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