Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, Jilin, 130033, P.R. China.
Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, Jilin, 130117, P.R. China.
BMC Complement Med Ther. 2020 Aug 17;20(1):254. doi: 10.1186/s12906-020-02969-6.
Primary insomnia (PI) is characterized by difficulties in initiating sleep or maintaining sleep, which lead to many serious diseases. Acupuncture for PI has drawn attention with its effectiveness and safety. However, the operation of choosing acupoints lacks scientific suggestion. Our trial aims to provide reference and scientific basis for the selection of acupoints and to explore its possible mechanism.
A patient-assessor-blinded, randomized and sham controlled trial was designed to compare the efficacy of 5-weeks acupuncture at a single acupoint, the combination of multi-acupoints, and a sham point. The Pittsburgh sleep quality index and Athens Insomnia Scale questionnaire were used for the primary clinical outcomes, while polysomnography was performed for the secondary clinical outcomes. The resting state functional MRI was employed to detect the cerebral responses to acupuncture. The brain activity in resting state was measured by calculating the fractional amplitude of low-frequency fluctuations (fALFF), which reflected the idiopathic activity level of neurons in the resting state. These results were analyzed by two factorial ANOVA test and post-hoc t-tests.
The clinical outcomes suggest that acupuncture could improve clinical symptoms, and the combination of multi-acupoints might lead to a better clinical efficacy. The rs-fMRI results suggested that the brain activity of certain regions was related to the sleep experience, and acupuncture could regulate the activity of these regions. Furthermore, the combination of multi-acupoints could impact more regions which were influenced by the sleep experience.
Acupuncture has been proven to be beneficial for PI patients, and the combination of multi-acupoints might improve its efficacy.
This trial has been registered on the U.S. National Library of Medicine (https://clinicaltrials.gov) ClinicalTrials.gov Identifier: NCT02448602 . Registered date: 14/04/2015.
原发性失眠（PI）的特征是难以入睡或维持睡眠，这会导致许多严重的疾病。针灸治疗 PI 因其有效性和安全性而受到关注。然而，选择穴位的操作缺乏科学的建议。我们的试验旨在为穴位选择提供参考和科学依据，并探讨其可能的机制。
设计了一项患者评估员盲法、随机对照和假对照试验，以比较单穴、多穴联合和假点 5 周针灸的疗效。匹兹堡睡眠质量指数和雅典失眠量表问卷用于主要临床结局，而多导睡眠图用于次要临床结局。静息态功能磁共振成像用于检测针刺的大脑反应。通过计算低频波动的分数幅度（fALFF）来测量静息状态下的大脑活动，该分数反映了神经元在静息状态下的自发性活动水平。这些结果通过双因素方差分析检验和事后 t 检验进行分析。
临床结果表明，针灸可以改善临床症状，多穴联合可能会产生更好的临床疗效。rs-fMRI 结果表明，某些区域的大脑活动与睡眠体验有关，而针灸可以调节这些区域的活动。此外，多穴联合可以影响更多受睡眠体验影响的区域。
针灸已被证明对 PI 患者有益，多穴联合可能会提高其疗效。
该试验已在美国国立医学图书馆（https://clinicaltrials.gov）注册。ClinicalTrials.gov 标识符：NCT02448602。注册日期：2015 年 4 月 14 日。
