Randomized controlled trial: roxatidine vs omeprazole for non-erosive reflux disease.
OBJECTIVE
Proton pump inhibitor (PPI) therapy is considered as the first choice for treatment of non-erosive reflux disease (NERD). However, NERD is less sensitive to PPIs than erosive gastroesophageal reflux disease (GERD) and the differences between PPIs and H2 receptor antagonists are less evident in NERD than in erosive GERD. Since gastric acid secretion is lower in the Japanese population than in Western populations, we aimed to investigate whether PPI therapy is really necessary for NERD patients in Japan.


METHODS
Thirty-three symptomatic endoscopically diagnosed NERD patients were randomly assigned to receive roxatidine acetate 75 mg twice daily (n = 16) or omeprazole 20 mg once daily (n = 17). Gastrointestinal symptoms were assessed using the Gastrointestinal Symptom Rating Scale at baseline and after 4 and 8 weeks of treatment.


RESULTS
Both roxatidine and omeprazole significantly improved the heartburn score at 4 and 8 weeks. The clinical response rates did not differ between roxatidine and omeprazole. Both roxatidine and omeprazole significantly relieved not only reflux but also abdominal pain and indigestion. The degrees of improvement did not differ between the two groups.


CONCLUSIONS
Roxatidine relieved the symptoms of NERD patients with similar effectiveness to omeprazole. Therefore, roxatidine may be a good choice for NERD treatment.
Nakamura
Kazuhiko
K
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan. knakamur@intmed3.med.kyushu-u.ac.jp
Akiho
Hirotada
H
Ochiai
Toshiaki
T
Motomura
Yasuaki
Y
Higuchi
Naomi
N
Okamoto
Risa
R
Matsui
Noriaki
N
Yasuda
Daisuke
D
Akahoshi
Kazuya
K
Kabemura
Teppei
T
Ihara
Eikichi
E
Harada
Naohiko
N
Ito
Tetsuhide
T
Takayanagi
Ryoichi
R
D000328:Adult; D000368:Aged; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006356:Heartburn / Q000188:drug therapy; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*
D006635:Histamine H2 Antagonists; D010880:Piperidines; D054328:Proton Pump Inhibitors; D009853:Omeprazole; C053742:roxatidine acetate