Comparison of two dosing regimens of cisapride in the treatment of reflux oesophagitis.

Aim: In an international, multicentre, double-blind trial, to document the therapeutic equivalence of two dosing regimens of cisapride on endoscopic healing and symptom improvement in patients with proven reflux oesophagitis grade I or II (Savary–Miller). Methods: Four hundred and seven patients were randomly allocated to treatment with either cisapride 10 mg q.d.s or cisapride 20 mg b.d. for 8–12 weeks depending on whether complete healing was found at endoscopy. The primary parameters of efficacy were cure of oesophagitis and improvement of the reflux symptom score. Results: The healing rates at endpoint were 73% in both treatment groups. The mean total reflux symptom score decreased from baseline to endpoint from 7.9–2.1 (cisapride 10 mg q.d.s.) and 7.9–2.5 (cisapride 20 mg b.d.). Each of the two treatment regimens was well tolerated. The most frequently (6.9%) reported adverse event (diarrhoea) was mild or moderate in most cases and can be explained by the pharmacological action of cisapride. Conclusions: The results of the study demonstrate that cisapride 10 mg q.d.s. and 20 mg b.d. are equivalent in terms of efficacy and safety in the treatment of reflux oesophagitis.