WorldWideScience

Sample records for placebo-controlled double blind

  1. Double blind placebo controlled exposure to molds

    DEFF Research Database (Denmark)

    Meyer, H W; Jensen, K A; Nielsen, K F

    2005-01-01

    with a positive histamine release test to Penicillium chrysogenum were exposed double- blinded to either placebo, approximately 600,000 spores/m3 air of P. chrysogenum or approximately 350,000 spores/m3 of Trichoderma harzianum for 6 min on three separate days. A statistically significant rise in symptoms from...... mucous membranes appeared from the 9-graded symptom scale after exposure to T. harzianum or placebo. Dichotomizing the data, whether the participants experienced at least a two-step rise on the symptom scale or not, gave borderline increase in mucous membrane symptoms after exposure to P. chrysogenum...... to placebo in eight sensitive school employees. However, a statistical type II error cannot be excluded because of the small sample size. PRACTICAL IMPLICATIONS: In this double blind, placebo controlled study of mold exposure changes in symptoms, objective measurements and blood samples were small and mostly...

  2. Double-blind, placebo-controlled food challenge with apple

    DEFF Research Database (Denmark)

    Skamstrup Hansen, K; Vestergaard, H; Stahl Skov, P

    2001-01-01

    The aim of the study was to develop and evaluate different methods of double-blind, placebo-controlled food challenge (DBPCFC) with apple. Three different DBPCFC models were evaluated: fresh apple juice, freshly grated apple, and freeze-dried apple powder. All challenges were performed outside...

  3. Placebo reactions in double-blind, placebo-controlled food challenges in children

    NARCIS (Netherlands)

    Vlieg-Boerstra, B. J.; van der Heide, S.; Bijleveld, C. M. A.; Kukler, J.; Duiverman, E. J.; Dubois, A. E. J.

    Background: A cardinal feature of the double-blind, placebo-controlled food challenge (DBPCFC) is that placebo administration is included as a control. To date, the occurrence and diagnostic significance of placebo events have not extensively been documented. Objective: To analyse the occurrence and

  4. A double-blind, placebo-controlled study of sertraline with naltrexone for alcohol dependence.

    LENUS (Irish Health Repository)

    Farren, Conor K

    2009-01-01

    Significant preclinical evidence exists for a synergistic interaction between the opioid and the serotonin systems in determining alcohol consumption. Naltrexone, an opiate receptor antagonist, is approved for the treatment of alcohol dependence. This double-blind placebo-controlled study examined whether the efficacy of naltrexone would be augmented by concurrent treatment with sertraline, a selective serotonin receptor uptake inhibitor (SSRI).

  5. No matrix effect in double-blind, placebo-controlled egg challenges in egg allergic children

    NARCIS (Netherlands)

    Libbers, L.; Flokstra-de Blok, B. M. J.; Vlieg-Boerstra, B. J.; van der Heide, S.; van der Meulen, G. N.; Kukler, J.; Kerkhof, M.; Dubois, A. E. J.

    Background Diagnostic and accidental food allergic reactions may be modified by the matrix containing the allergenic food. Previous studies of double-blind, placebo-controlled food challenges (DBPCFCs) with peanut found an effect of the fat content of the challenge matrix on the severity of the

  6. An alternative approach to treating lateral epicondylitis. A randomized, placebo-controlled, double-blinded study

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    2008-01-01

    Objective: To investigate the effect of noxious level electrical stimulation on pain, grip strength and functional abilities in subjects with chronic lateral epicondylitis. Design: Randomized, placebo-control, double-blinded study. Setting: Physical Therapy Department, North Georgia College and Stat

  7. Placebo reactions in double-blind, placebo-controlled food challenges in children

    NARCIS (Netherlands)

    Vlieg-Boerstra, B. J.; van der Heide, S.; Bijleveld, C. M. A.; Kukler, J.; Duiverman, E. J.; Dubois, A. E. J.

    2007-01-01

    Background: A cardinal feature of the double-blind, placebo-controlled food challenge (DBPCFC) is that placebo administration is included as a control. To date, the occurrence and diagnostic significance of placebo events have not extensively been documented. Objective: To analyse the occurrence and

  8. Clinical effects of buspirone in social phobia : A double-blind placebo-controlled study

    NARCIS (Netherlands)

    denBoer, JA; Westenberg, HGM; Pian, KLH

    1997-01-01

    Background: The results of open pilot studies suggest that the serotonin-1A (5-HT1A) receptor agonist buspirone might be effective in social phobia. Method: In the present study, the efficacy of buspirone was investigated in patients with social phobia using a 12-week double-blind placebo-controlled

  9. Influenza vaccination in children with asthma: randomized double-blind placebo- controlled trial.

    NARCIS (Netherlands)

    H.J. Bueving (Herman); R.M.D. Bernsen (Roos); J.C. de Jongste (Johan); L.W.A. van Suijlekom-Smit (Lisette); G.F. Rimmelzwaan (Guus); A.D.M.E. Osterhaus (Albert); M.P.M.H. Rutten-van Mölken (Maureen); S. Thomas (Siep); J.C. van der Wouden (Hans)

    2004-01-01

    textabstractThere is little evidence that influenza vaccination reduces asthma exacerbations. We determined whether influenza vaccination is more effective than placebo in 6-18-year-old children with asthma. We performed a randomized, double-blind, placebo-controlled trial. Parenteral vaccination

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

    DEFF Research Database (Denmark)

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

    2010-01-01

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

  11. Exposure of eyes to perfume: a double-blind, placebo-controlled experiment.

    Science.gov (United States)

    Elberling, J; Duus Johansen, J; Dirksen, A; Mosbech, H

    2006-08-01

    Environmental perfume exposure can elicit bothersome respiratory symptoms. Symptoms are induced at exposure levels which most people find tolerable, and the mechanisms are unclear. The aim of the study was to investigate patients with eye and respiratory symptoms related to environmental perfume, by exposing the eyes to perfume in a double-blind, placebo-controlled study.Twenty-one eczema patients with respiratory symptoms elicited by perfume were compared with 21 healthy volunteers in a sex- and age-matched case-control study. The participants completed a symptom questionnaire, and underwent a double-blind, placebo-controlled exposure to perfume. Of the 42 individuals tested, 10 had more eye symptoms (irritation, itching, and tears) during perfume exposure than during placebo exposures, and eight of these individuals (P = 0.07, Fisher's exact test) belonged to the patient group. A true positive eye reaction to perfume was significantly associated with identification of perfume as an active exposure (P perfume elicited irritation in the eyes independently of olfaction, but the relative importance of ocular chemoperception in relation to elicitation of respiratory symptoms from common environmental exposures to perfume remains unclear. We investigated the hypothesis of an association between respiratory symptoms related to perfume and ocular perfume sensitivity by exposing the eyes to perfume in a double blind, placebo-controlled experiment. Vapors of perfume provoked symptoms in the relevant eye in some patients and healthy control persons, but under our exposure conditions, ocular chemesthesis failed to elicit respiratory symptoms.

  12. New validated recipes for double-blind placebo-controlled low-dose food challenges.

    Science.gov (United States)

    Winberg, Anna; Nordström, Lisbeth; Strinnholm, Åsa; Nylander, Annica; Jonsäll, Anette; Rönmark, Eva; West, Christina E

    2013-05-01

    Double-blind placebo-controlled food challenges are considered the most reliable method to diagnose or rule out food allergy. Despite this, there are few validated challenge recipes available. The present study aimed to validate new recipes for low-dose double-blind placebo-controlled food challenges in school children, by investigating whether there were any sensory differences between the active materials containing cow's milk, hen's egg, soy, wheat or cod, and the placebo materials. The challenge materials contained the same hypoallergenic amino acid-based product, with or without added food allergens. The test panels consisted of 275 school children, aged 8-10 and 14-15 yr, respectively, from five Swedish schools. Each participant tested at least one recipe. Standardized blinded triangle tests were performed to investigate whether any sensory differences could be detected between the active and placebo materials. In our final recipes, no significant differences could be detected between the active and placebo materials for any challenge food (p > 0.05). These results remained after stratification for age and gender. The taste of challenge materials was acceptable, and no unfavourable side effects related to test materials were observed. In summary, these new validated recipes for low-dose double-blinded food challenges contain common allergenic foods in childhood; cow's milk, hen's egg, soy, wheat and cod. All test materials contain the same liquid vehicle, which facilitates preparation and dosing. Our validated recipes increase the range of available recipes, and as they are easily prepared and dosed, they may facilitate the use of double-blind placebo-controlled food challenges in daily clinical practice.

  13. Protection of salivary function by concomitant pilocarpine during radiotherapy : A double-blind, randomized, placebo-controlled study

    NARCIS (Netherlands)

    Burlage, Fred R.; Roesink, Judith M.; Kampinga, Harm H.; Coppes, Rob P.; Terhaard, Chris; Langendijk, Johannes A.; van Luijk, Peter; Stokman, Monique A.; Vissink, Arjan

    2008-01-01

    Purpose: To investigate the effect of concomitant administration of pilocarpine during radiotherapy for head-and-neck squamous cell carcinoma (HNSCC) on postradiotherapy xerostomia. Methods and Materials: A prospective, double blind, placebo-controlled randomized trial including 170 patients with

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

    National Research Council Canada - National Science Library

    Lavretsky, Helen; Reinlieb, Michelle; St. Cyr, Natalie; Siddarth, Prabha; Ercoli, Linda M; Senturk, Damla

    2015-01-01

    ... 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...

  15. [Probiotic prophylaxis in patients with predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Besselink, M.G.; Santvoort, H.C. van; Buskens, E.; Boermeester, M.A.; Goor, H. van; Timmerman, H.M.; Nieuwenhuijs, V.B.; Bollen, T.L.; Ramshorst, B. van; Witteman, B.J.M.; Rosman, C.; Ploeg, R.J.; Brink, M.; Schaapherder, A.F.; Dejong, C.H.; Wahab, P.J.; Laarhoven, C.J.H.M. van; Harst, E. van der; Eijck, C.H. van; Cuesta, M.A.; Akkermans, L.M.; Gooszen, H.G.

    2008-01-01

    OBJECTIVE: To evaluate whether enteral prophylaxis with probiotics in patients with predicted severe acute pancreatitis prevents infectious complications. DESIGN: Multicentre, randomised, double-blind, placebo-controlled trial. METHOD: A total of 296 patients with predicted severe acute pancreatitis

  16. "Live high-train low" using normobaric hypoxia: a double-blinded, placebo-controlled study

    DEFF Research Database (Denmark)

    Siebenmann, Christoph; Robach, Paul; Jacobs, Robert A

    2012-01-01

    The combination of living at altitude and training near sea level [live high-train low (LHTL)] may improve performance of endurance athletes. However, to date, no study can rule out a potential placebo effect as at least part of the explanation, especially for performance measures. With the use...... of a placebo-controlled, double-blinded design, we tested the hypothesis that LHTL-related improvements in endurance performance are mediated through physiological mechanisms and not through a placebo effect. Sixteen endurance cyclists trained for 8 wk at low altitude (...

  17. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study

    OpenAIRE

    2014-01-01

    Background Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments. This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years. Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract (7.5 mg/day) or placebo for 4 weeks. De...

  18. Randomised, double-blind, placebo-controlled study of pivagabine in neurasthenia.

    Science.gov (United States)

    Pizzolato, G; Cagnin, A; Mancia, D; Caffarra, P; Avanzi, S; Copelli, S; Ciappina, C; Lo Presti, F; Spilimbergo, P G; D'Antonio, E; Di Costanzo, E; Matrango, M; Pastres, P; Urbani, P P; Signorino, M; Simoncelli, M; Provinciali, L; Regnicolo, L; Albano, C; Roccatagliata, G; Rubino, V; Cultrera, S; Fracassi, M

    1997-11-01

    One hundred and eighteen patients with neurasthenia, as defined by ICD 10 (International Classification of Diseases), participated in a randomised, double-blind, placebo-controlled trial of pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg). Pivagabine 1800 mg/d was administered orally for four weeks. At the end of the trial, active medication was significantly superior to placebo on the Clinical Global Impression (CGI) improvement of illness scale. In addition, pivagabine treatment reduced the physical and mental fatigability of patients, and increased their sense of well-being.

  19. A double-blind, placebo controlled trial of high-dose lecithin in Alzheimer's disease.

    OpenAIRE

    Little, A.; Levy, R.; Chuaqui-Kidd, P; Hand, D

    1985-01-01

    The first long-term double-blind placebo controlled trial of high dose lecithin in senile dementia of the Alzheimer type is reported. Fifty one subjects were given 20-25 g/day of purified soya lecithin (containing 90% phosphatidyl plus lysophosphatidyl choline) for six months and followed up for at least a further six months. Plasma choline levels were monitored throughout the treatment period. There were no differences between the placebo group and the lecithin group but there was an improve...

  20. Randomized double blind placebo control studies, the "Gold Standard" in intervention based studies

    Directory of Open Access Journals (Sweden)

    Shobha Misra

    2012-01-01

    Full Text Available Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC studies are considered the "gold standard" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article employing this study design to answer the research question; "Does once daily dose of Valacyclovir reduce the risk of transmission of genital herpes in a susceptible partner?" RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality. Hope, this will be useful to neophyte researchers to understand causal hierarchy when critically evaluating epidemiologic literature.

  1. Randomized double blind placebo control studies, the "Gold Standard" in intervention based studies.

    Science.gov (United States)

    Misra, Shobha

    2012-07-01

    Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC) studies are considered the "gold standard" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article employing this study design to answer the research question; "Does once daily dose of Valacyclovir reduce the risk of transmission of genital herpes in a susceptible partner?" RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality. Hope, this will be useful to neophyte researchers to understand causal hierarchy when critically evaluating epidemiologic literature.

  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

    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......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...

  3. A double-blind placebo controlled trial of medroxyprogesterone acetate and cyproterone acetate with seven pedophiles.

    Science.gov (United States)

    Cooper, A J; Sandhu, S; Losztyn, S; Cernovsky, Z

    1992-12-01

    Seven of ten pedophiles in hospital completed a double-blind, placebo-controlled two-dose comparison of medroxyprogesterone acetate and cyproterone acetate. Sequential measures during the 28 week study were: patient self-reports, nurses' observations, phallometry, hormone levels and side-effects. The drugs, which performed equivalently, reduced sexual thoughts and fantasies, the frequency of early morning erections on awakening, the frequency and pleasure of masturbation, and level of sexual frustration. Penile responses were also reduced but to a lesser degree and were more variable. Serum testosterone FSH and LH all declined during drug administration, but by the end of the final placebo phase had essentially returned to (or exceeded) pre-drug values. Our experience suggests that only a minority of pedophiles are likely to accept libido-reducing drugs.

  4. [Periprostatic anaesthesic infiltration for prostatic biopsy: a prospective, randomized, double blind and placebo-controlled study].

    Science.gov (United States)

    Valero, Gonzalo; González, E U Roxana

    2005-06-01

    A prospective, randomized, double blind and placebo-controlled study to evaluate the effectiveness of periprostatic infiltration with lidocaine to reduce pain of prostatic biopsy. In a thirteen months period of time, 115 patients were randomized to receive 10 ml of lidocaine 1% (n=60) or saline (n=55). Evaluating the pain with visual analogue scale (0-10), the first group referred average pain of 3.83 and the second group of 6.87, being this difference clearly significant (panesthesic puncture. The periprostatic infiltration is easy to perform without complications and it is effective in reducing the pain of this procedure. It should be used as a routine procedure in prostatic biopsy.

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

    Science.gov (United States)

    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 in the five day period after the exercise test, symptom free days, maximum soreness score, days to no soreness, days on medication. RESULTS: The difference between group means was 0.17 in favour of placebo with 95% confidence intervals +/- 0.50. Similar results were found for other outcome measures. CONCLUSION: The study did not find benefit of the homoeopathic remedy in DOMS. Bench stepping may not be an appropriate model to evaluate the effects of a treatment on DOMS because of wide variation between subject soreness scores. PMID:9429007

  6. 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.

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

    Directory of Open Access Journals (Sweden)

    Shahin Akhondzadeh

    2010-06-01

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

  8. Treatment of knee osteoarthritis with pulsed electromagnetic fields: a randomized, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Thamsborg, G; Florescu, A; Oturai, P

    2005-01-01

    OBJECTIVE: The investigation aimed at determining the effectiveness of pulsed electromagnetic fields (PEMF) in the treatment of osteoarthritis (OA) of the knee by conducting a randomized, double-blind, placebo-controlled clinical trial. DESIGN: The trial consisted of 2h daily treatment 5 days per...

  9. Sensory testing of recipes masking peanut or hazelnut for double-blind placebo-controlled food challenges

    NARCIS (Netherlands)

    Ronteltap, A.; Schaik, van J.; Wensing, M.; Rynja, F.J.; Knulst, A.C.; Vries, de J.H.M.

    2004-01-01

    Background: In a double-blind placebo-controlled food challenge (DBPCFC), it is necessary that recipes comprising the allergen cannot be distinguished from placebo. Aims of the study: We investigated whether the method of paired comparisons, a sensory difference test, could be used to test the suita

  10. Identification of hazelnut major allergens in sensitive patients with positive double-blind, placebo-controlled food challenge results

    DEFF Research Database (Denmark)

    Pastorello, Elide A; Vieths, Stefan; Pravettoni, Valerio

    2002-01-01

    The hazelnut major allergens identified to date are an 18-kd protein homologous to Bet v 1 and a 14-kd allergen homologous to Bet v 2. No studies have reported hazelnut allergens recognized in patients with positive double-blind, placebo-controlled food challenge (DBPCFC) results or in patients...... allergic to hazelnut but not to birch....

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

    DEFF Research Database (Denmark)

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

    2002-01-01

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

  12. A Double-Blind, Placebo-Controlled Trial of Oral Human Immunoglobulin for Gastrointestinal Dysfunction in Children with Autistic Disorder

    Science.gov (United States)

    Handen, Benjamin L.; Melmed, Raun D.; Hansen, Robin L.; Aman, Michael G.; Burnham, David L.; Bruss, Jon B.; McDougle, Christopher J.

    2009-01-01

    Controversy exists regarding the extent and possible causal relationship between gastrointestinal symptoms and autism. A randomized, double-blind, placebo-controlled, parallel groups, dose-ranging study of oral, human immunoglobulin (IGOH 140, 420, or 840 mg/day) was utilized with 125 children (ages 2-17 years) with autism and persistent GI…

  13. Protection of salivary function by concomitant pilocarpine during radiotherapy : A double-blind, randomized, placebo-controlled study

    NARCIS (Netherlands)

    Burlage, Fred R.; Roesink, Judith M.; Kampinga, Harm H.; Coppes, Rob P.; Terhaard, Chris; Langendijk, Johannes A.; van Luijk, Peter; Stokman, Monique A.; Vissink, Arjan

    2008-01-01

    Purpose: To investigate the effect of concomitant administration of pilocarpine during radiotherapy for head-and-neck squamous cell carcinoma (HNSCC) on postradiotherapy xerostomia. Methods and Materials: A prospective, double blind, placebo-controlled randomized trial including 170 patients with HN

  14. Intrathecal Baclofen in Children with Spastic Cerebral Palsy: A Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study

    Science.gov (United States)

    Hoving, Marjanke A.; van Raak, Elisabeth P. M.; Spincemaille, Geert H. J. J.; Palmans, Liesbeth J.; Sleypen, Frans A. M.; Vles, Johan S. H.

    2007-01-01

    Intrathecal baclofen (ITB) therapy can be very effective in the treatment of intractable spasticity, but its effectiveness and safety have not yet been thoroughly studied in children with cerebral palsy (CP). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB…

  15. Development and validation of challenge materials for double-blind, placebo-controlled food challenges in children

    NARCIS (Netherlands)

    Vlieg-Boerstra, BJ; Bijleveld, CMA; van der Heide, S; Beusekamp, BJ; Wolt-Plompen, SAA; Kukler, J; Brinkman, J; Duiverman, EJ; Dubois, AEJ

    Background: The use of double-blind, placebo-controlled food challenges (DBPCFCs) is considered the gold standard for the diagnosis of food allergy. Despite this, materials and methods used in DBPCFCs have not been standardized. Objective: The purpose of this study was to develop and validate

  16. Topical glyceryl trinitrate treatment of chronic patellar tendinopathy : a randomised, double-blind, placebo-controlled clinical trial

    NARCIS (Netherlands)

    Steunebrink, Mirjam; Zwerver, Johannes; Brandsema, Ruben; Groenenboom, Petra; van den Akker-Scheek, Inge; Weir, Adam

    2013-01-01

    Objectives To assess if continuous topical glyceryl trinitrate (GTN) treatment improves outcome in patients with chronic patellar tendinopathy when compared with eccentric training alone. Methods Randomised double-blind, placebo-controlled clinical trial comparing a 12-week programme of using a GTN

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

    NARCIS (Netherlands)

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

    2013-01-01

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

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

    NARCIS (Netherlands)

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

    2013-01-01

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

  19. Effect of dry needling of gluteal muscles on straight leg raise: a randomised, placebo controlled, double blind trial

    OpenAIRE

    Huguenin, L; Brukner, P; McCrory, P; P. Smith; Wajswelner, H; Bennell, K

    2005-01-01

    Objectives: To use a randomised, double blind, placebo controlled trial to establish the effect on straight leg raise, hip internal rotation, and muscle pain of dry needling treatment to the gluteal muscles in athletes with posterior thigh pain referred from gluteal trigger points.

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

    Science.gov (United States)

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

    2007-01-01

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

  1. Sulfasalazine in the treatment of juvenile chronic arthritis - A randomized, double-blind, placebo-controlled, multicenter study

    NARCIS (Netherlands)

    Fiselier, TJW; Franssen, MJAM; Zwinderman, AH; ten Cate, R; van Suijlekom-Smit, LWA; van Luijk, WHJ; van Soesbergen, RM; Wulffraat, NM; Oostveen, JCM; Kuis, W; Dijkstra, PF; van Ede, CFP; Dijkmans, BAC

    1998-01-01

    Objective. To assess the efficacy, tolerability, and safety of sulfasalazine (SSZ) in the treatment of juvenile chronic arthritis (JCA). Methods. we conducted a 24-week randomized, placebo-controlled, double-blind, multicenter study of patients with active JCA of both oligoarticular and polyarticula

  2. Topical glyceryl trinitrate treatment of chronic patellar tendinopathy : a randomised, double-blind, placebo-controlled clinical trial

    NARCIS (Netherlands)

    Steunebrink, Mirjam; Zwerver, Johannes; Brandsema, Ruben; Groenenboom, Petra; van den Akker-Scheek, Inge; Weir, Adam

    Objectives To assess if continuous topical glyceryl trinitrate (GTN) treatment improves outcome in patients with chronic patellar tendinopathy when compared with eccentric training alone. Methods Randomised double-blind, placebo-controlled clinical trial comparing a 12-week programme of using a GTN

  3. 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

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

    NARCIS (Netherlands)

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

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

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

    NARCIS (Netherlands)

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

    2002-01-01

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

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

    NARCIS (Netherlands)

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

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

  7. Adjuvant Aspirin Therapy Reduces Symptoms of Schizophrenia Spectrum Disorders : Results From a Randomized, Double-Blind, Placebo-Controlled Trial

    NARCIS (Netherlands)

    Laan, Wijnand; Grobbee, Diederick E.; Selten, Jean-Paul; Heijnen, Cobi J.; Kahn, Rene S.; Burger, Huibert

    Objective: Inflammatory processes may play a role in the pathophysiology of schizophrenia. The aim of this study was to determine the efficacy of adjuvant treatment with aspirin (acetylsalicylic acid) in schizophrenia spectrum disorders. Method: This randomized, double-blind, placebo-controlled

  8. Development and validation of challenge materials for double-blind, placebo-controlled food challenges in children

    NARCIS (Netherlands)

    Vlieg-Boerstra, BJ; Bijleveld, CMA; van der Heide, S; Beusekamp, BJ; Wolt-Plompen, SAA; Kukler, J; Brinkman, J; Duiverman, EJ; Dubois, AEJ

    2004-01-01

    Background: The use of double-blind, placebo-controlled food challenges (DBPCFCs) is considered the gold standard for the diagnosis of food allergy. Despite this, materials and methods used in DBPCFCs have not been standardized. Objective: The purpose of this study was to develop and validate recipe

  9. 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.

  10. Valacyclovir for prevention of recurrent herpes labialis: 2 double-blind, placebo-controlled studies.

    Science.gov (United States)

    Baker, David; Eisen, Drore

    2003-03-01

    The oral antiviral valacyclovir, which is 3 to 5 times more bioavailable than its parent compound acyclovir, is a good candidate for effective therapy to suppress recurrent herpes labialis lesions. The efficacy of oral valacyclovir in the suppression of herpes labialis has not previously been reported. Two identical, randomized, double-blind, parallel-group studies were conducted to evaluate the efficacy of oral valacyclovir 500 mg (n=49) versus placebo (n=49) once daily for 16 weeks in the suppression of herpes labialis among patients with a history of 4 or more recurrent lesions in the previous year. Data from the studies were pooled for analysis. Twenty-eight patients (60%) in the valacyclovir group compared with only 18 patients (38%) in the placebo group were recurrence-free throughout the 4-month treatment period (P=.041). The mean time to first recurrence was significantly longer with valacyclovir (13.1 weeks) compared with placebo (9.6 weeks) (P=.016). The total number of recurrences in patients using valacyclovir was 24 compared with 41 in patients using placebo. The incidence of adverse events during the 4-month treatment period was slightly lower in the valacyclovir group (22 events, 33% of patients) compared with the placebo group (29 events, 39% of patients). The results of these small double-blind, placebo-controlled studies suggest that oral valacyclovir 500 mg once daily for 4 months is effective and well tolerated for the prevention of recurrent herpes labialis. More research with larger patient numbers is warranted to corroborate and extend these findings.

  11. Mirtazapine in essential tremor: a double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Pahwa, Rajesh; Lyons, Kelly E

    2003-05-01

    We sought to determine whether mirtazapine is safe and well-tolerated as a treatment for essential tremor (ET). We studied mirtazapine in a randomized, double-blind, placebo-controlled, crossover study of 17 ET patients. Patients were started with 15 mg per day of either mirtazapine or placebo for 1 week and the dose was escalated weekly until the targeted dose of 45 mg per day was achieved. This dose was maintained for 2 weeks. Tremor was assessed at baseline and after 14 days of 45 mg of mirtazapine or placebo. There was a minimum washout period of 14 days between the two arms of the study. Tremor assessments included global improvement, Fahn Tolosa Marin Tremor Rating Scale, Beck Depression Inventory and the Parkinson's Disease Questionnaire-39. Patient global improvement ratings indicated that in the placebo condition 12 patients were unchanged and 1 patient was mildly improved. In the mirtazapine condition, 10 patients were unchanged, 2 were moderately improved and 1 was markedly improved. There was no significant improvement with mirtazapine or placebo compared to baseline as measured by the Tremor Rating Scale. Adverse effects were more common in the mirtazapine group and included drowsiness, confusion, dry mouth, weight gain, polyuria, itching, nausea, gait and balance problems, blurred vision, and bad taste. We conclude that the majority of the ET patients do not benefit from mirtazapine. Mirtazapine has significant adverse effects and should be used cautiously in ET patients.

  12. 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.

  13. Smectite in acute diarrhea in children: a double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Madkour, A A; Madina, E M; el-Azzouni, O E; Amer, M A; el-Walili, T M; Abbass, T

    1993-08-01

    Dioctahedral smectite (DS) a natural adsorbent clay capable of adsorbing viruses, bacteria, and other intestinal irritants in vitro, is claimed to possess beneficial "antidiarrheal" properties. This study tested the effect of DS on the duration of diarrhea and the frequency and amount of liquid stools. Ninety well-nourished boys, aged 3-24 months, with acute watery diarrhea and mild, moderate, or severe dehydration were included in a randomized double-blind, placebo-controlled trial. After initial rehydration, they received DS or placebo (1.5 g freshly dissolved in 50 ml of water, four times daily for 3 days) along with oral rehydration solution (ORS) and adequate feeding. The clinical characteristics of both groups were comparable on admission. Patients in the smectite group had a significantly shorter duration of diarrhea (mean +/- SD, 54 +/- 16 vs. 73 +/- 13 h) and significantly fewer stools (2.6 +/- 0.8 vs. 3 +/- 0.7 on second day; 1.9 +/- 0.7 vs. 2.4 +/- 0.7 on third day; and 11.3 +/- 3.2 vs. 13.8 +/- 3 overall). The amount of liquid stools was not significantly reduced. Weight gain at 24, 48, and 72 h and on recovery was significantly higher in the smectite group despite the comparable fluid and food intake in both groups. These results suggest a beneficial effect of DS in shortening the duration of diarrhea and reducing the frequency of liquid stools in children rehydrated with ORS.

  14. Safety and effectiveness of autoinoculation therapy in cutaneous warts: A double - blind, randomized, placebo - controlled study

    Directory of Open Access Journals (Sweden)

    Niharika Ranjan Lal

    2014-01-01

    Full Text Available Background: In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians. Aims: To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts. Methods: A double-blind, placebo-controlled study was carried out. In the treatment group, full-thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks. Results: Forty-eight patients with cutaneous warts (male: female = 32:16 were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P = 0.293. Reduction in the number of warts was significantly more in the autoinoculation group (8.50 ± 13.88 than in the control group (10.04 ± 5.80 from 8 weeks onwards (P = 0.010. Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases, keloid formation (3 and hypopigmentation (3. Conclusion: Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results.

  15. Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

    2013-03-01

    Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

  16. Antiobesity effect of Gynostemma pentaphyllum extract (actiponin): a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Park, Soo-Hyun; Huh, Tae-Lin; Kim, Sun-Young; Oh, Mi-Ra; Tirupathi Pichiah, P B; Chae, Soo-Wan; Cha, Youn-Soo

    2014-01-01

    The effects of actiponin was investigated, a heat-processed Gynostemma pentaphyllum extract, on body weight, fat loss, and metabolic markers of Korean participants in a 12-week, randomized, double-blind, placebo-controlled clinical trial. Obese participants (BMI ≥ 25 kg m(-2) and WHR ≥ 0.90 for male or WHR ≥ 0.85 for female) who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 80 subjects were randomly divided into actiponin (n = 40, 450 mg day(-1) ) and placebo (n = 40) groups. Outcomes included measurement of efficacy (abdominal fat distribution, anthropometric parameters, and blood lipid profiles) and safety (adverse events, laboratory test results, electrocardiogram data, and vital signs). During 12-week of actiponin supplementation, total abdominal fat area, body weight, body fat mass, percent body fat, and BMI were significantly decreased (P = 0.044, P < 0.05, P < 0.0001, P < 0.0001, and P < 0.05, respectively) in the actiponin group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that actiponin is a potent antiobesity reagent that does not produce any significant adverse effects. These results suggest that actiponin supplementation may be effective for treating obese individuals. Copyright © 2013 The Obesity Society.

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Daniel M. Riche

    2014-01-01

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

  19. Cantharidin for the Treatment of Molluscum Contagiosum: A Prospective, Double-Blinded, Placebo-Controlled Trial

    Science.gov (United States)

    Dosal, Jacquelyn Coloe; Stewart, Paul W.; Lin, Ja-An; Williams, Christianna S.; Morrell, Dean S

    2012-01-01

    Background/Objective To study the effects and safety of cantharidin in the treatment of molluscum contagiosum. Methods We conducted a prospective, double-blinded, placebo-controlled, randomized clinical trial to evaluate the safety and efficacy of topical cantharidin for treatment of pediatric molluscum contagiosum in an academic ambulatory care center. Twenty-nine children aged 5–10 with the diagnosis of molluscum contagiosum were enrolled to receive treatment with cantharidin or placebo. The main outcome measure was complete clearance of molluscum lesions. Results In contrast to previous retrospective observational studies, the performance of cantharidin treatment over 2 months was not substantially better than the performance of placebo. Limitations The scope of follow-up was limited to 5 visits over 2 months of treatment. In hindsight, we can hypothesize that a longer follow up period may have captured a greater effect of cantharidin. Conclusion We conclude that during a 2 month period, the magnitude of the cantharidin treatment effects in the target population are, at best, not large. This study provided objective unbiased estimates of the magnitude of cantharidin treatment effects and provided important prospective safety data. Our subjects experienced minimal side effects when treated with cantharidin. PMID:22897595

  20. Acetylcysteine in the treatment of subacute sinusitis: A double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Bahtouee, Mehrzad; Monavarsadegh, Gholamhosein; Ahmadipour, Mohammadjavad; Motieilangroodi, Mazyar; Motamed, Niloofar; Saberifard, Jamshid; Eghbali, Seyyedsajjad; Adibi, Hooman; Maneshi, Hesam; Malekizadeh, Hasan

    2017-01-01

    Sinusitis is a common disease with harmful effects on the health and finances of patients and the economy of the community. It is easily treated in most of its acute stages but is associated with some management difficulties as it goes toward chronicity. Therefore, we tried to improve the treatment of subacute sinusitis by using acetylcysteine, which is a safe mucolytic and antioxidant agent. Thirty-nine adult patients with subacute sinusitis proved by computed tomography (CT) were enrolled in a double-blind, placebo-controlled trial. They received oral amoxicillin-clavulanic acid and normal saline nasal drops for 10 days and oral pseudoephedrine for 7 days. In addition, the patients received acetylcysteine (600 mg orally, once daily) in the intervention group or placebo in the control group for 10 days. A paranasal CT scan was taken at baseline and 30 days after patients finished the treatment and was evaluated quantitatively by Lund-Mackay (LM) score. Symptoms and some aspects of quality of life also were assessed at baseline and 14 days after initiation and 30 days after termination of the treatment via the Sino-Nasal Outcome Test questionnaire. The groups showed no significant difference in LM score after treatment. A positive correlation was observed between the LM and SNOT-20 scores. We concluded that adding oral acetylcysteine to amoxicillin-clavulanic acid, pseudoephedrine, and intranasal normal saline has no benefit for the treatment of subacute sinusitis.

  1. A double-blind, randomized, placebo-controlled study of nifedipine on early renal allograft function.

    Science.gov (United States)

    Wilkie, M E; Beer, J C; Evans, S J; Raftery, M J; Lord, R H; Moore, R; Marsh, F P

    1994-01-01

    A double-blind, randomized, placebo-controlled study was conducted to determine the effect of nifedipine on early renal allograft function when added to a triple therapy immunosuppression regime comprising low-dose cyclosporin (CsA), prednisolone and azathioprine. Fifty adult cadaveric renal allograft recipients were randomized to placebo (group P n = 17), nifedipine 10 mg preoperatively and 20 mg b.d. postoperatively for 48 h, followed by matching placebo for 3 months (group NS n = 16) or nifedipine 10 mg preoperatively and 20 mg b.d. postoperatively for 3 months (group NL n = 17). Donor and recipient exclusion criteria included recent calcium antagonist treatment. At 3 months after transplantation mean GFR adjusted for graft loss was significantly higher in group NL than in NS (mean +/- SD 61 +/- 28 versus 34 +/- 25 ml/min/1.73 m2; P nifedipine commenced preoperatively and continued for 3 months following transplantation has beneficial effects on early renal allograft function when incorporated as part of an immunotherapy regimen based on cyclosporin.

  2. Better than sham? A double-blind placebo-controlled neurofeedback study in primary insomnia

    Science.gov (United States)

    Griessenberger, Hermann; Gnjezda, Maria-Teresa; Heib, Dominik P. J.; Wislowska, Malgorzata; Hoedlmoser, Kerstin

    2017-01-01

    Abstract See Thibault et al. (doi:10.1093/awx033) for a scientific commentary on this article. Neurofeedback training builds upon the simple concept of instrumental conditioning, i.e. behaviour that is rewarded is more likely to reoccur, an effect Thorndike referred to as the ‘law of effect’. In the case of neurofeedback, information about specific electroencephalographic activity is fed back to the participant who is rewarded whenever the desired electroencephalography pattern is generated. If some kind of hyperarousal needs to be addressed, the neurofeedback community considers sensorimotor rhythm neurofeedback as the gold standard. Earlier treatment approaches using sensorimotor-rhythm neurofeedback indicated that training to increase 12–15 Hz sensorimotor rhythm over the sensorimotor cortex during wakefulness could reduce attention-deficit/hyperactivity disorder and epilepsy symptoms and even improve sleep quality by enhancing sleep spindle activity (lying in the same frequency range). In the present study we sought to critically test whether earlier findings on the positive effect of sensorimotor rhythm neurofeedback on sleep quality and memory could also be replicated in a double-blind placebo-controlled study on 25 patients with insomnia. Patients spent nine polysomnography nights and 12 sessions of neurofeedback and 12 sessions of placebo-feedback training (sham) in our laboratory. Crucially, we found both neurofeedback and placebo feedback to be equally effective as reflected in subjective measures of sleep complaints suggesting that the observed improvements were due to unspecific factors such as experiencing trust and receiving care and empathy from experimenters. In addition, these improvements were not reflected in objective electroencephalographic-derived measures of sleep quality. Furthermore, objective electroencephalographic measures that potentially reflected mechanisms underlying the efficacy of neurofeedback such as spectral

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

    Directory of Open Access Journals (Sweden)

    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.

  4. 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

  5. A randomized, double-blind, placebo-controlled trial of simvastatin to treat Alzheimer disease

    Science.gov (United States)

    Bell, K.L.; Galasko, D.; Galvin, J.E.; Thomas, R.G.; van Dyck, C.H.; Aisen, P.S.

    2011-01-01

    Background: Lowering cholesterol is associated with reduced CNS amyloid deposition and increased dietary cholesterol increases amyloid accumulation in animal studies. Epidemiologic data suggest that use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) may decrease the risk of Alzheimer disease (AD) and a single-site trial suggested possible benefit in cognition with statin treatment in AD, supporting the hypothesis that statin therapy is useful in the treatment of AD. Objective: To determine if the lipid-lowering agent simvastatin slows the progression of symptoms in AD. Methods: This randomized, double-blind, placebo-controlled trial of simvastatin was conducted in individuals with mild to moderate AD and normal lipid levels. Participants were randomly assigned to receive simvastatin, 20 mg/day, for 6 weeks then 40 mg per day for the remainder of 18 months or identical placebo. The primary outcome was the rate of change in the Alzheimer's Disease Assessment Scale–cognitive portion (ADAS-Cog). Secondary outcomes measured clinical global change, cognition, function, and behavior. Results: A total of 406 individuals were randomized: 204 to simvastatin and 202 to placebo. Simvastatin lowered lipid levels but had no effect on change in ADAS-Cog score or the secondary outcome measures. There was no evidence of increased adverse events with simvastatin treatment. Conclusion: Simvastatin had no benefit on the progression of symptoms in individuals with mild to moderate AD despite significant lowering of cholesterol. Classification of evidence: This study provides Class I evidence that simvastatin 40 mg/day does not slow decline on the ADAS-Cog. PMID:21795660

  6. Dexamethasone therapy for bacterial meningitis. Results of two double-blind, placebo-controlled trials.

    Science.gov (United States)

    Lebel, M H; Freij, B J; Syrogiannopoulos, G A; Chrane, D F; Hoyt, M J; Stewart, S M; Kennard, B D; Olsen, K D; McCracken, G H

    1988-10-13

    We enrolled 200 infants and older children with bacterial meningitis in two prospective double-blind, placebo-controlled trials to evaluate the efficacy of dexamethasone therapy in addition to either cefuroxime (Study 1) or ceftriaxone (Study 2). Altogether, 98 patients received placebo and 102 received dexamethasone (0.15 mg per kilogram of body weight every six hours for four days). At the beginning of therapy, the clinical and demographic characteristics of the patients in the treatment groups were comparable. The mean increase in the cerebrospinal fluid concentration of glucose and the decreases in lactate and protein levels after 24 hours of therapy were significantly greater in those who received dexamethasone than in those who received placebo (glucose, 2.0 vs. 0.4 mmol per liter [36.0 vs. 6.9 mg per deciliter], P less than 0.001; lactate, 4.0 vs. 2.1 mmol per liter [38.3 vs. 19.8 mg per deciliter], P less than 0.001; and protein, 0.64 vs. 0.25 g per liter [64.0 vs. 25.3 mg per deciliter], P less than 0.05). One patient in the placebo group in Study 1 died. As compared with those who received placebo, the patients who received dexamethasone became afebrile earlier (1.6 vs. 5.0 days; P less than 0.001) and were less likely to acquire moderate or more severe bilateral sensorineural hearing loss (15.5 vs. 3.3 percent; P less than 0.01). Twelve patients in the two placebo groups (14 percent) had severe or profound bilateral hearing loss requiring the use of a hearing aid, as compared with 1 (1 percent) in the two dexamethasone groups (P less than 0.001). We conclude that dexamethasone is beneficial in the treatment of infants and children with bacterial meningitis, particularly in preventing deafness.

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

    Directory of Open Access Journals (Sweden)

    Mokaberinejad Roshanak

    2012-12-01

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

  8. Memantine in frontotemporal lobar degeneration: A multicenter, randomised, double-blind, placebo-controlled trial

    Science.gov (United States)

    Boxer, Adam L.; Knopman, David S.; Kaufer, Daniel I.; Grossman, Murray; Onyike, Chiadi; Graf-Radford, Neill; Mendez, Mario; Kerwin, Diana; Lerner, Alan; Wu, Chuang-Kuo; Koestler, Mary; Shapira, Jill; Sullivan, Kathryn; Klepac, Kristen; Lipowski, Kristine; Ullah, Jerin; Fields, Scott; Kramer, Joel H.; Merrilees, Jennifer; Neuhaus, John; Mesulam, M. Marsel; Miller, Bruce L.

    2013-01-01

    Background Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26 week open label study suggested a transient, modest benefit on neuropsychiatric symptoms as measured by the Neuropsychiatric Inventory (NPI). Methods We performed a randomized, parallel group, double blind, placebo controlled trial of 20 mg memantine taken orally daily for 26 weeks in FTD. Participants met Neary criteria for behavioral variant (bvFTD) or semantic dementia (SD) and had characteristic brain atrophy. Use of cholinesterase inhibitors was prohibited. The objective of the study was to determine whether memantine is an effective treatment for FTD. Individuals were randomized to memantine or matched placebo tablets in blocks of two and four. Primary endpoints were the change in total NPI score and Clinical Global Impression of Change (CGIC) scores after 26 weeks. Secondary outcomes included a neuropsychological battery, and other cognitive, global and activity of daily living measures. Clinicaltrials.gov identifier: NCT00545974 Findings 100 subjects were screened, 81 were randomized, 5 (6%) discontinued and 76 completed all visits. Enrollment numbers were lower than planned due to many subjects’ preference to take memantine or cholinesterase inhibitors off-label rather than participate in a clinical trial. 39 memantine and 42 placebo subjects entered the primary intent to treat analysis. There was no effect of memantine treatment on either the NPI (mean difference [MD] 2.2, 95%CI: −3.9, 8.3, p = 0.47) or CGIC (MD 0, 95%CI: −0.4, 0.4, p = 0.90) after 26 weeks of treatment. Memantine was generally well tolerated, however there were more frequent cognitive adverse events in the memantine group. Interpretation There was no benefit of memantine treatment in bvFTD or SD. These data do not support memantine use in FTD. Funding Forest Research Institute PMID:23290598

  9. [Postoperative transcutaneous electrical nerve stimulation (TENS) in shoulder surgery (randomized, double blind, placebo controlled pilot trial)].

    Science.gov (United States)

    Likar, R; Molnar, M; Pipam, W; Koppert, W; Quantschnigg, B; Disselhoff, B; Sittl, R

    2001-06-01

    The aim of this study was to determine whether 3 days of TENS therapy postoperatively after shoulder operations would result in better pain relief and/or reduced analgesic intake when compared to placebo. The study was carried out randomized, double-blind and placebo controlled. Thirty patients were randomized to two groups. The verum group received TENS SM1AKS 80 Hz 6 mA and the placebo group received TENS SM1AKS 80 Hz 0 mA. The pain was assessed pre-operatively using the Hamburg Pain Adjective List. Premedication and Anaesthesia were standardized. TENS was applied to the patients immediately postoperatively for 8 hours and then on the following days 5 times daily for 45 minutes. The effectiveness was evaluated postoperatively using a visual analogue scale (rest, activity), the Hamburg Pain Adjective List and postoperative analgesic consumption. The visual analogue scale at rest and on activity showed no significant difference between the groups. Postoperative analgesic consumption of morphine hydrochloride in the first 24 hours was at time 8 hours postoperative significantly and at all other time points markedly less in the verum group compared to the placebo group. The sensory secondary scale score of the "Hamburg Pain Adjective List" was significantly lower postoperatively compared to preoperatively in the verum group. We were able to show in this study that TENS applied postoperatively after shoulder surgery clearly reduced analgesic consumption in the first 72 hours. Furthermore there was a significant difference in the pain scores using the "Hamburg Pain Adjective List" in favour of the verum group. TENS applied postoperatively is a effective, simple modality with few side-effects.

  10. Oral iloprost as a treatment for Raynaud's syndrome: a double blind multicentre placebo controlled study.

    Science.gov (United States)

    Belch, J J; Capell, H A; Cooke, E D; Kirby, J D; Lau, C S; Madhok, R; Murphy, E; Steinberg, M

    1995-01-01

    OBJECTIVE--To compare the efficacy, tolerance and safety of 50-150 micrograms orally administered iloprost given twice a day versus placebo in patients with Raynaud's syndrome. METHODS--The study was multicentre (n = 3), double blind and placebo controlled. Sixty three patients who had eight or more vasospastic attacks per week were enrolled. After a one week run-in period, all patients received either iloprost or placebo treatment to a maximum tolerated dose of 150 micrograms twice a day for 10 days. Diary cards assessed the duration and severity of the vasospastic attacks. Side effects were monitored by direct questioning. A global assessment of treatment efficacy was made by the patient at the end of treatment and two weeks later. RESULTS--Patient opinion tended to favour iloprost at the end of the 10 day treatment phase (p = 0.09) and this was significant at day 24 (the follow up visit) (p = 0.011). Although the duration and severity of attacks tended to decrease in the iloprost treated group, these results tended not to reach statistical significance (for severity p = 0.06 at end of treatment, p = 0.09 on day 24). CONCLUSION--Iloprost administered intravenously has been shown to be of benefit in the treatment of the Raynaud's syndrome associated with systemic sclerosis, but this route of administration is inconvenient. This study evaluated the use of iloprost administered orally to patients with Raynaud's syndrome. Patient documented improvement was significantly improved by iloprost. Diary card analysis showed a trend in favour of iloprost, but these results did not reach statistical significance. PMID:7538285

  11. A placebo-controlled, double-blind comparison of clobazam and diazepam in the treatment of anxiety.

    Science.gov (United States)

    Jacobson, A F; Goldstein, B J; Dominguez, R A; Steinbook, R M

    1983-08-01

    In a randomized, placebo-controlled, double-blind study, the efficacy and safety of clobazam and diazepam were compared in 114 anxious outpatients. During the 4-week double-blind phase of the study, the mean daily dose was 59 mg for clobazam and 25 mg for diazepam. Results indicate statistically significant efficacy, measured by both patient and physician rating scales, for both active drugs compared to placebo. The incidence of sedation was similar for the two active treatment groups; dizziness was more frequent in the diazepam group.

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

    OpenAIRE

    2015-01-01

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

  13. Efficacy and safety of drotaverine hydrochloride in irritable bowel syndrome: A randomized double-blind placebo-controlled study

    OpenAIRE

    Ramesh R Rai; Manisha Dwivedi; Nirmal Kumar

    2014-01-01

    Backgrounds/Aims: To study the efficacy and safety of drotaverine hydrochloride (HCl) 80 mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome (IBS). Patients and Methods: The study was a multicentric, randomized, double-blind, placebo-controlled parallel group study performed at three centers. The patients who fulfilled Rome II Criteria of IBS were included in the study. A total of 180 patients with IBS were randomized to drotaverine and placebo tre...

  14. 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...

  15. 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...

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

    Directory of Open Access Journals (Sweden)

    Roshanak Mokaberinejad

    2012-12-01

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

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

    Science.gov (United States)

    2012-01-01

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

  18. Antidepressant action of sulpiride. Results of a placebo-controlled double-blind trial.

    Science.gov (United States)

    Rüther, E; Degner, D; Munzel, U; Brunner, E; Lenhard, G; Biehl, J; Vögtle-Junkert, U

    1999-07-01

    The purpose of this multicenter, randomized, double-blind, placebo-controlled parallel-group comparative study was to prove the efficacy and tolerance of sulpiride (150-300 mg) against placebo in mild to moderate depressive syndrome. The primary criterion of efficacy was the course of the HAMD total score from day 1 to day 42, compared between the two treatment groups. The duration of the treatment was six weeks, preceded by a one-week placebo run-in phase. The HAMD, CGI and KUSTA scores were determined, the tolerance assessed, and the laboratory parameters and serum prolactin levels determined before, during and at the end of the trial. 177 outpatients aged from 18 to 70 years with mild to moderate depressive syndrome (ICD-10: F32.0, F32.1, F33.0, F33.1) and a score of 18-27 points on the 21-item HAMD scale were randomized, 171 of whom (sulpiride: n=83; placebo: n=88) were included in the intention-to-treat analysis. All the baseline data recorded for the two groups displayed comparable values. The decrease of the HAMD score between day 1 and day 42 yielded a difference of 2.5 points in favour of the sulpiride group. This difference is statistically significant (p = 0.0007). The evaluations of the cases treated for at least 14 days or for 42 days (per protocol) showed consistent values. The analysis of the CGI values showed similarly distinct and clinically relevant differences for sulpiride in comparison with placebo. The evaluation of the KUSTA scores yielded mostly comparable values for the two groups. Adverse events occurred with about the same type and frequency in both groups, with severe adverse events occurring only in two placebo patients. The laboratory parameters revealed no significant differences between the treatment groups, with the exception of prolactin which moderately exceeded the range of normal in 50% of the patients treated with sulpiride. This trial proved that sulpiride is effective and well-tolerated when given in a mean dose of 181 mg per

  19. Therapy of CF-Patients with Amitriptyline and Placebo - a Randomised, Double-Blind, Placebo-Controlled Phase IIb Multicenter, Cohort-Study

    National Research Council Canada - National Science Library

    Nährlich, Lutz; Mainz, Jochen G; Adams, Constantin; Engel, Corinna; Herrmann, Gloria; Icheva, Vanya; Lauer, Josefine; Deppisch, Caroline; Wirth, Andreas; Unger, Katy; Graepler-Mainka, Ute; Hector, Andreas; Heyder, Susanne; Stern, Martin; Döring, Gerd; Gulbins, Erich; Riethmüller, Joachim

    2013-01-01

    ... and infection susceptibility to pulmonary P. aeruginosa in these mice. To test for a beneficial effect of amitriptyline in vivo, we performed a phase IIb randomised, double-blind, placebo-controlled study...

  20. Effects of Lactobacillus gasseri OLL2809 and α-lactalbumin on university-student athletes: a randomized, double-blind, placebo-controlled clinical trial

    National Research Council Canada - National Science Library

    2013-01-01

    .... In this study, we conducted a randomized, double-blind, placebo-controlled clinical trial to evaluate the immunopotentiation and fatigue-alleviation effects of Lactobacillus gasseri OLL2809 (LG2809) and α-lactalbumin (αLA...

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

    NARCIS (Netherlands)

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

    2009-01-01

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

  2. 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:

  3. 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:

  4. Does EEG-Neurofeedback Improve Neurocognitive Functioning in Children with Attention-Deficit/Hyperactivity Disorder? A Systematic Review and a Double-Blind Placebo-Controlled Study

    Science.gov (United States)

    Vollebregt, Madelon A.; van Dongen-Boomsma, Martine; Buitelaar, Jan K.; Slaats-Willemse, Dorine

    2014-01-01

    Background: The number of placebo-controlled randomized studies relating to EEG-neurofeedback and its effect on neurocognition in attention-deficient/hyperactivity disorder (ADHD) is limited. For this reason, a double blind, randomized, placebo-controlled study was designed to assess the effects of EEG-neurofeedback on neurocognitive functioning…

  5. Probiotic Supplementation in Chronic Kidney Disease: A Double-blind, Randomized, Placebo-controlled Trial.

    Science.gov (United States)

    Borges, Natália A; Carmo, Flávia L; Stockler-Pinto, Milena B; de Brito, Jessyca S; Dolenga, Carla J; Ferreira, Dennis C; Nakao, Lia S; Rosado, Alexandre; Fouque, Denis; Mafra, Denise

    2017-09-06

    The objective of the study was to evaluate the effects of probiotic supplementation on the gut microbiota profile and inflammatory markers in chronic kidney disease patients undergoing maintenance hemodialysis (HD). This was a randomized, double-blind, placebo-controlled study. Forty-six HD patients were assigned to receive 1 of 2 treatments: probiotic (n = 23; Streptococcus thermophilus, Lactobacillus acidophilus e Bifidobacterialongum, 90 billion colony-forming units per day) or placebo (n = 23) daily for 3 months. Blood and feces were collected at baseline and after intervention. The inflammatory markers (C-reactive protein and interleukin-6) were analyzed by immunoenzymatic assay (enzyme-linked immunosorbent assay). Uremic toxins plasma levels (indoxyl sulfate, p-cresyl sulfate, and indole-3-acetic acid) were obtained by Reversed-Phase High-Performance Liquid Chromatography. Routine laboratory parameters were measured by standard techniques. Fecal pH was measured by the colorimetric method, and the gut microbiota profile was assessed by Denaturing Gradient Gel Electrophoresis analysis. Sixteen patients remained in the probiotic group (11 men, 53.6 ± 11.0 year old, 25.3 ± 4.6 kg/m(2)) and 17 in the placebo group (10 men, 50.3 ± 8.5 year old, 25.2 ± 5.7 kg/m(2)). After probiotic supplementation there was a significant increase in serum urea (from 149.6 ± 34.2 mg/dL to 172.6 ± 45.0 mg/dL, P = .02), potassium (from 4.4 ± 0.4 mmol/L to 4.8 ± 0.4 mmol/L, P = .02), and indoxyl sulfate (from 31.2 ± 15.9 to 36.5 ± 15.0 mg/dL, P = .02). The fecal pH was reduced from 7.2 ± 0.8 to 6.5 ± 0.5 (P = .01). These parameters did not change significantly in placebo group. Changes in the percentage delta (Δ) between groups were exhibited with no statistical differences observed. The inflammatory markers and gut profile were not altered by supplementation. Aprobiotic supplementation failed to reduce uremic toxins and

  6. Symptomatic improvement with gluten restriction in irritable bowel syndrome: a prospective, randomized, double blinded placebo controlled trial

    OpenAIRE

    Zanwar, Vinay G.; Pawar, Sunil V; Gambhire, Pravir A; Jain, Samit S.; Surude, Ravindra G.; Shah, Vinaya B; Contractor, Qais Q; Rathi, Pravin M.

    2016-01-01

    Background/Aims The existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms. Methods We performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who f...

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

    Directory of Open Access Journals (Sweden)

    Hooshang Gerami

    2015-10-01

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

  8. Double-blind placebo-controlled trial of methylphenidate in the treatment of adult ADHD patients with comorbid cocaine dependence.

