Traditional use and safety of herbal medicines1

Abstract

In the European Union, traditional herbal medicines that are regarded as "acceptably safe, albeit not having a recognized level of efficacy" fit into a special category of drugs ("traditional herbal medicine products") for which requirements of non-clinical and clinical studies are less rigorous. A regulation proposal published by the Brazilian National Health Surveillance (Anvisa) defines a similar drug category ("traditional phytotherapeutic products") for registration purposes. Regarding herbal medicines, both agencies seem to be lenient regarding proof of efficacy, and consider long-standing folk use as evidence of safety and a waiver of a thorough toxicological evaluation. Nonetheless, several herbal products and constituents with a long history of folk usage are suspected carcinogenic and/or hepatotoxic. Herbal products have also been shown to inhibit and/or induce drug-metabolizing enzymes. Since herbal medicines are often used in conjunction with conventional drugs, kinetic and clinical interactions are a cause for concern. A demonstration of the safety of herbal medicines for registration purposes should include at least in vitro and in vivo genotoxicity assays, long-term rodent carcinogenicity tests (for drugs intended to be continuously used for > 3 months or intermittently for > 6 months), reproductive and developmental toxicity studies (for drugs used by women of childbearing age), and investigation of the effects on drug-metabolizing enzymes.

Einstein's Special Principle of Relativity and Biological Resistance Control

“…However, medicinal plants do display a number of shortcomings including variability in chemical concentrations [13,14] and others [15]. Therefore, the challenge now facing the medical research community is designing drugs which will prevent the rise of resistance the way medicinal plants do while at the same time outperforming medicinal plants in terms of their shortcomings.…”

Wound Care: Traditional African Medicine Approach

“…"lso because of the high relative ratio of patients to conventional physicians, a lot of pressure is placed on medical personnel resulting in perceived or quasi-incompetence as many patients are often not satisied with the atention given to them by health workers. The patients have insuicient time to interact and discuss their problems with their physicians and other health workers in maters regarding their health condition [42].…”

Extended spectrum beta-lactamase producing enterobacteriaceae (ESBL) isolated from herbal preparations

“…The use of herbal preparations is on the increase in most developing and developed nations, with approximately 65% to 80% of the world's population depending on herbal preparations for their primary health care delivery (Barnes, 2003). Despite the continued dependence and/or use of herbal preparations, there are reported cases of adverse health effects such as suspected carcinogenicity and/or hepatotoxicity as well as induced drug-metabolizing enzymes (Moreira et al, 2014). These effects may be due to the poor quality of herbal products or poor hygienic conditions maintained by its manufacturers, and remain a serious threat to patient hygiene (WHO, 2008).…”