Therapeutic effects of domperidone on abdominal pain-predominant functional gastrointestinal disorders: randomized, double-blind, placebo- controlled trial.

Abstract

INTRODUCTION: The therapeutic effect of domperidone on abdominal pain-predominant functional gastrointestinal diseases (AP-FGIDs) was assessed on children in 5-12 year age group at the Gastroenterology Research Laboratory of Faculty of Medicine, University of Kelaniya, Sri Lanka. METHODS: Children fulfilling Rome III criteria for AP-FGIDs were recruited from the out-patient clinic of the University Paediatric Unit, North Colombo Teaching Hospital, Ragama, Sri Lanka, after obtaining parental consent. They were randomized in to 8 weeks of placebo or Domperidone (Motillium 10 mg, 3 times per day, before meals) groups, using computer generated random numbers. Placebo was a specially prepared dummy tablet without any active ingredients, had the same colour, size, shape and taste of domperidone tablet and were packaged similarly. Primary outcomes defined were cure (abdominal pain less than 25 mm on the visual analogue scale and no impact on daily activities) and improvement (pain relief and sense of improvement recorded on global assessment scale). Secondary outcomes were significant improvement in symptoms, gastric motility, quality of life (QoL) and family impact. Both patients and investigators who assessed primary and secondary outcomes before and after intervention were blind to inventions administered. Symptom severity was recorded on a validated 100 mm visual analogue scale. Translated and validated PedQL Generic Score Scale version 4.0 and Family Impact Module were used. Gastric motility was assessed using a validated ultrasound method. RESULTS: One hundred children were enrolled and 89 completed the trial [Placebo 42 (22 girls), Domperidone 47(33 girls)]. While comparing primary outcomes, domperidone group had significant improvement [37 (78.7%) vs. 25 (59.5%) in placebo group, p = 0.04], while no such difference was observed in cure. When assessing secondary outcomes, domperidone group reported significant reduction in abdominal pain severity (70.84% vs. 48.18% p = 0.03) and improvement in motility index (29.3% vs. 8.6% p = 0.04) after intervention. No such difference was seen in improvement of QoL and family impact (p > 0.05). CONCLUSIONS: Domperidone has a favorable therapeutic effect on improvement AP-FGIDs in children aged 5-12 years. It causes significant reduction in abdominal pain and improvement in motility of the gastric antrum. However, it has no significant effect on improvement of QoL and family impact.