Magnetic Resonance Spectroscopy (MRS were performed before and after treatment. RESULTS: At baseline, subjects were characterized by markedly impaired hepatic and peripheral insulin sensitivity. TRC150094 dosed 50 mg once daily was safe and well tolerated. Hepatic nor peripheral insulin sensitivity improved after TRC150094 treatment, expressed as the suppression of Endogenous Glucose Production from 59.5 to 62.1%; p = 0.477, and the rate of glucose disappearance from 28.8 to 26.4 µmol kg(-1min(-1, p = 0.185. TRC150094 administration did not result in differences in fasting plasma free fatty acids from 0.51 to 0.51 mmol/L, p = 0.887 or in insulin-mediated suppression of lipolysis from 57 to 54%, p = 0.102. Also, intrahepatic triglyceride content was unaltered. CONCLUSION: Collectively, these data show that, in contrast to the potent metabolic effects in experimental models, TRC150094 at a dose of 50 mg daily does not improve the metabolic homeostasis in subjects at an increased cardiometabolic risk. Further studies are needed to evaluate whether TRC150094 has beneficial effects in patients with more severe metabolic derangement, such as overt diabetes mellitus and hypertriglyceridemia. TRIAL REGISTRATION

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

    Directory of Open Access Journals (Sweden)

    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

  17. 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.

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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    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.

  20. Antispasmodic/analgesic associations in primary dysmenorrhea double-blind crossover placebo-controlled clinical trial.

    Science.gov (United States)

    de los Santos, A R; Zmijanovich, R; Pérez Macri, S; Martí, M L; Di Girolamo, G

    2001-01-01

    We studied 125 patients with primary dysmenorrhea in a prospective randomized double-blind crossover study. After an admission pretreatment period without medication, the patients completed three consecutive randomized treatment phases with lysine clonixinate 125 mg plus propinox 10 mg or paracetamol 500 mg plus hyoscine N-butylbromide 10 mg or placebo, according to a fixed-dose schedule of 1 tablet every 6 h, 3 days before onset of menses and for 5 days thereafter. Changes in menstrual pain intensity and duration, amount of bleeding measured according to the number of daily pads used and concomitant symptoms were assessed on the fifth day of each cycle. Every night, the patients recorded the average intensity of menstrual pain during the first 4 days of menstruation in a diary The follow-up visit carried out at day 5 showed significant reduction in pain intensity with both active treatments vs. the other two phases: baseline: 2.72 +/- 0.61; placebo: 1.85 +/- 0.87; lysine clonixinate plus propinox 1.36 +/- 0.81, and paracetamol plus hyosine N-butylbromide: 1.45 +/- 0.87. The patients' diaries showed increasingly lower pain intensities starting from day 1 with the three treatments. Active treatments revealed significantly higher analgesic efficacy from the outset compared with baseline and placebo; however, only the lysine clonixinate plus propinox combination reached a statistically significant difference by days 3 and 4. No changes in duration or intensity of menstrual bleeding or in the incidence of adverse effects were observed during the four study periods. PMID:11708572

  1. Prospective, double-blind, placebo-controlled trials of ecallantide for acute attacks of hereditary angioedema.

    Science.gov (United States)

    Stolz, Leslie E; Sheffer, Albert L

    2012-01-01

    Hereditary angioedema (HAE) is a rare genetic disorder characterized by unpredictable, episodic, incapacitating attacks of well-demarcated angioedema in the absence of urticaria and pruritus. HAE is due to deficient or dysfunctional C1-esterase inhibitor activity, which results in unopposed activation of plasma kallikrein, resulting in increased levels of bradykinin. Ecallantide is a potent and specific plasma kallikrein inhibitor approved for the treatment of acute attacks of HAE affecting any anatomic site. In Phase III clinical trials, subcutaneously administered ecallantide demonstrated significant, rapid and durable symptom relief. Ecallantide was effective for all attack types, including potentially life-threatening laryngeal attacks. The main safety concern is potentially serious hypersensitivity reactions, including anaphylaxis. Ecallantide represents an important treatment option for the management of acute attacks of HAE. PMID:22149337

  2. Recruitment, Retention, and Blinding in Clinical Trials

    OpenAIRE

    Page, Stephen J.; Persch, Andrew C.

    2013-01-01

    The recruitment and retention of participants and the blinding of participants, health care providers, and data collectors present challenges for clinical trial investigators. This article reviews challenges and alternative strategies associated with these three important clinical trial activities. Common recruiting pitfalls, including low sample size, unfriendly study designs, suboptimal testing locations, and untimely recruitment are discussed together with strategies for overcoming these b...

  3. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  5. Treatment of atypical depression with cognitive therapy or phenelzine: a double-blind, placebo-controlled trial.

    OpenAIRE

    Jarrett, Robin B.; Schaffer, Martin; McIntire, Donald; Witt-Browder, Amy; Kraft, Dolores; Risser, Richard C.

    1999-01-01

    Background: Patients with a typical depression are more likely to respond to monoamine oxidase inhibitors than to tricyclic antidepressants. They are frequently offered psychotherapy in the absence of controlled tests. There are no prospective, randomized, controlled trials, to our knowledge, of psychotherapy for atypical depression or of cognitive therapy compared with a monoamine oxidase inhibitor. Since there is only 1 placebo-controlled trial of cognitive therapy, this trial fills a gap i...

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

    Directory of Open Access Journals (Sweden)

    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

  7. Randomized Double-Blind Placebo-Controlled Trial of Bevacizumab Therapy for Radiation Necrosis of the Central Nervous System

    International Nuclear Information System (INIS)

    Purpose: To conduct a controlled trial of bevacizumab for the treatment of symptomatic radiation necrosis of the brain. Methods and Materials: A total of 14 patients were entered into a placebo-controlled randomized double-blind study of bevacizumab for the treatment of central nervous system radiation necrosis. All patients were required to have radiographic or biopsy proof of central nervous system radiation necrosis and progressive neurologic symptoms or signs. Eligible patients had undergone irradiation for head-and-neck carcinoma, meningioma, or low- to mid-grade glioma. Patients were randomized to receive intravenous saline or bevacizumab at 3-week intervals. The magnetic resonance imaging findings 3 weeks after the second treatment and clinical signs and symptoms defined the response or progression. Results: The volumes of necrosis estimated on T2-weighted fluid-attenuated inversion recovery and T1-weighted gadolinium-enhanced magnetic resonance imaging scans demonstrated that although no patient receiving placebo responded (0 of 7), all bevacizumab-treated patients did so (5 of 5 randomized and 7 of 7 crossover) with decreases in T2-weighted fluid-attenuated inversion recovery and T1-weighted gadolinium-enhanced volumes and a decrease in endothelial transfer constant. All bevacizumab-treated patients-and none of the placebo-treated patients-showed improvement in neurologic symptoms or signs. At a median of 10 months after the last dose of bevacizumab in patients receiving all four study doses, only 2 patients had experienced a recurrence of magnetic resonance imaging changes consistent with progressive radiation necrosis; one patient received a single additional dose of bevacizumab and the other patient received two doses. Conclusion: The Class I evidence of bevacizumab efficacy from the present study in the treatment of central nervous system radiation necrosis justifies consideration of this treatment option for people with radiation necrosis secondary to

  8. Water is a safe and effective alternative to sterile normal saline for wound irrigation prior to suturing: a prospective, double-blind, randomised, controlled clinical trial

    OpenAIRE

    Weiss, Eric Alan; Oldham, George; Lin, Michelle; Foster, Tammy; Quinn, James Victor

    2013-01-01

    Objective To determine if there is a significant difference in the infection rates of wounds irrigated with sterile normal saline (SS) versus tap water (TW), before primary wound closure. Design Single centre, prospective, randomised, double-blind controlled trial. Wound irrigation solution type was computer randomised and allocation was done on a sequential basis. Setting Stanford University Medical Center Department of Emergency Medicine. Participants Patients older than 1 year of age, who ...

  9. Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double‐blind, placebo‐controlled trials

    OpenAIRE

    Schoenfeld, P.; Pimentel, M; Chang, L.; Lembo, A; Chey, W. D.; Yu, J.; Paterson, C; Bortey, E.; Forbes, W P

    2014-01-01

    Summary Background The efficacy of rifaximin, a nonsystemic, gut‐targeted antibiotic for reducing non–constipation‐predominant irritable bowel syndrome (non‐C IBS) symptoms, has been demonstrated in one phase 2b and two phase 3 randomised, double‐blind, placebo‐controlled trials, but detailed data about rifaximin safety and tolerability during treatment and subsequent follow‐up periods are lacking. Aim To assess and determine the frequency of rifaximin and placebo adverse events (AEs) in phas...

  10. The Positive Effects of Zinc Supplements on the Improvement of Primary Dysmenorrhea and Premenstrual Symptoms: A Double-blind, Randomized, Controlled Trial

    OpenAIRE

    Gita Sangestani; Mahnaz Khatiban; Roberto Marci; Isabella Piva

    2015-01-01

    Background & aim:Primary dysmenorrhea can be relieved via some medical and non-medical approaches. In this regard, the probable therapeutic role of zinc supplements has been recently emphasized. The present study was conducted to determine the positive effects of zinc supplements on relieving primary dysmenorrhea and premenstrual symptoms. Methods:The present double-blind, randomized, controlled trial was conducted on 66 students at Hamadan University of Medical Sciences. Students with the ex...

  11. Antihypertensive Potential of Combined Extracts of Olive Leaf, Green Coffee Bean and Beetroot: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial

    OpenAIRE

    Rachel H. X. Wong; Garg, Manohar L.; Wood, Lisa G; Peter R. C. Howe

    2014-01-01

    Extracts of olive leaf, green coffee bean and beetroot may deliver cardiovascular benefits. This study sought to evaluate the effects of regularly consuming a combination of these extracts on blood pressure (BP), arterial compliance, blood lipids, blood glucose and insulin sensitivity. A double-blind randomised placebo-controlled crossover trial was conducted in adults with untreated high normal or borderline elevated BP. They were randomised to take an active supplement, comprising 500 mg ol...

  12. Morinda citrifolia (Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial

    OpenAIRE

    Fletcher, H. M.; Dawkins, J.; Rattray, C.; Wharfe, G.; Reid, M.; Gordon-Strachan, G.

    2013-01-01

    Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea. Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and ...

  13. Effect of onion peel extract supplementation on the lipid profile and antioxidative status of healthy young women: a randomized, placebo-controlled, double-blind, crossover trial

    OpenAIRE

    Kim, Jungmi; Cha, Yong-Jun; Lee, Kyung-Hea; Park, Eunju

    2013-01-01

    The consumption of fruits and vegetables that have high polyphenol content has been previously associated with a reduced risk for cardiovascular disease. We investigated the effects of onion peel extract on plasma total antioxidant capacity, lipid peroxidation, and leukocyte DNA damage. This study was a randomized, double-blind, placebo-controlled, crossover trial. Healthy female subjects received either onion peel extract or placebo (dextrin) for two weeks, underwent a 1-week washout period,...

  14. Sublingual versus Vaginal Misoprostol for the Induction of Labor at Term: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

    OpenAIRE

    Bahia Namavar Jahromi; Foroogh Poorgholam; Gholamhossein Yousefi; Leila Salarian

    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 t...

  15. Elderberry Supplementation Reduces Cold Duration and Symptoms in Air-Travellers: A Randomized, Double-Blind Placebo-Controlled Clinical Trial

    OpenAIRE

    Evelin Tiralongo; Shirley S. Wee; Lea, Rodney A.

    2016-01-01

    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 effec...

  16. An Evaluation of the Effectiveness of Hyaluronidase in the Selective Nerve Root Block of Radiculopathy: A Double Blind, Controlled Clinical Trial

    OpenAIRE

    Ko, Sang-Bong; Alexander R Vaccaro; Chang, Ho-Jin; Shin, Dong-Young

    2015-01-01

    Study Design Prospective, double-blind, randomized controlled trial. Purpose To determine the ability of hyaluronidase to provide longer lasting pain relief and functional improvement in patients with lumbar radiculopathy. Overview of Literature Selective nerve root block (SNRB) is a good treatment option in lumbar radiculopathy. We studied the effectiveness of hyaluronidase when added to the traditional SNRB regimen. Methods A sample size of 126 patients per group was necessary. A sample of ...

  17. Does single application of topical chloramphenicol to high risk sutured wounds reduce incidence of wound infection after minor surgery? Prospective randomised placebo controlled double blind trial

    OpenAIRE

    Heal, Clare F; Petra G Buettner; Cruickshank, Robert; Graham, David; Browning, Sheldon; Pendergast, Jayne; Drobetz, Herwig; Gluer, Robert; Lisec, Carl

    2009-01-01

    Objective To determine the effectiveness of a single application of topical chloramphenicol ointment in preventing wound infection after minor dermatological surgery. Design Prospective randomised placebo controlled double blind multicentre trial. Setting Primary care in a regional centre in Queensland, Australia. Participants 972 minor surgery patients. Interventions A single topical dose of chloramphenicol (n=488) or paraffin ointment (n=484; placebo). Main outcome measure Incidence of infe...

  18. 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

    OpenAIRE

    Verhaar Harald JJ; Sukel-Helleman Marja; Emmelot-Vonk Marielle H; Nakhai Pour Hamid Reza; Grobbee Diederick E; van der Schouw Yvonne T

    2006-01-01

    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 re...

  19. Oral epigallocatechin-3-gallate for treatment of dystrophic epidermolysis bullosa: a multicentre, randomized, crossover, double-blind, placebo-controlled clinical trial

    OpenAIRE

    Chiaverini, Christine; Roger, Coralie; Fontas, Eric; Bourrat, Emmanuelle; Bourdon-Lanoy, Eva; Labrèze, Christine; Mazereeuw, Juliette; Vabres, Pierre; Bodemer, Christine; Lacour, Jean-Philippe

    2016-01-01

    Abstract Recessive dystrophic epidermolysis bullosa (RDEB) is a rare genodermatosis with severe blistering. No curative treatment is available. Scientific data indicated that epigallocatechin-3-gallate (EGCG), a green tea extract, might improve the phenotype of RDEB patients. In a multicentre, randomized, crossover, double-blind, placebo-controlled clinical trial, we evaluated a 4-month oral EGCG treatment regimen in 17 RDEB patients. We found that EGCG treatment was not more effective than p...

  20. Dietary Supplementation with a Superoxide Dismutase-Melon Concentrate Reduces Stress, Physical and Mental Fatigue in Healthy People: A Randomised, Double-Blind, Placebo-Controlled Trial

    OpenAIRE

    Julie Carillon; Claire Notin; Karine Schmitt; Guy Simoneau; Dominique Lacan

    2014-01-01

    Background: We aimed to investigate effects of superoxide dismutase (SOD)-melon concentrate supplementation on psychological stress, physical and mental fatigue in healthy people. Methods: A randomized, double-blind, placebo-controlled trial was performed on 61 people divided in two groups: active supplement (n = 32) and placebo (n = 29) for 12 weeks. Volunteers were given one small hard capsule per day. One capsule contained 10 mg of SOD-melon concentrate (140 U of SOD) and starch for the a...

  1. An evaluation of the hypolipidemic effect of an extract of Hibiscus Sabdariffa leaves in hyperlipidemic Indians: a double blind, placebo controlled trial

    OpenAIRE

    Rajendran, R.; Kumar Divya R; Kuriyan Rebecca; Kurpad Anura V

    2010-01-01

    Abstract Background Hibiscus sabdariffa is used regularly in folk medicine to treat various conditions. Methods The study was a double blind, placebo controlled, randomized trial. Sixty subjects with serum LDL values in the range of 130-190 mg/dl and with no history of coronary heart disease were randomized into experimental and placebo groups. The experimental group received 1 gm of the extract for 90 days while the placebo received a similar amount of maltodextrin in addition to dietary and...

  2. Using a Low-Sodium, High-Potassium Salt Substitute to Reduce Blood Pressure among Tibetans with High Blood Pressure: A Patient-Blinded Randomized Controlled Trial

    OpenAIRE

    Xingshan Zhao; Xuejun Yin; Xian Li; Yan, Lijing L; Christopher T Lam; Shenshen Li; Feng He; Wuxiang Xie; Ba Sang; Gesang Luobu; Liang Ke; Yangfeng Wu

    2014-01-01

    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% sodiu...

  3. Effect of oxandrolone and timing of pubertal induction on final height in Turner’s syndrome: randomised, double blind, placebo controlled trial

    OpenAIRE

    Gault, E.J.; Perry, R J; Cole, T J; Casey, S.; Paterson, W.F.; Hindmarsh, P. C.; Betts, P; Dunger, D B; Donaldson, M D C

    2011-01-01

    Objective To examine the effect of oxandrolone and the timing of pubertal induction on final height in girls with Turner’s syndrome receiving a standard dose of growth hormone. Design Randomised, double blind, placebo controlled trial. Setting 36 paediatric endocrinology departments in UK hospitals. Participants Girls with Turner’s syndrome aged 7-13 years at recruitment, receiving recombinant growth hormone therapy (10 mg/m2/week). Interventions Participants were randomised to oxandrolone (0...

  4. The impact of oxandolone and timing of pubertal induction on final height in Turner sydrome: a randomised, double-blind, placebo-controlled trial

    OpenAIRE

    Gault, E.J.; Perry, R J; Cole, T J; Casey, S.; Paterson, W.M.; Hindmarsh, P.J.; Betts, P; Dunger, D B; Donaldson, M D C

    2011-01-01

    Objective: To examine the effect of oxandrolone and the timing of pubertal induction on final height in girls with Turner’s syndrome receiving a standard dose of growth hormone. Design: Randomised, double blind, placebo controlled trial. Setting:36 paediatric endocrinology departments in UK hospitals. Participants: Girls with Turner’s syndrome aged 7-13 years at recruitment, receiving recombinant growth hormone therapy (10 mg/m2/week). Interventions Participants were randomise...

  5. Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: A multicentre, randomised, blinded, controlled and non-inferiority trial

    OpenAIRE

    González de Vega, C; Speed, C; Wolfarth, B.; González, J.

    2013-01-01

    Background Acute ankle sprains are common and activity limiting injuries, and topical diclofenac gel has proven efficacy in alleviating pain and restoring function. This trial aimed to compare a topical natural agent, Traumeel with topical diclofenac gel (1%) in the management of acute ankle sprain. Methods This prospective, multicentre, randomised, blinded, active-control and non-inferiority study involved 449 physically active adults sustaining unilateral grade 1 or 2 ankle sprain within th...

  6. Effects of Two Chinese Herbal Formulae for the Treatment of Moderate to Severe Stable Chronic Obstructive Pulmonary Disease: A Multicenter, Double-Blind, Randomized Controlled Trial

    OpenAIRE

    Wang, Genfa; Liu, Baojun; Cao, Yuxue; Du, Yijie; Zhang, Hongying; Luo, Qingli; Li, Bei; Wu, Jinfeng; Lv, Yubao; Sun, Jing; Jin, Hualiang; Wei, Kai; Zhao, Zhengxiao; Kong, Lingwen; Zhou, Xianmei

    2014-01-01

    Objective The study aims to evaluate the efficacy and safety of two Chinese herbal formulae for the treatment of stable COPD. Methods A multicenter, double-blind, double-dummy, and randomized controlled trial (RCT) was conducted. All groups were treated with additional conventional medicines. There were a 6-month treatment and a 12-month follow-up for 5 times. Primary outcomes included lung function test, exacerbation frequency, score of SGRQ. Second outcomes consisted of 6MWD, BODE index, ps...

  7. Therapeutic Effect of Jinzhen Oral Liquid for Hand Foot and Mouth Disease: A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Trial

    OpenAIRE

    LIU Jun; Zhang, Guo-Liang; Huang, Gui-Qin; Li, Li; Li, Chun-Ping; Wang, Mei; Liang, Xiao-Yan; Xie, Di; Yang, Chang-Ming; Li, Yan; Sun, Xiu-Rong; Zhang, Hong-Sen; Wan, Bai-Song; Zhang, Wei-hua; Yu, Hao

    2014-01-01

    Background No specific antiviral agent against hand foot and mouth disease (HFMD) is available for clinical practice today. Objective To evaluate the efficacy and safety of Jinzhen oral solution in treating uncomplicated HFMD. Methods In this randomized, double-blind, placebo-controlled trial, 399 children aged 1 to 7 years with laboratory confirmed HFMD were randomized to receive Jinzhen oral liquid or placebo 3 times daily for 7 days with a 3-day follow-up. The primary outcomes were time to...

  8. Effectiveness of a Chinese herbal medicine preparation in the treatment of cough in uncomplicated upper respiratory tract infection: a randomised double-blinded placebo-control trial

    OpenAIRE

    WCW, Wong; A, Lee; AT, Lam; KT, Li; CYM, Leung; PC, Leung; ELY, Wong; JL, Tang

    2006-01-01

    Background Rigorous scientific and well-designed clinical trials to evaluate the effect of traditional Chinese medicine (TCM) is lacking. We, therefore, designed this study to evaluate the effectiveness of a commonly used TCM preparation in treating acute cough of uncomplicated URTI in adults and to search for a safe, effective and affordable alternative treatment for this common condition. Methods A randomised, double-blinded, placebo-control study comparing this TCM preparation with a place...

  9. The impact of isosorbide mononitrate on cervical ripening and labor induction in primiparous women with term pregnancy: A double-blind, randomized, controlled trial

    OpenAIRE

    Yazdizadeh, Hamideh; Abedi, Parvin; Najar, Shahnaz; Angali, Kambiz Ahmadi

    2013-01-01

    Background: The most favorable method for cervical ripening is not fully agreed upon by practitioners; however, vaginal administration of isosorbide mononitrate (IMN) is considered a low-risk method of labor induction for pregnant women at full term. Our study was designed to assess the effect of IMN on cervical ripening and labor induction among primiparous women in Iran. Materials and Methods: A randomized, double-blind, placebo-controlled trial was conducted on 90 primiparous women with Bi...

  10. A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single, Escalating Oral Doses of JDTic

    OpenAIRE

    Buda, Jeffrey J; Carroll, F. I.; Kosten, Thomas R.; Swearingen, Dennis; Walters, Bradford B

    2015-01-01

    Animal studies suggest that kappa opioid receptor antagonists (KORAn) potentially could treat a wide variety of addictive and depressive disorders. We assessed the KORAn JDTic for safety, tolerability, and pharmacokinetics in a double-blind, placebo-controlled, randomized trial evaluating single oral doses in healthy adult males. Predose and postdose safety assessments included orthostatic vital signs; 6-lead continuous telemetry monitoring (approximately 16 h predose to 24 h postdose); 12-le...

  11. Quetiapine versus haloperidol in the treatment of delirium: a double-blind, randomized, controlled trial

    OpenAIRE

    Maneeton B; Maneeton N; Srisurapanont M; Chittawatanarat K

    2013-01-01

    Benchalak Maneeton,1 Narong Maneeton,1 Manit Srisurapanont,1 Kaweesak Chittawatanarat2 1Department of Psychiatry, 2Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand Background: Atypical antipsychotic drugs may have low propensity to induce extrapyramidal side effects in delirious patients. This study aimed to compare the efficacy and tolerability between quetiapine and haloperidol in controlling delirious behavior. Methods: A 7-day prospective, double-bli...

  12. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

    Directory of Open Access Journals (Sweden)

    Booth Sara

    2009-07-01

    Full Text Available Abstract Background The Breathlessness Intervention Service is a novel service for patients with intractable breathlessness regardless of aetiology. It is being evaluated using the Medical Research Council's framework for the evaluation of complex interventions. This paper describes the feasibility results of Phase II: a single-blinded fast-track pragmatic randomised controlled trial. Methods A single-blinded fast-track pragmatic randomised controlled trial was conducted for patients with chronic obstructive pulmonary disease referred to the service. Patients were randomised to either receive the intervention immediately for an eight-week period, or receive the intervention after an eight-week period on a waiting list during which time they received standard care. Outcomes examined included: response rates to the trial; response rates to the individual questionnaires and items; comments relating to the trial functioning made during interviews with patients, carers, referrers and service providers; and, researcher fieldwork notes. Results 16 of the 20 eligible patients agreed to participate in a recruitment visit (16/20; 14 respondents went on to complete a recruitment visit/baseline interview. The majority of those who completed a recruitment visit/baseline interview completed the RCT protocol (13/14; 12 of their carers were recruited and completed the protocol. An unblinding rate of 6/25 respondents (patients and carers was identified. Missing data were minimal and only one patient was lost to follow up. The fast-track trial methodology proved feasible and acceptable. Two of the baseline/outcome measures proved unsuitable: the WHO performance scale and the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW. Conclusion This study adds to the evidence that fast-track randomised controlled trials are feasible and acceptable in evaluations of palliative care interventions for patients with non-malignant conditions

  13. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Kowey, Peter R; Dorian, Paul; Mitchell, L Brent;

    2009-01-01

    was a prospective, randomized, double-blind, placebo-controlled trial of vernakalant for the conversion of AF or AFL after coronary artery bypass graft, valvular surgery, or both. Patients were randomly assigned 2:1 to receive a 10-minute infusion of 3 mg/kg vernakalant or placebo. If AF or AFL was...... complete atrioventricular block). There were no cases of torsades de pointes, sustained ventricular tachycardia, or ventricular fibrillation. There were no deaths. CONCLUSIONS: Vernakalant was safe and effective in the rapid conversion of AF to sinus rhythm in patients who had AF after cardiac surgery....... CLINICAL TRIAL REGISTRATION: clinicaltrials.gov. Identifier: NCT00125320....

  14. Captopril for prevention of Contrast Induced Nephropathy in patients undergoing Coronary Angioplasty: A double blind placebo controlled clinical trial

    Directory of Open Access Journals (Sweden)

    M Hashemi

    2005-09-01

    Full Text Available Background: Contrast induced nephropathy is a potential cause of mortality and morbidity in patients undergoing angiography–angioplasty. Except for hydrating and probably low – isoosmolar contrast agents in high risk groups, other modalities have not provided benefit. We investigated preventive effects of captopril for contrast induced nephropathy during angiography–angioplasty. Methods: In a double blind placebo controlled clinical trial, 88 patients were randomized to two groups: 42 patients received captopril (12.5 mg every 8 hours from 2 hours before the procedure until 48 hours thereafter, and 46 patients received placebo in the same manner. Serum creatinine was measured before and 48 hours after angioplasty. The data were analyzed by SPSS software, using unpaired student t-test for comparing mean creatinine rise in both groups and paired student t-test for the changes in serum creatinine in each group. Results: The mean creatinine rise in captopril group (0.214 mg/dl and placebo group (0.226 mg/dl were not significantly different. The incidence of acute renal failure (creatinine rise more than 0.5 mg/dl in the captopril (11.9 % and placebo group (10.8 % were not significantly different. Conclusion: Captopril does not effectively prevent contrast nephropathy, but it is not harmful for renal function and can be administered safely during angiography – angioplasty in patients with normal renal function. However, the effect of captopril in patients with high- risk characteristics remains to be clarified. Of note, we found a trend for less creatinine rise in diabetics who received captopril during the procedure in comparison to diabetics who received placebo. Keywords: Angiography, Angioplasty, Contrast induced Nephropathy, Captopril, Angiotension Converting Enzyme Inhibitor, Creatinine

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

    Directory of Open Access Journals (Sweden)

    Ramin Mehrdad

    2015-10-01

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

  16. 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.

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

    Directory of Open Access Journals (Sweden)

    Cuevas-Ramos D

    2013-07-01

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

  18. Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.

    Science.gov (United States)

    Sterling, Michele; Vicenzino, Bill; Souvlis, Tina; Connelly, Luke B

    2015-04-01

    This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise. PMID:25790454

  19. Synbiotics could not Reduce the Scoring of Childhood Atopic Dermatitis (SCORAD: A Randomized Double Blind Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Alireza Shafiei

    2011-03-01

    Full Text Available Despite preliminary evidence, the role of probiotic and synbiotic in treatment of the atopic dermatitis has shown varying results. We aimed to evaluate whether synbiotic supplementation decrease severity of atopic dermatitis (AD in childhood. In a randomized double blind-placebo controlled trial, we evaluated the synbiotic supplementation efficiency on the treatment of atopic dermatitis.Infants aged 1–36 months with moderate to severe atopic dermatitis were randomized (n=41 and received either synbiotic (probiotic plus prebiotic (n=20 or placebo (n=21 daily as  a  powder  for  two  months.  Emollient  (Eucerin  and  topical  corticosteroid (Hydrocortisone were permitted.Children were scored for severity of atopic dermatitis (SCORAD. Also allergen Skin Prick Tests (SPT, IgE blood level and eosinophil count were measured at first visit. Patients’ SCORAD were reevaluated at the end of intervention.  We followed 36 out of 41 subjects for two months (drop out rate = 9%.In the whole group, the mean Total SCORAD (at base line 40.93 decreased by 56% (p=0.00. The mean Objective SCORAD (at base line 31.29 decreased by 53% (p=0.00. There was no significant difference in the mean decrease of total SCORAD between placebo (22.3 and synbiotic groups (24.2. There was also no difference between two intervention groups in the mean decrease of total SCORAD regarding to different demographic, clinical and para clinical subgroups.This study could not confirm synbiotic as an effective treatment for childhood atopic dermatitis and further studies are needed. These findings challenge the role of synbiotics in the treatment of childhood atopic dermatitis.

  20. Antifatigue effects of Panax ginseng C.A. Meyer: a randomised, double-blind, placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Hyeong-Geug Kim

    Full Text Available UNLABELLED: The present study investigated the antifatigue effects of Panax ginseng C.A. Meyer in 90 subjects (21 men and 69 women with idiopathic chronic fatigue (ICF in a randomised, double-blind, placebo-controlled and parallel designed trial. A bespoke 20% ethanol extract of P. ginseng (1 g or 2 g day(-1 or a placebo was administered to each group for 4 weeks, and then fatigue severity was monitored using a self-rating numeric scale (NRS and a visual analogue scale (VAS as a primary endpoint. Serum levels of reactive oxygen species (ROS, malondialdehyde (MDA, total glutathione (GSH contents and glutathione reductase (GSH-Rd activity were determined. After 4-week, P. ginseng administration decreased the total NRS score, but they were not statistically significant compared with placebo (P>0.05. Mental NRS score was significantly improved by P. ginseng administrations as 20.4 ± 5.0 to 15.1 ± 6.5 [95% CI 2.3 ~ 8.2] for 1 g and 20.7 ± 6.3 to 13.8 ± 6.2 [95% CI -0.1 ~ 4.2] for 2 g compared with placebo 20.9 ± 4.5 to 18.8 ± 2.9 [95% CI 4.1 ~ 9.9, P<0.01]. Only 2 g P. ginseng significantly reduced the VAS score from 7.3 ± 1.3 to 4.4 ± 1.8 [95% CI 0.7∼1.8] compared with the placebo 7.1 ± 1.0 to 5.8 ± 1.3 [95% CI 2.2 ~ 3.7, P<0.01]. ROS and MDA levels were lowered by P. ginseng compared to placebo. P. ginseng 1 g increased GSH concentration and GSH-Rd activity. Our results provide the first evidence of the antifatigue effects of P. ginseng in patients with ICF, and we submit that these changes in antioxidant properties contribute in part to its mechanism. TRIAL REGISTRATION: Clinical Research Information Service (CRIS KCT0000048.

  1. Quality of life and metabolic status in mildly depressed women with type 2 diabetes treated with paroxetine: A single-blind randomised placebo controlled trial

    OpenAIRE

    Wahlbeck Kristian; Paile-Hyvärinen Maria; Eriksson Johan G

    2003-01-01

    Abstract Background Depression is prevalent in people with type 2 diabetes and affects both glycemic control and overall quality of life. The aim of this trial was to evaluate the effect of the antidepressant paroxetine on metabolic control, quality of life and mental well-being in mildly depressed women with type 2 diabetes. Methods We randomised 15 mildly depressed women with non-optimally controlled type 2 diabetes to a 10-week single-blind treatment with either paroxetine 20 mg per day or...

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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.

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

    OpenAIRE

    Roberio Dias LEITE; Noelia Leal LIMA; Christiane Araujo Chaves LEITE; Calil Kairalla FARHAT; Guerrant, Richard Littleton; Aldo Angelo Moreira LIMA

    2013-01-01

    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 l...

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

    OpenAIRE

    Roberio Dias LEITE; Noelia Leal LIMA; Christiane Araujo Chaves LEITE; Calil Kairalla FARHAT; Guerrant, Richard Littleton; Aldo Angelo Moreira LIMA

    2013-01-01

    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...

  6. Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial

    Directory of Open Access Journals (Sweden)

    Osborne Richard

    2007-09-01

    Full Text Available Abstract Background Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA, there is currently limited evidence to support their use. The aim of this randomised, double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain, physical function and health-related quality of life, and slower structural disease progression as well as being more cost-effective, than control flat insoles in people with medial knee OA. Methods/Design Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and randomly allocated to lateral wedge or control insole groups using concealed allocation. Participants will be blinded as to which insole is considered therapeutic. Blinded follow up assessment will be conducted at 12 months after randomisation. The outcome measures are valid and reliable measures recommended for OA clinical trials. Questionnaires will assess changes in pain, physical function and health-related quality-of-life. Magnetic resonance imaging will measure changes in tibial cartilage volume. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. Discussion Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA. Trial registration ACTR12605000503628; NCT00415259.

  7. Effects of L-carnitine supplementation on respiratory distress syndrome development and prognosis in premature infants: A single blind randomized controlled trial

    OpenAIRE

    OZTURK, MEHMET ADNAN; KARDAS, ZEHRA; KARDAS, FATİH; GUNES, TAMER; KURTOGLU, SELİM

    2015-01-01

    The aim of the present study was to investigate the efficacy of L-carnitine therapy on the occurrence and prognosis of respiratory distress syndrome (RDS). A single blind, randomized controlled trial study was conducted on 130 infants with gestational ages of 28–36 weeks. Infants were assigned to experimental groups (groups 1 and 2) and control groups (groups 3 and 4). Groups 1 and 3 consisted of infants with RDS, and groups 2 and 4 groups were composed of infants without RDS. The experimenta...

  8. Randomized, single blind, controlled trial to evaluate the prime-boost strategy for pneumococcal vaccination in renal transplant recipients.

    Directory of Open Access Journals (Sweden)

    Selma Tobudic

    Full Text Available UNLABELLED: Renal transplant recipients are at increased risk of developing invasive pneumococcal diseases but may have poor response to the 23-valent pneumococcal polysaccharide vaccine (PPV. It may be possible to enhance immunogenicity by priming with 7-valent pneumococcal conjugate vaccine (7vPnC and boosting with PPV 1 year later. In a randomized single-blind, controlled study, adult recipients of renal transplants received either 7nPVC or PPV followed by PPV 1 year later. The vaccine response was defined as 2-fold increase in antibody concentration from baseline and an absolute post-vaccination values ≥1 µg/ml. The primary endpoint was vaccine response of the primed group (7vPnC/PPV compared with single PPV vaccination. Antibody concentrations for 10 serotypes were measured at baseline, 8 weeks after first vaccination, before second vaccination, and 8 weeks after second vaccination. Of 320 screened patients, 80 patients were randomized and 62 completed the study. Revaccination with PPV achieved no significant increase of immune response in the 7vPnC/PPV group compared with the single PPV recipients A response to at least 1 serotype was seen in 77.1% of patients who received 7vPnC and 93.1% of patients who received PPV (P = 0.046. After second vaccination response to at least 1 serotype was seen in 87.5% patients of 7vPnC/PPV group and 87.1% patients of PPV group (non significant p. The median number of serotypes eliciting a response was 3.5 (95% CI 2.5-4.5 in the 7vPnC/PPV group versus 5 (95% CI 3.9-6.1 in the PPV group (non-significant p. Immunogenicity of pneumococcal vaccination was not enhanced by the prime-boost strategy compared with vaccination with PPV alone. Administration of a single dose of PPV should continue to be the standard of care for adult recipients of renal transplants. TRIAL REGISTRATION: EudraCT 2007-004590-25.

  9. 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

  10. 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.

  11. Postural control in blind subjects

    Directory of Open Access Journals (Sweden)

    Antonio Vinicius Soares

    2011-12-01

    Full Text Available Objective: To analyze postural control in acquired and congenitally blind adults. Methods: A total of 40 visually impaired adults participated in the research, divided into 2 groups, 20 with acquired blindness and 20 with congenital blindness - 21 males and 19 females, mean age 35.8 ± 10.8. The Brazilian version of Berg Balance Scale and the motor domain of functional independence measure were utilized. Results: On Berg Balance Scale the mean for acquired blindness was 54.0 ± 2.4 and 54.4 ± 2.5 for congenitally blind subjects; on functional independence measure the mean for acquired blind group was 87.1 ± 4.8 and 87.3 ± 2.3 for congenitally blind group. Conclusion: Based upon the scale used the results suggest the ability to control posture can be developed by compensatory mechanisms and it is not affected by visual loss in congenitally and acquired blindness.

  12. The Belgian trial with azithromycin for acute COPD exacerbations requiring hospitalization: an investigator-initiated study protocol for a multicenter, randomized, double-blind, placebo-controlled trial

    Science.gov (United States)

    Vermeersch, Kristina; Gabrovska, Maria; Deslypere, Griet; Demedts, Ingel K; Slabbynck, Hans; Aumann, Joseph; Ninane, Vincent; Verleden, Geert M; Troosters, Thierry; Bogaerts, Kris; Brusselle, Guy G; Janssens, Wim

    2016-01-01

    Background Long-term use of macrolide antibiotics is effective to prevent exacerbations in chronic obstructive pulmonary disease (COPD). As risks and side effects of long-term intervention outweigh the benefits in the general COPD population, the optimal dose, duration of treatment, and target population are yet to be defined. Hospitalization for an acute exacerbation (AE) of COPD may offer a targeted risk group and an obvious risk period for studying macrolide interventions. Methods/design Patients with COPD, hospitalized for an AE, who have a smoking history of ≥10 pack-years and had ≥1 exacerbation in the previous year will be enrolled in a multicenter, randomized, double-blind, placebo-controlled trial (NCT02135354). On top of a standardized treatment of systemic corticosteroids and antibiotics, subjects will be randomized to receive either azithromycin or placebo during 3 months, at an uploading dose of 500 mg once a day for 3 days, followed by a maintenance dose of 250 mg once every 2 days. The primary endpoint is the time-to-treatment failure during the treatment phase (ie, from the moment of randomization until the end of intervention). Treatment failure is a novel composite endpoint defined as either death, the admission to intensive care or the requirement of additional systemic steroids or new antibiotics for respiratory reasons, or the diagnosis of a new AE after discharge. Discussion We investigate whether azithromycin initiated at the onset of a severe exacerbation, with a limited duration and at a low dose, might be effective and safe in the highest risk period during and immediately after the acute event. If proven effective and safe, this targeted approach may improve the treatment of severe AEs and redirect the preventive use of azithromycin in COPD to a temporary intervention in the subgroup with the highest unmet needs. PMID:27099485

  13. Study protocol for a randomised, double-blinded, placebo-controlled, clinical trial of S-ketamine for pain treatment in patients with chronic pancreatitis (RESET trial)

    DEFF Research Database (Denmark)

    Juel, Jacob; Olesen, Søren Schou; Olesen, Anne Estrup;

    2015-01-01

    central sensitisation is abnormal activation of the N-methyl-D-aspartate receptor, which can be antagonised by S-ketamine. The RESET trial is investigating the analgaesic and antihyperalgesic effect of S-ketamine in patients with CP. METHODS AND ANALYSIS: 40 patients with CP will be enrolled. Patients are...... randomised to receive 8 h of intravenous S-ketamine followed by oral S-ketamine, or matching placebo, for 4 weeks. To improve blinding, 1 mg of midazolam will be added to active and placebo treatment. The primary end point is clinical pain relief as assessed by a daily pain diary. Secondary end points...

