Comparative, Controlled Study of Cisapride Tartrate and Domperidone Maleate in Patients with Non-erosive reflux disease (Multicenter Study) / 대한소화관운동학회지

ABSTRACT

BACKGROUNDS/AIMS: The therapeutic requirements of patients with non-erosive reflux disease (NERD) are similar to those with erosive esophagitis. The pharmacological action mechanism of prokinetics is quite different; domperidone is a peripheral dopamine D2-antagonist and cisapride is a HT4-agonist. This study was performed to evaluate the therapeutic effect of these two different prokinetics in patients with NERD. METHODS: 178 patients, with heartburn and/or regurgitation, without reflux esophagitis were enrolled and divided into 2 groups by randomization code. In this prospective multicenter trial, 178 patients (93 patients in cisapride group, 85 patients in domperidone group) received 10 mg of cisapride three times a day or 10 mg of domperidone three time a day for 2 or 4 weeks. Symptom assessment was performed in each patients before treatments, 2 and 4 weeks after treatment. RESULTS: Of the 133 patients available for final analysis, 65 were allocated to the cisapride group and 68 to the domperidone group. After 2 weeks treatment, heartburn was reduced in 81.1% of cisapride group, 56.7% of domperidone group (p < 0.05) and regurgitation was reduced in 89.7% of cisapride group, 77.7% of domperidone group. After 4 weeks treatment, heartburn was reduced in 94.3% of cisapride group, 88.7% of domperidone group and this difference was not significant. The proportion of adverse events in cisapride group was 9.4% and was 5.5% in domperidone group. CONCLUSIONS: Cisapride tartrate was more effective in relieving heartburn in NERD patients than domperidone maleate after 2 week treatment. However, this superior effect dose not persist longer than 2 weeks.