The Council for Scientific and Industrial Research (CSIR) and a European Union (EU) consortium is researching plant food supplement and vitamin safety and benefits from 2011 to 2014. These substances are still unregulated in South Africa.
CSIR complimentary medicines project coordinator Paulo Meoni said suppliers currently must inform the Medicines Control Council (MCC) of new products, and take legal responsibility for safety and efficacy. MCC issues informal numbers to applicants.
Supplements may be regulated in SA within four years. Plant food supplements are still considered to be ‘complimentary medicines’ in SA legislation.
Future regulation will be based on existing European supplement and herbal data, and the eventual report on the current study.
Hundreds of natural herbs, herbal preparations, and synthesised vitamin compounds and products are available in South Africa.
Some herbs, herbal preparations and vitamins, interact with registered drugs, and could decrease or increase drugs effects or side effects. Plant based supplements may cause toxic effects, and may change properties with age, Meoni said.
Researchers warn against products containing combinations of little known plants.
Pharmacies hijack herbal cures
Effective herbal preparations that are patented and declared schedule 5 drugs, are legally removed from traditional and alternative health practice, and reserved to the pharmaceuticals industry.
Scientific trials on Sutherlandia, entering a large scale second round in 2011, are raising fears with some ethno and traditional medicine practitioners , and among alternative wellness and stress therapy modality operators, that use of the indigenous herb in simple preparations may be reserved to pharmacies, like DHEA preparations were scheduled.
Herbalists, traditional healers, ethno practitioners and biofeedback operators rely on a range of potent herbs and herbal combinations for treatment or therapy.
Some fear that clinical trials funded by pharmaceutical multinationals, may counteract the interests of public access to herbs.
The SA government had already declared DHEA preparations as a schedule 5 drug, meaning that only licenced and registered companies may produce, market and prescribe it.
The price of scheduled preparations are initially loaded to regain the expense of research and clinical trials.
Herbalists accused of ignorance
The legalised pharmaceutical, academic and medical system point out that several herbs, “traditionally used in therapy for a variety of ailments, particularly in rural areas… have not been assessed for safety or toxicity to tissue or organs of mammalian recipients.”
Herbs remain free of copyright
Natural Healers Association president Prof Marius Herholdt commented to SHEQafrica.com that pharmaceutical companies could not ‘hijack’ hebal applications which were not patented products. Any business could notify the Medicines Control Council (MCC) of its herbal mixtures, or register preparations as medicines.
Natural healers use herbs in a synergistic manner, that is, whole, and do not use extracts of active ingredients. Herbal medicinal value lies in secondary metabolites like coumarines, flavanoids, flavones, glucocides.
Some herbs contain alkaloids and may be toxic in larger doses, like Fox Glove used to make digitalis, a heart stimulant, or Catharanthus roseus, Madagscar periwinkle, used as a base for cancer preparations like Vinchristine and Vinblastine.
Prof Herholdt explained to SHEQafrica.com that ethno medicine was still ‘shady and unsure’. “The scope of ethno medicine has not been agreed or finalised, and there is no official pharmacopoeia available.
“The discipline will eventually be co-defined by tradition, uses, and conventions. One of the popular conventions is to use single herbs that by definition do not constitute medical registration potential.
“Some ethnomed practitioners combine two or more herbs to make remedies that could be registered. Medicine registration requires formal trials for efficacy and safety.
“Patenting of remedies containing natural products, in my view, could be patented only when combined with non natural products, such as chemical constituents. Simple preparations are also of interest, since combinations of three herbs may result in a complex medicine on bio-chemical level.
“Every herb already contains a wide spectrum of secondary metabolites, each working to enhance the pharmaceutical working of the next,” Prof Herhold explained.
Only medical doctors may administer scheduled medicines, but if a statutory ethno medicine body were instituted, registered ethno medical practitioners would then also be able to prescribe patented herbal medicines, Prof Herhold told SHEQafrica.com.
Clinical trials v anecdotes
In the White Paper for implementation of traditional medicine within the national health system, government pleads for a pharmacopeia including indigenous medicinal plants, requiring clinical studies of the safety and effectiveness of herbs, as the E Commission in Germany had done, Prof Herholdt explains.
Anecdotal evidence and informal trials, however, would play a role in ethno medicine for years to come, since clinical trials are extremely difficult and time consuming, Prof Herholdt said.
The natural protocol does not aim to treat illness, like bio medicine does, but to promote wellness, like nutritional support, lifestyle adaptation, and council. Wellness is a comprehensive approach, involving clients themselves.
Herbal trials report
Recent scientific trials evaluated cyto toxicity of some medicinal plants that could potentially treat diarrhea and stomach disorders.
Six selected medicinal plants were assessed for antibacterial activities against ampicillin resistant and kanamycin resistant strains of Escherichia coli, by broth micro dilution methods, report authors Mary Bisi-Johnson, Chikwelu Obi Toshio, Hattori Yoshiteru, Oshima Shenwei, Li Learnmore Kambizi, Jacobus Eloff, and Sandeep Vasaikar in BMC Complementary and Alternative Medicine, 2011 (reference 2011 11:14).
Eucomis autumnalis is toxic
Methanol fraction of Eucomis autumnalis has “profound cytotoxic effect, even though it possesses very significant antibacterial activity.” The trial team warn against its usage; “natural products are not necessarily safe”.
PHOTO; Sutherlandia is one of the South African herbs widely used whole, and in preparations. Medical control looms over the herbal and vitamins market.