MD, PhD, FMedSci, FSB, FRCP, FRCPEd

medical ethics

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In the past, I have been involved in several court cases where patients had complained about mistreatment by charlatans. Similarly I have acted as an expert witness for the General Medical Council in similar circumstances.

So, it is true, quacks are sometimes being held to account by their victims. But, generally speaking, patients seem to complain very rarely when they fall in the hands of even the most incompetent of quacks.

Here is one telling reminder showing how long it can take until a complaint is finally filed.

Dr Julian Kenyon is, according to his websitean integrated medicine physician and Medical Director of the Dove Clinic for Integrated Medicine, Winchester and London. Dr Julian Kenyon is Founder-Chairman of the British Medical Acupuncture Society in 1980 and Co-Founder of the Centre for the Study of Complementary Medicine in Southampton and London where he worked for many years before starting The Dove Clinic in 2000. He is also Founder/President of the British Society for Integrated Medicine and is an established authority in the field of complementary treatment approaches for a wide range of medical conditions. He has written approximately 20 books and has had many academic papers published in peer review journals* and has several patents to his name. He graduated from the University of Liverpool with a Bachelor of Medicine and Surgery and subsequently with a research degree, Doctor of Medicine. In 1972, he was appointed a Primary Fellow of the Royal College of Surgeons, Edinburgh.

*[I found only 4 on Medline]

Kenyon has been on sceptics’ radar for a very long time. For instance, he is one of the few UK doctors who use ‘LIVE BLOOD ANALYSIS’, a bogus diagnostic method that can harm patients through false-negative or false-positive diagnoses. A 2003 undercover investigation for BBC 1 South’s ‘Inside Out’ accused Dr Julian Kenyon of using yet another spurious diagnostic test at his clinic near Winchester. Kenyon has, for many years, been working together with George Lewith, another of the country’s ‘leading’ complementary doctors. In 1994, the two published an article about their co-operation; here is its abstract:

This paper outlines the main research effort that has taken place within the Centre for the Study of Complementary Medicine over the last 10 years. It demonstrates the Centre’s expertise and interest in a whole variety of areas, including the social implications and development of complementary medicine, clinical trial methodology, the evaluation of complementary medical machinery, the effects of electromagnetic fields on health and the investigation of the subtle energetic processes involved in complementary medicine. Our future plans are outlined.

Lewith and Kenyon have been using a technique called electrodermal testing for more than 20 years. Considering the fact that the two doctors authored a BMJ paper which concluded that electrodermal machines couldn’t detect environmental allergies, this seems more than a little surprising.

Using secret filming, ‘Inside Out’ showed Dr Kenyon testing a six-year-old boy and then deciding that he is sensitive to dust mites. Later, Dr Kenyon insists that he made his diagnosis purely on the boy’s symptoms and that he didn’t use the machine to test for dust mites. The BBC then took the boy for a conventional skin prick test, which suggested he didn’t have any allergies at all. But Dr Kenyon then says the conventional test may not be accurate: “He may be one of the 10% who actually are negative to the skin tests but benefit from measures to reduce dust mite exposure.”

Despite this very public disclosure, Kenyon was able to practice unrestrictedly for many years.

In December 2014, it was reported in the Hampshire Chronicle that Dr Kenyon eventually did, after a complaint from a patient, end up in front of the General Medical Council’s conduct tribunal. The panel heard that, after a 20-minute consultation, which cost £300, Dr Kenyon told one terminally-ill man with late-stage cancer: “I am not claiming we can cure you, but there is a strong possibility that we would be able to increase your median survival time with the relatively low-risk approaches described here.” He also made bold statements about the treatment’s supposed benefits to an undercover reporter who posed as the husband of a woman with breast cancer.

After considering the full details of the case, Ben Fitzgerald, for the General Medical Council, had called for Dr Kenyon to be suspended, but the panel’s chairman Dr Surendra Kumar said Dr Kenyon’s misconduct was not serious enough to warrant a ban. The panel eventually imposed restrictions on Kenyon’s licence lasting for 12 months.

