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Background-The relapse rate after steroid induced remission in Crohn's disease is high. Aims-To test whether oral pH modified release budesonide (3 × 1 mg/day) reduces the relapse rate and to identify patient subgroups with an increased risk of relapse. Methods-In a multicentre, randomised, double blind study, 179 patients with steroid induced remission of Crohn's disease received either 3 × 1 mg budesonide (n=84) or placebo (n=95) for one year. The primary study aim was the maintenance of remission of Crohn's disease for one year. Results-Patient characteristics at study entry were similar for both groups. The relapse rate was 67% (56/84) in the budesonide group and 65% (62/95) in the placebo group. The relapse curves in both groups were similar. The mean time to relapse was 93.5 days in the budesonide group and 67.0 days in the placebo group. No prognostic factors allowing prediction of an increased risk for relapse or definition of patient subgroups who derived benefit from low dose budesonide were found. Drug related side eVects were mild and no diVerent between the budesonide and the placebo group. Conclusion-Oral pH modified release budesonide at a dose of 3 × 1 mg/day is not eVective for maintaining steroid induced remission in Crohn's disease. (Gut 1998;42:493-496)

Recurrence rate is high after operation for Crohn’s disease. A multicenter trial was performed to study the effect of radical or nonradical operation and of sulfasalazine prophylaxis versus placebo on postoperative recurrence rate in 232 patients with Crohn’s disease. Sixteen medical and surgical centers participated in the study, 7 operating radically and 9 nonradically. The follow-up period lasted 3 years, the allocation to drug treatment was randomized and double blind. Recurrence was significantly less frequent and occurred later in patients who were operated nonradically. Patients on sulfasalazine prophylaxis had a better prognosis than on placebo. This effect was statistically significant in the first 2 years of treatment. Both strategies were additive: nonradical operation and sulfasalazine had the best prognosis, radical operation and placebo was worst. It is concluded that postoperative recurrence is best prevented by resecting nonradically and prescribing 3 g of sulfasalazine daily at least over 2 years.