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One-week versus two-week H2-receptor antagonist in combination with amoxicillin and tinidazole for eradication of Helicobacter pylori infection.

Author(s): Hsu CC, Chen JJ, Hu TH, Lu SN, Changchien CS

Affiliation(s): Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical Center Chang Gung Memorial Hospital, Tainan, Taiwan.

Publication date & source: 2005-09, Hepatogastroenterology., 52(65):1617-21.

Publication type: Clinical Trial; Randomized Controlled Trial

BACKGROUND/AIMS: Eradication regimens combining two antibiotics with a proton pump inhibitor have been studied intensively in Helicobacter pylori (H. pylori) infection; however, only a few reports have focused on the role of H2-receptor antagonists (H2-RAs) in eradication therapy. The mechanism involved in the synergy between antibiotics and H2RAs are still elusive. So we compared the efficacy of two regimens: a 1-week or 2-week course of high-dose H2-RA-based triple therapy in patients with H. pylori infection, and assessed the impact of primary resistance for metronidazole on the treatment outcome. METHODOLOGY: One hundred and twenty patients with peptic ulcers and nonulcer dyspepsia were randomly assigned to a one-week course of famotidine 40mg b.i.d., amoxicillin lg b.i.d. and tinidazole 500 mg b.i.d. (FAT1 group; n = 60) or a 2-week course of famotidine 40 mg b.i.d., amoxicillin lg b.i.d. and tinidazole 500 mg b.i.d. (FAT2 group; n = 60). Upper endoscopy was performed prior to treatment and at least 4 weeks after completion of treatment and discontinuation of the antisecretory therapy. H. pylori status was assessed by biopsy urease test, histology and culture. RESULTS: In the intention-to-treat analysis, eradication of H. pylori was achieved in 38 of 60 patients (63.3%; 95% CI: 51-76%) in the FAT1 group, compared to 48 of 60 patients (80%; 95% CI: 70-92%) in the FAT2 group (NS). In the per protocol analysis, eradication therapy was achieved in 38 of 54 patients (70.4%; 95% CI: 58-82%) in the FAT1 group and 48 of 53 patients (90.6%; 95% CI: 83-98%) in the FAT2 group (p < 0.05). The overall eradication rates for strains susceptible and resistant to metronidazole were 79.7% (95% CI: 71-89%) vs. 60% (95% CI: 44-74%) in the intention-to-treat analysis (p = 0.016) and 84% (95% CI: 76-92%) vs. 71.9% (95% CI: 56-88%) in the per protocol analysis (p = 0.12). Seven patients in the FAT1 group and six patients in the FAT2 group available for follow-up reported adverse events (11.7% and 10% respectively) without necessity of discontinuation of the study medications. Serious adverse events were not observed. CONCLUSIONS: A 2-week course of high-dose H2-RA-based triple therapy is well tolerated and sufficiently effective in eradicating H. pylori infection. Presence of metronidazole resistance has a negative impact on the treatment efficacy.

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