Safety, Standardization, and Future Perspectives of Herbal Therapeutics in Women’s Health
Corresponding author: [email protected]
Abstract
Herbal medicines are used by a large proportion of women for menstrual, reproductive, pregnancy-related and menopausal conditions, often on the assumption that a natural product is inherently safe. That assumption is incorrect, and the benefit of any herbal drug depends on its safety profile and on the consistency of the product. This chapter examines three connected questions. The first is safety: intrinsic toxicity is illustrated by aristolochic acid nephropathy, first recognised in women taking a slimming preparation, by pyrrolizidine alkaloid liver injury and by pennyroyal poisoning; pregnancy and lactation present special risks, including neonatal cardiac failure after maternal use of blue cohosh; and herb-drug interactions, of which St John's wort induction of cytochrome P450 3A4 and consequent oral contraceptive failure is the clearest example, affect women in all life stages. The use of phytoestrogens by women with oestrogen-sensitive cancers is considered against current observational and regulatory evidence. The second question is quality: adulteration with heavy metals, undeclared pharmaceuticals and substituted species is documented in products sold in India and internationally, and standardisation is explained through the distinction between standardised, quantified and other extracts, the choice of active and analytical markers, and the analytical methods now available, from macroscopy and high-performance thin-layer chromatography fingerprinting to liquid chromatography-mass spectrometry and DNA barcoding. Regulatory frameworks in India, the European Union and the United States, and the role of pharmacovigilance, are compared. The third question is the future: metabolomics, network pharmacology, reverse pharmacology, microbiome-guided personalisation, improved delivery systems and better-reported clinical trials offer a route by which traditional knowledge can be converted into evidence-based gynaecological therapy, provided that conservation and sustainable sourcing of the plants are addressed.
Author Affiliations
- 1 Assistant Professor, Department of Quality Assurance, Asian Institute of Pharmacy, G. D. Sawant Marg, Pathardi Phata, Nashik, Maharashtra, India.