January 09, 2019

Additional trials are warranted to further examine oral propranolol and topical timolol maleate, as well as other interventions for infantile hemangioma.

In patients with infantile hemangiomas of the skin, the use of oral propranolol and topical timolol maleate has been shown to be more beneficial than placebo with respect to clearance or other measures of resolution, with no increase in harm reported, according to the results of an abridged Cochrane systematic review that included GRADE assessments. Findings from the analysis were published in the British Journal of Dermatology.

The current Cochrane systematic review comprised 28 trials that included a total of 1728 participants and evaluated 12 interventions. The investigators downgraded the evidence from high to moderate/low for issues linked to risk for bias and imprecision.

The use of oral propranolol 3 mg/kg/day appeared to improve clinician-assessed clearance of hemangiomas compared with placebo (risk ratio [RR] 16.61; 95% CI, 4.2265.34; moderate quality of evidence). 

Moreover, when oral propranolol was compared with placebo, no differences with respect to adverse events (AEs) were reported (RR 1.05; 95% CI, 0.33 3.39). In fact, no significant difference was reported between the use of oral propranolol and placebo at any doses with respect to the development of serious cardiovascular AEs and other AEs, such as bronchospasm and hypoglycemia.

In addition, the likelihood of reduction of redness may be improved with the use of topical timolol maleate 0.5% gel applied twice daily compared with placebo (RR 8.11; 95% CI, 1.09-60.09; low quality of evidence). With respect to this comparison, no cases of bradycardia or hypotension were reported.

A major limitation of the review was the small sample sizes and risk for bias in some of the domains. Additional trials in which personnel and participants are both blinded, the studies are thoroughly described in publications, and a sufficient number of children are recruited are warranted in order to provide meaningful results. Moreover, future trials should evaluate patient-reported outcomes, as well as objective outcomes of benefit.

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References

Novoa M, Baselga E, Beltran S, et al. Interventions for infantile haemangiomas of the skin: abridged Cochrane systematic review including GRADE assessments [published online November 10, 2018]. Br J Dermatol. doi: 10.1111/bjd.17407