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.
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。.
Keywords: acupuncture and moxibustion; core outcome set; mild cognitive impairment; outcome indexes; randomized controlled trial (RCT).