Analysis of the outcome indexes in randomized controlled trials of acupuncture and moxibustion for mild cognitive impairment

QIN Yuan; FU Jinjie; XIAO Lingyong; ZHANG Xinyu; YANG Huan; WANG Xiaoxuan; DAI Xiaoyu

doi:10.13703/j.0255-2930.20240131-k0002

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Analysis of the outcome indexes in randomized controlled trials of acupuncture and moxibustion for mild cognitive impairment

Literature Research | 更新时间：2024-12-12

- Analysis of the outcome indexes in randomized controlled trials of acupuncture and moxibustion for mild cognitive impairment
- Chinese Acupuncture & Moxibustion Vol. 44, Issue 12, Pages: 1463-1471(2024)
- 作者机构：
  
  1.天津中医药大学第一附属医院，天津　300380
  2.国家中医针灸临床医学研究中心，天津　300380
  3.天津中医药大学研究生院
  4.天津中医药大学中医学院
- 作者简介：
- 基金信息：
- DOI：10.13703/j.0255-2930.20240131-k0002
  CLC：
- Received：31 January 2024，
  
  Online First：23 October 2024，
  
  Published：12 December 2024
- 稿件说明：
移动端阅览
QIN Yuan, FU Jinjie, XIAO Lingyong, et al. Analysis of the outcome indexes in randomized controlled trials of acupuncture and moxibustion for mild cognitive impairment[J]. Chinese Acupuncture & Moxibustion, 2024, 44(12): 1463-1471.
DOI：

QIN Yuan, FU Jinjie, XIAO Lingyong, et al. Analysis of the outcome indexes in randomized controlled trials of acupuncture and moxibustion for mild cognitive impairment[J]. Chinese Acupuncture & Moxibustion, 2024, 44(12): 1463-1471. DOI： 10.13703/j.0255-2930.20240131-k0002.

摘要

目的：

分析针灸治疗轻度认知功能障碍的随机对照试验（RCT）结局指标情况，为后续针灸治疗轻度认知障碍的相关临床试验方案设计及构建核心结局指标集提供参考。

方法：

检索中国期刊全文数据库（CNKI）、万方数据知识服务平台（Wanfang）、维普中文期刊全文数据库（VIP）、中国生物医学文献数据库（SinoMed）、PubMed、Cochrane Library、EMbase、Web of Science针灸治疗轻度认知功能障碍RCT文献，检索时间为2018年1月1日至2023年10月31日，通过文献筛选和资料提取汇总，对纳入研究的基本信息及结局指标进行整理和分析。

结果：

共纳入46篇文献，2 072例样本，涉及18项诊断标准，结局指标按功能属性分为7个指标域，即临床症状/体征、中医症状/证候、理化检查、生活质量、精神心理健康、安全性评价、患者满意度，共报告84个结局指标，使用总频次为237次。针灸治疗轻度认知功能障碍的RCT研究目前存在神经心理学评估工具使用差异大、对受教育程度/受教育年限报告不足、理化检测指标多样、结局评价时点差异大、主次要结局指标应用较少、中医诊断辨证及指标应用缺乏、远期预后与经济学评估不足的问题。

结论：

建议规范构建针灸治疗轻度认知功能障碍的核心指标集，以提高相关研究设计的规范性、结局指标选择的合理性以及研究结果的可靠性。

Abstract

Objective

To analyze the outcome indexes of randomized controlled trials (RCTs) of acupuncture and moxibustion for mild cognitive impairment (MCI) so as to provide a reference for the protocol design and the construction of a core outcome set in relevant clinical trials of acupuncture and moxibustion for MCI.

Methods

From CNKI

Wanfang

VIP

SinoMed

PubMed

Cochrane Library

EMbase

and Web of Science

RCTs of acupuncture and moxibustion for MCI were searched

and the time duration was ranged from January 1st

2018 to October 31th

2023. The general information and outcome indexes of the included studies were collected and analyzed through literature screening and data extraction.

Results

A total of 46 studies were eligible

with 2 072 samples and 18 diagnostic criteria involved. The outcome indexes were categorized into 7 domains according to functional attributes

including clinical symptoms/signs

TCM symptoms/syndromes

physical and chemical examination

quality of life

psychiatric and mental health

safety assessment

and patient satisfaction. Eighty-four outcome indexes were reported

with the use frequency of 237. Currently

RCTs of acupuncture and moxibustion for MCI were limited in the big difference in neuropsychological assessment tool

the inadequate reports on educational degree/educational years

the diversity of physical and chemical detection indexes

the inconsistency of the time points for outcome evaluation

the insufficient application of primary and secondary outcomes

the lack of the application of TCM diagnosis

pattern/syndrome differentiation and outcomes

and the shortage in long-term prognosis and economic assessment.

Conclusion

It is recommended to specify and develop the core outcome set of acupuncture and moxibustion for MCI to advance the standardization of related research design

the rational selection of outcome indexes

and the reliability of the research results.

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