A Triple and Quadruple Therapy with Doxycycline and Bismuth for First-Line Treatment of Helicobacter pylori Infection: A Pilot Study

Background: Tetracycline-containing triple therapy has been suggested as an alternative first-line therapy for H. pylori infection. Aim: To evaluate the effect of two dosages of doxycycline (DOX) associated with amoxicillin and esomeprazole with and without bismuth subcitrate as first-line treatment of H. pylori infection. Methods: Helicobacter pylori-positive patients underwent a 10-day therapy randomized into four groups: Group A received esomeprazole, amoxicillin, and DOX-100 mg b.i.d. (EAD-100), Group B a quadruple therapy with esomeprazole, amoxicillin, DOX-100 mg b.i.d. and bismuth subcitrate (EADB-100), Group C a triple therapy with esomeprazole, amoxicillin, and DOX-200 mg b.i.d. (EAD-200) and Group D a quadruple therapy with esomeprazole, amoxicillin, DOX-200 mg b.i.d., and bismuth subcitrate (EADB-200). Success was accessed by 13C urea breath test 2 months after the end of treatment. The number of patients to be recruited for each group had to be at least 50 subjects. Treatment success of 80% or less was considered unacceptable. Stopping rules therefore were anytime six failures had occurred. Results: In the EAD-100 group and in EAD-200 group, the recruitment was stopped at the 14th and 15th patient, respectively. Fifty-two patients entered in the EADB-100 group and 51 in the EADB-200 group. Intention to treat eradication was in EADB-100 group 46/52 (88.5%, 95% CI 76.6-95.6); in the EADB-200 group 47/51 (92.1%, 95% CI: 81.1-97.8) (n.s.). Side effects were absent. Conclusion: The adjunction of bismuth subcitrate to a triple therapy that includes esomeprazole, amoxicillin, and DOX in patients who are treated for the first time for the H. pylori infection potentiates the therapeutic effect. This regimen, however, deserves to be optimized in terms of duration and dose of DOX

Rifabutin Containing Triple Therapy and Rifabutin with Bismuth Containing Quadruple Therapy for Third-Line Treatment of Helicobacter pylori Infection: Two Pilot Studies

Aim: To evaluate the therapeutic gain of the addition of bismuth to a rifabutin containing triple therapy with amoxicillin and pantoprazole at standard dosages for the treatment of third-line Helicobacter pylori infection after a preliminary susceptibility test. Methods: Two separate groups of patients in two pilot studies which were carried out simultaneously. One group was treated with rifabutin 150 mg b.i.d., pantoprazole 20 mg b.i.d., and amoxicillin 1 g b.i.d. for 10 days and the other group with rifabutin 150 mg b.i.d., pantoprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and bismuth subcitrate 240 mg b.i.d. for 10 days. All patients underwent to culture and susceptibility testing prior to their inclusion in the study. A successful outcome was confirmed with an Urea Breath test performed 8 weeks after the end of treatment. A blood cell count was performed for all patients at the start and after 5 days of treatment since rifabutin has been shown to inhibit the growth of leucocytes. Results: Twenty-nine patients were recruited in the pantoprazole, amoxicillin, rifabutin group and 30 in the pantoprazole, amoxicillin, rifabutin, and bismuth subcitrate group. All patients had a positive H. pylori culture and the susceptibility test used showed H. pylori sensitivity to rifabutin and amoxicillin. H. pylori eradication during follow-up was 18/27 (66.7%, 95% CI: 47.7–85.7%) in the pantoprazole, amoxicillin, rifabutin group and 28/29 (96.6%, 95% CI: 89.5–100.0%) in the pantoprazole, amoxicillin, rifabutin, and bismuth subcitrate group. Both treatments were well-tolerated with no reported side effects. Blood cell count remained normal in all patients. Conclusion: The addition of bismuth subcitrate to a triple therapy that includes proton pump inhibitors, amoxicillin, and rifabutin in patients who are treated for the third time for H. pylori infection resulted in a 30% therapeutic gain