The Quackometer

The pharmaceuticals are deliberately included to make it work. People think they are getting something completely herbal but it contains up to four times the dose of pharmaceuticals found in legally prescribed medicinal products. Often, such marketing claims about the supposed natural ingredients in these unlicensed products are simply an attempt to divert the consumer's attention away from very low manufacturing and ethical standards.

It might be tempting to dismiss this as an exceptional case where the herbal product required adulteration in order for it to rise to the occasion. However, some independent research has been done into measuring the levels and frequency of adulteration in herbal medicines and the results are rather startling. Bandolier, the Oxford evidence based healthcare information journal, reports that a literature survey would suggest that adulteration was widespread and that “Chinese herbal medicines may work because of the adulterants.” Surveys reported conflicting levels of adulteration, from US reports of 7% to reports showing nearly all samples containing adulterants. Bandolier conclude that  “in the absence of better information, we should assume that Chinese medicines are adulterated.” A review by Edzard Ernst concluded, “that adulteration of CHMs [Chinese herbal medicines] with synthetic drugs is a potentially serious problem which needs to be addressed by adequate regulatory measures.”

Alarming stuff. And of course, if your are lucky enough to have got from your Chinese herbalist some unadulterated herbs, then you are still left with the problem that you are about to take an unquantified amount of probably pharmacological active ingredient, mixed in with many other compounds that may or not be good for you, in a way that has not been tested for safety or efficacy and without any recourse should the herb not work or even harm you. And at the same time, your condition and herb taking is not being monitored by a qualified health worker.

Fraud in Chinese Medicine does not appear to be restricted to herbalism. It is not just adulteration that distorts our view of Chinese Medicine. Claims of efficacy can also be subject to fraud. One interesting review is by Kevin W Chen, Ph.D., M.P.H. of the University of Medicine and Dentistry of New Jersey. The review is into a branch of TCM called QiGong. Qi is the mysterious life-force that binds together so much of so called Traditional Chinese Medicine. QiGong was really invented in the last fifty years, but it has spawned a lot of research in China. Despite Kevin Chen being a True Believer, his review is interesting because it paints a fascinating picture of the nature of research in China into TCM. 

The review (An Analytic Review of Studies on Measuring Effects of External Qi in China) describes the various methods used to research Qi. However, the author notes that there are few randomised controlled studies and the field does not tend to replicate any results. As you might expect, there is complete publication bias with no negative results being considered worthy of publication.  Thus, any spurious results stand without independent confirmation. The reasons for this are interesting. Chen describes the “deliberate deception by qigong healers and in the research conducted by special interest groups that are determined to find positive outcomes”. There is a complete lack of discussion of “potential covariates that may affect the results”: positive results are assumed to be due to Qi.

Rivalry between different research teams drove bias,

Few double-blind randomization methods were used in these exploratory studies, which may greatly discount the results or conclusions, because experimenter effect and measurement bias might all become part of the observed results, especially when the specific qigong schools sponsored the research and tried to prove their own styles of qigong to be most effective.

Ten years ago, a review by Vickers et al looked at the question “Do Certain Countries Produce Only Positive Results? A Systematic Review of Controlled Trials”. They looked specifically at thousands of acupuncture trials and noted that “No trial published in China or Russia/USSR found a test treatment to be ineffective.” Even in England, “75% gave the test treatment as superior to control.” Not publishing negative results massively distorts our view of the efficacy of treatments; it can make ineffective treatments look effective, and that is not good. Pharmaceutical companies are guilty of publication bias too, but not on the scale of Chinese researchers.

Tang, Zhan and Ernst (1999) wrote a paper on “Review of randomised controlled trials of traditional Chinese medicine”. They saw a list of similar problems over all TCM. They concluded that “the quality of trials of traditional Chinese medicine must be improved urgently.”

Misleading people about acupuncture has a long history. Since, the first diplomatic contacts with communist China with Nixon, reports emerged of major operations being undertaken with acupuncture being used as an anaesthetic. What was not reported was the massive levels of patient sedation and local anaesthetic. Even the BBC were fooled and, in turn, fooled their audience when Kathy Sykes broadcast her programme, Alternative Medicine, that claimed to show that “acupuncture was used instead of a general anaesthetic during open heart surgery in China”. After a complaint and an appeal to the BBC, it finally admitted that it had misled the audience over acupuncture.

