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A historical perspective
on
Evidence Based Medicine and Herbal Medicine
In the last century western countries have seen a dramatic movement of the population away from the countryside into cities and towns. There has been a shift in the exposure and thus mind set of modern man away from the energetic natural world of nature that they experienced in the countryside into the more physical material world of towns and cities. This has happened in parallel with the development of science and the scientific way, along with a reduction or even discontinuance in the use of the human senses of touch, taste, smell and visual observation as a means of evaluating one's surroundings. 'Civilized' man's mind is being drawn more and more through material possessions and electronic media into a world far removed from the natural world, to the extent that much of the younger generation's mindset is now focused on screen images and 'facebook' friends.
There has been a similar shift in the mindset of Medicinal Herb Practitioners where in the practice of their herbal medicine they now focus on the herbal extract as being a liquid extract of a stated quantity of chemical compounds rather than it being a vibrant energetic extract of a living plant containing an 'extract' of the plant's vibrational essence including its chemicals.
The Current Practice of Herbal Medicine
The practice of Herbal Medicine has evolved into two basic but disproportionate streams of expression. The predominant stream being where liquid extracts prepared from dried plant material (FEs) containing standardized and researched plant chemicals (phytochemicals) are used to treat symptom diagnosed disease states. This could be called the 'scientific' stream. The other stream is where the whole person is treated for their dis-ease and disease states using liquid extracts prepared from the fresh herb into Fresh Plant Tinctures (FPTs). This stream may be called the 'art' stream. There are of course 'many shades of grey' between the two streams and this elaboration is not intended to offend any but is an attempt to share a vision and perceived direction of where herbal medicine is heading. Further reading on this is available in the companion document: Energy Considerations in the Pharmacy of Herbal Medicines. (Also available at: www.pindariherbfarm.com/quality/energy.htm)
The separation of the two streams is being encouraged and reinforced by the evolution of the science of herbal medicine and through the publication of medical trials based on FEs. These trials being often funded by the rapidly developing medicinal herb processing industries that produce the FEs. The industry practice of standardizing herbal extracts based on the measure of certain agreed to chemical constituents within the herbal extract, being an essential step to enable this to proceed.
The development of the 'scientific' stream is being further encouraged through herbal medicine's educational institutions' acceptance of the marker compound standardization paradigm as the 'state of the art' and it is also being reinforced in the minds of its current practitioners via the publishing of research papers based on the medical trials of these standardized herbal extracts and through industry financed and run herbal seminars where these trials and their results are presented. The above is 'cemented' together by government regulatory authorities who base their controlling rules around this paradigm, and all of this is put forward as necessary for the betterment of the delivery of health care to the patient, under the ethics banner of "evidence based medicine."
Herbal medicine is increasingly more "allopathic" and drug orientated in its approach, mimicking the pharmaceutical drug industry's paradigm. Educational institutions in an attempt to address the need to expose students to the 'art' of herbal medicine, are including live herb identification and herbal lore as a part of the curriculum, but the overall focus in the teaching of herbal medicine is much more towards the scientific way with the mindset of the student accordingly programmed.
The practice of the 'art' stream of Herbal Medicine involving the preparation and prescribing of FPTs has been reduced to only a few practitioners. But it is this 'art' of herbal medicine that is the historical 'backbone' of this modality and there is an increasing risk that this 'art' and its lore may be further reduced and even lost through natural attrition and increased rules and regulations.
There are now volumes of eloquent publications on herbal medicines where established constituents are attributed 'proven' medicinal actions and activities through referenced clinical trials followed by toxicology reports and contraindications, interactions, side effects and researched dosages. This scientific process is coupled and in tandem with the regulatory controlling authority's rules.
But there are also many traditionally well established therapeutic herbs such as Rue, Couch grass and Horsetail that are not being fully taught to students as there is little research on them.
This could be seen as a necessity as the increasing use by the general population and commercialism sees increasing consumption and self medication of herbal medicines with all the inherent risks of side effects and over dosage etc. And within the scientific stream of the practice of Herbal Medicine, as within the practice of allopathic drug therapy, there is the tendency in practice to at times prescribe 'heroic' doses of singular or clusters of herbal extracts/marker chemicals in order to elicit a medicinal response. These high doses of herbal chemicals can at times be at the upper limit of their therapeutic window which then introduces the complication of increased side effects and the potential of toxicity.
This is an increasingly long way from the historical traditional use of medicinal herbs as being plant material which when freshly harvested from the meadows, woods and jungles was prepared and administered to the sick.