I estimate that patients are exposed to quackery from doctors and alternative practitioners thousands of times every day. Why then, I ask myself, do so few of them complain? Here are some of the possible answers to this important question:

  • They do not dare to.
  • They feel embarrassed.
  • They don’t know how to.
  • They cannot be bothered and fear the agro.
  • They fail to identify quackery and fall for the nonsense they are being told.
  • They even might perceive benefit from treatments which, in fact, are pure quackery.

Whatever the reasons, I think it is regrettable that not far more quacks are held to account – regardless of whether the charlatan in question as studied medicine or not. If you disagree, consider this: not filing a complaint means that many more patients will be put at risk.

A recent article in the BMJ about my new book seems to have upset fellow researchers of alternative medicine. I am told that the offending passage is the following:

“Too much research on complementary therapies is done by people who have already made up their minds,” the first UK professor of complementary medicine has said. Edzard Ernst, who left his chair at Exeter University early after clashing with the Prince of Wales, told journalists at the Science Media Centre in London that, although more research into alternative medicines was now taking place, “none of the centres is anywhere near critical enough.”

Following this publication, I received indignant inquiries from colleagues asking whether I meant to say that their work lacks critical thinking. As this is a valid question, I will try to answer it the best I presently can.

Any critical evaluation of alternative medicine has to yield its fair share of negative conclusions about the value of alternative medicine. If it fails to do that, one would need to assume that most or all alternative therapies generate more good than harm – and very few experts (who are not proponents of alternative medicine) would assume that this can possibly be the case.

Put differently, this means that a researcher or a research group that does not generate its fair share of negative conclusions is suspect of lacking a critical attitude. In a previous post, I have addressed this issue in more detail by creating an ‘index': THE TRUSTWORTHINESS INDEX. I have also provided a concrete example of a researcher who seems to be associated with a remarkably high index (the higher the index, the more suspicion of critical attitude).

Instead of unnecessarily upsetting my fellow researchers of alternative medicine any further, I will just issue this challenge: if any research group can demonstrate to have an index below 0.5 (which would mean the team has published twice as many negative conclusions as positive ones), I will gladly and publicly retract my suspicion that this group is “anywhere near critical enough”.

Homeopathy has many critics who claim that there is no good evidence for this type of therapy. Homeopaths invariably find this most unfair and point to a plethora of studies that show an effect. They are, of course, correct! There are plenty of trials that suggest that homeopathic remedies do work. The question, however, is HOW RELIABLE ARE THESE STUDIES?

Here is a brand new one which might stand for dozens of others.

In this study, homeopaths treated 50 multimorbid patients with homeopathic remedies identifies by a method called ‘polarity analysis’ (PA) and prospectively followed them over one year (PA enables homeopaths to calculate a relative healing probability, based on Boenninghausen’s grading of polar symptoms).

The 43 patients (86%) who completed the observation period experienced an average improvement of 91% in their initial symptoms. Six patients dropped out, and one did not achieve an improvement of 80%, and was therefore also counted as a treatment failure. The cost of homeopathic treatment was 41% of projected equivalent conventional treatment.

Good news then for enthusiasts of homeopathy? 91% improvement!

Yet, I am afraid that critics might not be bowled over. They might smell a whiff of selection bias, lament the lack of a control group or regret the absence of objective outcome measures. But I was prepared to go as far as stating that such results might be quite interesting… until I read the authors’ conclusions that is:

Polarity Analysis is an effective method for treating multimorbidity. The multitude of symptoms does not prevent the method from achieving good results. Homeopathy may be capable of taking over a considerable proportion of the treatment of multimorbid patients, at lower costs than conventional medicine.

Virtually nothing in these conclusions is based on the data provided. They are pure extrapolation and wild assumptions. Two questions seem to emerge from this:

  1. How on earth can we take this and so many other articles on homeopathy seriously?
  2. When does this sort of article cross the line between wishful thinking and scientific misconduct?

Guest post by Louise Lubetkin

(A SCIENTIST IN WONDERLAND: A MEMOIRE OF SEARCHING FOR TRUTH AND FINDING TROUBLE has now been published. An apt opportunity perhaps to post a letter and comment from the person who helped me GREATLY in finishing it.)

