- 2025-06-19
- Journal of the Chinese Medical Association : JCMA 89(1)
- Jiao Zhang
- Bin Shi
- Da Li
- Yan Du
- Shujiang Gu
- Haiying Yao
- Dongxuan Zhang
- Yuan Tao
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 80
- Population
- 80 patients with active ulcerative colitis
- Methods
- Randomly assigned to two treatment groups: a combination of mesalazine and TCM enemas and mesalazine alone
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. Primary outcome measures included clinical effective and recurrence rate. Secondary outcomes included TCM symptom scores, levels of inflammatory markers (interleukin-8 [IL-8], tumor necrosis factor α [TNF-α], high-sensitivity C-reactive protein [hs-CRP]), colonoscopy scores (Baron score), and disease activity indices (Sutherland Disease Activity Index [DAI], modified Mayo score).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 = 0.012). The recurrence rate was lower in the combined group (2.5%) than in the mesalazine group (17.5%), but this difference did not reach statistical significance ( p = 0.062). Regarding secondary outcomes, the combination group showed higher reductions in TCM symptom scores than the mesalazine group, particularly in the areas of bloody stool ( p < 0.001), diarrhea ( p < 0.001), and abdominal pain ( p = 0.044). The combination group also showed significantly lower inflammatory markers (IL-8, TNF-α, hs-CRP) and disease activity scores (Baron score, DAI, modified Mayo score) compared with the mesalazine group ( p < 0.05).Conclusion
The combination treatment may be more effective than mesalazine. The combination of TCM enema and mesalazine led to significant clinical improvement with lower inflammatory responses and reduced recurrence rates in patients with active UC.