conflict of interest
It almost goes without saying that alternative practitioners contribute importantly to the ‘sea of misinformation’ about alternative medicine. Again, I could write books about this subject but have to refrain myself and therefore will merely put quick spotlights on several types of practitioners, mostly drawing from my own research on these subjects.
A survey of more than 9000 patients of U.K. non-medically trained acupuncturists showed that a considerable number had received advice from their therapists about prescribed medicines. Since these acupuncturists hold no medical qualifications, they are not qualified to issue such advice. It is therefore clear to me that the advice given is likely to be misleading. In 2000, we directly asked the U.K. acupuncturists’ advice about electro-acupuncture treatment for smoking cessation, a treatment which we previously had identified to be ineffective. The advice we received was frequently not based on current best evidence and some of it also raised serious safety concerns (Schmidt, K., & Ernst, E. Internet advice by acupuncturists—a risk factor for cardiovascular patients? Perfusion,2002, 15: 44-50. Article not Medline-listed).
Many chiropractors from the UK and other countries make unsustainable therapeutic claims on their websites. In 2002, at the height of the ‘‘MMR scare’’ in Britain, we conducted a study revealing that a sizable proportion of U.K. chiropractors advised mothers against having the measles-mumps-rubella (MMR) jab for their children. A survey of the U.K. chiropractors demonstrated that an alarming percentage of the U.K. chiropractors fail to provide advice about the risks of spinal manipulation before commencing treatment. As these risks are, in fact, considerable, this behaviour amounts to misinformation and is an obvious violation of medical ethics.
With osteopaths, it is a very similar story; the main difference is that there are far less investigations than for chiropractors. This may be due to the fact that, in the US, osteopaths are not alternative but conventional clinicians with much the same training and skills as proper doctors. But in Europe, they are strictly alternative and make as many bogus claims as chiropractors. Systematic investigations are rare, but I only need to remind us of my recent blog-post where I pointed out that:
Most osteopaths treat children for a wide range of conditions and claim that their interventions are helpful. They believe that children are prone to structural problems which can be corrected by their interventions. Here is an example from just one of the numerous promotional websites on this topic:
STRUCTURAL PROBLEMS, such as those affecting the proper mobility and function of the body’s framework, can lead to a range of problems. These may include:
- Postural – such as scoliosis
- Respiratory – such as asthma
- Manifestations of brain injury – such as cerebral palsy and spasticity
- Developmental – with delayed physical or intellectual progress, perhaps triggering learning behaviour difficulties
- Infections – such as ear and throat infections or urinary disturbances, which may be recurrent.
OSTEOPATHY can assist in the prevention of health problems, helping children to make a smooth transition into normal, healthy adult life.
Encouraging evidence exists for some specific herbs in the treatment of some specific conditions. Yet, virtually no good evidence exists to suggest that the prescriptions of individualized herbal mixtures by traditional herbalists across the globe generate more good than harm. Despite this lack of evidence, herbalists do not seem to offer this information voluntarily to his or her patients. When we directly asked the UK herbalists for advice on a clinical case, we found that it was ‘‘misleading at best and dangerous at worst’’ . In other words, herbalists misinform their patients and the public about the value of their treatments.
Many non-medically trained homeopaths advise their clients against the immunization of children. Instead, these practitioners often recommend using ‘‘homeopathic vaccinations’’ for which no good evidence exists. For instance, the vice-chair of the board of directors of ‘‘The Society of Homeopaths’’ had a site with the following statements: ‘‘Homeopathic alternatives to children’s immunisation are now available.’’ ‘‘Our clinic offers alternative immunisation programmes for the whole family.’’ Such statements amounts to misinformation which puts children’s health at risk.
Other alternative practitioners
I have chosen the above-listed professions almost at random and could have selected any other type as well. Arguably, all alternative practitioners who employ unproven treatments – and that must be the vast majority – misinform their patients to some extend. The only way to avoid this is to say: ‘look, I am going to give you a therapy for which there is no good evidence – I hope you don’t mind’. If they did that, they would be out of business in a flash. It follows, I think, that being in business is tantamount to misleading patients.
And there is, of course, another way of misinforming patients which is often forgotten yet very important: withholding essential information. In all of health care, informed consent is a ‘sine qua non’. Alternative practitioners very rarely obtain informed consent from their patients. The reason seems obvious (see above). I would argue that not informing people when they should be informed is a form of misinformation.
