title: Final report on a placebo-controlled, double-blind, randomized, multicentre trial of cyclosporin treatment in active chronic Crohn's disease.
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.
authors.affiliation: Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen, Denmark.
authors.forename: J
authors.initials: J
authors.lastname: Brynskov
authors.forename: L
authors.initials: L
authors.lastname: Freund
authors.forename: S
authors.initials: S
authors.lastname: Nørby Rasmussen
authors.forename: K
authors.initials: K
authors.lastname: Lauritsen
authors.forename: O
authors.initials: O
authors.lastname: Schaffalitzky de Muckadell
authors.forename: C N
authors.initials: CN
authors.lastname: Williams
authors.forename: A S
authors.initials: AS
authors.lastname: MacDonald
authors.forename: R
authors.initials: R
authors.lastname: Tanton
authors.forename: F
authors.initials: F
authors.lastname: Molina
authors.forename: M C
authors.initials: MC
authors.lastname: Campanini
mesh_terms: D016009:Chi-Square Distribution; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy*; D003524:Cyclosporins / Q000097:blood / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D006801:Humans; D011239:Prednisolone / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D003524:Cyclosporins; D011239:Prednisolone