Kong Xiehe, Ma Zhao, Tang Ran, Wang Xuejun, Wei Kai, Yang Guang, Yang Yanting, Zhao Yue, Zhang Dan, Xie Chen, Wang Gang, Ma Xiaopeng
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Front Med (Lausanne). 2023 Feb 23;10:1014113. doi: 10.3389/fmed.2023.1014113. eCollection 2023.
Acupuncture is used as an adjuvant therapy for Alzheimer's disease (AD), but available evidence for efficacy is limited so far. Growing studies suggest that resident gut microbiota contributes to the development and progression of AD. Meanwhile, acupuncture is reported to treat gastrointestinal and neurodegenerative disorders the gut-brain axis. Therefore, our aim is to confirm the adjunctive therapeutic effects of acupuncture for AD, and explore the relationship between clinical efficacy and shifts of gut microbiota.
This is a randomized, participant-masked, sham-controlled trial. One hundred and sixty participants with mild AD will be randomly assigned (1:1) to either active acupuncture or non-penetrating sham acupuncture (three times weekly for 14 weeks) added to donepezil treatment (5 mg per day for 28 weeks). The primary efficacy outcome is the change from baseline to week 28 in the Alzheimer's disease Assessment Scale (ADAS-cog12). Secondary efficacy outcomes include other assessments of the Mini-Mental State Examination (MMSE), the Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL), and Neuropsychiatric Inventory (NPI). Gut microbiota will be measured using 16S rRNA tag sequencing.
This rigorous trial will provide high-quality evidence on the efficacy of acupuncture as adjunctive treatment for mild AD, and identify the possible mechanisms of acupuncture from gut microbiota.
[https://clinicaltrials.gov/ct2/show/NCT05078944], ClinicalTrials.gov [NCT05078944]. Registered 15 October 2021.
针灸被用作阿尔茨海默病（AD）的辅助治疗方法，但目前关于其疗效的现有证据有限。越来越多的研究表明，肠道常驻微生物群在AD的发生和发展中起作用。同时，据报道针灸可通过肠-脑轴治疗胃肠道和神经退行性疾病。因此，我们的目的是证实针灸对AD的辅助治疗效果，并探讨临床疗效与肠道微生物群变化之间的关系。
这是一项随机、参与者盲法、假针刺对照试验。160名轻度AD患者将被随机分配（1:1）至接受主动针灸或非穿透性假针刺治疗（每周三次，共14周），同时加用多奈哌齐治疗（每天5mg，共28周）。主要疗效指标是阿尔茨海默病评估量表（ADAS-cog12）从基线到第28周的变化。次要疗效指标包括简易精神状态检查表（MMSE）、阿尔茨海默病协作研究日常生活活动量表（ADCS-ADL）和神经精神科问卷（NPI）的其他评估。将使用16S rRNA标签测序法测量肠道微生物群。
这项严谨的试验将为针灸作为轻度AD辅助治疗的疗效提供高质量证据，并从肠道微生物群方面确定针灸可能的作用机制。
[https://clinicaltrials.gov/ct2/show/NCT05078944]，美国国立医学图书馆临床试验数据库 [NCT05078944]。于2021年10月15日注册。
