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Introducción: La parálisis facial genera limitaciones funcionales, estéticas y psicosociales que afectan la calidad de vida. La toxina botulínica tipo A (BoNT-A) se utiliza como estrategia terapéutica, pero la evidencia que respalda su efectividad y seguridad es heterogénea y de calidad variable. Este estudio como objetivo sintetizar la evidencia disponible y evaluar la calidad científica de los ensayos clínicos aleatorizados (ECAs). Métodos: Se realizaron búsquedas en PubMed, Scopus y Web of Science hasta junio de 2025. Se incluyeron ECAs que evaluaran BoNT-A en pacientes con parálisis facial de cualquier etiología. La extracción de datos fue independiente y en duplicado. El riesgo de sesgo se evaluó con la herramienta Cochrane RoB 2.0, la calidad metodológica con la lista de chequeo Joanna Briggs Institute para ECAs y la calidad del reporte con la guía CONSORT 2025. Resultados: Seis ECAs (n=262 pacientes) cumplieron los criterios de inclusión. BoNT-A mostró beneficios consistentes en simetría facial, reducción de sinquinesis y mejoría funcional, en comparación con tratamiento conservador, placebo o ausencia de tratamiento. El perfil de seguridad fue favorable, con efectos adversos leves y transitorios. No obstante, varios estudios presentaron limitaciones en el proceso de aleatorización, el cegamiento y el reporte selectivo de resultados, lo que restringe la certeza global de la evidencia. Conclusión: BoNT-A representa una intervención prometedora y segura en la parálisis facial. Sin embargo, la evidencia actual es limitada en número y calidad, lo que subraya la necesidad de futuros ensayos mejor diseñados y reportados, que permitan establecer recomendaciones clínicas sólidas.
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Derechos de autor 2026 Lucia Tatiana Romero Pineda, Isabella Vejarano Vega, Camilo Andrés Carbonell Melendrez, Ana Lucía Ordóñez Guerrero, Matías Díaz Perdomo, Camilo Villa González, Melissa Orozco Gallego, Miguel Ángel Bermúdez Lozano, Daniela García Pereira, Michael Ortega Sierra