Analysis on Outcome Indicators and Measurement Tools in Randomized Controlled Trials of TCM Treatment for Coronary Heart Disease Complicated with Anxiety and Depression
10.19879/j.cnki.1005-5304.202411065
- VernacularTitle:中医药治疗冠心病合并焦虑抑郁随机对照试验结局指标与测量工具分析
- Author:
Zelin QIN
1
;
Wenhui DUAN
;
Jinliang CHEN
;
Haokun CHEN
Author Information
1. 北京中医药大学研究生院,北京 100029;中国中医科学院西苑医院,北京 100091
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine;
coronary heart disease;
anxiety;
depression;
randomized controlled trials;
outcome indicators
- From:
Chinese Journal of Information on Traditional Chinese Medicine
2025;32(11):63-70
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the application of outcome indicators and measurement tools in randomized controlled trials(RCTs)of TCM treatment for coronary heart disease(CHD)complicated with anxiety and depression in recent years;To facilitate the construction of core outcome set in this field.Methods The RCTs of TCM treatment for CHD complicated with anxiety and depression were retrieved from CNKI,Wanfang Data,VIP,CBM,PubMed,Web of Science,Embase,Cochrane Library,and the included RCTs were evaluated for bias risk,data extracted and analyzed.Results A total of 163 articles were included,with 157 outcome indicators categorized into 6 indicator domains according to their functional attributes.The application rates in descending order were symptoms and signs(98.16%),physiological and chemical tests(58.90%),TCM syndromes(48.47%),safety events(44.17%),quality of life(39.88%),and long-term prognosis(9.20%).By analyzing the frequency and distribution of outcome indicators,indicator combinations,measurement time points and tools found that the experimental design and the registration of study protocols were ignored,and the diagnosis and evaluation criteria of anxiety and depression and TCM diagnosis/syndrome differentiation were not standardized.The selection of outcome indicators was characterized by lack of comorbidity between CHD and anxiety and depression,no separation of primary and secondary,excessive number of indicators,irregular composite indicators,inconsistent application of TCM-specific indicators,lack of long-term prognosis,safety indicators and health economics evaluation.Conclusion There are some limitations in the RCT design and outcome indicators in the TCM treatment of CHD complicated with anxiety and depression.It is imperative to establish a core outcome set and standardize trial designs to enhance research quality.
