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World J Gastroenterol. Mar 21, 2026; 32(11): 117149
Published online Mar 21, 2026. doi: 10.3748/wjg.v32.i11.117149
Published online Mar 21, 2026. doi: 10.3748/wjg.v32.i11.117149
Modified Hu-Lian-Bi-Guan decoction for wound healing in complex anal fistula: A randomized controlled trial
Han-Wen Yang, Ting-Ting Li, Xin-Bo Song, Li-Xia Lai, Qiang Yu, Huang-Fu Ma, Yue Wang, Xue-Cheng Zhang, Xiao-Yu Chen, Jia-Nan Li, Department of Proctology, China-Japan Friendship Hospital, Beijing 100029, China
Shu-Xin Zhang, Department of Proctology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
Co-first authors: Han-Wen Yang and Ting-Ting Li.
Author contributions: All authors contributed significantly to the research and approved the submitted manuscript; the study was conceived and designed by Li JN and Zhang SX; Li TT drafted the manuscript, which was revised and refined by Yang HW and Song XB; Lai LX, Yu Q, and Ma HF analyzed, interpreted, and visualized the data; Wang Y, Zhang XC, and Chen XY accessed and validated the data presented in the manuscript; Li TT and Yang HW contributed equally to this work as first co-authors.
Supported by the National High Level Hospital Clinical Research Funding, No. 2023-NHLHCRF-YYPPLC-ZR-03; and National High Level Hospital Clinical Research Funding, Elite Medical Professionals Initiative of the China-Japan Friendship Hospital, No. ZRJY2025-QM11.
Institutional review board statement: This work received approvals from the Ethics Committee of the China-Japan Friendship Hospital (Approval No. 2023-KY-363).
Clinical trial registration statement: This study is registered at International Traditional Medicine Clinical Trial Registry (itmctr.ccebtcm.org.cn). The registration identification number is ITMCTR2024000714.
Informed consent statement: All participants offered informed written consent before enrollment.
Conflict-of-interest statement: All the authors declare no conflicts of interest.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Data sharing statement: All data produced or construed during the current study are not publicly available due to privacy and ethical concerns but are available from the corresponding author on reasonable request.
Corresponding author: Jia-Nan Li, Department of Proctology, China-Japan Friendship Hospital, No. 2 Yingyuan Garden East Street, Chaoyang District, Beijing 100029, China.
Received: December 2, 2025
Revised: January 3, 2026
Accepted: January 12, 2026
Published online: March 21, 2026
Processing time: 103 Days and 23.4 Hours
Revised: January 3, 2026
Accepted: January 12, 2026
Published online: March 21, 2026
Processing time: 103 Days and 23.4 Hours
Core Tip
Core Tip: This randomized controlled trial evaluates the efficacy of modified Hu-Lian-Bi-Guan decoction (mHLBGD) in enhancing postoperative wound healing for complex anal fistula (AF). The study demonstrates that mHLBGD significantly accelerates healing time and reduces postoperative pain compared to standard care. Mechanistically, the research highlights that mHLBGD promotes tissue repair by modulating inflammatory cytokines, regulating the TGF-β/Smad signaling pathway, and influencing epithelial-mesenchymal transition. These findings provide compelling clinical and molecular evidence supporting mHLBGD as an effective adjunctive therapy for complex AF recovery.