Heartburn without Oesophagitis: Efficacy of Omeprazole Therapy and Features Determining Therapeutic Response

Abstract

Background: Data are limited on the value of effective antisecretory therapy in the relief of heartburn in patients without oesophagitis. Methods: Patients with heartburn, without endoscopic signs of oesophagitis, were randomized to double-blind treatment with omeprazole, 20 or 10 mg once daily, or placebo, for 4 weeks (n = 509). Pre-treatment oesophageal acid exposure was assessed using 24-h intra-oesophageal pH monitoring. Heartburn was assessed at 2 and 4 weeks. Results: At 4 weeks the proportion of patients with complete absence of heartburn was 46% (95% confidence interval, 39-53%) with 20 mg omeprazole, 31% (25-38%) with 10 mg omeprazole, and 13% (7-20%) with placebo. Satisfaction with therapy was reported by 66%, 57%, and 31% of the patients, respectively. Conclusions: Omeprazole, 20 and 10 mg once daily, provides rapid relief of heartburn in patients without endoscopic oesophagitis.

Key Words:

• Endoscopy-negative
• gastro-oesophageal reflux
• heartburn
• omeprazole
• placebo
• pH monitoring