针刺对慢性失眠患者睡眠及共病症状的影响：一项随机临床试验
Impact of Acupuncture on Sleep and Comorbid Symptoms for Chronic Insomnia: A Randomized Clinical Trial.
作者信息
Wang Cong, Xu Wen-Lin, Li Guan-Wu, Fu Cong, Li Jin-Jin, Wang Jing, Chen Xin-Yu, Liu Zhen, 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, People's Republic of China.
Department of Radiology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
出版信息
Nat Sci Sleep. 2021 Oct 10;13:1807-1822. doi: 10.2147/NSS.S326762. eCollection 2021.
STUDY OBJECTIVES
To evaluate the efficacy and safety of acupuncture at HT 7 (Shenmen) and KI 7 (Fuliu) on sleep and comorbid symptoms for chronic insomnia.
METHODS AND DESIGN
A randomized, single-blind, parallel and sham-controlled trial consisted of an acupuncture group (n = 41) and a sham acupuncture group (n = 41). Setting: a tertiary hospital of integrated Chinese and Western medicine. Participants: 82 subjects with chronic insomnia based on the International Classification of Sleep Disorders, Third Edition (ICSD-3). Interventions: a 10-session acupuncture treatment at bilateral HT 7 and KI 7 or sham acupoints with shallow needling was performed over 3 weeks. Measurements: the Pittsburgh sleep quality index (PSQI) and insomnia severity index (ISI) were evaluated at baseline, posttreatment, and at two follow-ups as the primary outcome measures. Polysomnography (PSG) on two consecutive nights, the Beck anxiety inventory (BAI), the Beck depression inventory (BDI) fatigue severity scale (FSS) and the Epworth sleepiness scale (ESS) were evaluated at baseline and posttreatment as the secondary outcome measures.
RESULTS
After the treatments, PSQI scores decreased by 5.04 in the acupuncture group and 2.92 in the sham acupuncture group. ISI scores decreased by 7.65 in the acupuncture group and 5.05 in the sham acupuncture group. The between-group differences in the primary outcome measures posttreatment were statistically significant. However, no differences were found between the two groups during the two follow-ups. Regarding the PSG data, there were significantly lower levels of sleep onset latency (SOL), a lower percentage of sleep stage N1 and a higher percentage of sleep stage N3 in the acupuncture group than in the sham acupuncture group. After treatment, there were lower levels of comorbid symptoms (BAI, BDI, FSS and ESS) in both groups. However, no significant differences were observed between the groups.
CONCLUSION
Acupuncture at HT 7 and KI 7 is an effective and safe nonpharmacologic intervention option for chronic insomnia.
CLINICAL TRIAL REGISTRATION
The study was registered at the Chinese Clinical Trial Registry, registration ID: ChiCTR1900023787, China.
研究目的
评估针刺心经神门穴（HT 7）和肾经复溜穴（KI 7）治疗慢性失眠及其共病症状的有效性和安全性。
方法与设计
一项随机、单盲、平行、假针刺对照试验，分为针刺组（n = 41）和假针刺组（n = 41）。地点：一所三级中西医结合医院。参与者：82名符合《国际睡眠障碍分类第三版》（ICSD - 3）标准的慢性失眠患者。干预措施：在3周内对双侧HT 7和KI 7或假穴位进行10次浅刺针刺治疗。测量指标：以匹兹堡睡眠质量指数（PSQI）和失眠严重程度指数（ISI）作为主要结局指标，在基线、治疗后及两次随访时进行评估。以连续两晚的多导睡眠图（PSG）、贝克焦虑量表（BAI）、贝克抑郁量表（BDI）、疲劳严重程度量表（FSS）和爱泼华嗜睡量表（ESS）作为次要结局指标，在基线和治疗后进行评估。
结果
治疗后，针刺组PSQI评分下降5.04，假针刺组下降2.92。针刺组ISI评分下降7.65，假针刺组下降5.05。治疗后主要结局指标的组间差异具有统计学意义。然而，在两次随访期间两组之间未发现差异。关于PSG数据，针刺组的睡眠起始潜伏期（SOL）显著缩短，N1睡眠期百分比降低，N3睡眠期百分比升高。治疗后，两组共病症状（BAI、BDI、FSS和ESS）水平均降低。然而，两组之间未观察到显著差异。
结论
针刺心经神门穴（HT 7）和肾经复溜穴（KI 7）是治疗慢性失眠有效且安全的非药物干预方法。
临床试验注册
本研究在中国临床试验注册中心注册，注册号：ChiCTR1900023787，中国。
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