People write memoirs for a variety of reasons but perhaps one of the strongest impelling forces is the need to make sense of one’s own experiences. It is not surprising that you, who spent your entire professional career searching for explanations, identifying associations and parsing correlations, found yourself looking at your own life with the same analytical curiosity. Memoir is in many respects a natural choice in this regard.

That you chose to undertake a profoundly personal inventory at this juncture is also understandable in human terms. Retirement, whether anticipated and planned for, or (as in your case) thrust rudely upon you, reorders one’s sense of identity in ways that cannot fail to prompt reflection. It would have been surprising had you not felt an urge to look back and take stock, to trace the narrative arc of your life from its beginnings in post-war Germany all the way to the quiet house in rural Suffolk where you now sit, surrounded by the comfort of books and the accumulated paraphernalia of a life spent digging and delving in search of the building blocks of truth.

Given the contentious circumstances surrounding your departure from academic life, it is quite likely that you will be asked whether your decision to write a memoir was driven, at least in part, by a desire to settle scores. I think you can dismiss such a question unhesitatingly. You have no scores to settle: you came to England after a steady and unbroken ascent to the apex of your professional career, voluntarily leaving behind a position that most people would regard with envy and deference. You were never a supplicant at Exeter’s door; far from it. The fact that things went inexorably downhill over the course of your 20 years’ tenure there, and ended so deplorably, is not a reflection on you, your department, or the quality or quantity of work you turned out. Rather, it is a reflection on the very nature of the work you went there to do – and if there is any message in your memoir, it is this:

Alternative medicine is not, at its heart, a logical enterprise, and its adherents are not committed to – nor even interested in – a rational evaluation of their methods. Rather, alternative medicine is primarily an ideological position, a political credo, a reaction against mainstream medicine. To many of its adherents and impassioned advocates, its appeal lies not in any demonstrable therapeutic efficacy but in its perceived outsider status as the countercultural medicine, the medicine for Everyman, the David to the bullying medical-pharmaceutical Goliath. That your research work would elicit howls of protest was perhaps inevitable, given the threat it posed to the profitable and powerful alternative medicine industry. But it didn’t stop there: astonishingly, your work drew the ire of none less than the meddlesome heir apparent to the British throne. Prince Charles’ attempts to stymie your work call to mind the twelfth century martyr Thomas à Becket, of whom Henry II reputedly cried: “Oh, who will rid me of this turbulent priest?” (Henry’s sycophantic henchmen were quick to oblige, dispatching the hapless cleric on the steps of Canterbury cathedral.)

It’s clear that you were acutely aware, as a young man growing up in Germany, that science was not immune to the corrupting influence of political ideology, and that the German medical profession had entered – enthusiastically – into a Faustian compact with the Nazi regime. You have exhibited a courageous insistence on confronting and examining a national past that has at times felt like an intensely personal burden to you. It is ironic that in going to sleepy Exeter in an earnest, conscious attempt to shake off the constricting, intrigue-ridden atmosphere of academic Vienna, you ultimately found yourself once again mired in a struggle against the influence of ideology and the manipulation of science for political ends.

You went to Exeter strictly as a scientist, a skilled inquirer, a methodical investigator, expecting to be able to bring the rigors of logic and the scientific method to bear on an area of medical practice that had until then not been subjected to any kind of systematic evaluation. Instead, you were caught in a maelstrom of intrigue far worse than that which you had gratefully left behind in Vienna, buffeted and bruised by forces against which a lesser man would surely not have had the fortitude to push back so long and so hard.

Guest post by Nick Ross

If you’re a fan of Edzard Ernst – and who with a rational mind would not be – then you will be a fan of HealthWatch.

Edzard is a distinguished supporter. Do join us. I can’t promise much in return except that you will be part of a small and noble organisation that campaigns for treatments that work – in other words for evidence based medicine. Oh, and you get a regular Newsletter, which is actually rather good.

