MD, PhD, FMedSci, FSB, FRCP, FRCPEd

Monthly Archives: January 2013

In my very first post on this blog, I proudly pronounced that this would not become one of those places where quack-busters have field-day. However, I am aware that, so far, I have not posted many complimentary things about alternative medicine. My ‘excuse’ might be that there are virtually millions of sites where this area is uncritically promoted and very few where an insider dares to express a critical view. In the interest of balance, I thus focus of critical assessments.

Yet I intend, of course, report positive news when I think it is relevant and sound. So, today I shall discuss a new trial which is impressively sound and generates some positive results:

French rheumatologists conducted a prospective, randomised, double blind, parallel group, placebo controlled  trial of avocado-soybean-unsaponifiables (ASU). This dietary supplement has complex pharmacological activities and has been used since years for osteoarthritis (OA) and other conditions. The clinical evidence has, so far, been encouraging, albeit not entirely convincing. My own review arrived at the conclusion that “the majority of rigorous trial data available to date suggest that ASU is effective for the symptomatic treatment of OA and more research seems warranted. However, the only real long-term trial yielded a largely negative result”.

For the new trial, patients with symptomatic hip OA and a minimum joint space width (JSW) of the target hip between 1 and 4 mm were randomly assigned to  three years of 300 mg/day ASU-E or placebo. The primary outcome was JSW change at year 3, measured radiographically at the narrowest point.

A total of 399 patients were randomised. Their mean baseline JSW was 2.8 mm. There was no significant difference on mean JSW loss, but there was 20% less progressors in the ASU than in the placebo group (40% vs 50%, respectively). No difference was observed in terms of clinical outcomes. Safety was excellent.

The authors concluded that 3 year treatment with ASU reduces the speed of JSW narrowing, indicating a potential structure modifying effect in hip OA. They cautioned that their results require independent confirmation and that the clinical relevance of their findings require further assessment.

I like this study, and here are just a few reasons why:

It reports a massive research effort; I think anyone who has ever attempted a 3-year RCT might agree with this view.

It is rigorous; all the major sources of bias are excluded as far as humanly possible.

It is well-reported; all the essential details are there and anyone who has the skills and funds would be able to attempt an independent replication.

The authors are cautious in their interpretation of the results.

The trial tackles an important clinical problem; OA is common and any treatment that helps without causing significant harm would be more than welcome.

It yielded findings which are positive or at least promising; contrary to what some people seem to believe, I do like good news as much as anyone else.

I WISH THERE WERE MORE ALT MED STUDIES/RESEARCHERS OF THIS CALIBER!

The ‘Samueli Institute’ might be known to many readers of this blog; it is a wealthy institution that is almost entirely dedicated to promoting the more implausible fringe of alternative medicine. The official aim is “to create a flourishing society through the scientific exploration of wellness and whole-person healing“. Much of its activity seems to be focused on military medical research. Its co-workers include Harald Walach who recently was awarded a rare distinction for his relentless efforts in introducing esoteric pseudo-science into academia.

Now researchers from the Californian branch of the Samueli Institute have published an articles whic, in my view, is another landmark in nonsense.

Jain and colleagues conducted a randomized controlled trial to determine whether Healing Touch with Guided Imagery [HT+GI] reduced post-traumatic stress disorder (PTSD) compared to treatment as usual (TAU) in “returning combat-exposed active duty military with significant PTSD symptoms“. HT is a popular form of para-normal healing where the therapist channels “energy” into the patient’s body; GI is a self-hypnotic from of relaxation-therapy. While the latter approach might be seen as plausible and, at least to some degree, evidence-based, the former cannot.

123 soldiers were randomized to 6 sessions of HT+GI, while the control group had no such therapies. All patients also received standard conventional therapies, and the treatment period was three weeks. The results showed significant reductions in PTSD symptoms as well as depression for HT+GI compared to controls. HT+GI also showed significant improvements in mental quality of life and cynicism.

The authors concluded that HT+GI resulted in a clinically significant reduction in PTSD and related symptoms, and that further investigations of biofield therapies for mitigating PTSD in military populations are warranted.

The Samueli Institute claims to “support science grounded in observation, investigation, and analysis, and [to have] the courage to ask challenging questions within a framework of systematic, high-quality, research methods and the peer-review process“. I do not think that the above-named paper lives up to these standards.

As discussed in some detail in a previous post, this type of study-design is next to useless for determining whether any intervention does any good at all: A+B is always more than B alone! Moreover, if we test HT+GI as a package, how can we conclude about the effectiveness of one of the two interventions? Thus this trial tells us next to nothing about the effectiveness of HT, nor about the effectiveness of HT+GI.

Previously, I have argued that conducting a trial for which the result is already clear before the first patient has been recruited, is not ethical. Samueli Institute, however, claims that it “acts with the highest respect for the public it serves by ensuring transparency, responsible management and ethical practices from discovery to policy and application“. Am I the only one who senses a contradiction here?

