The Effectiveness of Omeprazole and Esomeprazole in Infants (1- 11 Months of Age) with Gastroesophageal Reflux Disease: A Comparative Study

Background: Gastroesophageal Reflux Disease (GERD) is common in infants and its treatment remains extremely challenging in this age group. Therefore this study aimed to compare the efficacy and safety of omeprazole and esomeprazole in infants, aged 1-11 months old, presented with GERD. Methods: This double-blind randomized controlled trial was conducted on 80 infants. All patients were randomly divided into omeprazole and esomeprazole treatment groups for four weeks. The signs, symptoms, and disease severity based on the Visual Analog Scale (VAS) of GERD were evaluated after treatment in both groups. The data were then analyzed using the SPSS Statistics software (version 21). Results: The results of this study did not show significant differences between the mean disease severity based on VAS of both omeprazole- (81.1±55.7) and esomeprazole-receiving (79.1±77.6) groups (p=0.091). However, in each group, the mean disease severity after one month of treatment was significantly lower as compared to baseline (p 0.01). The recovery rates were similar in both groups (75% and 70% for omeprazole and esomeprazole groups, respectively) (p=0.799). Conclusion: Omeprazole and esomeprazole did not have significant differences in signs, symptoms, and disease severity of GERD, however, we observed a significant reduction in disease severity in both groups indicating that these two drugs could be used interchangeably for the treatment of GERD disorder.