One of the questions I hear frequently is ‘HOW CAN I BE SURE THIS STUDY IS SOUND’? Even though I have spent much of my professional life on this issue, I am invariably struggling to provide an answer. Firstly, because a comprehensive reply must inevitably have the size of a book, perhaps even several books. And secondly, to most lay people, the reply would be intensely boring, I am afraid.
Yet many readers of this blog evidently search for some guidance – so, let me try to provide a few indicators – indicators, not more!!! – as to what might signify a good and a poor clinical trial (other types of research would need different criteria).
INDICATORS SUGGESTIVE OF A GOOD CLINICAL TRIAL
- Author from a respected institution.
- Article published in a respected journal.
- A clear research question.
- Full description of the methods used such that an independent researcher could repeat the study.
- Randomisation of study participants into experimental and control groups.
- Use of a placebo in the control group where possible.
- Blinding of patients.
- Blinding of investigators, including clinicians administering the treatments.
- Clear definition of a primary outcome measure.
- Sufficiently large sample size demonstrated with a power calculation.
- Adequate statistical analyses.
- Clear presentation of the data such that an independent assessor can check them.
- Understandable write-up of the entire study.
- A discussion that puts the study into the context of all the important previous work in this area.
- Self-critical analysis of the study design, conduct and interpretation of the results.
- Cautious conclusion which are strictly based on the data presented.
- Full disclosure of ethics approval and informed consent,
- Full disclosure of funding sources.
- Full disclosure of conflicts of interest.
- List of references is up-to-date and includes also studies that contradict the authors’ findings.
I told you this would be boring! Not only that, but each bullet point is far too short to make real sense, and any full explanation would be even more boring to a lay person, I am sure.
What might be a little more fun is to list features of a clinical trial that might signify a poor study. So, let’s try that.
WARNIG SIGNALS INDICATING A POOR CLINICAL TRIAL
- published in one of the many dodgy CAM journals (or in a book, blog or similar),
- single author,
- authors are known to be proponents of the treatment tested,
- author has previously published only positive studies of the therapy in question (or member of my ‘ALT MED HALL OF FAME’),
- lack of plausible rationale for the study,
- lack of plausible rationale for the therapy that is being tested,
- stated aim of the study is ‘to demonstrate the effectiveness of…’ (clinical trials are for testing, not demonstrating effectiveness or efficacy),
- stated aim ‘to establish the effectiveness AND SAFETY of…’ (even large trials are usually far too small for establishing the safety of an intervention),
- text full of mistakes, e. g. spelling, grammar, etc.
- sample size is tiny,
- pilot study reporting anything other than the feasibility of a definitive trial,
- methods not described in sufficient detail,
- mismatch between aim, method, and conclusions of the study,
- results presented only as a graph (rather than figures which others can re-calculate),
- statistical approach inadequate or not sufficiently detailed,
- discussion without critical input,
- lack of disclosures of ethics, funding or conflicts of interest,
- conclusions which are not based on the results.
The problem here (as above) is that one would need to write at least an entire chapter on each point to render it comprehensible. Without further detailed explanations, the issues raised remain rather abstract or nebulous. Another problem is that both of the above lists are, of course, far from complete; they are merely an expression of my own experience in assessing clinical trials.
Despite these caveats, I hope that those readers who are not complete novices to the critical evaluation of clinical trials might be able to use my ‘warning signals’ as a form of check list that helps them to tell the chaff from the wheat.
We all know that alternative medicine is currently popular, and much of the evidence suggested that this is mostly because mostly people in the midst of their lives are using it. This may be so, but it is about to change; it stands to reason that these ‘baby boomers’ are getting older, and therefore the typical user of alternative medicine is or will soon be an elderly person. In addition, the ‘oldies’ (I am one of them) are likely to be multi-morbid and therefore have more reason to try everything that is on offer.
Not convinced? But that is roughly is what this website seems to suggest:
START OF QUOTE
Geriatric population is more susceptible to chronic diseases such as heart problems, joint disorders and others. Therefore, this population group needs regular use of the medicines to prevent the disease conditions. The use of complementary and alternative medicines is increasing among the geriatric population globally due to the fact that CAMs decreases the risk of adverse reactions and drug interactions.
Complementary and alternative medicines include products such as dietary medicine and herbal medicine products. These medicines can be used for the management of both communicable (i.e. tuberculosis, hantavirus and others) and non communicable diseases (i.e. chronic kidney disease, cardiovascular and others) in geriatric population. These medicines (i.e. CAM) treat the patients by healing therapies which is not based on principles of conventional medicine.
Geographically, North America is considered as the largest market of geriatric complementary and alternative medicines owing to high use of CAMs in this region. For example, Health and Retirement Study conducted one survey which concluded that around 85% of the geriatric population in North America reported the use of complementary and alternative medicines. Thus, high use of CAM modalities will establish healthy platform to develop the growth of geriatric complementary and alternative medicines market.
Europe is the second largest market of geriatric complementary and alternative medicines. The growth is mainly attributed to the increasing aging population coupled with rising use of complementary and alternative medicines in Europe. According to European Commission (Eurostat) report published in 2013, around 17.8% of the European population were aged 65 years and above. The organization has also stated that aging population is expected to increase at high rate in coming year in Europe. In addition, Asia-Pacific is the emerging market for geriatric complementary and alternative medicines market because of rising interest of key companies to expand their presence in Asia Pacific.
Key companies operating in the market for geriatric complementary and alternative medicines include Geriatric & Medical Companies, Inc., Merck Sharp & Dohme Corporation. Geri-Care pharmaceuticals, UAS Laboratories.
