title: Effect of magnesium alginate plus simethicone on gastroesophageal reflux in infants.
abstract: OBJECTIVE
  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.
authors: Department of Translational Medical Science, Section of Pediatrics, University of Naples "Federico II," Naples, Italy.
authors: Dario
authors: D
authors: Ummarino
authors: Erasmo
authors: E
authors: Miele
authors: Massimo
authors: M
authors: Martinelli
authors: Elena
authors: E
authors: Scarpato
authors: Felice
authors: F
authors: Crocetto
authors: Elisa
authors: E
authors: Sciorio
authors: Annamaria
authors: A
authors: Staiano
mesh_terms: D000464:Alginates / Q000627:therapeutic use*; D000934:Antifoaming Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000628:therapy; D020723:Glucuronic Acid / Q000627:therapeutic use; D006603:Hexuronic Acids / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000008:administration & dosage; D008019:Life Style; D008297:Male; D011446:Prospective Studies; D012720:Severity of Illness Index; D012841:Simethicone / Q000627:therapeutic use*; D011795:Surveys and Questionnaires
chemical_list: D000464:Alginates; D000934:Antifoaming Agents; D006603:Hexuronic Acids; D012841:Simethicone; D020723:Glucuronic Acid