MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

bias

This article was posted a few months ago. Then it mysteriously vanished without a trace; nobody knows quite why or how. Today I found an old draft on my computer, so I post the article again. It might not be identical with the original but it is close enough, I think.

Some time ago, Andy Lewis formulated a notion which he called ‘Ernst’s law’. Initially, I felt this was a bit o.t.t., then it made me chuckle, and eventually it got me thinking: could there be some truth in it, and if so, why?

The ‘law’ stipulates that, if a scientist investigating alternative medicine is much liked by the majority of enthusiasts in this field, the scientist is not doing his/her job properly. In any other area of healthcare, such a ‘law’ would be absurd. Why then does it seem to make sense, at least to some degree, in alternative medicine? The differences between any area of conventional and alternative medicine are diverse and profound.

Take neurology, for instance: here we have an organ-system, anatomy, physiology, pathophysiology, etiology and nosology all related more or less specifically to this field and all based on facts, rigorous science and substantial evidence. None of this knowledge, science and evidence is static, but each has evolved and can be predicted to do so in future. What we knew about neurology 50 years ago, for example, was dramatically different from what we know today. Scientific discovery discoveries in neurology link up with the knowledge gathered in other areas of medicine to generate a (more or less) complete bigger picture.

In alternative medicine or any single branch thereof, we have no specific organ-system, anatomy, physiology, pathophysiology, etiology or nosology to speak of. We also have few notions that are transferable from one branch of alternative medicine to another – on the contrary, the assumptions of homeopathy, for example, are in overt contradiction to those of acupuncture which, in turn, are out of sync with those of reflexology, aromatherapy and Reiki.

Instead, each branch of alternative medicine has its own axioms that are largely detached from reality or, indeed, from the axioms of other branches of alternative medicine. In acupuncture, for instance, we have concepts such as yin and yang, qi, meridians and acupuncture points, and there is hardly any development of these concepts. This renders them akin to dogmas, and there is no chance in hell that the combination of all the branches of alternative medicine would add up to provide a sensible ‘bigger picture’.

If a scientist were to instill scientific, critical, progressive thought in a field like neurology, thus overthrowing current concepts and assumptions, they would be greeted with open arms among many like-minded researchers who all pursue the aim of advancing their field and contributing to the knowledge base by overturning wrong assumptions and discovering new truths. If researchers were to spend their time trying to analyse the concepts or treatments of alternative medicine, thus overthrowing current concepts and assumptions, they would not only not be appreciated by the majority of the experts working in this field, they would be castigated for their actions.

If a scientist dedicated decades of hard work to the rigorous assessment of alternative medicine, that person would become a thorn in the flesh of believers. Instead of welcoming him with open arms, some disappointed enthusiasts of alternative treatments might even pay for defaming them.

On the other hand, if a researcher merely misused the tools of science to confirm the implausible assumptions of alternative medicine, he would quickly become the celebrated ‘heroes’ of this field.

This is the bizarre phenomenon that ‘Ernst’s law’ seems to capture quite well – and this is why I believe the ‘law’ is worth more than a laugh and a chuckle. In fact, ‘Ernst’s law’ might even describe the depressing reality of retrograde thinking in alternative medicine more accurately than most of us care to admit.

What do my readers feel? Their comments following this blog may well confirm or refute my theory.

Several sceptics including myself have previously commented on this GP’s bizarre promotion of bogus therapies, his use of disproven treatments, and his advocacy for quackery. An interview with Dr Michael Dixon, OBE, chair of the ‘College of Medicine’, and advisor to Prince Charles, and chair of NHS Alliance, and president of the ‘NHS Clinical Commissioners’ and, and, and…was published on 15 November. It is such a classic example of indulgence in fallacies, falsehoods and deceptions that I cannot resist adding a few words.

To make it very clear what is what: the interviewer’s questions are in bold Roman; MD’s answers are in simple Roman; and my comments are in bold italic typeface. The interview itself is reproduced without changes or cuts.

How did you take to alternative medicine?

I started trying out alternative medicine after 10 years of practising as a general physician. During this period, I found that conventional medicine was not helping too many patients. There were some (patients) with prolonged headaches, backaches and frequent infections whom I had to turn away without offering a solution. That burnt me out. I started looking for alternative solutions.

The idea of using alternative treatments because conventional ones have their limits is perhaps understandable. But which alternative therapies are effective for the conditions mentioned? Dr Dixon’s surgery offers many alternative therapies which are highly unlikely to be effective beyond placebo, e.g. ‘Thought Field Therapy’, reflexology, spiritual healing or homeopathy.

But alternative medicine has come under sharp criticism. It was even argued that it has a placebo effect?

I don’t mind what people call it as long as it is making patients better. If the help is more psychological than physiological, as they argue, all the better. There are less side-effects, less expenses and help is in your own hands.

I have posted several articles on this blog about this fundamental misunderstanding. The desire to help patients via placebo-effects is no good reason to employ bogus treatments; effective therapies also convey a placebo-response, if administered with compassion. Merely administering placebos means denying patients the specific effects of real medicine and is therefore not ethical.

Why are people unconvinced about alternative medicine?

One, there are vested interests – professional and organizational impact on it. Two, even practitioners in conventional medicine do not know much about it. And most importantly, we need to develop a scientific database for it. In conventional medicine, pharmaceutical companies have the advantage of having funds for research. Alternative medicine lacks that. Have people who say alternative medicine is rubbish ever done research on it to figure out whether it is rubbish? The best way to convince them is through the age-old saying: Seeing is believing.

