Cisapride treatment of patients with non-ulcer dyspepsia and erosive prepyloric changes. A double-blind, placebo-controlled trial.
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.
Hausken
T
T
Medical Dept., Haukeland Hospital, University of Bergen, Norway.
Berstad
A
A
D000328:Adult; D020117:Cisapride; D016001:Confidence Intervals; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D005260:Female; D005753:Gastric Mucosa / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000627:therapeutic use*
D010880:Piperidines; D012702:Serotonin Antagonists; D020117:Cisapride