LONG-TERM THERAPY WITH 5-AMINOSALICYLIC ACID IN CROHNS-DISEASE - IS IT USEFUL - OUR 4 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 diseas e (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 e valuate the efficacy of 5-ASA in maintaining the remission in inactive CDs followed up for 4 years. Sixty-six patients, 41 males, mean age 3 5 +/- 8, having a definitive diagnosis of CD made at least 2 years bef ore, with ileum localization in 39 and ileocolic in 27, entered the st udy when Crohn's disease activity index (CDAI) and a laboratory index (LI) values were lower than 150 and 100 respectively for at least 6 we eks. Subjects with previous surgical treatment or with an endoscopic i ndex severity (CDEIS) more than 4 were excluded, The patients were ran domly divided into two groups: 33 received 5-ASA at 2.4 g/day in a del ayed-release formulation (Eudragit-S-coated Mesaline) while another 33 as a control group received non-specific therapy. CDAI and LI were ev aluated every 6 months, relapse being defined by a CDAI greater than o r equal to 150 and LI greater than or equal to 100. To confirm the cli nical and laboratory diagnosis of relapse, all the patients with CDAI greater than or equal to 150 and LI greater than or equal to 100 under went X-ray and/or endoscopic examination. Statistical analysis was mad e at the end of the study. Drop-outs were 3(1 in group 5-ASA) and no p atient stopped the therapy for side-effects. The overall relapses obse rved were 39/63 (61.9%), of which 17/32 (53.1%) were in the 5-ASA grou p and 22/31 (70.9%) in the control group. No statistically significati ve difference was noted in relapse rates as regards location of CD. Tw o patients (one in group 5-ASA) with iliac disease requested surgical therapy. The patients who remained in remission were 46.8% in the 5-AS A group and 29% in the control group. In conclusion, 5-ASA proved to b e superior to non-specific therapy in the prevention of relapse of CD in remission (relapse rate 53.1% vs 70.9%, therapeutic advantage 17.8% ) even if the numerical difference was not statistically significant.