Study on the efficacy evaluation criteria of randomized controlled trials of TCM in the treatment for edema
10.3760/cma.j.cn115398-20220622-00290
- VernacularTitle:中医治疗水肿随机对照试验的疗效评价标准研究
- Author:
Xinxin MAO
1
;
Qingqiao SONG
;
Huaqin WU
;
Shuqing SHI
;
Yumeng LI
;
Xia XU
;
Jiayu LYU
;
Yajiao WANG
;
Haoran ZHENG
;
Bingxuan ZHANG
Author Information
1. 中国中医科学院广安门医院2021级硕士研究生，北京 100053
- Keywords:
Edema;
Traditional Chinese Medicine;
Efficacy evaluation standards;
Literature researches
- From:
International Journal of Traditional Chinese Medicine
2023;45(9):1157-1161
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the efficacy evaluation criteria of the existing TCM treatment for edema RCT research, and to provide reference for the construction of unified standards.Methods:The batabases CNKI, WanFang Data, VIP, CBM, Pubmed and Web of Science were retrieved. The randomized controlled trials for the treatment of edema of TCM research, from September 1, 1993 to July 31, 2022, were screened and included. The content of efficacy evaluation, performed statistics on evaluation standard, the curative effect evaluation indexes, as well as standard composition, usage were extracted. We analyzed the characteristics, application and problems of the existing efficacy evaluation criterion.Results:A total of 123 Chinese articles were included. The included literature involved nephrogenic edema, cardiogenic edema, idiopathic edema, apoplexy limb edema and other edema. In recent years, randomized controlled trials on the treatment of edema by TCM have mainly used four efficacy evaluation criteria. Of which the Guidelines for Clinical Research on New Chinese Medicines (Trial) in 2002 had the highest utilization rate of 29.27%. Secondly, the utilization rate of Standard for Diagnosis and Curative Effect of TCM Diseases and Syndromes was 21.14%. The rest of the criteria were used by less than 6%. While 39.02% of the literature did not use the standards or used self-designed standards. Among the composition of efficacy evaluation indices, the application rate of TCM syndrome or symptom efficacy index was the highest (91.87%), the utilization rate of the Minnesota Living with Heart Failure Questionnaire Indicators was only 4.88%; biochemical tests accounted for a large proportion of Western medical indicators, while the measurement of edema severity was rarely applied. Conclusions:At present, the evaluation criteria of edema curative effect are diversified and insufficiently popularized, which need to be further screened and improved. It is suggested to construct a TCM edema efficacy evaluation model based on the characteristics of edema syndrome, comprehensively evaluate the efficacy from multiple dimensions such as TCM syndromes, western medicine indicators, and quality of life, and improve the scientific indicators.
