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What’s in your herbal medicines?

The Conversation

by Ian Musgrave and Michael Bunce

Many people take herbal medicines, including traditional Chinese medicine (TCM) thinking they are doing something positive for their health. Ironically, in many cases they may be doing just the opposite.

Have you ever wondered what is actually in the herbal medicine products you buy? Has the herb on the label been replaced with another herb? Have pharmaceuticals been snuck in?

Making sure that a tablet claiming to have 500 milligrams of paracetamol really does contain 500 milligrams of paracetamol is relatively easy, there are established assays to measure paracetamol routinely. But how do you test for herbs?

Most herbal medicines are pills or powders that have removed all trace of structure we would normally use to identify plants, and many plants have no chemical signature that is able to definitively identify them. And what about all the other possible contaminants and adulterants that could hide in the complex brew of chemicals from herbal medicines?

Our research, which has just been published in the journal Nature Scientific Reports, goes a long way to answering that.

For the first time, our group of researchers from Curtin University, Murdoch University and the University of Adelaide have combined some of the most cutting-edge and sensitive analytical techniques to screen a set of traditional Chinese medicines available in Australia.

We used a three-pronged approach, combining DNA sequencing, toxicology and heavy metal testing to elucidate the true composition of 26 TCMs purchased at random from the Adelaide Markets; most were either for colds and flu’s or for general wellness.

What did we find?

Summary of the contaminants in traditional Chinese medicines (TCMs) tested in this study that contained toxic metals, undeclared or illegal contents as determined by DNA, toxicological, and heavy metal screening methods. Each TCM tested is represented in the diagram as a tablet; blue shading on tablets indicate AUST L listed medicines, red shading are not-listed with the TGA regulatory body. TCMs deemed non-compliant
for DNA (green), toxicology (pink) and heavy metals (yellow) or a combination thereof, are represented within the Venn diagram. 
Coglan et al.,Sci Reports 2015

Nearly nine in ten of these medicines had some form of undeclared substance in them as either adulteration or contamination. Sixteen of TCM’s had more than one contaminant or adulterant.

While around half of these medicines were not listed with the Therapeutic Goods Administration (TGA), and should not have been available for purchase, contaminants were found in both TGA-listed and non-listed medicines. These adulterants/contaminants included pharmaceuticals and toxic heavy metals.

Plant and/or animal DNA from species not listed on the labels were also found. The most concerning finding was snow leopard DNA (snow leopards are an endangered species), which was detected in one medicine. DNA from pit viper, frog, rat, cat and dog was also detected in several medicines.

Among the pharmaceuticals found were paracetamol, antihistamines, anti-inflammatories and antibiotics, and stimulants such as pseudoephedrine. Of particular concern were drugs such as warfarin, which have significant potential for harm if not taken under medical supervision, and ephedrine, which is banned in Australia.

Significant levels of toxic heavy metals such as arsenic, cadmium and lead were found in over half the medicines. In at least four of these medicines following the directions on the label would expose you to over ten times the TGA’s regulatory limit for heavy metals in medicines.

What does this mean?

Herbal Medicines. Megan Coglan

Are the levels of undeclared materials in these products adulteration or contamination? In adulteration, the material is added deliberately. In contamination, the material is added inadvertently, for example, through unclean workplaces or herbs grown on contaminated soil.

Whether a compound is a result of deliberate adulteration or contamination has different regulatory implications. It can mean the difference between banning a substance or cleaning up the workplace.

It can be tricky to decide which is which. In TCM materials, for instance, heavy metals or toad venom may be added as part of the treatment. However, by looking at the patterns of materials we found, we can get some hints.

One TCM claiming to enhance weight gain with appetite stimulation contained pharmaceutically relevant levels of the drug cyproheptadine, a known appetite enhancer.

In another, ephedrine was found without any evidence of DNA from plants of the Ephedra genus, suggesting that in both cases the drug was deliberately added.

Intriguingly, high levels of arsenic were often found with similar levels of lead. Lead arsenate has been used as a pesticide, and the high levels may come from persistently contaminated soils.

What this means is that you should be very careful about choosing and purchasing TCMs. Definitely avoid any medicine that does not have an ARTG listing (it should have a number like AUST L 123456 on the front of the bottle). But even medicines with these AUST L labels are no guarantee of safety.

This also highlights the importance of informing your health practitioner if you are taking TCMs as adulterants might interact with conventional medication to cause adverse effects.

What are the regulatory implications?

