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Consideraciones de seguridad para los productos naturales con actividades adaptogénicas e inmunomoduladoras
Chen Jia Wen Liang1, Herman J Woerdenbag2, Corine Ekhart3
1Pharmacy Master Programme, School of Science and Engineering, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.
Pharmaceuticals (Basel, Switzerland)
|August 28, 2025
Resumen
No se conoce bien la seguridad de los productos naturales adaptogénicos e inmunomoduladores. Los eventos adversos graves (EAG) fueron raros, pero se informaron, lo que pone de relieve la necesidad de una mejor investigación y advertencias.
Área de la Ciencia:
- Farmacovigilancia y investigación de productos naturales
- Seguridad de la medicina integradora y complementaria
Sus antecedentes:
- Los productos naturales adaptogénicos e inmunomoduladores se utilizan ampliamente en la medicina tradicional euroasiática.
- Los perfiles de seguridad, especialmente los eventos adversos y los eventos adversos graves, son insuficientemente conocidos.
- Esto incluye remedios a base de hierbas, hongos y sustancias de origen animal.
Objetivo del estudio:
- Evaluar el perfil de seguridad de los productos naturales adaptógenos e inmunomoduladores.
- Se utilizó una revisión del alcance de los estudios en humanos y el análisis de los informes de seguridad de casos individuales (ICSR) de la OMS-UMC VigiBase.
Principales métodos:
- Realizó una revisión de alcance de PubMed (1980-2024) siguiendo las directrices de PRISMA-ScR.
- Se incluyeron ensayos aleatorizados/no aleatorizados e informes de casos centrados en los resultados de seguridad.
- Se analizaron 45.042 ICSR de VigiBase para 49 productos naturales, categorizados por tipo de producto, AE y datos demográficos.
Principales resultados:
- Se identificaron 51 productos naturales; 285 ensayos clínicos y 119 estudios de casos para productos de un solo ingrediente; 54 ensayos y 21 estudios de casos para productos de múltiples ingredientes.
- Efectos adversos comunes: gastrointestinales, dermatológicos, hepáticos, cardiovasculares y inmunológicos.
- Las EAC fueron raras pero se informaron para productos específicos; el 15,8% de las EAC con un solo ingrediente fueron EAC, incluidas las muertes, aunque la causalidad no estaba clara.
Conclusiones:
- Una visión global de los perfiles de seguridad revela variabilidad en la composición del producto y falta de estandarización.
- La información incompleta en los estudios y la información insuficiente en las bases de datos de farmacovigilancia dificultan la evaluación precisa de los riesgos.
- Para la protección de los consumidores es esencial una mayor investigación de alta calidad, una mejor farmacovigilancia y claras advertencias de seguridad.
Palabras clave:
VigiBase también incluye:adaptógenosProductos de origen animalreacciones adversas relacionadas con el medicamentoLos hongosMedicinas a base de hierbasInteracciones entre hierbas y medicamentosInmunomoduladores y sus derivadosinformes individuales de seguridad de los casos (ICSR)Productos naturalesFitoseguridadMás Videos Relacionados
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