Cisapride treatment of patients with non-ulcer dyspepsia and erosive prepyloric changes. A double-blind, placebo-controlled trial

Scand J Gastroenterol. 1992;27(3):213-7. doi: 10.3109/00365529208999951.


One hundred and twenty consecutive outpatients with non-ulcer dyspepsia (NUD) and erosive prepyloric changes (EPC) were, after a 2-week placebo run-in period, randomly allocated to double-blind treatment with either 10-mg cisapride tablets or placebo three times daily for 4 weeks. The patients' global evaluation and total symptom score were significantly in favour of cisapride at 2 weeks (p less than 0.05). At 4 weeks the effect of cisapride was no longer significant (p = 0.22). Similarly, the investigators' global evaluation showed marked to moderate symptom improvement in 47% of the cisapride-treated patients as compared with 30% of the placebo-treated patients at 2 weeks. The 95% confidence interval of the difference (18%) was 0% to 35%. At 4 weeks the intergroup difference was only 10% (cisapride, 50% versus placebo 40%). Pain on awakening was the only symptom improved in favour of cisapride at 4 weeks. Thus, when patients with NUD and EPC are treated with cisapride, the therapeutic gain might vanish after the 2nd week of treatment.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Cisapride
  • Confidence Intervals
  • Double-Blind Method
  • Dyspepsia / drug therapy*
  • Dyspepsia / epidemiology
  • Dyspepsia / pathology
  • Female
  • Gastric Mucosa / pathology
  • Humans
  • Male
  • Middle Aged
  • Piperidines / therapeutic use*
  • Serotonin Antagonists / therapeutic use*


  • Piperidines
  • Serotonin Antagonists
  • Cisapride