Randomized comparison of two nonbismuth-containing rescue therapies for Helicobacter pylori
Abstract
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…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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