Traditional herbal medicines are naturally occurring, plant-derived substances with minimal or no industrial processing that have been used to treat illness within local or regional healing practices. Traditional herbal medicines are getting significant attention in global health debates.
In China, traditional herbal medicine played a prominent role in the strategy to contain and treat severe acute respiratory syndrome (SARS).
Eighty percent of African populations use some form of traditional herbal medicine,2,3 and the worldwide annual market for these products approaches US$ 60 billion.in research.
Case:
A government agency from a developed country is conducting an HIV-treatment trial in Africa. A traditional herbal medicine, Africa Flower, has been used for decades to treat wasting symptoms associated with HIV.
Local traditional medicine healers believe Africa Flower is an effective antiviral. It is already widely used for immune boosting in AIDS.
In vitro, pharmacokinetic studies suggest potential interference with vaccines, and animal models show liver toxicity at very high doses.
Ethical framework:
Cases like these present challenging questions related to the role of traditional herbal medicines in public health.
In general, international research on traditional herbal medicines should be subject to the same ethical requirements as all research related to human subjects.
Social value:
All research should hold the potential to achieve social value. Different entities may view the social value of traditional medicine research differently.
In the USA, the National Center for Complementary and Alternative Medicine at the National Institutes of Health spent approximately US$ 33 million on herbal medicines in fiscal year 2005.
Public-health officials are often eager to define the safety and effectiveness of herbal medicines for conditions such as malaria.
Conversely, harm can arise with the unscrupulous use of herbs such as Africa potato (various Hypoxis species).
While public-health entities may be concerned with defining the risks and benefits of herbal medicines already in use, entrepreneurs and corporations hope herbal medicines may yield immediate returns from herbal medicine sales.
Nongovernmental organizations may be primarily interested in preserving indigenous medical knowledge.
One such organization, the Association for the Promotion of Traditional Medicine (PROMETRA), based in Dakar, Senegal, is “dedicated to preserving and restoring African traditional medicine and indigenous science”.
The perceived need for the research may justifiably differ across countries, but without some basic agreement on the primary source of social value for the research it may be difficult to judge its ultimate impact.
Healthcare professionals will often encounter patients who are taking herbal medicines. However, many patients are reluctant to inform their healthcare professional, so enquiry is important.
Research commissioned by the MHRA indicated that approximately a third of UK adults had used herbal medicines.
These products have the potential to cause adverse reactions, as well as interact with conventional medicines.
We are responsible for monitoring the safety of herbal medicines in the UK and to do this we use many of the same tools that are used to monitor conventional medicines.
Furthermore, the Herbal Medicines Advisory Committee advises the MHRA on the safety and quality of herbal medicinal products for human use.
Key areas of concern about herbal medicines include:
poor and variable quality of unlicensed or unregulated products deliberate adulteration with potentially toxic ingredients such as heavy metals, arsenic, and prescription-only medicines (including products that have been banned because of safety concerns).
lack of detailed product information.
After international case reports of liver damage, we have recently issued warnings in conjunction with the Food Standards Agency about Hydroxycut (a weight-loss supplement) and For todo (also sold as Miradin, a turmeric-based food supplement, often promoted with unsubstantiated medicinal claims).
Regulated herbal medicines:
There is an increasing range of herbal medicines with a traditional herbal registration (shown by a THR number on the packaging) coming onto the UK market.
We have assessed safety, quality, and patient information for these products. The permitted minor indications are based on evidence of traditional use and not proven efficacy.
There are also some herbal medicines with a product licence (shown by a PL number) which are accompanied by necessary information for safe use.
Details of the Summary of Product Characteristics and Patient leaflets for products registered under the THR scheme are available on our website.
