This study sought to define the therapeutic efficacy of
domperidone in infants and children with
gastroesophageal reflux. A double-blind, placebo-controlled trial was performed in seventeen children (ages 5 months to 11.3 years) with moderate to severe
gastroesophageal reflux who had not responded to standard nonpharmacological
therapy. Subjective and objective measures (
weight gain, esophageal pH probe study,
radionuclide gastric emptying scan) of
gastroesophageal reflux were evaluated.
Therapy with
domperidone for 4 weeks was effective only in reducing the total number of reflux episodes in the two-hour postprandial period (p less than 0.01); however, it did not result in symptomatic improvement or significant improvement in other measures of
gastroesophageal reflux or gastric emptying. After
therapy for 8 weeks symptomatic improvement was reported in some patients who had denied improvement after 4 weeks of
therapy, suggesting that more than 4 weeks of
therapy may be required for some patients to obtain a clinical response. Mild self-limited
diarrhea was reported by six patients (four
domperidone, two placebo). We conclude that
domperidone is tolerated by most infants and children with
gastroesophageal reflux; however, 4 weeks of
therapy was only minimally effective in producing objective improvement of
gastroesophageal reflux and did not result in symptomatic improvement. Further studies of longer duration are needed to resolve the question raised by this study: that
domperidone may be beneficial for patients with
gastroesophageal reflux when given for more than four weeks.