耳穴疗法治疗围绝经期失眠有效性和安全性的系统评价

Efficacy and Safety of Auricular Point Therapy for Perimenopausal Insomnia:A Systematic Review

目的:评价耳穴疗法治疗围绝经期失眠的安全性与有效性。方法:检索中国期刊全文数据库(CNKI)、中国生物医学文献数据库(SinoMed)、万方学术期刊全文数据库(Wanfang)、维普中文科技期刊数据库(VIP)、PubMed、Cochrane Library、EMbase,搜集建库至2022年5月26日耳穴疗法治疗围绝经期失眠的随机对照试验(RCT),采用RevMan 5.3软件进行数据分析。结果:共纳入11个RCT,总样本量809例,试验组共405例,对照组共404例。Meta分析显示,与对照组相比,试验组在改善患者临床总有效率[MD=-2.7,95%CI(-3.46,-1.94),P<0.001]、匹兹堡睡眠指数评分(PSQI)总分[MD=-2.7,95%CI(-3.46,-1.94),P<0.001]、雌二醇(E2)[MD=2.23,95%CI(0.81,3.65),P=0.002]、血清卵泡刺激素(FSH)[MD=-4.55,95%CI(-6.35,-2.76),P<0.001]方面差异有统计学意义,于调整黄体生成素(LH)方面差异无统计学意义[MD=-1.54,95%CI(-5.05,1.97),P=0.39];安全性评价提示耳穴疗法未见明显不良反应。结论:耳穴疗法可有效改善围绝经期失眠患者的睡眠情况、激素水平,不良反应小,但确切结论仍需更多高质量、多中心、大样本的RCT来进一步印证。

Objective:To evaluate the efficacy and safety of auricular point therapy in the treatment of perimenopausal insomnia by systematic review.Methods:The randomized controlled trails of auricular point therapy in the treatment of perimenopausal insomnia on the databases of CNKI,Wanfang,VIP,SinoMed,PubMed,Cochrane Library and Embase were searched by computer to May 26,2022.Meta analysis was carried out by Rev‐Man 5.3 software.Results:A total of 11 RCTS were included.The total sample size was 809 cases,whlie 405 cases in the experimental group and 404 cases in control group.Meta analysis showed that compared with the control group,the treatment group improved the total clinical effective rate[MD=2.7,95%CI(3.46,1.94),P<0.001],reduced the total score of PSQI[MD=2.7,95%CI(3.46,1.94),P<0.001],decreased the FSH[MD=4.55,95%CI(6.35,2.76),P<0.001]and increased the Estradiol(E2)[MD=2.23,95%CI(0.81,3.65),P=0.002],but there was no significant difference in the improvement of LH[MD=1.54,95%CI(5.05,1.97),P=0.39];Safety evaluation indicated that auricular point therapy had no obvious adverse reactions.Conclusion:Auricular point therapy could significantly regulate the related hormone level,and ameliorate sleep quality from multiple dimensions of patients with perimenopausal insomnia,and which has less adverse effects.However,a multicenter,highquality and large sample RCT should be carried out in the future to confirm the conclusion.