CISAPRIDE COMPARED WITH RANITIDINE IN THE TREATMENT OF FUNCTIONAL DYSPEPSIA

Objective: To compare the efficacy of the prokinetic drug cisapride an d the antisecretory agent ranitidine in relieving symptoms of function al dyspepsia, as well as their effect on the recurrence of symptoms af ter the discontinuation of treatment. Design: A randomized double-blin d parallel-group trial of cisapride 30 mg daily and ranitidine 300 mg daily given for 2, 4 or 8 weeks, followed by a 4-week drug-free follow -up of the patients with a good or excellent response. Rescue antacid tablets were allowed only if pain was unbearable. Patients: A total of 203 patients (99 cisapride, 104 ranitidine) with symptoms of function al dyspepsia for more than 4 weeks, after the exclusion of organic dis ease by endoscopy and sonography or radiology. Results: Cisapride and ranitidine improved the symptoms of diffuse epigastric pain, postprand ial epigastric fullness, epigastric distension, belching, heartburn, r egurgitation, and nausea when compared with baseline. Pain at night an d gastric discomfort also greatly improved. Cisapride produced a great er reduction in epigastric pain (P=0.07) and epigastric distension (P= 0.03) scores than ranitidine. Both drugs were equally effective in red ucing the concomitant reflux-like symptoms of heartburn and regurgitat ion. At week 8, 87% of cisapride patients versus 61% of ranitidine pat ients had an excellent or good result. The deterioration of symptoms d uring the follow-up phase was limited in both groups. However, after t he withdrawal of medication there was a greater reduction in scores in the cisapride group than in the ranitidine group for diffuse epigastr ic pain (P=0.05), epigastric distension (P=0.002), the cluster of six symptoms of epigastric discomfort (P=0.05), and the cluster of all nin e upper gastrointestinal symptoms (P=0.06). Adverse events occurred in 15 cisapride patients and 18 ranitidine patients, and two of the rani tidine patients were withdrawn from treatment. Conclusions: Although c isapride and ranitidine both improved the symptoms of functional dyspe psia, cisapride was superior to ranitidine, particularly on the combin ed evaluation of the response to treatment and the recurrence of sympt oms.