    Science.gov (United States)

    Schubiner, Howard; Saules, Karen K; Arfken, Cynthia L; Johanson, Chris-Ellyn; Schuster, Charles R; Lockhart, Nancy; Edwards, Ann; Donlin, Judy; Pihlgren, Eric

    2002-08-01

    In this 12-week double-blind placebo-controlled trial of methylphenidate (MTP) versus placebo in 48 cocaine-dependent attention-deficit/hyperactivity disorder (ADHD) adults, the authors sought to determine whether MTP would be safe, control ADHD symptoms, and affect cocaine use. Efficacy indexes revealed significantly greater ADHD symptom relief in the MTP group. There were no group differences in self-reported cocaine use, urinalysis results, or cocaine craving. Because of the relatively small sample size, the results are preliminary. However, we found that MTP improved subjective reports of ADHD symptoms and did not worsen cocaine use while participants were in treatment.

  9. A randomized, double-blind, placebo-controlled, multicenter study on sibutramine in over-weighted and obese subjects

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    Objectives To assess weight loss efficacy ,safety and tolerability of sibutramine in simple obese subjects.Methods Randomized, double-blind, placebo-controlled clinical trial. Four hospital outpatient clinics in Shanghai, Chongqing, Shandong and Tianjin, respectively. Participants: 233 men and women, 18-65 years old, with body mass index (BMI) ranging from 27 to 40*!kg/m2 were randomly divided into an intervened group and a placebo control group. Sibutramine 10 mg or placebo once a day. Main outcome measures: Body weight, routine laboratory and clinical safety monitoring.Results Of 233 eligible patients, 120 received sibutramine and 113 received placebo. Weight reduction was significantly greater in the intervened group (6.8±3.1) kg than the placebo control group (0.48±2.6) kg from week 4 onwards to week 24 (P<0.001). Some minor side effects were noticed in the subjects who took sibutramine. But the symptoms were light and short term. Sibutramine was will tolerated.Conclusions Sibutramine 10*!mg once a day is an effective an safe therapy for weight reduction in simple over-weighted and obese subjects.

  10. Double-blinded, placebo-controlled study to evaluate an antipruritic shampoo for dogs with allergic pruritus.

    Science.gov (United States)

    Schilling, J; Mueller, R S

    2012-07-28

    Shampoo therapy is frequently used on pruritic dogs. However, there are few double-blinded, placebo-controlled studies of this form of therapy. This randomised, double-blinded, placebo-controlled study evaluated the efficacy of a commercial medicated shampoo (DermaTopic; Almapharm) containing chlorhexidine, lactoferrin, piroctone olamine, chitosan and essential fatty acids in 27 dogs with mild to moderate allergic pruritus without secondary skin infections. All dogs received shampoo therapy with either DermaTopic or a shampoo vehicle as placebo twice weekly for four weeks. The extent of pruritus was evaluated before the study and then on a daily basis by the owners using a visual analogue scale. Before beginning the treatment and after four weeks, the skin lesions were evaluated by an experienced clinician with a validated lesion score (Canine Atopic Dermatitis Extent and Severity Index - CADESI). The pruritus was reduced significantly by both DermaTopic and placebo. However, there was no significant difference between both groups. There was no statistically significant difference in the CADESI scores pre- and post-treatment in either group or between the two types of treatment. This study provides further evidence of the benefit of shampoo therapy for pruritic dogs.

  11. Caffeine improves endurance in 75-year old citizens. A randomized, double-blind, placebo-controlled, cross-over study

    DEFF Research Database (Denmark)

    Buchard Nørager, Charlotte; Jensen, Martin Bach; Madsen, Mogens Rørbæk

    2005-01-01

    This study investigated the effect of caffeine on physical performance in healthy citizens aged ≥70 yr. The randomized, double-blind, placebo-controlled, crossover study was conducted in 15 men and 15 women recruited by their general practitioner. Participants abstained from caffeine for 48 h...... = 0.0001). Caffeine also reduced the rating of perceived exertion after 5 min of cycling by 11% (95% CI: 5–17; P = 0.002) and postural stability with eyes open by 25% (95% CI: 2–53; P = 0.03). Caffeine ingestion did not affect muscle strength, walking speed, reaction, and movement times. At the end...... consumption. Further studies are required to investigate whether caffeine can be utilized to improve the physical performance of elderly citizens....

  12. Effects of tonabersat on migraine with aura: a randomised, double-blind, placebo-controlled crossover study

    DEFF Research Database (Denmark)

    Hauge, Anne Werner; Asghar, Mohammad Sohail; Schytz, Henrik W

    2009-01-01

    different between placebo and tonabersat groups (3.0 days in each group; p=0.09). Tonabersat was well tolerated but overall had more side-effects than placebo. INTERPRETATION: Tonabersat showed a preventive effect on attacks of migraine aura but no efficacy on non-aura attacks, in keeping with its known......BACKGROUND: Migraine with aura is thought likely to be caused by cortical spreading depression (CSD). Tonabersat inhibits CSD, and we therefore investigated whether tonabersat has a preventive effect in migraine with aura. METHODS: In this randomised, double-blind, placebo-controlled crossover...... inhibitory effect on CSD. The results support the theory that auras are caused by CSD and that this phenomenon is not involved in attacks without aura. FUNDING: Minster Pharmaceuticals; Lundbeck Foundation....

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

    DEFF Research Database (Denmark)

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

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

  14. 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....

  15. A double-blinded, placebo-controlled trial of garlic as a mosquito repellant: a preliminary study.

    Science.gov (United States)

    Rajan, T V; Hein, M; Porte, P; Wikel, S

    2005-03-01

    The hypothesis that the ingestion of garlic provides protection against bloodsucking pests such as mosquitoes was investigated using a randomized, double-blinded, placebo-controlled crossover study. Subjects were asked to consume either garlic (one visit) or a placebo (the other visit). They were then exposed to laboratory-reared Aedes aegypti (Linnaeus) (Diptera: Culicidae). The numbers of mosquitoes that did not feed on the subjects, the number of mosquito bites, the weights of the mosquitoes after feeding and the amounts of blood ingested were determined. The data did not provide evidence of significant systemic mosquito repellence. A limitation of the study is that more prolonged ingestion of garlic may be needed to accomplish repellence.

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

    Science.gov (United States)

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

    2016-09-01

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

  17. A randomized, double blind, placebo controlled study of spirulina supplementation on indices of mental and physical fatigue in men.

    Science.gov (United States)

    Johnson, Morgan; Hassinger, Lauren; Davis, Joshua; Devor, Steven T; DiSilvestro, Robert A

    2016-01-01

    Spirulina may increase people's ability to resist mental and physical fatigue. This study tested that hypothesis in a randomized, double blinded, placebo controlled study in men. After 1 week, a 3 g/day dose of spirulina produced a small, but statistically significant increase in exercise output (Kcals consumed in 30 min exercise on a cross trainer machine). A mathematical based mental fatigue test showed improved performance 4 h after the first time of supplementation as well as 8 weeks later. Similarly, a subjective survey for a sense of physical and mental fatigue showed improvement within 4 h of the first supplementation as well as 8 weeks later. These results show that spirulina intake can affect fatigue in men.

  18. Cerebrolysin enhances cognitive recovery of mild traumatic brain injury patients: double-blind, placebo-controlled, randomized study.

    Science.gov (United States)

    Chen, Chun-Chung; Wei, Sung-Tai; Tsaia, Shiu-Chiu; Chen, Xian-Xiu; Cho, Der-Yang

    2013-12-01

    In adults, mild traumatic brain injury (MTBI) frequently results in impairments of cognitive functions which would lead to psychological consequences in the future. Cerebrolysin is a nootropic drug, and can significantly improve cognitive function in patients with Alzheimer's disease and stroke. The purpose of this study was to investigate how Cerebrolysin therapy enhances cognitive recovery for mild traumatic brain injury patients using a double-blinded, placebo-controlled, randomized phase II pilot study. Patients having head injury within 24 h sent to our hospital were screened and recruited if patients were alert and conscious, and had intracranial contusion haemorrhage. From July 2009 to June 2010, totally, thirty-two patients were recruited in the double-blinded, placebo-controlled, and randomized study. Patients were randomized to receive Cerebrolysin (Group A, once daily intravenous infusion of 30 mL Cerebrolysin over a 60-min period for 5 days) or placebo (Group B, same dosage and administration of normal saline as Group A). The primary outcome measures were differences of cognitive function including Mini-Mental Status Examination (MMSE), and Cognitive Abilities Screening Instrument (CASI) scores between baseline and week 1, between baseline and week 4, and between baseline and week 12. Thirty-two patients completed the trial. For Group A, the CASI score difference between baseline and week 12 was 21.0 ± 20.4, a significantly greater change than that of Group B (7.6 ± 12.1) (p = 0.0461). Besides, drawing function (one of the domains of CASI; p = 0.0066) on week 4 and both drawing function (p = 0.0472) and long-term memory (one of the domains of CASI; p = 0.0256) on week 12 were also found to be significantly improved in the patients receiving Cerebrolysin treatment. Our results suggest that Cerebrolysin improves the cognitive function of the MTBI in patients at 3rd month after injury, especially for long-term memory and drawing function.

  19. A double-blind, placebo-controlled pilot trial of acamprosate for the treatment of cocaine dependence.

    Science.gov (United States)

    Kampman, Kyle M; Dackis, Charles; Pettinati, Helen M; Lynch, Kevin G; Sparkman, Thorne; O'Brien, Charles P

    2011-03-01

    Acamprosate is a medication shown to be effective for the treatment of alcohol dependence. Although the exact mechanism of action of acamprosate is unknown, evidence suggests that it decreases excitatory amino acid activity by post-synaptic inhibition of the NMDA subtype of glutamate receptors. It is possible that the activity of acamprosate via modulating glutamatergic activity could also reduce craving for cocaine and impact abstinence in cocaine dependence. Therefore, we conducted a double-blind placebo-controlled pilot trial of acamprosate for the treatment of cocaine dependence. Sixty male and female cocaine dependent patients were included in a nine week double-blind, placebo-controlled trial. After a one-week baseline, patients were randomized to receive acamprosate 666 mg three times daily or identical placebo tablets for eight weeks. The primary outcome measure was cocaine use as determined by twice weekly urine drug screens. Thirty-six patients (60%) completed the trial, with no significant between-group difference in treatment retention. Percent cocaine positive urine drug screens did not differ between the two groups. Acamprosate was no better than placebo in reducing cocaine craving, reducing cocaine withdrawal symptoms, or improving measures of drug use severity from the Addiction Severity Index. Adverse events in this trial were generally mild and were evenly distributed between the two groups. Acamprosate was well tolerated but was no more efficacious than placebo in promoting abstinence from cocaine in cocaine dependent patients. Acamprosate does not appear to be a promising medication for the treatment of cocaine dependence. Copyright © 2010 Elsevier Ltd. All rights reserved.

  20. Pentoxifylline Treatment in Severe Acute Pancreatitis: A Pilot, Double-Blind, Placebo-Controlled, Randomized Trial.

    Science.gov (United States)

    Vege, Santhi Swaroop; Atwal, Tegpal; Bi, Yan; Chari, Suresh T; Clemens, Magdalen A; Enders, Felicity T

    2015-08-01

    In acute pancreatitis (AP) tumor necrosis factor-α mediates multi-organ failure; in animal models its blockade with pentoxifylline ameliorates AP. The efficacy of pentoxifylline in predicted severe AP (pSAP) was tested in a double-blinded, randomized, control trial. Twenty-eight patients with pSAP were randomized within 72 hours of diagnosis to pentoxifylline or placebo. Baseline characteristics were similar in both groups. The pentoxifylline group had fewer intensive care unit admissions and shorter intensive care unit and hospital stays of longer than 4 days (all P < .05). Patients receiving pentoxifylline had no adverse effects. Pentoxifylline within 72 hours of pSAP is safe; a larger study of pentoxifylline in AP is needed to confirm efficacy. ClinicalTrials.gov number: NCT01292005. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

  1. Levetiracetam in primary orthostatic tremor: a double-blind placebo-controlled crossover study.

    Science.gov (United States)

    Hellriegel, Helge; Raethjen, Jan; Deuschl, G; Volkmann, Jens

    2011-11-01

    In a double-blind crossover study we evaluated the antitremor effect of a 4-week treatment with either escalating dosages of levetiracetam or placebo in orthostatic tremor. Twelve patients with orthostatic tremor participated in the study. Primary end point was improvement in stance duration. Secondary end points were total track length of the sway path and tremor total power. The patients' impression of impairment was assessed by a visual analog scale and quality of life by the SF-36. We found no significant effect of dosage or treatment on stance duration (P = .175), total track length (P = .690), total power (P = .280), or visual analog scale (P =.735). Neither was SF-36 differentially changed by levetiracetam or placebo (SF-36, Physical Component Summary: P = .079; SF-36, Mental Component Summary: P = .073). Side effects like dizziness, fatigue, or nausea were only mild to moderate. Levetiracetam is ineffective in the treatment of orthostatic tremor. Copyright © 2011 Movement Disorder Society.

  2. Antihirsutism activity of Fennel (fruits of Foeniculum vulgare) extract. A double-blind placebo controlled study.

    Science.gov (United States)

    Javidnia, K; Dastgheib, L; Mohammadi Samani, S; Nasiri, A

    2003-01-01

    Idiopathic hirsutism is defined as the occurrence of excessive male pattern hair growth in women who have a normal ovulatory menstrual cycle and normal levels of serum androgens. It may be a disorder of peripheral androgen metabolism. In this study we evaluated the clinical response of idiopathic hirsutism to topical Fennel extract. Fennel, Foeniculum vulgare, is a plant, which has been used as an estrogenic agent. The ethanolic extract of Fennel was obtained by using a soxhlete apparatus. In a double blind study, 38 patients were treated with creams containing 1%, 2% of Fennel extract and placebo. Hair diameter was measured and rate of growth was considered. The efficacy of treatment with the cream containing 2% Fennel is better than the cream containing 1% Fennel and these two were more potent than placebo. The mean values of hair diameter reduction was 7.8%, 18.3% and -0.5% for patients receiving the creams containing 1%, 2% and 0% (placebo) respectively.

  3. Treatment of intermittent claudication with mesoglycan--a placebo-controlled, double-blind study.

    Science.gov (United States)

    Nenci, G G; Gresele, P; Ferrari, G; Santoro, L; Gianese, F

    2001-11-01

    To assess the effect of treatment with mesoglycan, a sulphated polysaccharide compound, on the walking capacity of patients with stage II peripheral arterial disease. Non-diabetic outpatients with intermittent claudication, duplex ultrasound evidence of peripheral atherosclerosis, ankle/arm index 50 mmHg, and absolute walking distance (AWD) between 100 and 300 m (standardised treadmill test) were eligible. After a 5-week run-in on single-blind placebo, patients were randomised to double-blind treatment with mesoglycan, 30 mg/day intramuscularly for 3 weeks followed by 100 mg/day orally for 20 weeks, or matching placebo. All patients received low-dose aspirin and lifestyle instructions. Clinical response was defined as an AWD increase at Week 23 >50% over baseline. Health-related quality of life and ischaemic events were assessed as secondary efficacy variables. 242 patients were randomised and 237 were assessed for clinical response. Patients achieving clinical response were 59/118 with mesoglycan (50.0%) and 31/119 with placebo (26.1%; p mesoglycan, and from 192 to 238 m with placebo (p mesoglycan (p = 0.057). Changes in quality of life scores were in favour of mesoglycan. The rate of ischaemic events was 1/120 on mesoglycan and 6/122 on placebo (p = 0.053). The rate of non-ischaemic adverse events leading to treatment discontinuation was 7/120 and 4/122, respectively. Treatment with mesoglycan improves the walking capacity of patients with intermittent claudication, and might confer additional antithrombotic protection over that of aspirin.

  4. 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.

  5. Oxiracetam in dementia: a double-blind, placebo-controlled study.

    Science.gov (United States)

    Bottini, G; Vallar, G; Cappa, S; Monza, G C; Scarpini, E; Baron, P; Cheldi, A; Scarlato, G

    1992-09-01

    A multicentre, double-blind, between-patient study was carried out to evaluate the efficacy and tolerability of oxiracetam (800 mg tablet), in comparison with placebo, each given twice daily for 12 weeks to patients suffering from primary degenerative, multi-infarct or mixed dementia. Efficacy was assessed by a neuropsychological battery (simple reaction time, controlled associations, short story, Raven's Progressive Matrices, token test, digit span, word list learning), administered at the beginning and at the end of the study, and by a quality of life scale, administered at entry and after 6 and 12 weeks treatment. Sixty-five patients (28 men, 37 women, mean age 71 yrs) were enrolled; 58 completed the study: 2 on oxiracetam were withdrawn because of poor tolerability, 2 (one in each group) were withdrawn for poor compliance, one (on oxiracetam) for the occurrence of a transient ischaemic attack (defined as not related to the treatment) and 2 for administrative reasons. A significantly (p < 0.01) different effect in favour of oxiracetam was observed on the quality of life scale, and confirmed by significant (defined according to the Bonferroni technique) differences in some neuropsychological tests (e.g. controlled associations, short story). Four patients in the oxiracetam group complained of a total of 5 unwanted effects, and 1 on placebo complained of 3 unwanted effects, but none of them was withdrawn from the study.

  6. Citicoline Combination Therapy for Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Roohi-Azizi, Mahtab; Arabzadeh, Somaye; Amidfar, Meysam; Salimi, Samrand; Zarindast, Mohammad Reza; Talaei, Ali; Akhondzadeh, Shahin

    Residual symptoms of major depressive disorder are a source of long-term morbidity. New therapeutic strategies are required to alleviate this morbidity and enhance patient quality of life. Citicoline has been used for vascular accidents and has been effective in cognitive rehabilitation. It has been used successfully to reduce craving in patients with substance abuse disorder and for mood management of bipolar disorder. Here, we test citicoline effectiveness as an adjuvant therapy in major depression. A double-blind randomized trial was designed on 50 patients with major depressive disorder who were under treatment with citalopram. Patients were allocated to 2 groups and received citicoline (100 mg twice a day) or placebo as an adjuvant treatment for 6 weeks. Depressive symptoms were assessed by the Hamilton Depression Rating Scale (HDRS) at baseline and at weeks 2, 4, and 6. Significantly greater improvement was observed in the HDRS scores of the citicoline group compared with the placebo group from baseline to weeks 2, 4, and 6 (Ps = 0.030, 0.032, and 0.021, respectively). Repeated-measures general linear model demonstrated a significant effect for time × treatment interaction on the HDRS score (F2.10,101.22 = 3.12, P = 0.04). Remission rate was significantly higher in the citicoline group compared with the placebo group (P = 0.045). Citicoline was an effective adjuvant to citalopram in the therapy of major depressive disorder.

  7. Luteal Phase Support in the Intrauterine Insemination (IUI Cycles: A Randomized Double Blind, Placebo Controlled Study.

    Directory of Open Access Journals (Sweden)

    Batool Hossein Rashidi

    2014-12-01

    Full Text Available To evaluate the impact of luteal phase support with vaginal progesterone on pregnancy rates in the intrauterine insemination (IUI cycles, stimulated with clomiphene citrate and human menopausal gonadotropin (hMG, in sub fertile couples.This prospective, randomized, double blind study was performed in a tertiary infertility center from March 2011 to January 2012. It consisted of 253 sub fertile couples undergoing ovarian stimulation for IUI cycles. They underwent ovarian stimulation with clomiphene citrate (100 mg and hMG (75 IU in preparation for the IUI cycle. Study group (n = 127 received luteal phase support in the form of vaginal progesterone (400 mg twice a day, and control group (n = 126 received placebo. Clinical pregnancy and abortion rates were assessed and compared between the two groups.The clinical pregnancy rate was not significantly higher for supported cycles than that for the unsupported ones (15.75% vs. 12.69%, p = 0.3. The abortion rate in the patients with progesterone luteal support compared to placebo group was not statistically different (10% vs. 18.75%, p = 0.45.It seems that luteal phase support with vaginal progesterone was not enhanced the success of IUI cycles outcomes, when clomiphene citrate and hMG were used for ovulation stimulation.

  8. Development of a standardized low-dose double-blind placebo-controlled challenge vehicle for the EuroPrevall project

    NARCIS (Netherlands)

    Cochrane, S. A.; Salt, L. J.; Wantling, E.; Rogers, A.; Coutts, J.; Ballmer-Weber, B. K.; Fritsche, P.; Fernandez-Rivas, M.; Reig, I.; Knulst, A.; Le, T. -M.; Asero, R.; Beyer, K.; Golding, M.; Crevel, R.; Mills, E. N. Clare; Mackie, A. R.

    2012-01-01

    Background: Double-blind placebo-controlled food challenge (DBPCFC) is the gold standard for diagnosing food allergy. Standardized materials and protocols are essential for comparing DBPCFC results for multicentre studies such as EuroPrevall. This required the development and piloting of a standardi

  9. Development of a standardized low-dose double-blind placebo-controlled challenge vehicle for the EuroPrevall project.

    NARCIS (Netherlands)

    Cochrane, S.A.; Salt, L.J.; Wantling, E.; Rogers, A.; Coutts, J.; Ballmer-Weber, B.K.; Fritsche, P.; Fernandez-Rivas, M.; Reig, I.; Knulst, A.; Le, T.M.; Asero, R.; Beyer, K.; Golding, M.; Crevel, R. van; Mills, E.N.; Mackie, A.R.

    2012-01-01

    BACKGROUND: Double-blind placebo-controlled food challenge (DBPCFC) is the gold standard for diagnosing food allergy. Standardized materials and protocols are essential for comparing DBPCFC results for multicentre studies such as EuroPrevall. This required the development and piloting of a standardi

  10. ALFUZOSIN IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA - EFFECTS ON SYMPTOM SCORES, URINARY FLOW-RATES AND RESIDUAL VOLUME - A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

    NARCIS (Netherlands)

    HANSEN, BJ; NORDLING, J; MENSINK, HJA; WALTER, S; MEYHOFF, HH; LEENARTS, JAF; OOSTEN, JK; VANSOEST, FF; DIJKMAN, GA; HOEKSTRA, JW; VANBAASBANK, NJW; BIJLEVELD, RT; BRAAM, PFCM; SCHLATMANN, TJM; FELDERHOF, J; KHOE, GSS; DIK, P; MENSINK, HJA; SKOV, J; CHRISTOFFERSEN, J; GEERDSEN, JP; HVIDT, [No Value; DAHL, C; LUKE, M; LENDORPH, A; JACOBSEN, B; BILDE, T; MORTENSEN, S; LARSEN, EH

    1994-01-01

    In order to assess the efficacy and safety of alfuzosin, a selective alpha-1 receptor antagonist, 205 patients with Benign Prostatic Hyperplasia (BPH) were randomly assigned in a double-blind, placebo-controlled manner, to receive either alfuzosin 2,5 mg TID or placebo TID during 12 weeks. After 12

  11. 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;

    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 second...

  12. Low doses of mirtazapine or quetiapine for transient insomnia : A randomised, double-blind, cross-over, placebo-controlled trial

    NARCIS (Netherlands)

    Karsten, Julie; Hagenauw, Loes A.; Kamphuis, Jeanine; Lancel, Marike

    Low doses of the antidepressant mirtazapine or the neuroleptic quetiapine are often prescribed off-label for insomnia. However, studies on the effects on sleep and hangover effects the following day are scarce. In this randomised, double-blind, cross-over, placebo-controlled trial, the influence of

  13. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease : a randomised, double-blind, placebo controlled trial (ADAFI)

    NARCIS (Netherlands)

    Dewint, Pieter; Hansen, Bettina E.; Verhey, Elke; Oldenburg, Bas; Hommes, Daniel W.; Pierik, Marieke; Ponsioen, Cyriel I. J.; van Dullemen, Hendrik M.; Russel, Maurice; van Bodegraven, Ad A.; van der Woude, C. Janneke

    2014-01-01

    Objective To assess whether a combination of adalimumab and ciprofloxacin is superior to adalimumab alone in the treatment of perianal fistulising Crohn's disease (CD). Design Randomised, double-blind, placebo controlled trial in eight Dutch hospitals. In total, 76 CD patients with active perianal f

  14. A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

    Science.gov (United States)

    Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

    2011-01-01

    Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

  15. Laxation of critically ill patients with lactulose or polyethylene glycol : a two-center randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    van der Spoel, Johan I; Oudemans-van Straaten, Heleen M; Kuiper, Michael A; van Roon, Eric N; Zandstra, Durk F; van der Voort, Peter H J

    2007-01-01

    OBJECTIVE: To study whether lactulose or polyethylene glycol is effective to promote defecation in critically ill patients, whether either of the two is superior, and whether the use of enteral laxatives is related to clinical outcome. DESIGN: Double-blind, placebo-controlled, randomized study.

  16. High-Dose Pyridoxine and Magnesium Administration in Children with Autistic Disorder: An Absence of Salutary Effects in a Double-Blind, Placebo-Controlled Study.

    Science.gov (United States)

    Findling, Robert L.; Maxwell, Kathleen; Scotese-Wojtila, Lynette; Huang, Jie; Yamashita, Toyoko; Wiznitzer, Max

    1997-01-01

    Evaluation of high doses of pyridoxine and magnesium in a 10-week double-blind placebo-controlled trial with 10 patients (mean age 6 years) having autism concluded that the high doses used were ineffective in ameliorating autistic behaviors. (DB)

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

    NARCIS (Netherlands)

    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.; Lucca, U.; Banzi, R.; Pasquier, F.; Breuilh, L.; Riepe, M.; Kalman, J.; Wallin, A.; Borjesson, A.; Molloy, W.; Tsolaki, M.; Olde Rikkert, M.G.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 week

  18. EMLA for pain relief during arterial cannulation. A double-blind, placebo-controlled study of a lidocaine-prilocaine cream

    DEFF Research Database (Denmark)

    Nilsson, A; Danielson, K; Engberg, G

    1990-01-01

    The aim of the study was to evaluate the effect of a lidocaine-prilocaine cream (EMLA cream, Astra) in relieving pain during arterial cannulation. The study had a random, double-blind, placebo-controlled design and included altogether 90 patients. All the patients were premedicated with an opioid...

  19. A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

    Science.gov (United States)

    Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

    2011-01-01

    Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

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

    Science.gov (United States)

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

    2017-01-01

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

  1. 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…

  2. Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in College Students with ADHD

    Science.gov (United States)

    DuPaul, George J.; Weyandt, Lisa L.; Rossi, Joseph S.; Vilardo, Brigid A.; O'Dell, Sean M.; Carson, Kristen M.; Verdi, Genevieve; Swentosky, Anthony

    2012-01-01

    Objective: To evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) was examined for ADHD participants over five…

  3. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: A randomised, double-blind, placebo controlled trial (ADAFI)

    NARCIS (Netherlands)

    P. Dewint (Pieter); B.E. Hansen (Bettina); E. Verhey (Elke); B. Oldenburg (Bas); D.W.S. Hommes (Daniël); M. Pierik (Marieke); C.Y. Ponsioen (Cyril); H.M. van Dullemen (Hendrik); M. Russel (Maurice); A.A. van Bodegraven (Ad); C.J. van der Woude (Janneke)

    2014-01-01

    textabstractObjective: To assess whether a combination of adalimumab and ciprofloxacin is superior to adalimumab alone in the treatment of perianal fistulising Crohn's disease (CD). Design: Randomised, double-blind, placebo controlled trial in eight Dutch hospitals. In total, 76 CD patients with act

  4. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease : a randomised, double-blind, placebo controlled trial (ADAFI)

    NARCIS (Netherlands)

    Dewint, Pieter; Hansen, Bettina E.; Verhey, Elke; Oldenburg, Bas; Hommes, Daniel W.; Pierik, Marieke; Ponsioen, Cyriel I. J.; van Dullemen, Hendrik M.; Russel, Maurice; van Bodegraven, Ad A.; van der Woude, C. Janneke

    2014-01-01

    Objective To assess whether a combination of adalimumab and ciprofloxacin is superior to adalimumab alone in the treatment of perianal fistulising Crohn's disease (CD). Design Randomised, double-blind, placebo controlled trial in eight Dutch hospitals. In total, 76 CD patients with active perianal f

  5. The safety and efficacy of subcutaneous birch pollen immunotherapy - a one-year, randomised, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Bødtger, Uffe; Poulsen, L K; Jacobi, H H

    2002-01-01

    BACKGROUND: There is only very limited documentation of the efficacy and safety of high-dose subcutaneous birch pollen immunotherapy (IT) in double-blind, placebo-controlled (DBPC) studies. Birch pollen is a major cause of allergic morbidity in northern Europe and in eastern parts of North Americ...

  6. Laxation of critically ill patients with lactulose or polyethylene glycol : a two-center randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    van der Spoel, Johan I; Oudemans-van Straaten, Heleen M; Kuiper, Michael A; van Roon, Eric N; Zandstra, Durk F; van der Voort, Peter H J

    2007-01-01

    OBJECTIVE: To study whether lactulose or polyethylene glycol is effective to promote defecation in critically ill patients, whether either of the two is superior, and whether the use of enteral laxatives is related to clinical outcome. DESIGN: Double-blind, placebo-controlled, randomized study. SETT

  7. ALFUZOSIN IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA - EFFECTS ON SYMPTOM SCORES, URINARY FLOW-RATES AND RESIDUAL VOLUME - A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

    NARCIS (Netherlands)

    HANSEN, BJ; NORDLING, J; MENSINK, HJA; WALTER, S; MEYHOFF, HH; LEENARTS, JAF; OOSTEN, JK; VANSOEST, FF; DIJKMAN, GA; HOEKSTRA, JW; VANBAASBANK, NJW; BIJLEVELD, RT; BRAAM, PFCM; SCHLATMANN, TJM; FELDERHOF, J; KHOE, GSS; DIK, P; MENSINK, HJA; SKOV, J; CHRISTOFFERSEN, J; GEERDSEN, JP; HVIDT, [No Value; DAHL, C; LUKE, M; LENDORPH, A; JACOBSEN, B; BILDE, T; MORTENSEN, S; LARSEN, EH

    1994-01-01

    In order to assess the efficacy and safety of alfuzosin, a selective alpha-1 receptor antagonist, 205 patients with Benign Prostatic Hyperplasia (BPH) were randomly assigned in a double-blind, placebo-controlled manner, to receive either alfuzosin 2,5 mg TID or placebo TID during 12 weeks. After 12

  8. The angiotensin II receptor antagonist telmisartan reduces urinary albumin excretion in patients with isolated systolic hypertension: results of a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Vogt, Liffert; Navis, Gerjan; Koester, Juergen; Manolis, Athanasios J.; Reid, John L.; de Zeeuw, Dick

    2005-01-01

    Objective To examine the effect of telmisartan or hydrochlorothiazide on the control of urinary albumin excretion (UAE) in patients with isolated systolic hypertension (ISH) unselected for albuminuria in a pre-planned substudy of a large, multicentre, double-blind, placebo-controlled, randomized

  9. A randomized, double-blind, placebo-controlled study to assess QTc interval prolongation of standard dose aflibercept in cancer patients treated with docetaxel

    DEFF Research Database (Denmark)

    Maison-Blanche, Pierre; Vermorken, Jan B; Goksel, Tuncay;

    2013-01-01

    : The effect of repeated doses of aflibercept on ventricular repolarization in cancer patients was evaluated in an intensive electrocardiogram trial. This randomized, placebo-controlled, double-blind trial was conducted in 87 treated solid tumor patients. Treatment was with 6 mg/kg aflibercept, 1...

  10. 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,

  11. Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status : randomised double-blind, placebo-controlled crossover trial

    NARCIS (Netherlands)

    Muraro, Antonella; Hoekstra, Maarten O.; Meijer, Yolanda; Lifschitz, Carlos; Wampler, Jennifer L.; Harris, Cheryl; Scalabrin, Deolinda M. F.

    2012-01-01

    Objective: To evaluate the hypoallergenicity of an extensively hydrolysed (EH) casein formula supplemented with Lactobacillus rhamnosus GG (LGG). Design: A prospective, randomised, double-blind, placebo-controlled crossover trial. Setting: Two study sites in Italy and The Netherlands. Study particip

  12. The angiotensin II receptor antagonist telmisartan reduces urinary albumin excretion in patients with isolated systolic hypertension : results of a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Vogt, Liffert; Navis, Gerjan; Koester, Juergen; Manolis, Athanasios J.; Reid, John L.; de Zeeuw, Dick

    2005-01-01

    Objective To examine the effect of telmisartan or hydrochlorothiazide on the control of urinary albumin excretion (UAE) in patients with isolated systolic hypertension (ISH) unselected for albuminuria in a pre-planned substudy of a large, multicentre, double-blind, placebo-controlled, randomized stu

  13. The angiotensin II receptor antagonist telmisartan reduces urinary albumin excretion in patients with isolated systolic hypertension: results of a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Vogt, Liffert; Navis, Gerjan; Koester, Juergen; Manolis, Athanasios J.; Reid, John L.; de Zeeuw, Dick

    2005-01-01

    Objective To examine the effect of telmisartan or hydrochlorothiazide on the control of urinary albumin excretion (UAE) in patients with isolated systolic hypertension (ISH) unselected for albuminuria in a pre-planned substudy of a large, multicentre, double-blind, placebo-controlled, randomized stu

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

    NARCIS (Netherlands)

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

    2008-01-01

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

  15. The impact of double-blind placebo-controlled food challenge (DBPCFC) on the socioeconomic cost of food allergy in Europe

    NARCIS (Netherlands)

    Cerecedo, I.; Zamora, J.; Fox, M.; Voordouw, J.; Plana, N.; Rokicka, E.; Fernandez-Rivas, M.; Vazquez Cortes, S.; Reche, M.; Fiandor, A.; Kowalski, M.; Antonides, G.; Mugford, M.; Frewer, L.J.; Hoz, De la B.

    2014-01-01

    BACKGROUND: Double-blind placebo controlled food (DBPCFC) is the gold standard diagnostic test in food allergy because it minimizes diagnostic bias. OBJECTIVE: To investigate the potential effect of diagnosis on the socioeconomic costs of food allergy. METHODS: A prospective longitudinal cost analys

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

    Science.gov (United States)

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

    2017-01-01

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

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

    NARCIS (Netherlands)

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

    2005-01-01

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

  18. Development of a standardized low-dose double-blind placebo-controlled challenge vehicle for the EuroPrevall project

    NARCIS (Netherlands)

    Cochrane, S. A.; Salt, L. J.; Wantling, E.; Rogers, A.; Coutts, J.; Ballmer-Weber, B. K.; Fritsche, P.; Fernandez-Rivas, M.; Reig, I.; Knulst, A.; Le, T. -M.; Asero, R.; Beyer, K.; Golding, M.; Crevel, R.; Mills, E. N. Clare; Mackie, A. R.

    2012-01-01

    Background: Double-blind placebo-controlled food challenge (DBPCFC) is the gold standard for diagnosing food allergy. Standardized materials and protocols are essential for comparing DBPCFC results for multicentre studies such as EuroPrevall. This required the development and piloting of a standardi

  19. Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in College Students with ADHD

    Science.gov (United States)

    DuPaul, George J.; Weyandt, Lisa L.; Rossi, Joseph S.; Vilardo, Brigid A.; O'Dell, Sean M.; Carson, Kristen M.; Verdi, Genevieve; Swentosky, Anthony

    2012-01-01

    Objective: To evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) was examined for ADHD participants over five…

  20. The safety and efficacy of subcutaneous birch pollen immunotherapy - a one-year, randomised, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Bødtger, U; Poulsen, Lars K.; Jacobi, H H

    2002-01-01

    There is only very limited documentation of the efficacy and safety of high-dose subcutaneous birch pollen immunotherapy (IT) in double-blind, placebo-controlled (DBPC) studies. Birch pollen is a major cause of allergic morbidity in northern Europe and in eastern parts of North America....

  1. EMLA for pain relief during arterial cannulation. A double-blind, placebo-controlled study of a lidocaine-prilocaine cream

    DEFF Research Database (Denmark)

    Nilsson, A; Danielson, K; Engberg, G

    1990-01-01

    The aim of the study was to evaluate the effect of a lidocaine-prilocaine cream (EMLA cream, Astra) in relieving pain during arterial cannulation. The study had a random, double-blind, placebo-controlled design and included altogether 90 patients. All the patients were premedicated with an opioid...

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

    NARCIS (Netherlands)

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

    2008-01-01

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

  3. Randomized, double-blind, placebo-controlled trial using lidocaine patch 5% in traumatic rib fractures.

    Science.gov (United States)

    Ingalls, Nichole K; Horton, Zachary A; Bettendorf, Matthew; Frye, Ira; Rodriguez, Carlos

    2010-02-01

    The lidocaine patch 5% was developed to treat postherpetic neuralgia. Anecdotal experience at our institution suggests the lidocaine patch 5% decreases narcotic usage in patients with traumatic rib fractures. This trial was developed to define the patch's efficacy. Patients with rib fractures admitted to the trauma service at our Level I trauma center were enrolled and randomized in a 1 to 1 double-blind manner to receive a lidocaine patch 5% or placebo patch. Fifty-eight patients who met the inclusion criteria were enrolled from January 2007 to August 2008. Demographic and clinical information were recorded. The primary outcomes variable was total narcotic use, analyzed using the 1-tailed Mann-Whitney test. The secondary outcomes variables included non-narcotic pain medication, average pain score, pulmonary complications, and length of stay. Significance was defined based on a 1-sided test for the primary outcome and 2-sided tests for other comparisons, at p rib fractures, gender, trauma mechanism, preinjury lung disease, smoking history, percent of current smokers, and need for placement of chest tube between the lidocaine patch 5% and placebo groups. There was no difference between the lidocaine patch 5% and placebo groups, respectively, with regard to total IV narcotic usage: median, 0.23 units versus 0.26 units; total oral narcotics: median, 4 units versus 7 units; pain score: 5.6 +/- 0.4 versus 6.0 +/- 0.3 (mean +/- SEM); length of stay: 7.8 +/- 1.1 versus 6.2 +/- 0.7; or percentage of patients with pulmonary complications: 72.7% versus 72.0%. The lidocaine patch 5% does not significantly improve pain control in polytrauma patients with traumatic rib fractures.

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Andrew Scholey

    2017-02-01

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

  6. A double-blind, randomized, placebo-controlled trial of oral isotretinoin in the treatment of recalcitrant facial flat warts.

    Science.gov (United States)

    Olguin-García, María Guadalupe; Jurado-Santa Cruz, Fermín; Peralta-Pedrero, María Luisa; Morales-Sánchez, Martha Alejandra

    2015-02-01

    Abstract Background: Recalcitrant facial flat warts are caused by human papillomavirus and may persist for years despite treatment. Isotretinoin has demonstrated benefits in the treatment of recalcitrant, genital and common warts, but placebo-controlled trials have not been performed. To determine whether isotretinoin is safe and effective for recalcitrant facial flat warts. Isotretinoin 30 mg/day or placebo was administered to 16 and 15 patients, respectively, in double-blind, randomized fashion for 12 weeks. Cutaneous lesions were assessed and adverse events including serologic and ophthalmologic changes were recorded. It is considered that warts were recalcitrant if the patient was treated for at least 3 years with at least three of the following options: retinoids, 5-fluorouracil, imiquimod and cryotherapy using liquid nitrogen. Each patient in the istotretinoin group showed complete clearance of all flat warts, while none of the patients in the placebo group showed any improvement (p=0.0001). The most frequent adverse event was cheilitis. There were no statistically significant changes in the laboratory findings. The study design does not permit complete blinding of the dermatologist who can easily recognize the adverse effects of isotretinoin. The clinical findings, however, were so dramatic that this would not have impacted the findings. Another limitation of the study is a lack of follow-up to assess for recurrence after the drug was discontinued. Isotretinoin is an effective treatment for recalcitrant flat facial warts with a well-known, manageable safety profile.

  7. 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.

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

    Directory of Open Access Journals (Sweden)

    Audicana Maria T

    2011-08-01

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

  9. Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Whitlock, Richard P; Devereaux, P J; Teoh, Kevin H; Lamy, Andre; Vincent, Jessica; Pogue, Janice; Paparella, Domenico; Sessler, Daniel I; Karthikeyan, Ganesan; Villar, Juan Carlos; Zuo, Yunxia; Avezum, Álvaro; Quantz, Mackenzie; Tagarakis, Georgios I; Shah, Pallav J; Abbasi, Seyed Hesameddin; Zheng, Hong; Pettit, Shirley; Chrolavicius, Susan; Yusuf, Salim

    2015-09-26

    Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388. Patients were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone, compared

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

    Science.gov (United States)

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

    2012-11-01

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

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

    Science.gov (United States)

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

    2009-08-01

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

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

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    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

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

    Science.gov (United States)

    Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G

    2011-05-06

    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. 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 evaluated by CT-scanning, functional

  14. Effect of Uric Acid-Lowering Agents on Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Borgi, Lea; McMullan, Ciaran; Wohlhueter, Ann; Curhan, Gary C; Fisher, Naomi D; Forman, John P

    2017-02-01

    Higher levels of serum uric acid are independently associated with endothelial dysfunction, a mechanism for incident hypertension. Overweight/obese individuals are more prone to endothelial dysfunction than their lean counterparts. However, the effect of lowering serum uric acid on endothelial dysfunction in these individuals has not been examined thoroughly. In this randomized, double-blind, placebo-controlled trial of nonhypertensive, overweight, or obese individuals with higher serum uric acid (body mass index ≥25 kg/m(2) and serum uric acid ≥5.0 mg/dL), we assigned subjects to probenecid (500-1000 mg/d), allopurinol (300-600 mg/d), or matching placebo. The primary outcome was endothelium-dependent vasodilation measured by brachial artery ultrasound at baseline and 8 weeks. By the end of the trial, 47, 49, and 53 participants had been allocated to receive probenecid, allopurinol, and placebo, respectively. Mean serum uric acid levels significantly decreased in the probenecid (from 6.1 to 3.5 mg/dL) and allopurinol groups (from 6.1 to 2.9 mg/dL) but not in the placebo group (6.1 to 5.6 mg/dL). None of the interventions produced any significant change in endothelium-dependent vasodilation (probenecid, 7.4±5.1% at baseline and 8.3±5.1% at 8 weeks; allopurinol, 7.6±6.0% at baseline and 6.2±4.8% at 8 weeks; and placebo, 6.5±3.8% at baseline and 7.1±4.9% at 8 weeks). In this randomized, double-blind, placebo-controlled trial, uric acid lowering did not affect endothelial function in overweight or obese nonhypertensive individuals. These data do not support the hypothesis that uric acid is causally related to endothelial dysfunction, a potential mechanism for development of hypertension. © 2016 American Heart Association, Inc.

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

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    Amy S Chappell

    2008-12-01

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

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

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    Luc Dupuis

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

  17. A randomized, double-blind, placebo-controlled trial comparing pethidine to metamizol for treatment of post-anaesthetic shivering

    Science.gov (United States)

    MONSÓ, A.; RIUDEUBAS, J.; BARBAL, F.; LAPORTE, J-R.; ARNAU, J. M.

    1996-01-01

    1Shivering is frequent during the post-anaesthetic recovery period, and there is no clear consensus about the best strategy for its treatment. We tested the efficacy of two commonly used analgesic drugs, pethidine and metamizol. 2A randomized, double-blind, placebo-controlled clinical trial was performed, including 104 adult patients who presented with post-anaesthetic shivering during the recovery from general anaesthesia. They were randomized to receive placebo (n=32), metamizol 25 mg kg−1 (n=37), or pethidine 0.4 mg kg−1 (n=35). The response to treatment was assessed 5, 15 and 45 min after drug administration, and the main outcome variable was complete suppression of shivering. 3The efficacy at 5, 15 and 45 min was as follows: placebo 6%, 16% and 37%; metamizol 13.5%, 32% and 76%, and pethidine 89%, 91% and 89%. With both active drugs the efficacy at all three time intervals was significantly higher than that with placebo (Pmetamizol were statistically significant (Pmetamizol produces a better post-anaesthetic shivering response than placebo, especially 15 and 45 min after drug administration; the efficacy of pethidine was the highest and the response to it appeared more quickly; however, at 45 min it was similar to that observed with metamizol. 5Both metamizol and pethidine suppress postanaesthetic shivering, but the latter induces a quicker and more reliable response. PMID:8877020

  18. Emotional changes in men treated with sildenafil citrate for erectile dysfunction: a double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Moncada, Ignacio; Martínez-Jabaloyas, José M; Rodriguez-Vela, Luis; Gutiérrez, Pedro R; Giuliano, Francois; Koskimaki, Juha; Farmer, Ian S; Renedo, Virginia Pascual; Schnetzler, Gabriel

    2009-12-01

    Erectile dysfunction (ED) has been associated with several comorbidities and can cause significant loss of quality of life and self-esteem. In men with ED, to use the validated Self-Esteem and Relationship (SEAR) questionnaire to evaluate changes in self-esteem associated with sildenafil treatment of ED and to assess changes dependent on concomitant comorbid conditions. This was a 14-week, international, randomized, parallel-group, double-blind, flexible-dose (25, 50, or 100 mg), placebo-controlled study of sildenafil in men aged >or=18 years with a clinical diagnosis of ED (score Self-Esteem subscale score from baseline to the end of treatment. Secondary outcomes were the change in SEAR component scores stratified by ED comorbidity, the change in the International Index of Erectile Function (IIEF) domain scores and in the intercourse success rate, and the response to the global efficacy assessment and to the global satisfaction assessment. A total of 841 patients were included in the intent-to-treat efficacy analysis (559 sildenafil, 282 placebo). Patients randomized to sildenafil had significantly greater change scores from baseline to the end of treatment on all components of the SEAR and all domains of the IIEF (P Self-Esteem subscale score correlated with improvements in the mean Erectile Function domain score (r = 0.6338, P depression. Using both the IIEF and the SEAR questionnaires provides a more complete assessment of ED.

  19. Effect of GutGard in the Management of Helicobacter pylori: A Randomized Double Blind Placebo Controlled Study

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    Sreenivasulu Puram

    2013-01-01

    Full Text Available A randomized, double blind placebo controlled study was conducted to evaluate the efficacy of GutGard (root extract of Glycyrrhiza glabra in the management of Helicobacter pylori (H. pylori gastric load. Participants diagnosed with H. pylori infection were randomly assigned to two groups to orally receive 150 mg of GutGard (n=55 or placebo (n=52 once daily for 60 days. H. pylori infection was assessed using 13C-urea breath test (13C-UBT at days 0, 30, and 60. Stool Antigen test (HpSA was also performed on days 0, 30, and 60. Repeated measures of analysis of variance (RMANOVA, chi-square, and Fisher's exact probability tests were used to compare the treatment outcomes. A significant interaction effect between group and time (P=0.00 and significant difference in mean Delta Over Baseline (DOB values between GutGard (n=50 and placebo (n=50 treated groups after intervention period were observed. On day 60, the results of HpSA test were negative in 28 subjects (56% in GutGard treated group whereas in placebo treated group only 2 subjects (4% showed negative response; the difference between the groups was statistically significant. On day 60, the results of 13C-UBT were negative in 24 (48% in GutGard treated group and the difference between the groups was statistically significant. The findings suggest GutGard is effective in the management of H. pylori.

  20. Effect of yangxinkang tablets on chronic heart failure: A multi-center randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Xian, Shao-xiang; Yang, Zhong-qi; Ren, Pei-hua; Ye, Xiao-han; Ye, Sui-lin; Wang, Qing-hai; Wang, Zhao-hui; Shen, Shu-jing; Huang, Xi-wen

    2015-10-01

    To investigate the safety and efficacy of yangxinkang tablets in patients with chronic heart failure (CHF) and syndrome of qi and yin deficiency, blood stasis, and water retention. In a double-blinded, randomized, placebo-controlled, multicenter clinical trail, 228 patients with CHF New York Heart Association (NYHA) class II or III in stage C were assigned by randomized block method to two groups in a 1:1 ratio to undergo either conventional Western treatment or conventional treatment plus yangxinkang tablets for 4 weeks. The outcome measure were effect of cardiac function, Chinese medicine (CM) syndromes, scores of symptoms, signs, and quality of life measured by Minnesota Living with heart failure questionnaire (MLHFQ) before and after the treatment. Totally 112 patients were analyzed in the treatment group and 109 in the control group. They were comparable in NYHA functional class, basic parameters and primary diseases before treatment. Cardiac function and CM syndromes were greatly ameliorated in both groups after treatment. Total effective rates of cardiac function and CM syndrome in the treatment group were significantly higher than those in the control group (Pgasp, cough with phlegm, pulmonary rales and jugular vein engorgement between the two groups (P0.05). There was no obvious adverse reaction in either group noted during the study. Yangxinkang tablets were safe and efficacious in improving cardiac function, CM syndromes, symptoms, signs, and quality of life in patients with CHF class II or III in stage C on the base of conventional treatment.

  1. 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.

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

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    Miao Hu

    2014-01-01

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

  3. Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial.

    Science.gov (United States)

    Guekht, Alla B; Moessler, Herbert; Novak, Philipp H; Gusev, Evgenyi I

    2011-01-01

    No drug to treat vascular dementia (VaD) has yet been approved by the American or European authorities, leaving a large population of patients without effective therapy. Cerebrolysin has a long record of safety and might be efficacious in this condition. We conducted a large, multicenter, double-blind, placebo-controlled study in 242 patients meeting the criteria for VaD. The primary endpoint was the combined outcome of cognition (based on Alzheimer's Disease Assessment Scale Cognitive Subpart, Extended Version [ADAS-cog+] score) and overall clinical functioning (based on Clinician's Interview-Based Impression of Change plus Caregiver Input [CIBIC+] score) assessed after 24 weeks of treatment. Intravenous Cerebrolysin 20 mL was administered once daily over the course of 2 treatment cycles as add-on therapy to basic treatment with acetylsalicylic acid. The addition of Cerebrolysin was associated with significant improvement in both primary parameters. At week 24, ADAS-cog+ score improved by 10.6 points in the Cerebrolysin group, compared with 4.4 points in the placebo group (least squares mean difference, -6.17; P Cerebrolysin group (ADAS-cog+ improvement of ≥4 points from baseline, 82.1% vs 52.2%; CIBIC+ score of Cerebrolysin, the odds ratio for achieving a favorable CIBIC+ response was 5.08 (P Cerebrolysin significantly improved clinical outcome, and that the benefits persisted for at least 24 weeks. Cerebrolysin was safe and well tolerated.

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

    Science.gov (United States)

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

    2016-01-01

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

  5. Symptomatic improvement with gluten restriction in irritable bowel syndrome: a prospective, randomized, double blinded placebo controlled trial.

    Science.gov (United States)

    Zanwar, Vinay G; Pawar, Sunil V; Gambhire, Pravir A; Jain, Samit S; Surude, Ravindra G; Shah, Vinaya B; Contractor, Qais Q; Rathi, Pravin M

    2016-10-01

    The existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms. We performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who fulfilled the Rome III criteria. Patients with celiac disease and wheat allergy were appropriately excluded. The participants were administered a gluten-free diet for 4 weeks and were asked to complete a symptom-based questionnaire to assess their overall symptoms, abdominal pain, bloating, wind, and tiredness on the visual analog scale (0-100) at the baseline and every week thereafter. The participants who showed improvement were randomly assigned to one of two groups to receive either a placebo (gluten-free breads) or gluten (whole cereal breads) as a rechallenge for the next 4 weeks. In line with the protocol analysis, 60 patients completed the study. The overall symptom score on the visual analog scale was significantly different between the two groups (Pgluten intervention group scored significantly higher in terms of abdominal pain, bloating, and tiredness (Pgluten diet may worsen the symptoms of IBS patients. Therefore, some form of gluten sensitivity other than celiac disease exists in some of them, and patients with IBS may benefit from gluten restrictions.

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

    Science.gov (United States)

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

    2014-07-01

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

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

    Science.gov (United States)

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

    2015-10-01

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

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

    Directory of Open Access Journals (Sweden)

    Jae-Young Shin

    2015-01-01

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

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

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    C.-Y. Oliver Chen

    2017-02-01

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

  10. 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

    to investigate the efficacy and safety of a medicated plaster containing betamethasone valerate (BMV) 2.25 mg in patients with chronic elbow tendinopathy. 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. 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. 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.

  11. 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.

  12. Effects of daily treatment with citicoline: a double-blind, placebo-controlled study in cocaine-dependent volunteers.

    Science.gov (United States)

    Licata, Stephanie C; Penetar, David M; Ravichandran, Caitlin; Rodolico, John; Palmer, Christopher; Berko, Jeff; Geaghan, Thomas; Looby, Alison; Peters, Erica; Ryan, Elizabeth; Renshaw, Perry F; Lukas, Scott E

    2011-03-01

    Many pharmacotherapies for treating cocaine dependence are aimed at reducing drug effects, alleviating craving, and preventing relapse. We demonstrated previously that citicoline, a compound used to repair neuronal damage in stroke and brain injury, is safe in cocaine-abusing volunteers. This study assessed the effectiveness of an 8-week citicoline treatment period and 4-week follow-up in cocaine-dependent individuals. Twenty-nine healthy nontreatment-seeking, cocaine-dependent male and female volunteers were randomized in this double-blind, placebo-controlled study, 18 of whom completed the treatment period of the study. Participants took citicoline (500 mg twice daily) or matched placebo each day and recorded the measures of craving and drug use. Participants visited the laboratory twice a week for urine screens and to attend weekly group therapy sessions. Citicoline had no effect on cocaine craving or total use. Although the current preliminary results from this small trial suggest that citicoline is not an effective treatment for heavy cocaine users, further investigation on efficacy citicoline as a treatment for substance dependence in other settings may be warranted.

  13. Safety and effectiveness of autoinoculation therapy in cutaneous warts: a double--blind, randomized, placebo--controlled study.

    Science.gov (United States)

    Lal, Niharika Ranjan; Sil, Amrita; Gayen, Tirthankar; Bandyopadhyay, Debabrata; Das, Nilay Kanti

    2014-01-01

    In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians. To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts. A double-blind, placebo-controlled study was carried out. In the treatment group, full-thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks. Forty-eight patients with cutaneous warts (male: female=32:16) were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P=0.293). Reduction in the number of warts was significantly more in the autoinoculation group (8.50±13.88) than in the control group (10.04±5.80) from 8 weeks onwards (P=0.010). Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases), keloid formation (3) and hypopigmentation (3). Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results.

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

    Science.gov (United States)

    Chen, C.-Y. Oliver; Rasmussen, Helen; Kamil, Alison; Du, Peng; Blumberg, Jeffrey B.

    2017-01-01

    Orange pomace (OP), a fiber-rich byproduct of juice production, has the potential for being formulated into a variety of food products. We hypothesized that OP would diminish postprandial glycemic responses to a high carbohydrate/fat breakfast and lunch. We conducted an acute, randomized, placebo-controlled, double blind, crossover trial with 34 overweight men who consumed either a 255 g placebo (PLA), a low (35% OP (LOP)), or a high (77% (HOP)) dose OP beverage with breakfast. Blood was collected at 0, 10, 20, 30, and 45 min and at 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 8 h. Lunch was consumed after the 5.5-h blood draw. OP delayed the time (Tmax1) to the maximum concentration (Cmax1) of serum glucose during the 2-h period post breakfast by ≥36% from 33 (PLA) to 45 (HOP) and 47 (LOP) min (p = 0.055 and 0.013, respectively). OP decreased post-breakfast insulin Cmax1 by ≥10% and LOP delayed the Tmax1 by 14 min, compared to PLA at 46 min (p ≤ 0.05). HOP reduced the first 2-h insulin area under concentration time curve (AUC) by 23% compared to PLA. Thus, OP diminishes postprandial glycemic responses to a high carbohydrate/fat breakfast and the second meal in overweight men. PMID:28208806

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Foroogh Namjoyan

    2016-01-01

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

  17. Efficacy of the eradication of Helicobacter pylori infection in patients with chronic urticaria. A placebo-controlled double blind study.