Unlike countries such as the United States, where many herbal medicines are regulated as dietary supplements, in Australia, herbal medicines are regulated through the TGA as medicines.

TGA-regulated medicines can be approved as either “registered” or “listed”. Most herbal medicines are classified as “listed”. Unlike registered medicines such as paracetamol and warfarin, the evidence required for approval is much less stringent.

In many ways it is an honour system, where the herbal medicines sponsor says there’s no evidence of harm, and they hold documentation that shows this. Mostly, the evidence is historical, claiming that people have been using it for generations without evidence of harm. As well, if the compounds are on the TGA’s list of “generally recognised are safe” materials extensive safety testing is not required.

The TGA uses post marketing follow-up to check for compliance with the “listed” medicine regulations. This follow-up consists of random surveys as well as targeted surveys from concerns raised by consumers.

In Australia, nearly 2,000 new herbal medicines are registered each year.
In a TGA survey in 2012-2013, 145 complementary medicines were tested. Around 83% of complimentary medicines surveyed were deemed to be non-compliant, with 6% failing due to product composition, formulation or manufacturing.

Using a combination of new molecular approaches, our survey found a much higher level of adulteration and contamination in TCMs than found in the TGA’s surveys. Adding DNA ingredient screening to the TGA’s armoury of analytical methods would help ensure that undeclared ingredients are not included in the herbal medicines we consume.

And Finally:

The herbal medicine industry is a billion dollar international industry, with products travelling all over the world.

Globally, we need a better auditing “toolkit” to ensure consumers of herbal medicines, as well as people testing their efficacy, are not being misled.

This research, we think, provides a roadmap to more effective regulation of the herbal medicine sector.

* The results of our screening have been passed on to the TGA, which is following this up.

The ConversationIan Musgrave, Senior lecturer in Pharmacology

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.
 

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Tim Minchin on ‘alternative medicine’

‘By definition, alternative medicine has either not been proved to work or has been proved not to work. You know what they call alternative medicine that has been proved to work? Medicine.’ – Tim Minchin

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Thomas Paine on useless arguments

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Some Origins of Western Quackery

 By Tim Harding

             (An edited version of this essay was published in The Skeptic magazine, September 2013, Vol 33 No 3 p.16. The essay is based on a talk presented to the Mordi Skeptics in April 2013 ).

‘By definition, alternative medicine has either not been proved to work or has been proved not to work. You know what they call alternative medicine that has been proved to work? Medicine.’ – Tim Minchin

A corollary of Tim Minchin’s rhetorical question might be ‘What should we call alternative medicine that has been proved not to work?’  I recently asked this question at my local Skeptics in the Pub meeting, eliciting an immediate and resounding chorus of ‘Quackery!(When you think about it, if the part of ‘alternative medicine’ that works is medicine, and the part that doesn’t work is quackery, there is nothing left in the category of ‘alternative medicine’).

On his Quackwatch web site, Dr. Stephen Barrett defines quackery as ‘the promotion of unsubstantiated methods that lack a scientifically plausible rationale’.  This definition includes questionable ideas as well as questionable products and services, regardless of the sincerity of their promoters.  In line with this definition, Barrett reserves the word ‘fraud’ only for situations in which deliberate deception is involved.

So where did quackery come from?  The word ‘quack’ derives from the archaic word ‘quacksalver’, of Dutch origin, literally meaning ‘hawker of salve’.  The quacksalvers sold their wares on the market by shouting in a loud voice.  In the Middle Ages, the word ‘quack’ meant ‘shouting’.  These days, we tend to associate quackery with dodgy products and practices from the nineteenth century such as snake oil, miracle hair tonics, magnetic bracelets and homeopathic remedies.  But the origins of western quackery actually go back much further – to the cradle of western civilisation in ancient Greece and Rome.

In those ancient times, scientific experimental methods had not yet been developed – let alone clinical trials.  Medical observations were largely confined to patients as individuals rather as a cohort or group.  Ancient physicians were not much better than naturopaths when it came to empirical evidence.  Without scientific data from treatment groups versus control groups, it was difficult to know which treatments worked and which didn’t.  As a result, there was no clear dividing line between medicine and quackery.  Ancient ‘medicine’ consisted of a mish-mash of well-meaning but misguided treatment by physicians and surgeons, faith healers, herbal remedies, aromotherapy, other superstitions – and even sorcery or magic. Sounds familiar? That’s right – many of these weird ancient beliefs have carried through to the quackery of today as a legacy of the vast Roman Empire.

