Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis

Background: Up to three quarters of patients with gastroesophageal reflux d isease (GERD) have symptoms, such as heartburn, but no macroscopic evidence of erosive esophagitis, making symptomatic GERD a common clinical problem in the primary care setting. Objective: To compare the efficacy and safety of omeprazole, 20 mg once dai ly; omeprazole, 10 mg once daily; and placebo in the treatment of symptomat ic GERD without erosive esophagitis. Methods: Patients with a history of heartburn (greater than or equal to 12 months) and episodes of moderate to severe heartburn on 4 or more of the 7 days before endoscopy were eligible to participate in this dr-week, randomi zed, double-blind, placebo-controlled trial. The absence of erosive esophag itis was established through endoscopy. Eligible patients were randomized t o 1 of 3 treatment groups: omeprazole, 20 mg once daily; omeprazole, 10 mg once daily; or placebo. Patients were assessed at weeks 2 and 4. The effica cy of omeprazole for the treatment of heartburn was determined mainly throu gh the following diary card data: daily resolution of heartburn and complet e resolution of heartburn every day during 1 week of treatment. The efficac y of omeprazole for the treatment of acid regurgitation, dysphagia, epigast ric pain, and nausea was also assessed. Results: Of 359 randomized patients, 355 were included in the statistical a nalysis (intention-to-treat population). Daily proportions of patients with no heartburn were consistently greater in the 20-mg omeprazole group (62%, day 7; 74%, day 27) than in the 10-mg omeprazole group (41%, day 7; 49%, d ay 27) or the placebo group (14%, day 7; 23%; day 27). Complete resolution of heartburn every day during the last treatment week was significantly (P less than or equal to.002) higher in the 20-mg omeprazole group (48%) than in the 10-mg omeprazole (27%) or placebo (5%) group. Omeprazole was signifi cantly (P less than or equal to.003) more effective than placebo for the tr eatment of acid regurgitation, dysphagia, epigastric pain, and nausea. Conclusions: Patients with symptomatic GERD require profound acid suppressi on to achieve symptomatic relief. Omeprazole, 20 mg once daily, was superio r to omeprazole, 10 mg once daily, and to placebo in providing early and su stained resolution of heartburn, as well as treatment of other troublesome GERD symptoms.