MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

progress

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There is much propaganda for homeopathic vaccinations or homeoprophylaxis (as homeopaths like to call it, in order to give it a veneer of respectability), and on this blog we have discussed it repeatedly. The concept is unproven and dangerous. Yet it is being promoted relentlessly. Currently, I get > 12 million websites when I google ‘homeopathic vaccination’, and there are hundreds of dangerously misleading books and newspaper articles on the subject.

One study that I therefore always wanted to conduct was a trial comparing homeopathic ‘vaccines’ to placebo in terms of immunological response in human volunteers. Somehow, I never managed to get it going. Thus, I was delighted when, a few weeks ago, I received an article for peer-review (I hope I am allowed to disclose this fact here); it was almost exactly the trial I had dreamt of doing one day: the first ever study to test whether there is an antibody response to homeopathic vaccines. Now I am even more delighted to see that it has been published.

Its aim was to compare the antibody response of homeopathic and conventional vaccines and placebo in young adults. The authors hypothesized that there would be no significant difference between homeopathic vaccines and placebo, while there would be a significant increase in antibodies in those received conventional vaccines.

A placebo-controlled, double-blind RCT was conducted where 150 university students who had received childhood vaccinations were assigned to diphtheria, pertussis, tetanus, mumps, measles homeopathic vaccine, placebo, or conventional diphtheria, pertussis, tetanus (Tdap) and mumps, measles, rubella (MMR) vaccines. The primary outcome was a ≥ two-fold increase in antibodies from baseline following vaccination as measured by ELISA. Participants, investigators, study coordinator, data blood drawers, laboratory technician, and data analyst were blinded.

None of the participants in either the homeopathic vaccine or the placebo group showed a ≥ two-fold response to any of the antigens. In contrast, of those vaccinated with Tdap, 68% (33/48) had a ≥ two-fold response to diphtheria, 83% (40/48) to pertussis toxoid, 88% (42/48) to tetanus, and 35% (17/48) of those vaccinated with MMR had a response to measles or mumps antigens (p < 0.001 for each comparison of conventional vaccine to homeopathic vaccine or to placebo). There was a significant increase in geometric mean titres of antibody from baseline for conventional vaccine antigens (p < 0.001 for each), but none for the response to homeopathic antigens or placebo.

The authors concluded that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.

I think this is in every respect an excellent trial. It should once and for all get rid of what is arguably the homeopathy-cult’s most dangerous idea, namely that highly diluted homeopathic remedies can protect humans against infectious diseases. On this blog, I once called it ‘a danger for both the public and the individual who might believe in it … promoting HP is unethical, irresponsible and possibly even criminal.’

I said it ‘should’ get rid of this nonsense, but will it?

As homeopaths have, for now 200 years, showed themselves utterly impervious to evidence, I for one am not holding my breath. Yet, thanks to this excellent study, we can, when confronted with the notion of homeopathic vaccinations, henceforth point out that it is not just totally implausible but that, in addition, it has also been experimentally shown to be false.

My thanks to the Canadian investigators!

This paper reports a survey amongst European chiropractors during early 2017. Dissemination was through an on-line platform with links to the survey being sent to all European chiropractic associations regardless of European Chiropractors’ Union (ECU) membership and additionally through the European Academy of Chiropractic (EAC). Social media via Facebook groups was also used to disseminate links to the survey.

One thousand three hundred twenty and two responses from chiropractors across Europe representing approximately 17.2% of the profession were collected. Five initial self-determined chiropractic identities were collapsed into 2 groups categorised as orthodox (79.9%) and unorthodox (20.1%); by the latter term, the investigators mean the subluxationists/vitalists.

When comparing the percentage of new patients chiropractors x-rayed, 23% of the unorthodox group x-rayed > 50% of their new patients compared to 5% in the orthodox group. Furthermore, the proportion of respondents reporting > 150 patient encounters per week in the unorthodox group were double compared to the orthodox (22 v 11%). Lastly the proportion of those respondents disagreeing or strongly disagreeing with the statement “In general, vaccinations have had a positive effect on global public health” was 57 and 4% in unorthodox and orthodox categories respectively. Logistic regression models identified male gender, seeing more than 150 patients per week, no routine differential diagnosis, and not strongly agreeing that vaccines have generally had a positive impact on health as highly predictive of unorthodox categorisation.

The authors concluded that despite limitations with generalisability in this survey, the proportion of respondents adhering to the different belief categories are remarkably similar to other studies exploring this phenomenon. In addition, and in parallel with other research, this survey suggests that key practice characteristics in contravention of national radiation guidelines or opposition to evidence based public health policy are significantly more associated with non-orthodox chiropractic paradigms.

Country

N (%) Orthodox

N (%) Unorthodox

Belgium

51 (92.7)

4 (7.3)

Germany

43 (66.2)

22 (33.8)

Ireland

31 (79.5)

8 (20.5)

Italy

23 (59.0)

16 (41.0)

Norway

132 (93.0)

10 (7.0)

Spain

34 (43.6)

44 (56.4)

Sweden

101 (82.8)

21 (17.2)

Switzerland

102 (90.3)

11 (9.7)

The Netherlands

81 (82.7)

17 (17.3)

UK

236 (80.0)

59 (20.0)

The authors do laudably question that their findings are generalisable. However, this does not mean that this limitation is not significant. With such a dismal response rate, the value of any such survey approaches zero. I think, one has to be a chiropractor to publish such valueless paper nevertheless.

