A Multicenter, Randomized, Open-Label Trial: Efficacy of Once-Daily Versus Twice-Daily Double-Dose Rabeprazole on Refractory Gastroesophageal Reflux Disease-Related Symptoms and Quality of Life

• Published in: Current therapeutic research 2016-01, Vol.79, p.1-7
• 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: Original Research; proton-pump inhibitor; quality of life; refractory gastroesophageal reflux disease; sleep disturbances
• ISSN: 0011-393X; 1879-0313
• DOI: 10.1016/j.curtheres.2016.11.002

Approximately 20% to 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 effects of 20 mg once daily (QD) versus 10 mg twice daily (BID) rabeprazole (RPZ) in patients with refractory GERD-related symptoms and sleep disturbances. This multicenter, prospective, randomized, open-label study included patients in whom PPI treatment >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 symptoms. Seventy-eight patients were randomly assigned to 20 mg QD and 10 mg BID RPZ groups for 8 weeks. Efficacy was evaluated using self-reported questionnaires, including the GOS scale and Pittsburg Sleep Quality Index (PSQI), whereas quality of life was assessed using the Short-Form 8 Health Survey (SF-8), at 4 and 8 weeks. Patients showing improvement at 8 weeks received follow-up every 4 to 8 weeks. GOS scale 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 BID group significantly improved. The mental component summaries clearly improved in the 10 mg BID 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 QD and 10 mg BID groups, respectively) during the follow-up period at median (interquartile range) 24.0 (30.5) months. In patients with refractory GERD, there was no significant difference in GOS scale score, PSQI, or recurrence rate between the groups. With regard to subscores of the SF-8, the 10 mg BID group might be potentially effective. •This multicenter prospective randomized comparative study compares the efficacy on symptoms, QOL and sleep disturbance between two ways of double dose PPI; once-daily 20mg RPZ or twice-daily 10mg RPZ.•The patients with PPI refractory GERD were suffered from severe acid reflux symptoms, sleep disturbance and general distress. For these reasons, to establish the treatments to refractory GERD was important to improve their QOL. In patients with refractory GERD, there was no significant difference in GOS, PSQI, or recurrence rate between the groups.