ORAL MESALAZINE (5-AMINOSALICYLIC ACID - ASACOL) FOR THE PREVENTION OF POSTOPERATIVE RECURRENCE OF CROHNS-DISEASE

Methods: A multicentre randomized controlled trial was conducted to ev aluate the efficacy of oral mesalazine (5-aminosalicylic acid) for the prevention of post-operative recurrence in 110 patients operated on f or Crohn's disease by first intestinal resection. Patients were random ly allocated to receive 2.4 g/day of mesalazine, or no treatment at al l. The protocol included colonoscopy with ileoscopy at 6 months and ye arly thereafter. Recurrence was defined on the basis of endoscopic cri teria and classified as mild or severe. Results: The demographic and p re-trial characteristics were very similar in the two groups of patien ts. The cumulative proportion of recurrence at 6, 12 and 24 months was significantly lower in the mesalazine group than in untreated group ( P = 0.002). At 24 months the cumulative proportions of endoscopic recu rrence were 0.52 +/- 0.12 (+/- S.E.M.) and 0.85 (+/- 0.07), respective ly. At the same time the cumulative proportions of symptomatic recurre nce were 0.18 +/- 0.09 and 0.41 +/- 0.09 (P = 0.006). The cumulative p roportions of the severe recurrence was also significantly lower in th e mesalazine group (0.17 +/- 0.09 vs. 0.38 +/- 0.09; P = 0.021). Concl usions: The preliminary results of this study show that administration of oral mesalazine soon after surgery is effective in preventing post -operative endoscopic recurrence in Crohn's disease over a 2-year peri od. It is estimated that this treatment prevents 39% of all recurrence s and 55% of the severe recurrences.