W Vaughn McCall1, Ralph D'Agostino, Aaron Dunn. 1. Department of Psychiatry and Behavioral Medicine, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1071, USA. vmccall@wfubmc.edu
Abstract
OBJECTIVES: The effects associated with placebo (EAP) have been incompletely described in clinical trials of insomnia treatment. We conducted a meta-analysis of insomnia medication trials for the purpose of estimating the magnitude of sleep EAP. METHOD: We reviewed Medline for 1966 through 2000 for the meta-analysis. The subject heading of insomnia restricted to the subheading of drug therapy was crossed against the results of a search on the subjects heading placebo and text word placebo. We selected only papers that examined primary insomnia, incorporating both placebo and active medication therapies in a randomized, double-blind, parallel-group design. We required that results be reported for 1, 2, 3, or 4 weeks of treatment, and that outcomes be reported in hours/minutes. RESULTS: Five papers satisfied our requirements for eligibility, comprising 213 patients receiving placebo for a 2-week interval. Subjective sleep latency demonstrated a significant reduction (mean+/-S.E.) of 13.1+/-2.0 min (95% confidence interval (CI) 9.2, 17.0) for the placebo group after combining the data across studies. Subjective total sleep time demonstrated a significant increase of 13.5+/-5.4 min (95% CI 2.9, 24.0). Polysomnographic (PSG) sleep latency demonstrated a non-significant reduction of 2.5+/-4.3 min (95% CI -5.9, 10.9). CONCLUSIONS: The confirmation of EAP in insomnia clinical trials argues for the retention of a placebo control in future insomnia clinical trials.
OBJECTIVES: The effects associated with placebo (EAP) have been incompletely described in clinical trials of insomnia treatment. We conducted a meta-analysis of insomnia medication trials for the purpose of estimating the magnitude of sleep EAP. METHOD: We reviewed Medline for 1966 through 2000 for the meta-analysis. The subject heading of insomnia restricted to the subheading of drug therapy was crossed against the results of a search on the subjects heading placebo and text word placebo. We selected only papers that examined primary insomnia, incorporating both placebo and active medication therapies in a randomized, double-blind, parallel-group design. We required that results be reported for 1, 2, 3, or 4 weeks of treatment, and that outcomes be reported in hours/minutes. RESULTS: Five papers satisfied our requirements for eligibility, comprising 213 patients receiving placebo for a 2-week interval. Subjective sleep latency demonstrated a significant reduction (mean+/-S.E.) of 13.1+/-2.0 min (95% confidence interval (CI) 9.2, 17.0) for the placebo group after combining the data across studies. Subjective total sleep time demonstrated a significant increase of 13.5+/-5.4 min (95% CI 2.9, 24.0). Polysomnographic (PSG) sleep latency demonstrated a non-significant reduction of 2.5+/-4.3 min (95% CI -5.9, 10.9). CONCLUSIONS: The confirmation of EAP in insomnia clinical trials argues for the retention of a placebo control in future insomnia clinical trials.
Authors: Rachel E Fargason; Karen Gamble; Kristin T Avis; Rachel C Besing; Cherry W Jackson; Marshall E Cates; Roberta May Journal: Psychopharmacol Bull Date: 2011-05-15
Authors: Emiliangelo Ratti; David J Carpenter; Stefano Zamuner; Sofia Fernandes; Lisa Squassante; Heidi Danker-Hopfe; Graeme Archer; Jonathan Robertson; Robert Alexander; David G Trist; Emilio Merlo-Pich Journal: Sleep Date: 2013-12-01 Impact factor: 5.849