J. Pharm. Pharmacogn. Res., vol. 14, no. 5, Article ID 2828, Sep-Oct 2026.

DOI: https://doi.org/10.56499/jppres_14.5.2828

Review

Safety of herbal galactagogues: A systematic review of preclinical and clinical evidence

[Seguridad de los galactagogos a base de hierbas: una revisión sistemática de la evidencia preclínica y clínica]

Sara Nurmala^1,3, Neng F. Kurniati², Kusnandar Anggadiredja^2*

¹Doctoral Program, School of Pharmacy, Bandung Institute of Technology, Bandung, Indonesia.

²Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Bandung Institute of Technology, Bandung, Indonesia.

³Department of Pharmacy, Faculty of Mathematics and Natural Sciences, Pakuan University, Bogor, Indonesia.

*E-mail: kusnandar_a@itb.ac.id

Abstract

Context: Herbal galactagogues are commonly used to promote lactation. Despite their increasing use, concerns remain regarding their safety because evidence from preclinical and clinical studies is limited and heterogeneous. Therefore, an updated systematic review is needed to synthesize the current evidence and inform clinical practice and future research.

Aims: To provide a systematic and integrated assessment of the available preclinical and clinical evidence regarding the safety of herbal galactagogues.

Methods: This systematic review was conducted in accordance with the PRISMA 2020 Statement. Eligible studies were identified through systematic searches of PubMed, ScienceDirect, Springer Nature Link, and SAGE, including all records indexed from database inception to July 31, 2026. Study selection and data extraction were performed independently by two reviewers. Thirteen studies met the prespecified selection criteria after full-text review. Quality appraisal was undertaken using instruments appropriate to the study design, with the SYRCLE Risk of Bias tool and the Joanna Briggs Institute (JBI) Critical Appraisal Checklists.

Results: The review ultimately included 13 eligible studies. Preclinical studies generally reported no treatment-related toxicity, while clinical studies reported no serious treatment-related adverse events, although safety reporting varied across study designs. Heterogeneous interventions and inconsistent safety reporting limited the interpretation of the findings.

Conclusions: Current evidence did not identify major short-term treatment-related safety concerns. However, heterogeneous methods, inconsistent safety reporting, and limited long-term data warrant further clinical studies using standardized herbal preparations and integrated maternal–infant safety monitoring.

Keywords: adverse effects; animal models; breastfeeding; phytotherapy; postpartum period.

Resumen

Contexto: Los galactagogos a base de hierbas se utilizan habitualmente para fomentar la lactancia. A pesar de su creciente uso, persisten dudas sobre su seguridad, ya que la evidencia procedente de estudios preclínicos y clínicos es limitada y heterogénea. Por ello, es necesaria una revisión sistemática actualizada que sintetice la evidencia actual y oriente la práctica clínica y las investigaciones futuras.

Objetivos: Ofrecer una evaluación integrada y sistemática de la evidencia preclínica y clínica disponible sobre la seguridad de los galactagogos a base de hierbas.

Métodos: La metodología y la elaboración de esta revisión se ajustaron a las directrices PRISMA 2020. Se identificaron los estudios elegibles mediante búsquedas sistemáticas en PubMed, ScienceDirect, Springer Nature Link y SAGE, incluyendo todos los registros indexados desde la creación de las bases de datos hasta el 31 de julio de 2026. La selección de estudios y la extracción de datos fueron realizadas de forma independiente por dos revisores. Un total de 13 estudios cumplieron los criterios de selección preestablecidos tras la revisión del texto completo. La evaluación de la calidad se realizó utilizando instrumentos adecuados al diseño de cada estudio: la herramienta SYRCLE para evaluar el riesgo de sesgo y las listas de verificación de evaluación crítica del Joanna Briggs Institute (JBI).

Resultados: En última instancia, la revisión incluyó 13 estudios elegibles. Por lo general, los estudios preclínicos no notificaron toxicidad relacionada con el tratamiento, mientras que los estudios clínicos no registraron acontecimientos adversos graves asociados al mismo, si bien la notificación de datos de seguridad varió según el diseño de los estudios. La heterogeneidad de las intervenciones y la inconsistencia en la notificación de la seguridad limitaron la interpretación de los hallazgos.

Conclusiones: La evidencia actual no identificó problemas de seguridad importantes a corto plazo. Sin embargo, la heterogeneidad de los métodos, la inconsistencia en la notificación de seguridad y la escasez de datos a largo plazo justifican la realización de nuevos estudios clínicos que utilicen preparados herbales estandarizados y un seguimiento integrado de la seguridad materno-infantil.

Palabras Clave: efectos adversos; fitoterapia; lactancia materna; modelos animales; periodo posparto.

https://jppres.com/jppres/pdf/vol14/jppres_14.5.2828.pdf

Citation Format: Nurmala S, Kurniati NF, Anggadiredja K (2026) Safety of herbal galactagogues: A systematic review of preclinical and clinical evidence. J Pharm Pharmacogn Res 14(5): 2828. https://doi.org/10.56499/jppres_14.5.2828

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