    Science.gov (United States)

    Gaig, P; García-Ortega, P; Enrique, E; Papo, M; Quer, J C; Richard, C

    2002-01-01

    Helicobacter pylori has been involved in the pathogenesis of chronic idiopathic urticaria (CIU) in patients suffering both CIU and H. pylori infection. We selected 49 patients with 13C urea breath test positive, long-lasting CIU and H. pylori infection; 20 remained symptomatic, had positive urease test or H. pylori histologic identification in gastric biopsy material and accepted to participate in a pacebo-controlled treatment trial. They were randomized for a 7-day, double-blind, placebo-controlled H. pylori eradication treatment with amoxicillin, clarithromycin and omeprazol or placebo. H. pylori eradication was assessed by a second 13C urea breath test six weeks after the end of treatment. We observed a significant improvement of more than 70 % of CIU; baseline clinical score was seen in 4 of the 9 (44 %) patients who eradicated H. pylori after active treatment and in 1 of the 7 (12,3 %) of those who did not (p = 0.19). No clinical differences in CIU characteristics were found between patients with and without improvement. No serious adverse effects were observed in either treatment group. We conclude that the eradication of H. pylori may be useful for patients suffering long-lasting CIU and H. pylori infection, although theses results did not reach statistical significance probably owing to the strict conditions of the recruitment.

  18. An integral topical gel for cellulite reduction: results from a double-blind, randomized, placebo-controlled evaluation of efficacy.

    Science.gov (United States)

    Dupont, Eric; Journet, Michel; Oula, Marie-Laure; Gomez, Juan; Léveillé, Claude; Loing, Estelle; Bilodeau, Diane

    2014-01-01

    Cellulite is a serious cosmetic concern for most of the 90% of women affected by it. To assess the clinical efficacy of a complex integral anti-cellulite gel. This double-blind, randomized, placebo-controlled study involved 44 healthy women, aged 25-55 years. Subjects had a normal to slightly overweight body mass index and presented slight to moderate cellulite on their thighs, buttocks, and/or hips at baseline. Subjects were randomly assigned to either the treated or placebo group and accordingly applied the active product or placebo on their hips, stomach, buttocks, and thighs, twice daily for 3 months. Skin tonicity, orange-peel aspect, and stubborn cellulite were assessed at day 0, 28, 56, and 84. A self-evaluation questionnaire was completed by all volunteers. At the end of the study, an average of 81% of the subjects applying the active product presented improvement in their cellulite condition versus 32% for the placebo group (all descriptors and sites combined). At day 84, skin tonicity, orange-peel appearance, and stubborn cellulite were improved in a significant manner (Pcellulite was reduced on average by -19% for buttocks, -24% for hips, and -22% for thighs. Circumference measurements decreased in a significant manner (Pcellulite and reshape the silhouette.

  19. Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Lai, Chien-Hung; Leung, Ting-Kai; Peng, Chih-Wei; Chang, Kwang-Hwa; Lai, Ming-Jun; Lai, Wen-Fu; Chen, Shih-Ching

    2014-02-01

    The objective of this study was to determine the relative efficacy of irradiation using a device containing a far-infrared emitting ceramic powder (cFIR) for the management of chronic myofascial neck pain compared with a control treatment. This was a randomized, double-blind, placebo-controlled pilot study. The study comprised 48 patients with chronic, myofascial neck pain. Patients were randomly assigned to the experimental group or the control (sham-treatment) group. The patients in the experimental group wore a cFIR neck device for 1 week, and the control group wore an inert neck device for 1 week. Quantitative measurements based on a visual analogue scale (VAS) scoring of pain, a sleep quality assessment, pressure-pain threshold (PPT) testing, muscle tone and compliance analysis, and skin temperature analysis were obtained. Both the experimental and control groups demonstrated significant improvement in pain scores. However, no statistically significant difference in the pain scores was observed between the experimental and control groups. Significant decreases in muscle stiffness in the upper regions of the trapezius muscles were reported in the experimental group after 1 week of treatment. Short-term treatment using the cFIR neck device partly reduced muscle stiffness. Although the differences in the VAS and PPT scores for the experimental and control groups were not statistically significant, the improvement in muscle stiffness in the experimental group warrants further investigation of the long-term effects of cFIR treatment for pain management.

  20. A Randomized, Double-blind, Placebo-Controlled Study of Efficacy of Oral Acyclovir in the Treatment of Pityriasis Rosea.

    Science.gov (United States)

    Ganguly, Satyaki

    2014-05-01

    Pityriasis rosea is an acute self-limiting skin disorder of unknown aetiology. Recently human herpes virus 6 and 7 has been hypothesized to be the cause of pityriasis rosea. To determine the efficacy of acyclovir, an anti-viral drug, in the treatment of pityriasis rosea. A randomized, double-blind, placebo-controlled study of efficacy of oral acyclovir in the treatment of pityriasis rosea was conducted on 73 patients. Thirty eight randomly selected patients were started on oral acyclovir. Thirty-five patients were prescribed placebo. The patients as well as the chief investigator were unaware of the therapeutic group to which patients belonged (acyclovir or placebo). Patients in both the groups were evaluated clinically after 7 and 14 days following the first visit and the data were analysed. Follow up data of 60 patients was available and these were included in the statistical analysis. 53.33% and 86.66% of the patients belonging to the acyclovir group showed complete resolution on the 7(th) day and 14(th) day respectively following the first visit compared to 10% and 33.33% of patients from the placebo group. The findings were statistically significant. The study showed that high dose acyclovir is effective in the treatment of pityriasis rosea.

  1. A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder.

    Science.gov (United States)

    Septien-Velez, Lucia; Pitrosky, Bruno; Padmanabhan, Sudharshan Krishna; Germain, Jean-Michel; Tourian, Karen A

    2007-11-01

    The antidepressant efficacy and safety of desvenlafaxine succinate (desvenlafaxine) were evaluated in a phase III, double-blind, placebo-controlled study. Outpatients with a primary diagnosis of major depressive disorder were treated with fixed once-daily doses of desvenlafaxine 200 or 400 mg for 8 weeks. The primary efficacy measure was change from baseline on the 17-item Hamilton Rating Scale for Depression. At the final on-therapy evaluation, adjusted mean change from baseline in 17-item Hamilton Rating Scale for Depression total score was greater for desvenlafaxine 200 and 400 mg/day vs. placebo. Both desvenlafaxine doses showed greater efficacy than placebo on the secondary efficacy measures, including the Clinical Global Impressions-Improvement scale scores, Montgomery-Asberg Depression Rating Scale scores, CGI-Severity, and 17-item Hamilton Rating Scale for Depression response rate. Desvenlafaxine 200 mg/day was also significantly better than placebo on remission, Visual Analog Scale-Pain Intensity overall scores, and some Visual Analog Scale-Pain Intensity subscale scores. Desvenlafaxine 400 mg/day was significantly better than placebo on selected Visual Analog Scale-Pain Intensity subscale scores. Most adverse events were mild or moderate in severity, and safety assessments revealed few clinically significant changes in vital signs, laboratory tests, and electrocardiogram results. These data provide support for the efficacy and safety of desvenlafaxine in the treatment of major depressive disorder.

  2. Betahistine dihydrochloride in the treatment of vertigo of peripheral vestibular origin. A double-blind placebo-controlled study.

    Science.gov (United States)

    Oosterveld, W J

    1984-01-01

    A double-blind, cross-over, placebo-controlled study of betahistine dihydrochloride (12 mg, t.i.d.) was carried out in patients with vertigo of peripheral vestibular origin. Twenty-four patients completed the study, which consisted of two six-week treatment periods. The patients were diagnosed as suffering from Menière's disease (15 patients), vertigo due to other (specified) causes (five patients), or vertigo of unknown origin (four patients). Patients were examined by the investigator at the start of the study and were re-assessed at three-weekly intervals. In addition, they recorded the nature, frequency and severity of their symptoms on diary cards. Both the incidence and severity of dizziness (the predominant presenting complaint) were found to be significantly reduced during betahistine treatment (p = 0.004). The occurrence of nausea and vomiting was also significantly reduced during betahistine treatment (p = 0.014 and 0.036 respectively). There were no statistically significant differences in the results of audiometric or vestibulometric tests, or in the severity of tinnitus or deafness, between the two treatment periods. The overall comparisons of the two periods made by both the patients and the investigator were significantly in favour of betahistine (p less than 0.001). All diagnostic groups responded favourably to betahistine, confirming the efficacy of betahistine in the symptomatic treatment of peripheral vestibular vertigo. No unwanted signs or symptoms were reported.

  3. Probiotics and respiratory and gastrointestinal tract infections in Finnish military conscripts - a randomised placebo-controlled double-blinded study.

    Science.gov (United States)

    Kalima, K; Lehtoranta, L; He, L; Pitkäniemi, J; Lundell, R; Julkunen, I; Roivainen, M; Närkiö, M; Mäkelä, M J; Siitonen, S; Korpela, R; Pitkäranta, A

    2016-09-01

    Military conscripts are susceptible to respiratory and gastrointestinal tract infections. In previous studies probiotics have shown potency to reduce upper respiratory and gastrointestinal infections. The aim was to study whether probiotic intervention has an impact on seasonal occurrence of upper respiratory and gastrointestinal infections in two different conscript groups. In a randomised, double-blinded, placebo controlled study (https://clinicaltrials.gov NCT01651195), a total of 983 healthy adults were enrolled from two intakes of conscripts. Conscripts were randomised to receive either a probiotic combination of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium animalis ssp. lactis BB12 (BB12) or a control chewing tablet twice daily for 150 days (recruits) or for 90 days (reserve officer candidates). Clinical examinations were carried out and daily symptom diaries were collected. Outcome measures were the number of days with respiratory and gastrointestinal symptoms and symptom incidence, number and duration of infection episodes, number of antibiotic treatments received and number of days out of service because of the infection. Statistically no significant differences were found between the intervention groups either in the risk of symptom incidence or duration. However, probiotic intervention was associated with reduction of specific respiratory infection symptoms in military recruits, but not in reserve officer candidates. Probiotics did not significantly reduce overall respiratory and gastrointestinal infection morbidity.

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

    Science.gov (United States)

    Zeng, Weiwei; Tomlinson, Brian

    2014-01-01

    Background. We for the first time examined the effects of a multiherb formula containing Crataegus pinnatifida (1 g daily), Alisma orientalis, Stigma maydis, Ganoderma lucidum, Polygonum multiflorum, and Morus alba on plasma lipid and glucose levels in Chinese patients with dyslipidemia. Methods. In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c), and laboratory safety parameters were performed before and after treatment. Results. The difference in the changes in low-density lipoprotein cholesterol (LDL-C) levels between placebo and active treatment (−9%) was significantly (P < 0.05) better with active treatment. HbA1c levels significantly decreased by −3.9% in the active treatment group, but the change was not significantly different from that with placebo (−1.1%) (P = 0.098). There were no apparent adverse effects or changes in laboratory safety parameters with either treatment. Conclusions. The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects. PMID:24834096

  5. A double-blind placebo-controlled study of fluvoxamine and imipramine in out-patients with primary depression.

    Science.gov (United States)

    Itil, T M; Shrivastava, R K; Mukherjee, S; Coleman, B S; Michael, S T

    1983-01-01

    1 A double-blind placebo-controlled study of fluvoxamine and imipramine was performed in a group of depressed patients. Twenty-two patients received fluvoxamine (mean dose 101 mg/day), 25 received imipramine (mean dose 127 mg/day) and 22 received placebo. 2 Apart from an increase in the SGOT and SGPT values of four imipramine patients, no statistically significant changes in haematology or urinalysis were judged to be medically relevant. Fluvoxamine exhibited fewer anticholinergic side effects than imipramine. 3 Both fluvoxamine treated patients and imipramine-treated patients exhibited a statistically significant improvement at the end of the 28-day treatment period with respect to the placebo patients, as measured using the Hamilton Rating Scale for Depression, and the Clinical Global Impression Scale. Evaluations of the results of the Beck Depression Inventory and the Profile of Mood States revealed a statistically significant improvement for imipramine patients with respect to placebo at week 4, but not for fluvoxamine patients. It is postulated on the basis of quantitative pharmaco-EEG findings, that the slight superiority of imipramine over fluvoxamine was due to underdosing of the latter.

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

    Science.gov (United States)

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

    1997-04-01

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

  7. Randomised double-blind placebo-controlled study of the effect of Lactobacillus paracasei NCC 2461 on skin reactivity.

    Science.gov (United States)

    Gueniche, A; Philippe, D; Bastien, P; Reuteler, G; Blum, S; Castiel-Higounenc, I; Breton, L; Benyacoub, J

    2014-06-01

    In recent decades, the prevalence of subjects with reactive skin has considerably increased in industrialised countries. 50% of women and 30% of men report cutaneous discomfort classified under reactive/sensitive skin. Several topical approaches have been proposed, in particular through improvement of galenic forms or protection of epidermal surface. We propose to act differently, deeply from inside the body via an innovative nutritional approach. To this purpose, Lactobacillus paracasei NCC 2461 (ST11) was selected because of its specific beneficial skin properties discovered in in vitro studies, i.e. diminution of neurogenic inflammation and promotion of the recovery of skin barrier function. We designed a randomised double-blind placebo-controlled clinical study with a two-month supplementation in two female treatment groups (n=32 per group). A capsaicin test was performed to monitor the time course of skin sensitivity. Moreover, transepidermal water loss was assessed to analyse the rate of skin barrier function recovery; dryness of the leg and roughness of the cheeks was investigated by a dermatologist as well as by self-assessment. The results of the present clinical trial show that oral supplementation with the probiotic decreases skin sensitivity and increases the rate of barrier function recovery. Thus, the data provide evidence that daily intake of ST11 could improve reactive skin condition.

  8. Antidepressants and ejaculation: a double-blind, randomized, placebo-controlled, fixed-dose study with paroxetine, sertraline, and nefazodone.

    Science.gov (United States)

    Waldinger, M D; Zwinderman, A H; Olivier, B

    2001-06-01

    Antidepressant medication is often associated with sexual side effects. A double-blind, placebo-controlled study in men with lifelong rapid ejaculation was performed to assess the effects of two selective serotonin (5-HT) reuptake inhibitors--paroxetine and sertraline--and the 5-HT2 antagonist and 5-HT/noradrenaline reuptake inhibitor nefazodone on the latency to ejaculate. Forty-eight men with an intravaginal ejaculation latency time (IELT) of a maximum of 1 minute were randomly assigned to receive paroxetine (20 mg/day), sertraline (50 mg/day), nefazodone (400 mg/day), or placebo for 6 weeks. During the 1-month baseline and 6-week treatment period, IELTs were measured at home with a stopwatch. The trial was completed by 40 men. During the 6-week treatment period, the geometric mean IELT in the placebo group was stable at approximately 20 seconds. Analysis of variance revealed a between-group difference in the evolution of IELT delay over time (p = 0.002); the IELT after paroxetine and sertraline gradually increased to approximately 146 and 58 seconds, respectively, compared with 28 seconds in the nefazodone group. The paroxetine and sertraline groups differed significantly (p < 0.001 and p = 0.024, respectively) from placebo, but the nefazodone group did not (p = 0.85). Compared with baseline, paroxetine exerted the strongest delay in ejaculation, whereas sertraline delayed it only moderately. There was no clinically relevant delay in ejaculation with nefazodone.

  9. Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double-blind, Placebo-controlled Trial.

    Science.gov (United States)

    Smith, David; Cheek, Hugh; Denson, Brenda; Pruitt, Christopher M

    2017-02-01

    Intranasal (IN) midazolam is a commonly prescribed medication for pediatric sedation and anxiolysis. One of its most frequently encountered adverse effects is discomfort with administration. While it has been proposed that premedicating with lidocaine reduces this undesirable consequence, this combination has not been thoroughly researched. The objective of our study was to assess whether topical lidocaine lessens the discomfort associated with IN midazolam administration. This was a double-blind, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department. Children 6-12 years of age who were receiving IN midazolam for procedural sedation received either 4% lidocaine or 0.9% saline (placebo) via mucosal atomizer. Subjects were subsequently given IN midazolam in a similar fashion and then rated their discomfort using the Wong-Baker FACES Pain Rating Scale (WBS). The primary endpoint of WBS score was analyzed with a two-tailed Mann-Whitney U-test, with p midazolam administration (median WBS = 3, interquartile range [IQR] = 0-6) than those who received placebo (median WBS = 8, IQR = 2-9; p = 0.006). Premedication with topical lidocaine reduces the discomfort associated with administration of IN midazolam (ClinicalTrials.gov, NCT02396537). © 2016 by the Society for Academic Emergency Medicine.

  10. Double-blind, placebo-controlled trial on the effect of piracetam on breath-holding spells.

    Science.gov (United States)

    Sawires, Happy; Botrous, Osama

    2012-07-01

    Breath-holding spells (BHS) are apparently frightening events occurring in otherwise healthy children.The aim of this study was to evaluate the efficacy of piracetam in the treatment of breath-holding spells. Forty patients with BHS (who were classified into two groups)were involved in a double-blinded placebo-controlled prospective study. Piracetam was given to group A while group B received placebo. Patients were followed monthly for a total period of 4 months. The numbers of attacks/month before and monthly after treatment were documented, and the overall number of attacks/month after treatment was calculated in both groups. The median number of attacks/month before treatment in the two groups was 5.5 and 5,respectively, while after the first month of treatment, it was 2 and 5, respectively. The median overall number of attacks/month after treatment in both groups was 1 and 5, respectively.There was a significant decline of number of attacks after piracetam treatment compared to placebo (p valuepiracetam throughout the study period. In conclusion, piracetam is a safe and effective drug for the treatment of breath-holding spells in children.

  11. Once-daily rupatadine improves the symptoms of chronic idiopathic urticaria: a randomised, double-blind, placebo-controlled study.

    Science.gov (United States)

    Dubertret, Louis; Zalupca, Lavinia; Cristodoulo, Tania; Benea, Vasile; Medina, Iris; Fantin, Sara; Lahfa, Morad; Pérez, Iñaki; Izquierdo, Iñaki; Arnaiz, Eva

    2007-01-01

    This randomised, double-blind, placebo-controlled, parallel-group, international, dose-ranging study investigated the effect of treatment with rupatadine 5, 10 and 20 mg once daily for 4 weeks on symptoms and interference with daily activities and sleep in 12-65 years-old patients with moderate-to-severe chronic idiopathic urticaria (CIU). Rupatadine 10 and 20 mg significantly reduced pruritus severity by 62.05% and 71.87% respectively, from baseline, over a period of 4 weeks compared to reduction with placebo by 46.59% (p < 0.05). Linear trends were noted for reductions in mean number of wheals and interference with daily activities and sleep with rupatadine 10 and 20 mg over the 4-week treatment period. The two most frequently reported AEs were somnolence (2.90% for placebo, 4.29% for 5 mg-, 5.41% for 10 mg- and 21.43% for 20 mg-rupatadine-treated group) and headache (4.35% for placebo, 2.86% for 5 mg-, 4.05% for 10 mg- and 4.29% for 20 mg-rupatadine-treated group). These findings suggest that rupatadine 10 and 20 mg is a fast-acting, efficacious and safe treatment for the management of patients with moderate-to-severe CIU. Rupatadine decreased pruritus severity, in a dose- and time-dependent manner.

  12. A double-blind, placebo-controlled study of the opiate antagonist, naltrexone, in the treatment of kleptomania.

    Science.gov (United States)

    Grant, Jon E; Kim, Suck Won; Odlaug, Brian L

    2009-04-01

    Kleptomania is a rare psychiatric disorder characterized by recurrent stealing and for which there exists no empirically validated treatments. This study examined the efficacy and tolerability of the opioid antagonist naltrexone in adults with kleptomania who have urges to steal. An 8-week, double-blind, placebo-controlled trial was conducted to evaluate the safety and efficacy of oral naltrexone for kleptomania. Twenty-five individuals with DSM-IV kleptomania were randomized to naltrexone (dosing ranging from 50 mg/day to 150 mg/day) or placebo. Twenty-three subjects (92%) completed the study. Subjects were assessed every 2 weeks with the Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS), the urge and behavior subscales of the K-YBOCS, the Kleptomania Symptom Assessment Scale (K-SAS), the Clinical Global Impressions Scale (CGI), and measures of depression, anxiety, and psychosocial functioning. Subjects assigned to naltrexone had significantly greater reductions in K-YBOCS total scores (p = .001), stealing urges (p = .032), and stealing behavior (p kleptomania severity (reflected in the CGI scores) (p kleptomania. Naltrexone was well tolerated.

  13. Heart palpitation relief with Melissa officinalis leaf extract: double blind, randomized, placebo controlled trial of efficacy and safety.

    Science.gov (United States)

    Alijaniha, Fatemeh; Naseri, Mohsen; Afsharypuor, Suleiman; Fallahi, Faramarz; Noorbala, Ahmadali; Mosaddegh, Mahmood; Faghihzadeh, Soghrat; Sadrai, Sima

    2015-04-22

    In Traditional Iranian Medicine (TIM), Melissa officinalis L. is commonly regarded as an effective therapy for heart palpitations. Heart palpitation is a common complaint that is often benign and associated with a marked distress that makes the condition difficult to treat. Herbal medicines provide an alternative to conventional drugs for treating various kinds of diseases. This study was done as a double blind randomized placebo-controlled clinical trial to evaluate the efficacy and safety of the dried extract of M. officinalis on adults suffering from benign palpitations. Eligible volunteers were randomly assigned as outpatients to a 14 day treatment with 500 mg twice a day of lyophilized aqueous extract of M. officinalis leaves (or placebo). Participants in the tests, physicians and researchers were blind to group assignments. Both primary and secondary outcomes were patient-reported. Primary outcomes were obtained from two measures: mean frequency of palpitation episodes per week, derived from patients׳ diaries, and mean intensity of palpitation estimated through Visual Analogue Scale (VAS) in a self-report questionnaire. Psychiatric symptoms (somatization, anxiety and insomnia, social dysfunction and severe depression) were evaluated as secondary outcomes by General Health Questionnaire-28 (GHQ-28), before and after intervention. Fifty-five volunteers out of 71 recruited study subjects completed the trial. Results showed that 14-day of treatment with lyophilized aqueous extract of M. officinalis leaves reduced frequency of palpitation episodes and significantly reduced the number of anxious patients in comparison to the placebo (P=0.0001, P=0.004 resp.). Also, M. officinalis extract showed no indication of any serious side effects. Lyophilized aqueous extract of M. officinalis leaves may be a proper and safe herbal drug for the treatment of benign palpitations. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  14. Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Banerjee, Sube; Hellier, Jennifer; Dewey, Michael; Romeo, Renee; Ballard, Clive; Baldwin, Robert; Bentham, Peter; Fox, Chris; Holmes, Clive; Katona, Cornelius; Knapp, Martin; Lawton, Claire; Lindesay, James; Livingston, Gill; McCrae, Niall; Moniz-Cook, Esme; Murray, Joanna; Nurock, Shirley; Orrell, Martin; O'Brien, John; Poppe, Michaela; Thomas, Alan; Walwyn, Rebecca; Wilson, Kenneth; Burns, Alistair

    2011-07-30

    Depression is common in dementia but the evidence base for appropriate drug treatment is sparse and equivocal. We aimed to assess efficacy and safety of two of the most commonly prescribed drugs, sertraline and mirtazapine, compared with placebo. We undertook the parallel-group, double-blind, placebo-controlled, Health Technology Assessment Study of the Use of Antidepressants for Depression in Dementia (HTA-SADD) trial in participants from old-age psychiatry services in nine centres in England. Participants were eligible if they had probable or possible Alzheimer's disease, depression (lasting ≥4 weeks), and a Cornell scale for depression in dementia (CSDD) score of 8 or more. Participants were ineligible if they were clinically critical (eg, suicide risk), contraindicated to study drugs, on antidepressants, in another trial, or had no carer. The clinical trials unit at King's College London (UK) randomly allocated participants with a computer-generated block randomisation sequence, stratified by centre, with varying block sizes, in a 1:1:1 ratio to receive sertraline (target dose 150 mg per day), mirtazapine (45 mg), or placebo (control group), all with standard care. The primary outcome was reduction in depression (CSDD score) at 13 weeks (outcomes to 39 weeks were also assessed), assessed with a mixed linear-regression model adjusted for baseline CSDD, time, and treatment centre. This study is registered, number ISRCTN88882979 and EudraCT 2006-000105-38. Decreases in depression scores at 13 weeks did not differ between 111 controls and 107 participants allocated to receive sertraline (mean difference 1·17, 95% CI -0·23 to 2·58; p=0·10) or mirtazapine (0·01, -1·37 to 1·38; p=0·99), or between participants in the mirtazapine and sertraline groups (1·16, -0·25 to 2·57; p=0·11); these findings persisted to 39 weeks. Fewer controls had adverse reactions (29 of 111 [26%]) than did participants in the sertraline group (46 of 107, 43%; p=0·010) or

  15. Taurine Supplementation Lowers Blood Pressure and Improves Vascular Function in Prehypertension: Randomized, Double-Blind, Placebo-Controlled Study.

    Science.gov (United States)

    Sun, Qianqian; Wang, Bin; Li, Yingsha; Sun, Fang; Li, Peng; Xia, Weijie; Zhou, Xunmei; Li, Qiang; Wang, Xiaojing; Chen, Jing; Zeng, Xiangru; Zhao, Zhigang; He, Hongbo; Liu, Daoyan; Zhu, Zhiming

    2016-03-01

    Taurine, the most abundant, semiessential, sulfur-containing amino acid, is well known to lower blood pressure (BP) in hypertensive animal models. However, no rigorous clinical trial has validated whether this beneficial effect of taurine occurs in human hypertension or prehypertension, a key stage in the development of hypertension. In this randomized, double-blind, placebo-controlled study, we assessed the effects of taurine intervention on BP and vascular function in prehypertension. We randomly assigned 120 eligible prehypertensive individuals to receive either taurine supplementation (1.6 g per day) or a placebo for 12 weeks. Taurine supplementation significantly decreased the clinic and 24-hour ambulatory BPs, especially in those with high-normal BP. Mean clinic systolic BP reduction for taurine/placebo was 7.2/2.6 mm Hg, and diastolic BP was 4.7/1.3 mm Hg. Mean ambulatory systolic BP reduction for taurine/placebo was 3.8/0.3 mm Hg, and diastolic BP was 3.5/0.6 mm Hg. In addition, taurine supplementation significantly improved endothelium-dependent and endothelium-independent vasodilation and increased plasma H2S and taurine concentrations. Furthermore, changes in BP were negatively correlated with both the plasma H2S and taurine levels in taurine-treated prehypertensive individuals. To further elucidate the hypotensive mechanism, experimental studies were performed both in vivo and in vitro. The results showed that taurine treatment upregulated the expression of hydrogen sulfide-synthesizing enzymes and reduced agonist-induced vascular reactivity through the inhibition of transient receptor potential channel subtype 3-mediated calcium influx in human and mouse mesenteric arteries. In conclusion, the antihypertensive effect of chronic taurine supplementation shows promise in the treatment of prehypertension through improvement of vascular function. © 2016 American Heart Association, Inc.

  16. The effects of Kinesio taping on muscle tone in healthy subjects: a double-blind, placebo-controlled crossover trial.

    Science.gov (United States)

    Gómez-Soriano, Julio; Abián-Vicén, Javier; Aparicio-García, Carlos; Ruiz-Lázaro, Pilar; Simón-Martínez, Cristina; Bravo-Esteban, Elisabeth; Fernández-Rodríguez, José Manuel

    2014-04-01

    Kinesio taping (KT) has been proposed to modulate muscle tone. However no studies have systematically studied the efficacy of KTon this primary outcome measure. The objective of this study was to determine the effect of Kinesio taping (KT) applied over the gastrocnemius muscles on muscle tone, extensibility, electromyography (EMG) and strength. Nineteen healthy subjects were enrolled in a double-blind, placebo controlled crossover trial. KT and sham-tape were applied onto the gastrocnemius muscles of all subjects in two randomized sessions. Measurements before, at 10 min and 24 h after the intervention were taken. Outcome measurements included passive resistive torque to ankle dorsiflexion, dorsiflexion passive range of motion (PROM), surface Gastrocnemius Medialis (GM) EMG and maximal isometric voluntary force (MIVF). No significant differences were found between the sham-tape and KT groups for passive resistive torque, PROM nor maximal plantarflexion isometric voluntary force. A short-term increase of GM EMG activity was found in the KT group during the PROM mobilization, which was not maintained at 24 h following treatment. A short-term decrease in dorsiflexion force was produced 10 min after KT with respect to sham-tape application. These results demonstrate that the application of KT in the gastrocnemius muscles has no effect on healthy muscle tone, extensibility nor strength. However a short-term increase of GM EMG activity after KT treatment suggests the activation of central nervous system mechanisms, although without a therapeutic implication. Further studies with more appropriate designs are needed to clarify the physiological and therapeutic effects of this taping technique.

  17. Effect of clonazepam and clonidine on primary sleep bruxism: a double-blind, crossover, placebo-controlled trial.

    Science.gov (United States)

    Sakai, Takuro; Kato, Takafumi; Yoshizawa, Shuichiro; Suganuma, Takeshi; Takaba, Masayuki; Ono, Yasuhiro; Yoshizawa, Ayako; Yoshida, Yuya; Kurihara, Tatsuya; Ishii, Masakazu; Kawana, Fusae; Kiuchi, Yuji; Baba, Kazuyoshi

    2017-02-01

    The aim of this study was to assess the acute effects of clonazepam and clonidine on rhythmic masticatory muscle activity in young adults with primary sleep bruxism, as well as accompanying effects on sleep architecture and cardiac activity. This study used a double-blind, crossover, placebo-controlled design. Polysomnography was performed on 19 subjects [nine men and 10 women; mean age (±SE): 25.4 ± 2.7 years] for 5 nights. The first 2 nights were used for the habituation and diagnosis of sleep bruxism. The other 3 nights were randomly assigned for clonazepam (1.0 mg), clonidine (0.15 mg) or placebo (all administered 30 min before bedtime). Sleep, oromotor activity and cardiac activity variables were assessed and compared among the three drug conditions. Clonidine significantly reduced the median percentage of time spent in the rapid eye movement sleep stage compared with placebo and clonazepam. The number of rhythmic masticatory muscle activity episodes was reduced with clonidine by >30% compared with placebo and clonazepam. The reduction of rhythmic masticatory muscle activity index by clonidine was associated with an increase of mean RR intervals (slower heart rate) during quiet sleep periods and during a 70-s period before the onset of rhythmic masticatory muscle activity episodes. However, no changes in cardiac activity variables were observed for clonazepam. In young adults with primary sleep bruxism, clonidine was significantly more effective in suppressing sleep bruxism than clonazepam. The acute effects of clonidine on rhythmic masticatory muscle activity episodes may be mediated by suppression of autonomic nervous system activity and non-rapid eye movement-rapid eye movement sleep processes.

  18. A double-blind, placebo-controlled trial of dextromethorphan combined with clonidine in the treatment of heroin withdrawal.

    Science.gov (United States)

    Lin, Shih-Ku; Pan, Chun-Hung; Chen, Chia-Hui

    2014-08-01

    Dextromethorphan has been reported to ameliorate opioid withdrawal symptoms in both animal and human subjects. In the present study, we investigated the efficacy of dextromethorphan as an add-on medication in heroin detoxification treatment in a double-blind, placebo-controlled design. Sixty-five heroin-dependent patients (male, 63; female, 2) participated in this inpatient detoxification trial after giving informed consent. Clonidine 0.075 mg 4 times a day was given as an antiwithdrawal medication at baseline. Each patient was then randomly assigned to treatment with either dextromethorphan 60 mg or placebo 4 times a day as additional medication. Flurazepam 30 mg was given before bedtime for insomnia. Other medications that were allowed included loperamide for diarrhea and lorazepam for agitation. Participants were monitored using the Objective Opioid Withdrawal Scale 3 times a day as the primary outcome to compare drug efficacy between groups. Generalized estimating equation model analysis revealed that the Objective Opioid Withdrawal Scale had no group difference between dextromethorphan and placebo group overall (P = 0.29), whereas a significant difference between groups was found during day 3 to day 6 (P = 0.04) by post hoc analysis. There was no difference in the Clinical Global Impression Scale, patient's impression of treatment, and use of ancillary medications between groups. No severe adverse effects were noticed. We suggest that dextromethorphan has some beneficial effect in attenuating the severity of opioid withdrawal symptoms and can be used as an adjunction medication in the treatment of opioid withdrawal, whereas the exact efficacy needs further investigation.

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

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    Douglas Wilson

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

  20. Phellodendron and Citrus extracts benefit joint health in osteoarthritis patients: a pilot, double-blind, placebo-controlled study

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    Chambliss Walter

    2009-08-01

    Full Text Available Abstract Background The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on joint health in overweight and normal weight adults diagnosed with osteoarthritis. Methods An 8-week placebo-controlled, randomized, double-blind study was conducted with four groups comparing the effects of NP 06-1 to placebo on overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel or matching placebo were given in a dose of two capsules (370 mg each twice daily. The outcome measures were the Lequesne Algofunctional Index (LAI for joint pain and movement as well as biomarkers of inflammation (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]. Results Eighty (80 subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. The mean total LAI scores at baseline for the four groups ranged from 11.4 to 12.4 (SD 1.2 to 2.4. Treatment for 8 weeks resulted in a statistical improvement in the LAI score in the overweight treatment group compared to placebo (6.3 ± 2.3 vs 11.8 ± 1.5; p Conclusion In this pilot study, NP 06-1 had beneficial effects on symptoms of osteoarthritis of the knee as measured using LAI scores and had anti-inflammatory effects as measured using CRP. Administration of NP 06-1 was also associated with weight loss, which may have been a contributing factor to the other benefits.

  1. 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; plaevigata, 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 (plaevigata decreased NE and showed a trend to lower LDL-C compared to placebo as add-on-treatment for diabetic subjects with chronic CHD. Copyright © 2010 Elsevier GmbH. All rights reserved.

  2. Treatment of age-related memory complaints with Ginkgo biloba extract: a randomized double blind placebo-controlled study.

    Science.gov (United States)

    Brautigam, M R; Blommaert, F A; Verleye, G; Castermans, J; Jansen Steur, E N; Kleijnen, J

    1998-12-01

    A growing number of people is subject to age-related cognitive impairment due to the proportional increase of the ageing population. Therefore, there is a growing interest in cognition-enhancing substances. The efficacy of an alcohol/water extract of Ginkgo biloba in elderly individuals with memory- and/or concentration complaints was tested in a randomized, double-blind, placebo-controlled study by using both subjective and objective parameters. After a wash-out period of 4 weeks 241 non-institutionalised patients in the age range 55-86 years were randomly allocated to receive either Ginkgo biloba alcohol/water extract in a high dose (HD), a low dose (LD) or a placebo (PL) for 24 weeks. Patients were assessed using a psychometric testbattery in the following order: Expended Mental Control Test (EMCT) measuring attention and concentration, Benton Test of Visual Retention-Revised (measures short term visual memory), Rey Test part 1 (measures short term memory and learning curve), Beck Depressive Inventory (BDI) measuring the presence and severeness of a depression in order to exclude depressive patients and Rey Test part 2 (measures long term memory: recognition). Furthermore, subjective perception of memory and concentration was measured. 197 patients completed the study (mean MMSE score: 26.29). In the subjective test, the EMCT, the Rey 1 and Rey 2 no significant differences in improvement in time between the groups were observed. In the Benton test increases of 18%, 26% and 11% (expressed as percentage of baseline scores) were observed in the HD, LD and PL respectively (MANOVA; p = 0.0076). No substantial correlation was observed between subjective perception of the severeness of memory complaints and the objective test results. No differences in the number of (gastrointestinal) side effects were observed between placebo and verum groups. These results indicate that the use of Ginkgo extracts in elderly individuals with cognitive impairment might be promising

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

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    Dale GJ

    2016-12-01

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

  4. Gluten causes gastrointestinal symptoms in subjects without celiac disease: a double-blind randomized placebo-controlled trial.

    Science.gov (United States)

    Biesiekierski, Jessica R; Newnham, Evan D; Irving, Peter M; Barrett, Jacqueline S; Haines, Melissa; Doecke, James D; Shepherd, Susan J; Muir, Jane G; Gibson, Peter R

    2011-03-01

    Despite increased prescription of a gluten-free diet for gastrointestinal symptoms in individuals who do not have celiac disease, there is minimal evidence that suggests that gluten is a trigger. The aims of this study were to determine whether gluten ingestion can induce symptoms in non-celiac individuals and to examine the mechanism. A double-blind, randomized, placebo-controlled rechallenge trial was undertaken in patients with irritable bowel syndrome in whom celiac disease was excluded and who were symptomatically controlled on a gluten-free diet. Participants received either gluten or placebo in the form of two bread slices plus one muffin per day with a gluten-free diet for up to 6 weeks. Symptoms were evaluated using a visual analog scale and markers of intestinal inflammation, injury, and immune activation were monitored. A total of 34 patients (aged 29-59 years, 4 men) completed the study as per protocol. Overall, 56% had human leukocyte antigen (HLA)-DQ2 and/or HLA-DQ8. Adherence to diet and supplements was very high. Of 19 patients (68%) in the gluten group, 13 reported that symptoms were not adequately controlled compared with 6 of 15 (40%) on placebo (P=0.0001; generalized estimating equation). On a visual analog scale, patients were significantly worse with gluten within 1 week for overall symptoms (P=0.047), pain (P=0.016), bloating (P=0.031), satisfaction with stool consistency (P=0.024), and tiredness (P=0.001). Anti-gliadin antibodies were not induced. There were no significant changes in fecal lactoferrin, levels of celiac antibodies, highly sensitive C-reactive protein, or intestinal permeability. There were no differences in any end point in individuals with or without DQ2/DQ8. "Non-celiac gluten intolerance" may exist, but no clues to the mechanism were elucidated.

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

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    Arun Shyam

    2014-01-01

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

  6. 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.

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

    Science.gov (United States)

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

    2015-02-01

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

  8. Memantine add on to citalopram in elderly patients with depression: A double-blind placebo-controlled study

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    Victoria Omranifard

    2014-01-01

    Full Text Available Background: Proper management of depression in elderly population would improve the outcome of the disease and reduce its related disability and mortality. Use of memantine with minimal side effects and drug interaction seems reasonable in the elderly but its antidepressant activity is controversial. The aim of the current research is to investigate the effects of add-on memantine during citalopram therapy in elderly patients with depression, in Isfahan. Materials and Methods: In this double-blind, placebo controlled trial study; elderly patients aged more than 60 years who were recently diagnosed with depression, were enrolled. The selected patients were randomlysplit into two groups, viz. intervention and placebo groups. The intervention was memantine (20 mg daily or identical placebo plus citalopram for 8 weeks. The severity of depression and quality of life was evaluated using Geriatric Depression Scale (GDS-15, Hamilton Rating Scale for depression (HRSD and World Health Organization Quality of Life WHOQOL-BREF respectively. The mentioned scores were evaluated at baseline, 4 weeks and 8 weeks, after initiating the trial in two studied groups and compared with each other. Results: 28 and 29 patients were studied in the intervention and placebo groups, respectively. Score of GDS-15, HRSD and WHO-QOL-BREF scales at baseline, 4 weeks and 8 weeks, after initiating trial did not change significantly after use of memantine (P > 0.05. There was no significant difference in mean +/- SD of GDS-15, HRSD and WHO-QOL-BREF scales among intervention and placebo groups (P > 0.05. Conclusion: The outcome of this clinical trial did not support the antidepressant effect of add-on memantine in elderly patients with depression receiving citalopram. It is recommended to design further studies considering the limitations of the current study mentioned herein and the effect of memantine with other anti-depressant agents.

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

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    Tsuyoshi Miyaoka

    2015-01-01

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

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

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    Roberio Dias LEITE

    2013-03-01

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

  11. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial

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    D'Souza, Aloysius L; Muthu, Nirmala; Rogers, Thomas R; Want, Susan; Rajkumar, Chakravarthi; Bulpitt, Christopher J

    2007-01-01

    Objective To determine the efficacy of a probiotic drink containing Lactobacillus for the prevention of any diarrhoea associated with antibiotic use and that caused by Clostridium difficile. Design Randomised double blind placebo controlled study. Participants 135 hospital patients (mean age 74) taking antibiotics. Exclusions included diarrhoea on admission, bowel pathology that could result in diarrhoea, antibiotic use in the previous four weeks, severe illness, immunosuppression, bowel surgery, artificial heart valves, and history of rheumatic heart disease or infective endocarditis. Intervention Consumption of a 100 g (97 ml) drink containing Lactobacillus casei, L bulgaricus, and Streptococcus thermophilus twice a day during a course of antibiotics and for one week after the course finished. The placebo group received a longlife sterile milkshake. Main outcome measures Primary outcome: occurrence of antibiotic associated diarrhoea. Secondary outcome: presence of C difficile toxin and diarrhoea. Results 7/57 (12%) of the probiotic group developed diarrhoea associated with antibiotic use compared with 19/56 (34%) in the placebo group (P=0.007). Logistic regression to control for other factors gave an odds ratio 0.25 (95% confidence interval 0.07 to 0.85) for use of the probiotic, with low albumin and sodium also increasing the risk of diarrhoea. The absolute risk reduction was 21.6% (6.6% to 36.6%), and the number needed to treat was 5 (3 to 15). No one in the probiotic group and 9/53 (17%) in the placebo group had diarrhoea caused by C difficile (P=0.001). The absolute risk reduction was 17% (7% to 27%), and the number needed to treat was 6 (4 to 14). Conclusion Consumption of a probiotic drink containing L casei, L bulgaricus, and S thermophilus can reduce the incidence of antibiotic associated diarrhoea and C difficile associated diarrhoea. This has the potential to decrease morbidity, healthcare costs, and mortality if used routinely in patients aged over 50

  12. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity.

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    Carroccio, Antonio; Mansueto, Pasquale; Iacono, Giuseppe; Soresi, Maurizio; D'Alcamo, Alberto; Cavataio, Francesca; Brusca, Ignazio; Florena, Ada M; Ambrosiano, Giuseppe; Seidita, Aurelio; Pirrone, Giuseppe; Rini, Giovanni Battista

    2012-12-01

    Non-celiac wheat sensitivity (WS) is considered a new clinical entity. An increasing percentage of the general population avoids gluten ingestion. However, the real existence of this condition is debated and specific markers are lacking. Our aim was thus to demonstrate the existence of WS and define its clinical, serologic, and histological markers. We reviewed the clinical charts of all subjects with an irritable bowel syndrome (IBS)-like presentation who had been diagnosed with WS using a double-blind placebo-controlled (DBPC) challenge in the years 2001-2011. One hundred celiac disease (CD) patients and fifty IBS patients served as controls. Two hundred and seventy-six patients with WS, as diagnosed by DBPC challenge, were included. Two groups showing distinct clinical characteristics were identified: WS alone (group 1) and WS associated with multiple food hypersensitivity (group 2). As a whole group, the WS patients showed a higher frequency of anemia, weight loss, self-reported wheat intolerance, coexistent atopy, and food allergy in infancy than the IBS controls. There was also a higher frequency of positive serum assays for IgG/IgA anti-gliadin and cytometric basophil activation in "in vitro" assay. The main histology characteristic of WS patients was eosinophil infiltration of the duodenal and colon mucosa. Patients with WS alone were characterized by clinical features very similar to those found in CD patients. Patients with multiple food sensitivity were characterized by clinical features similar to those found in allergic patients. Our data confirm the existence of non-celiac WS as a distinct clinical condition. We also suggest the existence of two distinct populations of subjects with WS: one with characteristics more similar to CD and the other with characteristics pointing to food allergy.

  13. Efficacy of Plai Cream in Adult Patients with Muscle Strain: A Randomized, Double-Blind, Placebo-Controlled Trial.

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    Cheechareoan, Sukrom; Pathanawiriyasirikul, Thanate; Manmee, Charuwan; Janpol, Kanya

    2016-02-01

    Nonsteroidal anti-inflammatory drugs are a standard treatment option for muscle strain; however, side effects persist. This clinical trial was designed to compare the efficacy of Plai cream compared to placebos in adult patients with muscle strain. In this randomized, double-blind, placebo-controlled trial, 140 participants aged over 18 years with muscle strain were randomized to receive either Plai cream (n = 70 patients, treatment group) or placebos (n = 70 patients, control group) . Outcome assessments included the visual analog scale (VAS), quality of life (QoL), the amount of remaining cream, and the number of acetaminophen tablets used. After 2 weeks, the mean pain scores following treatment with both Plai cream and placebos in patients with muscle strain decreased from baseline to the end of the study at week 2. However, no significant difference for VA S score was found. The QoL of the two groups showed improvements in QoL as witnessed by increased mean QoL scores from baseline to week 2; however, these differences were not statistically significant. In general, mean QoL scores above 50 indicate good quality of life. The amount of Plai cream used reduced from baseline to week 2, but no significant difference in the amount of cream remaining was found between the two groups at each visit. Similarly, the number of acetaminophen tablets used was not statistically different between the treatment and control groups. There was no difference in pain reduction in the 2-week period between patients with muscle strain using Plai cream and those given placebos, but Plai cream tended to reduce pain in the long term. No side effects were found from Plai cream, so this non-invasive treatment may be offered to patients.

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

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    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.

  15. PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2): Results of a Randomized, Double-Blind Placebo-Controlled Clinical Trial.

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    de Ridder, Inger R; den Hertog, Heleen M; van Gemert, H Maarten A; Schreuder, A H C M L Tobien; Ruitenberg, Annemieke; Maasland, E Lisette; Saxena, Ritu; van Tuijl, Jordie H; Jansen, Ben P W; Van den Berg-Vos, Renske M; Vermeij, Frederique; Koudstaal, Peter J; Kappelle, L Jaap; Algra, Ale; van der Worp, H Bart; Dippel, Diederik W J

    2017-04-01

    Subfebrile body temperature and fever in the first days after stroke are strongly associated with unfavorable outcome. A subgroup analysis of a previous trial suggested that early treatment with paracetamol may improve functional outcome in patients with acute stroke and a body temperature of ≥36.5°C. In the present trial, we aimed to confirm this finding. PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2) was a multicenter, randomized, double-blind, placebo-controlled clinical trial. We aimed to include 1500 patients with acute ischemic stroke or intracerebral hemorrhage within 12 hours of symptom onset. Patients were treated with paracetamol in a daily dose of 6 g or matching placebo for 3 consecutive days. The primary outcome was functional outcome at 3 months, assessed with the modified Rankin Scale and analyzed with multivariable ordinal logistic regression. Because of slow recruitment and lack of funding, the study was stopped prematurely. Between December 2011 and October 2015, we included 256 patients, of whom 136 (53%) were allocated to paracetamol. In this small sample, paracetamol had no effect on functional outcome (adjusted common odds ratio, 1.15; 95% confidence interval, 0.74-1.79). There was no difference in the number of serious adverse events (paracetamol n=35 [26%] versus placebo n=28 [24%]). Treatment with high-dose paracetamol seemed to be safe. The effect of high-dose paracetamol on functional outcome remains uncertain. Therefore, a large trial of early treatment with high-dose paracetamol is still needed. URL: http://www.trialregister.nl. Unique identifier: NTR2365. © 2017 American Heart Association, Inc.

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

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    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.

  17. Clonidine as an adjunct to intravenous regional anesthesia: A randomized, double-blind, placebo-controlled dose ranging study

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    Clarence S Ivie

    2011-01-01

    Full Text Available Background : The addition of clonidine to lidocaine intravenous regional anesthesia (IVRA has been previously reported to improve postoperative analgesia in patients undergoing upper extremity surgery. Our objective was to perform a dose ranging study in order to determine the optimal dose of clonidine used with lidocaine in IVRA. Design & Setting : We performed a double-blinded randomized placebo-controlled study with 60 patients scheduled for elective endoscopic carpal tunnel release under IVRA with 50 ml lidocaine 0.5%. University-affiliated outpatient surgery center. Data collected in operating rooms, recovery room, and by telephone after discharge from surgery center. Materials & Methods : Sixty adult ASA I or II patients undergoing outpatient endoscopic carpal tunnel release under intravenous regional anesthesia.Patients were randomized into five study groups receiving different doses of clonidine in addition to 50 ml 0.5% lidocaine in their IVRA. Group A received 0 mcg/kg, group B 0.25 mcg/kg, group C 0.5 mcg/kg, group D 1.0 mcg/kg and group E 1.5 mcg/kg of clonidine.Intraoperative fentanyl, recovery room pain scores, time to first postsurgical analgesic, total number of acetaminophen/codeine tablets consumed postsurgery, incidence of sedation, hypotension and bradycardia. Results & Conclusions : There was no benefit from any dose of clonidine compared to placebo. There were no clonidine-related side effects seen within the dose range studied. In short duration minor hand surgery, the addition of clonidine to lidocaine-based intravenous regional anesthesia provides no measurable benefit.

  18. 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.

  19. Extended analysis of a double-blind, placebo-controlled, 15-week study with otilonium bromide in irritable bowel syndrome.

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    Glende, Manfred; Morselli-Labate, Antonio M; Battaglia, Giuseppe; Evangelista, Stefano

    2002-12-01

    In order to follow the most recent developments and recommendations in trial methodology for drug evaluation in patients with irritable bowel syndrome, we performed an extended analysis of a large clinical trial from a previously published study of otilonium bromide, using an assessment that integrates the key symptoms of irritable bowel syndrome. A large-scale clinical trial with a double-blind, placebo-controlled, parallel-group study design was conducted in 378 patients, treated for 15 weeks with the recommended standard dose of 40 mg otilonium bromide or placebo three times daily. The study was based on the collection of 12 single efficacy endpoints. The new efficacy assessment was based on the data reported by the patients. Rather than demonstrating score differences between the treatment groups of the study, we carried out an assessment that integrates the most frequent symptoms reported (pain frequency and intensity, presence of meteorism and distension) by the patient. The rate of response to treatment within 2-4 months (the primary efficacy outcome measure) was significantly higher in the otilonium bromide group (36.9%) than in the placebo group (22.5%; P = 0.007). In each month of treatment, the rate of monthly response was higher in the otilonium bromide group as compared to the placebo group (P otilonium bromide than in the placebo-treated group, with differences ranging from 10% to 20%. The subgroup analysis of the intestinal habits endpoint indicates that patients with diarrhoea have an additional benefit. The present re-evaluation of a previously published study confirms that otilonium bromide is more effective than placebo for the treatment of irritable bowel syndrome, being very efficient in relieving pain and discomfort.

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

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    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.

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

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    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

  2. Clinical Evidence of Effects of Lactobacillus plantarum HY7714 on Skin Aging: A Randomized, Double Blind, Placebo-Controlled Study.

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    Lee, Dong Eun; Huh, Chul-Sung; Ra, Jehyeon; Choi, Il-Dong; Jeong, Ji-Woong; Kim, Sung-Hwan; Ryu, Ja Hyun; Seo, Young Kyoung; Koh, Jae Sook; Lee, Jung-Hee; Sim, Jae-Hun; Ahn, Young-Tae

    2015-12-28

    The beneficial effects of probiotics are now widely reported, although there are only a few studies on their anti-aging effects. We have found that Lactobacillus plantarum HY7714 (HY7714) improves skin hydration and has anti-photoaging effects, and in the present study, we have further evaluated the anti-aging effect of HY7714 via a randomized, double blind, placebo-controlled clinical trial. The trial included 110 volunteers aged 41 and 59 years who have dry skin and wrinkles. Participants took 1 × 10(10) CFU/day of HY7714 (probiotic group) or a placebo (placebo group) for 12 weeks. Skin hydration, wrinkles, skin gloss, and skin elasticity were measured every 4 weeks during the study period. There were significant increases in the skin water content in the face (p < 0.01) and hands (p < 0.05) at week 12 in the probiotic group. Transepidermal water loss decreased significantly in both groups at weeks 4, 8, and 12 (p < 0.001 compared with baseline), and was suppressed to a greater extent in the face and forearm in the probiotic group at week 12. Volunteers in the probiotic group had a significant reduction in wrinkle depth at week 12, and skin gloss was also significantly improved by week 12. Finally, skin elasticity in the probiotic group improved by 13.17% (p < 0.05 vs. controls) after 4 weeks and by 21.73% (p < 0.01 vs. controls) after 12 weeks. These findings are preliminary confirmation of the anti-aging benefit to the skin of L. plantarum HY7714 as a nutricosmetic agent.

  3. Effects of American ginseng (Panax quinquefolius) on neurocognitive function: an acute, randomised, double-blind, placebo-controlled, crossover study

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    Ossoukhova, Anastasia; Owen, Lauren; Ibarra, Alvin; Pipingas, Andrew; He, Kan; Roller, Marc; Stough, Con

    2010-01-01

    Rationale Over the last decade, Asian ginseng (Panax ginseng) has been shown to improve aspects of human cognitive function. American ginseng (Panax quinquefolius) has a distinct ginsenoside profile from P. ginseng, promising cognitive enhancing properties in preclinical studies and benefits processes linked to human cognition. Objectives The availability of a highly standardised extract of P. quinquefolius (Cereboost™) led us to evaluate its neurocognitive properties in humans for the first time. Methods This randomised, double-blind, placebo-controlled, crossover trial (N = 32, healthy young adults) assessed the acute mood, neurocognitive and glycaemic effects of three doses (100, 200 400 mg) of Cereboost™ (P. quinquefolius standardised to 10.65% ginsenosides). Participants' mood, cognitive function and blood glucose were measured 1, 3 and 6 h following administration. Results There was a significant improvement of working memory (WM) performance associated with P. quinquefolius. Corsi block performance was improved by all doses at all testing times. There were differential effects of all doses on other WM tasks which were maintained across the testing day. Choice reaction time accuracy and ‘calmness’ were significantly improved by 100 mg. There were no changes in blood glucose levels. Conclusions This preliminary study has identified robust working memory enhancement following administration of American ginseng. These effects are distinct from those of Asian ginseng and suggest that psychopharmacological properties depend critically on ginsenoside profiles. These results have ramifications for the psychopharmacology of herbal extracts and merit further study using different dosing regimens and in populations where cognition is fragile. PMID:20676609

  4. A randomized, double-blind, placebo-controlled trial of niacinamide for reduction of phosphorus in hemodialysis patients.

