Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Am J Obstet Gynecol. 2018 Oct;219(4):373.e1-373.e10. doi: 10.1016/j.ajog.2018.08.019. Epub 2018 Aug 17.
Acupuncture has been used for women during menopause transition, but evidence is limited.
We sought to evaluate the efficacy of electroacupuncture on relieving symptoms of women during menopause transition.
We conducted a prospective, multicenter, randomized, participant-blinded trial in China mainland. Subjects were randomized to receive 24 treatment sessions of electroacupuncture at traditional acupoints or sham electroacupuncture at nonacupoints over 8 weeks with 24 weeks' follow-up. Primary outcome was the change from baseline in the total score of Menopause Rating Scale at week 8. Secondary outcomes included the changes from baseline in the average 24-hour hot flash score, the Menopause Rating Scale subscale scores, the total score of Menopause-Specific Quality of Life Questionnaire and its subscales, and serum female hormones. All analyses were performed with a 2-sided P value of < .05 considered significant based on the intention-to-treat principle.
A total of 360 women (180 in each group) with menopause-related symptoms during menopause transition were enrolled from June 9, 2013, through Dec 28, 2015. At week 8, the reduction from baseline in the Menopause Rating Scale total score was 6.3 (95% confidence interval, 5.0-7.7) in the electroacupuncture group and 4.5 (95% confidence interval, 3.2-5.8) in the sham electroacupuncture group with a between-group difference of 1.8 (95% confidence interval, 0.9-2.8; P = .0002), less than the minimal clinically important difference of 5 points' reduction. For secondary outcomes, the between-group differences for the decrease in the mean 24-hour hot flash score were significant at weeks 8, 20, and 32, but all were less than the minimal clinically important difference in previous reports. Interestingly, the between-group differences for the Menopause-Specific Quality of Life Questionnaire total score reduction were 5.7 at week 8, 7.1 at week 20, and 8.4 at week 32, greater than the minimal clinically important difference of 4 points. Changes from baseline in follicle-stimulating hormone, luteinizing hormone, and estradiol levels at weeks 8 and 20 (P > .05 for all), with the exception of follicle-stimulating hormone/luteinizing hormone ratios (P = .0024 at week 8 and .0499 at week 20), did not differ between groups.
Among women during menopause transition, 8 weeks' electroacupuncture treatment did not seem to relieve menopausal symptoms, even though it appeared to improve their quality of life. Generalizability of the trial results may be limited by mild baseline menopausal symptoms in the included participants.
针灸已被用于缓解女性更年期过渡期间的症状，但证据有限。
我们旨在评估电针对缓解女性更年期过渡期间症状的疗效。
我们在中国内地进行了一项前瞻性、多中心、随机、参与者盲法试验。受试者被随机分为接受 24 次电针治疗传统穴位或假电针非穴位，共 8 周，随访 24 周。主要结局为第 8 周时更年期评定量表总分的基线变化。次要结局包括平均 24 小时潮热评分、更年期评定量表亚量表评分、更年期特异性生活质量问卷总分及其亚量表评分以及血清女性激素的变化。所有分析均采用基于意向治疗原则的双侧 P 值<0.05。
2013 年 6 月 9 日至 2015 年 12 月 28 日，共纳入 360 名有更年期相关症状的女性（每组 180 名）进入更年期过渡。第 8 周时，电针组更年期评定量表总分下降 6.3（95%置信区间，5.0-7.7），假电针组下降 4.5（95%置信区间，3.2-5.8），组间差异为 1.8（95%置信区间，0.9-2.8；P=0.0002），小于先前报道的 5 分的最小临床重要差异。对于次要结局，第 8、20 和 32 周时 24 小时平均潮热评分下降的组间差异有统计学意义，但均小于先前报道的最小临床重要差异。有趣的是，第 8、20 和 32 周时更年期特异性生活质量问卷总分降低的组间差异分别为 5.7、7.1 和 8.4，大于 4 分的最小临床重要差异。第 8 和 20 周时卵泡刺激素、黄体生成素和雌二醇水平的基线变化（均 P>0.05），除卵泡刺激素/黄体生成素比值（第 8 周时 P=0.0024，第 20 周时 P=0.0499）外，组间无差异。
在处于更年期过渡的女性中，8 周的电针治疗似乎并未缓解更年期症状，尽管它似乎改善了她们的生活质量。纳入参与者的更年期症状基线较轻可能限制了试验结果的普遍性。
