| Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial. | |
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MedLine Citation:
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PMID: 9649455 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND & AIMS: Beclomethasone dipropionate (BDP), a topically active steroid, seemed to be an effective treatment for intestinal graft-versus-host disease (GVHD) in a phase I study. The aim of this study was to compare the effectiveness of oral BDP to that of placebo capsules in treatment of intestinal GVHD. METHODS: Sixty patients with anorexia and poor oral intake because of intestinal GVHD were randomized to receive prednisone (1 mg.kg-1.day-1) plus either oral BDP (8 mg/day) or placebo capsules. Initial responders who were eating at least 70% of caloric needs at evaluation on day 10 continued to take study capsules for an additional 20 days while the prednisone dose was rapidly tapered. The primary end point was the frequency of a durable treatment response at day 30 of treatment. RESULTS: The initial treatment response at day 10 was 22 of 31 (71%) in the BDP/prednisone group vs. 16 of 29 (55%) for the placebo/prednisone group. The durable treatment response at day 30 was 22 of 31 (71%) vs. 12 of 29 (41%), respectively (P = 0.02). CONCLUSIONS: The combination of oral BDP capsules and prednisone was more effective than prednisone alone in treating intestinal GVHD. Oral BDP allowed prednisone doses to be rapidly tapered without recurrent intestinal symptoms. |
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Authors:
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G B McDonald; M Bouvier; D M Hockenbery; J M Stern; T Gooley; A Farrand; C Murakami; D S Levine |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Gastroenterology Volume: 115 ISSN: 0016-5085 ISO Abbreviation: Gastroenterology Publication Date: 1998 Jul |
Date Detail:
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Created Date: 1998-07-23 Completed Date: 1998-07-23 Revised Date: 2007-11-14 |
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: 28-35 Citation Subset: AIM; IM |
Affiliation:
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Gastroenterology/Hepatology Section, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Adult Aged Beclomethasone / administration & dosage, adverse effects, therapeutic use* Female Graft vs Host Disease / drug therapy* Humans Inflammatory Bowel Diseases / drug therapy* Male Middle Aged Prednisone / therapeutic use |
| Grant Support | |
ID/Acronym/Agency:
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CA-15704/CA/NCI NIH HHS; CA-18029/CA/NCI NIH HHS; FD-R-000827/FD/FDA HHS |
| Chemical | |
Reg. No./Substance:
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4419-39-0/Beclomethasone; 53-03-2/Prednisone |
| Comments/Corrections | |
Comment In:
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Gastroenterology. 1998 Jul;115(1):220-2
[PMID:
9649479
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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