Herbal Products with Phytoestrogenic Activity and their Adverse Reactions

Phytoestrogens (PEs) are plant-based compounds that can interact with estrogen receptors and are mainly used to treat menopausal complaints. Hop and Soy are commonly used ingredients, among other. However, the safety of products with assumed phytoestrogenic activity is not fully understood.

Reports to Lareb, global database and literature
Reports submitted to the Netherlands Pharmacovigilance Centre Lareb and to VigiBase of the World Health Organization (WHO) were analysed. In addition, a literature review was performed.  

In the Lareb database, the most commonly reported plant species to cause ARs (total of 67 reports) were Actaea racemosa L. (black cohosh) (47.8%), Humulus lupulus L. (hops) (32.8%), and Glycine max (L.) Merr. (soybean) (22.4%).

In the VigiBase database (total of 21,944 reports), the top three consisted of Glycine max (L.) Merr. (71.4%), Actaea racemosa L. (11.6%), and Vitex agnus-castus L. (chaste tree) (6.4%).

In the scoping review (total of 73 articles), Actaea racemosa L. (30.1%), Glycine max (L.) Merr. (28.8%), and Trifolium pratense L. (13.7%) were the most frequently mentioned plant species. ARs were most frequently reported in the system organ classes “gastrointestinal disorders”, “skin and subcutaneous tissue disorders”, “reproductive system and breast disorders”, and “general disorders and administration site conditions”.
Furthermore, from the literature review, it appeared that the use of products with assumed phytoestrogenic activity was associated with postmenopausal bleeding.

Further monitoring and research needed
While the potential benefits of products with assumed phytoestrogenic activity have been extensively pursued, the potential occurrence of ARs after using these products is less well understood. This study highlights the need for further investigation and careful monitoring of these products to better understand their effects and ensure the safety and well-being of individuals using them.

The article (Open Access) is available here.