Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Chronic Kidney Disease
10.13422/j.cnki.syfjx.20251115
- VernacularTitle:中医药干预慢性肾脏病随机对照试验的结局指标现状分析
- Author:
Hairui HAN
1
;
Zushun ZHUO
1
;
Long LIN
1
;
Xiangying LIN
1
;
Wenjuan FENG
1
;
Mingshan LIN
1
;
Ziyao CAI
2
;
Zhaoyang YANG
1
Author Information
1. Traditional Chinese Medicine（TCM） Syndrome Research Base， Fujian University of TCM， Fuzhou 350122，China
2. College of Humanities and Management， Fujian University of TCM， Fuzhou 350122，China
- Publication Type:Journal Article
- Keywords:
chronic kidney disease;
traditional Chinese medicine;
randomized controlled trials;
outcome indicators;
core set of indicators
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(22):216-223
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo systematically collate the randomized controlled trials （RCTs） on the intervention of traditional Chinese medicine （TCM） in chronic kidney disease （CKD） and analyze the characteristics of clinical trials and the current situation of outcome indicators， thus providing references for constructing a core outcome set （COS） for CKD. MethodsThe RCTs on the intervention of TCM in CKD were retrieved from CNKI， Wanfang Data， VIP， SinoMed， PubMed， Cochrane Library， EMbase， and Web of Science with the time interval from January 2022 to December 2024. The risk of bias was evaluated， and the outcome indicators were qualitatively analyzed. ResultsA total of 242 RCTs were included， which reported 238 outcome indicators， with the cumulative frequency of 2 724 times. These outcome indicators can be classified into seven domains： TCM syndromes and diseases （270 times， accounting for 9.90%）， symptoms and signs （218 times， 8.00%）， physical and chemical examinations （1 609 times， 59.07%）， quality of life （29 times， 1.06%）， long-term prognosis （6 times， 0.22%）， economic evaluation （0 times）， and safety events （535 times， 19.64%）. The results demonstrated that the RCTs of TCM intervention for CKD had several shortcomings such as the lack of a basis for sample size estimation， lack of standardization in TCM syndrome differentiation and classification， room for improvement in methodological quality， flaws in the design of the timing of efficacy measurement， absence of long-term prognosis evaluation， imbalance in the selection of surrogate and endpoint indicators， disconnection between overall evaluation and individualized assessment， lack of TCM characteristic indicators， and insufficient reporting of safety indicators. ConclusionAt present， the design of outcome indicators in the RCTs for TCM intervention in CKD is still not standardized. It is recommended that future research endeavors to enhance methodological quality， establish a standardized COS for TCM intervention in CKD， and thereby propel the high-quality development of TCM.
