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: Several studies in Western countries showed that proton-pump inhibitors are superior to histamine2-receptor antagonists or placebo in the treatment of non-erosive gastro-oesophageal reflux disease. The efficacy of acid-suppressive drugs for non-erosive gastro-oesophageal reflux disease in Japan, in which the prevalence ofHelicobacter pyloriinfection is higher compared with Western countries, is unknown.: To compare the efficacy of famotidine and omeprazole in Japanese patients with non-erosive gastro-oesophageal reflux disease by a prospective randomized multicentre trial.: A total of 98 patients received either famotidine 20 mg b.d. (n = 48) or omeprazole once daily (n = 50). Frequency of gastro-oesophageal reflux disease symptoms and health-related quality of life were evaluated at baseline and after 4 weeks of treatment. Complete relief was defined as no gastro-oesophageal reflux disease symptoms during the 7-day interval in week 4.: Complete relief was achieved in 23 (48%) of patients receiving famotidine and 28 (56%) of patients treated with omeprazole. In the famotidine group, complete relief rate inH. pylori-negative patients was significantly lower thanH. pylori-positive patients (35% vs. 64%). Both famotidine and omeprazole improved most scales of health-related quality of life. Omeprazole significantly improved reflux score irrespective ofH. pyloriinfection while famotidine significantly improved reflux score inH. pylori-positive patients but not inH. pylori-negative patients.: Omeprazole is more effective than famotidine for the control of gastro-oesophageal reflux disease symptoms inH. pylori-negative patients, while similar efficacy is observed inH. pylori-positive patients with non-erosive gastro-oesophageal reflux disease. [ABSTRACT FROM AUTHOR]