RANDOMIZED OPEN CLINICAL-TRIAL OF 4-AMINO SALICYLIC ACID (4-ASA) AND 5-AMINOSALICYLIC ACID (5-ASA) ENEMAS IN DISTAL ULCERATIVE-COLITIS

Objectives and methods. - The aim of this multicentre, randomized open trial was to compare the efficacy and tolerance of 4-ASA vs 5-ASA ene mas in the treatment of distal moderately active ulcerative colitis. F ifty patients were randomized to receive enemas in 100 mt suspension o f 4-ASA (2 g, n = 26), or 5-ASA (1 g, n = 24). The subjects filled a d aily questionnaire on enema retention duration, and tolerance. Clinica l and endoscopic evaluations were performed at baseline and after 2 an d 4 weeks. Results. - Significant clinical and endoscopic improvements occurred in both groups. Efficacy and enema retention time did not di ffer between groups. Tolerance was significantly better for 4-ASA: sco re 0.46 +/- 0.77 vs 1.00 +/- 0.73, P = 0.03. Conclusion. - Efficacy of both treatments was equivalent, but 4-ASA enemas were better tolerate d than 5-ASA in this open trial.