Randomized study of two "rescue" therapies for Helicobacter pylori-infected patients after failure of standard triple therapies

OBJECTIVES: A novel rifabutin-based therapy is able to cure Helicobacter py lori infection in most patients who have failed eradication after standard proton pump inhibitor (PPI)based triple therapy. We compared this regimen w ith 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 citr ate 240 mg b.i.d., and tetracycline 500 mg q.i.d. (QT group). Before therap y, patients underwent endoscopy with biopsies for histology, culture and an tibiotic susceptibility tests. H. pylori eradication was assessed by the C- 13-urea breath test. RESULTS: On intention-to-treat analysis, eradication rates (with 95% confid ence intervals [CI]) were 66.6% (53-80%) in the RAP(150) and QT groups, res pectively, and 86.6% (76-96%) in RAP(300) group (p < 0.025). Most patients harboring metronidazole- and clarithromycin-resistant strains were eradicat ed at an equal rate by each of the three regimens. Side effects were observ ed in 9% and 11% of rifabutin-treated patients, and in 47% of those on quad ruple therapy (p < 0.0001). CONCLUSIONS: In patients who failed standard eradicating treatments, a 10-d ay course of rifabutin with pantoprazole and amoxycillin is more effective and well tolerated than the quadruple therapy. (Am J Gastroenterol 2001;96. 58-62. (C) 2001 by Am. Coll. of Gastroenterology).