Monthly Archives: November 2013
Alternative medicine thrives in the realm of common chronic conditions which conventional medicine cannot cure and which respond well to treatment with placebos. Irritable bowel syndrome (IBS) is such a condition, and IBS-sufferers who are often frustrated with the symptomatic relief conventional medicine has to offer are only too keen to try any therapy that promises help. There is hardly an alternative therapy which does not claim to be the solution to IBS-symptoms: herbal medicine, mind-body interventions, homeopathy (the subject of my next post), acupuncture, even ‘MOXIBUSTION‘.
Moxibustion is a derivative of acupuncture; instead of needles, this method employs heat to stimulate acupuncture points. Proponents believe that the effects of moxibustion are roughly equivalent to those of acupuncture but many acupuncturists feel that they are less powerful. One website explains: Moxibustion is a traditional Chinese medicine technique that involves the burning of mugwort, a small, spongy herb, to facilitate healing. Moxibustion has been used throughout Asia for thousands of years; in fact, the actual Chinese character for acupuncture, translated literally, means “acupuncture-moxibustion.” The purpose of moxibustion, as with most forms of traditional Chinese medicine, is to strengthen the blood, stimulate the flow of qi, and maintain general health.
Many proponents of moxibustion claim that their treatment works for IBS. The evidence is, however, far less clear. Two recent meta-analyses might tell us more.
The first systematic review and meta-analysis was published by Korean researchers and aimed at critically evaluating the current evidence on moxibustion for improving global symptoms of IBS. The authors conducted extensive searches and found a total of 20 RCTs to be included in their analyses. The risk of bias in these studies was generally high. Compared with pharmacological medications, moxibustion significantly alleviated overall IBS symptoms but there was a moderate inconsistency among the 7 RCTs. Moxibustion combined with acupuncture was more effective than pharmacological therapy but a moderate inconsistency among the 4 studies was found. When moxibustion was added to pharmacological medications or herbal medicine, no additive benefit of moxibustion was shown compared with pharmacological medications or herbal medicine alone. One small sham-controlled trial found no difference between moxibustion and sham control in symptom severity. Moxibustion appeared to be associated with few adverse events but the evidence is limited due to poor reporting.
The authors concluded that moxibustion may provide benefit to IBS patients although the risk of bias in the included studies is relatively high. Future studies are necessary to confirm whether this finding is reproducible in carefully-designed and conducted trials and to firmly establish the place of moxibustion in current practice.
The way I see it, these conclusions are far too optimistic. There was only one RCT that controlled for placebo-effects, and the results of that study were negative. Thus I would conclude that some studies report effectiveness of moxibustion for IBS, yet the effects seem not to be caused by the treatment per se but are most likely due to a placebo-effect.
The second systematic review and meta-analysis was published by Chinese researchers and aimed at evaluating the clinical efficacy and safety of moxibustion and acupuncture in treatment of IBS. The authors included randomized and quasi-randomized clinical trials in their analyses and were able to include 11 trials. Their meta analysis suggests that the effectiveness of the combined methods of acupuncture and moxibustion is superior to conventional western medication treatment. The authors concluded that acupuncture-moxibustion for IBS is better than the conventional western medication treatment.
While the first meta-analysis was at least technically sound, the second seems to have too many flaws to mention: the search methodology was flimsy, many available studies were not included, their risk of bias was not assessed critically, the conclusions are based more on wishful thinking than on the available data, etc.
If we consider that moxibustion is a method of stimulating acupoints, we have to assume that it can at best be as effective as acupuncture, quite possibly slightly less. Thus it is relevant to see what the evidence tells us about acupuncture for IBS. The current Cochrane review of acupuncture for IBS shows that sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life.
I think I rest my case.
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:
- The evidence for spinal manipulation as a treatment for back pain is generally not brilliant, regardless of the type of therapist.
- There seem to be considerable differences according to the nature of the therapist.
- Physiotherapists seem to have relatively sound evidence to justify their manipulations.
- Chiropractors and osteopaths are not backed by evidence which is as reliable as they so often try to make us believe.
- 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 2008, The 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 experts concede that chiropractic spinal manipulation is effective for chronic low back pain (cLBP). But what is the right dose? There have been no full-scale trials of the optimal number of treatments with spinal manipulation. This study was aimed at filling this gap by trying to identify a dose-response relationship between the number of visits to a chiropractor for spinal manipulation and cLBP outcomes. A further aim was to determine the efficacy of manipulation by comparison with a light massage control.
The primary cLBP outcomes were the 100-point pain intensity scale and functional disability scales evaluated at the 12- and 24-week primary end points. Secondary outcomes included days with pain and functional disability, pain unpleasantness, global perceived improvement, medication use, and general health status.
One hundred patients with cLBP were randomized to each of 4 dose levels of care: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for 6 weeks. At sessions when manipulation was not assigned, the patients received a focused light massage control. Covariate-adjusted linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 18, 24, 39, and 52 weeks.
For the primary outcomes, mean pain and disability improvement in the manipulation groups were 20 points by 12 weeks, an effect that was sustainable to 52 weeks. Linear dose-response effects were small, reaching about two points per 6 manipulation sessions at 12 and 52 weeks for both variables. At 12 weeks, the greatest differences compared to the no-manipulation controls were found for 12 sessions (8.6 pain and 7.6 disability points); at 24 weeks, differences were negligible; and at 52 weeks, the greatest group differences were seen for 18 visits (5.9 pain and 8.8 disability points).
The authors concluded that the number of spinal manipulation visits had modest effects on cLBP outcomes above those of 18 hands-on visits to a chiropractor. Overall, 12 visits yielded the most favorable results but was not well distinguished from other dose levels.
This study is interesting because it confirms that the effects of chiropractic spinal manipulation as a treatment for cLBP are tiny and probably not clinically relevant. And even these tiny effects might not be due to the treatment per se but could be caused by residual confounding and bias.
As for the optimal dose, the authors suggest that, on average, 18 sessions might be the best. But again, we have to be clear that the dose-response effects were small and of doubtful clinical relevance. Since the therapeutic effects are tiny, it is obviously difficult to establish a dose-response relationship.
In view of the cost of chiropractic spinal manipulation and the uncertainty about its safety, I would probably not rate this approach as the treatment of choice but would consider the current Cochrane review which concludes that “high quality evidence suggests that there is no clinically relevant difference between spinal manipulation and other interventions for reducing pain and improving function in patients with chronic low-back pain” Personally, I think it is more prudent to recommend exercise, back school, massage or perhaps even yoga to cLBP-sufferers.
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’)
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?
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.
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!
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.