Document Detail

A placebo-controlled, double-blind, randomized trial of cyclosporine therapy in active chronic Crohn's disease.
MedLine Citation:
PMID:  2671739     Owner:  NLM     Status:  MEDLINE    
We randomly assigned 71 patients with active chronic Crohn's disease who were resistant to or intolerant of corticosteroids to treatment with oral cyclosporine (5 to 7.5 mg per kilogram of body weight per day) or placebo for three months. Disease activity was assessed on a clinical grading scale without knowledge of the treatment given. At the end of the treatment period, 22 of the 37 cyclosporine-treated patients (59 percent) had improvement, as compared with 11 of the 34 placebo-treated patients (32 percent) (P = 0.032). During cyclosporine treatment, there was significant improvement in plasma orosomucoid levels (P = 0.0025) and the Crohn's Disease Activity Index (P = 0.00012). The effect of treatment became evident after two weeks. In the subsequent three months, during which the patients were gradually withdrawn from treatment, the improvement continued in 14 of the 37 patients (38 percent) in the cyclosporine group and in 5 of the 34 (15 percent) in the placebo group (P = 0.034). No serious adverse events were observed. We conclude that cyclosporine has a beneficial therapeutic effect in patients with active chronic Crohn's disease and resistance to or intolerance of corticosteroids.
J Brynskov; L Freund; S N Rasmussen; K Lauritsen; O S de Muckadell; N Williams; A S MacDonald; R Tanton; F Molina; M C Campanini
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  321     ISSN:  0028-4793     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  1989 Sep 
Date Detail:
Created Date:  1989-10-12     Completed Date:  1989-10-12     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  845-50     Citation Subset:  AIM; IM    
Department of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen, Denmark.
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MeSH Terms
Administration, Oral
Chronic Disease
Clinical Trials as Topic
Crohn Disease / blood,  drug therapy*
Cyclosporins / administration & dosage,  adverse effects,  therapeutic use*
Double-Blind Method
Middle Aged
Orosomucoid / blood
Random Allocation
Reg. No./Substance:
0/Cyclosporins; 0/Orosomucoid
Comment In:
N Engl J Med. 1990 Mar 1;322(9):636-7   [PMID:  2406605 ]
N Engl J Med. 1989 Sep 28;321(13):894-6   [PMID:  2770825 ]

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