Abstract
Aim: Gastroesophageal reflux (GER) is a frequent condition during the first year of life, that can be treated with lifestyle changes and reassurance. However, some children show distressing symptoms, which may require treatments that can improve the quality of life. The aim of our study was to evaluate the efficacy of Mg-alginate in the treatment of GER in infant compared with rice starch thickened formula or with reassurance. Methods: This prospective, comparative, randomized, controlled trial was conducted in patients younger than 1 year, affected by suggestive symptoms of gastroesophageal reflux. All patients underwent a validate questionnaire for assessment of clinical score (I-GERQ). The patients were randomized for 8 weeks into 3 groups according to the treatment (Group A: Mg-alginate; Group B: tickened formula feeding; Group C: reassurance, that consist in lifestyle changes and reassurance on the goodness of the condition). A clinical evaluation and score of symptoms was practiced after one month (T1) and after two months (T2) of treatment. Results: We enrolled 35 patients (mean age 5.56 ± 2.34). Fourteen children were treated with Mg-alginate (Group A), 10 with thickened formula (Group B) and 11 were only reassured (Group C). The mean values of the results of the questionnaire I-GERQ at T0 were similar in the three groups. At the end of the study (T2) in Group A 12 patients (85.7%) out of 14 showed a resolution of the symptoms, while the patients healed in Group B and in Group C were 6/10 (60%) and 6/11 (54.5%), respectively (ORG-TF: 4; ORG-R: 5; p < 0.05). Moreover, patients treated with alginate showed a lower clinical score in T2 compared with the other groups (Group A: 2.36; Group B: 5.67; Group C: 7.18). Conclusions: The results of our study showed a significant reduction in clinical score in patients treated with alginate, compared with those treated with rice starch thickened formula or only reassurance.
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