Abstract
Despite many reports from Western nations describing endoscopic and symptomatic improvements in patients with reflux esophagitis (RE) using proton pump inhibitors (PPI), PPI effects on the health-related quality of life (HRQOL), particularly for a dose duration of less than 8 weeks, have not been sufficiently clarified in Japanese RE patients. RE patients (n = 9,029) in general practice settings took rabeprazole once daily for 8 weeks. HRQOL, using the 8-item Short-Form Health Survey (SF-8™), and symptoms, using a frequency scale for the symptoms of gastroesophageal reflux disease (GERD), were evaluated at the initiation of therapy (0 W), week 4 (4 W), and week 8 (8 W). Endoscopy was performed at 0 and 8 W where possible. In efficacy analysis (n = 6,839), the mean ± SD values for the physical component summary of the SF-8™ at 0, 4, and 8 W were 45.005 ± 7.534, 48.517 ± 6.336, and 49.328 ± 6.207, respectively, while those for the mental component summary were 46.465 ± 7.743, 49.460 ± 6.470, and 50.388 ± 6.049, respectively. Significant improvements, compared to 0 W, were observed in eight domains and two summary scores at 4 W (P < 0.001), and further QOL score elevations were seen by 8 W. Regarding symptoms, the mean total frequency scale for the symptoms of GERD (FSSG) scores at 0, 4, and 8 W were 16.4 ± 9.8, 7.8 ± 7.4, and 6.0 ± 6.8, respectively. Significant improvements, compared to 0 W, were seen in the total, reflux, and dysmotility scores and in the scores for all 12 items at 4 W (P < 0.001). The score for the HRQOL of RE patients before rabeprazole therapy was below 50 points (the national mean for the general Japanese population), indicating harmed QOL. Rabeprazole markedly improved the HRQOL at 4 W, with recovery to the national mean by 8 W. Symptoms had also improved significantly at 4 W, with further improvements observed at 8 W.
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