Proton pump inhibitor or testing for Helicobacter pylori as the first step for patients presenting with dyspepsia? A cluster-randomized trial

Am J Gastroenterol. 2006 Jun;101(6):1200-8. doi: 10.1111/j.1572-0241.2006.00673.x.

Abstract

Objectives: The optimal approach for management of patients with dyspepsia has not been determined. The aim of this study was to compare the efficacy of three strategies for management of dyspepsia: empirical antisecretory therapy, testing for Helicobacter pylori (H. pylori), or a combination of the two.

Methods: Cluster-randomized trial in general practices. Initial treatment with proton pump inhibitor (PPI) was performed in 222 patients, H. pylori test-and-eradicate in 250 patients, and PPI followed by H. pylori-testing if symptoms improved in 250 patients. Symptoms, quality of life, patient satisfaction, and use of resources were recorded during a 1-yr follow-up.

Results: The prevalence of H. pylori infection was 24%. We found no difference among the three strategies (p=0.16) in terms of the proportion of days without dyspeptic symptoms. After 1 yr gastrointestinal symptom scores and quality-of-life scores had improved significantly and equally in the three groups (p<0.001), but no statistically significant differences were found among the groups. The mean use of endoscopies per patient after 1 yr was higher in the PPI group (0.36 [95% CI 0.30-0.43]) than in the test-and-eradicate group (0.28 [95% CI 0.23-0.34]) and the combination group (0.22 [95% CI 0.17-0.27]), p=0.02. H. pylori-positive patients given eradication therapy had more days without dyspeptic symptoms (p<0.001), used less antisecretory therapy (p<0.01), and were more satisfied (p<0.001) than H. pylori-negative patients.

Conclusion: The strategies based on H. pylori test enjoyed similar symptom resolution, but reduced endoscopic workload and lower 1-yr total costs compared with empirical antisecretory therapy.

Publication types

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

MeSH terms

  • Adult
  • Amoxicillin / therapeutic use
  • Anti-Ulcer Agents / therapeutic use*
  • Breath Tests
  • Clarithromycin / therapeutic use
  • Denmark / epidemiology
  • Drug Therapy, Combination
  • Dyspepsia / diagnosis*
  • Dyspepsia / drug therapy*
  • Dyspepsia / etiology
  • Female
  • Helicobacter Infections / diagnosis*
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / epidemiology
  • Helicobacter pylori*
  • Humans
  • Linear Models
  • Male
  • Middle Aged
  • Omeprazole / therapeutic use*
  • Prevalence
  • Prospective Studies
  • Statistics, Nonparametric
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Anti-Ulcer Agents
  • Amoxicillin
  • Clarithromycin
  • Omeprazole