The practice of herbal medicine has become far more elegant, far more scientific and because of this, possibility at times more efficacious, but:
Are marker compound levels an accurate means of measuring a herbal extract's medicinal activity when the chemical components in a herb have been shown to work synergistically (refer ahead)?
Are herbal extracts prepared from dried plant material as efficacious as fresh plant extracts for the same disease?
If not, what are the differences and is there an opportunity to improve the efficacy of herbal medicines?
Dried Herbal Extracts
versus Fresh Plant Extracts
Further reading on this is
again available at the link above.
The ongoing experience at Pindari suggests there is a difference in the medicinal activity between the two extract types. The FPT dosage required is often smaller and the activity subtly different to that of a FE prepared from dried plant material. This has been found anecdotally to vary from herb to herb and is often, but not always, most noticeable in extracts from aerial parts of herbs. The observation of this over many years is what has encouraged the writing of this document.
Chinese herbal medicine is largely based on dried plant material that has often been treated in very specific ways such that the herbal material is a preparation in itself. In other parts of the world dried plant material is also regularly used in medicine and historically in western herbal medicine it was dried plant material that was required and used when the fresh herb was not available. The pharmacy of herbal medicine is interwoven between the use of the fresh and dried herb with the pharmacology of the different herbal products from the same plant varying accordingly.
What of herbal medicines prepared from fresh plant material? What appears to have happened in Australia is that the advent of the government regulatory authority's entry into the control of the manufacture of herbal medicines led to standards being set that required enormous establishment costs for plants for processing of herbs. This led to the loss of diversity of suppliers with the closure of small local producers who were able to access locally grown fresh medicinal herbs, leaving only a few manufacturers able to afford the initial setup and ongoing compliance costs.
The larger plants being less able through logistics to manage seasonable variations and time constraints in handling fresh plant material plus the associated costs, thus concentrated on internationally sourced, broad acre or third world grown dried herb material. But there is this ongoing observed disparity between the efficacy of FPTs when compared with FEs and this potential disparity between the two can be exampled by asking the simple question, which is better for you, a fresh carrot out of the garden or a reconstituted dried carrot that has been stored for 6 months?
Shouldn't the health of a patient be a practitioner's first concern ahead of 'market convenience', and thus those products that best facilitate healing be the first considered for use?
There are also authoritative statements that indicate the complexity of herbal medicinal efficacy as in Weiss’s Herbal Medicine Classic Edition, authored by Rudolf Fritz Weiss, M. D. page 163 where it states in regards to Crataegus spp; “the sum of these individual constituents in the combination offered by Nature, has unique and valuable properties. It is obvious that the actions of the individual elements are not merely additive or synergic, but that genuine potentiation occurs.”
Given the above statement, how can the medicinal efficacy of a herb be reliably qualified and quantified by the measure of a single or group of similar chemicals in the plant termed marker compounds? Especially when live herbs are so variable and complex in their chemical composition? Also, what of the chemical decomposition that occurs as the herbal extract ages and what effect does this have on its medicinal properties?
Are marker compounds industry's attempt to standardize herbal medicines so that they can then be scientifically evaluated within the allopathic drug industry paradigm? In today's medical scientific world it is standard accepted practice to be able to standardize a medicine. Standardization enables medicinal trials to be completed according to the current medical industry standards of double blind, cross over trials. For medicinal herbs, attempts to achieve this via the use of marker chemicals has become the accepted practice, but is there evidence to support the validity of this process in the face of the variability of herbal material or is it a 'convenient' but un-scientific practice? Is this being done to "prove" a medicinal herb's efficacy and safety within the principle of "evidenced based medicine," watched over by the ever ready to condemn, enormously powerful and controlling allopathic drug industry?
It is this global, corporate, profit motivated industry that controls most of what happens in the delivery of medicine in developed countries. Its ethics have been seriously questioned in recent years with exposure of unreported but known drug toxicities, falsified medical papers, collusion with and interference in government regulatory authorities, price fixing and more. There is also the 'file draw effect' where adverse or negative research finding are not being published. This compromising of standards strongly indicates that it is a dollar motivated industry. To an observer, very little regard seems to be given to the health and wellbeing of its customers, the sick and dying. It and the orthodox medical establishment's principal code or ethic by which it prescribes medication is based on Evidence based Medicine." But what is the current evidence in relation to this "evidenced based medicine" and the health and wellbeing of the population for which it has assumed itself to be the authority?
The current delivery of health care in Australia is under severe challenge as particularly hospital costs escalate beyond the ability of the governments to fund them and the costs of the supply of drugs to the community is currently increasing at around 20% per annum. General practitioners are being forced via economics to spend less time with each patient with more and more 'diagnoses' being the result of pathology tests rather than physical examinations.
