OBJECTIVES: To evaluate the efficiency by which the 5-HT4 agonist cisapride affects important motor functions involved in the control of gastro-oesophageal reflux. METHOD:Thirty patients with proven gastro-oesophageal reflux disease (endoscopy and 24 h pH-metry) were included in a randomized, double-blind, placebo controlled study with a cross-over design. Cisapride, 20 mg b.i.d., during 4 weeks was compared with placebo. At baseline, as well as after 4 and 8 weeks all patients underwent symptom assessments, sleeve manometry with concomitant oesophageal pH-monitoring and an acid clearance test. RESULTS: Despite adequate plasma levels cisapride had no significant effect on swallow induced peristaltic amplitude, duration, propagation speed, the elicitation of secondary peristalsis nor on acid clearance. Neither the basal tone of the lower oesophageal sphincter nor the number of transient lower oesophageal sphincter relaxations induced by gas distension of the stomach was affected by the administered dose of cisapride. CONCLUSION: Although cisapride has been alleged to improve symptoms as well as the oesophagitis in patients with gastro-oesophageal reflux disease, we found the compound (20 mg b.i.d.) devoid of effects on important motor mechanisms involved in the pathogenesis of the disease.
RCT Entities:
OBJECTIVES: To evaluate the efficiency by which the 5-HT4 agonist cisapride affects important motor functions involved in the control of gastro-oesophageal reflux. METHOD: Thirty patients with proven gastro-oesophageal reflux disease (endoscopy and 24 h pH-metry) were included in a randomized, double-blind, placebo controlled study with a cross-over design. Cisapride, 20 mg b.i.d., during 4 weeks was compared with placebo. At baseline, as well as after 4 and 8 weeks all patients underwent symptom assessments, sleeve manometry with concomitant oesophageal pH-monitoring and an acid clearance test. RESULTS: Despite adequate plasma levels cisapride had no significant effect on swallow induced peristaltic amplitude, duration, propagation speed, the elicitation of secondary peristalsis nor on acid clearance. Neither the basal tone of the lower oesophageal sphincter nor the number of transient lower oesophageal sphincter relaxations induced by gas distension of the stomach was affected by the administered dose of cisapride. CONCLUSION: Although cisapride has been alleged to improve symptoms as well as the oesophagitis in patients with gastro-oesophageal reflux disease, we found the compound (20 mg b.i.d.) devoid of effects on important motor mechanisms involved in the pathogenesis of the disease.
Authors: J Tack; M Camilleri; L Chang; W D Chey; J J Galligan; B E Lacy; S Müller-Lissner; E M M Quigley; J Schuurkes; J H De Maeyer; V Stanghellini Journal: Aliment Pharmacol Ther Date: 2012-02-22 Impact factor: 8.171