Published online Jul 26, 2024. doi: 10.12998/wjcc.v12.i21.4703
Revised: May 14, 2024
Accepted: June 7, 2024
Published online: July 26, 2024
Processing time: 86 Days and 19.4 Hours
The benefits and risks of Xileisan (XLS) in the treatment of ulcerative colitis (UC) remain unclear.
The present study aimed to evaluate the efficacy and safety of the combination of XLS and mesalazine when treating UC.
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.
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).
Treatment with XLS alleviated the clinical symptoms, intestinal mucosal injury, and inflammatory response in patients with UC, while demonstrating good safety.
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.