BECLOMETHASONE DIPROPIONATE ENEMAS VERSUS PREDNISOLONE SODIUM-PHOSPHATE ENEMAS IN THE TREATMENT OF DISTAL ULCERATIVE-COLITIS

Aim: To compare beclomethasone dipropionate 3 mg/60 mL enema (BDP) and prednisolone sodium phosphate 30 mg/60mL enema (PP) once daily in pat ients with active distal ulcerative colitis. Methods: One hundred and fifty-seven patients were enrolled in a multicentre, 4-week, randomize d, double-blind trial. Patients were assessed at baseline, 2 and 4 wee ks. Results: Both treatment groups showed statistically significant im provement of clinical activity after 2 and 4 weeks, Endoscopy and biop sy showed a reduction in the activity score at the end of the treatmen t period in both groups. No statistically significant difference was o bserved between the two treatment groups. After 4 weeks, 29% of patien ts in the EDP group and 25% in the PP group were considered to be in c linical remission; an improvement was observed in 40% of patients on B DP and in 47% on PP, Mean morning plasma cortisol levels showed a slig ht but significant reduction in the PP group, while the ACTH test show ed that neither drug interfered with the hypothalamic-pituitary-adrena l (HPA) axis function. No significant changes were observed in the lab oratory tests. Finally, there was a low incidence of adverse events in both groups. Conclusions: It is concluded that, in the topical treatm ent of active distal ulcerative colitis, BDP 3 mg enemas are as effica cious as PP 30 mg enemas, without interference with the HPA axis.