Evidence Evaluation of Commonly Used Chinese Patent Medicines for Ulcerative Colitis Based on GRADE System and iEC-Eff Method
10.13422/j.cnki.syfjx.20251416
- VernacularTitle:基于GRADE系统和iEC-Eff法的常用中成药治疗溃疡性结肠炎证据评价
- Author:
Xuming HUANG
1
;
Na WU
2
;
Jiaqi CHEN
1
;
Xiaojun YAN
1
Author Information
1. Graduate School， Jiangxi University of Chinese Medicine， Nanchang 330004，China
2. Affiliated Hospital of Jiangxi University of Chinese Medicine， Nanchang 330006，China
- Publication Type:Journal Article
- Keywords:
Chinese patent medicines;
ulcerative colitis;
Grading of recommendations， assessment， development， and evaluation （GRADE） system;
integrated evidence chain-based effectiveness evaluation of traditional Chinese medicine （iEC-Eff） method;
evidence-based medicine
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(23):204-218
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveIn response to the policy promoting the "three-combination" evidence framework for the regulatory review of traditional Chinese medicine （TCM）， this study aimed to evaluate the efficacy evidence of commonly used Chinese patent medicines for ulcerative colitis （UC） by applying the Integrated Evidence Chain-Based Effectiveness Evaluation of Traditional Chinese Medicine （iEC-Eff） method and the Grading of Recommendations， Assessment， Development and Evaluation （GRADE） system in parallel， compare their grading results and assessment characteristics， and explore the applicability of the iEC-Eff method. MethodsUC-related guidelines and consensus statements were systematically retrieved， and commonly used Chinese patent medicines were selected using a modified formula based on Zipf's law. Evidence from clinical experience， experimental research， and clinical trials was retrieved separately. The iEC-Eff method and GRADE system were applied in parallel to assess evidence quality. The two methods were compared in terms of evidence sources， grading criteria， and grade assignments. The historical origins， composition， and related pharmacological studies of the medicines were also examined. ResultsSix guidelines and seven consensus statements were included， and five commonly used Chinese patent medicines were identified. Under the GRADE system， the evidence for Xilei powder， Kangfuxin liquid， Shenling Baizhu preparations， and Hudi Enteric-Coated Capsules was rated as grade C， indicating low-certainty evidence. Bupi Yichang Wan was not graded due to the lack of high-quality randomized controlled trials （RCTs）. Under the iEC-Eff method， Xilei powder （AAB）， Kangfuxin liquid （AAB）， and Shenling Baizhu preparations （A⁺A⁺⁺B） were classified as having high-level evidence， while Hudi Enteric-Coated Capsules （CC⁺A⁺） was classified as having moderate-level evidence. Bupi Yichang Wan remained ungraded because of an incomplete evidence chain. The two methods yielded different grading results and showed some complementarity in evidence sources and assessment dimensions. ConclusionThe parallel application of the iEC-Eff method and GRADE system may help present the available evidence for Chinese patent medicines in the treatment of UC from two perspectives： integration of evidence from multiple sources and assessment of evidence certainty. This approach may provide a reference for efficacy evidence evaluation and clinical use of Chinese patent medicines. The iEC-Eff method shows potential for the separate appraisal and integrated grading of evidence from clinical experience， experimental research， and clinical trials. However， its evaluation criteria and applicability require further validation and refinement.