Perhaps other research in this area might be more informative? Even the most superficial Medline-search brings to light a flurry of articles on HT and other biofield therapies that are relevant.

Several trials have indeed produces promissing evidence suggesting positive effects of such treatments on anxiety and other symptoms. But the data are far from uniform, and most investigations are wide open to bias. The more rigorous studies seem to suggest that these interventions are not effective beyond placebo. Our review demonstrated that “the evidence is insufficient” to suggest that reiki, another biofield therapy, is an effective treatment for any condition.

Another study showed that tactile touch led to significantly lower levels of anxiety. Conventional massage may even be better than HT, according to some trials. The conclusion from this body of evidence is, I think, fairly obvious: touch can be helpful (most clinicians knew that anyway) but this has nothing to do with energy, biofields, healing energy or any of the other implausible assumptions these treatments are based on.

I therefore disagree with the authors’ conclusion that “further investigation into biofield therapies… is warranted“. If we really want to help patients, let’s find out more about the benefits of touch and let’s not mislead the public about some mystical energies and implausible quackery. And if we truly want to improve heath care, as the Samueli Institute claims, let’s use our limited resources for research which meaningfully contributes to our knowledge.

On January 27, 1945, the concentration camp in Auschwitz was liberated. By May of the same year, around 20 similar camps had been discovered. What they revealed is so shocking that it is difficult to put it in words.

Today, on ‘HOCOCAUST MEMORIAL DAY’, I quote (shortened and slightly modified) from articles I published many years ago (references can be found in the originals) to remind us of the unspeakable atrocities that occurred during the Nazi period and of the crucial role the German medical profession played in them.

The Nazi’s euthanasia programme, also known as “Action T4″, started in specialized medicinal departments in 1939. Initially, it was aimed at children suffering from “idiocy, Down’s syndrome, hydrocephalus and other abnormalities”. By the end of 1939, the programme was extended to adults “unworthy of living.” We estimate that, when it was stopped, more than 70,000 patients had been killed.

Action T4 (named after its address: Tiergarten Strasse 4) was the Berlin headquarters of the euthanasia programme. It was run by approximately 50 physicians who, amongst other activities, sent questionnaires to (mostly psychiatric) hospitals urging them to return lists of patients for euthanasia. The victims were transported to specialized centers where they were gassed or poisoned. Action T4 was thus responsible for medically supervised, large-scale murder. Its true significance, however, lies elsewhere. Action T4 turned out to be nothing less than a “pilot project” for the extinction of millions of prisoners of the concentration camps.

The T4 units had developed the technology for killing on an industrial scale. It was only with this know-how that the total extinction of all Jews of the Reich could be planned. This truly monstrous task required medical expertise.

Almost without exception, those physicians who had worked for T4 went on to take charge of what the Nazis called the ‘Final Solution’. While action T4 had killed thousands, its offspring would murder millions under the trained instructions of Nazi doctors.

The medical profession’s role in these crimes was critical and essential. German physicians had been involved at all levels and stages. They had created and embraced the pseudo-science of race hygiene. They were instrumental in developing it further into applied racism. They had generated the know-how of mass extinction. Finally, they also performed outrageously cruel and criminal experiments under the guise of scientific inquiry [see below]. German doctors had thus betrayed all the ideals medicine had previously stood for, and had become involved in criminal activities unprecedented in the history of medicine (full details and references on all of this are provided in my article, see link above).

Alternative medicine

It is well-documented that alternative medicine was strongly supported by the Nazis. The general belief is that this had nothing to do with the sickening atrocities of this period. I believe that this assumption is not entirely correct. In 2001, I published an article which reviews the this subject; I take the liberty of borrowing from it here.

Based on a general movement in favour of all things natural, a powerful trend towards natural ways of healing had developed in the 19(th)century. By 1930, this had led to a situation in Germany where roughly as many lay-practitioners of alternative medicine as conventional doctors were in practice.This had led to considerable tensions between the two camps. To re-unify German medicine under the banner of ‘Neue Deutsche Heilkunde’ (New German Medicine), Nazi officials eventually decided to create  the profession of the ‘Heilpraktiker‘ (healing practitioner). Heilpraktiker were not allowed to train students and their profession was thus meant to become extinct within one generation; Goebbels spoke of having created the cradle and the grave of the Heilpraktiker. However, after 1945, this decision was challenged in the courts and eventually over-turned – and this is why Heilpraktiker are still thriving today.

The ‘flag ship’ of the ‘Neue Deutsche Heilkunde’ was the ‘Rudolf Hess Krankenhaus‘ in Dresden (which was re-named into Gerhard Wagner Krankenhaus after Hess’ flight to the UK). It represented a full integration of alternative and orthodox medicine.

‘Research’

An example of systematic research into alternative medicine is the Nazi government’s project to validate homoeopathy. The data of this massive research programme are now lost (some speculate that homeopaths made them disappear) but, according to an eye-witness report, its results were entirely negative (full details and references on alt med in 3rd Reich are in the article cited above).

