Bismuth-based quadruple therapy with bismuth subcitrate, metronidazole, tetracycline and omeprazole in the eradication of Helicobacter pylori

BACKGROUND: A previous study showed that 14 days of qid bismuth,based tripl e therapy with tetracycline 500 mg, metronidazole 250 mg and colloidal bism uth subcitrate 120 mg resulted in excellent Helicobacter pylori eradication rates (89.5%). The present study looked at a shorter treatment period by a dding omeprazole and by reducing the dose of tetracycline. METHODS: One hundred sixty-one patients with H pylori confirmed by histolog y and (13)carbon urea breath test were included in the study. They were tre ated for seven days with bismuth subcitrate 120 mg plus metronidazole 250 m g plus tetracycline 250 mg qid plus omeprazole 20 mg bid (OBMT). Patients w ere 18 to 75 years of age and had dyspepsia with or without a history of pe ptic ulcer. Patients with irritable bowel syndrome, active ulcer or previou s attempt at eradication, or those who had used antibiotics or antiulcer dr ugs in the previous 30 days were excluded. Eradication was determined by tw o (13)carbon urea breath tests done one and three months, respectively, aft er treatment. Strains with minimal inhibitory concentrations of 8 mug/mL or higher were considered to be resistant to metronidazole. RESULTS: The overall per protocol eradication rate was 84% - 89.5% in metro nidazole-sensitive and 70.8% in metronidazole-resistant strains. Modified i ntent-to,treat analysis resulted in a 80% eradication rate - 82.5% in metro nidazole,sensitive and 66.7% in metronidazole-resistant strains. Only one p atient discontinued treatment because of adverse events. CONCLUSIONS: The OBMT regimen used in this study is safe and effective agai nst metronidazole-sensitive H pylori strains.