COMPARATIVE TRIAL OF METHYLPREDNISOLONE AND BUDESONIDE ENEMAS IN ACTIVE DISTAL ULCERATIVE-COLITIS

Objective: To compare the clinical effects of budesonide enema 2 mg/10 0 ml and methylprednisolone hemisuccinate (MP) enema 20 mg/100 ml 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 week s followed by a 4-week open phase with the same budesonide dose in pat ients with partial remission. Patients were assessed at 2, 4 and 8 wee ks. Results: At 4 weeks, 39% of patients on budesonide and 36% on MP w ere considered to be in clinical remission; budesonide was more effect ive in patients with moderate disease at entry (36 versus 29%). On sig moidoscopy, no differences in the porportion of patients with no or on ly 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 budeso nide for a further 4 weeks, 65% achieved symptomatic remission and 47% showed mucosal healing or substantial improvement on endoscopy at 8 w eeks. Plasma cortisol levels fell significantly (P<0.01) after 4 weeks in patients on MP, while only a slight change was observed in those o n 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 adver se experiences were observed. Conclusions: Budesonide enema seems to b e as effective as MP enema in the topical treatment of distal ulcerati ve colitis but unlike conventional steroids, it causes minimal or no a drenal supression.