1) Here we have the old fallacy which assumes that ‘the establishment’ (or ‘BIG PHARMA’ ) does not want anyone to know how effective alternative treatments are. In truth, everyone would be delighted to have more effective therapies in the tool-kit and nobody does care at all where they originate from.

2) GPs do not know much about alternative medicine, true. But that does not really explain why they are ‘unconvinced’. The evidence shows that they need more convincing evidence to be convinced.

3) Dixon himself has done almost no research into alternative medicine (I know that because the few papers he did publish were in cooperation with my team). Contrary to what Dixon says, there are mountains of evidence (for instance ~ 20 000 articles on acupuncture and ~5000 on homeopathy in Medline alone); and the most reliable of this evidence usually shows that the alternative therapy in question does not work.

4) Apologists lament the lack of research funds ad nauseam. However, there is plenty of money in alternative medicine; currently it is estimated to be a $ 100 billion per year business worldwide. If they are unable to channel even the tiniest of proportions into a productive research budget, only they are to blame.

5) Have people who say alternative medicine is rubbish ever done research on it to figure out whether it is rubbish? Yes, there is probably nobody on this planet who has done more research on alternative medicine than I have (and DM knows it very well, for about 15 years, he tried everything to be associated with my team). The question I ask myself is: have apologists like Dixon ever done rigorous research or do they even know about the research that is out there?

6) Seeing is believing??? No, no, no! I have written several posts on this fallacy. Experience is no substitute for evidence in clinical medicine.

Will alternative medicine be taught in UK universities?

US already has 16 universities teaching it. The College of Medicine, UK, is fighting hard for it. We are historically drenched in conventional medicine and to think out of the box will take time. But we are at it and hope to have it soon.

1) Yes, the US has plenty of ‘quackademia‘ – and many experts are worried about the appalling lack of academic standards in this area.

2) The College of Medicine, UK, is fighting hard for getting alternative medicine into the medical curriculum. Interesting! Now we finally know what this lobby group really stands for.

3) Of course, we are ‘drenched’ in medicine at medical school. What else should we expose students to?

4) Thinking ‘out of the box’ can be productive and it is something medicine is often very good at. This is how it has evolved during the last 150 years in a breath-taking speed. Alternative medicine, by contrast, has remained stagnant; it is largely a dogma.

What more should India do to promote integrated medicine?

India needs to be prouder of its institutions and more critical of the West. The West has made massive mistakes. It has done very little about long-term diseases and in preventing them. India needs to be more cautious as it will lead the world in some diseases like the diabetes. It should not depend on conventional medicine for everything, but take the best for the worst.

To advise that India should not look towards the ‘West’ for treating diabetes and perhaps use more of their Ayurvedic medicines or homeopathic remedies (both very popular alternatives in India) is a cynical prescription for prematurely ending the lives of millions prematurely.

Irritable bowel syndrome (IBS) is common and often difficult to treat – unless, of course, you consult a homeopath. Here is just one of virtually thousands of quotes from homeopaths available on the Internet: Homeopathic medicine can reduce Irritable Bowel Syndrome (IBS) symptoms by lowering food sensitivities and allergies. Homeopathy treats the patient as a whole and does not simply focus on the disease. Careful attention is given to the minute details about the presenting complaints, including the severity of diarrhea, constipation, pain, cramps, mucus in the stools, nausea, heartburn, emotional triggers and conventional laboratory findings. In addition, the patient’s eating habits, food preferences, thermal attributes and sleep patterns are noted. The patient’s family history and diseases, along with the patient’s emotions are discussed. Then the homeopathic practitioner will select the remedy that most closely matches the symptoms.

Such optimism might be refreshing, but is there any reason for it? Is homeopathy really an effective treatment for IBS? To answer this question, we now have a brand-new Cochrane review. The aim of this review was to assess the effectiveness and safety of homeopathic treatment for treating irritable bowel syndrome (IBS). (This type of statement always makes me a little suspicious; how on earth can anyone truly assess the safety of a treatment by looking at a few studies? This is NOT how one evaluates safety!) The authors conducted extensive literature searches to identify all RCTs, cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care in adults with IBS. The primary outcome was global improvement in IBS.

Three RCTs with a total of 213 participants were included. No cohort or case-control studies were identified. Two studies compared homeopathic remedies to placebos for constipation-predominant IBS. One study compared individualised homeopathic treatment to usual care defined as high doses of dicyclomine hydrochloride, faecal bulking agents and a high fibre diet. Due to the low quality of reporting, the risk of bias in all three studies was unclear on most criteria and high for some criteria.

A meta-analysis of two studies with a total of 129 participants with constipation-predominant IBS found a statistically significant difference in global improvement between the homeopathic ‘asafoetida’ and placebo at a short-term follow-up of two weeks. Seventy-three per cent of patients in the homeopathy group improved compared to 45% of placebo patients. There was no statistically significant difference in global improvement between the homeopathic asafoetida plus nux vomica compared to placebo. Sixty-eight per cent of patients in the homeopathy group improved compared to 52% of placebo patients.

The overall quality of the evidence was very low. There was no statistically significant difference between individualised homeopathic treatment and usual care for the outcome “feeling unwell”. None of the studies reported on adverse events (which, by the way, should be seen as a breech in research ethics on the part of the authors of the three primary studies).

The authors concluded that a pooled analysis of two small studies suggests a possible benefit for clinical homeopathy, using the remedy asafoetida, over placebo for people with constipation-predominant IBS. These results should be interpreted with caution due to the low quality of reporting in these trials, high or unknown risk of bias, short-term follow-up, and sparse data. One small study found no statistically difference between individualised homeopathy and usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets advising a high fibre diet). No conclusions can be drawn from this study due to the low number of participants and the high risk of bias in this trial. In addition, it is likely that usual care has changed since this trial was conducted. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy compared to placebo or usual care.

