This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. It is estimated that about 7% of the US population experience heartburn daily and 20% experience it on a weekly basis (1). Heartburn is attributed to the reflux of acid from the stomach into the esophagus. The first scientific evidence that acid causes heartburn was provided by Baker and Bernstein who found that instillation of 0.1 N HC1 into the esophagus reproduces heartburn and chest pain (2). The esophagus is lined by a moist stratified squamous epithelium. In humans, this epithelium when healthy, as evidenced by the Bernstein test, has considerable capacity to resist damage and to prevent symptoms even upon direct contact with high concentrations of luminal acid. This intrinsic property of the epithelium to defend itself against luminal acid is call 'tissue resistance' (3). When the epithelium is damaged, acid from the esophageal lumen leaks across the defective barrier and stimulates acid sensitive nerve endings to cause heartburn. Electron microscopy of the mucosa in subjects with heartburn shows dilated intercellular spaces in between the squamous epithelial cells, which indicates a broken barrier that allows acid to gain access to the sensory nerve endings (4). Proton pump inhibitors are a class of agent that suppresses gastric acid. They have shown to heal the macroscopic lesions of esophagitis and control symptoms of heartburn when used for 8-12 weeks. The present study seeks to determine if treatment with a Food and Drug Administration (FDA) approved regimen of an over-the-counter (OTC) proton pump inhibitor for 2 weeks is sufficient to heal the microscopic damage that is present in subjects with heartburn and no erosive changes on endoscopy. The ability to document this would add considerably to our understanding of the rapidity of healing of microscopic esophageal damage from reflux and document that OTC therapy with a proton pump inhibitor may not only control symptoms but also heals milder forms of reflux disease in short term use. Heartburn, a common medical symptom, is the result of acid reflux into the esophagus and reflects the presence of a broken epithelial barrier to acid assess to the sensory nerve endings in the tissue.
The aim of the study is to assess the efficacy of omeprazole magnesium 20 mg (Prilosec OTC) in comparison to placebo with respect to its ability to control symtoms and heal the microscopic esophageal damage in subjects with non-erosive esophagitis (no macroscopic lesions on endoscopy).
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