Famotidine vs. omeprazole: a prospective randomized multicentre trial to determine efficacy in non-erosive gastro-oesophageal reflux disease.
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 reflux disease. The efficacy of acid-suppressive drugs for non-erosive gastro-oesophageal reflux disease in Japan, in which the prevalence of Helicobacter pylori infection is higher compared with Western countries, is unknown.


OBJECTIVE
To compare the efficacy of famotidine and omeprazole in Japanese patients with non-erosive gastro-oesophageal reflux disease by a prospective randomized multicentre trial.


METHODS
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.


RESULTS
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 in H. pylori-negative patients was significantly lower than H. 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 of H. pylori infection while famotidine significantly improved reflux score in H. pylori-positive patients but not in H. pylori-negative patients.


CONCLUSIONS
Omeprazole is more effective than famotidine for the control of gastro-oesophageal reflux disease symptoms in H. pylori-negative patients, while similar efficacy is observed in H. pylori-positive patients with non-erosive gastro-oesophageal reflux disease.
Fujiwara
Y
Y
Department of Gastroenterology, Osaka City University Graduate School of Medicine, Asahimachi, Osaka, Japan. yasu@med.osaka-cu.ac.jp
Higuchi
K
K
Nebiki
H
H
Chono
S
S
Uno
H
H
Kitada
K
K
Satoh
H
H
Nakagawa
K
K
Kobayashi
K
K
Tominaga
K
K
Watanabe
T
T
Oshitani
N
N
Arakawa
T
T
D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D015738:Famotidine / Q000627:therapeutic use*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D016481:Helicobacter Infections / Q000150:complications; D016480:Helicobacter pylori; D006551:Hernia, Hiatal / Q000150:complications; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D015738:Famotidine; D009853:Omeprazole