END OF QUOTE
I know, this text includes several glaring errors. But the main claim that alternative medicine is fast becoming a thing for the elderly might well be true. This, of course, has implications for marketing, research, etc. For us on this blog it means that we need to find better ways to get through to people who are no spring chickens any longer.
The elderly have special needs and can be vulnerable in several ways. When they are ill, they need efficacious treatments. By and large, this excludes alternative therapies. The elderly may also be more susceptible to the risks of alternative medicine. Moreover, they are often not that affluent and might need to watch their expenses. Making them spend large amounts of cash on treatments that are ineffective is therefore a particularly unethical.
I think that messages like these might convince some elderly people to stop putting unreasonable hope in, and wasting their time/money on bogus therapies. But I am very keen to hear from my readers about further ideas how to curb the boom of alternative medicine in this age group.
At a recent conference in Montréal (October 2016), the WFC (World Federation of Chiropractic) and the ACC (Association of Chiropractic Colleges) reached a consensus on education. Consequently, recommendations were produced that offer 12 key ‘take away messages’. I take the liberty of reproducing these statements entitled ‘Training Tomorrow’s Spine Care Experts’ (the square brackets were inserted by me and refer to brief comments I made below).
START OF QUOTE
1. Chiropractic educational institutions have a responsibility to equip students with the skills and attributes necessary to become future spinal health care experts. This includes a commitment to astute diagnostic ability, a comprehensive knowledge of spine-related disorders , appreciation for the contributions of other health professionals and a commitment to collaborative, patient-centered and evidence-informed care .
2. Technological advances  provide an opportunity for the chiropractic profession to enhance, evolve and standardize core education and practice. This is relevant to the teaching of chiropractic skills, sharing of learning resources and assessment of performance. Emerging technologies that support the development of clinically-competent practitioners should be embedded within chiropractic programs.
3. The teaching and learning of specialized manual assessment and treatment skills should remain a key distinguishing element of chiropractic curricula.
4. Surveys of the public have a demonstrated a desire for consistency in the provision of chiropractic services. Such consistency need not compromise the identities of individual institutions but will cultivate public trust and cultural authority .
5. Globally consistent educational and practice standards will facilitate international portability  and promote greater health equity in the delivery of spine care.
6. Chiropractic programs should espouse innovation and leadership in the context of ethical , sustainable business  practices.
7. Chiropractic educational curricula should reflect current evidence  and high quality guidelines , and be subjected to regular review to ensure that students are prepared to work in collaborative health care environments.
8. The training of tomorrow’ s spine care experts should incorporate current best practices in education.
9. Interdisciplinary collaboration and strategic partnerships present opportunities to position chiropractors as leaders  and integral team players in global spine care.
10. Chiropractic educational institutions should champion the integration of evidence informed clinical practice , including clinical practice guidelines, in order to optimize patient outcomes. This will in turn foster principles of lifelong learning and willingness to adapt practice methods in the light of emerging evidence .
11. Students, faculty, staff and administrators must all contribute to a learning environment that fosters cultural diversity, critical thinking , academic responsibility and scholarly activity.
12. Resources should be dedicated to embed and promote educational research activity in all chiropractic institutions.
END OF QUOTE
And here are my brief comments: Some chiropractors believe that all or most human conditions are ‘spine-related disorders’. We would need a clear statement here whether the WFC/ACC do support or reject this notion and what conditions we are actually talking about.  ‘Evidence-informed’??? I have come across this term before; it is used more and more by quacks of all types. It is clearly not synonymous with ‘evidence-based’, but aims at providing a veneer of respectability by creation an association with EBM. In concrete terms, asthma, for instance, might, in the eyes of some chiropractors, be an evidence-informed indication for chiropractic. In other words, ‘evidence-informed’ is merely a card blanch for promoting all sorts of nonsense.  It would be good to know which technical advances they are thinking of.  Public trust is best cultivated by demonstrating that chiropractic is doing more good than harm; by itself, this point sounds a bit like PR for maximising income. Sorry, I am not sure what they mean by ‘cultural authority’ – chiropractic as a cult?  ‘International portability’ – nice term, but what does it mean?  I get the impression that many chiropractors do not know what is meant by the term ‘ethics’.  But they certainly know much about business!  That is, I think, the most relevant statement in the entire text – see below.  Like those by NICE which no longer recommend chiropractic for back pain? No? They are not ‘high quality’? I see, only those that recommend chiropractic fulfil this criterion!  Chiropractors as leaders? Really? With their (largely ineffective) manipulations as the main contribution to the field? You have to be a chiropractor to find this realistic, I guess.  Again ‘evidence-informed’ instead of ‘evidence-based’ – who are they trying to kid?  The evidence that has been emerging since many years is that chiropractic manipulations fail to generate more good than harm.  In the past, I got the impression that critical thinking and chiropractic are a bit like fire and water.
MY CONCLUSION FROM ALL THIS
What we have here is, in my view, little more than a mixture between politically correct drivel and wishful thinking. If chiropractors truly want chiropractic educational curricula to “reflect current evidence”, they need to teach the following main tenets:
- Chiropractic manipulations have not been shown to be effective for any of the conditions they are currently used for.
- Other forms of treatment are invariably preferable.
- Subluxation, as defined by chiropractors, is a myth.
- Spine-related disorders, as taught in many chiropractic colleges, are a myth.
- ‘Evidence-informed’ is a term that has no meaning; the proper word is ‘evidence-based’ – and evidence-based chiropractic is a contradiction in terms.
Finally, chiropractors need to be aware of the fact that any curriculum for future clinicians must include the core elements of critical assessment and medical ethics. The two combined would automatically discontinue the worst excesses of chiropractic abuse, such as the promotion of bogus claims or the financial exploitation of the public.
