Methylprednisolone acetate versus oral prednisolone in moderately active ulcerative colitis.

ABSTRACT

BACKGROUND: Patients with active ulcerative colitis are treated with corticosteroids. We compared the efficacy and safety of intramuscular depot preparation of methylprednisolone acetate with oral prednisolone in the treatment of moderately active ulcerative colitis. DESIGN: Open labeled, randomized, prospective, four-month study. METHODS: 40 patients with moderately active ulcerative colitis (activity index 150-220) were randomized into two groups. Group A (n=21) received methylprednisolone acetate (80 mg intramuscularly once weekly for 6 weeks). Group B (n=19) received oral prednisolone (40 mg/day) in a 'tailing-off' regimen. In addition, patients in both the groups received sulfasalazine. Patients were followed up at 1, 2, 3, 4, 8, 12 and 16 weeks. The primary measure of therapeutic response was activity index. An index of <150 was considered as clinical remission. Secondary efficacy was assessed by subjective evaluation of acceptability of treatment by the patient. RESULTS: After one week of treatment, the decrease in mean activity index was significantly more with oral prednisolone (p<0.05), and five 5 patients (23.8%) in Group A and 12 (63.2%) in Group B were in clinical remission (p<0.05). However, after 2 weeks and beyond, the mean activity index and the number of patients with clinical remission were comparable in the two treatment groups. CONCLUSIONS: Methylprednisolone acetate as a depot preparation and oral prednisolone are equally effective in inducing remission in patients with moderately active ulcerative colitis. Though symptomatic improvement is quicker with oral prednisolone, the remission rate with the two drugs was similar after 2 weeks of treatment.