W V Mccall1, M L Perlis, X Tu, A E Groman, A Krystal, J K Walsh. 1. Department of Psychiatry and Behavioral Medicine, Wake Forest University School of Medicine, Winston-Salem, NC 27157-1071, USA. vmccall@wfubmc.edu
Abstract
OBJECTIVE: Sleep parameters commonly improve during placebo treatment in insomnia clinical trials. We examined whether the improvement seen with placebo was related to taking pills or other non-specific factors. METHOD:95 insomniacs took either aplacebo pill (pill+) or no pill (pill-) on nights of their choosing over 12 weeks. RESULTS: Pills were consumed on about half of the nights. Consistent improvement was seen with reduced reported sleep latency, wakefulness after sleep onset, number of awakenings, and total sleep time over the 12 weeks for both the pill+ and pill condition. A difference between pill+ and pill- was detected only for total sleep time, and this difference favored pill+. CONCLUSIONS: This study suggests that improvement seen during placebo treatment is more related to non-specific factors of participating in clinical trial than to pill taking behavior.
RCT Entities:
OBJECTIVE: Sleep parameters commonly improve during placebo treatment in insomnia clinical trials. We examined whether the improvement seen with placebo was related to taking pills or other non-specific factors. METHOD: 95 insomniacs took either a placebo pill (pill+) or no pill (pill-) on nights of their choosing over 12 weeks. RESULTS: Pills were consumed on about half of the nights. Consistent improvement was seen with reduced reported sleep latency, wakefulness after sleep onset, number of awakenings, and total sleep time over the 12 weeks for both the pill+ and pill condition. A difference between pill+ and pill- was detected only for total sleep time, and this difference favored pill+. CONCLUSIONS: This study suggests that improvement seen during placebo treatment is more related to non-specific factors of participating in clinical trial than to pill taking behavior.
Authors: W Vaughn McCall; Ralph D'Agostino; Peter B Rosenquist; James Kimball; Niki Boggs; Barbara Lasater; Jill Blocker Journal: Sleep Med Date: 2011-05-20 Impact factor: 3.492
Authors: Cenk Tek; Laura B Palmese; Andrew D Krystal; Vinod H Srihari; Pamela C DeGeorge; Erin L Reutenauer; Sinan Guloksuz Journal: Schizophr Res Date: 2014-10-29 Impact factor: 4.939
Authors: Erlend Faltinsen; Adnan Todorovac; Laura Staxen Bruun; Asbjørn Hróbjartsson; Christian Gluud; Mickey T Kongerslev; Erik Simonsen; Ole Jakob Storebø Journal: Cochrane Database Syst Rev Date: 2022-04-04
Authors: James K Walsh; Andrew D Krystal; David A Amato; Robert Rubens; Judy Caron; Thomas C Wessel; Kendyl Schaefer; James Roach; Gene Wallenstein; Thomas Roth Journal: Sleep Date: 2007-08 Impact factor: 5.849