Yang HW, Li TT, Song XB, Lai LX, Yu Q, Ma HF, Wang Y, Zhang XC, Chen XY, Zhang SX, Li JN. Modified Hu-Lian-Bi-Guan decoction for wound healing in complex anal fistula: A randomized controlled trial. World J Gastroenterol 2026; 32(11): 117149 [DOI: 10.3748/wjg.v32.i11.117149]
Corresponding Author of This Article
Jia-Nan Li, Department of Proctology, China-Japan Friendship Hospital, No. 2 Yingyuan Garden East Street, Chaoyang District, Beijing 100029, China. wuqu3@163.com
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Clinical Trials Study
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This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Mar 21, 2026 (publication date) through Mar 18, 2026
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Journal Information of This Article
Publication Name
World Journal of Gastroenterology
ISSN
1007-9327
Publisher of This Article
Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
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Yang HW, Li TT, Song XB, Lai LX, Yu Q, Ma HF, Wang Y, Zhang XC, Chen XY, Zhang SX, Li JN. Modified Hu-Lian-Bi-Guan decoction for wound healing in complex anal fistula: A randomized controlled trial. World J Gastroenterol 2026; 32(11): 117149 [DOI: 10.3748/wjg.v32.i11.117149]
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. wuqu3@163.com
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
Abstract
BACKGROUND
Complex anal fistulas (AFs) frequently require extensive surgical excision, leading to large, slow-healing wounds that significantly affect the quality of life. Therefore, the optimization of the postoperative wound microenvironment to accelerate healing is an urgent clinical priority.
AIM
To evaluate the clinical efficacy and mechanism of modified Hu-Lian-Bi-Guan decoction (mHLBGD) in promoting postoperative wound healing for complex AF.
METHODS
In this randomized controlled trial, 56 adults with complex AF were randomly assigned (1:1) to receive standard surgical care (control group, n = 28) or standard care with oral mHLBGD (treatment group, n = 28) for 14 days. Clinical outcomes included wound healing rate, Visual Analog Scale, wound exudate, wound edema, and Wexner incontinence scores, and complete healing time. Mechanistically, paired tissue samples were analyzed to assess the expression of inflammatory cytokines, TGF-β/Smad pathway components, and epithelial-mesenchymal transition (EMT) markers.
RESULTS
Baseline characteristics were comparable between the two groups. The mHLBGD group demonstrated a significantly shorter median time to complete wound healing than the control group (32 days vs 50 days; P < 0.001), and achieved higher wound healing rates at all postoperative follow-ups. Postoperative pain, wound exudate, and edema scores were significantly lower in the mHLBGD group (P < 0.001) with no adverse effects on continence. Per histological analysis, mHLBGD treatment significantly diminished inflammatory infiltration, edema, and hemorrhage while enhancing granulation tissue maturation and promoting reparative epithelial proliferation. At the molecular level, mHLBGD treatment significantly downregulated the expression of IL-1β, IL-6, TGF-β, Smad2, N-cadherin, and vimentin, and upregulated E-cadherin by day 14 compared to controls.
CONCLUSION
Oral mHLBGD effectively accelerates postoperative wound healing in complex AF by reducing local inflammation and TGF-β/Smad signaling pathway regulation to inhibit pathological EMT, suggesting its potential for improving recovery post-surgery.
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.
