Objective: The objective of the study was to evaluate the clinical efficacy of oral beclomethasone diproprionate (BDP) in inducing clinical and endoscopic remission in children with mild to moderate active ulcerative colitis (UC).
Patients and methods: Thirty patients with active UC (pancolitis or left-sided colitis) were enrolled in an open-labeled, randomized, head-to-head study. Group 1 (n = 15) received oral BDP (5 mg/day) for 8 weeks, followed by maintenance therapy with oral mesalazine, 5-aminosalycilate (5-ASA); group 2 (n = 15) received oral 5-ASA (80 mg . kg . day). Assessments were carried out (at 4, 8, and 12 weeks) for clinical scores and for endoscopy (at 12 weeks), together with a final clinical assessment after 1 year follow-up.
Results: Patients treated with BDP showed a significant reduced clinical activity within 4 weeks (P < 0.001 vs pretreatment values) with 80% achieving clinical remission compared with 33% treated with only 5-ASA (P < 0.025). A significant reduction in clinical activity was achieved by 5-ASA after 8 weeks. Comparing clinical activity between BDP and 5-ASA, the former did significantly better at 8 (P < 0.003) and at 12 weeks (P < 0.015). In 73% of BDP-treated patients colonoscopy showed remission compared with 27% of 5-ASA (P < 0.025). Both treatments led to better scores compared with pretreatment values (P < 0.001, both). Erythrocyte sedimentation rate was significantly reduced (P < 0.025 or less) with both treatments, whereas C-reactive protein dropped significantly (P < 0.02) only in BDP.
Conclusions: Oral BDP was well tolerated and acts significantly faster and more effectively than 5-ASA in inducing clinical remission and endoscopic improvement in pediatric mild-to-moderate UC.