    Science.gov (United States)

    Cheng, Steven C; Young, Daniel O; Huang, Yihung; Delmez, James A; Coyne, Daniel W

    2008-07-01

    Niacinamide inhibits intestinal sodium/phosphorus transporters and reduces serum phosphorus in open-label studies. A prospective, randomized, double-blind, placebo-controlled crossover trial was performed for assessment of the safety and efficacy of niacinamide. Hemodialysis patients with phosphorus levels > or =5.0 mg/dl were randomly assigned to 8 wk of niacinamide or placebo, titrated from 500 to 1500 mg/d. After a 2-wk washout period, patients switched to 8 wk of the alternative therapy. Vitamin D analogs and calcimimetics were held constant; phosphorus binders were not changed unless safety criteria were met. Thirty-three patients successfully completed the trial. Serum phosphorus fell significantly from 6.26 to 5.47 mg/dl with niacinamide but not with placebo (5.85 to 5.98 mg/dl). A concurrent fall in calcium-phosphorus product was seen with niacinamide, whereas serum calcium, intact parathyroid hormone, uric acid, platelet, triglyceride, LDL, and total cholesterol levels remained stable in both arms. Serum HDL levels rose with niacinamide (50 to 61 mg/dl but not with placebo. Adverse effects were similar between both groups. Among patients who were > or =80% compliant, results were similar, although the decrease in serum phosphorus with niacinamide was more pronounced (6.45 to 5.28 mg/dl) and the increase in HDL approached significance (49 to 58 mg/dl). In hemodialysis patients, niacinamide effectively reduces serum phosphorus when co-administered with binders and results in a potentially advantageous increase in HDL cholesterol. Further study in larger randomized trials and other chronic kidney disease populations is indicated.

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

    Science.gov (United States)

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

    2012-01-01

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

  6. A randomized, double-blind, placebo-controlled study of latrepirdine in patients with mild to moderate Huntington disease.

    Science.gov (United States)

    2013-01-01

    BACKGROUND Latrepirdine is an orally administered experimental small molecule that was initially developed as an antihistamine and subsequently was shown to stabilize mitochondrial membranes and function, which might be impaired in Huntington disease. OBJECTIVE To determine the effect of latrepirdine on cognition and global function in patients with mild to moderate Huntington disease. DESIGN Randomized, double-blind, placebo-controlled study. SETTING Sixty-four research centers in Australia, Europe, and North America. PATIENTS Four hundred three patients with mild to moderate Huntington disease and baseline cognitive impairment (Mini-Mental State Examination score, 10-26). INTERVENTION Latrepirdine (20 mg) vs matching placebo administered orally 3 times daily for 26 weeks. MAIN OUTCOME MEASURES The co-primary outcome measures were cognition as measured by the change in Mini-Mental State Examination score from baseline to week 26 and global function at week 26 as measured by the Clinician Interview-Based Impression of Change, plus carer interview, which ranges from 1 (marked improvement) to 7 (marked worsening). Secondary efficacy outcome measures included behavior, daily function, motor function, and safety. RESULTS The mean change in Mini-Mental State Examination score among participants randomized to latrepirdine (1.5-point improvement) did not differ significantly from that among participants randomized to placebo (1.3-point improvement) (P=.39). Similarly, the distribution of the Clinician Interview-Based Impression of Change, plus carer interview did not differ significantly among those randomized to latrepirdine compared with placebo (P=.84). No significant treatment effects were detected on the secondary efficacy outcome measures. The incidence of adverse events was similar between those randomized to latrepirdine (68.5%) and placebo (68.0%). CONCLUSION In patients with mild to moderate Huntington disease and cognitive impairment, treatment with

  7. Melatonin for sedative withdrawal in older patients with primary insomnia: a randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Lähteenmäki, Ritva; Puustinen, Juha; Vahlberg, Tero; Lyles, Alan; Neuvonen, Pertti J; Partinen, Markku; Räihä, Ismo; Kivelä, Sirkka-Liisa

    2014-06-01

    We compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam, zopiclone or zolpidem (here 'BZD') use. A double-blind, placebo-controlled, randomized trial was conducted in a primary health care outpatient clinic. Ninety-two men or women (≥55 years) with primary insomnia and chronic BZD use received controlled release melatonin 2 mg (CRM) (n = 46) or placebo (n = 46) during the 1 month withdrawal from BZDs. Psychosocial support was provided. Follow-up continued for up to 6 months. Successful BZD withdrawal by the end of 1 month was confirmed by BZD plasma determinations, while reduction in BZD use and abstinence continuing for 6 months were noted. There were two drop-outs on CRM and one on placebo. After a 1 month withdrawal, 31 participants (67%; 95% CI 54, 81) on CRM and 39 (85%; 74, 95) on placebo had withdrawn completely (intention-to-treat analysis between groups, P = 0.051; per protocol P = 0.043). Reduction in BZD use was similar or even more rare in the CRM than in the placebo group (P = 0.052 per protocol). After 6 months, 14 participants in the CRM group and 20 in the placebo group remained non-users of BZD (NS between groups). BZD doses were higher in the CRM than in the placebo group at the end of the 6 month follow-up (P = 0.025). Withdrawal symptoms did not differ between the groups. Gradual dose reduction of BZDs combined with CRM or placebo, and psychosocial support produced high short term and moderate long term BZD abstinence. CRM showed no withdrawal benefit compared with placebo. © 2013 The British Pharmacological Society.

  8. A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in adult outpatients with major depressive disorder.

    Science.gov (United States)

    Liebowitz, Michael R; Yeung, Paul P; Entsuah, Richard

    2007-11-01

    This study evaluated the efficacy and tolerability of desvenlafaxine succinate (desvenlafaxine) in the treatment of major depressive disorder (MDD). In this 8-week, multicenter, randomized, double-blind, placebo-controlled trial, adult outpatients (aged 18-75 years) with a primary diagnosis of MDD (DSM-IV criteria) were randomly assigned to treatment with desvenlafaxine (100-200 mg/day) or placebo. The primary outcome measure was the 17-item Hamilton Rating Scale for Depression (HAM-D(17)) score at final on-therapy evaluation. The Clinical Global Impressions-Improvement scale (CGI-I) was the key secondary measure. Other secondary measures included the Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impressions-Severity of Illness scale, Visual Analog Scale-Pain Intensity (VAS-PI) overall and subcomponent scores, and HAM-D(17) response and remission rates. The study was conducted from June 2003 to May 2004. Of the 247 patients randomly assigned to treatment, 234 comprised the intent-to-treat population. Following titration, mean daily desvenlafaxine doses ranged from 179 to 195 mg/day. At endpoint, there were no significant differences in scores between the desvenlafaxine (N = 120) and placebo (N = 114) groups on the HAM-D(17) or CGI-I. However, the desvenlafaxine group had significantly greater improvement in MADRS scores (p = .047) and in VAS-PI overall pain (p = .008), back pain (p = .006), and arm, leg, or joint pain (p Desvenlafaxine was generally safe and well tolerated. In this study, it did not show significantly greater efficacy than placebo on the primary or key secondary efficacy endpoints, but it did demonstrate efficacy on an alternate depression scale and pain measure associated with MDD. ClinicalTrials.gov identifier NCT00063206.

  9. [Analgesic efficacy of TENS therapy in patients with gonarthrosis. A prospective, randomised, placebo-controlled, double-blind study].

    Science.gov (United States)

    Gschiel, B; Kager, H; Pipam, W; Weichart, K; Likar, R

    2010-09-01

    The goal of the study was to substantiate the influence of TENS on pain development and medication needs of patients with proven gonarthrosis and chronic pain. The study included a 3-week stimulation period and 2-week observation period after the end of stimulation. Patients (at least 20 per group) were assigned to either an active treatment group or placebo group in a randomised, double-blind, placebo-controlled trial. For the active treatment group the TENS therapy device with HAN stimulation (alternating phase of stimulation) was used (TENStem eco).Total length of time: 30 min at least two times a day. The length of therapy was 3 weeks (therapy), followed by an observation period of 2 weeks (follow-up). The total length of the study was 5 weeks, whereby at the beginning and at the end of weeks 1, 3 and 5 the SF-36, WOMAC score and Lysholm score were documented; the pain score was documented daily. There are no significant demographic differences between the groups. In the active treatment group there was clear relief in pain intensity in the morning, midday and evening over the 3-week period of therapy. The Lysholm score in the active treatment group was 53.4 at the beginning, 90 after 1 week, 94.5 after the third week and 91 by the fifth week (significant difference). There were no side effects. TENS therapy with HAN stimulation resulted in pain relief in patients with gonarthrosis during the therapy period with TENS, but the pain relief did not last beyond the end of the TENS therapy. There was an improvement in the Lysholm score and the WOMAC score during the therapy. This improvement remained over the following 2-week period of observation without further TENS therapy. TENS therapy is a simple and effective method to treat gonarthrosis with very few side effects.

  10. A placebo-controlled, double-blind study of mesoglycan in the treatment of chronic venous ulcers.

    Science.gov (United States)

    Arosio, E; Ferrari, G; Santoro, L; Gianese, F; Coccheri, S

    2001-10-01

    to assess the effect of treatment with mesoglycan, a sulphated polysaccharide compound, on the healing of venous ulcers. Design randomised, placebo-controlled, double-blind, multicentre trial. non-diabetic outpatients with chronic venous insufficiency confirmed by duplex ultrasound, normal ankle/arm pressure index and presence of a leg ulcer were eligible. Patients were randomised to mesoglycan, 30 mg/day intramuscularly for 3 weeks followed by 100 mg/day orally, or matching placebo, as an adjunct to compression therapy and topical wound care. Treatment and observation were continued until complete ulcer healing or for 24+/-1 weeks. Time to ulcer healing and healing rates were estimated with the Kaplan-Meier method. One hundred and eighty-three patients were randomised and included in the analysis (92 mesoglycan, 91 placebo). Median ulcer area upon inclusion was 3.6 cm(2)in the mesoglycan group and 3.9 cm(2)in the placebo group. The estimated time to heal 75% of the patients was 90 days on mesoglycan versus 136 days on placebo, while the cumulative rate of healing by the end of observation was 97% versus 82%, respectively. The difference in favour of mesoglycan was statistically significant (p mesoglycan was 1.48. The rate of adverse events was 7/92 on mesoglycan and 6/91 on placebo. treatment with mesoglycan in addition to established venous ulcer therapy resulted in a significantly faster and more frequent ulcer healing, and did not raise any safety concerns. Copyright 2001 Harcourt Publishers Limited.

  11. Atomoxetine treatment for nicotine withdrawal: a pilot double-blind, placebo-controlled, fixed-dose study in adult smokers

    Directory of Open Access Journals (Sweden)

    Silverstone Peter H

    2012-03-01

    Full Text Available Abstract Background Many effective treatments for nicotine addiction inhibit noradrenaline reuptake. Three recent studies have suggested that another noradrenaline reuptake inhibitor, atomoxetine, may reduce smoking behaviors. Methods The present double-blind, placebo-controlled, fixed-dose study was carried out over 21 days during which administration of 40 mg atomoxetine was compared to placebo in 17 individuals. Of these, nine were randomized to atomoxetine and eight to placebo. Baseline and weekly measurements were made using the Cigarette Dependence Scale (CDS, Cigarette Withdrawal Scale (CWS, Questionnaire of Smoking Urges (QSU, reported number of cigarettes smoked, and salivary cotinine levels. Results The study results showed that all those on placebo completed the study. In marked contrast, of the nine individuals who started on atomoxetine, five dropped out due to side effects. In a completer analysis there were statistically significant differences at 14 and 21 days in several measures between the atomoxetine and placebo groups, including CDS, CWS, QSU, number of cigarettes smoked (decreasing to less than two per day in the treatment group who completed the study, and a trend towards lower mean salivary cotinine levels. However, these differences were not seen in a last observation carried forward (LOCF analysis. Conclusions In summary, this is the first study to examine the use of atomoxetine in non-psychiatric adult smokers for a period of more than 7 days, and the findings suggest that atomoxetine might be a useful treatment for nicotine addiction. However, the dose used in the current study was too high to be tolerated by many adults, and a dose-finding study is required to determine the most appropriate dose for future studies of this potential treatment for smoking cessation.

  12. Effects of oral phentolamine, taken before sleep, on nocturnal erectile activity: a double-blind, placebo-controlled, crossover study.

    Science.gov (United States)

    Hatzichristou, D G; Apostolidis, A; Tzortzis, V; Hatzimouratidis, K; Kouvelas, D

    2001-10-01

    The objective of this study was to determine the effects of oral phentolamine, administered before sleep, on nocturnal penile erectile activity of men with mild to moderate erectile dysfunction (ED). We studied five patients with mild to moderate ED (mean age 34.8 +/- 8.13 and mean duration of ED 31.8 +/- 23.5 months), in a double-blind, placebo-controlled, crossover study. All patients received oral phentolamine (Vasomax) at a dose of 40 mg and placebo for three consecutive nights respectively and were submitted to nocturnal penile tumescence and rigidity monitoring (NPTR) with the Rigiscan device. NPTR parameters of the two 3-night recordings were evaluated and compared. Administration of oral phentolamine before sleep was associated with a statistically significant increase in the number of erectile events with rigidity > or = 60% lasting > or = 10 min (P = 0.02), as well as the rigidity activity units (RAU) value per hour sleep, both at the base (P = 0.023) and the tip of the penis (P = 0.019). The number of events as measured by Rigiscan software (20% change in circumference), as well as tumescence activity units (TAU)/h values did not show any statistical difference. No adverse effects were recorded. It is concluded that oral phentolamine administered before sleep enhanced NPTR parameters associated with the quality of the erectile events. Such results provide a pathway for the development of a prevention strategy for ED. Future studies will elucidate whether vasoactive agents taken on a regular basis before sleep, can prevent ED in men at risk, protecting also minimally and moderately impotent patients to become moderately and severely impotent respectively.

  13. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial.

    Science.gov (United States)

    Heiss, Wolf-Dieter; Brainin, Michael; Bornstein, Natan M; Tuomilehto, Jaakko; Hong, Zhen

    2012-03-01

    Cerebrolysin showed neuroprotective and neurotrophic properties in various preclinical models of ischemia and small clinical trials. The aim of this large double-blind, placebo-controlled randomized clinical trial was to test its efficacy and safety in patients with acute ischemic stroke. Patients with acute ischemic hemispheric stroke were randomized within 12 hours of symptoms onset to active treatment (30 mL Cerebrolysin daily) or placebo (saline solution) given as intravenous infusion for 10 days in addition to aspirin (100 mg daily). The patients were followed up to 90 days. The primary end point was the result of a combined global directional test of modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale. Adverse events were documented to assess safety. A total of 1070 patients were enrolled in this study. Five hundred twenty-nine patients were assigned to Cerebrolysin and 541 to placebo. The confirmatory end point showed no significant difference between the treatment groups. When stratified by severity however, a post hoc analysis of National Institutes of Health Stroke Scale and modified Rankin Scale showed a trend in favor of Cerebrolysin in patients with National Institutes of Health Stroke Scale >12 (National Institutes of Health Stroke Scale: OR, 1.27; CI lower bound, 0.97; modified Rankin Scale: OR, 1.27; CI lower bound, 0.90). In this subgroup, the cumulative mortality by 90 days was 20.2% in the placebo and 10.5% in the Cerebrolysin group (hazard ratio, 1.9661; CI lower bound, 1.0013). In this study, the confirmatory end point showed neutral results between the treatment groups. However, a favorable outcome trend was seen in the severely affected patients with ischemic stroke treated with Cerebrolysin. This observation should be confirmed by a further clinical trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00868283.

  14. [A randomized, double blind, placebo-controlled study of the efficacy and safety of tolperisone in spasticity following cerebral stroke].

    Science.gov (United States)

    Stamenova, P; Koytchev, R; Kuhn, K; Hanasen, C; Horvath, F; Ramm, S; Pongratz, D

    2006-01-01

    To study the efficacy and safety of tolperisone--a centrally acting muscle relaxant with membrane stabilizing activity--in the treatment of stroke-related spasticity. This was a randomized, double-blind, placebo-controlled, multicenter study with parallel groups. Treatment lasted 12 weeks and was started with a titration period of variable length (dose range 300-900 mg tolperisone daily). The degree of spasticity determined on the Ashworth Scale in the most severely affected joint area was denned as primary target parameter. Hundred and twenty patients (43 females, 77 males) in a mean age of 63,3 +/- 10,6 years were recruited and received treatment. In the majority of patients both limbs of each side were affected by the spasticity which on average had been present for 3,3 +/- 4,4 years. A 62% of the patients were treated with a daily dose >600 mg tolperisone. Tolperisone reduced the mean Ashworth Score by a mean of 1,03 +/- 0,71 compared with a mean reduction of 0,47 +/- 0,54 in the placebo group (ptolperisone versus 45% of the placebo patients experienced a reduction by at least 1 point on the Ashworth Scale (ptolperisone. Adverse events occurred less often on active treatment (n=19) than on placebo (n=26) and were mostly of mild-to-moderate intensity. No withdrawals caused by adverse events were reported in the tolperisone group. The findings of the present study demonstrate the efficacy and excellent tolerance of tolperisone in the treatment of spastic hypertonia following cerebral stroke. Study data further suggest that an individual dose titration which may exceed the recommended maximum dose of 450 mg daily results in optimized therapeutic benefit.

  15. Efficacy and safety of drotaverine hydrochloride in irritable bowel syndrome: A randomized double-blind placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Ramesh R Rai

    2014-01-01

    Full Text Available Backgrounds/Aims: To study the efficacy and safety of drotaverine hydrochloride (HCl 80 mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome (IBS. Patients and Methods: The study was a multicentric, randomized, double-blind, placebo-controlled parallel group study performed at three centers. The patients who fulfilled Rome II Criteria of IBS were included in the study. A total of 180 patients with IBS were randomized to drotaverine and placebo treatment groups. Abdominal pain and stool frequency were measured every week in both the groups for all the 4 weeks of treatment duration. Subject Global Assessment of Relief (SGA of IBS symptoms was assessed at the end of the study. Appropriate statistical analysis was done using SPSS software. Statistical Analysis Used: Mann-Whitney U-test (two-tailed, Wilcoxon signed ranks test, and McNemar tests. Results: Pain frequency decreased significantly (P < 0.01 in 22 (25.9%, 51 (60%, and 66 (77.7% patients in the drotaverine group, at the end of 2 nd , 3 rd , and 4 th weeks, respectively, as compared with 8 (9.4%, 18 (21.2%, and 26 (30.6% in the placebo group. Pain severity scores also decreased significantly in the drotaverine group 66 (77.7% as compared with placebo 26 (30.6% after 4 weeks. Drotaverine HCl was shown to provide significant improvement (P < 0.01 in global relief in abdominal pain as perceived by the patient (85.9% vs 39.5% and the clinician (82.4% vs 36.5% in the drotaverine group as compared with placebo. There is significant (P < 0.01 improvement in stool frequency in drotaverine HCl treatment group as compared with placebo. The drug is well tolerated without any major side effects. Conclusions: A 4-week treatment with drotaverine significantly improves abdominal symptoms in patients with IBS.

  16. Efficacy of N-Acetylcysteine Augmentation on Obsessive Compulsive Disorder: A Multicenter Randomized Double Blind Placebo Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ahmad Ghanizadeh

    2017-04-01

    Full Text Available Objective: Glutamate is considered a target for treating obsessive-compulsive disorder (OCD. The efficacy and safety of the nutritional supplement of N-Acetylcysteine (NAC as an adjuvant to serotonin reuptake inhibitor (SSRI for treating children and adolescents with OCD has never been examined.Methods: This was a 10-week randomized double-blind placebo-controlled clinical trial with 34 OCD outpatients. The patients received citalopram plus NAC or placebo. Yale-Brown Obsessive-Compulsive Scale (YBOCS and Pediatric Quality of Life Inventory (PedsQL™ were used. Adverse effects were monitored.Results: YBOCS score was not different between the two groups at baseline, but the score was different between the two groups at the end of this trial (P<0.02. The YBOCS score of NAC group significantly decreased from 21.0(8.2 to 11.3(5.7 during this study. However, no statistically significant decrease of YBOCS was found in the placebo group. The Cohen’s d effect size was 0.83.The mean change of score of resistance/control to obsessions in the NAC and placebo groups was 1.8(2.3 and 0.8(2.1, respectively (P = 0.2. However, the mean score of change for resistance/control to compulsion in the NAC and placebo groups was 2.3(1.8 and 0.9(2.3, respectively. Cohen’s d effect size was 0.42.The score of three domains of quality of life significantly decreased in N-Acetylcysteine group during this trial. However, no statistically significant decrease was detected in the placebo group. No serious adverse effect was found in the two groups.Conclusion: This trial suggests that NAC adds to the effect of citalopram in improving resistance/control to compulsions in OCD children and adolescents. In addition, it is well tolerated.

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

    Science.gov (United States)

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

    2014-05-01

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

  18. Lithium in the Acute Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Study.

    Science.gov (United States)

    Findling, Robert L; Robb, Adelaide; McNamara, Nora K; Pavuluri, Mani N; Kafantaris, Vivian; Scheffer, Russell; Frazier, Jean A; Rynn, Moira; DelBello, Melissa; Kowatch, Robert A; Rowles, Brieana M; Lingler, Jacqui; Martz, Karen; Anand, Ravinder; Clemons, Traci E; Taylor-Zapata, Perdita

    2015-11-01

    Lithium is a benchmark treatment for bipolar disorder in adults. Definitive studies of lithium in pediatric bipolar I disorder (BP-I) are lacking. This multicenter, randomized, double-blind, placebo-controlled study of pediatric participants (ages 7-17 years) with BP-I/manic or mixed episodes compared lithium (n = 53) versus placebo (n = 28) for up to 8 weeks. The a priori primary efficacy measure was change from baseline to the end of study (week 8/ET) in the Young Mania Rating Scale (YMRS) score, based on last-observation-carried-forward analysis. The change in YMRS score was significantly larger in lithium-treated participants (5.51 [95% confidence interval: 0.51 to 10.50]) after adjustment for baseline YMRS score, age group, weight group, gender, and study site (P = .03). Overall Clinical Global Impression-Improvement scores favored lithium (n = 25; 47% very much/much improved) compared with placebo (n = 6; 21% very much/much improved) at week 8/ET (P = .03). A statistically significant increase in thyrotropin concentration was seen with lithium (3.0 ± 3.1 mIU/L) compared with placebo (-0.1 ± 0.9 mIU/L; P Lithium was superior to placebo in reducing manic symptoms in pediatric patients treated for BP-I in this clinical trial. Lithium was generally well tolerated in this patient population and was not associated with weight gain, distinguishing it from other agents commonly used to treat youth with bipolar disorder. Copyright © 2015 by the American Academy of Pediatrics.

  19. Acupuncture for post-operative pain after inguinal hernia repair: a placebo controlled, double-blinded clinical trial

    Directory of Open Access Journals (Sweden)

    Raji B

    2007-10-01

    Full Text Available Background: Acupuncture is one of the most effective methods of alleviating pain in different situations including chronic and acute pain management. The aim of this study was to evaluate the effectiveness of acupuncture in the reduction of post-operative pain after hernia repair.Methods: In this placebo-controlled, double-blinded clinical trial, we enrolled 60 male patients aged 30 to 60 years old with an ASA physical status of I or II undergoing elective inguinal hernia repair under general anesthesia in Imam Khomeini Hospital, Tehran, Iran. All patients experienced standard anesthetic and surgical procedures. After completion of the operation and while the patients were still under general anesthesia, they were randomly assigned to two groups: acupuncture (with stimulation of GV2, GV4 and SP6 points with sterile acupuncture needles, and control (with sham acupuncture stimulation. After termination of anesthesia, during the first six hours, the pain intensity was evaluated hourly. Pethidine (25 mg was administered for the patients when necessary. Pain intensity and pethidine use were recorded and compared between the two groups.Results: The mean age of two groups did not differ. Pain intensity was significantly lower in the acupuncture group between the second and fifth postoperative hours. Moreover, pethidine use was significantly lower in the acupuncture group versus the control group during the first six hours after surgery (12.07±7.5 mg vs. 12.91±6.5 mg, respectively; p=0.0001.Conclusion: The application of acupuncture in patients is associated with a marked decrease in pain after inguinal hernia repair and does not have any serious complications. Acupuncture is strongly recommended for all post-operative patients."n 

  20. Denosumab for treating periprosthetic osteolysis; study protocol for a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Sköldenberg, Olof; Rysinska, Agata; Eisler, Thomas; Salemyr, Mats; Bodén, Henrik; Muren, Olle

    2016-04-23

    Wear-induced osteolysis is the main factor in reducing the longevity of total hip arthroplasty (THA). The transmembrane Receptor Activator of Nuclear Factor κ B (RANK) and its corresponding ligand RANKL is an important regulator of osteoclast activity and bone resorption and is associated with osteolysis around implant. Inhibiting RANKL with denosumab is effective in vivo in preventing osteoporosis-related fractures. In vitro, osteoclasts can be blocked in animal models of osteolysis. We hypothesize that denosumab is effective in reducing wear-induced osteolysis around uncemented acetabular implants in THA. A randomized, double-blind, placebo-controlled trial will be conducted. We will include 110 patients, 40-85 years of age, with a known osteolytic lesion around an uncemented acetabular component ≥7 years after the primary operation. The patients will be randomized in a 1:1 ratio to subcutaneous injections of 60 mg denosumab or placebo for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months. The primary endpoint will be the change in volume of the osteolytic lesion at 3 years measured with three-dimensional computed tomography (3D-CT). Secondary endpoints include functional outcome scores, change in bone mineral density of the lumbar spine, serological markers of bone turnover and adverse events. In vitro results of both bisphosphonates and RANKL inhibitors have been promising, showing reduced osteolysis with treatment. This is, to our knowledge, the first clinical trial testing the efficacy of denosumab in reducing wear-induced osteolysis. The study is an academic, phase II trial from an independent center and is designed to demonstrate efficacy in reducing volume of osteolytic lesions around a total hip arthroplasty. ClinicalTrials.gov (NCT02299817) 2014-11-20.

  1. Gastrointestinal Complications of Ferrous Sulfate in Pregnant Women: A Randomized Double-Blind Placebo-Controlled Trial.

    Science.gov (United States)

    Jafarbegloo, Esmat; Ahmari Tehran, Hoda; Dadkhah Tehrani, Tahmineh

    2015-08-01

    Some pregnant women discontinue iron supplements consumption due to Gastrointestinal (GI) complications, whereas pregnancy induces the same complications physiologically. The aim of the present study was to assess GI complications of ferrous sulfate in pregnant women. This randomized, double-blind, placebo-controlled clinical trial was performed on 176 pregnant women referred to prenatal care clinic of Maryam Hospital from April 2011 to February 2012. Pregnant women with Hb ≥ 13.2 gr/dL at 13(th) - 18(th) weeks of gestation were selected based on the inclusion criteria and were randomly assigned to the ferrous sulfate and placebo groups. The ferrous sulfate group (n = 90) received a 50-mg ferrous sulfate tablet daily from the 20(th) week to the end of pregnancy and the placebo group (n = 89) received one placebo tablet in the same way. All participants were visited twice at 24(th) - 28(th) and 32(nd) - 36(th) weeks to assess the GI complications as well as Hb level to determine the Hb changes in two groups. Chi-square test, t-test and Kolmogorov-Smirnov test were used to analyze the data. P value of ferrous sulfate and placebo groups at 24(th) - 28(th) and 32(nd) - 36(th) weeks. Hemoglobin drop lower than 10.5 gr/dL at 24(th) - 28(th) weeks or lower than 11 g/dL at 32(nd) - 36(th) weeks was not observed in any cases. It can be concluded that GI complications in pregnant women using ferrous sulfate are mostly caused by physiologic changes of pregnancy rather than ferrous sulfate; therefore, it is not reasonable to stop using ferrous sulfate due to GI complications.

  2. Adjunctive treatment for cognitive impairment in patients with chronic schizophrenia: a double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Zhu W

    2014-07-01

    Full Text Available Weiwei Zhu,1,2,* Zhanchou Zhang,1,* Jingfeng Qi,1 Fang Liu,3 Jindong Chen,1,4,5 Jingping Zhao,1,4,5 Xiaofeng Guo1,4,5 1Institute of Mental Health, Second Xiangya Hospital, Central South University, 2Brain Hospital of Hunan Province, Changsha, 3First Affiliated Hospital of Kunming Medical University, Kunming, 4National Technology Institute of Psychiatry, 5Key Laboratory of Psychiatry and Mental Health of Hunan Province, Changsha, People’s Republic of China *These authors contributed equally to this work Abstract: Cognitive impairment is closely related to real-life functioning in patients with schizophrenia. The aim of the present study was to evaluate the effects of adjunctive treatment with donepezil on cognition in patients with chronic schizophrenia. This was a 12-week, double-blind, randomized, placebo-controlled study of donepezil as an adjunct to antipsychotic drug therapy in patients with chronic stable schizophrenia. Sixty-one subjects were randomized to receive donepezil 5 mg/day (n=31 and/or placebo (n=30. A nine-test neuropsychological assessment battery was administered at baseline and at the end of the study. At the 12-week end point, the donepezil group showed significant improvements in the Wechsler Memory Scale Third Edition Spatial Span, Brief Visuospatial Memory Test total recall and delayed recall, Trail-Making Test Part A, and Category Fluency Test-animal naming (all P≤0.018. Compared with placebo, donepezil was associated with significant improvement in several cognitive domains, including working memory, speed of information processing, and visual learning and memory (P≤0.008. The results of the present study suggest that adjunctive use of donepezil is beneficial for improving cognitive function in patients with schizophrenia. Keywords: schizophrenia, cognitive function, donepezil

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

    Science.gov (United States)

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

    2015-05-06

    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. Sixty soccer players who routinely trained at a sports school participated in a double-blind placebo-controlled trial and were randomly allocated to the treatment group or the placebo group. The participants in both groups were given either 180 mg of Kaempferia parviflora extract in capsules or a placebo once daily for 12 weeks. Baseline data were collected using the following 6 tests of physical performance: a sit-and-reach test, a hand grip strength test, a back-and-leg strength test, a 40-yard technical test, a 50-metre sprint test, and a cardiorespiratory fitness test. All of the tests were performed every 4 weeks throughout the 12-week study period. The study showed that after treatment with Kaempferia parviflora, the right-hand grip strength was significantly increased at weeks 4, 8, and 12. The left-hand grip strength was significantly increased at week 8. However, the back-and-leg strength, the 40-yard technical test, the sit-and-reach test, the 50-metre sprint test, and the cardiorespiratory fitness test results of the treatment group were not significantly different from those of the placebo group. Taking Kaempferia parviflora supplements for 12 weeks may significantly enhance some physical fitness components in soccer players.

  4. Efficacy of Levofloxacin in the Treatment of BK Viremia: A Multicenter, Double-Blinded, Randomized, Placebo-Controlled Trial

    Science.gov (United States)

    Lee, Belinda T.; Gabardi, Steven; Grafals, Monica; Hofmann, R. Michael; Akalin, Enver; Aljanabi, Aws; Mandelbrot, Didier A.; Adey, Deborah B.; Heher, Eliot; Fan, Pang-Yen; Conte, Sarah; Dyer-Ward, Christine

    2014-01-01

    Background and objectives BK virus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction of immunosuppression remains the cornerstone of treatment for active BK infection. Fluoroquinolone antibiotics are known to have in vitro antiviral properties, but the evidence for their use in patients with BK viremia is inconclusive. The objective of the study was to determine the efficacy of levofloxacin in the treatment of BK viremia. Design, setting, participants, & measurements Enrollment in this prospective, multicenter, double-blinded, placebo-controlled trial occurred from July 2009 to March 2012. Thirty-nine kidney transplant recipients with BK viremia were randomly assigned to receive levofloxacin, 500 mg daily, or placebo for 30 days. Immunosuppression in all patients was adjusted on the basis of standard clinical practices at each institution. Plasma BK viral load and serum creatinine were measured monthly for 3 months and at 6 months. Results At the 3-month follow-up, the percentage reductions in BK viral load were 70.3% and 69.1% in the levofloxacin group and the placebo group, respectively (P=0.93). The percentage reductions in BK viral load were also equivalent at 1 month (58% versus and 67.1%; P=0.47) and 6 months (82.1% versus 90.5%; P=0.38). Linear regression analysis of serum creatinine versus time showed no difference in allograft function between the two study groups during the follow-up period. Conclusions A 30-day course of levofloxacin does not significantly improve BK viral load reduction or allograft function when used in addition to overall reduction of immunosuppression. PMID:24482066

  5. Articles Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial

    OpenAIRE

    Szakacs, Zoltan; Dauvilliers, Yves; Mikhaylov, Vladimir; Poverennova, Irina; Krylov, Sergei; Jankovic, Slavko; Sonka, Karel; Lehert, Philippe; Lecomte, Isabelle; Lecomte, Jeanne-Marie; Schwartz, Jean-Charles

    2017-01-01

    International audience; BACKGROUND:Histaminergic neurons are crucial to maintain wakefulness, but their role in cataplexy is unknown. We assessed the safety and efficacy of pitolisant, a histamine H3 receptor inverse agonist, for treatment of cataplexy in patients with narcolepsy.METHODS:For this randomised, double-blind, placebo-controlled trial we recruited patients with narcolepsy from 16 sleep centres in nine countries (Bulgaria, Czech Republic, Hungary, Macedonia, Poland, Russia, Serbia,...

  6. Efficacy and safety of bilastine in Japanese patients with perennial allergic rhinitis: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III study

    OpenAIRE

    Kimihiro Okubo; Minoru Gotoh; Mikiya Asako; Yasuyuki Nomura; Michinori Togawa; Akihiro Saito; Takayuki Honda; Yoshihiro Ohashi

    2017-01-01

    Background: Bilastine, a novel non-sedating second-generation H1 antihistamine, has been approved in most European countries since 2010. This study aimed to evaluate the superiority of bilastine over placebo in Japanese patients with perennial allergic rhinitis (PAR). Methods: This randomized, double-blind, placebo-controlled, parallel-group, phase III study (trial registration number JapicCTI-142600) evaluated the effect of a 2-week treatment period with bilastine (20 mg once daily), fexo...

  7. Efficacy of prednisone 1–4 mg/day in patients with rheumatoid arthritis: a randomised, double-blind, placebo controlled withdrawal clinical trial

    OpenAIRE

    2008-01-01

    Objective: A randomised double-blind placebo controlled withdrawal clinical trial of prednisone versus placebo in patients with rheumatoid arthritis (RA), treated in usual clinical care with 1–4 mg/day prednisone, withdrawn to the same dose of 1 mg prednisone or identical placebo tablets. Methods: All patients were from one academic setting and all trial visits were conducted in usual clinical care. Patients were taking stable doses of 1–4 mg prednisone with stable clinical status, documented...

  8. 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

  9. Adjunctive Taurine in First-Episode Psychosis: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study.

    Science.gov (United States)

    O'Donnell, Colin P; Allott, Kelly A; Murphy, Brendan P; Yuen, Hok Pan; Proffitt, Tina-Marie; Papas, Alicia; Moral, Jennifer; Pham, Tee; O'Regan, Michaela K; Phassouliotis, Christina; Simpson, Raelene; McGorry, Patrick D

    2016-12-01

    Taurine is an inhibitory neuromodulatory amino acid in the central nervous system that activates the GABA- and glycine-insensitive chloride channel and inhibits the N-methyl-D-aspartate receptor. It also functions as a neuroprotective agent and has a role in neural development and neurogenesis. The aim of this study was to determine the efficacy of adjunctive taurine in improving symptomatology and cognition among patients with a DSM-IV first-episode psychotic disorder. 121 patients with first-episode psychosis, aged 18-25 years, attending early intervention services consented to participate in this randomized, double-blind, placebo-controlled trial conducted from January 2007 to May 2009. Patients taking low-dose antipsychotic medication were randomly assigned to receive once-daily taurine 4 g or placebo for 12 weeks. The coprimary outcomes were change in symptomatology (measured by the Brief Psychiatric Rating Scale [BPRS] total score) and change in cognition (measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS] Consensus Cognitive Battery composite score) at 12 weeks. Secondary outcomes included tolerability and safety and additional clinical and functioning measures. 86 participants (n = 47 taurine; n = 39 placebo) were included in the final analysis. Taurine significantly improved symptomatology measured by the BPRS total score (95% CI, 1.8-8.5; P = .004) and psychotic subscale (95% CI, 0.1-1.5; P = .026) compared to placebo. Additionally, improvements were observed in the Calgary Depression Scale for Schizophrenia (95% CI, 0.1-3.0; P = .047) and Global Assessment of Functioning (95% CI, 0.3-8.8; P = .04) scores. There was no group difference in composite cognitive score (95% CI, -1.7 to 1.0; P = .582). A significant group difference was found on one safety and tolerability item (psychic item 2, asthenia/lassitude/increased fatigability) of the Udvalg for Kliniske Undersogelser, with the taurine group showing a

  10. Phellodendron and Citrus extracts benefit cardiovascular health in osteoarthritis patients: a double-blind, placebo-controlled pilot study

    Directory of Open Access Journals (Sweden)

    Chambliss Walter

    2008-05-01

    Full Text Available Abstract Background The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on cardiovascular protective properties in overweight and normal weight adults diagnosed with osteoarthritis of the knee. Methods An 8-week, placebo-controlled, randomized, double-blind study was conducted with four groups, comparing the effects of NP 06-1 to placebo in overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel or matching placebo was given in a dose of two capsules (370 mg each twice daily. The outcome measures reported are lipid levels, weight, BMI, blood pressure and fasting glucose. Analyses of variance were used to compare changes of physiological measures over the trial period and between groups. Results Eighty (80 subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. NP 06-1 administration was associated with a general improvement in lipid levels. Both the overweight and normal weight treatment groups had significant reductions in triglycerides and LDL-cholesterol, as well as a significant increase in HDL-cholesterol compared to their respective control groups. Overall there were decreases in blood pressure in both overweight and normal weight treatment groups compared to respective placebo groups. There was also a significant decrease in fasting glucose levels in the overweight treatment group compared to the start of the study and to the overweight placebo group. There was no change in fasting blood sugar for the normal weight groups. Both overweight and normal weight treatment groups lost a significant amount of weight compared to their respective placebo groups. The overweight treatment group lost an average of 5% body weight after 8 weeks, which was associated with a significant loss in BMI over time. Conclusion In

  11. Adjuvant interferon gamma in patients with pulmonary atypical Mycobacteriosis: A randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Sánchez-de la Osa Reinaldo B

    2008-02-01

    Full Text Available Abstract Background High antibiotic resistance is described in atypical Mycobacteriosis, mainly by Mycobacterium avium complex (MAC. Methods A randomized, double-blind, placebo-controlled clinical trial was carried out in two hospitals to evaluate the effect of interferon (IFN gamma as immunoadjuvant to chemotherapy on patients with atypical mycobacteria lung disease. Patients received placebo or 1 × 106 IU recombinant human IFN gamma intramuscularly, daily for one month and then three times per week up to 6 months as adjuvant to daily oral azithromycin, ciprofloxacin, ethambutol and rifampin. Sputum samples collection for direct smear observation and culture as well as clinical and thorax radiography assessments were done during treatment and one year after. Cytokines and oxidative stress determinations were carried out in peripheral blood before and after treatment. Results Eighteen patients were included in the IFN group and 14 received placebo. Groups were homogeneous at entry; average age was 60 years, 75% men, 84% white; MAC infection prevailed (94%. At the end of treatment, 72% of patients treated with IFN gamma were evaluated as complete responders, but only 36% in the placebo group. The difference was maintained during follow-up. A more rapid complete response was obtained in the IFN group (5 months before, with a significantly earlier improvement in respiratory symptoms and pulmonary lesions reduction. Disease-related deaths were 35.7% of the patients in the placebo group and only 11.1% in the IFN group. Three patients in the IFN group normalized their globular sedimentation rate values. Although differences in bacteriology were not significant during the treatment period, some patients in the placebo group converted again to positive during follow-up. Significant increments in serum TGF-beta and advanced oxidation protein products were observed in the placebo group but not among IFN receiving patients. Treatments were well tolerated

  12. A double blind, placebo-controlled, randomized crossover study of the acute metabolic effects of olanzapine in healthy volunteers.

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    Vance L Albaugh

    Full Text Available Atypical antipsychotics exhibit metabolic side effects including diabetes mellitus and obesity. The adverse events are preceded by acute worsening of oral glucose tolerance (oGTT along with reduced plasma free fatty acids (FFA and leptin in animal models. It is unclear whether the same acute effects occur in humans.A double blind, randomized, placebo-controlled crossover trial was conducted to examine the potential metabolic effects of olanzapine in healthy volunteers. Participants included male (8 and female (7 subjects [18-30 years old, BMI 18.5-25]. Subjects received placebo or olanzapine (10 mg/day for three days prior to oGTT testing. Primary endpoints included measurement of plasma leptin, oral glucose tolerance, and plasma free fatty acids (FFA. Secondary metabolic endpoints included: triglycerides, total cholesterol, high- and low-density lipoprotein cholesterol, heart rate, blood pressure, body weight and BMI. Olanzapine increased glucose Area Under the Curve (AUC by 42% (2808±474 vs. 3984±444 mg/dl·min; P = 0.0105 during an oGTT. Fasting plasma leptin and triglycerides were elevated 24% (Leptin: 6.8±1.3 vs. 8.4±1.7 ng/ml; P = 0.0203 and 22% (Triglycerides: 88.9±10.1 vs. 108.2±11.6 mg/dl; P = 0.0170, whereas FFA and HDL declined by 32% (FFA: 0.38±0.06 vs. 0.26±0.04 mM; P = 0.0166 and 11% (54.2±4.7 vs. 48.9±4.3 mg/dl; P = 0.0184, respectively after olanzapine. Other measures were unchanged.Olanzapine exerts some but not all of the early endocrine/metabolic changes observed in rodent models of the metabolic side effects, and this suggest that antipsychotic effects are not limited to perturbations in glucose metabolism alone. Future prospective clinical studies should focus on identifying which reliable metabolic alterations might be useful as potential screening tools in assessing patient susceptibility to weight gain and diabetes caused by atypical antipsychotics.ClinicalTrials.gov NCT00741026.

  13. Effect of fesoterodine in vulnerable elderly subjects with urgency incontinence: a double-blind, placebo controlled trial.

    Science.gov (United States)

    Dubeau, Catherine E; Kraus, Stephen R; Griebling, Tomas L; Newman, Diane K; Wyman, Jean F; Johnson, Theodore M; Ouslander, Joseph G; Sun, Franklin; Gong, Jason; Bavendam, Tamara

    2014-02-01

    We evaluated the efficacy and safety of flexible dose fesoterodine in medically complex vulnerable elderly subjects with urgency urinary incontinence. In this 12-week, randomized, double-blind, flexible dose, placebo controlled trial, subjects were community dwelling men and women 65 years old or older. Subjects had scores of 3 or more on the VES-13 (Vulnerable Elders Survey) and 20 or more on the MMSE (Mini-Mental State Examination), and 2 to 15 urgency urinary incontinence episodes and 8 or more micturitions per 24 hours on 3-day baseline diaries. Subjects randomized to fesoterodine received 4 mg once daily for 4 weeks and could then increase to 8 mg based on discussion with the investigator. Subjects receiving 8 mg could decrease the dose to 4 mg at any time (sham escalation and de-escalation for placebo). The primary outcome measure was change in daily urgency urinary incontinence episodes. Secondary outcomes included changes in other diary variables and patient reported quality of life measures. Safety evaluations included self-reported symptoms and post-void residual volume. A total of 562 patients were randomized (mean age 75 years, 50.4% age 75 years or greater). Subjects had high rates of comorbidities, polypharmacy and functional impairment. At week 12 the fesoterodine group had significantly greater improvements in urgency urinary incontinence episodes per 24 hours (-2.84 vs -2.20, p = 0.002) and most other diary variables and quality of life, as well as a higher diary dry rate (50.8% vs 36.0%, p = 0.002). Adverse effects were generally similar to those of younger populations including risk of urinary retention. To our knowledge this is the first antimuscarinic study in a community based, significantly older, medically complex elderly population with urgency urinary incontinence. Flexible dose fesoterodine significantly improved urgency urinary incontinence episodes and other outcomes vs placebo, and was generally well tolerated. Copyright © 2014

  14. Acute Dietary Nitrate Supplementation and Exercise Performance in COPD: A Double-Blind, Placebo-Controlled, Randomised Controlled Pilot Study.

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    Katrina J Curtis

    Full Text Available Dietary nitrate supplementation can enhance exercise performance in healthy people, but it is not clear if it is beneficial in COPD. We investigated the hypotheses that acute nitrate dosing would improve exercise performance and reduce the oxygen cost of submaximal exercise in people with COPD.We performed a double-blind, placebo-controlled, cross-over single dose study. Subjects were randomised to consume either nitrate-rich beetroot juice (containing 12.9 mmoles nitrate or placebo (nitrate-depleted beetroot juice 3 hours prior to endurance cycle ergometry, performed at 70% of maximal workload assessed by a prior incremental exercise test. After a minimum washout period of 7 days the protocol was repeated with the crossover beverage.21 subjects successfully completed the study (age 68 ± 7 years; BMI 25.2 ± 5.5 kg/m2; FEV1 percentage predicted 50.1 ± 21.6%; peak VO2 18.0 ± 5.9 ml/min/kg. Resting diastolic blood pressure fell significantly with nitrate supplementation compared to placebo (-7 ± 8 mmHg nitrate vs. -1 ± 8 mmHg placebo; p = 0.008. Median endurance time did not differ significantly; nitrate 5.65 (3.90-10.40 minutes vs. placebo 6.40 (4.01-9.67 minutes (p = 0.50. However, isotime oxygen consumption (VO2 was lower following nitrate supplementation (16.6 ± 6.0 ml/min/kg nitrate vs. 17.2 ± 6.0 ml/min/kg placebo; p = 0.043, and consequently nitrate supplementation caused a significant lowering of the amplitude of the VO2-percentage isotime curve.Acute administration of oral nitrate did not enhance endurance exercise performance; however the observation that beetroot juice caused reduced oxygen consumption at isotime suggests that further investigation of this treatment approach is warranted, perhaps targeting a more hypoxic phenotype.ISRCTN Registry ISRCTN66099139.

  15. A double-blind, randomized, placebo-controlled multicenter study of oseltamivir phosphate for treatment of influenza infection in China

    Institute of Scientific and Technical Information of China (English)

    龙芸; 蔡伯蔷; 王孟昭; 朱元珏

    2003-01-01

    Objective To evaluate the efficacy and safety of oseltamivir phosphate as treatment for naturally acquired influenza infection. Methods This study was conducted as a double-blind, randomized, placebo-controlled, multicenter trial during the influenza epidemic season from January to April 2001 at 7 centers in China. A total of 478 adults without other medical history, aged 18 to 65 years, were enrolled into the study. All subjects demonstrated febrile respiratory illness of no more than 36 hours' duration with a temperature of 37.8℃ or more plus at least two of the following symptoms: coryza/nasal congestion, sore throat, cough, myalgia/muscles aches and pain, fatigue, headache or chills/sweats. Individuals were randomized into either the oseltamivir phosphate or placebo group with identical-looking capsules. Either oral oseltamivir phosphate, 75 mg twice daily, or placebo was administered to the subjects for 5 days.Results A total of 451 individuals were analyzed for efficacy as the intent-to-treat population (ITT) (216 oseltamivir and 235 placebo) and 273 individuals were identified as influenza-infected through laboratory test, who were then defined as the intent-to-treat infected population (ITTI) (134 oseltamivir and 139 placebo). Four hundred and fifty nine individuals were included in the safety analysis. In the ITTI population, the cumulative alleviation proportion of oseltamivir group was significantly higher than that of the placebo group (P=0.0466)). The median duration of illness was 91.6 h [95% confidence interval (CI)=80.2-101.3 h] in the oseltamivir group and 95 h (95% CI=84.5-105.3 h) in the placebo group. The median area under the curve of decreased total score was significantly higher in the oseltamivir group than in the placebo group, 1382.9 and 1236.7 score-hours, respectively (P=0.0196). For the ITT population, similar results were observed. Adverse events (AE) were similarly reported in both the oseltamivir group and the placebo group. The

  16. 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.

  17. An integral topical gel for cellulite reduction: results from a double-blind, randomized, placebo-controlled evaluation of efficacy

    Directory of Open Access Journals (Sweden)

    Dupont E

    2014-02-01

    Full Text Available Eric Dupont,1 Michel Journet,2 Marie-Laure Oula,3 Juan Gomez,1 Claude Léveillé,4 Estelle Loing,5 Diane Bilodeau6 1Immanence IDC Inc, Québec, QC, Canada; 2Clinique de Dermatologie St-Joseph, Montréal, QC, Canada; 3Evalulab Inc, Mont-Royal, QC, Canada; 4Clinique de Chirurgie Esthétique du Québec Métropolitain, Lévis, QC, Canada; 5Lucas Meyer Cosmetics, Québec, QC, Canada; 6CosmeConsult, Québec, QC, Canada Background: Cellulite is a serious cosmetic concern for most of the 90% of women affected by it. Objective: To assess the clinical efficacy of a complex integral anti-cellulite gel. Methods: This double-blind, randomized, placebo-controlled study involved 44 healthy women, aged 25–55 years. Subjects had a normal to slightly overweight body mass index and presented slight to moderate cellulite on their thighs, buttocks, and/or hips at baseline. Subjects were randomly assigned to either the treated or placebo group and accordingly applied the active product or placebo on their hips, stomach, buttocks, and thighs, twice daily for 3 months. Skin tonicity, orange-peel aspect, and stubborn cellulite were assessed at day 0, 28, 56, and 84. A self-evaluation questionnaire was completed by all volunteers. Results: At the end of the study, an average of 81% of the subjects applying the active product presented improvement in their cellulite condition versus 32% for the placebo group (all descriptors and sites combined. At day 84, skin tonicity, orange-peel appearance, and stubborn cellulite were improved in a significant manner (P<0.05 over placebo, on all studied areas. Skin tonicity improved on average by +41% for buttocks, +35% for hips, and +31% for thighs. Orange peel appearance was reduced on average by -25% for buttocks, -22% for hips, and -22% for thighs. Stubborn cellulite was reduced on average by -19% for buttocks, -24% for hips, and -22% for thighs. Circumference measurements decreased in a significant manner (P<0.05 over placebo

  18. Otilonium bromide in irritable bowel syndrome: a dose-ranging randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Chmielewska-Wilkoń, Danuta; Reggiardo, Giorgio; Egan, Colin Gerard

    2014-09-14

    To examine the efficacy and safety of otilonium bromide (OB) in treatment-sensitive functional irritable bowel syndrome (IBS) clinical parameters. Ninety-three patients (44.8 ± 12.6 years, 69% female) with IBS symptoms complying with Rome II criteria participated in this double-blind, placebo-controlled, randomised, dose-ranging phase I/II study. Patients were administered OB 20 mg (n = 24), 40 mg (n = 23) and 80 mg (n = 23) tid or placebo (n = 23) in 4 parallel groups for 4 wk. Primary efficacy variables included abdominal discomfort, intestinal habits, number of daily evacuations and stool consistency. Secondary efficacy measures included return to regular intestinal habits and global discomfort. Safety was also assessed. Baseline clinical characteristics were similar among the 4 groups. Although individual parameters such as intensity and frequency of abdominal discomfort, bloating or pain were reduced by OB over the 4 wk, no significant differences were observed between groups. Similarly, no difference was observed between OB treatment or placebo for mucus in stool and incomplete or difficulty of evacuation. However, evacuation frequency was significantly reduced after 4 wk by 80 mg OB compared to placebo (-8.36% for placebo vs -41.9% for 80 mg OB, P < 0.01). While 21.7% of patients in the placebo group experienced regular intestinal habits after 4 wk, this improvement was greater for patients treated with 40 mg OB (P < 0.01 vs placebo). Furthermore, a dose-dependent reduction in frequency of diarrhoea (χ(2)-test for trend = 11.5, P < 0.001) and an increase in normal stool frequency was observed. Combining individual variables into a global discomfort index revealed significant improvement among increasing OB doses, favouring 40 mg (P = 0.013) and 80 mg OB (P = 0.001) over placebo. No difference was observed between frequency of adverse events for placebo vs OB. This dose-ranging study demonstrates that OB at 40 and 80 mg can improve individual and global

  19. Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial.

    Science.gov (United States)

    Brusselle, Guy G; Vanderstichele, Christine; Jordens, Paul; Deman, René; Slabbynck, Hans; Ringoet, Veerle; Verleden, Geert; Demedts, Ingel K; Verhamme, Katia; Delporte, Anja; Demeyere, Bénédicte; Claeys, Geert; Boelens, Jerina; Padalko, Elizaveta; Verschakelen, Johny; Van Maele, Georges; Deschepper, Ellen; Joos, Guy F P

    2013-04-01

    Patients with severe asthma are at increased risk of exacerbations and lower respiratory tract infections (LRTI). Severe asthma is heterogeneous, encompassing eosinophilic and non-eosinophilic (mainly neutrophilic) phenotypes. Patients with neutropilic airway diseases may benefit from macrolides. We performed a randomised double-blind placebo-controlled trial in subjects with exacerbation-prone severe asthma. Subjects received low-dose azithromycin (n=55) or placebo (n=54) as add-on treatment to combination therapy of inhaled corticosteroids and long-acting β2 agonists for 6 months. The primary outcome was the rate of severe exacerbations and LRTI requiring treatment with antibiotics during the 26-week treatment phase. Secondary efficacy outcomes included lung function and scores on the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ). The rate of primary endpoints (PEPs) during 6 months was not significantly different between the two treatment groups: 0.75 PEPs (95% CI 0.55 to 1.01) per subject in the azithromycin group versus 0.81 PEPs (95% CI 0.61 to 1.09) in the placebo group (p=0.682). In a predefined subgroup analysis according to the inflammatory phenotype, azithromycin was associated with a significantly lower PEP rate than placebo in subjects with non-eosinophilic severe asthma (blood eosinophilia ≤200/µl): 0.44 PEPs (95% CI 0.25 to 0.78) versus 1.03 PEPs (95% CI 0.72 to 1.48) (p=0.013). Azithromycin significantly improved the AQLQ score but there were no significant between-group differences in the ACQ score or lung function. Azithromycin was well tolerated, but was associated with increased oropharyngeal carriage of macrolide-resistant streptococci. Azithromycin did not reduce the rate of severe exacerbations and LRTI in patients with severe asthma. However, the significant reduction in the PEP rate in azithromycin-treated patients with non-eosinophilic severe asthma warrants further study. CLINICALTRIALS.GOV NUMBER

  20. Antifatigue Effects of Panax ginseng C.A. Meyer: A Randomised, Double-Blind, Placebo-Controlled Trial

    Science.gov (United States)

    Yoo, Sa-Ra; Lee, Jin-Seok; Han, Jong-Min; Lee, Nam-Hun; Ahn, Yo-Chan; Son, Chang-Gue

    2013-01-01

    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, Pginseng 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, Pginseng 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 PMID:23613825

  1. Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Szakacs, Zoltan; Dauvilliers, Yves; Mikhaylov, Vladimir; Poverennova, Irina; Krylov, Sergei; Jankovic, Slavko; Sonka, Karel; Lehert, Philippe; Lecomte, Isabelle; Lecomte, Jeanne-Marie; Schwartz, Jean-Charles

    2017-03-01

    Histaminergic neurons are crucial to maintain wakefulness, but their role in cataplexy is unknown. We assessed the safety and efficacy of pitolisant, a histamine H3 receptor inverse agonist, for treatment of cataplexy in patients with narcolepsy. For this randomised, double-blind, placebo-controlled trial we recruited patients with narcolepsy from 16 sleep centres in nine countries (Bulgaria, Czech Republic, Hungary, Macedonia, Poland, Russia, Serbia, Turkey, and Ukraine). Patients were eligible if they were aged 18 years or older, diagnosed with narcolepsy with cataplexy according to version two of the International Classification of Sleep Disorders criteria, experienced at least three cataplexies per week, and had excessive daytime sleepiness (defined as an Epworth Sleepiness Scale score ≥12). We used a computer-generated sequence via an interactive web response system to randomly assign patients to receive either pitolisant or placebo once per day (1:1 ratio). Randomisation was done in blocks of four. Participants and investigators were masked to treatment allocation. Treatment lasted for 7 weeks: 3 weeks of flexible dosing decided by investigators according to efficacy and tolerance (5 mg, 10 mg, or 20 mg oral pitolisant), followed by 4 weeks of stable dosing (5 mg, 10 mg, 20 mg, or 40 mg). The primary endpoint was the change in the average number of cataplexy attacks per week as recorded in patient diaries (weekly cataplexy rate [WCR]) between the 2 weeks of baseline and the 4 weeks of stable dosing period. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01800045. The trial was done between April 19, 2013, and Jan 28, 2015. We screened 117 patients, 106 of whom were randomly assigned to treatment (54 to pitolisant and 52 to placebo) and, after dropout, 54 patients from the pitolisant group and 51 from the placebo group were included in the intention-to-treat analysis. The WCR during the stable dosing period

  2. The effect of azithromycin in adults with stable neutrophilic COPD: a double blind randomised, placebo controlled trial.