  14. Double blind, randomised, placebo-controlled trial to evaluate the efficacy of esomeprazole to treat early onset pre-eclampsia (PIE Trial): a study protocol

    Science.gov (United States)

    Cluver, Catherine A; Walker, Susan P; Mol, Ben W; Theron, Gerard B; Hall, David R; Hiscock, Richard; Hannan, N; Tong, S

    2015-01-01

    Introduction Pre-eclampsia is a major complication of pregnancy, globally responsible for 60 000 maternal deaths per year, and far greater numbers of fetal losses. There is no definitive treatment other than delivery. A drug that can quench the disease process could be useful to treat early onset pre-eclampsia, as it could allow pregnancies to safely continue to a gestation where fetal outcomes are significantly improved. We have generated preclinical data to show esomeprazole, a proton pump inhibitor used for gastric reflux, has potent biological effects that makes it a worthwhile therapeutic candidate. Esomeprazole potently decreases soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin secretion from placenta and endothelial cells, and has biological actions to mitigate endothelial dysfunction and oxidative stress. Methods and analysis We propose undertaking a phase II, double blind, randomised controlled clinical trial to examine whether administering 40 mg esomeprazole daily may prolong gestation in women with early onset pre-eclampsia. We will recruit 120 women (gestational age of 26+0 to 31+6 weeks) who will be randomised to receive either esomeprazole or an identical placebo. The primary outcome will be the number of days from randomisation to delivery. Secondary outcomes include maternal, fetal and neonatal composite and individual outcomes. Maternal outcomes include maternal death, eclampsia, pulmonary oedema, severe renal impairment, cerebral vascular events and liver haematoma or rupture. Neonatal outcomes include neonatal death within 6 weeks after the due date, intraventricular haemorrhage, necrotising enterocolitis and bronchopulmonary dysplasia. We will examine whether esomeprazole can decrease serum sFlt-1 and soluble endoglin levels and we will record the safety of esomeprazole in these pregnancies. Ethics and dissemination This study has ethical approval (Protocol V.2.4, M14/09/038, Federal Wide assurance Number 00001372, IRB

  15. Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Cyrus Cooper

    2013-12-01

    Full Text Available Objective: The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro. Exploratory studies in the osteoporosis trialsreport that strontium ranelate reduces biomarkers of cartilage degradation, and attenuates the progression and clinical symptoms of spinal osteoarthritis, suggesting symptom- and structure-modifying activity in osteoarthritis. We describethe rationale and design of a randomised trial evaluating the efficacy and safety of strontium ranelate in knee osteoarthritis.Research design, methods, and results: This double-blind, placebo-controlled trial (98 centres, 18 countries includes ambulatory Caucasian men and women aged ≥50 years with primary knee osteoarthritis of the medial tibiofemoralcompartment (Kellgren and Lawrence grade 2 or 3, joint space width (JSW 2.5 to 5 mm, and knee pain on most days in the previous month (intensity ≥40 mm on a visual analogue scale. Patients are randomly allocated to three groups (strontium ranelate 1 or 2g/day, or placebo. Follow-up is expected to last 3 years. The primary endpoint is radiographic change in JSW from baseline in each group versus placebo. The main clinical secondary endpoint is WOMAC score at the knee. Safety is assessed at every visit. It is estimated that 1600 patients are required to establish statistical significance with power >90% (0.2 mm ±10% between-group difference in change in JSW over 3 years. Recruitment started in April 2006. The results are expected in spring 2012.Clinical trial registration: The trial is registered on www.controlled-trials.com (number ISRCTN41323372.Conclusions: This randomised, double blind, placebo-controlled study will establish the potential of strontium ranelate in improving structure and symptoms in patients with knee osteoarthritis.

  16. NILVAD protocol: a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease.

    OpenAIRE

    Lawlor, B.; Kennelly, S.; O'Dwyer, S; Cregg, F.; Walsh, C; Coen, R; Kenny, R.A.; Howard, R.; Murphy, C; Adams, J.; Daly, L; Segurado, R.; Gaynor, S.; Crawford, F.; Mullan, M.

    2014-01-01

    INTRODUCTION: This study is a European multicentre, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer's disease (AD) in a phase III study that will run for a period of 82 weeks with a treatment period of 78 weeks. METHODS AND ANALYSIS: Adult patients, males and females over 50 years with mild-to-moderate AD as defined by the National Institute of Neurological and Commun...

  17. A randomized, double-blind, placebo-controlled trial of naltrexone in the treatment of concurrent alcohol use disorder and pathological gambling.

    Science.gov (United States)

    Toneatto, Tony; Brands, Bruna; Selby, Peter

    2009-01-01

    The efficacy of naltrexone as a treatment for concurrent alcohol abuse or dependence and pathological gambling was evaluated in a randomized, double-blind, placebo-controlled trial. Fifty-two, mostly male, subjects were recruited from the community and received 11 weeks of medication during which cognitive-behavioral counseling was also provided. No significant group differences were found on any alcohol or gambling variable (ie, frequency, quantity, expenditures) at post-treatment or at the one year follow-up. However, a strong time effect was found suggesting that treatment, in general, was effective. The use of naltrexone to treat concurrent alcohol use and gambling problems was not supported. PMID:19340640

  18. Double blind, randomised controlled clinical trial of hypo-osmolar oral rehydration salt solution in dehydrating acute diarrhoea in severely malnourished (marasmic) children

    OpenAIRE

    Dutta, P; Mitra, U.; Manna, B.; Niyogi, S; K Roy; Mondal, C.; Bhattacharya, S.

    2001-01-01

    AIMS—To compare the clinical efficacy of hypo-osmolar oral rehydration salt (ORS) solution (224 mmol/l) and standard ORS solution (311 mmol/l) in severely malnourished (marasmic) children having less than 60% Harvard standard weight for age with dehydrating acute watery diarrhoea.
METHODS—In a double blind, randomised, controlled trial, 64 children aged 6-48 months were randomly assigned standard (n = 32) or hypo-osmolar ORS (n = 32).
RESULTS—Stool output (52.3 v 96.6 g/kg/day)...

  19. Comparison of Clinical Efficacy of Intravenous Acetaminophen with Intravenous Morphine in Acute Renal Colic: A Randomized, Double-Blind, Controlled Trial

    OpenAIRE

    Kambiz Masoumi; Arash Forouzan; Ali Asgari Darian; Maryam Feli; Hassan Barzegari; Ali Khavanin

    2014-01-01

    The aim of this study was to compare the clinical efficacy of intravenous acetaminophen with intravenous morphine in acute renal colic pain management. In this double-blind controlled trial, patients aged 18–55 years, diagnosed with acute renal colic, who met the inclusion and exclusion criteria, were randomized into two groups. First, using the visual analogue scale (VAS), intensity of pain was assessed in both groups. Then, one gram of intravenous acetaminophen or 0.1 mg/kg morphine was inf...

  20. Escitalopram Versus Citalopram and Sertraline: A Double-Blind Controlled, Multi-centric Trial in Indian Patients with Unipolar Major Depression

    OpenAIRE

    Lalit, Vaya; Appaya, Prakash M.; Hegde, Rajendra P.; Mital, Anukant K.; Mittal, Sunil; Nagpal, Rajesh; Palaniappun, Vaiapuri; Ramsubramaniam, C.; Rao, Gundugurti P.; Roy, Krishna; Trivedi, Jitendra K.; Ganpat K. Vankar; Karan, Rajesh S.; Shah, Sweety; Patel, Ronak B.

    2004-01-01

    The present randomized, double blind, parallel group, controlled, multi-centric trial was designed to evaluate the efficacy and tolerability of escitalopram in comparison with citalopram and sertraline in the treatment of major depressive disorder. Outpatients (N=214) with an ongoing/newly diagnosed ICD-10 major depressive episode and a Hamilton Rating Scale for Depression (HAM-D) score of > 18 were randomly assigned to citalopram, 20–40 mg/day (74 patients), escitalopram, 10–20 mg/day (69 pa...

  1. Effect of the serotonin receptor agonist, buspirone, on immune function in HIV-infected individuals: a six-month randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Eugen-Olsen, J; Benfield, Thomas; Axen, T E;

    2000-01-01

    , and response to pokeweed mitogen (PWM) in antiretroviral naive HIV-1-infected individuals. METHOD: Twenty-three HIV-infected patients with CD4 T-cell counts above 300 per microL were enrolled in a 6-month double-blinded placebo controlled trial. No patients received antiretroviral therapy during the...... compared to placebo-treated patients was observed. There were no significant differences in CD4 T-cell counts, HIV viral load,or proliferative response to PWM between those receiving placebo and those receiving buspirone. CONCLUSION: Buspirone treatment leads to significant changes in CD8 T-cell count and...

  2. Effect of the serotonin receptor agonist, buspirone, on immune function in HIV-infected individuals: a six-month randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Eugen-Olsen, Jesper; Benfield, T; Axen, T E;

    2000-01-01

    , and response to pokeweed mitogen (PWM) in antiretroviral naive HIV-1-infected individuals. METHOD: Twenty-three HIV-infected patients with CD4 T-cell counts above 300 per microL were enrolled in a 6-month double-blinded placebo controlled trial. No patients received antiretroviral therapy during the...... compared to placebo-treated patients was observed. There were no significant differences in CD4 T-cell counts, HIV viral load, or proliferative response to PWM between those receiving placebo and those receiving buspirone. CONCLUSION: Buspirone treatment leads to significant changes in CD8 T-cell count and...

  3. Randomized, Double-Blind, Placebo-Controlled Trial of Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Idiopathic Pneumonia Syndrome after Allogeneic Stem Cell Transplantation: Blood and Marrow Transplant Clinical Trials Network Protocol

    OpenAIRE

    Yanik, Gregory A.; Horowitz, Mary M.; Weisdorf, Daniel J.; Logan, Brent R.; Ho, Vincent T.; Soiffer, Robert J.; Carter, Shelly L.; Wu, Juan; Wingard, John R.; DiFronzo, Nancy L.; Ferrara, James L.; Giralt, Sergio; Madtes, David K.; Drexler, Rebecca; White, Eric S.

    2014-01-01

    Idiopathic pneumonia syndrome (IPS) is a diffuse, noninfectious lung injury that occurs acutely after allogeneic hematopoietic cell transplantation (HCT). IPS-related mortality has been historically high (>50%) despite treatment with systemic corticosteroids and supportive care measures. We have now examined the role of tumor necrosis factor inhibition in a randomized, double-blind, placebo-controlled trial of corticosteroids with etanercept or placebo. Thirty-four subjects (≥18 years) with I...

  4. A single blind randomized controlled trial of cognitive behavioural therapy in a help-seeking population with an At Risk Mental State for psychosis: the Dutch Early Detection and Intervention Evaluation (EDIE-NL) trial

    OpenAIRE

    Delespaul Philippe; Wunderink Lex; Nieman Dorien; Ising Helga; Klaassen Rianne; Dragt Sara; Rietdijk Judith; Cuijpers Pim; Linszen Don; van der Gaag Mark

    2010-01-01

    Abstract Background Psychotic disorders are a serious mental health problem. Intervention before the onset of psychosis might result in delaying the onset, reducing the impact or even preventing the first episode of psychosis. This study explores the effectiveness of cognitive behavioural therapy (CBT) in targeting cognitive biases that are involved in the formation of delusions in persons with an ultra-high risk for developing psychosis. A single blind randomised controlled trial compares CB...

  5. 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.

    Directory of Open Access Journals (Sweden)

    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.

  6. 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

  7. Pantoea agglomerans lipopolysaccharide maintains bone density in premenopausal women: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Nakata, Kazue; Nakata, Yoko; Inagawa, Hiroyuki; Nakamoto, Takeru; Yoshimura, Hiroshi; Soma, Gen-Ichiro

    2014-11-01

    Lipopolysaccharide fromPantoea agglomerans (LPSp) facilitates Ca and P turnover in chicken calvaria and femurs. This study investigated osteoporosis prevention by the oral administration of LPSp in mice and in double-blind clinical tests. Using ovariectomized (OVX) osteoporosis mice model, we investigated the effects of LPSp on the bone density and Ca concentration after ingesting LPSp-containing water for 4 weeks. Oral administration of LPSp tended to suppress the decline in the bone density and the cortical bone thickness in the OVX mice. Moreover, the Ca concentrations were maintained in the OVX-LPSp mice. The effects of LPSp on bone turnover were tested in randomized and double-blind clinical test subjects, who were healthy women aged 40-79 years. The subjects ingested either soy milk without LPSp (control group) or with LPSp (LPSp group) for 3 months. The results showed that the LPSp group on premenopause maintained their bone density compared with the control group pre- and postmenopause. Moreover, these effects were maintained for 2 months postobservation. LPSp maintains bone volume and density in vivo. Thus, a combination of soy milk and LPSp may be useful for osteoporosis prevention. PMID:25493180

  8. The effects of hip muscle strengthening on knee load, pain, and function in people with knee osteoarthritis: a protocol for a randomised, single-blind controlled trial

    Directory of Open Access Journals (Sweden)

    Hunter David J

    2007-12-01

    Full Text Available Abstract Background Lower limb strengthening exercises are an important component of the treatment for knee osteoarthritis (OA. Strengthening the hip abductor and adductor muscles may influence joint loading and/or OA-related symptoms, but no study has evaluated these hypotheses directly. The aim of this randomised, single-blind controlled trial is to determine whether hip abductor and adductor muscle strengthening can reduce knee load and improve pain and physical function in people with medial compartment knee OA. Methods/Design 88 participants with painful, radiographically confirmed medial compartment knee OA and varus alignment will be recruited from the community and randomly allocated to a hip strengthening or control group using concealed allocation stratified by disease severity. The hip strengthening group will perform 6 exercises to strengthen the hip abductor and adductor muscles at home 5 times per week for 12 weeks. They will consult with a physiotherapist on 7 occasions to be taught the exercises and progress exercise resistance. The control group will be requested to continue with their usual care. Blinded follow up assessment will be conducted at 12 weeks after randomisation. The primary outcome measure is the change in the peak external knee adduction moment measured during walking. Questionnaires will assess changes in pain and physical function as well as overall perceived rating of change. An intention-to-treat analysis will be performed using linear regression modelling and adjusting for baseline outcome values and other demographic characteristics. Discussion Results from this trial will contribute to the evidence regarding the effect of hip strengthening on knee loads and symptoms in people with medial compartment knee OA. If shown to reduce the knee adduction moment, hip strengthening has the potential to slow disease progression. Trial Registration Australia New Zealand Clinical Trials Registry ACTR12607000001493

  9. Neurofeedback to improve neurocognitive functioning of children treated for a brain tumor: design of a randomized controlled double-blind trial

    Directory of Open Access Journals (Sweden)

    de Ruiter Marieke A

    2012-12-01

    Full Text Available Abstract Background Neurotoxicity caused by treatment for a brain tumor is a major cause of neurocognitive decline in survivors. Studies have shown that neurofeedback may enhance neurocognitive functioning. This paper describes the protocol of the PRISMA study, a randomized controlled trial to investigate the efficacy of neurofeedback to improve neurocognitive functioning in children treated for a brain tumor. Methods/Design Efficacy of neurofeedback will be compared to placebo training in a randomized controlled double-blind trial. A total of 70 brain tumor survivors in the age range of 8 to 18 years will be recruited. Inclusion also requires caregiver-reported neurocognitive problems and being off treatment for more than two years. A group of 35 healthy siblings will be included as the control group. On the basis of a qEEG patients will be assigned to one of three treatment protocols. Thereafter patients will be randomized to receive either neurofeedback training (n=35 or placebo training (n=35. Neurocognitive tests, and questionnaires administered to the patient, caregivers, and teacher, will be used to evaluate pre- and post-intervention functioning, as well as at 6-month follow-up. Siblings will be administered the same tests and questionnaires once. Discussion If neurofeedback proves to be effective for pediatric brain tumor survivors, this can be a valuable addition to the scarce interventions available to improve neurocognitive and psychosocial functioning. Trial registration ClinicalTrials.gov NCT00961922.

  10. Symptoms after Ingestion of Pig Whipworm Trichuris suis Eggs in a Randomized Placebo-Controlled Double-Blind Clinical Trial

    Science.gov (United States)

    Bager, Peter; Kapel, Christian; Roepstorff, Allan; Thamsborg, Stig; Arnved, John; Rønborg, Steen; Kristensen, Bjarne; Poulsen, Lars K.; Wohlfahrt, Jan; Melbye, Mads

    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 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-hoc analyses of gastrointestinal reactions. Adverse events and severity (mild, moderate, severe) were recorded daily by subjects, classified by organ using MedDRA 10.0, and event rates compared between subjects on T. suis treatment vs. subjects on placebo. T. suis-specific serum IgG antibodies were measured 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 = 47). The highest incidence of affected subjects was seen from the first few days and until day 42 (3rd dose): 63% vs. 29% for placebo; day 163: 76% vs. 49% for placebo. Seroprevalences increased concurrently in the T. suis group: Day 59, 50%; day 90, 91%; day 170, 93%. The combined duration of episodes with onset before day 42 was ≤14 days in 80% of affected subjects. Age, gender, total IgE, and recent intestinal symptoms at baseline did not predict gastrointestinal side effects. In conclusion, during the first 2 months, repeated ingestions of 2500 T. suis eggs caused frequent gastrointestinal reactions lasting up to 14 days, whereas 4 months further treatment mainly provoked a subclinical stimulation. Trial registration University hospital Medical

  11. Local steroid injection for moderately severe idiopathic carpal tunnel syndrome: Protocol of a randomized double-blind placebo-controlled trial (NCT 00806871

    Directory of Open Access Journals (Sweden)

    Björk Jonas

    2010-04-01

    Full Text Available Abstract Background Patients with idiopathic carpal tunnel syndrome (CTS are commonly treated with steroid injection into or proximal to the carpal tunnel. However, evidence for its efficacy beyond one month has not been established in randomized placebo-controlled trials. The primary aim of this randomized trial is to assess the efficacy of steroid injection into the carpal tunnel in relieving symptoms of CTS in patients with symptoms of such severity to warrant surgical treatment but have not been treated with steroid injection. Methods/Design The study is a randomized double-blind placebo-controlled trial. Patients referred to one orthopedic department because of CTS are screened. Eligibility criteria are age 18 to 70 years, clinical diagnosis of primary idiopathic CTS and abnormal nerve conduction tests or clinical diagnosis made independently by two orthopedic surgeons, failed treatment with wrist splinting, symptom severity of such magnitude that the patient is willing to undergo surgery, no severe sensory loss or thenar muscle atrophy, and no previous steroid injection for CTS. A total of 120 patients will be randomized to injection of 80 mg Methylprednisolone, 40 mg Methylprednisolone, or normal saline, each also containing 10 mg Lidocaine. Evaluation at baseline and at 5, 10, 24 and 52 weeks after injection includes validated questionnaires (CTS symptom severity scale, QuickDASH and SF-6D, adverse events, physical examination by a blinded assessor, and nerve conduction tests. The primary outcome measures are change in the CTS symptom severity score at 10 weeks and the rate of surgery at 52 weeks. The secondary outcome measures are the score change in the CTS symptom severity scale at 52 weeks, time to surgery, and change in QuickDASH and SF-6D scores and patient satisfaction at 10 and 52 weeks. The primary analysis will be carried out using mixed model analysis of repeated measures. Discussion This paper describes the rationale and

  12. A double-blind, randomised, placebo-controlled trial of Ganoderma lucidum for the treatment of cardiovascular risk factors of metabolic syndrome.

    Science.gov (United States)

    Klupp, Nerida L; Kiat, Hosen; Bensoussan, Alan; Steiner, Genevieve Z; Chang, Dennis H

    2016-01-01

    This study aimed to evaluate the efficacy and safety of Ganoderma lucidum for the treatment of hyperglycaemia and other cardiovascular risk components of metabolic syndrome using a prospective, double-blind, randomised, placebo-controlled trial. Eighty-four participants with type 2 diabetes mellitus and metabolic syndrome were randomised to one of three intervention groups: Ganoderma lucidum, Ganoderma lucidum with Cordyceps sinensis, or placebo. The dosage was 3 g/day of Ganoderma lucidum, with or without Cordyceps sinensis, for 16 weeks. The primary outcome measure was blood glucose (glycosylated haemoglobin [HbA1c] and fasting plasma glucose [FPG]); a number of secondary outcome measures were also tested. Data from the two intervention groups were combined. The combined intervention had no effect on any of the primary (baseline-adjusted difference in means: HbA1c = 0.13%, 95% CI [-0.35, 0.60], p = 0.60; FPG = 0.03 mmol/L, 95% CI [-0.90, 0.96], p = 0.95) or secondary outcome measures over the course of the 16-week trial, and no overall increased risk of adverse events with either active treatment. Evidence from this randomised clinical trial does not support the use of Ganoderma lucidum for treatment of cardiovascular risk factors in people with diabetes mellitus or metabolic syndrome. This Clinical Trial was registered with the Australian New Zealand Clinical Trials Registry on November 23, 2006. Trial ID: ACTRN12606000485538 and can be accessed here: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81705. PMID:27511742

  13. Intraoperative music reduces perceived pain after total knee arthroplasty: a blinded, prospective, randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Simcock, Xavier C; Yoon, Richard S; Chalmers, Peter; Geller, Jeffrey A; Kiernan, Howard A; Macaulay, William

    2008-10-01

    Patients undergoing total knee arthroplasty (TKA) often experience a difficult recovery due to severe postoperative pain. Using a multimodal pain management protocol, a blinded, randomized, placebo-controlled study was designed to evaluate the efficacy of patient-selected music on reducing perceived pain. Thirty patients undergoing primary unilateral TKA were enrolled and randomized into the music group (15 patients) or the control group (15 patients). Postoperative pain scores, assessed with the visual analog scale, indicated the music group experienced less pain at 3 and 24 hours postoperatively than did the nonmusic group (at 3 hours: 1.47+/-1.39 versus 3.87+/-3.44, P=.01; at 24 hours: 2.41+/-1.67 versus 4.03+/-2.89, P=.04). Intraoperative music provides an inexpensive nonpharmacological option to further reduce postoperative pain. PMID:18979928

  14. HEGPOL: Randomized, placebo controlled, multicenter, double-blind clinical trial to investigate hepatoprotective effects of glycine in the postoperative phase of liver transplantation [ISRCTN69350312

    Directory of Open Access Journals (Sweden)

    Kraus Thomas W

    2005-08-01

    Full Text Available Abstract Background Kupffer cell-dependent ischemia / reperfusion (I/R injury after liver transplantation is still of high clinical relevance, as it is strongly associated with primary dysfunction and primary nonfunction of the graft. Glycine, a non-toxic, non-essential amino acid has been conclusively shown in various experiments to prevent both activation of Kupffer cells and reperfusion injury. Based on both experimental and preliminary clinical data this study protocol was designed to further evaluate the early effect of glycine after liver transplantation. Methods / design A prospective double-blinded randomized placebo-controlled multicenter study with two parallel groups in a total of 130 liver transplant recipients was designed to assess the effect of multiple intravenous doses of glycine after transplantation. Primary endpoints in hierarchical order are: peak levels of both aspartat-amino-transaminase (AST and alanine-amino-transaminase (ALT as surrogates for the progression of liver related injury, as well as both graft and patient survival up to 2 years after transplantation. Furthermore, the effect of glycine on cyclosporine A-induced nephrotoxicity is evaluated. Discussion The ongoing clinical trial represents an advanced element of the research chain, along which a scientific hypothesis has to go by, in order to reach the highest level of evidence; a randomized, prospective, controlled double-blinded clinical trial. If the data of this ongoing research project confirm prior findings, glycine would improve the general outcome after liver transplantation.

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

    Directory of Open Access Journals (Sweden)

    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.

  16. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  18. Acupuncture for Frequent Migraine: A Randomized, Patient/Assessor Blinded, Controlled Trial with One-Year Follow-Up

    Directory of Open Access Journals (Sweden)

    Yanyi Wang

    2015-01-01

    Full Text Available Objectives. This study aimed to evaluate the efficacy and safety of manual acupuncture as a prophylaxis for frequent migraine. Methods. Fifty frequent migraineurs were randomly allocated to receive 16 sessions of either real acupuncture (RA = 26 or sham acupuncture (SA = 24 during 20 weeks. The primary outcomes were days with migraine over four weeks, duration, and intensity of migraine and the number of responders with more than 50% reduction of migraine days. The secondary outcomes were the relief medication, quality of migraine, quality of life, and pressure pain thresholds. Results. The two groups were comparable at baseline. At the end of the treatment, when compared with the SA group, the RA group reported significant less migraine days (RA: 5.2 ± 5.0; SA: 10.1 ± 7.1; P=0.008, less severe migraine (RA: 2.18 ± 1.05; SA: 2.93 ± 0.61; P=0.004, more responders (RA: 19 versus SA: 7, and increased pressure pain thresholds. No other group difference was found. Group differences were maintained at the end of the three-month follow-up, but not at the one-year follow-up. No severe adverse event was reported. Blinding was successful. Discussion. Manual acupuncture was an effective and safe treatment for short-term relief of frequent migraine in adults. Larger trials are warranted.

  19. Participant experiences from chronic administration of a multivitamin versus placebo on subjective health and wellbeing: a double-blind qualitative analysis of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sarris Jerome

    2012-12-01

    Full Text Available Abstract Background While many randomised controlled trials have been conducted on multivitamins, to our knowledge no qualitative research exploring the subjective experience of taking a multivitamin during a clinical trial has been reported. Methods Semi-structured and open-ended written questions were incorporated into a 16-week double-blind, randomised, placebo-controlled, parallel groups trial of once-daily multivitamin administration. At the final study visit (week 16, three open-ended questions were posed to elucidate any positive, negative or unusual experiences from taking either the multivitamin or matched placebo. Qualitative thematic analysis was undertaken by researchers who were blind as to treatment condition of participants, and triangulation (independent analysis from three researchers was employed to ensure methodological rigour. Participant’s experiences were categorised as “positive” or “negative” and a Chi Square analysis was then applied to each of the experiential themes, to compare experiences between the multivitamin and placebo groups, (subdividing the groups by gender. Usual experiences were categorised and discussed separately. Results Of the 182 participants enrolled, 116 completed the study and qualitative data were available from 114 participants. Thematic analysis revealed significant effects in favour of the multivitamin over placebo for participants experiencing increased energy levels (p=.022 and enhanced mood (p=.027. The beneficial effect on energy levels was particularly evident among female participants. A trend was found for participants reporting better sleep in the multivitamin over placebo. The multivitamin and placebo groups did not significantly differ in perceived positive or negative effects in areas relating to other aspects of mental function or physical health. No significant negative effects were revealed, although there was a non-significant trend for more people in the multivitamin

  20. No-reflow protection and long-term efficacy for acute myocardial infarction with Tongxinluo: a randomized double-blind placebo-controlled multicenter clinical trial (ENLEAT Trial)

    Institute of Scientific and Technical Information of China (English)

    ZHANG Hai-tao; YANG Yue-jin; JIA Zhen-hua; ZHANG Jian; YE Zan-kai; YANG Wei-xian; TIAN Yue-qin; JIA Xuan; LI Wei; WU Yi-ling

    2010-01-01

    Background No-reflow after emergency percutaneous coronary intervention (PCI) for acute ST segment elevation myocardial infarction (STEMI) is related to the severe prognosis. The aim of this study was to evaluate the efficacy of Tongxinluo, a traditional Chinese medicine, on no-reflow and the infarction area after emergency PCI for STEMI.Methods A total of 219 patients (female 31, 14%) undergoing emergency PCI for STEMI from nine clinical centers were consecutively enrolled in this randomized, double-blind, placebo-controlled, multicenter clinical trial from January 2007 to May 2009. All patients were randomly divided into Tongxinluo group (n=108) and control group (n=111), given Tongxinluo or placebo in loading dose 2.08 g respectively before emergency PCI with asprin 300 mg and clopidogrel 300 mg together, then 1.04 g three times daily for six months after PCI. The ST segment elevation was recorded by electrocardiogram at hospitalization and 1, 2, 6, 12, 24 hours after coronary balloon dilation to evaluate the myocardial no-flow; myocardial perfusion scores of 17 segments were evaluated on day 7 and day 180 after STEMI with static single-photon emission computed tomography (SPECT) to determine the infarct area.Results There was no statistical significance in sex, age, past history, chest pain, onset-to-reperfusion time, Killip classification, TIMI flow grade just before and after PCI, either in the medication treatment during the follow up such as statin, β-blocker, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) between two groups. There was significant ST segment restoration in Tongxinluo group compared to the control group at 6 hours ((-0.22±0.18) mV vs. (-0.18±0.16) mV, P=0.0394), 12 hours ((-0.24 ± 0.18) mV vs. (-0.18±0.15) mV, P=0.0158) and 24 hours ((-0.27±0.16) mV vs. (-0.20±0.16) mV, P=0.0021) reperfusion; and the incidence of myocardial no-reflow was also reduced significantly at 24-hour reperfusion (34.3% vs

  1. The ACTIVE (Acute Cholecystitis Trial Invasive Versus Endoscopic study: Multicenter randomized, double-blind, controlled trial of laparoscopic (LC versus open (LTC surgery for acute cholecystitis (AC in adults

    Directory of Open Access Journals (Sweden)

    Bassi Uberto A

    2008-01-01

    Full Text Available Abstract Background In some randomized trials successful laparoscopic cholecystectomy for cholecystitis is associated with an earlier recovery and shorter hospital stay when compared with open cholecystectomy. Other studies did not confirm these results and showed that the potential advantages of laparoscopic cholecystectomy for cholecystitis can be offset by a high conversion rate to open surgery. Moreover in these studies a similar postoperative programme to optimize recovery comparing laparoscopic and open approaches was not standardized. These studies also do not report all eligible patients and are not double blinded. Design The present study project is a prospective, randomized investigation. The study will be performed in the Department of General, Emergency and Transplant Surgery St Orsola-Malpighi University Hospital (Bologna, Italy, a large teaching institutions, with the participation of all surgeons who accept to be involved in (and together with other selected centers. The patients will be divided in two groups: in the first group the patient will be submitted to laparoscopic cholecystectomy within 72 hours after the diagnosis while in the second group will be submitted to laparotomic cholecystectomy within 72 hours after the diagnosis. Trial Registration TRIAL REGISTRATION NUMBER ISRCTN27929536 – The ACTIVE (Acute Cholecystitis Trial Invasive Versus Endoscopic study. A multicentre randomised, double-blind, controlled trial of laparoscopic versus open surgery for acute cholecystitis in adults.

  2. Randomized Placebo-Controlled Double-Blind Clinical Trial of Cannabis-Based Medicinal Product (Sativex) in Painful Diabetic Neuropathy

    OpenAIRE

    Selvarajah, D.; Gandhi, R.; Emery, C.J.; Tesfaye, S.

    2010-01-01

    Objective: To assess the efficacy of Sativex, a cannabis-based medicinal extract, as adjuvant treatment in painful diabetic peripheral neuropathy (DPN). Research design and methods: In this randomized controlled trial, 30 subjects with painful DPN received daily Sativex or placebo. The primary outcome measure was change in mean daily pain scores, and secondary outcome measures included quality-of-life assessments. Results: There was significant improvement in pain scores in ...

  3. Nebulised fentanyl for post-operative pain relief, a prospective double-blind controlled randomised clinical trial

    OpenAIRE

    Singh, Anil P.; Jena, Sritam S; Rajesh Kr Meena; Mallika Tewari; V Rastogi

    2013-01-01

    Background and Aim: Intravenous (IV) route for fentanyl administration is the gold standard for post-operative pain relief, but complications such as respiratory depression, bradycardia and hypotension have limited this route. The aim of this randomised controlled trial was to compare the efficacy of nebulised fentanyl with IV fentanyl for post-operative pain relief after lower abdominal surgery. Methods: In the post-operative care unit, at the time of first onset of pain (visual analogue sca...

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

    OpenAIRE

    Zamiri B.; Eftekharian HR.; Arasteh N.

    2012-01-01

    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,...

  5. Are homeopathics able to replace antibiotics in the therapy of bovine mastitis? A placebo controlled randomized double-blind trial

    OpenAIRE

    Klocke, Peter; Fidelak, Christian; Garbe, Sylvia; Rothe, Johanna; Paal, Kerstin; Spranger, Joerg; Merck, Carl-Christian

    2004-01-01

    To evaluate the effects of homeopathics on clinical mastitis cows and herd udder health this investigation was conducted in a Brandenburg bio-dyn herd of about 300 cows in two phases using a randomized doubleblind control trial design. After the first part in July 2002 the results preliminarily were evaluated and then the whole concept due to unsatisfying results was adapted. In Phase 1 a number of 121 clinical mastitis cases with 137 affected quarters matched the including criteria, in Phase...

  6. 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 patients...... were randomized to intravenous dexamethasone (8 mg) or placebo 90 minutes before LC. Patients received a similar standardized anesthetic, surgical, and multimodal analgesic treatment. All patients were recommended 2 days postoperative duration of convalescence. The primary endpoints were fatigue and...... drug. Dexamethasone significantly reduced postoperative levels of CRP (P = 0.01), fatigue (P = 0.01), overall pain, and incisional pain during the first 24 postoperative hours (P < 0.05) and total requirements of opioids (P < 0.05). In addition, cumulated overall and visceral pain scores during the...

  7. 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

    . 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...... Syndrome (PANSS) subscales, Global Assessment of Functioning subscale (GAF-F) and Clinical Global Impression (CGI) with 20 neurocognitive indices was conducted, but no significant correlations were found. Second, we tested change from baseline to endpoint for the PANSS, GAF-F, and CGI, vs. the concomitant...... 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 on...

  8. 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

  9. Neurofeedback to improve neurocognitive functioning of children treated for a brain tumor: design of a randomized controlled double-blind trial

    International Nuclear Information System (INIS)

    Neurotoxicity caused by treatment for a brain tumor is a major cause of neurocognitive decline in survivors. Studies have shown that neurofeedback may enhance neurocognitive functioning. This paper describes the protocol of the PRISMA study, a randomized controlled trial to investigate the efficacy of neurofeedback to improve neurocognitive functioning in children treated for a brain tumor. Efficacy of neurofeedback will be compared to placebo training in a randomized controlled double-blind trial. A total of 70 brain tumor survivors in the age range of 8 to 18 years will be recruited. Inclusion also requires caregiver-reported neurocognitive problems and being off treatment for more than two years. A group of 35 healthy siblings will be included as the control group. On the basis of a qEEG patients will be assigned to one of three treatment protocols. Thereafter patients will be randomized to receive either neurofeedback training (n=35) or placebo training (n=35). Neurocognitive tests, and questionnaires administered to the patient, caregivers, and teacher, will be used to evaluate pre- and post-intervention functioning, as well as at 6-month follow-up. Siblings will be administered the same tests and questionnaires once. If neurofeedback proves to be effective for pediatric brain tumor survivors, this can be a valuable addition to the scarce interventions available to improve neurocognitive and psychosocial functioning. ClinicalTrials.gov NCT00961922

  10. Dietary Supplementation with a Superoxide Dismutase-Melon Concentrate Reduces Stress, Physical and Mental Fatigue in Healthy People: A Randomised, Double-Blind, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Julie Carillon

    2014-06-01

    Full Text Available Background: We aimed to investigate effects of superoxide dismutase (SOD-melon concentrate supplementation on psychological stress, physical and mental fatigue in healthy people. Methods: A randomized, double-blind, placebo-controlled trial was performed on 61 people divided in two groups: active supplement (n = 32 and placebo (n = 29 for 12 weeks. Volunteers were given one small hard capsule per day. One capsule contained 10 mg of SOD-melon concentrate (140 U of SOD and starch for the active supplement and starch only for the placebo. Stress and fatigue were evaluated using four psychometric scales: PSS-14; SF-36; Stroop tests and Prevost scale. Results: The supplementation with SOD-melon concentrate significantly decreased perceived stress, compared to placebo. Moreover, quality of life was improved and physical and mental fatigue were reduced with SOD-melon concentrate supplementation. Conclusion: SOD-melon concentrate supplementation appears to be an effective and natural way to reduce stress and fatigue. Trial registration: trial approved by the ethical committee of Poitiers (France, and the ClinicalTrials.gov Identifier is NCT01767922.

  11. PORTAL: Pilot study on the safety and tolerance of preoperative melatonin application in patients undergoing major liver resection: a double-blind randomized placebo-controlled trial

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    Koch Moritz

    2008-01-01

    Full Text Available Abstract Background Major surgical procedures facilitate systemic endotoxinemia and formation of free radicals with subsequent inflammatory changes that can influence the postoperative course. Experimental data suggest that preoperative supraphysiological doses of melatonin, a potent immuno-modulator and antioxidant, would decrease postoperative infectious and non-infectious complications induced by major abdominal surgery. Methods/Design A randomized controlled double blind single center clinical trial with two study arms comprising a total of 40 patients has been designed to assess the effects of a single preoperative dose of melatonin before major liver resection. Primary endpoints include the determination of safety and tolerance of the regimen as well as clinical parameters reflecting pathophysiological functions of the liver. Furthermore, data on clinical outcome (infectious and non-infectious complications will be collected as secondary endpoints to allow a power calculation for a randomized clinical trial aiming at clinical efficacy. Discussion Based on experimental data, this ongoing clinical trial represents an advanced element of the research chain from bench to bedside in order to reach the highest level of evidence-based clinical facts to determine if melatonin can improve the general outcome after liver resection. Trial Registration EudraCT200600530815

  12. Effect of household-based drinking water chlorination on diarrhoea among children under five in Orissa, India: a double-blind randomised placebo-controlled trial.

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    Sophie Boisson

    2013-08-01

    Full Text Available BACKGROUND: Boiling, disinfecting, and filtering water within the home can improve the microbiological quality of drinking water among the hundreds of millions of people who rely on unsafe water supplies. However, the impact of these interventions on diarrhoea is unclear. Most studies using open trial designs have reported a protective effect on diarrhoea while blinded studies of household water treatment in low-income settings have found no such effect. However, none of those studies were powered to detect an impact among children under five and participants were followed-up over short periods of time. The aim of this study was to measure the effect of in-home water disinfection on diarrhoea among children under five. METHODS AND FINDINGS: We conducted a double-blind randomised controlled trial between November 2010 and December 2011. The study included 2,163 households and 2,986 children under five in rural and urban communities of Orissa, India. The intervention consisted of an intensive promotion campaign and free distribution of sodium dichloroisocyanurate (NaDCC tablets during bi-monthly households visits. An independent evaluation team visited households monthly for one year to collect health data and water samples. The primary outcome was the longitudinal prevalence of diarrhoea (3-day point prevalence among children aged under five. Weight-for-age was also measured at each visit to assess its potential as a proxy marker for diarrhoea. Adherence was monitored each month through caregiver's reports and the presence of residual free chlorine in the child's drinking water at the time of visit. On 20% of the total household visits, children's drinking water was assayed for thermotolerant coliforms (TTC, an indicator of faecal contamination. The primary analysis was on an intention-to-treat basis. Binomial regression with a log link function and robust standard errors was used to compare prevalence of diarrhoea between arms. We used

  13. 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.

  14. Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial

    DEFF Research Database (Denmark)

    Juul, Anne Benedicte; Wetterslev, Jørn; Gluud, Christian;

    2006-01-01

    Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University...... anaesthesia and surgical centres and one coordinating centre. Participants 921 patients aged > 39 scheduled for major non-cardiac surgery. Interventions 100 mg metoprolol controlled and extended release or placebo administered from the day before surgery to a maximum of eight perioperative days. Main outcome...... was 4.6 days in the metoprolol group and 4.9 days in the placebo group. Metoprolol significantly reduced the mean heart rate by 11% (95% confidence interval 9% to 13%) and mean blood pressure by 3% (1% to 5%). The primary outcome occurred in 99 of 462 patients in the metoprolol group (21%) and 93 of...

  15. A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Paton Joanne S

    2012-12-01

    Full Text Available Abstract Background Neuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues is reduced. Insole therapy is one practical method commonly used to reduce plantar loads and ulceration risk. The type of insole best suited to achieve this is unknown. This trial compared custom-made functional insoles with prefabricated insoles to reduce risk factors for ulceration of neuropathic diabetic feet. Method A participant-blinded randomised controlled trial recruited 119 neuropathic participants with diabetes who were randomly allocated to custom-made functional or prefabricated insoles. Data were collected at issue and six month follow-up using the F-scan in-shoe pressure measurement system. Primary outcomes were: peak pressure, forefoot pressure time integral, total contact area, forefoot rate of load, duration of load as a percentage of stance. Secondary outcomes were patient perceived foot health (Bristol Foot Score, quality of life (Audit of Diabetes Dependent Quality of Life. We also assessed cost of supply and fitting. Analysis was by intention-to-treat. Results There were no differences between insoles in peak pressure, or three of the other four kinetic measures. The custom-made functional insole was slightly more effective than the prefabricated insole in reducing forefoot pressure time integral at issue (27% vs. 22%, remained more effective at six month follow-up (30% vs. 24%, p=0.001, but was more expensive (UK £656 vs. £554, p Conclusion The custom-made insoles are more expensive than prefabricated insoles evaluated in this trial and no better in reducing peak pressure. We recommend that where clinically appropriate, the more cost effective prefabricated insole should be considered for use by patients with diabetes and neuropathy. Trial registration Clinical trials.gov (NCT00999635. Note: this trial was registered on completion.