The general public's health is not improving; this can be attributed to lifestyle and eating habits but also to the quality and effectiveness of the delivery of medical care. Two papers amongst many that support this are:
The Journal of the American Medical Association (JAMA) reports in their Journal (July 26, 2000 -Vol. 284 page 483) that the third leading cause of death in the USA after cancer is their own practice of medicine (iatrogenic disease). "One hundred and six thousand people alone, die annually from non-error, adverse effects of medications" (drugs).
Dr. Wallace Bain PhD, New Zealand acting Chief Coroner, reported that in 1998 in New Zealand zero deaths were attributable to natural remedies, whereas in contrast, 1,524 New Zealanders died as a result of adverse reactions to pharmaceutical drugs. Dr Bain goes on to say: " What is ironic here in that what is being held out as justification for high regulation and compliance in the area of Complementary Medicines, Natural Products, Traditional Products, Supplements, Vitamins etc, is public safety and risk. Despite a diligent search of Coronial records and the literature, no instances have been found to demonstrate that, in fact with these products in NZ, there is any serious public health issue or risk to the public. He then went onto say: "The problem is clearly with prescription and other drugs and no demonstrable risk at all with these natural products." (http://www.newhealth.co.nz/pdf/Coronial_report_by_Wallace_Bain_Risk_Based_Analysis.pdf)
If you consider that there is documentary evidence that there is under reporting of medical errors and adverse drug reactions in Australia, (the author has observed many cases) then it could well be that iatrogenic disease (doctor/drug caused disease) could be the second leading cause of death. And this is and continues to be practised under the principle of "Evidence based Medicine." One could argue that without the current medical delivery system the health of the population would be worse, but it is hard to imagine a worse case scenario in the face of the strong evidence of adverse and lethal reactions to prescribed drug medications.
This is not to belittle the individual practitioners within this industry who daily strive to help their patients, nor the incredible advances of surgeons with their surgical procedures that have helped so many, including the author, but the figures that this system of medicine delivers speak for themselves. If the health of the patient is to be the first concern of the practitioner as it is in the pharmacy profession, then the system of delivery and care of the sick needs drastic change, for it dismally fails its own code, being the second or third leading cause of death. This being clear evidence of a need for change, and it is unacceptable as evidenced by drug reactions.
Currently modern allopathic drug medicine is one of the largest of the multinational global industries and it is very much profit orientated. The healing professions of old where a practitioner of the healing arts endeavored to facilitate the healing in a patient has been replaced by a 'pseudo-supermarket infrastructure' where the scientifically diagnosed patient is 'wheeled' to that part of the 'drug supermarket' shelves that carry the drugs scientifically proven to be of value for that diagnosis. And of course, alongside these drugs sit the 'me too' drugs that are required to alleviate the drugs' side effects. Meanwhile, the patient's 'now hidden' disease process continues on unabated until the next bodily expression of un-wellness surfaces to again be suppressed by more medication with more side effects. This is known as poly-pharmacy and is common practice seen in pharmacy today.
Whilst the above may be considered an exaggerated negative description of the medical drug industry, it none-the-less is at times true.
There are clear indications that the 'scientific way' and 'evidence base' of the 'standardized' herbal industry is heading down the same path as the current allopathic drug industry. This is in order to 'prove itself' and to also thus enable it to 'get into bed' with governments and their funding streams. But at the same time it is exposing itself to a multinational corporate system that has very little or no interest in seeing herbal medicine further expand. The system's options through its enormous wealth and influence are perhaps three fold:
Buy into the medical herb industry and then suppress it.
Demand more evidence based trials and other cost increasing measures enforced by government regulations.
Restrict availability of herbs through government controls. This is currently happening in Europe.
Never before in the practice of herbal medicine, other than perhaps in the Middle Ages with the burning of many herbalists at the stake, has herbal medicine been so vulnerable. And much of this is at this time of its own volition. It is also at a time when much, much change is afoot on earth and it could be these changes that 'see' herbal medicine's reprieve. This is discussed ahead.
Evidence Based Medicine and Medicinal Herbs.
As the basis for the practice of herbal medicine becomes more scientific in its approach, the question that needs to be asked is: is the practice direction in order to maximize the healing potential of herbal extracts and is this direction in the best interests of the patient? Or is it more to prove herbal medicines are therapeutically beneficial to governments and pharmaceutical companies?
