A Multicenter, Randomized, Open-labeled Trial: Efficacy of Once-daily vs. Twice-daily Double-Dose Rabeprazole on Refractory Gastroesophageal Reflux Disease-Related Symptoms and Quality of Life

• Published in: Current therapeutic research 2016
• Main Authors: Mizuki, Akira, Tatemichi, Masayuki, Sakakibara, Terue, Miura, Yukihiko, Zeki, Shigeyuki, Ohata, Mitsuru, Matsuo, Kenji, Kawamura, Fumio, Nagata, Hiroshi
• Format: Article
• Language: English
• Subjects: Internal Medicine; Medical Education
• ISSN: 0011-393X
• DOI: 10.1016/j.curtheres.2016.11.002

Abstract Purpose Approximately 20%–40% of patients with gastroesophageal reflux disease (GERD) are refractory to standard-dose proton-pump inhibitor (PPI) treatment. We compared the efficacy and quality-of-life (QOL) effects of 20-mg once-daily vs. 10-mg twice-daily rabeprazole (RPZ) in patients with refractory GERD-related symptoms and sleep disturbances. Method This multicenter, prospective, randomized, open labeled study included patients in whom PPI treatment of >4 weeks was ineffective. According to the Global Overall Symptom (GOS) scale, PPI-refractory GERD was defined as ≥1 category with >3 points among 10 specific upper gastrointestinal (GI) symptoms. Seventy-eight patients were randomly assigned to 20 mg × 1 and 10 mg × 2 RPZ groups for 8 weeks. Efficacy was evaluated using self-reported questionnaires, including the GOS scale and Pittsburg Sleep Quality Index (PSQI), whereas QOL was assessed using the Short-Form 8 (SF-8) Health Survey, at 4 and 8 weeks. Patients showing improvement at 8 weeks were followed up every 4-8 weeks. Results GOS scores were significantly improved at 8 weeks in both groups, with no significant intergroup differences. Although SF-8 scores showed an increasing trend over 8 weeks in both groups, the physical component summaries in the 10 mg × 2 group significantly improved. The mental component summaries clearly improved in the 10 mg × 2 group. Of the 74 cases (4 missing), 51 (68.9%) had PSQI scores ≥5.5. PSQI scores remained unchanged during follow up in both groups. The recurrence rate was not significantly different (46.1% vs 47.1% in the 20 mg × 1 and 10 mg × 2 groups, respectively) during the follow-up period at [median (interquartile range)] 24.0 (30.5) months. Conclusion In patients with refractory GERD, there was no significant difference in GOS, PSQI, or recurrence rate between the groups. With regards to sub-scores of SF-8, however, the 10 mg twice-daily RPZ group might be potentially effective.