  16. Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: A double-blind placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    LaMoreaux Linda

    2008-09-01

    Full Text Available Abstract Background Recent consensus guidelines recommend pregabalin as a first-tier treatment for painful diabetic peripheral neuropathy (DPN. We evaluated the efficacy of pregabalin 600 mg/d (300 mg dosed BID versus placebo for relieving DPN-associated neuropathic pain, and assessed its safety using objective measures of nerve conduction (NC. Methods In this randomized, double-blind, placebo-controlled trial, the primary efficacy measure was endpoint mean pain score (MPS from daily pain diaries (11-point scale. NC velocity and sensory and motor amplitudes were assessed at baseline, endpoint, and end of follow-up (2 weeks post-treatment. At each timepoint, the median-motor, median-sensory, ulnar-sensory, and peroneal-motor nerves were evaluated. Secondary efficacy measures included weekly MPS and proportion of responders (patients achieving ≥50% reduction in MPS from baseline to endpoint. After 1-weeks' dosage escalation, pregabalin-treated patients received 300 mg BID for 12 weeks. Results Eighty-two patients received pregabalin and 85 placebo. Mean durations were 10 years for diabetes and ~5 years for painful DPN. Pregabalin-treated patients had lower MPS than controls (mean difference, -1.28; p Conclusion Pregabalin 600 mg/d (300 mg BID effectively reduced pain, was well tolerated, and had no statistically significant or clinically meaningful effect on NC in patients with painful DPN. Trial registration ClinicalTrials.gov NCT00159679

  17. A Randomised Controlled Single-Blind Trial of the Efficacy of Reiki at Benefitting Mood and Well-Being

    OpenAIRE

    John Gruzelier; Lorna Goddard; Deborah Bowden

    2011-01-01

    This is a constructive replication of a previous trial conducted by Bowden et al. (2010), where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students—half with high depression and/or anxiety and half with low depression and/or anxiety—were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions ove...

  18. 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

    This randomized controlled trial found no effect of ultramicronized palmitoylethanolamide as add-on-therapy on neuropathic pain after spinal cord injury.Neuropathic pain and spasticity after spinal cord injury (SCI) represent significant problems. Palmitoylethanolamide (PEA), a fatty acid amide t...... in pain scores 0.4 (-0.1 to 0.9) vs 0.7 (0.2 to 1.2); difference of means 0.3 (-0.4 to 0.9)). There was also no effect of PEA-um as add-on therapy on spasticity, insomnia, or psychological functioning. PEA was not associated with more adverse effects than placebo....

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

    Directory of Open Access Journals (Sweden)

    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

  20. Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial

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    Sartory Gudrun

    2010-12-01

    Full Text Available Abstract Background It has been demonstrated that cognitive behavioural therapy (CBT has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the specific efficacy of CBT, the treatment safety, the cost-effectiveness, and the moderators and mediators of treatment effects are still a major issue. The major objective of this trial is to investigate whether CBT is specifically efficacious in reducing positive symptoms when compared with non-specific supportive therapy (ST which does not implement CBT-techniques but provides comparable therapeutic attention. Methods/Design The POSITIVE study is a multicenter, prospective, single-blind, parallel group, randomised clinical trial, comparing CBT and ST with respect to the efficacy in reducing positive symptoms in psychotic disorders. CBT as well as ST consist of 20 sessions altogether, 165 participants receiving CBT and 165 participants receiving ST. Major methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, analysis by intention to treat, data management using remote data entry, measures of quality assurance (e.g. on-site monitoring with source data verification, regular query process, advanced statistical analysis, manualized treatment, checks of adherence and competence of therapists. Research relating the psychotherapy process with outcome, neurobiological research addressing basic questions of delusion formation using fMRI and neuropsychological assessment and treatment research investigating adaptations of CBT for adolescents is combined in this network. Problems of transfer into routine clinical care will be identified and addressed by a project focusing on cost efficiency. Discussion This clinical trial is part of efforts to intensify psychotherapy research in the field of psychosis in Germany, to contribute to the

  1. 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

    2016-06-01

    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.

  2. Double blind trial of bezafibrate in familial hypercholesterolaemia.

    OpenAIRE

    Wheeler, K A; West, R J; Lloyd, J K; Barley, J.

    1985-01-01

    A six month, double blind, crossover controlled trial of bezafibrate was conducted in 14 children with familial hypercholesterolaemia all of whom had a strong family history of early coronary heart disease. The bezafibrate was given twice daily in a dose of 10 to 20 mg/kg/day. The mean plasma total cholesterol concentration on bezafibrate was 22% lower than during the period on placebo and there was a moderate rise in high density lipoprotein cholesterol. Bezafibrate may be a useful adjunct t...

  3. Use of pentosan polysulphate in cats with idiopathic, non-obstructive lower urinary tract disease: a double-blind, randomised, placebo-controlled trial.

    Science.gov (United States)

    Wallius, Barbro M; Tidholm, Anna E

    2009-06-01

    Idiopathic feline lower urinary tract disease (FLUTD) is a common clinical entity where different treatments, for example glycosaminoglycans (GAGs) such as pentosan polysulphate (PPS), are advocated. However, few treatments have been investigated by well-controlled clinical trials. This paper compares the use of PPS in FLUTD compared to placebo. Of the 18 cats in the experiment, nine were treated with PPS and nine were treated with placebo with subcutaneous injections of 3mg/kg PPS or placebo day 1, 2, 5 and 10. The study was double-blind, randomised and placebo-controlled. Revaluation was performed after 5 and 10 days, 2 weeks, 2, 6 and 12 months. There were no statistically significant differences concerning clinical signs between groups during treatment or at re-evaluation, except for pretreatment stressful events where PPS-treated cats had experienced significantly more stressful events compared to cats treated with placebo before entering the study. Six cats (33%) showed recurrence of clinical signs during the entire study period, and only one of these cats had more than one recurrent episode. One cat (placebo) was euthanased 7 days after initial treatment because of recurrence of clinical signs. Another cat (placebo) was euthanased due to other reasons after 6 months. At 2 weeks two cats (placebo and PPS) showed clinical signs. At 2 months re-evaluation one cat showed mild clinical signs. At 6 and 12 months all remaining 16 cats were healthy. Idiopathic, non-obstructive FLUTD is a self-limiting disease with good short-term and excellent long-term prognosis without treatment. Whether or not PPS may be beneficial in a subpopulation of cats with continuous or frequently recurring clinical signs may be elucidated in forthcoming double-blind, randomised and placebo-controlled trials including only this subpopulation of cats. PMID:18996037

  4. Low-Dose Daily Intake of Vitamin K2 (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. PMID:26875489

  5. Smoking cessation or reduction with nicotine replacement therapy: a placebo-controlled double blind trial with nicotine gum and inhaler

    Directory of Open Access Journals (Sweden)

    Gustavsson Gunnar

    2009-11-01

    Full Text Available Abstract Background Even with effective smoking cessation medications, many smokers are unable to abruptly stop using tobacco. This finding has increased interest in smoking reduction as an interim step towards complete cessation. Methods This multi-center, double-blind placebo-controlled study evaluated the efficacy and safety of nicotine 4 mg gum or nicotine 10 mg inhaler in helping smokers (N = 314 to reduce or quit smoking. It included smokers willing to control their smoking, and participants could set individual goals, to reduce or quit. The study was placebo-controlled, randomized in a ratio of 2:1 (Active:Placebo, and subjects could choose inhaler or gum after randomization. Outcome was short-term (from Week 6 to Month 4 and long-term (from Month 6 to Month 12 abstinence or reduction. Abstinence was defined as not a single cigarette smoked and expired CO readings of Results Significantly more smokers managed to quit in the Active group than in the Placebo group. Sustained abstinence rates at 4 months were 42/209 (20.1% subjects in the Active group and 9/105 (8.6% subjects in the Placebo group (p = 0.009. Sustained abstinence rates at 12 months were 39/209 (18.7% and 9/105 (8.6%, respectively (p = 0.019. Smoking reduction did not differ between the groups, either at short-term or long-term. Twelve-month reduction results were 17.2% vs. 18.1%, respectively. No serious adverse events were reported. Conclusion In conclusion, treatment with 10 mg nicotine inhaler or 4 mg nicotine chewing gum resulted in a significantly higher abstinence rate than placebo. In addition a large number of smokers managed to reduce their cigarette consumption by more than 50% compared to baseline.

  6. Efficacy of betamethasone valerate medicated plaster on painful chronic elbow tendinopathy: a double-blind, randomized, placebo-controlled trial

    Science.gov (United States)

    Frizziero, Antonio; Causero, Araldo; Bernasconi, Stefano; Papalia, Rocco; Longo, Mario; Sessa, Vincenzo; Sadile, Francesco; Greco, Pasquale; Tarantino, Umberto; Masiero, Stefano; Rovati, Stefano; Frangione, Valeria

    2016-01-01

    Summary Objective to investigate the efficacy and safety of a medicated plaster containing betamethasone valerate (BMV) 2.25 mg in patients with chronic elbow tendinopathy. Methods randomized, double-blind, placebo-controlled study with assignment 2:2:1:1 to BMV medicated plaster applied daily for 12 hours, daily for 24 hours or matched placebo. 62 patients aged ≥18 years with chronic lateral elbow tendinopathy were randomized. The primary efficacy variable was pain reduction (VAS) at day 28. Secondary objectives included summed pain intensity differences (SPID), overall treatment efficacy and tolerability. Results mean reduction in VAS pain score at day 28 was greater in both BMV medicated plaster groups, −39.35±27.69 mm for BMV12-h and −36.91±32.50 mm for BMV24-h, than with placebo, −20.20±27.32 mm. Considering the adjusted mean decreases, there was a statistically significant difference between BMV12-h and placebo (p=0.0110). Global pain relief (SPID) and overall treatment efficacy were significantly better with BMV. BMV and placebo plasters had similar local tolerability and there were few treatment-related adverse events. Conclusions BMV plaster was significantly more effective than placebo at reducing pain in patients with chronic elbow tendinopathies. The BMV plaster was safe and well tolerated. PMID:27331041

  7. Effect of a novel essential oil mouthrinse without alcohol on gingivitis: a double-blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marco Antonio Botelho

    2007-06-01

    Full Text Available Several different plant extracts have been evaluated with respect to their antimicrobial effects against oral pathogens and for reduction of gingivitis. Given that a large number of these substances have been associated with significant side effects that contraindicate their long-term use, new compounds need to be tested. The aim of this study was to assess the short-term safety and efficacy of a Lippia sidoides ("alecrim pimenta"-based essential oil mouthrinse on gingival inflammation and bacterial plaque. Fifty-five patients were enrolled into a pilot, double-blinded, randomized, parallel-armed study. Patients were randomly assigned to undergo a 7-day treatment regimen with either the L. sidoides-based mouthrinse or 0.12% chlorhexidine mouthrinse. The results demonstrated decreased plaque index, gingival index and gingival bleeding index scores at 7 days, as compared to baseline. There was no statistically significance difference (p>0.05 between test and control groups for any of the clinical parameters assessed throughout the study. Adverse events were mild and transient. The findings of this study demonstrated that the L. sidoides-based mouthrinse was safe and efficacious in reducing bacterial plaque and gingival inflammation.

  8. Evaluation of a crataegus-based multiherb formula for dyslipidemia: a randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Hu, Miao; 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

  9. The effect of magnesium supplementation on primary insomnia in elderly: A double-blind placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Behnood Abbasi

    2012-01-01

    Full Text Available Background: Nearly 50% of older adults have insomnia, with difficulty in getting to sleep, early awakening, or feeling unrefreshed on waking. With aging, several changes occur that can place one at risk for insomnia, including age-related changes in various circadian rhythms, environmental and lifestyle changes, and decreased nutrients intake, absorption, retention, and utilization. The natural N-methyl-D-aspartic acid (NMDA antagonist and GABA agonist, Mg 2+ , seems to play a key role in the regulation of sleep. The objective of this study was to determine the efficacy of magnesium supplementation to improve insomnia in elderly. Materials and Methods: A double-blind randomized clinical trial was conducted in 46 elderly subjects, randomly allocated into the magnesium or the placebo group and received 500 mg magnesium or placebo daily for 8 weeks. Questionnaires of insomnia severity index (ISI, physical activity, and sleep log were completed at baseline and after the intervention period. Anthropometric confounding factors, daily intake of magnesium, calcium, potassium, caffeine, calories form carbohydrates, and total calorie intake, were obtained using 24-h recall for 3 days. Blood samples were taken at baseline and after the intervention period for analysis of serum magnesium, renin, melatonin, and cortisol. Statistical analyses were performed using SPSS 19 and P values < 0.05 were considered as statistically significant. Results: No significant differences were observed in assessed variables between the two groups at the baseline. As compared to the placebo group, in the experimental group, dietary magnesium supplementation brought about statistically significant increases in sleep time ( P = 0.002, sleep efficiency ( P = 0.03, concentration of serum renin ( P < 0.001, and melatonin ( P = 0.007, and also resulted in significant decrease of ISI score ( P = 0.006, sleep onset latency ( P = 0.02 and serum cortisol concentration ( P = 0

  10. Intravenous immunoglobulins for the treatment of mild to moderate Alzheimer’s disease: a phase II, randomised, double-blind, placebo-controlled dose-finding trial

    Science.gov (United States)

    Dodel, Richard; Rominger, Axel; Bartenstein, Peter; Barkhof, Frederik; Blennow, Kai; Förster, Stefan; Winter, Yaroslav; Bach, Jan-Philipp; Popp, Julius; Alferink, Judith; Wiltfang, Jens; Buerger, Katharina; Otto, Markus; Antuono, Piero; Jacoby, Michael; Richter, Ralph; Stevens, James; Melamed, Isaac; Goldstein, Jerome; Haag, Stefan; Wietek, Stefan; Farlow, Martin; Jessen, Frank

    2016-01-01

    Background Three small trials have suggested effects of intravenous immunoglobulins (IVIG) on biomarkers and symptoms of mild-to-moderate Alzheimer’s disease (AD). We explored the safety, the effective dose, and the infusion interval for Octagam®10% in this patients’ group. Methods The study was a 24-week multicentre, double-blind, placebo-controlled phase II trial with 8 treatment arms at 7 sites in the USA and 5 sites in Germany. Participants aged 50–85 years were randomised (using a computer-generated randomisation sequence) to either 4 weekly infusions (n=22) (0.2 g/0.5 g/0.8 g/kg body weight), 2 weekly infusions (0.1g/0.25 g/0.4 g/kg) (n=21) or to placebo (n=7, 4-weekly, n=8, 2 weekly). The primary endpoint was the mean area under the curve (AUC) of plasma Aβ1–40 after the last infusion for one infusion interval. We considered the AUC of plasma Aβ1–40 being more representative of the potential effect of IVIG than a single time point measurement. Secondary outcomes included changes in (a) the concentrations of Aβ1–40, Aβ1–42, anti-Aβ autoantibodies in CSF/plasma and tau/ptau181 in CSF, (b) cognitive and functional scales, and (c) brain imaging (MRI/FDG-PET). Patients’ safety was assessed by recording of adverse events, clinical examinations, MRI investigations, electrocardiography and laboratory tests. The infusions were performed by site personnel who were otherwise not involved in any other assessments; therefore, the patients, caregivers, and investigators were blinded to the treatment allocations. The study medication was blinded by using intransparent overpouches and infusion lines. The trial is registered at ClinicalTrials.gov (NCT00812565) and controlled-trials.com (ISRCTN64846759). Findings Fifty-six patients were randomized. AUC of plasma Aβ1–40, was not significantly different from the placebo for five of the six IVIG arms (median with range: −18.00 [−1347.0; 1068.5] for 0.2 g/kg; 364.25 [−5834.5; 1953.5] for 0.5 g

  11. 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

    2016-04-01

    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 mucositis was observed throughout the trial period, while in the placebo group no such effect was observed. Sucralfate mouthwash reduced the frequency and severity of 5-FU-induced oral mucositis in patients with gastrointestinal malignancies compared with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis. PMID:27007594

  12. 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

  13. The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial

    DEFF Research Database (Denmark)

    Sandset, Else Charlotte; Bath, Philip M W; Boysen, Gudrun;

    2011-01-01

    BACKGROUND: Raised blood pressure is common in acute stroke, and is associated with an increased risk of poor outcomes. We aimed to examine whether careful blood-pressure lowering treatment with the angiotensin-receptor blocker candesartan is beneficial in patients with acute stroke and raised...... blood pressure. METHODS: Participants in this randomised, placebo-controlled, double-blind trial were recruited from 146 centres in nine north European countries. Patients older than 18 years with acute stroke (ischaemic or haemorrhagic) and systolic blood pressure of 140 mm Hg or higher were included...... within 30 h of symptom onset. Patients were randomly allocated to candesartan or placebo (1:1) for 7 days, with doses increasing from 4 mg on day 1 to 16 mg on days 3 to 7. Randomisation was stratified by centre, with blocks of six packs of candesartan or placebo. Patients and investigators were masked...

  14. Membranes and Bone Substitutes in a One-Stage Procedure for Horizontal Bone Augmentation: A Histologic Double-Blind Parallel Randomized Controlled Trial.

    Science.gov (United States)

    Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Pagliaro, Umberto; Breschi, Lorenzo; Mazzoni, Annalisa; Nieri, Michele

    2015-01-01

    The aim of this histologic, double-blind, parallel, randomized controlled trial was to compare anorganic bone mineral-collagen membranes (BB) and betatricalcium phosphate-pericardium collagen membranes (CJ) in a one-stage procedure for horizontal bone augmentation. A biopsy was performed in the regenerated area at abutment connection 6 months after surgery. Five patients were assigned and treated with the BB combination and five patients were treated with the CJ combination. At abutment connection, 6 months after grafting, no significant differences were evident in the histomorphometric comparisons, even if the percentage of residual graft, using the marrow spaces and soft tissue as a reference, tended to be greater in the CJ group (P = .0759). PMID:26133135

  15. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Astrup, Arne; Madsbad, Sten; Breum, Leif; Jensen, Thomas J; Kroustrup, Jens Peter; Larsen, Thomas Meinert

    2008-01-01

    BACKGROUND: Weight-loss drugs produce an additional mean weight loss of only 3-5 kg above that of diet and placebo over 6 months, and more effective pharmacotherapy of obesity is needed. We assessed the efficacy and safety of tesofensine-an inhibitor of the presynaptic uptake of noradrenaline, do......, dopamine, and serotonin-in patients with obesity. METHODS: We undertook a phase II, randomised, double-blind, placebo-controlled trial in five Danish obesity management centres. After a 2 week run-in phase, 203 obese patients (body-mass index 30-......BACKGROUND: Weight-loss drugs produce an additional mean weight loss of only 3-5 kg above that of diet and placebo over 6 months, and more effective pharmacotherapy of obesity is needed. We assessed the efficacy and safety of tesofensine-an inhibitor of the presynaptic uptake of noradrenaline...

  16. The Effect of Viola odorata Flower Syrup on the Cough of Children With Asthma: A Double-Blind, Randomized Controlled Trial.

    Science.gov (United States)

    Qasemzadeh, Mohammad Javad; Sharifi, Hosein; Hamedanian, Mohammad; Gharehbeglou, Mohammad; Heydari, Mojtaba; Sardari, Mehdi; Akhlaghdoust, Meisam; Minae, Mohammad Bagher

    2015-10-01

    This study aimed to investigate the effect of violet syrup on cough alleviation in children with intermittent asthma. In a parallel, double-blind, randomized controlled trial, 182 children aged 2 to 12 years with intermittent asthma were randomly assigned 1:1 to receive violet syrup or placebo along with the common standard treatments in both groups (short-acting β-agonist). Both groups were evaluated in terms of the duration until cough suppression was achieved. No significant difference was observed in basic characteristics. The duration lasting to yield more than 50% cough reduction and 100% cough suppression was significantly less in the violet syrup group compared to placebo (P = .001, P cough alleviation and suppression by violet syrup. This study showed that the adjuvant use of violet syrup with short-acting β-agonist can enhance the cough suppression in children with intermittent asthma. PMID:25954025

  17. 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 AND...... i.v. placebo (group II). All patients were given 1.5 g metronidazole plus 3.0 g cefuroxime at the time of surgery. Patients with perforation of the colon or rectum were given metronidazole and cefuroxime for further 3 days. All patients were assessed daily until discharge from the hospital. Thirty...... < 0.05). Wound infection, intraabdominal abscess, septicemia, and 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...

  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...... (n = 33) or placebo (n = 31) by concealed allocation. Patients were followed with strict recording of beneficial and harmful effects including masked assessment of time to complete wound closure. Analysis was carried out on an intention-to-treat basis. Median healing times were 54 days (interquartile...... 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 < 0.001) wound fluid zinc levels to 1,540 (1,035-2,265) microM and decreased (p < 0.05) the occurrence of Staphylococcus aureus in wounds. Fewer zinc oxide (n = 3) than placebo...

  19. Effects of angiotensin II blockade on intermediate cardiovascular endpoints in haemodialysis patients: a randomised double-blind placebo-controlled one-year intervention trial (SAFIR study)

    DEFF Research Database (Denmark)

    Peters, Christian Daugaard; Kjærgaard, Krista Dybtved; Jensen, Jens Dam;

    (HD) patients in a double-blind randomised placebo-controlled one year intervention trial using a pre-defined systolic blood pressure (BP) target of 140 mmHg. Patients (41 in each group) did not differ in terms of age, BP, co-morbidity, antihypertensive treatment, dialysis parameters, and residual...... such as central aortic BP, carotid-femoral pulse wave velocity, left ventricular mass index, N-terminal prohormone of brain natriuretic peptide, heart rate variability, and plasma catecholamines were not significantly affected by irbesartan treatment. Changes in systolic BP during the study period...... correlated significantly with changes in left ventricular mass (P=0.02) and changes in arterial stiffness (P<0.001). In conclusion, significant effects of irbesartan on intermediate CV endpoints beyond BP reduction were absent in HD patients....

  20. 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

  1. 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. PMID:25819143

  2. Low-dose adrenaline, promethazine, and hydrocortisone in the prevention of acute adverse reactions to antivenom following snakebite: a randomised, double-blind, placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    H Asita de Silva

    2011-05-01

    Full Text Available BACKGROUND: Envenoming from snakebites is most effectively treated by antivenom. However, the antivenom available in South Asian countries commonly causes acute allergic reactions, anaphylactic reactions being particularly serious. We investigated whether adrenaline, promethazine, and hydrocortisone prevent such reactions in secondary referral hospitals in Sri Lanka by conducting a randomised, double-blind placebo-controlled trial. METHODS AND FINDINGS: In total, 1,007 patients were randomized, using a 2 × 2 × 2 factorial design, in a double-blind, placebo-controlled trial of adrenaline (0.25 ml of a 1∶1,000 solution subcutaneously, promethazine (25 mg intravenously, and hydrocortisone (200 mg intravenously, each alone and in all possible combinations. The interventions, or matching placebo, were given immediately before infusion of antivenom. Patients were monitored for mild, moderate, or severe adverse reactions for at least 96 h. The prespecified primary end point was the effect of the interventions on the incidence of severe reactions up to and including 48 h after antivenom administration. In total, 752 (75% patients had acute reactions to antivenom: 9% mild, 48% moderate, and 43% severe; 89% of the reactions occurred within 1 h; and 40% of all patients were given rescue medication (adrenaline, promethazine, and hydrocortisone during the first hour. Compared with placebo, adrenaline significantly reduced severe reactions to antivenom by 43% (95% CI 25-67 at 1 h and by 38% (95% CI 26-49 up to and including 48 h after antivenom administration; hydrocortisone and promethazine did not. Adding hydrocortisone negated the benefit of adrenaline. CONCLUSIONS: Pretreatment with low-dose adrenaline was safe and reduced the risk of acute severe reactions to snake antivenom. This may be of particular importance in countries where adverse reactions to antivenom are common, although the need to improve the quality of available antivenom cannot be

  3. Using a Low-Sodium, High-Potassium Salt Substitute to Reduce Blood Pressure among Tibetans with High Blood Pressure: A Patient-Blinded Randomized Controlled Trial

    Science.gov (United States)

    Zhao, Xingshan; Yin, Xuejun; Li, Xian; Yan, Lijing L.; Lam, Christopher T.; Li, Shenshen; He, Feng; Xie, Wuxiang; Sang, Ba; Luobu, Gesang; Ke, Liang; Wu, Yangfeng

    2014-01-01

    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 PMID:25338053

  4. A double blind, randomised placebo controlled trial of topical 2% viscous lidocaine in improving oral intake in children with painful infectious mouth conditions

    Directory of Open Access Journals (Sweden)

    Hopper Sandy M

    2011-11-01

    Full Text Available Abstract Background Painful infectious mouth conditions are a common presentation to emergency departments. Although self limiting, painful ulcerative lesions and inflamed mucosa can decrease oral intake and can lead to dehydration. Oral analgesia is of limited efficacy and is often refused by the patient. Despite widespread use of oral 2% viscous lidocaine for many years, there is little evidence for its efficacy as an analgesic and in aiding oral intake in children with painful infectious mouth conditions. This study aims to establish the effectiveness of 2% viscous lidocaine in increasing oral intake in these children by comparing it with placebo. Methods/Design This study is a randomised double-blind placebo controlled trial of children between 6 months and 8 years of age with painful infectious mouth conditions defined as gingivostomatitis (herpetic or non herpetic, ulcerative pharyngitis, herpangina and hand foot and mouth disease as assessed by the treating clinician in association with a history of poor oral fluid intake. It will be conducted at a single tertiary paediatric emergency department in Melbourne Australia. 20 patients have already been randomised to receive 2% lidocaine or placebo in a pilot study to determine the sample size in a preplanned adaptive design. A further 80 patients will be randomised to receive either 2% lidocaine or placebo. The placebo agent is identical to lidocaine in terms of appearance, flavour and smell. All clinical and research staff involved, patients and their parents will be blinded to treatment allocation. The primary endpoint is the amount of fluid ingested by each child, expressed in ml/kg, within 60 minutes from the time of administration of the study mixture. Secondary endpoints are the proportion of patients ingesting 5 ml/kg and 10 ml/kg at 30 and 60 minutes after drug administration and the incidence of adverse events. Longer term outcomes will include the proportion of patients requiring

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

    Directory of Open Access Journals (Sweden)

    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

  6. Lactobacillus reuteri influences regrowth of mutans streptococci after full-mouth disinfection: a double-blind, randomised controlled trial.

    Science.gov (United States)

    Romani Vestman, N; Hasslöf, P; Keller, M K; Granström, E; Roos, S; Twetman, S; Stecksén-Blicks, C

    2013-01-01

    This study assessed whether the persistence of Lactobacillus reuteri DSM 17938 and ATCC PTA 5289 in saliva could delay the regrowth of mutans streptococci (MS) after a full-mouth disinfection with chlorhexidine (CHX). A randomised, double-blind, placebo-controlled study with a 6-week intervention period and 3- and 6-month follow-up was performed. 62 healthy subjects with moderate to high counts of MS were randomly assigned to a test group (n = 32) or a placebo group (n = 30). Before onset of the intervention, subjects received two sessions of professional cleaning, flossing, and application of CHX varnish and rinsed their mouth with a CHX solution between the sessions (2 days). Thereafter, the test group used probiotic lozenges (2/day) containing L. reuteri (DSM 17938 and ATCC PTA 5289; 1 × 10(8) CFU of each strain), and the placebo group used identical lozenges lacking the lactobacilli. Saliva samples were collected and cultured onto selective media, and isolates of L. reuteri as well as DNA directly extracted from saliva were tested by polymerase chain reaction (PCR) with specific primers. Presence of salivary MS was analysed with a chair-side test. L. reuteri was frequently detected by culture during the intervention period but in only 3 test group subjects at follow-ups. Regrowth of MS statistically significantly differed depending on the presence or absence of L. reuteri DSM 17938 detected by PCR. We conclude that cultivable L. reuteri strains may only sporadically be confirmed after termination of the intervention, but subjects with PCR-detected L. reuteri demonstrated slower regrowth of MS. PMID:23486236

  7. A randomized, double-blind, placebo-controlled trial of injected capsaicin for pain in Morton's neuroma.

    Science.gov (United States)

    Campbell, Claudia M; Diamond, Eric; Schmidt, William K; Kelly, Margaret; Allen, Robert; Houghton, William; Brady, Kerrie L; Campbell, James N

    2016-06-01

    Intermetatarsal neuroma or Morton's neuroma is a painful condition of the foot resulting from an entrapment of the common digital nerve typically in the third intermetatarsal space. The pain can be severe and especially problematic with walking. Treatment options are limited and surgery may lead to permanent numbness in the toes. Capsaicin, the pungent ingredient of hot peppers, produces analgesia by inducing retraction of nociceptive afferents from the area of innervation and is effective in treating certain neuropathic pain disorders. A randomized double-blind placebo-controlled study was conducted to test the efficacy, tolerability, and safety of a single 0.1 mg dose of capsaicin vs placebo injected into the region of the neuroma. A total of 58 subjects diagnosed with Morton's neuroma with foot pain ≥4 (0-10 numerical pain rating scale) were injected with 2 mL of lidocaine into the intermetatarsal space proximal to the neuroma to provide local anesthesia. After 5 minutes, 0.1 mg capsaicin or placebo was injected into the intermetatarsal space containing the painful neuroma. Average foot pain was rated for 2 weeks before through 4 weeks after injection. At weeks 1 and 4, the decrease in pain was significantly greater in the subjects treated with capsaicin (P = 0.021 and P = 0.019, respectively). A trend toward significance was noted at weeks 2 and 3. Improvements in functional interference scores and reductions in oral analgesic use were also seen in the capsaicin-treated group. These findings suggest that injection of capsaicin is an efficacious treatment option for patients with painful intermetatarsal neuroma. PMID:26963851

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

    Directory of Open Access Journals (Sweden)

    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.

  9. 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.

  10. Crataegus laevigata decreases neutrophil elastase and has hypolipidemic effect: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Dalli, E; Colomer, E; Tormos, M C; Cosín-Sales, J; Milara, J; Esteban, E; Sáez, G

    2011-06-15

    Crataegus laevigata is a medicinal plant most commonly used for the treatment of heart failure and psychosomatic disorders. Based on previous experimental findings, this double-blind placebo-controlled study was aimed at finding beneficial effects of C. laevigata on biomarkers of coronary heart disease (CHD). The study included 49 diabetic subjects with chronic CHD who were randomly assigned to the treatment for 6 months with either a micronized flower and leaf preparation of C. laevigata (400 mg three times a day) or a matching placebo. Blood cell count, lipid profile, C-reactive protein, neutrophil elastase (NE) and malondialdehyde were analyzed in plasma at baseline, at one month and six months. The main results were that NE decreased in the C. laevigata group compared to the placebo group. In the C. laevigata group, baseline figures (median and interquartile range) were 35.8 (4.5) and in the placebo group 31 (5.9). At the end of the study, values were 33.2 (4.7) ng/ml and 36.7 (2.2) ng/ml, respectively; p<0.0001. C. laevigata, added to statins, decreased LDL cholesterol (LDL-C) (mean±SD) from 105±28.5 mg/dl at baseline to 92.7±25.1 mg/dl at 6 months (p=0.03), and non-HDL cholesterol from 131±37.5 mg/dl to 119.6±33 mg/dl (p<0.001). Differences between groups did not reach statistical significance at 6 months. No significant changes were observed in the rest of parameters. In conclusion, C. laevigata decreased NE and showed a trend to lower LDL-C compared to placebo as add-on-treatment for diabetic subjects with chronic CHD. PMID:21242072

  11. Ultramicronized palmitoylethanolamide in spinal cord injury neuropathic pain: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Andresen, Sven R; Bing, Jette; Hansen, Rikke M; Biering-Sørensen, Fin; Johannesen, Inger L; Hagen, Ellen Merete; Rice, Andrew S C; Nielsen, Jørgen F; Bach, Flemming W; Finnerup, Nanna B

    2016-09-01

    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, double-blind, placebo-controlled, parallel multicenter study was performed to investigate the effect of ultramicronized PEA (PEA-um) as add-on therapy on neuropathic pain in individuals with SCI. A pain diary was completed and questionnaires were completed before and after the 12-week treatment with either placebo or PEA-um. The primary outcome measure was the change in mean neuropathic pain intensity from the 1-week baseline period to the last week of treatment measured on a numeric rating scale ranging from 0 to 10. The primary efficacy analysis was the intention to treat (baseline observation carried forward). Secondary outcomes included a per protocol analysis and effects on spasticity, evoked pain, sleep problems, anxiety, depression, and global impression of change. We randomized 73 individuals with neuropathic pain due to SCI, of which 5 had a major protocol violation, and thus 68 were included in the primary analysis. There was no difference in mean pain intensity between PEA-um and placebo treatment (P = 0.46, mean reductions in pain scores 0.4 (-0.1 to 0.9) vs 0.7 (0.2-1.2); difference of means 0.3 (-0.4 to 0.9)). There was also no effect of PEA-um as add-on therapy on spasticity, insomnia, or psychological functioning. PEA was not associated with more adverse effects than placebo. PMID:27227691

  12. The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: A protocol for a double-blind randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Smith Alison J

    2011-02-01

    Full Text Available Abstract Background For the majority of patients with osteoarthritis (OA, joint replacement is a successful intervention for relieving chronic joint pain. However, between 10-30% of patients continue to experience chronic pain after joint replacement. Evidence suggests that a risk factor for chronic pain after joint replacement is the severity of acute post-operative pain. The aim of this randomised controlled trial (RCT is to determine if intra-operative local anaesthethic wound infiltration additional to a standard anaethesia regimen can reduce the severity of joint pain at 12-months after total knee replacement (TKR and total hip replacement (THR for OA. Methods 300 TKR patients and 300 THR patients are being recruited into this single-centre double-blind RCT. Participants are recruited before surgery and randomised to either the standard care group or the intervention group. Participants and outcome assessors are blind to treatment allocation throughout the study. The intervention consists of an intra-operative local anaesthetic wound infiltration, consisting of 60 mls of 0.25% bupivacaine with 1 in 200,000 adrenaline. Participants are assessed on the first 5 days post-operative, and then at 3-months, 6-months and 12-months. The primary outcome is the WOMAC Pain Scale, a validated measure of joint pain at 12-months. Secondary outcomes include pain severity during the in-patient stay, post-operative nausea and vomiting, satisfaction with pain relief, length of hospital stay, joint pain and disability, pain sensitivity, complications and cost-effectiveness. A nested qualitative study within the RCT will examine the acceptability and feasibility of the intervention for both patients and healthcare professionals. Discussion Large-scale RCTs assessing the effectiveness of a surgical intervention are uncommon, particulary in orthopaedics. The results from this trial will inform evidence-based recommendations for both short-term and long-term pain

  13. Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: A protocol for a randomised, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Harris Anthony

    2007-08-01

    Full Text Available Abstract Background Chronic rotator cuff pathology (CRCP is a common shoulder condition causing pain and disability. Physiotherapy is often the first line of management for CRCP yet there is little conclusive evidence to support or refute its effectiveness and no formal evaluation of its cost-effectiveness. Methods/Design This randomised, double-blind, placebo-controlled trial will involve 200 participants with CRCP recruited from medical practices, outpatient departments and the community via print and radio media. Participants will be randomly allocated to a physiotherapy or placebo group using concealed allocation stratified by treating physiotherapist. Both groups will receive 10 sessions of individual standardised treatment over 10 weeks from one of 10 project physiotherapists. For the following 12 weeks, the physiotherapy group will continue a home exercise program and the placebo group will receive no treatment. The physiotherapy program will comprise shoulder joint and spinal mobilisation, soft tissue massage, postural taping, and home exercises for scapular control, posture and rotator cuff strengthening. The placebo group will receive inactive ultrasound and gentle application of an inert gel over the shoulder region. Blinded assessment will be conducted at baseline and at 10 weeks and 22 weeks after randomisation. The primary outcome measures are self reported questionnaires including the shoulder pain and disability index (SPADI, average pain on an 11-point numeric rating scale and participant perceived global rating of change. Secondary measures include Medical Outcomes Study 36-item short form (SF-36, Assessment of Quality of Life index, numeric rating scales for shoulder pain and stiffness, participant perceived rating of change for pain, strength and stiffness, and manual muscle testing for shoulder strength using a handheld dynamometer. To evaluate cost-effectiveness, participants will record the use of all health

  14. 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

    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......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...

  15. Antihypertensive potential of combined extracts of olive leaf, green coffee bean and beetroot: a randomized, double-blind, placebo-controlled crossover trial.

    Science.gov (United States)

    Wong, Rachel H X; Garg, Manohar L; Wood, Lisa G; Howe, Peter R C

    2014-11-01

    Extracts of olive leaf, green coffee bean and beetroot may deliver cardiovascular benefits. This study sought to evaluate the effects of regularly consuming a combination of these extracts on blood pressure (BP), arterial compliance, blood lipids, blood glucose and insulin sensitivity. A double-blind randomised placebo-controlled crossover trial was conducted in adults with untreated high normal or borderline elevated BP. They were randomised to take an active supplement, comprising 500 mg olive leaf extract, 100 mg green coffee bean extract and 150 mg beet powder, or a matching placebo twice daily for six weeks, followed by the alternate supplement for a further six weeks. Assessments of 24-h ambulatory BP (ABP), clinic BP arterial compliance (pulse-wave analysis), blood lipids, blood glucose and insulin were obtained at baseline and at the end of each treatment phase. Baseline clinic BP in 37 overweight middle-aged men and women who completed the trial averaged 145/84 mmHg. There was no significant effect of treatment on ABP or any other outcome measure. The failure to confirm prior evidence of the antihypertensive benefits of these extracts emphasises the importance of placebo control and the value of ABP monitoring. Further dose-response evaluation of olive leaf, green coffee bean or beetroot extracts is required to confirm or refute the purported benefits. PMID:25379688

  16. Antihypertensive Potential of Combined Extracts of Olive Leaf, Green Coffee Bean and Beetroot: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial

    Directory of Open Access Journals (Sweden)

    Rachel H.X. Wong

    2014-11-01

    Full Text Available Extracts of olive leaf, green coffee bean and beetroot may deliver cardiovascular benefits. This study sought to evaluate the effects of regularly consuming a combination of these extracts on blood pressure (BP, arterial compliance, blood lipids, blood glucose and insulin sensitivity. A double-blind randomised placebo-controlled crossover trial was conducted in adults with untreated high normal or borderline elevated BP. They were randomised to take an active supplement, comprising 500 mg olive leaf extract, 100 mg green coffee bean extract and 150 mg beet powder, or a matching placebo twice daily for six weeks, followed by the alternate supplement for a further six weeks. Assessments of 24-h ambulatory BP (ABP, clinic BP arterial compliance (pulse-wave analysis, blood lipids, blood glucose and insulin were obtained at baseline and at the end of each treatment phase. Baseline clinic BP in 37 overweight middle-aged men and women who completed the trial averaged 145/84 mmHg. There was no significant effect of treatment on ABP or any other outcome measure. The failure to confirm prior evidence of the antihypertensive benefits of these extracts emphasises the importance of placebo control and the value of ABP monitoring. Further dose-response evaluation of olive leaf, green coffee bean or beetroot extracts is required to confirm or refute the purported benefits.

  17. A randomized, controlled, double-blinded clinical trial of gabapentin 300 versus 900 mg versus placebo for anxiety symptoms in breast cancer survivors.

