5-Aminosalicylic acid in the treatment of Crohn's disease. A 16-week double-blind, placebo-controlled, multicentre study with Pentasa
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5-Aminosalicylic acid in the treatment of Crohn's disease. A 16-week double-blind, placebo-controlled, multicentre study with Pentasa. / Rasmussen, S N; Lauritsen, K.; Tage-Jensen, U; Nielsen, O H; Bytzer, P; Jacobsen, O; Ladefoged, K; Vilien, M; Binder, V; Rask-Madsen, J.
I: Scandinavian Journal of Gastroenterology, Bind 22, Nr. 7, 1987, s. 877-83.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - 5-Aminosalicylic acid in the treatment of Crohn's disease. 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
PY - 1987
Y1 - 1987
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 greater than 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 greater than 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 Three patients (one given 5-ASA) were withdrawn from the study because of presumed side effects, but no serious adverse reactions were recorded.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 greater than 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 greater than 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 - Adolescent
KW - Adult
KW - Aged
KW - Aminosalicylic Acids/adverse effects
KW - Clinical Trials as Topic
KW - Crohn Disease/drug therapy
KW - Double-Blind Method
KW - Female
KW - Humans
KW - Male
KW - Mesalamine
KW - Middle Aged
KW - Random Allocation
U2 - 10.3109/00365528708991929
DO - 10.3109/00365528708991929
M3 - Journal article
C2 - 3313678
VL - 22
SP - 877
EP - 883
JO - Scandinavian Journal of Gastroenterology. Supplement
JF - Scandinavian Journal of Gastroenterology. Supplement
SN - 0085-5928
IS - 7
ER -
ID: 218729863