If, for a minute, I disregarded the non-generalisability of these data, what I would find most remarkable here is the high proportion of subluxationists/vitalists/anti-vaccinationists amongst today’s chiropractors. Chiropractic subluxation is an obsolete theory which should have been banned to the history books a long time ago. Yet, in some European countries around half of the chiropractors would adhere to it (I speculate that the figures would be significantly higher, if the response rate had been 100%).

I would find this unacceptable.

The reason I said ‘would find it acceptable’ is that I do not accept the validity of the survey results in the first place.

I have just given two lectures on so-called alternative medicine (SCAM) in France.

Why should that be anything to write home about?

Perhaps it isn’t; but during the last 25 years I have been lecturing all over the world and, even though I live partly in France and speak the language, I never attended a single SCAM-conference there. I have tried for a long time to establish contact with French SCAM-researchers, but somehow this never happened.

Eventually, I came to the conclusion that, although the practice of SCAM is hugely popular in this country, there was no or very little SCAM-research in France. This conclusion seems to be confirmed by simple Medline searches. For instance, Medline lists just 171 papers for ‘homeopathy/France’ (homeopathy is much-used in France), while the figures for Germany and the UK are 490 and 448.

These are, of course, only very rough indicators, and therefore I was delighted to be invited to participate for the first time in a French SCAM-conference. It was well-organised, and I am most grateful to the organisers to have me. Actually, the meeting was about non-pharmacological treatments but the focus was clearly on SCAM. Here are a few impressions purely on the SCAM-elements of this conference.

TERMINOLOGY

Already the title of the conference, ‘Non-pharmacological Interventions: Integrative, Preventive, Complementary and Personalised Medicines‘, contained a confusing shopping-list of terms. The actual lectures offered even more. Clear definitions of these terms were not forthcoming and are, as far as I can see, impossible. This meant that much of the discussion lacked focus. In both my presentations, I used the term ‘alternative medicine’ and stressed that all such umbrella terms are fairly useless. In my view, it is therefore best to name the precise modality (acupuncture, osteopathy, homeopathy etc.) one wants to discuss.

INTEGRATIVE MEDICINE

The term that seemed to dominate the conference was ‘INTEGRATIVE MEDICINE’ (IM). I got the impression that it was employed uncritically by some for bypassing the need for proper evaluation of any specific SCAM. The experts seemed to imply that, because IM is the politically and socially correct approach, there is no longer a need for asking whether the treatments to be integrated actually generate more good than harm. I got the impression that most of these researchers were confusing science with promotion.

RESEARCH METHODOLOGY

The discussions regularly touched upon research methodology – but they did little more than lightly touch it. People tended to lament that ‘conventional research methodology’ was inadequate for assessing SCAM, and that we therefore needed different methods and even paradigms. I did not hear any reasonable explanations in what respect the ‘conventional methodology’ might be insufficient, nor did I understand the concept of an alternative science or paradigm. My caution that double standards in medicine can only be detrimental, seemed to irritate and fell mostly on deaf ears.

RESEARCH QUESTIONS

My own research agenda has always been the efficacy and safety of SCAM; and I still have no doubt that these are the issues that need addressing more urgently than any others. My impression was that, during this conference, the researchers seemed to aim in entirely different directions. One speaker even explained that, if a homeopath is fully convinced of the assumptions of homeopathy, he is entirely within the ethical standards to treat his patients homeopathically, regardless of the fact that homeopathy is demonstrably wrong. Another speaker claimed that there is no doubt any longer about the efficacy of acupuncture; the research question therefore must be how to best implement it in routine healthcare. And yet another expert tried to explain TCM with quantum physics. I have, of course, heard similar nonsense before during such conferences, but rarely did it pass without objection or debate.

RESEARCH FUNDING

The lack of research funding was bemoaned repeatedly. Most researchers seemed to think that they needed dedicated funding streams for SCAM to take account of the need of softer methodologies and the unique nature of SCAM. The argument that there should be only one set of standards for spending scarce research funds – scientific rigor and relevance – was not one shared by the French SCAM enthusiasts. The US example was frequently cited as the one that we ought to follow. In my view, the US example foremost shows impressively that a ring-fenced funding stream for SCAM is a wasteful mistake.

THE COLLEGE

To my surprise I learnt during a conference presentation that there is such a thing as the ‘Collège Universitaire de Médecines Intégratives et Complémentaires‘ (How could I have been unaware of it all those years? Why did I never see any of their published work? Why did they never contact me and cooperate?). Its president is Prof Jacques Kopferschmitt from the University of Strasbourg, and many French Universities are members of this organisation. Here is the abstract of Kopferschmitt’s lecture on the topic of this College:

The multitude of complementary therapies or non-pharmacological interventions (NPIs) first requires pedagogical semantic harmonization to bring down the historical tensions that persist. If users often remain very or too seduced, it is not the same with health professionals! Behind the words, there are concepts that disturb because between efficiency and efficiency the nuances are subtle. However, nothing really stands in the way of modern western medicine, but there are really gaps that we could fill in the face of the growing scale of chronic diseases, the prerogative of the Western world. The need for a university investment in verification, validation and certification is essential in the face of the diversity of offers. The main beneficiaries are health professionals who need to invest in an integrative approach, particularly in France. The CUMIC promotes a different vision of efficiency and effectiveness with a broader vision of multidisciplinary evaluation, which we will discuss the main targets.