THIS REVIEW REQUIRES A FEW FURTHER COMMENTS, I THINK

Asafoetida, the remedy used in two of the studies, is a plant native to Pakistan, Iran and Afghanistan. It is used in Ayurvedic herbal medicine to treat colic, intestinal parasites and irritable bowel syndrome. In the ‘homeopathic’ trials, asafoetida was used in relatively low dilutions, one that still contains molecules. It is therefore debatable whether this was really homeopathy or whether it is more akin to herbal medicine – it was certainly not homeopathy with its typical ultra-high dilutions.

Regardless of this detail, the Cochrane review does hardly provide sound evidence for homeopathy’s efficacy. On the contrary, my reading of its findings is that the ‘possible benefit’ is NOT real but a false positive result caused by the serious limitations of the original studies. The authors stress that the apparently positive result ‘should be interpreted with caution’; that is certainly correct.

So, if you are a proponent of homeopathy, as the authors of the review seem to be, you will claim that homeopathy offers ‘possible benefits’ for IBS-sufferers. But if you are not convinced of the merits of homeopathy, you might suggest that the evidence is insufficient to recommend homeopathy. I imagine that IBS-sufferers might get as frustrated with such confusion as most scientists will be. Yet there is hope; the answer could be imminent: apparently, a new trial is to report its results within this year.

IS THIS NEW TRIAL GOING TO CONTRIBUTE MEANINGFULLY TO OUR KNOWLEDGE?

It is a three-armed study (same 1st author as in the Cochrane review) which, according to its authors, seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with IBS. (Why “explore” and not “determine”, I ask myself.) Patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. (“To be offered” looks odd to me; does that mean patients are not blinded to the interventions? Yes, indeed it does.) The primary clinical outcome is the IBS Symptom Severity at 26 weeks. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis.

Hold on…the primary analysis “will compare homeopathic treatment with usual care“. Are they pulling my leg? They just told me that patients will be “offered, 5 sessions of homeopathic treatment plus usual care… or usual care alone“.

Oh, I see! We are again dealing with an A+B versus B design, on top of it without patient- or therapist-blinding. This type of analysis cannot ever produce a negative result, even if the experimental treatment is a pure placebo: placebo + usual care is always more than usual care alone. IBS-patients will certainly experience benefit from having the homeopaths’ time, empathy and compassion – never mind the remedies they get from them. And for the secondary analyses, things do not seem to be much more rigorous either.

Do we really need more trials of this nature? The Cochrane review shows that we currently have three studies which are too flimsy to be interpretable. What difference will a further flimsy trial make in this situation? When will we stop wasting time and money on such useless ‘research’? All it can possibly achieve is that apologists of homeopathy will misinterpret the results and suggest that they demonstrate efficacy.

Obviously, I have not seen the data (they have not yet been published) but I think I can nevertheless predict the conclusions of the primary analysis of this trial; they will read something like this: HOMEOPATHY PROVED TO BE SIGNIFICANTLY MORE EFFECTIVE THAN USUAL CARE. I have asked the question before and I do it again: when does this sort of ‘research’ cross the line into the realm of scientific misconduct?

If we ask how effective spinal manipulation is as a treatment of back pain, we get all sorts of answers. Therapists who earn their money with it – mostly chiropractors, osteopaths and physiotherapists – are obviously convinced that it is effective. But if we consult more objective sources, the picture changes dramatically. The current Cochrane review, for instance, arrives at this conclusion: SMT is no more effective in participants with acute low-back pain than inert interventions, sham SMT, or when added to another intervention. SMT also appears to be no better than other recommended therapies.

Such reviews tend to pool all studies together regardless of the nature of the practitioner. But perhaps one type of clinician is better than the next? Certainly many chiropractors are on record claiming that they are the best at spinal manipulations. Yet it is conceivable that physiotherapists who do manipulations without being guided by the myth of ‘adjusting subluxations’ have an advantage over chiropractors. Three very recent systematic reviews might go some way to answer these questions.

The purpose of the first systematic review was to examine the effectiveness of spinal manipulations performed by physiotherapists for the treatment of patients with low back pain. The authors found 6 RCTs that met their inclusion criteria. The most commonly used outcomes were pain rating scales and disability indexes. Notable results included varying degrees of effect sizes favouring spinal manipulations and minimal adverse events resulting from this intervention. Additionally, the manipulation group in one study reported significantly less medication use, health care utilization, and lost work time. The authors concluded that there is evidence to support the use of spinal manipulation by physical therapists in clinical practice. Physical therapy spinal manipulation appears to be a safe intervention that improves clinical outcomes for patients with low back pain.

The second systematic Review was of osteopathic intervention for chronic, non-specific low back pain (CNSLBP). Only two trials met the authors’ inclusion criteria. They had a lack of methodological and clinical homogeneity, precluding a meta-analysis. The trials used different comparators with regards to the primary outcomes, the number of treatments, the duration of treatment and the duration of follow-up. The authors drew the following conclusions: There are only two studies assessing the effect of the manual therapy intervention applied by osteopathic clinicians in adults with CNSLBP. One trial concluded that the osteopathic intervention was similar in effect to a sham intervention, and the other suggests similarity of effect between osteopathic intervention, exercise and physiotherapy. Further clinical trials into this subject are required that have consistent and rigorous methods. These trials need to include an appropriate control and utilise an intervention that reflects actual practice.

