Addition of bedtime lafutidine inhibits nocturnal acid-breakthrough and improves sleep quality in gastroesophageal reflux disease patients on esomeprazole: a randomized controlled trial

This study aims to evaluate the acid inhibition and clinical improvement of the addition of bedtime lafutidine to esomeprazole in comparison with esomeprazole only in Gastroesophageal reflux disease (GERD) patients with nocturnal symptoms. We conducted a single-center, observer-blinded, randomized, clinical trial. Forty-eight consecutive GERD patients with nocturnal symptoms were randomized to take twice daily esomeprazole, 20 mg (ESO Group, n = 24) or twice daily esomeprazole, 20 mg, with bedtime lafutidine, 10 mg (LAF & ESO Group, n = 24) for one week. The 24-h impedance-pH monitoring, and high-resolution manometry were measured on the seventh day during the treatment. The symptoms and sleep quality were assessed both at baseline and following treatment. Intragastric pH > 4 holding time ratios were significantly higher in the LAF & ESO Group compared to the ESO Group, both overall (85.4% vs. 77.7%, P = 0.003) and specifically during nighttime (92.6% vs. 77.2%, P = 0.006). Furthermore, the incidence of nocturnal acid breakthrough (NAB) was markedly reduced in the LAF & ESO Group (29.2% vs. 75.0%, P = 0.001). Esophageal acid exposure times, however, were comparable between the two groups (P > 0.05). Although both groups experienced symptom improvement, patients in the LAF & ESO Group demonstrated superior enhancement in sleep quality, as measured by the Pittsburgh Sleep Quality Index. Notably, patients without NAB exhibited a more substantial improvement in sleep quality from baseline after treatment. Therefore, adding bedtime lafutidine to esomeprazole effectively inhibits nocturnal gastric acid secretion and reduces the incidence of NAB. GERD patients who received lafutidine in addition to esomeprazole achieved a more significant improvement in sleep quality correlated with NAB reduction.