Tailored triple plus bismuth therapy based on previous antibiotic medication history for first-line Helicobacter pylori eradication: A randomized trial.

INTRODUCTION: There are no randomized controlled trials that demonstrate the role of tailored therapy based on past medication history in improving efficacy of H. pylori eradication compared to empiric therapies. The objective of this study was to determine whether tailored triple plus bismuth therapy (TBT) can achieve higher eradication rates based on previous antibiotic history than empiric TBTs. METHODS: 800 treatment-naïve patients were randomly assigned to four groups receiving clarithromycin-, levofloxacin- or metronidazole-containing empiric TBT and tailored TBT (clarithromycin and levofloxacin chosen based on previous macrolides and quinolones medication history). Correlation analyses were performed between past medication history and resistance or eradication rate. RESULTS: The eradication rates of tailored TBT were significantly higher than clarithromycin-, levofloxacin- and metronidazole-containing empiric TBT in both intention-to-treat (89.5%, 80.8%, 81.5% and 81.5%) and per-protocol (95.1%, 86.7%, 86.5% and 87.8%) analyses (P<0.05). In patients with previous macrolides, quinolones or nitroimidazoles medication history, the resistance rates of corresponding clarithromycin, levofloxacin or metronidazole were significantly higher than patients without past medication history, and the eradication rates of corresponding clarithromycin- or levofloxacin-containing empiric TBT were significantly lower. CONCLUSION: Tailored TBT based on previous antibiotic history can achieve higher eradication rates than empiric TBT for first-line H. pylori eradication.