Prophylactic effects of olsalazine v sulphasalazine during 12 months maintenance treatment of ulcerative colitis. The Danish Olsalazine Study Group.
In a Danish multicentre trial we compared the relapse preventing effects of olsalazine and sulphasalazine in patients with ulcerative colitis over a 12 month treatment period. Two hundred and twenty seven patients (118 men) with at least two previous attacks of ulcerative colitis were randomly allocated according to a prearranged treatment schedule to olsalazine 500 mg bd or sulphasalazine 1 g bd in a double blind, double dummy fashion. One hundred and ninety seven patients completed the trial. The relapse rate after 12 month in the olsalazine group was 46.9% v 42.4% in the sulphasalazine group with a 95% confidence interval for the difference in proportions of -9% to 18%. Seven per cent of the patients were withdrawn from the trial because of adverse drug reactions and these were equally distributed between the two groups.
Department of Medical Gastroenterology, Central Hospital, Hillerød, Denmark.
S
S
Kiilerich
K
K
Ladefoged
T
T
Rannem
P J
PJ
Ranløv
D000293:Adolescent; D000328:Adult; D000368:Aged; D000636:Aminosalicylic Acids / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000517:prevention & control*; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D012008:Recurrence; D012460:Sulfasalazine / Q000627:therapeutic use*
D000636:Aminosalicylic Acids; D012460:Sulfasalazine; C032587:olsalazine