Shi Meng-Long, Zhao Min, Wang Yan-Hua, Sun Tian-Ye, Li Xuan-Lin, Ren Fang, Bian Song-Bo, Cui Zhi-Hui, Li Shan-Shan
Henan University of Chinese Medicine Zhengzhou 450046, China.
the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China.
Zhongguo Zhong Yao Za Zhi. 2021 Oct;46(20):5403-5417. doi: 10.19540/j.cnki.cjcmm.20210407.503.
To evaluate the efficacy and safety of Chinese patent medicines in the treatment of insomnia by frequency network Meta-analysis. Randomized controlled trials of Chinese patent medicines for insomnia were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase and Cochrane Library databases from the time of database establishment to October 2020. The quality of the included RCTs was evaluated according to the Cochrane bias risk standard, and the data was analyzed by RevMan 5.3 and Stata/MP 15.1. A total of 11 kinds of Chinese patent medicines in 27 RCTs were included. According to Meta-analysis, in term of the effective rate, Tianmeng Liquid, Zaoren Anshen Capsules, Shumian Capsules, Shensong Yangxin Capsules, Shenqi Wuweizi Tablets, Shugan Jieyu Capsules, Anshen Bunao Liquid and Qiye Anshen Tablets combined with nonbenzodiazepine drugs(NBZDs) were superior to NBZDs alone. In term of the improvement of Pittsburg sleeping quality index(PSQI) score, Tianmeng Liquid, Shumian Capsules, Shensong Yangxin Capsules, Bailemian Capsules, Shenqi Wuweizi Tablets, Shugan Jieyu Capsules, Yangxue Qingnao Granules and Yindan Xinnaotong Capsules combined with NBZDs were superior to NBZDs alone. In terms of the safety, Shumian Capsules, Shensong Yangxin Capsules, Shenqi Wuweizi Tablets and Qiye Anshen Tablets combined with NBZDs were superior to NBZDs alone. In terms of the avoidance of dizziness and headache, Qiye Anshen Tablets combined with NBZDs were superior to NBZDs alone. The results of Network Meta-analysis indicated that in term of the effective rate, top three optimal medication regimens were NBZDs combined with Shugan Jieyu Capsules, combined with Zaoren Anshen Capsules and combined with Shensong Yangxin Capsules in the order from high to low. With the respect of improvement of PSQI score, top three optimal medication regimens were NBZDs combined with Yangxue Qingnao Granules, combined with Tianmeng Liquid and combined with Yindan Xinnaotong Capsules in the order from high to low. In terms of the safety, top three optimal medication regimens were NBZDs combined with Qiye Anshen Tablets, combined with Shensong Yangxin Capsules and combined with Shenqi Wuweizi Tablets in the order from high to low. In terms of the avoidance of dizziness and headache, top three optimal medication regimens were NBZDs combined with Qiye Anshen Tablets, combined with Zaoren Anshen Capsules and combined with Shumian Capsules in the order from high to low. In terms of the avoidance of fatigue, top three optimal medication regimens were NBZDs combined with Shensong Yangxin Capsules, combined with Shumian Capsules and combined with Qiye Anshen Tablets in the order from high to low. In conclusion, Chinese patent medicines combined with NBZDs can effectively alleviate the symptoms of insomnia with a high safety. However, the conclusion of this study needs to be verified by more high-quality studies because of the low methodological quality of the included studies.
通过频率网络Meta分析评估中成药治疗失眠的有效性和安全性。从中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase和考克兰图书馆数据库中检索自建库至2020年10月期间关于中成药治疗失眠的随机对照试验。根据Cochrane偏倚风险标准评估纳入的随机对照试验的质量,并使用RevMan 5.3和Stata/MP 15.1进行数据分析。共纳入27项随机对照试验中的11种中成药。Meta分析结果显示,在有效率方面,甜梦口服液、枣仁安神胶囊、舒眠胶囊、参松养心胶囊、神芪五味子片、疏肝解郁胶囊、安神补脑液和七叶安神片联合非苯二氮䓬类药物(NBZDs)优于单纯使用NBZDs。在匹兹堡睡眠质量指数(PSQI)评分改善方面,甜梦口服液、舒眠胶囊、参松养心胶囊、百乐眠胶囊、神芪五味子片、疏肝解郁胶囊、养血清脑颗粒和银丹心脑通软胶囊联合NBZDs优于单纯使用NBZDs。在安全性方面,舒眠胶囊、参松养心胶囊、神芪五味子片和七叶安神片联合NBZDs优于单纯使用NBZDs。在避免头晕和头痛方面,七叶安神片联合NBZDs优于单纯使用NBZDs。网络Meta分析结果表明,在有效率方面,最优的三种用药方案从高到低依次为NBZDs联合疏肝解郁胶囊、联合枣仁安神胶囊和联合参松养心胶囊。在PSQI评分改善方面,最优的三种用药方案从高到低依次为NBZDs联合养血清脑颗粒、联合甜梦口服液和联合银丹心脑通软胶囊。在安全性方面,最优的三种用药方案从高到低依次为NBZDs联合七叶安神片、联合参松养心胶囊和联合神芪五味子片。在避免头晕和头痛方面,最优的三种用药方案从高到低依次为NBZDs联合七叶安神片、联合枣仁安神胶囊和联合舒眠胶囊。在避免疲劳方面,最优的三种用药方案从高到低依次为NBZDs联合参松养心胶囊、联合舒眠胶囊和联合七叶安神片。总之,中成药联合NBZDs可有效缓解失眠症状,安全性高。然而,由于纳入研究的方法学质量较低,本研究的结论需要更多高质量研究进行验证。