Yang Xi-Qian, Liu Ling, Ming Shu-Ping, Fang Jie, Wu Dong-Nan
The TCM Clinical Institute, Hubei University of Chinese Medicine, Hubei 430065, China.
The First Clinical Institute, Hubei University of Chinese Medicine, Hubei 430065, China.
Evid Based Complement Alternat Med. 2019 Mar 24;2019:4260801. doi: 10.1155/2019/4260801. eCollection 2019.
The Traditional Chinese Medicine (TCM) Tian Wang Bu Xin Dan (TWBXD) has been used widely for treating insomnia in China. The purpose of this meta-analysis was to evaluate the efficacy and safety of TWBXD in the treatment of insomnia.
This study evaluated the efficacy and safety of TWBXD for insomnia.
We searched seven main databases including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Chinese Biomedicine Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wan-fang. We identified randomized-controlled trials (RCTs) for insomnia treatment involving TWBXD, TWBXD combined with conventional Western medicine, and conventional Western medicine from their inception to May 2018. The quality of literature was evaluated by Cochrane assessing tool to reduce the risk of bias. Meta-analysis and heterogeneity of results across the trials were performed. RevMan 5.3 was used to synthesize the results.
14 studies involving 1,256 participants were identified in this systematic review. Methodological deficiencies existed in most of the included trials. Few studies described the generation of a random sequence in detail, the concealment of allocation, and the methods of blinding. No placebo was used in treatment. 12 trials compared TWBXD with conventional Western medicine and 2 trials compared TWBXD combined with conventional Western medicine. The results of our meta-analysis showed relative benefits in effective rates in favor of TWBXD (Odds Ratio [OR] 2.71, 95% confidence interval [CI] 1.67 to 4.39, P < 0.00001) and TWBXD combined with conventional Western medicine (OR 5.05, 95% CI 1.58 to 16.12, P=0.006). The Pittsburgh Sleep Quality Index (PSQI) scores showed similar results, which favored TWBXD (Weighted Mean Difference [WMD] -1.82, 95% CI -3.00 to -0.64, P=0.003). Only 5 trials reported adverse events, whereas the other 9 trials did not provide the safety information.
This review demonstrates that although the effects of TWBXD on insomnia were promising, they need to be interpreted with caution, due to the poor methodological quality and the small number of trials of the included studies. TWBXD seems to be generally safe, but there is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further studies on a larger scale with more rigorous designs are required to evaluate the role of TWBXD in the insomnia treatment.
中药天王补心丹（TWBXD）在中国已被广泛用于治疗失眠。本荟萃分析的目的是评估天王补心丹治疗失眠的疗效和安全性。
本研究评估天王补心丹治疗失眠的疗效和安全性。
我们检索了七个主要数据库，包括PubMed、EMBASE、Cochrane对照试验中心注册库、中国生物医学数据库（CBM）、中国知网（CNKI）、维普中文科技期刊数据库（VIP）和万方数据库。我们确定了从开始到2018年5月涉及天王补心丹、天王补心丹联合传统西药以及传统西药治疗失眠的随机对照试验（RCT）。采用Cochrane评估工具评估文献质量，以降低偏倚风险。对各试验结果进行荟萃分析和异质性分析。使用RevMan 5.3对结果进行综合分析。
本系统评价共纳入14项研究，涉及1256名参与者。大多数纳入试验存在方法学缺陷。很少有研究详细描述随机序列的产生、分配隐藏和盲法。治疗中未使用安慰剂。12项试验将天王补心丹与传统西药进行比较，2项试验将天王补心丹联合传统西药进行比较。我们的荟萃分析结果显示，在有效率方面，天王补心丹（优势比[OR]2.71，95%置信区间[CI]1.67至4.39，P<0.00001）和天王补心丹联合传统西药（OR 5.05，95%CI 1.58至16.12，P=0.006）具有相对优势。匹兹堡睡眠质量指数（PSQI）评分显示了类似的结果，支持天王补心丹（加权均数差[WMD]-1.82，95%CI -3.00至-0.64，P=0.003）。只有5项试验报告了不良事件，而其他9项试验未提供安全性信息。
本综述表明，尽管天王补心丹对失眠的疗效有前景，但由于纳入研究的方法学质量差且试验数量少，需要谨慎解读。天王补心丹似乎总体安全，但由于报告不良事件的研究较少，没有足够的证据得出关于安全性的结论。需要进行更大规模、设计更严谨的进一步研究，以评估天王补心丹在失眠治疗中的作用。