    Directory of Open Access Journals (Sweden)

    Jodie L Simpson

    Full Text Available Chronic Obstructive Pulmonary Disease (COPD is a progressive airway disease characterised by neutrophilic airway inflammation or bronchitis. Neutrophilic bronchitis is associated with both bacterial colonisation and lung function decline and is common in exacerbations of COPD. Despite current available therapies to control inflammation, neutrophilic bronchitis remains common. This study tested the hypothesis that azithromycin treatment, as an add-on to standard medication, would significantly reduce airway neutrophil and neutrophils chemokine (CXCL8 levels, as well as bacterial load. We conducted a randomised, double-blind, placebo-controlled study in COPD participants with stable neutrophilic bronchitis.Eligible participants (n = 30 were randomised to azithromycin 250 mg daily or placebo for 12 weeks in addition to their standard respiratory medications. Sputum was induced at screening, randomisation and monthly for a 12 week treatment period and processed for differential cell counts, CXCL8 and neutrophil elastase assessment. Quantitative bacteriology was assessed in sputum samples at randomisation and the end of treatment visit. Severe exacerbations where symptoms increased requiring unscheduled treatment were recorded during the 12 week treatment period and for 14 weeks following treatment. A sub-group of participants underwent chest computed tomography scans (n = 15.Nine participants with neutrophilic bronchitis had a potentially pathogenic bacteria isolated and the median total bacterial load of all participants was 5.22×107 cfu/mL. Azithromycin treatment resulted in a non-significant reduction in sputum neutrophil proportion, CXCL8 levels and bacterial load. The mean severe exacerbation rate was 0.33 per person per 26 weeks in the azithromycin group compared to 0.93 exacerbations per person in the placebo group (incidence rate ratio (95%CI: 0.37 (0.11,1.21, p = 0.062. For participants who underwent chest CT scans, no

  3. Homeopathy for Depression - DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study

    Directory of Open Access Journals (Sweden)

    Willich Stefan N

    2011-02-01

    Full Text Available Abstract Background Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remedy. Previous data suggest that individualized homeopathic Q-potencies were not inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. However, the question remains whether individualized homeopathic Q-potencies and/or the type of the homeopathic case history have a specific therapeutical effect in acute depression as this has not yet been investigated. The study aims to assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history. Methods/Design A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 × 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history. Discussion For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an

  4. Effect of melatonin on duration of delirium in organophosphorus compound poisoning patients: A double-blind randomised placebo controlled trial

    Directory of Open Access Journals (Sweden)

    H N Vijayakumar

    2016-01-01

    Full Text Available Background and Aims: Organophosphate compound poisoning (OPCP is associated with high incidence of delirium. Melatonin has been tried in the treatment of delirium and has shown a beneficial effect in OPCP. This study was conducted to know the effect of melatonin on duration of delirium and recovery profile in OPCP patients. Methods: Double-blind randomised placebo control trial in which 56 patients of OPCP confirmed by history and syndrome of OPCP with low plasma pseudocholinesterase, aged >18 years and weighing between 50 and 100 kg, and Acute Physiology and Chronic Health Evaluation II score of <20 were studied. Group M (n = 26 received tablet melatonin 3 mg and Group C (n = 30 received placebo tablet at 9 PM, every night throughout the Intensive Care Unit (ICU stay. Delirium was assessed using the Confusion Assessment Method for ICU, thrice a day. Sedation was provided with injection midazolam, fentanyl and lorazepam. Duration of mechanical ventilation, vital parameters, ICU stay, sedative and atropine requirement, were recorded. Results: The time taken to be delirium free was significantly lower in Group M (6 ± 2.92 days compared to Group C (9.05 ± 2.75 days (P = 0.001 and prevalence of delirium was significantly decreased in Group M compared to Group C from day 3 onwards. The requirement of midazolam (Group M - 2.98 ± 4.99 mg/day, Group C - 9.68 ± 9.17 mg/day, P < 0.001 and fentanyl (Group M - 94.09 ± 170.05 μg/day, Group C - 189.33 ± 156.38 μg/day, P = 0.03 decreased significantly in Group M. There was no significant difference in the average atropine consumption (P = 0.27, duration of mechanical ventilation (P = 0.26, ICU stay (P = 0.21 and the number of patients requiring mechanical ventilation (P = 0.50. Conclusion: Orally given melatonin in organophosphate compound poisoning patients reduces the duration of delirium and the requirement of sedation and analgesia.

  5. 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

  6. 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

  7. 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.

  8. Randomised double blind placebo controlled trial of prednisolone in children admitted to hospital with respiratory syncytial virus bronchiolitis

    NARCIS (Netherlands)

    van Woensel, JBM; Wolfs, TFW; vanAalderen, WMC; Brand, PLP; Kimpen, JLL

    Background - Experimental and clinical evidence suggests that respiratory syncytial virus (RSV) bronchiolitis is an immune mediated disease. Corticosteroids might therefore be effective in the treatment of RSV bronchiolitis. Methods - A randomised double blind trial was conducted in children up to

  9. Tramadol versus Celecoxib for reducing pain associated with outpatient hysteroscopy: a randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Hassan, A; Wahba, A; Haggag, H

    2016-01-01

    Which is better, Tramadol or Celecoxib, in reducing pain associated with outpatient hysteroscopy? Both Tramadol and Celecoxib are effective in reducing pain associated with outpatient hysteroscopy but Celecoxib may be better tolerated. Pain is the most common cause of failure of outpatient hysteroscopy. A systematic review and meta-analysis showed that local anaesthetics were effective in reducing pain associated with hysteroscopy but there was insufficient evidence to support the use of oral analgesics, opioids and non-steroidal anti-inflammatory drugs, to reduce hysteroscopy-associated pain and further studies were recommended. This was a randomized double-blind placebo-controlled trial with balanced randomization (allocation ratio 1:1:1) conducted in a university hospital from May 2014 to November 2014. Two hundred and ten women who had diagnostic outpatient hysteroscopy were randomly divided into three equal groups: Group 1 received oral Tramadol 100 mg, group 2 received Celecoxib 200 mg and group 3 received an oral placebo. All the drugs were given 1 h before the procedure. A patient's perception of pain was assessed during the procedure, immediately afterwards and 30 min after the procedure with the use of a visual analogue scale (VAS). There was a significant difference in the pain scores among the groups during the procedure, immediately afterwards and 30 min after the procedure (PTramadol had significantly lower pain scores when compared with the placebo during the procedure (mean difference = 1.54, 95% confidence interval (CI) (0.86, 2.22), P Tramadol and Celecoxib at any time. Time until no pain differed significantly among the groups (P = 0.01); it was shorter with both Tramadol and Celecoxib groups when compared with placebo (P = 0.002 and 0.046, respectively). The procedure failed to be completed in one patient in the placebo group but no failure to complete the procedure occurred in Tramadol and Celecoxib groups. Four women in the Tramadol group

  10. 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

  11. Intravenous lysine clonixinate for the acute treatment of severe migraine attacks: a double-blind, randomized, placebo-controlled study☆

    Science.gov (United States)

    Krymchantowski, Abouch Valenty; Silva, Marcus Tulius T

    2003-01-01

    Background Several nonsteroidal anti-inflammatory drugs (NSAIDs) have been shown to be effective in the treatment of migraine. However, few commercially available NSAIDs can be administered IV. Lysine clonixinate (LC), an NSAID derived from nicotinic acid, has been proved effective in various algesic syndromes (eg, renal colic, muscular pain, nerve compression, odontalgia). The oral formulation of LC has been shown to be effective in the treatment of migraine of moderate severity. Objective The aim of this study was to assess the efficacy and tolerability of the IV formulation of LC in the treatment of severe migraine. Methods This double-blind, randomized, placebo-controlled, prospective study enrolled patients with severe migraine (without aura) as defined by the criteria of the International Headache Society. When patients presented to a neurology hospital with an outpatient headache unit (Instituto de Neurologia Deolindo Couto, Rio de Janeiro, Brazil) with a severe migraine attack that had lasted <4 hours, they were randomized to 1 of 2 groups (IV placebo [25 mL of 0.9% saline] or IV LC [21 mL of 0.9% saline plus 4 mL of LC 200 mg]). Headache intensity and adverse effects (AEs) were assessed before (0 minute) and 30, 60, and 90 minutes after study drug administration. Rescue medication was available 2 hours after study drug administration, and its use was compared between groups. Results Thirty-two patients (23 women, 9 men; mean [SD] age, 32 [2] years; range, 18–58 years) entered the study. Twenty-nine patients (21 women, 8 men; mean [SD] age, 32 [2] years; range, 18–56 years) completed the study. Three patients (all in the placebo group) did not complete the study (1 patient was unable to rate the pain severity after drug administration and 2 patients refused IV drug administration). Among study completers, 17 patients received LC and 12 placebo. At 30 minutes, 1 patient (8.3%) in the placebo group and 5 patients (29.4%) in the LC group were pain free

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

    Directory of Open Access Journals (Sweden)

    Srinivasan Maheswari G

    2012-02-01

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

  13. 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

    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......, 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-...

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

    OpenAIRE

    2014-01-01

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

  15. Gabapentin monotherapy for the symptomatic treatment of painful neuropathy: a multicenter, double-blind, placebo-controlled trial in patients with diabetes mellitus.

    Science.gov (United States)

    Backonja, M M

    1999-01-01

    Pain is the most disturbing symptom of diabetic neuropathy. Traditionally this type of pain was treated with tricyclic antidepressants which frequently have many side effects. In the study reported here, gabapentin was administered in escalating doses up to 3600 mg per day to eligible patients with moderate to severe diabetic neuropathy pain in a double blind placebo controlled fashion. Gabapentin provided superior and significant pain relief over placebo. In addition, patients taking gabapentin had improvement of sleep scores and a number of items on mood and quality of life questionnaires. Gabapentin was tolerated well with mild and tolerable side effects.

  16. 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......) or 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...

  17. Analgesic and sedative effects of perioperative gabapentin in total knee arthroplasty A randomized, double-blind, placebo-controlled, dose-finding study

    DEFF Research Database (Denmark)

    Lunn, Troels Haxholdt; Husted, Henrik; Laursen, Mogens Berg

    2015-01-01

    Gabapentin has shown acute postoperative analgesic effects, but the optimal dose and procedure-specific benefits vs harm have not been clarified. In this randomized, double-blind, placebo-controlled dose-finding study, 300 opioid-naive patients scheduled for total knee arthroplasty were randomized......, and the secondary outcome was sedation 6 hours after surgery. Other outcomes were overall pain during well-defined mobilizations and at rest and sedation during the first 48 hours and from days 2-6, morphine use, anxiety, depression, sleep quality, and nausea, vomiting, dizziness, concentration difficulty, headache...

  18. 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...... (Zyban) compared with placebo as an aid to smoking cessation in health care workers. A total of 336 hospital employees who smoked at least 10 cigarettes daily were randomized (2:1) to 7 weeks of treatment with bupropion (n=222) or placebo (n=114). All participants were motivated to quit smoking......% in the bupropion group and 18% in the placebo group, pinsomnia, and pruritus appeared...

  19. 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,

  20. 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

  1. Randomised double blind placebo controlled trial of prednisolone in children admitted to hospital with respiratory syncytial virus bronchiolitis

    NARCIS (Netherlands)

    van Woensel, JBM; Wolfs, TFW; vanAalderen, WMC; Brand, PLP; Kimpen, JLL

    1997-01-01

    Background - Experimental and clinical evidence suggests that respiratory syncytial virus (RSV) bronchiolitis is an immune mediated disease. Corticosteroids might therefore be effective in the treatment of RSV bronchiolitis. Methods - A randomised double blind trial was conducted in children up to t

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

    Directory of Open Access Journals (Sweden)

    Geraghty Dominic P

    2008-03-01

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

  3. Suspected Nonceliac Gluten Sensitivity Confirmed in Few Patients After Gluten Challenge in Double-Blind, Placebo-Controlled Trials.

    Science.gov (United States)

    Molina-Infante, Javier; Carroccio, Antonio

    2017-03-01

    A double-blind, placebo-controlled, gluten challenge has been proposed to confirm a diagnosis of nonceliac gluten sensitivity (NCGS) in patients without celiac disease who respond to a gluten-free diet. To determine the accuracy of this approach, we analyzed data from 10 double-blind, placebo-controlled, gluten-challenge trials, comprising 1312 adults. The studies varied in the duration of the challenge (range, 1 d to 6 wk), daily doses for the gluten challenge (range, 2-52 g; 3 studies administered gluten-free products, xylose, whey protein, rice, or corn starch containing fermentable carbohydrates). Most of the studies found gluten challenge to significantly increase symptom scores compared with placebo. However, only 38 of 231 NCGS patients (16%) showed gluten-specific symptoms. Furthermore, 40% of these subjects had a nocebo response (similar or increased symptoms in response to placebo). These findings reveal heterogeneity and potential methodology flaws among studies of gluten challenge, cast doubt on gluten as the culprit food component in most patients with presumptive NCGS, and highlight the importance of the nocebo effect in these types of studies. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

  4. Examining the nootropic effects of a special extract of Bacopa monniera on human cognitive functioning: 90 day double-blind placebo-controlled randomized trial.

    Science.gov (United States)

    Stough, Con; Downey, Luke A; Lloyd, Jenny; Silber, Beata; Redman, Stephanie; Hutchison, Chris; Wesnes, Keith; Nathan, Pradeep J

    2008-12-01

    While Ayurvedic medicine has touted the cognitive enhancing effects of Bacopa monniera for centuries, there is a need for double-blind placebo-controlled investigations. One hundred and seven healthy participants were recruited for this double-blind placebo-controlled independent group design investigation. Sixty-two participants completed the study with 80% treatment compliance. Neuropsychological testing using the Cognitive Drug Research cognitive assessment system was conducted at baseline and after 90 days of treatment with a special extract of Bacopa monniera (2 x 150 mg KeenMind) or placebo. The Bacopa monniera product significantly improved performance on the 'Working Memory' factor, more specifically spatial working memory accuracy. The number of false-positives recorded in the Rapid visual information processing task was also reduced for the Bacopa monniera group following the treatment period. The current study provides support for the two other published studies reporting cognitive enhancing effects in healthy humans after a 90 day administration of the Bacopa monniera extract. Further studies are required to ascertain the effective dosage range, the time required to attain therapeutic levels and the effects over a longer term of administration.

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

    Directory of Open Access Journals (Sweden)

    Robério Dias LEITE

    2013-03-01

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

  6. 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.

  7. Fusidic acid cream in the treatment of impetigo in general practice: double blind randomised placebo controlled trial

    NARCIS (Netherlands)

    S. Koning (Sander); L.W.A. van Suijlekom-Smit (Lisette); J.L. Nouwen (Jan); C.M. Verduin (Cees); R.M.D. Bernsen (Roos); A.P. Oranje (Arnold); S. Thomas (Siep); J.C. van der Wouden (Hans)

    2002-01-01

    textabstractOBJECTIVE: To test the hypothesis that fusidic acid would not increase the treatment effect of disinfecting with povidone-iodine alone in children with impetigo. DESIGN: Randomised placebo controlled trial. SETTING: General practices in Greater Rotterdam. PARTICIPANTS:

  8. Fusidic acid cream in the treatment of impetigo in general practice: double blind randomised placebo controlled trial

    NARCIS (Netherlands)

    S. Koning (Sander); L.W.A. van Suijlekom-Smit (Lisette); J.L. Nouwen (Jan); C.M. Verduin (Cees); R.M.D. Bernsen (Roos); A.P. Oranje (Arnold); S. Thomas (Siep); J.C. van der Wouden (Hans)

    2002-01-01

    textabstractOBJECTIVE: To test the hypothesis that fusidic acid would not increase the treatment effect of disinfecting with povidone-iodine alone in children with impetigo. DESIGN: Randomised placebo controlled trial. SETTING: General practices in Greater Rotterdam. PARTICIPANTS:

  9. Efficacy and safety of suanzaoren decoction for chronic insomnia disorder in adults: study protocol for randomised, double-blind, double-dummy, placebo-controlled trial

    Science.gov (United States)

    Zhou, Qi-Hui; Wang, Hui-Lin; Zhou, Xiao-Li; Xu, Meng-Bei; Zhang, Hong-feng; Huang, Li-bo; Lin, Yan

    2017-01-01

    Background Insomnia disorder is defined as a combination of dissatisfaction with sleep quantity or quality and a significant negative impact on daytime functioning. Chronic insomnia disorder refers to clinical symptoms of persistent insomnia at least three nights a week for at least 3 months. Prevalence estimates of insomnia disorder range from 12% to 20% in the adult population, with approximately 50% having a chronic course. The potential side effects of hypnotic medications hinder their clinical application. Thus, traditional Chinese medicine is considered as an alternative option for treating insomnia. Objective To evaluate the efficacy and safety of suanzaoren decoction (SZRD), a classic Chinese herbal prescription, for adult chronic insomnia disorder. Methods/analysis This is a randomised, double-blind, double-dummy, placebo-controlled clinical trial. A total of 150 patients with chronic insomnia disorder are randomised, allocated in a ratio of 1:1:1 to three groups: intervention group, control group and placebo group. The intervention group receives SZRD granule plus zolpidem tartrate (ZT) placebo; the control group receives ZT tablet plus SZRD granule placebo; and the placebo group receives ZT placebo and SZRD granule placebo. The patients receive medicine or placebo for 5 weeks and are followed up at 20 weeks. The primary outcome measures are polysomnography and Pittsburgh Sleep Quality Index. Secondary outcome measures are the Insomnia Severity Index, sleep diary and safety assessment. Outcomes will be assessed at baseline and after treatment. Trial registration number ChiCTR-IOR-16009198. pre-results. PMID:28377394

  10. A randomised, double-blind, placebo-controlled trial of Trichuris suis ova (TSO) in active Crohn's disease

    DEFF Research Database (Denmark)

    Schölmerich, Jürgen; Fellermann, Klaus; Seibold, Frank W

    2016-01-01

    BACKGROUND & AIMS: To investigate the efficacy and safety of three different dosages of embryonated, viable eggs of Trichuris suis (TSO) versus placebo for induction of remission in mildly-to-moderately active ileocolonic, uncomplicated Crohn's disease (CD). METHODS: Adults with active CD (n=252......) randomly received six fortnightly doses of 250, 2500 or 7500 TSO/15 ml suspension/day (TSO 250, TSO 2500, TSO 7500), or 15ml placebo solution/day, in a double-blind fashion, with four weeks' follow-up. Primary endpoint was the rate of clinical remission (Crohn's disease activity index [CDAI

  11. Acrivastine versus terfenadine in the treatment of symptomatic dermographism--a double-blind, placebo-controlled study.

    Science.gov (United States)

    Boyle, J; Marks, P; Gibson, J R

    1989-01-01

    Twelve patients with symptomatic dermographism were entered into a double-blind, crossover study. Patients received 8 mg acrivastine three times daily, 60 mg terfenadine three times daily or placebo, according to a fully randomized balanced treatment plan. Subjective clinical assessments were performed and the response to experimentally induced dermographism was assessed. Both active treatments were well tolerated and were shown to be significantly more effective than placebo in the treatment of symptomatic dermographism and in reducing the signs and symptoms of wealing induced by a dermographometer.

  12. 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....

  13. Transient improvement of poststroke apathy with zolpidem: a single-case, placebo-controlled double-blind study

    Science.gov (United States)

    Autret, Katell; Arnould, Annabelle; Mathieu, Sarah; Azouvi, Philippe

    2013-01-01

    We report the case of a 44-year-old patient with severe and disabling apathy nearly 2 years after a right hemisphere haemorrhagic stroke. The effect of a single dose of zolpidem was tested over a 2-week period, in alternation with either no treatment or a placebo in a double-blind randomised trial. Zolpidem was associated with a dramatic improvement in apathy, as assessed with the Apathy Inventory and the Behavioral Dysexecutive Syndrome Inventory. No adverse effect occurred during the trial. PMID:23396925

  14. L-carnitine supplementation in patients with advanced cancer and carnitine deficiency: a double-blind, placebo-controlled study.

    Science.gov (United States)

    Cruciani, Ricardo A; Dvorkin, Ella; Homel, Peter; Culliney, Bruce; Malamud, Stephen; Lapin, Jeanne; Portenoy, Russell K; Esteban-Cruciani, Nora

    2009-04-01

    Carnitine deficiency is prevalent in populations with chronic illness, including cancer. In a recent open-label study, L-carnitine supplementation was well tolerated and appeared to improve fatigue and other outcomes in cancer patients. To further evaluate this finding, adult patients with advanced cancer, carnitine deficiency (free carnitine more than 35 micromol/L for males or less than 25 micromol/L for females, or acyl/free carnitine ratio of more than 0.4), moderate to severe fatigue, and a Karnofsky Performance Status (KPS) score of 50 or more, were randomly assigned to receive either L-carnitine (0.5 g/day for two days, followed by 1g/day for two days, and then 2g/day for 10 days) or placebo. This double-blind phase was followed by an open-label phase, during which all patients received L-carnitine supplementation for two weeks. Outcomes included the fatigue subscale of the Functional Assessment of Cancer Therapy-Anemia (FACT-An), the Linear Analog Scale Assessments (LASA), the Mini-Mental State Exam (MMSE), and the KPS. Twenty-nine patients (12 placebo, 17 L-carnitine) were included in the intent-to-treat (ITT) analysis. From baseline to the end of the double-blind phase, serum total and free L-carnitine increased from 32.9+/-3.8 to 56.6+/-20.5 (P=0.004), and from 22.9+/-19.4 to 45.3+/-17.2 (P=0.004), respectively, in the L-carnitine-treated group, and from 28.2+/-10.2 to 36.2+/-8.7 (P=ns), and from 22.6+/-7.9 to 28.7+/-8.6 (P=ns) in the placebo group, respectively. The planned ITT analysis revealed no significant improvement in any of the study's endpoints, and these negative findings were not different when data from two patients who did not adhere to the protocol were eliminated. However, an exploratory covariate analysis that excluded these two protocol violators and included outcome data from both the double-blind and open-label phases demonstrated significantly improved fatigue on the FACT-An fatigue subscale (Pcarnitine during the double-blind phase

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

    Science.gov (United States)

    2011-01-01

    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 treatments were well-tolerated. 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. PMID:21958958

  16. Dexmedetomidine oromucosal gel for noise-associated acute anxiety and fear in dogs-a randomised, double-blind, placebo-controlled clinical study.

    Science.gov (United States)

    Korpivaara, M; Laapas, K; Huhtinen, M; Schöning, B; Overall, K

    2017-04-08

    The aim of this randomised, double-blind, placebo-controlled, clinical-field study was to evaluate the effect of dexmedetomidine oromucosal gel at subsedative doses in alleviation of noise-associated acute anxiety and fear in dogs. On New Year's Eve, 182 dogs with a history of acute anxiety and fear associated with fireworks received treatment as needed up to five times: 89 dogs received dexmedetomidine and 93 dogs received placebo. For the primary efficacy variables, dog owners assessed the overall treatment effect as well as signs and extent of anxiety and fear. The overall treatment effect was statistically significant (Pfear and anxiety despite the noise of fireworks. No local tolerance or clinical safety concerns occurred during the study. This study demonstrated that oromucosal dexmedetomidine at subsedative doses alleviates noise-associated acute anxiety and fear in dogs. British Veterinary Association.

  17. No Effect of a Homeopathic Preparation on Neonatal Calf Diarrhoea in a Randomised Double-Blind, Placebo-Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Alenius S

    2003-06-01

    Full Text Available A double-blind, placebo-controlled clinical trial of a homeopathic treatment of neonatal calf diarrhoea was performed using 44 calves in 12 dairy herds. Calves with spontaneously derived diarrhoea were treated with either the homeopathic remedy Podophyllum (D30 (n = 24 or a placebo (n = 20. No clinically or statistically significant difference between the 2 groups was demonstrated. Calves treated with Podophyllum had an average of 3.1 days of diarrhoea compared with 2.9 days for the placebo group. Depression, inappetence and fever were presented equally in the 2 groups. These results support the widely held opinion that scientific proof for the efficacy of veterinary homeopathy is lacking. In the European Union this implies a considerable risk for animal welfare, since in some countries priority is given to homeopathic treatments in organic farming.

  18. 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

    (Zyban) compared with placebo as an aid to smoking cessation in health care workers. A total of 336 hospital employees who smoked at least 10 cigarettes daily were randomized (2:1) to 7 weeks of treatment with bupropion (n=222) or placebo (n=114). All participants were motivated to quit smoking......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...... more frequently in the bupropion group than in the placebo group. Bupropion was effective as an aid to smoking cessation in a broad group of hospital employees in Denmark....

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

    DEFF Research Database (Denmark)

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

    2006-01-01

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

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

    Science.gov (United States)

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

    2015-10-01

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

  1. Therapeutic effect of pirenzepine for clozapine-induced hypersalivation: a randomized, double-blind, placebo-controlled, cross-over study.

    Science.gov (United States)

    Bai, Y M; Lin, C C; Chen, J Y; Liu, W C

    2001-12-01

    The objective of this study was to investigate the efficacy of pirenzepine in the treatment of clozapine-induced hypersalivation. Pirenzepine is reported to counteract hypersalivation by its selective antagonistic activity on the M4-muscarinic receptor, which is stimulated by clozapine. Twenty patients with clozapine-induced hypersalivation underwent a random-order, double-blind, placebo-controlled, cross-over trial which lasted 8 weeks each for the pirenzepine and placebo investigations, with a 4-week washout period in between. The severity of hypersalivation was assessed using an objective measure: saliva production monitored through the diameter of wetted surface on tissue paper placed over the patient's pillow. Our study showed that pirenzepine had no significant therapeutic effect on hypersalivation compared with placebo, suggesting that hypersalivation induced by clozapine might have a neurobiological basis other than the M4-muscarinic receptor.

  2. Antihyperalgesic efficacy of 5% lidocaine medicated plaster in capsaicin and sunburn pain models--two randomized, double-blinded, placebo-controlled crossover trials in healthy volunteers.

    Science.gov (United States)

    Gustorff, Burkhard; Hauer, David; Thaler, Johannes; Seis, Astrid; Draxler, Julia

    2011-12-01

    The aim of this research is to analyze analgesic efficacy of the 5% lidocaine medicated plaster in two randomized, double-blinded, placebo-controlled, crossover studies in 16 healthy volunteers using capsaicin and sunburn pain models. Lidocaine and placebo plasters were simultaneously applied to forearms and thighs at contralateral body sites for three alternating 12-h plaster-on/plaster-off periods. Between the second and third plaster-on period, 4.2-cm circular spots on both pretreated thighs were irradiated with three times the individual minimal erythema dose of UVB light. After the last plaster-on period, 20 μl of 0.1% capsaicin was injected intradermally into both forearms. The study was repeated using a single 12-h plaster application. The area of pinprick hyperalgesia was diminished by 53% (p plaster effectively treats mechanical hyperalgesia and cold pain.

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

    Directory of Open Access Journals (Sweden)

    Beyrer Julie

    2008-01-01

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

  4. 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.

  5. A randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, and pharmacokinetics of single enantiomer (+)-mefloquine compared with racemic mefloquine in healthy persons.

    Science.gov (United States)

    Tansley, Robert; Lotharius, Julie; Priestley, Anthony; Bull, Fiona; Duparc, Stephan; Möhrle, Jörg

    2010-12-01

    Racemic mefloquine is a highly effective antimalarial whose clinical utility has been compromised by its association with neuropsychiatric and gastrointestinal side effects. It is hypothesized that the cause of the side effects may reside in the (-) enantiomer. We sought to compare the safety, tolerability and pharmacokinetic profile of (+)-mefloquine with racemic mefloquine in a randomized, ascending-dose, double-blind, active and placebo-controlled, parallel cohort study in healthy male and female adult volunteers. Although differing in its manifestations, both study drugs displayed a substantially worse tolerability profile compared with placebo. The systemic clearance was slower for (-)-mefloquine than (+)-mefloquine. Thus, (+)-mefloquine has a different safety and tolerability profile compared with racemic mefloquine but its global safety profile is not superior and replacement of the currently used antimalarial drug with (+)-mefloquine is not warranted.

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

    DEFF Research Database (Denmark)

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

    1998-01-01

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

  7. The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study

    DEFF Research Database (Denmark)

    Gerhardsen, G.; Hansen, A.V.; Killi, M.

    2008-01-01

    Introduction: A double-blind, placebo-controlled, randomised, parallel-group, multicentre study was conducted to evaluate the effect of a pollen-based herbal medicinal product, Femal (R) (Sea-Band Ltd, Leicestershire, UK), on premenstrual sleep disturbances (PSD) in women with premenstrual syndrome...... (PMS). Methods: Femal, 160 mg twice-daily, was given for four menstrual cycles to 50 women, and placebo to 51 women. PSD were evaluated on a visual analogue scale prior to and after the four cycles. The effect on overall PMS symptoms was assessed with the Steiner premenstrual tension syndrome (PMTS......) self-rating questionnaire. The results were analysed statistically based on intention to treat. Results: Femal treatment resulted in a significant reduction in PSD (P 0.05). In a subgroup analysis of women with irritability as their main PMS...

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

    DEFF Research Database (Denmark)

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

    2006-01-01

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

  9. Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year

    DEFF Research Database (Denmark)

    Jørgensen, Anette; Stengaard-Pedersen, Kristian; Simonsen, Lars Ole;

    2010-01-01

    Objective To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis. Methods A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee...... efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention...... to treat (ITT) and per protocol (PP). All adverse events (AE) were recorded as safety parameters. Results Time to recurrence showed no significant treatment effect (ITT analysis, p = 0.26). Change from baseline in LFI and VAS pain 50 m for the ITT population showed no treatment effect. Paracetamol...

  10. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Fox, Kim; Ford, Ian; Steg, P Gabriel

    2008-01-01

    BACKGROUND: Ivabradine specifically inhibits the I(f) current in the sinoatrial node to lower heart rate, without affecting other aspects of cardiac function. We aimed to test whether lowering the heart rate with ivabradine reduces cardiovascular death and morbidity in patients with coronary artery......, double-blind, placebo-controlled, parallel-group trial. 5479 patients received 5 mg ivabradine, with the intention of increasing to the target dose of 7.5 mg twice a day, and 5438 received matched placebo in addition to appropriate cardiovascular medication. The primary endpoint was a composite.......9) beats per minute (bpm). Median follow-up was 19 months (IQR 16-24). Ivabradine reduced heart rate by 6 bpm (SE 0.2) at 12 months, corrected for placebo. Most (87%) patients were receiving beta blockers in addition to study drugs, and no safety concerns were identified. Ivabradine did not affect...

  11. The effect of dipeptidyl peptidase 4 inhibition on gastric volume, satiation and enteroendocrine secretion in Type 2 diabetes: a double blind, placebo-controlled crossover study

    DEFF Research Database (Denmark)

    Vella, Adrian; Bock, Gerlies; Giesler, Paula D

    2008-01-01

    with type 2 diabetes. Methods: In a double blind, placebo-controlled crossover design, 14 subjects with type 2 diabetes received vildagliptin (50mg bid) or placebo for 10-days in random order separated by a 2-week washout. On day 7, fasting and post-meal gastric volumes were measured by a (99m......)Tc-SPECT method. On day 8, a liquid Ensure((R)) meal was consumed at 30 ml/min, and maximum tolerated volume (MTV) as well as symptoms 30 minutes later were measured using visual analog scales (VAS) to assess effects on satiation. On day 10, subjects ingested water till maximum satiation was achieved. Volume...... pmol/l, p= 0.01) Conclusions: vildagliptin does not alter satiation or gastric volume in people with type 2 diabetes despite elevated GLP-1 concentrations. Compensatory changes in enteroendocrine secretion could account for the lack of gastrointestinal symptoms....

  12. Beneficial effects of artichoke leaf extract supplementation on increasing HDL-cholesterol in subjects with primary mild hypercholesterolaemia: a double-blind, randomized, placebo-controlled trial.

    Science.gov (United States)

    Rondanelli, Mariangela; Giacosa, Attilio; Opizzi, Annalisa; Faliva, Milena Anna; Sala, Patrizio; Perna, Simone; Riva, Antonella; Morazzoni, Paolo; Bombardelli, Ezio

    2013-02-01

    The aim of this study was to evaluate the effects of artichoke leaf extract (ALE) supplementation (250 mg, 2 b.i.d.) on the lipid pattern. A randomized, double-blind, placebo-controlled clinical trial was performed on 92 overweight subjects with primary mild hypercholesterolaemia for 8 weeks. Forty-six subjects were randomized to supplementation (age: 54.2 ± 6.6 years, body mass index (BMI): 25.8 ± 3.9 kg/m(2), male/female: 20/26) and 46 subjects to placebo (age: 53.8 ± 9.0 years, BMI: 24.8 ± 1.6 kg/m(2), male/female: 21/25). Verum supplementation was associated with a significant increase in mean high-density lipoprotein (HDL)-cholesterol (p hypercholesterolaemia, favouring in particular the increase in HDL-C, besides decreasing total cholesterol and LDL-cholesterol.

  13. 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.

  14. Inverse Effects of Oxytocin on Attributing Mental Activity to Others in Depressed and Healthy Subjects: A Double-Blind Placebo Controlled fMRI Study.

    Directory of Open Access Journals (Sweden)

    David Pincus

    2010-10-01

    Full Text Available Background: Oxytocin is a stress-attenuating and pro-social neuropeptide. To date, no study has looked at the effects of oxytocin in modulating brain activity in depressed individuals nor attempted to correlate this activity with attribution of mental activity in others. Method: We enrolled 10 unmedicated depressed adults and 10 matched healthy controls in a crossover, double blind placebo controlled fmri 40 i.u. intra-nasal oxytocin study (20 i.u. per nostril. Each subject performed Reading the Mind in the Eyes task (RMET before and after inhalation of oxytocin or placebo control for a total of 80 scans. Results: Before oxytocin administration, RMET engaged medial and lateral prefrontal cortex, amygdala, insula and associative areas. Depressed subjects showed increased anterior ventral activation for the RMET minus gender identification contrast whereas matched controls showed increased dorsal and frontal activity. Compared to placebo, oxytocin in depressed subjects showed increased activity in the superior middle frontal gyrus and insula, while controls exhibited more activity in ventral regions. Oxytocin also led to inverse effects in reaction times on attribution task between groups, with controls getting faster and depressed individuals slower to respond. Conclusion: Depression is associated with increased paralimbic activity during emotional mental attribution of others, appearing to be distinctly modulated by oxytocin when compared to healthy controls. Further studies are needed to explore long-term exposure to pro-social neuropeptides on mood in depressed populations and assess their clinical relevance.

  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

    2014-11-05

    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.

  16. Results of a double-blind, placebo-controlled pharmacotherapy trial in alcoholism conducted in Germany and comparison with the US COMBINE study.

    Science.gov (United States)

    Mann, Karl; Lemenager, Tagrid; Hoffmann, Sabine; Reinhard, Iris; Hermann, Derik; Batra, Anil; Berner, Michael; Wodarz, Norbert; Heinz, Andreas; Smolka, Michael N; Zimmermann, Ulrich S; Wellek, Stefan; Kiefer, Falk; Anton, Raymond F

    2013-11-01

    The results of placebo-controlled trials (RCTs) with acamprosate or naltrexone vary substantially. Those differences have been attributed to differing patient characteristics, recruitment strategies, treatment settings and remuneration systems. We tested these assumptions by comparing a new double-blind, placebo-controlled randomized trial conducted in Germany (called PREDICT Study) with data from the US COMBINE Study. PREDICT was designed according to the protocol of the COMBINE Study. A total of 426 alcohol-dependent patients were compared to 459 COMBINE Study patients corresponding to the treatment cells in PREDICT. All patients received acamprosate, naltrexone or placebo for 3 months (PREDICT) or 4 months (COMBINE). Biweekly manualized 'medical management' to enhance compliance was delivered in both studies. Time until the first occurrence of heavy drinking was the main outcome measure. PREDICT found neither acamprosate nor naltrexone to supply any additional benefit compared with placebo, which is at variance with a positive naltrexone effect being reported in the COMBINE Study. A secondary comparison between both studies showed better overall treatment outcomes in PREDICT, although these patients had been more severely affected than their COMBINE counterparts. The divergence in results may be attributable to basic differences in the treatment environments (such as in-patient pre-treatment versus primary outpatient care). We suggest that identically designed RCTs conducted in different parts of the world may help improve the external validity of RCTs. This approach could be called 'comparative efficacy research'.

  17. Effect of oral administration of freshly pressed juice of Echinacea purpurea on the number of various subpopulations of B- and T-lymphocytes in healthy volunteers: results of a double-blind, placebo-controlled cross-over study

    DEFF Research Database (Denmark)

    Schwarz, Evelyn; Parlesak, Alexandr; Henneicke-von-Zeppelin, H. H.;

    2005-01-01

    BACKGROUND: In a recent double-blind placebo-controlled crossover-study the "immune stimulatory" effects (activation of macrophages leading to enhanced phagocytosis and production of several cytokines) of Echinacea purpurea preparations (EPP) which were observed in vitro experiments and following......-40 years) participated in the study. They received either a commercially available pressed juice of E. purpurea herbs or placebo juice using a double-blind placebo-controlled cross-over design with two treatment periods of 14 days. The total number of lymphocytes and 12 subgroups of lymphocytes were...

  18. 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

    2013-01-01

    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.

  19. 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.

  20. A Phase 3 Placebo-Controlled, Double Blind, Multi-Site Trial of the alpha-2-adrenergic Agonist, Lofexidine, for Opioid Withdrawal

    Science.gov (United States)

    Yu, Elmer; Miotto, Karen; Akerele, Evaristo; Montgomery, Ann; Elkashef, Ahmed; Walsh, Robert; Montoya, Ivan; Fischman, Marian W.; Collins, Joseph; McSherry, Frances; Boardman, Kathy; Davies, David K.; O’Brien, Charles P.; Ling, Walter; Kleber, Herbert; Herman, Barbara H.

    2008-01-01

    Context Lofexidine is an alpha-2-A noradrenergic receptor agonist that is approved in the United Kingdom for the treatment of opioid withdrawal symptoms. Lofexidine has been reported to have more significant effects on decreasing opioid withdrawal symptoms with less hypotension than clonidine. Objective To demonstrate that lofexidine is well tolerated and effective in the alleviation of observationally-defined opioid withdrawal symptoms in opioid dependent individuals undergoing medically supervised opioid detoxification as compared to placebo. Design An inpatient, Phase 3, placebo-controlled, double blind, randomized multi-site trial with three phases: (1) Opioid Agonist Stabilization Phase (days 1–3), (2) Detoxification/Medication or Placebo Phase (days 4–8), and (3) Post Detoxification/Medication Phase (days 9–11). Subjects Sixty-eight opioid dependent subjects were enrolled at three sites with 35 randomized to lofexidine and 33 to placebo. Main Outcome Measure Modified Himmelsbach Opiate Withdrawal Scale (MHOWS) on study day 5 (2nd opioid detoxification treatment day). Results Due to significant findings, the study was terminated early. On the study day 5 MHOWS, subjects treated with lofexidine had significantly lower scores (equating to fewer/less severe withdrawal symptoms) than placebo subjects (Least squares means 19.5 ± 2.1 versus 30.9 ± 2.7; p=0.0019). Lofexidine subjects had significantly better retention in treatment than placebo subjects (38.2% versus 15.2%; Log rank test p=0.01). Conclusions Lofexidine is well tolerated and more efficacious than placebo for reducing opioid withdrawal symptoms in inpatients undergoing medically supervised opioid detoxification. Trial Registration trial registry name A Phase 3 Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal, registration number NCT00032942, URL for the registry http://clinicaltrials.gov/ct/show/NCT00032942?order=4. PMID:18508207

  1. Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

    Science.gov (United States)

    Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

    2014-09-06

    This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

  2. Prophylactic use of pregabalin for prevention of succinylcholine-induced fasciculation and myalgia: a randomized, double-blinded, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Vinit K. Srivastava

    2016-04-01

    Full Text Available ABSTRACT BACKGROUND: Succinylcholine is commonly used to achieve profound neuromuscular blockade of rapid onset and short duration. OBJECTIVE: The present study compared the efficacy of pregabalin for prevention of succinylcholine-induced fasciculation and myalgia. DESIGN: Prospective, randomized, placebo controlled, double blinded study. MATERIALS AND METHODS: Patients of both genders undergoing elective spine surgery were randomly assigned to two groups. Patients in Group P (pregabalin group received 150 mg of pregabalin orally 1 h prior to induction of anesthesia with sips of water and patients in Group C (control group received placebo. Anesthesia was induced with fentanyl 1.5 mcg/kg, propofol 1.5-2.0 mg/kg followed by succinylcholine 1.5 mg/kg. The intensity of fasciculations was assessed by an observer blinded to the group allotment of the patient on a 4-point scale. A blinded observer recorded postoperative myalgia grade after 24 h of surgery. Patients were provided patient-controlled analgesia with fentanyl for postoperative pain relief. RESULTS: Demographic data of both groups were comparable (p > 0.05. The incidence of muscle fasciculation's was not significant between two groups (p = 0.707, while more patients in group C had moderate to severe fasciculation's compared to group P (p = 0.028. The incidence and severity of myalgia were significantly lower in group P (p < 0.05. CONCLUSION: Pregabalin 150 mg prevents succinylcholine-induced fasciculations and myalgia and also decreases the fentanyl consumption in elective sine surgery.

  3. Novel Form of Curcumin Improves Endothelial Function in Young, Healthy Individuals: A Double-Blind Placebo Controlled Study

    Science.gov (United States)

    Stoner, Lee; Rowlands, David S.; Caldwell, Aaron R.; Sanders, Elizabeth; Kreutzer, Andreas; Mitchell, Joel B.; Purpura, Martin; Jäger, Ralf

    2016-01-01

    Curcumin, a turmeric extract, may protect against cardiovascular diseases by enhancing endothelial function. In this randomized controlled double-blind parallel prospective study, fifty-nine healthy adults were assigned to placebo, 50 mg (50 mg), or 200 mg (200 mg) curcumin, for 8 weeks. The higher curcumin (200 mg) supplementation produced a dose-mediated improvement in endothelial function measured by flow-mediated dilation (FMD). The outcome was a clinically substantial 3.0% increase (90% CI 0.7 to 5.3%, p = 0.032; benefit : harm odds ratio 546 : 1) with the 200 mg dose, relative to placebo. The 50 mg dose also increased FMD relative to placebo by 1.7% (−0.6 to 4.0%, p = 0.23; 25 : 1), but the outcome was not clinically decisive. In apparently healthy adults, 8 weeks of 200 mg oral curcumin supplementation resulted in a clinically meaningful improvement in endothelial function as measured by FMD. Oral curcumin supplementation may present a simple lifestyle strategy for decreasing the risk of cardiovascular diseases. This trial was registered at ISRCTN registry (ISRCTN90184217). PMID:27630772

  4. 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.

  5. Clonidine premedication in patients with sleep apnea syndrome: a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Pawlik, Michael T; Hansen, Ernil; Waldhauser, Daniela; Selig, Christoph; Kuehnel, Thomas S

    2005-11-01

    Patients with sleep apnea often present with cardiac diseases and breathing difficulties, with a high risk of postoperative respiratory depression. We conducted a randomized, double-blind, prospective study in 30 adult patients with obstructive sleep apnea, undergoing elective ear-nose-throat surgery. The patients were randomly assigned to receive placebo or clonidine (2 microg/kg oral) the night before and the next morning 2 h before surgery. Spo2, heart rate, mean arterial blood pressure, snoring, and oronasal airflow were monitored for 36 h. A standard anesthesia was used consisting of propofol and remifentanil. Anesthetic drug consumption, postoperative analgesics, and pain score were recorded. In the clonidine group, mean arterial blood pressures were significantly lower during induction, operation, and emergence from anesthesia. Both propofol dose required for induction (190 +/- 32.2 mg) and anesthesia (6.3 +/- 1.3 mg . kg(-1).h(-1)) during surgery were significantly reduced in the clonidine group compared with the placebo group (induction 218 +/- 32.4, anesthesia 7.70 +/- 1.5; P clonidine group. Apnea and desaturation index were not different between the groups, whereas the minimal postoperative oxygen saturation on the day of surgery was significantly lower in the placebo than in the clonidine group (76.7% +/- 8.0% versus 82.4% +/- 5.8%; P clonidine premedication stabilizes hemodynamic variables during induction, maintenance, and emergence from anesthesia and reduces the amount of intraoperative anesthetics and postoperative opioids without deterioration of ventilation.

  6. Randomized, double-blind, placebo-controlled trial of flexible-dose fesoterodine in subjects with overactive bladder.

    Science.gov (United States)

    Dmochowski, Roger R; Peters, Kenneth M; Morrow, Jon D; Guan, Zhonghong; Gong, Jason; Sun, Franklin; Siami, Paul; Staskin, David R

    2010-01-01

    To evaluate the efficacy and tolerability of flexible-dose fesoterodine vs placebo in subjects with overactive bladder (OAB). In a 12-week double-blind trial, subjects were randomized to fesoterodine 4 mg or placebo once daily, taken within 4 hours of bedtime. At week 2, subjects could increase the fesoterodine dose to 8 mg (sham escalation for placebo). Subjects completed 3-day bladder diaries, Patient Perception of Bladder Condition, and Urgency Perception Scale at baseline and weeks 2, 6, and 12 as well as OAB Questionnaire at baseline and week 12. Of 883 subjects, 63% and 73% of the fesoterodine (n = 438) and placebo (n = 445) groups, respectively, opted for dose escalation. Week 12 improvements from baseline in total micturitions, urgency episodes, urgency urinary incontinence episodes, frequency-urgency sum, and all OAB Questionnaire scales and domains, but not nocturnal micturitions or nocturnal urgency episodes, were significantly greater with fesoterodine than placebo (all P fesoterodine had improved Patient Perception of Bladder Condition and Urgency Perception Scale scores at weeks 2, 6, and 12 (P fesoterodine, 26%; placebo, 8%) and constipation (fesoterodine, 11%; placebo, 6%) were the most common adverse events. In both groups, 87% of the subjects completed the trial; 8% and 5% of the fesoterodine and placebo groups, respectively, discontinued because of an adverse event. Flexible-dose fesoterodine was efficacious and generally well tolerated for treatment of OAB symptoms. 2010 Elsevier Inc. All rights reserved.

  7. Increasing work-place healthiness with the probiotic Lactobacillus reuteri: A randomised, double-blind placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Stan Vlaicu

    2005-11-01

    Full Text Available Abstract Background Short term illnesses, usually caused by respiratory or gastrointestinal diseases are disruptive to productivity and there is relatively little focus on preventative measures. This study examined the effect of the probiotic Lactobacillus reuteri protectis (ATCC55730 on its ability to improve work-place healthiness by reducing short term sick-leave caused by respiratory or gastrointestinal infections. Methods 262 employees at TetraPak in Sweden (day-workers and three-shift-workers that were healthy at study start were randomised in a double-blind fashion to receive either a daily dose of 108 Colony Forming Units of L. reuteri or placebo for 80 days. The study products were administered with a drinking straw. 181 subjects complied with the study protocol, 94 were randomised to receive L. reuteri and 87 received placebo. Results In the placebo group 26.4% reported sick-leave for the defined causes during the study as compared with 10.6% in the L. reuteri group (p L. reuteri group (p L. reuteri group(p

  8. A pilot double-blind placebo-controlled trial of low-dose pramipexole in sleep-related eating disorder.

    Science.gov (United States)

    Provini, F; Albani, F; Vetrugno, R; Vignatelli, L; Lombardi, C; Plazzi, G; Montagna, P

    2005-06-01

    Sleep-related eating disorder (SRED) is characterized by recurrent arousals from sleep associated with compulsive ingestion of food. No controlled therapeutic trials are available for SRED. We assessed the safety, tolerability and efficacy of pramipexole, a dopamine D3-receptor agonist, in the treatment of SRED. Eleven consecutive patients with SRED in the absence of concurrent daytime eating disorders underwent actigraphic recording and subjective sleep diary evaluation for a week before and every week for 2 weeks of treatment with pramipexole 0.18-0.36 mg or placebo, administered in a double-blind crossover randomized sequence. The primary outcomes of the trial were actigraphic measures of night sleep parameters (sleep efficiency, motor activity mean and median, number and duration of wake episodes), secondary outcomes were the number of good sleep nights/weekly, number and duration of nocturnal awakenings/night, and visual analogue preference score. Pramipexole was well tolerated without any patient withdrawing from the study. Pramipexole reduced night-time activity median (P = 0.02) and increased the number of nights of good sleep/week (P = 0.02). All other measurements remained unaffected. Pramipexole at low doses was well tolerated, improving some measures of sleep quality and reducing median night activity in SRED. Further studies with higher dosages and for longer time-periods are warranted.

  9. 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.

  10. Analgesic effect of salmon calcitonin in osteoporotic vertebral fractures: a double-blind placebo-controlled clinical study.

    Science.gov (United States)

    Lyritis, G P; Tsakalakos, N; Magiasis, B; Karachalios, T; Yiatzides, A; Tsekoura, M

    1991-12-01

    Back pain due to vertebral collapse is the main symptom of postmenopausal osteoporosis. The clinical picture in these crush fractures varies, depending on the type and the location of fracture, but in general, a new vertebral crush fracture gives rise to severe pain that immobilizes the patient and necessitates bedrest. In this double-blind controlled clinical trial, 56 patients who had recently (within the last 3 days) suffered an osteoporotic vertebral fracture were hospitalized for a period of 14 days. Salmon calcitonin (100 IU) or placebo injections were given daily. Pain was rated daily on a 10-point scale by the same observers. Blood and urinary parameters were also evaluated. The results showed a significant (P less than 0.001) difference in pain intensity between the calcitonin group and the placebo group. This beneficial effect was generally apparent from the second day of treatment onward, and over the following 2 weeks, the patients were able to sit and stand, and gradually started to walk again. A significant decrease in urinary hydroxyproline and urinary calcium was also noted in the calcitonin group. It is concluded that calcitonin exerts a beneficial effect on back pain following a vertebral crush fracture.

  11. 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.

  12. Effect of Brazilian green propolis in patients with type 2 diabetes: A double-blind randomized placebo-controlled study

    Science.gov (United States)

    FUKUDA, TAKUYA; FUKUI, MICHIAKI; TANAKA, MUHEI; SENMARU, TAKAFUMI; IWASE, HIROYA; YAMAZAKI, MASAHIRO; AOI, WATARU; INUI, TOSHIO; NAKAMURA, NAOTO; MARUNAKA, YOSHINORI

    2015-01-01

    Propolis contains a variety of chemical compounds, including polyphenols, flavonoids, phenolic aldehydes, amino acids and vitamins, and presents numerous biological and pharmacological properties. The aim of the present study was to evaluate the effect of propolis on blood examination data in patients with type 2 diabetes. In the double-blind, 8-week randomized controlled study, 80 patients with type 2 diabetes were enrolled. Patients were randomly assigned to receive Brazilian green propolis (226.8 mg/day for 8 weeks) (n=41) or the placebo (n=39). The primary endpoint was to detect changes in blood examination data associated with metabolic disorders in patients suffering from diabetes mellitus, including the homeostasis model assessment of insulin resistance (HOMA-IR), uric acid and estimated glomerular filtration rate (eGFR) from baseline to the end of this study. The value of HOMA-IR was not significantly changed by the 8-week administration of propolis or placebo from the baseline data. Values of blood uric acid and eGFR in patients taking the placebo became worse at 8 weeks compared to the baseline, whereas this did not occur in patients consuming Brazilian green propolis. However, HOMA-IR was not improved by propolis intake. A randomized, controlled 8-week trial suggests that Brazilian green propolis (226.8 mg/day) prevents patients with type 2 diabetes from developing worse blood uric acid and eGFR. PMID:26137235

  13. The effect of ondansetron on analgesic efficacy of acetaminophen after hysterectomy: A randomized double blinded placebo controlled trial.

    Science.gov (United States)

    Koyuncu, Onur; Leung, Steve; You, Jing; Oksar, Menekse; Turhanoglu, Selim; Akkurt, Cagla; Dolapcioglu, Kenan; Sahin, Hanifi; Sessler, Daniel I; Turan, Alparslan

    2017-08-01

    To determine that perioperative ondansetron reduces the analgesic efficacy of acetaminophen. Randomized, double-blinded study. 120 patients ASA I-II who underwent abdominal hysterectomy. All the patients were given 1g acetaminophen at skin closure. Patients were divided into two groups; ondansetron HCl (8mg, 2ml IV) (Group I, N=60) and saline (2ml IV) (Group II, N=60) at the skin closure. Postoperative pain scores (VAS) while resting in bed and sitting, total opioid consumption were noted. Patients randomized to ondansetron had significantly worse pain scores upon arrival to the recovery unit [by 1.7 (99.7% CI: 0.75, 2.59) cm] and at 1h [by 1.3 (0.5, 2.1) cm] while resting in bed. Pain scores while sitting were also significantly greater in ondansetron group at arrival in PACU by 0.6 (99.7% CI: 0.1, 1.0) cm. Thereafter, pain scores did not differ significantly. Median total opioid (tramadol) consumption was 441 [Q1, Q3: 280, 578] mg in the ondansetron group and 412 [309, 574] mg in the placebo group, P=0.95. Ondansetron significantly decreased the analgesic effect of acetaminophen during the initial postoperative period. Our results thus confirm that acetaminophen analgesia is partially mediated by serotonin receptors. However, the reduction was of marginal clinical importance and short-lived. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Cessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Diener, Hans-Christoph; Agosti, Reto; Allais, Gianni; Bergmans, Paul; Bussone, Gennaro; Davies, Brendan; Ertas, Mustafa; Lanteri-Minet, Michel; Reuter, Uwe; Sánchez Del Río, Margarita; Schoenen, Jean; Schwalen, Susanne; van Oene, Joop

    2007-12-01

    Use of preventive therapy for migraine is often recommended for only 6-9 months, but no randomised, placebo-controlled trials have investigated migraine frequency after the end of prophylaxis. We assessed the effects of discontinuation of topiramate after a treatment period of 6 months. 818 patients who have migraines were enrolled from 88 clinics in 21 countries. After a 4-8-week lead-in period, patients received topiramate in a 26-week open-label phase. Daily dose was increased from 25 mg to 100 mg in steps of 25 mg every week; the dose could be adjusted further in the range 50-200 mg/day, but was stable for the final 4 weeks. Patients were randomly assigned to continue this dose or switch to placebo for a 26-week double-blind phase. The primary endpoint was the difference in number of days with migraine during the last 4 weeks of the double-blind phase compared with the last 4 weeks of the open-label phase. Analysis was by intention to treat. This trial is registered with EudraCT, number 2005-000321-29. 559 patients (68.3%) completed the open-label phase; 514 entered the double-blind phase and were assigned to topiramate (n=255) or placebo (n=259). The mean increase in number of migraine days was greater in the placebo group (1.19 days in 4 weeks, 95% CI 0.71 to 1.66; plife, as assessed by the MIDAS questionnaire, fell in the placebo group but remained stable in the topiramate group. Patients were more satisfied with the efficacy of topiramate than with that of placebo, whereas satisfaction with tolerability was similar in both treatment groups. Sustained benefit was reported after discontinuation of topiramate, although number of migraine days did increase. These findings suggest that patients should be treated for 6 months, with the option to continue to 12 months in some patients.

