BACKGROUND/AIMS: This study aims to investigate whether histamine H2-receptor antagonists are sufficient to treat nonerosive reflux disease in Japanese patients. The efficacy of lafutidine in Japanese nonerosive reflux disease patients was studied. METHODOLOGY: The subjects were 24 heartburn patients with two or more cases of heartburn in a week before the period of observation, QUEST score of 6 or above and diagnosed as no erosion in esophagus by upper gastrointestinal endoscopy. Following obtained informed consent, gastroesophageal 24-hour pH was monitored after the placebo period (2 weeks) and the completion of the lafitidine period (at the dose of 10 mg twice daily for 4 weeks). RESULTS:Twenty three patients completed the study. The percentage of time that the intraesophageal pH was less than 4 decreased significantly, from 3.07% to 1.17%, after the lafutidine administration. The overall percentage of time that the intragastric pH was above 3 increased significantly from 26.6% to 56.5% after the lafutidine administration, and increased from 22.7% to 51.0% (daytime period) and 34.6% to 67.2% (nighttime period), respectively. Lafutidine markedly improved heartburn and other symptoms, as recorded in patient diaries. CONCLUSIONS:Lafutidine markedly improved the intraesophageal pH and the symptoms of heartburn in Japanese patients with nonerosive reflux disease. Lafutidine also inhibited gastric acid secretion not only during the nighttime but also during the daytime.
RCT Entities:
BACKGROUND/AIMS: This study aims to investigate whether histamine H2-receptor antagonists are sufficient to treat nonerosive reflux disease in Japanese patients. The efficacy of lafutidine in Japanese nonerosive reflux diseasepatients was studied. METHODOLOGY: The subjects were 24 heartburnpatients with two or more cases of heartburn in a week before the period of observation, QUEST score of 6 or above and diagnosed as no erosion in esophagus by upper gastrointestinal endoscopy. Following obtained informed consent, gastroesophageal 24-hour pH was monitored after the placebo period (2 weeks) and the completion of the lafitidine period (at the dose of 10 mg twice daily for 4 weeks). RESULTS: Twenty three patients completed the study. The percentage of time that the intraesophageal pH was less than 4 decreased significantly, from 3.07% to 1.17%, after the lafutidine administration. The overall percentage of time that the intragastric pH was above 3 increased significantly from 26.6% to 56.5% after the lafutidine administration, and increased from 22.7% to 51.0% (daytime period) and 34.6% to 67.2% (nighttime period), respectively. Lafutidine markedly improved heartburn and other symptoms, as recorded in patient diaries. CONCLUSIONS:Lafutidine markedly improved the intraesophageal pH and the symptoms of heartburn in Japanese patients with nonerosive reflux disease. Lafutidine also inhibited gastric acid secretion not only during the nighttime but also during the daytime.