Alimentary TractOral contraceptive use and smoking are risk factors for relapse in Crohn's disease☆,☆☆
Section snippets
Patients
The analysis was based on placebo-treated patients participating in a multicenter, randomized, controlled clinical trial.25 Each of the 31 Canadian centers participating in the trial was responsible for obtaining ethical approval of the respective local Institutional Review Board. Patients were recruited after informed consent between January 1990 and January 1993. Inclusion criteria were age of at least 18 years and Crohn's disease confirmed by barium radiograph, endoscopy, macroscopic
Results
All 152 patients randomized to placebo treatment were included in the analysis. Demographic and disease characteristics are shown in Table 1. Eighty-eight of the patients were women (58%). The median age was 34.4 years (range, 18–82 years). About half of the patients had disease confined to the ileum. The current remission had been induced by surgery in 40 patients (26%). Thirty-nine percent of the patients were current smokers, 26% were ex-smokers, and 35% had never smoked. Ex-smokers were
Discussion
A large placebo-controlled clinical trial offered several advantages for efficiently examining risk factors for relapse in Crohn's disease. Placebo-treated patients may be considered as close as possible, under controlled circumstances, to be patients experiencing the natural course of the disease. Treatment effects that might otherwise mask the effects of risk factors are abolished. The prospective design, with exposure assessment during remission, and the focus on treatment assignment rather
Acknowledgements
The authors thank Dr. R. Brant (Department of Community Health Sciences, University of Calgary) for statistical advice; and Drs. R. J. Hilsden and C. MacArthur for thoughtful comments on the manuscript.
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Address requests for reprints: Lloyd R. Sutherland, M.D., Department of Community Health Sciences, 3330 Hospital Drive Northwest, Calgary, Alberta, T2N 4N1, Canada. e-mail: [email protected]; fax: (403) 270-7307.
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Dr. Timmer is a fellow of the German Academic Exchange Service.