Effect of cisapride on nocturnal transient LES relaxations and gastroesophageal reflux in patients with esophagitis: A double-blind placebo-controlled study

Abstract

BACKGROUND:The positive effect of cisapride on esophageal and LES pressure is well documented. However, its effect on nocturnal transient lower esophageal sphincter relaxations (TLESRs) during sleep is still not well studied. Our AIM was to investigate the affect of cisapride on the frequency of TLESRs and esophageal acid exposure during sleep in patients with endoscopic erosive esophagitis using a double-blind placebo-controlled design. METHODS:IO pts (6 M, 4 F, mean age 54.4_+10.4) entered the study. They were randomly assigned to 5 days of treatment with cisapride 10 mg QID, or placebo, separated by 2 days washout period before the crossover of the treatments. At the end of each treatment regimen, pts were admitted to a sleep lab for overnight monitoring of the sleep stages by electroencephalography (EEG), LES tone and esophageal pressures at 5 and lO-cm levels above LES by a water-perfused catheter equipped with a Dent-sleeve, esophageal pH at 5 cm above LES, and swallowing recorded by a microphone. RESULTS: 9 pts completed the study. All pts revealed normal peristaltic esophageal contractions with wet swallows. According to the EEG tracings, pts had only 3.7+_1.9 hrs and 3.2_+2.3 hrs sleep during the nights with cieapride and placebo, respectively, P = 0.65. Only TLESRs dunng sleep were considered for the analysis (table). CONCLUSION: This study has shown that cisapride, a 5-HT, agoniet, decreased the frequency but not the duration of nocturnal TLESRs during sleep in patients with erosive esophagifis. These data suggest that in developing future pharmacotherapy for reducing of TLESRs to treat GERD, the role of 5-HT4 agonists should be considered.