Efficacy of a high-dose proton pump inhibitor in patients with gastroesophageal reflux disease: a single center, randomized, open-label trial

Jae Ho Cho, Cheol Min Shin, Hyuk Yoon, Young Soo Park, Nayoung Kim, Dong Ho Lee, Jae Ho Cho, Cheol Min Shin, Hyuk Yoon, Young Soo Park, Nayoung Kim, Dong Ho Lee

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: 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.

Keywords: Extraesophageal manifestation; Gastroesophageal reflux disease; Proton pump inhibitor; Rabeprazole.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Overview of the study design. q.d. Once daily, b.i.d. twice daily
Fig. 2
Fig. 2
Flow diagram of study patients

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