The Long-term Prophylactic Effect of Salazosulfapyridine (SalazopyrinR) in Primarily Resected Patients with Crohn's Disease

Abstract

The therapeutic role of salazosulphapyridine in Crohn's disease (CD) is still disputable. No clearcut answers from controlled trials have yet appeared. We have previously reported the results of two preliminary controlled trials in earlier resected and in non-operated patients with CD, showing a trend towards effectiveness in non-operated patients. In this report we present the results of the third part of the Inter-Nordic Cooperative Study on Salazosulphapyridine (SASP) in CD. The patient group comprised 33 women and 33 men. The design was double-blind with no cross-over, and the treatment period one year, later prolonged to 18 months. Relapse-free patients were observed for a total of 24 months. In this way the trial made possible an additional calculation of the 2-year cumulated relapse rate in medically untreated CD (0.39; 95% confidence limits: 0.22-0.56). 32 patients received SASP and 34 placebo. Relapses were defined clinically from a number of data from special control charts. By aid of an actuarial analysis the 4 relapses in the SASP group and the 9 in the placebo group after 18 months corresponded to cumulative relapse rates of 0.13 (SASP) with 95% confidence limits: 0.01-0.25, and 0.45 (placebo) with 95% confidence limits: 0.21-0.70, 0.10 < p < 0.15 (one-sided test). The risk of overlooking that SASP in fact could reduce the relapse rate from for instance 0.40 to 0.20, compared to placebo (the type II error risk) was approx. 0.20. In conclusion: The relapse-prophylactic effect in CD is still unproven. The present multicentre-trial supports this presumption and emphasizes the need for large-scale trials.