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A randomized, double-blind, placebo-controlled clinical study of the histamine H2-receptor antagonist famotidine in Japanese patients with nonerosive reflux disease

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Abstract

Background

To investigate whether histamine H2-receptor antagonists are sufficient to treat heartburn in nonerosive reflux disease in Japanese, who produce less gastric acid than Westerners, the efficacy of famotidine in Japanese nonerosive reflux disease patients was studied in a double-blind, placebo-controlled, parallel group-comparative, multicenter study.

Methods

The Los Angeles classification system with Japanese modifications was used to assess the severity of nonerosive reflux disease. Famotidine (10-or 20-mg doses) or placebo was administered to patients twice daily for 8 weeks. Heartburn symptoms were recorded daily by patients.

Results

A total of 528 patients participated in the study. The percentage of days without heartburn, the primary end point of the efficacy evaluation, was 62% for 40 mg and 59% for 20 mg of famotidine, and 55% for placebo, with a statistically significant difference between the 40-mg dose and placebo (P = 0.001; significance level, 0.025 one-sided). Famotidine at both doses provided immediate relief from heartburn, and relief persisted throughout the 8-week study with the 40-mg dose.

Conclusions

The results indicate that famotidine relieves heartburn symptoms in Japanese nonerosive reflux disease patients.

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Authors and Affiliations

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

    Michio Hongo

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

    Yoshikazu Kinoshita

  3. Division of Gastroenterology, Department of Internal Medicine, Kawasaki Medical School, Okayama, Japan

    Ken Haruma

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  1. Michio Hongo
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  2. Yoshikazu Kinoshita
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  3. Ken Haruma
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Hongo, M., Kinoshita, Y. & Haruma, K. A randomized, double-blind, placebo-controlled clinical study of the histamine H2-receptor antagonist famotidine in Japanese patients with nonerosive reflux disease. J Gastroenterol 43, 448–456 (2008). https://doi.org/10.1007/s00535-008-2186-5

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  • DOI: https://doi.org/10.1007/s00535-008-2186-5

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