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针刺治疗轻度认知障碍患者:一项随机、患者和评估者双盲、假针刺对照的试点研究。

Acupuncture for patients with mild cognitive impairment: a randomized, patient-assessor-blinded, sham-controlled pilot study.

作者信息

Choi Yujin, Kim Pyung-Wha, Jung In-Chul, Kim Ae-Ran, Park Hyo-Ju, Kwon Ojin, Lee Jun-Hwan, Kim Joo-Hee

机构信息

KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.

Department of Neuropsychiatry, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.

出版信息

BMC Complement Med Ther. 2025 Jul 19;25(1):277. doi: 10.1186/s12906-025-05023-5.

DOI:10.1186/s12906-025-05023-5
PMID:40684196
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12275449/
Abstract

BACKGROUND

Mild cognitive impairment (MCI) is the transitional stage between normal aging and early dementia. Although acupuncture is a promising non-pharmacological treatment, higher-quality evidence is needed to confirm its effectiveness.

METHODS

A randomized, patient- and assessor-blinded, sham-controlled, pilot clinical trial was conducted to evaluate the feasibility of acupuncture for treating MCI. In total, 30 participants were randomized into acupuncture and sham acupuncture groups. The participants underwent 24 treatment sessions over 12 weeks. The primary outcome was a change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) score over 12 weeks, whereas the secondary outcomes included the Seoul Neuropsychological Screening Battery (SNSB-II) score. Adverse events and the success of blinding were also assessed.

RESULTS

Of the 30 participants, 28 completed the study. Participants in the acupuncture and sham acupuncture groups exhibited a decrease in ADAS-cog scores from 10.27 ± 4.03 and 11.47 ± 3.85 at baseline to 5.78 ± 3.04 and 6.27 ± 2.83 at week 12, respectively. Both groups exhibited clinically meaningful improvements, with no significant difference between groups (P = 0.6590). The SNSB-II memory domain exhibited a moderate effect size favoring acupuncture (Cohen's d = 0.57, P = 0.1317). No intervention-related adverse events were reported, and participant blinding was adequate throughout the trial.

CONCLUSIONS

The 12-week acupuncture treatment is feasible for patients with MCI and may improve memory. Although the primary outcomes did not reach statistical significance, the secondary outcomes suggested potential benefits. Larger confirmatory trials are warranted to investigate the effectiveness of acupuncture in patients with MCI.

TRIAL REGISTRATION

Clinical Research Information Service (cris.nih.go.kr) KCT0001938 (Registered on June 3, 2016).

摘要

背景

轻度认知障碍(MCI)是正常衰老与早期痴呆之间的过渡阶段。尽管针灸是一种很有前景的非药物治疗方法,但仍需要更高质量的证据来证实其有效性。

方法

进行了一项随机、患者和评估者双盲、假针刺对照的试点临床试验,以评估针灸治疗MCI的可行性。总共30名参与者被随机分为针灸组和假针灸组。参与者在12周内接受24次治疗。主要结局是12周内阿尔茨海默病评估量表认知子量表(ADAS-cog)评分的变化,次要结局包括首尔神经心理筛查量表(SNSB-II)评分。还评估了不良事件和盲法的成功情况。

结果

30名参与者中,28名完成了研究。针灸组和假针灸组的参与者的ADAS-cog评分分别从基线时的10.27±4.03和11.47±3.85降至第12周时的5.78±3.04和6.27±2.83。两组均表现出具有临床意义的改善,组间无显著差异(P = 0.6590)。SNSB-II记忆领域显示出有利于针灸的中等效应量(Cohen's d = 0.57,P = 0.1317)。未报告与干预相关的不良事件,并且在整个试验过程中参与者的盲法是充分的。

结论

为期12周的针灸治疗对MCI患者是可行的,并且可能改善记忆力。尽管主要结局未达到统计学显著性,但次要结局提示了潜在益处。有必要进行更大规模的验证性试验来研究针灸对MCI患者的有效性。

试验注册

临床研究信息服务(cris.nih.go.kr)KCT0001938(于2016年6月3日注册)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9db7/12275449/6a32a00ab452/12906_2025_5023_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9db7/12275449/6eafbee49423/12906_2025_5023_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9db7/12275449/6a32a00ab452/12906_2025_5023_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9db7/12275449/6eafbee49423/12906_2025_5023_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9db7/12275449/6a32a00ab452/12906_2025_5023_Fig2_HTML.jpg

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本文引用的文献

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Efficacy and safety of acupuncture for cognitive impairment in Alzheimer's disease: a systematic review and meta-analysis.针刺治疗阿尔茨海默病认知障碍的疗效与安全性:一项系统评价与荟萃分析
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Acupuncture on mild cognitive impairment: A systematic review of neuroimaging studies.针刺治疗轻度认知障碍:神经影像学研究的系统评价
Front Aging Neurosci. 2023 Feb 15;15:1007436. doi: 10.3389/fnagi.2023.1007436. eCollection 2023.
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The Seoul Neuropsychological Screening Battery (SNSB) for Comprehensive Neuropsychological Assessment.用于综合神经心理学评估的首尔神经心理学筛查量表(SNSB)。
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Establishing Clinically Meaningful Change on Outcome Assessments Frequently Used in Trials of Mild Cognitive Impairment Due to Alzheimer's Disease.确立阿尔茨海默病导致轻度认知障碍临床试验中常用结局评估的临床有意义变化。
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