Objective: 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.
Materials and methods: 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.
Results: 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).
Conclusions: 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.