The long-term prophylactic effect of salazosulphapyridine (Salazopyrin) in primarily resected patients with Crohn's disease. A controlled double-blind trial
Wenckert, A.; Kristensen, M.; Eklund, A.E.; Barany, F.; Jarnum, S.; Worning, H.; Folkenborg, O.; Holtz, A.; Bonnevie, O.; Riis, P.
Scandinavian Journal of Gastroenterology 13(2): 161-167
1978
ISSN/ISBN: 0036-5521 PMID: 24891 Document Number: 136644
The therapeutic role of salazosulfhapyridine in Crohn's disease (CD) is still disputable. No clearcut answers from controlled trials have yet appeared. Previous reports of 2 preliminary controlled trials in earlier resected and 6 non-operated patients with CD, showed a trend towards effectiveness in non-operated patients. The results of the 3rd part of the Inter-Nordic Cooperative Study on Salazosulfphapyridine (SASP) in CD are presented. The patient group comprised 33 women and 33 men. The design was double-blind with no cross-over and the 1 yr treatment period was prolonged to 18 mo. Relapse-free patients were observed for a total of 24 mo. which made possible an additional calculation of the 2 yr cumulated relapse rate in medically untreated CD (0.39; 95% confidence limits: 0.22-0.56). SASP was given to 32 patients and 34 received placebo. Relapses were defined clinically from a number of data from special control charts. An actuarial analysis showed that the 4 relapses in the SASP group and the 9 in the placebo group after 18 mo. 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 could in fact reduce the relapse rate from for instance, 0.40 to 0.20, compared to placebo (the type II error risk) was .apprx. 0.20. The relapse-prophylactic effect in CD is still unproven. This multicenter-trial supports this presumption and emphasizes the need for large-scale trials.