Prevention of peptic ulcer and dyspeptic symptoms with omeprazole in patients receiving continuous non-steroidal anti-inflammatory drug therapy. A Nordic multicentre study

Scand J Gastroenterol. 1996 Aug;31(8):753-8. doi: 10.3109/00365529609010347.


Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are known to cause gastroduodenal lesions and dyspeptic symptoms.

Methods: Patients with a history of dyspepsia or uncomplicated peptic ulcer disease and with a need for continuous NSAID treatment were randomized to receive either 20 mg omeprazole once daily or placebo. Gastroduodenal ulcers, erosions, and dyspeptic symptoms were evaluated after 1 and 3 months.

Results: During a 3-month study period 4.7% (4 of 85) of omeprazole-treated patients developed peptic ulcer, compared with 16.7% (15 of 90) of patients treated with placebo. This prophylactic effect of omeprazole was sustained independently of previous peptic ulcer history or Helicobacter pylori status. Development of dyspeptic symptoms requiring active treatment, either alone or in combination with ulcer(s) or erosions, occurred in 15.3% (15 of 85) of patients treated with omeprazole and 35.6% of those who received placebo.

Conclusions: Omeprazole, 20 mg once daily, provides effective prophylactic therapy in patients at risk of developing NSAID-associated peptic ulcers or dyspeptic symptoms.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Anti-Ulcer Agents / therapeutic use*
  • Double-Blind Method
  • Dyspepsia / chemically induced
  • Dyspepsia / microbiology
  • Dyspepsia / prevention & control*
  • Female
  • Helicobacter Infections / diagnosis
  • Helicobacter pylori / isolation & purification
  • Humans
  • Male
  • Middle Aged
  • Omeprazole / therapeutic use*
  • Peptic Ulcer / chemically induced
  • Peptic Ulcer / microbiology
  • Peptic Ulcer / prevention & control*
  • Prognosis
  • Regression Analysis


  • Anti-Inflammatory Agents, Non-Steroidal
  • Anti-Ulcer Agents
  • Omeprazole