The third systematic review sought to determine the benefits of chiropractic treatment and care for back pain on well-being, and aimed to explore to what extent chiropractic treatment and care improve quality of life. The authors identified 6 studies (4 RCTs and two observational studies) of varying quality. There was a high degree of inconsistency and lack of standardisation in measurement instruments and outcome measures. Three studies reported reduced use of other/extra treatments as a positive outcome; two studies reported a positive effect of chiropractic intervention on pain, and two studies reported a positive effect on disability. The authors concluded that it is difficult to defend any conclusion about the impact of chiropractic intervention on the quality of life, lifestyle, health and economic impact on chiropractic patients presenting with back pain.

Yes, yes, yes, I know: the three reviews are not exactly comparable; so we cannot draw firm conclusions from comparing them. Five points seem to emerge nevertheless:

  1. The evidence for spinal manipulation as a treatment for back pain is generally not brilliant, regardless of the type of therapist.
  2. There seem to be considerable differences according to the nature of the therapist.
  3. Physiotherapists seem to have relatively sound evidence to justify their manipulations.
  4. Chiropractors and osteopaths are not backed by evidence which is as reliable as they so often try to make us believe.
  5. Considering that the vast majority of serious complications after spinal manipulation has occurred with chiropractors, it would seem that chiropractors are the profession with the worst track record regarding manipulation for back pain.

Today, Prince Charles celebrates his 65th birthday. He is one of the world’s most tenacious, outspoken and influential proponent of alternative medicine and attacker of science – sufficient reason, I think, to join the birthday-celebrations by outlining a chronology of his love affair with quackery. The following post highlights just a few events (there are so many more!) which I happen to find interesting. As I was personally involved in several of them, I have tried to stay as close as possible to the text published by journalists at the time (with links to the originals); this, I thought, was fairer than providing my own, possibly biased interpretations.

The origins Charles’ passion for all things alternative are not difficult to trace. The Royal family is famous for using homeopathy and other doubtful treatments while they are healthy, and for employing the very best conventional medicine has to offer as soon as they are ill. This pattern also applied to Charles’ childhood, and it is more than likely that this is how his weakness for alternative medicine and charlatans first started.

The young Prince Charles went on a journey of ‘spiritual discovery’ into the wilderness of northern Kenya. His guru and guide was Laurens van der Post (who was 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’ young intuitive 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 (long obsolete in medicine and science) 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 seems to have 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 utter nonsense.

In 1993, Charles founded his often re-named 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. For instance, when it published a DoH-sponsored ‘patient guide’ that was entirely devoid of evidence, arguably the most important feature of such a document. They claimed evidence was never meant to be included. But I had seen a draft where it had been part of it, and friends have seen the contract with the DoH where “evidence” was an important element.

In 2000, Charles wrote an open letter to The Times (citing my work twice!!!) 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 was working on plans to help build a model hospital that would tap into the power of alternative therapy. 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. In a speech he had urged the NHS not to dismiss it as a “woolly cul-de-sac”. Groups interested in alternative medicine were delighted at the news. 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. He was also responsible for raising finance for its construction.

To the best of my knowledge, this 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 2003, Prince Charles’ Prince of Wales’ FIH has launched a five-year plan which outlined how to improve access to 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, commissioned by Charles and paid for by Dame Shirley Porter, specifically 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. 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, specifically of violating confidentiality, all local support stopped which 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. The Prince 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, thirteen of Britain’s most eminent physicians and scientists issued a widely quoted “Open Letter: Use of ‘Alternative’ Medicine in the NHS”. The letter expressed concern over “ways in which unproven or disproved treatments are being encouraged for general use in Britain’s National Health Service.” The signatories, who included three Fellows of the Royal Society, one Nobel Laureate (Sir James Black, FRS) and the son of another (Professor Gustav Born, FRS), cited the overt promotion of homeopathy by the NHS, including its official website. The Open Letter warned that “it would be highly irresponsible to embrace any medicine as though it were a matter of principle.”

In 2008The Times published my letter asking the FIH to recall 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 government to protect alternative medicine medicine because “we fear that we will see a black market in herbal products”, as Dr Michael Dixon, medical director of Charles’ FIH, put it.

In 2009, Charles seemed to have promised that his London-based ‘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, Edzard Ernst. It also suggests 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, Devon, who was formerly medical director of the Foundation for Integrated Health. The others are George Lewith, who runs a complementary medicine unit at Southampton University; David Peters, the chairman of the British Holistic Medical Association; and Christine Glover, a holistic health consultant. All are former fellows of the prince’s charity. My own analysis of the activities of the new college leaves little doubt that it is promoting quackery.

In 2010, Charles published his book HARMONY which is full of praise for even the most absurd forms of quackery.

In 2011, after the launch of his very own range of herbal tinctures Charles was harshly criticised. Consequently, a public row was re-ignited with Clarence House by branding the Prince of Wales a “snake oil salesman”. I had the audacity to criticise the heir to the throne for lending his support to homeopathic remedies and for selling the Duchy Herbals detox tincture.

In 2011, Charles forged a link between ‘The College of Medicine’ and an Indian holistic health centre. The collaboration has been 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; Andrew Wakefield beat him to it, but Charles was a well-deserved 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. Emphasising that his point is not to confront accepted medical wisdom, HRH suggests reasons for encouraging a wider perspective on health. Rather than simply treating the symptoms of disease, The Prince advocates a health service that puts patients at the heart of the process by incorporating the core human elements of mind, body and spirit. Explaining that symptoms may often be a metaphor for underlying disease and unhappiness, he calls for a scientific and therapeutic approach that understands, values and uses patient perspective and belief rather than seeking to exclude them.

