Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis

Background Both gastroesophageal reflux disease and allergy/atopy have been implicated in the pathogenesis of eosinophilic esophagitis (EoE). There are no prospective studies comparing treatment of EoE with acid suppression versus topical corticosteroids. Objective To determine the outcome of adult eosinophilic esophagitis patients treated with esomeprazole versus topical fluticasone. Design Prospective randomized controlled trial. Setting Academic medical center. Participants Adults (18-80) diagnosed with EoE by symptoms of dysphagia and esophageal biopsies with ≥15 eosinophils/hpf. Interventions Subjects were randomized to esomeprazole (40 mg by mouth every morning) or aerosolized, swallowed fluticasone (440 mcg by mouth twice a day) for 8 weeks. Main Outcome Measurements Improvement in dysphagia (8-point scale), esophageal eosinophil infiltration before and after treatment, prevalence of GERD measured by validated questionnaire and baseline pH study. Results About 56% (14/25) had acid reflux by pH study. There was no difference between treatment groups in improvement in dysphagia scores [3/12 (25%) of the esomeprazole group versus 6/12 (50%) in the fluticasone group, P = 0.40]. Eosinophil infiltration decreased with treatment in both groups, and there was no difference in the amount of decrease between groups (P = 0.70). Limitations Small sample size, unexpectedly high drop-out rate. Conclusions Gastroesophageal reflux disease is common in adult eosinophilic esophagitis patients. Dysphagia improves and esophageal eosinophilic infiltration decreases with either treatment. There was no difference in degree of improvement in dysphagia or eosinophil infiltration in patients treated with either topical fluticasone or oral esomeprazole. GERD may be important in the pathogenesis of adult EoE.