The Efficacy of Baclofen to Treat Gastroesophageal Reflux disease in Children Aged 6 Months to 12 Years: A Clinical Trial Study

Background Gastroesophageal Reflux is a physiological phenomenon, which occurs in infants, children, and normal adults. Various studies have shown that Baclofen is a potent inhibitor of lower esophageal sphincter and has beneficial effects in adult reflux disease. We aimed to evaluate the Baclofen effect in pediatric Gastroesophageal disease. Materials and Methods: Children 6 months to 12 years old, with Gastroesophageal reflux disease were enrolled in this Clinical trial study. Patients referred to Taleghani Children’s Center in Gorgan, Golestan province, Iran from May to August 2019.  Patients were randomly divided into two intervention group and control group. The controls received only proton pump inhibitor 1 mg per kg treatment, and intervention group received proton pump inhibitor (PPI) plus baclofen 0.25 mg per kg two times per day. Patient data including age, gender, family history, growth status, reflux symptoms, previous drug treatment history, and symptoms in two groups, were compared. Results: Fifty-four patients in the baclofen treatment group and 58 patients in the non-baclofen treatment group were included. The mean age of the patients was 6.61+ 3.55 years. The most common symptoms of all patients were abdominal pain (73.2%), nausea (73.2%), regurgitation (64.3%), and dental erosion (55.4%). The rate of recovery was significantly related to gender, with 69.9% of patients having moderate to full recovery (p = 0.017). Weight gain in baclofen treated group was significantly higher. Conclusion: The results suggest that baclofen along with routine Gastroesophageal reflux treatments in children can help reduce or improve symptoms of the disease. Due to limited studies, further studies are needed to confirm the positive effect of this drug with higher sample size.