Randomized Comparison of Ranitidine Bismuth Citrate-Based Triple Therapies for Helicobacter pylori

Objectives: In an attempt to increase the efficacy and simplicity of FDA-approved regimens for Helicobacter pylori , we studied (1) addition of an inexpensive antibiotic (amoxicillin) to twice-daily ranitidine bismuth citrate (RBO-clarithromycin dual therapy, and (2) substitution of RBC for bismuth subsalicylate + H2-receptor antagonist in bismuth-based triple therapy. Methods : Subjects with previously untreated Helicobacter pylori infection documented by ¹³C-urea breath test plus either endoscopic biopsy or serology were randomly assigned to a 2-wk course of (1) RBC 400 mg b.i.d. , amoxicillin 1 g b.i.d. , and clarithromycin 500 mg b.i.d. (RAC), or (2) RBC 400 mg b.i.d. , metronidazole 250 mg t.i.d. , and tetracycline 500 mg t.i.d. (RMT). Repeat breath test was performed 4 wk after the completion of therapy. Results : Intent-to-treat and per-protocol cure rates for RAC were 46 of 50 patients (92%) and 45 of 47 patients (96%); for RMT they were 40 of 50 patients (80%) and 37 of 42 patients (88%). Study drugs were stopped due to side effects in three patients (6%) taking RAC and six patients (12%) taking RMT. Conclusions : Twice-daily RBC-based triple therapy with clarithromycin and amoxicillin produces Helicobacter pylori eradication rates over 90%, which is comparable to rates seen with proton pump inhibitor-based triple therapies. RBC also may be substituted for bismuth subsalicylate and an + H2-receptor antagonist in standard bismuth-based triple therapy.