A Systematic Review on the Efficacy and Safety of Alginate-based Liquid Formulations in Reducing Gastroesophageal Reflux in Neonates and Infants.

ABSTRACT

Background: Neonates and infants experience gastroesophageal reflux as manifested through vomiting, reflux, and coughing. The complaint from many caregivers begins around the 2nd or 3rd month of life and subside around the 6th month of infancy. The standard of care has not been established and treatment options are limited owing to the pharmacological interventions that are deemed safe and effective. Alginate-based formulations, a widely used product in adults such as Gaviscon™, have been explored as another option to treat gastroesophageal reflux. Objectives: To determine the safety and efficacy of alginate-based formulations in reducing symptoms of gastroesophageal reflux in neonates and infants. Methods: An electronic search was conducted for randomized control trials in MEDLINE via PubMed, Herdin Plus, Cochrane Central Register of Controlled Trials, SCOPUS, and Clinical Trials Registry. The search terms were "gastroesophageal reflux," "acid reflux," "neonates," "newborn," "infants," "baby," "babies,", and "alginate." Two review authors independently assessed the available full text articles and a third author intervened to settle the discussion. Results: Two studies were identified and included in this study. Due to the difference in the period of measurement of the trials, a meta-analysis was not pursued. However, a systematic review was still conducted. The two studies suggest a significant improvement of symptoms with alginate-based liquid formulations as intervention. No significant adverse events have been noted making this treatment option generally safe for use in infants. Conclusion: There is insufficient evidence to conclude that alginate-based formulations ultimately help decrease gastroesophageal reflux in neonates and infants, but initial trials show promising results. There is also insufficient data to conclude the safety profile of this treatment option given the small sample.