Randomized controlled trial: roxatidine vs omeprazole for non-erosive reflux disease

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.

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.

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.

Roxatidine relieved the symptoms of NERD patients with similar effectiveness to omeprazole. Therefore, roxatidine may be a good choice for NERD treatment.