The Mean Vertigo Score (MVS) Outcome Scale and Its Use in Clinical Research for Quantifying Vestibular Disorders.

The Mean Vertigo Score (MVS) is a composite score for defining the burden of disease of patients suffering from vestibular disorders. It has been used in clinical research for about 30 years. This study investigates discriminant validity of the MVS and describes structural relationships of the 12 single criteria used for construction of the MVS.

Effect size measures and their benchmark values for quantifying benefit or risk of medicinal products.

The standardized mean difference is a well-known effect size measure for continuous, normally distributed data. In this paper we present a general basis for important other distribution families. As a general concept, usable for every distribution family, we introduce the relative effect, also called Mann-Whitney effect size measure of stochastic superiority.

Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials.

This meta-analysis combines the results of nine ischemic stroke trials, assessing efficacy of Cerebrolysin on global neurological improvement during early post-stroke period. Cerebrolysin is a parenterally administered neuropeptide preparation approved for treatment of stroke. All included studies had a prospective, randomized, double-blind, placebo-controlled design.

Randomized Placebo-Controlled Placebo Trial to Determine the Placebo Effect Size.

Background: It is the gold standard to use a placebo treatment as the control group in prospective randomized controlled trials (RCTs). Although placebo-controlled trials can reveal an effect of an active treatment, the pure effect of a placebo treatment alone has never been presented or evaluated. No evidence-based, placebo-therapeutic options are currently available, and no placebo-controlled trials have been performed to elucidate the pure placebo effect.

Safety and efficacy of Cerebrolysin in motor function recovery after stroke: a meta-analysis of the CARS trials.

This meta-analysis combines the results of two identical stroke studies (CARS-1 and CARS-2) assessing efficacy of Cerebrolysin on motor recovery during early rehabilitation. Cerebrolysin is a parenterally administered neuropeptide preparation approved for the treatment of stroke. Both studies had a prospective, randomized, double-blind, placebo-controlled design.

Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial.

Background And Purpose: The aim of this trial was to investigate whether stroke patients who receive Cerebrolysin show improved motor function in the upper extremities at day 90 compared with patients who receive a placebo.

Methods: This study was a prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study. Patients were treated with Cerebrolysin (30 mL/d) or a placebo (saline) once daily for 21 days, beginning at 24 to 72 hours after stroke onset.

A simple, assumption-free, and clinically interpretable approach for analysis of modified Rankin outcomes.

Background And Purpose: There is debate regarding the approach for analysis of modified Rankin scale scores, the most common functional outcome scale used in acute stroke trials.

Methods: We propose to use tests to assess treatment differences addressing the metric, "if a patient is chosen at random from each treatment group and if they have different outcomes, what is the chance the patient who received the investigational treatment will have a better outcome than will the patient receiving the standard treatment?" This approach has an associated statement of treatment efficacy easily understood by patients and clinicians, and leads to statistical testing of treatment differences by tests closely related to the Mann-Whitney U test (Wilcoxon Rank-Sum test), which can be tested precisely by permutation tests (randomization tests).

Results: We show that a permutation test is as powerful as are other approaches assessing ordinal outcomes of the modified Rankin scores, and we provide data from several examples contrasting alternative approaches.

Glycemic control in patients with type 2 diabetes mellitus with a disease-specific enteral formula: stage II of a randomized, controlled multicenter trial.

Background: Stage I of a preplanned 2-stage study has provided good evidence for improved glycemic control with a disease-specific enteral formula low in carbohydrates and high in monounsaturated fatty acids (MUFAs), fish oil, chromium, and antioxidants in insulin-treated type 2 diabetes. The study was continued with stage II to give confirmatory proof of these beneficial effects.

Methods: 105 patients with HbA1C>or=7.

Extracorporeal shock wave therapy for chronic painful heel syndrome: a prospective, double blind, randomized trial assessing the efficacy of a new electromagnetic shock wave device.

Published data describing the efficacy of extracorporeal shock wave therapy for the treatment of plantar heel pain provide conflicting results, and optimal treatment guidelines are yet to be determined. To assess the efficacy and safety of extracorporeal shockwave therapy compared with placebo in the treatment of chronic painful heel syndrome with a new electromagnetic device, we undertook a prospective, double-blind, randomized, placebo-controlled trial conducted among 40 participants who were randomly allocated to either active, focused extracorporeal shockwave therapy (0.25 mJ/mm(2)) or sham shockwave therapy.

Treatment of somatoform disorders with St. John's wort: a randomized, double-blind and placebo-controlled trial.

Objective: To investigate efficacy and safety of St. John's wort (SJW) LI 160 in somatoform disorders.

Methods: In a prospective, randomized, placebo-controlled, and double-blind parallel group study, 184 outpatients with somatization disorder (ICD-10 F45.

Prevention of recurrent urinary tract infections with immuno-active E. coli fractions: a meta-analysis of five placebo-controlled double-blind studies.

A meta-analysis was performed on five studies conducted over the last decade to demonstrate a positive effect for the drug Uro-Vaxom compared with Placebo in double-blind studies in patients with urinary tract infection (601 women), with special reference to the prevention of recurrences over an observation period of 6 months, the treatment being given for the first 3 months. The five studies were similar in design. The analysis by means of the Wilcoxon-Mann-Whitney test showed superiority of Uro-Vaxom in all five studies, (P<1%).