HealthWatch was inspired 25 years ago by Professor Michael Baum, the breast cancer surgeon who was incandescent that so many women presented to his clinic late, doomed and with suppurating sores, because they had been persuaded to try ‘alternative treatment’ rather than the real thing.

But like Edzard (and indeed like Michael Baum), HealthWatch keeps an open mind. If there are reliable data to show that an apparently weirdo treatment works, hallelujah. If there is evidence that an orthodox one doesn’t then it deserves a raspberry. HealthWatch has worked to expose quacks and swindlers and to get the Advertising Standards Authority to do its job regulating against false claims and flimflam. It has fought the NHS to have women given fair and balanced advice about the perils of mass screening. It has campaigned with Sense About Science, English Pen and Index to protect whistleblowing scientists from vexatious libel laws, and it has joined the AllTrials battle for transparency in drug trials. It has an annual competition for medical and nursing students to encourage critical analysis of clinical research protocols, and it stages the annual HealthWatch Award and Lecture which has featured Edzard (in 2005) and a galaxy of other champions of scepticism and good evidence including Sir Iain Chalmers, Richard Smith, David Colquhoun, Tim Harford, John Diamond, Richard Doll, Peter Wilmshurst, Ray Tallis, Ben Goldacre, Fiona Godlee and, last year, Simon Singh. We are shortly to sponsor a national debate on Lord Saatchi’s controversial Medical innovation Bill.

But we need new blood. Do please check us out. Be careful, because since we first registered our name a host of brazen copycats have emerged, not least Her Majesty’s Government with ‘Healthwatch England’ which is part of the Care Quality Commission. We have had to put ‘uk’ at the end of our web address to retain our identity. So take the link to http://www.healthwatch-uk.org/, or better still take out a (very modestly priced) subscription.

As Edmund Burke might well have said, all it takes for quackery to flourish is that good men and women do nothing.

I would have never thought that someone would be able to identify the author of the text I quoted in the previous post:

It is known that not just novel therapies but also traditional ones, such as homeopathy, suffer opposition and rejection by some doctors without having ever been subjected to serious tests. The doctor is in charge of medical treatment; he is thus responsible foremost for making sure all knowledge and all methods are employed for the benefit of public health…I ask the medical profession to consider even previously excluded therapies with an open mind. It is necessary that an unbiased evaluation takes place, not just of the theories but also of the clinical effectiveness of alternative medicine.

More often than once has science, when it relied on theory alone, arrived at verdicts which later had to be overturned – frequently this occurred only after long periods of time, after progress had been hindered and most acclaimed pioneers had suffered serious injustice. I do not need to remind you of the doctor who, more than 100 years ago, in fighting puerperal fever, discovered sepsis and asepsis but was laughed at and ousted by his colleagues throughout his lifetime. Yet nobody would today deny that this knowledge is most relevant to medicine and that it belongs to the basis of medicine. Insightful doctors, some of whom famous, have, during the recent years, spoken openly about the crisis in medicine and the dead end that health care has maneuvered itself into. It seems obvious that the solution is going in directions which embrace nature. Hardly any other form of science is so tightly bound to nature as is the science occupied with healing living creatures. The demand for holism is getting stronger and stronger, a general demand which has already been fruitful on the political level. For medicine, the challenge is to treat more than previously by influencing the whole organism when we aim to heal a diseased organ.

It is from the opening speech by Rudolf Hess on the occasion of the WORLD CONFERENCE ON HOMEOPATHY 1937, in Berlin. Hess, at the time Hitler’s deputy, was not the only Nazi-leader. I knew of the opening speech because, a few years ago, DER SPIEGEL published a theme issue on homeopathy, and they published a photo of the opening ceremony of this meeting. It shows many men in SS-uniform and, in the first row of the auditorium, we see Hess (as well as Himmler) ready to spring into action.

