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- Title
Efficacy of a high-dose proton pump inhibitor in patients with gastroesophageal reflux disease: a single center, randomized, open-label trial.
- Authors
Cho, Jae Ho; Shin, Cheol Min; Yoon, Hyuk; Park, Young Soo; Kim, Nayoung; Lee, Dong Ho
- Abstract
<bold>Background: </bold>The extraesophageal manifestations of gastroesophageal reflux disease (GERD) are more difficult to manage than the typical symptoms. The efficacy of high-dose and standard-dose proton pump inhibitors against these atypical symptoms is not yet established.<bold>Methods: </bold>In this single center, randomized, open-label study, patients with GERD received rabeprazole for 8 weeks, either 20 mg once daily (standard-dose group) or 20 mg twice daily (high-dose group). Patients were assessed before treatment and at weeks 4 and 8 with a 5-graded scale questionnaire consisting of 2 typical symptoms (heartburn and acid regurgitation) and 8 atypical symptoms (chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching, and dysphagia). Sufficient improvement of reflux symptoms was defined as ≥50% reduction from the initial questionnaire score.<bold>Results: </bold>Final analyses included 35 patients in the standard-dose group and 38 patients in the high-dose group. The rate of sufficient improvement for typical symptoms was significantly higher in the high-dose group than in the standard-dose group (100.0% vs. 84.0%, P = 0.040). For atypical symptoms, the rate of sufficient improvement tended to be higher in the high-dose group than in the standard-dose group (82.4% vs. 63.0%, P = 0.087). Scores of typical and some atypical symptoms (cough and globus) improved after treatment, with significant inter-group differences in time-course changes.<bold>Conclusions: </bold>High-dose rabeprazole is more effective for relieving typical GERD symptoms and some atypical symptoms such as cough and globus than a standard-dose regimen.<bold>Trial Registration: </bold>This research was enrolled in a registry of clinical trials run by United States National Library of Medicine at the National Institutes of Health ( ClinicalTrials.gov Protocol Registration and Results system ID: NCT04001400 ). This study was registered on June 26, 2019 - Retrospectively registered.
- Subjects
NATIONAL Library of Medicine (U.S.); NATIONAL Institutes of Health (U.S.); PROTON pump inhibitors; GASTROESOPHAGEAL reflux; FUNDOPLICATION; SYMPTOMS; CLINICAL trial registries; NATIONAL libraries; TREATMENT effectiveness; RANDOMIZED controlled trials; QUESTIONNAIRES; HEARTBURN; STATISTICAL sampling
- Publication
BMC Gastroenterology, 2020, Vol 20, Issue 1, pN.PAG
- ISSN
1471-230X
- Publication type
journal article
- DOI
10.1186/s12876-020-01410-z