Prospective, randomized study of seven versus fourteen days omeprazole quadruple therapy for eradication of Helicobacterpylori infection in patients with duodenal ulcer after failure of omeprazole triple therapy

 
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Annals of Gastroenterology
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Prospective, randomized study of seven versus fourteen days omeprazole quadruple therapy for eradication of Helicobacterpylori infection in patients with duodenal ulcer after failure of omeprazole triple therapy (EN)

Kalliopi Petraki,3 A. Roussos,1 A. Karagiannidis,, G.J. Mantzaris,1 Constantina Petraki,
Paraskevi Polyzou,1 Stavroula Koilakou,1 G. Triantafyllou1, Aggeliki Christidou,1 P. Christoforidis,

Objective: To evaluate the efficacy and compliance with quadruple omeprazole as a second-line therapy for eradication of H. pylori in duodenal ulcer patients. Methodology: This is a prospective, randomized, singlecentre trial. One hundred and fifteen consecutive patients with active duodenal ulcer who had failed to eradicate H. pylori infection on omeprazole (20 mg b.d.), amoxycillin (1 g b.d.), and clarithromycin (500 mg b.d.) (OAC10) for 10 days were randomized to receive as second-line therapy omeprazole (20mg bd), colloidal bismuth subcitrate (120mg qid), metronidazole (0.5g tid) and tetracycline hydrochloride (0.5g qid) for 7 (OBMT7, n=54) or 14 days (OBMT14, n=61). Failure of OAC10 had been confirmed by CLO-tests, histology and immunohistochemistry on gastric biopsies taken at endoscopy two months after therapy, and, in doubtful cases by 13C-Urea-breath test (UBT). Compliance with treatment and treatment-related side effects were assessed. Eradication of H. pylori was confirmed by UBT 6 weeks after therapy. Patients with a negative UBT were re-evaluated at 6 and 12 months after treatment when a new UBT was performed whereas those with dyspepsia or de novo reflux symptoms were re-endoscoped. Results: At baseline, there were no significant differences in any patient- or disease-related parameters between treatment groups. Six and four patients in the OBMT7 and OBMT14 groups, respectively, were lost to follow up. Three and seven patients in the OBMT7 and OBMT14 groups, respectively, were non-compliant. By intention-to-treat (ITT) analysis no significant differences were found in eradication rates between OBMT7 and OBMT14 [66.7% (36/54) vs 80% (36/45), respectively, 95% CI -5% to 27%, p=0.215). However, by per-protocol (PP) analysis eradication rates with OBMT14 were significantly higher than with OBMT7 [96% (48/50) vs 78.7% (48/61), respectively, 95% CI 14.7% to 17.3%, p=0.035]. Side effects were more common with OBMT14. Conclusions: OBMT7 appears to be equally effective to OBMT14 as second-line therapy for H. pylori after failure of OAC10 because a considerable number of patients cannot tolerate OBMT14. However, if tolerated, OBMT14 is an excellent second-line therapy for eradication of H. pylori. Key words: omeprazole triple therapy, omeprazole quadruple therapy, duodenal ulcer, Helicobacter pylori. (EN)

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info:eu-repo/semantics/publishedVersion

Ελληνική Γαστροεντερολογική Εταιρία (EL)
Hellenic Society of Gastroenterology (EN)

2007-03-19


Hellenic Society of Gastroenterology (EN)

1792-7463
1108-7471
Annals of Gastroenterology; Volume 18, No 3 (2005) (EN)



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