  15. The efficacy and safety of a nicotine conjugate vaccine (NicVAX®) or placebo co-administered with varenicline (Champix®) for smoking cessation: study protocol of a phase IIb, double blind, randomized, placebo controlled trial

    National Research Council Canada - National Science Library

    Hoogsteder, Philippe H J; Kotz, Daniel; van Spiegel, Paul I; Viechtbauer, Wolfgang; Brauer, Ruth; Kessler, Paul D; Kalnik, Matthew W; Fahim, Raafat E F; van Schayck, Onno C P

    2012-01-01

    ... its receptors in the brain and causing the release of dopamine. The aim of this paper is to describe the design of a phase IIb, multi-center, double blind, randomized, placebo controlled trial to assess the efficacy of the nicotine vaccine...

  16. European multicentre double-blind placebo-controlled trial of Nilvadipine in mild-to-moderate Alzheimer's disease-the substudy protocols: NILVAD frailty; NILVAD blood and genetic biomarkers; NILVAD cerebrospinal fluid biomarkers; NILVAD cerebral blood flow

    NARCIS (Netherlands)

    Meulenbroek, O.V.; O'Dwyer, S.; Jong, D. de; Spijker, G.J. van; Kennelly, S.; Cregg, F.; Olde Rikkert, M.G.M.; Abdullah, L.; Wallin, A.; Walsh, C.; Coen, R.; Kenny, R.A.; Daly, L.; Segurado, R.; Borjesson-Hanson, A.; Crawford, F.; Mullan, M.; Lucca, U.; Banzi, R.; Pasquier, F.; Breuilh, L.; Riepe, M.; Kalman, J.; Molloy, W.; Tsolaki, M.; Howard, R.; Adams, J.; Gaynor, S.; Lawlor, B.

    2016-01-01

    INTRODUCTION: In conjunction with the NILVAD trial, a European Multicentre Double-Blind Placebo Controlled trial of Nilvadipine in Mild-to-Moderate Alzheimer's disease (AD), there are four NILVAD substudies in which eligible NILVAD patients are also invited to participate. The main NILVAD protocol

  17. A randomised, double-blind, placebo-controlled, multicentre study of the safety and efficacy of BIOBYPASS (AdGVVEGF121.10NH) gene therapy in patients with refractory advanced coronary artery disease: the NOVA trial

    DEFF Research Database (Denmark)

    Kastrup, Jens; Jørgensen, Erik; Fuchs, Shmuel

    2011-01-01

    Genes encoding vascular endothelial growth factor (VEGF) can potentially augment myocardial perfusion in patients with coronary artery disease (CAD). We conducted a randomised, double-blind, placebo-controlled gene therapy study with the adenovirus carrying VEGF121 (BIOBYPASS [AdGVVEGF121.10NH])....

  18. The effects of a new mouthrinse containing chlorhexidine, cetylpyridinium chloride and zinc lactate on the microflora of oral halitosis patients : a dual-centre, double-blind placebo-controlled study

    NARCIS (Netherlands)

    Roldan, S; Winkel, EG; Herrera, D; Sanz, M; Van Winkelhoff, AJ

    2003-01-01

    Aim: This study evaluated the microbial effects of a newly formulated mouthwash (Halita((R)) ) on oral halitosis patients. Methods: Forty subjects were included in this dual-centre, double-blind, placebo-controlled parallel study. Inclusion and exclusion criteria were used to select patients. At bas

  19. 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...

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

    NARCIS (Netherlands)

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

    1992-01-01

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

  1. Clinical and microbiological effects of initial periodontal therapy in conjunction with amoxicillin and clavulanic acid in patients with adult periodontitis : A randomised double-blind, placebo-controlled study

    NARCIS (Netherlands)

    Winkel, EG; van Winkelhoff, AJ; Barendregt, DS; van der Weijden, GA; Timmerman, MF; van der Velden, U

    1999-01-01

    The aim of the present study was to investigate the clinical and microbiological effects of initial periodontal therapy in conjunction with systemic amoxicillin plus clavulanic acid in adult periodontitis patients using a double-blind, parallel-group, and placebo-controlled protocol. 21 patients wit

  2. Oxybutynin reduces sweating in depressed patients treated with sertraline: a double-blind, placebo-controlled, clinical study

    Directory of Open Access Journals (Sweden)

    Ghaleiha A

    2012-09-01

    Full Text Available Ali Ghaleiha,1 Leila Jahangard,1 Zahra Sherafat,1 Mohammad Ahmadpanah,1 Serge Brand,2 Edith Holsboer-Trachsler,2 Hafez Bajoghli,3 Mohammad Haghighi11Research Center for Behavioral Disorders and Substances Abuse, Hamadan University of Medical Sciences, Hamadan, Iran; 2Psychiatric Hospital of the University of Basel, Center for Affective, Stress and Sleep Disorders, University of Basel, Basel, Switzerland; 3Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, IranBackground: Selective serotonin reuptake inhibitors are primarily used in the pharmacological treatment of patients experiencing a major depressive disorder. However, one of the common unwanted effects is excessive sweating or hyperhidrosis. Oxybutynin is an anticholinergic medication which reduces sweating. The aim of this double-blind study was to examine the effect of administration of oxybutynin on subjective sweating in patients treated with sertraline.Methods: A total of 140 patients experiencing a major depressive disorder (mean age 37.69 ± 10.44 years, 86 females [61.4%] treated with sertraline (mean dose 83 mg/day were consecutively enrolled in the study, and all reported excessive sweating as a side effect. Thereafter, the patients were randomly assigned to either an oxybutynin 5 mg/day group or to a placebo group. At the beginning and end of the 2-week trial, the patients completed questionnaires related to sweating and medication-related side effects.Results: Over time, subjective sweating reduced significantly in the treatment group as compared with the control group. Oxybutynin-induced side effects were uncommon. Relative to male patients, female patients reported less subjective sweating.Conclusion: Administration of oxybutynin successfully reduced excessive sweating in patients experiencing a major depressive disorder and treated with sertraline. However, possible gender effects should be taken into account

  3. Effects of cooking plant oils on recurrent aphthous stomatitis: a randomized, placebo-controlled, double-blind trial.

    Science.gov (United States)

    Hamazaki, Kei; Itomura, Miho; Hamazaki, Tomohito; Sawazaki, Shigeki

    2006-05-01

    One-third of the total population seems to develop minor recurrent aphthous stomatitis (RAS) during their lifetime. However, well-controlled dietary intervention studies to prevent minor RAS are very rare. The objective of the present study was to investigate whether the prevalence of RAS decreased with perilla oil (rich in alpha-linolenic acid). Thirty subjects (8 men and 22 women) who had minor RAS at least once a month were randomly allocated to a soybean oil group or a perilla oil group in a double-blind manner (experimental phase) after a run-in phase of 4 mo during which subjects used a reference oil, the most popular cooking oil in Japan, or a 50/50 mixture of soybean oil and rapeseed oil. During the experimental phase, subjects were asked to use soybean oil or perilla oil as the sole cooking oil for 8 mo. Blood samples were collected at the start and end of the experimental phase for fatty acid analysis of total plasma phospholipid fraction. Occurrence and needed days for healing of minor RAS were recorded during the two phases and compared. alpha-Linolenic acid concentrations in the plasma phospholipid fraction increased significantly in both groups during the experimental phase to a similar extent. The prevalence of minor RAS in the experimental phase decreased significantly in both groups compared with the run-in phase to a similar extent, without intergroup differences. Perilla oil, which is rich in alpha-linolenic acid, was not superior to soybean oil in preventing minor RAS. There was a possibility that avoiding rapeseed oil might be beneficial for prevention of minor RAS.

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

    Institute of Scientific and Technical Information of China (English)

    Thomas Mc Graw

    2016-01-01

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

  5. 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.

  6. Effects of add-on mirtazapine on neurocognition in schizophrenia: a double-blind, randomized, placebo-controlled study.

    Science.gov (United States)

    Stenberg, Jan-Henry; Terevnikov, Viatcheslav; Joffe, Marina; Tiihonen, Jari; Tchoukhine, Evgueni; Burkin, Mark; Joffe, Grigori

    2010-05-01

    Mirtazapine added to antipsychotics appears to improve the clinical picture of schizophrenia, including both negative and positive symptoms. This study explored the effect of adjunctive mirtazapine on neurocognition in patients with schizophrenia who had shown an insufficient response to first-generation antipsychotics (FGAs). Thirty-seven schizophrenia patients, who were at least moderately ill despite their FGA treatment, received add-on mirtazapine (n=19) or placebo (n=18) in a 6-wk double-blind, randomized trial. Widely used neuropsychological tests were performed to explore visual-spatial functions, verbal and visual memory, executive functions, verbal fluency and general mental and psychomotor speed. The data were analysed on the modified intent-to-treat basis with last observation carried forward. False discovery rate was applied to correct for multiple testing. Mirtazapine outperformed placebo in the domains of visual-spatial ability and general mental speed/attentional control as assessed by, correspondingly, Block Design and Stroop dots. The difference in the degree of change (i.e. change while on mirtazapine minus that on placebo) was 18.6% (p=0.044) and 11.1% (p=0.044), respectively. Adjunctive mirtazapine might offer a safe, effective and cost-saving option as a neurocognitive enhancer for FGA-treated schizophrenia patients. Mirtazapine+FGA combinations may become especially useful in light of the currently increasing attention towards FGAs. Larger and longer studies that incorporate functional outcomes, as well as comparisons with second-generation antipsychotics are, however, still needed for more definite conclusions.

  7. Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features: A Randomized, Double-Blind, Placebo-Controlled Study.

    Science.gov (United States)

    Suppes, Trisha; Silva, Robert; Cucchiaro, Josephine; Mao, Yongcai; Targum, Steven; Streicher, Caroline; Pikalov, Andrei; Loebel, Antony

    2016-04-01

    Accumulating evidence indicates that manic symptoms below the threshold for hypomania (mixed features) are common in individuals with major depressive disorder. This form of depression is often severe and is associated with an increased risk for recurrence, suicide attempts, substance abuse, and functional disability. This study evaluated the efficacy and safety of lurasidone in major depressive disorder with mixed features. Patients meeting DSM-IV-TR criteria for major depressive disorder who presented with two or three protocol-defined manic symptoms were randomly assigned to 6 weeks of double-blind treatment with either lurasidone at 20-60 mg/day (N=109) or placebo (N=100). Changes from baseline in Montgomery-Åsberg Depression Rating Scale score (MADRS; primary outcome measure) and Clinical Global Impressions severity subscale score (CGI-S; key secondary outcome measure) were evaluated using a mixed model for repeated-measures analysis. Lurasidone significantly improved depressive symptoms and overall illness severity, assessed by least squares mean change at week 6 in the MADRS and CGI-S scores: -20.5 compared with -13.0 (effect size, 0.80) and -1.8 compared with -1.2 (effect size, 0.60), respectively. Significant improvement in manic symptoms, assessed by the Young Mania Rating Scale, was also observed, in addition to other secondary efficacy endpoints. Rates of discontinuation due to adverse events were low. The most common adverse events were nausea (6.4% and 2.0% in the lurasidone and placebo groups, respectively) and somnolence (5.5% and 1.0%). Lurasidone was effective and well tolerated in this study involving patients with major depressive disorder associated with subthreshold hypomanic symptoms (mixed features).

  8. Effect of n-3 fatty acids on patients with advanced lung cancer: a double-blind, placebo-controlled study.

    Science.gov (United States)

    Finocchiaro, Concetta; Segre, Olivia; Fadda, Maurizio; Monge, Taira; Scigliano, Mara; Schena, Marina; Tinivella, Marco; Tiozzo, Elisa; Catalano, Maria G; Pugliese, Mariateresa; Fortunati, Nicoletta; Aragno, Manuela; Muzio, Giuliana; Maggiora, Marina; Oraldi, Manuela; Canuto, Rosa A

    2012-07-01

    PUFA from fish oil appear to have anti-inflammatory and anti-oxidative effects and improve nutritional status in cancer patients. With this as background, the aim of the present study was to investigate the effect of EPA plus DHA on inflammatory condition, and oxidative and nutritional status in patients with lung cancer. In our multicentre, randomised, double-blind trial, thirty-three patients with a diagnosis of advanced inoperable non-small-cell lung cancer and undergoing chemotherapy were divided into two groups, receiving four capsules/d containing 510 mg of EPA and 340 mg of DHA, or 850 mg of placebo, for 66 d. At the start of chemotherapy (T₀), after 8 d (T₁), 22 d (T₂) and 66 d (T₃), biochemical (inflammatory and oxidative status parameters) and anthropometric parameters were measured in both groups. A significant increase of body weight in the n-3 group at T₃ v. T₀ was observed. Concerning inflammation, C-reactive protein and IL-6 levels differed significantly between the n-3 and placebo groups at T₃, and progressively decreased during chemotherapy in the n-3 group, evidencing n-3 PUFA anti-inflammatory action. Concerning oxidative status, plasma reactive oxygen species levels increased in the placebo group v. the n-3 group at the later treatment times. Hydroxynonenal levels increased in the placebo group during the study, while they stabilised in the n-3 group. Our data confirm that the continual assumption of EPA plus DHA determined an anti-inflammatory and anti-oxidative action which could be considered a preliminary goal in anti-cachectic therapy.

  9. 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.

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

    Directory of Open Access Journals (Sweden)

    Zakir Arslan

    2016-08-01

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

  11. A randomized, double-blind, placebo-controlled trial of a chemokine receptor 2 (CCR2) antagonist in posttraumatic neuralgia.

    Science.gov (United States)

    Kalliomäki, Jarkko; Attal, Nadine; Jonzon, Bror; Bach, Flemming W; Huizar, Karin; Ratcliffe, Stuart; Eriksson, Britta; Janecki, Marcin; Danilov, Andrei; Bouhassira, Didier

    2013-05-01

    We evaluated the analgesic efficacy, safety and tolerability of a novel chemokine receptor 2 (CCR2) antagonist, AZD2423, in posttraumatic neuralgia. This was a double-blind, randomized, parallel-group, multicentre study. One hundred thirty-three patients with posttraumatic neuralgia were equally randomized to 28days' oral administration of 20mg AZD2423, 150mg AZD2423 or placebo. The primary efficacy variable was the change of average pain score from 5days at baseline to the last 5days of treatment, measured by a numerical rating scale (NRS, 0-10). The secondary efficacy measures included NRS worst pain score, patient global impression of change, pain interference on sleep and activity, and Neuropathic Pain Symptom Inventory (NPSI). The change of the NRS average pain score was not significantly different between treatment groups (AZD2423 20mg -1.54; AZD2423 150mg -1.53; placebo -1.44). There were trends towards larger reduction of NPSI total score and NPSI subscores for paroxysmal pain and paresthesia/dysesthesia by AZD2423 150mg compared to placebo. No other secondary efficacy variables differed between treatment groups. The frequency and type of adverse events for AZD2423 were similar to placebo. Increased plasma levels of chemokine ligand 2 and reduced mean levels of monocytes (-30% by AZD2423 150mg) suggested that the administrated doses of AZD2423 had interacted with the CCR2 target. The CCR2 antagonist AZD2423 demonstrated no efficacy on NRS average pain scores and most of the secondary pain variables. The NPSI data suggested possible effects on certain sensory components of pain. There were no major safety or tolerability concerns. Copyright © 2013 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  12. Oats in the Diet of Children with Celiac Disease: Preliminary Results of a Double-Blind, Randomized, Placebo-Controlled Multicenter Italian Study

    Science.gov (United States)

    Gatti, Simona; Caporelli, Nicole; Galeazzi, Tiziana; Francavilla, Ruggiero; Barbato, Maria; Roggero, Paola; Malamisura, Basilio; Iacono, Giuseppe; Budelli, Andrea; Gesuita, Rosaria; Catassi, Carlo; Lionetti, Elena

    2013-01-01

    A gluten-free diet (GFD) is currently the only available treatment for patients with celiac disease (CD). Several clinical trials have demonstrated that most celiac patients can tolerate a medium-high quantity of oats without any negative clinical effects; however, the inclusion of oats in GFD is still a matter of debate. In this study, Italian children with CD were enrolled in a 15-month, randomized, double-blind, placebo-controlled multicenter trial. Participants were randomized in two groups following either A-B treatment (6 months of diet “A”, 3 months of standard GFD, 6 months of diet “B”), or B-A treatment (6 months of diet “B”, 3 months of standard GFD, 6 months of diet “A”). A and B diets included gluten-free (GF) products (flour, pasta, biscuits, cakes and crisp toasts) with either purified oats or placebo. Clinical data (Gastrointestinal Symptoms Rate Scale [GSRS] score) and intestinal permeability tests (IPT), were measured through the study period. Although the study is still blinded, no significant differences were found in GSRS score or the urinary lactulose/mannitol (L/M) ratio between the two groups after 6 months of treatment. These preliminary results suggest that the addition of non-contaminated oats from selected varieties in the treatment of children with CD does not determine changes in intestinal permeability and gastrointestinal symptoms. PMID:24264227

  13. Oats in the diet of children with celiac disease: preliminary results of a double-blind, randomized, placebo-controlled multicenter Italian study.

    Science.gov (United States)

    Gatti, Simona; Caporelli, Nicole; Galeazzi, Tiziana; Francavilla, Ruggiero; Barbato, Maria; Roggero, Paola; Malamisura, Basilio; Iacono, Giuseppe; Budelli, Andrea; Gesuita, Rosaria; Catassi, Carlo; Lionetti, Elena

    2013-11-20

    A gluten-free diet (GFD) is currently the only available treatment for patients with celiac disease (CD). Several clinical trials have demonstrated that most celiac patients can tolerate a medium-high quantity of oats without any negative clinical effects; however, the inclusion of oats in GFD is still a matter of debate. In this study, Italian children with CD were enrolled in a 15-month, randomized, double-blind, placebo-controlled multicenter trial. Participants were randomized in two groups following either A-B treatment (6 months of diet "A", 3 months of standard GFD, 6 months of diet "B"), or B-A treatment (6 months of diet "B", 3 months of standard GFD, 6 months of diet "A"). A and B diets included gluten-free (GF) products (flour, pasta, biscuits, cakes and crisp toasts) with either purified oats or placebo. Clinical data (Gastrointestinal Symptoms Rate Scale [GSRS] score) and intestinal permeability tests (IPT), were measured through the study period. Although the study is still blinded, no significant differences were found in GSRS score or the urinary lactulose/mannitol (L/M) ratio between the two groups after 6 months of treatment. These preliminary results suggest that the addition of non-contaminated oats from selected varieties in the treatment of children with CD does not determine changes in intestinal permeability and gastrointestinal symptoms.

  14. Lack of efficacy of moclobemide or imipramine in the treatment of recurrent brief depression: results from an exploratory randomized, double-blind, placebo-controlled treatment study.

    Science.gov (United States)

    Baldwin, David S; Green, Mary; Montgomery, Stuart A

    2014-11-01

    'Recurrent brief depression' (RBD) is a common, distressing and impairing depressive disorder for which there is no current proven pharmacological or psychological treatment. This multicentre, randomized, fixed-dose, parallel-group, placebo-controlled study of the reversible inhibitor of monoamine oxidase moclobemide (450 mg/day) and the tricyclic antidepressant imipramine (150 mg/day) evaluated the potential efficacy of active medication, when compared with placebo, in patients with recurrent brief depression, recruited in the mid-1990s. After a 2-4-week single-blind placebo run-in period, a total of 35 patients were randomized to receive double-blind medication for 4 months, but only 16 completed the active treatment period. An intention-to-treat analysis of the 34 evaluable patients found no evidence for the efficacy of moclobemide or imipramine, when compared with placebo, in significantly reducing the severity, duration or frequency of depressive episodes. A total of 28 patients experienced at least one adverse event, and four patients engaged in nonfatal self-harm. Limitations of the study include the small sample size and the high rate of participant withdrawal. The lack of efficacy of these antidepressant drugs and the previous finding of the lack of efficacy of the selective serotonin reuptake inhibitor fluoxetine together indicate that medications other than antidepressant drugs should be investigated as potential treatments for what remains a common, distressing and potentially hazardous condition.

  15. Oats in the Diet of Children with Celiac Disease: Preliminary Results of a Double-Blind, Randomized, Placebo-Controlled Multicenter Italian Study

    Directory of Open Access Journals (Sweden)

    Simona Gatti

    2013-11-01

    Full Text Available A gluten-free diet (GFD is currently the only available treatment for patients with celiac disease (CD. Several clinical trials have demonstrated that most celiac patients can tolerate a medium-high quantity of oats without any negative clinical effects; however, the inclusion of oats in GFD is still a matter of debate. In this study, Italian children with CD were enrolled in a 15-month, randomized, double-blind, placebo-controlled multicenter trial. Participants were randomized in two groups following either A-B treatment (6 months of diet “A”, 3 months of standard GFD, 6 months of diet “B”, or B-A treatment (6 months of diet “B”, 3 months of standard GFD, 6 months of diet “A”. A and B diets included gluten-free (GF products (flour, pasta, biscuits, cakes and crisp toasts with either purified oats or placebo. Clinical data (Gastrointestinal Symptoms Rate Scale [GSRS] score and intestinal permeability tests (IPT, were measured through the study period. Although the study is still blinded, no significant differences were found in GSRS score or the urinary lactulose/mannitol (L/M ratio between the two groups after 6 months of treatment. These preliminary results suggest that the addition of non-contaminated oats from selected varieties in the treatment of children with CD does not determine changes in intestinal permeability and gastrointestinal symptoms.

  16. Effect of Pumpkin Seed Oil on Hair Growth in Men with Androgenetic Alopecia: A Randomized, Double-Blind, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Young Hye Cho

    2014-01-01

    Full Text Available Pumpkin seed oil (PSO has been shown to block the action of 5-alpha reductase and to have antiandrogenic effects on rats. This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of PSO for treatment of hair growth in male patients with mild to moderate androgenetic alopecia (AGA. 76 male patients with AGA received 400 mg of PSO per day or a placebo for 24 weeks. Change over time in scalp hair growth was evaluated by four outcomes: assessment of standardized clinical photographs by a blinded investigator; patient self-assessment scores; scalp hair thickness; and scalp hair counts. Reports of adverse events were collected throughout the study. After 24 weeks of treatment, self-rated improvement score and self-rated satisfaction scores in the PSO-treated group were higher than in the placebo group (P = 0.013, 0.003. The PSO-treated group had more hair after treatment than at baseline, compared to the placebo group (P<0.001. Mean hair count increases of 40% were observed in PSO-treated men at 24 weeks, whereas increases of 10% were observed in placebo-treated men (P<0.001. Adverse effects were not different in the two groups.

  17. Improved training tolerance by supplementation with α-Keto acids in untrained young adults: a randomized, double blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Liu Yuefei

    2012-08-01

    Full Text Available Abstract Background Exercise causes a variety of physiological and metabolic changes that can in turn reduce exercise tolerance. One of the potential mechanisms responsible for fatigue is “exercise-induced hyperammonemia”. Previous studies have shown that supplementation with amino acids can increase training tolerance. The α-keto acids are biochemical analogs of amino acids and can be converted to amino acids through transamination, thus reducing the cellular ammonia level. This double blind, placebo-controlled study was designed to investigate the effects of α-keto acid supplementation (KAS on training tolerance, training effect, and stress-recovery state. Methods Thirty-three untrained young male adults underwent four weeks of training (5 sessions/week; 30 minutes running at the individual anaerobic threshold followed by 3 x 3 minute sprints/each session. Throughout the 4 weeks of training and one week of recovery, subjects took α-ketoglutarate (AKG group, 0.2 g/kg/d, n = 9, branched-chain keto acids (BCKA group, 0.2 g/kg/d, n = 12 or isocaloric placebo (control group, n = 12 daily. Results The 4th week training volume, maximum power output and muscle torque were higher in the AKG group (175 ± 42 min, 412 ± 49 Watts and 293 ± 58 Newton meters, respectively, Prd week of training increased significantly in the control group (P Conclusions Under KAS, subjects could bear a higher training volume and reach a higher power output and peak muscle torque, accompanied by a better stress-recovery-state. Thus, KAS improves exercise tolerance and training effects along with a better stress-recovery state. Whether the improved training tolerance by KAS is associated with effects on ammonia homeostasis requires further observation.

  18. Evaluation of the effect of Vaccinium arctostaphylos L. fruit extract on serum inflammatory biomarkers in adult hyperlipidemic patients: a randomized double-blind placebo-controlled clinical trial

    Science.gov (United States)

    Asgary, Sedigheh; Soltani, Rasool; Mirvakili, Saeide; Sarrafzadegan, Nizal

    2016-01-01

    Atherosclerosis is a chronic inflammatory condition. Many pro-inflammatory factors including interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and adhesion molecules including intercellular adhesion molecule (ICAM-1) and vascular cell adhesion molecule (VCAM-1) are expressed in atherosclerotic lesions. The plants of genus Vaccinium are rich in anthocyanins with anti-inflammatory effects. This study aimed to evaluate the effects of Vaccinium arctostaphylos fruit extract on the serum level of TNF-α, IL-6, ICAM-1, and VCAM-1 in adult patients with mild hyperlipidemia to detect its possible inhibitory effects on progression of atherosclerosis. In a randomized double-blind placebo-controlled clinical trial, eligible hyperlipidemic patients were randomly and equally divided in to two groups of study drug or placebo control to receive either the Vaccinium extract or placebo capsules, respectively, twice daily for four consecutive weeks. Each drug capsule contained 0.8 mg of anthocyanins. Serum levels of TNF-α, IL-6, ICAM-1, and VCAM-1 were measured before and after the interventions and finally were compared.A total of 8 men and 12 women in drug group as well as 11 men and 9 women in placebo group completed the study (P = 0.527). The use of Vaccinium extract significantly reduced only the IL-6 level (P = 0.037); however, this reduction was not significant compared to placebo (P = 0.062). Consumption of Vaccinium arctostaphylos fruit extract with the dose of 500 mg twice daily did not show any significant effect on serum levels of TNF-α, IL-6, ICAM-1, and VCAM-1 in adult hyperlipidemic patients. However, considering slight decrease in the level of IL-6, ICAM-1, and VCAM-1, the use of higher doses with longer duration might have significant effects on these factors. PMID:27651815

  19. 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

  20. 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.

  1. Effect of caffeine on maximal oxygen uptake in wheelchair rugby players: A randomized, placebo-controlled, double-blind study

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    Iva Klimešová

    2017-03-01

    Full Text Available Background: The positive effects of caffeine supplementation on strength-power and endurance performance in healthy athletes have been demonstrated in many studies. A possible mechanism for its ergogenic effect relates to its influence on the central nervous system. Post-traumatic complications in cervical spinal cord injury affect almost all body systems including the nervous system. For this reason, we expect that caffeine will have a different effect of performance in the group of athletes with spinal cord injuries. Objective: To examine the effects of caffeine supplementation on maximal aerobic power in elite wheelchair rugby players. Methods: Seven elite male wheelchair rugby players with complete cervical-level SCI (C4-Th1 were recruited (mean age: 28 ± 5.42 years; mean body mass index: 26 ± 2.84 kg/m2. The effect of caffeine was assessed by an incremental arm ergometer test until volitional exhaustion. The maximal oxygen uptake (VO2max/kg, maximum power (W max/kg, peak heart rate (HR peak, and intensity of perceived exertion (RPE were measured. Participants performed the test twice with a two-week washout period. One hour before each exercise test subjects ingested a capsule of placebo or caffeine (3 mg per kg of body weight. The tests were applied in a double-blind, randomized, repeated-measures, and cross-over design. Wheelchair rugby players were chosen because of the expected high homogeneity of participants - in terms of the type and degree of disability, gender, and age of the players. Results: The monitored parameters were not significantly influenced by caffeine intervention as compared to placebo: VO2max/kg (p = .40, W max/kg (p = .34, HR peak (p = .50 and RPE (p = .50. Conclusions: The current findings suggest that a caffeine dose of 3 mg/kg body mass does not improve oxygen uptake and maximal power in elite wheelchair rugby players.

  2. Are postoperative intravenous antibiotics necessary after bimaxillary orthognathic surgery? A prospective, randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Tan, S K; Lo, J; Zwahlen, R A

    2011-12-01

    Postoperative antibiotic prophylaxis is often administered intravenously, despite an increased morbidity rate compared with oral application. This study investigates whether a postoperative oral antibiotic regimen is as effective as incorporation of intravenous antibiotics after bimaxillary orthognathic surgery. 42 patients who underwent bimaxillary orthognathic surgery between December 2008 and May 2010 were randomly allocated to 2 placebo-controlled postoperative antibiotic prophylaxis groups. Group 1 received oral amoxicillin 500mg three times daily; group 2 received intravenous ampicillin 1g four times daily, during the first two postoperative days. Both groups subsequently took oral amoxicillin for three more days. Clinically, the infection rate was assessed in both study groups for a period of 6 weeks after the surgery. 9 patients (21.4%) developed infection. No adverse drug event was detected. No significant difference (p=0.45) was detected in the infection rate between group 1 (3/21) and group 2 (6/21). Age, type of surgical procedures, duration of the operative procedure, surgical procedure-related events, blood loss, and blood transfusion were all found not related to infection (p>0.05). Administration of more cost-effective oral antibiotic prophylaxis, which causes less comorbidity, can be considered to be safe in bimaxillary orthognathic surgery with segmentalizations. Copyright © 2011 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  3. Double-blind, placebo-controlled evaluation of extended-release bupropion in elderly patients with major depressive disorder.

    Science.gov (United States)

    Hewett, K; Chrzanowski, W; Jokinen, R; Felgentreff, R; Shrivastava, R K; Gee, M D; Wightman, D S; O'Leary, M C; Millen, L S; Leon, M C; Briggs, M A; Krishen, A; Modell, J G

    2010-04-01

    Major depressive disorder in the elderly is associated with increased morbidity and reduced quality of life. This 10 week, placebo-controlled study investigated the efficacy and tolerability of extended-release bupropion (150-300 mg once daily) in depressed patients aged 65 years or older. The statistical assumptions necessary for the validity of the protocol-specified analysis of covariance were not met for the analysis of the primary outcome variable (Montgomery-Asberg Depression Rating Scale total score at Week 10, last observation carried forward). Alternative statistical methods used for the analysis of this variable demonstrated statistical significance. Statistically significant improvements were observed on the majority of secondary end points when compared with placebo, including the health outcome measures for motivation and energy, and life satisfaction and contentment. Adverse events were generally mild to moderate and similar between treatment groups. This study demonstrated that the extended-release bupropion is an effective, well-tolerated treatment for major depression in the elderly.

  4. Efficacy of a CO2-releasing suppository in dyschezia: a double-blind, randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Tarrerias, Anne Laure; Abramowitz, Laurent; Marty, Marc M L; Coulom, Pierre; Staumont, Ghislain; Merlette, Christophe; Berger, Véronique; Savarieau, Bernard; Ducrotté, Philippe

    2014-08-01

    Constipation has a significant impact on quality of life. Aim of this study was to evaluate the safety and the efficacy for relieving dyschezia symptoms of a CO2-releasing suppository in a randomized, placebo-controlled, clinical trial. Fifty-three office-based primary care physicians and 24 gastroenterologists conducted the study in France, between November 2010 and January 2012. Patients (aged 18-75 years) with dyschezia were eligible. Patients were randomly allocated a once-a-day suppository (CO2-releasing suppository or placebo) for 21 days. Primary endpoint was the change, from Day 0 to Day 21, in the intensity of discomfort related to dyschezia based on a self-assessed 0-100 visual analogue scale. A total of 323 patients were randomized, i.e. 166 into the intervention group and 157 into the placebo group. Co-variance analysis showed a greater reduction in discomfort visual analogue scale score in the intervention group (-34.5mm; standard error of the mean: 1.8mm) than in the placebo group (-26.2mm; standard error of the mean: 1.9 mm; psuppository was confirmed for all secondary efficacy parameters. No significant side effects for either treatment were observed. A CO2-releasing suppository is more effective than a placebo for the relief of symptoms of dyschezia. This efficacy is associated with a good safety profile. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  5. Photobiomodulation Therapy Improves Performance and Accelerates Recovery of High-Level Rugby Players in Field Test: A Randomized, Crossover, Double-Blind, Placebo-Controlled Clinical Study.

    Science.gov (United States)

    Pinto, Henrique D; Vanin, Adriane A; Miranda, Eduardo F; Tomazoni, Shaiane S; Johnson, Douglas S; Albuquerque-Pontes, Gianna M; Aleixo, Ivo de O; Grandinetti, Vanessa Dos S; Casalechi, Heliodora L; de Carvalho, Paulo de Tarso C; Leal, Ernesto Cesar P

    2016-12-01

    Pinto, HD, Vanin, AA, Miranda, EF, Tomazoni, SS, Johnson, DS, Albuquerque-Pontes, GM, de Oliveira Aleixo Junior, I, Grandinetti, VdS, Casalechi, HL, de Tarso Camillo de Carvalho, P, and Pinto Leal Junior. Photobiomodulation therapy improves performance and accelerates recovery of high-level rugby players in field test: A randomized, crossover, double-blind, placebo-controlled clinical study. J Strength Cond Res 30(12): 3329-3338, 2016-Although growing evidence supports the use of photobiomodulation therapy (PBMT) for performance and recovery enhancement, there have only been laboratory-controlled studies. Therefore, the aim of this study was to analyze the effects of PBMT in performance and recovery of high-level rugby players during an anaerobic field test. Twelve male high-level rugby athletes were recruited in this randomized, crossover, double-blinded, placebo-controlled trial. No interventions were performed before the Bangsbo sprint test (BST) at familiarization phase (week 1); at weeks 2 and 3, pre-exercise PBMT or placebo were randomly applied to each athlete. Photobiomodulation therapy irradiation was performed at 17 sites of each lower limb, employing a cluster with 12 diodes (4 laser diodes of 905 nm, 4 light emitting diodes [LEDs] of 875 nm, and 4 LEDs of 640 nm, 30 J per site, manufactured by Multi Radiance Medical). Average time of sprints, best time of sprints, and fatigue index were obtained from BST. Blood lactate levels were assessed at baseline, and at 3, 10, 30, and 60 minutes after BST. Athletes' perceived fatigue was also assessed through a questionnaire. Photobiomodulation therapy significantly (p ≤ 0.05) improved the average time of sprints and fatigue index in BST. Photobiomodulation therapy significantly decreased percentage of change in blood lactate levels (p ≤ 0.05) and perceived fatigue (p ≤ 0.05). Pre-exercise PBMT with the combination of super-pulsed laser (low-level laser), red LEDs, and infrared LEDs can enhance performance

  6. Proprietary arabinogalactan extract increases antibody response to the pneumonia vaccine: a randomized, double-blind, placebo-controlled, pilot study in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Udani Jay K

    2010-08-01

    Full Text Available Abstract Background Arabinogalactan from Larch tree (Larix spp. bark has previously demonstrated immunostimulatory activity. The purpose of this study was to test the hypothesis that ingestion of a proprietary arabinogalactan extract, ResistAid™, would selectively enhance the antibody response to the pneumococcal (pneumonia vaccine in healthy adults. Methods This randomized, double-blind, placebo-controlled, parallel group pilot study included 45 healthy adults who had not previously been vaccinated against Streptococcus pneumoniae. The volunteers began taking the study product or placebo (daily dosage 4.5 g at the screening visit (V1-Day 0 and continued over the entire 72 day study period. After 30 days the subjects received the 23-valent pneumococcal vaccine (V2. They were monitored the following day (V3-Day 31, as well as 21 days (V4-Day 51 and 42 days (V5-Day 72 after vaccination. Responses by the adaptive immune system (antigen specific were measured via pneumococcal IgG antibodies (subtypes 4, 6B, 9V, 14, 18C, 19F, and 23F and salivary IgA levels. Responses by the innate immune system (non-specific were measured via white blood cell counts, inflammatory cytokines and the complement system. Results Vaccination significantly increased pneumococcal IgG levels as expected. The arabinogalactan group demonstrated a statistically significant greater IgG antibody response than the placebo group in two antibodies subtypes (18C and 23F at both Day 51 (p = 0.006 and p = 0.002 and at Day 72 (p = 0.008 and p = 0.041. These same subtypes (18C and 23F also demonstrated change scores from baseline which were significant, in favor of the arabinogalactan group, at Day 51 (p = 0.033 and 0.001 and at Day 72 (p = 0.012 and p = 0.003. Change scores from baseline and mean values were greater in the arabinogalactan group than placebo for most time points in antibody subtypes 4, 6B, 9V, and 19F, but these differences did not reach statistical significance. There

  7. A randomized, double-blind, placebo-controlled trial of citicoline for bipolar and unipolar depression and methamphetamine dependence.

    Science.gov (United States)

    Brown, E Sherwood; Gabrielson, Barry

    2012-12-20

    Methamphetamine use disorders are common and severe problems. Persons with mood disorders, particularly bipolar disorder, have high rates of substance use disorders. We previously reported promising findings on drug use, memory and study retention in patients with a history of mania and cocaine dependence given the nutritional supplement citicoline. In the current proof-of-concept study, we examined citicoline in bipolar or unipolar depression and methamphetamine dependence. Sixty adults with bipolar depression or major depressive disorder and methamphetamine dependence were randomized to citicoline (2000mg/day) or placebo for 12 weeks. Mood was assessed using Inventory of Depressive Symptomatology-Clinician Version (IDS-C), and cognition with the Hopkins Auditory Verbal Learning Test (HVLT). Drug use was assessed by urine drug screens. An ANCOVA of the intent-to-treat sample showed that those receiving citicoline (n=28) had a statistically significantly greater improvement in IDS-C scores than those receiving placebo (n=20). Survival in the study was significantly longer and completion rates significantly greater with citicoline than placebo. No significant differences were observed in memory or methamphetamine use. Citicoline was well tolerated. Sample heterogeneity and small sample size were limitations. To our knowledge this is the first placebo-controlled trial in a dual diagnosis sample with methamphetamine use disorders. Findings suggest that citicoline may have antidepressant properties in this population. Greater treatment retention with citicoline is also noteworthy in a patient population with substance dependence. Larger trials targeting depressive symptoms and treatment retention seem warranted. Copyright © 2012 Elsevier B.V. All rights reserved.

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

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    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.

  9. Utility of intranasal Ketamine and Midazolam to perform gastric aspirates in children: a double-blind, placebo controlled, randomized study

    Science.gov (United States)

    2014-01-01

    Background We performed a prospective, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal Ketamine and Midazolam (INKM) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis. Primary outcome: evaluation of Modified Objective Pain Score (MOPS) reduction in children undergoing INKM compared to the placebo group. Secondary outcomes: evaluation of safety of INKM protocol, start time sedation effect, duration of sedation and evaluation of parents and doctors’ satisfaction about the procedure. Methods In the sedation group, 19 children, mean age 41.5 months, received intranasal Midazolam (0.5 mg/kg) and Ketamine (2 mg/kg). In the placebo group, 17 children received normal saline solution twice in each nostril. The child’s degree of sedation was scored using the MOPS. A questionnaire was designed to evaluate the parents’ and doctors’ opinions on the procedures of both groups. Results Fifty-seven gastric washings were performed in the sedation-group, while in the placebo-group we performed 51 gastric aspirates. The degree of sedation achieved by INMK enabled all procedures to be completed without additional drugs. The mean duration of sedation was 71.5 min. Mean MOPS was 3.5 (range 1-8) in the sedation-group, 7.2 (range 4-9) in the placebo-group (p <0.0001). The questionnaire revealed high levels of satisfaction by both doctors and parents in the sedation-group compared to the placebo-group. The only side effect registered was post-sedation agitation in 6 procedures in the sedation group (10.5%). Conclusions Our experience suggests that atomized INKM makes gastric aspirates more acceptable and easy to perform in children. Trial registration Unique trial Number: UMIN000010623; Receipt Number: R000012422. PMID:24598046

  10. Effects of infrared laser moxibustion on cancer-related fatigue: A randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Mao, Huijuan; Mao, Jun J; Guo, Menghu; Cheng, Ke; Wei, Jianzi; Shen, Xubo; Shen, Xueyong

    2016-12-01

    Fatigue is the most common symptom negatively affecting the quality of life of patients with cancer. The objective of the current study was to evaluate the preliminary efficacy and safety of 10.6-μm infrared laser moxibustion for cancer-related fatigue (CRF). The authors conducted a randomized, placebo-controlled trial among 78 patients with cancer who were diagnosed with CRF. The group treated with infrared laser moxibustion received 10.6 μm of infrared laser moxibustion on the ST36 (bilateral), CV4, and CV6 acupoints. Each participant received a 20-minute treatment session 3 times per week for 4 weeks. The sham group received the same treatment duration on the same acupoints, but without infrared laser output. The outcome was change in fatigue as measured by the Chinese version of the Brief Fatigue Inventory between groups at week 4 with additional evaluation at week 8 for durability of treatment effects. A mixed effects model was used to evaluate the difference in treatment effect over time. Among those randomized, 61 patients (78%) completed the entire study. At the end of the intervention, the individuals in the group treated with the laser were found to have significantly less fatigue than those in the sham group (3.01 vs 4.40; P = .002). The improvement in fatigue persisted to week 8, favoring the group treated with laser moxibustion (3.03 vs 4.26; P = .006). Laser moxibustion was safe, with 3 cases of mild local erythema that resolved without medical intervention reported. Infrared laser moxibustion appeared to be safe and efficacious for improving CRF in a Chinese patient population. Larger studies in more racial/ethnically diverse populations are needed to confirm the benefit of this technique for fatigue in patients with cancer. Cancer 2016;122:3667-72. © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution

  11. Prophylactic use of gabapentin for prevention of succinylcholine-induced fasciculation and myalgia: A randomized, double-blinded, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    C K Pandey

    2012-01-01

    Full Text Available Background: Succinylcholine is used for rapid-sequence induction of anesthesia. Fasciculations and myalgia are adverse effects. The pretreatment modalities prevent or minimize its adverse effects. Aims: The present study is designed to evaluate the efficacy of gabapentin on the incidence of fasciculation and succinylcholine-induced myalgia. Settings and Design: The study was conducted at a tertiary care teaching hospital in a randomized, double-blinded, placebo-controlled manner. Materials and Methods: Patients of both genders undergoing laparoscopic cholecystectomy were randomly assigned to two groups. Patients in Group I (Gabapentin group received 600 mg of gabapentin orally 2 h prior to surgery and patients in Group II (placebo group received matching placebo. Anesthesia was induced with fentanyl 3 μg/kg, thiopentone 3-5 mg/kg and succinylcholine 1.5 mg/kg. All patients were observed and graded for fasciculations by a blinded observer and patients were intubated. Anesthesia was maintained with oxygen in air, sevoflurane and intermittent vecuronium bromide. After completion of surgery, neuromuscular blockade was reversed. A blinded observer recorded myalgia grade at 24 h. Patients were provided patient-controlled analgesia with fentanyl for postoperative pain relief. Statistical analysis: Demographic data, fasciculation grade, fentanyl consumption, and myalgia grade were compared using student t test and test of proportions. Results: The study included 76 American Society of Anesthesiologists′ Grade I or II patients of either gender undergoing laparoscopic cholecystectomy. But only 70 patients completed the study. Results demonstrated that the prophylactic use of gabapentin significantly decreases the incidence and the severity of myalgia (20/35 vs. 11/35 (P<0.05 and decreases fentanyl consumption significantly in the study group (620+164 μg vs. 989+238 μg (P<0.05 without any effects on the incidence and severity of fasciculations

  12. The role of preoperative prophylactic antibiotic administration in periapical endodontic surgery: a randomized, prospective double-blind placebo-controlled study.

    Science.gov (United States)

    Lindeboom, J A H; Frenken, J W H; Valkenburg, P; van den Akker, H P

    2005-12-01

    To determine the value of clindamycin prophylaxis in the prevention of postoperative wound infections in patients undergoing endodontic surgery. This study included 256 patients undergoing endodontic surgery in a prospective double-blind placebo-controlled trial comparing oral administration of an oral placebo versus a preoperative 600 mg dose of clindamycin. After randomization the study medication was administered orally 1 h before surgery in a double-blind fashion. For a period of 4 weeks the postoperative course was observed according to clinical parameters of infection. Primary end-point was infection at the surgical site. The mean age of the study population was 44.4 years (SD 11.4, range 18-82 years) with a sex distribution of 147 females (47.4%) and 109 males (42.6%). Mean age of the patients in the clindamycin group was 44.7 years (SD 12.0), and the mean age in the placebo group was 44.1 years (SD 10.8) (P = 0.49). In the clindamycin group, the mean duration of surgery was 32.3 min (SD 8.8) and in the placebo group the mean duration of surgery was 32.5 min (SD 8.4) (P = 0.89). Two infections [1.6%; 95 confidence interval (CI): 0.48-4.72] were identified in the clindamycin group and four (3.2%; 95 CI: 0.42-1.33) in the placebo group (P = 0.448). No statistically significant difference was found between clindamycin prophylaxis and placebo with regard to the prevention of postoperative infection in endodontic surgical procedures.

  13. Interleukin-1 antagonism in type 1 diabetes of recent onset: two multicentre, randomised, double-blind, placebo-controlled trials

    Science.gov (United States)

    Moran, Antoinette; Bundy, Brian; Becker, Dorothy J; DiMeglio, Linda A; Gitelman, Stephen E; Goland, Robin; Greenbaum, Carla J; Herold, Kevan C; Marks, Jennifer B; Raskin, Philip; Sanda, Srinath; Schatz, Desmond; Wherrett, Diane K; Wilson, Darrell M; Krischer, Jeffrey P; Skyler, Jay S; Pickersgill, Linda; de Koning, Eelco; Ziegler, Anette-G; Böehm, Bernhard; Badenhoop, Klaus; Schloot, Nanette; Bak, Jens Friis; Pozzilli, Paolo; Mauricio, Didac; Donath, Marc Y; Castaño, Luis; Wägner, Ana; Lervang, Hans Henrik; Perrild, Hans; Poulsen, Thomas Mandrup

    2013-01-01

    Summary Background Innate immunity contributes to the pathogenesis of autoimmune diseases, such as type 1 diabetes, but until now no randomised, controlled trials of blockade of the key innate immune mediator interleukin-1 have been done. We aimed to assess whether canakinumab, a human monoclonal anti-interleukin-1 antibody, or anakinra, a human interleukin-1 receptor antagonist, improved β-cell function in recent-onset type 1 diabetes. Methods We did two randomised, placebo-controlled trials in two groups of patients with recent-onset type 1 diabetes and mixed-meal-tolerance-test-stimulated C peptide of at least 0·2 nM. Patients in the canakinumab trial were aged 6–45 years and those in the anakinra trial were aged 18–35 years. Patients in the canakinumab trial were enrolled at 12 sites in the USA and Canada and those in the anakinra trial were enrolled at 14 sites across Europe. Participants were randomly assigned by computer-generated blocked randomisation to subcutaneous injection of either 2 mg/kg (maximum 300 mg) canakinumab or placebo monthly for 12 months or 100 mg anakinra or placebo daily for 9 months. Participants and carers were masked to treatment assignment. The primary endpoint was baseline-adjusted 2-h area under curve C-peptide response to the mixed meal tolerance test at 12 months (canakinumab trial) and 9 months (anakinra trial). Analyses were by intention to treat. These studies are registered with ClinicalTrials.gov, numbers NCT00947427 and NCT00711503, and EudraCT number 2007-007146-34. Findings Patients were enrolled in the canakinumab trial between Nov 12, 2010, and April 11, 2011, and in the anakinra trial between Jan 26, 2009, and May 25, 2011. 69 patients were randomly assigned to canakinumab (n=47) or placebo (n=22) monthly for 12 months and 69 were randomly assigned to anakinra (n=35) or placebo (n=34) daily for 9 months. No interim analyses were done. 45 canakinumab-treated and 21 placebo-treated patients in the canakinumab trial

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

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

    2012-06-01

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

  15. Testosterone replacement therapy in older male subjective memory complainers: double-blind randomized crossover placebo-controlled clinical trial of physiological assessment and safety.

    Science.gov (United States)

    Asih, Prita R; Wahjoepramono, Eka J; Aniwiyanti, Vilia; Wijaya, Linda K; de Ruyck, Karl; Taddei, Kevin; Fuller, Stephanie J; Sohrabi, Hamid; Dhaliwal, Satvinder S; Verdile, Giuseppe; Carruthers, Malcolm; Martins, Ralph N

    2015-01-01

    Testosterone replacement therapy (TRT) has been investigated in older men as a preventative treatment against Alzheimer's disease and dementia. However, previous studies have been contradictory. We assessed TRT physiological effects in 44 older men (aged 61 ± 7.7 years) with subjective memory complaints using a double blind, randomized, crossover, placebo-controlled study. Participants were randomized into 2 groups, one group received transdermal testosterone (50 mg) daily for 24 weeks, followed by a 4 week wash-out period, then 24 weeks of placebo; the other group received the reverse treatment. Blood evaluation revealed significant increases in total testosterone, free (calculated) testosterone, dihydrotestosterone, and a decrease in luteinizing hormone levels (p<0.001) following TRT. Although there were significant increases in red blood cell counts, hemoglobin and prostate specific antigen levels following TRT, they remained within normal ranges. No significant differences in plasma amyloid beta, estradiol, sex hormone binding globulin, insulin levels, body fat percentage, or body mass index were detected. This is the first carefully controlled study that has investigated the influence of TRT in Indonesian men on blood biomarkers linked to dementia risk. Our study suggests TRT is safe and well-tolerated in this Indonesian cohort, yet longitudinal studies with larger cohorts are needed to assess TRT further, and to establish whether TRT reduces dementia risk.

  16. Schisandra chinensis fruit modulates the gut microbiota composition in association with metabolic markers in obese women: a randomized, double-blind placebo-controlled study.

    Science.gov (United States)

    Song, Mi-young; Wang, Jing-hua; Eom, Taewoong; Kim, Hojun

    2015-08-01

    Schisandra chinensis fruit (SCF) is known to have beneficial effects on metabolic diseases, including obesity, and to affect gut microbiota in in vivo studies. However, in human research, there have been a few studies in terms of its clinical roles in lipid metabolism and modulation of gut microbiota. A double-blind, placebo-controlled study with 28 obese women with SCF or placebo was conducted for 12 weeks. Anthropometry and blood and fecal sampling were performed before and after treatment. Analysis of the gut microbiota in feces was performed using denaturing gradient gel electrophoresis and quantitative polymerase chain reaction. Although the values did not differ significantly between the 2 groups, the SCF group tended to show a greater decrease in waist circumference, fat mass, fasting blood glucose, triglycerides, aspartate aminotransferase, and alanine aminotransferase than the placebo group. Clustering of the denaturing gradient gel electrophoresis fingerprints for total bacteria before and after treatment indicated more separate clustering in SCF group than placebo. In correlation analysis, Bacteroides and Bacteroidetes (both increased by SCF) showed significant negative correlation with fat mass, aspartate aminotransferase, and/or alanine aminotransferase, respectively. Ruminococcus (decreased by SCF) showed negative correlation with high-density lipoprotein cholesterol and fasting blood glucose. In conclusion, administration of SCF for 12 weeks resulted in modulation of the gut microbiota composition in Korean obese women, and significant correlations with some bacterial genera and metabolic parameters were noted. However, in general, SCF was not sufficient to induce significant changes in obesity-related parameters compared with placebo.

  17. Factors predictive of treatment-emergent adverse events of prucalopride: an integrated analysis of four randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Leelakusolvong, Somchai; Ke, MeiYun; Zou, Duowu; Choi, Suck Chei; Tack, Jan; Quigley, Eamonn M M; Liu, Andy; Kim, Jin Yong

    2015-03-01

    This integrated analysis aimed to identify the factors associated with the most frequently re-ported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on pa-tients treated with prucalopride 2 mg or placebo were ana-lyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly as-sociated with diarrhea, headache, and nausea (pdiarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. Con-clusions Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians. (Gut Liver, 2015;9208-213).

  18. An Extract of Glycyrrhiza glabra (GutGard Alleviates Symptoms of Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study

    Directory of Open Access Journals (Sweden)

    Kadur Ramamurthy Raveendra

    2012-01-01

    Full Text Available A randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of GutGard, an extract of Glycyrrhiza glabra, in patients with functional dyspepsia. The primary outcome variables of the study were the change in the severity symptoms and the global assessment of efficacy. The quality of life was evaluated as a secondary outcome measure. The patients received either placebo or GutGard (75 mg twice daily for 30 days. Efficacy was evaluated in terms of change in the severity of symptoms (as measured by 7-point Likert scale, the global assessment of efficacy, and the assessment of quality of life using the short-form Nepean Dyspepsia Index. In comparison with placebo, GutGard showed a significant decrease (P≤.05 in total symptom scores on day 15 and day 30, respectively. Similarly, GutGard showed marked improvement in the global assessment of efficacy in comparison to the placebo. The GutGard group also showed a significant decrease (P≤.05 in the Nepean dyspepsia index on day 15 and 30, respectively, when compared to placebo. GutGard was generally found to be safe and well-tolerated by all patients. GutGard has shown significant efficacy in the management of functional dyspepsia.

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

    Directory of Open Access Journals (Sweden)

    Xiumei Ren

    2015-01-01

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

  20. Double-blind, placebo-controlled study to evaluate the efficacy and safety of botulinum toxin type A in the treatment of drooling in parkinsonism.

