Lin Yan-Hua, Chen Cong, Zhao Xiu, Mao Yi-Fei, Xiang Guang-Xin, Yang Meng-Qi, Song Yong-Mei
Institute for Literature and Culture of Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan 250355, China.
Department of Scientific Research Management, Shandong University of Traditional Chinese Medicine, Jinan 250355, China.
Evid Based Complement Alternat Med. 2021 May 26;2021:8833168. doi: 10.1155/2021/8833168. eCollection 2021.
To systematically evaluate the efficacy and safety of Banxia (Pinellia Tuber) formulae in the treatment of insomnia compared with those of conventional western medicines.
Randomized controlled trials (RCTs) evaluating the efficacy and safety of Banxia formulae in the treatment of insomnia were searched from the following databases: PubMed, Cochrane Library, EMBASE, the China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang database. The literature collected was from the time when the databases were established to April 2020. Quality assessment and meta-analysis were conducted by using Cochrane bias risk assessment tool and RevMan 5.2, respectively. Publication bias was assessed by Egger's test.
Fourteen RCTs with 910 participants were identified. A total of 46 traditional Chinese medicines involving 2 different dosage forms were used in the included studies. Meta-analysis indicated that Banxia formulae had more significant effects on improving the total effective rate ( = 1.23, 95% 1.16 to 1.31), Pittsburgh Sleep Quality Index (PSQI, = -1.05, 95% -1.63 to -0.47), and the TCM syndrome score ( = -0.78, 95% -1.18 to -0.39). Meanwhile, on reducing adverse events, Banxia formulae also showed an advantage ( = 0.48, 95% 0.24 to 0.93).
According to the current studies, the efficacy of Banxia formulae in the treatment of insomnia is better than that of the conventional western medicines, and its safety is relatively stable. However, due to the limitations of this study, further research and evaluation are needed.
系统评价半夏方剂与传统西药相比治疗失眠的疗效和安全性。
从以下数据库检索评估半夏方剂治疗失眠疗效和安全性的随机对照试验（RCT）：PubMed、Cochrane图书馆、EMBASE、中国知网（CNKI）、维普中文科技期刊数据库（VIP）和万方数据库。收集的文献为各数据库建库至2020年4月期间的。分别采用Cochrane偏倚风险评估工具和RevMan 5.2进行质量评估和Meta分析。采用Egger检验评估发表偏倚。
共纳入14项RCT，涉及910名参与者。纳入研究共使用了46种涉及2种不同剂型的中药。Meta分析表明，半夏方剂在提高总有效率（=1.23，95%可信区间1.16至1.31）、匹兹堡睡眠质量指数（PSQI，= -1.05，95%可信区间-1.63至-0.47）和中医证候评分（= -0.78，95%可信区间-1.18至-0.39）方面有更显著效果。同时，在减少不良事件方面，半夏方剂也显示出优势（=0.48，95%可信区间0.24至0.93）。
根据目前研究，半夏方剂治疗失眠的疗效优于传统西药，且安全性相对稳定。然而，由于本研究存在局限性，仍需进一步研究和评估。