Kopferschmitt is Professor of Medical Therapy, which introduced him to a pluralism of approach to health concerns, including innovative by the introduction of the CT in the first and second cycle of medical studies. He is responsible for the teaching of Acupuncture, Auriculotherapy and hypnosis clinic. He is vice President of the Groupe d’Évaluation des Thérapies complémentaires Personnalisées (GETCOP). By founding the association of complementary Therapies at the University hospitals of Strasbourg he coordinates the introduction, teaching and research in both in Hospital and in University, who was organized many seminars on CT. He currently chairs the French University of Integrative and Complementary Medicine College (CUMIC).

This sounded odd to me; however, it got truly bizarre after I looked up what SCAM-research Kopferschmitt or any of the other officers of the College have published. I could not find a single SCAM-article authored by him/them.

DIFFERENT PLANET

Altogether I found the conference enjoyable and was pleased to meet many interesting and very kind people. But I often felt like having arrived on a different planet. Many of the discussions, lectures, ideas, comments, etc. reminded me of 1993, the year I had arrived in the UK to start our research in SCAM. What is more, I fear that French experts involved in real science might feel the same about those colleagues who seem to engage themselves in SCAM research with more enthusiasm than expertise, scientific rigour or track record. The planet I had landed on was one where critical thinking was yet to be discovered, I felt.

ADVICE

Who am I to teach others what to do?

Yes, I do hesitate to give advice – but, after all, I have researched SCAM for 25 years and published more on the subject that any researcher on the planet; and I too was once more of a SCAM-enthusiast as is apparent today. So, for what it’s worth, here is some hopefully constructive advice that crossed my mind while driving home through the beautiful French landscape:

  • Sort out the confusion in terminology and define your terms as accurately as you can.
  • Try to focus on the research questions that are justifiably the most important ones for improving healthcare.
  • Do not attempt to re-invent the wheel.
  • Once you have identified a truly relevant research question, read up what has already been published on it.
  • While doing this, differentiate between rigorous research and fluff that does not meet this criterion.
  • Remember to abandon your own prejudices; research is about finding the truth and not about confirming your beliefs.
  • Avoid double standards like the pest.
  • Publish your research in top journals and avoid SCAM-journals that nobody outside SCAM takes seriously.
  • If you do not have a track record of publishing articles in top journals, please do not pretend to be an expert.
  • Involve sceptics in discussions and projects.
  • Remember that criticism is a precondition of progress.

I sincerely hope that this advice is not taken the wrong way. I certainly do not mean to hurt anyone’s feelings. What I do want is foremost that my French colleagues don’t have to repeat all the mistakes we did in the UK and that they are able to make swift progress.

Actually, the article is not entitled ‘Explaining Homeopathy with Quantum Bollocks’, it has the title ‘Explaining Homeopathy with Quantum Electrodynamics’. Its two Italian authors have prestigious affiliations in the world of quantum physics:

  • Independent Researcher
  • Homeopathic Clinic, Bassano del Grappa

What they write must therefore be authorative and important. Let’s have a look; here is the abstract:

Every living organism is an open system operating far from thermodynamic equilibrium and exchanging energy, matter and information with an external environment. These exchanges are performed through non-linear interactions of billions of different biological components, at different levels, from the quantum to the macro-dimensional. The concept of quantum coherence is an inherent property of living cells, used for long-range interactions such as synchronization of cell division processes. There is support from recent advances in quantum biology, which demonstrate that coherence, as a state of order of matter coupled with electromagnetic (EM) fields, is one of the key quantum phenomena supporting life dynamics. Coherent phenomena are well explained by quantum field theory (QFT), a well-established theoretical framework in quantum physics. Water is essential for life, being the medium used by living organisms to carry out various biochemical reactions and playing a fundamental role in coherent phenomena.

Quantum electrodynamics (QED), which is the relativistic QFT of electrodynamics, deals with the interactions between EM fields and matter. QED provides theoretical models and experimental frameworks for the emergence and dynamics of coherent structures, even in living organisms. This article provides a model of multi-level coherence for living organisms in which fractal phase oscillations of water are able to link and regulate a biochemical reaction. A mathematical approach, based on the eigenfunctions of Laplace operator in hyper-structures, is explored as a valuable framework to simulate and explain the oneness dynamics of multi-level coherence in life. The preparation process of a homeopathic medicine is analyzed according to QED principles, thus providing a scientific explanation for the theoretical model of “information transfer” from the substance to the water solution. A subsequent step explores the action of a homeopathic medicine in a living organism according to QED principles and the phase-space attractor’s dynamics.

