Schaefer 2008.
| Methods | RCT | |
| Participants | Included: 80 children (age range 1 to 16 years) with EE (> 15 eosinophils per hpf) and negative pH probe study. 58% of children tested positive for food allergies at entry and were asked to eliminate the relevant food. Excluded: other esophageal condition, H. pylori infection, chronic inflammatory bowel disease, current treatment with corticosteroids. |
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| Interventions | 1. Oral prednisone (1mg/kg/dose twice daily (each dose maximum of 30mg) for 4 weeks then weaned for 8 weeks n=32. 2. Topical (swallowed) fluticasone via metered dose inhaler (110 µg per puff (age 1 to 10 years) and 22 µg per puff (>11 years of age) n=36. |
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| Outcomes | Histological improvement (to <15 eosinophils per hpf) at 4 weeks; Symptom remission; Adverse drug effects; Symptom relapse. |
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| Notes | hpf = high power field. PPI = proton pump inhibitor. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Random number assignment. Quote: "Random number assignment was used to generate a concealed allocation schedule that was maintained by a research coordinator. No blocking or stratification schemes were used.". |
| Allocation concealment? | Low risk | Quote: "concealed allocation schedule that was maintained by a research coordinator". |
| Blinding? All outcomes | High risk | Open label. Quote: "the allocated treatment was revealed to enrolled subjects after consent was obtained by the treating physician". |
| Incomplete outcome data addressed? All outcomes | Low risk | Quote: "The patient exited the study if any of the following occurred: 1. clinical resolution was not achieved with the allocated therapy, 2. no histologic improvement was found, 3. relapse of symptoms was noted at follow‐up evaluation, and/or 4. if the subject was noncompliant with the medication or tests. Clinical response data were analyzed based on an intention‐to‐treat approach. In keeping with intention‐to‐treat analysis, complete data from all randomized patients were included, unavailable data were censored, and protocol deviations were reported.". |
| Free of selective reporting? | Low risk | Quote "A daily symptom diary was maintained by the patient/guardian while on corticosteroid therapy. Clinical assessment was performed at weeks 4, 12, 18, and 24". "The primary end point was defined as a histologic response by an improvement in biopsy grade after 4 weeks of corticosteroid therapy. The secondary end point was defined as a clinical response to corticosteroids based on the presence or absence of the presenting symptom by patient/guardian report and by physician assessment at predetermined intervals." All prospectively stated outcomes were reported. |
| Free of other bias? | Unclear risk | Baseline characteristics: similar. ITT analysis: no. Adequate sample power. Follow‐up: 6 months. Quote "We acknowledge the potential for allergy testing and food elimination to act as a confounder". |