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The effect of electroacupuncture combined with donepezil on cognitive function in Alzheimer’s disease patients: study protocol for a randomized controlled trial

机译:电针联合多奈哌齐对阿尔茨海默氏病患者认知功能的影响:一项随机对照试验的研究方案

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Background Alzheimer’s disease is a progressive neurodegenerative disease. Although some of the current treatments offer some symptomatic relief, this disease cannot be cured at present. Electroacupuncture may be effective for Alzheimer’s disease for cognitive function, but the evidence for its effectiveness is still limited. The aim of this study is to evaluate the add-on effect of electroacupuncture to donepezil for improving the cognitive function of Alzheimer’s disease. Methods/design A total of 334 participants with Alzheimer’s disease will be randomly assigned to either an electroacupuncture combined with donepezil group or a donepezil group with a ratio of 1:1. Participants in the electroacupuncture combined with donepezil group will receive electroacupuncture in addition to donepezil for 12?weeks and will keep taking donepezil for the following 24?weeks. Participants in the control group will take donepezil only. The primary outcome is the change from baseline in the total score of the Alzheimer’s Disease Assessment Scale-cognition at week 12. A follow-up will be conducted 24?weeks after the treatment. Discussion We expect to verify the hypothesis that acupuncture in addition to donepezil is better than donepezil in improving the cognitive function of patients with Alzheimer’s disease. This trial has a limitation that participant blinding is impossible. Trial registration Clinical Trials.gov: ID: NCT02305836 . Registered on 13 November 2014.
机译:背景阿尔茨海默氏病是一种进行性神经退行性疾病。尽管目前的某些疗法可缓解症状,但目前尚无法治愈。电针可能对阿尔茨海默氏病的认知功能有效,但其有效性的证据仍然有限。这项研究的目的是评估电针对多奈哌齐对改善阿尔茨海默氏病认知功能的作用。方法/设计总共334名阿尔茨海默氏病患者将被随机分为电针联合多奈哌齐组或多奈哌齐组,比例为1:1。电针结合多奈哌齐组的参与者除多奈哌齐外还将接受电针治疗12周,并在接下来的24周内继续服用多奈哌齐。对照组的参与者只能服用多奈哌齐。主要结果是在第12周时阿尔茨海默氏病疾病评估量表的总分与基线相比有所变化。治疗后24周将进行随访。讨论我们希望验证这一假说,即在改善阿尔茨海默氏病患者的认知功能方面,除多奈哌齐外,针灸比多奈哌齐更好。该试验有一个局限性,即参与者盲法是不可能的。试用注册Clinical Trials.gov:ID:NCT02305836。 2014年11月13日注册。

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