In this context, it is worth mentioning an investigation we did in 2009: We obtained the ethical codes of the following bodies: Association of Naturopathic Practitioners, Association of Traditional Chinese Medicine (UK), Ayurvedic Practitioners Association, British Acupuncture Council, Complementary and Natural Healthcare Council, European Herbal Practitioners Association, General Chiropractic Council, General Osteopathic Council, General Regulatory Council for Complementary Therapies, National Institute of Medical Herbalists, Register of Chinese Herbal Medicine, Society of Homeopaths, UK Healers, Unified Register of Herbal Practitioners. We then extracted the statements from these codes referring to evidence-based practice (EBP). The results showed that only the General Chiropractic Council, the General Osteopathic Council and the General Regulatory Council for Complementary Therapies oblige their members to adopt EBP.
It seems that misinformation is an alternative practitioner’s daily bread. Without it, alternative therapists would need to confine their practice to the few treatments/conditions for which the evidence is positive. If they ever followed this strategy, they would hardly be able to earn a living.
Where can someone turn to who wants reliable information on alternative medicine? Many consumers and patients who ask themselves this question might already be somewhat weary of the Internet; everybody should by now know that websites can be dangerously misleading and usually commercially driven. What about books then? People still tend to trust books; they are written by experts, published by responsible enterprises, and sold through respectable outlets. Surely we can trust books, or can’t we?
The first thing that strikes you when you look into the subject is the fact that there are thousands of books on alternative medicine. You only need to visit a major book shop in your high street and admire the rows and rows of these volumes. Since many years, I have been evaluating such volumes, for instance, for our journal FACT where we regularly publish reviews of new material. Through this and other work, I have gained the impression, that most of these books are not worth the paper they are printed on and constitute a major contributor to the misinformation bombarding the consumer in this area. But that was just an impression, hard data would be better.
In 1998, we assessed for the first time the quality of books on alternative medicine ( Int J Risk Safety Med 1998, 11: 209-215. [For some reason, this article is not Medline-listed]). We chose a random sample of 6 such books all published in 1997, and we assessed their contents according to pre-defined criteria. The findings were sobering: the advice given in these volumes was frequently misleading, not based on good evidence and often inaccurate. If followed, it would have caused significant harm to patients.
In 2006, we conducted a similar investigation which we then reported in the first and second editions of our book THE DESKTOP GUIDE TO COMPLEMENTARY AND ALTERNATIVE MEDICINE. This time, we selected 7 best-sellers in alternative medicine and scrutinised them in much the same way. What we found was revealing. Almost every treatment seemed to be recommended for almost every condition. There was no agreement between the different books which therapy might be effective for which condition. Some treatments were even named as indications for a certain condition, while, in other books, they were listed as contra-indications for the same problem. A bewildering plethora of treatments was recommended for most conditions, for instance:
- addictions: 120 different treatments
- arthritis: 131 different treatments
- asthma: 119 different treatments
- cancer: 133 different treatments
- etc. etc.
This experience, which we published as a chapter in our book entitled AN EPITAPH TO OPINION-BASED MEDICINE, confirmed our suspicion that books on alternative medicine are a major contributor to the ‘sea of misinformation’ in this area – and, as they are read by many people, a significant risk factor to public health.
Why do publishers allow such rubbish to be printed? Why do so many authors spend their time misleading the public with their dangerous half-knowledge? Why do consumers buy such overtly uncritical nonsense? I do not know the answers, I must admit. But I know that books of this nature do a disservice to everyone involved, including the few respectable aspect of alternative medicine which might actually exist.
Has the situation changed since 2006? We cannot be sure; there is, to the best of my knowledge, no hard data; and nobody has repeated our investigations. But my impression from regularly reviewing new books for FACT and other journals is far from encouraging. I fear that our ‘epitaph to opinion-based medicine’ might have been a little premature.
The WHO is one of the most respected organisations in all of health care. It therefore might come as a surprise that it features in my series of institutions contributing to the ‘sea of misinformation’ in the area of alternative medicine. I have deliberately selected the WHO from many other organisations engaging in similarly misleading activities in order to show that even the most respectable bodies can have little enclaves of quackery hidden in their midst.