Ancient Greek medicine

The first notable Greek physician may have been the poet Homer in the 7th or 8th centuries BCE.  In his Iliad, Homer describes various medical techniques such as the extraction of arrows, the treatment of wounds, the application of dressings and the dispensing of soothing drugs.  The Homeric poems provide a glimpse of ancient medical ideas and practices long before the formal documentation of medical literature.  It is significant that practical medical treatment appears to have been provided in this early period, probably as a matter of military necessity, so that wounded soldiers could be saved to fight another day.

Homer

Reliance on the gods or faith healing seems to have come later, to some extent in parallel with advances in medical treatment.  The god of healing, Asklepios, had a shrine at Epidaurus in southern Greece, where miraculous recoveries were said to have been made by the sick and lame by sleeping in the temple overnight.  A Greek lyric poet from Thebes named Pindar (c.522– c.443 BCE) wrote:

‘[Asklepios] delivered all of them from their different pains, tending some of them with gentle incantations, others with soothing potions, or by wrapping remedies all around their limbs, and others he set right with surgery.’

The following picture is of a cast showing a physician examining a patient while Asklepios stands nearby holding the symbol of medicine, a snake coiled round a staff.

Asklepios

There were also apothecaries who harvested herbs and prepared drugs, accompanying their ministrations with important rituals and incantations.  Theophrastus (c.371 – c.287 BCE), who was a student of Aristotle, described some of these weird rituals in his History of Plants:

‘They say that the peony, which some call glykyside, should be dug up at night, for, if a man does it in the day-time and is observed by a woodpecker while he is gathering the fruit, he risks the loss of his eyesight; and if he is cutting the root at the time, he gets a prolapsed anus’.

‘One should draw three circles around mandrake with a sword, and cut it with one’s face to the west; and at the cutting of the second piece one should dance around the plant and say as many things as possible about the mysteries of love’.

On the other hand, the medical literature subsequently found in Greece differs markedly from that found elsewhere.  It includes reasoned arguments and debates, reflecting an intellectual openness consistent with Greek philosophy, rather than medicine as some sort of secret mystical art.  The links between medicine and philosophy can be traced back to Parmenides, Empedocles and even Pythagoras, whose ideas on appropriate living included a ban on eating beans!

Athens was one of the first city states to employ a publicly funded physician as a more rational alternative to traditional folk medicine.  Other Greek cities also maintained a public physician as well as several private practitioners.

The Greek historian Herodotus tells the tale of the early Greek physician Democedes of Croton, who started his career in the civil service of Athens and Aegina.  In 522 BCE, Democedes was captured by the Persians and sent to Susa.  The Persian King Darius once sprained his ankle while he was hunting, and his Egyptian doctors seemed to make it worse.  Darius then summoned Democedes, who was able to heal the ankle using Greek remedies.  Democedes was richly rewarded and hired as a physician of the Persian court.  Darius’s wife, Atossa, later had a breast ulcer.  When Democedes cured her ulcer, he was allowed to visit Greece as a reward.

Schools of medicine had existed for some time in various regions of Greece, most notably on the island of Kos, associated with the famous name of Hippokrates, a younger contemporary of Herodotus.  Hippokrates’ contribution to medicine is best remembered today by the ethical oath bearing his name.  Very little is known of Hippokrates himself, or how much of the Hippokrates medical treatises he personally wrote.  Hippokrates is cited in later works by Aristotle and Plato; but the Greek habit of composing imaginary speeches or letters by famous people from the past gradually blurred the distinction between the genuine and the false.  The following references to Hippokrates are actually references to the large body of medical literature bearing his name, the Hippokratic Corpus.

Hippokrates attempted to put medical diagnosis and treatment on a rational basis.  He viewed the human body as an organism whose parts must be understand as a whole.  Hippokrates thought that human physiology was comprised of four fluids or ‘humors’: blood, phlegm, black bile and yellow bile, corresponding to the four inanimate elements of earth, air, fire and water, as shown in the diagram below.

Four humours

Disease was thought to result from an imbalance of these humors, resulting in a disturbance of the natural harmony and order of the world so important to Classical Greek thought.  Hippokrates also placed emphasis on prognosis as well as diagnosis, so that the course of an illness could be predicted.  The more familiarity a physician showed with a disease, the more confidence his patients would have in him.  Prognosis also had practical benefits in planning the medical interventions that would be needed at different times.

