| Oral versus combination mesalazine therapy in active ulcerative colitis: a double-blind, double-dummy, randomized multicentre study. | |
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MedLine Citation:
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PMID: 11148445 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Oral and topical mesalazine formulations are effective in active ulcerative colitis, but little is known on the efficacy of combined treatment. AIM: To compare the efficacy of oral mesalazine vs. combined oral and topical mesalazine in mildly to moderately active ulcerative colitis. METHODS: Patients with mildly to moderately active ulcerative colitis (Clinical Activity Index, CAI 4-12) were identified at 15 participating centres. They were randomized to receive either mesalazine 4 g orally plus placebo enema, or mesalazine 2 g orally plus mesalazine 2 g rectally as a liquid enema for 6 weeks. The rate of clinical remission (CAI < 4) or clinical remission/improvement (reduction of CAI of 50% from baseline) at 6 weeks and time to clinical remission/improvement were primary end-points; the rate of endoscopic remission was a secondary end-point. RESULTS: 67 patients were assigned to oral treatment and 63 to combined treatment. One patient in the oral group and 2 in the combined group discontinued the treatment due to adverse events. Following an intention-to-treat analysis, the rate of clinical remission was 82% for oral treatment and 87% for combined treatment (P=0.56); the mean time to remission 22.2 and 20.2 days, respectively (P=0.29); the rate of clinical remission/improvement and the rate of endoscopic remission were 85% and 91% (P=0.503) and 58% and 71% (P=0.21), respectively. CONCLUSIONS: In patients with mild active ulcerative colitis, mesalazine 4 g orally and 2 g orally plus 2 g enema are equally effective in inducing disease remission. |
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Authors:
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M Vecchi; G Meucci; P Gionchetti; M Beltrami; P Di Maurizio ; L Beretta; E Ganio; P Usai; M Campieri; G Fornaciari; R de Franchis |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Alimentary pharmacology & therapeutics Volume: 15 ISSN: 0269-2813 ISO Abbreviation: Aliment. Pharmacol. Ther. Publication Date: 2001 Feb |
Date Detail:
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Created Date: 2001-01-26 Completed Date: 2001-02-22 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8707234 Medline TA: Aliment Pharmacol Ther Country: England |
Other Details:
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Languages: eng Pagination: 251-6 Citation Subset: IM |
Affiliation:
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Gastroenterology and Gastrointestinal Endoscopy Service, Department of Internal Medicine, IRCCS Ospedale Policlinico, Milan, Italy. gastro@polic.cilea.it |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Administration, Topical Adolescent Adult Aged Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*, therapeutic use Colitis, Ulcerative / drug therapy* Double-Blind Method Female Humans Male Mesalamine / administration & dosage*, therapeutic use Middle Aged Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents, Non-Steroidal; 89-57-6/Mesalamine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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