In 2006, the WHO invited Prince Charles to elaborate on his most bizarre concepts in relation to ‘integrated medicine’. He told the World Health Assembly in Geneva: “The proper mix of proven complementary, traditional and modern remedies, which emphasises the active participation of the patient, can help to create a powerful healing force in the world…Many of today’s complementary therapies are rooted in ancient traditions that intuitively understood the need to maintain balance and harmony with our minds, bodies and the natural world…Much of this knowledge, often based on oral traditions, is sadly being lost, yet orthodox medicine has so much to learn from it.” He urged countries across the globe to improve the health of their populations through a more integrated approach to health care. What he failed to mention is the fact that integrating disproven therapies into our clinical routine, as proponents of ‘integrated medicine’ demonstrably do, will not render medicine better or more compassionate but worse and less evidence-based. Or as my more brash US friends often point out: adding cow pie to apple pie is no improvement.
For many years during the early 2000s, the WHO had also been working on a document that would have promoted homeopathy worldwide. They had convened a panel of ‘experts’ including the Queen’s homeopath Peter Fisher. They advocated using this disproven treatment for potentially deadly diseases such as malaria, childhood diarrhoea, or TB as an alternative to conventional medicine. I had been invited to comment on a draft version of this document, but judging from the second draft, my criticism had been totally ignored. Fortunately, the publication of this disastrous advice could be stopped through a concerted initiative of concerned scientists who protested and pointed out that the implementation of this nonsense would kill millions.
In 2003, the WHO had already published a very similar report: a long consensus document on acupuncture. It includes the following list of diseases, symptoms or conditions for which acupuncture has been proved-through controlled trials-to be an effective treatment:
Adverse reactions to radiotherapy and/or chemotherapy
Allergic rhinitis (including hay fever)
Depression (including depressive neurosis and depression following stroke)
Dysentery, acute bacillary
Epigastralgia, acute (in peptic ulcer, acute and chronic gastritis, and gastrospasm)
Facial pain (including craniomandibular disorders)
Induction of labour
Low back pain
Malposition of fetus, correction of
Nausea and vomiting
Pain in dentistry (including dental pain and temporomandibular dysfunction)
Periarthritis of shoulder
If we compare these claims to the reliable evidence on the subject, we find that the vast majority of these indications is not supported by sound data (a fuller discussion on the WHO report and its history can be found in our book TRICK OR TREATMENT…). So, how can any organisation as well-respected globally as the WHO arrive at such outrageously misleading conclusions? The recipe for achieving this is relatively simple and time-tested by many similarly reputable institutions:
- One convenes a panel of ‘experts’ all or most of whom have a known preconceived opinion in the direction on has decided to go.
- One allows this panel to work out their own methodology for arriving at the conclusion they desire.
- One encourages cherry-picking of the data.
- One omits a meaningful evaluation of the quality of the reviewed studies.
- One prevents any type of critical assessment of the report such as peer-review by sceptics.
- If criticism does emerge nevertheless, one ignores it.
I should stress again that the WHO is, on the whole, a very good and useful organisation. This is precisely why I chose it for this post. As long as it is big enough, ANY such institution is likely to contain a little niche where woo and anti-science flourishes. There are far too many examples to mention, e.g. NICE, the NIH, UK and other governments. And this is the reason we must be watchful. It is all to human to assume that information is reliable simply because it originates from an authoritative source; the appeal to authority is appealing, of course, but it also is fallacious!
Colonic irrigation is the alternative therapy of celebrities (and those who like to imitate them): they tend to use it for all sorts of ailments, predominantly for loosing weight. And it works! When they have paid for the session, they are relieved of some cash as well as of about half a kilo of body weight. By the time they wake up the next morning, the money is still gone, but the weight is back. This is a most effective method for getting rid of some £s, but NOT an effective way for shedding a few pounds.
Numerous synonyms for colonic irrigation exist, e.g. colonic treatment, colon cleansing, rectal irrigation, colon therapy, colon hydrotherapy, colonic. The treatment is based on the ancient but obsolete theory of ‘autointoxication’, i.e. the body is assumed to poison itself with, ‘autotoxins’ which, in turn, cause various illnesses. So, it is implausible and there is also no evidence to suggest it is effective. But this does not stop professional organisations to make claims which are good for business.