    Science.gov (United States)

    Mancini, Francesca; Zangaglia, Roberta; Cristina, Silvano; Sommaruga, Maria Grazia; Martignoni, Emilia; Nappi, Giuseppe; Pacchetti, Claudio

    2003-06-01

    Drooling is a frequent symptom in Parkinson's disease (PD), occurring in almost 75% of all patients. Although it is now well known that drooling in PD is the result of swallowing difficulties rather than excessive saliva production, few treatments have been developed to reduce it. Clinical studies suggest that botulinum toxin A (BTX) injections into salivary glands are effective in decreasing drooling in PD patients. In this double-blind, placebo-controlled study, 20 patients with parkinsonism (idiopathic PD or multiple system atrophy), were randomly assigned to receive 450 U of BTX (Dysport; Ipsen, Berkshire, UK) or 2 ml of placebo, injected into the parotids and submandibular glands under ultrasonographic guidance. Treatment efficacy and safety were assessed at baseline, 1 week and 3 months after BTX injections using clinical scales (Drooling Severity and Drooling Frequency scales) and side effects surveillance. After treatment, the average secretion of saliva in the BTX group was significantly lower than in the placebo group, as appraised by clinical measurements. No side effects were observed in either group. BTX injection into parotids and submandibular glands, under ultrasonographic guidance, is an effective and safe treatment for drooling in parkinsonism. Copyright 2003 Movement Disorder Society

  1. Effect of low-level laser therapy (808 nm) on markers of muscle damage: a randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Felismino, Amanda Soares; Costa, Eduardo Caldas; Aoki, Marcelo Saldanha; Ferraresi, Cleber; de Araújo Moura Lemos, Telma Maria; de Brito Vieira, Wouber Hérickson

    2014-05-01

    The aim of this randomized double-blind placebo-controlled study was to investigate the effect of low-level laser therapy (LLLT) on markers of muscle damage (creatine kinase (CK) and strength performance) in the biceps brachii. Twenty-two physically active men were randomized into two groups: placebo and laser. All volunteers were submitted to an exercise-induced muscle damage protocol for biceps brachii (biceps curl, 10 sets of 10 repetitions with load of 50% of one-repetition maximum test (1RM)). Active LLLT (808 nm; 100 mW; 35.7 W/cm(2), 357.14 J/cm(2) per point, energy of 1 J per point applied for 10 s on four points of the biceps brachii belly of each arm) or placebo was applied between the sets of the biceps curl exercise. CK activity and maximum strength performance (1RM) were measured before, immediately after, 24, 48, and 72 h after the exercise-induced muscle damage protocol. There was an increase in CK activity after the muscle damage protocol in both groups; however, this increase was attenuated in the laser group compared to the placebo group at 72 h (placebo = 841 vs. laser = 357%; p effect on the recovery of strength performance.

  2. 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.

  3. Effectiveness of Topical Curcumin for Treatment of Mastitis in Breastfeeding Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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    Raha Afshariani

    2014-09-01

    Full Text Available Objective: To determine the efficacy of topical curcumin in reducing breast inflammation in women suffering from lactational mastitis. Methods: A randomized double-blind, placebo-controlled study including 63 breastfeeding women with lactational mastitis were randomly assigned to receive curcumin topical cream, one pump every 8 hours for 3 days (n=32 or topical moisturizer as placebo (n=31. Using an index for severity of breast inflammation, all of the patients had moderate breast inflammation before entering the study. The outcome of treatment was evaluated using the same index at 24, 48 and 72 hours of starting the treatment. Results: There was no significant difference between two study groups regarding the baseline characteristics such as age (p=0.361 and duration of lactation (p=0.551. After 72-hour of therapy, patients in curcumin groups had significantly lower rate of moderate (p=0.019 and mild (p=0.002 mastitis. Patients in curcumin group had significantly lower scores for tension (p<0.001, erythema (p<0.001 and pain (p<0.001, after 72-hour of treatment. Conclusion: The results of the current study indicate that topical preparation of curcumin successfully decrease the markers of lactational mastitis such as pain, breast tension and erythema within 72 hours of administration without side effects. Thus, topical preparation of curcumin could be safely administered for those suffering from lactational mastitis after excluding infectious etiologies.

  4. Lubiprostone plus PEG electrolytes versus placebo plus PEG electrolytes for outpatient colonoscopy preparation: a randomized, double-blind placebo-controlled trial.

    Science.gov (United States)

    Sofi, Aijaz A; Nawras, Ali T; Pai, Chetan; Samuels, Qiana; Silverman, Ann L

    2015-01-01

    Bowel preparation using large volume of polyethylene glycol (PEG) solutions is often poorly tolerated. Therefore, there are ongoing efforts to develop an alternative bowel cleansing regimen that should be equally effective and better tolerated. The aim of this study was to assess the efficacy of lubiprostone (versus placebo) plus PEG as a bowel cleansing preparation for colonoscopy. Our study was a randomized, double-blind placebo-controlled design. Patients scheduled for screening colonoscopy were randomized 1:1 to lubiprostone (group 1) or placebo (group 2) plus 1 gallon of PEG. The primary endpoints were patient's tolerability and endoscopist's evaluation of the preparation quality. The secondary endpoint was to determine any reduction in the amount of PEG consumed in the lubiprostone group compared with the placebo group. One hundred twenty-three patients completed the study and were included in the analysis. There was no difference in overall cleanliness. The volume of PEG was similar in both the groups. The volume of PEG approached significance as a predictor of improved score for both the groups (P = 0.054). Lubiprostone plus PEG was similar to placebo plus PEG in colon cleansing and volume of PEG consumed. The volume of PEG consumed showed a trend toward improving the quality of the colon cleansing.

  5. Efficacy of ketamine in the rapid treatment of major depressive disorder: a meta-analysis of randomized, double-blind, placebo-controlled studies

    Science.gov (United States)

    Han, Yu; Chen, Jianjun; Zou, Dezhi; Zheng, Peng; Li, Qi; Wang, Haiyang; Li, Pengfei; Zhou, Xinyu; Zhang, Yuqing; Liu, Yiyun; Xie, Peng

    2016-01-01

    Background An increasing number of studies are reporting that ketamine could be treated as a novel antidepressant for major depressive disorder (MDD). Therefore, we performed this meta-analysis to comprehensively and systematically assess the efficacy of ketamine for treating patients with MDD. Method Randomized, double-blind, placebo-controlled studies on ketamine versus placebo for treating MDD were searched up to April 2016 in medical databases (PubMed, CCTR, Web of Science, Embase, CBM-disc, and CNKI). Three treatment time points (24 and 72 h, and day 7) were chosen. Response and remission rates were the main outcomes. The random effects model was used. An intention-to-treat analysis was conducted. Results Nine high-quality studies that included 368 patients were selected to compare the efficacy of ketamine to placebo. The therapeutic effects of ketamine at 24 and 72 h, and day 7 were found to be significantly better than placebo. Response and remission rates in the ketamine group at 24 and 72 h, and day 7 were 52.2% and 20.6%; 47.9% and 23.8%; and 39.8% and 26.2%, respectively. No significant heterogeneity existed, and the Egger’s test showed no publication bias. Conclusion These results indicated that ketamine could yield a good efficacy in the rapid treatment of MDD. Future large-scale clinical studies are needed to confirm our results and investigate the mid- and long-term efficacy of ketamine in treating MDD. PMID:27843321

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

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    Jingfen Zhu

    2016-01-01

    Full Text Available 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.

  7. A Double Blind, Placebo-Controlled Trial that Combines Disulfiram and Naltrexone for Treating Co-Occurring Cocaine and Alcohol Dependence

    Science.gov (United States)

    Pettinati, Helen; Kampman, Kyle M.; Lynch, Kevin G.; Xie, Hu; Dackis, Charles; Rabinowitz, Amanda R.; O’Brien, Charles P.

    2008-01-01

    BACKGROUND This is a double blind, placebo-controlled trial that evaluated the efficacy of disulfiram, naltrexone and their combination in patients with co-occurring cocaine and alcohol dependence. METHODS 208 patients were randomized to disulfiram (250mg/day), naltrexone (100mg/day), the combination, or placebo for 11 weeks. Outcomes were in-trial abstinence from cocaine and/or alcohol. RESULTS Few safety concerns were reported, although medication adherence was low in a number of patients for both medications, alone or in combination. In the primary analyses (GEE modeling), abstinence from cocaine as measured by cocaine-negative urines and days of self-reported abstinence from cocaine or alcohol did not differ between placebo and any of the medication groups. However, patients taking disulfiram (alone or in combination) were most likely to achieve combined abstinence from cocaine and alcohol. Secondary analyses revealed that patients taking the disulfiram-naltrexone combination were most likely to achieve 3 consecutive weeks of abstinence from cocaine and alcohol. CONCLUSION There was an association between disulfiram treatment and abstinence from cocaine and alcohol. More patients taking the disulfiram-naltrexone combination achieved 3 consecutive weeks of abstinence in treatment than placebo-treated patients. PMID:18079068

  8. Effects of carvedilol in heart failure due to dilated cardiomyopathy. Results of a double-blind randomized placebo-controlled study (CARIBE study

    Directory of Open Access Journals (Sweden)

    Paulo Roberto Chizzola

    2000-03-01

    Full Text Available OBJECTIVE: To assess the effects of carvedilol in patients with idiopathic dilated cardiomyopathy. METHODS: In a double-blind randomized placebo-controlled study, 30 patients (7 women with functional class II and III heart failure were assessed. Their ages ranged from 28 to 66 years (mean of 43±9 years, and their left ventricular ejection fraction varied from 8% to 35%. Carvedilol was added to the usual therapy of 20 patients; placebo was added to the usual therapy of 10 patients. The initial dose of carvedilol was 12.5 mg, which was increased weekly until it reached 75 mg/day, according to the patient's tolerance. Clinical assessment, electrocardiogram, echocardiogram, and radionuclide ventriculography were performed in the pretreatment phase, being repeated after 2 and 6 months of medication use. RESULTS: A reduction in heart rate (p=0.016 as well as an increase in left ventricular shortening fraction (p=0.02 and in left ventricular ejection fraction (p=0.017 occurred in the group using carvedilol as compared with that using placebo. CONCLUSION: Carvedilol added to the usual therapy for heart failure resulted in better heart function.

  9. Acute anxiolytic effects of quetiapine during virtual reality exposure--a double-blind placebo-controlled trial in patients with specific phobia.

    Science.gov (United States)

    Diemer, Julia; Domschke, Katharina; Mühlberger, Andreas; Winter, Bernward; Zavorotnyy, Maxim; Notzon, Swantje; Silling, Karen; Arolt, Volker; Zwanzger, Peter

    2013-11-01

    Anxiety disorders are among the most frequent psychiatric disorders. With regard to pharmacological treatment, antidepressants, the calcium modulator pregabalin and benzodiazepines are recommended according to current treatment guidelines. With regard to acute states of anxiety, so far practically only benzodiazepines provide an immediate anxiolytic effect. However, the risk of tolerance and dependency limits the use of this class of medication. Therefore, there is still a need for alternative pharmacologic strategies. Increasing evidence points towards anxiety-reducing properties of atypical antipsychotics, particularly quetiapine. Therefore, we aimed to evaluate the putative acute anxiolytic effects of this compound, choosing the induction of acute anxiety in patients with specific phobia as a model for the evaluation of ad-hoc anxiolytic properties in a proof-of-concept approach. In a randomized, double-blind, placebo-controlled study, 58 patients with arachnophobia were treated with a single dose of quetiapine XR or placebo prior to a virtual reality spider challenge procedure. Treatment effects were monitored using rating scales for acute anxiety as well as measurements of heart rate and skin conductance. Overall, quetiapine showed significant anxiolytic effects compared to placebo. However, effects were not seen on the primary outcome measure (VAS Anxiety), but were limited to somatic anxiety symptoms. Additionally, a significant reduction of skin conductance was observed. Further exploratory analyses hint towards a mediating role of the (COMT) val158met genotype on treatment response. The present results thus suggest a possible suitability of quetiapine in the acute treatment of anxiety, particularly with regard to somatic symptoms.

  10. 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

    . Blood samples were drawn prior to treatment, after 1 week, 1 month, 3 months, and 6 months, and as a follow-up sample 1 month after completion of study. RESULTS: A significant decrease in CD8+ T-cell counts (p =.02) and an increase in CD4/CD8 ratio (p =.0003) in buspirone-treated patients compared......PURPOSE: Previous studies have shown that agents modulating the cAMP/PKA pathway have a beneficial effect on immune reconstitution in HIV-infected individuals. Here we evaluate the effect of buspirone on immune function as measured by CD4 and CD8 T-cell counts, CD4/CD8 T-cell ratio, HIV viral load......, 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 study...

  11. The effects of repeated administration of camphor-crataegus berry extract combination on blood pressure and on attentional performance - a randomized, placebo-controlled, double-blind study.

    Science.gov (United States)

    Erfurt, L; Schandry, R; Rubenbauer, S; Braun, U

    2014-09-25

    The present study investigated the effects of repeated administration of Korodin(®), a combination of camphor and crataegus berry extract, on blood pressure and attentional functioning. This study was conducted based on a randomized, placebo-controlled, double-blind design. 54 persons participated (33 female, 21 male) with a mean age of 24.3 years. Blood pressure and body mass index were in the normal range. Participants received 20 drops of either Korodin(®) or a placebo for four times with interjacent time intervals of about 10 min. Blood pressure was measured sphygmomanometrically before and after each administration. Attentional performance was quantified by using two paper-and-pencil tests, the d2 Test of Attention and Digit Symbol Test. Greater increases in blood pressure occurred after the four Korodin(®) administrations in comparison to the four placebo administrations. The performance in two parameters of d2 Test of Attention was consistently superior after the intake of Korodin(®). The excellent tolerability and safety of Korodin(®), even after a total consumption of 80 drops, was confirmed. Copyright © 2014 Elsevier GmbH. All rights reserved.

  12. BounceBack™ capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study

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    Singh Betsy B

    2009-06-01

    Full Text Available Abstract Background Delayed onset muscle soreness (DOMS is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack™, to alleviate the severity of DOMS after standardized eccentric exercise. Methods The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18–45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. Results In this controlled pilot study, intake of BounceBack™ capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein and muscle damage (creatine phosphokinase and myoglobin. Conclusion BounceBack™ capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results.

  13. Antihyperlipidemic effects of Salvia officinalis L. leaf extract in patients with hyperlipidemia: a randomized double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Kianbakht, S; Abasi, B; Perham, M; Hashem Dabaghian, F

    2011-12-01

    Hyperlipidemia is a common metabolic disorder contributing to morbidities and mortalities due to cardiovascular and cerebrovascular diseases. Conventional antihyperlipidemic drugs have limited efficacies and important side effects, so that alternative lipid lowering agents are needed. Salvia officinalis L. (sage) leaves have PPAR γ agonistic, pancreatic lipase and lipid absorption inhibitory, antioxidant, lipid peroxidation inhibitory and antiinflammatory effects. Thus, in this randomized double-blind placebo-controlled clinical trial with 67 hyperlipidemic (hypercholesterolemic and/or hypertriglyceridemic) patients aged 56.4 ± 30.3 years (mean ± SD), the effects of taking sage leaf extract (one 500 mg capsule every 8 h for 2 months) on fasting blood levels of lipids, creatinine and liver enzymes including SGOT and SGPT were evaluated in 34 patients and compared with the placebo group (n = 33). The extract lowered the blood levels of total cholesterol (p  0.05) compared with the placebo group at the endpoint. No adverse effects were reported. The results suggest that sage may be effective and safe in the treatment of hyperlipidemia.

  14. Treatment of cyclical mastalgia with a solution containing a Vitex agnus castus extract: results of a placebo-controlled double-blind study.

    Science.gov (United States)

    Halaska, M; Beles, P; Gorkow, C; Sieder, C

    1999-08-01

    In a placebo-controlled, randomized, double-blind study the efficacy of a Vitex agnus castus extract-containing solution (VACS) was investigated in patients suffering from cyclical mastalgia. Patients had mastalgia on at least 5 days in the pre-treatment cycle. During this cycle and during treatment (3 cycles; 2 x 30 drops/day), the intensity of mastalgia was recorded once per cycle using a visual analogue scale (VAS). After one/two treatment cycles, the mean decrease in pain intensity (mm, VAS) was 21.4 mm /33.7 mm in women taking VACS (n=48) and 10.6 mm/20.3 mm with placebo (n=49). The differences of the VAS-values for VACS were significantly greater than those with placebo (p=0.018; p=0.006). After three cycles, the mean VAS-score reduction for women taking VACS was 34.3 mm, a reduction of 'borderline significance' (p=0.064) on statistical testing compared with placebo (25.7 mm). There was no difference in the frequency of adverse events between both groups (VACS: n=5; placebo : n=4). VACS appears effective and was well tolerated and further evaluation of this agent in the treatment of cyclical mastalgia is warranted.

  15. Randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of live oral cholera vaccine 638 in Cuban adults.

    Science.gov (United States)

    Valera, Rodrigo; García, Hilda María; Jidy, Manuel Díaz; Mirabal, Mayelin; Armesto, Marlene Isabel; Fando, Rafael; García, Luis; Fernández, Roberto; Año, Gemma; Cedré, Bárbara; Ramírez, Margarita; Bravo, Laura; Serrano, Teresita; Palma, Sara; González, Daniel; Miralles, Fernando; Medina, Vilma; Nuñez, Felicita; Plasencia, Yilian; Martínez, Juan Carlos; Mandarioti, Aleyda; Lugones, Juan; Rodríguez, Boris Luis; Moreno, Arlenis; González, Domingo; Baro, Morelia; Solis, Rosa Lidia; Sierra, Gustavo; Barbera, Ramón; Domínguez, Francisco; Gutiérrez, Carlos; Kouri, Gustavo; Campa, Concepción; Menéndez, Jorge

    2009-11-01

    A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the safety, reactogenicity and the immunogenicity of a 2 x 10(9)CFU dose of the 638 lyophilized live attenuated cholera vaccine for oral administration, formulated and produced at Finlay Institute, City of Havana, Cuba. Thirty-six healthy female and male adult volunteers from 18 to 40 years old were involved, clinically examined and laboratory tested after the informed consent signature. Adverse events were monitored and seroconversion rates and geometrical mean titer (GMT) of vibriocidal antibodies were tested in volunteer's sera samples. Neither serious adverse events nor other damages to the volunteers due to vaccine or placebo feeding were reported during the clinical follow-up period of this study; none of the adverse events registered within the first 72 h after inoculation were life-threatening for volunteers. Neither severe nor moderate adverse events were reported. Sixty-one percent of subjects showed mild expected adverse events in an interval lower than 24h up to the first 72 h, 75% of these in the vaccinated group and 18% in the placebo group. Fourteen days after inoculation the GMT of vibriocidal antibodies in the vaccine group significantly increased in comparison to the placebo group. All subjects in the vaccine group (24) seroconverted (100%). Results show that this vaccine is safe, well tolerated and immunogenic in healthy female and male volunteers.

  16. Discontinuing long-term Iloprost treatment for Raynaud's Phenomenon and systemic sclerosis: a single-center, randomized, placebo-controlled, double-blind study.

    Science.gov (United States)

    Bali, G; Schwantzer, G; Aberer, F; Kraenke, B; Aberer, E

    2011-01-01

    Iloprost has been reported to reduce Raynaud`s phenomenon (RP) and to inhibit progression of systemic sclerosis (SSc). The aim of our study was to compare monthly iloprost infusions with placebo in patients treated long-term. Seventeen patients, six with RP and 11 with SSc on monthly treatment with iloprost, received either a 3-hour intravenous infusion of iloprost or an equal volume of placebo once per month for 4 months in a monocentric, randomized, placebo-controlled, double-blind study. Raynaud attacks as measured by diary entries, skin temperature, skin sclerosis, fist closure, mouth opening, and digital ulcers were recorded during the observation period. Whereas mouth opening improved significantly (p = 0.043) in the iloprost-treated group, RS improved in both patient groups. However, no significant differences were found in the outcome measures. Although iloprost influences the inflammatory cascade in SSc, no statistical differences were seen in our study, indicating that treatment strategies with iloprost should be modified.

  17. A pilot double-blind placebo-controlled trial of pioglitazone as adjunctive treatment to risperidone: Effects on aberrant behavior in children with autism.

    Science.gov (United States)

    Ghaleiha, Ali; Rasa, Soudeh Mohebbi; Nikoo, Mohammadali; Farokhnia, Mehdi; Mohammadi, Mohammad-Reza; Akhondzadeh, Shahin

    2015-09-30

    To assess the safety and efficacy of pioglitazone added to risperidone in the treatment of irritability in autistic disorder (AD), we conducted this study. In a 10-week, randomized, double-blind, parallel-group, placebo-controlled clinical trial, 44 outpatients of both genders aged 4-12 years with a diagnosis of AD and a score of ≥12 on the Aberrant Behavior Checklist-Community (ABC-C) irritability subscale were included. Mean change of ABC-C irritability subscale score as primary outcome, change in other ABC-C subscale scores and partial and complete responses were compared between two groups. Twenty patients completed the trial in each group. Level of reduction and effect of time×treatment interaction in the treatment group were significant for irritability (P=0.03), lethargy/social withdrawal (P=0.04) and hyperactivity/non-compliance (P=0.03) but not for stereotypic behavior and inappropriate speech subscales compared with the placebo group. Vomiting and headache were the most frequent reported side-effects. Results of this preliminary study indicate positive effects of pioglitazone compared with placebo in improving the behavioral symptoms of AD.

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

    Science.gov (United States)

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

    2015-06-05

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

  19. Postoperative Analgesic Efficacy of Bilateral Transversus Abdominis Plane Block in Patients Undergoing Midline Colorectal Surgeries Using Ropivacaine: A Randomized, Double-blind, Placebo-controlled Trial

    Science.gov (United States)

    Qazi, Nahida; Bhat, Wasim Mohammad; Iqbal, Malik Zaffar; Wani, Anisur Rehman; Gurcoo, Showkat A.; Rasool, Sahir

    2017-01-01

    Background: Ultrasound-guided transversus abdominis plane (TAP) block is done as a part of multimodal analgesia for pain relief after abdominal surgeries. This prospective randomized, double-blind, placebo-controlled trial was conducted to evaluate the postoperative analgesic efficacy of bilateral TAP block in patients undergoing midline colorectal surgeries using ropivacaine. Materials and Methods: Eighty patients scheduled for elective colorectal surgeries involving midline abdominal wall incision under general anesthesia were enrolled in this prospective randomized controlled trial. Group A received TAP block with 20 ml of 0.2% ropivacaine on either side of the abdominal wall, and Group B received 20 ml of normal saline. The time to request for rescue analgesia, total analgesic consumption in 24 h, and satisfaction with the anesthetic technique were assessed. Results: The mean visual analog scale scores at rest and on coughing were higher in control group (P > 0.05). Time (min) to request for the first rescue analgesia was prolonged in study group compared to control group (P tramadol consumption in 24 h postoperatively was significantly high in control group (P 0.05). The level of satisfaction concerning postoperative pain control/anesthetic technique was higher in study group (P tramadol requirements, reduction in postoperative pain scores, and increased time to first request for further analgesia, both at rest and on movement. PMID:28928585

  20. 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.

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

    Science.gov (United States)

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

    2017-01-01

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

  2. Effects of gum Arabic ingestion on body mass index and body fat percentage in healthy adult females: two-arm randomized, placebo controlled, double-blind trial

    Directory of Open Access Journals (Sweden)

    Babiker Rasha

    2012-12-01

    Full Text Available Abstract Background Gum Arabic (acacia Senegal is a complex polysaccharide indigestible to both humans and animals. It has been considered as a safe dietary fiber by the United States, Food and Drug Administration (FDA since the 1970s. Although its effects were extensively studied in animals, there is paucity of data regarding its quantified use in humans. This study was conducted to determine effects of regular Gum Arabic (GA ingestion on body mass index and body fat percentage among healthy adult females. Methods A two-arm randomized, placebo controlled, double-blind trial was conducted in the Department of Physiology at the Khartoum University. A total of 120 healthy females completed the study. They were divided to two groups: A test group of 60 volunteers receiving GA (30 gm /day for 6 weeks and a placebo group of 60 volunteers receiving pectin (1 gm/day for the same period of time. Weight and height were measured before and after intervention using standardized height and weight scales. Skin fold thickness was measured using Harpenden Skin fold caliper. Fat percentage was calculated using Jackson and Pollock 7 caliper method and Siri equation. Results Pre and post analysis among the study group showed significant reduction in BMI by 0.32 (95% CI: 0.17 to 0.47; P Conclusions GA ingestion causes significant reduction in BMI and body fat percentage among healthy adult females. The effect could be exploited in the treatment of obesity.

  3. Efficacy of an Extract of Ocimum tenuiflorum (OciBest in the Management of General Stress: A Double-Blind, Placebo-Controlled Study

    Directory of Open Access Journals (Sweden)

    Ram Chandra Saxena

    2012-01-01

    Full Text Available A randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of OciBest, an extract of Ocimum tenuiflorum Linn. in symptomatic control of general stress. The participants received either placebo (n=79 or OciBest (n=71; 1200 mg of actives per day for six weeks. The severity of stress-related symptoms was self-evaluated by patients at weeks 0, 2, 4 and 6 of the trial period using a symptom rating scale. After six weeks of intervention, scores of symptoms such as forgetfulness, sexual problems of recent origin, frequent feeling of exhaustion, and frequent sleep problems of recent origin decreased significantly (P≤0.05 in OciBest group as compared with placebo group. Also, the total symptom scores of OciBest group revealed significant reduction (P≤0.05 as compared to placebo group. The overall improvement in OciBest group was found to be 1.6 times or 39% more in the control of general stress symptoms with respect to placebo. No adverse events were reported during the study. The findings revealed that OciBest was found to be effective and well tolerated by all the patients over the six weeks of study period.

  4. Efficacy of a microencapsulated iron pyrophosphate-fortified fruit juice: a randomised, double-blind, placebo-controlled study in Spanish iron-deficient women.

    Science.gov (United States)

    Blanco-Rojo, Ruth; Pérez-Granados, Ana M; Toxqui, Laura; González-Vizcayno, Carmen; Delgado, Marco A; Vaquero, M Pilar

    2011-06-01

    Fe-deficiency anaemia is a worldwide health problem. We studied the influence of consuming an Fe-fortified fruit juice on Fe status in menstruating women. A randomised, double-blind, placebo-controlled study of 16 weeks of duration was performed. Subjects were randomised into two groups: the P group (n 58) or the F group (n 64), and consumed, as a supplement to their usual diet, 500 ml/d of a placebo fruit juice or an Fe-fortified fruit juice, respectively. The Fe-fortified fruit juice, containing microencapsulated iron pyrophosphate, provided 18 mg Fe/d (100 % of the RDA). At baseline and monthly, dietary intake, body weight and Fe parameters were determined: total erythrocytes, haematocrit, mean corpuscular volume (MCV), red blood cell distribution width (RDW), Hb, serum Fe, serum ferritin, serum transferrin, transferrin saturation, soluble transferrin receptor (sTfR) and zinc protoporphyrin (ZnPP). The fruit juice consumption involved increased intake of carbohydrates and vitamin C, and increased BMI within normal limits. Ferritin was higher in the F group after week 4 (P fruit juice improves Fe status and may be used to prevent Fe-deficiency anaemia.

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

    Science.gov (United States)

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

    2009-10-01

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

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

    Directory of Open Access Journals (Sweden)

    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.

  7. The effect of Sailuotong (SLT) on neurocognitive and cardiovascular function in healthy adults: a randomised, double-blind, placebo controlled crossover pilot trial.

    Science.gov (United States)

    Steiner, Genevieve Z; Yeung, Alan; Liu, Jian-Xun; Camfield, David A; Blasio, Frances M de; Pipingas, Andrew; Scholey, Andrew B; Stough, Con; Chang, Dennis H

    2016-01-13

    Sailuotong (SLT) is a standardised herbal medicine formula consisting of Panax ginseng, Ginkgo biloba, and Crocus sativus, and has been designed to enhance cognitive and cardiovascular function. Using a randomised, double-blind, placebo controlled crossover design, this pilot study assessed the effect of treatment for 1 week with SLT and placebo (1 week washout period) on neurocognitive and cardiovascular function in healthy adults. Sixteen adults completed a computerised neuropsychological test battery (Compass), and had their electroencephalographic (EEG) activity and cardiovascular system function assessed. Primary outcome measures were cognitive test scores and oddball task event-related potential (ERP) component amplitudes. Secondary outcome measures were resting EEG spectral band amplitudes, and cardiovascular parameters. Treatment with SLT, compared to placebo, resulted in small improvements in working memory, a slight increase in auditory target (cf. nontarget) P3a amplitude, and a decrease in auditory N1 target (cf. nontarget) amplitude. There was no effect of SLT on EEG amplitude in delta, theta, alpha, or beta bands in both eyes open and eyes closed resting conditions, or on aortic and peripheral pulse pressure, and resting heartrate. Findings suggest that SLT has the potential to improve working memory performance in healthy adults; a larger sample size is needed to confirm this. Australia New Zealand Clinical Trials Registry Trial Registration Id: ACTRN12610000947000 .

  8. Effectiveness of Lactobacillus helveticus and Lactobacillus rhamnosus for the management of antibiotic-associated diarrhoea in healthy adults: a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Evans, Malkanthi; Salewski, Ryan P; Christman, Mary C; Girard, Stephanie-Anne; Tompkins, Thomas A

    2016-07-01

    Broad-spectrum antibiotic use can disrupt the gastrointestinal microbiota resulting in diarrhoea. Probiotics may be beneficial in managing this type of diarrhoea. The aim of this 10-week randomised, double-blind, placebo-controlled, parallel study was to investigate the effect of Lactobacillus helveticus R0052 and Lactobacillus rhamnosus R0011 supplementation on antibiotic-associated diarrhoea in healthy adults. Subjects were randomised to receive 1 week of amoxicillin-clavulanic acid (875 mg/125 mg) once per day, plus a daily dose of 8×109 colony-forming units of a multi-strain probiotic (n 80) or placebo (n 80). The probiotic or placebo intervention was maintained for 1 week after completion of the antibiotic. Primary study outcomes of consistency and frequency of bowel movements were not significantly different between the probiotic and placebo groups. The secondary outcomes of diarrhoea-like defecations, Gastrointestinal Symptoms Rating Scale scores, safety parameters and adverse events were not significantly different between the probiotic intervention and the placebo. A post hoc analysis on the duration of diarrhoea-like defecations showed that probiotic intervention reduced the length of these events by 1 full day (probiotic, 2·70 (sem 0·36) d; placebo, 3·71 (sem 0·36) d; P=0·037; effect size=0·52). In conclusion, this study provides novel evidence that L. helveticus R0052 and L. rhamnosus R0011 supplementation significantly reduced the duration of diarrhoea-like defecations in healthy adults receiving antibiotics.

  9. Effect of Paracetamol Pretreatment on Rocuronium-Induced Injection Pain: A Randomized, Double-Blind, Placebo-Controlled Comparison with Lidocaine

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    Gulnaz Ates

    2013-10-01

    Full Text Available Aim: To compare the effect of intravenous paracetamol on rocuronium-induced injection pain with that of lidocaine. Material and Method: One hundred and eighty patients scheduled for elective surgery under general anesthesia were recruited to this prospective, randomized, double-blinded, placebo-controlled study. A 20-gauge cannula was inserted into a vein on the dorsum of the patient%u2019s left hand and lactated Ringer%u2019s solution was infused at 100 ml/h. After 5 minutes, infusion was stopped and the left arm of the patient%u2019s was elevated for 15 seconds for gravity of venous blood. While venous occlusion was applied to the left upper arm using a pneumatic tourniquet, one of the pretreatment solutions (normal saline 5 mL, lidocaine 40 mg, paracetamol 50 mg was injected over a period of 10 seconds. The intensity of the pain patients experienced was assessed using a 4-point verbal rating scale in Group C (normal saline 5 mL, n=60, Group L (lidocaine 40 mg, n=60 and Group P (paracetamol 50 mg, n=60. After 2 minutes, the venous occlusion was released and the patients received 0.06 mg/kg rocuronim bromide over 10 seconds and the rocuronim-induced pain was assessed. Results: The overall incidence of rocuronium-induced injection pain was significantly more in Group C than the other groups (p

  10. Combination of glucosamine and low-dose cyclosporine for atopic dermatitis treatment: a randomized, placebo-controlled, double-blind, parallel clinical trial.

    Science.gov (United States)

    Jin, Sang-Yoon; Lim, Won-Suk; Sung, Nam Hee; Cheong, Kyung Ah; Lee, Ai-Young

    2015-01-01

    Our recent pilot study showed better outcomes using a combination of low-dose cyclosporine and glucosamine than cyclosporine alone in the treatment of atopic dermatitis (AD). Here, a randomized, placebo-controlled, double-blind, parallel-designed study was planned to compare the efficacy and safety of low-dose cyclosporine and glucosamine combination to low-dose cyclosporine alone for the treatment of patients with moderate to severe AD. AD patients with a Severity Scoring of Atopic Dermatitis (SCORAD) index ≥ 30 were randomly assigned in a 1:1 ratio to receive either cyclosporine 2 mg/kg and glucosamine 25 mg/kg (group A) or cyclosporine and placebo (group B) for 8 weeks. SCORAD indices, serum levels of chemokine ligand 17 and interleukin-31, eosinophil counts, and blood cyclosporine levels were examined before and after treatment. The SCORAD indices for group A (n = 19) were significantly reduced after the treatment and a significant correlation between the changes in the SCORAD indices and changes in the serum levels of chemokine ligand 17, but not interleukin-31, was detected. Glucosamine combined with cyclosporine did not increase adverse events and serum cyclosporine levels compared with cyclosporine alone. Therefore, combination of low-dose cyclosporine and glucosamine may be useful to allow the long-term use of cyclosporine in the treatment of patients with moderate to severe AD.

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

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

    2011-01-01

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

  12. A double blind placebo controlled randomized trial of the effect of acute uric acid changes on inflammatory markers in humans: A pilot study.

    Science.gov (United States)

    Tanaka, Toshiko; Milaneschi, Yuri; Zhang, Yongqing; Becker, Kevin G; Zukley, Linda; Ferrucci, Luigi

    2017-01-01

    Uric acid has been linked with increased risk of chronic disease such as cardiovascular disease and this association has been attributed to a pro-inflammatory effect. Indeed, observational studies have shown that high uric acid is associated with high level of pro-inflammatory cytokines in the blood. However, whether high uric acid directly affects inflammation or rather represents a parallel defensive antioxidant mechanism in response to pathology that causes inflammation is unknown. To determine whether acute increase or decrease uric acid levels affects inflammation in healthy individuals, a randomized, placebo-controlled, double blind clinical study of uric acid or rasburicase with 20 healthy volunteers in each treatment-placebo group was conducted at the National Institute on Aging (NIA) Clinical Research Unit (CRU) at Harbor Hospital in Baltimore, MD. Change in inflammatory response was assessed by administering an oral lipid tolerance before and after the treatment of uric acid, rasburicase and placebo. Following uric acid administration, there was an accentuated increase in IL-6 during the oral lipid tolerance test (Puric acid with rasburicase. No side effects were reported throughout the trial. In health individuals, acute increase in uric acid results in an increased IL-6 response when challenged with lipid load. Such effect of amplification of inflammatory response may explain the higher risk of chronic diseases observed in subclinical hyperuricemia in observational studies. ClinicalTrials.gov NCT01323335.

  13. Effect of an extract of Ganoderma lucidum in men with lower urinary tract symptoms: a double-blind, placebo-controlled randomized and dose-ranging study

    Institute of Scientific and Technical Information of China (English)

    Masanori Noguchi; Kei Matsuoka; Tatsuyuki Kakuma; Katsnro Tomiyasu; Yoshiko Kurita; Hiroko Kukihara; Fumiko Konishi; Shoichiro Kumamoto; Kuniyoshi Shimizu; Ryuichiro Kondo

    2008-01-01

    Aim: To conduct a double-blind, placebo-controlled randomized and dose-ranging study to evaluate the safety and efficacy of the extract of Ganoderma lucidum (G. lucidum) in men with lower urinary tract symptoms (LUTS). Methods: We enrolled male volunteers (> 50 years) with an International Prostate Symptom Score (IPSS; questions 1-7)≥ 5 and a prostate-specific antigen (PSA) value < 4 ng/mL. Volunteers were randomized into groups of placebo (n = 12), G. lucidum of 0.6 mg (n = 12), 6 mg (n = 12) or 60 mg (n = 14), administered once daily. Efficacy was measured as a change from baseline in IPSS and the peak urine flow rate (Qmax). Prostate volume and residual urine were estimated by ultrasonography, and blood tests, including PSA levels, were measured at baseline and at the end of the treatment. Results: The overall administration was well tolerated, with no major adverse effects. Statistical significances in the magnitude of changes between the experimental groups were observed at weeks 4 and 8. No changes were observed with respect to Qmax, residual urine, prostate volume or PSA levels. Conclusion: The extract of G. lucidum was well tolerated and an improvement in IPSS was observed. The recommended dose of the extract of G. lucidum is 6 mg in men with LUTS. (Asian J Androl 2008 Jul; 10: 651-658)

  14. A randomized, double-blind, placebo-controlled exploratory study to evaluate the potential of pycnogenol for improving allergic rhinitis symptoms.

    Science.gov (United States)

    Wilson, Dale; Evans, Malkanthi; Guthrie, Najla; Sharma, Prachi; Baisley, Joshua; Schonlau, Frank; Burki, Carolina

    2010-08-01

    The potential of Pycnogenol for relieving allergic rhinitis (birch pollen) symptoms was explored in a double-blind, placebo-controlled trial. In 2008 19 subjects started treatment 3 weeks prior to the onset of birch pollen season in Ontario, Canada. While there was an improvement of eye and nasal symptoms with Pycnogenol, there was no significance versus placebo. It was postulated that Pycnogenol may require a lag-time between the start of therapy and the onset of action. Therefore 39 subjects were treated 5-8 weeks prior to the 2009 birch allergy season. The evaluation of subjects in 2009 showed much lower scores for eye (-35%) and nasal (-20.5%) symptoms with Pycnogenol compared with placebo. In succession of the allergy season birch specific IgE increased by 31.9% in the placebo group compared with only 19.4% in the Pycnogenol group. Detailed analysis suggested that symptom-relief was better the longer subjects were on Pycnogenol prior to the allergen exposure. The best results were found with subjects who took Pycnogenol 7-8 weeks ahead of the allergy season. With the limited number of 39 patients statistical predications were unattainable. In conclusion, Pycnogenol improved allergic rhinitis symptoms when supplementation was started at least 5 weeks before the onset of the allergy season.

  15. Metformin administration versus laparoscopic ovarian diathermy in clomiphene citrate-resistant women with polycystic ovary syndrome: a prospective parallel randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Palomba, Stefano; Orio, Francesco; Nardo, Luciano Giovanni; Falbo, Angela; Russo, Tiziana; Corea, Domenico; Doldo, Patrizia; Lombardi, Gaetano; Tolino, Achille; Colao, Annamaria; Zullo, Fulvio

    2004-10-01

    At present, it is unclear what the role is of laparoscopic ovarian diathermy (LOD) and of metformin administration as second-line treatments for ovulation induction in women with polycystic ovary syndrome (PCOS) after failure of clomiphene citrate (CC) treatment. The aim of the present study was to compare in a randomized double-blind placebo-controlled fashion the effectiveness of LOD with metformin administration in the treatment of CC-resistant women with PCOS. A total of 120 overweight primary infertile anovulatory CC-resistant women with PCOS were enrolled and randomized into two groups of treatment. Group A underwent diagnostic laparoscopy, whereas group B underwent LOD. At hospital discharge, the patients were treated for 6 months with metformin cloridrate (group A; 850 mg twice daily) or with multivitamins (group B). The ovulation, pregnancy, abortion, and live-birth rates were evaluated. At the end of the study, the total ovulation rate was not statistically different between both treatment groups (54.8 vs. 53.2% [correction] in groups A and B, respectively), whereas the pregnancy (21.8 [correction] vs. 13.4%), the abortion (9.3 [correction] vs. 29.0%), and the live-birth (86.0 [correction] vs. 64.5%) rates were significantly (P < 0.05) different between the two groups. Our data show that metformin administration is more effective than LOD in overall reproductive outcomes in overweight infertile CC-resistant women with PCOS.

  16. The use of a Cissus quadrangularis/Irvingia gabonensis combination in the management of weight loss: a double-blind placebo-controlled study.

    Science.gov (United States)

    Oben, Julius E; Ngondi, Judith L; Momo, Claudia N; Agbor, Gabriel A; Sobgui, Caroline S Makamto

    2008-03-31

    To evaluate the effects of two formulations, Cissus quadrangularis-only and a Cissus quadrangularis/Irvingia gabonensis combination, on weight loss in overweight and obese human subjects. The study was a 10 week randomized, double-blind, placebo-controlled design involving 72 obese or overweight participants (45.8% male; 54.2% female; ages 21-44; mean age = 29.3). The participants were randomly divided into three equal (n = 24) groups: placebo, Cissus quadrangularis-only, and Cissus quadrangularis/Irvingia gabonensis combination. Capsules containing the placebo or active formulations were administered twice daily before meals; no major dietary changes nor exercises were suggested during the study. A total of six anthropomorphic and serological measurements (body weight, body fat, waist size; total plasma cholesterol, LDL cholesterol, fasting blood glucose level) were taken at baseline and at 4, 8 and 10 weeks. Compared to the placebo group, the two active groups showed a statistically significant difference on all six variables by week 10. The magnitude of the differences was noticeable by week 4 and continued to increase over the trial period. Although the Cissus quadrangularis-only group showed significant reductions on all variables compared to the placebo group, the Cissus quadrangularis/Irvingia gabonensis combination resulted in even larger reductions. This apparently synergistic formulation should prove helpful in the management of obesity and its related complications.

  17. The use of a Cissus quadrangularis/Irvingia gabonensis combination in the management of weight loss: a double-blind placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Agbor Gabriel A

    2008-03-01

    Full Text Available Abstract Aim To evaluate the effects of two formulations, Cissus quadrangularis-only and a Cissus quadrangularis/Irvingia gabonensis combination, on weight loss in overweight and obese human subjects. Methods The study was a 10 week randomized, double-blind, placebo-controlled design involving 72 obese or overweight participants (45.8% male; 54.2% female; ages 21–44; mean age = 29.3. The participants were randomly divided into three equal (n = 24 groups: placebo, Cissus quadrangularis-only, and Cissus quadrangularis/Irvingia gabonensis combination. Capsules containing the placebo or active formulations were administered twice daily before meals; no major dietary changes nor exercises were suggested during the study. A total of six anthropomorphic and serological measurements (body weight, body fat, waist size; total plasma cholesterol, LDL cholesterol, fasting blood glucose level were taken at baseline and at 4, 8 and 10 weeks. Results Compared to the placebo group, the two active groups showed a statistically significant difference on all six variables by week 10. The magnitude of the differences was noticeable by week 4 and continued to increase over the trial period. Conclusion Although the Cissus quadrangularis-only group showed significant reductions on all variables compared to the placebo group, the Cissus quadrangularis/Irvingia gabonensis combination resulted in even larger reductions. This apparently synergistic formulation should prove helpful in the management of obesity and its related complications.

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

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    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. Risperidone for the treatment of acute mania in children and adolescents with bipolar disorder: a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Haas, Magali; Delbello, Melissa P; Pandina, Gahan; Kushner, Stuart; Van Hove, Ilse; Augustyns, Ilse; Quiroz, Jorge; Kusumakar, Vivek

    2009-11-01

    To evaluate the efficacy, safety, and tolerability of risperidone monotherapy for the treatment of an acute mixed or manic episode in children and adolescents with bipolar I disorder. This randomized, placebo-controlled, double-blind, 3-arm study (N = 169) included children and adolescents (ages 10-17 years) with a DSM-IV diagnosis of bipolar I disorder, experiencing a manic or mixed episode. Study participants were randomized to placebo (n = 58), risperidone 0.5-2.5 mg/day (n = 50), or risperidone 3-6 mg/day (n = 61) for 3 weeks. The primary efficacy measure was change in Young Mania Rating Scale (YMRS) total score from baseline to end point. Safety assessments included adverse event (AE) monitoring and scores on extrapyramidal symptom rating scales. Improvement in mean YMRS total score was significantly greater in risperidone-treated subjects than in placebo-treated subjects [mean change (SD) -9.1 (11.0) for placebo; -18.5 (9.7) for risperidone 0.5-2.5 mg (p children and adolescents experiencing acute manic or mixed episodes of bipolar I disorder. Results indicate that risperidone 0.5-2.5 mg has a better benefit-risk profile than risperidone 3-6 mg.

  20. Treatment of distal subungual onychomycosis with a topical preparation of urea, propylene glycol and lactic acid: results of a 24-week, double-blind, placebo-controlled study.

    Science.gov (United States)

    Emtestam, L; Kaaman, T; Rensfeldt, K

    2012-11-01

    Onychomycosis is difficult to cure as this requires eradication of the primary infection and protection of new areas of growth from reinfection. A new topical treatment (K101) has been developed. The aim of this study was to assess the efficacy, safety and tolerability of K101 treatment of distal subungual onychomycosis. This was a 24-week (plus 2-week washout), multicentre, randomised, double-blind, placebo-controlled study in 493 patients with distal subungual onychomycosis (K101, n = 346; placebo, n = 147), stratified according to degree of nail involvement. More patients with ≤50% nail involvement achieved the primary endpoint (mycological cure after 26 weeks) in the K101 group (27.2%) than placebo (10.4%; P = 0.0012). Proportions for patients with 51-75% involvement were 19.1% for K101 and 7.0% for placebo (not significant). More patients applying K101 than placebo judged that their condition had improved from week 2 (P = 0.0148) to week 24 (P = 0.0004). No safety issues were identified. K101 provides early visible improvements in nail appearance and a clinically meaningful antifungal activity.

  1. A randomized, double-blind, placebo-controlled study evaluating the effects of quercetin-rich onion on cognitive function in elderly subjects

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    Mie Nishimura

    2017-05-01

    Full Text Available Background: Quercetin, a phenolic compound, exhibits various functional effectsthat includeanti-oxidant, anti-dyslipidemic, and anti-dysglycemic activities, in addition tobeneficial effects on cognitive function. We evaluated the effects of a powder made from quercetin-rich onions (‘Quergold’ and ‘Sarasara-gold’ on cognitive function.Methods:In this randomized, double-blind, placebo-controlled study, we randomized 50 adults (25 males and 25 females, aged 65–84 years and made them consume products made from quercetin-rich (active test food group or quercetin-free(placebo food group onions. Cognitive function,hematological, and biological examinations were performed at the beginning (week 0 of the study and at weeks 12 and 24 after the start of the study. Results:There were no differences in the Mini-Mental State Examination (MMSE and cognitive impairment rating scale scores between the two groups. However, in younger subjects, the MMSE scores were significantly higher in the active test food group than in the placebo food group at week 24 (p = 0.019. Conclusion: These results suggest that the ingestion of quercetin-rich onions improves cognitive function and reduce cognitive declinein elderly people.

  2. A randomized, double-blind, placebo-controlled study of rebamipide for gastric mucosal injury taking aspirin with or without clopidogrel.

    Science.gov (United States)

    Tozawa, Katsuyuki; Oshima, Tadayuki; Okugawa, Takuya; Ogawa, Tomohiro; Ohda, Yoshio; Tomita, Toshihiko; Hida, Nobuyuki; Fukui, Hirokazu; Hori, Kazutoshi; Watari, Jiro; Nakamura, Shiro; Miwa, Hiroto

    2014-08-01

    Antithrombotic drugs, such as low-dose aspirin (LDA) and clopidogrel, can cause upper gastrointestinal complications. The goal of the present study was to investigate whether a mucosal-protective agent, rebamipide, could prevent gastric mucosal injuries induced by LDA with or without clopidogrel in healthy subjects. A randomized, double-blind, placebo-controlled trial was performed with 32 healthy male volunteers. Subjects were randomly assigned to a 14-day course of one of the following regimens: group A, placebo (tid) + LDA; group B, rebamipide (100 mg tid) + LDA (100 mg once-daily); group C, placebo + LDA + clopidogrel (75 mg once-daily); or group D, rebamipide + LDA + clopidogrel. The grade of gastric mucosal injuries was evaluated by esophagogastroduodenoscopy before and after dosing (on day 0 and day 14), and the grade of gastric mucosal injury was assessed according to the modified Lanza score. Subjective symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS). A rapid urease test was performed on day 0, and blood tests were performed on day 0 and day 14. Rebamipide significantly inhibited gastric mucosal injury induced by LDA alone or by LDA plus clopidogrel when compared with placebo in healthy subjects. GSRS score and hemoglobin level were not significantly different among the four groups. Rebamipide is useful for the primary prevention of gastric mucosal injury induced by LDA alone or by LDA plus clopidogrel in healthy subjects.

  3. Anti-Stress, Behavioural and Magnetoencephalography Effects of an L-Theanine-Based Nutrient Drink: A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial.

    Science.gov (United States)

    White, David J; de Klerk, Suzanne; Woods, William; Gondalia, Shakuntla; Noonan, Chris; Scholey, Andrew B

    2016-01-19

    L-theanine (γ-glutamylethylamide) is an amino acid found primarily in the green tea plant. This study explored the effects of an L-theanine-based nutrient drink on mood responses to a cognitive stressor. Additional measures included an assessment of cognitive performance and resting state alpha oscillatory activity using magnetoencephalography (MEG). Thirty-four healthy adults aged 18-40 participated in this double-blind, placebo-controlled, balanced crossover study. The primary outcome measure, subjective stress response to a multitasking cognitive stressor, was significantly reduced one hour after administration of the L-theanine drink when compared to placebo. The salivary cortisol response to the stressor was reduced three hours post-dose following active treatment. No treatment-related cognitive performance changes were observed. Resting state alpha oscillatory activity was significantly greater in posterior MEG sensors after active treatment compared to placebo two hours post-dose; however, this effect was only apparent for those higher in trait anxiety. This change in resting state alpha oscillatory activity was not correlated with the change in subjective stress response or the cortisol response, suggesting further research is required to assess the functional relevance of these treatment-related changes in resting alpha activity. These findings further support the anti-stress effects of L-theanine.

  4. A double-blind, randomized, placebo-controlled pilot trial to determine the efficacy and safety of ibudilast, a potential glial attenuator, in chronic migraine

    Science.gov (United States)

    Kwok, Yuen H; Swift, James E; Gazerani, Parisa; Rolan, Paul

    2016-01-01

    Background Chronic migraine (CM) is problematic, and there are few effective treatments. Recently, it has been hypothesized that glial activation may be a contributor to migraine; therefore, this study investigated whether the potential glial inhibitor, ibudilast, could attenuate CM. Methods The study was of double-blind, randomized, placebo-controlled, two-period crossover design. Participants were randomized to receive either ibudilast (40 mg twice daily) or placebo treatment for 8 weeks. Subsequently, the participants underwent a 4-week washout period followed by a second 8-week treatment block with the alternative treatment. CM participants completed a headache diary 4 weeks before randomization throughout both treatment periods and 4 weeks after treatment. Questionnaires assessing quality of life and cutaneous allodynia were collected on eight occasions throughout the study. Results A total of 33 participants were randomized, and 14 participants completed the study. Ibudilast was generally well tolerated with mild, transient adverse events, principally nausea. Eight weeks of ibudilast treatment did not reduce the frequency of moderate to severe headache or of secondary outcome measures such as headache index, intake of symptomatic medications, quality of life or change in cutaneous allodynia. Conclusion Using the current regimen, ibudilast does not improve migraine with CM participants. PMID:27826212

  5. Evaluation of a diclofenac transdermal patch for the attenuation of venous cannulation pain: a prospective, randomised, double-blind, placebo-controlled study.

    Science.gov (United States)

    Agarwal, A; Dhiraaj, S; Kumar, A; Singhal, V; Singh, U

    2006-04-01

    Venous cannulation, although a minor procedure, is often painful. The present study was planned to evaluate the efficacy of a diclofenac transdermal patch placed over the venepuncture site in decreasing the pain of cannulation. Seventy-two adults undergoing elective surgery were included in this randomised, prospective, double-blind, placebo-controlled study. Patients were divided into three equal groups. The Control group had a placebo adhesive patch placed on the both the dorsum of hand and the buttock; the Diclofenac-Buttock group had a placebo patch placed on the dorsum of the hand and a diclofenac transdermal patch on the buttock; the Diclofenac-Hand group had a diclofenac transdermal patch placed on the dorsum of hand and a placebo patch on the buttock. The patches were applied 1 h before cannulation. An 18G cannula was used for all venous cannulations. Pain during cannulation was assessed on a non-graduated 10-cm visual analogue scale. Median [interquartile range] pain scores were 3.0 [2.0-4.0] in the Diclofenac-Hand group, 5.0 [4.3-7.8] in the Diclofenac-Buttock group and 6.5 [4.5-7.0] in the Control group, p Diclofenac-Buttock and Diclofenac-Hand groups, respectively. The application of a diclofenac transdermal patch at the cannulation site appears to be effective in decreasing cannulation pain.

  6. Telmisartan combined with probucol effectively reduces urinary protein in patients with type 2 diabetes: A randomized double-blind placebo-controlled multicenter clinical study.

    Science.gov (United States)

    Zhu, Hanyu; Chen, Xiangmei; Cai, Guangyan; Zheng, Ying; Liu, Moyan; Liu, Wenhu; Yao, Hebin; Wang, Yaping; Li, Wenge; Wu, Hua; Lun, Lide; Zhang, Jianrong; Guan, Xiaohong; Yin, Shinan; Zhuang, Xiaoming; Li, Jijun; Liu, Yanjun; Zhou, Chunhua

    2016-09-01

    Persistent proteinuria is an important factor contributing to the progression of diabetic nephropathy. The present randomized double-blind placebo-controlled multicenter clinical study evaluated the efficacy and safety of telmisartan combined with the antioxidant probucol in reducing urinary protein levels in patients with type 2 diabetes (T2D). Patients with T2D and 24-h proteinuria 0.5-3 g were enrolled in the study and randomly assigned to one of two groups: a telmisartan or a probucol + telmisartan group. Both groups were given telmisartan 80 mg q.d. for 48 weeks. The probucol + telmisartan group was given probucol 500 mg b.i.d. for the first 24 weeks, with the dosage then reduced to 250 mg b.i.d. for the remaining 24 weeks. The telmisartan group was given probucol placebo. In all, 160 patients were enrolled in the present study. The 24-h proteinuria levels were significantly reduced in the probucol + telmisartan compared with telmisartan group. For patients with baseline 24-h proteinuria levels telmisartan group. There was no significant difference between the two groups for either adverse cardiovascular or other events. In patients with diabetic nephropathy, probucol combined with telmisartan more effectively reduces urinary protein levels than telmisartan alone. © 2015 The Authors. Journal of Diabetes published by Wiley Publishing Asia Pty Ltd and Ruijin Hospital, Shanghai Jiaotong University School of Medicine.

