Maintenance treatment for gastro-oesophageal reflux disease. A placebo-controlled evaluation of 10 milligrams omeprazole once daily in general practice

Scand J Gastroenterol. 1997 Jul;32(7):627-32. doi: 10.3109/00365529708996509.


Background: Gastro-oesophageal reflux disease (GORD) is a frequent cause for consultation in general practice and is a chronically relapsing disease.

Methods: This general practice study was a 6-month randomized, double-blind parallel-group placebo-controlled assessment of the efficacy and safety of continuous treatment with 10 mg omeprazole every morning after initial symptom control in 495 patients with GORD but without erosive oesophagitis.

Results: On the basis of life-table estimates for cumulative relapse rates, patients in the placebo group (52%) were almost twice as likely as those in the omeprazole group (27%) to discontinue therapy before 24 weeks because of inadequate relief of heartburn or for other reasons including adverse events (all-patients-treated analysis, log rank test, P = 0.0001).

Conclusions: This study has shown that 10 mg omeprazole once daily is an effective and well-tolerated treatment strategy in general practice for the long-term management of symptoms of GORD in patients without erosive oesophagitis.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Anti-Ulcer Agents / administration & dosage*
  • Anti-Ulcer Agents / therapeutic use
  • Double-Blind Method
  • Drug Administration Schedule
  • Family Practice
  • Female
  • Gastroesophageal Reflux / drug therapy*
  • Humans
  • Life Tables
  • Male
  • Middle Aged
  • Omeprazole / administration & dosage*
  • Omeprazole / therapeutic use
  • Recurrence
  • Time Factors


  • Anti-Ulcer Agents
  • Omeprazole