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-daily 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 13C-urea breath test were randomly assigned to a 7 or 10-day course of ranitidine bismuth 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-effects and pill count. A repeat 13C-urea breath test was obtained 4 or more weeks after completion of therapy and cure of infection was defined as a negative 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% for 7-day and 61% for 10-day therapy (P = N.S.). The 10-day intention-to-treat eradication rate for males was 78% and 32% 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 days of therapy with twice-daily ranitidine bismuth citrate, metronidazole and tetracycline are adequate as a treatment of H. pylori infection.