Li Shanshan, Wang Zhaoqin, Wu Huangan, Yue Hongyu, Yin Ping, Zhang Wei, Lao Lixing, Mi Yiqun, Xu Shifen
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, People's Republic of China.
Department of Aeronautics and Astronautics, Shanghai Key Laboratory of Acupuncture Mechanism and Acupoint Function, Fudan University, Shanghai 200433, People's Republic of China.
Nat Sci Sleep. 2020 Dec 22;12:1201-1213. doi: 10.2147/NSS.S282315. eCollection 2020.
OBJECTIVE: To evaluate the short- and long-term effects of acupuncture on perimenopausal insomnia (PMI) and quality of life. PATIENTS AND METHODS: We designed a semi-standardized, patient-blinded, randomized placebo-controlled trial. A total of 84 patients were recruited, all of whom met the criteria for diagnosis of PMI. Either acupuncture therapy or a noninvasive placebo acupuncture therapy designed to treat insomnia was implemented 18 times over the course of 8 weeks (3 times per week for 4 weeks, twice per week for 2 weeks, once per week for 2 weeks). The primary outcome was the change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to the end of treatment, week 8. Secondary outcomes included climacteric symptoms and quality of life measured by the Menopause Quality of Life (Men-QoL), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), sleep parameters recorded in the actigraphy and adverse events. The PSQI and Men-QoL were assessed at weeks 0, 4, 8, 12 and 20. Other assessments were performed at week 0 and week 8. RESULTS: The participants were randomly assigned to either acupuncture (n=42) or sham acupuncture (n=42) groups. The mean difference from baseline of PSQI score at the end of treatment between real acupuncture and sham acupuncture group was -2.38 (95% CI, -3.46 to -1.30; P<0.001). The acupuncture group was associated with significantly lower scores than the sham acupuncture group at week 12 and during the 20-week follow-up visits (all <0.001). Acupuncture was also associated with significantly higher quality of life in vasomotor and other physical dimensions (all P <0.001). At the end of treatment, researchers found a significantly higher total sleep time (TST), sleep efficiency (SE) and lower number of average awakenings (AA) ( =0.007 0.023 and 0.011, respectively) in the acupuncture group than in the sham acupuncture group. No severe adverse events were reported. CONCLUSION: The findings suggest that acupuncture may be a safe and effective treatment for PMI and improving quality of sleep in patients with menopause and could have a long-lasting effect. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR); Trial ID: ChiCTR1800018645. URL: http://www.chictr.org.cn/showproj.aspx?proj=31482.
目的：评估针灸对围绝经期失眠（PMI）及生活质量的短期和长期影响。 患者与方法：我们设计了一项半标准化、患者盲法、随机安慰剂对照试验。共招募了84名患者，所有患者均符合PMI的诊断标准。在8周内实施18次针灸治疗或旨在治疗失眠的非侵入性安慰剂针灸治疗（每周3次，共4周；每周2次，共2周；每周1次，共2周）。主要结局是匹兹堡睡眠质量指数（PSQI）评分从基线至治疗结束时（第8周）的变化。次要结局包括更年期症状和通过更年期生活质量量表（Men-QoL）、失眠严重程度指数（ISI）、自评焦虑量表（SAS）、自评抑郁量表（SDS）测量的生活质量、活动记录仪记录的睡眠参数以及不良事件。在第0、4、8、12和20周评估PSQI和Men-QoL。其他评估在第0周和第8周进行。 结果：参与者被随机分配到针灸组（n = 42）或假针灸组（n = 42）。真针灸组与假针灸组在治疗结束时PSQI评分相对于基线的平均差值为-2.38（95%CI，-3.46至-1.30；P<0.001）。在第12周和20周的随访中，针灸组的评分显著低于假针灸组（均P<0.001）。针灸在血管舒缩和其他身体维度上也与显著更高的生活质量相关（均P<0.001）。治疗结束时，研究人员发现针灸组的总睡眠时间（TST）、睡眠效率（SE）显著高于假针灸组，平均觉醒次数（AA）显著低于假针灸组（分别为P = 0.007、0.023和0.011）。未报告严重不良事件。 结论：研究结果表明，针灸可能是治疗PMI以及改善更年期患者睡眠质量的一种安全有效的方法，且可能具有持久的效果。 试验注册：中国临床试验注册中心（ChiCTR）；试验编号：ChiCTR1800018645。网址：http://www.chictr.org.cn/showproj.aspx?proj=31482 。
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