Randomized comparison of two nonbismuth-containing rescue therapies for Helicobacter pylori.

INTRODUCTION

A triple therapy consisting of proton pump inhibitor, amoxicillin and metronidazole or tetracycline has been recommended as the second-line regimen for Helicobacter pylori eradication if bismuth is not available. This study compared the efficacy of esomeprazole/amoxicillin/levofloxacin (EAL) and esomeprazole/amoxicillin/metronidazole (EAM) as second-line therapy for H pylori eradication.

METHODS

From April 2008 to September 2009, 90 patients who failed H pylori eradication using the standard triple therapy were randomized to receive either EAL (40 mg esomeprazole twice daily, 1 g amoxicillin twice daily and 500 mg levofloxacin once daily for 7 days) or EAM (40 mg esomeprazole twice daily, 1 g amoxicillin twice daily and 250 mg metronidazole 4 times daily for 14 days). The primary outcome variables were the rates of eradication, adverse events and compliance.

RESULTS

Our results demonstrated no differences in the eradication rates of the EAL and EAM groups in intention-to-treat analysis (68.9% versus 84.4%, respectively, P = 0.134) and per-protocol analysis (75.6% versus 88.4%, respectively, P = 0.160). Both groups exhibited similar drug compliance (EAL 95.6% versus EAM 100%, P = 0.494) and adverse events (EAL 13.3% versus EAM 8.9%, P = 0.739).

CONCLUSIONS

The 14-day EAM regimen was not inferior to the 7-day EAL regimen for second-line anti-H Pylori therapy in Taiwan. It may be an option in hospitals where bismuth salts are not available. However, regional metronidazole resistance rate and extended length of levofloxacin-base therapy should be considered.