Efficacy and Safety of Traditional Chinese Medicine Interventions in Unresponsive Mild-to-Moderate Ulcerative Colitis: A Meta-Analysis of Randomized Controlled Trials

ABSTRACT

Background: Treatments for ulcerative colitis (UC), a chronic inflammatory bowel illness, have been investigated using Traditional Chinese Medicine (TCM). Uncertainty surrounds the relative safety and effectiveness of TCM in comparison to more traditional therapies like 5-aminosalicylic acid (5-ASA). Objectives: The purpose of this systematic review and meta-analysis is to assess the safety and effectiveness of TCM therapies in comparison to 5-ASA and placebo in patients with mild-to-moderate UC. Materials and Methods: We conducted a systematically searched China National Knowledge Infrastructure (CHKD- CNKI), Chinese Biomedical Literature Database (CBM), CINAHL, Embase, MEDLINE, PubMed, Cochrane Library, WANFANG, as well as Web of Science from June 2012 to February 2024 for randomized controlled trials assessing TCM interventions against 5-ASA or placebo for UC. Eligible studies included TCM treatments such as Qing-Chang-Hua-Shi, Curcumin-QingDai (CurQD), and Fufangkushen colon-coated capsules (FCC). The Volunteer-Intervention-ComparatorOutcome-Study (VICOS) framework guided our inclusion criteria, and we excluded nonrandomized controls (RCTs) and studies with incomplete data. Data extraction, quality evaluation, and the risk of bias were independently performed by the two researchers, and discrepancies were resolved through discussion. Results: Four studies in all (n = 532) satisfied the requirements for inclusion. According to the meta-analysis, TCM therapies considerably enhanced mucosal healing (RR = 1.52, 95% CI: 1.25–1.85), clinical response (RR = 1.88, 95% CI: 1.54–2.29), and clinical remission (RR = 1.45, 95% CI: 1.21–1.73) when compared to a placebo. There was significant variation in treatment effects among trials, as evidenced by the high heterogeneity (I2 > 70%). Sensitivity analysis supported the robustness of these findings, showing no significant change in the probability of antagonistic events but notable increases in clinical outcomes (RR = 1.02, p = 0.8900). Conclusion: Although there is a lot of variation among trials, TCM therapies seem to be more successful than placebo at improving clinical outcomes in UC. Although more study using standardized methodology is required to validate these effects, the results suggest that TCM may be used as a supplementary therapy for UC.

KEYWORDS

• Traditional Chinese medicines
• ulcerative colitis
• randomized control trials
• clinical remission
• mucosal healing

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• DOI10.1177/09731296241307093Copy

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