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[Multicenter study of sodium alginate in the treatment of regurgitation in infants]
B Le Luyer1, J F Mougenot, L Mashako
1Département de Pédiatrie, Centre Hospitalier, Le Havre.
Insights
Alginic acid effectively reduced regurgitation and vomiting in pediatric patients with gastroesophageal reflux. This study found alginic acid to be safe and well-tolerated in children, with no adverse effects reported.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
Background:
- Gastroesophageal reflux (GER) is a common condition in pediatric patients.
- Esophagitis, an inflammation of the esophagus, can be a complication of GER.
Purpose of the Study:
- To evaluate the efficacy and safety of alginic acid for treating pediatric GER.
- To determine an optimal dosage for alginic acid in this patient population.
Main Methods:
- An open-label, multicenter study involving 76 pediatric patients with confirmed GER.
- Patients received alginic acid at two different dosages.
- Efficacy was assessed by monitoring the frequency of regurgitation and vomiting.
- Endoscopy was performed before treatment in a subset of patients to assess esophagitis.
Main Results:
- A significant decrease in the frequency of regurgitation (p < 0.00001) and vomiting (p = 0.01) was observed, irrespective of the alginic acid dosage.
- Endoscopic evaluation revealed esophagitis in 18 patients (erythematous) and 5 patients (erosive) prior to treatment.
- Alginic acid demonstrated excellent clinical and biochemical tolerance, with no adverse effects reported.
Conclusions:
- Alginic acid is an effective and safe treatment for pediatric gastroesophageal reflux.
- The recommended dosage for alginic acid in pediatric patients is 1 to 2 ml/kg/day, administered in divided doses after meals.
Abstract:
An open multicenter study was performed to assess the efficacy and safety of alginic acid in two different dosages in 76 pediatric patients with gastroesophageal reflux confirmed by pH monitoring. Among the 69 patients in whom endoscopy was carried out before treatment, 18 had erythematous esophagitis and 5 had erosive esophagitis. Irrespective of the dosage used, the frequency of regurgitation and vomiting decreased significantly (p < 0.00001 and p = 0.01, respectively). Clinical and biochemical tolerance were outstanding and no adverse effects were recorded. On the basis of these data, the recommended dosage is 1 to 2 ml/kg/day in divided doses after meals.