My analysis of the claims made by professional organisations of practitioners of colonic irrigation across the globe aimed at assessing the therapeutic claims made by these institutions. Six such organisations were identified, and the contents of their websites were studied. The results showed that all of the six organisations make therapeutic claims on their websites. Frequently mentioned themes are ‘detoxification’, normalisation of intestinal functions, treatment of inflammatory bowel diseases and body weight reduction. The claims are mostly confined to symptomatic improvements – but there are exceptions, e.g. prevention of bowel cancer or sorting out Irritable Bowel Syndrome ‘once and for all’ . Other therapeutic claims pertain to asthma, menstrual irregularities, circulatory disorders, skin problems, improvement in energy levels and no longer requiring pharmacotherapy. All these claims represent testable hypotheses.
The question therefore arises whether these hypotheses have been tested and, if so, what the results of such investigations suggest? The use of colonic irrigation by alternative practitioners for any indications is not supported by any sound evidence at all. There are simply no trials to show effectiveness. Even worse is the fact that, although touted as safe, colonic irrigation can lead to serious complications.
The conclusion is therefore simple: colonic irrigation is neither demonstrably effective nor safe, and the information supplied by its professional organisations is therefore a significant contributor to the sea of misinformation in the realm of alternative medicine.
One thing that unites all (well, almost all, in my experience) proponents of alternative medicine is their intense dislike for BIG PHARMA. Essentially, they see this sector as:
- Driven by profit
- Employing unethical means to maximise profit
- Not caring for the needs of patients
- Attacking alternative medicine for fear of losing profit
And, of course, they claim that alternative medicine, LITTLE ALT MED, is fundamentally different from the cynically capitalist, malign BIG PHARMA.
I have no intention to defend the ways of the pharmaceutical industry – neither on this blog nor anywhere else. This industry is usually responsible to their share-holders and that constellation can lead to excesses which are counter-productive to our needs, to put it mildly. However, what I will question is the notion that LITTLE ALT MED is fundamentally different from BIG PHARMA.
We all have to make a living; to some extend at least we are therefore all driven by our desire to earn money. In alternative medicine, there are certainly not as many mega-enterprises as in the pharmaceutical industry but nobody can deny that many sizable firms exist which make a profit selling alternative remedies of one type or another.
And those parts of alternative medicine which are not into the sale of remedies, you may well ask – think of acupuncture, for instance. Well, those therapists are not exempt either from the need to make a living. Sure, this is on a different scale from BIG PHARMA, but it constitutes still a need for profit. If we multiply the relatively small sums involved by the vast number of therapists, the grand total of LITTLE ALT MED might approach similar orders of magnitude as that of BIG PHARMA.
Ok, but the alternative sector would not employ unethical means for securing or maximising profits! Wrong again, I am afraid.
My 20 years of experience of LITTLE ALT MED have let me witness several incidents which I would not hesitate to call unethical. One of the most recent and least pleasant, from my point of view, was the discovery that several German homeopathic manufacturers had given money to a ‘journalist’ who used these funds to systematically defame me.
What about the charge that BIG PHARMA does not care for the suffering patient? LITTLE ALT MED would never do that!!! Sadly this is a myth too.
Alternative practitioners and their organisations make a plethora of therapeutic claims which are not substantiated. Who would deny that misleading patients into making wrong health care decisions is not the opposite from ‘caring’? What seems even worse, in my view, is the behaviour that might follow the exposure of such behaviour. If someone is courageous enough to disclose the irresponsibility of bogus claims, he might be attacked or even taken to court by those who, in reality should be in the dock or, at least, do their utmost to get their house in order.
Finally, we have the notion of BIG PHARMA trying to suppress LITTLE ALT MED. I call this a myth too because I see absolutely no evidence for this rumour. Even those who circulate it can, when challenged, not produce any.
And, anyway, we all know how many of the big pharmaceutical firms buy into the alternative medicine market as soon as they see a commercially viable opportunity. Does that look like suppression?
So, what is the conclusion? BIG PHARMA can behave badly, no doubt, and when they do, I am as disgusted as the next man. However, LITTLE ALT MED also can behave badly – in fact, wherever there is money to be made, some people will behave badly some of the time.
Perhaps we should not judge an entire sector just by the bad actions of some of its members, but perhaps we should also consider whether or not it has done any good. Who would doubt that BIG PHARMA has helped to save lives – millions of lives?!
And now ask yourself: can we honestly say the same about LITTLE ALT MED?
Hot flushes are a big problem; they are not life-threatening, of course, but they do make life a misery for countless menopausal women. Hormone therapy is effective, but many women have gone off the idea since we know that hormone therapy might increase their risk of getting cancer and cardiovascular disease. So, what does work and is also risk-free? Acupuncture?
