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A Study on the Efficacy of Rebamipide for Patients with Proton Pump Inhibitor-Refractory Non-Erosive Reflux Disease

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Abstract

Background and Aim

Reflux symptoms in patients with non-erosive reflux disease (NERD) cannot be easily controlled by treatment with proton pump inhibitors (PPI). The anti-inflammatory function of rebamipide may be effective for protecting the esophageal mucosa. This prospective randomized multicenter placebo-controlled study was performed to clarify the efficacy of rebamipide for NERD patients whose reflux symptoms were refractory to PPI treatment.

Methods

One hundred forty-nine patients were enrolled on the basis of a QUEST score of over 6 and absence of endoscopically proven esophageal mucosal breaks. All the patients were initially administered 15 mg of lansoprazole for 4 weeks, and the symptoms were then assessed using QUEST and GSRS. PPI-refractory patients were randomly assigned to administration of rebamipide or placebo t.i.d. for 4 weeks.

Results

Three of the 149 patients were lost to follow-up, and 60 among the remaining 146 patients were found to be PPI-refractory. Among these PPI-refractory patients, 31 were randomly assigned to a rebamipide group and 29 to a placebo group. At the end of drug administration, the QUEST and GSRS scores did not differ between the rebamipide and placebo groups, although a significantly higher proportion of patients in the rebamipide group showed amelioration of abdominal pain and diarrhea.

Conclusion

Administration of rebamipide cannot effectively control reflux symptoms in NERD patients whose symptoms are refractory to PPI therapy.

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Acknowledgments

We wish to thank Ms Keiko Kawakami for her secretarial assistance. The authors gratefully acknowledge individuals who helped identify cases and collected clinical data: Fujishiro H. and Miyaoka Y. at Shimane Prefectural Hospital; Fujisawa T. at Matsue Red Cross Hospital; Kawashima K. at Matsue Coop Hospital; Karino T., Furuta K. and Mishima I. at Masuda Medical Association Hospital; Nagami H. at Nagami Clinic; Kawamura A. and Ebisutani C. at Ono Municipal Hospital; Shibagaki K. at Tottori Municipal Hospital; Takashima T. at Takatsuki General Hospital; Unakami H. and Horii T. at Tohoku University Graduate School of Medicine. Kyoichi Adachi, Hiroto Miwa, Katsuhiko Iwakiri, Takahisa Furuta, Tomoyuki Koike, Tomohiko Shimatani and Yoshikazu Kinoshita had received research funding from Otsuka Pharmaceutical Co. Ltd.

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Authors and Affiliations

  1. Department of Clinical Nursing, Shimane University Faculty of Medicine, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan

    Kyoichi Adachi

  2. Department of Gastroenterology and Hepatology, Shimane University Faculty of Medicine, Izumo, Japan

    Kenji Furuta & Yoshikazu Kinoshita

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

    Hiroto Miwa & Tadayuki Oshima

  4. Department of Gastroenterology, Hyogo Prefectural Awaji Hospital, Sumoto, Japan

    Masaharu Miki

  5. Division of Internal Medicine, Izumo City General Medical Center, Izumo, Japan

    Yoshinori Komazawa

  6. Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan

    Katsuhiko Iwakiri

  7. Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan

    Takahisa Furuta

  8. Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan

    Tomoyuki Koike

  9. Department of General Medicine, Hiroshima University Hospital, Hiroshima, Japan

    Tomohiko Shimatani

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  1. Kyoichi Adachi
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Correspondence to Kyoichi Adachi.

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Adachi, K., Furuta, K., Miwa, H. et al. A Study on the Efficacy of Rebamipide for Patients with Proton Pump Inhibitor-Refractory Non-Erosive Reflux Disease. Dig Dis Sci 57, 1609–1617 (2012). https://doi.org/10.1007/s10620-012-2087-6

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  • DOI: https://doi.org/10.1007/s10620-012-2087-6

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