PROPHYLACTIC MESALAMINE TREATMENT DECREASES POSTOPERATIVE RECURRENCE OF CROHNS-DISEASE

Background & Aims: Recurrence of Crohn's disease frequently occurs aft er surgery. A randomized controlled trial was performed to determine i f mesalamine is effective in decreasing the risk of recurrent Crohn's disease after surgical resection is performed. Methods: One hundred si xty-three patients who underwent a surgical resection and had no evide nce of residual disease were randomized to a treatment group (1.5 g me salamine twice a day) or a placebo control group within 8 weeks of sur gery. The follow-up period was a maximum of 72 months. Results: The sy mptomatic recurrence rate (symptoms plus endoscopic and/or radiologica l confirmation of disease) in the treatment group was 31% (27 of 87) c ompared with 41% (31 of 76) in the control group (P = 0.031). The rela tive risk of developing recurrent disease was 0.628 (90% confidence in terval, 0.40-0.97) for those in the treatment group (P = 0.039; one-ta il test) using an intention-to-treat analysis and 0.532 (90% confidenc e interval, 0.32-0.87) using an efficacy analysis. The endoscopic and radiological rate of recurrence was also significantly decreased with relative risks of 0.654 (90% confidence interval, 0.47-0.91) in the ef fectiveness analysis and 0.635 (90% confidence interval, 0.44-0.91.) i n the efficacy analysis. There was only one serious side effect (pancr eatitis) in subjects in the treatment group. Conclusions: Mesalamine ( 3.0 g/day) is effective in decreasing the risk of recurrence of Crohn' s disease after surgical resection is performed.