Document Detail

5-Aminosalicylic acid in the treatment of Crohn's disease. A 16-week double-blind, placebo-controlled, multicentre study with Pentasa.
MedLine Citation:
PMID:  3313678     Owner:  NLM     Status:  MEDLINE    
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 Three patients (one given 5-ASA) were withdrawn from the study because of presumed side effects, but no serious adverse reactions were recorded.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.
S N Rasmussen; K Lauritsen; U Tage-Jensen; O H Nielsen; P Bytzer; O Jacobsen; K Ladefoged; M Vilien; V Binder; J Rask-Madsen
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Scandinavian journal of gastroenterology     Volume:  22     ISSN:  0036-5521     ISO Abbreviation:  Scand. J. Gastroenterol.     Publication Date:  1987 Sep 
Date Detail:
Created Date:  1987-12-15     Completed Date:  1987-12-15     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0060105     Medline TA:  Scand J Gastroenterol     Country:  NORWAY    
Other Details:
Languages:  eng     Pagination:  877-83     Citation Subset:  IM    
Dept. of Medical Gastroenterology F, Glostrup Hospital, Denmark.
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MeSH Terms
Aminosalicylic Acids / adverse effects,  therapeutic use*
Clinical Trials as Topic
Crohn Disease / drug therapy*
Double-Blind Method
Middle Aged
Random Allocation
Reg. No./Substance:
0/Aminosalicylic Acids; 89-57-6/Mesalamine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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