Together with researchers from Quebec, we wanted to determine whether acupuncture is effective for reducing hot flushes and for improving the quality of life of menopausal women. We decided to do this in form of a Cochrane review which was just published.
We searched 16 electronic databases in order to identify all relevant studies and included all RCTs comparing any type of acupuncture to no treatment/control or other treatments. Sixteen studies, with a total of 1155 women, were eligible for inclusion. Three review authors independently assessed trial eligibility and quality, and extracted data. We pooled data where appropriate.
Eight studies compared acupuncture versus sham acupuncture. No significant difference was found between the groups for hot flush frequency, but flushes were significantly less severe in the acupuncture group, with a small effect size. There was substantial heterogeneity for both these outcomes. In a post hoc sensitivity analysis excluding studies of women with breast cancer, heterogeneity was reduced to 0% for hot flush frequency and 34% for hot flush severity and there was no significant difference between the groups for either outcome. Three studies compared acupuncture with hormone therapy, and acupuncture turned out to be associated with significantly more frequent hot flushes. There was no significant difference between the groups for hot flush severity. One study compared electro-acupuncture with relaxation, and there was no significant difference between the groups for either hot flush frequency or hot flush severity. Four studies compared acupuncture with waiting list or no intervention. Traditional acupuncture was significantly more effective in reducing hot flush frequency, and was also significantly more effective in reducing hot flush severity. The effect size was moderate in both cases.
For quality of life measures, acupuncture was significantly less effective than HT, but traditional acupuncture was significantly more effective than no intervention. There was no significant difference between acupuncture and other comparators for quality of life. Data on adverse effects were lacking.
Our conclusion: We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.
I still have to meet an acupuncturist who is not convinced that acupuncture is not an effective treatment for hot flushes. You only need to go on the Internet to see the claims that are being made along those lines. Yet this review shows quite clearly that it is not better than placebo. It also demonstrates that studies which do suggest an effect do so because they fail to adequately control for a placebo response. This means that the benefit patients and therapists observe in routine clinical practice is not due to the acupuncture per se, but to the placebo-effect.
And what could be wrong with that? Quite a bit, is my answer; here are just 4 things that immediately spring into my mind:
1) Arguably, it is dishonest and unethical to use a placebo on ill patients in routine clinical practice and charge for it pretending it is a specific and effective treatment.
2) Placebo-effects are unreliable, small and usually of short duration.
3) In order to generate a placebo-effect, I don’t need a placebo-therapy; an effective one administered with compassion does that too (and generates specific effects on top of that).
4) Not all placebos are risk-free. Acupuncture, for instance, has been associated with serious complications.
The last point is interesting also in the context of our finding that the RCTs analysed failed to mention adverse-effects. This is a phenomenon we observe regularly in studies of alternative medicine: trialists tend to violate the most fundamental rules of research ethics by simply ignoring the need to report adverse-effects. In plain English, this is called ‘scientific misconduct’. Consequently, we find very little published evidence on this issue, and enthusiasts claim their treatment is risk-free, simply because no risks are being reported. Yet one wonders to what extend systematic under-reporting is the cause of that impression!
So, what about the legion of acupuncturists who earn a good part of their living by recommending to their patients acupuncture for hot flushes?
They may, of course, not know about the evidence which shows that it is not more than a placebo. Would this be ok then? No, emphatically no! All clinicians have a duty to be up to date regarding the scientific evidence in relation to the treatments they use. A therapist who does not abide by this fundamental rule of medical ethics is, in my view, a fraud. On the other hand, some acupuncturists might be well aware of the evidence and employ acupuncture nevertheless; after all, it brings good money! Well, I would say that such a therapist is a fraud too.
In a recent comment, US chiropractors stated that there is a growing recognition within the profession that the practicing chiropractor must be able to do the following: formulate a searchable clinical question, rapidly access the best evidence available, assess the quality of that evidence, determine if it is applicable to a particular patient or group of patients, and decide if and how to incorporate the evidence into the care being offered. In a word, they believe, that evidence-based chiropractic is possible, perhaps even (almost) a reality. For evidence-based practice to penetrate and transform a profession, the penetration must occur at two levels, they explain. One level is the degree to which individual practitioners possess the willingness and basic skills to search and assess the literature.