In the absence of the modern germ theory of infectious disease, the danger to health from overcrowding within the Long Walls of Athens was not foreseen, resulting in a devastating plague in 430BCE.  Thucydides did not attempt to explain the reasons for the plague, but in the prognostic tradition of Hippokrates, he tried to describe its symptoms and effects so that if it struck again it could be recognised.

Active medical interventions included cauterisation and blood-letting, as well as surgery, the rectification of dislocations and the setting of bone fractures.  Other therapies included cupping, special diets, herbal remedies, potions, purgatives and exercises, consistent with the idea of ‘bringing the body back into balance’.  One rather spectacular treatment often performed in public was succussion, where the patient would be tied upside down to a ladder and then repeatedly dropped from a height of several feet as illustrated below.

succussion

It is unclear what succussion was supposed to achieve, but it is worth noting that succussion is a word still used by homeopaths to describe a shaking step in the preparation of their water doses.  The founder of homeopathy, Samuel Hahnemann falsely believed that succussion activated the ‘vital energy’ of the diluted substance and made it stronger.

The rise of quackery in Rome

Traditional Roman medicine was initially an amateur activity using simple home remedies based on easily available agricultural ingredients such as wool, eggs and the humble but miraculous cabbage.  Cato the Elder wrote in his treatise On Agriculture:

‘For those who are troubled by colic, cabbage should be steeped in water…. ‘

‘Now as to patients for whom urination is painful or dribbling. Take cabbage, put in boiling water, boil briefly till half cooked…. ‘

‘If any sore or cancer develops in the breasts, apply ground cabbage …’

‘In case of dislocation, foment with hot water twice a day and apply ground cabbage: it will soon cure it…’

The Romans were a highly superstitious people.  For instance, the Roman Senate only sat on ‘auspicious days’.  In around 78 CE Pliny the Elder wrote in his Natural History:

‘I find that a bad cold in the head clears up if the sufferer kisses a mule on the nose.’

‘Some people keep a weasel’s heart in a small silver container, for swollen glands.’

The number three was regarded as a ‘lucky number’.  An anonymous Roman inscription reads:

‘To Julian who was spitting up blood and had been despaired of by all men the god revealed that he should go and from the threefold altar take the seeds of a pine cone and eat them with honey for three days. And he was saved and went and publicly offered thanks before the people’

Later Roman culture was greatly influenced by the ancient Greeks in many things, including philosophy, literature, art, science and medicine.

Galen of Pergamon (c. 129-200 CE) was a leading surgeon, physician, and philosopher of Greek origin.  In 162 CE, he established a large and successful practice in Rome, where he attended the Emperor Marcus Aurelias.  Amongst his voluminous works was a short essay entitled That the Best Physician is also a Philosopher, where he urged physicians to emulate Hippokrates and to embrace logic and rationality:

‘What reason, then, remains why the doctor, who practises the Art in a manner worthy of Hippocrates, should not be a philosopher? For since, in order to  discover the nature of the body, and the distinctions between diseases, and the indications for remedies, he must exercise his mind in rational thought, and since, so that he may persevere laboriously in the practice of these things, he must despise riches and exercise temperance,  he must already possess all the parts of philosophy: the logical, the scientific, and the ethical’.

Consistent with this approach, Galen saw the bodies of living things and their various parts as designed and operated by a craftsman-like nature with a purpose in mind; thus an important key to anatomical and physiological knowledge is an understanding of nature’s purposes.  This form of ‘intelligent design’ has been described as a teleological view of biology by modern reviewers of Galen’s writings.  Galen held that nature rules the body from three anatomical centres – the liver, the heart and the brain (in contrast to the Aristotelian view that all faculties are centred in the heart).  He claimed that human physiology can be explained by the principal activities of nature, which are genesis, growth and nutrition.

Like Hippokrates, Galen believed in the need for the ‘four humors’ to be in balance: blood, black bile, yellow bile and phlegm.  He thought that the human body had three physiological spheres: the nutritive, the vital and the logical.  According to Galen, stomach cooks food to what was called ‘chyle’ and sends it to the liver.  The liver adds ‘natural spirit’ and sends it to other organs and the heart.  The heart adds ‘vital spirit’ and sends it to the brain.  The brain adds what was called ‘pneuma’ and sends to the body through nerves.  Such views were the likely origin of the modern naturopathic belief in ‘vitalism’ that persists today.  Naturopathy posits that a special energy called ‘vital energy’ or ‘vital force’ guides bodily processes such as metabolism, reproduction, growth, and adaptation.  Such energies and forces are unknown to modern science.

