Aim This systematic review and meta‐analysis aimed to compare the efficacy and safety of oral propranolol versus topical timolol for the treatment of superficial infantile haemangiomas. Methods We systematically searched PubMed, Cochrane Library, Embase, Web of Science and China National Knowledge Infrastructure from inception to April 23, 2026. Only randomized controlled trials comparing oral propranolol with topical timolol for superficial infantile haemangiomas were included. Two reviewers independently screened studies, extracted data and assessed risk of bias using the Cochrane risk of bias 2.0 tool. The primary outcomes were overall response rate and incidence of systemic adverse events. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using fixed‐effect models. Results Seven randomized controlled trials comprising 428 infants were included. Topical timolol was comparable to oral propranolol in overall response rate (RR = 1.09, 95% CI 0.97–1.23, p = 0.17; I 2 = 0%). Topical timolol significantly reduced the risk of systemic adverse events compared with oral propranolol (RR = 0.35, 95% CI 0.20–0.59, p < 0.0001; I 2 = 9%). Conclusions Topical timolol demonstrates comparable efficacy to oral propranolol for superficial infantile haemangiomas and has a significantly superior safety profile with a 65% reduction in systemic adverse events.
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