Home About us Contact
|
Home About us Contact | ||
|
|
||
Double Blind Trial (double + blind_trial)
Selected AbstractsCoenzyme Q10 and vitamin E deficiency in Friedreich's ataxia: predictor of efficacy of vitamin E and coenzyme Q10 therapyEUROPEAN JOURNAL OF NEUROLOGY, Issue 12 2008J. M. Cooper Background and purpose:, A pilot study of high dose coenzyme Q10 (CoQ10)/vitamin E therapy in Friedreich's ataxia (FRDA) patients resulted in significant clinical improvements in most patients. This study investigated the potential for this treatment to modify clinical progression in FRDA in a randomized double blind trial. Methods:, Fifty FRDA patients were randomly divided into high or low dose CoQ10/ vitamin E groups. The change in International Co-operative Ataxia Ratings Scale (ICARS) was assessed over 2 years as the primary end-point. A post hoc analysis was made using cross-sectional data. Results:, At baseline serum CoQ10 and vitamin E levels were significantly decreased in the FRDA patients (P < 0.001). During the trial CoQ10 and vitamin E levels significantly increased in both groups (P < 0.01). The primary and secondary end-points were not significantly different between the therapy groups. When compared to cross-sectional data 49% of all patients demonstrated improved ICARS scores. This responder group had significantly lower baseline serum CoQ10 levels. Conclusions:, A high proportion of FRDA patients have a decreased serum CoQ10 level which was the best predictor of a positive clinical response to CoQ10/vitamin E therapy. Low and high dose CoQ10/vitamin E therapies were equally effective in improving ICARS scores. [source] Tianeptine and paroxetine in major depressive disorder, with a special focus on the anxious component in depression: an international, 6-week double-blind study,HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 3 2001Jean Pierre Lepine Abstract Tianeptine (37.5,mg/day) and paroxetine (20,mg/day) were compared in a population of depressive patients without past or current history of co-morbid anxiety and/or important anxiolytic treatment. In a 6-week, double blind trial, the special focus was on anxious symptoms. Both drugs showed good efficacy on depressive symptomatology, assessed with MADRS and HDRS, but no difference was detected between tianeptine and paroxetine, for any assessment criterion. Despite the choice of selected depressive patients, without any co-morbid anxious disorder, anxiety scale scores at inclusion (HAMA and BAS) were appreciable but correlated poorly with depressive scores. Both tianeptine and paroxetine improved the apparent anxious component in depression. Tolerability of both drugs was good, although significantly better with tianeptine. Thus tianeptine and paroxetine are effective and safe treatments for major depression and may also act directly on the anxious component of the psychopathology. Copyright © 2001 John Wiley & Sons, Ltd. [source] Growth Hormone Administration and Exercise Effects on Muscle Fiber Type and Diameter in Moderately Frail Older PeopleJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 7 2001James V. Hennessey MD OBJECTIVE: Reduced muscle mass and strength are characteristic findings of growth hormone deficiency (GHD) and aging. We evaluated measures of muscle strength, muscle fiber type, and cross sectional area in response to treatment with recombinant human growth hormone (rhGH) with or without a structured resistance exercise program in frail older subjects. DESIGN: Placebo-controlled, randomized, double blind trial. SETTING: Outpatient clinical research center at an urban university-affiliated teaching hospital. PARTICIPANTS: Thirty-one consenting older subjects (mean age 71.3 ± 4.5 years) recruited as a subset of a larger project evaluating rhGH and exercise in older people, who underwent 62 quadricep-muscle biopsies. INTERVENTION: Random assignment to a 6-month course of one of four protocols: rhGH administered subcutaneously daily at bedtime, rhGH and a structured resistance exercise program, structured resistance exercise with placebo injections, or placebo injections only. MEASUREMENTS: Muscle biopsy specimens were obtained from the vastus lateralis muscle. Isokinetic dynamometry strength tests were used to monitor individual progress and to adjust the weights used in the exercise program. Serum insulin-like growth factor-I (IGF-I) was measured and body composition was measured using a Hologic QDR 1000W dual X-ray densitometer. RESULTS: The administration of rhGH resulted in significant increase in circulating IGF-I levels in the individuals receiving rhGH treatment. Muscle strength increased significantly in both the rhGH/exercise (+55.6%, P = .0004) as well as the exercise alone (+47.8%, P = .0005) groups. There was a significant increase in the proportion of type 2 fibers between baseline and six months in the combined rhGH treated subjects versus those not receiving rhGH (P = .027). CONCLUSIONS: Our results are encouraging in that they suggest an effect of growth hormone on a specific aging-correlated deficit. IGF-I was increased by administrating rhGH and muscle strength was increased by exercise. The administration of rhGH to frail older individuals in this study resulted in