Document Type : original article

Authors

1 Department of Pediatrics, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran

2 Department of Biostatistics, Kashan University of Medical Sciences, Isfahan, Iran

3 Student Research Committee, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran

4 Department of Pediatrics, School of Medicine, Infectious Diseases Research Center, Shahid Beheshti Hospital, Kashan University of Medical Sciences

5 Associated professor, Pediatric Department, Kashan University of Medical Sciences, Isfahan, Iran.

6 Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.

7 Department of Biostatistics and Epidemiology, Kashan University of Medical Sciences, Kashan, Iran.

10.22038/ijp.2024.76553.5401

Abstract

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 presenting with GERD.

Materials and Methods: This double-blind randomized controlled trial was conducted on 80 infants ages 1-11 months. 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 the visual analog scale (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 that indicates these two drugs could be used interchangeably for the treatment of GERD disorder.

Keywords

Comparative Research,, ,،Gastroesophageal Reflux Disease,, ,،GERD,, ,،Omeprazole,, ,،Esomeprazole,, ,،Infants