Why should Chinese Medicine be associated with so much fraud? I find this alarming. For the best part, I believe that most people working in alternative medicine are simply naive and deluded, and only harm people through omission and a negligence in not doing enough due diligence over their own beliefs. The examples I report here go somewhat further than this. China, being a nationalistic and totalitarian regime, will not produce the strongest incentives to produce honest and open research and industrial methods. Accountability will be low and  the rewards for producing ‘success’ high. Examining the research and claims of Chinese medicine in the UK is naturally made more difficult by language.

But what is more alarming is that there are signs we are approaching the regulation of much of Chinese Alternative Medicine in the belief that we simply need to uphold standards of training and ensure that traders are of ‘good character’. This will do little to stop adulterated products arriving in the UK or false and misleading claims being made by practitioners. Even unadulterated products present significant risks to customers. At the heart of the regulatory problem is a double standard. Real medicine is tightly regulated. Only a few qualified people can prescribe and dispense. There are professional regulators with teeth and drug companies are not allowed to advertise to the public and make misleading claims in their literature. Somehow, we allow herbalists to imply all sorts of unproven claims. They do not have to provide proof of efficacy or safety. There is no follow up and monitoring of side effects. We do this under the mistaken belief that Chinese Medicine is “traditional, natural and safe”. None of this is true. It is a business based on fraud, misleading claims and dangerous practices. I rarely say this sort of thing, but there is a strong case to be made to make the dispensing of herbal medicines illegal.

Labels: regulation, Traditional Chinese Medicine

 

A new form of acupuncture is dramatically improving the quality of life of patients suffering from a range of diseases, including cancer, anxiety and autoimmune diseases, according to a new study.

The therapy, Tong Ren, has been pioneered in the USA since 2001 by Tom Tam, an acupuncturist and Traditional Chinese Medicine (TCM) practitioner.  He has used it to treat patients suffering from cancer, diabetes, AIDS, arthritis, anxiety and depression.

Researchers from the Virginia Commonwealth University School of Medicine have tracked the health of 265 patients after weekly sessions of Tong Ren.  Around a third noted improved quality of life, and with no adverse effects.  ‘Substantial’ improvements were noted by 63 per cent of patients suffering anxiety, and 60 per cent of cancer patients.

Although the survey is based on subjective and anecdotal evidence, the researchers say the results warrant further research into Tong Ren.

Tong Ren is a form of energy therapy for restoring health and vitality.   Tong Ren is based on a belief that disease is related to interruptions, or blockages,   in the body's natural flow of chi, neural bioelectricity, blood, or hormones. Tong Ren seeks to remove these blockages, restoring the body's natural ability to heal itself, even when illnesses are chronic, debilitating, or otherwise untreatable.

In a typical therapy session, the Tong Ren practitioner uses a small human anatomical model as   an   energetic representation of the patient, tapping on targeted points on the model with a lightweight magnetic hammer.

Labels: acupuncture, Traditional Chinese Medicine, WDDTY, What Doctors Don't Tell You

 

Prince Charles' Foundation for Integrated Health (FIH) is listened to by many in our Government as a sound source of information on complementary medicine. It has been given large sums of money over recent years by the Department of Health to set ways of regulating CAM sellers. The result has been the moribund Ofquack: the Complementary and Natural Healthcare Council.

FIH has been regularly criticised for being hopelessly naive and uncritical of alternative medicine. FIH likes to call quackery ' Integrative Medicine' and sound like it is calling for the integration of 'natural' ways of healing with modern healthcare. In reality, it does little but uncritically promote bonkers charlatanism.

The latest promotion comes in the form a news item on their web site telling us that "Dr Richard Niemtzow has developed a form of 'Battlefield acupuncture' which will be used by the US Air Force in Iraq and Afghanistan." We are told that,

This method of acupucture [sic] involves inserting very tiny semi-permanent needles into very specific acupoints in the skin on the ear to block pain signals from reaching the brain. This method can lessen the need for pain medications that may cause adverse or allergic reactions or addiction.

...

'This is one of the fastest pain attenuators in existence,' said Dr. Niemtzow 'The pain can be gone in five minutes.

Remarkable stuff. Niemtzow is the Editor in Chief of Medical Acupuncture, the journal of the American Academy of Medical Acupuncture. Are we seeing the integration of ancient Chinese practices into modern battlefield care? Of course not. The whole thing is a fanciful charade.

