Evaluation of esophagoprotective therapy for gastroesophageal reflux disease with extraesophageal symptoms in children and adolescents: results of an open-label, multicenter, observational study

Abstract

Objective. To study the effect of esophagoprotector Alfasoxx on extraesophageal symptoms in children and adolescents with gastroesophageal reflux disease (GERD). Patients and methods. This article presents a prospective, open-label, multicenter, post-registration, observational study (the pediatric part of the EXTRASOXX protocol). The study enrolled 61 patients aged between 6 and 17 years (mean age: 12.5 ± 3.2 years) with a confirmed diagnosis of GERD who were prescribed a course of treatment with the esophagoprotector Alfasoxx (a combination of hyaluronic acid, chondroitin sulfate, and poloxamer 407) by their attending physician according to the instructions for medical use. The study consisted of two stages: a screening visit and two follow-up visits during administration of the esophagoprotector Alfasoxx. Screening was performed on the day of the patient’s visit. Visit 1 could take place on the same day as the screening visit, whereas visit 2 took place 4–5 weeks after visit 1 at the end of treatment. At each visit, the researcher completed a patient record form (RSI questionnaire, esophageal symptom frequency and severity assessment questionnaire, patient satisfaction questionnaire using a 5-point Likert scale). Results. By the end of the study, 70.5% (95% CI: 57.4–81.5) of patients had complete resolution of extraesophageal GERD symptoms (RSI score 0). When comparing mean RSI scores before and after treatment, a statistically significant regression was noted: from 13 points (95% CI: 11.5–14.5) at visit 1 to 0.5 points (95% CI: 0.2–0.7) at visit 2. Thus, the decrease in the total RSI score was significant and exceeded 90% of the baseline value. The proportion of patients taking antacid-containing medications decreased significantly: from 34.4% (95% CI: 21.7–47.2) at visit 1 to 4.9% (95% CI: 0.0–11.2) at visit 2. Mean treatment satisfaction score on the Likert scale was 4.9 (95% CI: 4.9–5.0), Alfasoxx’s ease of use was 4.9 (95% CI: 4.9–5.0). Conclusion. This prospective, observational, multicenter study demonstrated that adding Alfasoxx to standard therapy for GERD in children and adolescents contributes to a significant regression of both esophageal and extraesophageal symptoms and reduces the need for antacid-containing medications. Key words: gastroesophageal reflux disease, children, adolescents, extraesophageal symptoms, esophagoprotector, hyaluronic acid, chondroitin sulfate