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电针治疗早发性更年期潮热:一项随机假对照试验。

Electroacupuncture for hot flashes in early menopause: A randomized sham-controlled trial.

作者信息

Wang Hui-Xian, Yu Xin-Tong, Hu Jing, Chen Jin-Jia, Mei Yu-Ting, Chen Yun-Fei

机构信息

Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.

Acupuncture Anesthesia Clinical Research Institute, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.

出版信息

J Integr Med. 2025 Jul 28. doi: 10.1016/j.joim.2025.07.008.

DOI:10.1016/j.joim.2025.07.008
PMID:40846522
Abstract

BACKGROUND

Electroacupuncture (EA) may affect the severity of hot flashes (HFs) associated with natural menopause and provide additional benefits for postmenopausal women. However, the evidence for its effectiveness in the management of early postmenopausal HFs remains inadequately understood.

OBJECTIVE

We designed this trial to assess the efficacy and safety of EA for relieving early postmenopausal HFs.

DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This randomized sham-controlled trial involved 72 women with HFs. The participants were divided equally into the intervention and control groups. The intervention group was treated with EA, while the control group was treated with sham acupuncture. The main acupoints used were Hegu (LI4), Guanyuan (RN4), Sanyinjiao (SP6), Taixi (KI3), Fuliu (KI7) and Shenshu (BL23). All participants received 18 treatment sessions, distributed across a 6-week period. The treatment was administered on three occasions per week, adhering to a fixed weekday schedule (Monday, Wednesday, Friday or Tuesday, Thursday, Saturday) with a minimum interval of one day between sessions. Each patient received a 12-week follow-up.

MAIN OUTCOME MEASURES

The HF score was the primary outcome. Participants documented the frequency and severity of HFs in a 7-day symptom diary, which provided data for calculating the HF score. Secondary outcomes were the Menopause Rating Scale (MRS), Menopause-Specific Quality of Life Questionnaire (MENQOL), Pittsburgh Sleep Quality Index (PSQI) and Traditional Chinese Medicine Syndrome Score Scale (TCMSSS), as well as estradiol (E), luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels.

RESULTS

Both groups demonstrated significant reductions in HF scores after the treatment and during the follow-up (P < 0.001). Immediately after completion of the 6-week treatment cycle and at 12 weeks post-intervention, the HF scores were similar in both groups. At week 6, the intervention group showed significantly greater improvements in MRS, MENQOL (vasomotor, psychosocial, and physical), PSQI and TCMSSS scores (P < 0.05). The improvements in the MENQOL (vasomotor, and psychosocial) and PSQI total scores persisted through the follow-up (P < 0.05). However, the results showed no significant inter- or intragroup differences in sexual scores on the MENQOL (P > 0.05). EA did not significantly decrease E, LH or FSH levels compared to placebo. The incidence of adverse events was similar in both groups.

CONCLUSION

EA does not significantly improve HFs in early postmenopausal patients. However, it enhances the quality of sleep and decreases menopausal symptoms across vasomotor, psychosocial and physical domains.

TRIAL REGISTRATION

Chinese Clinical Trial Registry (http://www.chictr.org.cn); Trial ID: ChiCTR2300072002. Please cite this article as: Wang HX, Yu XT, Hu J, Chen JJ, Mei YT, Chen YF. Electroacupuncture for hot flashes in early menopause: A randomized sham-controlled trial. J Integr Med. 2025; Epub ahead of print.

摘要

背景

电针(EA)可能会影响自然绝经相关潮热(HFs)的严重程度,并为绝经后女性带来额外益处。然而,其在管理绝经后早期潮热方面的有效性证据仍未得到充分理解。

目的

我们设计了这项试验,以评估电针缓解绝经后早期潮热的疗效和安全性。

设计、地点、参与者和干预措施:这项随机假针刺对照试验纳入了72名有潮热症状的女性。参与者被平均分为干预组和对照组。干预组接受电针治疗,而对照组接受假针刺治疗。主要使用的穴位为合谷(LI4)、关元(RN4)、三阴交(SP6)、太溪(KI3)、复溜(KI7)和肾俞(BL23)。所有参与者接受18次治疗,为期6周。治疗每周进行3次,按照固定的工作日时间表(周一、周三、周五或周二、周四、周六)进行,每次治疗间隔至少1天。每位患者接受12周的随访。

主要观察指标

潮热评分是主要结局指标。参与者在7天症状日记中记录潮热的频率和严重程度,该日记为计算潮热评分提供数据。次要结局指标包括绝经评定量表(MRS)、绝经特异性生活质量问卷(MENQOL)、匹兹堡睡眠质量指数(PSQI)和中医证候评分量表(TCMSSS),以及雌二醇(E)、促黄体生成素(LH)和促卵泡生成素(FSH)水平。

结果

两组在治疗后及随访期间潮热评分均显著降低(P < 0.001)。在6周治疗周期结束后及干预后12周时,两组的潮热评分相似。在第6周时,干预组在MRS、MENQOL(血管舒缩、心理社会和身体方面)、PSQI和TCMSSS评分方面有显著更大的改善(P < 0.05)。MENQOL(血管舒缩和心理社会方面)和PSQI总分的改善在随访期间持续存在(P < 0.05)。然而,结果显示MENQOL上的性评分在组间或组内均无显著差异(P > 0.05)。与安慰剂相比,电针并未显著降低E、LH或FSH水平。两组不良事件的发生率相似。

结论

电针在绝经后早期患者中并未显著改善潮热。然而,它提高了睡眠质量,并减轻了血管舒缩、心理社会和身体方面的绝经症状。

试验注册

中国临床试验注册中心(http://www.chictr.org.cn);试验编号:ChiCTR2300072(002)。请引用本文:Wang HX, Yu XT, Hu J, Chen JJ, Mei YT, Chen YF. Electroacupuncture for hot flashes in early menopause: A randomized sham-controlled trial. J Integr Med. 2025; Epub ahead of print.

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