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

Aliment Pharmacol Ther. 2003 Oct 15;18(8):791-7. doi: 10.1046/j.1365-2036.2003.01759.x.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Amoxicillin / administration & dosage
  • Amoxicillin / adverse effects
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / adverse effects
  • Anti-Ulcer Agents / administration & dosage*
  • Anti-Ulcer Agents / adverse effects
  • Breath Tests
  • Clarithromycin / adverse effects
  • Clarithromycin / therapeutic use
  • Drug Therapy, Combination / administration & dosage
  • Drug Therapy, Combination / adverse effects
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori*
  • Humans
  • Male
  • Metronidazole / administration & dosage
  • Metronidazole / adverse effects
  • Middle Aged
  • Omeprazole / administration & dosage*
  • Omeprazole / adverse effects
  • Treatment Failure

Substances

  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Metronidazole
  • Amoxicillin
  • Clarithromycin
  • Omeprazole