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原发性失眠中安慰剂反应的双相特征:来自食欲素受体拮抗剂随机对照临床试验数据的汇总分析。

Biphasic feature of placebo response in primary insomnia: pooled analysis of data from randomized controlled clinical trials of orexin receptor antagonists.

机构信息

Department of Neurology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College, Nanchong, Sichuan, China.

Imaging Institute of Brain Function, Department of Radiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College, Nanchong, Sichuan, China.

出版信息

Sleep. 2020 Mar 12;43(3). doi: 10.1093/sleep/zsz238.

DOI:10.1093/sleep/zsz238
PMID:31593985
Abstract

OBJECTIVES

The placebo response to orexin receptor antagonists in primary insomnia is little-known. Our aim was, therefore, to conduct a systematic review of placebo-controlled randomized clinical trials to characterize placebo response.

METHODS

We performed a comprehensive literature search for randomized, placebo-controlled, double-blind clinical trials evaluating the efficacy of orexin receptor antagonists addressing primary insomnia. To pool effect size estimates (Cohen's d) of placebo and orexin receptor antagonists across trials for outcome measures, a meta-analysis was done according to the Cochrane guideline.

RESULTS

The placebo response was significant and robust to improve the symptoms of insomnia in terms of objective and subjective measures, and the effects (0.70 ± 0.51) in subjective measures were smaller than that (1.10 ± 1.14) in objective measures (p = 0.027). The biphasic feature of placebo response showed an initial short-term increase of placebo effect and subsequent changeless long-term effect.

CONCLUSION

The biphasic feature of placebo response is clinically useful, and neuroimaging is essential to clarify the long-term mechanism in the future.

摘要

目的

奥曲肽受体拮抗剂治疗原发性失眠的安慰剂反应鲜为人知。因此,我们旨在进行一项系统评价,以评估安慰剂对照随机临床试验的特征。

方法

我们对评估奥曲肽受体拮抗剂治疗原发性失眠疗效的随机、安慰剂对照、双盲临床试验进行了全面的文献检索。为了对各种试验的结局指标进行效应大小(Cohen's d)的合并估计,我们根据 Cochrane 指南进行了荟萃分析。

结果

安慰剂在改善失眠症状方面的反应显著而稳定,无论是客观还是主观指标,且主观指标的效应(0.70±0.51)小于客观指标的效应(1.10±1.14)(p=0.027)。安慰剂反应的双相特征表现为初始短期的安慰剂效应增加和随后长期的不变效应。

结论

安慰剂反应的双相特征在临床上是有用的,神经影像学对未来阐明长期机制至关重要。

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