Objectives: The increasing levels of bacterial antibiotic resistance have increased the need to evaluate the second-line treatments for Helicobacter pylori. Bismuth-based quadruple therapy is recommended as a second-line treatment, but the optimal duration of this treatment is still debatable. We prospectively analyzed the eradication rate of H. pylori according to the duration of the second-line bismuth-based quadruple therapy.
Methods: One hundred and ninety-nine patients who failed at H. pylori eradication were prospectively randomized to receive pantoprazole 40 mg twice daily, metronidazole 500 mg thrice daily, and bismuth subcitrate 300 mg and tetracycline 500 mg four times daily for 7 days (PBMT7) or for 14 days (PBMT14). The post-treatment H. pylori status was determined by the (13) C-urea breath test. The eradication rates, drug compliance, and side effects of each group were evaluated.
Results: The intention-to-treat (ITT) eradication rates were 81.6% (95% CI 73.9-89.3%, 80/98) in the PBMT7 arm and 85.1% (95% CI 78.2-92.0%, 86/101) in the PBMT14 arm (p=.028, noninferiority test), while the per-protocol (PP) eradication rates were 89.6% (95% CI 83.2-96.0%, 78/87) and 96.2% (95% CI 92.0-100.0% 77/80) (p=.015, noninferiority test), respectively. The compliance was 88.8% (87/98) and 79.2% (80/101) in the PBMT7 and PBMT14 groups, respectively. (p=.066) The number of patients having severe side effects was 15.3% (15/98) and 21.8% (22/101) in the PBMT7 and PBMT14 groups, respectively, which was similar between both groups. (p=.243).
Conclusions: Although PBMT7 was not inferior to PBMT14 statistically, PBMT could not demonstrate enough ITT/PP eradication rate. Therefore, it could be better to extend the duration of treatment for 2 weeks for the second-line treatment of H. pylori in Korea.
Trial registration: ClinicalTrials.gov NCT00841854.
© 2011 Blackwell Publishing Ltd.