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

misleading consumers

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.

Some sceptics are convinced that, in alternative medicine, there is no evidence. This assumption is wrong, I am afraid, and statements of this nature can actually play into the hands of apologists of bogus treatments: they can then easily demonstrate the sceptics to be mistaken or “biased”, as they would probably say. The truth is that there is plenty of evidence – and lots of it is positive, at least at first glance.

Alternative medicine researchers have been very industrious during the last two decades to build up a sizable body of ‘evidence’. Consequently, one often finds data even for the most bizarre and implausible treatments. Take, for instance, the claim that homeopathy is an effective treatment for cancer. Those who promote this assumption have no difficulties in locating some weird in-vitro study that seems to support their opinion. When sceptics subsequently counter that in-vitro experiments tell us nothing about the clinical situation, apologists quickly unearth what they consider to be sound clinical evidence.

An example is this prospective observational 2011 study of cancer patients from two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (HG; n = 259), and one cohort with conventionally treated cancer patients (CG; n = 380). Its main outcome measures were the change of quality life after 3 months, after one year and impairment by fatigue, anxiety or depression. The results of this study show significant improvements in most of these endpoints, and the authors concluded that we observed an improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment.

Another, in some ways even better example is this 2005 observational study of 6544 consecutive patients from the Bristol Homeopathic Hospital. Every patient attending the hospital outpatient unit for a follow-up appointment was included, commencing with their first follow-up attendance. Of these patients 70.7% (n = 4627) reported positive health changes, with 50.7% (n = 3318) recording their improvement as better or much better. The authors concluded that homeopathic intervention offered positive health changes to a substantial proportion of a large cohort of patients with a wide range of chronic diseases.

The principle that is being followed here is simple:

  • believers in a bogus therapy conduct a clinical trial which is designed to generate an apparently positive finding;
  • the fact that the study cannot tell us anything about cause and effect is cleverly hidden or belittled;
  • they publish their findings in one of the many journals that specialise in this sort of nonsense;
  • they make sure that advocates across the world learn about their results;
  • the community of apologists of this treatment picks up the information without the slightest critical analysis;
  • the researchers conduct more and more of such pseudo-research;
  • nobody attempts to do some real science: the believers do not truly want to falsify their hypotheses, and the real scientists find it unreasonable to conduct research on utterly implausible interventions;
  • thus the body of false or misleading ‘evidence’ grows and grows;
  • proponents start publishing systematic reviews and meta-analyses of their studies which are devoid of critical input;
  • too few critics point out that these reviews are fatally flawed – ‘rubbish in, rubbish out’!
  • eventually politicians, journalists, health care professionals and other people who did not necessarily start out as believers in the bogus therapy are convinced that the body of evidence is impressive and justifies implementation;
  • important health care decisions are thus based on data which are false and misleading.

So, what can be done to prevent that such pseudo-evidence is mistaken as solid proof which might eventually mislead many into believing that bogus treatments are based on reasonably sound data? I think the following measures would be helpful:

  • authors should abstain from publishing over-enthusiastic conclusions which can all too easily be misinterpreted (given that the authors are believers in the therapy, this is not a realistic option);
  • editors might consider rejecting studies which contribute next to nothing to our current knowledge (given that these studies are usually published in journals that are in the business of promoting alternative medicine at any cost, this option is also not realistic);
  • if researchers report highly preliminary findings, there should be an obligation to do further studies in order to confirm or refute the initial results (not realistic either, I am afraid);
  • in case this does not happen, editors should consider retracting the paper reporting unconfirmed preliminary findings (utterly unrealistic).

What then can REALISTICALLY be done? I wish I knew the answer! All I can think of is that sceptics should educate the rest of the population to think and analyse such ‘evidence’ critically…but how realistic is that?

To write an AT FAP seems far from easy. The reason for this is simple: the reality of alternative medicine is often more fantastic than what our fantasy can make up. I hope you give it a try nevertheless and send me your stories. Here are AT FAPs 10, 11 and 12.