The second level, the authors explain, relates to whether the therapeutic interventions commonly employed by a particular health care discipline are supported by clinical research. The authors believe that a growing body of randomized controlled trials provides evidence of the effectiveness and safety of manual therapies. Is this really true, I wonder.
In support of these fairly bold statements, they cite a paper by Bronfort et al which, in their view, is currently the most comprehensive review of the evidence for the efficacy of manual therapies. According to these authors, the ‘Bronfort-report’ stated that evidence is inconclusive for pneumonia, stage 1 hypertension, pre-menstrual syndrome, nocturnal enuresis, and otitis media. The authors also believe that it is unlikely manipulation of the neck is causally related to stroke.
When I read this article, I could not stop myself from giggling. It seems to me that it provides pretty good evidence for the fact that the chiropractic profession is nowhere near reaching the stage where anyone could reasonably claim that chiropractors practice evidence-based medicine – not even the authors themselves seem to abide by the rules of evidence-based medicine! If they had truly been able to access the best evidence available and assess the quality of that evidence surely they would not have (mis-) quoted the ‘Bronfort-report’.
Bronfort’s overview was commissioned by the General Chiropractic Council, it was hastily compiled by ardent believers of chiropractic, published in a journal that non-chiropractors would not touch with a barge pole, and crucially it lacks some of the most important qualities of an unbiased systematic review. In my view, it is nothing short of a white-wash and not worth the paper it was printed on. Conclusions, such as the evidence regarding pneumonia, bed-wetting and otitis is inconclusive are just embarrassing; the correct conclusion is that the evidence fails to be positive for these and most other indications.
Similarly, if the authors had really studied and quoted the best evidence, how on earth could they have stated that manipulation of the neck cannot cause a stroke? The evidence for that is fairly overwhelming, and the only open question here is, how often do such complications occur? And even the biased ‘Bronfort-report’ states: Adverse events associated with manual treatment can be classified into two categories: 1) benign, minor or non-serious and 2) serious. Generally those that are benign are transient, mild to moderate in intensity, have little effect on activities, and are short lasting. Most commonly, these involve pain or discomfort to the musculoskeletal system. Less commonly, nausea, dizziness or tiredness are reported. Serious adverse events are disabling, require hospitalization and may be life-threatening. The most documented and discussed serious adverse event associated with spinal manipulation (specifically to the cervical spine) is vertebrobasilar artery (VBA) stroke. Less commonly reported are serious adverse events associated with lumbar spine manipulation, including lumbar disc herniation and cauda equina syndrome.
Evidence-based practice? Who are these chiropractors kidding? This article very neatly reflects the exact opposite. It ignores hundreds of peer-reviewed papers which are critical of chiropractic. The best one can do with this paper, I think, is to use it as a hilarious bit of involuntary humour or as a classic example of cherry-picking.
Come to think of it, chiropractic and evidence-based practice are contradictions in terms. Either a therapist claims to adjust mystical subluxations, in which case he/she does not practice evidence-based medicine. Or he/she practices evidence-based medicine, in which case adjusting mystical subluxations cannot be part of their therapeutic repertoire.
Towards the end of the article, we learn further fascinating things: the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article – oh, really?!?! Furthermore, we are told that this ‘research’ was funded by the ‘National Center of Complementary and Alternative Medicine’ (NCCAM) of the National Institutes of Health.
Can it be true? Does the otherwise most respectable NIH really give its name for such overt nonsense? Yes, it is true, and it is by no means the first time. In fact, our analysis shows that, when it comes to chiropractic, this organisation has sponsored almost nothing but utter rubbish, and our conclusion was blunt: the criticism repeatedly aimed at NCCAM seems justified, as far as their RCTs of chiropractic is concerned. It seems questionable whether such research is worthwhile.
S.O. Hansson from the Royal Institute of Technology, Stockholm, Sweden recently published an interesting comment on the law regulating the labelling of homeopathic products. In it he points out that, in the European Union (EU), all pre-packaged food products must contain a list of ingredients and their quantities. The list should be “accurate, clear and easy to understand for the consumer.” Similar requirements apply to pharmaceutical drugs and products – with one notable exception: homeopathic preparations.
For such products, the ingredients need not be disclosed on the label, which should instead specify “the scientific name of the stock or stocks followed by the degree of dilution.” The degree of homeopathic dilutions is, in turn, given in an understandable jargon, such as “C60”, which actually describes a dilution of 1:10120.
