Objectives: Gastroesophageal reflux (GER) is a frequently occurring condition in infants capable of causing distressing symptoms. The aim of our study is to evaluate the efficacy of Mg alginate plus simethicone (Gastrotuss Baby, DMG Italia SRL, Pomezia, Italy), compared with rice-starch-thickened formula or with reassurance alone, in the treatment of GER in infants.
Methods: The present randomized controlled trial was conducted in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised). The patients were randomized into 3 groups according to treatment (group A: Mg alginate plus simethicone; group B: thickened formula; group C: reassurance with lifestyle changes). Evaluation of symptom scores was performed after 1 month (T1) and 2 months (T2).
Results: A total of 64 (85.3%) of 75 enrolled infants (median age 5 months; range 1-10) concluded the study. After 1 month of treatment (T1), infants treated with Mg alginate plus simethicone showed a statistically significant improvement in symptoms compared with the thickened formula and reassurance (P < 0.03, <0.0001, respectively). At the end of the study, all 3 groups of patients showed a significant reduction in symptom scores (P < 0.002, <0.038, <0.03, respectively). Median symptom score values were more significantly reduced in group A than in group B and in group C (group A vs group B P < 0.002; group A vs group C P < 0.0001; group B vs group C P < 0.001).
Conclusions: Mg alginate plus simethicone seems to be more efficacious on GER symptom scores than thickened formula and reassurance with lifestyle changes alone.
Trial registration: ClinicalTrials.gov NCT01858584.