Abstract and Background
Abstract
Background: Although gastroesophageal reflux disease (GERD) is common in adolescents, the burden of GERD on health-related quality of life (HRQOL) in adolescents has not been previously evaluated. Therefore, the objective of the study was to examine the effect of GERD on HRQOL in adolescents.
Methods: This international, 31-site, 8-week safety study randomized adolescents, aged 12 to 17 years inclusive, with GERD to receive esomeprazole 20 or 40 mg once daily. The Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), previously validated in adults, consists of 25 questions grouped into 5 domains: emotional distress, sleep disturbance, food/drink problems, physical/social functioning, and vitality. The QOLRAD was administered at the baseline and week-8 (final) visits.
Results: Of the 149 patients randomized, 134 completed the QOLRAD at baseline and final visits and were eligible for analysis of their HRQOL data. Baseline QOLRAD scores indicated GERD had a negative effect on the HRQOL of these adolescents, especially in the domains of vitality and emotional distress, and problems with food/drink. At the final visit, mean scores for all 5 QOLRAD domains improved significantly (P < .0001); change of scores (ie, delta) for all domains met or exceeded the adult QOLRAD minimal clinically significant difference standard of 0.5 units.
Conclusion: GERD had a negative effect on QOL in adolescents. After esomeprazole treatment, statistically and clinically significant improvements occurred in all domains of the QOLRAD for these adolescents.
Background
Gastroesophageal reflux disease (GERD) is recognized increasingly as a common condition in adolescents. Recent surveys of high school students show that at least 21% had significant GERD symptoms occurring a minimum of 1 time per month. A survey conducted in pediatric practices revealed that 5.2%, 5.0%, and 8.2% of children and adolescents aged 10 to 17 years reported experiencing heartburn, epigastric pain, and regurgitation, respectively, in the previous week. Moreover, in the same time period, 27.9% of children aged 10 to 17 years experienced abdominal pain, which may be a symptom of GERD.
Findings of numerous studies have shown the negative effect of GERD on health-related quality of life (HRQOL) in adults; however, few studies have assessed the effect of GERD on HRQOL in children and adolescents. Although previously validated in adults, no data are available on the validity and performance of the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) in adolescent GERD patients or on the burden of GERD on HRQOL in adolescents.
Proton pump inhibitors (PPIs) have been recommended as the most effective acid suppression therapy for adults and children with GERD. PPIs have been shown to relieve or resolve GERD symptoms in most adult and pediatric patients. In Gold et al, we reported the safety and efficacy of esomeprazole in treating the symptoms of GERD in adolescents. In the current article, we explore the effects of esomeprazole on QOL in the adolescent patients from the Gold et al study.