针灸治疗围绝经期失眠疗效的Meta分析及试验序贯分析

Efficacy of acupuncture for perimenopausal insomnia:Meta⁃analysis and trial sequential analysis

目的:应用Meta分析方法评价针灸治疗围绝经期失眠的疗效,并运用试验序贯(TSA)分析检验Meta分析结果的有效性。方法:计算机检索PubMed、EMbase、Web of Science、The Cochrane Library、中国生物医学文献数据库(CBM)、万方、中国知网、维普数据库从建库至2020年3月10日公开发表的关于针灸治疗围绝经期失眠效果的随机对照试验,由2名研究员独立筛选文献、评价文献质量并提取资料。对符合质量标准的研究进行Meta分析,同时采用试验序贯分析方法评价研究结果的有效性,用GRADE profiler软件评估证据质量。结果:共纳入10篇文献,包括研究对象879例。Meta分析结果显示:试验组围绝经期病人失眠总有效率高于对照组[OR=4.14,95%CI(2.66,6.46),P<0.00001];试验组围绝经期病人失眠痊愈率高于对照组[OR=1.80,95%CI(1.22,2.67),P=0.003],试验组围绝经期病人匹兹堡睡眠质量指数评分低于对照组[MD=-3.46,95%CI(-4.95,-1.96),P<0.00001],试验组围绝经期病人阿森斯失眠量表评分低于对照组[MD=-2.47,95%CI(-4.00,-0.93),P=0.002],试验组围绝经期病人汉密尔顿抑郁量表评分低于对照组[MD=-5.18,95%CI(-9.20,-1.15),P=0.01];试验序贯分析结果显示,与西药相比,针灸治疗围绝经期失眠有效性纳入的研究同时穿过了传统界值和试验序贯界值。结论:现有证据表明,针灸及相关手法治疗围绝经期失眠的疗效优于西药。但基于目前研究样本量较少、文献质量不高,未来仍需进一步研究以提高临床决策的可靠性。

Objective:To evaluate effect of acupuncture for perimenopausal insomnia by Meta⁃analysis.And to verity results'effectiveness of Meta-analysis by trial sequential analysis(TSA).Methods:Randomized controlled trials on effect of acupuncture for perimenopausal insomnia were retrieved from PubMed,EMbase,Web of Science,The Cochrane Library,CBM,Wanfang Data,CNKI and VIP.These randomized controlled trials were published from databases establishment to 10 March,2020.Screening of literature,evaluation of quality of literatures and extraction of data were performed by two researchers independently.Meta⁃analysis was conducted on studies meeting quality standards.Meanwhile,trial sequential analysis method was used to evaluate effectiveness of research results and GRADE profiler was used to evaluate quality of evidence.Results:A total of 10 literatures were included,involving 879 patients.The Meta⁃analysis results showed that total effective rate of insomnia in perimenopausal patients in experimental group was higher than that in control group[OR=4.14,95%CI(2.66,6.46),P<0.00001],the recovery rate of insomnia in perimenopausal patients in experimental group was higher than that in control group[OR=1.80,95%CI(1.22,2.67),P=0.003],the Pittsburgh Sleep Quality Index score of perimenopausal patients in experimental group was lower than that in control group[MD=-3.46,95%CI(-4.95,-1.96),P<0.00001],Athens Insomnia Scale score in experimental group was lower than that in control group[MD=-2.47,95%CI(-4.00,-0.93),P=0.002],Hamilton Depressive Scale score in experimental group was lower than that in control group[MD=-5.18,95%CI(-9.20,-1.15),P=0.01].Results of trial sequential analysis showed that comparing with western medicine,the included studies of effectiveness of acupuncture for perimenopausal insomnia had crossed traditional boundary value and trial sequence boundary.Conclusions:Existing evidence showed that effect of acupuncture and related manipulations for perimenopausal insomnia was better than western medicine.However,due to the fewer sample of current studies and poor quality of studies,in the future,research was furtherly needed in order to improve reliability of clinical decision making.