| Oral budesonide for prevention of postsurgical recurrence in Crohn's disease. The IOIBD Budesonide Study Group. | |
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MedLine Citation:
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PMID: 9922309 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND & AIMS: Prevention of postoperative recurrence after resection for Crohn's disease (CD) would be of great clinical benefit. The efficacy of oral budesonide for prevention of endoscopic recurrence was evaluated in patients undergoing resection for ileal or ileocecal CD. METHODS: Sixty-three patients received budesonide and 66 received placebo in a double-blind, randomized trial with parallel groups. Ileocolonoscopy, including biopsy, was performed after 3 and 12 months. Indications for surgery were fibrostenosis (78 patients), disease activity (41), and other reasons (10). RESULTS: The frequency of endoscopic recurrence did not differ between the groups at 3 and 12 months. In patients with disease activity as indication for surgery, the endoscopic recurrence rate at the anastomosis was lower in the budesonide group at 3 months, although not significantly (21% vs. 47%; P = 0.11), and at 12 months (32% vs. 65%; P = 0.047). There was no such difference with respect to fibrostenosis as indication for surgery. No differences in adverse event patterns were found between the two groups. CONCLUSIONS: Oral budesonide, 6 mg daily, offered no benefit in prevention of endoscopic recurrence after surgery for ileal/ileocecal fibrostenotic CD but decreased the recurrence rate in patients who had undergone surgery for disease activity. |
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Authors:
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G Hellers; A Cortot; D Jewell; C E Leijonmarck; R Löfberg; H Malchow; L G Nilsson; F Pallone; S Pena; T Persson; C Prantera; P Rutgeerts |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Gastroenterology Volume: 116 ISSN: 0016-5085 ISO Abbreviation: Gastroenterology Publication Date: 1999 Feb |
Date Detail:
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Created Date: 1999-02-18 Completed Date: 1999-02-18 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0374630 Medline TA: Gastroenterology Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 294-300 Citation Subset: AIM; IM |
Affiliation:
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Department of Gastroenterology, Huddinge University Hospital, Huddinge, Sweden. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Aged, 80 and over Anti-Inflammatory Agents / adverse effects, therapeutic use* Budesonide / adverse effects, therapeutic use* Colitis / prevention & control Colonoscopy Crohn Disease / blood, prevention & control*, surgery Double-Blind Method Europe Female Humans Hydrocortisone / blood Ileitis / prevention & control Male Middle Aged Recurrence Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents; 50-23-7/Hydrocortisone; 51333-22-3/Budesonide |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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