S1925 A Multi-Center, Randomized, Comparative Study to Determine the Appropriate Dose of Lansoprazole for the Diagnostic Test in Korean Patients with Gastroesophageal Reflux Disease

Abstract

Introduction: An empiric trial of acid suppression with a proton pump inhibitor (PPI) is widely used as a diagnostic test for gastroesophageal reflux disease (GERD). However, the report about diagnostic value of a short trial with standard dose PPI is rare. The aim of this study was to determine the onset of symptom relief with standard or double dose of lansoprazole in Korean patients with erosive esophagitis or nonerosive reflux disease (NERD). Methods: This multi-center randomized study enrolled 93 patients with erosive esophagitis (n=30) or NERD (n=63) to receive lansoprazole treatment using 30 mg or 60 mg once daily for 14 days. Between two clinical visits (at enrolment and 14 days), patients were asked to keep a diary in which they recorded severity of GERD symptoms daily. Substantial symptom relief was defined as a more than 50% reduction in total symptom score. Results: In total patients, substantial symptom relief was achieved by the end of the first week (day 6). There were no significant differences of total symptom score reductions between standard and double dose groups of patients with erosive esophagitis. But onset of substantial symptom relief was faster in the double dose group (day 2) than the standard dose group (day 6). In patients with NERD, there were no significant differences of total symptom score reductions between standard and double dose group. Onset of substantial symptom relief was same in the standard and double dose groups of patients with NERD (day 8). Conclusions: In this multi-center, randomized study of Korean patients, standard-dose lansoprazole was as effective as double-dose lansoprazole in relieving symptoms by day 14 of treatment. Onset of substantial symptom relief was slower in the patients with non-erosive reflux disease than those with erosive esophagitis.