But, of course, none of this is ever going to happen! Why? Because it would mean teaching students that they need to find a different profession. And this is why I feel that statements like the above are politically correct drivel which can serve only one purpose: to distract everyone from the fundamental problems in that profession.
‘How to convince someone when facts fail’ – this is the title of a very good and ‘must read’ article by Michael Shermer recently published in SCIENTIFIC AMERICAN. The issue is clearly relevant to numerous discussions we have on this blog. Therefore, I will repeat Shermer’s conclusions here:
If corrective facts only make matters worse, what can we do to convince people of the error of their beliefs? From my experience,
1. keep emotions out of the exchange,
2. discuss, don’t attack (no ad hominem and no ad Hitlerum),
3. listen carefully and try to articulate the other position accurately,
4. show respect,
5. acknowledge that you understand why someone might hold that opinion, and
6. try to show how changing facts does not necessarily mean changing worldviews.
These strategies may not always work to change people’s minds, but now that the nation has just been put through a political fact-check wringer, they may help reduce unnecessary divisiveness.
Wise words and good strategies! But, as Shermer himself admits, they unfortunately don’t always work. This blog and the comments made by its readers provide ample examples of failures in this respect.
By and large, I try my very best to adhere to Shermer’s principles. Yet, I do not pretend that I always succeed brilliantly – on the contrary, far too often, I lose my rag. I am not particularly proud of it, but neither am I all that deeply ashamed.
The thing is that any attempt at a respectful and constructive dialogue requires the co-operation of both sides. If the opponent is continually disrespectful, offensive, dishonest, unable to grasp even the simplest concepts, etc., I often just stop the dialogue. If that does not prevent my opponent from being a belligerent nuisance, I have been known to get impatient or even rude. TO ALL WHO I OFFENDED IN 2016, I CAN ONLY SAY THIS: THERE PROBABLY WAS A GOOD REASON FOR MY BEHAVIOUR.
I know, this is not good enough, particularly as I should set an example for others. How can I expect all the commentators on this blog to be respectful and constructive, if I too loose my temper from time to time? The answer is I cannot (by the way, this is one reason why I have passed other people’s outbursts and ,so far, published them largely uncensored; as long as I cannot fully control myself, I must not censor others with the same predicament).
So, here is my resolution for 2017:
I will continue to be provocative (this is part of the ‘raison d’etre’ of this blog) but, at the same time, I will try harder to show respect, politeness and understanding. Crucially, I am herewith asking everyone to PLEASE do likewise. Failing this, I will start censoring those sections of the comments that I consider abusive; and [I almost forgot] I will ban those commentators who repeatedly need censoring.
Alternative medicine suffers from what might be called ‘survey overload’: there are far too much such investigations and most of them are of deplorably poor quality producing nothing of value except some promotion for alternative medicine. Yet, every now and then, one finds a paper that is worth reading, and I am happy to say that this survey (even though it has several methodological shortcomings) belongs in this category.
This cross-sectional assessment of the views of general practitioners towards chiropractors and osteopaths was funded by the Department of Chiropractic at Macquarie University. It was designed as a quantitative descriptive study using an anonymous online survey that included closed and open-ended questions with opportunities provided for free text. The target population was Australian general practitioners. Inclusion criteria included current medical registration, membership of the Royal Australian College of General Practitioners and currently practicing as a general practitioner in Australia. The data being reported here were collected between May and December, 2014.
There were 630 respondents to the online survey during this period representing a response rate of 2.6 %. Results were not uniform for the two professions. More general practitioners believed chiropractic education was not evidence-based compared to osteopathic education (70 % and 50 % respectively), while the scope of practice was viewed as similar for both professions. A majority of general practitioners had never referred a patient to either profession (chiropractic: 60 %; osteopathy: 66 %) and indicated that they would not want to co-manage patients with either profession. Approximately two-thirds of general practitioners were not interested in learning more about their education (chiropractors: 68 %; osteopaths: 63 %).
The authors concluded that this study provides an indication of the current views of Australian general practitioners towards chiropractors and osteopaths. The findings suggest that attitudes may have become less favourable with a growing intolerance towards both professions. If confirmed, this has the potential to impact health service provision. The results from this cross-sectional study suggest that obtaining representative general practitioner views using online surveys is difficult and another approach is needed to supplement or replace the current recruitment strategy.
The authors do not speculate on the reasons why the attitudes of general practitioners towards chiropractic and osteopathy might have become more critical. Therefore I decided to offer a few possibilities here. The more negative views could be due to:
- better education of general practitioners,
- tightening of healthcare budgets,
- recent ‘bad press’ and loss of reputation (for instance, the BCA’s libel action against Simon Singh),
- the work of sceptics in informing the public about the numerous bogus claims made by osteopaths and chiropractors,
- the plethora of overtly bogus claims which nevertheless continue to be made by these practitioners on a daily basis,
- a more general realisation that these therapies can cause very serious harm,
- a mixture of the above factors.
Whatever the reasons are, the finding that there now seems to be a growing scepticism (in Australia, but hopefully elsewhere as well) about the value of chiropractic and osteopathy is something that cheers me up no end.
Meniscus-injuries are common and there is no consensus as to how best treat them. Physiotherapists tend to advocate exercise, while surgeons tend to advise surgery.
Of course, exercise is not a typical alternative therapy but, as many alternative practitioners might disagree with this statement because they regularly recommend it to their patients, it makes sense to cover it on this blog. So, is exercise better than surgery for meniscus-problems?
The aim of this recent Norwegian study aimed to shed some light on this question. Specifically wanted to determine whether exercise therapy is superior to arthroscopic partial meniscectomy for knee function in patients with degenerative meniscal tears.
