A double-blind, placebo-controlled trial was performed to determine the therapeutic efficacy of
cisapride in patients with refractory functional
dyspepsia. A total of 147 patients with functional
dyspepsia characterized by prominent epigastric
pain or discomfort were randomized to 2 weeks' treatment with
metoclopramide or
domperidone (both 30 mg/day); of these, 53 patients unresponsive to
dopamine antagonist treatment were randomized to
cisapride 30 mg/day or placebo for an additional 2 weeks.
Metoclopramide and
domperidone produced comparable alleviation of epigastric symptoms; global efficacy was good or excellent in 62% and 57% of patients, respectively. In refractory patients,
cisapride tended to display greater efficacy than placebo against epigastric
pain, particularly at night. Global assessments of efficacy significantly favored
cisapride over placebo, with good or excellent ratings in 65% and 32% of patients, respectively.
Cisapride was well tolerated. Thus,
cisapride appears to be an effective agent in functional
dyspepsia unresponsive to other gastrokinetic agents.