A randomized, double-blind, placebo-controlled study of the use of viscous oral cromolyn sodium for the treatment of eosinophilic esophagitis

Publication date: Available online 12 March 2018
Source:Annals of Allergy, Asthma & Immunology
Author(s): Jay Adam Lieberman, Jie Zhang, John Whitworth, Cary Cavender
BackgroundThere is a need for effective, non-steroid pharmacologic therapies for eosinophilic esophagitis (EoE). Cromolyn sodium offers an option as mast cells have been implicated in the symptomatology of EoE and cromolyn has also been shown to have some anti-eosinophilic properties.ObjectiveTo evaluate the efficacy of cromolyn in reducing esophageal eosinophilia in patients with eosinophilic esophagitis. Secondary outcomes included symptom improvement and adverse effects.MethodsWe conducted a randomized, double-blind, placebo-controlled trial of viscous oral cromolyn for EoE in pediatric patients. Subjects were randomized to 100 mg (2-11 years of age) or 200 mg (12-17 years of age) of cromolyn or placebo four-times daily. The medications were mixed with powdered sugar at home to make viscous.Results16 subjects (50% male, median age 11.4 years) were enrolled. Nine were randomized to cromolyn, 7 to placebo. Cromolyn reduced peak eosinophil count from 62.1 to 57.3 eos/hpf (p = 0.78) and placebo reduced peak eosinophil count from 87.0 to 71.3 eos/hpf (p = 0.62) One subject randomized to cromolyn and none in the placebo arm had complete resolution of eosinophilia. Cromolyn decreased symptoms scores from a mean baseline score of 37.8 to a mean post-therapy score of 17.5, which was a 54% reduction (p = 0.04). Placebo decreased the symptom scores from a baseline score of 32.2 to a post-therapy score of 23.3, which was a 28% reduction (p = 0.05)ConclusionCromolyn, when mixed into a viscous preparation, did not significantly reduce esophageal eosinophilia. It did however reduce symptom scores (although not significantly more than placebo) and led tocomplete resolution in one subject.



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