There is,of course, plenty of literature on the subject of Nazi ‘research’ (actually, it was pseudo-research) and the unspeakable crimes it entailed. By contrast, there is almost no published evidence that these activities included in any way alternative medicine, and the general opinion seems to be that there are no connections whatsoever. I fear that this notion might be erroneous.

As far as I can make out, no systematic study of the subject has so far been published, but I found several hints and indications that the criminal experiments of Nazi doctors also involved alternative medicine (the sources are provided in my articles cited above or in the links provided below). Here are but a few leads:

Dr Wagner, the chief medical officer of the Nazis was a dedicated and most active proponent of alternative medicine.

Doctors in the alternative “Rudolf Hess Krankenhaus” [see above] experimented on speeding up the recovery of wounded soldiers, on curing syphilis with fasting, and on various other projects to help the war effort.

The Dachau concentration camp housed the largest plantation of medicinal herbs in Germany.

Dr Madaus (founder of the still existing company for natural medicines by the same name) experimented on the sterilisation of humans with herbal and homeopathic remedies, a project that was deemed of great importance for controlling the predicted population growth in the East of the expanding Reich.

Dr Grawitz infected Dachau prisoners with various pathogens to test the effectiveness of homeopathic remedies.

Schuessler salts were also tested on concentration camp inmates.

So, why bring all of this up today? Is it not time that we let grass grow over these most disturbing events? I think not! For many years, I actively researched this area (you can find many of my articles on Medline) because I am convinced that the unprecedented horrors of Nazi medicine need to be told and re-told – not just on HOLOCAUST MEMORIAL DAY, but continually. This, I hope, will minimize the risk of such incredible abuses ever happening again.

In my last post, I strongly criticised Prince Charles for his recently published vision of “integrated health and post-modern medicine”. In fact, I wrote that it would lead us back to the dark ages. “That is all very well”, I hear my critics mutter, “but can Ernst offer anything better?” After all, as Prof Michael Baum once remarked, Charles has his authority merely through an accident of birth, whereas I have been to medical school, served as a professor in three different countries and pride myself of being an outspoken proponent of evidence-based medicine. I should thus know better and have something to put against Charles’ odd love affair with the ‘endarkenment’.

I have to admit that I am not exactly what one might call a visionary; all my life I have been slightly weary of people who wear a ‘vision’ on their sleeve for everyone to see. But I could produce some concepts about what might constitute good medicine (apart from the obvious statement that I think EBM is the correct approach). To be truthful, these are not really my concepts either - but, as far as I can see, they simply are ideas held by most responsible health care professionals across the world. So, for what it’s worth, here it is:

Two elements

In a nut-shell, good medicine consists of two main elements: the science and the ‘art’ of medicine. This division is, of course, somewhat artificial; for instance, the art of medicine does not defy science, and compassion is an empty word, if it is not combined with effective therapy. Yet for clarity it can be helpful to separate the two elements.

Science

Medicine has started to make progress about 150 years ago when we managed to free ourselves from the dogmas and beliefs that had previously dominated heath care. The first major randomised trial was published only in 1948. Since then, progress in both basic and clinical research has advanced at a breath-taking speed. Consequently, enormous improvements in health care have occurred, and the life-expectancy as well as the quality of life of millions have grown to a remarkable degree.

These developments are fairly recent and tend to be frustratingly slow; it is therefore clear that there is still much room for improvement. But improvement is surely being generated every day: the outlook of patients who suffer from MS, AIDS, cancer and many other conditions will be better tomorrow than it is today. Similar advances are being made in the areas of disease prevention, rehabilitation, palliative care etc. All of these improvements is almost exclusively the result of the hard work by thousands of brilliant scientists who tirelessly struggle to improve the status quo.

But the task is, of course, huge and virtually endless. We therefore need to be patient and remind ourselves how very young medicine’s marriage with science still is. To change direction at this stage would be wrong and lead to disastrous consequences. To doubt the power of science in generating progress displays ignorance. To call on “ancient wisdom” for help is ridiculous.

Art

The ‘art of medicine’ seems a somewhat old-fashioned term to use. My reason for employing it anyway is that I do not know any other word that captures all of the following characteristics and attributes:

Compassion

Empathy

Sympathy

Time to listen

Good therapeutic relationships

Provision of choice, information, guidance

Holism

Professionalism

They are all important features of  good medicine – they always have been and always will be. To deny this would be to destroy the basis on which health care stands. To neglect them risks good medicine to deteriorate. To call this “ancient wisdom” is grossly misleading.

Sadly, the system doctors have to work in makes it often difficult to respect all the features listed above. And sadly, not everyone working in health care is naturally gifted in showing compassion, empathy etc. to patients. This is why medical schools do their very best to teach these qualities to students. I do not deny that this endeavour is not always fully successful, and one can only hope that young doctors make career-choices according to their natural abilities. If you cannot produce a placebo-response in your patient, I was taught at medical school, go and train as a pathologist!