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

    Science.gov (United States)

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

    2016-04-01

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

  8. Therapy of CF-Patients with Amitriptyline and Placebo - a Randomised, Double-Blind, Placebo-Controlled Phase IIb Multicenter, Cohort-Study

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    Lutz Nährlich

    2013-04-01

    Full Text Available Background/Aims: Several recent studies revealed an accumulation of ceramide in bronchial, tracheal and intestinal epithelial cells of mice and patients with cystic fibrosis (CF. Normalization of ceramide concentrations in lungs of CF mice employing the functional acid sphingomyelinase inhibitor amitriptyline also normalized mucociliary clearance, chronic inflammation and infection susceptibility to pulmonary P. aeruginosa in these mice. Methods: To test for a beneficial effect of amitriptyline in vivo, we performed a phase IIb randomised, double-blind, placebo-controlled study. Twenty-one CF patients were treated with 25 mg/d amitriptyline twice daily for 28 days. The placebo consisted of 19 patients and was also treated twice per day. The primary endpoint was the change in lung function in the intention-to-treat (ITT population. Secondary endpoints were ceramide levels in epithelial cells and safety. Results: After treatment, forced expiratory volume in 1 sec predicted (FEV1 increased 6.3±11.5% (p=0.08 in the ITT population (36 of 40 CF patients and 8.5±10% (p=0.013 in the per protocol (PP population (29 of 40 patients. Ceramide levels decreased in nasal epithelial cells after amitriptyline treatment. Amitriptyline had no severe and only mild and mostly transient adverse effects, i.e. xerostomia and tiredness. Conclusion: Amitriptyline is safe in CF-patients, increases FEV1 and reduces ceramide in lung cells of CF patients.

  9. Body Weight Management in Adults Under Chronic Stress Through Treatment With Ashwagandha Root Extract: A Double-Blind, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Choudhary, Dnyanraj; Bhattacharyya, Sauvik; Joshi, Kedar

    2017-01-01

    Chronic stress has been associated with a number of illnesses, including obesity. Ashwagandha is a well-known adaptogen and known for reducing stress and anxiety in humans. The objective of this study was to evaluate the safety and efficacy of a standardized root extract of Ashwagandha through a double-blind, randomized, placebo-controlled trial. A total of 52 subjects under chronic stress received either Ashwagandha (300 mg) or placebo twice daily. Primary efficacy measures were Perceived Stress Scale and Food Cravings Questionnaire. Secondary efficacy measures were Oxford Happiness Questionnaire, Three-Factor Eating Questionnaire, serum cortisol, body weight, and body mass index. Each subject was assessed at the start and at 4 and 8 weeks. The treatment with Ashwagandha resulted in significant improvements in primary and secondary measures. Also, the extract was found to be safe and tolerable. The outcome of this study suggests that Ashwagandha root extract can be used for body weight management in adults under chronic stress. © The Author(s) 2016.

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

    Science.gov (United States)

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

    2010-02-01

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

  11. Long-term oral calcium supplementation reduces diastolic blood pressure in end stage renal disease. A randomized, double-blind, placebo controlled study.

    Science.gov (United States)

    Petersen, L J; Rudnicki, M; Højsted, J

    1994-01-01

    Previous studies suggest that oral calcium supply reduces blood pressure in patients with mild to moderate hypertension. The aim of this study was to determine whether oral calcium supply reduces blood pressure in patients undergoing haemodialysis. The study was randomized, double-blind, and placebo controlled. Eleven patients received two grams of calcium per day and 12 patients received placebo. Three patients (one from the calcium group and two from the placebo group) dropped out within the first month. The groups were comparable at inclusion regarding blood pressure, weight, and serum values. Blood pressure measurements were auscultatory with a mercury manometer and diastolic blood pressure was measured as Korotkoff phase V. At inclusion a significant positive correlation between serum phosphate and blood pressure was found. After a study period of six months a significant reduction in diastolic blood pressure was found between the two groups (p < 0.05), but no difference was found in systolic blood pressure. The reduction in diastolic blood pressure was 6.9 mmHg of the pretreatment level in the calcium group. In conclusion, the treatment of secondary hyperparathyroidism with oral calcium gives good benefits in the regulation of diastolic blood pressure. A well controlled phosphate homeostasis may also be of importance for the control of blood pressure in haemodialysis patients.

  12. Effect of vitamin D supplementation on bone and vitamin D status among Pakistani immigrants in Denmark: a randomised double-blinded placebo-controlled intervention study

    DEFF Research Database (Denmark)

    Andersen, Rikke; Mølgaard, Christian; Skovgaard, Lene T.

    2008-01-01

    Severe vitamin D deficiency is common among Muslim immigrants. The dose necessary to correct the deficiency and its consequence for bone health are not known for immigrants. The aim was to assess the effect of relatively low dosages of supplemental vitamin D on vitamin D and bone status...... in Pakistani immigrants. This 1-year-long randomised double-blinded placebo-controlled intervention with vitamin D-3 (10 and 20 mu g/d) included girls (10.1 - 14.7 years), women (18.1 - 52.7 years) and men (17.9-63.5 years) of Pakistani origin living in Denmark. The main endpoints were serum 25-hydroxyvitamin...... D (S-25OHD), parathyroid hormone, bone turnover markers and bone mass. The study showed that supplementation with 10 and 20 mu g vitamin D-3 per d increased S-25OHD concentrations similarly in vitamin D-deficient Pakistani women (4-fold), and that 10 mu g increased S-25OHD concentrations 2-fold...

  13. 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.

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

    Science.gov (United States)

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

    2016-03-24

    Intercontinental air travel can be stressful, especially for respiratory health. Elderberries have been used traditionally, and in some observational and clinical studies, as supportive agents against the common cold and influenza. This randomized, double-blind placebo-controlled clinical trial of 312 economy class passengers travelling from Australia to an overseas destination aimed to investigate if a standardised membrane filtered elderberry (Sambucus nigra L.) extract has beneficial effects on physical, especially respiratory, and mental health. Cold episodes, cold duration and symptoms were noted in a daily diary and assessed using the Jackson score. Participants also completed three surveys containing questions regarding upper respiratory symptoms (WURSS-21) and quality of life (SF-12) at baseline, just before travel and at 4-days after travel. Most cold episodes occurred in the placebo group (17 vs. 12), however the difference was not significant (p = 0.4). Placebo group participants had a significantly longer duration of cold episode days (117 vs. 57, p = 0.02) and the average symptom score over these days was also significantly higher (583 vs. 247, p = 0.05). These data suggest a significant reduction of cold duration and severity in air travelers. More research is warranted to confirm this effect and to evaluate elderberry's physical and mental health benefits.

  15. Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT(®)) for cellulite treatment.

    Science.gov (United States)

    Russe-Wilflingseder, Katharina; Russe-Wilfingsleder, Katharina; Russe, Elisabeth; Vester, Johannes C; Haller, Gerd; Novak, Pavel; Krotz, Alexander

    2013-06-01

    Placebo controlled double-blinded, prospectively randomized clinical trial with 17 patients (11 verum, 5 placebo) for evaluation of cellulite treatment with Acoustic Wave Therapy, (AWT(®)) was performed. The patients were treated once a week for 7 weeks, a total of 8 treatments with the D-ACTOR(®) 200 by Storz Medical AG. Data were collected at baseline, before 8th treatment, at 1 month (follow-up 1) and at 3 months (follow-up 2) after the last treatment with a patients' questionnaire, weight control, measurement of circumference and standardized photography. Treatment progress was further documented using a specially designed 3D imaging system (SkinSCAN(3D), 3D-Shape GmbH) providing an objective measure of cellulite (primary efficacy criteria). Patient's questionnaire in the verum group revealed an improvement in number and depth of dimples, skin firmness and texture, in shape and in reduction of circumference. The overall result (of skin waviness, Sq and Sz, surface and volume of depressions and elevations, Vvv and Vmp) at two follow-up visits indicates a more than medium sized superiority (MW = 0.6706) and is statistically significant (pWei-Lachin = 0.0106). The placebo group revealed no statistical significance. No side effects were seen. This indicates the efficacy and safety of AWT(®) for patients with cellulite.

  16. Enhancement of the Th1-phenotype immune system by the intake of Oyster mushroom (Tamogitake extract in a double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Aiko Tanaka

    2016-10-01

    Full Text Available Pleurotus cornucopiae (Oyster mushroom, Tamogitake has long been eaten as a functional food for enhancement of the immune system, but its effectiveness has not been well confirmed in humans. To this end, we set up a double-blind placebo-controlled human clinical trial to investigate the potential of Oyster mushrooms with respect to the up-regulation of the immune system. The subjects ingested Oyster mushroom extract for 8 weeks. We measured the serum cytokine levels involved in regulation of the immune system, including interferon (IFN-γ, interleukin (IL-4, IL-5, IL-10, IL-12, IL-13, and tumor-necrosis factor (TNF-α. We found that intake of Oyster mushroom extract elevated IFN-γ (P = 0.013 and IL-12, whereas serum levels of IL-10 and IL-13 and other cytokines were minimally changed. We also measured natural killer (NK cell activity, the levels of which tended to increase, but not significantly. Taken together, these facts suggest that Oyster mushrooms have the potential to enhance the immune system, through Th1 phenotype potentiation as the macrophage-IL-12 – IFN-γ pathway. This results in activation of the cell-mediated immune system as exemplified by up-regulation of NK cell activity. Oyster mushroom extract may be beneficial for the prevention of various diseases, including infectious diseases and cancer, due to its stimulation of the immune system.

  17. A double-blind, randomized, placebo-controlled pilot trial to determine the efficacy and safety of ibudilast, a potential glial attenuator, in chronic migraine

    Directory of Open Access Journals (Sweden)

    Kwok YH

    2016-10-01

    Full Text Available Yuen H Kwok,1 James E Swift,1 Parisa Gazerani,2 Paul Rolan1 1Discipline of Pharmacology, University of Adelaide, Level 5 Medical School North, South Australia, Australia; 2Department of Health Science & Technology, Aalborg University, Aalborg, Denmark Background: Chronic migraine (CM is problematic, and there are few effective treatments. Recently, it has been hypothesized that glial activation may be a contributor to migraine; therefore, this study investigated whether the potential glial inhibitor, ibudilast, could attenuate CM. Methods: The study was of double-blind, randomized, placebo-controlled, two-period crossover design. Participants were randomized to receive either ibudilast (40 mg twice daily or placebo treatment for 8 weeks. Subsequently, the participants underwent a 4-week washout period followed by a second 8-week treatment block with the alternative treatment. CM participants completed a headache diary 4 weeks before randomization throughout both treatment periods and 4 weeks after treatment. Questionnaires assessing quality of life and cutaneous allodynia were collected on eight occasions throughout the study. Results: A total of 33 participants were randomized, and 14 participants completed the study. Ibudilast was generally well tolerated with mild, transient adverse events, principally nausea. Eight weeks of ibudilast treatment did not reduce the frequency of moderate to severe headache or of secondary outcome measures such as headache index, intake of symptomatic medications, quality of life or change in cutaneous allodynia. Conclusion: Using the current regimen, ibudilast does not improve migraine with CM participants. Keywords: chronic migraine, glia, ibudilast, headache, immune system

  18. Overall skin tone and skin-lightening-improving effects with oral supplementation of lutein and zeaxanthin isomers: a double-blind, placebo-controlled clinical trial

    Science.gov (United States)

    Juturu, Vijaya; Bowman, James P; Deshpande, Jayant

    2016-01-01

    Purpose Carotenoids, especially lutein and zeaxanthin isomers (L/Zi), filter blue light and protect skin from environmental factors including high-energy sources. These carotenoids may be able to block the formation of melanin pathways, decrease cytokines, and increase antioxidants. Subjects and methods This is a randomized, double-blind, placebo-controlled clinical trial over a 12-week supplementation period. Fifty healthy people (50 healthy subjects were recruited and 46 subjects completed the study) (males and females, age: 18–45 years) with mild-to-moderate dry skin were included in this study. Skin type of the subjects was classified as Fitzpatrick skin type II–IV scale. Subjects were administered with either an oral dietary supplement containing 10 mg lutein (L) and 2 mg zeaxanthin isomers (Zi) (L/Zi: RR-zeaxanthin and RS (meso)-zeaxanthin) or a placebo daily for 12 weeks. The minimal erythemal dose and skin lightening (L*) were measured via the Chromameter®. The individual typological angle was calculated. Subjective assessments were also recorded. Results Overall skin tone was significantly improved in the L/Zi group compared to placebo (Pskin conditions. PMID:27785083

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

    Directory of Open Access Journals (Sweden)

    H. M. Fletcher

    2013-01-01

    Full Text Available 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.

  20. Green tea beverages enriched with catechins with a galloyl moiety reduce body fat in moderately obese adults: a randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Kobayashi, Makoto; Kawano, Takanori; Ukawa, Yuuichi; Sagesaka, Yuko M; Fukuhara, Ikuo

    2016-01-01

    Objective To determine whether ingesting a green tea beverage enriched with catechins with a galloyl moiety during a meal reduces body fat in moderately obese adults. Design Randomized double-blind placebo-controlled study. Subjects A total of 126 obese subjects (25 ≤ body mass index tea beverages without catechins (placebo), or a group receiving green tea beverages with a low or high content of catechins with a galloyl moiety. Each subject ingested 500 mL bottled green tea beverages containing 25, 180, or 279.5 mg green tea catechins (0, 149.5, or 246.5 mg catechins with a galloyl moiety, respectively), at mealtimes for 12 weeks; the subjects were instructed to ingest the beverage during the meal that had the highest fat content on that day. Methods Anthropometric measurements and blood chemistry analysis were performed during the run-in period; at weeks 0, 4, 8, and 12 of the intake period; and at the end of the withdrawal period. Abdominal fat area was measured by computed tomography at weeks 0, 8, and 12 of the intake period and at the end of the withdrawal period. Results Both the low- and high-dose groups exhibited significant reductions in visceral and subcutaneous fat areas compared to the control group at 12 weeks post-intervention. Conclusion Ingestion of a green tea beverage enriched with catechins with a galloyl moiety during a high-fat meal reduces body fat in moderately obese adults.

  1. Anti-Stress, Behavioural and Magnetoencephalography Effects of an l-Theanine-Based Nutrient Drink: A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial

    Directory of Open Access Journals (Sweden)

    David J. White

    2016-01-01

    Full Text Available l-theanine (γ-glutamylethylamide is an amino acid found primarily in the green tea plant. This study explored the effects of an l-theanine-based nutrient drink on mood responses to a cognitive stressor. Additional measures included an assessment of cognitive performance and resting state alpha oscillatory activity using magnetoencephalography (MEG. Thirty-four healthy adults aged 18–40 participated in this double-blind, placebo-controlled, balanced crossover study. The primary outcome measure, subjective stress response to a multitasking cognitive stressor, was significantly reduced one hour after administration of the l-theanine drink when compared to placebo. The salivary cortisol response to the stressor was reduced three hours post-dose following active treatment. No treatment-related cognitive performance changes were observed. Resting state alpha oscillatory activity was significantly greater in posterior MEG sensors after active treatment compared to placebo two hours post-dose; however, this effect was only apparent for those higher in trait anxiety. This change in resting state alpha oscillatory activity was not correlated with the change in subjective stress response or the cortisol response, suggesting further research is required to assess the functional relevance of these treatment-related changes in resting alpha activity. These findings further support the anti-stress effects of l-theanine.

  2. A phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness: North Central Cancer Treatment group study N04CA.

    Science.gov (United States)

    Loprinzi, Charles L; Balcueva, Ernie P; Liu, Heshan; Sloan, Jeff A; Kottschade, Lisa A; Stella, Philip J; Carlson, Mark D; Moore, Dennis F; Zon, Robin T; Levitt, Ralph; Jaslowski, Anthony J

    2011-01-01

    Vaginal dryness is a common problem for which effective and safe nonestrogenic treatments are needed. Based on preliminary promising data that pilocarpine attenuated vaginal dryness, the current trial was conducted. A double-blind, placebo-controlled, randomized trial design was used to compare pilocarpine, at target doses of 5 mg twice daily and 5 mg four times daily, with a placebo. Vaginal dryness was recorded by patient-completed questionnaires at baseline and weekly for 6 weeks after study initiation. The primary endpoint for this study was the area under the curve summary statistic composed of the longitudinal responses obtained at baseline and through the 6 weeks of treatment to a numerical analogue scale asking patients to rate their perceived amount of vaginal dryness. The primary analysis was carried out by a single t test using a two-side alternative to compare the collective pilocarpine treatment arms with the collective placebo arms. A total of 201 patients enrolled in this trial. The primary analysis, comparing vaginal dryness symptoms in the collective pilocarpine arms against the placebo arm, did not reveal any benefit for the pilocarpine treatment. This finding was confirmed by other secondary analyses. Toxicity evaluation revealed more nausea, sweating, rigors, and urinary frequency with the pilocarpine arms compared with the placebo arm.

  3. A randomized, double-blind, placebo-controlled study to test the efficacy of topical 2-hydroxypropyl-Beta-cyclodextrin in the prophylaxis of recurrent herpes labialis.

    Science.gov (United States)

    Senti, Gabriela; Iannaccone, Reto; Graf, Nicole; Felder, Manuela; Tay, Fabian; Kündig, Thomas

    2013-01-01

    Herpes labialis affects one third of the population. We evaluated the topical application of an antiviral compound, hydroxypropyl-β-cyclodextrin (2-HPβCD), in reducing herpes labialis relapses. In this double-blind, randomized, placebo-controlled trial, 40 patients were randomized to a polyethylene glycol (PEG) formulation containing 20% 2-HPβCD or to a vehicle control arm. The gel was applied to the lips twice daily for 6 months. The primary objective was reducing herpes relapses. Surprisingly, the drug group had significantly more relapses than the vehicle group (p = 0.003). While the median numbers of relapses in the preceding year were 12 in the vehicle group and 10 in the drug group, both groups experienced very few relapses during the 6-month treatment period, with a median of 0 in the vehicle group and a median of 2 in the drug group. The impressive reduction of relapses in both groups may be due to a placebo effect or due to the topical treatment with PEG.

  4. Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a double-blind, placebo-controlled study.

    Science.gov (United States)

    Proksch, E; Segger, D; Degwert, J; Schunck, M; Zague, V; Oesser, S

    2014-01-01

    Various dietary supplements are claimed to have cutaneous anti-aging properties; however, there are a limited number of research studies supporting these claims. The objective of this research was to study the effectiveness of collagen hydrolysate (CH) composed of specific collagen peptides on skin biophysical parameters related to cutaneous aging. In this double-blind, placebo-controlled trial, 69 women aged 35-55 years were randomized to receive 2.5 g or 5.0 g of CH or placebo once daily for 8 weeks, with 23 subjects being allocated to each treatment group. Skin elasticity, skin moisture, transepidermal water loss and skin roughness were objectively measured before the first oral product application (t0) and after 4 (t1) and 8 weeks (t2) of regular intake. Skin elasticity (primary interest) was also assessed at follow-up 4 weeks after the last intake of CH (t3, 4-week regression phase). At the end of the study, skin elasticity in both CH dosage groups showed a statistically significant improvement in comparison to placebo. After 4 weeks of follow-up treatment, a statistically significantly higher skin elasticity level was determined in elderly women. With regard to skin moisture and skin evaporation, a positive influence of CH treatment could be observed in a subgroup analysis, but data failed to reach a level of statistical significance. No side effects were noted throughout the study.

  5. The effect of dietary intake of coenzyme Q10 on skin parameters and condition: Results of a randomised, placebo-controlled, double-blind study.

    Science.gov (United States)

    Žmitek, Katja; Pogačnik, Tina; Mervic, Liljana; Žmitek, Janko; Pravst, Igor

    2017-01-02

    Coenzyme Q10 (CoQ10) is a natural constituent of foods and is also often used in both functional foods and supplements. In addition, it is a common ingredient of cosmetics where it is believed to reduce the signs of skin ageing. However, the existing data about the effect of dietary intake of CoQ10 on skin parameters and condition are scarce. To gain an insight into this issue, we conducted a double-blind, placebo-controlled experiment with 33 healthy subjects. Our objective was to investigate the effects of 12 weeks of daily supplementation with 50 and 150 mg of CoQ10 on skin parameters and condition. Study was conducted with a water-soluble form of CoQ10 with superior bioavailability (Q10Vital(®) ). While the results of some previous in vitro studies showed possible protection in UVB response, we did not observe significant changes in the minimal erythema dose (MED). On the other hand, the intake of CoQ10 limited seasonal deterioration of viscoelasticity and reduced some visible signs of ageing. We determined significantly reduced wrinkles and microrelief lines, and improved skin smoothness. Supplementation with CoQ10 did not significantly affect skin hydration and dermis thickness. © 2016 BioFactors, 43(1):132-140, 2017.

  6. Pilot study of aprepitant for prevention of post-ERCP pancreatitis in high risk patients: a phase II randomized, double-blind placebo controlled trial

    Science.gov (United States)

    Shah, Tilak; Liddle, Rodger A.; Branch, M. Stanley; Jowell, Paul; Obando, Jorge; Poleski, Martin H.

    2013-01-01

    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. Methods Randomized, double-blind, placebo controlled trial at a single academic medical center. 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. Fisher's exact test was used to compare incidence of post-ERCP pancreatitis in the two groups. Results 34 patients received aprepitant and 39 patients received placebo. 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=0.77). 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. PMID:22964958

  7. Desvenlafaxine for the treatment of vasomotor symptoms associated with menopause: a double-blind, randomized, placebo-controlled trial of efficacy and safety.

    Science.gov (United States)

    Archer, David F; Dupont, Caroline M; Constantine, Ginger D; Pickar, James H; Olivier, Sophie

    2009-03-01

    The objective of the study was to assess the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) for the treatment of vasomotor symptoms. This was a 26 week, double-blind, placebo-controlled trial of 567 postmenopausal women (mean age, 53.7 years; time since natural menopause, 4.8 years) experiencing 50 or more hot flushes (HFs) per week, randomly assigned to desvenlafaxine (100 or 150 mg) or placebo. Change from baseline in average daily number of moderate to severe HFs and average daily HF severity were compared with placebo at weeks 4, 12, and 26. A significantly greater decrease from baseline in number of HFs occurred at weeks 4 and 12 with 100 and 150 mg desvenlafaxine compared with placebo (week 12 reductions: 60%, 66%, and 47%, respectively; all P desvenlafaxine compared with placebo (all P desvenlafaxine-treated subjects than placebo-treated subjects discontinued because of adverse events during week 1 only. Desvenlafaxine is an effective treatment for menopausal HFs.

  8. Analysis of the effect of desvenlafaxine on anxiety symptoms associated with major depressive disorder: pooled data from 9 short-term, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Tourian, Karen A; Jiang, Qin; Ninan, Philip T

    2010-03-01

    This analysis evaluated the effects of the serotonin-norepinephrine reuptake inhibitor, desvenlafaxine (administered as desvenlafaxine succinate), on anxiety symptoms associated with depression. Data were pooled from 9 randomized, placebo-controlled, double-blind, 8 week studies of desvenlafaxine (50-400 mg/day, fixed or flexible dose) in patients with major depressive disorder (MDD), without a primary anxiety diagnosis. Changes from baseline in scores on the anxiety/somatization factor of the 17-item Hamilton Rating Scale for Depression (HAM-D17) and on the Covi Anxiety Scale at the final evaluation (last observation carried forward) were compared between desvenlafaxine and placebo groups using analysis of covariance. In the overall data set (intent to treat n=2,913 [desvenlafaxine, n=1,805; placebo, n=1,108]), desvenlafaxine was associated with significantly greater reductions compared with placebo in scores on the HAM-D17 anxiety/somatization factor (-3.41 vs -2.92, PDesvenlafaxine was associated with significantly greater improvement in anxiety symptoms compared with placebo in patients with MDD.

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

    Directory of Open Access Journals (Sweden)

    M Hemmatabadi

    2010-01-01

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

  10. 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.

  11. Effects of spirulina consumption on body weight, blood pressure, and endothelial function in overweight hypertensive Caucasians: a double-blind, placebo-controlled, randomized trial.

    Science.gov (United States)

    Miczke, A; Szulińska, M; Hansdorfer-Korzon, R; Kręgielska-Narożna, M; Suliburska, J; Walkowiak, J; Bogdański, P

    2016-01-01

    Some studies have demonstrated the beneficial effects of Spirulina maxima (Arthrospira maxima) consumption on glycemic, lipid, and blood pressure parameters. The aim of this study was to investigate the effect of Spirulina maxima on body weight, blood pressure, and endothelial function. In this randomized double-blind placebo-controlled trial, 40 patients with hypertension but lacking evidence of cardiovascular disease were enrolled to receive daily either 2.0 g Hawaiian spirulina or placebo for three months. Anthropometric parameters, systolic blood pressure (SBP), diastolic blood pressure (DBP), and stiffness index (SI) using digital plethysmography were measured before and after the intervention. After three months, there was no change in body mass index (BMI) or weight in either the spirulina or the placebo group. However, a significant reduction in SBP and SI was observed. The patients in the spirulina group showed significant reductions in BMI (26.9 ± 3.1 vs. 25.0 ± 2.7 kg/m(2), p = 0.0032), weight (75.5 ± 11.8 vs. 70.5 ± 10.3 kg, p Spirulina maxima not only improves BMI and weight but also results in improvements in blood pressure and endothelial function spirulina in overweight patients with hypertension but lacking evidence of cardiovascular disease.

  12. Assessment of cetirizine, an antihistamine, to prevent cutaneous reactions to nevirapine therapy: results of the viramune-zyrtec double-blind, placebo-controlled trial.

    Science.gov (United States)

    Launay, O; Roudière, L; Boukli, N; Dupont, B; Prévoteau du Clary, F; Patey, O; David, F; Lortholary, O; Devidas, A; Piketty, C; Rey, E; Urbinelli, R; Allaert, F A; Tréluyer, J M; Caumes, E

    2004-04-15

    We conducted a 12-week, multicenter, randomized, double-blind, placebo-controlled trial of cetirizine to assess the ability of antihistamines to prevent nevirapine-associated rash in patients infected with human immunodeficiency virus type 1. Patients initiating treatment with nevirapine were randomized to receive either cetirizine, 10 mg q.d. (104 patients), or placebo (96 patients) during the first 6 weeks of therapy. Rash occurred in 22 (11%) of 200 patients; 10 (9.6%) were in the cetirizine group and 12 (12.5%) were in the placebo group (odds ratio [OR], 0.75; 95% confidence interval [CI], 0.31-1.81; P=.5). Five of 22 rashes were cases of hypersensitivity syndrome. The rate of nevirapine discontinuation due to rash was similar in the 2 groups (7.7% and 6.25% in the cetirizine and placebo groups, respectively; P=.4). Multivariate analysis showed no treatment-group effect but indicated that age >40 years (OR, 3.83; 95% CI, 1.4-10.46; P=.008) was associated with an increased risk of rash. Cetirizine has no preventive effect on nevirapine-associated rash.

  13. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies.

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    Mannix, L K; Loder, E; Nett, R; Mueller, L; Rodgers, A; Hustad, C M; Ramsey, K E; Skobieranda, F

    2007-05-01

    These are the first prospective studies to use criteria for menstrual migraine proposed in the 2004 revision of the International Classification of Headache Disorders (ICHD-II) to examine the efficacy of rizatriptan for treatment of a menstrual attack. Two identical protocols (MM1 and MM2) were randomized, parallel, placebo-controlled, double-blind studies. Adult women with ICHD-II menstrual migraine were assigned to either rizatriptan 10-mg tablet or placebo in a 2 : 1 ratio. Patients treated a single menstrual migraine attack of moderate or severe pain intensity. The primary end-point was 2-h pain relief and the secondary end-point was 24-h sustained pain relief. A total of 707 patients (MM1 357, MM2 350) treated a menstrual migraine attack. The percentage of patients reporting 2-h pain relief was significantly greater for rizatriptan than for placebo (MM1 70% vs. 53%, MM2 73% vs. 50%), as was the percentage of patients reporting 24-h sustained pain relief (MM1 46% vs. 33%; MM2 46% vs. 33%). Rizatriptan 10 mg was effective for the treatment of ICHD-II menstrual migraine, as measured by 2-h pain relief and 24-h sustained pain relief.

  14. Ipragliflozin in combination with metformin for the treatment of Japanese patients with type 2 diabetes: ILLUMINATE, a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Kashiwagi, A; Kazuta, K; Goto, K; Yoshida, S; Ueyama, E; Utsuno, A

    2015-03-01

    This multicenter, double-blind, placebo-controlled study examined the efficacy and safety of ipragliflozin, a sodium-glucose co-transporter 2 inhibitor, in combination with metformin in Japanese patients with type 2 diabetes mellitus (T2DM). Patients were randomized in a 2 : 1 ratio to 50 mg ipragliflozin (n = 112) or placebo (n = 56) once daily for 24 weeks, followed by a 28-week open-label extension in which all patients received 50 or 100 mg ipragliflozin, while continuing metformin. The primary outcome was the change in glycated haemoglobin (HbA1c) from baseline to week 24. HbA1c decreased significantly in the ipragliflozin group (-0.87%; adjusted mean difference from placebo: -1.30%; p < 0.001). The overall incidence of treatment-emergent adverse events was similar in both groups, although pollakiuria and constipation were more common in the ipragliflozin group; thus, ipragliflozin significantly improved glycaemic control and reduced body weight without major safety issues in Japanese patients with T2DM.

  15. A double-blind, placebo-controlled pilot study to estimate the efficacy and tolerability of a nonsteroidal cream for the treatment of cradle cap (seborrheic dermatitis).

    Science.gov (United States)

    David, Elmer; Tanuos, Hanan; Sullivan, Timothy; Yan, Albert; Kircik, Leon H

    2013-04-01

    This study was a multicenter, double-blind, placebo-controlled, parallel-group pilot study of efficacy and tolerability of a nonsteroidal cream (Promiseb® Topical Cream; Promius Pharma, LLC, Bridgewater, NJ) for treatment of cradle cap when applied topically twice daily for up to 14 days in 42 pediatric subjects. Both treatments were similarly effective in reducing disease severity, as measured by success with Investigator's Global Assessment scores at day 7 or end of treatment, with 96% of subjects achieving success in the nonsteroidal cream group and 92% of subjects achieving success in the placebo cream group. Both treatments resulted in significant reductions from baseline in terms of erythema, crusting, scaling, and oiliness (P<.05), with no significant difference between treatments. There was a significant difference (P=.03) between treatment groups for percent reduction in scaling at the end of treatment, with a 90% reduction in the nonsteroidal cream group compared with a 58% reduction in the placebo cream group. All subjects in both groups had an overall safety score of excellent, and there were no adverse events related to treatment for either group.

  16. Efficacy of Topical Compound Danxiong Granules for Treatment of Dermatologic Toxicities Induced by Targeted Anticancer Therapy: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Tian, Aiping; Zhou, Aiping; Bi, Xinyu; Hu, Shangying; Jiang, Zhichao; Zhang, Wen; Huang, Zhen; Shi, Hongzhe; Yang, Boyan; Chen, Wei

    2017-01-01

    Dermatologic toxicities resulting in dose reduction or discontinuation of treatment pose challenges for targeted anticancer therapies. We conducted this randomized, double-blind, placebo-controlled trial to investigate the efficacy of topical application of Compound Danxiong Granules (CDG) for treatment of dermatologic toxicities associated with targeted anticancer therapies. One hundred and ten patients with dermatologic toxicities induced by targeted anticancer therapies were randomly assigned to CDG or placebo group. Each crude herb (Rhizoma Chuanxiong, Paeonia suffruticosa Andr., Cortex Phellodendri, Geranium sibiricum L., and Flos Carthami) was prepared as an instant herbal powder. Application of the CDG via topical washes lasted 20 minutes, twice daily, for 10 days. The primary outcome was the total effective rate, defined as reduction in at least one grade of skin toxicity. The total effective rate was 77.61% (52/67) in the CDG group and 27.27% (9/33) in the placebo group (P dermatologic toxicities induced by targeted anticancer therapies. The effect of CDG was more pronounced in hand-foot skin reaction.

  17. Effect of topical application of melatonin cream 12.5% on cognitive parameters: A randomized, placebo-controlled, double-blind crossover study in healthy volunteers.

    Science.gov (United States)

    Scheuer, Cecilie; Pommergaard, Hans-Christian; Rosenberg, Jacob; Gögenur, Ismail

    2016-11-01

    Skin cancer is an increasing problem in modern dermatology. Earlier studies have shown protective effects against ultraviolet radiation (UVR)-induced skin damage by topical treatment with melatonin. However, the potential sedative effects of full body topical application of melatonin have never been investigated. Objectives The aim of this study was to assess the degree of cognitive dysfunction when using melatonin cream as full body topical application. In a randomized, placebo-controlled, double-blind crossover study in healthy volunteers, the degree of cognitive dysfunction when using cream containing 12.5% melatonin as full body application was assessed. A group of ten volunteers had melatonin cream 12.5% applied on 80% of their body surface area, and degree of cognitive dysfunction was assessed using a test battery consisting of Karolinska sleepiness scale (KSS), Finger tapping test (FTT) and Continuous Reaction time (CRT). No significant effects on cognitive parameters were found. However, great inter-individual variations on cognitive parameters were observed. This study was the first to assess degree of cognitive dysfunction resulting from application of melatonin cream on a full body surface area. The results support that melatonin is a safe drug for dermal application even in a high dosage.

  18. Quercetin lowers plasma uric acid in pre-hyperuricaemic males: a randomised, double-blinded, placebo-controlled, cross-over trial.

    Science.gov (United States)

    Shi, Yuanlu; Williamson, Gary

    2016-03-14

    Elevated plasma uric acid concentration is a risk factor for gout, insulin resistance and type 2 diabetes. Quercetin, a flavonoid found in high levels in onions, tea and apples, inhibits xanthine oxidoreductase in vitro, the final step in intracellular uric acid production, indicating that quercetin might be able to lower blood uric acid in humans. We determined the effects of 4 weeks of oral supplementation of quercetin on plasma uric acid, blood pressure and fasting glucose. This randomised, double-blinded, placebo-controlled, cross-over trial recruited twenty-two healthy males (19-60 years) with baseline plasma uric acid concentration in the higher, but still considered healthy, range (339 (SD 51) µmol/l). The intervention included one tablet containing 500 mg quercetin daily for 4 weeks, compared with placebo, with a 4-week washout period between treatments. The primary outcome was change in concentrations of plasma uric acid after 2 and 4 weeks; secondary outcome measures were changes in fasting plasma glucose, 24-h urinary excretion of uric acid and resting blood pressure. After quercetin treatment, plasma uric acid concentrations were significantly lowered by -26·5 µmol/l (95% CI, -7·6, -45·5; P=0·008), without affecting fasting glucose, urinary excretion of uric acid or blood pressure. Daily supplementation of 500 mg quercetin, containing the bioavailable amount of quercetin as present in approximately 100 g red onions, for 4 weeks, significantly reduces elevated plasma uric acid concentrations in healthy males.

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

    Directory of Open Access Journals (Sweden)

    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.

  20. A 6-month, randomized, double-blind, placebo-controlled study evaluating the ability of a marine complex supplement to promote hair growth in men with thinning hair.

    Science.gov (United States)

    Ablon, Glynis

    2016-12-01

    Male pattern baldness, or androgenetic alopecia, affects approximately 50% of the adult population and can cause poor self-image, low self-esteem and have a significant negative impact on the quality of life. An oral nutraceutical supplement based on a marine complex formulation has previously been reported to significantly increase the number of terminal hairs in women with thinning hair. The objective of this double-blind, placebo-controlled study was to confirm the beneficial effects of a similar marine complex supplement in adult male subjects with thinning hair (Viviscal(®) Man; Lifes2good, Inc., Chicago, IL, USA). Healthy adult male subjects with thinning hair associated with clinically diagnosed male pattern hair loss were enrolled and randomized to receive study drug or placebo twice daily. At Day 90, subjects indicated a significant improvement in three of six quality of life measures as well as a significant overall improvement in quality of life. After 180 days, significant increases were observed for total hair count, total hair density, and terminal hair density (for each, P = 0.001). The investigator assessments revealed significant improvements in terminal and vellus hair count and terminal hair density. Hair pull test results were significantly lower (fewer hairs removed) for study drug vs. placebo at Days 90 (P hair shedding and promote hair growth in men with thinning hair. © 2016 Wiley Periodicals, Inc.

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

    Science.gov (United States)

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

    2017-01-01

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

  2. The role of the dopaminergic system in mood, motivation and cognition in Parkinson's disease: a double blind randomized placebo-controlled experimental challenge with pramipexole and methylphenidate.

    Science.gov (United States)

    Drijgers, Rosa L; Verhey, Frans R J; Tissingh, Gerrit; van Domburg, Peter H M F; Aalten, Pauline; Leentjens, Albert F G

    2012-09-15

    In Parkinson's disease (PD) reduced dopaminergic activity in the mesocorticolimbic pathway is implied in the pathophysiology of several non-motor symptoms related to mood, motivation and cognition. Insight in the pathophysiology of these syndromes may pave the way for more rational treatments. In a double-blind, randomized, placebo controlled, crossover design with three arms, we studied the effects of a direct dopaminergic challenge with the dopamine 2 receptor agonist pramipexole, an indirect challenge with the dopamine reuptake inhibitor methylphenidate, and placebo on measures of mood, motivation and cognition in 23 agonist-naïve PD patients and 23 healthy controls. Acute challenge with pramipexole had a negative effect on mood and fatigue in both patients and controls. In addition, challenge with pramipexole led to increased anger, fatigue, vigor and tension in healthy control subjects, but not in PD patients. Challenge with methylphenidate had a positive effect on anhedonia and vigor in PD patients. Due to its side effects after a single administration, pramipexole is probably less suitable for acute challenge studies. The acute effects of a methylphenidate challenge on anhedonia and vigor in PD patients make this drug an interesting choice for further studies of the treatment of mood and motivational disorders in this population.

  3. No negative symptoms in healthy volunteers after single doses of amisulpride, aripiprazole, and haloperidol: a double-blind placebo-controlled trial.

    Science.gov (United States)

    Park, Chul-Hyun; Park, Tae-Won; Yang, Jong-Chul; Lee, Keon-Hak; Huang, Guang-Biao; Tong, Zhao; Park, Myung-Sook; Chung, Young-Chul

    2012-03-01

    Noncompliance and poor outcome in patients with schizophrenia are closely related to the negative symptoms secondary to antipsychotics. No controlled study has evaluated whether amisulpride and aripiprazole induce negative symptoms. The aim of this study was to assess the effects of single doses of amisulpride, aripiprazole, haloperidol, and risperidone in healthy volunteers. Seventy-eight young volunteers took part in this double-blind, randomized, placebo-controlled, parallel study of four antipsychotics: 400 mg amisulpride, 10 mg aripiprazole, 3 mg haloperidol, and 2 mg risperidone. Assessments of negative symptoms were done 4 h after administration using both subjective rating scales (Neuroleptic Induced Deficit Syndrome Scale and Subjective Deficit Syndrome Scale) and an objective rating scale (Scale for the Assessment of Negative Symptoms). Risperidone only produced significant increases on the avolition score of the Neuroleptic Induced Deficit Syndrome Scale and blunted affect and alogia scores of the Scale for the Assessment of Negative Symptoms compared with placebo. The effect on blunted affect persisted after controlling for mental sedation. Amisulpride, aripiprazole, and haloperidol did not induce negative symptoms. Aripiprazole and risperidone induced mild extrapyramidal symptoms. The most common adverse events were somnolence and cognitive slowing. These data indicate that a single risperidone dose induces negative symptoms in normal volunteers, whereas amisulpride, aripiprazole, and haloperidol do not. These characteristics of antipsychotics should be considered when choosing optimal drugs for patients with psychosis.

  4. The Effect of Korean Red Ginseng on Sexual Function in Premenopausal Women: Placebo-Controlled, Double-Blind, Crossover Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ho Seok Chung

    2015-01-01

    Full Text Available This study investigated whether Korean red ginseng (KRG extracts could improve sexual function in premenopausal women. Forty-one premenopausal women participated in this placebo-controlled, double-blind, and crossover clinical study with administration of either three ginseng capsules (1 g per capsule or placebo daily. After 8 weeks of medication of KRG or placebo, medication was changed for the subjects to placebo or KRG after 2 weeks of washout period. The efficacy of KRG extracts was measured by using Female Sexual Function Index (FSFI. Results. Twenty-three women completed the study. Total FSFI scores increased after KRG treatment (from 20.13±2.87 to 23.98±4.10, p=0.015 and placebo treatment (from 20.06±2.64 to 23.78±3.28, p=0.003. However, this change was not significantly different between the two groups (p=0.702. KRG treatment significantly improved sexual desire, arousal, orgasm, and satisfaction domains; however, there was no treatment effect compared with placebo. There was a case of gastric discomfort after taking KRG extracts. Oral administration of KRG extracts improved sexual function in premenopausal women; however, there were no statistical significant changes compared to placebo. It implies that KRG extracts have a substantial placebo effect in premenopausal women with sexual dysfunction.

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

    Directory of Open Access Journals (Sweden)

    Ahmad Ghanizadeh

    2014-01-01

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

  6. Local and Systemic Cardiovascular Effects from Monochromatic Infrared Therapy in Patients with Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Study

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    Ru-Lan Hsieh

    2012-01-01

    Full Text Available Infrared (IR therapy is used for pain relief in patients with knee osteoarthritis (OA. However, IR’s effects on the cardiovascular system remain uncertain. Therefore, we investigated the local and systemic cardiovascular effects of monochromatic IR therapy on patients with knee OA in a double-blind, randomized, placebo-controlled study. Seventy-one subjects with knee OA received one session of 40 min of active or placebo monochromatic IR treatment (with power output of 6.24 W, wavelength of 890 nm, power density of 34.7 mW/cm2 for 40 min, total energy of 41.6 J/cm2 per knee per session over the knee joints. Heart rate, blood pressure, and knee arterial blood flow velocity were periodically assessed at the baseline, during, and after treatment. Data were analyzed by repeated-measure analysis of covariance. Compared to baseline, there were no statistically significant group x time interaction effects between the 2 groups for heart rate (P=0.160, blood pressure (systolic blood pressure: P=0.861; diastolic blood pressure: P=0.757, or mean arterial blood flow velocity (P=0.769 in follow-up assessments. The present study revealed that although there was no increase of knee arterial blood flow velocity, monochromatic IR therapy produced no detrimental systemic cardiovascular effects.

  7. Efficacy and safety of topical alprostadil cream for the treatment of female sexual arousal disorder (FSAD): a double-blind, multicenter, randomized, and placebo-controlled clinical trial.

    Science.gov (United States)

    Padma-Nathan, Harin; Brown, Candace; Fendl, Jane; Salem, Shawki; Yeager, James; Harningr, Ronald

    2003-01-01

    We evaluated the efficacy and safety of three doses of a novel alprostadil cream in a randomized, double-blind, placebo-controlled study in 94 women presenting with female sexual arousal disorder of at least 6 month s duration. We sent the subjects home with 10 premeasured doses of 500 g, 1000 g, or 1500 g alprostadil or a placebo cream to be applied to the vulvar area prior to vaginal intercourse over a period of 6 weeks. The primary efficacy parameter, the arousal success rate (as measured by diary responses to the Female Sexual Encounter Profile [FSEP]), was highest in the alprostadil 1000 g group and lowest in the 500 g group, but the responses were not different from that of the placebo cream, at the p = 0.05 level, for any of the three alprostadil doses. However, the change from baseline for Item 6 of the Female Sexual Function Index (FSFI; Rosen et al., 2000; satisfaction with arousal during sexual activity) suggested an important dose-related trend (p = 0.173; 1500 g versus placebo). The mean percent responder rate (responder = > 50% arousal success rate with > 3 sexual attempts) suggested a dose-response effect (p = 0.157; 1500 g versus placebo). Adverse events were generally mild or moderate in intensity and mainly involved localized reactions in the genital area.

  8. Low-dose atorvastatin reduces ambulatory blood pressure in patients with mild hypertension and hypercholesterolaemia: a double-blind, randomized, placebo-controlled study.

    Science.gov (United States)

    Kanaki, A I; Sarafidis, P A; Georgianos, P I; Stafylas, P C; Kanavos, K; Tziolas, I M; Lasaridis, A N

    2012-10-01

    Among several beneficial cardiovascular actions of statins, experimental studies have suggested that statins may also induce a mild blood pressure (BP) reduction. However, clinical data were controversial and the potential hypotensive statin effect remains uncertain. This study aimed to investigate the effect of atorvastatin on ambulatory BP in patients with mild hypertension and hypercholesterolaemia. A total of 50 patients with mild hypertension and hypercholesterolaemia participated in this double-blind, randomized, placebo-controlled study. Patients were randomized to either 10 mg atorvastatin or placebo for 26 weeks. Background antihypertensive treatment, if any, remained unchanged during follow-up. At baseline and study-end (26 weeks), ambulatory BP monitoring and blood sampling for determination of standard biochemical and safety parameters were performed in all participants. BP loads were defined as the percentage of BP measurements exceeding the hypertension threshold of 140/90 mm Hg for daytime and 125/75 mm Hg nighttime period. Atorvastatin significantly reduced 24-h systolic and diastolic BP (DBP; median (range)) as compared with placebo (-5.0 (-21.0, 4.0) vs +1.0 (-6.0, 7.0) mm Hg, Phypercholesterolaemia. This beneficial effect of atorvastatin on BP may represent another pathway through which this drug class provides cardiovascular risk reduction.

  9. A double-blind placebo-controlled randomized trial on probiotics in small bowel bacterial overgrowth in children treated with omeprazole.

    Science.gov (United States)

    Hegar, Badriul; Hutapea, Esther I; Advani, Najid; Vandenplas, Yvan

    2013-01-01

    To evaluate the incidence of small bowel bacterial overgrowth (SBBO) in children treated with omeprazole, and to test whether probiotics influence the incidence. A double-blinded, placebo-controlled trial was performed in 70 children treated orally during four weeks with 20mg omeprazole per day. Lactobacillus rhamnosus R0011 (1.9×10(9) cfu) and Lactobacillus acidophilus R0052 (0.1×10(9) cfu) were simultaneously given daily to 36 subjects (probiotic group), while 34 subjects received placebo (placebo group). The diagnosis of SBBO was based on the development of suggestive symptoms, in combination with a positive glucose breath test. After one month of proton pump inhibitor (PPI) treatment, 30% (21/70) had a positive breath test suggesting SBBO; of these 62% were symptomatic. Five children developed SBBO-like symptoms, but had a negative breath test; and 44 (63%) were symptom free and had a negative breath test. There was no difference in the incidence of positive breath tests in the probiotic versus the placebo group (33% vs 26.5%; p=0.13). Since symptoms suggesting SBBO developed in 26% of PPI-treated children, and since the glucose breath test was abnormal in 72% of these, this side-effect should be more frequently considered. The probiotic tested did not decrease the risk to develop SBBO. Copyright © 2013 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

  10. 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

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

    Directory of Open Access Journals (Sweden)

    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.

  12. Effect of hyoscine-N-butyl bromide rectal suppository on labor progress in primigravid women: a randomized double-blind placebo-controlled clinical trial

    Science.gov (United States)

    Makvandi, Somayeh; Tadayon, Mitra; Abbaspour, Mohammadreza

    2011-01-01

    Aim To determine the effects of hyoscine-N-butyl bromide (HBB) rectal suppository on labor progress in primigravid women. Methods A randomized double-blind placebo-controlled clinical trial was carried out on 130 primigravid women admitted for spontaneous labor. The women were recruited based on the inclusion and exclusion criteria and randomized into the experimental (n = 65) and control group (n = 65). In the beginning of the active phase of labor, 20 mg of HBB rectal suppository was administered to the experimental group, while a placebo suppository was administered to the control group. Cervical dilatation and duration of active phase and second stage of labor were recorded. Results The rate of cervical dilatation was 2.6 cm/h in the experimental and 1.5 cm/h in the control group (P suppository in the active management of labor can shorten both the active phase and second stage of labor without significant side-effects. Registration No IRCT138804282204N1. PMID:21495198

  13. Effect of a Growing-up Milk Containing Synbiotics on Immune Function and Growth in Children: A Cluster Randomized, Multicenter, Double-blind, Placebo Controlled Study.

    Science.gov (United States)

    Xuan, Ninh Nguyen; Wang, Dantong; Grathwohl, Dominik; Lan, Phuong Nguyen Thi; Kim, Hoa Vu Thi; Goyer, Amélie; Benyacoub, Jalil

    2013-01-01

    Common infectious diseases, such as diarrhea, are still the major cause of death in children under 5-years-old, particularly in developing countries. It is known that there is a close relationship between nutrition and immune function. To evaluate the effect of a growing-up milk containing synbiotics on immune function and child growth, we conducted a cluster randomized, multicenter, double-blind, placebo controlled clinical trial in children between 18 and 36 months of age in Vietnam. Eligible children from eight and seven kindergartens were randomly assigned to receive test and isocaloric/ isoproteic control milk, respectively, for 5 months. We found that the blood immunoglobulin A (IgA) level and growth parameters were increased in the test group. Compared to the control group, there was also a trend of decreased vitamin A deficiency and fewer adverse events in the test group. These data suggest that a growing-up milk containing synbiotics may be useful in supporting immune function and promoting growth in children.

  14. Intravenous dipyrone for the acute treatment of episodic tension-type headache: A randomized, placebo-controlled, double-blind study

    Directory of Open Access Journals (Sweden)

    M.E. Bigal

    2002-10-01

    Full Text Available Acute headaches are responsible for a significant percentage of the case load at primary care units and emergency rooms in Brazil. Dipyrone (metamizol is easily available in these settings, being the most frequently used drug. We conducted a randomized, placebo-controlled, double-blind study to assess the effect of dipyrone in the acute treatment of episodic tension-type headache. Sixty patients were randomized to receive placebo (intravenous injection of 10 ml saline or 1 g dipyrone in 10 ml saline. We used seven parameters of analgesic evaluation. The patients receiving dipyrone showed a statistically significant improvement (P<0.05 of pain compared to placebo up to 30 min after drug administration. The therapeutic gain was 30% in 30 min and 40% in 60 min. The number of patients needed to be treated for at least one to have benefit was 3.3 in 30 min and 2.2 in 60 min. There were statistically significant reductions in the recurrence (dipyrone = 25%, placebo = 50% and use of rescue medication (dipyrone = 20%, placebo = 47.6% for the dipyrone group. Intravenous dipyrone is an effective drug for the relief of pain in tension-type headache and its use is justified in the emergency room setting.

  15. 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

    subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing...... the outcomes were blinded to group assignment. The primary efficacy endpoints were changes in the HS scores (Sartorius and Hurley scoring systems). Secondary efficacy endpoints included changes in pain (visual analogue scale), days with lesions and Dermatology Life Quality Index, and evaluation of scarring...

  16. 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.

    Directory of Open Access Journals (Sweden)

    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

  17. Topical 5% lidocaine (lignocaine) medicated plaster treatment for post-herpetic neuralgia: results of a double-blind, placebo-controlled, multinational efficacy and safety trial.

    Science.gov (United States)

    Binder, Andreas; Bruxelle, Jean; Rogers, Peter; Hans, Guy; Bösl, Irmgard; Baron, Ralf

    2009-01-01

    Post-herpetic neuralgia (PHN) is a distressing neuropathic pain condition mainly affecting elderly patients. Neuropathic pain symptoms can be of a burning, shooting and stabbing nature, and may continue for prolonged periods and are often poorly controlled by polymedication. The aim of this study was to evaluate the analgesic efficacy and safety of topical analgesic treatment (5% lidocaine [lignocaine] medicated plaster) compared with placebo plaster in patients with PHN. This was a double-blind, placebo plaster-controlled, parallel-group, multicentre study employing enriched enrolment with randomized withdrawal methodology. After an initial 8-week open-label, active run-in phase, responders entered a 2-week randomized, double-blind, placebo-controlled phase. The study was conducted at 33 outpatient investigational centres in 12 European countries. Patients with PHN were selected who were aged >/=50 years, had experienced neuropathic pain persisting for >/=3 months after rash healing, and had a mean pain intensity of >/=4 on an 11-point numerical rating scale. A total of 265 patients entered the open-label phase and subsequently a pre-defined number of 71 patients entered the randomized phase. Patients applied up to three 5% lidocaine medicated plasters for up to 12 hours per day. The primary endpoint of the study was time-to-exit due to a >/=2-point reduction in pain relief on two consecutive days of plaster application using a 6-point verbal rating scale. Of the 265 patients entering the run-in phase, 51.7% achieved at least moderate pain relief. In the double-blind phase (full analysis set, n = 71), median times-to-exit were 13.5 (range 2-14) and 9.0 (range 1-14) days for lidocaine and placebo plaster groups, respectively (p = 0.151). For per-protocol patients (n = 34), median time-to-exit was 14.0 (range 3-14) and 6.0 (range 1-14) days for lidocaine and placebo plaster groups, respectively (p = 0.0398). Drug-related adverse events occurred in 13.6% of patients

  18. Bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomized, placebo-controlled, double-blind clinical trial.

    Science.gov (United States)

    Leitner, Lorenz; Sybesma, Wilbert; Chanishvili, Nina; Goderdzishvili, Marina; Chkhotua, Archil; Ujmajuridze, Aleksandre; Schneider, Marc P; Sartori, Andrea; Mehnert, Ulrich; Bachmann, Lucas M; Kessler, Thomas M

    2017-09-26

    Urinary tract infections (UTI) are among the most prevalent microbial diseases and their financial burden on society is substantial. The continuing increase of antibiotic resistance worldwide is alarming. Thus, well-tolerated, highly effective therapeutic alternatives are urgently needed. Although there is evidence indicating that bacteriophage therapy may be effective and safe for treating UTIs, the number of investigated patients is low and there is a lack of randomized controlled trials. This study is the first randomized, placebo-controlled, double-blind trial investigating bacteriophages in UTI treatment. Patients planned for transurethral resection of the prostate are screened for UTIs and enrolled if in urine culture eligible microorganisms ≥10(4) colony forming units/mL are found. Patients are randomized in a double-blind fashion to the 3 study treatment arms in a 1:1:1 ratio to receive either: a) bacteriophage (i.e. commercially available Pyo bacteriophage) solution, b) placebo solution, or c) antibiotic treatment according to the antibiotic sensitivity pattern. All treatments are intended for 7 days. No antibiotic prophylaxes will be given to the double-blinded treatment arms a) and b). As common practice, the Pyo bacteriophage cocktail is subjected to periodic adaptation cycles during the study. Urinalysis, urine culture, bladder and pain diary, and IPSS questionnaire will be completed prior to and at the end of treatment (i.e. after 7 days) or at withdrawal/drop out from the study. Patients with persistent UTIs will undergo antibiotic treatment according to antibiotic sensitivity pattern. Based on the high lytic activity and the potential of resistance optimization by direct adaptation of bacteriophages, and considering the continuing increase of antibiotic resistance worldwide, bacteriophage therapy is a very promising treatment option for UTIs. Thus, our randomized controlled trial investigating bacteriophages for treating UTIs will provide

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

    Directory of Open Access Journals (Sweden)

    Ito Mikako

    2011-10-01

    Full Text Available Abstract Background Molecular hydrogen has prominent effects on more than 30 animal models especially of oxidative stress-mediated diseases and inflammatory diseases. In addition, hydrogen effects on humans have been reported in diabetes mellitus type 2, hemodialysis, metabolic syndrome, radiotherapy for liver cancer, and brain stem infarction. Hydrogen effects are ascribed to specific radical-scavenging activities that eliminate hydroxyl radical and peroxynitrite, and also to signal-modulat