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’ are seeking to become regulated in statute, with the help of Prince Charles as their patron. An Osteomyologist will treat both the symptoms and the root cause of a condition with the aim of alleviating symptoms and preventing reoccurrence whenever possible. Osteomyology encourages the skilled use of techniques including Cranial and Cranio-Sacral therapy.

In November 2013, Charles invited alternative medicine proponents from across the world, including Dean Michael Ornish, Sausalito, California, 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.

I am sure that, in the future, we will hear much more about Charles’ indulgence in quackery; and, of course, we will hear more criticism of it. But I doubt that anyone can put it better that the late Christopher Hitchens who repeatedly wrote about Charles’ passion for anti-science:

“Once the hard-won principles of reason and science have been discredited, the world will not pass into the hands of credulous herbivores who keep crystals by their sides and swoon over the poems of Khalil Gibran. The “vacuum” will be invaded instead by determined fundamentalists of every stripe who already know the truth by means of revelation and who actually seek real and serious power in the here and now. One thinks of the painstaking, cloud-dispelling labour of British scientists from Isaac Newton to Joseph Priestley to Charles Darwin to Ernest Rutherford to Alan Turing and Francis Crick, much of it built upon the shoulders of Galileo and Copernicus, only to see it causally slandered by a moral and intellectual weakling from the usurping House of Hanover.”

And perhaps even better here:

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. But this latest departure promotes him from an advocate of harmless nonsense to positively sinister nonsense….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.

According to its authors, this RCT was aimed at investigating the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression. In particular the second research question is intriguing, I think – so let’s have a closer look at this trial.

The study was designed as a randomized, partially double-blind, placebo-controlled, four-armed, 2×2 factorial trial with a 6-week study duration. A total of 44 patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was thus underpowered for the pre-planned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI -1.2;5.2) for Q-potencies vs. placebo, and -3.1 (-5.9;-0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups.

The conclusions were remarkable: although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting.

Alright, the authors encountered problems in recruiting enough patients and they therefore decided to stop the trial early. This sort of thing happens. Most researchers would then not publish any data at all. This team, however, did publish a report, and the decision to do so might be perfectly fine: other investigators might learn from the problems which led to early termination of the study.

But why do they conclude that the results were INCONCLUSIVE? I think the results were not inconclusive but non-existent; these were no results to report other than those related to the recruitment problems. And even if one insists on presenting outcome data as an exploratory analysis, one cannot honestly say they were INCONCLUSIVE, all one might state in this case is that the results failed to show an effect of the remedy or the consultation. This is far less favourable for homeopathy than stating the results were INCONCLUSIVE.

And why on earth do the authors conclude “we cannot recommend undertaking a further trial addressing this question in a similar setting”? This does not make the slightest sense to me. If the trialists encountered recruitment problems, others might find ways of overcoming them. The research question asking whether the effects of an extensive homeopathic case taking differ from those of a shorter conventional one seems important. If answered accurately, it could disentangle much of the confusion that surrounds clinical trials of homeopathy.

I have repeatedly commented on the odd conclusions drawn by proponents of alternative medicine on the basis of data that did not quite fulfil their expectations, and I often ask myself at what point this ‘prettification’ of the results via false positive conclusions crosses the line to scientific misconduct. My theory is that these conclusions appear odd to those capable of critical analysis because the authors bend over backwards in order to conclude more positively than the data would seem to permit. If we see it this way, such conclusions might even prove useful as a fairly sensitive ‘bullshit-detector’.

We have probably all fallen into the trap of thinking that something which has stood the ‘test of time’, i.e. something that has been used for centuries with apparent success, must be ok. In alternative medicine, this belief is extremely wide-spread, and one could argue that the entire sector is built on it. Influential proponents of ‘traditional’ medicine like Prince Charles do their best to strengthen this assumption. Sadly, however, it is easily disclosed as a classical fallacy: things that have stood the ‘test of time’ might work, of course, but the ‘test of time’ is never a proof of anything.

A recent study brought this message home loud and clear. This trial tested the efficacy of Rhodiola crenulata (R. crenulata), a traditional remedy which has been used widely in the Himalayan areas and in Tibet to prevent acute mountain sickness . As no scientific studies of this traditional treatment existed, the researchers conducted a double-blind, placebo-controlled crossover RCT to test its efficacy in acute mountain sickness prevention.

Healthy adult volunteers were randomized to two treatment sequences, receiving either 800 mg R. crenulata extract or placebo daily for 7 days before ascent and two days during mountaineering. After a three-month wash-out period, they were crossed over to the alternate treatment. On each occasion, the participants ascended rapidly from 250 m to 3421 m. The primary outcome measure was the incidence of acute mountain sickness with headache and at least one of the symptoms of nausea or vomiting, fatigue, dizziness, or difficulty sleeping.

One hundred and two participants completed the trial. No significant differences in the incidence of acute mountain sickness were found between R. crenulata extract and placebo groups. If anything, the incidence of severe acute mountain sickness with Rhodiola extract was slightly higher compared to the one with placebo: 35.3% vs. 29.4%.

R. crenulata extract was not effective in reducing the incidence or severity of acute mountain sickness as compared to placebo.

Similar examples could be found by the dozen. They demonstrate very clearly that the notion of the ‘test of time’ is erroneous: a treatment which has a long history of usage is not necessarily effective (or safe) – not only that, it might be dangerous. The true value of a therapy cannot be judged by experience, to be sure, we need rigorous clinical trials. Acute mountain sickness is a potentially life-threatening condition for which there are reasonably effective treatments. If people relied on the ‘ancient wisdom’ instead of using a therapy that actually works, they might pay for their error with their lives. The sooner alternative medicine proponents realise that, the better.