AT FAP No 10 (by Edzard Ernst)

IMPORTANT NEW ARTICLE IN ‘SOS’

A little-known but nevertheless important monthly journal called ‘Snake-Oil Salesman’ (SOS) has just published a remarkable article which, I think, deserves a mention here. The paper entitled HOW TO BE SUCCESSFUL IN HARD TIMES – A ROAD-MAP TO HEALTH AND WEALTH was authored by the chief executive of ‘Dutchy Originals Herbal Tinctures’ (DOHT) but the grapevine has it that Prince Charles had important input as well. The article explains that, during recessions, snake-oil salesmen are the ones who suffer most. People are just not educated enough to realise the importance of snake oil to public health and wealth, the paper stated. The sale figures for Dutchy Originals Herbal Detox Tincture, for instance, have been declining steadily ever since the world financial crisis started. And that during a time when people need our products most, the SOS-paper stressed. In view of this dire situation, the experts at DOHT have conducted a multi-facetted research project funded by HRH with the aim of designing an effective strategy that will boost sale figures of any snake-oil product, even during hard times. The main part of the SOS-article goes into the strategy point by point. Here I take the liberty of listing from the executive summary the main landmarks on the road to snake-oil success:

  • snake-oil is natural and natural means good, effective and foremost safe
  • synthetic medicines have none of these qualities, on the contrary, they are amongst the leading causes of death in most countries
  • snake-oils have stood the test of time; they were used much before today’s pharmaceuticals were even invented; in other words, they have been field tested for hundreds of years on millions of patients, and that is certainly more important than a few clinical trials
  •  snake-oils are thus supported by thousands of anecdotes and satisfied customers
  • highly respected pharmacies like Boots sell snake-oil and some are even available on the NHS
  • famous people, politicians and other pillars of society regularly use snake-oil; some even have a Royal warrant!
  • several Nobel-prize winners endorse snake-oil
  • compared to some modern drugs, snake-oil is cheap
  • snake-oil is not just for one or two conditions, it is a ‘cure all’
  • snake-oil is holistic, i.e. it takes care not just of your physical symptoms, like conventional drugs might do, it also increases wellness on the emotional and spiritual levels
  • snake-oil is in tune with the current emphasis on patient choice in health care

The SOS-article concludes with the advice for snake-oil manufacturers to employ the above-listed elements for an effective sales-strategy wisely. Do not use all you ammunition at once, writes the paper states, if you adapt a small selection of them carefully to optimally suit your product, you will be able to sell your snake-oil well, and your customers will be delighted forthwith. It really is a win/win situation.

AT FAP No 11 (by Edzard Ernst)

THE ‘NO BRAIN DRAIN’

At a recent meeting of the ‘International Medical Research Standard Panel’ (IMRSP), a governance body of major research funding bodies across the globe aimed at watching over, as well as increasing the quality of medical research, members surprised the world of science: in an official statement, they expressed their pleasure with and approval of alternative medicine.

The panel had commissioned an investigation into the impact on research standards of the plethora of alternative medicine research groups (AMRGs). The investigators applied powerful statistical methods and demonstrated an unexpected but consistent effect: In regions where particularly many AMRGs had emerged, the quality of mainstream medical research seemed to improve; there was even something akin to a dose-effect relationship: the more AMRGs, the larger the improvement in quality.

The panel concluded that alternative medicine seems to attract those researchers who are “perhaps not the brightest buttons in the drawer”, as they elegantly put it. This ‘no brain drain’, they argued, has the effect that the less gifted scientists are drawn away from mainstream research which, in turn, means that the quality of mainstream science increases. A spokesman said: “we are pleased that so many AMRGs are emerging these days and hope the trend continues for the benefit of real medicine”.

AT FAP No 12 (submitted by ‘stopthequacks’)

CASE REPORT:

Homeopathy successfully treats heart attack

As part of the intensive on-going research effort in the School of Homeopathy Education and Denialism (Shed) in our garden we’re delighted to report another success for homeopathy.