A total of 140 adults with degenerative medial meniscal tear verified by magnetic resonance imaging were randomised to either receiving 12 week supervised exercise therapy alone, or arthroscopic partial meniscectomy alone. Intention to treat analysis of between group difference in change in knee injury and osteoarthritis outcome score (KOOS4), defined a priori as the mean score for four of five KOOS subscale scores (pain, other symptoms, function in sport and recreation, and knee related quality of life) from baseline to two-year follow-up and change in thigh muscle strength from baseline to three months.
The results showed no clinically relevant difference between the two groups in change in KOOS4 at two years (0.9 points, 95% confidence interval −4.3 to 6.1; P=0.72). At three months, muscle strength had improved in the exercise group (P≤0.004). No serious adverse events occurred in either group during the two-year follow-up. 19% of the participants allocated to exercise therapy crossed over to surgery during the two-year follow-up, with no additional benefit.
The authors concluded that the observed difference in treatment effect was minute after two years of follow-up, and the trial’s inferential uncertainty was sufficiently small to exclude clinically relevant differences. Exercise therapy showed positive effects over surgery in improving thigh muscle strength, at least in the short-term. Our results should encourage clinicians and middle-aged patients with degenerative meniscal tear and no definitive radiographic evidence of osteoarthritis to consider supervised exercise therapy as a treatment option.
As I stated above, I mention this trial because exercise might be considered by some as an alternative therapy. The main reason for including it is, however, that it is in many ways an exemplary good study from which researchers in alternative medicine could learn.
Like so many alternative therapies, exercise is a treatment for which placebo-controlled studies are difficult, if not impossible. But that does not mean that rigorous tests of its value are impossible. The present study shows the way how it can be done.
Meaningful clinical research is no rocket science; it merely needs well-trained scientists who are willing to test the (rather than promote) their hypotheses. Sadly such individuals are as rare as gold dust in the realm of alternative medicine.
Price Charles celebrates his 68th birthday today. Time to update the tribute which I dedicated to him on this occasion three years ago. Charles is, of course, one of the world’s most outspoken and influential proponent of alternative medicine and a notorious attacker of science. This is why he has featured on this blog with some regularity. His love affair with all things alternative started early in his life.
As a youngster, Charles went on a journey of ‘spiritual discovery’ into the wilderness of northern Kenya. His guru and guide was Laurens van der Post (later discovered to be a fraud and compulsive fantasist and to have fathered a child with a 14-year old girl entrusted to him during a sea voyage). Van der Post wanted to awake Charles’ mind and attune it to the ideas of Carl Jung’s ‘collective unconscious’ which allegedly unites us all through a common vital force. It is this belief in vitalism that provides the crucial link to alternative medicine: virtually every form of the otherwise highly diverse range of alternative therapies is based on the assumption that some sort of vital force or energy exists. Charles was so taken by van der Post that, after his death, he established an annual lecture in his honour.
Throughout the 1980s, Charles lobbied for the statutory regulation of chiropractors and osteopaths in the UK. In 1993, it finally became reality.
Osteopathy has strong Royal links: Prince Charles is the President of the GOsC; Princess Diana was the President of the GCRO; and Princess Anne is the patron of the British School of Osteopathy (statement dated 2011).
In 1982, Prince Charles was elected as President of the British Medical Association (BMA) and promptly challenged the medical orthodoxy by advocating alternative medicine. In a speech at his inaugural dinner as President, the Prince lectured the medics: ‘Through the centuries healing has been practised by folk healers who are guided by traditional wisdom which sees illness as a disorder of the whole person, involving not only the patient’s body, but his mind, his self-image, his dependence on the physical and social environment, as well as his relation to the cosmos.’ The BMA-officials were impressed – so much so that they ordered a full report on alternative medicine which promptly condemned this area as nonsense.
In 1993, Charles founded his lobby group that ended up being called the ‘Foundation for Integrated Health’ (FIH). It was closed down in 2010 amidst allegations of money laundering and fraud. Its chief executive, George Gray, was later convicted and went to jail. The FIH had repeatedly been economical with the truth.
In 2000, Charles wrote an open letter to The Times stating that…It makes good sense to evaluate complementary and alternative therapies. For one thing, since an estimated £1.6 billion is spent each year on them, then we want value for our money. The very popularity of the non-conventional approaches suggests that people are either dissatisfied with their orthodox treatment, or they find genuine relief in such therapies. Whatever the case, if they are proved to work, they should be made more widely available on the NHS…But there remains the cry from the medical establishment of “where’s the proof?” — and clinical trials of the calibre that science demands cost money…The truth is that funding in the UK for research into complementary medicine is pitiful…So where can funding come from?…Figures from the department of complementary medicine at the University of Exeter show that less than 8p out of every £100 of NHS funds for medical research was spent on complementary medicine. In 1998-99 the Medical Research Council spent no money on it at all, and in 1999 only 0.05 per cent of the total research budget of UK medical charities went to this area…
In 2001, Charles worked on plans to help build a model hospital of integrated medicine. It was to train doctors to combine conventional medicine and alternative treatments, such as homeopathy, Ayurvedic medicine and acupuncture, and was to have have up to 100 beds. The prince’s intervention marked the culmination of years of campaigning by him for the NHS to assign a greater role to alternative medicine. Teresa Hale, founder of the Hale Clinic in London, said: “Twenty-five years ago people said we were quacks. Now several branches, including homeopathy, acupuncture and osteopathy, have gained official recognition.” The proposed hospital, which was due to open in London in 2003 or early 2004, was to be overseen by Mosaraf Ali, who runs the Integrated Medical Centre (IMC) in London. But the hospital never materialised. This might be due to Mosaraf Ali falling in disrepute: Raj Bathija, 69 and from India, went for a massage at the clinic of Dr Mosaraf Ali and his brother Imran in 2005 after suffering from two strokes. However, he claims that shortly after the treatment, his legs became pale and discoloured. Four days afterwards, Mr Bathija was admitted to hospital, where he had to have both legs amputated below the knee due to a shortage of blood. According to Mr Bathija, Dr Ali and his brother were negligent in that they failed to diagnose his condition and neglected to advise him to go to hospital. His daughter Shibani said: “My father was in a wheelchair but was making progress with his walking. He hoped he might become a bit more independent. With the amputations, that’s all gone.”
