Konikoff 2006.
| Methods | RCT | |
| Participants | Included: 36 children (age range 3 to 18 years) with EE (>24 eosinophils per 400 X hpf in at least one biopsy from either the distal or proximal esophagus; and the presence of epithelial hyperplasia). Prior acid suppression therapy was not necessary for the diagnosis of EE. Excluded: Participants identified with a food allergy on skin prick testing and who responded to an exclusion diet; previous poor tolerance to Fluticasone Propionate; steroid use within the last 3 months; pregnant. |
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| Interventions | Intervention: Fluticasone propionate (400µg twice daily for 3 months) via metered dose inhaler and swallowed (N=20). Comparison: Placebo (twice daily for 3 months) via metered dose inhaler (N=11). Normal diet and PPI (if taken) were continued in both groups. |
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| Outcomes | Histological remission (<1 eosinophil per hpf). Adverse effects. |
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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 | Computer generated. Quote: "A clinical research coordinator dispensed metered‐dose inhalers containing either active drug or placebo to each patient according to a computer‐generated randomization list. No blocking or stratification schemes were used.". |
| Allocation concealment? | Low risk | Quote: "A clinical research coordinator dispensed metered‐dose inhalers containing either active drug or placebo to each patient according to a computer‐generated randomization list." "All participants and study personnel (with the exception of the above clinical research co‐ordinator) were blinded to treatment assignment for the duration of the study.". |
| Blinding? All outcomes | Low risk | Participants, clinicians and histologists were all blinded. Quote: "All participants and study personnel (with the exception of the above clinical research co‐ordinator) were blinded to treatment assignment for the duration of the study. Only the study statisticians had access to the unblinded data, but they did not have contact with study participants.". |
| Incomplete outcome data addressed? All outcomes | Low risk | Quote: "One patient was excluded from the FP group after randomization, because this patient did not meet the inclusion criteria for the diagnosis of EE. Four patients withdrew from the placebo group: 3 for increased symptoms and one for noncompliance. These 5 patients were excluded from the analysis, because they did not have follow‐up esophageal biopsy specimens on which to base their response to treatment.". |
| Free of selective reporting? | Low risk | Quote: "The primary outcome measure, as specified before the study was initiated, was complete histologic response to treatment as defined by a peak eosinophil count of 1 eosinophil in all 400 HPFs in both the proximal and distal esophagus. Secondary outcome measures included presence of endoscopic furrowing, presence of epithelial hyperplasia, and presence of clinical symptoms.". The outcomes were all reported. |
| Free of other bias? | Unclear risk | Small sample, adequate power. Follow‐up at 3 months: 100%. Compliance monitored: yes. |