BACKGROUND In the USA, tegaserod is contraindicated in patients with a history of bowel obstruction, abdominal adhesions or symptomatic gall-bladder disease due to a non-significant difference in abdominal surgery between tegaserod-using and placebo-using patients in Phase III trials. AIM To calculate the incidence of abdominal and pelvic surgery in tegaserod-using and placebo-using patients ...

STUDY OBJECTIVE To assess the efficacy of botulinum toxin type A in lowering the frequency of migraine headaches in patients with episodic migraines. DESIGN Meta-analysis of eight randomized, double-blind, placebo-controlled trials. PATIENTS A total of 1601 patients with a history of episodic migraine headaches classified as those experiencing headaches fewer than 15 times/month over a 3-mo...

OBJECTIVE To assess the efficacy and safety of glatiramer acetate (GA) 40mg administered 3× weekly (tiw) compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS This randomized, double-blind study was conducted in 142 sites in 17 countries. Patients with RRMS with at least 1 documented relapse in the 12 months before screening, or at least 2 documented re...

Background. Sleep disturbances and cognitive dysfunction are common in patients with breast cancer. Disturbed sleep leads to poor cognitive performance and exogenous melatonin may improve sleep and attenuate cognitive dysfunction. We hypothesized that melatonin would improve sleep and cognitive function after surgery. Methods. This study reports secondary endpoints from a randomized, double-bli...

Purpose To evaluate ocular comfort of lifitegrast ophthalmic solution 5.0% among patients with dry eye disease (DED) in the OPUS-3 trial. Methods OPUS-3 was a multicenter, randomized, double-masked, placebo-controlled study. Adults with DED and recent artificial tear use were randomized 1:1 (lifitegrast:placebo) to ophthalmic drops twice daily for 84 days. On days 0 (baseline), 14, 42, and 84...

OBJECTIVE To evaluate whether selective digestive decontamination (SDD) reduces mortality from any cause, and the incidence of pneumonia among patients with severe burns. SUMMARY BACKGROUND DATA SDD is a prophylactic strategy to reduce infectious morbidity and mortality in critically ill patients. Two meta-analyses and a recent randomized controlled trial demonstrated a mortality reduction va...

OBJECTIVES To compare the efficacy of the Epley maneuver with that of a placebo maneuver in patients presenting to the emergency department (ED) with benign positional vertigo (BPV). METHODS This was a prospective, randomized, single-blind placebo-controlled trial. Consecutive adult ED patients presenting to a university teaching hospital with BPV were randomized to treatment with either the ...

The reasons why many patients seemingly benefit from arthroscopic treatment of osteoarthritis of the knee remain obscure. The purpose of this pilot study was to determine if a placebo effect might play a role in arthroscopic treatment of this condition. After giving full informed consent, including full knowledge of the possibility and nature of a placebo surgery, five subjects were randomized ...

Citation: Goltz JS and Rice TR (2017) Commentary: A Randomized, Double-Blind, Placebo-Controlled Trial of Metformin Treatment of Weight Gain Associated with Initiation of Atypical Antipsychotic Therapy in Children and Adolescents. Front. Psychiatry 8:59. doi: 10.3389/fpsyt.2017.00059 Commentary: a randomized, Double-Blind, Placebo-Controlled trial of metformin treatment of Weight Gain associate...

Citation: Linares IMP, Guimaraes FS, Eckeli A, Crippa ACS, Zuardi AW, Souza JDS, Hallak JE and Crippa JAS (2018) No Acute Effects of Cannabidiol on the Sleep-Wake Cycle of Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study. Front. Pharmacol. 9:315. doi: 10.3389/fphar.2018.00315 No Acute Effects of Cannabidiol on the Sleep-Wake Cycle of Healthy Subjects: A Randomiz...