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Randomized Controlled Clinical Trial on Value of Domperidone in Functional Abdominal Pain in Children
Amaranath Karunanayake1, Niranga M Devanarayana2, Asita de Silva3
1Department of Physiology, Faculty of Medicine, University of Ruhuna, Galle.
Insights
Domperidone significantly improved general well-being and reduced abdominal pain in children with functional gastrointestinal disorders. This treatment offers a safe and effective option for lasting symptom relief in pediatric patients.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Clinical Therapeutics
Background:
- Functional gastrointestinal disorders (FGIDs) are common in children.
- Abdominal pain-predominant FGIDs (AP-FGIDs) significantly impact quality of life.
- Limited therapeutic options exist for pediatric AP-FGIDs.
Purpose of the Study:
- To evaluate the therapeutic efficacy of domperidone in children diagnosed with AP-FGIDs.
- To assess the impact of domperidone on symptom severity and patient-reported outcomes.
- To determine the safety profile of domperidone in this pediatric population.
Main Methods:
- A randomized, placebo-controlled trial involving 100 children (5-12 years) with AP-FGIDs.
- Treatment duration was 8 weeks, with a 6-month follow-up period.
- Primary outcomes included cure and general improvement; secondary outcomes were pain reduction and gastric motility.
Main Results:
- Domperidone showed significant patient-reported general improvement at 8 weeks (74% vs 50%, P=0.013) and 6 months (88% vs 66%, P=0.009).
- Cure rates were significantly higher with domperidone at 6-month follow-up (60% vs 38%, P=0.028).
- Domperidone significantly reduced abdominal pain severity and increased gastric motility without reported adverse effects.
Conclusions:
- Domperidone is a safe and effective treatment for pediatric AP-FGIDs.
- The drug facilitates lasting symptom remission in children.
- Domperidone improves both subjective and objective measures of gastrointestinal function.
Objectives:
The aim of the study was to evaluate the therapeutic effect of domperidone on children with abdominal pain predominant functional gastrointestinal disorders (AP-FGIDs).
Methods:
One hundred children (aged 5-12 years) fulfilling Rome III criteria for AP-FGIDs were randomized into 8 weeks of domperidone or placebo treatment. Primary outcomes defined were cure and patient-reported general improvement. Secondary outcomes were reduction in the severity of abdominal pain and increase in gastric motility. Patients were followed up for 6 months.
Results:
Eighty-nine (42 in placebo group, 47 in domperidone group) completed the trial at 8 weeks. Seventy-nine completed the 6-month follow-up. When primary outcomes were assessed at 8 weeks, 37 (74%) in the domperidone group and 25 (50%) in the placebo group showed patient-reported general improvement (P = 0.013), whereas no significant difference was observed in cure (22 [44%] vs 14 [28%] P = 0.09). At 6-month follow-up 30 (60%) in the domperidone group and 19 (38%) in the placebo group reported cure (P = 0.028), whereas 44 (88%) in the domperidone group and 33 (66%) in the placebo group showed patient-reported general improvement (P = 0.009). When assessing secondary outcomes at 8 weeks, the domperidone group reported significant reduction in the severity of abdominal pain (54.1% vs 24.7%, P = 0.008) and an increase in the antral motility index (27.5% vs 7.2%, P = 0.029). None of the patients reported intervention-related adverse effects.
Conclusions:
Domperidone may be a safe and effective therapeutic modality to achieve a lasting remission of symptoms in children with AP-FGIDs.
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