    Science.gov (United States)

    Lavigne, Jill E; Heckler, Charles; Mathews, Jennifer L; Palesh, Oxana; Kirshner, Jeffrey J; Lord, Raymond; Jacobs, Andrew; Amos, Eric; Morrow, Gary R; Mustian, Karen

    2012-11-01

    Gabapentin is used for the treatment of hot flashes and neuropathic pain in breast cancer survivors, and is commonly used off-label for the treatment of anxiety. Yet, clinical trial evidence to support the use of gabapentin for anxiety symptoms is lacking. In a randomized, double-blinded controlled trial we compared 300 mg gabapentin versus 900 mg gabapentin versus placebo. Subjects were 420 breast cancer patients who had completed all chemotherapy cycles. Anxiety traits and current (state) anxiety were measured using the Speilberger Strait-Trait Anxiety Inventory at baseline, 4 and 8 weeks. Pain was measured at baseline using a 10-point scale. Analyses included analysis of covariance and ordinary least squares regression. At 4 weeks, state anxiety change scores were significantly better for gabapentin 300 and 900 mg (p = 0.005) compared to placebo. The magnitude of improvement was proportional to baseline state anxiety. At 8 weeks, the anxiolytic effects of gabapentin compared to placebo persisted (p drug price. For patients reluctant to take a controlled substance, such as a benzodiazepine, gabapentin may offer an alternative therapy. Similarly, patients with a history of substance use may benefit from gabapentin without risk of addiction or abuse. For cancer survivors experiencing both hot flashes and anxiety, gabapentin may provide a single effective treatment for both and is an alternative therapy for anxiety for patients unwilling to take a benzodiazepine or those with a history of substance use. PMID:23053645

  18. An evaluation of the hypolipidemic effect of an extract of Hibiscus Sabdariffa leaves in hyperlipidemic Indians: a double blind, placebo controlled trial

    Directory of Open Access Journals (Sweden)

    R Rajendran

    2010-06-01

    Full Text Available Abstract Background Hibiscus sabdariffa is used regularly in folk medicine to treat various conditions. Methods The study was a double blind, placebo controlled, randomized trial. Sixty subjects with serum LDL values in the range of 130-190 mg/dl and with no history of coronary heart disease were randomized into experimental and placebo groups. The experimental group received 1 gm of the extract for 90 days while the placebo received a similar amount of maltodextrin in addition to dietary and physical activity advice for the control of their blood lipids. Anthropometry, blood biochemistry, dietary and physical activity were assessed at baseline, day 45 and day 90. Results While body weight, serum LDL cholesterol and triglyceride levels decreased in both groups, there were no significant differences between the experimental and placebo group. Conclusions It is likely that the observed effects were as a result of the patients following the standard dietary and physical activity advice. At a dose of 1 gm/day, hibiscus sabdariffa leaf extract did not appear to have a blood lipid lowering effect. Trial Registration REFCTRI2009000472

  19. Internet-based treatment for older adults with depression and co-morbid cardiovascular disease: protocol for a randomised, double-blind, placebo controlled trial

    Directory of Open Access Journals (Sweden)

    Christensen Helen

    2011-01-01

    Full Text Available Abstract Background Depression, cardiovascular disease (CVD risk factors and cognitive impairment are important causes of disability and poor health outcomes. In combination they lead to an even worse prognosis. Internet or web-based interventions have been shown to deliver efficacious psychological intervention programs for depression on a large scale, yet no published studies have evaluated their impact among patients with co-existing physical conditions. The aims of this randomised controlled trial are to determine the effects of an evidence-based internet intervention program for depression on depressive mood symptoms, cognitive function and treatment adherence in patients at risk of CVD. Methods/Design This study is an internet-based, double-blind, parallel group randomised controlled trial. The trial will compare the effectiveness of online cognitive behavioural therapy with an online attention control placebo. The trial will consist of a 12-week intervention phase with a 40-week follow-up. It will be conducted in urban and rural New South Wales, Australia and will recruit a community-based sample of adults aged 45 to 75 years. Recruitment, intervention, cognitive testing and follow-up data collection will all be internet-based and automated. The primary outcome is a change in severity of depressive symptoms from baseline to three-months. Secondary outcomes are changes in cognitive function and adherence to treatment for CVD from baseline to three, six and 12-months. Discussion Prior studies of depression amongst patients with CVD have targeted those with previous vascular events and major depression. The potential for intervening earlier in these disease states appears to have significant potential and has yet to be tested. Scalable psychological programs using web-based interventions could deliver care to large numbers in a cost effective way if efficacy were proved. This study will determine the effects of a web-based intervention on

  20. 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.

  1. 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.

  2. 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

  3. 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

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    Ahmad Ghanizadeh

    2013-09-01

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

  6. GC/MS detection of central nervous tissues as specified BSE risk material in meat products: validation by an externally controlled blind trial.

    Science.gov (United States)

    Lücker, Ernst; Biedermann, Wolfgang; Lachhab, Sandra; Hensel, Andreas

    2010-11-01

    The addition of central nervous tissues (CNT), such as brain and spinal cord, in the manufacturing of meat products is either forbidden--if the material falls under the legal definition of specified risk material (SRM)--or must be labelled on the packed product. To foster official food control, several CNT detection methods were developed, but only fatty acid patterns as detected by gas chromatography/mass spectrometry (GC/MS) allow the further characterization of the detected CNT as to both the animal species and--surprisingly--the age of the animal from which the CNT was derived in accordance with the legal definition. Complementing a previous report in this journal by Lücker et al. 2010 (doi: 10.1007/s00216-010-3956-5) on CNT quantification by GC/MS, we now report results of the validation of this new analytical approach by an externally controlled blind trial elucidating its potential to identify the species and age of the CNT detected. The 72 samples (24 standards of emulsion-type sausage, each heated in three different batches: 75°C, 30 min; 115°C, 25 min; 133°C, 40 min) containing porcine, ovine or bovine muscle tissue and differing amounts of CNT (bovine or ovine brain: 0, 0.1, 0.5, 1.0, 3.0% m/m) were produced externally and provided blind for analyses to our laboratory. In accordance with the previous study, heating had no detectable effect on the GC/MS analysis. Judged by the present sensitivity of this method (cut-off 0.2% CNT), all of the samples containing 0.5% or more CNT (n = 57, 100%) were identified correctly as CNT-positive. The CNT species was identified correctly in 54 samples (94.7%), with three samples of one specific standard (0.5% ovine CNT) falsely classified as bovine CNT. However, the CNT age of these samples was correctly classified (more than 12 months). Overall, 57 samples (100%) were correctly classified as SRM-positive and 15 samples (100%) as SRM-negative. To the best of our knowledge, this is the first time that a legal demand

  7. 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 of......: Bone marrow stem cell mobilization with subcutaneous G-CSF is safe but did not lead to further improvement in ventricular function after acute myocardial infarction compared with the recovery observed in the placebo group....

  8. Grape Resveratrol Increases Serum Adiponectin and Downregulates Inflammatory Genes in Peripheral Blood Mononuclear Cells: A Triple-Blind, Placebo-Controlled, One-Year Clinical Trial in Patients with Stable Coronary Artery Disease

    OpenAIRE

    Tomé-Carneiro, João; Gonzálvez, Manuel; Larrosa, Mar; Yáñez-Gascón, María J.; García-Almagro, Francisco J.; Ruiz-Ros, José A.; Tomás-Barberán, Francisco A.; García-Conesa, María T.; Espín, Juan Carlos

    2012-01-01

    Purpose The grape and wine polyphenol resveratrol exerts cardiovascular benefits but evidence from randomized human clinical trials is very limited. We investigated dose-depending effects of a resveratrol-containing grape supplement on stable patients with coronary artery disease (CAD) treated according to currently accepted guidelines for secondary prevention of cardiovascular disease. Methods In a triple-blind, randomized, placebo-controlled, one-year follow-up, 3-arm pilot clinical trial, ...

  9. Effects of Green Tea Extract on Insulin Resistance and Glucagon-Like Peptide 1 in Patients with Type 2 Diabetes and Lipid Abnormalities: A Randomized, Double-Blinded, and Placebo-Controlled Trial

    OpenAIRE

    Chia-Yu Liu; Chien-Jung Huang; Lin-Huang Huang; I-Ju Chen; Jung-Peng Chiu; Chung-Hua Hsu

    2014-01-01

    The aim of this study is to investigate the effect of green tea extract on patients with type 2 diabetes mellitus and lipid abnormalities on glycemic and lipid profiles, and hormone peptides by a double-blinded, randomized and placebo-controlled clinical trial. This trial enrolled 92 subjects with type 2 diabetes mellitus and lipid abnormalities randomized into 2 arms, each arm comprising 46 participants. Of the participants, 39 in therapeutic arm took 500 mg green tea extract, three times a ...

  10. The effectiveness of ENAR® for the treatment of chronic neck pain in Australian adults: a preliminary single-blind, randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Pollard Henry

    2007-07-01

    Full Text Available Abstract Background Current evidence on electrotherapies for the management of chronic neck pain is either lacking or conflicting. New therapeutic devices being introduced to the market should be investigated for their effectiveness and efficacy. The ENAR® (Electro Neuro Adaptive Regulator therapy device combines Western biofeedback with Eastern energy medicine. Methods A small, preliminary randomised and controlled single-blinded trial was conducted on 24 participants (ten males, 14 females between the ages of 18 to 50 years (median age of 40.5 Consent was obtained and participants were randomly allocated to one of three groups – ENAR, Transcutaneous Electrical Nerve Stimulation (TENS, or control therapy – to test the hypothesis that ENAR therapy would result in superior pain reduction/disability and improvements in neck function compared with TENS or control intervention. The treatment regimen included twelve 15-minute treatment sessions over a six week period, followed by two assessment periods. Visual Analogue Scale (VAS pain scores, Neck Disability Index (NDI scores, Patient Specific Functional Scale (PSFS scores and Short Form 36v1 (SF-36 quality of life scores reported by participants were collected at each of the assessments points throughout the trial (0, 6, 12, 18 and 24 weeks. Results Eligible participants (n = 30 were recruited and attended clinic visits for 6 months from the time of randomisation. Final trial sample (n = 24 comprised 9 within the ENAR group, 7 within the TENS group and 8 within the control group. With an overall study power of 0.92, the ENAR group showed a decrease in mean pain score from measurement at time zero (5.0 ± 0.79 95%CI to the first follow-up measurement at six weeks (1.4 ± 0.83 95%CI. Improvement was maintained until week 24 (1.75 ± 0.9 95%CI. The TENS and control groups showed consistent pain levels throughout the trial (3.4 ± 0.96 95%CI and 4.1 ± 0.9 95%CI respectively. Wald analysis for pain

  11. The Effect of Camellia Sinensis (Green Tea Mouthwash on Plaque-Induced Gingivitis: a Single-Blinded Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Poorsattar Bejeh Mir A

    2012-09-01

    Full Text Available Background and the purpose of the Study Complementary medicine received high attention during last decades. We aimed to assess the efficacy of Green tea mouthwash on plaque-induced gingivitis as the most common form of periodontal disease.Methods and materials: We designed a single blinded placebo controlled clinical trial. High school female students with chronic generalized plaque-induced gingivitis were distributed to receive either 5 ml of Green tea 5% two times/day or normal saline with the same dosage. Gingival index (Sillness & Loe, plaque index (Sillness & Loeand bleeding index (Barnett were recorded at baseline and five consecutive weeks. Comparisons were made by a general linear model, repeated measure ANOVA and a Bonferroni test applied for multiple comparisons.Results: Twenty five students were recruited in each arm of the study. A significant improvement was observed in all periodontal indices during the study (P 0.05, observed power for GI: 0.09, PI: 0.11 and BI: 0.07.Conclusion: Green tea mouthwash may be a safe and feasible adjunct treatment for inflammatory periodontal diseases. A future larger scale study is warranted for better evaluating the effect of green tea.Keywords: Camellia Sinensis, Gingivitis, Complementary medicine, Clinical trial, Mouth wash

  12. The effect of desvenlafaxine on cognitive functioning in employed outpatients with major depressive disorder: a substudy of a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Reddy, Sujana; Fayyad, Rana; Edgar, Chris J; Guico-Pabia, Christine J; Wesnes, Keith

    2016-06-01

    The objective of this substudy was to examine the effect of desvenlafaxine 50 mg/day compared with placebo on cognitive function in employed outpatients with major depressive disorder. A total of 11/55 (20%) study sites in a 12-week, randomized, double-blind, placebo-controlled trial administered cognitive assessments in memory, attention, and executive functioning domains using the cognitive drug research system. Changes from baseline were subjected to analysis of covariance with baseline levels as covariates, using last observation carried forward data. A significant improvement with desvenlafaxine 50 mg/day (n=52) compared with placebo (n=29) was observed on the quality of working memory composite measure (0.081 units (0.005, 0.156); P=0.0365) at last observation carried forward. Improvement from baseline on the speed of working memory composite was significant for desvenlafaxine (-226.6 msec (-316.7, -136.4); Pfunctioning, including working memory.Clinical Trial Registry No.: Clinicaltrials.gov identifier: NCT00824291. PMID:27009044

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

    Directory of Open Access Journals (Sweden)

    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.

  14. A randomized double-blind placebo-controlled trial to evaluate the immunogenicity of a candidate vaccine against American tegumentary leishmaniasis.

    Science.gov (United States)

    De Luca, P M; Mayrink, W; Pinto, J A; Coutinho, S G; Santiago, M A; Toledo, V P; Costa, C A; Genaro, O; Reis, A B; Mendonça, S C

    2001-12-21

    This study was aimed at evaluating the immunogenicity of a vaccine composed of killed Leishmania amazonensis promastigotes using several different protocols in a randomized, double-blind and controlled trial design in order to select one of them for further efficacy trials. One hundred and fourteen leishmanin skin test (LST)-negative healthy volunteers were allocated into eight groups that received either two or three deep intramuscular injections of vaccine at doses of 180, 360 and 540 microg or similar injections of placebo. Cell-mediated immune responses were evaluated before and after vaccination by means of LST as well as proliferative responses and cytokine production in Leishmania antigen-stimulated peripheral blood mononuclear cell cultures. The majority of the subjects who actually received vaccine converted to positive LST (89.5%). On the other hand, none of the subjects who received placebo converted to positive LST. Proliferative responses and production of interferon-gamma and interleukin-2 were significantly higher after vaccination than before vaccination in all groups, including those that received placebo. The dose of 360 microg provided the highest LST conversion rate (100%), as well as the greatest increase in interferon-gamma and interleukin-2 production after vaccination. PMID:11700183

  15. Effects of two Chinese herbal formulae for the treatment of moderate to severe stable chronic obstructive pulmonary disease: a multicenter, double-blind, randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Genfa Wang

    Full Text Available The study aims to evaluate the efficacy and safety of two Chinese herbal formulae for the treatment of stable COPD.A multicenter, double-blind, double-dummy, and randomized controlled trial (RCT was conducted. All groups were treated with additional conventional medicines. There were a 6-month treatment and a 12-month follow-up for 5 times. Primary outcomes included lung function test, exacerbation frequency, score of SGRQ. Second outcomes consisted of 6MWD, BODE index, psychological field score, inflammatory factors and cortisol.A total of 331 patients were randomly divided into two active treatment groups (Bushen Yiqi (BY granule group, n = 109; Bushen Fangchuan (BF tablet group, n = 109 and a placebo group (n = 113. Finally 262 patients completed the study. BY granule & BF tablet increased the values of VC, FEV1 (% and FEV1/FVC (%, compared with placebo. BY granule improved PEF. Both treatments reduced acute exacerbation frequency (P = 0.067, BODE index and psychological field score, while improved 6MWD. In terms of descent rang of SGRQ score, both treatments increased (P = 0.01. Both treatments decreased inflammatory cytokines, such as IL-8, and IL-17(P = 0.0219. BY granule obviously descended IL-17(P0.05 among three groups.BY granule and BF tablet were positively effective for the treatment of COPD, and the former performed better in general.Chinese Clinical Trial Register center ChiCTR-TRC-09000530.

  16. Randomized, double-blind, controlled, comparative trial of formula food containing soy protein vs. milk protein in visceral fat obesity. FLAVO study

    International Nuclear Information System (INIS)

    The purpose of the present study was to clarify the efficacy of soy at reducing visceral fat. A randomized, double-blind, controlled, comparative trial was carried out to compare formula food containing soy protein (SP) to the same food in which soy was replaced with milk protein (MP). Forty-eight participants were enrolled for the treatment of visceral fat obesity (visceral fat area >100 cm2 on computed tomography). The SP formula contained 12 g of SP, 9 g of MP, and other nutrients, and was given for 20 weeks in the morning, while in the MP formula SP was replaced with MP. During the 20 weeks of the trial period, visceral fat area and subcutaneous fat area in the MP group were significantly reduced, while those in the SP group did not change as assessed on analysis of covariance. Although waist circumference was reduced in both the SP and MP groups, body weight and body mass index were significantly reduced only in the MP group. Based on a mixed-effects model, the difference in log-transformed visceral fat profiles between the 2 groups was statistically significant (P<0.05), while a negative relationship was observed between the changes in visceral fat and adiponectin in the MP group (P<0.001), but not in the SP group. Formula food containing MP is superior to that containing SP for reducing visceral and subcutaneous fat. (author)

  17. Treatment of chronic diabetic lower leg ulcers with activated protein C: a randomised placebo-controlled, double-blind pilot clinical trial.

    Science.gov (United States)

    Whitmont, Kaley; McKelvey, Kelly J; Fulcher, Gregory; Reid, Ian; March, Lyn; Xue, Meilang; Cooper, Alan; Jackson, Christopher J

    2015-08-01

    Lower leg ulcers are a serious and long-term complication in patients with diabetes and pose a major health concern because of the increasing number of patients diagnosed with diabetes each year. This study sought to evaluate the clinical benefit of topical activated protein C (APC) on chronic lower leg ulcers in patients with diabetes. Twelve patients were randomly assigned to receive either APC (N = 6) or physiological saline (placebo; N = 6) in a randomised, placebo-controlled, double-blind pilot clinical trial. Treatment was administered topically, twice weekly for 6 weeks with final follow-up at 20 weeks. Wound area was significantly reduced to 34·8 ± 16·4% of week 0 levels at 20 weeks in APC-treated wounds (p = 0·01). At 20 weeks, three APC-treated wounds had completely healed, compared to one saline-treated wound. Full-thickness wound edge skin biopsies showed reduced inflammatory cell infiltration and increased vascular proliferation following APC treatment. Patient stress scores were also significantly reduced following APC treatment (p ulcers in patients with diabetes and provides supporting evidence for a larger clinical trial. PMID:23848141

  18. A randomized, double-blind, placebo-controlled trial of calcium acetate on serum phosphorus concentrations in patients with advanced non-dialysis-dependent chronic kidney disease

    Directory of Open Access Journals (Sweden)

    Ho Chiang-Hong

    2011-02-01

    Full Text Available Abstract Background Hyperphosphatemia in patients with chronic kidney disease (CKD contributes to secondary hyperparathyroidism, soft tissue calcification, and increased mortality risk. This trial was conducted to examine the efficacy and safety of calcium acetate in controlling serum phosphorus in pre-dialysis patients with CKD. Methods In this randomized, double-blind, placebo-controlled trial, 110 nondialyzed patients from 34 sites with estimated GFR 2 and serum phosphorus > 4.5 mg/dL were randomized to calcium acetate or placebo for 12 weeks. The dose of study drugs was titrated to achieve target serum phosphorus of 2.7-4.5 mg/dL. Serum phosphorus, calcium, iPTH, bicarbonate and serum albumin were measured at baseline and every 2 weeks for the 12 week study period. The primary efficacy endpoint was serum phosphorus at 12 weeks. Secondary endpoints were to measure serum calcium and intact parathyroid hormone (iPTH levels. Results At 12 weeks, serum phosphorus concentration was significantly lower in the calcium acetate group compared to the placebo group (4.4 ± 1.2 mg/dL vs. 5.1 ± 1.4 mg/dL; p = 0.04. The albumin-adjusted serum calcium concentration was significantly higher (9.5 ± 0.8 vs. 8.8 ± 0.8; p p Conclusions In CKD patients not yet on dialysis, calcium acetate was effective in reducing serum phosphorus and iPTH over a 12 week period. Trial Registration www.clinicaltrials.gov NCT00211978.

  19. Diabetes Health, Residence & Metabolism in Asians: the DHRMA study, research into foods from the Indian subcontinent - a blinded, randomised, placebo controlled trial

    Directory of Open Access Journals (Sweden)

    Patel Jeetesh V

    2011-12-01

    Full Text Available Abstract Background Coronary heart disease (CHD is highly prevalent amongst the South Asian communities in Britain. The reasons for this excess CHD risk are multifactorial, but in part relate to a susceptibility to diabetes mellitus - where the aberrant metabolism of non-esterified fatty acids (NEFA and glucose are likely to underpin vascular disease in this population. Dietary intervention is an important and first line approach to manage increased CHD risk. However, there is limited information on the impact of the South Asian diet on CHD risk. Methods/Design The Diabetes Health, Residence & Metabolism in Asians (DHRMA study is a blinded, randomised, placebo controlled trial that analyses the efficacy of reduced glycaemic index (GI staples of the South Asian diet, in relation to cardio-metabolic risk factors that are commonly perturbed amongst South Asian populations - primarily glucose, fatty acid and lipoprotein metabolism and central adiposity. Using a 10-week dietary intervention study, 50 healthy South Asians will be randomised to receive either a DHRMA (reduced GI supply of chapatti (bread, stone ground, high protein wheat flour and white basmati rice (high bran, unpolished or commercially available (leading brand versions chapatti wheat flour and basmati rice. Volunteers will be asked to complete a 75g oral glucose tolerance test at baseline and at 10-weeks follow-up, where blood metabolites and hormones, blood pressure and anthropometry will also be assessed in a standardised manner. Discussion It is anticipated that the information collected from this study help develop healthy diet options specific (but not exclusive for South Asian ethnic communities. Trial registration Current Controlled Trials ISRCTN02839188

  20. Beneficial Effect of a Cellulose-Containing Chew Treat on Canine Periodontal Disease in a Double-Blind, Placebo-Controlled Trial

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    A. C. Beynen

    2010-01-01

    Full Text Available Problem statement: There are indications that appropriate chew treats can contribute to the control of canine periodontal disease. It was reasoned that the incorporation of a cellulose fiber network into the treat may improve the efficacy, but for proof experimental data were required. Approach: A double-blind, placebo-controlled trial with privately owned dogs was carried out to assess the efficacy of a cellulose preparation (Arbocel BWW40® in the treatment of periodontal disease. With the use of a questionnaire, the clinical signs were evaluated by the owners. There were 10 clinical signs: extent and severity of dental plaque and calculus, extent of gingivitis, redness, swelling, bleeding and firmness of gingivae and halitosis. For a period of 8 weeks, the test dogs daily received a chew treat to which 4% of the cellulose preparation was added. The control dogs were given a chew treat with identical formula, but without added cellulose. During the trial, all dogs were fed the same, complete dry food. There were 16 test dogs and 15 control dogs. Results: When compared with the baseline values, the administration of the test chew significantly improved 8 out of the 10 clinical signs. In the placebo group there was a significant improvement for 6 clinical signs. When the improvements over time for the two groups were compared, there were no statistically significant differences. When the score changes for all 10 clinical signs were added up as an overall index of improvement of periodontal disease, the test group showed a 17% greater amelioration than did the control group. Conclusion: The addition of the cellulose preparation had further enhanced the efficacy of the treat, possibly through an increase in mechanical cleansing and chewing time. This study indicates that a cellulose-containing treat is beneficial for dogs with periodontal disease and it is suggested that it may also impair its development.

  1. 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.

  2. Probiotics in the treatment of acute rotavirus diarrhoea. A randomized, double-blind, controlled trial using two different probiotic preparations in Bolivian children

    Directory of Open Access Journals (Sweden)

    Grandy Giuseppe

    2010-08-01

    Full Text Available Abstract Background Evidence suggests that probiotics reduce rotavirus diarrhoea duration. Although there are several probiotic strains potentially useful, daily practice is often limited by the type and number of products locally available. In general, information about combined products is scarce. In this study we compare the effect of two probiotic products in the treatment of diarrhoea in children less than 2 years of age. Methods A Randomized double-blind controlled clinical trial in children hospitalized for acute rotavirus diarrhoea, in the Paediatric Centre Albina Patino, Cochabamba, Bolivia. Participants were children aged 1 - 23 months, who were randomly assigned to receive one of three treatments: Oral rehydration therapy plus placebo; Oral rehydration solution plus Saccharomyces boulardii; or Oral rehydration solution plus a compound containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardii. Sample size was 20 per group and the outcomes were duration of diarrhoea, of fever, of vomiting and of hospitalization. Results 64 cases finished the protocol. On admission, patients' characteristics were similar. Median duration of diarrhoea (p = 0.04 in children who received the single species product (58 hours was shorter than in controls (84.5 hrs. Comparing children that received the single probiotic product and controls showed shorter duration of fever (18 vs 67 hrs (p = 0.0042 and the mixed probiotic of vomiting (0 vs 42.5 hrs (p = 0.041. There was no effect on duration of hospitalization (p = 0.31. When experimental groups were merged, statistical significance of changes increased (total duration of diarrhoea, fever and vomiting P = 0.025, P = 0.025 and P = 0.014, respectively. Conclusions Both products decreased the duration of diarrhoea compared to oral rehydration solution alone. This decrease was significant only for the single species product which also decreased the duration of

  3. 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

    -test and ANCOVA (P <0.05). Discussion The results of this study will allow evaluation of contralateral acupuncture from two aspects. First, if the contralateral acupuncture shows the effects similar to ipsilateral acupuncture, this will establish clinical basis for contralateral acupuncture. Second, if the effects of contralateral acupuncture are not comparable to the effects of ipsilateral acupuncture, but are shown to be similar to the effects of the sham acupuncture, we can establish the basis for using the same acupoints of the unaffected side as a control in acupuncture clinical studies. Trial registration This trial has been registered with the ‘Clinical Research Information Service (CRIS)’, Republic of Korea: KCT0000628. PMID:23768129

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

    Directory of Open Access Journals (Sweden)

    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. Effects of Olanzapine, Risperidone and Haloperidol on Prepulse Inhibition in Schizophrenia Patients: A Double-Blind, Randomized Controlled Trial

    OpenAIRE

    Wynn, Jonathan K.; Green, Michael F; Sprock, Joyce; Light, Gregory A.; Widmark, Clifford; Reist, Christopher; Erhart, Stephen; Marder, Stephen R.; Mintz, Jim; David L Braff

    2007-01-01

    Prepulse inhibition (PPI), whereby the startle eyeblink response is inhibited by a relatively weak non-startling stimulus preceding the powerful startle eliciting stimulus, is a measure of sensorimotor gating and has been shown to be deficient in schizophrenia patients. There is considerable interest in whether conventional and/or atypical antipsychotic medications can “normalize” PPI deficits in schizophrenia patients. 51 schizophrenia patients participated in a randomized, double-blind cont...

  6. Pantoea agglomerans lipopolysaccharide maintains bone density in premenopausal women: a randomized, double-blind, placebo-controlled trial

    OpenAIRE

    Nakata, Kazue; Nakata, Yoko; Inagawa, Hiroyuki; Nakamoto, Takeru; Yoshimura, Hiroshi; Soma, Gen-Ichiro

    2014-01-01

    Lipopolysaccharide fromPantoea agglomerans (LPSp) facilitates Ca and P turnover in chicken calvaria and femurs. This study investigated osteoporosis prevention by the oral administration of LPSp in mice and in double-blind clinical tests. Using ovariectomized (OVX) osteoporosis mice model, we investigated the effects of LPSp on the bone density and Ca concentration after ingesting LPSp-containing water for 4 weeks. Oral administration of LPSp tended to suppress the decline in the bone density...

  7. Double blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629

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    Silva Federico A

    2006-05-01

    Full Text Available Abstract Background Cutaneous Leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. Methods and design A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for Leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be daily administered and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The

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

    Science.gov (United States)

    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...

  9. Antidepressant Efficacy of Adjunctive Aerobic Activity and Associated Biomarkers in Major Depression: A 4-Week, Randomized, Single-Blind, Controlled Clinical Trial

    Science.gov (United States)

    Siqueira, Cristiana Carvalho; Valiengo, Leandro L.; Carvalho, André F.; Santos-Silva, Paulo Roberto; Missio, Giovani; de Sousa, Rafael T.; Di Natale, Georgia; Gattaz, Wagner F.; Moreno, Ricardo Alberto; Machado-Vieira, Rodrigo

    2016-01-01

    Background Major depressive disorder (MDD) is a highly prevalent, heterogeneous and systemic medical condition. Treatment options are limited, and recent studies have suggested that physical exercise can play an important role in the therapeutics of MDD. The aim of this study was to evaluate the antidepressant efficacy of adjunctive aerobic activity in association with pharmacotherapy (selective serotonin reuptake inhibitor) in symptomatic MDD as well as its association with physiological biomarkers. Methods In this randomized, single-blind, add-on, controlled clinical trial, 57 patients (18–55 years of age) were followed-up for 28 days. All patients were drug-free, had been diagnosed with symptomatic MDD and received flexible dose of sertraline during the trial. Patients were randomized to either a 4-week program (4x/week) of add-on aerobic exercise (exercise group, N = 29) or no activity (control group, N = 28). Depression severity was assessed using the Hamilton Rating Scale for Depression (HAM-D) as the primary outcome. At baseline and endpoint, all patients underwent a comprehensive metabolic/cardiopulmonary exercise testing—including determination of maximal oxygen uptake (VO2max), VO2 at the second ventilatory threshold (VO2-VT2), and oxygen pulse (O2 pulse). Results Depression scores significantly decreased in both groups after intervention. Importantly, patients in the aerobic exercise group required lower sertraline dose compared to the control group (sertraline monotherapy). The VO2max and O2 pulse parameters increased over time only in the exercise group and remained unchanged in the control group. Conclusions The present findings suggest that a 4-week training of aerobic exercise significantly improves functional capacity in patients with MDD and may be associated with antidepressant efficacy. This approach may also decrease the need for higher doses of antidepressants to achieve response. Further studies in unmedicated and treatment-resistant MDD

  10. Quality of life and metabolic status in mildly depressed patients with type 2 diabetes treated with paroxetine: A double-blind randomised placebo controlled 6-month trial

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    Wahlbeck Kristian

    2007-06-01

    Full Text Available Abstract Background Depression is prevalent in people with type 2 diabetes and affects both glycaemic control and overall quality of life. The aim of this investigator-initiated trial was to evaluate the effect of the antidepressant paroxetine on quality of life, metabolic control, and mental well-being in mildly depressed diabetics aged 50–70 years. Methods We randomised 49 mildly depressed primary care outpatients with non-optimally controlled diabetes to a 6-month double-blind treatment with either paroxetine 20 mg per day or matching placebo. Primary efficacy measurements were quality of life and glycaemic control. The primary global outcome of the study was defined as a 10 points improvement in the SF-36 quality of life score. The primary metabolic outcome of the study was defined as a 0.8%-units decrease in glycosylated haemoglobin A1c(GHbA1c. Psychiatric symptoms were assessed with the Hospital Anxiety and Depression Scale. Results Six patients withdrew their consent before starting medication and six dropped out later in the study. We performed analysis of covariance with the baseline value as a covariate. Quality of life and glycaemic control as well as symptoms of depression and anxiety improved in both groups over the 6-month study period. After three months of treatment we found a statistically significant difference between the two treatment groups in GHbA1c (mean difference = 0.59%-units, p = 0.018 and in SF-36 score (mean difference = 11.0 points, p = 0.039. However, at the end of the study, no statistically significant differences between the treatment groups were observed. No severe adverse events occurred. Conclusion This pragmatic study of primary care patients did not confirm earlier preliminary findings indicating a beneficial effect of paroxetine on glycaemic control. The study indicates that in pragmatic circumstances any possible benefit from administration of paroxetine in diabetic patients with sub

  11. Differences in homeostatic model assessment (HOMA) values and insulin levels after vitamin D supplementation in healthy men: a double-blind randomized controlled trial.

    Science.gov (United States)

    Tepper, S; Shahar, D R; Geva, D; Ish-Shalom, S

    2016-06-01

    Vitamin D is thought to play a role in glucose metabolism. The aim of the present study was to determine the effect of vitamin D supplementation on markers of insulin sensitivity and inflammation in men without diabetes with vitamin D deficiency/insufficiency. In this 1-year double-blind randomized controlled trial, 130 men aged 20-65 years (mean age 47.52 ± 11.84 years) with serum 25-hydroxyvitamin D levels treatment (100 000 IU vitamin D bimonthly) or placebo. Anthropometric measurements, demographic questionnaires, and blood indices (fasting glucose, insulin, high-sensitivity C-reactive protein, lipids) were collected and repeated after 6 and 12 months. The compliance rate was 98.5%. Multivariate models, adjusted for baseline levels, age, body mass index, sun exposure, physical activity and LDL, showed significant differences in insulin and homeostatic model assessment of insulin resistance (HOMA-IR) values between groups. Levels of insulin and HOMA-IR values remained steady during the study period in the treatment group but increased by 16% in the control group (p = 0.038 and p = 0.048, respectively). Vitamin D supplementation administered for 12 months in healthy men maintained insulin levels and HOMA-IR values relative to the increase in the control group. Further studies are needed to establish the long-term effect of vitamin D supplementation on the risk of diabetes. PMID:26890031

  12. 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.

  13. 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

  14. Effect of Remote Ischaemic Conditioning in Oncology Patients Undergoing Chemotherapy: Rationale and Design of the ERIC‐ONC Study—A Single‐Center, Blinded, Randomized Controlled Trial

    Science.gov (United States)

    Chung, Robin; Maulik, Angshuman; Hamarneh, Ashraf; Hochhauser, Daniel; Hausenloy, Derek J.; Walker, J. Malcolm

    2016-01-01

    ABSTRACT Cancer survival continues to improve, and thus cardiovascular consequences of chemotherapy are increasingly important determinants of long‐term morbidity and mortality. Conventional strategies to protect the heart from chemotherapy have important hemodynamic or myelosuppressive side effects. Remote ischemic conditioning (RIC) using intermittent limb ischemia‐reperfusion reduces myocardial injury in the setting of percutaneous coronary intervention. Anthracycline cardiotoxicity and ischemia‐reperfusion injury share common biochemical pathways in cardiomyocytes. The potential for RIC as a novel treatment to reduce subclinical myocyte injury in chemotherapy has never been explored and will be investigated in the Effect of Remote Ischaemic Conditioning in Oncology (ERIC‐ONC) trial (clinicaltrials.gov NCT 02471885). The ERIC‐ONC trial is a single‐center, blinded, randomized, sham‐controlled study. We aim to recruit 128 adult oncology patients undergoing anthracycline‐based chemotherapy treatment, randomized in a 1:1 ratio into 2 groups: (1) sham procedure or (2) RIC, comprising 4, 5‐minute cycles of upper arm blood pressure cuff inflations and deflations, immediately before each cycle of chemotherapy. The primary outcome measure, defining cardiac injury, will be high‐sensitivity troponin‐T over 6 cycles of chemotherapy and 12 months follow‐up. Secondary outcome measures will include clinical, electrical, structural, and biochemical endpoints comprising major adverse cardiovascular clinical events, incidence of cardiac arrhythmia over 14 days at cycle 5/6, echocardiographic ventricular function, N‐terminal pro‐brain natriuretic peptide levels at 3 months follow‐up, and changes in mitochondrial DNA, micro‐RNA, and proteomics after chemotherapy. The ERIC‐ONC trial will determine the efficacy of RIC as a novel, noninvasive, nonpharmacological, low‐cost cardioprotectant in cancer patients undergoing anthracycline

  15. Effects of Two Chinese Herbal Formulae for the Treatment of Moderate to Severe Stable Chronic Obstructive Pulmonary Disease: A Multicenter, Double-Blind, Randomized Controlled Trial

    Science.gov (United States)

    Cao, Yuxue; Du, Yijie; Zhang, Hongying; Luo, Qingli; Li, Bei; Wu, Jinfeng; Lv, Yubao; Sun, Jing; Jin, Hualiang; Wei, Kai; Zhao, Zhengxiao; Kong, Lingwen; Zhou, Xianmei; Miao, Qing; Wang, Gang; Zhou, Qingwei; Dong, Jingcheng

    2014-01-01

    Objective The study aims to evaluate the efficacy and safety of two Chinese herbal formulae for the treatment of stable COPD. Methods A multicenter, double-blind, double-dummy, and randomized controlled trial (RCT) was conducted. All groups were treated with additional conventional medicines. There were a 6-month treatment and a 12-month follow-up for 5 times. Primary outcomes included lung function test, exacerbation frequency, score of SGRQ. Second outcomes consisted of 6MWD, BODE index, psychological field score, inflammatory factors and cortisol. Results A total of 331 patients were randomly divided into two active treatment groups (Bushen Yiqi (BY) granule group, n = 109; Bushen Fangchuan (BF) tablet group, n = 109) and a placebo group (n = 113). Finally 262 patients completed the study. BY granule & BF tablet increased the values of VC, FEV1 (%) and FEV1/FVC (%), compared with placebo. BY granule improved PEF. Both treatments reduced acute exacerbation frequency (P = 0.067), BODE index and psychological field score, while improved 6MWD. In terms of descent rang of SGRQ score, both treatments increased (P = 0.01). Both treatments decreased inflammatory cytokines, such as IL-8, and IL-17(P = 0.0219). BY granule obviously descended IL-17(P0.05) among three groups. Conclusions BY granule and BF tablet were positively effective for the treatment of COPD, and the former performed better in general. Trial Registration Chinese Clinical Trial Register center ChiCTR-TRC-09000530 PMID:25118962

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

    Directory of Open Access Journals (Sweden)

    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.

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

    OpenAIRE

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

    2013-01-01

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

  18. The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial

    OpenAIRE

    Lian, Fengmei; Tian, Jiaxing; Chen, Xinyan; Li, Zhibin; Piao, Chunli; Guo, Junjie; Ma, Licheng; Zhao, Lijuan; Xia, Chengdong; Wang, Chong-Zhi; Yuan, Chun-Su; Tong, Xiaolin

    2015-01-01

    Background Metformin plays an important role in diabetes treatment. Studies have shown that the combined use of oral hypoglycemic medications is more effective than metformin monotherapy. In this double-blind, randomized, placebo-controlled, multicenter trial, we evaluated whether Jinlida, a Chinese herbal medicine, enhances the glycemic control of metformin in type 2 diabetes patients whose HbA1c was ineffectively controlled with metformin alone. Methods A total of 186 diabetes patients were...

  19. Metformin intervention in obese non-diabetic patients with breast cancer: phase II randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Ko, Kwang-Pil; Ma, Seung Hyun; Yang, Jae-Jeong; Hwang, Yunji; Ahn, Choonghyun; Cho, Young-Min; Noh, Dong-Young; Park, Byung-Joo; Han, Wonshik; Park, Sue K

    2015-09-01

    Previous observational studies have suggested that metformin in diabetes patients may reduce breast cancer risk more than the reductions from other anti-diabetes medications. This randomized, double-blind, placebo-controlled trial was performed to evaluate the efficacy of metformin for controlling physical and metabolic profiles related to prognosis and adverse events in non-diabetic breast cancer patients. Female breast cancer patients (N = 105), at least 6 months post-mastectomy, with obesity (≥25 kg/m(2)) and/or pre-diabetes (fasting blood sugar levels ≥100 mg/dL), were randomly assigned to three groups (placebo, metformin 500 mg, and metformin 1000 mg) stratified by tamoxifen use. A linear mixed model for repeated measurements among three groups and ANOVA for profile differences during 6 months of treatment were used for the intention-to-treat analysis. The metformin 1000 mg group had a significantly greater decline in glucose and HbA1c levels between treatment weeks 0 and 6 month (p = 0.008 and 0.009, respectively), and the declines increased with an increase in body mass index (BMI) level (p interaction with BMI = 0.007 and 0.067, respectively). A marginally significant different effect from the metformin 1000 mg treatment was detected for glucose and HbA1c levels (p interaction = 0.084 and 0.063, respectively) in the intention-to-treat analysis. Metformin 1000 mg treatment had a favorable effect on controlling glucose and HbA1C levels in obese non-diabetic breast cancer patients, indicating prognostic importance. Further trials are needed to elucidate the risk-benefit ratio of long-term use of metformin. PMID:26293146

  20. Effect on skin hydration of using baby wipes to clean the napkin area of newborn babies: assessor-blinded randomised controlled equivalence trial

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    Lavender Tina

    2012-06-01

    Full Text Available Abstract Background Some national guidelines recommend the use of water alone for napkin cleansing. Yet, there is a readiness, amongst many parents, to use baby wipes. Evidence from randomised controlled trials, of the effect of baby wipes on newborn skin integrity is lacking. We conducted a study to examine the hypothesis that the use of a specifically formulated cleansing wipe on the napkin area of newborn infants ( Methods A prospective, assessor-blinded, randomised controlled equivalence trial was conducted during 2010. Healthy, term babies (n = 280, recruited within 48 hours of birth, were randomly assigned to have their napkin area cleansed with an alcohol-free baby wipe (140 babies or cotton wool and water (140 babies. Primary outcome was change in hydration from within 48 hours of birth to 4 weeks post-birth. Secondary outcomes comprised changes in trans-epidermal water loss, skin surface pH and erythema, presence of microbial skin contaminants/irritants at 4 weeks and napkin dermatitis reported by midwife at 4 weeks and mother during the 4 weeks. Results Complete hydration data were obtained for 254 (90.7 % babies. Wipes were shown to be equivalent to water and cotton wool in terms of skin hydration (intention-to-treat analysis: wipes 65.4 (SD 12.4 vs. water 63.5 (14.2, p = 0.47, 95 % CI -2.5 to 4.2; per protocol analysis: wipes 64.6 (12.4 vs. water 63.6 (14.3, p = 0.53, 95 % CI -2.4 to 4.2. No significant differences were found in the secondary outcomes, except for maternal-reported napkin dermatitis, which was higher in the water group (p = 0.025 for complete responses. Conclusions Baby wipes had an equivalent effect on skin hydration when compared with cotton wool and water. We found no evidence of any adverse effects of using these wipes. These findings offer reassurance to parents who choose to use baby wipes and to health professionals who support their use. Trial registration Current Controlled

  1. 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

  2. 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

  3. Effectiveness of zinc supplementation to full term normal infants: a community based double blind, randomized, controlled, clinical trial.

