Mi Zhou,1 Jieyun Li,1 Xinang Xiao,1 Jiekee Lim,1 Zhaoxia Xu1,2 

1School of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 2Shanghai Key Laboratory of Health Identification and Assessment, Shanghai, People’s Republic of China

Correspondence: Zhaoxia Xu, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Pudong New Area, Shanghai, 201203, People’s Republic of China, Email zhaoxia7001@shutcm.edu.cn

Purpose: To analyse the current status of outcome indicators in randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for the treatment of coronary heart disease (CHD) with deficiency of qi and yin, and to provide a basis for constructing a core indicator set (COS) for TCM treatment of CHD.
Methods: We searched the database of China National Knowledge Infrastructure (CNKI), PubMed,etc. 8 databases in the last 5 years. RCTs of TCM for CHD included in core journals were evaluated for the risk of bias of the included studies, and the current status of the selection of outcome indicators was statistically analysed.
Results: A total of 39 RCTs with a sample size of 44~398 cases were included, and 164 outcome indicators were reported, with a frequency of 383 applications. The outcome indicators were categorised into 6 indicator domains according to their functional attributes, which were, in descending order, safety indicators, physicochemical examination, effective rate, economic assessment, disease evidence score, and quality of life. The top 3 indicators in terms of frequency of application of outcome indicators were safety indicators, physical and chemical examination indicators, and efficiency, among which electrocardiogram, inflammation indicators, and clinical efficacy were the most frequently used; there were many different types of measurement tools for outcome indicators, among which total efficiency and TCM symptom points were the most frequently used; the time point of measurement was not the same.
Conclusion: The RCTs of TCM for CHD in the last 5 years have many shortage in the selection of outcome indicators, and should actively promote the construction of the COS of TCM for CHD.

Keywords: Coronary heart disease, deficiency of qi and yin, TCM, randomised controlled trials, outcome indicators, core indicator set