On demand therapy with omeprazole for the long‐term management of patients with heartburn without oesophagitis—a placebo‐controlled randomized trial

Aim : To observe the natural course of gastro‐oesophageal reflux disease (GERD) in patients without oesophagitis following effective symptom relief, and to determine the place of acid pump inhibitor therapy in the long‐term management of these patients. Methods : We investigated the efficacy of on‐demand therapy with omeprazole 20 mg or 10 mg, or placebo in a double‐blind, randomized multicentre trial. It involved 424 patients with troublesome heartburn without endoscopic evidence of oesophagitis in whom heartburn had been resolved with short‐term treatment. Patients were told to take study medication on demand once daily on recurrence of symptoms until symptoms resolved over a 6‐month period. They also had access to antacids. The primary efficacy variable was time to discontinuation of treatment, due to unwillingness to continue. Results : According to life‐table analysis, after 6 months the remission rates were 83% (95% CI: 77–89%) with omeprazole 20 mg, 69% (61–77%) with omeprazole 10 mg, and 56% (46–64%) with placebo (P