Combination of ranitidine and cisapride in the treatment of reflux oesophagitis.

OBJECTIVE

To compare the efficacy of treatment for 8 or 12 weeks with a combination of 150 mg ranitidine twice daily plus 20 mg cisapride twice daily with ranitidine 150 mg twice daily alone in patients with moderate-to-severe reflux oesophagitis.

DESIGN

A double-blind, randomized, parallel-group clinical trial.

SETTING

Forty-two out-patient centres in the UK, Germany, Ireland, Denmark and South Africa.

PATIENTS: A total of 344 symptomatic patients with endoscopically confirmed reflux oesophagitis (Hetzel grade 3 or 4) were randomly assigned to receive the study medication.

INTERVENTIONS: Patients underwent a follow-up endoscopy after 8 weeks' treatment. Healing was defined as Hetzel grade 0 or 1 upon endoscopy. Patients with unhealed oesophagitis continued their allocated treatment regimen for a further 4 weeks before undergoing a repeat endoscopy.

MAIN OUTCOME MEASURES: The primary efficacy analysis was based on a comparison of 12-week cumulative healing rates between the two groups.

RESULTS

A statistically significant difference (P = 0.015) in the cumulative healing rate was observed between patients given ranitidine plus cisapride (82%) and those given ranitidine alone (71%). Oesophagitis in patients who received the combination was twice as likely to heal as that in patients who received ranitidine alone.

CONCLUSION

A combination of 150 mg ranitidine twice daily and 20 mg cisapride twice daily is a safe and effective treatment for moderate-to-severe reflux oesophagitis and offers increased efficacy over ranitidine alone.