NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.
Beijing University of Chinese Medicine, Beijing, China.
Sleep Med. 2020 May;69:41-50. doi: 10.1016/j.sleep.2019.12.023. Epub 2020 Jan 11.
To assess the effectiveness and safety of Zao Ren An Shen (ZRAS), a Chinese herbal medicine formula, for the treatment of insomnia.
Seven databases (ie, EMBASE, PubMed, the Cochrane library, and PsycINFO, Chinese National Knowledge Infrastructure, Wanfang and Chongqing VIP) were searched from their inception to 6 November 2018. Controlled trials comparing the effectiveness or safety of ZRAS to conventional treatments, a placebo or no-treatment in an insomnia population were selected. Primary outcomes were: sleep quality (assessed with the Pittsburgh Sleep Quality Index, PSQI), and the number of adverse events at post-treatment. The risk of bias was assessed with the Cochrane Collaboration's tool and meta-analyses were performed using RevMan 5.3.
A total of 19 studies (1780 participants) were included. The effect of ZRAS on sleep quality (mean difference) was found to be superior compared to placebo in the sole placebo-controlled study located [-0.90 (-1.56, -0.24; 95% CI), p = 0.007] and similar to Benzodiazepine Receptor Agonists (BzRAs) [0.17 (-0.29, 0.64); 95% CI, p = 0.46]. The number of adverse events (relative risk) was lower for ZRAS than BzRAs [0.16 (0.12, 0.23; 95% CI), p < 0.001]. An overall high risk of bias was found in the selected studies.
The results favor ZRAS against BzRAs and placebo for the treatment of insomnia. However, the poor methodology of the studies prevents strong recommendations for ZRAS. Clinical trials with higher quality designs are required.
评估中药复方枣仁安神治疗失眠的有效性和安全性。
从建库至 2018 年 11 月 6 日，检索了 7 个数据库（即 EMBASE、PubMed、Cochrane 图书馆、PsycINFO、中国知网、万方和重庆维普）。选择比较枣仁安神与常规治疗、安慰剂或不治疗失眠人群疗效或安全性的对照试验。主要结局指标为：睡眠质量（采用匹兹堡睡眠质量指数评估）和治疗后不良反应发生情况。采用 Cochrane 协作工具评估偏倚风险，并使用 RevMan 5.3 进行荟萃分析。
共纳入 19 项研究（1780 名参与者）。仅在 1 项安慰剂对照研究中发现，与安慰剂相比，枣仁安神治疗失眠的睡眠质量（均数差）改善更为显著[-0.90（-1.56，-0.24；95%CI），p=0.007]，与苯二氮䓬类受体激动剂（BzRAs）相似[0.17（-0.29，0.64）；95%CI，p=0.46]。与 BzRAs 相比，枣仁安神治疗的不良反应发生情况（相对风险）较低[0.16（0.12，0.23；95%CI），p<0.001]。纳入研究的总体偏倚风险较高。
结果表明，与 BzRAs 和安慰剂相比，枣仁安神治疗失眠更有效。然而，研究方法学较差，不支持推荐使用枣仁安神。需要开展设计质量更高的临床试验。
