Discontinuation of long-term proton pump inhibitor therapy in primary care patients: a randomized placebo-controlled trial in patients with symptom relapse

Eur J Gastroenterol Hepatol. 2010 Oct;22(10):1182-8. doi: 10.1097/MEG.0b013e32833d56d1.


Background: A significant proportion of patients treated empirically with a proton pump inhibitor (PPI) present with symptoms of functional dyspepsia with a high placebo-response to therapy. It is possible that a subgroup of empirically treated patients redeem repeated prescriptions because of a positive response to therapy despite symptoms that are not acid related.

Objectives: To study whether discontinuation of long-term PPI therapy is possible in symptomatically treated patients. To investigate the effect of a PPI in patients with symptom relapse without abnormal endoscopic findings.

Methods: Seventy-eight long-term primary care PPI users without verified indication for therapy discontinued treatment. In case of symptom recurrence, an endoscopy was performed. Patients without abnormal endoscopic findings were randomized to 7 days oesomeprazole 40 mg once daily or placebo.

Results: A total of 11 of 78 (14%) patients discontinued the therapy successfully. Fifty-three of 78 patients (68%) experienced symptom recurrence. Thirty-one of 53 patients (59%) had a normal endoscopy. Successful effect of therapy after 7 days was observed in 12 of 15 patients (80%) in the oesomeprazole group versus two of 16 (13%) in the placebo group (P<0.001).

Conclusion: Discontinuation of long-term PPI therapy is possible in a minority of primary care patients. Short-term oesomeprazole was superior to placebo in patients with symptom recurrence and a normal endoscopy.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Dyspepsia / drug therapy*
  • Dyspepsia / pathology
  • Endoscopy, Gastrointestinal
  • Female
  • Heart Neoplasms
  • Humans
  • Male
  • Middle Aged
  • Omeprazole / administration & dosage
  • Omeprazole / adverse effects*
  • Placebos
  • Proton Pump Inhibitors / administration & dosage
  • Proton Pump Inhibitors / adverse effects*
  • Recurrence
  • Substance Withdrawal Syndrome / diagnosis*


  • Placebos
  • Proton Pump Inhibitors
  • Omeprazole