Final report on a placebo-controlled, double-blind, randomized, multicentre trial of cyclosporin treatment in active chronic Crohn's disease.
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.
Brynskov
J
J
Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen, Denmark.
Freund
L
L
Nørby Rasmussen
S
S
Lauritsen
K
K
Schaffalitzky de Muckadell
O
O
Williams
C N
CN
MacDonald
A S
AS
Tanton
R
R
Molina
F
F
Campanini
M C
MC
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
D003524:Cyclosporins; D011239:Prednisolone