Mesalazine sustained-release granules taking once daily or multi-times daily in the treatment of mild to moderate active ulcerative colitis: a randomised controlled clinical trial

Abstract

Objective To investigate the efficacy, safety and compliance of mesalazine sustained-release (SR) granules taking once daily or multi-times daily in the treatment of patients with mild to moderate active ulcerative colitis. Methods Sixty patients with mild to moderate active ulcerative colitis were divided into group A, B and C with 20 patients in each group. Group A received mesalazine SR granules 4 g once daily, Group B with 2 g each time and twice daily, Group C with 1 g each time and four times daily. The total course was eight weeks. The vital signs, Mayo score, compliance and adverse effects of patients were monitored at 0, 4th, 8th weeks.At 0 and 8th weeks, colonoscopy were performed. The parameters of efficacy assessment were clinical complete remission rate, clinical remission rate, efficacy rate, mucosal healing rate, remission time and safety. The F test, t test or Chi-square test was performed for comparison among groups. Results The clinical complete remission rate of group A, B and C was 20%(4/20), 10%(2/20) and 10%(2/20), respectively. The clinical complete remission rate was 70%(14/20), 65%(13/20) and 70%(14/20), respectively. The efficacy rate was 95%(19/20), 85%(17/20) and 90%(18/20), respectively. The mucosal healing rate was 70%(14/20), 60%(12/20) and 50%(10/20), respectively. The side effects rate was 20%(4/20), 15%(3/20) and 20%(4/20). There was no significant difference between groups (all P>0.05). The remission time of group A and B was (15.4±3.7) days and (15.6±2.9) days, which were both shorter than that of group C (18.4±3.6) days, and the differences were statistically significant (t=2.661 and 2.710, both P<0.05). There was no significant difference among three groups in gender, disease course, severity, location and clinical remission rate of sub-groups. Conclusions The efficacy and safety of mesalazine SR granules taking once daily or multi-times daily are similar in the treatment of patients with mild to moderate active ulcerative colitis. Once daily have better compliance than other regimens. Key words: Colitis, ulcerative; Mesalazine sustained-release granules; Once-daily; Efficacy; Safety