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 Seven per cent of the patients were withdrawn from the trial because of adverse drug reactions and these were equally distributed between the two groups.
Kiilerich
S
S
Department of Medical Gastroenterology, Central Hospital, Hillerød, Denmark.
Ladefoged
K
K
Rannem
T
T
Ranløv
P J
PJ
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