Randomized study of two “rescue” therapies for helicobacter pylori-infected patients after failure of standard triple therapies

Abstract

OBJECTIVES: A novel rifabutin-based therapy is able to cure Helicobacter pylori infection in most patients who have failed eradication after standard proton pump inhibitor (PPI)based triple therapy. We compared this regimen with the quadruple therapy. METHODS: A total of 135 patients were randomized into three groups who were treated for 10 days with pantoprazole 40 mg b.i.d., amoxycillin 1 g b.i.d., and rifabutin 150 mg o.d. (RAP 150 group), or 300 mg o.d. (RAP 300 group), and pantoprazole 40 mg b.i.d., metronidazole 250 mg t.i.d., bismuth citrate 240 mg b.i.d., and tetracycline 500 mg q.i.d. (QT group). Before therapy, patients underwent endoscopy with biopsies for histology, culture and antibiotic susceptibility tests. H. pylori eradication was assessed by the 13C-urea breath test. RESULTS: On intention-to-treat analysis, eradication rates (with 95% confidence intervals [CI]) were 66.6% (53–80%) in the RAP 150 and QT groups, respectively, and 86.6% (76–96%) in RAP 300 group ( p < 0.025). Most patients harboring metronidazole- and clarithromycin-resistant strains were eradicated at an equal rate by each of the three regimens. Side effects were observed in 9% and 11% of rifabutin-treated patients, and in 47% of those on quadruple therapy ( p < 0.0001). CONCLUSIONS: In patients who failed standard eradicating treatments, a 10-day course of rifabutin with pantoprazole and amoxycillin is more effective and well tolerated than the quadruple therapy.