On demand therapy with omeprazole for the long-term management of patientswith heartburn without oesophagitis - a placebo-controlled randomized trial

Aim: To observe the natural course of gastrooesophageal reflux disease (GER D) in patients without oesophagitis following effective symptom relief, and to determine the place of acid pump inhibitor therapy in the long-term man agement 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 evi dence of oesophagitis in whom heartburn had been resolved with short-term t reatment. Patients were told to take study medication on demand once daily on recurrence of symptoms until symptoms resolved over a 6-month period. Th ey also had access to antacids. The primary efficacy variable was time to d iscontinuation of treatment, due to unwillingness to continue. Results: According to life-table analysis, after 6 months the remission rat es were 83% (95% CI: 77-89%) with omeprazole 20 mg, 69% (61-77%) with omepr azole 10 mg, and 56% (46-64%) with placebo (P < 0.01 for all intergroup dif ferences). The mean (s.d.) number of study medications used per day in thes e groups was 0.43 (0.27), 0.41 (0.27) and 0.47 (0.27), respectively. The us e of antacids was highest in the placebo group and lowest in the omeprazole 20 mg group. Treatment failure was associated with more than a doubling of antacid use, and a deterioration in patient quality of life. Conclusions: Approximately 50% of patients with heartburn who do not have o esophagitis need acid inhibitory therapy in addition to antacid medication to maintain a normal quality of life, On-demand therapy with omeprazole 20 mg, is an effective treatment strategy in these patients.