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    K V Radhakrishna

    Full Text Available UNLABELLED: The study was aimed to test whether zinc supplementation, if initiated early, can prevent stunting and promote optimum body composition in full term infants. For this, full term pregnant women from low income urban community were enrolled and were followed-up for 24 months postpartum. Body mass index (BMI was calculated from maternal weight and height that were collected one month after delivery. Infants' weight, and length, head, chest and mid upper arm circumferences and skin fold thicknesses at triceps, biceps and subscapular area were collected at baseline (before randomization and once in three months up till 24 months. Three hundred and twenty four infants were randomized and allocated to zinc (163 or placebo (161 groups respectively. Supplementation of zinc was initiated from 4 months of age and continued till children attained 18 months. The control (placebo group of children received riboflavin 0.5 mg/day, whereas the intervention (zinc group received 5 mg zinc plus riboflavin 0.5 mg/day. When infants were 18 months old, dietary intakes (in 78 children were calculated by 24 hour diet recall method and hemoglobin, zinc, copper and vitamin A were quantified in blood samples collected from 70 children. The results showed prevalence of undernutrition (body mass index <18.5 in 37% of the mothers. Mean±SD calorie consumption and zinc intakes from diets in infants were 590±282.8 Kcal/day and 0.97±0.608 mg/day respectively. Multiple linear regression models demonstrated maternal weight as a strong predictor of infants' weight and length at 18 months of age. As expected, diarrhea duration impacted infants' linear growth and weight gain adversely. Zinc supplementation for a mean period of 190 days, starting from 4 months up to 18 months of age, in full term normal infants, consuming an average energy of 590 Kcal/day, had significant effect on the skin fold thicknesses, but not on their linear growth. TRIAL REGISTRATION: Clinical

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

    International Nuclear Information System (INIS)

    Objectives: the aim of the present study was to investigate the effectiveness of Samarium153-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 Samarium153-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 (p153-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)

  5. 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

  6. Chinese herbal medicine for chronic heart failure: a multicenter, randomized, double-blind, placebo-controlled trial

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    Liangtao Luo

    2014-10-01

    Conclusion: CHM treatment according to syndrome differentiation effectively improved the LVEF, TCM-SS, and NYHA-FC in patients with CHF and also appeared to be safe. Thus, CHM treatment could be used as an adjuvant therapy in the treatment of CHF (Clinical trial registration: NCT01939236.

  7. 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. PMID:26632177

  8. Morinda citrifolia (Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial.

    Science.gov (United States)

    Fletcher, H M; Dawkins, J; Rattray, C; Wharfe, G; Reid, M; Gordon-Strachan, G

    2013-01-01

    Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea. Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume. Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls. Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo. PMID:23431314

  9. Effects of a Gentle, Self-Administered Stimulation of Perineal Skin for Nocturia in Elderly Women: A Randomized, Placebo-Controlled, Double-Blind Crossover Trial

    Science.gov (United States)

    Iimura, Kaori; Watanabe, Nobuhiro; Masunaga, Koichi; Miyazaki, Shogo; Hotta, Harumi; Kim, Hunkyung; Hisajima, Tatsuya; Takahashi, Hidenori; Kasuya, Yutaka

    2016-01-01

    Background 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. Methods 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. Results 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 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. Trial Registration UMIN Clinical Trial Registry (CTR) UMIN000015809 PMID:27003163

  10. Use of a specific anti-stretch mark cream for preventing or reducing the severity of striae gravidarum. Randomized, double-blind, controlled trial.

    Science.gov (United States)

    García Hernández, J Á; Madera González, D; Padilla Castillo, M; Figueras Falcón, T

    2013-06-01

    Few studies have tested the efficacy of commercially available cosmetic products for preventing striae gravidarum. Therefore, the objective of this study was to evaluate efficacy on prevention of striae gravidarum using a specific anti-stretch mark cream containing hydroxyprolisilane-C, rosehip oil, Centella asiatica triterpenes and vitamin E. A randomized, double-blind, placebo-controlled trial was conducted between November 2009 and April 2011. Pregnant women were included and classified as treated group (emollient and moisturizer containing hydroxyprolisilane C, rosehip oil, Centella asiatica triterpenes and vitamin E) and control group (cream without the active ingredients). Overall incidence of stretch marks during pregnancy was 33.3% for the control group and 37.6% for the treated group (n.s.). Severity of previous stretch marks significantly increased in the control group during the study (17.8%, P = 0.001), but not in the treated group (6.3%, ns). In women who developed new stretch marks during the study, there was a significantly greater 'difference in severity' (between baseline and maximum severity) in control group vs. treated group (0.47 [0.57] vs. 0.14 [0.60], P = 0.031). In women without previous striae, incidence of these marks was significantly lower for the treated group patients compared with control group (5.6% vs. 35%, P = 0.031, OR: 9.2 [95% CI: 1.0-83.3]). The use of the anti-stretch mark product is proved to be effective in reducing severity of the striae during pregnancy, prevents the appearance of new striae and halts progression of those already present. In women who had no striae at baseline, use of the anti-stretch mark cream was more effective than placebo in preventing new stretch marks. PMID:23237514

  11. Protocol for German trial of Acyclovir and corticosteroids in Herpes-simplex-virus-encephalitis (GACHE: a multicenter, multinational, randomized, double-blind, placebo-controlled German, Austrian and Dutch trial [ISRCTN45122933

    Directory of Open Access Journals (Sweden)

    Schielke Eva

    2008-10-01

    Full Text Available Abstract Background The treatment of Herpes-simplex-virus-encephalitis (HSVE remains a major unsolved problem in Neurology. Current gold standard for therapy is acyclovir, a drug that inhibits viral replication. Despite antiviral treatment, mortality remains up to 15%, less than 20% of patients are able to go back to work, and the majority of patients suffer from severe disability. This is a discouraging, unsatisfactory situation for treating physicians, the disabled patients and their families, and constitutes an enormous burden to the public health services. The information obtained from experimental animal research and from recent retrospective clinical observations, indicates that a substantial benefit in outcome can be expected in patients with HSVE who are treated with adjuvant dexamethasone. But currently there is no available evidence to support the routine use of adjuvant corticosteroid treatment in HSVE. A randomized multicenter trial is the only useful instrument to address this question. Design GACHE is a multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial of treatment with acyclovir and adjuvant dexamethasone, as compared with acyclovir and placebo in adults with HSVE. The statistical design will be that of a 3-stage-group sequential trial with potential sample size adaptation in the last stage. Conclusion 372 patients with proven HSVE (positive HSV-DNA-PCR, aged 18 up to 85 years; with focal neurological signs no longer than 5 days prior to admission, and who give informed consent will be recruited from Departments of Neurology of academic medical centers in Germany, Austria and The Netherlands. Sample size will potentially be extended after the second interim analysis up to a maximum of 450 patients. Trial Registration Current Controlled Trials ISRCTN45122933

  12. 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

  13. Advanced Cardiac Resuscitation Evaluation (ACRE: A randomised single-blind controlled trial of peer-led vs. expert-led advanced resuscitation training

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    Hughes Thomas C

    2010-01-01

    Full Text Available Abstract Background Advanced resuscitation skills training is an important and enjoyable part of medical training, but requires small group instruction to ensure active participation of all students. Increases in student numbers have made this increasingly difficult to achieve. Methods A single-blind randomised controlled trial of peer-led vs. expert-led resuscitation training was performed using a group of sixth-year medical students as peer instructors. The expert instructors were a senior and a middle grade doctor, and a nurse who is an Advanced Life Support (ALS Instructor. A power calculation showed that the trial would have a greater than 90% chance of rejecting the null hypothesis (that expert-led groups performed 20% better than peer-led groups if that were the true situation. Secondary outcome measures were the proportion of High Pass grades in each groups and safety incidents. The peer instructors designed and delivered their own course material. To ensure safety, the peer-led groups used modified defibrillators that could deliver only low-energy shocks. Blinded assessment was conducted using an Objective Structured Clinical Examination (OSCE. The checklist items were based on International Liaison Committee on Resuscitation (ILCOR guidelines using Ebel standard-setting methods that emphasised patient and staff safety and clinical effectiveness. The results were analysed using Exact methods, chi-squared and t-test. Results A total of 132 students were randomised: 58 into the expert-led group, 74 into the peer-led group. 57/58 (98% of students from the expert-led group achieved a Pass compared to 72/74 (97% from the peer-led group: Exact statistics confirmed that it was very unlikely (p = 0.0001 that the expert-led group was 20% better than the peer-led group. There were no safety incidents, and High Pass grades were achieved by 64 (49% of students: 33/58 (57% from the expert-led group, 31/74 (42% from the peer-led group. Exact

  14. A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome

    OpenAIRE

    Kruis, Wolfgang; Chrubasik, Sigrun; Boehm, Stephan; Stange, Christiane; Schulze, Juergen

    2011-01-01

    Purpose To study the therapeutic effects of probiotic Escherichia coli Nissle 1917 (EcN) in irritable bowel syndrome (IBS) and identify subgroups benefiting most. Background Some trials investigating therapeutic effects in irritable bowel syndrome have shown benefits in IBS subgroups only. Probiotic treatment seems to be promising. Methods Patients with irritable bowel syndrome (120; Rome II) were recruited to a prospective double-blind study and randomized to either EcN (n = 60) or placebo (...

  15. Effect of saffron on liver metastases in patients suffering from cancers with liver metastases: A randomized, double blind, placebo-controlled clinical trial

    OpenAIRE

    Azar Hosseini; Seyed Hamed Mousavi; Anis Ghanbari; Fatemeh Homaei-Shandiz; Hamid-Reza Raziee; Masoud Pezeshki-Rad; Seyed Hadi Mousavi

    2015-01-01

    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 ...

  16. Effect of double dose oseltamivir on clinical and virological outcomes in children and adults admitted to hospital with severe influenza: double blind randomised controlled trial

    OpenAIRE

    ,

    2013-01-01

    Objective To investigate the validity of recommendations in treatment guidelines to use higher than approved doses of oseltamivir in patients with severe influenza. Design Double blind randomised trial. Setting Thirteen hospitals in Indonesia, Singapore, Thailand, and Vietnam. Participants Patients aged ≥1 year admitted to hospital with confirmed severe influenza. Interventions Oral oseltamivir at double dose (150 mg twice a day/paediatric equivalent) versus standard dose (75 mg twice a day/p...

  17. Effects of an exercise and manual therapy program on physical impairments, function and quality-of-life in people with osteoporotic vertebral fracture: a randomised, single-blind controlled pilot trial

    OpenAIRE

    Sherburn Margaret; Kelly Anne; Briggs Andrew; Greig Alison; Matthews Bernadette; Bennell Kim L; Larsen Judy; Wark John

    2010-01-01

    Abstract Background This randomised, single-blind controlled pilot trial aimed to determine the effectiveness of a physiotherapy program, including exercise and manual therapy, in reducing impairments and improving physical function and health-related quality of life in people with a history of painful osteoporotic vertebral fracture. Methods 20 participants were randomly allocated to an intervention (n = 11) or control (n = 9) group. The intervention group attended individual sessions with a...

  18. Effect of Self Care Education with and without Telephone Follow-Up on the Level of Hope in Renal Dialysis Patients: A Single-Blind Randomized Controlled Clinical Trial

    OpenAIRE

    Farzad Poorgholami; Parisa Mansoori; Zohreh Montaseri; Kazem Najafi

    2016-01-01

    Background: Various strategies such as teaching self care to hemodialysis patients have been employed to increase the level of their hope. This study aimed at examining the effects of a telephone follow-up program on the level of hope in a self care education program. Methods: In this single-blind randomized controlled clinical trial, 75 hemodialysis patients, selected by convenient sampling, were randomly assigned to 3 groups (n=25 each) including a control, a self care education, or a s...

  19. Topical rapamycin as a treatment for fibrofolliculomas in Birt-Hogg-Dube syndrome: a double-blind placebo-controlled randomized split-face trial.

    Directory of Open Access Journals (Sweden)

    Lieke M C Gijezen

    Full Text Available BACKGROUND: Birt-Hogg-Dubé syndrome (BHD is a rare autosomal dominant disorder characterised by the occurrence of benign, mostly facial, skin tumours called fibrofolliculomas, multiple lung cysts, spontaneous pneumothorax and an increased renal cancer risk. Current treatments for fibrofolliculomas have high rates of recurrence and carry a risk of complications. It would be desirable to have a treatment that could prevent fibrofolliculomas from growing. Animal models of BHD have previously shown deregulation of mammalian target of rapamycin (mTOR. Topical use of the mTOR inhibitor rapamycin is an effective treatment for the skin tumours (angiofibromas in tuberous sclerosis complex, which is also characterised by mTOR deregulation. In this study we aimed to determine if topical rapamycin is also an effective treatment for fibrofolliculomas in BHD. METHODS: We performed a double blinded, randomised, facial left-right controlled trial of topical rapamycin 0.1% versus placebo in 19 BHD patients. Trial duration was 6 months. The primary outcome was cosmetic improvement as measured by doctors and patients. Changes in fibrofolliculoma number and size were also measured, as was occurrence of side effects. RESULTS: No change in cosmetic status of fibrofolliculomas was reported in the majority of cases for the rapamycin treated (79% by doctors, 53% by patients as well as the placebo treated facial sides (both 74%. No significant differences between rapamycin and placebo treated facial halves were observed (p = 1.000 for doctors opinion, p = 0.344 for patients opinion. No significant difference in fibrofolliculoma number or change in size of the fibrofolliculomas was seen after 6 months. Side effects occurred more often after rapamycin treatment (68% of patients than after placebo (58% of patients; p = 0.625. A burning sensation, erythema, itching and dryness were most frequently reported. CONCLUSIONS: This study provides no evidence that

  20. Etoricoxib in the treatment of osteoarthritis over 52-weeks: a double-blind, active-comparator controlled trial [NCT00242489

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    Olaleye Joseph

    2005-12-01

    Full Text Available Abstract Background The aim of this study was to evaluate the long-term efficacy and tolerability of etoricoxib, a COX-2 selective inhibitor, in osteoarthritis (OA patients. Methods A double-blind, randomized, multicenter study was conducted in 617 patients with OA of the knee. The base study was 14 weeks in duration and consisted of 2 parts; in Part I (6 weeks, patients were allocated to once daily oral etoricoxib 5, 10, 30, 60, 90 mg or placebo. In Part II (8 weeks; the placebo, etoricoxib 5 and 10 mg groups were reallocated to etoricoxib 30, 60, or 90 mg qd or diclofenac 50 mg t.i.d. Treatment was continued for consecutive 12 and 26 week extensions. Primary efficacy endpoints were the WOMAC VA 3.0 pain subscale and investigator global assessment of disease status. Safety and tolerability were assessed by collecting adverse events throughout the study. Results Compared with placebo, the etoricoxib groups displayed significant (p Conclusion In this extension study, etoricoxib, at doses ranging from 30 to 90 mg, demonstrated a maintenance of significant clinical efficacy in patients with OA through 52 weeks of treatment. Etoricoxib displayed clinical efficacy similar to diclofenac 150 mg and was generally well tolerated.

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

    OpenAIRE

    Patki, Pralhad

    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...

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

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    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.

  3. Effect of Conjugated Linoleic Acid Associated With Aerobic Exercise on Body Fat and Lipid Profile in Obese Women: A Randomized, Double-Blinded, and Placebo-Controlled Trial.

    Science.gov (United States)

    Ribeiro, Alex S; Pina, Fábio Luiz; Dodero, Soraya R; Silva, Danilo R; Schoenfeld, Brad J; Sugihara Júnior, Paulo; Fernandes, Rodrigo R; Barbosa, Décio S; Cyrino, Edilson S; Tirapegui, Julio

    2016-04-01

    The aim of this study was to analyze the effects of 8 weeks of conjugated linoleic acid (CLA) supplementation associated with aerobic exercise on body fat and lipid profile on obese women. We performed a randomized, double-blinded and placebo-controlled trial with 28 obese women who received 3.2 g/day of CLA or 4 g/day of olive oil (placebo group) while performing an 8-week protocol of aerobic exercise. Dietary intake (food record), body fat (dual-energy X-ray absorptiometry), and biochemical analysis (blood sample) were assessed before and after the intervention period. Independent of CLA supplementation, both groups improved (p CLA group, 13.2%; PLC group, 14.8%), trunk fat (CLA group, -1.0%; PLC group, -0.5%), leg fat (CLA group, -1.0%; PLC group, -1.6%), and total body fat (CLA group, -1.7%; PLC group, -1.3%) after the 8-week intervention. No main effect or Group × Time interaction was found for total cholesterol, triglycerides, and plasma lipoproteins (p > .05). We conclude that CLA supplementation associated with aerobic exercise has no effect on body fat reduction and lipid profile improvements over placebo in young adult obese women. PMID:26402730

  4. 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. PMID:26045552

  5. The effect of Camellia Sinensis (green tea mouthwash on plaque-induced gingivitis: a single-blinded randomized controlled clinical trial

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    Jenabian Niloofar

    2012-09-01

    Full Text Available Abstract Background and the purpose of the Study Complementary medicine received high attention during last decades. We aimed to assess the efficacy of Green tea mouthwash on plaque-induced gingivitis as the most common form of periodontal disease. Methods and materials We designed a single blinded placebo controlled clinical trial. High school female students with chronic generalized plaque-induced gingivitis were distributed to receive either 5 ml of Green tea 5% two times/day or normal saline with the same dosage. Gingival index (Sillness & Loe, plaque index (Sillness & Loe and bleeding index (Barnett were recorded at baseline and five consecutive weeks. Comparisons were made by a general linear model, repeated measure ANOVA and a Bonferroni test applied for multiple comparisons. Results Twenty five students were recruited in each arm of the study. A significant improvement was observed in all periodontal indices during the study (P  0.05, observed power for GI: 0.09, PI: 0.11 and BI: 0.07. Conclusion Green tea mouthwash may be a safe and feasible adjunct treatment for inflammatory periodontal diseases. A future larger scale study is warranted for better evaluating the effect of green tea.

  6. The effect of Camellia Sinensis (green tea) mouthwash on plaque-induced gingivitis: a single-blinded randomized controlled clinical trial

    Science.gov (United States)

    2012-01-01

    Abstract Background and the purpose of the Study Complementary medicine received high attention during last decades. We aimed to assess the efficacy of Green tea mouthwash on plaque-induced gingivitis as the most common form of periodontal disease. Methods and materials We designed a single blinded placebo controlled clinical trial. High school female students with chronic generalized plaque-induced gingivitis were distributed to receive either 5 ml of Green tea 5% two times/day or normal saline with the same dosage. Gingival index (Sillness & Loe), plaque index (Sillness & Loe) and bleeding index (Barnett) were recorded at baseline and five consecutive weeks. Comparisons were made by a general linear model, repeated measure ANOVA and a Bonferroni test applied for multiple comparisons. Results Twenty five students were recruited in each arm of the study. A significant improvement was observed in all periodontal indices during the study (P  0.05, observed power for GI: 0.09, PI: 0.11 and BI: 0.07). Conclusion Green tea mouthwash may be a safe and feasible adjunct treatment for inflammatory periodontal diseases. A future larger scale study is warranted for better evaluating the effect of green tea. PMID:23351842

  7. Chronic Effects of a Wild Green Oat Extract Supplementation on Cognitive Performance in Older Adults: A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial

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    Narelle M. Berry

    2012-05-01

    Full Text Available Background and aim: Preliminary evaluation of a wild green oat extract (WGOE (Neuravena® ELFA®955, Frutarom, Switzerland revealed an acute cognitive benefit of supplementation. This study investigated whether regular daily WGOE supplementation would result in sustained cognitive improvements. Method: A 12-week randomised, double-blind, placebo-controlled cross-over trial of WGOE supplementation (1500 mg/day versus placebo was undertaken in 37 healthy adults aged 67 ± 0.8 years (mean ± SEM. Cognitive assessments included the Stroop colour-word test, letter cancellation, the rule-shift task, a computerised multi-tasking test battery and the trail-making task. All assessments were conducted in Week 12 and repeated in Week 24 whilst subjects were fasted and at least 18 h after taking the last dose of supplement. Result: Chronic WGOE supplementation did not affect any measures of cognition. Conclusion: It appears that the cognitive benefit of acute WGOE supplementation does not persist with chronic treatment in older adults with normal cognition. It remains to be seen whether sustained effects of WGOE supplementation may be more evident in those with mild cognitive impairment.

  8. Homeopathic medicine for acute cough in upper respiratory tract infections and acute bronchitis: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Zanasi, Alessandro; Mazzolini, Massimiliano; Tursi, Francesco; Morselli-Labate, Antonio Maria; Paccapelo, Alexandro; Lecchi, Marzia

    2014-02-01

    Cough is a frequent symptom associated to upper respiratory tract infections (URTIs) and, although being self-limiting, it might deeply affect the quality of life. Homeopathic products are often employed by patients to treat cough, but the evidence on their efficacy is scarce. Thus, we tested the efficacy of a homeopathic syrup in treating cough arising from URTIs with a randomized, double blind, placebo controlled clinical trial. Patients were treated with either the homeopathic syrup or a placebo for a week, and recorded cough severity in a diary by means of a verbal category-descriptive score for two weeks. Sputum viscosity was assessed with a viscosimeter before and after 4 days of treatment; patients were also asked to provide a subjective evaluation of viscosity. Eighty patients were randomized to receive placebo (n = 40) or the homeopathic syrup (n = 40). All patients completed the study. In each group cough scores decreased over time, however, after 4 and 7 days of treatment, cough severity was significantly lower in the homeopathic group than in the placebo one (p syrup employed in the study was able to effectively reduce cough severity and sputum viscosity, thereby representing a valid remedy for the management of acute cough induced by URTIs. PMID:23714686

  9. The Relieving Effects of BrainPower Advanced, a Dietary Supplement, in Older Adults with Subjective Memory Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial

    Science.gov (United States)

    Zhu, Jingfen; Shi, Rong; Chen, Su; Dai, Lihua; Shen, Tian; Feng, Yi; Gu, Pingping; Shariff, Mina; Nguyen, Tuong; Ye, Yeats; Rao, Jianyu; Xing, Guoqiang

    2016-01-01

    Subjective memory complaints (SMCs) are common in older adults that can often predict further cognitive impairment. No proven effective agents are available for SMCs. The effect of BrainPower Advanced, a dietary supplement consisting of herbal extracts, nutrients, and vitamins, was evaluated in 98 volunteers with SMCs, averaging 67 years of age (47–88), in a randomized, double-blind, placebo-controlled trial. Subjective hypomnesis/memory loss (SML) and attention/concentration deficits (SAD) were evaluated before and after 12-week supplementation of BrainPower Advanced capsules (n = 47) or placebo (n = 51), using a 5-point memory questionnaire (1 = no/slight, 5 = severe). Objective memory function was evaluated using 3 subtests of visual/audio memory, abstraction, and memory recall that gave a combined total score. The BrainPower Advanced group had more cases of severe SML (severity ⩾ 3) (44/47) and severe SAD (43/47) than the placebo group (39/51 and 37/51, < 0.05, < 0.05, resp.) before the treatment. BrainPower Advanced intervention, however, improved a greater proportion of the severe SML (29.5%)(13/44) (P < 0.01) and SAD (34.9%)(15/43)(P < 0.01) than placebo (5.1% (2/39) and 13.5% (5/37), resp.). Thus, 3-month BrainPower Advanced supplementation appears to be beneficial to older adults with SMCs.

  10. 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

    Directory of Open Access Journals (Sweden)

    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.

  11. Age-response effectiveness of gallopamil for the treatment of myocardial exertional ischemia. A medium-term randomized cross-over double-blind placebo-controlled trial.

    Science.gov (United States)

    Acanfora, D; Odierna, L; De Caprio, L; Longobardi, G; Rengo, C; Guerra, N; Furgi, G; Bollella, O F; Picone, C; Rengo, F

    1995-04-01

    We evaluated the efficacy and safety of gallopamil 150 mg daily in middle-aged and elderly patients with stable exertional ischemia, using a medium-term randomized double-blind cross-over placebo-controlled trial. Twenty middle-aged patients (52.8 +/- 6 years; range 38-61 years) and 14 elderly patients (67.4 +/- 2.8 years; range 65-73 years) with stable exertional ischemia underwent a bicycle exercise test. After a run-in period, both groups received treatment with either placebo or gallopamil 50 mg tid for 28 days. At the end of this time, each patient crossed over to the alternate regimen. Gallopamil significantly reduced heart rate, blood pressure and rate pressure product (from 15.37 +/- 2.7 to 13.65 +/- 4.16 U x 10(-3); p pressure products similar to those reached during placebo at higher work loads. Exercise duration and maximal work load significantly increased in both groups. Electrocardiographic signs of ischemia were favorably influenced by gallopamil in both groups (from 1.39 +/- 0.5 mm to 0.76 +/- 0.73 mm; p < 0.001 in the middle-aged patients and from 1.5 +/- 0.34 mm to 1 +/- 0.76 mm; p < 0.01 in the elderly patients).(ABSTRACT TRUNCATED AT 250 WORDS) PMID:7548266

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

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    Fabiana Valadares

    2013-01-01

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

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

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    Bijan Shahbazkhani

    2015-06-01

    Full Text Available 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 < 0.001. A large number of patients labelled as irritable bowel syndrome are sensitive to 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.

  14. Pilot Study of Aprepitant for Prevention of Post-ERCP Pancreatitis in High Risk Patients: A Phase II Randomized, Double-Blind Placebo Controlled Trial

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    Tilak Upendra Shah

    2012-09-01

    Full Text Available Objectives Animal studies have demonstrated a role for substance P binding to neurokinin-1 receptor in the pathogenesis of acute pancreatitis. Our aim was to assess the efficacy of a neurokinin-1 receptor antagonist (aprepitant at preventing post-ERCP pancreatitis in high risk patients. Design Randomized, double-blind, placebo controlled trial at a single academic medical center. Intervention Patients at high risk for post-ERCP pancreatitis received either placebo or oral aprepitant administered 4 hours prior to ERCP, 80 mg 24 hours after the first dose, and then 80 mg 24 hours after the second dose. Patients Thirty-four patients received aprepitant and 39 patients received placebo. Statistics Fisher’s exact test was used to compare incidence of post-ERCP pancreatitis in the two groups. Results Baseline characteristics were similar between the two groups. Incidence of acute pancreatitis was 7 in the aprepitant group and 7 in the placebo group. Hospitalization within 7 days post-procedure for abdominal pain that did not meet criteria for acute pancreatitis occurred in 6 and 9 patients in the aprepitant and placebo groups respectively (P=0.772. Conclusions Aprepitant did not lower incidence of post-ERCP pancreatitis in this preliminary human study. Larger studies potentially using the recently available intravenous formulation are necessary to conclusively clarify the efficacy of aprepitant in this setting.

  15. A Randomised, Double-Blind, Placebo-Controlled Trial with Vitamin D3 in MS: Subgroup Analysis of Patients with Baseline Disease Activity Despite Interferon Treatment

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    J. Åivo

    2012-01-01

    Full Text Available We present a subgroup analysis of the first double-blind, placebo-controlled, randomised trial with vitamin D3 in MS. In the overall study population, there were 34 patients in the vitamin D arm and 32 patients in the placebo arm. All the patients were using interferon-β-1b (IFNB therapy. The subgroup consisted of 15 patients in the vitamin D arm and 15 patients in the placebo arm, who had either at least one relapse during the year preceding the study or enhancing T1 lesions at the baseline MRI scan. We measured the total number of MRI T1 enhancing lesions, the number of new/enlarging T2 lesions and T2 lesion volume (BOD (mm3, EDSS (Expanded Disability Status Scale, annual relapse Rate (ARR, timed 25-foot walk (T25FW, and timed 10-foot tandem walk (TT10W at baseline and at 12 months in the vitamin D-treated and in the placebo-treated patients. There was a statistically significant reduction in the number of T1 enhancing lesions, a smaller T2 lesion volume growth and less new/enlarging T2 brain MRI lesions in the vitamin D3-treated than in the placebo-treated subgroup patients. The MRI results were slightly more pronounced in the subgroup than in the overall study population.

  16. 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

    2016-01-01

    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. PMID:27023596

  17. 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

  18. Impact of Preemptive Fibrinogen Concentrate on Transfusion Requirements in Liver Transplantation: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Sabate, A; Gutierrez, R; Beltran, J; Mellado, P; Blasi, A; Acosta, F; Costa, M; Reyes, R; Torres, F

    2016-08-01

    We hypothesized that preemptive fibrinogen administration to obtain an initial plasma level of 2.9 g/L would reduce transfusion requirements in liver transplantation. A randomized, multicenter, hemoglobin-stratified, double-blind, fibrinogen-versus-saline-controlled trial was conducted. The primary end point was the percentage of patients requiring red blood cells. We evaluated 51 patients allocated to fibrinogen and 48 allocated to saline; the primary end point was assessed using data for 92 patients because the electronic record forms were offline for three patients in the fibrinogen group and four in the saline group. We injected a median of 3.54 g fibrinogen preemptively in the fibrinogen group. Nine patients in the saline group (20.9%) required fibrinogen at graft reperfusion (compared with one patient [2.1%] in the fibrinogen group; p = 0.005). Blood was transfused to 52.9% (95% confidence interval [CI] 42.5-63.3%) in the fibrinogen group and 42.74% (95% CI 28.3-57.2%) in the saline group (p = 0.217). Relative risk for blood transfusion was 0.80 (95% CI 0.57-1.13). Thrombotic events occurred in one patient (2.1%) and five patients (11.4%) in the fibrinogen and saline groups, respectively. Seven patients (14.6%) in the fibrinogen group and nine (20.3%) in the saline group required reoperation. Preemptive administration of fibrinogen concentrate did not influence transfusion requirements. PMID:26880105

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

    Directory of Open Access Journals (Sweden)

    Abbas Javadzadeh Bolouri

    2015-10-01

    Full Text Available 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.

  20. 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.

  1. Cellular therapy with Ixmyelocel-T to treat critical limb ischemia: the randomized, double-blind, placebo-controlled RESTORE-CLI trial.

    Science.gov (United States)

    Powell, Richard J; Marston, William A; Berceli, Scott A; Guzman, Raul; Henry, Timothy D; Longcore, Amy T; Stern, Theresa P; Watling, Sharon; Bartel, Ronnda L

    2012-06-01

    Ixmyelocel-T is a patient-specific, expanded, multicellular therapy evaluated in patients with lower extremity critical limb ischemia (CLI) with no options for revascularization. This randomized, double-blind, placebo-controlled, phase 2 trial (RESTORE-CLI) compared the efficacy and safety of intramuscular injections of ixmyelocel-T with placebo. Patients received one-time injections over 20 locations in a single leg and were followed for 12 months. Safety assessments included occurrence of adverse events. Efficacy assessments included time to first occurrence of treatment failure (TTF; major amputation of injected leg; all-cause mortality; doubling of total wound surface area from baseline; de novo gangrene) and amputation-free survival (AFS; major amputation of injected leg; all-cause mortality). A total of 77 patients underwent bone marrow or sham aspiration; 72 patients received ixmyelocel-T (48 patients) or placebo (24 patients). Adverse event rates were similar. Ixmyelocel-T treatment led to a significantly prolonged TTF (P = 0.0032, logrank test). AFS had a clinically meaningful 32% reduction in event rate that was not statistically significant (P = 0.3880, logrank test). Treatment effect in post hoc analyses of patients with baseline wounds was more pronounced (TTF: P < 0.0001, AFS: P = 0.0802, logrank test). Ixmyelocel-T treatment was well tolerated and may offer a potential new treatment option. PMID:22453769

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2012-06-01

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

  3. A double-blind, placebo-controlled, crossover trial of the selective dopamine D1 receptor antagonist ecopipam in patients with Lesch-Nyhan disease.

    Science.gov (United States)

    Khasnavis, Tanya; Torres, Rosa J; Sommerfeld, Barbara; Puig, Juan Garcia; Chipkin, Richard; Jinnah, H A

    2016-07-01

    Lesch-Nyhan disease (LND) is a genetic disorder that has characteristic metabolic, neurologic, and behavioral features. There are multiple behavioral problems including impulsivity, aggressiveness, and severe recurrent self-injurious behavior (SIB). This last behavior varies considerably across subjects and may encompass self-biting, self-hitting, scratching, head banging, and other injurious actions. Current treatments for SIB involve behavioral extinction, sedatives, physical restraints, and removal of teeth. Because these interventions do not reliably control SIB, better treatments are urgently needed. Animal studies have suggested that D1-dopamine receptor antagonists such as ecopipam may suppress SIB. These observations have led to proposals that such drugs might provide effective treatment for in LND. The current study describes the results of a double-blind, three-period, crossover trial of a single dose of ecopipam in subjects with LND. The study was designed for 20 patients, but it was terminated after recruitment of only 10 patients, because interim analysis revealed unanticipated side effects. These side effects were most likely related to starting with a single large dose without any titration phase. Despite the limited data due to early termination, the drug appeared to reduce SIB in most cases. Subjects who completed the trial were eligible to continue the drug in an open-label extension phase lasting a year, and one patient who elected to continue has maintained a striking reduction in SIB for more than a year with no apparent side effects. These results suggest ecopipam could be a useful treatment for SIB in, but further studies are needed to establish an appropriate dosing regimen. PMID:27179999

  4. Oxidative Stress Responses to Nigella sativa Oil Concurrent with a Low-Calorie Diet in Obese Women: A Randomized, Double-Blind Controlled Clinical Trial.

    Science.gov (United States)

    Namazi, Nazli; Mahdavi, Reza; Alizadeh, Mohammad; Farajnia, Safar

    2015-11-01

    The aim of the present study was to determine the effects of Nigella sativa (NS) oil concurrent with a low-calorie diet on lipid peroxidation and oxidative status in obese women. In this double-blind placebo-controlled randomized clinical trial, 50 volunteer obese (body mass index = 30-35 kg/m(2)) women aged 25-50 years old were recruited. Participants were randomly divided into intervention (n = 25) and placebo (n = 25) groups. They received a low-calorie diet with 3 g/day NS oil or low-calorie diet with 3 g/day placebo for 8 weeks. Forty-nine women (intervention group = 25; placebo group = 24) completed the trial. NS oil concurrent with a low-calorie diet decreased weight in the NS group compared to the placebo group (-4.80 ± 1.50 vs. -1.40 ± 1.90 kg; p < 0.01). Comparison of red blood cell superoxidase dismutase (SOD) indicated significant changes in the NS group compared to the placebo group at the end of the study (88.98 ± 87.46 vs. -3.30 ± 109.80 U/gHb; p < 0.01). But no significant changes in lipid peroxidation, glutathione peroxidase, and total antioxidant capacity concentrations were observed. NS oil concurrent with a low-calorie diet decreased weight and increased SOD levels in obese women. However, more studies are suggested to confirm the positive effects of NS in obesity and its complications. PMID:26179113

  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. Effect of family members’ voice on level of consciousness of comatose patients admitted to the intensive care unit: A single-blind randomized controlled trial

    Science.gov (United States)

    Tavangar, Hossein; Shahriary-Kalantary, Manijeh; Salimi, Tahereh; Jarahzadeh, Mohammadhossein; Sarebanhassanabadi, Mohammadtaghi

    2015-01-01

    Background: Coma is one of the most important complications of brain injury. Comatose patients in the intensive care units are exposed to sensory deprivation. This study aims to survey the effect of family members’ voice on level of consciousness of comatose patients hospitalized in the intensive care units. Materials and Methods: In this single-blind randomized controlled trial, 40 comatose patients with brain injury with acute subdural hematoma in intensive care units were randomly assigned into two groups. The intervention group was stimulated twice a day each time 5-15 min with a recorded MP3 from family members’ voice for 10 days. The patients’ level of consciousness was measured with Glasgow Coma Scale before and after auditory stimulations. In the control group, GCS was measured without auditory stimulation with the same time duration like intervention group. Data analysis in software SPSS version 15 and using Chi-square test, independent t-test, paired t- test and analysis of variance with repeated measures was done. Results: On the first day before the intervention, there was no a statistically significant difference between the mean of GCS in both groups (P = 0.89), but on the tenth day after the intervention, there was a significant difference (P = 0.0001) between the mean GCS in both control and intervention groups. Also, there was a significant difference between the mean daily GCS scores in two groups (P = 0.003). The findings during ten days showed the changes in the level of consciousness in the intervention group from the 4rd day of the study were more in the mean daily GCS scores than control group. Conclusion: This study indicated that family members’ voice can increase level of consciousness of comatose patients with acute subdural hematoma. PMID:26261808

  7. Serum metabolomics profiles in response to n-3 fatty acids in Chinese patients with type 2 diabetes: a double-blind randomised controlled trial

    Science.gov (United States)

    Zheng, Ju-Sheng; Lin, Mei; Imamura, Fumiaki; Cai, Wenwen; Wang, Ling; Feng, Jue-Ping; Ruan, Yue; Tang, Jun; Wang, Fenglei; Yang, Hong; Li, Duo

    2016-01-01

    We aimed to investigate the change of serum metabolomics in response to n-3 fatty acid supplements in Chinese patients with type 2 diabetes (T2D). In a double-blind parallel randomised controlled trial, 59 Chinese T2D patients were randomised to receive either fish oil (FO), flaxseed oil (FSO) or corn oil capsules (CO, served as a control group) and followed up for 180 days. An additional 17 healthy non-T2D participants were recruited at baseline for cross-sectional comparison between cases and non-cases. A total of 296 serum metabolites were measured among healthy controls and T2D patients before and after the intervention. Serum 3-carboxy-4-methyl-5-propyl-2-furanpropanoate (CMPF) (P-interaction = 1.8 × 10−7) was the most significant metabolite identified by repeated-measures ANOVA, followed by eicosapentaenoate (P-interaction = 4.6 × 10−6), 1-eicosapentaenoylglycerophosphocholine (P-interaction = 3.4 × 10−4), docosahexaenoate (P-interaction = 0.001), linolenate (n-3 or n-6, P-interaction = 0.005) and docosapentaenoate (n-3, P-interaction = 0.021). CMPF level was lower in T2D patients than in the healthy controls (P = 0.014) and it was significantly increased in the FO compared with CO group (P = 1.17 × 10−7). Furthermore, change of CMPF during the intervention was negatively correlated with change of serum triglycerides (P = 0.016). In conclusion, furan fatty acid metabolite CMPF was the strongest biomarker of fish oil intake. The association of CMPF with metabolic markers warrants further investigation. PMID:27404516

  8. Intravenous iron isomaltoside 1000 (Monofer®) reduces postoperative anaemia in preoperatively non-anaemic patients undergoing elective or subacute coronary artery bypass graft, valve replacement or a combination thereof: a randomized double-blind placebo-controlled clinical trial (the PROTECT trial)

    OpenAIRE

    Johansson, P. I.; Rasmussen, A.S.; Thomsen, L. L.

    2015-01-01

    Background and Objectives This trial explores whether intravenous iron isomaltoside 1000 (Monofer®) results in a better regeneration of haemoglobin levels and prevents anaemia compared to placebo in preoperative non-anaemic patients undergoing cardiac surgery. Study Design and Methods The trial is a prospective, double-blind, comparative, placebo-controlled trial of 60 non-anaemic patients undergoing cardiac surgery. The patients were randomized 1:1 to either 1000 mg intravenous iron isomalto...

  9. Intrathecal opioid versus ultrasound guided fascia iliaca plane block for analgesia after primary hip arthroplasty: study protocol for a randomised, blinded, noninferiority controlled trial

    Directory of Open Access Journals (Sweden)

    Kinsella John

    2011-02-01

    Full Text Available Abstract Background Hip replacement surgery is increasingly common due to an ageing population, and rising levels of obesity. The provision of excellent pain relief with minimal side effects is important in order to facilitate patient mobilisation and rehabilitation. Spinal opioids provide excellent analgesia but are associated with adverse effects. The fascia-iliaca block is an alternative technique which provides analgesia to the nerves innervating the hip. The success of fascia iliaca blocks has been demonstrated to be superior when using ultrasound compared to landmark techniques. However, the clinical benefit of this improvement has yet to be investigated. The aim of this study is to compare the efficacy and safety of ultrasound guided fascia iliaca block with spinal morphine for hip replacement surgery. Methods/Design This study is a randomised, blinded, placebo-controlled, noninferiority trial. Patients scheduled to undergo unilateral primary hip arthroplasty will receive a study information sheet and consent will be obtained in keeping with the Declaration of Helsinki. Patients will be randomised to receive either; (i Ultrasound guided fascia iliaca block using levobupivacaine, plus spinal anaesthesia with hyperbaric bupivacaine containing no morphine, or (ii sham ultrasound guided fascia iliaca block performed with sterile saline, and spinal anaesthesia containing hyperbaric bupivacaine and 0.1 mg of spinal morphine. A total of 108 patients will be recruited. Primary outcome is post-operative morphine consumption in a 24 hour period. Secondary outcomes include; pain scores at 3, 6, 12, 24, 36 and 48 hours, episodes of respiratory depression, hypotension, nausea and vomiting, pruritus, sedation, time to first mobilisation and patient satisfaction. Conclusions There are no studies to date comparing ultrasound guided fascia iliaca block with spinal morphine for pain control after hip arthroplasty. If the ultrasound guided fascia iliaca

  10. Randomised controlled double-blind non-inferiority trial of two antivenoms for saw-scaled or carpet viper (Echis ocellatus envenoming in Nigeria.