Hess in particular was besotted with alternative medicine which the Nazis elected to call NEUE DEUTSCHE HEILKUNDE. Somewhat to the dismay of today’s alternative medicine enthusiasts, I have repeatedly published on this aspect of alternative medicine’s past, and it also is an important part of my new book A SCIENTIST IN WONDERLAND which the lucky winner (my congratulations!) of my little competition to identify the author has won. The abstract of an 2001 article explains this history succinctly:

The aim of this article is to discuss complementary/alternative medicine (CAM) in the Third Reich. Based on a general movement towards 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 where roughly as many lay practitioners of CAM existed in Germany as doctors. To re-unify German medicine under the banner of ‘Neue Deutsche Heilkunde’, the Nazi officials created the ‘Heilpraktiker’ – a profession which was meant to become extinct within one generation. The ‘flag ship’ of the ‘Neue Deutsche Heilkunde’ was the ‘Rudolf Hess Krankenhaus’ in Dresden. It represented a full integration of CAM and orthodox medicine. An example of systematic research into CAM is the Nazi government’s project to validate homoeopathy. Even though the data are now lost, the results of this research seem to have been negative. Even though there are some striking similarities between today’s CAM and yesterday’s ‘Neue Deutsche Heilkunde’ there are important differences. Most importantly, perhaps, today’s CAM is concerned with the welfare of the individual, whereas the ‘Neue Deutsche Heilkunde’ was aimed at ensuring the dominance of the Aryan race.

One fascinating aspect of this past is the fact that the NEUE DEUTSCHE HEILKUNDE was de facto the invention of what we today call ‘integrated medicine’. Then it was more like a ‘shot-gun marriage’, while today it seems to be driven more by political correctness and sloppy thinking. It did not work 70 years ago for the same reason that it will fail today: the integration of bogus (non-evidence based) treatments into conventional medicine must inevitably render health care not better but worse!

One does not need to be a rocket scientist to understand that, and Hess as well as other proponents of alternative medicine of his time had certainly got the idea. So they initiated the largest ever series of scientific tests of homeopathy. This research program was not just left to the homeopaths, who never had a reputation of being either rigorous or unbiased, but some of the best scientists of the era were recruited for it. The results vanished in the hands of the homeopaths during the turmoil of the war. But one eye-witness report of a homeopaths, Fritz Donner, makes it very clear: as it turned out, there was not a jot of evidence in favour of homeopathy.

And this, I think, is the other fascinating aspect of the story: homeopaths did not give up their plight to popularise homeopathy. On the contrary, they re-doubled their efforts to fool us all and to convince us with dodgy results (see recent posts on this blog) that homeopathy somehow does defy the laws of nature and is, in effect, very effective for all sorts of diseases.

My readers suggested all sorts of potential authors for the Hess speech; and they are right! It could have been written by any proponent of alternative medicine. This fact is amusing and depressing at the same time. Amusing because it discloses the lack of new ideas and arguments (even the same fallacies are being used). Depressing because it suggests that progress in alternative medicine is almost totally absent.

I know, it’s not really original to come up with the 10000th article on “10 things…” – but you will have to forgive me, I read so many of these articles over the holiday period that I can’t help but jump on the already over-crowded bandwagon and compose yet another one.

So, here are 10 things which could, if implemented, bring considerable improvement in 2015 to my field of inquiry, alternative medicine.