For religious reasons, there was little or no dissection of human corpses in ancient Rome.  Nevertheless, Galen believed in the supreme importance of anatomy, so he regularly performed dissections on animals.  Although he was conscious of the limitations of extrapolating from animals to humans, he did express some erroneous views about human anatomy, such as the following description by Galen in his work On the Usefulness of Parts of the Body:

‘All the parts, then, that men have, women have too, the difference between them lying in only one thing, which must be kept in mind throughout the discussion, namely, that in women the parts are within [the body],   whereas in men they are outside, in the region called the perineum. Consider first whichever ones you please, turn outward the woman’s, turn inward, so to speak and fold double the man’s, and you will find them the   same in both in every respect’.

Women were treated by male physicians and the gynaecological treatises of the Hippokratic Corpus were almost certainly written by and for men.  Part of the deficiency of observational evidence stems from the failure of male medical writers to speak to women about their illnesses.  Women were traditionally presented as being incapable of knowing what was wrong with them or telling a doctor if they did know.  Galen’s teleological view of biology also appears to have influenced his attitudes towards women:

‘So too the woman is less perfect than the man in respect to the generative parts. For the parts were formed within her when she was still a foetus, but could not because of the defect in the heart emerge and project on  the outside, and this, though making the animal itself that was being formed less perfect than one that is complete in all respects, provided no small advantage for the race; for there needs must be a female. Indeed,  you ought not to think that our creator would purposely make half the whole race imperfect and, as it were, mutilated, unless there was to be some great advantage in such a mutilation’.

These biased attitudes impacted wider Greek and Roman society.  For example, it was believed, on false medical grounds, that a man’s seed was most potent when he was about 30 years of age; and a woman’s body best suited for childbirth when she was still a teenager.

The medical theories of ancient Greece and Rome formed the foundation of Western medicine for centuries, even if they were eventually rejected.  The main reasons for this rejection were the development of empirical scientific methods after the Renaissance; coupled with advances such as the invention of the microscope and the germ theory of infectious disease.  Whilst there were observations of individual patients, there is no evidence of any organised medical experiments being conducted in ancient Greece and Rome, let alone clinical trials.  In some ways, the Greek philosophical traditions of logic and reasoning held back a more empirical scientific approach to medicine.  Instead of conducting practical experiments on illnesses, ancient Greek and Roman physicians became diverted into a search for the underlying purposes of diseases – a relatively fruitless ‘search for meaning’ rather than for empirical evidence.  This mystical and unscientific approach is one of the hallmarks of quackery today.

REFERENCES

 Ancient Sources

Aristotle On the Generation of Animals excerpt translated by A.L. Peck.  Published online http://www.stoa.org/diotima/anthology/wlgr/wlgr-medicine339.shtml

(Accessed 20 September 2012)

Galen That the Best Physician is also a Philosopher translated by Brain, P., 1977, “Galen on the ideal of the physician”, South Africa Medical Journal, 52: 936–938.

Galen On the Usefulness of Parts of the Body excerpt translated by M.T. May.  Published online http://www.stoa.org/diotima/anthology/wlgr/wlgr-medicine351.shtml

(Accessed 20 September 2012)

Herodotus The Histories R.B. Strassler (ed), The Landmark Herodotus, Quercus, London, 2008.

Thucydides A Comprehensive Guide to the Peloponnesian War, R.B. Strassler (ed), The Landmark Thucydides, Free Press, New York, 1996.

Modern Sources

Brain, P., 1986    Galen on Bloodletting: A Study of the Origins, Development and Validity of his Opinions, with a Translation of the Three Works Cambridge University Press, Cambridge.

Flaceliere, R., 2002    Daily Life in Greece at the Time of Pericles. Phoenix Press, London.

King, H., 1995    ‘Medical texts as a source for women’s history ‘  in The Greek World Anton Powell (ed.) Routledge, London and New York.

Martin, T. R., 2000    Ancient Greece – From Prehistoric to Hellenistic Times, Yale University Press, New Haven and London.

Nutton, V., 2004    Ancient Medicine Routledge, London and New York.

Pagel, W., 1970    Book Review of Galen and the Usefulness of Parts of the Body in Medical History/ Volume14 / Issue04 / October 1970, 406-408.  Published online: 16 August 2012

Roberts, J.W., 1998    City of Sokrates: An Introduction to Classical Athens (2nd edition), Routledge, London.

Roebuck, C., 1966    The World of Ancient Times Charles Scribner’s Sons, New York.

Waterfield, R., 2004    Athens – A History, Macmillan, London, Basingstoke and Oxford.

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