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Olsalazine and sulphasalazine were compared in a double-blind, double-dummy trial in the prevention of relapse of ulcerative colitis over 6 months. The majority were taking sulphasalazine. They were randomized to receive either olsalazine, 500 mg b.d., or sulphasalazine, 1 g b.d. Of 82 patients, 16 relapsed on olsalazine compared with 10 of 82 on sulphasalazine. This difference was not statistically significant (p = 0.16). Twenty-one patients reported adverse events in the olsalazine group, of whom 16 were withdrawn, while 20 patients reported adverse events in the sulphasalazine group, with 9 of them being withdrawn. The differences were not statistically significant. No major haematological or biochemical abnormalities occurred. Thus, olsalazine is similar to sulphasalazine for the prevention of relapse of ulcerative colitis.

Type

Journal article

Journal

Scand J Gastroenterol Suppl

Publication Date

1988

Volume

148

Pages

45 - 47

Keywords

Aminosalicylic Acids, Clinical Trials as Topic, Colitis, Ulcerative, Double-Blind Method, Female, Humans, Male, Middle Aged, Random Allocation, Recurrence, Sulfasalazine, Time Factors