The efficacy of medicinal herbs does need to be established and toxicity, contraindications and side effects also need to be investigated, and this is best done with clinical research and trials that at this time are being conducted almost exclusively on FE's and are limited in number most probably because of funding. Very little to no attention is being given to the more traditional fresh herbal extracts.
The practice of medicine based on medical efficacy proven by clinical trials otherwise known as "evidenced based medicine," is the drug industry's catch cry phrase and in relation to the healing potential of medicinal herbs, it is regularly "offered" as a put down of traditional fresh herbal extracts. To answer the question of the efficacy and ethicality of medicinal herbs, one only needs to "stand back a little" and look at the bigger picture and the history of this medicine and consider the points below:
Mankind has used plant based medicines as his primary source of medicine for many thousands of years.
Animals have used plant based medicines since the beginning of time.
The use of plant based medicines by communities who historically and presently retain their indigenous cultures.
Medical research is currently scouring the planet's remaining rainforests researching these communities' herbal lore in an attempt to discover new drugs as most major drug discoveries have originated from plant based material.
Much of the starting material used in producing drug medicines today comes from plant material.
It has only been in the last 150 years and mostly within the last 50 years that drug medicines have replaced plant based medicines as the primary resource for medicines in developed countries. World wide herbal medicine is still used by around 80 percent of the people (WHO).
Given the above, then as far as evidence of the validity of the modality of herbal medicine, their use by most if not all cultures on earth going back into antiquity and the modality's thus, in general, safety record and success would have to be the longest, largest cohort medical trial in the history of medicine. In comparison, drug medicine's proven toxicity and very poor if not failing community health record should suggest to any practitioner of medicine whose first and foremost consideration is the health of the patient, that herbal medicines should be the principle modality used to treat the sick and that every resource available should be focused on developing both streams of this modality.
Instead we have a hugely powerful monopoly based drug industry more focused on profits, that is gathering information on traditional medicinal herbs from the still remaining indigenous peoples in order to establish and research the principal active ingredients which are then chemically manipulated, trialed and where possible, patented.
The exponential rise in the use of drugs as medicines has happened as science has developed and through the power of commerce and monopoly. Reports suggest that in the year 2000, the drug industry was the most profitable industry in the world. Its enormous financial resources and its influence within governments via its powerful medical lobby has seen that influence affect the direction of governments' medical policies and the flow their way of funds.
Of the Pharmaceutical drug industry's annual turnover, they reportedly spend 11% on research and 27% on promotion. It is not financially viable for them to pour the required millions of dollars into research and trials for products they cannot monopolize and thus obtain a guaranteed return on their investment. This is the 'catch 22' for herbal medicines. Herbal companies have only minimal funds in comparison for research and when they do trials, they use the results to promote their product, and thus the research can lose objectivity.
Medical drug treatments for acute conditions have saved many lives and the technological advances such as in surgery are successfully treating much human trauma and illness. But if one is to practice evidenced based medicine according to the Hippocratic principle of "first do no harm" then a broader and more balanced practice between the use of drugs and herbs needs to be established. This starting with the unbiased education of the medical establishment as a whole to the value of herbal medicines and the unlocking of community funds currently favouring drug medication, so that the community has choice of access to both herbal medications and drug therapies.
In an 'unbiased' medical world the art of herbal medicine practice would be able to maintain its presence and its practitioners practice its art with the support of the community and the ongoing medical research into the efficacy of all medicinal products including extracts from fresh herbs. Then and perhaps only then the differing healing potentials of different herbal extract types would be more fully understood. Again for the benefit of the patient.
It is not possible to do anything but to look at the now and possible future scenarios in order to forecast where medicine will be in the future. What can be said is that science suggests and records that:
The climate is changing. (This is currently being validated across the planet)
There still is a global financial crisis. (This too is currently being validated)
The price of energy is rapidly increasing with a question over the availability of enough oil for the world's needs.
The population is still increasing but available agricultural land is not.
The price of food is increasing.
Social unrest and population movements caused by the above are increasing.
Globally the environment is under profound challenge due to the above pressures and man's greed.
Should any or all of the above result in a collapse of the current world order, it will be to herbal medicines that the population has to turn. For if industries and transport systems collapse, it will be to the locally available medicinal herbs that all will turn. Thus it is now critically important that the genetic stock of known herbal medicines be locally available, accurately identified and with their pharmacy understood.
As drug medicines and pathology become unavailable, those who have skills and experience in the art of herbal medicine will be in high demand as teachers and healing facilitators. And that is why it is critical to maintain now the lore of the art of herbal medicine.
Ken Atherton
January 2011
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