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Scandinavian Journal of Gastroenterology Volume 26, 1991 - Issue 7
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Original Article

Final Report on a Placebo-Controlled, Double-Blind, Randomized, Multicentre Trial of Cyclosporin Treatment in Active Chronic Crohn's Disease

J. Brynskov Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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L. Freund Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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S. Nørby Rasmussen Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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K. Lauritsen Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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O. Schaffalitzky De Muckadell Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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C. N. Williams Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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A. S. Macdonald Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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R. Tanton Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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F. Molina Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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M. C. Campanini Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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P. Bianchi Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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T. Ranzi Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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F. Quarto Di Palo Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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A. Malchow-Møller Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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O. Østergaard Thomsen Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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U. Tage-jensen Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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V. Binder Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
&
P. Riis Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen; Dept. of Internal Medicine and Gastroenterology, Aalborg Hospital, Aalborg; Dept. of Internal Medicine and Gastroenterology S, Odense University Hospital, Odense; Dept. of Internal Medicine and Gastroenterology, Rigshospitalet, Copenhagen, Denmark; Division of Gastroenterology, Dept. of Medicine, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Surgery, Dalhousie University, Victoria General Hospital, Halifax, Nova Scotia, Canada; Dept. of Internal Medicine and Gastroenterology, Ospedale Maggiore, Milan, Italy
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Pages 689-695 | Received 30 Nov 1990, Accepted 25 Feb 1991, Published online: 08 Jul 2009
 
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Abstract

In a previous report we published the immediate results of a 3-month placebo-controlled trial (n = 34) showing that cyclosporin (n = 37) has a beneficial therapeutic effect in active chronic Crohn's disease. Here we report on the final outcome of the patients. During the 3-month tapering-off period eight initially improved patients (36%) in the cyclosporin group worsened, as did six (55%) in the placebo group. The therapeutic gain of cyclosporin treatment was consistently significant during this period. It ranged from 22% to 25% (95% confidence limits, 2-46%). An outcome ranking showed that 7 patients of the cyclosporin group (19%) were substantially improved, 7 (19%) moderately improved, and 23 (62%) not improved after the tapering off. In contrast, no significant differences were seen during the 6-month follow-up period. Four patients of the cyclosporin group (11%) were substantially improved, 3 (8%) moderately improved, and 30 (81%) not improved at final follow-up. Significant interactions between cyclosporin and prednisolone treatment were demonstrated both at the end of the initial treatment period and at the end of the tapering-off period. We conclude that a short course of cyclosporin treatment does not result in long-term improvement in active chronic Crohn's disease

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