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Diagnosis and Management of Infantile Hemangioma

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Table C. Summary <strong>of</strong> evidence in studies addressing effectiveness <strong>of</strong> pharmacologic interventions<br />

Intervention<br />

Type/Number <strong>of</strong><br />

Studies (Total N<br />

Participants)<br />

Key Outcome(s)<br />

Strength <strong>of</strong><br />

Evidence<br />

(SOE) Grade<br />

Steroids<br />

Oral steroids vs.<br />

Observation or<br />

Placebo<br />

Findings<br />

Improvement in IH Moderate In network meta-analysis oral steroids had a mean expected clearance<br />

rate <strong>of</strong> 43% (95% BCI: 21%-66%) compared with 6% (95% BCI: 1%-<br />

11%) for placebo/observation arms.<br />

Network metaanalysis<br />

Intralesional Steroids<br />

vs. Observation or<br />

Placebo<br />

Moderate SOE for greater effectiveness <strong>of</strong> oral steroids vs.<br />

placebo/observation given low precision <strong>and</strong> high study limitations.<br />

Improvement in IH Low In network meta-analysis intralesional steroids had a mean expected<br />

clearance rate <strong>of</strong> 58% (95% BCI: 22%-93%) compared with 6% (95%<br />

BCI: 1%-11%) for placebo/observation arms.<br />

Network metaanalysis<br />

All steroids<br />

RCT: 3 (138)<br />

Cohort studies: 3<br />

(179)<br />

Case series: 10<br />

(2974)<br />

Clinically important<br />

harms (Cushingoid<br />

facies, growth<br />

retardation, mood<br />

changes /irritability,<br />

hypertension,<br />

infection)<br />

Moderate<br />

Low SOE for greater effectiveness <strong>of</strong> intralesional steroids vs.<br />

placebo/observation given relatively small numbers <strong>of</strong> participants<br />

contributing to this comparison <strong>and</strong> low precision.<br />

Comparative studies, case series, <strong>and</strong> package insert data consistently<br />

reported these adverse effects.<br />

Moderate SOE for association <strong>of</strong> steroids with clinically important harms<br />

due to high study limitations.<br />

ES-19

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