Department of First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China.
Eur Rev Med Pharmacol Sci. 2022 Nov;26(22):8523-8533. doi: 10.26355/eurrev_202211_30388.
Suanzaoren decoction (SZRD) in Traditional Chinese Medicine is a common prescription for chronic insomnia. This study systematically and accurately evaluated the safety and efficacy of SZRD in the treatment of chronic insomnia, thus providing a reference for its clinical application.
From the establishment of the corresponding database until May 2022, we systematically queried EMbase, PubMed, Cochrane Library, Web of Science, CNKI, VIP, and Wanfang Database. Randomized control trials (RCTs) were included in this study, and the results that qualified for inclusion were screened and cross-checked by two researchers. After the relevant data were extracted, a meta-analysis was performed using RevMan 5.3 software.
A total of 1,311 patients with chronic insomnia from 12 RCTs were enrolled in the meta-analysis, showing that the use of SZRD alone or in combination was superior to the control group in improving the clinical effective rate (RR=1.22, 95%CI [1.16, 1.29], p<0.00001), reducing the recurrence rate (RR=0.47, 95%CI [0.28, 0.80], p=0.005), and lowering the Pittsburgh Sleep Quality Index (PSQI) scores (MDSZRD+WM=-3.35,95%CI [-5.22, -1.47], p<0.00001); (MDSZRD=-1.94, 95%CI [-3.80, -0.07], p = 0.04). SZRD also could reduce the adverse effects rate (RR=0.30, 95% CI [0.22, 0.40], p<0.00001).
It was therefore concluded that SZRD alone or in combination with Western medicine can increase the clinical effective rate, reduce the recurrence rate, improve the quality of life of chronic insomnia patients, and decrease the incidence of adverse effects. However, studies included in this analysis varied in quality, and more large-sample, high-quality, multi-center RCTs are still needed to verify the above conclusions.
中医中的酸枣仁汤是治疗慢性失眠的常用方剂。本研究系统、准确地评估了酸枣仁汤治疗慢性失眠的安全性和疗效，为其临床应用提供了参考。
自相应数据库建立至 2022 年 5 月，我们系统地检索了 EMbase、PubMed、Cochrane Library、Web of Science、CNKI、VIP 和万方数据库。纳入了随机对照试验（RCTs），并由两位研究人员对符合纳入标准的结果进行筛选和交叉核对。提取相关数据后，使用 RevMan 5.3 软件进行荟萃分析。
共有 12 项 RCT 纳入 1311 例慢性失眠患者进行荟萃分析，结果显示，单独使用或联合使用酸枣仁汤治疗在提高临床有效率（RR=1.22，95%CI [1.16, 1.29]，p<0.00001）、降低复发率（RR=0.47，95%CI [0.28, 0.80]，p=0.005）和降低匹兹堡睡眠质量指数（PSQI）评分（MDSZRD+WM=-3.35，95%CI [-5.22, -1.47]，p<0.00001）方面均优于对照组；（MDSZRD=-1.94，95%CI [-3.80, -0.07]，p = 0.04）。酸枣仁汤还可以降低不良反应发生率（RR=0.30，95%CI [0.22, 0.40]，p<0.00001）。
因此得出结论，单独使用或联合使用酸枣仁汤可提高慢性失眠患者的临床有效率，降低复发率，改善生活质量，降低不良反应发生率。然而，纳入本分析的研究质量存在差异，仍需要更多大样本、高质量、多中心 RCT 来验证上述结论。