  1. Consumers need to get better at acting as bull shit (BS) detectors. Let’s face it, much of what we read or hear about this subject is utter BS. Yet consumers frequently lap up even the worst drivel like it were some source of deep wisdom. They could save themselves so much money, if they learnt to be just a little bit more critical.
  2. Dr Oz should focus on being a heart surgeon. His TV show has been demonstrated far too often to be promoting dangerous quackery. Yet as a heart surgeon, he actually might do some good.
  3. Journalists ought to remember that they have a job that extends well beyond their ambition to sell copy. They have a responsibility to inform the public truthfully and responsibly.
  4. Book publishers should abstain from churning out book after book that does little else but mislead the public about alternative medicine in a way that all to often is dangerous to the readers’ health. The world does not need the 1000th book repeating nonsense on detox, wellness etc.!
  5. Alternative practitioners must realise that claiming that therapy x cures condition y is not just slightly over-optimistic (or based on ‘years of experience’); if the claim is not based on sound evidence, it is what most people would call an outright lie.
  6. Proponents of alternative medicine should learn that it is neither fair nor productive to fiercely attack everyone personally who disagrees with their enthusiasm for this or that form of alternative medicine. In fact, it merely highlights the acute lack of rational arguments.
  7. Researchers of alternative medicine have to remember how important it is to think critically – an uncritical scientist is at best a contradiction in terms and at worst a pseudo-scientist who is likely to cause harm.
  8. Authorities should amass the courage, the political power and the financial means of going after those charlatans who ruthlessly exploit the public by making a fast and easy buck on the gullibility of consumers. Only if there is the likelihood of hefty fines will we see a meaningful decrease in the current epidemic of alternative health fraud.
  9. Politicians should realise that alternative medicine is not just a trivial subject with which one might win votes, if one issues platitudes to please the majority; alternative medicine is used by so many people that it has become an important public health issue.
  10. Prince Charles need to learn how to control himself and abstain from meddling in health politics by using every conceivable occasion to promote what he thinks is ‘integrated medicine’ but which, in fact, can easily be disclosed to be quackery.

As you see, my list almost instantly turned into a wish-list, and the big questions that follow from it are:

  1. How could we increase the likelihood of these wishes to come true?
  2. And would there be anything left of alternative medicine, if all of these wishes miraculously became true in 2015?

I do not pretend to have the answers, but I do feel strongly that a healthy dose of critical thinking in all levels of education – from kindergartens to schools, from colleges to universities etc. – would be a good and necessary starting point.

I know, my list is not just a wish list, it also is a wishful thinking list. It would be hopelessly naïve to assume that major advances will be made in 2015. I am realistic, sometimes even quite pessimistic, about progress in alternative medicine. But this does not mean that I or anyone else should just give up. 2015 will be a year where at least one thing is certain: you will see me continuing me my fight for reason, critical analysis, rational debate and good evidence – and that’s a promise!

Complementary treatments have become a popular (and ‘political correct’) option to keep desperate cancer patients happy. But how widely accepted is their use in oncology units? A brand-new article tried to find the answer to this question.

The principal aim of this survey was to map centres across Europe prioritizing those that provide public health services and operating within the national health system in integrative oncology (IO). A cross-sectional descriptive survey design was used to collect data. A questionnaire was elaborated concerning integrative oncology therapies to be administered to all the national health system oncology centres or hospitals in each European country. These institutes were identified by convenience sampling, searching on oncology websites and forums. The official websites of these structures were analysed to obtain more information about their activities and contacts.

Information was received from 123 (52.1 %) out of the 236 centres contacted until 31 December 2013. Forty-seven out of 99 responding centres meeting inclusion criteria (47.5 %) provided integrative oncology treatments, 24 from Italy and 23 from other European countries. The number of patients seen per year was on average 301.2 ± 337. Among the centres providing these kinds of therapies, 33 (70.2 %) use fixed protocols and 35 (74.5 %) use systems for the evaluation of results. Thirty-two centres (68.1 %) had research in progress or carried out until the deadline of the survey. The complementary and alternative medicines (CAMs) more frequently provided to cancer patients were acupuncture 26 (55.3 %), homeopathy 19 (40.4 %), herbal medicine 18 (38.3 %) and traditional Chinese medicine 17 (36.2 %); anthroposophic medicine 10 (21.3 %); homotoxicology 6 (12.8 %); and other therapies 30 (63.8 %). Treatments are mainly directed to reduce adverse reactions to chemo-radiotherapy (23.9 %), in particular nausea and vomiting (13.4 %) and leucopenia (5 %). The CAMs were also used to reduce pain and fatigue (10.9 %), to reduce side effects of iatrogenic menopause (8.8 %) and to improve anxiety and depression (5.9 %), gastrointestinal disorders (5 %), sleep disturbances and neuropathy (3.8 %).

As so often with surveys of this nature, the high non-response rate creates a problem: it is not unreasonable to assume that those centres that responded had an interest in IO, while those that failed to respond tended to have none. Thus the figures reported here for the usage of alternative therapies might be far higher than they actually are. One can only hope that this is the case. The idea that 40% of all cancer patients receive homeopathy, for instance, is hardly one that is in accordance with the principles of evidence-based practice.

