Cisapride and ranitidine in the treatment of gastro-oesophageal 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 classification) 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 37 patients who completed the trial, 18 in the cisapride group and 19 in the ranitidine group. Three patients were withdrawn from the trial; one on ranitidine developed severe anaphylactic reaction, one on cisapride severe dizziness and one on cisapride did not wish to continue on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 effective in controlling symptoms, such as acid regurgitation, retrosternal pain, retrosternal burning, epigastric fullness and discomfort (pain, burning, sense of pressure) and resulted in endoscopic healing of oesophagitis. With few exceptions, symptoms remained in remission 1 month after treatment in the majority of patients. Globally, both drugs were tolerated comparably, and adverse effects other than those which resulted 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 therapeutic effect in symptomatic improvement and endoscopic healing in patients with mild to moderate gastro-oesophageal reflux disease.

RCT Entities:   Population Interventions Outcomes