Zhongguo quanke yixue (Jan 2024)
Application Analysis of the Outcome Measures in Randomized Controlled Trials of Traditional Chinese Medicine in the Treatment of Coronary Microvascular Disease
Abstract
Background Coronary microvascular disease (CMVD) is currently a research hotspot in the field of cardiovascular disease, traditional Chinese medicine (TCM) has unique advantages and significant efficacy in the treatment of CMVD, but there are problems in relevant clinical trials, such as inconsistencies in the diagnostic and efficacy criteria, exploring the core outcome set of TCM in the treatment of CMVD is conducive to the development of high-quality evidence in the future. Objective To analyze the application of outcomes measures in randomized controlled trials (RCTs) of CMVD treated with TCM, and propose corresponding questions and recommendations. Methods CNKI, SinoMed, VIP, Wanfang, PubMed, Embase and Cochrane Library were systematically searched for RCTs of CMVD treated with TCM from inception to February 09, 2023. The basic information, interventions and outcome measures in RCTs of CMVD treated with TCM were extracted, the Cochrane systematic review manual bias risk assessment tool was used to evaluate the bias risk of the included literature and the Excel software was used to statistically analyze the outcome measures. Results A total of 88 articles were included, involving 2 clinical trial registration protocols and 1 English literature. Cochrane systematic review manual bias risk assessment showed that the included literature were evaluated as unclear in terms of random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessors, and other bias; mostly low risk in terms of outcome data completeness and selective reporting. A total of 18 RCTs were analyzed for TCM syndromes of patients diagnosed with CMVD, involving 6 RCTs related to blood stasis due to qi deficiency, 3 RCTs related to intermingled phlegm and blood stasis. A total of 115 outcome measures were obtained by statistical analysis, the total frequency was 571 times, which can be divided into 7 categories, including clinical efficacy, physicochemical testing, signs and symptoms, TCM syndrome points, quality of life, long-term prognosis, and safety testing. The frequency of total clinical efficacy rate was the highest (46 times), 3 months was the most commonly used intervention node. and the highest frequency of composite outcome measures was the clinical efficacy combined with physicochemical testing. Conclusion It was found that the overall quality of RCTs of TCM in the treatment of CMVD was generally low, and there are some problems in the outcome measures, such as the lack of standardized TCM syndrome diagnosis criteria and efficacy criteria, and the lack of long-term prognosis monitoring. In the future, it is also necessary to conduct high-quality RCTs, combined with the characteristics of TCM treatment, to construct a standardized core outcome set of TCM in the treatment of CMVD.
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