COMPARISON BETWEEN HIGH-DOSE 5-AMINOSALICYLIC ACID AND 6-METHYLPREDNISOLONE IN ACTIVE CROHNS ILEOCOLITIS - A MULTICENTER RANDOMIZED DOUBLE-BLIND-STUDY

GROSS, V and ANDUS, T and FISCHBACH, W and WEBER, A and GIEREND, M and HARTMANN, F and SCHOLMERICH, J (1995) COMPARISON BETWEEN HIGH-DOSE 5-AMINOSALICYLIC ACID AND 6-METHYLPREDNISOLONE IN ACTIVE CROHNS ILEOCOLITIS - A MULTICENTER RANDOMIZED DOUBLE-BLIND-STUDY. ZEITSCHRIFT FUR GASTROENTEROLOGIE, 33 (10). pp. 581-584. ISSN 0044-2771,

Full text not available from this repository.

Abstract

Background: The value of 5-aminosalicylic acid (5-ASA) in Crohn's disease (CD) is still under discussion. In a previous study 2 g 5-ASA per day were inferior to a standard glucocorticoid treatment with 6-methylprednisolone (6-MPred) (Can J Gastroenterol 1990; 4: 446-51). In the present study we tested whether in active CD response rates to 4.5 g 5-ASA/day were not different from those to 6-MPred. Methods: Multicenter randomized double-blind double-dummy trial. 34 patients with active CD (CDAI > 150) were included. 17 patients were in the 5-ASA group (Salofalk(R), 4.5 g/day), 17 patients in the 6-MPred group (Urbason(R), initial dose 48 mg/day, weekly tapering). Duration of treatment was 8 weeks. Main outcome measure was remission of CD (CDAI < 150) and decrease of at least 60 points. Results: Both groups were comparable with respect to demographic and clinical parameters. The median CDAI decrease in the 5-ASA group was 85, in the 6-MPred group 122 (p = 0.7437). The median AUC of the CDAI in the 5-ASA group was 1027, in the 6-MPred group 950 (p = 0.137). The median AUC of the CDAI per treatment day was 22.94 in the 5-ASA group, and 17.33 in the 6-MPred group (p = 0.0555). On an intention-to-treat basis remission rates after 8 weeks were 40.0% in the 5-ASA group and 56.3% in the 6-MPred group (p = 0.5867). Conclusions: Response rates to 5-ASA or 6-MPred were not significantly different although there was a trend towards a higher efficacy of 6-MPred. 5-ASA may be considered as alternative treatment in patients with activer CD who are intolerant to or refuse glucocorticoids.

Item Type: Article
Uncontrolled Keywords: MESALAMINE CAPSULES; DRUG-TREATMENT; DISEASE; MANAGEMENT; CROHNS DISEASE; GLUCOCORTICOIDS; 5-AMINOSALICYLIC ACID
Depositing User: Dr. Gernot Deinzer
Last Modified: 19 Oct 2022 08:37
URI: https://pred.uni-regensburg.de/id/eprint/52308

Actions (login required)

View Item View Item