Science and art

Let me stress this again: the science and the art of medicine are essential elements of good medicine. In other words, if one is missing, medicine is by definition  not optimal. In vast areas of alternative medicine, the science-element is woefully neglected or even totally absent. It follows, that these areas cannot be good medicine. In some areas of conventional medicine, the art-element is weak or neglected. It follows that, in these areas, medicine is not good either.

My rough outline of a ‘vision’ is, of course, rather vague and schematic; it cannot serve as a recipe for creating good medicine nor as a road map towards improving today’s health care. It is also somewhat naive and simplistic: it generalises across the entire, diverse field of medicine which problematic, to say the least.

One challenge for heath care practitioners is to find the optimal balance between the two elements for the situation at hand. A surgeon pulling an in-grown toenail will need a different mix of science and art than a GP treating a patient suffering from chronic depression, for instance.

The essential nature of both the science and the art of medicine also means that a deficit of one element cannot normally be compensated by a surplus of the other. In the absence of an effective treatment, even an over-dose of compassion will not suffice (and it is for this reason that the integration of alt med needs to be seen with great scepticism). Conversely, science alone will do a poor job in many others circumstances (and it is for that reason that we need to remind the medical profession of the importance of the ‘art’).

We cannot expect that the introduction of compassionate quacks will improve health care; it might make it appear more human, while, in fact, it would only become less effective. And is it truly compassionate to pretend that homeopathic placebos, administered by a kind and empathetic homeopath, generate more good than harm? I do not think so. The integration of alternative medicine makes sense only for those modalities which have been scientifically tested and demonstrated to be effective. True compassion must always include the desire to administer those treatments which demonstrably generate more good than harm.

Conclusion

I must admit, I do feel slightly embarrassed to pompously entitle this post “a vision of good medicine”. It really amounts to little more than common sense and is merely a reflection of what many health care professionals believe. Yet it does differ significantly from the ‘integrated health and post-modern medicine’ as proposed by Charles – and perhaps this is one reason why it might not be totally irrelevant.

His Royal Highness, the Prince of Wales has today published in the JOURNAL OF THE ROYAL SOCIETY his vision of what he now calls “post-modern medicine” and previously  named integrated health care. As the article does not seem to be available on-line, allow me to quote those sections which, in my view, are crucial.

“By integrated medicine, I mean the kind of care that integrates the best of new technology and current knowledge with ancient wisdom. More specifically, perhaps, it is an approach to care of the patient which includes mind, body and spirit and which maximizes the potential of conventional, lifestyle and complementary approaches in the process of healing”.

Charles believes that conventional medicine aims “to treat the symptoms of disease” his vision of a post-modern medicine therefore is “actively to create health and to put the patient at the heart of this process by incorporating those core human elements of mind, body and spirit

The article continues: “This whole area of work – what I can only describe as an ‘integrated approach’ in the UK, or ‘integrative’ in the USA – takes what we know about appropriate conventional, lifestyle and complementary approaches and applies them to patients. I cannot help feeling that we need to be prepared to offer the patient the ‘best of all worlds’ according to a patient’s wishes, beliefs and needs“.

Charles also points out that “health inequalities have lowered life-expectancy” in parts of the UK and suggests, if we “tackle some of these admittedly deep-seated problems, not only do you begin to witness improvements in health and other inequalities, but this can lead to improvements in the overall cost-efficiency and effectiveness of local services“.

MY RESPONSE

1)Integrated medicine is a smoke screen behind which any conceivable form of quackery is being promoted and administered.

2) The fact that patients are human beings who consist of mind, body and spirit is a core concept of all good health care and not a monopoly of integrated medicine.

3) The notion of ‘ancient wisdom’ is a classical fallacy.

4) The assumption that conventional medicine only treats symptoms displays a remarkable ignorance about modern health care.

5) The patient is at the heart of any good health care.

6) The application of unproven or disproved treatments to patients would make modern health care not more human but less effective.

7) The value of the notion of the “best of all worlds” crucially depends on what we mean by “best”. In medicine, this must describe interventions which demonstrably generate more good than harm – not ‘preferred by the future king of England’.

8) Some might find the point about inequalities affecting health offensive when it is made by an individual who profits millions without paying tax for the benefit of society.

I don’t think anyone doubts that medicine needs improving. However, I do doubt that Charles’ vision of a “post-modern medicine” is the way to achieve improvement – in fact, I fear that is would lead us straight back to the dark ages.

As I am drafting this post, I am in a plane flying back from Finland. The in-flight meal reminded me of the fact that no food is so delicious that it cannot be spoilt by the addition of too many capers. In turn, this made me think about the paper I happened to be reading at the time, and I arrived at the following theory: no trial design is so rigorous that it cannot to be turned into something utterly nonsensical by the addition of a few amateur researchers.