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    Isa S Abubakar

    Full Text Available BACKGROUND: In West Africa, envenoming by saw-scaled or carpet vipers (Echis ocellatus causes great morbidity and mortality, but there is a crisis in supply of effective and affordable antivenom (ISRCTN01257358. METHODS: In a randomised, double-blind, controlled, non-inferiority trial, "EchiTAb Plus-ICP" (ET-Plus equine antivenom made by Instituto Clodomiro Picado was compared to "EchiTAb G" (ET-G ovine antivenom made by MicroPharm, which is the standard of care in Nigeria and was developed from the original EchiTAb-Fab introduced in 1998. Both are caprylic acid purified whole IgG antivenoms. ET-G is monospecific for Echis ocellatus antivenom (initial dose 1 vial and ET-Plus is polyspecific for E. ocellatus, Naja nigricollis and Bitis arietans (initial dose 3 vials. Both had been screened by pre-clinical and preliminary clinical dose-finding and safety studies. Patients who presented with incoagulable blood, indicative of systemic envenoming by E. ocellatus, were recruited in Kaltungo, north-eastern Nigeria. Those eligible and consenting were randomly allocated with equal probability to receive ET-Plus or ET-G. The primary outcome was permanent restoration of blood coagulability 6 hours after the start of treatment, assessed by a simple whole blood clotting test repeated 6, 12, 18, 24 and 48 hr after treatment. Secondary (safety outcomes were the incidences of anaphylactic, pyrogenic and late serum sickness-type antivenom reactions. FINDINGS: Initial doses permanently restored blood coagulability at 6 hours in 161/194 (83.0% of ET-Plus and 156/206 (75.7% of ET-G treated patients (Relative Risk [RR] 1.10 one-sided 95% CI lower limit 1.01; P = 0.05. ET-Plus caused early reactions on more occasions than did ET-G [50/194 (25.8% and 39/206 (18.9% respectively RR (1.36 one-sided 95% CI 1.86 upper limit; P = 0.06. These reactions were classified as severe in 21 (10.8% and 11 (5.3% of patients, respectively. CONCLUSION: At these doses, ET-Plus was

  11. Recombinant human growth hormone and rosiglitazone for abdominal fat accumulation in HIV-infected patients with insulin resistance: a randomized, double-blind, placebo-controlled, factorial trial.

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    Marshall J Glesby

    Full Text Available BACKGROUND: Recombinant human growth hormone (rhGH reduces visceral adipose tissue (VAT volume in HIV-infected patients but can worsen glucose homeostasis and lipoatrophy. We aimed to determine if adding rosiglitazone to rhGH would abrogate the adverse effects of rhGH on insulin sensitivity (SI and subcutaneous adipose tissue (SAT volume. METHODOLOGY/PRINCIPAL FINDINGS: Randomized, double-blind, placebo-controlled, multicenter trial using a 2×2 factorial design in which HIV-infected subjects with abdominal obesity and insulin resistance were randomized to rhGH 3 mg daily, rosiglitazone 4 mg twice daily, combination rhGH + rosiglitazone, or double placebo (control for 12 weeks. The primary endpoint was change in SI by frequently sampled intravenous glucose tolerance test from entry to week 12. Body composition was assessed by whole body magnetic resonance imaging (MRI and dual Xray absorptiometry (DEXA. Seventy-seven subjects were randomized of whom 72 initiated study drugs. Change in SI from entry to week 12 differed across the 4 arms by 1-way ANCOVA (P = 0.02; by pair-wise comparisons, only rhGH (decreasing SI; P = 0.03 differed significantly from control. Changes from entry to week 12 in fasting glucose and glucose area under the curve on 2-hour oral glucose tolerance test differed across arms (1-way ANCOVA P = 0.004, increasing in the rhGH arm relative to control. VAT decreased significantly in the rhGH arms (-17.5% in rhGH/rosiglitazone and -22.7% in rhGH but not in the rosiglitazone alone (-2.5% or control arms (-1.9%. SAT did not change significantly in any arm. DEXA results were consistent with the MRI data. There was no significant rhGH x rosiglitazone interaction for any body composition parameter. CONCLUSIONS/SIGNIFICANCE: The addition of rosiglitazone abrogated the adverse effects of rhGH on insulin sensitivity and glucose tolerance while not significantly modifying the lowering effect of rhGH on VAT. TRIAL REGISTRATION

  12. Acetaminophen and diphenhydramine as premedication for platelet transfusions: a prospective randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Wang, Stephen E; Lara, Primo N; Lee-Ow, Angie; Reed, Jeanne; Wang, Lori R; Palmer, Patti; Tuscano, Joseph M; Richman, Carol M; Beckett, Laurel; Wun, Ted

    2002-07-01

    Non-hemolytic transfusion reactions (NHTR) occur in up to 30% of patients receiving platelet transfusions. Premedication with acetaminophen and diphenhydramine is a common strategy to prevent NHTR, but its efficacy has not been studied. In this prospective trial, transfusions in patients receiving pre-storage leukocyte-reduced single-donor apheresis platelets (SDP) were randomized to premedication with either acetaminophen 650 mg PO and diphenhydramine 25 mg IV, or placebo. Fifty-one patients received 98 transfusions. Thirteen patients had 15 NHTR: 15.4% (8/52) in the treatment arm and 15.2% (7/46) in the placebo arm. Premedication prior to transfusion of pre-storage leukocyte reduced SDP does not significantly lower the incidence of NHTR as compared to placebo. PMID:12111764

  13. Transcranial direct current stimulation and exercises for treatment of chronic temporomandibular disorders: a blind randomised-controlled trial.

    Science.gov (United States)

    Oliveira, L B; Lopes, T S; Soares, C; Maluf, R; Goes, B T; Sá, K N; Baptista, A F

    2015-10-01

    To evaluate the effect of adding transcranial direct current stimulation (tDCS) to exercises for chronic pain, dysfunction and quality of life in subjects with temporomandibular disorders (TMD). Participants were selected based on the RDC/TMD criteria and assessed for pain intensity, pressure pain threshold over temporomandibular joint and cervical muscles and quality of life. After initial assessment, all individuals underwent a 4-week protocol of exercises and manual therapy, together with active or sham primary motor cortex tDCS. Stimulation was delivered through sponge electrodes, with 2 mA amplitude, for 20 min daily, over the first 5 days of the trial. A total of 32 subjects (mean age 24.7 ± 6.8 years) participated in the evaluations and treatment protocol. Mean pain intensity pre-treatment was 5.5 ± 1.4 for active tDCS group, and 6.3 ± 1.2 for sham tDCS. Both groups showed a decrease in pain intensity scores during the trial period (time factor--F(4.5,137.5) = 28.7, P 0.05). Pressure pain thresholds decrease and improvement in quality of life were also noticeable in both groups, but again without significant differences between them. Absolute benefit increase was 37.5% (CI 95%: -15.9% to 90.9%), and number needed to treat was 2.66. This study suggests that there is no additional benefit in adding tDCS to exercises for the treatment of chronic TMD in young adults. PMID:25891021

  14. Occupant satisfaction with two blind control strategies

    DEFF Research Database (Denmark)

    Karlsen, Line Røseth; Heiselberg, Per Kvols; Bryn, Ida

    2015-01-01

    Highlights •Occupant satisfaction with two blind control strategies has been studied. •Control based on cut-off position of slats was more popular than closed slats. •Results from the study are helpful in development of control strategies for blinds. •The results give indications of how blinds...

  15. 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.

  16. Concord grape juice supplementation reduces blood pressure in Korean hypertensive men: double-blind, placebo controlled intervention trial.

    Science.gov (United States)

    Park, Yoo Kyoung; Kim, Jung-Shin; Kang, Myung-Hee

    2004-01-01

    Many of the flavonoids found in grapes and grape products such as juice or wine have been known to exert antioxidant, anti-inflammatory, platelet inhibitory and arterial relaxing effects either in vitro, in animal studies and in human trials. This study was designed to test the effect of Concord grape juice consumption on altering blood pressure in hypertensive patients. Forty subjects were given 5.5 ml/kg body weight/day of either Concord grape juice (CGJ) or a calorie-matched placebo drink every day for 8 weeks. Blood pressure (BP) was measured on weeks 0, 4 and 8. Compared to baseline, in the CGJ group systolic BP was reduced on average by 7.2 mm Hg (p = 0.005) and diastolic BP was reduced on average by 6.2 mm Hg (p = 0.001) at the end of 8 weeks. Comparable changes in the group getting the placebo product were -3.5 mm Hg (NS) and -3.2 mm Hg (p = 0.05) Consuming Concord grape juice, which is high in polyphenolic compounds, may favorably affect BP in hypertensive individuals. PMID:15630270

  17. The effects of melatonin versus placebo on delirium in hip fracture patients: study protocol of a randomised, placebo-controlled, double blind trial

    Directory of Open Access Journals (Sweden)

    van Velde Romuald

    2011-07-01

    Full Text Available Abstract Background With an ageing population, older persons become a larger part of the hospital population. The incidence of delirium is high in this group, and experiencing delirium has major short- and long-term sequelae, which makes prevention crucial. During delirium, a disruption of the sleep-wake cycle is frequently observed. Melatonin plays an important role in the regulation of the sleep-wake cycle, so this raised the hypothesis that alterations in the metabolism of melatonin might play an important role in the development of delirium. The aim of this article is to describe the design of a randomised, placebo controlled double-blind trial that is currently in progress and that investigates the effects of melatonin versus placebo on delirium in older, postoperative hip fracture patients. Methods/Design Acutely hospitalised patients aged 65 years or older admitted for surgical repair of hip fracture are randomised (n = 452 into a treatment or placebo group. Prophylactic treatment consists of orally administered melatonin (3 mg at 21:00 h on five consecutive days. The primary outcome is the occurrence of delirium, to be diagnosed according to the Confusion Assessment Method, within eight days after start of the study medication. Secondary outcomes are delirium severity, measured by the Delirium Rating Scale; duration of delirium; differences in subtypes of delirium; differences in total length of hospital stay; total dose of antipsychotics and/or benzodiazepine use during delirium; and in-hospital complications. In the twelve-month follow up visit, cognitive function is measured by a Mini-Mental state examination and the Informant Questionnaire on Cognitive Decline in the Elderly. Functional status is assessed with the Katz ADL index score (patient and family version and grip strength measurement. The outcomes of these assessments are compared to the outcomes that were obtained during admission. Discussion The proposed study will

  18. Minimally invasive computer-navigated total hip arthroplasty, following the concept of femur first and combined anteversion: design of a blinded randomized controlled trial

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    Woerner Michael

    2011-08-01

    Full Text Available Abstract Background Impingement can be a serious complication after total hip arthroplasty (THA, and is one of the major causes of postoperative pain, dislocation, aseptic loosening, and implant breakage. Minimally invasive THA and computer-navigated surgery were introduced several years ago. We have developed a novel, computer-assisted operation method for THA following the concept of "femur first"/"combined anteversion", which incorporates various aspects of performing a functional optimization of the cup position, and comprehensively addresses range of motion (ROM as well as cup containment and alignment parameters. Hence, the purpose of this study is to assess whether the artificial joint's ROM can be improved by this computer-assisted operation method. Second, the clinical and radiological outcome will be evaluated. Methods/Design A registered patient- and observer-blinded randomized controlled trial will be conducted. Patients between the ages of 50 and 75 admitted for primary unilateral THA will be included. Patients will be randomly allocated to either receive minimally invasive computer-navigated "femur first" THA or the conventional minimally invasive THA procedure. Self-reported functional status and health-related quality of life (questionnaires will be assessed both preoperatively and postoperatively. Perioperative complications will be registered. Radiographic evaluation will take place up to 6 weeks postoperatively with a computed tomography (CT scan. Component position will be evaluated by an independent external institute on a 3D reconstruction of the femur/pelvis using image-processing software. Postoperative ROM will be calculated by an algorithm which automatically determines bony and prosthetic impingements. Discussion In the past, computer navigation has improved the accuracy of component positioning. So far, there are only few objective data quantifying the risks and benefits of computer navigated THA. Therefore, this

  19. A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor

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    Yokoyama Sayaka

    2008-12-01

    Full Text Available Abstract Background Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2, however, its clinical efficacies on oral malodor have been evaluated only with organoleptic measurements (OM or sulphide monitors. No clinical studies have investigated the inhibitory effects of ClO2 on volatile sulfur compounds (VSCs using gas chromatography (GC. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor using OM and GC. Methods A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups. In the first test phase, the group 1 subjects (N = 8 were instructed to rinse with the experimental mouthwash containing ClO2, and those in group 2 (N = 7 to rinse with the placebo mouthwash without ClO2. In the second test, phase after a one week washout period, each group used the opposite mouthwash. Oral malodor was evaluated before rinsing, right after rinsing and every 30 minutes up to 4 hours with OM, and concentrations of hydrogen sulfide (H2S, methyl mercaptan (CH3SH and dimethyl sulfide ((CH32S, the main VSCs of human oral malodor, were evaluated with GC. Results The baseline oral condition in the subjects in the 2 groups did not differ significantly. The mouthwash containing ClO2 improved morning bad breath according to OM and reduced concentrations of H2S, CH3SH and (CH32S according to GC up to 4 hours after rinsing. OM scores with ClO2 were significantly lower than those without ClO2 at all examination times. Significant reductions in the concentrations of the three kinds of VSCs measured by GC were also evident at all examination times. The concentrations of the three gases with ClO2 were significantly lower than those without ClO2 at most examination times. Conclusion In this explorative study, ClO2 mouthwash was effective at reducing morning malodor for 4

  20. A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating an Oral Anti-aging Skin Care Supplement for Treating Photodamaged Skin

    Science.gov (United States)

    Sigler, Monya L.; Hino, Peter D.; Moigne, Anne Le; Dispensa, Lisa

    2016-01-01

    Objective: Evaluate an anti-aging skin care supplement on the appearance of photodamaged skin. Design: Randomized, double-blind, placebo-controlled clinical trial. Following a one-month washout period, subjects received two anti-aging skin care formula tablets (total daily dose: marine complex 210mg, vitamin C 54mg, zinc 4mg) or placebo daily for 16 weeks. Subjects were restricted from products/procedures that may affect the condition/appearance of skin, including direct facial sun or tanning bed exposure. Participants utilized a standardized facial cleanser and SPF15 moisturizer. Setting: Single study center (Texas, United States; June-November 2007). Participants: Healthy women aged 35 to 60 years (mean, 50 years), Fitzpatrick skin type I-IV, modified Glogau type II—III. Measurements: Subjects were assessed at Weeks 6, 12, and 16 on clinical grading (0-10 VAS), bioinstrumentation, digital photography, and self-assessments. Analysis of variance with treatment in the model was used for between-group comparisons (alpha P≤0.05). Results: Eighty-two anti-aging skin care formula subjects and 70 placebo subjects completed the study. Significant differences in change from baseline to Week 16 scores were observed for clinical grading of overall facial appearance (0.26; P<0.0001), radiant complexion (0.59; P<0.0001), periocular wrinkles (0.08; P<0.05), visual (0.56; P<0.0001) and tactile (0.48; P<0.0001) roughness, and mottled hyperpigmentation (0.15; P<0.001) favoring the subjects in the anti-aging skin care supplement group. Ultrasound skin density (Week 16) was significantly reduced for placebo versus anti-aging skin care supplement group (-1.4% vs. 0%; P<0.01). Other outcomes were not significant. Mild gastrointestinal symptoms possibly related to the anti-aging skin care supplement (n=1) and placebo (n=2) were observed. Conclusion: Women with photodamaged skin receiving anti-aging skin care supplement showed significant improvements in the appearance of facial

  1. Therapeutic effect of Jinzhen oral liquid for hand foot and mouth disease: a randomized, multi-center, double-blind, placebo-controlled trial.

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    Jun Liu

    Full Text Available BACKGROUND: No specific antiviral agent against hand foot and mouth disease (HFMD is available for clinical practice today. OBJECTIVE: To evaluate the efficacy and safety of Jinzhen oral solution in treating uncomplicated HFMD. METHODS: In this randomized, double-blind, placebo-controlled trial, 399 children aged 1 to 7 years with laboratory confirmed HFMD were randomized to receive Jinzhen oral liquid or placebo 3 times daily for 7 days with a 3-day follow-up. The primary outcomes were time to the first disappearance of oral ulcers and vesicles on hand or foot and time to the first normalization of temperature (fever clearance. RESULTS: There were 199 children enrolling into the Jinzhen group including 79 with fever and 200 into the placebo group including 93 with fever. Jinzhen reduced the time to the first disappearance of oral ulcers and vesicles on hand or foot to 4.9 days (95% CI, 4.6 to 5.2 days, compared with 5.7 days (95% CI, 5.4 to 6.0 days in the placebo group (P = 0.0036. The median time of fever clearance was shorter in the 79 children who received Jinzhen (43.41 hrs, 95% CI, 37.05 to 49.76 than that in the 93 children who received placebo (54.92 hrs, 95% CI, 48.16 to 61.68 (P = 0.0161. Moreover, Jinzhen reduced the risk of symptoms by 28.5% compared with placebo (HR, 0.7150, 95% CI, 0.5719 to 0.8940, P = 0.0032. More importantly, treatment failure rate was significantly lower in the Jinzhen group (8.04% compared with that in the placebo group (15.00% (P = 0.0434. The incidence of serious adverse events did not differ significantly between the two groups (9 in Jinzhen group vs. 18 in placebo, P = 0.075. CONCLUSIONS: Children with HFMD may benefit from Jinzhen oral liquid treatment as compared with placebo. TRIAL REGISTRATION: Chinese Clinical Trial Registry (http://www.chictr.org/en/ ChiCTR-TRC-10000937.

  2. Dexamethasone for the prevention of a pain flare after palliative radiotherapy for painful bone metastases: a multicenter double-blind placebo-controlled randomized trial

    International Nuclear Information System (INIS)

    Radiotherapy has a good effect in palliation of painful bone metastases, with a pain response rate of more than 60%. However, shortly after treatment, in approximately 40% of patients a temporary pain flare occurs, which is defined as a two-point increase of the worst pain score on an 11-point rating scale compared to baseline, without a decrease in analgesic intake, or a 25% increase in analgesic intake without a decrease in worst pain score, compared to baseline. A pain flare has a negative impact on daily functioning and mood of patients. It is thought to be caused by periostial edema after radiotherapy. Dexamethasone might diminish this edema and thereby reduce the incidence of pain flare. Two non-randomized studies suggest that dexamethasone reduces the incidence of a pain flare by 50%. The aim of this trial is to study the effectiveness of dexamethasone to prevent a pain flare after palliative radiotherapy for painful bone metastases and to determine the optimal dose schedule. This study is a three-armed, double-blind, placebo-controlled multicenter trial. We aim to include 411 patients with uncomplicated painful bone metastases from any type of primary solid tumor who receive short schedule radiotherapy (all conventional treatment schedules from one to six fractions). Arm 1 consists of daily placebo for four days, arm 2 starts with 8 mg dexamethasone before the (first) radiotherapy and three days placebo thereafter. Arm 3 consists of four days 8 mg dexamethasone. The primary endpoint is the occurrence of a pain flare. Secondary endpoints are pain, quality of life and side-effects of dexamethasone versus placebo. Patients complete a questionnaire (Brief Pain Inventory with two added questions about side-effects of medication, the EORTC QLQ-C15-PAL and QLQ-BM22 for quality of life) at baseline, daily for two weeks and lastly at four weeks. This study will show whether dexamethasone is effective in preventing a pain flare after palliative radiotherapy for

  3. Skin-whitening and skin-condition-improving effects of topical oxidized glutathione: a double-blind and placebo-controlled clinical trial in healthy women

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    Watanabe F

    2014-10-01

    Full Text Available Fumiko Watanabe,1 Erika Hashizume,1 Gertrude P Chan,2 Ayako Kamimura11Healthcare Products Development Center, KYOWA HAKKO BIO CO., LTD., Tsukuba, Ibaraki, Japan; 2Clinical Trial Management and Testing Associates, Inc., Filinvest Corporate City, Alabang, Muntinlupa City, PhilippinesPurpose: Glutathione is a tripeptide consisting of cysteine, glycine, and glutamate and functions as a major antioxidant. It is synthesized endogenously in humans. Glutathione protects thiol protein groups from oxidation and is involved in cellular detoxification for maintenance of the cell environment. Reduced glutathione (GSH has a skin-whitening effect in humans through its tyrosinase inhibitory activity, but in the case of oxidized glutathione (GSSG this effect is unclear. We examined the skin-whitening and skin-condition effects of topical GSSG in healthy women.Subjects and methods: The subjects were 30 healthy adult women aged 30 to 50 years. The study design was a randomized, double-blind, matched-pair, placebo-controlled clinical trial. Subjects applied GSSG 2% (weight/weight [w/w] lotion to one side of the face and a placebo lotion to the other side twice daily for 10 weeks. We objectively measured changes in melanin index values, moisture content of the stratum corneum, smoothness, wrinkle formation, and elasticity of the skin. The principal investigator and each subject also used subjective scores to investigate skin whitening, wrinkle reduction, and smoothness. Analysis of variance was used to evaluate differences between groups.Results: The skin melanin index was significantly lower with GSSG treatment than with placebo from the early weeks after the start of the trial through to the end of the study period (at 10 weeks, P<0.001. In addition, in the latter half of the study period GSSG-treated sites had significant increases in moisture content of the stratum corneum, suppression of wrinkle formation, and improvement in skin smoothness. There were no

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

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    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.

  5. 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.

  6. Growth and tolerance of infants fed formula supplemented with polydextrose (PDX and/or galactooligosaccharides (GOS: double-blind, randomized, controlled trial

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    Ashley Claude

    2012-06-01

    Full Text Available Abstract Background To ensure the suitability of an infant formula as the sole source of nutrition or provide benefits similar to outcomes in breastfed infants, advancements in formula composition are warranted as more research detailing the nutrient composition of human milk becomes available. This study was designed to evaluate growth and tolerance in healthy infants who received one of two investigational cow’s milk-based formulas with adjustments in carbohydrate, fat, and calcium content and supplemented with a prebiotic blend of polydextrose (PDX and galactooligosaccharides (GOS or GOS alone. Methods In this multi-center, double-blind, parallel-designed, gender-stratified prospective study 419 infants were randomized and consumed either a marketed routine cow’s milk-based infant formula (Control; Enfamil® LIPIL®, Mead Johnson Nutrition, Evansville, IN (n = 142 or one of two investigational formulas from 14 to 120 days of age. Investigational formulas were supplemented with 4 g/L (1:1 ratio of a prebiotic blend of PDX and GOS (PDX/GOS; n = 139 or 4 g/L of GOS alone (GOS; n = 138. Anthropometric measurements were taken at 14, 30, 60, 90, and 120 days of age. Daily recall of formula intake, tolerance, and stool characteristics was collected during study weeks 1 and 2 and 24-h recall was collected at 60, 90, and 120 days of age. Medically-confirmed adverse events were recorded throughout the study. Results There were no group differences in growth rate from 14 to 120 days of age. Discontinuation rates were not significantly different among study groups. No differences in formula intake or infant fussiness or gassiness were observed. During study weeks 1 and 2 and at 60 days of age stool consistency ratings were higher (i.e. softer stools for infants in the PDX/GOS and GOS groups versus Control and remained higher at 120 days for the PDX/GOS group (all P  Conclusions Investigational routine infant formulas

  7. Efficacy of Low-Level Laser Therapy in Relieving Nipple Pain in Breastfeeding Women: A Triple-Blind, Randomized, Controlled Trial.

    Science.gov (United States)

    Coca, Kelly Pereira; Marcacine, Karla Oliveira; Gamba, Mônica Antar; Corrêa, Luciana; Aranha, Ana Cecília Corrêa; Abrão, Ana Cristina Freitas de Vilhena

    2016-08-01

    Pain accruing from nipple lesions caused by inadequate latching by the baby is a common complaint among breastfeeding women and an important obstacle to successful breastfeeding. Nipple pain occurs during the first days after delivery and is considered one of the main causes for early weaning. To investigate the efficacy of low-level laser therapy as a treatment for nipple pain due to breastfeeding. A triple-blind, randomized, clinical study. A university-affiliated hospital in São Paulo, Brazil. Fifty-nine women with nipple lesions at the time of their admission. Thirty women (intervention group) received three sessions of laser therapy (InGaAIP laser, 660 nanometer, 40 milliwatts of power, 5 Joules per square centimeter of energy density for 5 seconds each, total energy = 0.6 Joules) in the region of the nipples at three different points in time (0 hour, 24 hours, and 48 hours after diagnosis of nipple lesion). Twenty-nine women with similar clinical conditions were randomly assigned to the control group. Self-reported pain was recorded before and after laser therapy using a visual analogue scale. The intervention group experienced a decrease of 2.0 centimeters in intensity of pain (p = .016) 24 hours after the first intervention and also presented lower levels of pain compared with the control group. Low-level laser therapy was considered effective for treating nipple lesions in breastfeeding women with pain, providing relief and prolonging exclusive breastfeeding. More clinical trials with different laser dosimetry and parameters are necessary to optimize laser therapy protocols for breastfeeding women. PMID:27363734

  8. Comparison of the analgesic effect of ibuprofen with mesalamine after discectomy surgery in patients with lumbar disc herniation: A double-blind randomized controlled trial

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    Toroudi Hamidreza

    2009-01-01

    Full Text Available Background: Pain management is an important component in the postoperative period following discectomy. Aims: We hypothesized that mesalamine considering its better safety profile, is likely to be a better choice, if it would be as effective as ibuprofen in controlling post-discectomy pain. Settings and Design: A double-blind randomized controlled trial was performed on patients who underwent lumbar discectomy surgery. Materials and Methods: Of the 58 patients who had lumbar discectomy, 27 patients were randomized to oral ibuprofen 500 mg and 31 patients to mesalamine 400 mg, three times a day for nine days following surgery. There was no placebo group. Severity of pain was assessed by using 10- cm visual analogue scale (VAS, once before operation and for nine days after. Statistical Analysis: Mean ± SD pain scores were compared between groups and the statistical difference was estimated by Student′s test using SPSS (Version 13. We also calculated the power of each t-test. Repeated measure ANOVA was performed for measuring the effect of time. Results: The age range of the patients was 35 to 60 years (mean: 42.2 years. Mean ± SD preoperative pain scores for ibuprofen or mesalamine-treated groups were 7.852 ± 2.441 and 7.806 ± 2.892, respectively. At the end of day 9, mean ± SD of pain score was 2.704 ± 2.284 and 2.717 ± 2.273 for ibuprofen and mesalamine-treated groups respectively. Both drugs significantly reduced postoperative pain and there was no statistically significant difference between the two groups.Conclusions: Since both drugs showed almost equal analgesic effect, considering its safety profile mesalamine, seems to be the preferred choice to alleviate post-discectomy surgery pain.

  9. Xenotransplantation of Human Cardiomyocyte Progenitor Cells Does Not Improve Cardiac Function in a Porcine Model of Chronic Ischemic Heart Failure. Results from a Randomized, Blinded, Placebo Controlled Trial

    Science.gov (United States)

    Jansen of Lorkeers, Sanne J.; Gho, Johannes M. I. H.; Koudstaal, Stefan; van Hout, Gerardus P. J.; Zwetsloot, Peter Paul M.; van Oorschot, Joep W. M.; van Eeuwijk, Esther C. M.; Leiner, Tim; Hoefer, Imo E.; Goumans, Marie-José; Doevendans, Pieter A.; Sluijter, Joost P. G.; Chamuleau, Steven A. J.

    2015-01-01

    Background Recently cardiomyocyte progenitor cells (CMPCs) were successfully isolated from fetal and adult human hearts. Direct intramyocardial injection of human CMPCs (hCMPCs) in experimental mouse models of acute myocardial infarction significantly improved cardiac function compared to controls. Aim Here, our aim was to investigate whether xenotransplantation via intracoronary infusion of fetal hCMPCs in a pig model of chronic myocardial infarction is safe and efficacious, in view of translation purposes. Methods & Results We performed a randomized, blinded, placebo controlled trial. Four weeks after ischemia/reperfusion injury by 90 minutes of percutaneous left anterior descending artery occlusion, pigs (n = 16, 68.5 ± 5.4 kg) received intracoronary infusion of 10 million fetal hCMPCs or placebo. All animals were immunosuppressed by cyclosporin (CsA). Four weeks after infusion, endpoint analysis by MRI displayed no difference in left ventricular ejection fraction, left ventricular end diastolic and left ventricular end systolic volumes between both groups. Serial pressure volume (PV-)loop and echocardiography showed no differences in functional parameters between groups at any timepoint. Infarct size at follow-up, measured by late gadolinium enhancement MRI showed no difference between groups. Intracoronary pressure and flow measurements showed no signs of coronary obstruction 30 minutes after cell infusion. No premature death occurred in cell treated animals. Conclusion Xenotransplantation via intracoronary infusion of hCMPCs is feasible and safe, but not associated with improved left ventricular performance and infarct size compared to placebo in a porcine model of chronic myocardial infarction. PMID:26678993

  10. Effects of a Gentle, Self-Administered Stimulation of Perineal Skin for Nocturia in Elderly Women: A Randomized, Placebo-Controlled, Double-Blind Crossover Trial.

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    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

  11. Xenotransplantation of Human Cardiomyocyte Progenitor Cells Does Not Improve Cardiac Function in a Porcine Model of Chronic Ischemic Heart Failure. Results from a Randomized, Blinded, Placebo Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Sanne J Jansen of Lorkeers

    Full Text Available Recently cardiomyocyte progenitor cells (CMPCs were successfully isolated from fetal and adult human hearts. Direct intramyocardial injection of human CMPCs (hCMPCs in experimental mouse models of acute myocardial infarction significantly improved cardiac function compared to controls.Here, our aim was to investigate whether xenotransplantation via intracoronary infusion of fetal hCMPCs in a pig model of chronic myocardial infarction is safe and efficacious, in view of translation purposes.We performed a randomized, blinded, placebo controlled trial. Four weeks after ischemia/reperfusion injury by 90 minutes of percutaneous left anterior descending artery occlusion, pigs (n = 16, 68.5 ± 5.4 kg received intracoronary infusion of 10 million fetal hCMPCs or placebo. All animals were immunosuppressed by cyclosporin (CsA. Four weeks after infusion, endpoint analysis by MRI displayed no difference in left ventricular ejection fraction, left ventricular end diastolic and left ventricular end systolic volumes between both groups. Serial pressure volume (PV-loop and echocardiography showed no differences in functional parameters between groups at any timepoint. Infarct size at follow-up, measured by late gadolinium enhancement MRI showed no difference between groups. Intracoronary pressure and flow measurements showed no signs of coronary obstruction 30 minutes after cell infusion. No premature death occurred in cell treated animals.Xenotransplantation via intracoronary infusion of hCMPCs is feasible and safe, but not associated with improved left ventricular performance and infarct size compared to placebo in a porcine model of chronic myocardial infarction.

  12. Double-blind, placebo-controlled, randomised phase II trial of IH636 grape seed proanthocyanidin extract (GSPE) in patients with radiation-induced breast induration

    International Nuclear Information System (INIS)

    Background and purpose: Tissue hardness (induration), pain and tenderness are common late adverse effects of curative radiotherapy for early breast cancer. The purpose of this study was to test the efficacy of IH636 grape seed proanthocyanidin extract (GSPE) in patients with tissue induration after high-dose radiotherapy for early breast cancer in a double-blind placebo-controlled randomised phase II trial. Patients and methods: Sixty-six eligible research volunteers with moderate or marked breast induration at a mean 10.8 years since radiotherapy for early breast cancer were randomised to active drug (n=44) or placebo (n=22). All patients were given grape seed proanthocyanidin extract (GSPE) 100 mg three times a day orally, or corresponding placebo capsules, for 6 months. The primary endpoint was percentage change in surface area (cm2) of palpable breast induration measured at the skin surface 12 months after randomisation. Secondary endpoints included change in photographic breast appearance and patient self-assessment of breast hardness, pain and tenderness. Results: At 12 months post-randomisation, ≥50% reduction in surface area (cm2) of breast induration was recorded in13/44 (29.5%) GSPE and 6/22 (27%) placebo group patients (NS). At 12 months post-randomisation, there was no significant difference between treatment and control groups in terms of external assessments of tissue hardness, breast appearance or patient self-assessments of breast hardness, pain or tenderness. Conclusions: The study failed to show efficacy of orally-adminstered GSPE in patients with breast induration following radiotherapy for breast cancer

  13. L-glutamine decreases the severity of mucositis induced by chemoradiotherapy in patients with locally advanced head and neck cancer: A double-blind, randomized, placebo-controlled trial

    OpenAIRE

    TSUJIMOTO, TAKAE; Yamamoto, Yoshifumi; WASA, MASAFUMI; Takenaka, Yukinori; Nakahara, Susumu; TAKAGI, TASTUYA; TSUGANE, MAMIKO; Hayashi, Noriyuki; Maeda, Kazuhisa; Inohara, Hidenori; Uejima, Etsuko; Ito, Toshinori

    2014-01-01

    The incidence of severe mucositis in the oral cavity, pharynx and larynx is high among patients with head and neck cancer (HNC) receiving chemoradiotherapy (CRT), resulting in significant pain and impairment of quality of life. The present study investigated whether L-glutamine (glutamine) decreases the severity of mucositis in the oral cavity, pharynx and larynx induced by CRT. This double-blind, randomized, placebo-controlled trial included 40 untreated patients with squamous cell carcinoma...

  14. Fortification of yogurts with vitamin D and calcium enhances the inhibition of serum parathyroid hormone and bone resorption markers: A double blind randomized controlled trial in women over 60 living in a community dwelling home

    OpenAIRE

    Bonjour, Jean-Philippe; Benoit, V.; Atkin, S; Walrand, S.

    2015-01-01

    Objective To evaluate whether fortification of yogurts with vitamin D and calcium exerts an additional lowering effect on serum parathyroid hormone (PTH) and bone resorption markers (BRM) as compared to iso-caloric and iso-protein dairy products in aged white women at risk of fragility fractures. Design A randomized double-blind controlled trial. Setting A community dwelling home. Participants Forty-eight women over 60 years (mean age 73.4). Intervention Consumption during 84 days of two 125 ...

  15. Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Pildal, Julie; Chan, An-Wen;

    2009-01-01

    OBJECTIVE: To compare the reporting on blinding in protocols and articles describing randomized controlled trials. STUDY DESIGN AND SETTING: We studied 73 protocols of trials approved by the scientific/ethical committees for Copenhagen and Frederiksberg, 1994 and 1995, and their corresponding pub...

  16. Protocol for the Smoking, Nicotine and Pregnancy (SNAP trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy

    Directory of Open Access Journals (Sweden)

    Coughtrie Michael WH

    2007-01-01

    Full Text Available Abstract Background Smoking in pregnancy remains a public health challenge. Nicotine replacement therapy (NRT is effective for smoking cessation in non-pregnant people, but because women metabolise nicotine and cotinine much faster in pregnancy, it is unclear whether this will be effective for smoking cessation in pregnancy. The NHS Health Technology Assessment Programme (HTA-funded smoking, nicotine and pregnancy (SNAP trial will investigate whether or not nicotine replacement therapy (NRT is effective, cost-effective and safe when used for smoking cessation by pregnant women. Methods/Design Over two years, in 5 trial centres, 1050 pregnant women who are between 12 and 24 weeks pregnant will be randomised as they attend hospital for ante-natal ultrasound scans. Women will receive either nicotine or placebo transdermal patches with behavioural support. The primary outcome measure is biochemically-validated, self-reported, prolonged and total abstinence from smoking between a quit date (defined before randomisation and set within two weeks of this and delivery. At six months after childbirth self-reported maternal smoking status will be ascertained and two years after childbirth, self-reported maternal smoking status and the behaviour, cognitive development and respiratory symptoms of children born in the trial will be compared in both groups. Discussion This trial is designed to ascertain whether or not standard doses of NRT (as transdermal patches are effective and safe when used for smoking cessation during pregnancy.

  17. Red clover-derived isoflavones and mammographic breast density: a double-blind, randomized, placebo-controlled trial [ISRCTN42940165

    International Nuclear Information System (INIS)

    Isoflavones are hypothesized to protect against breast cancer, but it is not clear whether they act as oestrogens or anti-oestrogens in breast tissue. Our aim was to determine the effects of taking a red clover-derived isoflavone supplement daily for 1 year on mammographic breast density. Effects on oestradiol, follicle-stimulating hormone (FSH), luteinizing hormone (LH), lymphocyte tyrosine kinase activity and menopausal symptoms were also assessed. A total of 205 women (age range 49–65 years) with Wolfe P2 or DY mammographic breast patterns were randomly assigned to receive either a red clover-derived isoflavone tablet (26 mg biochanin A, 16 mg formononetin, 1 mg genistein and 0.5 mg daidzein) or placebo. Change in mammographic breast density, serum oestradiol, FSH, LH, menopausal symptoms and lymphocyte tyrosine kinase activity from baseline to 12 months were assessed. A total of 177 women completed the trial. Mammographic breast density decreased in both groups but the difference between the treatment and placebo was not statistically significant. There was a significant interaction between treatment group and oestrogen receptor (ESR1) PvuII polymorphism for the change in estimated percentage breast density (mean ± standard deviation): TT isoflavone 1.4 ± 12.3% and TT placebo -9.6 ± 14.2%; CT isoflavone -5.2 ± 12.0% and CT placebo -2.8 ± 10.3%; and CC isoflavone -3.4 ± 9.7% and CC placebo -1.1 ± 9.5%. There were no statistically significant treatment effects on oestradiol, FSH, or LH (assessed only in postmenopausal women), or on lymphocyte tyrosine kinase activity. Baseline levels of menopausal symptoms were low, and there were no statistically significant treatment effects on frequency of hot flushes or other menopausal symptoms. In contrast to studies showing that conventional hormone replacement therapies increase mammographic breast density, the isoflavone supplement did not increase mammographic breast density in this population of women

  18. Can active music-making ameliorate neglect? An assessor-blind, within-subject, controlled clinical trial

    DEFF Research Database (Denmark)

    Bodak, Rebeka; Mazhari-Jensen, Daniel; Evald, Lars;

    Neglect often manifests following a right hemisphere stroke, and it is a strong predictor of poor rehabilitation outcome. Although many neglect interventions exist, systematic reviews repeatedly highlight that they yield limited clinical effectiveness and that there is little to no evidence of any......-aligned instrument from the stroke survivor’s right side into their left neglected space; the control involves playing novel rhythmic patterns on a single drum at midline. We hypothesise that the stroke survivors will perform better after the intervention than after the control on clinical neglect tests...... and on an assessment of their activities-of-daily-living. By validating and extending published case study work, the knowledge gained from this study has the capacity to pave the way for future clinical interventions and deepen our understanding of the use of music as a clinical tool in neurorehabilitation settings....

  19. Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial

    OpenAIRE

    van den Dool, Joost; Visser, Bart; Koelman, J Hans TM; Engelbert, Raoul hh; Tijssen, Marina AJ

    2013-01-01

    Background Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions ...