significant changes in the proportions of fiber types. Whether changes in fiber cross-sectional area or absolute number occur with long-term growth hormone administration requires further study. [source] Effects of vitamin D supplementation on symptoms of depression in overweight and obese subjects: randomized double blind trialJOURNAL OF INTERNAL MEDICINE, Issue 6 2008R. Jorde Abstract. Objectives., The objective of the present study was to examine the cross-sectional relation between serum 25-hydoxyvitamin D [25-(OH) D] levels and depression in overweight and obese subjects and to assess the effect of vitamin D supplementation on depressive symptoms. Design., Cross-sectional study and randomized double blind controlled trial of 20.000 or 40.000 IU vitamin D per week versus placebo for 1 year. Setting., A total of 441 subjects (body mass index 28,47 kg m,2, 159 men and 282 women, aged 21,70 years) recruited by advertisements or from the out-patient clinic at the University Hospital of North Norway. Main outcome measures., Beck Depression Inventory (BDI) score with subscales 1,13 and 14,21. Results., Subjects with serum 25(OH)D levels <40 nmol L,1 scored significantly higher (more depressive traits) than those with serum 25(OH)D levels ,40 nmol L,1 on the BDI total [6.0 (0,23) versus 4.5 (0,28) (median and range)] and the BDI subscale 1,13 [2.0 (0,15) versus 1.0 (0,29.5)] (P < 0.05). In the two groups given vitamin D, but not in the placebo group, there was a significant improvement in BDI scores after 1 year. There was a significant decrease in serum parathyroid hormone in the two vitamin D groups without a concomitant increase in serum calcium. Conclusions., It appears to be a relation between serum levels of 25(OH)D and symptoms of depression. Supplementation with high doses of vitamin D seems to ameliorate these symptoms indicating a possible causal relationship. [source] Yellow Nail Syndrome in Three Siblings: A Randomized Double-Blind Trial of Topical Vitamin EPEDIATRIC DERMATOLOGY, Issue 4 2006Emily M. Lambert M.D. It has rarely been reported in children and this is the first report of congenital yellow nails in siblings. The purpose of this study was to determine whether topical vitamin E applied to the nail plates and periungual skin would affect the growth rate or appearance of the fingernails in patients with congenital yellow nail syndrome. This study was the first trial of a treatment for this entity in children and the largest randomized double blind trial to date. We found that vitamin E solution had no significant effect (p = 0.84) on fingernail growth or the global appearance score (p = 1.0) when compared with placebo. The average growth rates and global assessment scores improved and onycholysis and onychomadesis decreased from baseline with both vitamin E and placebo treatment, although these were not primary end points of the study. Topical vitamin E did not result in a statistically significant improvement when compared with oil alone for the treatment of the nails in our three patients with yellow nail syndrome. However, it is interesting and perhaps clinically useful that both vitamin E and placebo oil improved the condition of the nails. [source] A single versus multiple doses of dexamethasone in infants wheezing for the first timePEDIATRIC PULMONOLOGY, Issue 9 2008Suzanne Schuh MD Abstract Rationale: Corticosteroid therapy is not routinely recommended in true bronchiolitis. However, since bronchiolitis and the first asthma attack are impossible to distinguish, some infants with the first wheezing episode receive corticosteroids. Optimal duration of corticosteroid therapy in this scenario is unknown. This study compared efficacy of multiple administrations and a single dose of dexamethasone in bronchiolitis. Methods: In this randomized double blind trial, previously healthy outpatients 2,23 months of age with bronchiolitis and Respiratory Disease Assessment Instrument (RDAI) score 6 or more received 1 mg/kg of oral dexamethasone in the Emergency Department. Prior to discharge at 4 hr they were randomized to either 4 daily doses of dexamethasone 0.15 mg/kg or placebo equivalent. Primary outcome was the proportion of subsequent hospitalizations or prescribed trials of bronchodilator/corticosteroid therapy for dyspnea by day 6 in the groups. Secondary outcomes were changes in the RDAI to day 6, and proportions with unscheduled visits by days 6 and 28. Results: The rate of primary outcome in the single dose group (SDG, N,=,64) was 9/64 or 14.1% versus 7/61 or 11.5% in the multiple dose group (MDG, N,=,61) [95% CI 0.09; 0.14]. Twelve (18.8%) children in the SDG had unscheduled medical visits by day 6 versus 11 (18.0%) children in the MDG [95% CI 0.13; 0.14]. On day 6 the RDAI decreased from 9.5,±,2.1 to 2.1,±,2.4 in the SDG and from 9.8,±,2.2 to 1.6,±,2.3 in the MDG [95% CI 0.36; 2.06]. Between days 7,28, 24/64 (37.5%) SDG infants returned for care versus 20/61 (32.8%) of the MDG [95% CI 0.12; 0.21]. Conclusions: Our study suggests that, in outpatients with bronchiolitis who receive dexamethasone, continuation of this agent beyond the initial dose does not provide significant benefit. Pediatr Pulmonol. 2008; 43:844,850. © 2008 Wiley-Liss, Inc. [source] | ||||||||||