Wang Xinyi, Ju Jianqing, Li Jingen, Fan Yixuan, Xu Hao
Graduate School, Beijing University of Chinese Medicine.
Cardiovascular Disease Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences.
Medicine (Baltimore). 2020 Oct 2;99(40):e22462. doi: 10.1097/MD.0000000000022462.
To review the literature on the efficacy and safety of Chaihu Longgu Muli decoction (CLMD) for insomnia.
A systematic literature search was performed for five databases up to May of 2019 to identify randomized control trials involving CLMD for patients with insomnia. The experimental group was CLMD monotherapy or CLMD plus conventional treatment. Comparators were placebo, no treatment, or conventional medicine. The main comparison was CLMD against conventional drugs. The primary outcome was sleep quality (assessed using the Pittsburgh Sleep Quality Index, PSQI). The secondary outcomes were clinical effectiveness rate, total sleep time, and adverse event rate. RevMan 5.3 software was used for meta-analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with 95% confidence interval (CI).
A total of 22 studies involving 2029 patients were included. All the included studies presented some risk of bias, especially risks of performance, and detection bias. The main meta-analysis showed that CLMD alone was more effective than conventional medications by reducing PSQI (MD = -2.80, 95% CI [-5.48, -0.13], P = .04), improving the clinical effectiveness rate (RR = 1.23, 95% CI [1.16, 1.31], P < .00001), and prolonging total sleep time (MD = 1.01, 95% CI [0.19, 1.83], P = .002). The adverse event rate in the CLMD group was lower than that of the control group (RR = 0.22, 95% CI [0.09, 0.51], P = .0005). CLMD also improved sleep quality better than conventional medications as an adjunct therapy (P < .05). The funnel plot was symmetrical, representing a low risk of publication bias.
CLMD presented better efficacy and safety than conventional medications and had the potential to become an alternative to conventional medications for the treatment of insomnia. However, as the included studies showed significant risks of bias, these results will need to be confirmed by future double-blind randomized controlled trials.
CRD42019133103.
回顾关于柴胡龙骨牡蛎汤（CLMD）治疗失眠的疗效和安全性的文献。
对截至2019年5月的五个数据库进行系统文献检索，以确定涉及CLMD治疗失眠患者的随机对照试验。实验组为CLMD单药治疗或CLMD联合传统治疗。对照为安慰剂、不治疗或传统药物。主要比较为CLMD与传统药物。主要结局为睡眠质量（使用匹兹堡睡眠质量指数，PSQI进行评估）。次要结局为临床有效率、总睡眠时间和不良事件发生率。使用RevMan 5.3软件进行荟萃分析，效应估计值以相对风险（RR）和平均差（MD）以及95%置信区间（CI）表示。
共纳入22项研究，涉及2029例患者。所有纳入研究均存在一定的偏倚风险，尤其是实施和检测偏倚风险。主要荟萃分析表明，单独使用CLMD比传统药物更有效，可降低PSQI（MD = -2.80，95%CI [-5.48，-0.13]，P = 0.04），提高临床有效率（RR = 1.23，95%CI [1.16，1.31]，P < 0.00001），并延长总睡眠时间（MD = 1.01，95%CI [0.19，1.83]，P = 0.002）。CLMD组的不良事件发生率低于对照组（RR = 0.22，95%CI [0.09，0.51]，P = 0.0005）。作为辅助治疗，CLMD在改善睡眠质量方面也比传统药物更好（P < 0.05）。漏斗图对称，表明发表偏倚风险较低。
CLMD比传统药物具有更好的疗效和安全性，有潜力成为治疗失眠的传统药物的替代药物。然而，由于纳入研究显示存在显著的偏倚风险，这些结果需要未来的双盲随机对照试验予以证实。
PROSPERO注册号：CRD42019133103。
