逍遥散治疗失眠临床疗效的Meta分析

Meta-Analysis of the Clinical Efficacy of Xiaoyao Powder on Insomnia

目的:Meta分析系统评价逍遥散治疗失眠相较于常规西药治疗的临床疗效差异。方法:检索数据库CNKI、万方、维普、CBM、Pubmed、Embase、Web of Science和Cochrane Library,对符合纳入标准的随机对照文献进行质量评价,利用Revman5.3和Stata16.0分析相关研究的有效率、不良反应率及匹兹堡睡眠质量指数(Pittsburgh sleep quality index,PSQI)。结果:筛选所得540篇文献,最终纳入10篇(包含693名患者),通过Meta分析可得,相较于西药组,逍遥散组具有更高的临床治疗有效率(RR=1.27,95%CI(1.16,1.38),P<0.00001)、更低的临床不良反应率(RR=0.38,95%CI(0.21,0.70),P=0.002)及更为明显的PSQI降幅(MD=1.43,95%CI(0.13,2.72),P=0.03)。结论:逍遥散相较于常规西药治疗失眠临床疗效较好、安全性较高,可显著提高失眠患者的睡眠质量,但纳入相关随机对照试验的质量较低,亟待大量兼具科学性及合理性的临床研究进一步验证。

Objective:A meta-analysis was conducted to compare the clinical efficacy of Xiaoyaosan and Western medicine in the treatment of insomnia.Methods:The databases included CNKI,WanFang,VIP,CBM,Pubmed,Embase,Web of Science and Cochrane Library,et al.The quality evaluation was conducted for eligible clinical randomized controlled trials literature which meet inclusion and exclusion criteria.The effective rate,adverse reaction rate and Pittsburgh sleep quality index(PSQI)of related studies were analyzed by Revman 5.3 and Stata 16.0.Results:A total of 540 literature studies were screened,and 10 of them(including 693 patients)were finally selected.According to meta-analysis,compared with the west medicine group,the Xiaoyaosan group has a higher effective rate(RR=1.27,95%CI(1.16,1.38),P<0.00001),a lower clinical adverse reaction rate(RR=0.38,95%CI(0.21,0.70),P=0.002)and a more significant decrease in the PSQI(MD=1.43,95%CI(0.13,2.72),P=0.03).Conclusion:Compared with conventional western medicine,the efficacy and the safety of insomnia treatment as well as the sleep quality of insomnia patients are significantly improved by Xiaoyaosan.However,due to the low quality of the included randomized controlled trials,a large number of scientifically reasonable clinical studies are urgently needed for further verification.