THE EFFECT OF CISAPRIDE IN MAINTAINING SYMPTOMATIC REMISSION IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE

Background: Successful treatment of gastro-oesophageal reflux disease (GORD) has traditionally been assessed as healing of reflux oesophagit is, which may not be relevant in patients with moderate disease. In th ese patients symptom relief and patient satisfaction with therapy are of fundamental importance. Cisapride has well-documented prokinetic ef fects and may be well suited for long-term therapy of GORD, but its ef fectiveness in purely symptomatic treatment is unknown. We therefore c ompared two dosage regimens of cisapride with placebo over a period of 6 months in patients with evidence of gastrooesophageal reflux, initi ally treated with antisecretory medication, with regard to maintaining symptom relief and satisfaction with treatment. Methods: Five hundred and thirty-five patients with reflux oesophagitis grade 1 (n = 293) o r 2 (n = 124) or with no reflux oesophagitis but pathologic 24-h pH-me try (n = 118) achieved satisfactory symptom relief with an H-2-recepto r antagonist or proton pump inhibitor within 4-8 weeks. In a double-bl ind randomized, parallel-group study, they were then treated with cisa pride, 20 mg at night or 20 mg twice daily, or placebo and followed up for a maximum period of 6 months. Relapse was defined as dissatisfact ion with therapy or an average consumption of more than two antacid ta blets a day. Results: Median time to relapse was 63 days for cisapride , 20 mg twice daily; 59 days for cisapride, 20 mg at night; and 49 day s for placebo. Time to relapse was not significantly different (P = 0. 09). Presence and grade of oesophagitis at base line, type of therapy before randomization, and pattern of non-reflux symptoms at base line did not influence these findings significantly. Conclusion: The study indicates that cisapride is of limited value in maintenance therapy of GORD in patients in whom symptom relief has been accomplished with po tent antisecretory medication. This 'step-down' approach to therapy se ems disadvantageous in the long-term therapy of GORD.