Alimentary TractOral budesonide for prevention of postsurgical recurrence in Crohn's disease☆,☆☆
Section snippets
Materials and methods
The study was a parallel-group, double-blind, placebo-controlled, multicenter study involving 13 centers in Belgium, Denmark, France, Germany, Italy, the Netherlands, the United Kingdom, and Sweden. The study was approved by the ethics committee at each participating center.
Patients
Of 134 patients recruited (February 1992 through August 1993), a total of 130 were randomized into the study. One patient never took any study drug and was omitted from all further analyses. Patient characteristics and disease history are shown in Table 3.
Empty Cell Budesonide, 6 mg (n = 63) Placebo (n = 66) Sex ratio (M/F) 35/28 27/39 Age (yr)a 34 (20–76) 36 (17–81) Weight (kg)a 64 (38–96) 63 (39–83) Previous resection (Y/N) 19/44 17/49 Time since resection
Discussion
Surgery for CD is most often performed because of complications such as abscess, fistula, and bowel obstruction or because of lack of response to medical treatment. However, disease recurrence is a major problem, and approximately 50% of patients required repeat surgery within 10 years.9 Endoscopic recurrence at the anastomosis has been shown to occur in a high percentage within a year after surgery.11, 12
Over the past years, different drugs have been investigated for recurrence prevention; no
Acknowledgements
The participation of the General Hospital, Birmingham, England; Herlev Hospital, Herlev, Denmark; Centre Hospitalier Lyon-Sud, Lyon, France; and Hospital Saint-Louis, Paris, France, in this study is gratefully acknowledged.
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Address requests for reprints to: Robert Löfberg, M.D., Ph.D., Department of Gastroenterology, Huddinge University Hospital, SE-141 86 Huddinge, Sweden. Fax: (46) 8-585-82-335.
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Supported by Astra Draco AB, Lund, Sweden.