Abstract
BACKGROUND: To systematically evaluate the clinical efficacy and safety of a Gegen Qinlian decoction combined with mesalazine for the treatment of ulcerative colitis (UC). METHODS: Chinese (CNKI, CSPD, CCD, and CBM) and foreign databases (PubMed, Web of Science, Cochrane Library, and Embase) were searched for randomized controlled trials related to the treatment regimen used in this study. The risk of bias of the included studies was evaluated using the Cochrane assessment tool. Revman5.0 and Stata17.0 were used for the meta-analysis and sensitivity analysis. Trial sequential analysis was used for sequential analysis. Gradepro3.6 was used to evaluate the level of evidence quality of outcome indicators. RESULTS: Fifteen studies involving 1428 patients were included. The results of meta-analysis showed that the intervention group in the treatment of UC improved the total clinical effective rate (P < .001, relative risk = 1.22, 95% confidence interval (CI) [1.16-1.28]), the main clinical symptoms (P < .001, standard mean difference [SMD] = 1.58, 95% CI [1.86, 1.30]), intestinal mucosal barrier function (P < .001, SMD = 1.02, 95% CI [1.20, 0.84]), reduce the incidence of adverse reactions (P = .05, relative risk = 0.59, 95% CI [0.35, 1.00]), modified Mayo score (P < .001, SMD = 1.53, 95% CI [2.17, 0.89]), Baron endoscopic score (P < .001, SMD = 0.93, 95 CI [1.18, 0.68]), regulate immune function (P < .001, SMD = 0.69, 95% CI [0.47, 0.90]), inflammatory factor levels (P < .001, SMD = 0.69, 95% CI [0.47, 0.90]), intestinal flora (P = .004, SMD = 1.42, 95% CI [0.44, 2.39]), the intervention group were better than the comparison group. But there was no significant difference in oxidative stress index (P = .54, SMD = -0.44, 95% CI [-1.82, 0.95]). CONCLUSION: Gegen Qinlian decoction combined with mesalazine has definite clinical efficacy and safety for the treatment of UC. Owing to the limited methodological quality of the included studies, high-quality randomized controlled trials are still needed for verification in the future.