Eradication of Helicobacter pylori infection after ranitidine bismuth citrate, metronidazole and tetracycline for 7 or 10 days

Background: We assessed the efficacy, tolerance, and compliance of twice-da ily triple therapy for Helicobacter pylori with ranitidine bismuth citrate, metronidazole and tetracycline for 7 or 10 days. Methods: 105 subjects with H. pylori infection documented by the C-13-urea breath test were randomly assigned to a 7 or 10-day course of ranitidine bi smuth citrate 400 mg b.d. metronidazole 500 mg b.d. and tetracycline 500 mg b.d. Subjects returned at the end of therapy for assessment of side-effect s and pill count. A repeat C-13-urea breath tet was obtained 4 or more week s after completion of therapy and cure of infection was defined as a negati ve test result. Results: Poor compliance (< 80% of medications) was seen in 2% of subjects randomized to 7 days of therapy and in 10% randomized to 10 days of therapy (P = N.S.). Intention-to-treat eradication rates were 56% for 7-day and 60 % for 10-day therapy (P = N,S,). Per protocol eradication rates were 58% fo r 7-day and 61% for 10-day therapy (P = N.S.). The 10-day intention-to-trea t eradication rate for males was 78% and 33% for females (P < 0.01) and per protocol eradication rates were 79% and 31%, respectively (P < 0.01). Conclusions: Despite excellent compliance and tolerance, neither 7 nor 10 d ays of therapy with twice-daily ranitidine bismuth citrate, metronidazole a nd tetracycline are adequate as a treatment of H. pylori infection.