The paper I was reading when this idea occurred to me was a randomised, triple-blind, placebo-controlled cross-over trial of homeopathy. Sounds rigorous and top quality? Yes, but wait!

Essentially, the authors recruited 86 volunteers who all claimed to be suffering from “mental fatigue” and treated them with Kali-Phos 6X or placebo for one week (X-potencies signify dilution steps of 1: 10, and 6X therefore means that the salt had been diluted 1: 1000000 ). Subsequently, the volunteers were crossed-over to receive the other treatment for one week.

The results failed to show that the homeopathic medication had any effect (not even homeopaths can be surprised about this!). The authors concluded that Kali-Phos was not effective but cautioned that, because of the possibility of a type-2-error, they might have missed an effect which, in truth, does exist.

In my view, this article provides an almost classic example of how time, money and other resources can be wasted in a pretence of conducting reasonable research. As we all know, clinical trials usually are for testing hypotheses. But what is the hypothesis tested here?

According to the authors, the aim was to “assess the effectiveness of Kali-Phos 6X for attention problems associated with mental fatigue”. In other words, their hyposesis was that this remedy is effective for treating the symptom of mental fatigue. This notion, I would claim, is not a scientific hypothesis, it is a foolish conjecture!

Arguably any hypothesis about the effectiveness of a highly diluted homeopathic remedy is mere wishful thinking. But, if there were at least some promissing data, some might conclude that a trial was justified. By way of justification for the RCT in question, the authors inform us that one previous trial had suggested an effect; however, this study did not employ just Kali-Phos but a combined homeopathic preparation which contained Kalium-Phos as one of several components. Thus the authors’ “hypothesis” does not even amount to a hunch, not even to a slight incling! To me, it is less than a shot in the dark fired by blind optimists - nobody should be surprised that the bullet failed to hit anything.

It could even be that the investigators themselves dimly realised that something is amiss with the basis of their study; this might be the reason why they called it an “exploratory trial”. But an exploratory study is one whithout a hypothesis, and the trial in question does have a hyposis of sorts – only that it is rubbish. And what exactly did the authos meant to explore anyway?

That self-reported mental fatigue in healthy volunteers is a condition that can be mediatised such that it merits treatment?

That the test they used for quantifying its severity is adequate?

That a homeopathic remedy with virtually no active ingredient generates outcomes which are different from placebo?

That Hahnemann’s teaching of homeopathy was nonsense and can thus be discarded (he would have sharply condemned the approach of treating all volunteers with the same remedy, as it contradicts many of his concepts)?

That funding bodies can be fooled to pay for even the most ridiculous trial?

That ethics-committees might pass applications which are pure nonsense and which are thus unethical?

A scientific hypothesis should be more than a vague hunch; at its simplest, it aims to explain an observation or phenomenon, and it ought to have certain features which many alt med researchers seem to have never heard of. If they test nonsense, the result can only be nonsense.

The issue of conducting research that does not make much sense is far from trivial, particularly as so much (I would say most) of alt med research is of such or even worst calibre (if you do not believe me, please go on Medline and see for yourself how many of the recent articles in the category “complementary alternative medicine” truly contribute to knowledge worth knowing). It would be easy therefore to cite more hypothesis-free trials of homeopathy.

One recent example from Germany will have to suffice: in this trial, the only justification for conducting a full-blown RCT was that the manufacturer of the remedy allegedly knew of a few unpublished case-reports which suggested the treatment to work – and, of course, the results of the RCT eventually showed that it didn’t. Anyone with a background in science might have predicied that outcome – which is why such trials are so deplorably wastefull.

Research-funds are increasingly scarce, and they must not be spent on nonsensical projects! The money and time should be invested more fruitfully elsewhere. Participants of clinical trials give their cooperation willingly; but if they learn that their efforts have been wasted unnecessarily, they might think twice next time they are asked. Thus nonsensical research may have knock-on effects with far-reaching consequences.

Being a researcher is at least as serious a profession as most other occupations; perhaps we should stop allowing total amateurs wasting money while playing at being professioal. If someone driving a car does something seriously wrong, we take away his licence; why is there not a similar mechanism for inadequate researchers, funders, ethics-committees which prevents them doing further damage?

At the very minimum, we should critically evaluate the hypothesis that the applicants for research-funds propose to test. Had someone done this properly in relatiom to the two above-named studies, we would have saved about £150,000 per trial (my estimate). But as it stands, the authors will probably claim that they have produced fascinating findings which urgently need further investigation – and we (normally you and I) will have to spend three times the above-named amount (again, my estimate) to finance a “definitive” trial. Nonsense, I am afraid, tends to beget more nonsense.

 

Since homeopathy was invented by Samuel Hahnemann about 200 years ago, a steadily growing group of critics have raised their voices more and more loudly. Usually they come from doctors or scientists and only rarely from the legal profession.