  20. Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer

    International Nuclear Information System (INIS)

    Background and purpose: Treatment-induced arm lymphoedema is a common and distressing complication of curative surgery and radiotherapy for early breast cancer. A number of studies testing alpha-tocopherol (vitamin E) and pentoxifylline suggest evidence of clinical regression of superficial radiation-induced fibrosis but there is only very limited evidence from randomised trials. Arm lymphoedema after lymphatic radiotherapy and surgery has been used in the present study as a clinical system for testing these drugs in a double-blind placebo-controlled randomised phase II trial. Patients and methods: Sixty-eight eligible research volunteers with a minimum 20% increase in arm volume at a median 15.5 years (range 2-41) after axillary/supraclavicular radiotherapy (plus axillary surgery in 51/68 (75%) cases) were randomised to active drugs or placebo. All volunteers were given dl-alpha tocopheryl acetate 500 mg twice a day orally plus pentoxifylline 400 mg twice a day orally, or corresponding placebos, for 6 months. The primary endpoint was volume of the ipsilateral limb measured opto-electronically using a perometer and expressed as a percentage of the contralateral limb volume. Results: At 12 months post-randomisation, there was no significant difference between treatment and control groups in terms of arm volume. Absolute change in arm volume at 12 months was 2.5% (95% CI -0.40 to 5.3) in the treatment group compared to 1.2% (95% CI -2.8 to 5.1) in the placebo group. The difference in mean volume change between randomisation groups at 12 months was not statistically significant (P=0.6), -1.3% (95% CI -6.1 to 3.5), nor was there a significant difference in response at 6 months (P=0.7), where mean change in arm volume from baseline in the treatment and placebo groups was -2.3% (95% CI -7.9 to 3.4) and -1.1% (95% CI -3.9 to 1.7), respectively. There were no significant differences between randomised groups in terms of secondary endpoints, including tissue induration

  1. Effect of Hominis placenta Pharmacopuncture on the Dysmenorrhea (A Pilot study, Single blind, Randomized, Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Su-Min Kim

    2008-09-01

    Full Text Available Objective : This study was designed to evaluate the effect of Hominis placenta Pharmacopuncture treatment on Dysmenorrhea of Women. Methods : 49 subjects who were suffering from dysmenorrhea volunteered to answer the MMP(Measure of Menstrual Pain and MSSL(Menstrual Symptom Severity List questionnaire. They were divided into two groups, a Hominis placenta Pharmacopuncture treatment group(Experiment al group, n=25 and a Normal Saline(N/S treatment group(Control group, n=24. The two groups were injected on the CV4, S36, Sp9 and Sp6 acupuncture point. They were treated totally five times depending on the individual menstruation cycles. The scores of MMP and MSSL were measured overall three times before and after the menstruation cycle. The collected data were analyzed as paired t-test, independent t-test using SPSS 12.0 WIN Program. Results : As a result of the evaluation by MMP and MSSL, a significant improvement on dysmenorrhea was made in the two groups(p<0.05, and both scores of Experiment group were decreased more than Control group. But there was no significant difference between the two groups. Conclusions : The Hominis placenta Pharmacopuncture treatment and the Normal Saline treatment were effective in decreasing the symptom of Dysmenorrhea.

  2. Wii-Workouts on Chronic Pain, Physical Capabilities and Mood of Older Women: A Randomized Controlled Double Blind Trial.

    Science.gov (United States)

    Monteiro-Junior, Renato Sobral; de Souza, Cíntia Pereira; Lattari, Eduardo; Rocha, Nuno Barbosa Ferreira; Mura, Gioia; Machado, Sérgio; da Silva, Elirez Bezerra

    2015-01-01

    Chronic Low Back Pain (CLBP) is a public health problem and older women have higher incidence of this symptom, which affect body balance, functional capacity and behavior. The purpose of this study was to verifying the effect of exercises with Nintendo Wii on CLBP, functional capacity and mood of elderly. Thirty older women (68 ± 4 years; 68 ± 12 kg; 154 ± 5 cm) with CLBP participated in this study. Elderly individuals were divided into a Control Exercise Group (n = 14) and an Experimental Wii Group (n = 16). Control Exercise Group did strength exercises and core training, while Experimental Wii Group did ones additionally to exercises with Wii. CLBP, balance, functional capacity and mood were assessed pre and post training by the numeric pain scale, Wii Balance Board, sit to stand test and Profile of Mood States, respectively. Training lasted eight weeks and sessions were performed three times weekly. MANOVA 2 x 2 showed no interaction on pain, siting, stand-up and mood (P = 0.53). However, there was significant difference within groups (P = 0.0001). ANOVA 2 x 2 showed no interaction for each variable (P > 0.05). However, there were significant differences within groups in these variables (P 0.01). Capacity to Sit improved only in Experimental Wii Group (P = 0.04). In conclusion, physical exercises with Nintendo Wii Fit Plus additional to strength and core training were effective only for sitting capacity, but effect size was small. PMID:26556092

  3. Japanese POEMS syndrome with Thalidomide (J-POST) Trial: study protocol for a phase II/III multicentre, randomised, double-blind, placebo-controlled trial

    OpenAIRE

    Katayama, Kanako; Misawa, Sonoko; Sato, Yasunori; Sobue, Gen; Yabe, Ichiro; Watanabe, Osamu; Nishizawa, Masatoyo; Kusunoki, Susumu; Kikuchi, Seiji; Nakashima, Ichiro; Ikeda, Shu-ichi; Kohara, Nobuo; Kanda, Takashi; Kira, Jun-ichi; Hanaoka, Hideki

    2015-01-01

    Introduction Polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes (POEMS) syndrome is a fatal systemic disorder associated with plasma cell dyscrasia and the overproduction of the vascular endothelial growth factor (VEGF). Recently, the prognosis of POEMS was substantially improved by introduction of therapeutic intervention for myeloma. However, no randomised clinical trial has been performed because of the rarity and severity of the disease. Methods and analysis The Japa...

  4. A walking programme and a supervised exercise class versus usual physiotherapy for chronic low back pain: a single-blinded randomised controlled trial. (The Supervised Walking In comparison to Fitness Training for Back Pain (SWIFT) Trial).

    LENUS (Irish Health Repository)

    Hurley, Deirdre A

    2009-01-01

    BACKGROUND: Chronic low back pain (CLBP) is a persistent disabling condition with rising significant healthcare, social and economic costs. Current research supports the use of exercise-based treatment approaches that encourage people with CLBP to assume a physically active role in their recovery. While international clinical guidelines and systematic reviews for CLBP support supervised group exercise as an attractive first-line option for treating large numbers of CLBP patients at low cost, barriers to their delivery include space and time restrictions in healthcare settings and poor patient attendance. The European Clinical Guidelines have identified the need for research in the use of brief\\/minimal contact self-activation interventions that encourage participation in physical activity for CLBP. Walking may be an ideally suited form of individualized exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all ages with little risk of injury, but its effectiveness for LBP is unproven. METHODS AND DESIGN: This study will be an assessor-blinded randomized controlled trial that will investigate the difference in clinical effectiveness and costs of an individualized walking programme and a supervised general exercise programme compared to usual physiotherapy, which will act as the control group, in people with chronic low back pain. A sample of 246 patients will be recruited in Dublin, Ireland through acute general hospital outpatient physiotherapy departments that provide treatment for people with CLBP. Patients will be randomly allocated to one of the three groups in a concealed manner. The main outcomes will be functional disability, pain, quality of life, fear avoidance, back beliefs, physical activity, satisfaction and costs, which will be evaluated at baseline, and 3, 6 and 12 months [follow-up by pre-paid postage]. Qualitative telephone interviews and focus groups will be embedded in the research

  5. A walking programme and a supervised exercise class versus usual physiotherapy for chronic low back pain: a single-blinded randomised controlled trial. (The Supervised Walking In comparison to Fitness Training for Back Pain (SWIFT Trial

    Directory of Open Access Journals (Sweden)

    Daly Leslie

    2009-07-01

    Full Text Available Abstract Background Chronic low back pain (CLBP is a persistent disabling condition with rising significant healthcare, social and economic costs. Current research supports the use of exercise-based treatment approaches that encourage people with CLBP to assume a physically active role in their recovery. While international clinical guidelines and systematic reviews for CLBP support supervised group exercise as an attractive first-line option for treating large numbers of CLBP patients at low cost, barriers to their delivery include space and time restrictions in healthcare settings and poor patient attendance. The European Clinical Guidelines have identified the need for research in the use of brief/minimal contact self-activation interventions that encourage participation in physical activity for CLBP. Walking may be an ideally suited form of individualized exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all ages with little risk of injury, but its effectiveness for LBP is unproven. Methods and design This study will be an assessor-blinded randomized controlled trial that will investigate the difference in clinical effectiveness and costs of an individualized walking programme and a supervised general exercise programme compared to usual physiotherapy, which will act as the control group, in people with chronic low back pain. A sample of 246 patients will be recruited in Dublin, Ireland through acute general hospital outpatient physiotherapy departments that provide treatment for people with CLBP. Patients will be randomly allocated to one of the three groups in a concealed manner. The main outcomes will be functional disability, pain, quality of life, fear avoidance, back beliefs, physical activity, satisfaction and costs, which will be evaluated at baseline, and 3, 6 and 12 months [follow-up by pre-paid postage]. Qualitative telephone interviews and focus groups will be

  6. A multicenter, randomized, double-blind, placebo-controlled, 6-month trial of bupropion hydrochloride sustained-release tablets as an aid to smoking cessation in hospital employees

    DEFF Research Database (Denmark)

    Dalsgareth, Oli Jacob; Hansen, Niels-Christian Gerner; Søes-Petersen, Ulrik;

    2004-01-01

    Despite changes in smoking behavior, one-third of the Danish population continues to smoke. Many of these smokers are hospital employees. This 6-month, multicenter, parallel group, randomized, double-blind, placebo-controlled study evaluated treatment with bupropion hydrochloride sustained release...

  7. N-Acetylcysteine in the Treatment of Pediatric Trichotillomania: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial

    Science.gov (United States)

    Bloch, Michael H.; Panza, Kaitlyn E.; Grant, Jon E.; Pittenger, Christopher; Leckman, James F.

    2013-01-01

    Objective: To examine the efficacy of N-acetylcysteine (NAC) for the treatment of pediatric trichotillomania (TTM) in a double-blind, placebo-controlled, add-on study. Method: A total of 39 children and adolescents aged 8 to 17 years with pediatric trichotillomania were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary…

  8. Effect of levamisole supplementation on tetanus vaccination response rates in haemodialysis patients: a randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Fallahzadeh, Mohammad Kazem; Sajjadi, Sharareh; Singh, Neeraj; Khajeh, Masomeh; Sagheb, Mohammad Mahdi

    2014-01-01

    Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to hepatitis B virus vaccination in haemodialysis patients. The aim of this randomized double-blind placebo-controlled trial was to evaluate the effect of levamisole supplementation on tetanus-diphtheria (Td) vaccine response rates in haemodialysis patients. Forty haemodialysis patients who had not received tetanus vaccination in a year before investigation and had unprotective anti-tetanus immunoglobulin G (IgG) levels (intramuscular Td vaccine supplemented with either levamisole (100 mg) or placebo daily, for 6 days before and 6 days after vaccination. The anti-tetanus IgG levels were measured 1 and 6 months after vaccination. One month post-vaccination, four patients were excluded from the levamisole group and two from the placebo group because of either death or renal transplantation. At 1 month, 13 out of 16 (81%) patients in the levamisole group as compared with six out of 18 (33%) patients in the placebo group developed protective anti-tetanus IgG levels (relative risk = 2.44, 95% confidence interval (CI) = 1.21, 4.88). From 1 to 6 months post-vaccination, one more patient in the levamisole group and two more patients in the placebo group were excluded because of renal transplantation. At 6 months, 11 out of 15 (73%) patients in the levamisole group as compared with four out of 16 (25%) patients in the placebo group still had protective anti-tetanus IgG levels (relative risk = 2.93, 95% CI = 1.19, 7.23). Supplementation of Td vaccination with levamisole may enhance seroconversion against tetanus in haemodialysis patients. PMID:24341659

  9. Application of the essential oil from copaiba (Copaifera langsdori Desf.) for acne vulgaris: a double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    da Silva, Ary Gomes; Puziol, Paula de Freitas; Leitao, Roane Nunes; Gomes, Tatiana Rafaela; Scherer, Rodrigo; Martins, Monica Lacerda Lopes; Cavalcanti, Aurea Scardua Saade; Cavalcanti, Luiz Carlos

    2012-03-01

    Copaiba oil-resin is widely used in traditional medicine due to its anti-inflammatory, healing, and antiseptic activities. This research aims to extract and evaluate the qualitative and quantitative composition of copaiba essential oil from the oil-resin, and test its effects, after incorporation in a gel applied in volunteers with acne, in a double-blind placebo controlled clinical trial. The essential oil was extracted by steam distillation, and purified by freezing to remove the residual remnant water. The density of the essential oil was gravimetrically determined by weighing 1 mL of liquid at 20 degree C. The identification of the essential oil components was carried out through high-resolution gas chromatography analysis, coupled with mass spectrometry. The essential oil has a density of 0.9175 mg/mL and was composed of 48 substances, 14 of which were the major components representing 95.80% of total essential oil composition. Cis-thujopsene was the main component (46.96% of total essential oil composition). The surface affected with acne decreased when treated with placebo (F = 13.931, p = 0.001, r = 0.518; r2 = 0.268), but the linear model could explain only 26.8% of total variance in original data matrix. There was a highly significant decrease in the surface affected with acne in the areas treated with the 1.0% copaiba essential oil preparation (F = 86.494, p = 0.000, r = 0.834; r2 = 0.695). PMID:22502624

  10. Prevention of cardiac dysfunction during adjuvant breast cancer therapy (PRADA): a 2 × 2 factorial, randomized, placebo-controlled, double-blind clinical trial of candesartan and metoprolol

    Science.gov (United States)

    Gulati, Geeta; Heck, Siri Lagethon; Ree, Anne Hansen; Hoffmann, Pavel; Schulz-Menger, Jeanette; Fagerland, Morten W.; Gravdehaug, Berit; von Knobelsdorff-Brenkenhoff, Florian; Bratland, Åse; Storås, Tryggve H.; Hagve, Tor-Arne; Røsjø, Helge; Steine, Kjetil; Geisler, Jürgen; Omland, Torbjørn

    2016-01-01

    Aims Contemporary adjuvant treatment for early breast cancer is associated with improved survival but at the cost of increased risk of cardiotoxicity and cardiac dysfunction. We tested the hypothesis that concomitant therapy with the angiotensin receptor blocker candesartan or the β-blocker metoprolol will alleviate the decline in left ventricular ejection fraction (LVEF) associated with adjuvant, anthracycline-containing regimens with or without trastuzumab and radiation. Methods and results In a 2 × 2 factorial, randomized, placebo-controlled, double-blind trial, we assigned 130 adult women with early breast cancer and no serious co-morbidity to the angiotensin receptor blocker candesartan cilexetil, the β-blocker metoprolol succinate, or matching placebos in parallel with adjuvant anticancer therapy. The primary outcome measure was change in LVEF by cardiac magnetic resonance imaging. A priori, a change of 5 percentage points was considered clinically important. There was no interaction between candesartan and metoprolol treatments (P = 0.530). The overall decline in LVEF was 2.6 (95% CI 1.5, 3.8) percentage points in the placebo group and 0.8 (95% CI −0.4, 1.9) in the candesartan group in the intention-to-treat analysis (P-value for between-group difference: 0.026). No effect of metoprolol on the overall decline in LVEF was observed. Conclusion In patients treated for early breast cancer with adjuvant anthracycline-containing regimens with or without trastuzumab and radiation, concomitant treatment with candesartan provides protection against early decline in global left ventricular function. PMID:26903532

  11. Probiotic prophylaxis in patients with predicted severe acute pancreatitis (PROPATRIA: design and rationale of a double-blind, placebo-controlled randomised multicenter trial [ISRCTN38327949

    Directory of Open Access Journals (Sweden)

    Akkermans Louis MA

    2004-09-01

    Full Text Available Abstract Background Infectious complications are the major cause of death in acute pancreatitis. Small bowel bacterial overgrowth and subsequent bacterial translocation are held responsible for the vast majority of these infections. Goal of this study is to determine whether selected probiotics are capable of preventing infectious complications without the disadvantages of antibiotic prophylaxis; antibiotic resistance and fungal overgrowth. Methods/design PROPATRIA is a double-blind, placebo-controlled randomised multicenter trial in which 200 patients will be randomly allocated to a multispecies probiotic preparation (Ecologic 641 or placebo. The study is performed in all 8 Dutch University Hospitals and 7 non-University hospitals. The study-product is administered twice daily through a nasojejunal tube for 28 days or until discharge. Patients eligible for randomisation are adult patients with a first onset of predicted severe acute pancreatitis: Imrie criteria 3 or more, CRP 150 mg/L or more, APACHE II score 8 or more. Exclusion criteria are post-ERCP pancreatitis, malignancy, infection/sepsis caused by a second disease, intra-operative diagnosis of pancreatitis and use of probiotics during the study. Administration of the study product is started within 72 hours after onset of abdominal pain. The primary endpoint is the total number of infectious complications. Secondary endpoints are mortality, necrosectomy, antibiotic resistance, hospital stay and adverse events. To demonstrate that probiotic prophylaxis reduces the proportion of patients with infectious complications from 50% to 30%, with alpha 0,05 and power 80%, a total sample size of 200 patients was calculated. Conclusion The PROPATRIA study is aimed to show a reduction in infectious complications due to early enteral use of multispecies probiotics in severe acute pancreatitis.

  12. Erlotinib, erlotinib-sulindac vs. placebo: a randomized, double-blind, placebo-controlled window trial in operable head and neck cancer

    Science.gov (United States)

    Gross, Neil D.; Bauman, Julie E.; Gooding, William E.; Denq, William; Thomas, Sufi M.; Wang, Lin; Chiosea, Simion; Hood, Brian L.; Flint, Melanie S.; Sun, Mai; Conrads, Thomas P.; Ferris, Robert L.; Johnson, Jonas T.; Kim, Seungwon; Argiris, Athanassios; Wirth, Lori; Nikiforova, Marina N.; Siegfried, Jill M.; Grandis, Jennifer R.

    2014-01-01

    Purpose The epidermal growth factor receptor (EGFR) and cyclooxygenase-2 (COX-2) pathways are upregulated in head and neck squamous cell carcinoma (HNSCC). Preclinical models indicate synergistic anti-tumor activity from dual blockade. We conducted a randomized, double-blind, placebo-controlled window trial of erlotinib, an EGFR inhibitor; erlotinib plus sulindac, a non-selective COX inhibitor, vs. placebo. Experimental Design Patients with untreated, operable Stage II-IVb HNSCC were randomized 5:5:3 to erlotinib, erlotinib-sulindac, or placebo. Tumor specimens were collected before and after 7-14 days of treatment. The primary endpoint was change in Ki-67 proliferation index. We hypothesized an ordering effect in Ki-67 reduction: erlotinib-sulindac > erlotinib > placebo. We evaluated tissue microarrays by immunohistochemistry for pharmacodynamic modulation of EGFR and COX-2 signaling intermediates. Results From 2005-2009, 47 patients were randomized for the target 39 evaluable patients. Thirty-four tumor pairs were of sufficient quality to assess biomarker modulation. Ki-67 was significantly decreased by erlotinib or erlotinib-sulindac (omnibus comparison, two-sided Kruskal-Wallis, p=0.04). Wilcoxon pairwise contrasts confirmed greater Ki-67 effect in both erlotinib groups (erlotinib-sulindac vs. placebo p=0.043; erlobinib vs. placebo, p=0.027). There was a significant trend in ordering of Ki-67 reduction: erlotinib-sulindac > erlotinib > placebo (two-sided exact Jonckheere-Terpstra, p =0.0185). Low baseline pSrc correlated with greater Ki-67 reduction (R2 = .312, p = 0.024). Conclusions Brief treatment with erlotinib significantly decreased proliferation in HNSCC, with additive effect from sulindac. Efficacy studies of dual EGFR-COX inhibition are justified. pSrc is a potential resistance biomarker for anti-EGFR therapy, and warrants investigation as a molecular target. PMID:24727329

  13. In patients with HIV-infection, chromium supplementation improves insulin resistance and other metabolic abnormalities: a randomized, double-blind, placebo controlled trial.

    Science.gov (United States)

    Aghdassi, Elaheh; Arendt, Bianca M; Salit, Irving E; Mohammed, Saira S; Jalali, Pegah; Bondar, Helena; Allard, Johane P

    2010-03-01

    Chromium is an essential micronutrient; chromium deficiency has been reported to cause insulin resistance, hyperglycemia and hyperlipidemia. The aim was to investigate the effect of chromium supplementation on insulin-resistance, other metabolic abnormalities, and body composition in people living with HIV. This was a randomized, double-blind, placebo-controlled trial. Fifty-two HIV-positive subjects with elevated glucose, lipids, or evidence of body fat redistribution, and who had insulin-resistance based on the calculation of homeostasis model of assessment (HOMA-IR > or = 2.5) were assessed. Subjects who were on insulin or hypoglycemic medications were excluded. Subjects were randomized to receive either 400 microg/day chromium-nicotinate or placebo for 16 weeks. Forty-six subjects, 23 in each group, completed the study. Fasting blood insulin, glucose, lipid profile and body composition were measured before and after intervention. Chromium was tolerated without side effects and resulted in a significant decrease in HOMA-IR (median (IQR) (pre:4.09 (3.02-8.79); post: 3.66 (2.40-5.46), p=0.004), insulin (pre: 102 (85-226); post: 99 (59-131) pmol/L, p=0.003), triglycerides, total body fat mass (mean+/-SEM) (pre: 17.3+/-1.7; post: 16.3+/-1.7 kg; p=0.002) and trunk fat mass (pre: 23.8+/-1.9; post: 22.7+/-2.0 %; p=0.008). Blood glucose, C-peptide, total, HDL and LDL cholesterol, and hemoglobin A1c remained unchanged. Biochemical parameters did not change in the placebo group except for LDL cholesterol which increased significantly. Body weight and medication profile remained stable throughout the study for both groups. In summary, chromium improved insulin resistance, metabolic abnormalities, and body composition in HIV+ patients. This suggests that chromium supplements alleviate some of the antiretroviral-associated metabolic abnormalities. PMID:20163347

  14. Protocol and Rationale-The Efficacy of Minocycline as an Adjunctive Treatment for Major Depressive Disorder: A Double Blind, Randomised, Placebo Controlled Trial

    Science.gov (United States)

    Maes, Michael; Ashton, Melanie; Berk, Lesley; Kanchanatawan, Buranee; Sughondhabirom, Atapol; Tangwongchai, Sookjareon; Ng, Chee; Dowling, Nathan; Malhi, Gin S.; Berk, MIchael

    2014-01-01

    While current pharmacotherapies are efficacious, there remain a clear shortfall between symptom remission and functional recovery. With the explosion in our understanding of the biology of these disorders, the time is ripe for the investigation of novel therapies. Recently depression is conceptualized as an immune-inflammatory and nitro-oxidative stress related disorder. Minocycline is a tetracycline antibiotic that has anti-inflammatory, pro-oxidant, glutamatergic, neurotrophic and neuroprotective properties that make it a viable target to explore as a new therapy. This double blind, randomised, placebo controlled adjunctive trial will investigate the benefits of 200 mg/day of minocycline treatment, in addition to any usual treatment, as an adjunctive treatment for moderate-severe major depressive disorder. Sixty adults are being randomised to 12 weeks of treatment (with a 4 week follow-up post-discontinuation). The primary outcome measure for the study is mean change on the Montgomery-Asberg Depression Rating Scale (MADRS), with secondary outcomes including the Social and Occupational Functioning Assessment Scale (SOFAS), Clinical Global Impressions (CGI), Hamilton Rating Scale for Anxiety (HAM-A), Patient Global Impression (PGI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Range of Impaired Functioning Tool (LIFE-RIFT). Biomarker analyses will also be conducted at baseline and week 12. The study has the potential to provide new treatment targets, both by showing efficacy with a new class of 'antidepressant' but also through the analysis of biomarkers that may further inform our understanding of the pathophysiology of unipolar depression. PMID:25598820

  15. PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING IN ELECTIVE LSCS UNDER SPINAL ANAESTHESIA BY PRE-OPERATIVE ONDANSETRON VERSUS METOCLOPRAMIDE: A PROSPECTIVE SINGLE-BLINDED RANDOMISED CONTROL TRIAL

    Directory of Open Access Journals (Sweden)

    Prasada Rao

    2016-02-01

    Full Text Available CONTEXT Obstetric anaesthesia during modern day practice has become challenge for the anaesthesiologist as the patients are generally young women and expecting a smooth outcome, not only in terms of the baby born but also herself. The problem of PONV has become challenging, though appear small problem, tough to control postoperatively. Many drugs have been on trial, but not effective completely. Of late the central 5HT3 antagonists have been promising in achieving the objectives in comparison to the ones previously used. AIMS To compare the efficacy and safety of prophylactic use of intravenous Metoclopramide (10mg and Ondansetron (4mg in preventing incidence of PONV, in patients undergoing elective LSCS under spinal anaesthesia. SETTINGS AND DESIGN A prospective randomized single blinded study conducted after obtaining written informed consent, 100 women patients aged above 18 years belonging to ASA grade I and II scheduled to undergo elective LSCS under spinal anaesthesia were enrolled in the study. METHODS AND MATERIAL Patients were randomly divided into 2 groups of 50 each. Group-M: received IV Metoclopramide 10mg. Group-O: received IV Ondansetron 4mg. STATISTICAL ANALYSIS USED ‘Z test’ and Student’s ‘t’ test. RESULTS Number of episodes of emesis, nausea and retching were recorded at time intervals of 1 hr, 2 hr, 6 hr and 24 hr for all the patients in both groups. Incidence of Nausea was more in Group – M than Group – O at 1 hr and 2 hr, but was statistically significant (p<0.05 at 2 hr only. Incidence of vomiting was decreased in Group – O than Group – M, but was not statistically significant. Incidence of retching was more in the 1 hr and 2 hr in Group - M. CONCLUSION Fair to conclude that IV Ondansetron has proved a better prophylactic than IV Metoclopramide in preventing PONV for elective LSCS cases under spinal anaesthesia.

  16. The effect of continuous ultrasound on chronic non-specific low back pain: a single blind placebo-controlled randomized trial

    Directory of Open Access Journals (Sweden)

    Ebadi Safoora

    2012-10-01

    Full Text Available Abstract Background Non-specific chronic low back pain (NSCLBP is one of the most common musculoskeletal disorders around the world including Iran. One of the most widely used modalities in the field of physiotherapy is therapeutic ultrasound (US. Despite its common use, there is still inconclusive evidence to support its effectiveness in patients with NSCLBP. The objective of this study was to evaluate the effect of continuous US compared with placebo US additional to exercise therapy for patients with NSCLBP. Methods In this single blind placebo controlled study, 50 patients with NSCLBP were randomized into two treatment groups: 1 continuous US (1 MHz &1.5 W/cm2 plus exercise 2 placebo US plus exercise. Patients received treatments for 4 weeks, 10 treatment sessions, 3 times per week, every other day. Treatment effects were assessed in terms of primary outcome measures: 1 functional disability, measured by Functional Rating Index, and 2 global pain, measured by a visual analog scale. Secondary outcome measures were lumbar flexion and extension range of motion (ROM, endurance time and rate of decline in median frequency of electromyography spectrum during a Biering Sorensen test. All outcome variables were measured before, after treatment, and after one-month follow-up. An intention to treat analysis was performed. Main effects of Time and Group as well as their interaction effect on outcome measures were investigated using repeated measure ANOVA. Results Analysis showed that both groups had improved regarding function (FRI and global pain (VAS (P .05. Improvement in function and lumbar ROM as well as endurance time were significantly greater in the group receiving continuous US (P Conclusions The study showed that adding continuous US to a semi supervised exercise program significantly improved function, lumbar ROM and endurance time. Further studies including a third group of only exercise and no US can establish the possible effects of

  17. A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction, in Ethiopia.

    Directory of Open Access Journals (Sweden)

    Saba M Lambert

    2016-04-01

    Full Text Available Leprosy Type 1 (T1R reactions are immune-mediated events leading to nerve damage and preventable disability affecting hands, feet and eyes. Type 1 Reactions are treated with oral corticosteroids. There is little evidence on alternative treatments for patients who do not respond to steroids or experience steroid adverse effects. We report the results of a randomized controlled trial testing the efficacy and adverse effect profile of ciclosporin and prednisolone (CnP in comparison to prednisolone only (P in patients with new T1R in Ethiopia. Ciclosporin is a potent immunosuppressant. Outcomes were measured using a clinical severity score, recurrence rate, adverse events and quality of life.Seventy three patients with new T1R were randomized to receive CnP or P for 20 weeks. Recovery rates in skin signs was similar in both groups (91% vs 88%. Improvements in nerve function both, new and old, sensory (66% vs 49% and motor (75% vs 74% loss were higher (but not significantly so in the patients on CnP. Recurrences rates of T1R (85% were high in both groups, and recurrences occurred significantly earlier (8 weeks in patients CnP, who needed 10% more additional prednisolone. Serious major and minor adverse events rates were similar in patients in the two treatment arms of the study. Both groups had a significant improvement in their quality of life after the study, measured by the SF-36.This is the first double-blind RCT assessing ciclosporin, in the management of T1R in Africa. Ciclosporin could be a safe alternative second-line drug for patients with T1R who are not improving with prednisolone or are experiencing adverse events related to prednisolone. This study illustrates the difficulty in switching off leprosy inflammation. Better treatment agents for leprosy patients with reactions and nerve damage are needed.

  18. Does magnesium supplementation improve body composition and muscle strength in middle-aged overweight women? A double-blind, placebo-controlled, randomized clinical trial.

    Science.gov (United States)

    Moslehi, Nazanin; Vafa, Mohammadreza; Sarrafzadeh, Javad; Rahimi-Foroushani, Abbas

    2013-06-01

    Muscle strength, an independent predictor of metabolic disorders, disability, and mortality, reduces gradually with advancing age. Little is known about the influence of nutritional intervention on muscle strength in middle-aged. The aim of the present study is to examine whether magnesium could improve body composition and muscle strength in middle-aged overweight women. In this double-blinded, placebo-controlled, randomized trial, a total of 74 healthy middle-aged overweight women (25 ≤ BMI ≤ 30 kg/m(2)) received either 250 mg magnesium in the form of magnesium oxide or placebo daily for 8 weeks. Body composition was assessed using Bioelectrical Impedance Analysis (BIA). Handgrip strength and knee extension strength were measured with isometric dynamometry. Functional mobility was assessed using Time Get Up and Go Test (TGUG). A significant increase in mean lean body mass was observed (P = 0.05) accompanied with a significant decrease in fat mass (P = 0.02) solely in the magnesium group at the end of 8 weeks compared to baseline values but the changes did not reach significant as compared to placebo group. Handgrip strength and TGUG improved in the magnesium group compared to baseline but they were not significant compared to placebo. There were no significant differences in increasing knee extension strength in the magnesium group as compared with placebo. Baseline values of serum magnesium and muscle strength of participants did not indicate any influences on response to magnesium supplementation. Our findings indicate that magnesium as magnesium oxide, 250 mg/day, for 8 weeks do not lead to a significant greater gain in muscle strength and function compared to placebo. PMID:23619906

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

    International Nuclear Information System (INIS)

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

  20. Hyperbaric Oxygen Treatment of Chronic Refractory Radiation Proctitis: A Randomized and Controlled Double-Blind Crossover Trial With Long-Term Follow-Up

    International Nuclear Information System (INIS)

    Purpose: Cancer patients who undergo radiotherapy remain at life-long risk of radiation-induced injury to normal tissues. We conducted a randomized, controlled, double-blind crossover trial with long-term follow-up to evaluate the effectiveness of hyperbaric oxygen for refractory radiation proctitis. Methods and Materials: Patients with refractory radiation proctitis were randomized to hyperbaric oxygen at 2.0 atmospheres absolute (Group 1) or air at 1.1 atmospheres absolute (Group 2). The sham patients were subsequently crossed to Group 1. All patients were re-evaluated by an investigator who was unaware of the treatment allocation at 3 and 6 months and Years 1-5. The primary outcome measures were the late effects normal tissue-subjective, objective, management, analytic (SOMA-LENT) score and standardized clinical assessment. The secondary outcome was the change in quality of life. Results: Of 226 patients assessed, 150 were entered in the study and 120 were evaluable. After the initial allocation, the mean SOMA-LENT score improved in both groups. For Group 1, the mean was lower (p 0.0150) and the amount of improvement nearly twice as great (5.00 vs. 2.61, p = 0.0019). Similarly, Group 1 had a greater portion of responders per clinical assessment than did Group 2 (88.9% vs. 62.5%, respectively; p 0.0009). Significance improved when the data were analyzed from an intention to treat perspective (p = 0.0006). Group 1 had a better result in the quality of life bowel bother subscale. These differences were abolished after the crossover. Conclusion: Hyperbaric oxygen therapy significantly improved the healing responses in patients with refractory radiation proctitis, generating an absolute risk reduction of 32% (number needed to treat of 3) between the groups after the initial allocation. Other medical management requirements were discontinued, and advanced interventions were largely avoided. Enhanced bowel-specific quality of life resulted

  1. The Effects of Side Branch Predilation During Provisional Stenting of Coronary Bifurcation Lesions: A Double-Blind Randomized Controlled Trial

    Science.gov (United States)

    Peighambari, Mohammadmehdi; Sanati, Hamidreza; Hadjikarimi, Majid; Zahedmehr, Ali; Shakerian, Farshad; Firouzi, Ata; Kiani, Reza; Sadeghipour, Parham; Kzaemi Asl, Siamak

    2016-01-01

    Background: There is a paucity of data regarding the role of side branch (SB) predilation during the provisional stenting of bifurcation lesions. Objectives: The present study aimed to assess the effects of SB predilation on the outcomes of true bifurcation interventions. Patients and Methods: Sixty patients with true bifurcation lesions according to the Medina classification were included in the study and randomly assigned to receive SB predilation before stenting the main branch (n = 30) or no predilation as the control group (n = 30). Results: There was a trend toward the higher occurrence of dissection in the predilated ostial lesions of the SB compared to the non-predilated group (16.7% vs. 0, P = 0.07). Performance of the SB predilation was not associated with improved flow of the SB or fewer degrees of ostial stenosis after stenting the main branch, the need to rewire, rewiring time, or the rate of use of the final kissing balloon dilation and double stents procedures. Conclusions: Routine predilation of the SB in provisional stenting of true bifurcation lesions seems to be ineffective and might be associated with some undesirable consequences. Still, there are some complex ostial lesions of the SB which could benefit from predilation. PMID:26949691

  2. Development of thrombophlebitis in peripheral veins with Vialon and PTFE-Teflon cannulas: a double-blind, randomised, controlled trial.

    Science.gov (United States)

    Payne-James, J J; Rogers, J; Bray, M J; Rana, S K; McSwiggan, D; Silk, D B

    1991-09-01

    A series of 54 normal subjects were randomised to have either a Vialon or a PTFE-Teflon peripheral vein cannula inserted in a vein in each forearm to observe the development of thrombophlebitis. Cannulas were inspected twice daily for up to 5 days to observe the development of three signs, erythema, oedema or hardness and one symptom, pain. Each sign and symptom was recorded twice daily at three points, the cannula insertion site, the mid-point of the cannula and the cannula tip. The degree of change was recorded as less than 1, 1-2 and greater than 2 cm. Any cannula causing any sign greater than 2 cm was removed. By the end of the study over 40% of both types of cannula had been removed. There were no significant differences between the numbers of each type of cannula removed at any time point throughout the duration of the study. There were no significant differences in the amounts of erythema or hardness, but minimally increased swelling was observed at the mid-point of the PTFE-Teflon cannulas (P = 0.022). Despite the theoretical superiority of Vialon as a cannula material, under controlled conditions there appears to be little difference in its inherent capacity to cause the thrombophlebitis. PMID:1929137

  3. Acetaminophen Versus Liquefied Ibuprofen for Control of Pain During Separation in Orthodontic Patients: A Randomized Triple Blinded Clinical Trial.

    Science.gov (United States)

    Hosseinzadeh Nik, Tahereh; Shahsavari, Negin; Ghadirian, Hannaneh; Ostad, Seyed Nasser

    2016-07-01

    The aim of this randomized clinical study was to investigate the effectiveness of acetaminophen 650 mg or liquefied ibuprofen 400 mg in pain control of orthodontic patients during separation with an elastic separator. A total of 101 patients with specific inclusion criteria were divided randomly into three groups (acetaminophen, liquefied ibuprofen, and placebo). They were instructed to take their drugs one hour before separator placement and every six hours afterward (five doses in total). They recorded their discomfort on visual analog scales immediately after separator placement, 2 hours later, 6 hours later, at bedtime, and 24 hours after separator placement. Repeated measure analysis of variance (ANOVA) was used to compare the mean pain scores between the three groups. Data were collected from 89 patients. The pain increased with time in all groups. Pain scores were statistically lower in the analgesic groups compared with the placebo group (P.valueacetaminophen and liquefied ibuprofen) (P.value=1). Acetaminophen and liquefied ibuprofen have similar potential in pain reduction during separation. PMID:27424011

  4. Effect of spa therapy with saline balneotherapy on oxidant/antioxidant status in patients with rheumatoid arthritis: a single-blind randomized controlled trial

    Science.gov (United States)

    Karagülle, Mine; Kardeş, Sinan; Karagülle, Oğuz; Dişçi, Rian; Avcı, Aslıhan; Durak, İlker; Karagülle, Müfit Zeki

    2016-06-01

    Oxidative stress has been shown to play a contributory role in the pathogenesis of rheumatoid arthritis (RA). Recent studies have provided evidence for antioxidant properties of spa therapy. The purpose of this study is to investigate whether spa therapy with saline balneotherapy has any influence on the oxidant/antioxidant status in patients with RA and to assess clinical effects of spa therapy. In this investigator-blind randomized controlled trial, we randomly assigned 50 patients in a 1:1 ratio to spa therapy plus standard drug treatment (spa group) or standard drug treatment alone (control group). Spa group followed a 2-week course of spa therapy regimen consisting of a total of 12 balneotherapy sessions in a thermal mineral water pool at 36-37 °C for 20 min every day except Sunday. All clinical and biochemical parameters were assessed at baseline and after spa therapy (2 weeks). The clinical parameters were pain intensity, patient global assessment, physician global assessment, Health Assessment Questionnaire disability index (HAQ-DI), Disease Activity Score for 28-joints based on erythrocyte sedimentation rate (DAS28-4[ESR]). Oxidative status parameters were malondialdehyde (MDA), nonenzymatic superoxide radical scavenger activity (NSSA), antioxidant potential (AOP), and superoxide dismutase (SOD). The NSSA levels were increased significantly in the spa group (p = 0.003) but not in the control group (p = 0.509); and there was a trend in favor of spa therapy for improvements in NSSA levels compared to control (p = 0.091). Significant clinical improvement was found in the spa group compared to the control in terms of patient global assessment (p = 0.011), physician global assessment (p = 0.043), function (HAQ-DI) (p = 0.037), disease activity (DAS28-4[ESR]) (0.044) and swollen joint count (0.009), and a trend toward improvement in pain scores (0.057). Spa therapy with saline balneotherapy exerts antioxidant effect in patients with RA as reflected by the

  5. Loperamide in acute diarrhoea in childhood: results of a double blind, placebo controlled multicentre clinical trial. Diarrhoeal Diseases Study Group (UK).

    OpenAIRE

    1984-01-01

    A total of 315 young children with acute diarrhoea were included in a double blind, hospital based multicentre trial of loperamide at two dose levels (0.8 mg and 0.4 mg/kg/24 h), given with standard oral rehydration therapy versus placebo plus oral rehydration therapy. The overall recovery rate was slowest in the placebo group and fastest in the group given loperamide 0.8 mg. Comparisons between weights on admission and weights by day 3 showed that a larger proportion of children in the loper...

  6. Predicting Methylphenidate Response in Long-Term Survivors of Childhood Cancer: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial

    OpenAIRE

    Conklin, Heather M.; Helton, Susan; Ashford, Jason; Mulhern, Raymond K.; Reddick, Wilburn E.; Brown, Ronald; Bonner, Melanie; Jasper, Bruce W.; Wu, Shengjie; Xiong, Xiaoping; Khan, Raja B.

    2009-01-01

    Objective To investigate the methylphenidate (MPH) response rate among childhood survivors of acute lymphoblastic leukemia (ALL) and brain tumors (BTs) and to identify predictors of positive MPH response. Methods Cancer survivors (N = 106; BT = 51 and ALL = 55) identified as having attention deficits and learning problems participated in a 3-week, double-blind, crossover trial consisting of placebo, low-dose MPH (0.3 mg/kg), and moderate-dose MPH (0.6 mg/kg). Weekly teacher and parent reports...

  7. Effect of lidocaine gel on pain from copper IUD insertion: A randomized double-blind controlled trial

    Directory of Open Access Journals (Sweden)

    S Mohammad-Alizadeh-Charandabi

    2010-01-01

    Full Text Available Context: Insertion pain or fear of it may make women hesitate to use the intrauterine device (IUD; a long-term, reversible, highly-effective contraception method. Further study has been recommended on the effects of lidocaine (xylocaine gel on IUD insertion pain in the recent Cochran review. Aims: To determine the effect of lidocaine gel on pain from TCu-380AIUD insertion. Materials and Methods: At a health center in Tabriz, Iran, 96 women were allocated into 3 groups using block randomization with 6 and 9 block sizes considering allocation concealment. In 1 >st group, lidocaine 2% gel and in the 2 >nd , lubricant gel was placed in the cervical canal 1 minute before an IUD insertion, and the 3 >rd group got no intervention. Immediately after IUD insertion, pain during the insertion was measured using 0-10 cm visual analogue scale. Statistical Analysis Used: Kruskal-Wallis and linear regression in SPSS-13 were used to identify effect of lidocaine gel on the pain. Results: Overall, the mean pain score was 3.5 ± 1.8. In univariate analysis, there was no significant difference in pain scores between the 3 groups. Also, results of linear regression model by controlling effect of the possible confounding showed no significant effect of lidocaine gel on the insertion pain. The mean pain score in the lidocaine group was 0.39 less than the no intervention group, but it was not significant (CI 95% of the difference: -1.3, 0.57. Conclusions: Use of 2% lidocaine gel into the cervical canal has no effect on reducing overall pain during IUD insertion.

