Comparative trial of methylprednisolone and budesonide enemas in active distal ulcerative colitis

Abstract

Objective To compare the clinical effects of budesonide enema 2mg/100ml and methylprednisolone hemisuccinate (MP) enema 20mg/100ml once daily in active distal ulcerative colitis. Design Patients with mild or moderate distal ulcerative colitis (n = 88), which did not extend beyond the splenic flexure, were enrolled in a multicentre randomized investigator blind study comprising a blind treatment period of 4 weeks followed by a 4-week open phase with the same budesonide dose in patients with partial remission. Patients were assessed at 2, 4 and 8 weeks. Results At 4 weeks, 39% of patients on budesonide and 36% on MP were considered to be in clinical remission; budesonide was more effective in patients with moderate disease at entry (36 versus 29%). On sigmoidoscopy, no differences in the porportion of patients with no or only mild signs of mucosal inflammation were observed between budesonide and MP (43 versus 46%, respectively). No significant differences were observed in the histology scores. Of the 37 patients receiving budesonide for a further 4 weeks, 65% achieved symptomatic remission and 47% showed mucosal healing or substantial improvement on endoscopy at 8 weeks. Plasma cortisol levels fell significantly (P < 0.01) after 4 weeks in patients on MP, while only a slight change was observed in those on budesonide. After 8 weeks, plasma cortisol levels were unchanged in patients continuing on budesonide whereas in those switched from MP to budesonide, they approached the baseline value. No drug-related adverse experiences were observed. Conclusions Budesonide enema seems to be as effective as MP enema in the topical treatment of distal ulcerative colitis but unlike conventional steroids, it causes minimal or no adrenal supression.