Yet, there are exceptions: an Australian barrister and professor of law has published an analysis of “a series of criminal, civil, disciplinary and coronial decisions from difference countries in relation to homeopathic medicine where outcomes have been tragic”. He concludes that “there is an urgent need for reflection and response within the health sector generally, consumer protection authorities, and legal policy-makers about the steps that should be taken to provide community protection from dangerous homeopathic practice”.

He also questions whether homeopathy can ever be registered alongside other health care professionals:

“Until such time as homoeopathy can scientifically justify its fundamental tenets,… it cannot be said that its claims for therapeutic efficacy can be justifiable. This leaves the profession not just exposed to criticisms,… but potentially open to consumer protection actions directed toward whether its representations are false, misleading and deceptive, to civil litigation when its promises have not been fulfilled, and especially when persons have died, and to criminal actions in respect of the financial advantage that is obtained by its practitioners from their representations.

The distressing cases referred to here which led to avoidable deaths and the multiple accusations leveled against homoeopathy require of the profession at least a formal repudiation of the practitioners concerned… In addition, they demand an unequivocal response that homoeopathy will discipline its own in a robust and open way. If the profession is to acquire any scientific credibility, which is difficult to conceive of, the deaths to which homoeopathy has contributed…also require that homoeopathy actively generate a defensible research basis that justifies its claims to efficacy of outcome for its patients. It is only then that the claims of the medical establishment that homoeopathy is a dangerous and too often a lethal form of quackery will be able to be contested rationally. In the meantime, it is timely to consider further the status that homoeopathy has within the general and health care communities and whether that status can be scientifically, ethically or legally justified”.

I believe this legal view to be highly significant. The persistent criticism from skeptics, concerned scientists and doctors has rarely been translated into decisions about health care provision. Homeopaths tended to respond to our criticism by producing anecdotes, unconvincing or cherry-picked data or by producing outright lies, for instance in relation to the “Swiss government’s report” on homeopathy.

In this context, it is worth noting that, in some countries, homeopaths who have no medical qualifications have been accused to practice medicine without a licence. The case of Dana Ullman in the US is probably the most spectecular such incident; this is how one pro-homeopathy site describes it:

Dana is perhaps the person who has done the most for homeopathy since his court case in that he pursues the evangelism of homeopathy through the NCH and his mail order company… He prescribed homeopathic medicine and was arrested for practicing medicine without a license. But he won an important settlement in 1977 in the Oakland Municipal Court in which the court allowed his practice under two stipulations:

  1. that he did not diagnose or treat disease and that he refers to medical doctors for the diagnosis and treatment of disease;
  2. that he makes contracts with his patients that clearly define his role as a non-medical homeopathic practitioner and the patient’s role in seeking his care.

But such cases are not the only occasions for lawyers to look at homeopathy. Recently there has been a class action against the Boiron, the world’s largest manufacturer of homeopathic preparations. It was alleged that Boiron made bogus claims for one of its remedies, and there was a settlement worth millions of dollars. Similar cases  are likely to follow, e.g.:

  • Nelsons Homeopathy (Rescue Remedy, Bach Original Flower Remedies, Pure & Clear, Arnileve, H+Care)
  • CVS Homeopathic Products (Flu Relief, Cold Relief, Cold Remedy, Ear Pain Relief)
  • Nature’s Innovation (Naturasil Skin Tags, Bed Bug Patrol, Naturasil Scabies)
  • Boericke & Tafel Cold/Flu
  • Homeolab USA (Kids Relief Cough & Cold)

In June 2003, a British High Court Judge ordered two mothers to ensure that their daughters are appropriately vaccinated. The ruling concerned two separate cases brought by fathers who wanted their daughters immunized despite opposition by the girls’ unwed mothers

The fact that, in the UK and other countries, homeopathic placebos are still being sold as “vaccines” for the prevention of serious, life-threatening infections is, in my view nothing short of a scandal. The fact that a leading figure at Ainsworth actively misleads the public about these products is an outrage. It is high time therefore that the legal profession looks seriously at the full range of issues related to homeopathy with a view of stopping the dangerous nonsense.

I don’t suppose that many readers of this blog believe all things natural to be entirely safe, but the general public seems to be hard-wired victims of this myth: Mother Nature is benign, and herbal remedies must be harmless!

There are, of course, several reasons why supposedly “natural” herbal treatments can be unsafe. Plants extracts can be toxic, they might interact with prescribed drugs or they can be contaminated or adulterated.

The latter two terms describe similar but not identical phenomena: contamination means the accidental addition of substances which should not be present in an herbal remedy; and adulteration signifies the deliberate addition of ingredients. If the substances in question are not pharmacologically inert, their presence in herbal remedies can cause adverse effects.

Both contamination and adulteration break laws and regulations; both are therefore illegal. Sadly, this does not mean that such things do not happen.

