Labarca Gonzalo, Montenegro Rodrigo, Oscullo Grace, Henriquez-Beltran Mario, Uribe Juan P, Gómez-Olivas Jose Daniel, Garcia-Ortega Alberto, Martínez-García Miguel Ángel
Division of Sleep Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Division of Health Care Sciences, Dresden International University, 01067, Dresden, Germany.
Sleep Med Rev. 2023 Feb;67:101720. doi: 10.1016/j.smrv.2022.101720. Epub 2022 Nov 21.
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.
嗜睡是阻塞性睡眠呼吸暂停（OSA）治疗效果随机临床试验（RCT）中最常使用的结果指标之一。此外，已知存在安慰剂效应，尤其是在主观测量中。因此，鉴于嗜睡是一种主观测量指标，本项进行了荟萃分析和三级元回归的系统评价的目的是评估OSA的RCT中使用的不同安慰剂（药丸和假持续气道正压通气[CPAP]）对主观（爱泼华嗜睡量表[ESS]）和客观（多次睡眠潜伏期试验[MSLT]、维持觉醒试验[MWT]、奥斯勒试验和精神运动警觉任务[PVT]）测量指标的反应。我们在主观和客观的嗜睡测量指标中，以及在假CPAP和药丸中均观察到了具有统计学意义的安慰剂效应。这种安慰剂效应在主观测量指标（ESS：-2.84分）以及使用药丸作为安慰剂的RCT中更大，甚至具有临床意义。在元回归中，只有ESS和奥斯勒试验的较高基线值与安慰剂效应相关。
