COMBINED THERAPY WITH 5-AMINOSALICYLIC ACID TABLETS AND ENEMAS FOR MAINTAINING REMISSION IN ULCERATIVE-COLITIS - A RANDOMIZED DOUBLE-BLIND-STUDY

Objectives: To assess the efficacy of a combination of oral and topica l 5-aminosalicylic acid (5-ASA) for the maintenance treatment of ulcer ative colitis, we undertook a double-blind randomized clinical trial. Methods: Patients aged 18 to 65 yr (with disease extent greater than p roctitis only) were eligible for inclusion in the study if they met th e following criteria: (a) history of two or more relapses in the last gear; (b) achievement of remission in the last 3 months (with maintena nce of remission for at least 1 month). Patients enrolled in the study were randomly assigned to one of the two following l-yr treatments: ( 1) combined therapy with 5-ASA tablets 1.6 g/day and 5-ASA enemas 3 g/ 100 ml twice weekly; (2) oral therapy with 5-ASA tablets 1.6 g/day and placebo enemas/twice weekly. The main end point of the study was the maintenance of remission at 12 months. Results: Upon completion of the study, relapse occurred in 13 of 33 patients in the combined treatmen t group versus 23 of 36 patients in the oral treatment group (39 vs 69 %; p = 0.036). No significant side effects related to treatment were o bserved in either group. A simplified pharmacoeconomic analysis shows that this form of combined treatment can have a favorable cost-effecti veness ratio. Conclusions: Our results indicate that 5-ASA given daily by oral route and intermittently by topical route can be more effecti ve than oral therapy alone. This form of combination treatment can be appropriate for patients at high risk of relapse.