Acupressure is a treatment-variation of acupuncture; instead of sticking needles into the skin, pressure is applied over ‘acupuncture points’ which is supposed to provide a stimulus similar to needling. Therefore the effects of both treatments should theoretically be similar.

Acupressure could have several advantages over acupuncture:

  • it can be used for self-treatment
  • it is suitable for people with needle-phobia
  • it is painless
  • it is not invasive
  • it has less risks
  • it could be cheaper

But is acupressure really effective? What do the trial data tell us? Our own systematic review concluded that the effectiveness of acupressure is currently not well documented for any condition. But now there is a new study which might change this negative verdict.

The primary objective of this 3-armed RCT was to assess the effectiveness and cost-effectiveness of self-acupressure using wristbands compared with sham acupressure wristbands and standard care alone in the management of chemotherapy-induced nausea. 500 patients from outpatient chemotherapy clinics in three regions in the UK involving 14 different cancer units/centres were randomised to the wristband arm, the sham wristband arm and the standard care only arm. Participants were chemotherapy-naive cancer patients receiving chemotherapy of low, moderate and high emetogenic risk. The experimental group were given acupressure wristbands pressing the P6 point (anterior surface of the forearm). The Rhodes Index for Nausea/Vomiting, the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool and the Functional Assessment of Cancer Therapy General (FACT-G) served as outcome measures. At baseline, participants completed measures of anxiety/depression, nausea/vomiting expectation and expectations from using the wristbands.

Data were available for 361 participants for the primary outcome. The primary outcome analysis (nausea in cycle 1) revealed no statistically significant differences between the three arms. The median nausea experience in patients using wristbands (both real and sham ones) was somewhat lower than that in the anti-emetics only group (median nausea experience scores for the four cycles: standard care arm 1.43, 1.71, 1.14, 1.14; sham acupressure arm 0.57, 0.71, 0.71, 0.43; acupressure arm 1.00, 0.93, 0.43, 0). Women responded more favourably to the use of sham acupressure wristbands than men (odds ratio 0.35 for men and 2.02 for women in the sham acupressure group; 1.27 for men and 1.17 for women in the acupressure group). No significant differences were detected in relation to vomiting outcomes, anxiety and quality of life. Some transient adverse effects were reported, including tightness in the area of the wristbands, feeling uncomfortable when wearing them and minor swelling in the wristband area (n = 6). There were no statistically significant differences in the costs associated with the use of real acupressure band.

26 subjects took part in qualitative interviews. Participants perceived the wristbands (both real and sham) as effective and helpful in managing their nausea during chemotherapy.

The authors concluded that there were no statistically significant differences between the three arms in terms of nausea, vomiting and quality of life, although apparent resource use was less in both the real acupressure arm and the sham acupressure arm compared with standard care only; therefore; no clear conclusions can be drawn about the use of acupressure wristbands in the management of chemotherapy-related nausea and vomiting. However, the study provided encouraging evidence in relation to an improved nausea experience and some indications of possible cost savings to warrant further consideration of acupressure both in practice and in further clinical trials.

I could argue about several of the methodological details of this study. But I resist the temptation in order to focus on just one single point which I find important and which has implications beyond the realm of acupressure.

Why on earth do the authors conclude that no clear conclusions can be drawn about the use of acupressure wristbands in the management of chemotherapy-related nausea and vomiting? The stated aim of this RCT was to assess the effectiveness and cost-effectiveness of self-acupressure using wristbands compared with sham acupressure wristbands and standard care. The results failed to show significant differences of the primary outcome measures, consequently the conclusion cannot be “unclear”, it has to be that ACUPRESSURE WRIST BANDS ARE NOT MORE EFFECTIVE THAN SHAM ACUPRESSURE WRIST BANDS AS AN ADJUNCT TO ANTI-EMETIC DRUG TREATMENT (or something to that extent).

As long as RCTs of alternative therapies are run by evangelic believers in the respective therapy, we are bound to regularly encounter this lamentable phenomenon of white-washing negative findings with an inadequate conclusion. In my view, this is not research or science, it is pseudo-research or pseudo-science. And it is much more than a nuisance or a trivial matter; it is a waste of research funds, a waste of patients’ good will that has reached a point where people will lose trust in alternative medicine research. Someone should really do a systematic study to identify those research teams that regularly commit such scientific misconduct and ensure that they are cut off public funding and support.

A recent article  by a South African homeopath promoted the concept of homeopaths taking over the role of primary care practitioners. His argument essentially was that, in South Africa, homeopaths are well trained and thus adequately equipped to do this job responsibly. Responsibly, really? You find that hard to believe? Here are the essentials of his arguments including all his references in full. I think they are worth reading.

Currently, the Durban University of Technology (DUT) and the University of Johannesburg (UJ) offer degree’s in homoeopathy. This involves a 5-year full-time theoretical and practical training course, followed by a Master’s level research project. After fulfilment of these criteria, a Master’s Degree in Technology (Homoeopathy) is awarded. The course comprises of a strong core of medical subjects, such as the basic sciences of Anatomy, Physiology, Medical Microbiology, Biochemistry and Epidemiology, and the clinical sciences of Pathology and Diagnostics. This is complemented with subjects in Classical, Clinical and Modern Homoeopathy and Homoeopharmaceutics4,5