According to the developed model, all levels of a living organism organelles, cells, tissues, organs, organ systems, whole organism-are characterized by their own specific wave functions, whose phases are perfectly orchestrated in a multi-level coherence oneness. When this multi-level coherence is broken, a disease emerges. An example shows how a homeopathic medicine can bring back a patient from a disease state to a healthy one. In particular, by adopting QED, it is argued that in the preparation of homeopathic medicines, the progressive dilution/succussion processes create the conditions for the emergence of coherence domains (CDs) in the aqueous solution. Those domains code the original substance information (in terms of phase oscillations) and therefore they can transfer said information (by phase resonance) to the multi-level coherent structures of the living organism.

We encourage that QED principles and explanations become embodied in the fundamental teachings of the homeopathic method, thus providing the homeopath with a firm grounding in the practice of rational medicine. Systematic efforts in this direction should include multiple disciplines, such as quantum physics, quantum biology, conventional and homeopathic medicine and psychology.

I hope you agree that this is remarkable, perhaps even unique. The only similar paper I can remember is the one by my good friend Lionel Milgrom which concluded that quantum field theory demonstrates that quantum properties can be physical without being observable. Thus, an underlying similarity in discourse could exist between homeopathy and quantum theory which could be useful for modelling the homeopathic process. This preliminary investigation also suggested that key elements of previous quantum models of the homeopathic process, may become unified within this new QFT-type approach.

As far as I can see, the two authors of the new paper (published in the journal ‘Homeopathy‘) have just revolutionised our understanding of:

  • quantum physics,
  • human physiology,
  • pathophysiology,
  • therapeutics,
  • homeopathy.

Not a mean feast, you must admit.

Alternatively – and I am genuinely uncertain here – the journal ‘Homeopathy’ has just fallen victim of a hilarious spoof.

Please, do tell me which is the case.

As you can imagine, I get quite a lot of ‘fan-post’. Most of the correspondence amounts to personal attacks and insults which I usually discard. But some of these ‘love-letters’ are so remarkable in one way or another that I answer them. This short email was received on 20/3/19; it belongs to the latter category:

Dr Ernst,

You have been trashing homeopathy ad nauseum for so many years based on your limited understanding of it. You seem to know little more than that the remedies are so extremely dilute as to be impossibly effective in your opinion. Everybody knows this and has to confront their initial disbelief.

Why dont you get some direct understanding of homeopathy by doing a homeopathic proving of an unknown (to you) remedy? Only once was I able to convince a skeptic to take the challenge to do a homeopathic proving. He was amazed at all the new symptoms he experienced after taking the remedy repeatedly over several days.

Please have a similar bravery in your approach to homeopathy instead of basing your thoughts purely on your speculation on the subject, grounded in little understanding and no experience of it.

THIS IS HOW I RESPONDED

Dear Mr …

thank you for this email which I would like to answer as follows.

Your lines give the impression that you might not be familiar with the concept of critical analysis. In fact, you seem to confuse my criticism of homeopathy with ‘trashing it’. I strongly recommend you read up about critical analysis. No doubt you will then realise that it is a necessary and valuable process towards generating progress in healthcare and beyond.

You assume that I have limited understanding of homeopathy. In fact, I grew up with homeopathy, practised homeopathy as a young doctor, researched the subject for more than 25 years and published several books as well as over 100 peer-reviewed scientific papers about it. All of this, I have disclosed publicly, for instance, in my memoir which might interest you.

The challenge you mention has been taken by me and others many times. It cannot convince critical thinkers and, frankly, I am surprised that you found a sceptic who was convinced by what essentially amounts to little more than a party trick. But, as you seem to like challenges, I invite you to consider taking the challenge of the INH which even offers a sizable amount of money, in case you are successful.

Your final claim that my thoughts are based purely on speculation is almost farcically wrong. The truth is that sceptics try their very best to counter-balance the mostly weird speculations of homeopaths with scientific facts. I am sure that, once you have acquired the skills of critical thinking, you will do the same.

Best of luck.

Edzard Ernst

I stared my Exeter post in October 1993. It took the best part of a year to set up a research team, find rooms etc. So, our research began in earnest only mid 1994. From the very outset, it was clear to me that investigating the risks of so-called alternative medicine (SCAM) should be our priority. The reason, I felt, was simple: SCAM was being used a million times every day; therefore it was an ethical imperative to check whether these treatments were as really safe as most people seemed to believe.

In the course of this line of investigation, we did discover many surprises (and lost many friends). One of the very first revelation was that homeopathy might not be harmless. Our initial results on this topic were published in this 1995 article. In view of the still ongoing debate about homeopathy, I’d like to re-publish the short paper here:

Homoeopathic remedies are believed by doctors and patients to be almost totally safe. Is homoeopathic advice safe, for example on the subject of immunization? In order to answer this question, a questionnaire survey was undertaken in 1995 of all 45 homoeopaths listed in the Exeter ‘yellow pages’ business directory. A total of 23 replies (51%) were received, 10 from medically qualified and 13 from non-medically qualified homoeopaths.

The homoeopaths were asked to suggest which conditions they perceived as being most responsive to homoeopathy. The three most frequently cited conditions were allergies (suggested by 10 respondents), gynaecological problems (seven) and bowel problems (five).

They were then asked to estimate the proportion of patients that were referred to them by orthodox doctors and the proportion that they referred to orthodox doctors. The mean estimated percentages were 1 % and 8%, respectively. The 23 respondents estimated that they spent a mean of 73 minutes on the first consultation.

