Empiric treatment with high and standard dose of omeprazole in general practice: two-week randomized placebo-controlled trial and 12-month follow-up of health-care consumption

Am J Gastroenterol. 2004 Jun;99(6):1050-8. doi: 10.1111/j.1572-0241.2004.30089.x.


Objectives: Patients with acid-related symptoms in general practice are often treated empirically with a standard dose of proton pump inhibitors (PPIs). The effect of higher doses is not known. The study compared the immediate symptom relieving as well as the long-term effect of standard and double dose of omeprazole in such patients.

Methods: Consecutive patients with dyspeptic symptoms, normally treated by the general practitioner with PPIs or H2-blockers were randomized to treatment with omeprazole 40 mg, 20 mg, or placebo in the morning for 2 wk. Patients with alarm symptoms, IBS, and PPI-treated patients were excluded. Dyspeptic symptoms and Helicobacter pylori status were recorded. The study endpoint was complete relief of the dyspeptic symptoms, which initiated the consultation. Relapse rates and health-care consumption were recorded during 12-month observation.

Results: Eight hundred and twenty-nine patients were randomized. Complete relief of the predominant symptom was obtained by 66%, 63%, and 35% in patients treated with omeprazole 40 mg, 20 mg, and placebo, respectively. No difference was found comparing H. pylori-positive and -negative patients. Relapse rates were high and health-care consumption during 12 months was related to the treatment outcome, but not to the omeprazole dose or the H. pylori status.

Conclusions: Compared to placebo, omeprazole 40 mg and 20 mg were equally and significantly better in relieving acid-related symptoms; the numbers needed-to-treat (NNT) were 3.2 (40 mg) and 3.7 (20 mg). Relief of the dyspeptic complaint was followed by significantly reduced health-care consumption during 12-month observation.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Delivery of Health Care / statistics & numerical data
  • Denmark
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Dyspepsia / diagnosis*
  • Dyspepsia / drug therapy*
  • Enzyme Inhibitors / administration & dosage
  • Family Practice / methods
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Omeprazole / administration & dosage*
  • Patient Satisfaction
  • Probability
  • Recurrence
  • Reference Values
  • Risk Assessment
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome


  • Enzyme Inhibitors
  • Omeprazole