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Effect of rabeprazole treatment on health-related quality of life and symptoms in patients with reflux esophagitis: a prospective multicenter observational study in Japan

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Abstract

Background

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.

Methods

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.

Results

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).

Conclusions

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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Acknowledgments

The authors would like to thank the physicians at the 1,326 institutions in the J-FAST (Japan F-scale and SF-8 Trial) group. This study was supported by Eisai Co., Ltd. Michio Hongo, M.D., Ph.D., serves as a consultant to Eisai Co., Ltd.; Abbott Japan Co., Ltd.; Astellas Pharma Inc.; AstraZeneca Japan; Asubio Pharma Co., Ltd.; Dainippon-Sumitomo Pharma Co., Ltd.; Kyowa Hakko Co. Ltd; Sucampo Pharmaceuticals, Inc.; Takeda Pharmaceutical Co., Ltd.; and Zeria Pharmaceutical Co., Ltd. Hiroto Miwa, M.D., Ph.D., serves as a consultant to Eisai Co., Ltd.; AstraZeneca Pharmaceuticals; AstraZeneca; Dainippon-Sumitomo Pharma Co., Ltd.; Takeda Pharmaceutical Co., Ltd.; and Tsumura & Co. Motoyasu Kusano, M.D., Ph.D., declares no conflict of interest.

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Authors and Affiliations

  1. Department of Comprehensive Medicine and Psychosomatic Medicine, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba, Sendai, Miyagi, 980-8574, Japan

    Michio Hongo

  2. Division of Upper Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan

    Hiroto Miwa

  3. Department of Endoscopy and Endoscopic Surgery, Gunma University Hospital, Maebashi, Japan

    Motoyasu Kusano

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  1. Michio Hongo
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  2. Hiroto Miwa
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  3. Motoyasu Kusano
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J-FAST group

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Correspondence to Michio Hongo.

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Hongo, M., Miwa, H., Kusano, M. et al. Effect of rabeprazole treatment on health-related quality of life and symptoms in patients with reflux esophagitis: a prospective multicenter observational study in Japan. J Gastroenterol 46, 297–304 (2011). https://doi.org/10.1007/s00535-010-0342-1

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  • DOI: https://doi.org/10.1007/s00535-010-0342-1

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