BACKGROUND: Stimulation of gastric motility has been supposed to accelerate the healing of gastric ulcer. The combination of the prokinetic drug cisapride and the H2 blocker ranitidine was tested in the treatment of uncomplicated gastric ulcer. METHODS:Cisapride, 20 mg twice daily (Cis), and ranitidine, 150 mg twice daily (Ran), were given as monotherapies and in the combination 20 mg cisapride and 150 mg ranitidine daily (Cis + Ran) for a maximum of 8 weeks. The study was multicentre, randomized, and double-blind. RESULTS:A total of 197 patients were included. Healing rates in the per-protocol analysis after 4 and 8 weeks' treatment were 61%/84%, 52%/69%, and 61%/92% for the Cis + Ran (n = 56), Cis (n = 58), and Ran (n = 59) treatment groups. No statistically significant difference in healing rates was seen when comparing Cis + Ran with the monotherapies. Symptom relief at the end of treatment was significantly better in the Ran group than in the Cis + Ran group with regard to epigastric pain (p = 0.01) and vomiting (p = 0.05). Patients' global evaluation of treatment was in favour of Ran in comparison with Cis + Ran treatment (p = 0.04). CONCLUSIONS: Combination of cisapride and ranitidine in the treatment of gastric ulcer did not enhance the healing rate or improve symptom relief in patients treated for uncomplicated gastric ulcer when compared with the monotherapies.
RCT Entities:
BACKGROUND: Stimulation of gastric motility has been supposed to accelerate the healing of gastric ulcer. The combination of the prokinetic drug cisapride and the H2 blocker ranitidine was tested in the treatment of uncomplicated gastric ulcer. METHODS:Cisapride, 20 mg twice daily (Cis), and ranitidine, 150 mg twice daily (Ran), were given as monotherapies and in the combination 20 mg cisapride and 150 mg ranitidine daily (Cis + Ran) for a maximum of 8 weeks. The study was multicentre, randomized, and double-blind. RESULTS: A total of 197 patients were included. Healing rates in the per-protocol analysis after 4 and 8 weeks' treatment were 61%/84%, 52%/69%, and 61%/92% for the Cis + Ran (n = 56), Cis (n = 58), and Ran (n = 59) treatment groups. No statistically significant difference in healing rates was seen when comparing Cis + Ran with the monotherapies. Symptom relief at the end of treatment was significantly better in the Ran group than in the Cis + Ran group with regard to epigastric pain (p = 0.01) and vomiting (p = 0.05). Patients' global evaluation of treatment was in favour of Ran in comparison with Cis + Ran treatment (p = 0.04). CONCLUSIONS: Combination of cisapride and ranitidine in the treatment of gastric ulcer did not enhance the healing rate or improve symptom relief in patients treated for uncomplicated gastric ulcer when compared with the monotherapies.