Analysis on Current Status of Outcome Indicators in Randomized Controlled Trials of TCM Intervention in Pediatric Myocarditis
10.19879/j.cnki.1005-5304.202411646
- VernacularTitle:中医药干预儿童心肌炎随机对照试验的结局指标现状分析
- Author:
Fengye JI
1
;
Zhongyi ZHU
;
Ling WANG
;
Sihui SU
;
Zhaoxin ZHOU
;
Xiaoxuan XIE
;
Yan YANG
Author Information
1. 北京中医药大学东直门医院,北京 100700
- Publication Type:Journal Article
- Keywords:
pediatric myocarditis;
TCM;
randomized controlled trial;
outcome indicators;
core indicator set
- From:
Chinese Journal of Information on Traditional Chinese Medicine
2025;32(8):31-37
- CountryChina
- Language:Chinese
-
Abstract:
Objective To summarize the current status of outcome indicators in randomized controlled trials of TCM intervention in pediatric myocarditis,to explore the existing problems,and to provide a reference for the construction of a core set of indicators for the treatment of pediatric myocarditis with TCM.Methods Randomized controlled trial literature on the treatment of pediatric myocarditis with TCM was retrieved from CNKI,Wanfang Data,VIP,SinoMed,PubMed,Embase,Cochrane Library and Web of Science from the establishment of the databases to 16th,Nov.2024.The basic characteristics,diagnostic criteria,TCM evidence,interventions and outcome indicators of the studies were extracted.The risk of bias was assessed for the selected studies using the Cochrane Collaboration's risk of bias tool(RoB 2.0),and the outcome indicators were statistically analyzed using Excel 2019.Results Finally,totally of 250 articles were included in the literature.The outcome indicators were counted to obtain 187 outcome indicators with a cumulative total of 1 540 occurrences,which were categorized into six indicator domains:symptoms and signs,physicochemical testing,TCM symptoms/signs,clinical efficacy evaluation,safety evaluation and quality of life evaluation;among them,the physicochemical testing indicators(112 types,926 times)had the highest frequency of occurrences,followed by the clinical efficacy evaluation(13 types.340 times),and safety evaluation(24 types,193 times).Conclusion The overall quality of randomized controlled trials of TCM treatment of pediatric myocarditis is low,and there are problems with primary and secondary differentiation of outcome indicators and lack of TCM characteristics.There is an urgent need to improve the core set of endpoint indicators that highlight the characteristics of TCM in order to improve the quality of clinical research.
