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

Abstract

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 (OAC₇), clarithromycin, 500 mg b.d., for 14 days (OAC₁₄) or metronidazole, 500 mg b.d., for 14 days (OAM₁₄). In the susceptibility‐based strategy, patients with clarithromycin‐susceptible strains received OAC₁₄, whilst the others received OAM₁₄. The ¹³C‐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: OAC₇, 47.4% (27/57); OAC₁₄, 34.5% (20/58); OAM₁₄, 63.2% (36/57); it was 74.3% (84/113) for the susceptibility‐based treatment (P < 0.01 when compared with OAC₇ and OAC₁₄). In patients receiving clarithromycin, the eradication rates were 80% for clarithromycin‐susceptible strains and 16% for clarithromycin‐resistant strains; in patients receiving OAM₁₄, 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, OAM₁₄ is an appropriate alternative.