Seven-day rifabutin containing triple therapy versus seven-day levofloxacin containing quadruple therapy as second-line treatment for Helicobacter pylori in Chinese patients: an open label, randomized trial

Abstract

INTRODUCTION: Rifabutin containing triple therapy (RIF) and levofloxacin containing quadruple therapy (QUAD) has been used as rescue therapy for resistant H. pylori infection. We compared the efficacy and tolerability of 7-day RIF with 7-day QUAD as second-line treatment for H. pylori infection. Levofloxacin was used instead of bismuth subcitrate for the quadruple therapy, as bismuth is no longer available in Hong Kong. METHODS: Patients who have failed the triple therapy (esomeprazole, amoxicillin, and clarithromycin) and remained H. pyloripositive were randomly assigned to receive either 7-day RIF (esomeprazole, rifabutin and amoxicillin) or QUAD (esomeprazole, levofloxacin, tetracycline and metronidazole) treatments. H. pylori eradication was confirmed by urea breath test at 8 weeks. The primary outcome was the eradication rates by intention-to-treat (ITT) and per-protocol (PP) analyses. RESULTS: One hundred and fifty-one patients were randomized to receive either RIF or QUAD. The PP eradication rate of the RIF and QUAD groups were 89.3% and 95.6%, respectively (P = 0.16). Base on ITT analysis, the corresponding eradication rate was 88.2% and 90.7% (P = 0.62). One patient (1.3%) in the RIF and seven (9.3%) patients in the QUAD failed to complete the treatment regime. The overall incidences of adverse events were higher in the QUAD (30.7%) than in the RIF (15.8%) group (P = 0.03). CONCLUSION: Seven-day rifabutin containing triple therapy and levofloxacin containing quadruple therapy are both highly effective and should be considered as second-line treatment for resistant H. pylori infection.