Long-term therapy with 5-aminosalicylic acid in Crohn's disease: is it useful? Our four years experience

At present it is not clear if long-term therapy with 5-aminosalicylic acid (5-ASA) is useful in the prevention of relapses of Crohn's disease (CD) in remission. Long-lasting randomized studies are necessary to gauge the efficacy of a long-term therapy, but actually the trials are rarely longer than 12 months. The aim of our study was therefore to evaluate the efficacy of 5-ASA in maintaining the remission in inactive CDs followed up for 4 years. Sixty-six patients, 41 males, mean age 35 +/- 8, having a definitive diagnosis of CD made at least 2 years before, with ileum localization in 39 and ileocolic in 27, entered the study when Crohn's disease activity index (CDAI) and a laboratory index (LI) values were lower than 150 and 100 respectively for at least 6 weeks. Subjects with previous surgical treatment or with an endoscopic index severity (CDEIS) more than 4 were excluded. The patients were randomly divided into two groups: 33 received 5-ASA at 2.4 g/day in a delayed-release formulation (Eudragit-S-coated Mesaline) while another 33 as a control group received non-specific therapy. CDAI and LI were evaluated every 6 months, relapse being defined by a CDAI > or = 150 and LI > or = 100. To confirm the clinical and laboratory diagnosis of relapse, all the patients with CDAI > or = 150 and LI > or = 100 underwent X-ray and/or endoscopic examination. Statistical analysis was made at the end of the study.(ABSTRACT TRUNCATED AT 250 WORDS)