摘要/Abstract
摘要： 目的·探讨安慰剂治疗原发性失眠症患者的效果及影响程度。方法·检索PubMed、Cochrane、Embase数据库，以试验报告统一标准（Consolidated Standards of Reporting Trials，CONSORT）声明为参照标准进行入组和评价文献。收集纳入文献中安慰剂治疗前后的客观和主观睡眠评定指标，采用RevMan 5.3和Comprehensive Meta-Analysis V2软件进行meta分析。结果·共有17篇文献（18项研究）纳入分析，总样本量1 980例，根据年龄进行亚组(成人组和老年组)分析。客观评定指标中，觉醒次数仅在老年组差异有统计学意义（P0.043），睡眠潜伏期、睡眠发作后的觉醒时间、总睡眠时间在2个亚组的差异均有统计学意义（均PPP0.000），总效应值绝对值的范围为0.289～0.474。结论·安慰剂对原发性失眠症患者的主观和客观睡眠评定指标有一定改善作用，但影响程度较小。
关键词: 安慰剂, 原发性失眠症, meta分析, 随机对照研究
Abstract:
Objective · To investigate the clinical efficacy and degree of impact of placebo in the patients with primary insomnia. Methods · Databases including PubMed, Cochrane, and Embase were searched. The Consolidated Standards of Reporting Trials (CONSORT) was used as a reference standard for enrollment and evaluation. The objective and subjective sleep assessment indicators were collected before and after placebo treatment. Meta-analysis was performed using RevMan 5.3 and Comprehensive Meta-Analysis V2 softwares. Results · A total of 17 articles (18 studies) were included in the systematic review, and the total sample size was 1 980. These indicators were analyzedage subgroups (adults and elderly adults). The objective indicators showed that the number of awaking was only statistically different in elderly adults group (P0.043), while the latency period of sleep, wakefulness time after sleep onset and total sleep time were statistically different in both groups (P-0.414. Subjective indicators showed that the subjective total sleep time, subjective wakefulness time after sleep onset, and subjective number of awaking were statistically different in both groups (PP0.000). The absolute value of total effect range was 0.289-0.474. Conclusion · Placebo in the patients with primary insomnia can improve objective and subjective sleep assessment indicators, but the effect is small.
Key words: placebo, primary insomnia, meta-analysis, randomized controlled trial
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