Comparison of budesonide and 5‐aminosalicylic acid enemas in active distal ulcerative colitis

SUMMARY Background: Budesonide is a new corticosteroid with high topical anti‐inflammatory activity but little systemic effect. The aim of the present 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. Methods: Ninety‐seven patients were studied in a multicentre single‐blind randomized group‐comparative trial. The primary efficacy variables were 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: Budesonide and 5‐ASA enemas both resulted in a significant improvement in endoscopy and histopathology scores but no difference could be demonstrated between the two treatment groups. There was also a significant improvement of symptoms (number of bowel movements per day, quality of stools, presence of blood and mucus, and state of well‐being) within both groups but no difference between the two treatment groups. The clinical 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 in either of the groups. Conclusions: Budesonide enema 2 mg/100 mL appears to be as efficient and well‐tolerated as 5‐ASA enema in the treatment of active distal ulcerative colitis and proctitis.