TY - JOUR
T1 - 5-aminosalicylic acid in the treatment of crohn's disease
T2 - A 16-week double-blind, placebo-controlled, multicentre study with pentasa®
AU - Rasmussen, S. N.
AU - Lauritsen, K.
AU - Tage-Jensen, U.
AU - Nielsen, O. H.
AU - Bytzer, P.
AU - Jacobsen, O.
AU - Ladefoged, K.
AU - Vilien, M.
AU - Binder, V.
AU - Rask-Madsen, J.
AU - Bondesen, S.
AU - Hansen, S. Honore
AU - Hvidberg, E. F.
PY - 1987/1/1
Y1 - 1987/1/1
N2 - 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 Three patients (one given 5-ASA) were withdrawn from the study because of presumed side effects, but no serious adverse reactions were recorded.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.
AB - 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 Three patients (one given 5-ASA) were withdrawn from the study because of presumed side effects, but no serious adverse reactions were recorded.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.
KW - 5-Aminosalicylic acid
KW - Crohn's disease
KW - Placebo control
KW - Randomized clinical trial
UR - http://www.scopus.com/inward/record.url?scp=0023609361&partnerID=8YFLogxK
U2 - 10.3109/00365528708991929
DO - 10.3109/00365528708991929
M3 - Article
C2 - 3313678
AN - SCOPUS:0023609361
SN - 0036-5521
VL - 22
SP - 877
EP - 883
JO - Scandinavian journal of gastroenterology
JF - Scandinavian journal of gastroenterology
IS - 7
ER -