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

Abstract

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.