Current status and standardization issues analysis of outcome indicators in randomized controlled trials of treating vascular dementia with acupuncture

To analyze the current status of outcome measures in randomized controlled trials (RCTs) of acupuncture treatment for vascular dementia (VD) and promote the development of a standardized set of outcome measures.

Chinese and English literature databases were searched, including the Chinese Medical Periodical Full-Text Database, the Chinese Biology Medicine disc, China National Knowledge Infrastructure, Wanfang Data, VIP Database, PubMed, Embase, the Cochrane Library, MEDLINE, Web of Science, Chinese Clinical Trials Registry, and the International Traditional Medicine Clinical Trial Registry. Two researchers independently screened RCT literature on acupuncture treatment for VD between January 1, 2015 and January 1, 2025, risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Extract basic study information, intervention measures, diagnostic criteria for both Chinese and Western medicine, TCM syndromes, and outcome measures. Summarize the indicator domains of RCT studies on acupuncture treatment for VD, and analyze the basic information and outcome measures of the included studies.

A preliminary search identified 2, 898 articles, of which 93 RCTs were ultimately included. These studies involved 84 outcome measures, covering six indicator domains: symptoms/signs (23.81%), traditional Chinese medicine (TCM) syndromes (3.57%), medical checkups (60.71%), quality of life (5.95%), safety assessment (4.76%), and prognosis follow-up (1.19%). A total of 91 (97.85%) RCTs reported treatment duration, ranging from 2 to 24 weeks; 72 (77.42%) RCTs used clinical efficacy as the outcome indicator; 11 studies (11.83%) reported safety assessments and adverse events.

Currently, the RCT study design for acupuncture treatment of VD lacks unified standards and has numerous methodological issues. These include insufficient description of sample size estimation processes, strong reliance on subjective rating scales, ambiguous definitions of primary and secondary outcome measures, incomplete integration of Chinese and Western medical indicators, and insufficient reflection of individualized syndrome differentiation and treatment characteristics. In addition, safety assessments and follow-up mechanisms remain relatively weak. Future research should focus on the essential nature of VD, establish a core set of indicators aligned with the clinical characteristics of traditional Chinese medicine, promote the scientific and standardized development of acupuncture research for VD, and provide more compelling evidence-based support for clinical practice.