One of our leading researchers Del Usional was investigating homeopathic preparations of mains voltage alternating current. In these highly technical and detailed scientific experiments Del first cut the end off a kettle lead and  removed the shielding from the live and neutral wires. He then plugged in the cable and put the exposed copper ends into some fresh tap water in a clean jam jar.

This resulted in Del being thrown backwards and landing on the lawnmower and suffering a cardiac arrest. Luckily a colleague witnessed this and called the paramedics. However, with great presence of mind, he began to succus and dilute the water that remained in the jar. The paramedics arrived and despite defibrillating Del were having no success, the race was on. !0, 20, 30C and Del was still in problems, chest compressions and oxygen  were doing nothing. Finally 200C, we’d need a really potent remedy for this situation.

Just as the paramedics shocked Del again some of the 200C Alt Curr preparation was dripped on Del’s lips. Instantly he coughed and opened his eyes. He made a full recovery and the burns on his hands were successfully treated with homeopathic preparations (after skin grafting).

This clear and unequivocal result shows the power of homeopathy. The sceptics may well say we “don’t know” that it wasn’t quantum nano-bollock particles of copper from the wire rather than the electricity itself. But that’s just stupid – like cures like so it couldn’t be the copper, it is obviously the memory of the electricity in the water that had the effect.

We offered some of this highly potent medicine to the paramedic crew but they mysteriously declined, we can only assume they are in the pay of big Pharma.

HRH, The Prince of Wales has supported quackery on uncounted occasions. Several years ago, Charles even began selling his very own line of snake-oil. Now he surprises the British public with a brand new product: the ‘Baby Organic Hamper’. It is being sold for £195 under Prince Charles’ Highgrove-label and advertised with the following words:

A limited edition, hand-numbered hamper box packed with our new gentle organic bath and body products and a Highgrove Baby Bear. An ideal gift for new babies and parents. The blend of organic Roman chamomile and mandarin has been developed to be calm and gentle on delicate skin.

Roman chamomile has been known for centuries for its calming and relaxing benefits and also acts as an anti-inflammatory. Mandarin, known as ‘happy-oil’, has been chosen for its antiseptic properties and ability to boost immunity. Combined, this blend of ingredients produces a calming, protective barrier helping babies to relax. The exclusive, fully jointed Highgrove Baby Bear in antique mohair is made by Merrythought.

Provenance The unique bath and body collection has been created with Daniel Galvin Jr. in collaboration with Alexandra Soveral. Daniel Galvin Jr. has pioneered and developed organic products for hair and beauty over the last decade and Alexandra Soveral is a renowned and highly respected aromatherapist and facialist.

This new collection has been formulated in accordance with The Soil Association’s standards for health and beauty products, ensuring the purity of the range. Hamper Contents Body Lotion 100ml. Bath and Massage Oil 100ml. Flower Water 100ml. Bath and Body Wash 100ml. Balm 50ml. Highgrove Baby Bear.

Terms like relaxing benefits … anti-inflammatory … antiseptic properties … ability to boost immunity … protective barrier … helping babies to relax do undoubtedly amount to medical/therapeutic claims which, by definition (and by English law), need to be supported by evidence. I fail to see any sound evidence that either chamomile or mandarin oil or their combination have any of these effects on babies when applied as a body lotion, bath oil, massage oil, flower water, body wash.

The only RCT for mandarin-oil I could find concluded that results do not support a benefit of ‘M’ technique massage with or without mandarin oil in these young postoperative patients. Several reasons may account for this: massage given too soon after general anaesthesia, young patients’ fear of strangers touching them, patients not used to massage. For Roman Chamomile, I also identified just one relevant study; its results do not seem to suggest that the oil is the decisive factor in producing relaxation: Massage with or without essential oils appears to reduce levels of anxiety. Neither of these trials were done with babies, and crucially, no clinical trial at all seems to exist of the combination of the two oils as used in the Charles’ products.

As Charles and his team are clearly not scientists or health care experts, they took advice from people who might know about such matters: Daniel Galvin Jr. in collaboration with Alexandra Soveral. Daniel Galvin Jr. has pioneered and developed organic products for hair and beauty over the last decade and Alexandra Soveral is a renowned and highly respected aromatherapist and facialist.

