MAINTENANCE THERAPY WITH CISAPRIDE AFTER HEALING OF EROSIVE ESOPHAGITIS - A DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

Background: There are few data on the role of prokinetic agents as mai ntenance therapy in moderately severe reflux oesophagitis despite the high relapse rate of this condition after healing. Aims: To determine whether cisapride is more effective than placebo as maintenance therap y after healing of moderate erosive oesophagitis in two respects: firs t, in preventing symptomatic relapse and preserving quality of life; a nd, second, in improving oesophageal motor function. Patients: Forty-t wo patients whose grade II-III oesophagitis had been healed with omepr azole were randomized to receive either cisapride 20 mg nocte or place bo for 6 months. Oesophageal pH monitoring and manometry were performe d before starting maintenance therapy and after 4 weeks, and symptomat ic status and quality of life were assessed at weeks 0, 4, 13 and 26. Results: After 4 weeks of maintenance therapy, lower oesophageal sphin cter pressure improved in the cisapride group (16.4-21.9 mmHg, P = 0.0 1) but not in the placebo group (25.5-22.7 mmHg, P = 0.2). Oesophageal pH monitoring showed no significant changes in either group. Sixteen (76%) cisapride patients and 12 (57%) placebo patients withdrew within 4 weeks owing to symptomatic relapse (P = 0.2). After 26 weeks, 21 (1 00%) cisapride and 17 (81%) placebo patients had relapsed (log-rank an alysis of survival time P = 0.07). Quality of life parameters deterior ated in both treatment groups to a similar degree. Conclusion: Mainten ance therapy with cisapride 20 mg nocte improves the lower oesophageal sphincter pressure in patients whose oesophagitis has been healed wit h omeprazole. However, cisapride is no better than placebo in preventi ng symptomatic relapse or deterioration in quality of life.