In 2002, the The Royal London Homeopathic Hospital (today called the Royal London Hospital for Integrated Medicine (RLHIM)) received £18.5 million of NHS funds to pay for an extensive refurbishment and restoration of the grand Victorian building. It seems likely that Royal protection facilitated this action.
In 2003, Prince Charles’ FIH launched a five-year plan which outlined how to improve access to alternative therapies.
In 2004, Charles publicly supported the Gerson diet as a treatment for cancer and Prof Baum, one of the UK’s most eminent oncologists, was invited to respond in an open letter to the British Medical Journal: …Over the past 20 years I have treated thousands of patients with cancer and lost some dear friends and relatives to this dreaded disease…The power of my authority comes with knowledge built on 40 years of study and 25 years of active involvement in cancer research. Your power and authority rest on an accident of birth. I don’t begrudge you that authority but I do beg you to exercise your power with extreme caution when advising patients with life-threatening diseases to embrace unproven therapies.
In 2005, the ‘Smallwood-Report’ was published; it had been commissioned by Charles and paid for by Dame Shirley Porter to inform health ministers. It stated that up to 480 million pounds could be saved, if one in 10 family doctors offered homeopathy as an alternative to standard drugs for asthma. Savings of up to 3.5 billion pounds could be achieved by offering spinal manipulation rather than drugs to people with back pain. Because I had commented on this report, Prince Charles’ first private secretary asked my vice chancellor to investigate my activities; even though I was found to be not guilty of any wrong-doing, all local support stopped which eventually led to my early retirement. ITV later used this incident in a film entitled THE MEDDLING PRINCE.
In a 2006 speech, Prince Charles told the World Health Organisation in Geneva that alternative medicine should have a more prominent place in health care and urged every country to come up with a plan to integrate conventional and alternative medicine into the mainstream. But British science struck back. Anticipating Prince Charles’s sermon in Geneva, 13 of Britain’s most eminent physicians and scientists wrote an “Open Letter” which expressed concern over “ways in which unproven or disproved treatments are being encouraged for general use in Britain’s National Health Service.” The signatories argued that “it would be highly irresponsible to embrace any medicine as though it were a matter of principle.”
In 2008, The Times published my letter asking the FIH to withdraw two guides promoting “alternative medicine”, saying: “the majority of alternative therapies appear to be clinically ineffective, and many are downright dangerous.” A speaker for the FIH countered the criticism by stating: “We entirely reject the accusation that our online publication Complementary Healthcare: A Guide contains any misleading or inaccurate claims about the benefits of complementary therapies. On the contrary, it treats people as adults and takes a responsible approach by encouraging people to look at reliable sources of information… so that they can make informed decisions. The foundation does not promote complementary therapies.”
In 2009, the Prince held talks with the health Secretary to persuade him to introduce safeguards amid a crackdown by the EU that could prevent anyone who is not a registered health practitioner from selling remedies. This, it seems, was yet another example of Charles’ disregard of his constitutional role.
In the same year, Charles urged the government to protect alternative medicine because “we fear that we will see a black market in herbal products”, as Dr Michael Dixon, then medical director of Charles’ FIH, put it.
In 2009, the health secretary wrote to the prince suggesting a meeting on the possibility of a study on integrating complementary and conventional healthcare approaches in England. The prince had written to Burnham’s predecessor, Alan Johnson, to demand greater access to complementary therapies in the NHS alongside conventional medicine. The prince told him that “despite waves of invective over the years from parts of the medical and scientific establishment” he continued to lobby “because I cannot bear people suffering unnecessarily when a complementary approach could make a real difference”. He opposed “large and threatened cuts” in the funding of homeopathic hospitals and their possible closure. He complained that referrals to the Royal London homeopathic hospital were increasing “until what seems to amount to a recent ‘anti-homeopathic campaign’”. He warned against cuts despite “the fact that these homeopathic hospitals deal with many patients with real health problems who otherwise would require treatment elsewhere, often at greater expense”.
In 2009, the ‘College of Integrated Medicine’ (the name was only later changed to ‘College of Medicine’, see below) was to have a second base in India. An Indian spokesman commented: “The second campus of the Royal College will be in Bangalore. We have already proposed the setting up of an All India Institute of Integrated Medicine to the Union health ministry. At a meeting in London last week with Prince Charles, we finalized the project which will kick off in July 2010”.
In 2010, Charles publicly stated that he was proud to be perceived as ‘an enemy of the enlightenment’.
In 2010, ‘Republic’ filed an official complaint about FIH alleging that its trustees allowed the foundation’s staff to pursue a public “vendetta” against a prominent critic of the prince’s support for complementary medicines. It also suggested that the imminent closure of Ernst’s department may be partly down to the charity’s official complaint about him after he publicly attacked its draft guide to complementary medicines as “outrageous and deeply flawed”.
