Aurora SK, Dodick DW, Turkel CC, et al.: OnabotulinumtoxinA for treatment of chronic migraine: results from the doubleblind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia 2010, 30: 793–803. Diener HC, Dodick DW, Aurora SK, et al.: OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 ...

Classical meta-analysis requires the same data from each clinical trial, thus data-reporting must be of a high-quality. Imputation methods are used to include studies that provide incomplete information on variability and the fixed and random effects of a drug. Regression models can be used to include studies other than randomized placebo-controlled studies. In the example outlined here, the us...

a double-blind, placebo-controlled, randomized crossover protocol using serial treadmill tests. Verapamil, 480 mg/day, reduced anginal frequency from 5.6 + 7.3 to 2.2 ± 3.9 attacks per week (p < 0.001) and nitroglycerin consumption from 3.4 ± 4.9 to 1.2 ± 2.5 tablets.per week (p < 0.05) compared with placebo. Treadmill time increased from 6.4 ± 2.1 minutes during the placebo phase to 7.5 ± 1.8 ...

Critically ill patients often suffer from disturbance of sleep-wake cycle and consequently delirium development, in intensive care units (ICU). In this study, we aimed to evaluate the effect of exogenous melatonin on delirium development and its related adverse sequelae in the subgroup of medical and surgical ICU patients. We performed a double-blind placebo-controlled randomized pilot study i...

Critically ill patients often suffer from disturbance of sleep-wake cycle and consequently delirium development, in intensive care units (ICU). In this study, we aimed to evaluate the effect of exogenous melatonin on delirium development and its related adverse sequelae in the subgroup of medical and surgical ICU patients. We performed a double-blind placebo-controlled randomized pilot study i...

MATERIALS AND METHODS: From 125 male patients with T2DM were randomized 85 subjects with age 49.8 ± 6.74 and BMI from 35.83 ± 3.65 kg/m 2 in placebo-controlled study. We divided patients into two groups: 1) Treatment group, where was used testosterone replacement therapy. 2) Placebo group, where was used placebo. In both groups was added Life style modification, but Antidiabetic therapy was unc...

Placebo, or sham surgery, as a control condition in surgical clinical trials in Parkinson disease (PD) remains controversial. The authors reviewed the adverse effects reported in double blind, placebo surgery controlled trials for PD. Placebo surgeries were generally safe and well tolerated but the number of subjects receiving the procedure was small. Harm occurred more frequently in subjects r...

Many clinical trials of uncommon diseases are underpowered because of the difficulty of recruiting adequate numbers of subjects. We propose a clinical trial design with improved statistical power compared to the traditional randomized trial for use in clinical trials of rare diseases. The three-stage clinical trial design consists of an initial randomized placebo-controlled stage, a randomized ...

background: we aimed to assess the effects of anise on quality of life (qol) of patients with functional dyspepsia (fd) in a double-blind randomized clinical trial. materials and methods: of 180 patients attending the gastroenterology clinic, 107 ones with the diagnosis of postprandial distress syndrome according to rome iii criteria were enrolled. they were randomized into two groups, anise an...

purpose: to evaluate the effect of oral tranexamic acid, oral prednisolone and placebo on prevention of recurrent hemorrhage in traumatic hyphema. methods: this randomized placebo-controlled double-blind clinical trial was performed on 182 subjects affected by hyphema after blunt trauma. the patients were hospitalized for at least 5 days and were randomly assigned for receiving oral tranexamic ...