5-aminosalicylic acid in the treatment of crohn's disease: A 16-week double-blind, placebo-controlled, multicentre study with pentasa®

S. N. Rasmussen, K. Lauritsen, U. Tage-Jensen, O. H. Nielsen, P. Bytzer, O. Jacobsen, K. Ladefoged, M. Vilien, V. Binder, J. Rask-Madsen, S. Bondesen, S. Honore Hansen, E. F. Hvidberg*

*Corresponding author af dette arbejde

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    Abstrakt

    The response to 5-aminosalicylic acid (5-ASA) in mild and moderately active Crohn's disease localized in the small bowel was studied in a randomized, double-blind, placebo-controlled trial in four centres. Sixty-seven patients were included, of whom 30 were treated with 1500 mg slow-release 5-ASA/day (Pentasa® for a scheduled period of 16 weeks. In the 5-ASA group 40% of the patients improved, versus 30% of the placebo-treated group ('intent to treat' basis; p > 0.1). Four of the patients treated with 5-ASA left the study owing to disease deterioration, versus 10 of the placebo-treated patients (p>0.2). Seventeen patients were secondarily excluded, and the remaining 50 patients (23 receiving 5-ASA) were reevaluated in greater detail. No statistically significant differences in outcome were shown. Three patients (one given 5-ASA) were withdrawn from the study because of presumed side effects, but no serious adverse reactions were recorded. The present results indicate that 5-ASA, at least in the dosage used, is not superior to placebo. Nevertheless, trends towards a beneficial effect in Crohn's disease in the small bowel justify further clinical trials with a larger dosage of 5-ASA.

    OriginalsprogEngelsk
    Sider (fra-til)877-883
    Antal sider7
    TidsskriftScandinavian journal of gastroenterology
    Vol/bind22
    Udgave nummer7
    DOI
    StatusUdgivet - 1 jan. 1987

    Fingeraftryk

    Udforsk hvilke forskningsemner '5-aminosalicylic acid in the treatment of crohn's disease: A 16-week double-blind, placebo-controlled, multicentre study with pentasa®' indeholder.

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