The list of medical reasons for using largely unproven treatments is interesting, I think. I am not aware of lots of strong evidence to show that any of the treatments in question would generate more good than harm for any of the conditions in question.

What follows from all of this is worrying, in my view: thousands of desperate cancer patients are being duped into having bogus treatments paid for by their national health system. This, I think, begs the question whether these most vulnerable patients do not deserve better.

This investigation was aimed at examining the messages utilised by the chiropractic profession around issues of scope and efficacy through website communication with the public. For this purpose, the authors submitted the website content of 11 major Canadian chiropractic associations and colleges, and of 80 commercial clinics to a mixed-methods analysis. Content was reviewed to quantify specific health conditions described as treatable by chiropractic care. A qualitative textual analysis identified the primary messages related to evidence and efficacy utilised by the websites.

The results show that chiropractic was claimed to be capable of addressing a wide range of health issues. Quantitative analysis revealed that association and college websites identified a total of 41 unique conditions treatable by chiropractic, while private clinic websites named 159 distinct conditions. The most commonly cited conditions included back pain, headaches/migraines and neck pain. Qualitative analysis revealed three prominent themes drawn upon in discussions of efficacy and evidence: grounded in science, the conflation of safety and efficacy and “natural” healing.

The authors concluded that the chiropractic profession claims the capacity to treat health conditions that exceed those more traditionally associated with chiropractic. Website content persistently declared that such claims are supported by research and scientific evidence, and at times blurred the lines between safety and efficacy. The chiropractic profession may be struggling to define themselves both within the paradigm of conventional science as well as an alternative paradigm that embraces natural approaches.

These findings strike me as being similar to the ones we published 4 years ago. At this stage, we had conducted a review of 200 chiropractor websites and 9 chiropractic associations’ World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States. The outcome measures were claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment: asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence).

We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain.

At the time, we concluded that the majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.

Comparing the two studies, what should we conclude? Of course, the new investigation was confined to Canada; we therefore cannot generalise its results to other countries. Nevertheless it provides a fascinating insight into the (lack of) development of chiropractic in this part of the world. My conclusion is that, at least in Canada, there is very little evidence that chiropractic is about to become an ethical and evidence-based profession.

Guest post by Jan Oude-Aost

ADHD is a common disorder among children. There are evidence based pharmacological treatments, the best known being methylphenidate (MPH). MPH has kind of a bad reputation, but is effective and reasonably safe. The market is also full of alternative treatments, pharmacological and others, some of them under investigation, some unproven and many disproven. So I was not surprised to find a study about Ginkgo biloba as a treatment for ADHD. I was surprised, however, to find this study in the German Journal of Child and Adolescent Psychiatry and Psychotherapy, officially published by the “German Society of Child and Adolescent Psychiatry and Psychotherapy“ (Deutsche Gesellschaft für Kinder- und Jugendpsychiatrie und Psychotherapie). The journal’s guidelines state that studies should provide new scientific results.

The study is called “Ginkgo biloba Extract EGb 761® in Children with ADHD“. EGb 761® is the key ingredient in “Tebonin®“, a herbal drug made by “Dr. Wilma Schwabe GmbH“. The abstract states:

One possible treatment, at least for cognitive problems, might be the administration of Ginkgo biloba, though evidence is rare.This study tests the clinical efficacy of a Ginkgo biloba special extract (EGb 761®) (…) in children with ADHD (…).

Eine erfolgversprechende, bislang kaum untersuchte Möglichkeit zur Behandlung kognitiver Aspekte ist die Gabe von Ginkgo biloba. Ziel der vorliegenden Studie war die Prüfung klinischer Wirksamkeit (…) von Ginkgo biloba-Extrakt Egb 761® bei Kindern mit ADHS.“ (Taken from the English and German abstracts.)

