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Total enteral immunomodulatory nutrition (TEIN) treatment for severe active ulcerative colitis

1995; Elsevier BV; Volume: 108; Issue: 4 Linguagem: Inglês

10.1016/0016-5085(95)27616-5

1528-0012

Susan Greenbloom, Barbara Wendland, A.H. Steinhart, Robin S. McLeod, Z. Cohen, G.R. Greenberg,

Intraperitoneal and Appendiceal Malignancies

_P.=_~__k,~-o~: Corticosteroids are effective treatment for active Crohn's disease but chronic administration to prevent relapse may cause serious side effects.Budesonide is a cort/costeroid with high topical anti-inflammatory activity and low systemic activity due to rapid hepatic metabolism.We investigated the efficacy and safety of an oral controlled ileal-release preparation of budesonide for maintenance of remission in patients with Crohn's disease involving the ileum or ileum and proximal colon.Methods: In a double-blind, multi-centre trial, 105 patients were randomly assigned to receive placebo or budesonide at doses of 3 or 6 mg dally for one year.The primary outcome measure was relapse of Crohn's disease as defined by a CDAI score above 150 and an increment of 60 points, or withdrawal due to disease deterioration that required other treatment.Results.Patients receiving 6 mg of budesonide had a median time to relapse or discontinuation of therapy of 178 days compared with 124 days in those receiving 3 rag of budesonide and 39 days in those receiving placebo (P=0.026).At one year, the rate of relapse in the group receiving 6 mg of budesonide (61%) was similar to the rates in the 3 rng (70%) and the placebo groups (67%) (P=0.75).Basal plasma cortisol levels were uniform in the three treatment groups throughout one year.Budesonide caused a dose-related reduction in cortiootrophin-sfimulated plasma cortisol concentrations but was not associated with clinically important corticosteroid-associated symptoms or other toxic effects.Conclusions: In a one year trial, an oral controlled-release preparation of budesonide at a daffy dose of 6 mg was well tolerated and effective in prolonging the time to relapse in patients with Crohn's disease of the ileum and proximal colon.