The homoeopaths were asked whether they used or recommended orthodox immunization for children and whether they only used and recommended homoeopathic immunization. Seven of the 10 homoeopaths who were medically qualified recommended orthodox immunization but none of the 13 non-medically qualified homoeopaths did. One non-medically qualified homoeopath only used and recommended homoeopathic immunization.

Homoeopaths have been reported as being against orthodox immunization’ and advocating homoeopathic immunization for which no evidence of effectiveness exists. As yet there has been no attempt in the United Kingdom to monitor homoeopaths’ attitudes in this respect. The above findings imply that there may be a problem. The British homoeopathic doctors’ organization (the Faculty of Homoeopathy) has distanced itself from the polemic of other homoeopaths against orthodox immunization, and editorials in the British Homoeopathic Journal call the abandonment of mass immunization ‘criminally irresponsible’ and ‘most unfortunate, in that it will be seen by most people as irresponsible and poorly based’.’

Homoeopathic remedies may be safe, but do all homoeopaths merit this attribute?

This tiny and seemingly insignificant piece of research triggered debate and research (my group must have published well over 100 papers in the years that followed) that continue to the present day. The debate has spread to many other countries and now involves numerous forms of SCAM other than just homeopathy. It relates to many complex issues such as the competence of SCAM practitioners, their ethical standards, education, regulation, trustworthiness and the risk of neglect.

Looking back, it feels odd that, at least for me, all this started with such a humble investigation almost a quarter of a century ago. Looking towards the future, I predict that we have so far merely seen the tip of the iceberg. The investigation of the risks of SCAM has finally started in earnest and will, I am sure, continue thus leading to a better protection of patients and consumers from charlatans and their bogus claims.

In a previous post, I have tried to explain that someone could be an expert in certain aspects of homeopathy; for instance, one could be an expert:

  • in the history of homeopathy,
  • in the manufacture of homeopathics,
  • in the research of homeopathy.

But can anyone really be an expert in homeopathy in a more general sense?

Are homeopaths experts in homeopathy?

OF COURSE THEY ARE!!!

What is he talking about?, I hear homeopathy-fans exclaim.

Yet, I am not so sure.

Can one be an expert in something that is fundamentally flawed or wrong?

Can one be an expert in flying carpets?

Can one be an expert in quantum healing?

Can one be an expert in clod fusion?

Can one be an expert in astrology?

Can one be an expert in telekinetics?

Can one be an expert in tea-leaf reading?

I am not sure that classical homeopaths can rightfully called experts in classical homeopathy (there are so many forms of homeopathy that, for the purpose of this discussion, I need to focus on the classical Hahnemannian version).

An expert is a person who is very knowledgeable about or skilful in a particular area. An expert in any medical field (say neurology, gynaecology, nephrology or oncology) would need to have sound knowledge and practical skills in areas including:

  • organ-specific anatomy,
  • organ-specific physiology,
  • organ-specific pathophysiology,
  • nosology of the medical field,
  • disease-specific diagnostics,
  • disease-specific etiology,
  • disease-specific therapy,
  • etc.

None of the listed items apply to classical homeopathy. There are no homeopathic diseases, homeopathy is largely detached from knowledge in anatomy, physiology and pathophysiology, homeopathy disregards the current knowledge of etiology, homeopathy does not apply current criteria of diagnostics, homeopathy offers no rational mode of action for its interventions.

An expert in any medical field would need to:

  • deal with facts,
  • be able to show the effectiveness of his methods,
  • be part of an area that makes progress,
  • benefit from advances made elsewhere in medicine,
  • would associate with other disciplines,
  • understand the principles of evidence-based medicine,
  • etc.

None of these features apply to a classical homeopath. Homeopaths substitute facts for fantasy and wishful thinking, homeopaths cannot rely on sound evidence regarding the effectiveness of their therapy, classical homeopaths are not interested in progressing their field but religiously adhere to Hahnemann’s dogma, homeopaths do not benefit from the advances made in other areas of medicine, homeopaths pursue their sectarian activities in near-complete isolation, homeopaths make a mockery of evidence-based medicine.

Collectively, these considerations would seem to indicate that an expert in homeopathy is a contradiction in terms. Either you are an expert, or you are a homeopath. To be both seems an impossibility – or, to put it bluntly, an ‘expert’ in homeopathy is an adept in nonsense and a virtuoso in ignorance.

We have discussed the diagnostic methods used by practitioners of alternative medicine several times before (see for instance here, here, here, here, here and here). Now a new article has been published which sheds more light on this important issue.

The authors point out that the so-called alternative medicine (SCAM) community promote and sell a wide range of tests, many of which are of dubious clinical significance. Many have little or no clinical utility and have been widely discredited, whilst others are established tests that are used for unvalidated purposes.

  1. The paper mentions the 4 key factors for evaluation of diagnostic methods:
    Analytic validity of a test defines its ability to measure accurately and reliably the component of interest. Relevant parameters include analytical accuracy and precision, susceptibility to interferences and quality assurance.
  2. Clinical validity defines the ability to detect or predict the presence or absence of an accepted clinical disease or predisposition to such a disease. Relevant parameters include sensitivity, specificity, and an understanding of how these parameters change in different populations.
  3. Clinical utility refers to the likelihood that the test will lead to an improved outcome. What is the value of the information to the individual being tested and/or to the broader population?
  4. Ethical, legal and social implications (ELSI) of a test. Issues include how the test is promoted, how the reasons for testing are explained to the patient, the incidence of false-positive results and incorrect diagnoses, the potential for unnecessary treatment and the cost-effectiveness of testing.

