BETTER QUALITY OF THERAPY WITH 5-ASA COLONIC FOAM IN ACTIVE ULCERATIVE-COLITIS - A MULTICENTER COMPARATIVE TRIAL WITH 5-ASA ENEMA

We evaluated the efficacy, tolerance, and acceptance of a new 5-ASA co lonic foam versus 5-ASA liquid enema in the short-term treatment of ac tive ulcerative colitis in a three-week prospective, randomized, inves tigator-blind study, enrolling 233 patients from 12 outpatient clinics in Italy. In arm 1 of the study, 117 patients with mild attacks recei ved 2 g of 5-ASA as foam or enema at bedtime. In arm 2, 116 patients w ith moderate attacks were given 4 g of 5-ASA as foam or enema at bedti me. End points were defined as complete relief of symptoms, and endosc opic and histological evidence of remission or improvement. In patient s with mild relapse, 34 of 63 (54%) treated with foam were in clinical remission after only 10 days compared with 17 of 51 (31%) treated wit h enemas (P < 0.05). However, there was no statistically significant d ifference between foam (83%) and enema (74%) after three weeks. In pat ients with moderate relapse, a higher proportion of patients achieved complete clinical remission in the foam group (63%) compared with enem a group (52%) after three weeks (difference 11%, 95% CI-7 to 29). No s ignificant differences were observed in endoscopic and histological ev aluation of colonic mucosa between treatment groups in either arm. 5-A SA foam was well tolerated. No unexpected adverse events were reported Patient evaluation of therapy showed that foam was much better accept ed than enema because foam was. more comfortable, more practical, easi er to retain, and interfered less with daily living. The results of th is study suggest that 5-ASA foam may provide prompter remission of sym ptoms compared to liquid enema and it improves the quality of topical therapy in ulcerative colitis.