Comparison of oral prednisone and topical fluticasone in the treatment of eosinophilic esophagitis: a randomized trial in children.
OBJECTIVE
Although eosinophilic esophagitis is recognized increasingly, outcome data guiding therapy are limited. We conducted a prospective randomized trial comparing oral prednisone (P) and swallowed fluticasone (F) for histologic and clinical response.


METHODS
Patients were randomized to receive P or F for 4 weeks, followed by an 8-week weaning protocol. Esophageal histology was evaluated at baseline and after 4 weeks of therapy. Clinical assessments were performed at weeks 0, 4, 12, 18, and 24.


RESULTS
Eighty patients with eosinophilic esophagitis were enrolled: 40 in the P arm and 40 in the F arm. Histologic improvement was seen in 30 of 32 P and 34 of 36 F patients, with a greater degree of histologic improvement in the P group. All P and 35 of 36 F patients were free of presenting symptom(s) at week 4. Symptom relapse was seen in 45% of patients by week 24. Kaplan-Meier analysis showed no difference between P and F with regard to relapse rate (P = .7399). No significant difference in time to relapse was found between groups (P = .2529). Systemic adverse effects were noted in 40% of the P arm, whereas esophageal candidal overgrowth was seen in 15% of the F arm.


CONCLUSIONS
Systemic and topical corticosteroids were effective in achieving initial histologic and clinical improvement. P resulted in a greater degree of histologic improvement, without evidence of an associated clinical advantage over F in terms of symptom resolution, relapse rates, or time to relapse. Symptom relapse was common to both groups upon therapy discontinuation, highlighting the need for maintenance treatment protocols.
Schaefer
Elizabeth T
ET
Indiana University School of Medicine, James Whitcomb Riley Hospital for Children, Division of Pediatric Gastroenterology, Indianapolis, Indiana 46202, USA.
Fitzgerald
Joseph F
JF
Molleston
Jean P
JP
Croffie
Joseph M
JM
Pfefferkorn
Marian D
MD
Corkins
Mark R
MR
Lim
Joel D
JD
Steiner
Steven J
SJ
Gupta
Sandeep K
SK
D000284:Administration, Oral; D000293:Adolescent; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004941:Esophagitis / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology / Q000517:prevention & control; D004947:Esophagus / Q000473:pathology; D005260:Female; D000068298:Fluticasone; D006801:Humans; D007223:Infant; D008297:Male; D009181:Mycoses; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012008:Recurrence; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000730:Androstadienes; D000068298:Fluticasone; D011241:Prednisone