Auricular Acupuncture, or Ear Acupuncture, or even auricolotherapy, is indeed part of what is called 'Traditional Chinese Medicine'. It was included into Mao's re-invention of Chinese medicine as part of the Cultural Revolution's Barefoot Doctors' repertoire. However, the roots of ear acupuncture do not lie in ancient Chinese medical beliefs but in 1950's France. Yes, like its auricular cousin, Hopi Ear Candling - also found in your High Street Chinese Medicine Shop, it has roots that are thoroughly western. Ear Candling is a recent invention and nothing to do with the Hopi Tribe - who are hopping mad about the appropriation of their name to Western quackery.





The UK Auricular Acupuncture College tell us that it "is an ancient Oriental therapy using acupuncture on points of the ear to treat specific parts of the body". This looks like it is simply untrue. In a 2007 review, published in Evidence Based Complement Alternative Medicine, Luigi Gori and Fabio Firenzuoli tell us that ear acupuncture was invented by Lyon based doctor, Dr Paul Nogier, who is now known as the "Father of modern auricolotherapy".

The son of Paul Nogier, Raphaël Nogier, tells us,

1951, Paul NOGIER received in his consultation a patient, who explained to him that he was relieved from a sciatica pain by a cauterisation on the ear carried out by a quack in Marseille, Madame BARRIN

Nogier's remarkable 'insight' was to realise that the ear was a little homunculus - a man in the ear - in the form of a foetus. Thus, sticking a pin in the right part of the ear could somehow heal the corresponding part of the body. It turns out that Dr Nogier was a homeopath and so we do not need to concern ourselves too greatly about the battiness of these ideas.

Nogier's son, Raphaël, continues the pace of invention admirably and has developed this science to even greater extents. From Madame Barrin's humble quackery has grown a mighty and imaginative worldwide quackery. Electrical instruments are used to detect the appropriate points on ears to stick pins in. Furthermore, Nogier developed "auriculomedicine" - a technique for diagnosing problems by measuring the pulse whilst putting pressure on various parts of the ear.

It would appear that the French ear pin therapy quickly spread via Japan back to China where it was re-interpreted in terms of Chinese acupuncture:

The discovery of the system spread to China and led to intensive research by the Chinese medical authorities at a time of renewed interest in Traditional Chinese Medicine. After learning about the Nogier ear charts in 1958, a massive study was initiated by the Nanjing Army Ear Acupuncture research Team. This Chinese medical group verified the clinical effectiveness of the Nogier approach and assessed the conditions of over 2000 clinical patients, recording which ear points corresponded to specific diseases. The outcome of that research was very positive and resulted in the utilization of this therapy by the ‘Barefoot Doctors’ of the Cultural Revolution. In China was published an Ear Chart remarkably similar to that of Dr Nogier in 1958.

So, from the Chinese Army to the US Air Force. Richard Niemtzow, MD, PhD, MPH appears to have been developing his own version of ear acupuncture using tiny needles that you leave in your ear until they drop out. We are told,

Using ancient Chinese medical techniques, a small team of military doctors here has begun treating wounded troops suffering from severe or chronic pain with acupuncture.

In a deviation from the Nogier philosophy, Niemtzow believes that the "ear acts as a "monitor" of signals passing from body sensors to the brain. Those signals can be intercepted and manipulated to stop pain or for other purposes." A remarkable scientific discovery. Give that man a Nobel Prize.

The clincher for me is that he calls on the Wisdom of Pirates. Niemtzow says" Even 18th-century pirates were convinced of the value, piercing their lobes with earrings 'to improve their night vision'". Did the British ever tell the US that eating carrots improved the night vision of Royal Air Force pilots during the Battle of Britain?

This French, Chinese and Pirate wisdom is proving very useful apparently as "Battlefield acupuncture has been especially effective among patients suffering from a combination of combat wounds, typically a brain injury or severed limbs, burns and penetrating wounds along with severe disorientation and anxiety."

So, we shall see. It has yet to be deployed into Iraq battlefield operations and has to "overcome skepticism within the ranks of military doctors". I doubt it ever will be. What we do know is that the organisation that Niemtzow works for does quite a good job of promoting acupuncture in the US. For an academic institution, it is quite surprising to find on their home page that the American Academy of Medical Acupuncture says that it can "Find an Acupuncturist Near You".