In 2010, former fellows of Charles’ disgraced FIH launched a new organisation, The College of Medicine’ supporting the use of integrated treatments in the NHS. One director of the college is Michael Dixon, a GP in Cullompton, formerly medical director of the Foundation for Integrated Health. My own analysis of the activities of the new college leaves little doubt that it is promoting quackery.
In 2011, after the launch of Charles’ range of herbal tinctures, I had the audacity to publicly criticise Charles for selling the Duchy Herbals detox tincture.
In 2011, Charles forged a link between ‘The College of Medicine’ and an Indian holistic health centre (see also above). The collaboration was reported to include clinical training to European and Western doctors in ayurveda and homoeopathy and traditional forms of medicine to integrate them in their practice. The foundation stone for the extended campus of the Royal College known as the International Institution for Holistic and Integrated Medicine was laid by Dr Michael Dixon in collaboration with the Royal College of Medicine.
In 2012, Charles was nominated for ‘THE GOLDEN DUCK AWARD’ for his achievements in promoting quackery. However, Andrew Wakefield beat him to it; Charles certainly was a deserving runner-up.
In 2013, Charles called for society to embrace a broader and more complex concept of health. In his article he described a vision of health that includes the physical and social environment, education, agriculture and architecture.
In 2013, Charles’ Highgrove enterprise offered ‘baby-hampers’ for sale at £195 a piece and made a range of medicinal claims for the products it contained. As these claims were not supported by evidence, there is no way to classify them other than quackery.
By 2013, the ‘Association of Osteomyologists’ were seeking to become regulated by statute, with the help of Prince Charles as their patron. The chairman and founder of this organisation was knighted for services to alternative medicine. Osteomyologists encourage the use of techniques including cranio-sacral therapy and claim that “we all know that Colleges, Institutions, and Medical Practitioners, are brain washed from the very outset into believing that their discipline is the only way to go.”
In November 2013, Charles invited alternative medicine proponents from across the world, including Dean Ornish, Michael Dixon, chair of College of Medicine, UK and Issac Mathai of Soukya Foundation, Bangalore, to India for a ‘brain storm’ and a subsequent conference on alternative medicine. The prince wanted the experts to collaborate and explore the possibilities of integrating different systems of medicines and to better the healthcare delivery globally, one of the organisers said.
In June 2014, BBC NEWS published the following text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day: Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in. He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it. Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do.*** I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved. And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain. On this blog, I have pointed out that the research in question was fatally flawed and that Charles, once again, overstepped the boundaries of his constitutional role.
In 2015, two books were published which are relevant in this context. My memoir A SCIENTIST IN WONDERLAND recounts most of my dealings with Charles and his sycophants, including how an intervention from his first private secretary eventually led to the closure of my department. The book by Catherine Meyer CHARLES, THE HEART OF A KING is far less critical about our heir to the throne; it nevertheless severely criticises his stance on alternative medicine.
In October 2015, the Guardian obtained the infamous “black spider memos” which revealed that Charles had repeatedly lobbied politicians in favour of alternative medicine (see also above).
In 2016, speaking at a global leaders summit on antimicrobial resistance, Prince Charles warned that Britain faced a “potentially disastrous scenario” because of the “overuse and abuse” of antibiotics. The Prince explained that he had switched to organic farming on his estates because of the growing threat from antibiotic resistance and now treats his cattle with homeopathic remedies rather than conventional medication. “As some of you may be aware, this issue has been a long-standing and acute concern to me,” he told delegates from 20 countries “I have enormous sympathy for those engaged in the vital task of ensuring that, as the world population continues to increase unsustainably and travel becomes easier, antibiotics retain their availability to overcome disease… It must be incredibly frustrating to witness the fact that antibiotics have too often simply acted as a substitute for basic hygiene, or as it would seem, a way of placating a patient who has a viral infection or who actually needs little more than patience to allow a minor bacterial infection to resolve itself.”
It seems that, in recent years (and perhaps in view of soon becoming our King), the Prince has tried to keep a low profile in controversial areas such as alternative medicine. But, every now and then, his passion for quackery seems to get the better of him. The late Christopher Hitchens repeatedly wrote about this passion, and his comments are, in my view, unsurpassable:
We have known for a long time that Prince Charles’ empty sails are so rigged as to be swelled by any passing waft or breeze of crankiness and cant. He fell for the fake anthropologist Laurens van der Post. He was bowled over by the charms of homeopathic medicine. He has been believably reported as saying that plants do better if you talk to them in a soothing and encouraging way… The heir to the throne seems to possess the ability to surround himself—perhaps by some mysterious ultramagnetic force?—with every moon-faced spoon-bender, shrub-flatterer, and water-diviner within range.
HAPPY BIRTHDAY YOUR ROYAL HIGHNESS
Yes, I have a new book out. It is on homeopathy, and the publisher thought it important enough to issue a press-release. I thought you might be interested in reading it – if nothing else, it could be a welcome distraction from the catastrophic new from America. Here it is:
As a junior doctor, Edzard Ernst worked in a homeopathic hospital, practised homeopathy, and was impressed with its results. As his career progressed and he became a research scientist, he investigated the reasons for this efficacy and began to publish the evidence. This new book Homeopathy – The Undiluted Facts presents what he has learned to a lay audience. As an authoritative guide, it is complemented by an 80-page lexicon on the subject, covering definitions, key ingredients and protagonists in its history from founder Samuel Hahnemann to supporter Prince Charles.
Edzard Ernst says: “Homeopathy has been with us for more than 200 years and today millions of patients and consumers swear use its remedies on a daily basis. While some people seem to believe in it with a quasi-religious fervor, others loath it with a similarly deeply-felt passion. In this climate, it is far from easy for consumers to find simple, factual and reliable material on this subject. My book aims to fill this gap.”
