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天王补心丹治疗轻度认知障碍的疗效与安全性:一项随机安慰剂对照试验。

Efficacy and safety of Cheonwangbosim-dan (Tian Wang Bu Xin Dan) for treatment of mild cognitive impairment: A randomized placebo-controlled pilot trial.

作者信息

Kim Jae-Hong, Kim Ae-Ran, Seo Bok-Nam, Park Gwang-Cheon, Lee Jeong-Soon

机构信息

Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Dongshin University, Naju, Republic of Korea.

Clinical Research Center, Dongshin University Gwangju Korean Medicine Hospital, Gwangju, Republic of Korea.

出版信息

PLoS One. 2025 Jul 11;20(7):e0326227. doi: 10.1371/journal.pone.0326227. eCollection 2025.


DOI:10.1371/journal.pone.0326227
PMID:40644493
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12250166/
Abstract

Mild cognitive impairment (MCI), an intermediate condition between healthy cognitive changes due to aging and dementia, is a risk factor for dementia. Cheonwangbosim-dan (CWBSD) is a traditional herbal medicine widely used to improve mental and physical illness in East Asia. We aimed to investigate the safety and efficacy of CWBSD in the treatment of MCI. This clinical trial adopted a double-blind, single-center, parallel-arm, prospective, randomized controlled pilot study design with a full analysis set. Forty-eight participants with MCI were randomized to the control or CWBSD groups. The participants were administered either placebo or CWBSD once daily (at a dose of 3 g) for twenty-four weeks. The primary outcome measure was a change in the Korean version of the Montreal Cognitive Assessment Scale (MoCA-K). The secondary outcome measures included memory, quality of life, depression, and level of activity in daily living. Safety measures were conducted by comparing the occurrence of adverse events and changes in blood chemistry parameters, pulse rate, and blood pressure between the two groups. After 24 weeks of treatment, no significant differences in the changes in the total MoCA-K scores were detected between the two groups. Changes in secondary outcomes were not significantly different between the two groups. In the safety evaluation, there was no significant difference between the two groups with regard to the occurrence of adverse events and changes in blood chemistry parameters, blood pressure, and pulse rate. We demonstrated that CWBSD treatment may be safe and does not significantly improve cognitive function, quality of life, daily activities, or depression in individuals with MCI. Further studies are necessary to validate the efficacy and safety of CWBSD in the treatment of MCI. Trial registration Clinical Research Information Service KCT0006787.

摘要

轻度认知障碍(MCI)是介于因衰老导致的健康认知变化与痴呆之间的一种中间状态,是痴呆的一个危险因素。天王补心丹(CWBSD)是一种在东亚广泛用于改善精神和身体疾病的传统草药。我们旨在研究CWBSD治疗MCI的安全性和有效性。本临床试验采用双盲、单中心、平行组、前瞻性、随机对照试验设计,并进行全分析集分析。48名MCI参与者被随机分为对照组或CWBSD组。参与者每天服用一次安慰剂或CWBSD(剂量为3克),持续24周。主要结局指标是韩国版蒙特利尔认知评估量表(MoCA-K)的变化。次要结局指标包括记忆力、生活质量、抑郁和日常生活活动水平。通过比较两组不良事件的发生情况以及血液化学参数、脉搏率和血压的变化来进行安全性评估。治疗24周后,两组之间MoCA-K总分的变化未发现显著差异。两组次要结局的变化没有显著差异。在安全性评估中,两组在不良事件的发生以及血液化学参数、血压和脉搏率的变化方面没有显著差异。我们证明,CWBSD治疗可能是安全的,但对MCI个体的认知功能、生活质量、日常活动或抑郁没有显著改善。需要进一步研究来验证CWBSD治疗MCI的有效性和安全性。试验注册 韩国临床研究信息服务中心KCT0006787。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/234c/12250166/292498712a1f/pone.0326227.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/234c/12250166/ae4b8c27e2fe/pone.0326227.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/234c/12250166/b296bca7a50a/pone.0326227.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/234c/12250166/292498712a1f/pone.0326227.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/234c/12250166/ae4b8c27e2fe/pone.0326227.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/234c/12250166/b296bca7a50a/pone.0326227.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/234c/12250166/292498712a1f/pone.0326227.g003.jpg

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本文引用的文献

[1]
Effects of Kami Guibi-tang in patients with mild cognitive impairment: study protocol for a phase III, randomized, double-blind, and placebo-controlled trial.

BMC Complement Med Ther. 2022-12-2

[2]
Cognitive improvement effects of Tian Wang Bu Xin Dan (Cheonwangbosimdan) in patients with mild cognitive impairment: protocol for a randomized placebo-controlled pilot clinical trial.

Ann Palliat Med. 2022-10

[3]
Chinese Herbal Medicine for Mild Cognitive Impairment: A Systematic Review of Randomized Controlled Trials.

Front Neurol. 2022-6-30

[4]
Effectiveness and Safety of the Korean Medicine Senior Health Promotion Program Using Herbal Medicine and Acupuncture for Mild Cognitive Impairment: A Retrospective Study of 500 Patients in Seoul, Korea.

Evid Based Complement Alternat Med. 2021-12-6

[5]
Diagnosis and Treatment for Mild Cognitive Impairment: A Systematic Review of Clinical Practice Guidelines and Consensus Statements.

Front Neurol. 2021-10-12

[6]
Herbal Medicine for Patients with Cognitive Impairment: An Observational Study.

Neuropsychiatr Dis Treat. 2021-10-21

[7]
Efficacy and safety of Kami-guibi-tang for mild cognitive impairment: a pilot, randomized, double-blind, placebo-controlled trial.

BMC Complement Med Ther. 2021-10-7

[8]
The Herbal Formula CWBSD Improves Sleep Quality Dependent on Oral Microbial Type and Tongue Diagnostic Features in Insomnia.

J Pers Med. 2021-4-21

[9]
Characteristics of TCM Constitution and Related Biomarkers for Mild Cognitive Impairment.

Neuropsychiatr Dis Treat. 2021-4-20

[10]
Prevalence, risk factors, and management of dementia and mild cognitive impairment in adults aged 60 years or older in China: a cross-sectional study.

Lancet Public Health. 2020-12

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