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.


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


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


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


METHODS
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.


METHODS
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.


CONCLUSIONS
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.
McKenna
C J
CJ
Department of Gastroenterology, Glaxo Research and Development Ltd, Uxbridge, Middlesex, UK.
Mills
J G
JG
Goodwin
C
C
Wood
J R
JR
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020117:Cisapride; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000473:pathology; D004945:Esophagoscopy; D005260:Female; D005500:Follow-Up Studies; D006635:Histamine H2 Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage* / Q000627:therapeutic use; D011899:Ranitidine / Q000008:administration & dosage* / Q000627:therapeutic use; D012702:Serotonin Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
D006635:Histamine H2 Antagonists; D010880:Piperidines; D012702:Serotonin Antagonists; D011899:Ranitidine; D020117:Cisapride