There are many misconceptions and myths surrounding homeopathy which Ernst is able to dispel. In the final chapter, he covers both spurious arguments made by proponents of homeopathy and spurious arguments made by its opponents.
For example, in countering the notion that patients who use homeopathy must be stupid, he points out that many patients consult homeopaths because they have needs which are not met by conventional medicine. During a consultation with a homeopath, patients often experience more sympathy, empathy, and compassion. To dismiss this as stupidity would mean missing a chance to learn a lesson.
Ernst encourages both skepticism and openness to new ideas. He says: “This book is based on the all-important principle that good medicine must demonstrably generate more good than harm. Where this is not the case, I will say so without attempting to hide the truth.”
I have been alerted to the fact that my former medical school in Munich at one of Germany’s highest-ranked universities is currently running an elective course in homeopathy. For those who do not read German (the original announcement [apparently posted all over Munich university hospitals] is copied below), it teaches the use of homeopathy in/for:
- INTERNAL MEDICINE
- RECURRENT OTITIS MEDIA
- PALLIATION OF RESPIRATORY PROBLEMS
- PROSTATE CANCER
- POST-TRAUMATIC SYNDROMES
- BIPOLAR DISEASE
- MULTIMORBID PATIENTS WITH UVEITIS
- DISEASES OF THE FEMALE BREAST
- SUPPORTIVE CANCER CARE
- PAEDIATRIC ASTHMA
The course is being organised by Dr. med. Sigrid Kruse, von Haunersches Kinderspital des Klinikums der Universität München in co-operation with the ‘Landesverband Bayern des Deutschen Zentralvereins homöopathischer Ärzte’. The lecturers of this course seem to be mostly homeopaths from practices in and around Munich.
This article provides further explanations:
The project „Homeopathy in pediatrics“ was established in the Dr. von Hauner’s Children’s Hospital University of Munich in 1995 to integrate homeopathy into a university hospital. Selected children (outpatients and in the wards) are treated conventionally and homeopathically. The Karl and Veronica Carstens-Foundation initially financed the project over six years. An association of parents, whose children were treated for cancer, funded the project for one year. Since 2002, for the first time in Germany, the National Health Insurance is providing the financial background for two consultants for Homeopathy at this University hospital.
Who are we?
Dr. Mira Dorcsi-Ulrich, who initiated the project and carries out the supervision. She is a pediatrician in her own practice with 23 years of experience.
Dr. Sigrid Kruse has managed to integrate homeopathy into the clinic, starting at first in 1995 as a resident for pediatrics. Now she fulfills the requests of doctors and parents in the wards demanding concomitant homeopathic treatment.
Dr. Christian Lucae mainly treats the outpatients while focussing on his research project with children showing attention-deficit-hyperactivity-syndrome (ADHS).
Concomitant homeopathic therapy was successful in the following cases: intracerebral bleeding 3rd degree in premature babies, drug withdrawal in neonates addicted mothers, epilepsy, handicapped children, ADHS, migraine, tic, recurrent infections, asthma and atopic eczema, complications in wound healing and other problems. Homeopathic treatment of children parallel to conventional methods is particularly well accepted in the treatment of cancer. The side effects of oncological treatment like vomiting and stomatitis can be relieved, aggressions and anxiety intercepted and life quality improved.
END OF QUOTE
Which journal with a modicum of self-respect or rigor allows a homeopath to publish anything like the last paragraph without providing a jot of evidence? The answer is the ‘ALLGEMEINE HOMOEOPATHISCHE ZEITUNG’ – no further explanation needed, I think.
Courses like the one above, run at university level, make me first a little speechless and then more than a little angry. Medical schools should have other roles than teaching impressionable students things that fly in the face of science and evidence. They should guide them to become responsible doctors not misguide them to turn into irresponsible quacks. The fact that this comes from the medical school where I, many years ago, studied, graduated, worked and made both my MD and PhD theses renders the whole thing painfully sad for me personally.
But let’s not get depressed… ‘always look on the bright side of life’!!!
Luckily, there are glimpses of a bright side here. For instance, the fact that doctor Quak is one of the lecturers of this course (see below) is not without jollity, I must admit. Also amusing – at least to me – is be the vision of Dr. med. Mira Dorcsi-Ulrich (see below) standing in front of her students explaining the findings of one of the few RCT of individualised homeopathy for paediatric asthma. This study from my team found no evidence that “adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo in improving the quality of life of children with mild to moderate asthma in addition to conventional treatment in primary care.”
