Mesalazine versus sulfasalazine in treatment of ulcerative colitis:a randomized controlled clinical trial

Objective To evaluate the therapeutic effect and safety of mesalazine sodium and sulfasalazine in treatment of patients with ulcerative colitis.Methods Patients with ulcerative colitis were randomly selected to receive either mesalazine sodium,3 g/d(trial group,n=105),or sulfasalazine,4 g/d(control group,n=30),for up to 4 weeks.Results The therapeutic effects of patients in trial group and control group were 86.0% and 76.7% respectively.Effective rates of improvement in diarrhoea,bellyache,hematochezia in patients of trial group and control group were 85.6%,91.3%,92.5% and 84.0%,90.0%,68.0% respectively.The therapeutic effect of improvement in hematochezia in mesalazine sodium-treated patients was better than that of patients treated with sulfasalazine(P=0.027).Among patients treated with mesalazine sodium,79.4% of them achieved endoscopic remission in comparison with 42.9% of patients treated with sulfasalazine.This difference was significant(P=0.007).Among adverse reactions,diarrhoea was seen in 20.0% of patients in trial group and leucopenia was frequently seen in 33.3%of patients in control group.Five patients in trial group withdrew from the study due to deterioration of diarrhoea.Conclusion Mesalazine sodium is effective and safe in treatment of patients with ulcerative colitis.