Zhang WF, Fan WT, Gao WW, Wu Z, Liu RR, Ruan CW. Crohn’s disease-related perianal fistula: A clinic research. World J Gastrointest Surg 2026; 18(3): 117693 [DOI: 10.4240/wjgs.v18.i3.117693]
Corresponding Author of This Article
Cheng-Wei Ruan, Researcher, Department of Colorectal Surgery, The Affiliated Hospital of Xuzhou Medical University, No. 99 Huaihai West Road, Xuzhou 221004, Jiangsu Province, China. ruancw666@126.com
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Randomized Controlled Trial
Open-Access Policy of This Article
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/
Wei-Feng Zhang, Wei-Wei Gao, Zheng Wu, Ran-Ran Liu, Cheng-Wei Ruan, Department of Colorectal Surgery, The Affiliated Hospital of Xuzhou Medical University, Xuzhou 221004, Jiangsu Province, China
Wen-Ting Fan, Department of Clinical Laboratory, The Affiliated Hospital of Xuzhou Medical University, Xuzhou 221004, Jiangsu Province, China
Author contributions: Ruan CW served as the guarantor of integrity for the entire study; Zhang WF, Wu Z and Fan WT led the manuscript drafting; Zhang WF and Gao WW conducted the literature research; Zhang WF and Gao WW, and Liu RR performed statistical analysis; Zhang WF and Ruan CW completed manuscript editing. All authors have read, approved, and agreed to submit the final version of this manuscript, and ensure that any questions related to the work will be appropriately resolved. All authors contributed to study conception and design, data acquisition, analysis, and interpretation.
Supported by Construction Project of High Level Hospital of Jiangsu Province, No. GSPJS202508.
Institutional review board statement: This study was conducted in accordance with the Declaration of Helsinki and was reviewed and approved by the Institutional Review Board of The Affiliated Hospital of Xuzhou Medical University (approval No. XYFY2020-JS025-01).
Informed consent statement: Written informed consent was obtained from all individual participants and their family members included in the study. Patients were fully informed about the study’s purpose, procedures, potential risks, and benefits, and they participated voluntarily.
Conflict-of-interest statement: The authors declare that they have no competing interests.
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 generated or analyzed during this study are included in this article. Further inquiries can be directed to the corresponding author.
Corresponding author: Cheng-Wei Ruan, Researcher, Department of Colorectal Surgery, The Affiliated Hospital of Xuzhou Medical University, No. 99 Huaihai West Road, Xuzhou 221004, Jiangsu Province, China. ruancw666@126.com
Received: December 26, 2025 Revised: January 19, 2026 Accepted: February 3, 2026 Published online: March 27, 2026 Processing time: 91 Days and 3.9 Hours
Abstract
BACKGROUND
Crohn’s disease-related perianal fistula (PFCD) is a common refractory complication of Crohn’s disease, characterized by a high recurrence rate and impaired wound healing. Biological agents such as adalimumab exhibit limited local therapeutic efficacy and are associated with substantial costs. Traditional Chinese medicine (TCM) internal-external therapy has demonstrated distinct advantages in facilitating wound healing. This study hypothesizes that loose seton drainage combined with oral Mahuang Shengma Decoction and external TCM irrigation-packing can safely improve the therapeutic efficacy in the management of simple PFCD.
AIM
To evaluate the clinical efficacy and safety of loose seton drainage combined with oral Mahuang Shengma Decoction and external TCM (irrigation plus packing) for the treatment of simple PFCD.
METHODS
A total of 60 patients with simple PFCD who were consecutively recruited from the Anorectal Department of The Affiliated Hospital of Xuzhou Medical University between January 2021 and October 2024 were randomly allocated to either the treatment group or the control group, with 30 patients in each group. All patients underwent loose seton drainage. The control group received subcutaneous injections of standard-dose adalimumab postoperatively, while the treatment group received oral Mahuang Shengma Decoction combined with external TCM irrigation (composed of Phellodendri Chinensis Cortex, Sophorae Flavescentis Radix, and other ingredients) and TCM gauze packing in addition to the same treatment as the control group. Wound healing time, recurrence rate, TCM syndrome scores, Perianal Disease Activity Index (PDAI), Crohn’s Disease Activity Index (CDAI), and adverse events (AEs) were evaluated in both groups.
RESULTS
The mean wound healing time in the treatment group was 35.2 ± 4.8 days, which was significantly shorter than that in the control group (42.5 ± 5.6 days) (independent samples t-test: t = 5.832, P < 0.001). Improvements in TCM syndrome scores and reductions in PDAI scores were more pronounced in the treatment group than in the control group (P < 0.05). No statistically significant differences were detected in the recurrence rate (10.0% in the treatment group vs 16.7% in the control group) or improvements in CDAI scores between the two groups (P > 0.05). During treatment, all patients underwent complete blood counts and liver and renal function tests at baseline, week 4, week 12, and the end of treatment. No serious AEs related to the protocol occurred in the treatment group. All liver and renal function parameters [including alanine aminotransferase (ALT), aspartate aminotransferase, serum creatinine (Cr), and estimated glomerular filtration rate] fluctuated within the normal reference range. Specifically, in the treatment group, the mean change from baseline to study end was 3.4 ± 0.5 U/L for ALT and 4.2 ± 1.0 μmol/L for Cr; neither intra-group nor inter-group comparisons reached statistical significance (all P > 0.05).
CONCLUSION
Oral Mahuang Shengma Decoction combined with external TCM therapy is effective for the treatment of simple PFCD, with distinct advantages in facilitating wound healing and alleviating local symptoms. It exhibits a favorable safety profile and can serve as an effective therapeutic option for simple PFCD, thus warranting further clinical adoption and application.
Core Tip: This study is the first to evaluate the efficacy of the comprehensive regimen of seton drainage combined with oral and external Traditional Chinese medicine (TCM) for the treatment of simple Crohn’s disease-related perianal fistula. The results demonstrate that this regimen can significantly shorten wound healing time, improve TCM syndromes and perianal symptoms, and has a favorable safety profile, thereby providing a novel integrated TCM and Western medicine therapeutic strategy for clinical practice.