The study sample (20!) was recruited among children who “did not tolerate or were unwilling“ to take MPH. The unwilling part struck me as problematic. There is likely a strong selection bias towards parents who are unwilling to give their children MPH. I guess it is not the children who are unwilling to take MPH, but the parents who are unwilling to administer it. At least some of these parents might be biased against MPH and might already favor CAMmodalities.

The authors state three main problems with “herbal therapy“ that require more empirical evidence: First of all the question of adverse reactions, which they claim occur in about 1% of cases with “some CAMs“ (mind you, not “herbal therapy“). Secondly, the question of drug interactions and thirdly, the lack of information physicians have about the CAMs their patients use.

A large part of the study is based on results of an EEG-protocol, which I choose to ignore, because the clinical results are too weak to give the EEG findings any clinical relevance.

Before looking at the study itself, let’s look at what is known about Ginkgo biloba as a drug. Ginkgo is best known for its use in patients with dementia, cognitive impairment und tinnitus. A Cochrane review from 2009 concluded:

There is no convincing evidence that Ginkgo biloba is efficacious for dementia and cognitive impairment“ [1].

The authors of the current Study cite Sarris et al. (2011), a systematic review of complementary treatment of ADHD. Sarris et al. mention Salehi et al. (2010) who tested Ginkgo against MPH. MPH turned out to be much more effective than Ginkgo, but Sarris et al. argue that the duration of treatment (6 weeks) might have been too short to see the full effects of Ginkgo.

Given the above information it is unclear why Ginkgo is judged a “possible“ treatment, properly translated from German even “promising”, and why the authors state that Ginkgo has been “barely studied“.

In an unblinded, uncontrolled study with a sample likely to be biased toward the tested intervention, anything other than a positive result would be odd. In the treatment of autism there are several examples of implausible treatments that worked as long as parents knew that their children were getting the treatment, but didn’t after proper blinding (e.g. secretin).

This study’s aim was to test clinical efficacy, but the conclusion begins with how well tolerated Ginkgo was. The efficacy is mentioned subsequently: “Following administration, interrelated improvements on behavioral ratings of ADHD symptoms (…) were detected (…).“ But the way they where “detected“ is interesting. The authors used an established questionnaire (FBB-HKS) to let parents rate their children. Only the parents. The children and their teachers where not given the FBB-HKS-questionnaires, inspite of this being standard clinical practice (and inspite of giving children questionnaires to determine changes in quality of life, which were not found).

None of the three problems that the authors describe as important (adverse reactions, drug interactions, lack of information) can be answered by this study. I am no expert in statistics but it seems unlikely to me to meaningfully determine adverse effects in just 20 patients especially when adverse effects occur at a rate of 1%. The authors claim they found an incidence rate of 0,004% in “700 observation days“. Well, if they say so.

The authors conclude:

Taken together, the current study provides some preliminary evidence that Ginkgo biloba Egb 761® seems to be well tolerated in the short term and may be a clinically useful treatment for children with ADHD. Double-blind randomized trials are required to clarify the value of the presented data.

Given the available information mentioned earlier, one could have started with that conclusion and conducted a double blind RCT in the first place!

Clinical Significance

The trends of this preliminary open study may suggest that Ginkgo biloba Egb 761® might be considered as a complementary or alternative medicine for treating children with ADHD.“

So, why do I care? If preliminary evidence “may suggest“ that something “might be considered“ as a treatment? Because I think that this study does not answer any important questions or give us any new or useful knowledge. Following the journal’s guidelines, it should therefore not have been published. I also think it is an example of bad science. Bad not just because of the lack of critical thinking. It also adds to the misinformation about possible ADHD treatments spreading through the internet. The study was published in September. In November I found a website citing the study and calling it “clinical proof“ when it is not. But child psychiatrists will have to explain that to many parents, instead of talking about their children’s health.

I somehow got the impression that this study was more about marketing than about science. I wonder if Schwabe will help finance the necessary double-blind randomized trial…

[1] See more at: http://summaries.cochrane.org/CD003120/DEMENTIA_there-is-no-convincing-evidence-that-ginkgo-biloba-is-efficacious-for-dementia-and-cognitive-impairment#sthash.oqKFrSCC.dpuf

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