The clinical trial for the treatment of ulcerative colitis with Bawei xilei san (BWXLS) enema

Objective: Ulcerative colitis (UC) is thought to result from inappropriate and ongoing activation of the mucosal immune system. In China, UC mostly affect left sided colon and topical therapy play a vital role in UC treatment. The trial was carried out to investigate the efficacy and safety of Baweixileisan (BWXLS) enema, a compound of traditional Chinese herbal medicine and to explore the therapeutical mechanisms. Methods: A prospective randomized controlled trial was carried out. Patients with active left‐sided mild to moderate UC from the outpatient clinic of West China Hospital from June, 2009 to October, 2010 were allocated alternatively into treatment group with BWXLS enama 1 g/60 ml and the control group with hydrocortisone enema 50 mg/60 ml for 4 weeks. The clinical, endoscopic and histologic manifestations were evaluated according to the protocols in the end of trial. The expression of TLR4, NF‐κB and Occludin were investigated immunohistochemically before and after the treatment. Results: 103 patients were included. The clinical remission rate and response rate in the treatment group were 78.2% and 89.1% respectively and 58.3% and 72.9% in the control (p < 0.05). Endoscopically, mucosal healing rate was 50.9% in the treatment group and 31.3% in the control (p < 0.05). The histological remission and improvement rate in the treatment goup were 46.2% and 65.5% respectively, but 27.1% and 58.3% in the control (p > 0.05). The rate of adverse events in the reatment and control group was 3.8% and 4.3% (p > 0.05). Comparing with pretreatmeat, the expressions of TLR4 and NF‐κB p65 were significantly decreased (p < 0.01), while the expression of Occludin was significantly increased (p < 0.01). There were no statistical differences of the integrated optical density (IOD) value for the three makers between the two groups (p > 0.05). Conclusion: The BWXLS enema is effective and safe for patients with active mild to moderate UC. The mechinisms of effect might be involved in the inhibition of expression of TLR4 and NF‐κB and upregulation of Occludin to repair the mucosa barrier function.