This might look responsible at first glance; at closer scrutiny, Daniel Galvin turns out to be more an expert in cosmetics than in medicine; his own website explains: Born into the country’s most influential hairdressing dynasty, Daniel Galvin Jr, has been instrumental in the growth of the organic beauty market for the past 12 years and has been in the industry for 27 years. As a salon owner and creator of natural, organic professional haircare, he is at the forefront of colour expertise, with a client list including a ‘who’s who’ of TV personalities, British actors, royalty and London’s most beautiful socialites.

Alexandra Soveral might have once worked as an aromatherapist, but today she is the co-owner of a firm marketing natural beauty products; her website explains: We use rare & organic ingredients of the highest quality to create products that work in synergy with nature. We work towards a synthetic chemical free world. The scents from our essential oils evoke mind, body and soul reactions that promote well-being. We aim to continue our journey by always ensuring we source out new ways to improve our products and be kind to the planet.

At this point, two questions emerge in my mind: 1) is this just foolish nonsense or is it more sinister than that? 2) Why on earth does Charles venture into this sort of thing?

Ad 1

I would be inclined to file Charles’ baby-hamper under the category of ‘foolish nonsense’. Ok, it exploits the love of parents for their new-borns – £195 per item is not exactly cheap (even considering that it is HAND-NUMBERED!) – but the type of customer who might buy this product is probably not on the brink of financial hardship. The ‘foolish nonsense’ does, however, acquire a more sinister significance through the fact that the heir to the throne, who arguably should be an example to us all, yet again is responsible for unsubstantiated therapeutic claims. So, on balance, I think this is more than just foolish nonsense; in fact, it is yet another example of Charles misguiding the public through his passion for quackery.

Ad 2

Why does he do it? Does Charles need the money? No, unlike other quacks, he is not motivated by commercial interests. Is it for boosting his public image? Charles has certainly had an alternative bee under his royal bonnet for a very long time; in his quest to spread his abstruse notions of integrated health care, he has aquired an image to live up to. This new foray into quackery seems nevertheless baffling, in my view, because it is so obviously and cynically disregarding the law, regulations and evidence.

The way I see it, there are only two explanations for all this: either Charles is less aware of reality than one might have hoped, or he delegates trivial matters of this nature to one of his many sycophants without caring about the embarrassing details. Both of these possibilities are neither flattering for him nor reassuring for us…GOD SAVE THE QUEEN!

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.

According to a recent comment by Dr Larry Dossey, sceptics are afflicted by “randomania,” “statisticalitis,” “coincidentitis,” or “ODD” (Obsessive Debunking Disorder). I thought his opinion was hilariously funny; it shows that this prominent apologist of alternative medicine who claims that he is deeply rooted in the scientific world has, in fact, understood next to nothing about the scientific method. Like all quacks who have run out of rational arguments, he resorts to primitive ad hominem attacks in order to defend his bizarre notions. It also suggests that he could do with a little scepticism himself, perhaps.

In case anyone wonders how the long-obsolete notions of vitalism, which Dossey promotes, not just survive but are becoming again wide-spread, they only need to look into the best-selling books of Dossey and other vitalists. And it is not just lay people, the target audience of such books, who are taken by such nonsense. Health care professionals are by no means immune to these remnants from the prescientific era.

A recent survey is a good case in point. It was aimed at exploring US student pharmacists’ attitudes toward complementary and alternative medicine (CAM) and examine factors shaping students’ attitudes. In total, 887 student pharmacists in 10 U.S. colleges/schools of pharmacy took part. Student pharmacists’ attitudes regarding CAM were quantified using the attitudes toward CAM scale (15 items), attitudes toward specific CAM therapies (13 items), influence of factors (e.g., coursework, personal experience) on attitudes (18 items), and demographic characteristics (15 items).

The results show a mean (±SD) score on the attitudes toward CAM scale of 52.57 ± 7.65 (of a possible 75; higher score indicated more favorable attitudes). There were strong indications that students agreed with the concepts of vitalism. When asked about specific CAMs, many students revealed positive views even on the least plausible and least evidence-based modalities like homeopathy or Reiki.