By law, any person practicing homoeopathy in South Africa must be registered with the Allied Health Professions Council of South Africa (AHPCSA). This is essential, as the Council ensures both medical and homoeopathic competency of practitioners, and that the activities of registered practitioners are closely monitored by the Professional Board. The purpose of the AHPCSA is to ensure that only those with legitimate qualifications of a high enough standard are registered and allowed to practice in South Africa, thus protecting the public against any fraudulent behaviour and illegal practitioners. Therefore, in order to ensure effective homoeopathic treatment, it is essential that any person wishing to prescribe homoeopathic medicine or practice homoeopathy in South Africa must be registered as a Homoeopathic Practitioner with the Allied Health Professions Council of South Africa. This includes conventional Medical Practitioners (dual registration is allowed for Medical Practitioners with both the Health Professions Council and AHPCSA)6,  as homoeopathy requires several years of training in order to apply effectively in clinical practice… 

Registration with the Council affords medico-legal rights similar to those of a medical professional, where treatment is limited to the scope of homoeopathic practice. Thus a homoeopath is firstly a trained diagnostician, and with successful registration with the Council, obtains the title Doctor. A homoeopath is trained and legally obliged to conduct a full medical history, a comprehensive clinical examination, and request further medical investigations, such as blood tests and X-rays, in order to fully assess patients. This is coupled with the ability to consult with specialist pathologists and other medical specialists when necessary, and refer a patient to the appropriate practitioner if the condition falls outside the scope of homoeopathic practice. A homoeopath may also legally issue a certificate of dispensation (‘Doctor’s note’) with appropriate evidence and within reason, and is deemed responsible for the diagnosis and treatment of patients under their care6. A homoeopath is not trained or licensed in any form of surgery, specialist diagnostics (e.g. colonoscopy or angiograms), cannot prescribe prescription medication and is not lawfully allowed to conduct intra-venous treatment of any kind. However, a registered homoeopath is licensed to use intra-muscular homoeopathic injectables in the treatment of various local or systemic complaints when necessary.

Conventional (allopathic) medicine generally targets specific biochemical processes with mostly chemically synthesised medication, in an attempt to suppress a symptom. However, in doing so, this usually negatively affects other biochemical reactions which results in an imbalance within the system. Homoeopathy, by contrast, seeks to re-establish a balance within the natural functioning of the body, restore proper function and results in the reduction or cessation of symptoms.  Homoeopathy therefore enables the body to self-regulate and self-heal, a process known as homeostasis that is intrinsic to every living organism.

Conventional medical treatment is by no means risk free. Iatrogenic (medically induced) deaths in the United States are estimated at 786 000 per year, deaths which are considered avoidable by medical doctors7,8. These figures put annual iatrogenic death in the American medical system above that of cardiovascular disease and cancer as the leading cause of death in that country9, a fact that is not widely reported! South African figures are not easily available, but it is likely that we have similar rates. Although conventional medications have a vital role, are sometimes necessary and can of-course be life-saving, all too often too many patients are put on chronic medication when there are numerous effective, natural, safe and scientifically substantiated options available….

According to the World Health Organisation (WHO), homeopathy is the second largest system of medicine in the world, and world-wide use continues to grow in developed and developing nations10. Homoeopathy is widely considered to be safe and effective, with both clinical and laboratory research providing evidence for the efficacy of homoeopathy11. As the range of potential conditions that homoeopathy can treat is almost limitless, and that treatment is not associated with adverse reactions, homoeopathy should be considered a first-line therapy for all ages. As homoeopaths in South Africa are considered primary health care practitioners, if a conventional approach is deemed necessary, and further diagnostics are required, your practitioner will not hesitate to refer you to the appropriate health care practitioner. Homeopathy is also used alongside conventional medicine and any other form of therapy, and should be seen as ‘complementary’ medicine and not ‘alternative’ medicine.

 

Conclusion

Homoeopathy is an approach that is widely considered to be safe, and when utilised correctly, can be effective for a wide range of conditions. As a primary health care practitioner, a homoeopath is able to handle all aspects of general practice and family health care, including diagnostics, case management and referral to other practitioners or medical specialists. A registered homoeopath is legally responsible to ensure the adequate treatment of their patients, and is accountable for all clinical decisions and advice. A registered homoeopath understands the role of conventional medicine, and will refer to the appropriate specialist in cases that fall outside the legal scope of practice.

 

 

References

1. http://homeopathyresource.wordpress.com/what-is-homeopathy (accessed 31 March 2010)

2.  Bloch R, Lewis B. Homoeopathy for the home. Cape Town, South Africa: Struik Publishers: 2003

3. http://www.dut.ac.za/site/awdep.asp?depnum=22609 (accessed 1 April 2010)

4. http://dutweb.dut.ac.za/handbooks/HEALTH%20Homoeopathy.pdf (accessed 1 April 2010)

5. http://www.uj.ac.za/EN/Faculties/health/departments/homeopathy/coursesandprogrammes/undergraduate/Pages/default.aspx (accessed 1 April 2010)

6. http://www.ahpcsa.co.za/pb_pbhnp_homoeopathy.htm (accessed 6 April 2010)

7. Starfield, B. Is US Health Really the Best in the World? JAMA 2000; 284(4).

8. Null G, Dean C, et al. Death by Medicine. Nutrition Institute of America 2003. 9. http://www4.dr-rath-foundation.org/features/death_by_medicine.html (accessed 7 April 2010)

10. http://ukiahcommunityblog.wordpress.com/2010/03/04/worldwide-popularity-grows-for-homeopathy-alternative-medicine/#comments (accessed 7 April 2010)

11. http://liga.iwmh.net/dokumente/upload/556c7_SCIEN_FRA_2009_final_approved.pdf (accessed 7 April 2010)

I found this article extremely revealing and scary. It gives us an important glimpse into the way some or perhaps even most homeopaths think. They clearly believe that:

1) Their training is sufficient for them to become competent primary care professionals, i.e. clinicians who are the first port of call for sick people  to be diagnosed and treated effectively.

