CISAPRIDE AND RANITIDINE IN THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE - A COMPARATIVE RANDOMIZED DOUBLE-BLIND TRIAL

Forty patients with gastro-oesophageal reflux disease and oesophagitis , documented by endoscopy (grades I to III by the Savary-Miller classi fication) were randomized to participate in a comparative double-blind trial to receive cisapride (10 mg q.d.s.) or ranitidine (150 mg b.d.) for an 8-week period. Upper gastrointestinal endoscopy was performed immediately before the entry to the trial and after the 8-week period at the completion of the trial. The evaluable cohort included 3 7 pati ents who completed the trial, 1 8 in the cisapride group and 19 in the ranitidine group. Three patients were withdrawn from the trial; one o n ranitidine developed severe anaphylactic reaction, one on cisapride severe dizziness and one on cisapride did not wish to continue on the trial. The results of the trial, regarding symptomatic and endoscopic improvement were comparable in the two groups. Both drugs were effecti ve in controlling symptoms, such as acid regurgitation, retrosternal p ain, retrosternal burning, epigastric fullness and discomfort (pain, b urning, sense of pressure) and resulted in endoscopic healing of oesop hagitis. With few exceptions, symptoms remained in remission 1 month a fter treatment in the majority of patients. Globally, both drugs were tolerated comparably, and adverse effects other than those which resul ted in the withdrawal from the trial were minimal in both groups. The results of this trial indicate that cisapride and ranitidine, although of different pharmacological action, are comparable in their therapeu tic effect in symptomatic improvement and endoscopic healing in patien ts with mild to moderate gastro-oesophageal reflux disease.