  8. Effects of probiotics on biomarkers of oxidative stress and inflammatory factors in petrochemical workers: A randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Ali Akbar Mohammadi

    2015-01-01

    Full Text Available Background: The aim of the current study was to determine effects of probiotic yoghurt and multispecies probiotic capsule supplementation on biomarkers of oxidative stress and inflammatory factors in petrochemical workers. Methods: This randomized, double-blind, placebo-controlled trial was done among petrochemical workers. Subjects were randomly divided into three groups to receive 100 g/day probiotic yogurt (n = 12 or one probiotic capsule daily (n = 13 or 100 g/day conventional yogurt (n = 10 for 6 weeks. The probiotic yoghurt was containing two strains of Lactobacillus acidophilus and Bifidobacterium lactis with a total of min 1 Χ 10 7 CFU. Multispecies probiotic capsule contains seven probiotic bacteria spices Actobacillus casei 3 Χ 10 3 , L. acidophilus 3 Χ 10 7 , Lactobacillus rhamnosus 7 Χ 10 9 , Lactobacillus bulgaricus 5 Χ 10 8 , Bifidobacterium breve 2 Χ 10 10 , Bifidobacterium longum 1 Χ 10 9 and Streptococcus thermophilus 3 Χ 10 8 CFU/g. Fasting blood samples were obtained at the beginning and end of the trial to quantify biomarkers of oxidative stress and inflammatory factors. Results: Although a significant within-group decrease in plasma protein carbonyl levels was seen in the probiotic capsule group (326.0 ± 308.9 vs. 251.0 ± 176.3 ng/mL, P = 0.02, the changes were similar among the three groups. In addition, significant within-group decreases in plasma iso prostaglandin were observed in the probiotic supplements group (111.9 ± 85.4 vs. 88.0 ± 71.0 pg/mL, P = 0.003 and in the probiotic yogurt group (116.3 ± 93.0 vs. 92.0 ± 66.0 pg/mL, P = 0.02, nevertheless there were no significant change among the three groups. Conclusions: Taken together, consumption of probiotic yogurt or multispecies probiotic capsule had beneficial effects on biomarkers of oxidative stress in petrochemical workers.

  9. Probiotic supplementation affects markers of intestinal barrier, oxidation, and inflammation in trained men; a randomized, double-blinded, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Lamprecht Manfred

    2012-09-01

    Full Text Available Abstract Background Probiotics are an upcoming group of nutraceuticals claiming positive effects on athlete’s gut health, redox biology and immunity but there is lack of evidence to support these statements. Methods We conducted a randomized, double-blinded, placebo controlled trial to observe effects of probiotic supplementation on markers of intestinal barrier, oxidation and inflammation, at rest and after intense exercise. 23 trained men received multi-species probiotics (1010 CFU/day, Ecologic®Performance or OMNi-BiOTiC®POWER, n = 11 or placebo (n = 12 for 14 weeks and performed an intense cycle ergometry over 90 minutes at baseline and after 14 weeks. Zonulin and α1-antitrypsin were measured from feces to estimate gut leakage at baseline and at the end of treatment. Venous blood was collected at baseline and after 14 weeks, before and immediately post exercise, to determine carbonyl proteins (CP, malondialdehyde (MDA, total oxidation status of lipids (TOS, tumor necrosis factor-alpha (TNF-α, and interleukin-6 (IL-6. Statistical analysis used multifactorial analysis of variance (ANOVA. Level of significance was set at p  Results Zonulin decreased with supplementation from values slightly above normal into normal ranges ( 0.1. CP increased significantly from pre to post exercise in both groups at baseline and in the placebo group after 14 weeks of treatment (p = 0.006. After 14 weeks, CP concentrations were tendentially lower with probiotics (p = 0.061. TOS was slightly increased above normal in both groups, at baseline and after 14 weeks of treatment. There was no effect of supplementation or exercise on TOS. At baseline, both groups showed considerably higher TNF-α concentrations than normal. After 14 weeks TNF-α was tendentially lower in the supplemented group (p = 0.054. IL-6 increased significantly from pre to post exercise in both groups (p = 0.001, but supplementation had no effect. MDA

  10. Comparison of driving simulator performance with real driving after alcohol intake: a randomised, single blind, placebo-controlled, cross-over trial.

    Science.gov (United States)

    Helland, Arne; Jenssen, Gunnar D; Lervåg, Lone-Eirin; Westin, Andreas Austgulen; Moen, Terje; Sakshaug, Kristian; Lydersen, Stian; Mørland, Jørg; Slørdal, Lars

    2013-04-01

    The purpose of this study was to establish and validate a driving simulator method for assessing drug effects on driving. To achieve this, we used ethanol as a positive control, and examined whether ethanol affects driving performance in the simulator, and whether these effects are consistent with performance during real driving on a test track, also under the influence of ethanol. Twenty healthy male volunteers underwent a total of six driving trials of 1h duration; three in an instrumented vehicle on a closed-circuit test track that closely resembled rural Norwegian road conditions, and three in the simulator with a driving scenario modelled after the test track. Test subjects were either sober or titrated to blood alcohol concentration (BAC) levels of 0.5g/L and 0.9g/L. The study was conducted in a randomised, cross-over, single-blind fashion, using placebo drinks and placebo pills as confounders. The primary outcome measure was standard deviation of lateral position (SDLP; "weaving"). Eighteen test subjects completed all six driving trials, and complete data were acquired from 18 subjects in the simulator and 10 subjects on the test track, respectively. There was a positive dose-response relationship between higher ethanol concentrations and increases in SDLP in both the simulator and on the test track (psimulator, this dose-response was evident already after 15min of driving. SDLP values were higher and showed a larger inter-individual variability in the simulator than on the test track. Most subjects displayed a similar relationship between BAC and SDLP in the simulator and on the test track; however, a few subjects showed striking dissimilarities, with very high SDLP values in the simulator. This may reflect the lack of perceived danger in the simulator, causing reckless driving in a few test subjects. Overall, the results suggest that SDLP in the driving simulator is a sensitive measure of ethanol impaired driving. The comparison with real driving implies

  11. Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Jean-Yves Reginster

    2014-02-01

    Full Text Available Objective. Background Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its effect on radiological progression of knee osteoarthritis.Methods. Patients with knee osteoarthritis (Kellgren and Lawrence grade 2 or 3, and joint space width (JSW 2.5-5 mm were randomly allocated to strontium ranelate 1 g/day (n=558, 2 g/day (n=566 or placebo (n=559. The primary endpoint was radiographical change in JSW (medial tibiofemoral compartment over 3 years versus placebo. Secondary endpoints included radiological progression, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score, and knee pain. The trial is registered (ISRCTN41323372.Results. The intention-to-treat population included 1371 patients. Treatment with strontium ranelate was associated with smaller degradations in JSW than placebo (1 g/day: -0.23 (SD 0.56 mm; 2 g/day: -0.27 (SD 0.63 mm; placebo:-0.37 (SD 0.59 mm; treatment-placebo differences were 0.14 (SE 0.04, 95% CI 0.05 to 0.23, p<0.001 for 1 g/day and 0.10 (SE 0.04, 95% CI 0.02 to 0.19, p=0.018 for 2 g/day. Fewer radiological progressors were observed withstrontium ranelate (p<0.001 and p=0.012 for 1 and 2 g/day. There were greater reductions in total WOMAC score (p=0.045, pain subscore (p=0.028, physical function subscore (p=0.099 and knee pain (p=0.065 with strontium ranelate 2 g/day. Strontium ranelate was well tolerated. Conclusions. Treatment with strontium ranelate 1 and 2 g/day is associated with a significant effect on structure in patients with knee osteoarthritis, and a beneficial effect on symptoms for strontium ranelate 2 g/day.Additional supplementary data are published online only. To view these files please visit the journal online (http://dx.doi. org/10.1136/annrheumdis-2012-202231

  12. The Effect of G-ORS Along With Rice Soup in the Treatment of Acute Diarrhea in Children: A Single-Blind Randomized Controlled Trial

    Science.gov (United States)

    Kianmehr, Mojtaba; Saber, Ashraf; Moshari, Jalil; Ahmadi, Reza; Basiri-moghadam, Mahdi

    2016-01-01

    Background The world health organization guidelines for treatment of diarrhea in children emphasize on continued feeding together with prescription of oral rehydration solution (ORS) and supplementary zinc therapy. However, conflicting viewpoints exist regarding the optimal diet and dietary ingredients for children with diarrhea. Moreover, few studies have investigated the effect of rice soup along with ORS in the treatment of this disease. Objectives This study aimed to explore effects of simultaneous taking of glucose oral rehydration solution (G-ORS) and rice soup in the treatment of acute diarrhea in 8 to 24-month-old children. Patients and Methods This single-blind controlled clinical trial was conducted in the pediatric ward of 22nd of Bahman hospital, Gonabad, Iran between June 2013 and February 2014. Forty children aged 8-24 months with acute diarrhea were randomly assigned into an intervention group (G-ORS plus rice soup group) comprising 20 babies and a control group (G-ORS) of 20 children based on balanced blocking randomization. The variables under investigation were diarrhea duration, patient hospitalization, need for intravenous (IV) fluids and stool output frequency. Data was analyzed using independent samples t and chi-square test. Results At the end of study, the time for treating acute watery diarrhea in the intervention and control groups were 21.10 ± 8.81 and 34.55 ± 5.82 hours (P < 0.001) and hospital stay were 34.05 ± 6.62 and 40.20 ± 6.32 hours (P = 0.005). Moreover, stool output frequency were 4.20 ± 0.95 and 8.00 ± 1.37 (P < 0.001) in the first 24 hours, and 2.18 ± 0.60 and 2.80 ± 0.76 (P = 0.03) in the second 24 hours of treatment in intervention and control groups, respectively. Conclusions Rice soup regimen was highly effective and inexpensive in the treatment of acute diarrhea in children. Thus, in addition to the common treatment by G-ORS, rice soup can be consumed simultaneously with G-ORS.

  13. The effect of selective serotonin reuptake inhibitors in healthy first-degree relatives of patients with major depressive disorder - an experimental medicine blinded controlled trial

    DEFF Research Database (Denmark)

    Knorr, Ulla Benedichte

    2012-01-01

    whether SSRI enhance cognitive function in healthy first-degree relatives of patients with MDD. Eighty healthy first-degree relatives to patients with MDD were randomised to receive escitalopram 10 mg versus matching pla-cebo daily for four weeks in a blinded trial. The primary outcome measure was the...... the escitalopram and the placebo group, p = 0.47. Fur-ther, escitalopram did not significantly affect self-reported neu-roticism compared with placebo, NEO-PI-R (p = 0.09) and EPQ (p = 0.73). Finally, mean change in the general cognition score was not significantly increased with escitalopram compared...... with placebo, (p = 0.37). In univariate analyses, no statistically significant correlations were found between change in the primary and secondary outcomes, respectively, and the covariates age, sex, Hamilton depression score 17-items, and plasma escitalopram levels. In conclusion, the present trial...

  14. Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV in young Latin American children: A double-blind randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Miguel W Tregnaghi

    2014-06-01

    Full Text Available BACKGROUND: The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia (CAP and acute otitis media (AOM is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV on these end points. The primary objective was to demonstrate vaccine efficacy (VE in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml; other protocol-specified outcomes were also assessed. METHODS AND FINDINGS: This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at booster at 2, 4, 6, and 15-18 mo of age. Interim analysis of the primary end point was planned when 535 first B-CAP episodes, occurring ≥2 wk after dose 3, were identified in the per-protocol cohort. After a mean follow-up of 23 mo (PHiD-CV, n = 10,295; control, n = 10,201, per-protocol VE was 22.0% (95% CI: 7.7, 34.2; one-sided p = 0.002 against B-CAP (conclusive for primary objective and 25.7% (95% CI: 8.4%, 39.6% against World Health Organization-defined consolidated CAP. Intent-to-treat VE was 18.2% (95% CI: 5.5%, 29.1% against B-CAP and 23.4% (95% CI: 8.8%, 35.7% against consolidated CAP. End-of-study per-protocol analyses were performed after a mean follow-up of 28-30 mo for CAP and invasive pneumococcal disease (IPD (PHiD-CV, n = 10,211; control, n = 10,140 and AOM (n = 3,010 and 2,979, respectively. Per-protocol VE was 16.1% (95% CI: -1.1%, 30.4%; one-sided p = 0.032 against clinically confirmed AOM, 67.1% (95% CI: 17.0%, 86

  15. A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Metformin Therapy in Overweight/Obese Youth with Type 1 Diabetes.

    Directory of Open Access Journals (Sweden)

    Benjamin Udoka Nwosu

    Full Text Available Insulin resistance has been proposed as one of the causes of poor glycemic control in overweight/obese youth with type 1 diabetes (T1D. However, the role of adjunctive metformin, an insulin sensitizer, on glycemic control in these patients is unclear.To compare the effect of metformin vs. placebo on hemoglobin A1c (HbA1c, total daily dose (TDD of insulin, and other parameters in overweight/obese youth with T1D.Adjunctive metformin therapy will improve glycemic control in overweight/obese youth with T1D.A 9-mo randomized, double-blind, placebo controlled trial of metformin and placebo in 28 subjects (13m/15f of ages 10-20years (y, with HbA1c >8% (64 mmol/mol, BMI >85%, and T1D > 12 months was conducted at a university outpatient facility. The metformin group consisted of 15 subjects (8 m/ 7f, of age 15.0 ± 2.5 y; while the control group was made up of 13 subjects (5m/ 8f, of age 14.5 ± 3.1y. All participants employed a self-directed treat-to-target insulin regimen based on a titration algorithm of (-2-0-(+2 units to adjust their long-acting insulin dose every 3rd day from -3 mo through +9 mo to maintain fasting plasma glucose (FPG between 90-120 mg/dL (5.0-6.7 mmol/L. Pubertal maturation was determined by Tanner stage.Over the course of the 9 months of observation, the between-treatment differences in HbA1c of 0.4% (9.85% [8.82 to 10.88] for placebo versus 9.46% [8.47 to 10.46] for metformin was not significant (p = 0.903. There were non-significant reduction in fasting plasma glucose (189.4 mg/dL [133.2 to 245.6] for placebo versus 170.5 mg/dL [114.3 to 226.7] for metformin, (p = 0.927; total daily dose (TDD of short-acting insulin per kg body weight/day(p = 0.936; and the TDD of long-acting insulin per kg body weight per day (1.15 units/kg/day [0.89 to 1.41] for placebo versus 0.90 units/kg/day [0.64 to 1.16] for metformin (p = 0.221. There was no difference in the occurrence of hypoglycemia between the groups.This 9-month RCT of adjunctive

  16. A single blind randomized controlled trial of cognitive behavioural therapy in a help-seeking population with an At Risk Mental State for psychosis: the Dutch Early Detection and Intervention Evaluation (EDIE-NL trial

    Directory of Open Access Journals (Sweden)

    Delespaul Philippe

    2010-03-01

    Full Text Available Abstract Background Psychotic disorders are a serious mental health problem. Intervention before the onset of psychosis might result in delaying the onset, reducing the impact or even preventing the first episode of psychosis. This study explores the effectiveness of cognitive behavioural therapy (CBT in targeting cognitive biases that are involved in the formation of delusions in persons with an ultra-high risk for developing psychosis. A single blind randomised controlled trial compares CBT with treatment as usual in preventing or delaying the onset of psychosis. Method/design All help seeking patients aged 14 to 35 years referred to the mental health services in three regions in the Netherlands are pre-screened with the Prodromal Questionnaire during a period of two years. Patients with a score of 18 or more on the sub-clinical positive symptoms items (45 items in total will be assessed with the Comprehensive Assessment of At Risk Mental State (CAARMS. In a different pathway to care model all referrals from the mental health services in Amsterdam to the specialized psychosis clinic of the Academic Medical Centre in Amsterdam are also assessed with the CAARMS. The primary outcome is the transition rate to psychosis according to the CAARMS-criteria. Group differences will be analysed with chi-square tests and survival analyses. Discussion CBT is a highly tolerated treatment. The psycho-educational CBT approach may prove to be a successful strategy since most people with an At Risk Mental State (ARMS are distressed by odd disturbing experiences. Giving explanations for and normalising these experiences may reduce the arousal (distress and therefore may prevent people from developing a catastrophic delusional explanation for their odd experiences and thus prevent them from developing psychosis. Screening the entire help-seeking population referred to community mental health services with a two-stage strategy, as compared with traditional referral

  17. The Effect of Bee Venom Acupuncture(BVA on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study

    Directory of Open Access Journals (Sweden)

    Song, Ho-Seub

    2005-06-01

    Full Text Available Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC participated in the study, who were divided into two groups (A and B randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41 of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo or BVA was done and then acupuncture at 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41, 足三里(ST36, 陽陵泉(G34 of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS and Visual Analogue Scale(VAS were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective

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

    Directory of Open Access Journals (Sweden)

    Marlène Perignon

    2016-01-01

    Full Text Available 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 < 0.01. After six months, children receiving NutriRice and URN had 4 and 5 times less risk of low VA 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

  19. Natural herbal medicine Lianhuaqingwen capsule anti-influenza A (H1N1) trial: a randomized, double blind, positive controlled clinical trial

    Institute of Scientific and Technical Information of China (English)

    DUAN Zhong-ping; ZHANG Shu-qin; WANG Yong-yan; WU Yi-ling; JIA Zhen-hua; ZHANG Jian; LIU Shuang; CHEN Yu; LIANG Lian-chun; ZHANG Chang-qing; ZHANG Zong; SUN Yan

    2011-01-01

    Background The 2009 influenza A (H1N1) virus infection is associated with the high risk of severe complications and is spreading more rapidly throughout the wodd than other reported seasonal influenzas. This study aimed to evaluate the efficacy and safety of the nature herbal medicine Lianhuaqingwen capsule (LHC) in patients infected with influenza A (H1N1) virus.Methods A total of 244 patients aged 16-65 years confirmed with influenza A (H1N1) virus infection by the real time RT-PCR were randomized to one of two treatment groups of 122 patients each. Each group assigned to receive either LHC or Oseltamivir for five days and observation for seven days. The patients were enrolled within 36 hours of illness onset if they had an axillary temperature of ≥37.4℃ and with at least one of the following symptoms: nasal obstruction, runny nose,cough, sore throat, fatigue, headache, myalgia, chills and sweating. The primary end point was the duration of illness.Results Of 244 patients, 240 (98.36%) patients with a median age 21 years completed the study between October 24,2009 and November 23, 2009. There were no significant overall differences between LHC treated and Oseltamivir treated patients in the median duration of illness (LHC 69 hours vs. Oseltamivir 85 hours P >0.05) or the median duration of viral shedding (LHC 103 hours vs. Oseltamivir 96 hours, P >0.05). However, it was worthwhile to note that LHC significantly reduced the severity of illness and the duration of symptoms including fever, cough, sore throat, and fatigue (P <0.05). Both study medications were well tolerated. No drug related serious adverse events occurred during the study.Conclusions Compared with Oseltamivir, LHC achieved a similar therapeutic effectiveness reduction of the duration of illness and duration of viral shedding. Therefore, LHC might be an alternative therapeutic measure for influenza A (H1N1)virus infections. (Clinical trial number: ChiCTR-TRC-00000589).

  20. Efficacy and safety of Tinospora cordifolia lotion in Sarcoptes scabiei var hominis-infected pediatric patients: A single blind, randomized controlled trial

    OpenAIRE

    Castillo, Agnes L.; Osi, Marina O.; Ramos, John Donnie A.; De Francia, Jean L.; Marylaine U Dujunco; Quilala, Peter F.

    2013-01-01

    Objective: To evaluate the clinical efficacy and safety of Tinospora cordifolia lotion including its cure rate and clearance time compared with permethrin lotion. Materials and Methods: A single blind, randomized, controlled, pilot clinical study was performed in three government institutions to investigate clinical efficacy of T. cordifolia lotion in sixty-six clinically-diagnosed scabies-infected patients. The patients were treated with T. cordifolia or permethrin lotions for three consecut...

  1. Efficacy and safety of Tinospora cordifolia lotion in Sarcoptes scabiei var hominis-infected pediatric patients: A single blind, randomized controlled trial

    OpenAIRE

    Castillo, Agnes L.; Osi, Marina O.; Ramos, John Donnie A.; De Francia, Jean L.; Marylaine U Dujunco; Quilala, Peter F.

    2013-01-01

    Objective: To evaluate the clinical efficacy and safety of Tinospora cordifolia lotion including its cure rate and clearance time compared with permethrin lotion . Materials and Methods: A single blind, randomized, controlled, pilot clinical study was performed in three government institutions to investigate clinical efficacy of T.cordifolia lotion in sixty-six clinically-diagnosed scabies-infected patients. The patients were treated with T.cordifolia or permethrin lotions for three consecuti...

  2. USE OF MUVEASE IN THE TREATMENT OF JOINT PAIN AND BACK PAIN: A RANDOMIZED DOUBLE-BLIND PLACEBO CONTROLLED CLINICAL TRIAL

    OpenAIRE

    Adhikari Anjan; Biswas Sharmistha; Maity Tamoghna; Radharaman De; Debnath Pratip Kumar

    2011-01-01

    Joint and back pain is a common problem throughout the world. Indian population were also suffering from this disorder. Aetiology of this disease is varied & therapeutic remedy in modern medicine is not enough. Not only that, the side effects of the existing medicine are causing deterioration of quality of life. A randomized double-blind placebo controlled clinical study was conducted to evaluate the efficacy, safety and tolerability of Muvease, a herbal formulation, in the management of joi...

  3. Ananas comosus Effect on Perineal Pain and Wound Healing After Episiotomy: A Randomized Double-Blind Placebo-Controlled Clinical Trial

    OpenAIRE

    Golezar, Samira

    2016-01-01

    Background: Ananas comosus has long been used for medical purposes. Currently, we are experiencing an unprecedented interest in the use of complementary medicine as well as a growing attention to traditional products such as bromelain for wound healing and reducing pain. Objectives: The aim of this study was to determine the effect of oral bromelain on perineal pain and wound healing after episiotomy in primiparous women. Patients and Methods: In this double-blind placebo-controlled clinical ...

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

    OpenAIRE

    Fabiana Valadares; Maria Rita Carvalho Garbi Novaes; Roberto Cañete

    2013-01-01

    Background: Breast cancer (BC) represents the highest incidence of malignancy in women throughout the world. Medicinal fungi can stimulate the body, reduce side-effects associated with chemotherapy and improve the quality of life in patients with cancer. Aim: To evaluate the effects of dietary supplementation of Agaricus sylvaticus on clinical and nutritional parameters in BC patients undergoing chemotherapy. Materials and Methods: A randomized, placebo-controlled, double-blind, clini...

  5. Evaluation of effect of isoflavone on thyroid economy & autoimmunity in oophorectomised women: A randomised, double-blind, placebo-controlled trial

    OpenAIRE

    Mittal, Niti; Hota, Debasish; Dutta, Pinaki; Bhansali, Anil; Suri, Vanita; Aggarwal, Neelam; Marwah, R.K.; Chakrabarti, Amitava

    2011-01-01

    Background and objectives: The potential of soy isoflavones to interfere with thyroid function has been reported. However, there are limited data regarding their effect on thyroid function and autoimmunity in surgical menopausal women. The present study aimed to evaluate the effect of isoflavones on thyroid function and autoimmunity, menopausal symptoms, serum follicle stimulating hormone (FSH) and estradiol levels in oophorectomised women. Methods: A randomized, double blind, placebo-control...

  6. Eslicarbazepine acetate as adjunctive therapy in patients with uncontrolled partial-onset seizures: Results of a phase III, double-blind, randomized, placebo-controlled trial

    OpenAIRE

    Sperling, Michael R.; Abou-Khalil, Bassel; Harvey, Jay; Rogin, Joanne B; Biraben, Arnaud; Galimberti, Carlo A; Kowacs, Pedro A.; Hong, Seung Bong; Cheng, Hailong; Blum, David; Nunes, Teresa; Soares-da-Silva, Patrício

    2014-01-01

    Objective To evaluate the efficacy and safety of adjunctive eslicarbazepine acetate (ESL) in patients with refractory partial-onset seizures. Methods This randomized, placebo-controlled, double-blind, parallel-group, phase III study was conducted at 173 centers in 19 countries, including the United States and Canada. Eligible patients were aged ≥16 years and had uncontrolled partial-onset seizures despite treatment with 1–2 antiepileptic drugs (AEDs). After an 8-week baseline period, patients...

  7. The effect of barusiban, a selective oxytocin antagonist, in threatened preterm labor at late gestational age: a randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Thornton, Steven; Goodwin, Thomas M; Greisen, Gorm; Hedegaard, Morten; Arce, Joan-Carles

    2009-01-01

    OBJECTIVE: The objective of the study was to compare barusiban with placebo in threatened preterm labor. STUDY DESIGN: This was a randomized, double-blind, placebo-controlled, multicenter study. One hundred sixty-three women at 34-35 weeks plus 6 days, and with 6 or more contractions of 30 seconds......, fetus, neonate, or infant. CONCLUSION: An intravenous bolus of barusiban was no more effective than placebo in stopping preterm labor in pregnant women at late gestational age....

  8. EFFICACY OF MUSIC THERAPY IN THE REDUCTION OF REQUIREMENT OF SEDATIVE AGENTS, IN SURGERIES PERFORMED UNDER CAUDAL ANAESTHESIA: A ONE YEAR DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    Manjunath C

    2014-09-01

    Full Text Available CONTEXT: Paediatric patients undergoing surgeries under regional anaesthesia require adequate sedation. Various intravenous agents and inhalational anaesthetics have been used for this purpose. The purpose of this study is to establish a relationship between music and intra operative requirement of sedative agents (inhalational and intravenous agents in pediatric patients undergoing surgeries under caudal epidural anaesthesia. AIM: The aim of this study is to establish a relationship between music and reduction in intra operative requirement of sedative agents (inhalational and intravenous agents in pediatric patients undergoing surgeries under caudal epidural anaesthesia. SETTINGS AND DESIGN: One year hospital based double blinded randomized clinical controlled trial. MATERIALS AND METHODS: 50 ASA grade I and II children in the age group of 1 to 6 years who were scheduled for herniotomy were included in this study. Children were randomly divided into two groups A and B. All the children received 1 ml/kg body weight of 0.25% bupivacaine in caudal epidural space, in addition all the a head phone was applied in all the children, the children in Group A were played a classical Indian music via head phone whereas children in Group B were devoid of any music in the intra operative period. SpO2, ECG, NIBP were monitored intra operatively. Level of sedation using “Ramsay Sedation Scale”. If the sedation scale was < 3, Inj.midazolam-0.03 mg/kg was administered i.v. as and when required, so that the maximum dose did not cross 0.6mg/kg4. If the midazolam requirement exceeded the maximum dose then adequate sedation scores were achieved using sevoflurane. The total number of doses of sedatives required and the total dose required were noted. STASTICAL ANALYSIS: The data was analyzed using the Mann Whitney test and Student’s t test comparing the sedation scores of between the two groups. RESULTS: The demographic parameters, duration of surgery were

  9. A placebo-controlled, double-blind clinical trial to evaluate the efficacy of Imedeen® Time Perfection® for improving the appearance of photodamaged skin

    Science.gov (United States)

    Stephens, Thomas J; Sigler, Monya L; Herndon, James H; Dispensa, Lisa; Le Moigne, Anne

    2016-01-01

    Objective To assess the efficacy of Imedeen Time Perfection for improving the appearance and condition of photoaged skin in healthy women. Methods This randomized, double-blind, placebo-controlled clinical trial enrolled healthy women, 35–60 years of age, with Fitzpatrick I–III and Glogau II–III skin types and mild-to-moderate facial fine lines/wrinkles. The eligible subjects were randomized to receive two tablets daily of either Imedeen Time Perfection (Imedeen) or a matching placebo for 12 weeks. Efficacy assessments included investigator rating of 16 photoaging parameters (ie, global facial appearance and 15 individual facial parameters and the average of all parameters), instrumentation (ie, ultrasound dermal density, moisture level of the stratum corneum, transepidermal water loss, cutometry), and subjects’ self-assessment. Differences in the mean change from baseline to week 12 values on these outcomes were compared between Imedeen and placebo using analysis of variance or a paired t-test. Results Seventy-four subjects with primarily Fitzpatrick skin type III (78%–79%) and Glogau type III (53%–58%) completed the study (Imedeen: n=36; placebo: n=38). The mean difference in change from baseline to week 12 for global facial assessment significantly favored Imedeen over placebo (−0.52; P=0.0017). Additionally, the mean differences in the average of all facial photoaging parameters (−0.29), mottled hyperpigmentation (−0.25), tactile laxity (−0.24), dullness (−0.47), and tactile roughness (−0.62) significantly favored Imedeen over placebo (P≤0.05). Significantly greater increases in ultrasound dermal density (+11% vs +1%; P≤0.05) and stratum corneum moisturization (+30% vs +6%; P≤0.05) were also observed for Imedeen than for placebo. There were no significant differences on other instrumental outcomes. Conclusion The results of this study suggest that Imedeen Time Perfection can positively affect the appearance of photoaged skin

  10. Analgesic effect of paracetamol combined with low-dose morphine versus morphine alone on patients with biliary colic: a double blind, randomized controlled trial

    Science.gov (United States)

    Farnia, Mohammad Reza; Babaei, Rasoul; Shirani, Farzaneh; Momeni, Mehdi; Hajimaghsoudi, Majid; Vahidi, Elnaz; Saeedi, Morteza

    2016-01-01

    BACKGROUND: Numerous drugs have been proposed to alleviate pain in patients with biliary colic, especially opioids, but still there is a tendency to use less narcotics because of their side effects and the unwillingness of some patients. The present study aimed to compare the analgesic effect of paracetamol combined with low-dose morphine versus morphine alone in patients with biliary colic. METHODS: A randomized double-blind controlled trial was performed in 98 patients with biliary colic, recruited from two emergency departments from August 2012 to August 2013. Eleven patients were excluded and the remaining were randomized into two groups: group A received 0.05 mg/kg morphine+1 000 mg paracetamol in 100 mL normal saline and group B received 0.1 mg/kg morphine+normal saline (100 mL) as placebo. Pain scores were recorded using visual analogue scale (VAS) at baseline and 15 and 30 minutes after drug administration. Adverse effects and the need for rescue medication (0.75 µg/kg intravenous fentanyl) were also reported within 60 minutes of drug administration. RESULTS: Before the infusion, the mean±SD VAS scores were 8.73±1.57 in group A and 8.53±1.99 in group B. At 15 minutes after drug administration, the mean±SD VAS scores were 2.16±1.90 in group A vs. 2.51±1.86 in group B; mean difference was –0.35, and 95%CI –1.15 to 0.45 (P=0.38). At 30 minutes the mean±SD VAS scores were 1.66±1.59 in group A vs. 2.14±1.79 in group B; mean difference was –0.48, and 95%CI –1.20 to 0.24 (P=0.19). The mean pain scores in the two groups at 15 and 30 minutes demonstrated no significant difference. CONCLUSION: Paracetamol combined with low-dose morphine may be effective for pain management in patients with biliary colic. PMID:27006734

  11. A randomized, double-blind, placebo-controlled, clinical trial of the impact of malaria prevention on the educational attainment of school children.

    Science.gov (United States)

    Fernando, Deepika; de Silva, Damani; Carter, Richard; Mendis, Kamini N; Wickremasinghe, Rajitha

    2006-03-01

    A double-blind, placebo-controlled trial of nine months duration was carried out to investigate the impact of malaria and its prevention on the educational attainment of school children in a malaria-endemic area in southern Sri Lanka where both Plasmodium falciparum and P. vivax infections are prevalent. A total of 587 children attending grades 1-5 in four schools and resident in the area were randomly allocated to chloroquine (n = 295) and placebo (n = 292) arms. Language and mathematics scores of end-of-term school examinations for 1998 and 1999 and number of days absent and reasons for absenteeism during seven months pre-intervention and nine months of the intervention were recorded. The results indicate that there were no differences in language (95% confidence interval [CI] = 48.44-53.78 in chloroquine group and 50.43-55.81 in placebo group) and mathematics (95% CI = 49.24-54.38 in chloroquine group and 51.12-56.38 in placebo group) scores between the two groups prior to the intervention. During the intervention, the malaria incidence rate decreased by 55% (95% CI = 49-61%) and school absenteeism due to malaria was reduced by 62.5% (95% CI = 57-68%) in children who received chloroquine compared with the placebo group. Post-intervention, children who received chloroquine scored approximately 26% higher in both language (95% CI = 21-31%) and mathematics (95% CI = 23-33%) than children who received placebo. In a multivariate model, educational attainment was significantly associated with taking chloroquine prophylaxis and absenteeism due to malaria (P < 0.001 for both) but not due to health causes other than malaria or non-health causes. Language scores were associated with number of malaria attacks (P < 0.022). Educational attainment was significantly better among children whose compliance to chloroquine prophylaxis was higher (P < 0.001). The data suggest that malarial attacks have an adverse impact on the educational attainment of the school child and

  12. Influence of methylphenidate treatment assumptions on cognitive function in healthy young adults in a double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Mommaerts JL

    2013-08-01

    Full Text Available Jean-Luc Mommaerts,1 Gerlinde Beerens,1 Lieve Van den Block,1 Eric Soetens,2 Sandrina Schol,1 Erwin Van De Vijver,1 Dirk Devroey1 1Department of Family Medicine, 2Department of Cognitive and Biological Psychology, Vrije Universiteit Brussel, Belgium Background: Increasing numbers of students use stimulants such as methylphenidate (MPH to improve their study capacity, making them prone to subsequent prolonged drug abuse. This study explored the cognitive effects of MPH in students who either assumed they received MPH or assumed they received a placebo. Methods: In a double-blind, randomized, placebo-controlled trial with a between-subjects design, 21 students were subjected to partial sleep deprivation, receiving no more than 4 hours sleep the night before they were tested. In the morning, they were given either a placebo or 20 mg of MPH. They then performed free recall verbal tests and Go/No-Go tasks repeatedly, their moods were evaluated using Profile of Mood States and their tiredness was assessed using a visual analog scale, with evaluation of vigilance. Results: No significant differences were found between those subjects who received MPH and those who received a placebo. However, significant differences were found between subjects who assumed they had received MPH or had no opinion, and those who assumed they had received a placebo. At three minutes, one hour, and one day after memorizing ten lists of 20 words, those who assumed they had received MPH recalled 54%, 58%, and 54% of the words, respectively, whereas those who assumed they had received placebo only recalled 35%, 37%, and 34%. Conclusion: Healthy, partially sleep-deprived young students who assume they have received 20 mg of MPH experience a substantial placebo effect that improves consolidation of information into long-term memory. This is independent of any pharmacologic effects of MPH, which had no significant effects on verbal memory in this study. This information may be

  13. The Efficacy and Safety of Wenxin Keli in Patients with Frequent Premature Ventricular Contractions: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial

    Institute of Scientific and Technical Information of China (English)

    Wei Hua; Run-Lin Gao; Bu-Chang Zhao; Jing Wang; Xu-Hua Chen; Chi Cai; Shu Zhang

    2015-01-01

    Background:Premature ventricular contractions (PVCs) are common in the general population,and frequent PVCs may result in the poor quality of life or even the damage of cardiac function.We examined the efficacy and safety of a traditional Chinese medicine Wenxin Keli for the treatment of frequent PVCs among a relatively large Chinese cohort.Methods:We performed a randomized,double-blind,placebo-controlled,parallel-group,multicenter trial.A total of 1200 eligible participants were randomly assigned in a ratio of 1:1 to receive Wenxin Keli or the placebo for 4 weeks.The primary and secondary endpoint was the change of PVC numbers and PVC-related symptoms after a 4-week treatment compared with baseline,respectively.In addition,vital signs,laboratory values,and electrocardiographic parameters were assessed in a safety analysis.Results:At the initial evaluation,no significant differences in the baseline characteristics were observed between the Wenxin Keli group and the placebo group.A smaller number of PVCs was observed after the 4-week treatment than at baseline,in both the Wenxin Keli group (5686 ± 5940 vs.15,138 ± 7597 beats/d,P < 0.001) and the placebo group (10,592 ± 8009 vs.14,529 ± 5929 beats/d,P < 0.001);moreover,the Wenxin Keli group demonstrated a significantly greater reduction in the frequency of PVCs than the placebo group (P < 0.001).In a full analysis set,patients in the Wenxin Keli group exhibited significantly higher total effective responses in the reduction of PVCs compared to those in the placebo group (83.8% vs.43.5%,P < 0.001).The per-protocol analysis yielded similar results (83.0% vs.39.3%,P < 0.001).Treatment with Wenxin Keli also demonstrated superior performance compared to the placebo with respect to PVC-related symptoms.No severe adverse effects attributable to Wenxin Keli were reported.Conclusions:Wenxin Keli treatment effectively reduced the overall number of PVCs and alleviated PVC-related symptoms in patients

  14. A double-blind, placebo-controlled trial related to the effects of melatonin on oxidative stress and inflammatory parameters of obese women.

    Science.gov (United States)

    Mesri Alamdari, N; Mahdavi, R; Roshanravan, N; Lotfi Yaghin, N; Ostadrahimi, A R; Faramarzi, E

    2015-06-01

    Obesity, the global epidemic health problem, results in chronic disorders. Melatonin supplementation may prevent the adverse health consequences of obesity. The aim of this study was to assess the effects of melatonin supplementation on inflammatory and oxidative stress parameters in obese women. In randomized, double-blind, placebo-controlled trial, 44 obese women were randomly assigned to melatonin (n=22) and placebo (n=22) groups. Subjects were supplemented with a daily dose of 6 mg melatonin or placebo with low calorie diet for 40 days. Serum TNF-α, IL-6, hsCRP, TAC, and MDA levels were assessed before and after intervention. In the melatonin group, mean serum TNF-α, IL-6, hsCRP, and MDA levels decreased significantly (p<0.05) from 3.52±0.72 pg/ml, 27.12±6.32 pg/ml, 2.54±0.49 mg/l, and 3.81±0.29 nmol/l to 1.73±0.07, 16.34±6.32, 1.67±0.27, and 2.79±0.29, respectively. Whilst in the placebo group the decrease in values were not statistically significant. Mean TAC level increased slightly (from 1.11±0.30 to 1.14±0.45 mmol/l) in the melatonin group whereas it decreased slightly (from 1.13±0.15 to 1.08±0.21 nmol/l) in the placebo group. Significant differences were observed only for TNF-α (p=0.02) and IL-6 (p=0.03) between the 2 study groups. Considering the improvements in inflammatory and oxidative stress factors in obese women, it seems that melatonin supplementation may provide beneficial effects in obesity treatment by ameliorating some of its complications. However, further studies are needed to make concise conclusions. PMID:25126957

  15. Daily intake of rosehip extract decreases abdominal visceral fat in preobese subjects: a randomized, double-blind, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Nagatomo A

    2015-03-01

    Full Text Available Akifumi Nagatomo,1 Norihisa Nishida,1 Ikuo Fukuhara,2 Akira Noro,3 Yoshimichi Kozai,3 Hisao Sato,3 Yoichi Matsuura1 1Research and Development Division, Morishita Jintan Co, Ltd, Osaka, Japan; 2Fukuhara Clinic, Hokkaido, Japan; 3New Drug Research Center, Inc., Hokkaido, Japan Background: Obesity has become a great problem all over the world. We repeatedly screened to find an effective food to treat obesity and discovered that rosehip extract shows potent antiobesity effects. Investigations in mice have demonstrated that rosehip extract inhibits body weight gain and decreases visceral fat. Thus, the present study examined the effect of rosehip extract on human body fat in preobese subjects. Methods: We conducted a 12-week, single-center, double-blind, randomized, placebo-controlled study of 32 subjects who had a body mass index of ≥25 but <30. The subjects were assigned to two random groups, and they received one tablet of placebo or rosehip that contained 100 mg of rosehip extract once each day for 12 weeks with no dietary intervention. Abdominal fat area and body fat percent were measured as primary outcomes. The other outcomes were body weight and body mass index. Results: Abdominal total fat area, abdominal visceral fat area, body weight, and body mass index decreased significantly in the rosehip group at week 12 compared with their