A randomized comparison of four omeprazole-based triple therapy regimens for the eradication of Helicobacter pylori in patients with non-ulcer dyspepsia

Aliment Pharmacol Ther. 2001 Nov;15(11):1787-93. doi: 10.1046/j.1365-2036.2001.01104.x.

Abstract

Background: Helicobacter pylori eradication rates in France after therapy with omeprazole, amoxicillin and clarithromycin are among the lowest in Europe. This study evaluated alternative eradication regimens.

Methods: Helicobacter pylori-positive patients (n=323) with non-ulcer dyspepsia were randomized to receive one of four 1-week regimens consisting of omeprazole, 20 mg b.d., plus either: amoxicillin, 1000 mg b.d., and clarithromycin, 500 mg b.d. (OAC); bacampicillin, 1200 mg b.d., and clarithromycin, 500 mg b.d. (OBC); clarithromycin, 250 mg b.d., and metronidazole, 500 mg b.d. (OCM); or amoxicillin, 1000 mg b.d, and azithromycin, 500 mg on day 1 and 250 mg on days 2-5 (OAAz). Eradication was confirmed by urea breath test 4-6 weeks after treatment. Susceptibility testing was performed in the case of eradication failure.

Results: The eradication rate with OAAz was 38% (95% CI, 25.6-49.4) on intention-to-treat analysis, which was lower (P < 0.05) than with the other regimens [OCM, 61% (50.0-72.8); OBC, 65% (54.0-76.5); OAC, 72% (61.8-81.8)]. Of the strains isolated following treatment failure with OAC, OBC or OCM, 84% were clarithromycin resistant.

Conclusions: OAC remains the reference treatment for H. pylori eradication in France, although bacampicillin offers a useful alternative to amoxicillin. Susceptibility testing should be considered after unsuccessful eradication therapy.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Amoxicillin / administration & dosage
  • Ampicillin / administration & dosage
  • Ampicillin / analogs & derivatives*
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / pharmacology*
  • Azithromycin / administration & dosage
  • Breath Tests
  • Clarithromycin / administration & dosage
  • Drug Therapy, Combination
  • Dyspepsia / drug therapy
  • Dyspepsia / etiology*
  • Dyspepsia / microbiology
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / pathology
  • Helicobacter pylori / pathogenicity*
  • Humans
  • Male
  • Metronidazole / administration & dosage
  • Omeprazole / administration & dosage
  • Omeprazole / pharmacology*
  • Penicillins / administration & dosage
  • Treatment Outcome
  • Urea / analysis

Substances

  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Penicillins
  • Metronidazole
  • Ampicillin
  • Amoxicillin
  • Azithromycin
  • bacampicillin
  • Urea
  • Clarithromycin
  • Omeprazole