Quadruple therapy with moxifloxacin and bismuth for first-line treatment of Helicobacter pylori.

AIM: To compare triple therapy vs quadruple therapy for 10 d as first-line treatment of Helicobacter pylori (H. pylori) infection. METHODS: Consecutive H. pylori positive patients never treated in the past for this infection were randomly treated with triple therapy of pantoprazole (PAN) 20 mg bid, amoxicillin (AMO) 1 g bid and moxifloxacin (MOX) 400 mg bid for 10 d (PAM) or with quadruple therapy of PAN 20 mg bid, AMO 1 g bid, MOX 400 mg bid and bismuth subcitrate 240 mg bid for 10 d (PAMB). All patients were found positive at 13 C-Urea breath test (UBT) performed within ten days prior to the start of the study. A successful outcome was confirmed with an UBT performed 8 wk after the end of treatment. χ(2) analysis was used for statistical comparison. Per protocol (PP) and intention-to-treat (ITT) values were also calculated. RESULTS: Fifty-seven patients were enrolled in the PAM group and 50 in the PAMB group. One patient in each group did not return for further assessment. Eradication was higher in the PAMB group (negative: 46 and positive: 3) vs the PAM group (negative: 44 and positive: 12). The H. pylori eradication rate was statistically significantly higher in the PAMB group vs the PAM group, both with the PP and ITT analyses (PP: PAMB 93.8%, PAM 78.5%, P < 0.02; ITT: PAMB 92%, PAM 77.1 %, P <0.03). CONCLUSION: The addition of bismuth subcitrate can be considered a valuable adjuvant to triple therapy in those areas where H. pylori shows a high resistance to fluoroquinolones.