A Multicenter, Randomized, Comparative Study to Determine the Appropriate Dose of Lansoprazole for Use in the Diagnostic Test for Gastroesophageal Reflux Disease

Abstract

Background/Aims: The diagnostic proton pump inhibitor test (PPI test) is a method used in diagnosing gastroesophageal reflux disease (GERD). This study aimed to determine the appropriate dose of lansoprazole for use in the diagnostic test for GERD. Methods: This study was a randomized, controlled, multicenter trial in the Daegu-Gyeongbuk area. Patients with typical reflux symptoms such as regurgitation and heartburn for at least three months were enrolled in this study. Patients were divided into two groups, the erosive reflux disease (ERD) group and the non-erosive reflux disease (NERD) group, and randomized to 14 days of treatment with lansoprazole at a dose of 15 mg, 30 mg or 60 mg once daily. The PPI test was considered positive if the patient’s symptoms improved by more than 50%. Results: A total of 218 patients were enrolled, and analysis was performed on the 188 patients who completed the study. The PPI test was positive in 93.2% of the ERD group and 87.2% of the NERD group. A positive PPI test was observed in 91.7%, 89.4%, and 87.2% of the 15 mg, 30 mg, and 60 mg groups, respectively. Significant symptom score changes were observed starting on day 8 for the 15 mg, 30 mg, and 60 mg groups. Conclusions: In this multicenter, randomized study of Korean patients, the standard dose of lansoprazole was as effective as a high dose of lansoprazole in relieving the symptoms of GERD, regardless of the presence of ERD, by day 14 of treatment. (Gut Liver 2011;5:302-307)