Comparative study of Chinese herbal enema combined with Mesalazine versus Mesalazine alone in the treatment of ulcerative colitis: A randomized controlled trial.

Abstract

Background: Mesalazine is a standard treatment for ulcerative colitis (UC). However, it is unclear whether the efficacy of mesalazine combined with traditional Chinese medicine (TCM) enemas is superior to that of mesalazine alone. Therefore, this study aimed to evaluate the clinical effectiveness of TCM enema hydrotherapy combined with mesalazine for active UC.

Methods: Patients with active UC were randomly assigned to two treatment groups: a combination of mesalazine and TCM enemas and mesalazine alone. Outcome measures included TCM symptom scores, levels of inflammatory markerss [interleukin-8 (IL-8), tumor necrosis factor α (TNF-α), high-sensitivity C-reactive protein (hs-CRP)], colonoscopy scores (Baron score), disease activity indices [Sutherland Disease Activity Index (DAI), modified Mayo score], and recurrence rates.

Results: A total of 80 patients were included in the study. Regarding the primary outcomes, the total effective rate in the combination group was 95%, which was significantly higher than the 75% observed in the mesalazine group (p < 0.05). The recurrence rate was lower in the combined group (2.5%) than in the mesalazine group (17.5%) (p < 0.05). Regarding secondary outcomes, the combination group showed higher reductions in TCM symptom scores than the mesalazine group, particularly in the areas of bloody stool, diarrhea, and abdominal pain (p < 0.05). The combined group also showed significantly lower inflammatory markers (IL-8, TNF-α, hs-CRP) and disease activity scores (Baron score, DAI, modified Mayo score) compared to the mesalazine group (p < 0.05).

Conclusion: The combination of TCM enema hydrotherapy and mesalazine therapy led to significant clinical improvement with lower inflammatory responses and reduced recurrence rates in patients with active UC. The combination treatment may be more effective than mesalazine alone and shows promise as a management option for UC.