Miehlke, Stephan and Heymer, Peter and Bethke, Birgit and Bastlein, Elke and Meier, Eberhard and Bartram, Hans-Peter and Wilhelms, Günther and Lehn, Norbert and Dorta, Gian and Delarive, Joachim and Tromm, Andreas and Bayerdoerffer, Ekkehard and Stolte, Manfred (2002) Budesonide treatment for collagenous colitis: A randomized, double-blind, placebo-controlled, multicenter trial. GASTROENTEROLOGY, 123 (4). pp. 978-984. ISSN 0016-5085
Full text not available from this repository.Abstract
Background & Aims: Collagenous colitis is an idiopathic microscopic colitis characterized by chronic watery diarrhea, a typical subepithelial collagen layer, and lymphoplasmacellular infiltration. We investigated the effect of budesonide on symptoms and histology in patients with collagenous colitis in a randomized, double-blind, placebo-controlled multicenter trial. Methods: Patients with chronic diarrhea and histologically proven collagenous colitis were randomized to receive either oral budesonide (Entocort capsules; AstraZeneca, Sodertalje, Sweden) 9 mg/day for 6 weeks or placebo. Complete colonoscopy was performed before and after treatment. Histopathology was assessed by a single pathologist blinded to the patients' treatment. Clinical symptoms were assessed by standardized questionnaires. Results: Fifty-one patients were randomized; 45 patients were available for per protocol analysis. The rate of clinical remission was significantly higher (P < 0.001) in the budesonide group than in the placebo group (per protocol 86.9% vs. 13.6%, respectively; intention-to-treat 76.9% vs. 12.0%, respectively). Histologic improvement was observed in :14 patients of the budesonide group (60.9%) and in 1 patient of the placebo group (4.5%; P < 0.001). Two patients in the budesonide group (7.7%) and 1 patient in the placebo group (4.0%) discontinued treatment prematurely because of side effects. Conclusions: Oral budesonide (Entocort capsules) is an effective and safe treatment modality for patients with collagenous colitis. Long-term follow-up of these patients is necessary to investigate whether clinical and histologic remission is sustained.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ACTIVE CROHNS-DISEASE; LYMPHOCYTIC COLITIS; GENE-EXPRESSION; ORAL BUDESONIDE; PREDNISOLONE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 04 Oct 2021 08:25 |
| Last Modified: | 04 Oct 2021 08:25 |
| URI: | https://pred.uni-regensburg.de/id/eprint/39817 |
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