Abstract
Concerns about the effects of propranolol on the central nervous system (CNS) in the infantile hemangioma (IH) population have been raised. We conducted a meta-analysis of the CNS and sleep-related effects of oral propranolol in IH patients. PubMed, Embase, Cochrance, Web of Science, and Clinicaltrials.gov were searched for relevant studies. We included clinical trials that compared oral propranolol with other treatments among IH patients under 6 years old and monitored and reported any adverse events. Study characteristics, types and number of adverse events were abstracted. Cochrane Collaboration Risk of Bias Tool was used to assess risk of bias. Our main outcomes were CNS and sleep-related effects. Random-effects models were used to estimate the pooled risk ratio. We did not observe statistically significant associations between oral propranolol and CNS or sleep-related effects. Oral propranolol appeared to have a safer profile of CNS effects than corticosteroids (RR = 0.27, 95% CI 0.02–3.00), but had an increased risk versus non-corticosteroids (for CNS effect, RR = 1.40, 95% CI 0.86–2.27; for sleep-related effects, RR = 1.63, 95% CI 0.88–3.03). Despite no statistically significant associations, there were suggestive findings of increased CNS effects and sleep-related risk of propranolol versus non-corticosteroids. In practice, CNS and sleep-related events should be monitored more closely among IH patients treated with oral propranolol.
Highlights
Infantile hemangioma (IH), a form of soft-tissue tumors, is the most common vascular tumor in infants
Propranolol did not have statistically significant associations with overall central nervous system (CNS) or sleep-related effects among infants with IH, oral propranolol appeared to have a safer profile for CNS effects when compared to corticosteroids, but have an increased risk of CNS effects and sleep-related effects as compared to placebo and other non-corticosteroids comparisons
We restricted our research to studies that reported adverse events in both treatment and comparison groups and provided a direct comparison for CNS effects and sleep-related events between propranolol and controls
Summary
Infantile hemangioma (IH), a form of soft-tissue tumors, is the most common vascular tumor in infants. Treatment options for IH include systemic treatments, local treatments, and laser and surgical therapy [2]. Systemic treatments include oral propranolol and corticosteroids [2]. Since 2008, oral propranolol has replaced corticosteroids as the first line systemic treatment for IH as an off-label indication, and later on, guidelines have recommended oral propranolol for complicated IH in many countries [3,4,5,6,7]. Oral propranolol has demonstrated superior efficacy and safety relative to corticosteroids, surgery, or placebo [8,9]. It is recommended to initiate oral propranolol at age of 5 weeks to 5 months with 6.5-month treatment duration at a starting dose of 0.6 mg/kg twice daily and a maintenance dose of 1.7 mg/kg twice daily [7]
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