Placebo response in objective and subjective measures of hypersomnia in randomized clinical trials on obstructive sleep apnea. A systematic review and meta-analysis.

Autor: Labarca G; Division of Sleep Medicine, Brigham and Women's Hospital, Boston, MA, USA., Montenegro R; Division of Health Care Sciences, Dresden International University, 01067, Dresden, Germany., Oscullo G; Respiratory Department, La Fe University and Polytechnic Hospital, Valencia, Spain., Henriquez-Beltran M; Escuela de Kinesiologia, Facultad de Salud, Universidad Santo Tomas, Chile., Uribe JP; Internal Medicine, University of Miami, Miami, FL, USA., Gómez-Olivas JD; Respiratory Department, La Fe University and Polytechnic Hospital, Valencia, Spain., Garcia-Ortega A; Respiratory Department, Doctor Peset University Hospital, Valencia, Spain., Martínez-García MÁ; Respiratory Department, La Fe University and Polytechnic Hospital, Valencia, Spain; CIBERes de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain. Electronic address: mianmartinezgarcia@gmail.com.
Jazyk: angličtina
Zdroj: Sleep medicine reviews [Sleep Med Rev] 2023 Feb; Vol. 67, pp. 101720. Date of Electronic Publication: 2022 Nov 21.
DOI: 10.1016/j.smrv.2022.101720
Abstrakt: Sleepiness is one of the outcomes most used in randomized clinical trials (RCT) on the effect of treatments for obstructive sleep apnea (OSA). Furthermore, it is known that there is a placebo effect, especially in subjective measures. Therefore, given that sleepiness is a subjective measure, the objective of this systematic review with meta-analysis and three-level meta-regression was to assess the response to different placebos (pills and sham-CPAP) used in RCTs in OSA, both on subjective (Epworth Sleepiness Scale [ESS]) and objective (Multiple Sleep Latency Test [MSLT], Maintenance Wake Test [MWT], the Osler test and the Psychomotor Vigilance Task [PVT]). We observed a statistically significant placebo effect in both subjective and objective measures of hypersomnia, and in both sham-CPAP and pills. This placebo effect was greater, even clinically significant, in subjective measures (ESS: -2.84 points) and in those RCTs that used pills as a placebo. In the meta-regression, only a higher baseline value of the ESS and Osler test was related to the placebo effect.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2022 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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