Abstract | BACKGROUND & AIMS:
Eosinophilic esophagitis (EoE) is caused by immunologic reactions to ingested/inhaled allergens. The diagnosis is considered if >or=15 eosinophils per high-powered field (eos/hpf) are detected in mucosal biopsies. Placebo-controlled studies have not been conducted to evaluate the safety and efficacy of oral viscous budesonide (OVB). METHODS: Children with EoE were randomly assigned to groups that were given OVB (n=15) or placebo (n=9). Patients<5 feet and >or=5 feet tall received 1 mg and 2 mg OVB daily, respectively. All patients received lansoprazole. Duration of treatment was 3 months, followed by repeat endoscopy and biopsies. Patients were classified as responders if their peak eosinophil counts were <or=6 eos/hpf, partial responders were 7-19 eos/hpf, and nonresponders were >or=20 eos/hpf. Baseline and post-treatment symptoms and endoscopic and histologic features were scored. RESULTS: Thirteen (86.7%) children given OVB (P<.0001) and none who received placebo (P=.3) were classified as responders. Mean pre-/post-treatment peak eosinophil counts were 66.7 and 4.8 eos/hpf, respectively, in the group given OVB (P<.0001); they were 83.9 and 65.6 eos/hpf, respectively, in the group given placebo (P=.3). In the group given OVB, there were significant reductions from baseline values in proximal (P=.002), mid (P=.0003), and distal (P=.001) esophageal eosinophilia. After OVB therapy, compared with baseline, the mean symptom (P=.0007), endoscopy (P=.0005), and histology scores improved (P=.0035) significantly. CONCLUSIONS:
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Authors | Ranjan Dohil, Robert Newbury, Lyman Fox, John Bastian, Seema Aceves |
Journal | Gastroenterology
(Gastroenterology)
Vol. 139
Issue 2
Pg. 418-29
(Aug 2010)
ISSN: 1528-0012 [Electronic] United States |
PMID | 20457157
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright (c) 2010 AGA Institute. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Anti-Inflammatory Agents
- Dosage Forms
- Proton Pump Inhibitors
- Transforming Growth Factor beta1
- Lansoprazole
- Budesonide
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Topics |
- 2-Pyridinylmethylsulfinylbenzimidazoles
(therapeutic use)
- Administration, Oral
- Adolescent
- Anti-Inflammatory Agents
(administration & dosage, chemistry)
- Biopsy
- Budesonide
(administration & dosage, chemistry)
- Child
- Child, Preschool
- Dosage Forms
- Double-Blind Method
- Drug Therapy, Combination
- Eosinophilia
(drug therapy, genetics, pathology)
- Esophagitis
(drug therapy, genetics, pathology)
- Esophagoscopy
- Esophagus
(chemistry, drug effects, pathology)
- Female
- Fibrosis
- Genotype
- Humans
- Immunohistochemistry
- Infant
- Lansoprazole
- Male
- Mucous Membrane
(drug effects, pathology)
- Phenotype
- Placebo Effect
- Polymorphism, Single Nucleotide
- Promoter Regions, Genetic
- Proton Pump Inhibitors
(pharmacology)
- Transforming Growth Factor beta1
(analysis, genetics)
- Treatment Outcome
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