Second-line treatment for failure to eradicate Helicobacter pylori:: a randomized trial comparing four treatment strategies

Aim: To compare the efficacy of different regimens in patients in whom previous Helicobacter pylori eradication therapy has failed. Methods: In this study named StratHegy patients (n = 287) were randomized to receive one of three empirical triple therapy regimens or a strategy based on antibiotic susceptibility. The empirical regimens were omeprazole, 20 mg b.d., plus amoxicillin, 1000 mg b.d., and clarithromycin, 500 mg b.d., for 7 days (OAC(7)), clarithromycin, 500 mg b.d., for 14 days (OAC(14)) or metronidazole, 500 mg b.d., for 14 days (OAM(14)). In the susceptibility-based strategy, patients with clarithromycin-susceptible strains received OAC(14), whilst the others received OAM(14). The C-13-urea breath test was performed before randomization and 4-5 weeks after eradication therapy. Results: In the intention-to-treat analysis, the eradication rates for empirical therapies were as follows: OAC(7), 47.4% (27/57); OAC(14), 34.5% (20/58); OAM(14), 63.2% (36/57); it was 74.3% (84/113) for the susceptibility-based treatment (P < 0.01 when compared with OAC(7) and OAC(14)). In patients receiving clarithromycin, the eradication rates were 80% for clarithromycin-susceptible strains and 16% for clarithromycin-resistant strains; in patients receiving OAM(14), the eradication rates were 81% for metronidazole-susceptible strains and 59% for metronidazole-resistant strains. Conclusions: Eradication rates of approximately 75% can be achieved with second-line triple therapy based on antibiotic susceptibility testing. If susceptibility testing is not available, OAM(14) is an appropriate alternative.