Famotidine vs. omeprazole: a prospective randomized multicentre trial to determine efficacy in non‐erosive gastro‐oesophageal reflux disease

Summary Background : 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 refluxdisease. The efficacy of acid-suppressive drugs for non-erosive gastro-oesophageal refluxdisease in Japan, in which the prevalence of Helicobacter pylori infectionis higher compared with Western countries, is unknown. Aim : To compare the efficacy of famotidineand omeprazole in Japanese patients with non-erosive gastro-oesophageal refluxdisease by a prospective randomized multicentre trial. Methods : A total of 98 patients received either famotidine20 mg b.d. (n = 48) or omeprazole once daily (n = 50). Frequency of gastro-oesophageal refluxdisease 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 refluxdisease symptoms during the 7-day interval in week 4. Results : Complete relief was achieved in 23 (48%) of patients receiving famotidineand 28 (56%) of patients treated with omeprazole. In the famotidinegroup, complete relief rate in H. pylori-negative patients was significantly lower than H. pylori-positive patients (35% vs. 64%). Both famotidineand omeprazole improved most scales of health-related quality of life. Omeprazole significantly improved refluxscore irrespective of H. pylori infection while famotidinesignificantly improved refluxscore in H. pylori-positive patients but not in H. pylori-negative patients. Conclusions : Omeprazole is more effective than famotidinefor the control of gastro-oesophageal refluxdisease symptoms in H. pylori-negative patients, while similar efficacy is observed in H. pylori-positive patients with non-erosive gastro-oesophageal refluxdisease.