Effect of long-term oral therapy with cisapride in reflux antral gastritis. Results of a double-blind placebo-controlled trial

Thirty-six subjects with endoscopic/histologic diagnosis of chronic reflux antral gastritis and with proven duodenogastric bile reflux were studied in a double-blind trial (cisapride, orally, 10 mg x 4/day vs placebo). The following determinants were considered in the study: endoscopy, histology, and dyspeptic symptoms. All except the endoscopic parameters were evaluated by means of a severity score (0 = absent to 3 = severe). Symptoms were assessed after four and eight weeks of treatment, whereas endoscopic and histologic controls were performed after eight weeks. All the subjects showed a significant reduction of the symptom score (P = 0.001 in the cisapride group; P = 0.002 in the placebo group) without any differences between the two treatment groups. On the other hand, cisapride appeared to significantly improve (P <0.001) the endoscopic lesions of the antral mucosa, which was not observed in the placebo group. Finally, there were no variations in the histological score in either group, probably due to the short period of treatment.