The tests used by  SCAM-practitioners range from the highly complex, employing state of the art technology, e.g. heavy metal analysis using inductively coupled plasma-mass spectrometry, to the rudimentary, e.g. live blood cell analysis. Results of ‘SCAM tests’ are often accompanied by extensive clinical interpretations which may recommend, or be used to justify, unnecessary or harmful treatments. There are now a small number of laboratories across the globe that specialize in SCAM testing. Some SCAM laboratories operate completely outside of any accreditation programme whilst others are fully accredited to the standard of established clinical laboratories.

In their review, the authors explore SCAM testing in the United States, the United Kingdom and Australia with a focus on the common tests on offer, how they are reported, the evidence base for their clinical application and the regulations governing their use. They also review proposed changed to in-vitro diagnostic device regulations and how these might impact on SCAM testing.

The authors conclude hat the common factor in all these tests is the lack of evidence for clinical validity and utility as used in SCAM practice. This should not be surprising since this is true for SCAM practice in general. Once there is a sound evidence base for an intervention, such as a laboratory test, then it generally becomes incorporated into conventional medical practice.

The paper also discusses possible reasons why SCAM-tests are appealing:

  • Adding an element of science to the consultation. Patients know that conventional medicine relies heavily on laboratory diagnostics. If the SCAM practitioner orders laboratory tests, the patient may feel they are benefiting from a scientific approach.
  • Producing material diagnostic data to support a diagnosis. SCAM lab reports are well presented in a format that is attractive to patients adding legitimacy to a diagnosis. Tests are often ordered as large profiles of multiple analytes. It follows that this will increase the probability of getting results outside of a given reference interval purely by chance. ‘Abnormal’ results give the SCAM practitioner something to build a narrative around if clinical findings are unclear. This is particularly relevant for patients who have chronic conditions, such as CFS or fibromyalgia where a definitive cause has not been established and treatment options are limited.
  • Generating business opportunities using abnormal results. Some practitioners may use abnormal laboratory results to justify further testing, supplements or therapies that they can offer.
  • By offering tests that are not available through traditional healthcare services some SCAM practitioners may claim they are offering a unique specialist service that their doctor is unable to provide. This can be particularly appealing to patients with unexplained symptoms for which there are a limited range of evidenced-based investigations and treatments available.

Regulation of SCAM laboratory testing is clearly deficient, the authors of this paper conclude. Where SCAM testing is regulated at all, regulatory authorities primarily evaluate analytical validity of the tests a laboratory offers. Clinical validity and clinical utility are either not evaluated adequately or not evaluated at all and the ethical, legal and social implications of a test may only be considered on a reactive basis when consumers complain about how tests are advertised.

I have always thought that the issue of SCAM tests is hugely important; yet it remains much-neglected. A rubbish diagnosis is likely to result in a rubbish treatment. Unreliable diagnostic methods lead to false-positive and false-negative diagnoses. Both harm the patient. In 1995, I thus published a review that concluded with this warning “alternative” diagnostic methods may seriously threaten the safety and health of patients submitted to them. Orthodox doctors should be aware of the problem and inform their patients accordingly.

Sadly, my warning has so far had no effect whatsoever.

I hope this new paper is more successful.

Pertussis (whooping-cough) is a serious condition. Today, we have vaccinations and antibiotics against it and therefore it is rarely a fatal disease. A century or so, the situation was different. Then all sorts of quacks claimed to be able to treat pertussis and many patients, particularly children, died.

This article starts with this amazing introduction: Osteopathic physicians may want to consider using osteopathic manipulative treatment (OMT) as an adjunctive treatment modality for pertussis; however, suitable OMT techniques are not specified in the research literature.

For the paper, the author then searched the historical osteopathic literature to identify OMT techniques that were used in the management of pertussis in the pre-antibiotic era. The 24 identified sources included 8 articles and 16 book contributions from the years 1886 to 1958. Most sources were published within the first quarter of the 20th century. Commonly identified OMT techniques included mobilization techniques, lymphatic pump techniques, and other manipulative techniques predominantly in the cervical and thoracic regions.

The author concluded that the wealth of OMT techniques for patients with pertussis that were identified suggests that pertussis was commonly treated by early osteopaths. Further research is necessary to identify or establish the evidence base for these techniques so that in case of favorable outcomes, their use by osteopathic physicians is justified as adjunctive modalities when encountering a patient with pertussis.

I found it hard to decide whether to laugh or to cry after reading this. One could easily have a good giggle about the silliness of the idea to revive obsolete techniques for treating a potentially serious infection. One the other hand, I cannot help but ask myself:

  • Is there any suggestion at all that OMT was successful in treating pertussis?
  • If the answer is negative (and I fear it is), why would anyone spend considerable resources to establish the evidence base for these techniques?
  • Do osteopaths believe in progress at all?
  • Do they really think that there is even a remote chance that mobilization techniques, lymphatic pump techniques, and other manipulative techniques will, one day, come back as adjunctive therapies for pertussis?
  • Do they not believe in a rational approach to prioritising medical research such that scarce resources are spent ethically and wisely?

