耳针治疗围绝经期综合征多中心临床疗效观察

A Multicenter Observational Study of the Clinical Efficacy of Ear Acupuncture in Treating Perimenopausal Syndrome

目的观察耳针治疗围绝经期综合征的临床疗效,客观评价该疗法的依从性及安全性。方法采用多中心、分层随机、对照、单盲临床试验,将受试者分为耳针组和更年安片组,耳针组取双侧耳穴内分泌、交感、神门、内生殖器针刺后给予频率为15Hz电针连续波刺激30min,更年安组患者口服更年安片,均连续治疗10d。结果绝经前期患者,耳针组总有效率为96.8%,更年安片组总有效率为56.3%;绝经后期患者,耳针组总有效率为85.7%,更年安片组总有效率为53.0%。结论耳针疗法及更年安片均可有效改善围绝经期综合征患者的临床症状;耳针疗法的临床疗效优于更年安片;两种疗法均具有较好的依从性和安全性。

Objective To investigate the clinical efficacy of ear acupuncture in treating perimenopausal syndrome and objectively assess compliance with and the safety of the treatment. Methods A multicenter stratified randomized single-blind controlled trial was performed. The subjects were allocated to an ear acupuncture group （treatment group） and a Gengnianan Pian group （control group）. The ear acupuncture group received acupuncture at bilateral ear points Endocrine, Sympathetic, Shenmen and Internal genitalia followed by 30 min continuous wave electroacupuncture at a frequency of 15 Hz. The Gengnianan group took Gengnianan Pian orally. Both groups were treated for 10 days. Results The total efficacy rate was 96.8% in the ear acupuncture group of premenopausal patients and 56.3% in the Gengnianan Pian group. The total efficacy rate was 85.7% in the ear acupuncture group of postmenopausal patients and 53.0% in the Gengnianan Pian group. Conclusion Both ear acupuncture and Gengnianan Pian can effectively improve the clinical symptoms in patients with perimenopausal syndrome. The clinical therapeutic effect of ear acupuncture is superior to that of Gengnianan Pian. Both therapies have better compliance and safety.