Olsalazine versus sulfasalazine in the treatment of ulcerative colitis: Randomized controlled Clinical trial

Objective To evaluate the therapeutic effect and safety of olsalazine sodium and sulfasalazine in patients with ulcerative colitis. Methods Patients with ulcerative colitis were randomized to receive either olsalazine sodium, 3 g/d ( n =105), or sulfasalazine, 4 g/d ( n =30), for up to 4 weeks. Results There were 86.0% of the patients treated with olsalazine sodium and 76.7% of the ones with sulfasalazine in the therapeutic effect. Effect rate of diarrhoea, bellyache, hematochezia in the patients treated with olsalazine sodium and sulfasalazine is 85.6%, 91.3%, 92.5% and 84.0%, 90.0%, 68.0%, respectively. The therapeutic effect of olsalazine sodium treated patients was better than one of patients treated with sulfasalazine in hematochezia ( P =0.027). Of the patients treated with olsalazine sodium, 79.4% achieved endoscopic remission, compared with 42.9% of patients treated with sulfasalazine. This difference was significant ( P =0.007). Adverse events were seen in 20.0% diarrhoea of olsalazine sodium treated patients and in 33.3% leucopenia of sulfasalazine treated patients. Five patients treated with olsalazine sodium withdrew from the study because of diarrhoea. Conclusion Olsalazine sodium is effective and safe in treating patients with ulcerative colitis.