Here is the German original announcement of the course:
RINGVORLESUNG IM WINTERSEMESTER 2016/2017
HOMÖOPATHIE VON DER THEORIE ZUR PRAXIS MIT PRAXISBEISPIELEN UND PATIENTENVORSTELLUNGEN
1. 20.10.2016 … IN DER INNEREN MEDIZIN: MÖGLICHKEITEN UND GRENZEN Dr. med. Ulf Riker
2. 27.10.2016 … IN DER NEONATOLOGIE: IKTERUS, ASPHYXIE UND UNRUHE Dr. med. Monika Grasser
3. 03.11.2016 … BEI PATIENTEN MIT SINUSITIS Dr. med. Michael Schreiner
4. 10.11.2016 … BEI KINDERN MIT REZIDIVIERENDER OTITIS MEDIA Dr. med. Christian Lucae
5. 17.11.2016 … BEI SCHLAFSTÖRUNGEN Dr. med. Brigitte Seul
6. 24.11.2016 … BEI PALLIATIV-PATIENTEN MIT RESPIRATORISCHEN PROBLEMEN Herbert Michalczyk
7. 01.12.2016 … IN DER BEGLEITUNG VON PATIENTEN MIT EINEM PROSTATA-CARCINOM Uwe Kraemer-Hoenes
8. 08.12.2016 … BEI POSTTRAUMATISCHER BELASTUNGS-STÖRUNG Dr. med. Ingrid Pfanzelt
9. 15.12.2016 … BEI EINER PATIENTIN MIT BIPOLARER AFFEKTIVER STÖRUNG Dr. med. Stephan Gerke
10. 12.01.2017 … BEI EINEM MULTIMORBIDEN PATIENTEN MIT UVEITIS Dr. med. Thomas Quak
11. 19.01.2017 … BEI PATIENTEN MIT HUSTEN Dr. med. Renate Grötsch
12. 26.01.2017 … BEI ERKRANKUNGEN DER WEIBLICHEN BRUST Dr. med. Ute Bullemer
13. 02.02.2017 … IN DER BEGLEITUNG VON KREBSPATIENTEN MIT Q-POTENZEN Miclós Takács
15. 09.02.2017… BEI KINDERN MIT ASTHMA BRONCHIALE Dr. med. Mira Dorcsi-Ulrich
Organisation: Dr. med. Sigrid Kruse, Dr. von Haunersches Kinderspital des Klinikums der Universität München
E-Mail: email@example.com in Zusammenarbeit mit dem Landesverband Bayern des Deutschen Zentralvereins homöopathischer Ärzte,
I have published many articles on the risks of various alternative treatments (see for instance here, here, here, here, here and here) – not because I am alarmist but because I have always felt very strongly that, for a researcher into alternative medicine, the most important issue must be to make sure users of these therapies are as safe as possible. Usually I differentiated between direct and indirect risks. The former relate to the risks of the treatment and include, for instance, liver damage caused by a herbal remedy or stroke due to neck manipulation. The latter are mainly due to the poor, often irresponsible advice given by many therapists.
A recent article adopted the same terminology when reviewing the risks of alternative medicine specifically for cancer patients. As the indirect risks are often neglected, I will here quote the relevant section of this paper in full:
…Health care physicians and oncology experts have an ethical responsibility to initiate the communication regarding the use of complementary therapies with cancer patients. However, according to data obtained from this literature review, oncology doctors and physicians will discuss complementary therapies only when a patient him/herself raises this issue within a consultation. This passive attitude was linked to a lack of sufficient scientific evidence for positive outcomes of complementary therapies found in high quality randomized controlled trials (RCTs). Oncology nurses, on the other hand, sometimes actively promote complementary modalities that they find to correspond with their vision of holistic care.
According to the included studies, complementary providers often differ from conventional health care providers in their understanding of treatment concepts, philosophies and diagnostic procedures. This leads to different models of disease causality (cells, blood, nerves vs. energy, vital force, meridians) and treatment philosophy (reductionism vs. holism). As many complementary providers are philosophically oriented towards personal and spiritual growth, patients may feel guilty if the disease continues to advance despite the patients’ best spiritual and mental efforts. According to Broom and colleagues, such philosophies may also give patients false hope of recovery.
Another indirect risk connected to the combination of conventional and complementary treatment in cancer care is the lack of regulation and standardized education in many countries. Currently, there are, for example, no standard training requirements for complementary providers working in cancer care or any other health care setting in the EU. According to Mackareth et al., complementary providers in England need specific training to learn how to practice safely.
Moreover, there is a need for common medical terminology to bridge the communication gap between health care providers working outside the conventional health care system. Common medical terminology may reduce the existing communication gap between conventional and complementary providers about mutual patients. To minimize communication gap between physicians, oncology experts and complementary providers, a medical complementary record should include a treatment plan with conventional and complementary diagnosis, explanation of terminology, possible treatment interactions, description of the complementary treatment plan and goals. If possible, the quality of any complementary supplement given should be reported.
END OF QUOTE
As I said, I find it important to discuss the indirect risks of alternative medicine, and I am therefore pleased that the authors of this article addressed them. At the same time, I find their text remarkably tame.
Why are they not more open and forceful about what, after all, amounts to a serious public health issue? The answer might be simpler than expected: most of them are affiliated with the ‘National Research Center in Complementary and Alternative Medicine (NAFKAM), UiT The Arctic University of Norway, Tromsø, Norway’. Could it be that open warnings about outright quackery is not what suits this unit?
So, what might be an open and frank approach to discussing the indirect risks of alternative medicine? In my view, it should make several points abundantly clear and transparent:
- Alternative practitioners (APs) are usually not trained to advise patients responsibly, particularly in cases serious disease.
- The training of APs is often inadequate and sometimes resembles more to brain-washing than to proper education.
- Consequently, APs often woefully over-estimate what their therapy can achieve.
- The patients of APs are often desperate and ready to believe even the tallest tales.
- APs have a huge conflict of interest – in order to make a living they need to treat as many patients as possible and are therefore not motivated to refer them to more suitable care.
- APs are frequently in denial when it comes to the risks of their treatments.
- APs are not educated such that they understand the full complexities of serious illness.
- As a result, APs far too often misguide their patients to make tragically wrong choices thus putting their health at serious risk.
- In most countries, the regulators turn a blind eye to this huge problem.
These are by no means trivial points, and they have nothing to do with a ‘turf war’ between conventional and alternative medicine. They relate to our ethical duty to keep our patients as safe as we can. It has been estimated that, in oncology alone, 1 – 5% of deaths are due to patients opting to have alternative instead of conventional treatments. This amounts to an unbearably high absolute number of patients dying prematurely due to the indirect risks of alternative medicine.
It is high time, I think, that we tackle this issue systematically and seriously.