You may think that none of this really matters. The author of this paper is just a lone loon! That may well be so, but even lone loons can do a lot of harm, if they convince consumers of their bizarre ideas.

But surely, the profession of osteopathy would not tolerate this, you say. I am not convinced. The article was published in the Journal of the American Osteopathic Association. This seems significant to me. It is comparable to the JAMA or the BMJ publishing an article calling for a programme of research into the possible benefits of blood-letting as a treatment of pneumonia!

 

 

Robert Verkerk, Executive & scientific director, Alliance for Natural Health (ANH), seems to adore me (maybe that’s why I kept this post for Valentine’s Day?). In 2006, he published this article about me (it is lengthy, and I therefore shortened a bit, but feel free to study it in its full beauty):

START OF QUOTE

PROFESSOR EDZARD ERNST, the UK’s first professor of complementary medicine, gets lots of exposure for his often overtly negative views on complementary medicine. He’s become the media’s favourite resource for a view on this controversial subject…

The interesting thing about Prof Ernst is that he seems to have come a long way from his humble beginnings as a recipient of the therapies that he now seems so critical of. Profiled by Geoff Watts in the British Medical Journal, the Prof tells us: ‘Our family doctor in the little village outside Munich where I grew up was a homoeopath. My mother swore by it. As a kid I was treated homoeopathically. So this kind of medicine just came naturally. Even during my studies I pursued other things like massage therapy and acupuncture. As a young doctor I had an appointment in a homeopathic hospital, and I was very impressed with its success rate. My boss told me that much of this success came from discontinuing main stream medication. This made a big impression on me.’ (BMJ Career Focus 2003; 327:166; doi:10.1136/bmj.327.7425.s166)…

After his early support for homeopathy, Professor Ernst has now become, de facto, one of its main opponents. Robin McKie, science editor for The Observer (December 18, 2005) reported Ernst as saying, ‘Homeopathic remedies don’t work. Study after study has shown it is simply the purest form of placebo. You may as well take a glass of water than a homeopathic medicine.’ Ernst, having done the proverbial 180 degree turn, has decided to stand firmly shoulder to shoulder with a number of other leading assailants of non-pharmaceutical therapies, such as Professors Michael Baum and Jonathan Waxman. On 22 May 2006, Baum and twelve other mainly retired surgeons, including Ernst himself, bandied together and co-signed an open letter, published in The Times, which condemned the NHS decision to include increasing numbers of complementary therapies…

As high profile as the Ernsts, Baums and Waxmans of this world might be—their views are not unanimous across the orthodox medical profession. Some of these contrary views were expressed just last Sunday in The Sunday Times (Lost in the cancer maze, 10 December 2006)…

The real loser in open battles between warring factions in healthcare could be the consumer. Imagine how schizophrenic you could become after reading any one of the many newspapers that contains both pro-natural therapy articles and stinging attacks like that found in this week’s Daily Mail. But then again, we may misjudge the consumer who is well known for his or her ability to vote with the feet—regardless. The consumer, just like Robert Sandall, and the millions around the world who continue to indulge in complementary therapies, will ultimately make choices that work for them. ‘Survival of the fittest’ could provide an explanation for why hostile attacks from the orthodox medical community, the media and over-zealous regulators have not dented the steady increase in the popularity of alternative medicine.

Although we live in a technocratic age where we’ve handed so much decision making to the specialists, perhaps this is one area where the might of the individual will reign. Maybe the disillusionment many feel for pharmaceutically-biased healthcare is beginning to kick in. Perhaps the dictates from the white coats will be overruled by the ever-powerful survival instinct and our need to stay in touch with nature, from which we’ve evolved.

END OF QUOTE

Elsewhere, Robert Verkerk even called me the ‘master trickster of evidence-based medicine’ and stated that Prof Ernst and his colleagues appear to be evaluating the ‘wrong’ variable. As Ernst himself admitted, his team are focused on exploring only one of the variables, the ‘specific therapeutic effect’ (Figs 1 and 2). It is apparent, however, that the outcome that is of much greater consequence to healthcare is the combined effect of all variables, referred to by Ernst as the ‘total effect’ (Fig 1). Ernst does not appear to acknowledge that the sum of these effects might differ greatly between experimental and non-experimental situations.

Adding insult to injury, Ernst’s next major apparent faux pas involves his interpretation, or misinterpretation, of results. These fundamental problems exist within a very significant body of Prof Ernst’s work, particularly that which has been most widely publicised because it is so antagonistic towards healing cultures that have in many cases existed and evolved over thousands of years.

