Comparing the Effect of Acupuncture, Sham Acupuncture, and Waiting-List Control on Patients with Post-stroke Cognitive Impairment: A Randomized Clinical Trial.

IF 6.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Xiaolin Chen, Lili Zhang, Wenhui Mao, Jian Wen, Yuting Wang, Kaixuan Ma, Xi Nan, Xiayu Li, Hui Yang, Wei Liu, Xiaochan Tan, Lingling Luo, Geshu Du, He Bu, Yanhong Wang, Yuzheng Du
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引用次数: 0

Abstract

Background: There remains no global consensus on the use of acupuncture therapy in post-stroke cognitive impairment (PSCI), particularly in large sample multi-center RCTs.

Aim: To determine whether acupuncture can enhance cognitive function in PSCI.

Design and methods: This RCT was conducted from December 2019 to February 2024. A total of 360 participants were recruited and randomly assigned to manual acupuncture (MA), sham acupuncture (SA), or waiting-list control (WC) groups in a 1:1:1 ratio. This study utilized centralized randomization with allocation concealment by Minimpy software and was executed in five hospitals located in Tianjin, Changchun, Changsha, Baotou, and Changzhi, China. The MA group underwent 36 acupuncture sessions for 12 weeks. Participants were observed for a further 24 weeks without any intervention. The primary outcome was measured by MoCA scale. Secondary outcomes were evaluated by MMSE, CDR, NPI, FAQ, WHOQOL-BREF, and Aβ-42. Statistical analysis was conducted by t-tests, the Kruskal-Wallis test, one-way ANOVA, and linear mixed-effects model.

Results and conclusion: 307 of the 360 patients were analyzed. The MA group showed significant improvement in MoCA scores compared to the SA and WC groups, with increases of 2.21 [95% CI, 1.28 to 3.13; P < 0.001] and 2.76 [95% CI, 1.74 to 3.77; P < 0.001] at week 36. The results derived from the MMSE, CDR, NPI, FAQ, and WHOQOL-BREF indicate that acupuncture therapy may enhance cognitive function and overall quality of life, although it does not appear to affect Aβ-42 levels when contrasting the MA group with the SA or WC groups. Acupuncture therapy could significantly improve cognitive function in adults with PSCI.

Trial registration: Chinese Clinical Trial Registry: ChiCTR2000033801.

比较针刺、假针刺和候补对照对脑卒中后认知功能障碍患者的影响:一项随机临床试验。
背景:针刺疗法在脑卒中后认知障碍(PSCI)中的应用尚无全球共识,特别是在大样本多中心随机对照试验中。目的:探讨针刺是否能增强PSCI患者的认知功能。设计与方法:本随机对照试验于2019年12月至2024年2月进行。共招募了360名参与者,并按1:1:1的比例随机分配到手动针灸组(MA)、假针灸组(SA)和等候名单对照组(WC)。本研究采用Minimpy软件进行集中随机化和分配隐藏,在中国天津、长春、长沙、包头和长治的5家医院进行。MA组接受36次针灸治疗,为期12周。参与者在没有任何干预的情况下观察了24周。主要结局采用MoCA量表测量。次要结局采用MMSE、CDR、NPI、FAQ、WHOQOL-BREF和Aβ-42进行评价。统计分析采用t检验、Kruskal-Wallis检验、单因素方差分析和线性混合效应模型。结果与结论:对360例患者中的307例进行了分析。与SA和WC组相比,MA组的MoCA评分有显著改善,增加了2.21 [95% CI, 1.28 ~ 3.13;P试验注册:中国临床试验注册中心:ChiCTR2000033801。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
6.90
自引率
5.30%
发文量
263
审稿时长
4-8 weeks
期刊介绍: QJM, a renowned and reputable general medical journal, has been a prominent source of knowledge in the field of internal medicine. With a steadfast commitment to advancing medical science and practice, it features a selection of rigorously reviewed articles. Released on a monthly basis, QJM encompasses a wide range of article types. These include original papers that contribute innovative research, editorials that offer expert opinions, and reviews that provide comprehensive analyses of specific topics. The journal also presents commentary papers aimed at initiating discussions on controversial subjects and allocates a dedicated section for reader correspondence. In summary, QJM's reputable standing stems from its enduring presence in the medical community, consistent publication schedule, and diverse range of content designed to inform and engage readers.
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