Current Status of Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine for Treating Chronic Atrophic Gastritis
10.13422/j.cnki.syfjx.20231714
- VernacularTitle:中医药治疗慢性萎缩性胃炎随机对照试验结局指标的现状分析
- Author:
Jie ZHANG
1
;
Yaxi SHANG
2
;
Qingrui YANG
1
;
Yuyu LEI
3
;
Huan CHEN
1
;
Cailing LI
1
;
Yu KANG
1
;
Xiaoquan DU
2
Author Information
1. Shaanxi University of Chinese Medicine， Xianyang 712046， China
2. Affiliated Hospital of Shaanxi University of Chinese Medicine， Xianyang 712000， China
3. Qinghai University， Xining 810016， China
- Publication Type:Journal Article
- Keywords:
chronic atrophic gastritis;
traditional Chinese medicine;
randomized controlled trial;
outcome indicators;
core outcome set
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(17):193-202
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveThis paper aims to analyze the current status of outcome indicators in randomized controlled trials （RCT） of traditional Chinese medicine （TCM） for treating chronic atrophic gastritis （CAG）， so as to provide references for constructing the core outcome set （COS） of TCM in the treatment of CAG. MethodChina National Knowledge Infrastructure （CNKI）， Wanfang， VIP， SinoMed， PubMed， Embase， and Cochrane Library databases were searched for RCTs of TCM in the treatment of CAG in the last five years. The risk of bias of included studies was evaluated， and the selection status of outcome indicators was statistically analyzed. ResultA total of 150 RCTs were included， with a sample size of 44-398 cases. 164 outcome indicators were reported， with an application frequency of 1 229 times. The outcome indicators were classified into seven indicator domains according to functional attributes， followed by physical and chemical examination （69.41%）， TCM syndrome （12.69%）， symptoms and signs （11.15%）， safety indicators （5.37%）， quality of life （0.65%）， long-term prognosis （0.65%）， and economic evaluation （0.08%）. According to the statistical analysis， there were problems in the selection of outcome indicators in RCTs of TCM for treating CAG， including various indicators， non-standard name reports， unclear primary and secondary indicators， random combination of subjective and objective indicators， neglected patient report outcome indicators， missing long-term prognosis and economic indicators， insufficient reporting of safety indicators， and inconsistent measurement tools and measurement time points. ConclusionIn the past five years， there have been many problems in the selection of outcome indicators in RCTs of TCM for treating CAG. It is necessary to actively promote the construction of the COS of TCM in the treatment of CAG and promote the high-quality development of clinical research of TCM.