By example, a recent ‘systematic review’ of individualised herbal medicine undertaken by Ernst and colleagues started with 1345 peer-reviewed studies. However, all but three (0.2%) of the studies (RCTs) were rejected. These three RCTs in turn each involved very specific types of herbal treatment, targeting patients with IBS, knee osteoarthritis and cancer, the latter also undergoing chemotherapy, respectively. The conclusions of the study, which fuelled negative media worldwide, disconcertingly extended well beyond the remit of the study or its results. An extract follows: “Individualised herbal medicine, as practised in European medical herbalism, Chinese herbal medicine and Ayurvedic herbal medicine, has a very sparse evidence base and there is no convincing evidence that it is effective in any [our emphasis] indication. Because of the high potential for adverse events and negative herb-herb and herb-drug interactions, this lack of evidence for effectiveness means that its use cannot be recommended (Postgrad Med J 2007; 83: 633-637).

Robert Verkerk has recently come to my attention again – as the main author of a lengthy report published in December 2018. Its ‘Executive Summary’ makes the following points relevant in the context of this blog (the numbers in his text were added by me and refer to my comments below):

  • This position paper proposes a universal framework, based on ecological and sustainability principles, aimed at allowing qualified health professionals (1), regardless of their respective modalities (disciplines), to work collaboratively and with full participation of the public in efforts to maintain or regenerate health and wellbeing. Accordingly, rather than offering ‘fixes’ for the NHS, the paper offers an approach that may significantly reduce the NHS’s current and growing disease burden that is set to reach crisis point given current levels of demand and funding.
  • A major factor driving the relentlessly rising costs of the NHS is its over-reliance on pharmaceuticals (2) to treat a variety of preventable, chronic disorders. These (3) are the result — not of infection or trauma — but rather of our 21st century lifestyles, to which the human body is not well adapted. The failure of pharmaceutically-based approaches to slow down, let alone reverse, the dual burden of obesity and type 2 diabetes means wider roll-out of effective multi-factorial approaches are desperately needed (4).
  • The NHS was created at a time when infectious diseases were the biggest killers (5). This is no longer the case, which is why the NHS must become part of a wider system that facilitates health regeneration or maintenance. The paper describes the major mechanisms underlying these chronic metabolic diseases, which are claiming an increasingly large portion of NHS funding. It identifies 12 domains of human health, many of which are routinely thrown out of balance by our contemporary lifestyles. The most effective way of treating lifestyle disorders is with appropriate lifestyle changes that are tailored to individuals, their needs and their circumstances. Such approaches, if appropriately supported and guided, tend to be far more economical and more sustainable as a means of maintaining or restoring people’s health (6).
  • A sustainable health system, as proposed in this position paper, is one in which the individual becomes much more responsible for maintaining his or her own health and where more effort is invested earlier in an individual’s life prior to the downstream manifestation of chronic, degenerative and preventable diseases (7). Substantially more education, support and guidance than is typically available in the NHS today will need to be provided by health professionals (1), informed as necessary by a range of markers and diagnostic techniques (8). Healthy dietary and lifestyle choices and behaviours (9) are most effective when imparted early, prior to symptoms of chronic diseases becoming evident and before additional diseases or disorders (comorbidities) have become deeply embedded.
  • The timing of the position paper’s release coincides not only with a time when the NHS is in crisis, but also when the UK is deep in negotiations over its extraction from the European Union (EU). The paper includes the identification of EU laws that are incompatible with sustainable health systems, that the UK would do well to reject when the time comes to re-consider the British statute books following the implementation of the Great Repeal Bill (10).
  • This paper represents the first comprehensive attempt to apply sustainability principles to the management of human health in the context of our current understanding of human biology and ecology, tailored specifically to the UK’s unique situation. It embodies approaches that work with, rather than against, nature (11). Sustainability principles have already been applied successfully to other sectors such as energy, construction and agriculture.
  • It is now imperative that the diverse range of interests and specialisms (12) involved in the management of human health come together. We owe it to future generations to work together urgently, earnestly and cooperatively to develop and thoroughly evaluate new ways of managing and creating health in our society. This blueprint represents a collaborative effort to give this process much needed momentum.

My very short comments:

  1. I fear that this is meant to include SCAM-practitioners who are neither qualified nor skilled to tackle such tasks.
  2. Dietary supplements (heavily promoted by the ANH) either have pharmacological effects, in which case they too must be seen as pharmaceuticals, or they are useless, in which case we should not promote them.
  3. I think ‘some of these’ would be more correct.
  4. Multifactorial yes, but we must make sure that useless SCAMs are not being pushed in through the back-door. Quackery must not be allowed to become a ‘factor’.
  5. Only, if we discount cancer and arteriosclerosis, I think.
  6. SCAM-practitioners have repeatedly demonstrated to be a risk to public health.
  7. All we know about disease prevention originates from conventional medicine and nothing from SCAM.
  8. Informed by…??? I would prefer ‘based on evidence’ (evidence being one term that the report does not seem to be fond of).
  9. All healthy dietary and lifestyle choices and behaviours that are backed by good evidence originate from and are part of conventional medicine, not SCAM.
  10. Do I detect the nasty whiff a pro-Brexit attitude her? I wonder what the ANH hopes for in a post-Brexit UK.
  11. The old chestnut of conventional medicine = unnatural and SCAM = natural is being warmed up here, it seems to me. Fallacy galore!
  12. The ANH would probably like to include a few SCAM-practitioners here.

Call me suspicious, but to me this ANH-initiative seems like a clever smoke-screen behind which they hope to sell their useless dietary supplements and homeopathic remedies to the unsuspecting British public. Am I mistaken?

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