COMPARISON OF BUDESONIDE AND 5-AMINOSALICYLIC ACID ENEMAS IN ACTIVE DISTAL ULCERATIVE-COLITIS

Background: Budesonide is a new corticosteroid with high topical anti- inflammatory activity but little systemic effect. The aim of the prese nt study was to compare the efficacy and safety of budesonide enema (2 mg/100 mL) and 5-ASA enema (mesalazine 1 g/100 mL) given for 4 weeks in the treatment of active distal ulcerative colitis and proctitis. Me thods: Ninety-seven patients were studied in a multicentre single-blin d randomized group-comparative trial. The primary efficacy variables w ere endoscopy and histopathology scores obtained at 0, 2 and 4 weeks. Clinical symptoms were the secondary efficacy variables. Haematology, chemistry and adverse events were the safety variables. Results: Budes onide and 5-ASA enemas both resulted in a significant improvement in e ndoscopy and histopathology scores but no difference could be demonstr ated between the two treatment groups. There was also a significant im provement of symptoms (number of bowel movements per day, quality of s tools, presence of blood and mucus, and state of well-being) within bo th groups but no difference between the two treatment groups. The clin ical remission rate at 4 weeks was, however, 38% for patients treated with budesonide enema but 60% for those treated with 5-ASA enema (P = 0.03). No adverse events attributed to the study drugs were recorded i n either of the groups. Conclusions: Budesonide enema 2 mg/100 mL appe ars to be as efficient and well-tolerated as 5-ASA enema in the treatm ent of active distal ulcerative colitis and proctitis.