Meta-Analysis
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jul 26, 2024; 12(21): 4703-4716
Published online Jul 26, 2024. doi: 10.12998/wjcc.v12.i21.4703
Efficacy and safety of Xileisan combined with mesalazine for ulcerative colitis: A meta-analysis and trial sequential analysis
Xin-Yu Yang, Yun-Feng Yu, Ke-Ke Tong, Gang Hu, Rong Yu, Lian-Jun Su
Xin-Yu Yang, Yun-Feng Yu, Ke-Ke Tong, Rong Yu, Lian-Jun Su, School of Traditional Chinese Medicine, Hunan University of Chinese Medicine, Changsha 410208, Hunan Province, China
Gang Hu, The First Hospital of Hunan University of Chinese Medicine, Hunan University of Chinese Medicine, Changsha 410007, Hunan Province, China
Co-first authors: Xin-Yu Yang and Yun-Feng Yu.
Author contributions: Yang XY and Yu YF conceived and designed the study; Yang XY, Yu YF, and Tong KK participated in data processing and data curation; Yang XY, Yu YF, Tong KK, and Hu G wrote the original draft; Yu R and Su LJ supervised the review of the study; Yang XY and Yu YF have made equal contributions to this work as co-first authors for three reasons.
Supported by Discipline Construction Project of Hunan University of Chinese Medicine, No. 22JBZ002.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Lian-Jun Su, Doctor, School of Traditional Chinese Medicine, Hunan University of Chinese Medicine, No. 300 Xueshi Road, Hanpu Science and Education Park, Yuelu District, Changsha 410208, Hunan Province, China. sulianjun@hnucm.edu.cn
Received: April 4, 2024
Revised: May 14, 2024
Accepted: June 7, 2024
Published online: July 26, 2024
Processing time: 86 Days and 19.4 Hours
Abstract
BACKGROUND

The benefits and risks of Xileisan (XLS) in the treatment of ulcerative colitis (UC) remain unclear.

AIM

The present study aimed to evaluate the efficacy and safety of the combination of XLS and mesalazine when treating UC.

METHODS

We searched eight databases for clinical trials evaluating the combination of XLS and mesalazine in the treatment of UC, up to January 2024. Meta-analysis and trial sequential analysis (TSA) were performed using Revman 5.3 and TSA 0.9.5.10 beta, respectively.

RESULTS

The present study included 13 clinical studies involving 990 patients, of which 501 patients received XLS combined with mesalazine while 489 patients received mesalazine alone. The meta-analysis showed that, in terms of efficacy, the combination of XLS and mesalazine significantly improved the clinical efficacy rate by 22% [risk ratio (RR) = 1.22; 95%CI: 1.15–1.28; P < 0.00001] and mucosal improvement rate by 25% (RR = 1.25; 95%CI: 1.12–1.39; P = 0.0001), while significantly reducing the duration of abdominal pain by 2.25 days [mean difference (MD) = -2.25; 95%CI: -3.35 to -1.14; P < 0.0001], diarrhea by 2.06 days (MD = -2.06; 95%CI: -3.92 to -0.20; P = 0.03), hematochezia by 2.32 days (MD = -2.32; 95%CI: -4.02 to -0.62; P = 0.008), tumor necrosis factor alpha by 16.25 ng/mL (MD = -16.25; 95%CI: -20.48 to -12.01; P < 0.00001), and interleukin-6 by 14.14 ng/mL (MD = -14.14; 95%CI: -24.89 to -3.39; P = 0.01). The TSA indicated conclusiveness in the meta-analysis of the efficacy endpoints. In terms of safety, the meta-analysis revealed that the combination of XLS and mesalazine did not increase the occurrence of total and gastrointestinal adverse events, abdominal distension, and erythema (P > 0.05). The TSA showed non conclusive findings in the meta-analysis of the safety endpoints. Harbord’s test showed no publication bias (P = 0.734).

CONCLUSION

Treatment with XLS alleviated the clinical symptoms, intestinal mucosal injury, and inflammatory response in patients with UC, while demonstrating good safety.

Keywords: Xileisan, Mesalazine, Ulcerative colitis, Meta-analysis, Trial sequential analysis

Core Tip: The benefits and potential risks of Xileisan (XLS) in the treatment of ulcerative colitis (UC) remain unclear. The present study aimed to evaluate the efficacy and safety of XLS combined with mesalazine in the treatment of UC through meta-analysis and trial sequential analysis. The meta-analysis showed that XLS alleviated the clinical symptoms, intestinal mucosal injury, and inflammatory response in patients with UC, while demonstrating good safety. XLS, therefore, represents a safe and effective treatment strategy for UC.