We have recently published an overview of the existing knowledge in this area. For this purpose, we summarised the evidence from 26 previously published reviews. Our findings were interesting but far from reassuring: the most commonly found contaminants were dust, pollen, insects, rodents, parasites, microbes, fungi, mould, pesticides, and heavy metals. The adulterants invariably were prescription drugs such as steroids, anti-diabetic medications etc.

These substances were implicated in a wide range of serious adverse effects in the unfortunate patients who took the remedies in question: agranulocytosis, meningitis, multi-organ failure, stroke, arsenic poisoning, mercury poisoning, lead poisoning, caner, encephalopathy, hepato-renal syndrome, kidney damage, rhabdomyolosis, metabolic acidosis, renal failure, liver failure, cerebral oedema, coma, and intra-cerebral bleeding. Several patients did not survive.

To avoid such disasters, consumers need to know which types of herbal remedies are most frequently implicated; our review showed that these were foremost Chinese and Indian remedies. While herbal medicines from the US or Europe ought to comply with certain rules and regulations regarding their quality and safety, Chinese and Indian herbal mixtures frequently enter our countries illegally or are bought from dubious sources, for instance, over the Internet. It is this type of herbal remedy that we should be concerned about.

We have to ask whether the risks outweigh the proven benefits of Chinese or Indian herbal mixtures. The short answer to this question is NO. There is very little compelling evidence to suggest that these treatments are efficacious. In the absence of proven benefit, even small or rare risks weigh heavily.

If the risk-benefit profile for any medical intervention fails to be positive, there can only be one reasonable conclusion regarding the use of this therapy – and that is: DON’T DO IT!

According to Wikipedia, Gua sha involves repeated pressured strokes over lubricated skin with a smooth edge placed against the pre-oiled skin surface, pressed down firmly, and then moved downwards along muscles or meridians.This intervention causes bleeding from capillaries and sub-cutaneous blemishing which usually last for several days. According to a recent article on Gua Sha, it is a traditional healing technique popular in Asia and Asian immigrant communities involving unidirectional scraping and scratching of the skin until ‘Sha-blemishes’ appear.

Gua Sha paractitioners make far-reaching therapeutic claims, e.g.” Gua Sha is used whenever a patient has pain whether associated with an acute or chronic disorder… In addition to resolving musculo skeletal pain, Gua Sha is used to treat as well as prevent common cold, flu, bronchitis, asthma, as well as any chronic disorder involving pain, congestion of Qi and Blood“. Another source informs us that ” Gua Sha is performed to treat systemic toxicity, poor circulation, physical and  emotional stress, and migraines. Gua Sha healing promotes the flow of Qi  (energy) and blood throughout the body for overall health“.

Gua Sha “blemishes” can look frightful – more like the result of torture than of treatment. Yet with our current craze for all things exotic in medicine, Gua Sha is becoming popular also in Western countries. One German team has even published several RCTs of Gua Sha.

This group treated 40 patients with neck pain either with Gua Sha or locally applied heat packs. They found that, after one week, the pain was significantly reduced in the former compared to the latter group. The same team also published a study with 40 back or neck-pain patients who either received a single session of Gua Sha or were left untreated. The results indicate that one week later, the treated patients had less pain than the untreated ones.

My favoutite article on the subject must be a case report by the same German research team. It describes a woman suffering from chronic headaches. She was treated with a range of interventions, including Gua Sha – and her symptoms improved. From this course of events, the authors conclude that “this case provides first evidence that Gua Sha is effective in the treatment of headaches”

The truth, of course, is that neither this case nor the two RCTs provide any good evidence at all. The case-report is, in fact, a classic example of drawing hilariously over-optimistic conclusions from data that are everything but conclusive. And the two RCTs  just show how remarkable placebo-effects can be, particularly if the treatment is exotic, impressive, involves physical touch, is slightly painful and raises high expectations.

My explanation for the observed effects after Gua Sha is quite simple: imagine you have a headache and accidentally injure yourself - say you fall off your bike and the tarmac scrapes off an area of skin on your thigh. This hurts quite a bit and distracts you from your headache, perhaps even to such an extend that you do not feel it any more. As the wound heals, it gets a bit infected and thus hurts for several days; chances are that your headache will be gone for that period of time. Of course, the Gua Sha- effect would be larger because the factors mentioned above (exotic treatment, expectation etc.) but essentially the accident and the treatment work via similar mechanisms, namely distraction and counter-irritation. And neither Gua Sha nor injuring yourself on the tarmac are truly recommendable therapies, in my view.

But surely, for the patient, it does not matter how she gets rid of her headache! The main point is that Gua Sha works! In a way, this attitude is understandable – except, we do not need the hocus pocus of meridians, qi, TCM, ancient wisdom etc. nor do we need to tolerate claims that Gua Sha is “serious medicine” and has any specific effects whatsoever. All we do need is to apply some common sense and then use any other method of therapeutic counter-irritation; that might be more honest, safer and would roughly do the same trick.

No, I am wrong! I forgot something important: it would not be nearly as lucrative for the TCM-practitioner.