2) Homeopathy is scientifically proven to be efficacious for an ‘almost limitless’ range of conditions. Interestingly, not a single reference is provided to support this claim. Nevertheless, homeopath believe it, and that seems to be enough.

3) Homeopaths seem convinced that they perfectly understand real medicine; yet all they really do is to denounce it as one of the biggest killer of mankind.

4) The fact that homeopaths cannot prescribe real medicine is not seen as a hindrance to their role as primary care practitioner; if anything, homeopaths consider this to be an advantage.

5) Homeopaths view registration with some sort of governing body as the ultimate legitimation of their trade. Once such regulatory measures are in place, the need to support any of their claims with evidence is nil and void.

This article did remind me of the wry statement that ‘HOMEOPATHY IS TO MEDICINE WHAT THE CARPET INDUSTRY IS TO AVIATION’. Homeopaths truly live on a different planet, a planet where belief is everything and responsibility is an alien concept. I certainly hope that they will not take over planet earth in a hurry. If I imagine a world where homeopaths dominate primary care in the way it is suggested in this article, I start having nightmares. It seems to me that people who harbour ideas of this type are not just deluded to the point of madness but they are a danger to public health.

This post will probably work best, if you have read the previous one describing how the parallel universe of acupuncture research insists on going in circles in order to avoid admitting that their treatment might not be as effective as they pretend. The way they achieve this is fairly simple: they conduct trials that are designed in such a way that they cannot possibly produce a negative result.

A brand-new investigation which was recently vociferously touted via press releases etc. as a major advance in proving the effectiveness of acupuncture is an excellent case in point. According to its authors, the aim of this study was to evaluate acupuncture versus usual care and counselling versus usual care for patients who continue to experience depression in primary care. This sounds alright, but wait!

755 patients with depression were randomised to one of three arms to 1)acupuncture, 2)counselling, and 3)usual care alone. The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months with secondary analyses over 12 months follow-up. Analysis was by intention-to-treat. PHQ-9 data were available for 614 patients at 3 months and 572 patients at 12 months. Patients attended a mean of 10 sessions for acupuncture and 9 sessions for counselling. Compared to usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 and 12 months for acupuncture and counselling.

From this, the authors conclude that both interventions were associated with significantly reduced depression at 3 months when compared to usual care alone.

Acupuncture for depression? Really? Our own systematic review with co-authors who are the most ardent apologists of acupuncture I have come across showed that the evidence is inconsistent on whether manual acupuncture is superior to sham… Therefore, I thought it might be a good idea to have a closer look at this new study.

One needs to search this article very closely indeed to find out that the authors did not actually evaluate acupuncture versus usual care and counselling versus usual care at all, and that comparisons were not made between acupuncture, counselling, and usual care (hints like the use of the word “alone” are all we get to guess that the authors’ text is outrageously misleading). Not even the methods section informs us what really happened in this trial. You find this hard to believe? Here is the unabbreviated part of the article that describes the interventions applied:

Patients allocated to the acupuncture and counselling groups were offered up to 12 sessions usually on a weekly basis. Participating acupuncturists were registered with the British Acupuncture Council with at least 3 years post-qualification experience. An acupuncture treatment protocol was developed and subsequently refined in consultation with participating acupuncturists. It allowed for customised treatments within a standardised theory-driven framework. Counselling was provided by members of the British Association for Counselling and Psychotherapy who were accredited or were eligible for accreditation having completed 400 supervised hours post-qualification. A manualised protocol, using a humanistic approach, was based on competences independently developed for Skills for Health. Practitioners recorded in logbooks the number and length of sessions, treatment provided, and adverse events. Further details of the two interventions are presented in Tables S2 and S3. Usual care, both NHS and private, was available according to need and monitored for all patients in all three groups for the purposes of comparison.

It is only in the results tables that we can determine what treatments were actually given; and these were:

1) Acupuncture PLUS usual care (i.e. medication)

2) Counselling PLUS usual care

3) Usual care

Its almost a ‘no-brainer’ that, if you compare A+B to B (or in this three-armed study A+B vs C+B vs B), you find that the former is more than the latter – unless A is a negative, of course. As acupuncture has significant placebo-effects, it never can be a negative, and thus this trial is an entirely foregone conclusion. As, in alternative medicine, one seems to need experimental proof even for ‘no-brainers’, we have some time ago demonstrated that this common sense theory is correct by conducting a systematic review of all acupuncture trials with such a design. We concluded that the ‘A + B versus B’ design is prone to false positive results…What makes this whole thing even worse is the fact that I once presented our review in a lecture where the lead author of the new trial was in the audience; so there can be no excuse of not being aware of the ‘no-brainer’.

Some might argue that this is a pragmatic trial, that it would have been unethical to not give anti-depressants to depressed patients and that therefore it was not possible to design this study differently. However, none of these arguments are convincing, if you analyse them closely (I might leave that to the comment section, if there is interest in such aspects). At the very minimum, the authors should have explained in full detail what interventions were given; and that means disclosing these essentials even in the abstract (and press release) – the part of the publication that is most widely read and quoted.

It is arguably unethical to ask patients’ co-operation, use research funds etc. for a study, the results of which were known even before the first patient had been recruited. And it is surely dishonest to hide the true nature of the design so very sneakily in the final report.

In my view, this trial begs at least 5 questions:

1) How on earth did it pass the peer review process of one of the most highly reputed medical journals?

2) How did the protocol get ethics approval?

3) How did it get funding?

4) Does the scientific community really allow itself to be fooled by such pseudo-research?

5) What do I do to not get depressed by studies of acupuncture for depression?

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