Well done to the Foundation for Integrated Health for uncritically carrying this story. I am sure the acupuncturists of the USA are very pleased.

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If you want to know more about Niemtzow, the excellent blog Science Based Medicine takes him apart here.

Labels: acupuncture, Prince Charles, pseudoscience, quacks, Traditional Chinese Medicine

 

I have received this comment from an anonymous poster after reading my post on The World Health Organisation Traditional Medicine Hoax and I thought it deserved a wider readership. I wish all anonymous comments were like this...

As one of the people who has been directly involved in the development of artemisinin based therapy for treating malaria, I just wanted to set the record straight on the use of herbal Artemisinin for treating malaria and its origins.

It was indeed known from old times that an aqueous extract, i.e. a tea, of a plant called Artemisia Annua, could be used for lowering fever. However, the extension of its use to the treatment of malaria has only taken place during the 1960’s after research performed in China.

At the time, a war was going on in Vietnam and one of the main problems for the Vietcong was not the US soldiers on the ground, but the lack of proper medication against malaria, as quinine or other products could not be shipped to them as they were under Western control. The Vietcong asked Mao to help them and several hundred Chinese researchers started investigating whether they could find an alternative. After a considerable search, they found that a petroleum ether extract, so not the aqueous extract, of the herb Artemisia Annua showed antimalarial activity. Further research showed that this action was due to one single compound, called artemisinin and this substance was subsequently extracted and purified.

Even so, the extracted artemisin itself has a very poor solubility and therefore bioavailability and it was further chemically modified to other derivatives like artesunate, artemether and arteether.

In the early 1990’s the existence of this product was revealed to the west at a WHO conference on malaria held in China. This was a major breakthrough, as the malaria parasite had developed resistance against most known Western drugs. Therefore, several pharmaceutical companies, Sanofi, Roche & Novartis then started the full clinical development of the product. The reason for going through the whole process of toxicological and clinical research was to be able to clearly define the safety and to find the proper dose and administration regime for the compounds.

In the early 1990’s some companies started marketing the product in Asia as a monotherapy of about 100 mg artesunate daily for a duration of 7 days. This treatment in itself is very effective, but as most people feel better quickly there are not many patients that take the pills for the full duration, so to shorten therapy length and to prevent resistance from building up, it was then decided by WHO, to state that artesunate and artemether are only to be used in combination with other drugs like lumefantrine, sulfadoxine or amodiaquine.

This lead to new toxicological and clinical research and finally around 1998, and a clinical program including up to 4 000 patients, the first combination therapy artemether-lumefantrine was launched by Novartis, this was later followed by other combinations like artesunate-sulfadoxine-pyrimethamine and artesunate-amodiaquine.

These fixed dose therapies, in which an artemisinin derivate is combined with another chemical western based drug molecule are nowadays the only recognized and formally approved artemisinin combination therapies (ACT) as endorsed by WHO for the treatment of malaria.

In conclusion, although the origin of ACT therapy certainly is to be found in Traditional Medicine, because off the chemical modifications and purifactions performed after extracting a single clearly defined substance from the herb, the combination with western synthetic drugs, and the clinical research programs that went into it before its acceptance by the WHO and other health authorities, I feel it would be hard pressed to use the current ACT treatment as an example of the effectivity of Traditional Medicine or herbal medicine.

I find this quite interesting. Artemisinin is one of the drugs that supporters of Chinese Medicine trot out to show that Chinese herbalism is full of untapped wisdom. Frankly, I think it is more like the exception that proves the rule, and this comment highlights what had to be done in order for it to become an effective, quantified and deliverable treatment.

My guess is that most herbal products of all traditions are more cultural in meaning than pharmaceutical. Homeopathy is a derivative of Western herbalism that grew out of the Doctrine of Signatures. This form of sympathetic magic stated that a disease could be cured by herbs that somehow resembled the illness. For example, an "arrow-shaped leaf might be a good treatment for arrow wounds. Plants with yellow sap would be jaundice treatments, and plants and animals with long lives could be used to extend human life.". Homeopathy extends this principle with its central concept of 'like-cures-like' and still continues in this tradition - e.g. shipwreck if you feel 'stuck' in your life.

Undoubtedly, other forms of herbalism are founded on similar culturally derived ideas. There maybe a few more gems hidden in traditional pharmacopeias, but this does not mean we should uncritically accept the claims of herbalists at face value.

Labels: Traditional Chinese Medicine