Musculoskeletal and rheumatic conditions, often just called “arthritis” by lay people, bring more patients to alternative practitioners than any other type of disease. It is therefore particularly important to know whether alternative medicines (AMs) demonstrably generate more good than harm for such patients. Most alternative practitioners, of course, firmly believe in what they are doing. But what does the reliable evidence show?

To find out, ‘Arthritis Research UK’ has sponsored a massive project  lasting several years to review the literature and critically evaluate the trial data. They convened a panel of experts (I was one of them) to evaluate all the clinical trials that are available in 4 specific clinical areas. The results for those forms of AM that are to be taken by mouth or applied topically have been published some time ago, now the report, especially written for lay people, on those treatments that are practitioner-based has been published. It covers the following 25 modalities: 

Acupuncture

Alexander technique

Aromatherapy

Autogenic training

Biofeedback

Chiropractic (spinal manipulation)

Copper bracelets

Craniosacral therapy

Crystal healing

Feldenkrais

Kinesiology (applied kinesiology)

Healing therapies

Hypnotherapy

Imagery

Magnet therapy (static magnets)

Massage

Meditation

Music therapy

Osteopathy (spinal manipulation)

Qigong (internal qigong)

Reflexology

Relaxation therapy

Shiatsu

Tai chi

Yoga 

Our findings are somewhat disappointing: only very few treatments were shown to be effective.

In the case of rheumatoid arthritis, 24 trials were included with a total of 1,500 patients. The totality of this evidence failed to provide convincing evidence that any form of AM is effective for this particular condition.

For osteoarthritis, 53 trials with a total of ~6,000 patients were available. They showed reasonably sound evidence only for two treatments: Tai chi and acupuncture.

Fifty trials were included with a total of ~3,000 patients suffering from fibromyalgia. The results provided weak evidence for Tai chi and relaxation-therapies, as well as more conclusive evidence for acupuncture and massage therapy.

Low back pain had attracted more research than any of the other diseases: 75 trials with ~11,600 patients. The evidence for Alexander Technique, osteopathy and relaxation therapies was promising by not ultimately convincing, and reasonably good evidence in support of yoga and acupuncture was also found.

The majority of the experts felt that the therapies in question did not frequently cause harm, but there were two important exceptions: osteopathy and chiropractic. For both, the report noted the existence of frequent yet mild, as well as serious but rare adverse effects.

As virtually all osteopaths and chiropractors earn their living by treating patients with musculoskeletal problems, the report comes as an embarrassment for these two professions. In particular, our conclusions about chiropractic were quite clear:

There are serious doubts as to whether chiropractic works for the conditions considered here: the trial evidence suggests that it’s not effective in the treatment of fibromyalgia and there’s only little evidence that it’s effective in osteoarthritis or chronic low back pain. There’s currently no evidence for rheumatoid arthritis.

Our point that chiropractic is not demonstrably effective for chronic back pain deserves some further comment, I think. It seems to be in contradiction to the guideline by NICE, as chiropractors will surely be quick to point out. How can this be?

One explanation is that, since the NICE-guidelines were drawn up, new evidence has emerged which was not positive. The recent Cochrane review, for instance, concludes that spinal manipulation “is no more effective for acute low-back pain than inert interventions, sham SMT or as adjunct therapy”

Another explanation could be that the experts on the panel writing the NICE-guideline were less than impartial towards chiropractic and thus arrived at false-positive or over-optimistic conclusions.

Chiropractors might say that my presence on the ‘Arthritis Research’-panel suggests that we were biased against chiropractic. If anything, the opposite is true: firstly, I am not even aware of having a bias against chiropractic, and no chiropractor has ever demonstrated otherwise; all I ever aim at( in my scientific publications) is to produce fair, unbiased but critical assessments of the existing evidence. Secondly, I was only one of a total of 9 panel members. As the following list shows, the panel included three experts in AM, and most sceptics would probably categorise two of them (Lewith and MacPherson) as being clearly pro-AM:

Professor Michael Doherty – professor of rheumatology, University of Nottingham

Professor Edzard Ernst – emeritus professor of complementary medicine, Peninsula Medical School

Margaret Fisken – patient representative, Aberdeenshire

Dr Gareth Jones (project lead) – senior lecturer in epidemiology, University of Aberdeen

Professor George Lewith – professor of health research, University of Southampton

Dr Hugh MacPherson – senior research fellow in health sciences, University of York

Professor Gary Macfarlane (chair of committee) professor of epidemiology, University of Aberdeen

Professor Julius Sim – professor of health care research, Keele University

Jane Tadman – representative from Arthritis Research UK, Chesterfield

What can we conclude from all that? I think it is safe to say that the evidence for practitioner-based AMs as a treatment of the 4 named conditions is disappointing. In particular, chiropractic is not a demonstrably effective therapy for any of them. This, of course begs the question, for what condition is chiropractic proven to work! I am not aware of any, are you?

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