Comparison of Hypoallergenic Diet vs. Ranitidine in Treatment of Gastroesophageal Reflux Disease of Infants: A Randomized Clinical Trial

Abstract

Background: Gastroesophageal reflux disease (GERD) is defined as “troublesome symptoms or complications of GER”, and is a multifactorial disorder. This study aimed to compare the treatment outcomes of hypoallergenic diet vs. ranitidine on symptoms of gastroesophageal reflux disease (GERD) in infants. Methods: In this randomized clinical trial, 50 patients aged less than 1 year, who were suspected to have GERD on the basis of I-GERQ-R, were enrolled. They were randomly allocated to two groups of equal number, one group received ranitidine and the other hypoallergenic diet for 2 weeks. The frequency of GERD symptoms, including irritability, vomiting, anorexia, respiratory symptoms and arching, were compared between the two groups before and after the trial. Results: After a two-week trial, the frequency of vomiting and respiratory symptoms decreased significantly in both groups (P < 0.05). The frequency of vomiting decreased in 19 (76%) and 19 (76%) of infants in ranitidine and hypoallergenic diet groups, respectively (P = 0.05 between groups). Moreover, the respiratory symptoms improved significantly in both groups (P < 0.05). The frequency of irritability did not decrease significantly in any of the groups (P = 0.18). Conclusions: The current findings suggest that the hypoallergenic diet might have significant effect on GERD symptoms; these effects are comparable with those of ranitidine. Considering the possibility of cow’s milk protein allergy in this group of patients, we recommend that the treatment of GERD in pediatric population be initiated with hypoallergenic diet and in case of not achieving significant effect, pharmacological treatment be added and applied as a combination therapy.