Efficacy and safety of electroacupuncture for perimenopausal insomnia: a randomized controlled trial  

电针干预围绝经期失眠的疗效与安全性随机对照研究

作　　者：Zhao Fei-yi Yan Hai-xia Zhao Ying-xia Chen Si-han Xu Hong 赵非一;燕海霞;赵英侠;陈思翰;许红(Shanghai Municipal Hospital of TCM Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China;School of Basic Medical Sciences, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China)

机构地区：[1]Shanghai Municipal Hospital of TCM Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China [2]School of Basic Medical Sciences, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China

出　　处：《Journal of Acupuncture and Tuina Science》2019年第3期188-195,共8页针灸推拿医学（英文版）

基　　金：国家"十一五"科技支撑计划项目,No. 2007BAI10B01-027;上海市卫生和计划生育委员会中医药科研基金项目,No. ZYKC20161016.

摘　　要：Objective: To observe the effectiveness and safety of electroacupuncture (EA) plus Luohua Anshen oral liquid for patients with perimenopausal insomnia. Methods: A total of 66 participants who met the inclusion criteria were enrolled in the randomized controlled trial and allocated to a treatment group and a control group at a ratio of 1:1, with 33 cases in each group. Both groups were given Luohua Anshen oral liquid as a basic treatment. The treatment group was additionally given EA every other day, three times a week. Both groups were treated for four weeks and a four-week follow-up was conducted. The scores of Pittsburgh sleep quality index (PSQI), Kupperman index (KI) and traditional Chinese medicine sleep syndrome scale (TCMSSS) were recorded at pre- and post-treatment, and at the follow-up. Meanwhile, adverse effects were monitored and recorded. Results: After four-week treatment, the global scores of PSQI, KI and TCMSSS in both groups declined significantly (all P<0.05), and the decreases in the treatment group were more significant than those in the control group (allP<0.05). The global scores of PSQI, KI and TCMSSS in both groups at the follow-up visit were significantly different from the corresponding baseline (allP<0.05), while insignificantly different from those assessed at post-treatment (allP>0.05). The total effective rate was 93.9% in the treatment group, significantly higher than 72.2% in the control group (P<0.05). No significant adverse event was reported in this trial excepted one patient experienced slight dizziness in the first acupuncture treatment. Conclusion: EA plus Luohua Anshen oral liquid is safe for perimenopausal insomnia with satisfactory short- and long-term effectiveness, and it shows certain advantage compared with using Luohua Anshen oral liquid alone.目的:观察电针结合落花安神口服液干预围绝经期失眠症的有效性及安全性.方法:将符合纳入标准的66例受试者按1:1的比例随机分为治疗组和对照组,每组33例.落花安神口服液作为两组的基础治疗.治疗组在此基础上加电针疗法,隔日1次,每周3次.两组均连续治疗4周,治疗结束4周后随访.治疗前、治疗后及随访时,采用匹兹堡睡眠质量指数(PSQI)、Kupperman指数(KI)及中医睡眠证候量表(TCMSSS)评估.同时观察并记录不良反应事件.结果:治疗4周后,对照组与治疗组PSQI、KI及TCMSSS总分均明显下降,治疗前后评分差异具有统计学意义(均P<0.05),且治疗组评分下降比对照组更显著(均P<0.05).随访时,两组PSQI、KI及TCMSSS总分与本组治疗前差异均具有统计学意义(均P<0.05),但与治疗后评分无统计学差异(均P>0.05).治疗组总有效率为93.9%,对照组总有效率为72.7%,两组差异具有统计学意义(P<0.05).研究过程中,除1例患者在初次接受电针治疗时出现轻微晕针外,未发生其他严重不良反应事件.结论:电针结合落花安神口服液治疗围绝经期失眠症有效、安全,近期、远期疗效佳;与单纯使用落花安神口服液相比具有一定优势.

关 键 词：Acupuncture Therapy ELECTROACUPUNCTURE INSOMNIA PERIMENOPAUSE CLIMACTERIC Acupuncture Medication Combined Randomized Controlled Trial 

分 类 号：R246.6[医药卫生—针灸推拿学]