Bismuth-based triple therapy with bismuth subcitrate, metronidazole and tetracycline in the eradication of Helicobacter pylori: A randomized, placebocontrolled, double-blind study

OBJECTIVE: To determine the rate of Helicobacter pylori eradication followi ng bismuth-based triple therapy with colloidal bismuth subcitrate, tetracyc line hydrochloride and metronidazole. PATIENTS AND METHODS: One hundred and eleven patients were randomly assigne d, in a two to one ratio, to colloidal bismuth subcitrate 120 mg qid plus m etronidazole 250 mg qid plus tetracycline 500 mg qid (Gastrostat), or match ing placebo tablets and capsules for 14 days. Presence or absence of H pylo ri was documented by histology at entry and at least 28 days after treatmen t. Patients had dyspeptic symptoms with or without a history of peptic ulce r. Patients with any previous attempt(s) at eradication of H pylori, who us ed bismuth, antibiotics, H, receptor antagonists or proton pump inhibitors in the previous four weeks were excluded. RESULTS: Fifty three of 59 (90%) patients on bismuth-based treatment and on ly one of 35 (3%) on placebo achieved eradication by per protocol analysis. Fifty-three of 65 (82%) patients on bismuth-based treatment achieved eradi cation, while only two of 34 (5%) achieved eradication on placebo by intent ion to treat analysis. Eradication rates for bismuth-based treatment across sites ranged from 83% to 100%. Only two patients in the bismuth based trea tment group (4%) and one in the placebo group (3%) discontinued treatment b ecause of adverse events. CONCLUSIONS: Colloidal bismuth subcitrate plus metronidazole plus tetracycl ine, given in the doses studied for 14 days, is safe and highly effective a gainst H pylori infection and would be appropriate as a first-line therapy for eradication.