A prospective, randomized study of quadruple therapy and high-dose dual therapy for treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin

Helicobacter. 2003 Aug;8(4):310-9. doi: 10.1046/j.1523-5378.2003.00158.x.

Abstract

Background and aim: Failure of primary anti-H. pylori therapy results in a high rate of antimicrobial resistance. Here, we investigated the efficacy of high-dose dual therapy and quadruple therapy as salvage treatments for eradication of H. pylori resistant to both metronidazole and clarithromycin.

Patients and methods: Patients with at least one treatment failure and infected with H. pylori resistant to both metronidazole and clarithromycin, were randomized to receive either omeprazole 4 x 40 mg and amoxicillin 4 x 750 mg; or omeprazole 2 x 20 mg, bismuthcitrate 4 x 107 mg, metronidazole 4 x 500 mg and tetracycline 4 x 500 mg. Both regimens were given for 14 days. In cases of persistent infection, a cross-over therapy was performed.

Results: Eighty-four patients were randomized. Cure of H. pylori infection was achieved in 31 patients after dual therapy and in 35 patients after quadruple therapy (per protocol: 83.8% (95% CI, 67.9-93.8) and 92.1% (95% CI, 78.6-98.3), respectively (p=0.71); intention to treat: 75.6% (95% CI: 59.7-87.6) and 81.4% (95% CI: 66.6-91.6), respectively (p=0.60)). Cross-over therapy was performed in six of nine patients, four of whom were cured of the infection.

Conclusion: Both high-dose dual therapy and quadruple therapy are effective in curing H. pylori infection resistant to both metronidazole and clarithromycin in patients who experienced previous treatment failures.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Amoxicillin / administration & dosage
  • Amoxicillin / therapeutic use
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / therapeutic use*
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / therapeutic use*
  • Bismuth / administration & dosage
  • Bismuth / therapeutic use
  • Clarithromycin / pharmacology
  • Drug Resistance, Multiple, Bacterial
  • Drug Therapy, Combination
  • Female
  • Gastric Mucosa / microbiology
  • Gastric Mucosa / pathology
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / microbiology
  • Helicobacter pylori / drug effects*
  • Helicobacter pylori / genetics
  • Humans
  • Male
  • Metronidazole / administration & dosage
  • Metronidazole / pharmacology
  • Metronidazole / therapeutic use
  • Middle Aged
  • Omeprazole / administration & dosage
  • Omeprazole / therapeutic use
  • Organometallic Compounds / administration & dosage
  • Organometallic Compounds / therapeutic use
  • Penicillins / therapeutic use
  • Tetracycline / administration & dosage
  • Tetracycline / therapeutic use
  • Urea / analysis

Substances

  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Organometallic Compounds
  • Penicillins
  • Metronidazole
  • Amoxicillin
  • Urea
  • Tetracycline
  • Clarithromycin
  • bismuth tripotassium dicitrate
  • Omeprazole
  • Bismuth