Unsurprisingly, students agreed that a patient’s health beliefs should be integrated in the patient care process and that knowledge about CAM would be required in future pharmacy practice. Scores on the attitudes toward CAM scale varied by gender, race/ethnicity, type of institution, previous CAM coursework, and previous CAM use. Personal experience, pharmacy education, and family background were important factors shaping students’ attitudes.

The authors concluded: Student pharmacists hold generally favorable views of CAM, and both personal and educational factors shape their views. These results provide insight into factors shaping future pharmacists’ perceptions of CAM. Additional research is needed to examine how attitudes influence future pharmacists’ confidence and willingness to talk to patients about CAM.

I find the overwhelmingly positive views of pharmacists on even over quackery quite troubling. One of the few critical pharmacists shares my worries and commented that this survey on CAM attitudes paints a concerning portrait of American pharmacy students. However, limitations in the survey process may have created biases that could have exaggerated the overall perspective presented. More concerning than the results themselves are the researchers’ interpretation of this data: Critical and negative perspectives on CAM seem to be viewed as problematic, rather than positive examples of good critical thinking.

One lesson from surveys like these is they illustrate the educational goals of CAM proponents. Just like “integrative” medicine that is making its ways into academic hospital settings, CAM education on campus is another tactic that is being used by proponents to shape health professional attitudes and perspectives early in their careers. The objective is obvious: normalize pseudoscience with students, and watch it become embedded into pharmacy practice.

Is this going to change? Unless there is a deliberate and explicit attempt to call out and push back against the degradation of academic and scientific standards created by existing forms of CAM education and “integrative medicine” programs, we should expect to see a growing normalizing of pseudoscience in health professions like pharmacy.

I have criticised pharmacists’ attitude and behaviour towards alternative medicine more often than I care to remember. I even contributed an entire series of articles (around 10; I forgot the precise number) to THE PHARMACEUTICAL JOURNAL in an attempt to stimulate their abilities to think critically about alternative medicine. Pharmacists could certainly do with a high dose of “randomania,” “statisticalitis,” “coincidentitis,” or “ODD” (Obsessive Debunking Disorder). In particular, pharmacists who sell bogus remedies, i.e. virtually all retail pharmacists, need to remember that

  • they are breaking their own ethical code
  • they are putting profit before responsible health care
  • by selling bogus products, they give credibility to quackery
  • they are risking their reputation as professionals who provide evidence-based advice to the public
  • they might seriously endanger the health of many of their customers

In discussions about these issues, pharmacists usually defend themselves and argue that

  • those working in retail chains cannot do anything about this situation; head office decides what is sold on their premises and what not
  • many medicinal products we sell are as bogus as the alternative medicines in question
  • other health care professions are also not perfect, blameless or free of fault and error
  • many pharmacists, particularly those not working in retail, are aware of this lamentable situation but cannot do anything about it
  • retail pharmacists are both shopkeepers and health care professionals and are trying their very best to cope with this difficult dual role
  • we usually appreciate your work and critical comments but, in this case, you are talking nonsense

I do not agree with any of these arguments. Of course, each single individual pharmacist is fairly powerless when it comes to changing the system (but nobody forces anyone to work in a chain that breaks the ethical code of their profession). Yet pharmacists have their professional organisations, and it is up to each individual pharmacist to exert influence, if necessary pressure, via their professional bodies and representatives, such that eventually the system changes. In all this distasteful mess, only one thing seems certain: without a groundswell of opinion from pharmacists, nothing will happen simply because too many pharmacists are doing very nicely with fooling their customers into buying expensive rubbish.

And when eventually something does happen, it will almost certainly be a slow and long process until quackery has been fully expelled from retail pharmacies. My big concern is not so much the slowness of the process but the fact that, currently, I see virtually no groundswell of opinion that might produce anything. For the foreseeable future pharmacists seem to have decided to be content with a role as shopkeepers who do not sufficiently care about healthcare-ethics to change the status quo.

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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