For many classes of medications, such as analgesics, antidepressants, angina treatments, antihistamines and nonsteriodal asthma prophylaxis, well-designed, randomized, placebo-controlled trials (RCTs) often show no difference between drug and placebo [1]. As a consequence, RCTs commonly use various ‘enrichment’ strategies that can selectively exclude participants based on pretreatment response ...

OBJECTIVES Statins partially block the production of coenzyme Q10 (CoQ10), an essential component for mitochondrial function. Reduced skeletal muscle mitochondrial oxidative capacity has been proposed to be a cause of statin myalgia and can be measured using 31phosphorus magnetic resonance spectroscopy (31P-MRS). The purpose of this study is to assess the effect of CoQ10 oral supplementation on...

BACKGROUND Sample size calculation is a key aspect in the planning of any trial. Planning a randomized placebo-controlled trial in relapsing-remitting multiple sclerosis (RRMS) requires knowledge of the annualized relapse rate (ARR) in the placebo group. OBJECTIVES This paper aims (i) to characterize the uncertainty in ARR by conducting a systematic review of placebo-controlled, randomized tr...

Background Vomiting is a common side effect of ketamine in children's sedation and there is still controversy about the use of an anti-emetic drug along with ketamine to reduce this complication. The aim of this study was to evaluate the effectiveness of ondansetron in controlling vomiting induced by intramuscular (IM), and intravenous (IV) ketamine for procedural sedation and analgesia in chil...

BACKGROUND Nonsteroidal antiinflammatory drugs (NSAIDs) may alter blood pressure through their inhibitory effects on prostaglandin biosynthesis. Such potential hypertensive effects of NSAIDs have not been adequately examined in the elderly, who are the largest group of NSAID users. METHODS We performed a randomized, double-blind, two-period crossover trial of ibuprofen (1800 mg per day) vs pl...

This is the first study to investigate the efficacy of intravenous iron in treating fatigue in nonanemic patients with low serum ferritin concentration. In a randomized, double-blinded, placebo-controlled study, 90 premenopausal women presenting with fatigue, serum ferritin ≤ 50 ng/mL, and hemoglobin ≥ 120 g/L were randomized to receive either 800 mg of intravenous iron (III)-hydroxide sucrose ...

Abstract Prurigo nodularis (PN) is characterized by the presence of itchy nodules on trunk/extremities and often accompanied skin pain sleep disruption. Patient needs are highest regarding symptom control improvement itch, which one main hallmarks PN. Using pooled blinded data from two randomized, double-blind, placebo-controlled phase III trials dupilumab in adults with PN uncontrolled topical...

conclusions orange peel essential oil did not reduce postpartum depression and anxiety. background mothers are vulnerable to mental disorders, such as depression and anxiety, in the 6-week postpartum period after delivery. objectives this study was performed to determine the potential effect of orange peel essential oil on postpartum depression and anxiety. patients and methods this double-blin...

background: it is still a challenge to find an effective treatment for tinnitus. the aim of this study was the evaluation of carbamazepine and oxcarbazepine effects on tinnitus. methods: in a randomized double-blind clinical trial, 57 patients who were visited in a university hospital due to chronic non-pulsatile tinnitus, were randomized in three groups and treated with carbamazepine (300-600 ...

objective: 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. method: this was a randomized and double blind clinical trial. the trial was conducted between november 2009 and a...