The point Hansson is trying to make is that very few health care professionals and even fewer consumers would understand such abbreviations and jargon. This means that, manufacturers of homeopathic products are legally permitted to hide the fact from their customers that their remedies typically contain no active ingredient at all. Considering that homeopathic products are typically bought ‘over the counter’ (OTC), i.e. without interference from a health care professional, just like food products, the exemption seems most surprising.
The most OTC homeopathic remedies are in the “C30” potency; this signifies a dilution of 1: 1 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000. The likelihood that any potency higher than “C12” might contain a single molecule of active ingredient is very close to zero. In order to comprehend the degree of dilution in homeopathy more fully, a visual approach might be best: for it to have a reasonable chance to contain just one single molecule of active ingredient, a homeopathic pill in a “C30” potency would need to have a diameter roughly equal to the distance between the earth and the sun. Homeopathy is truly impossible to swallow.
If homeopathic manufacturers were obliged to provide a description that is “accurate, clear and easy to understand for the consumer”, it would need to state that any dilution beyond “C12” contains no active molecule. It seems clear that such accurate, clear and understandable information would discourage most consumers to spend their hard-earned money for such nonsense. It seems thus to be obvious that the EU exemption of homeopathic remedies from honest labelling protects the interests of the homeopathic industry.
But surely, this is deeply wrong. Regulations in health care are not supposed to protect commercial interests, they should protect the consumer. In my view, it is time to change such profoundly misguided EU-regulation – in the interest of honesty, single standards, transparency and foremost in the interest of the patient and the consumer.
Even after all these years of full-time research into alternative medicine and uncounted exchanges with enthusiasts involved in this sector, I find the logic that is often applied in this field bewildering and the unproductiveness of the dialogue disturbing.
To explain what I mean, it be might best to publish a (fictitious, perhaps slightly exaggerated) debate between a critical thinker or scientist (S) and an uncritical proponent (P) of one particular form of alternative medicine.
P: Did you see this interesting study demonstrating that treatment X is now widely accepted, even by highly critical GPs at the cutting edge of health care?
S: This was a survey, not a ‘study’, and I never found the average GP “highly critical”. Surveys of this nature are fairly useless and they “demonstrate” nothing of real value.
P: Whatever, but it showed that GPs accept treatment X. This can only mean that they realise how safe and effective it is.
S: Not necessarily, GPs might just give in to consumer demand, or the sample was cleverly selected, or the question was asked in a leading manner, etc.
P: Hardly, because there is plenty of good evidence for treatment X.
S: Really? Show me.
P: There is this study here which proves that treatment X works and is risk-free.
S: The study was far too small to demonstrate safety, and it is wide open to multiple sources of bias. Therefore it does not conclusively show efficacy either.
P: You just say this because you don’t like its result! You have a closed mind!
In any case, it was merely an example! There are plenty more positive studies; do your research properly before you talk such nonsense.
S: I did do some research and I found a recent, high quality systematic review that arrived at a negative conclusion about the value of treatment X.
P: That review was done by sceptics who clearly have an axe to grind. It is based on studies which do not account for the intrinsic subtleties of treatment X. Therefore they are unfair tests of treatment X. These trials don’t really count at all. Every insider knows that! The fact that you cite it merely confirms that you do not understand what you are talking about.
S: It seems to me, that you like scientific evidence only when it confirms your belief. This, I am afraid, is what quacks tend to do!
P: I strongly object to being insulted in this way.
S: I did not insult you, I merely made a statement of fact.
P: If you like facts, you have to see that one needs to have sufficient expertise in treatment X in order to apply it properly and effectively. This important fact is neglected in all of those trials that report negative results; and that’s why they are negative. Simple! I really don’t understand why you are too stupid to understand this. Such studies do not show that treatment X is ineffective, but they demonstrate that the investigators were incompetent or hired with the remit to discredit treatment X.
S: I would have thought they are negative because they minimised bias and the danger of generating a false positive result.
P: No, by minimising bias, as you put it, these trials eliminated the factors that are important elements of treatment X.
S: Such as the placebo-effect?
P: That’s what you call it because you irrationally believe in reductionist science.
S: Science requires no belief, I think you are the believer here.
P: The fact is that scientists of your ilk negate all factors related to human interactions. Patients are no machines, you know, they need compassion; we clinicians know that because we work at the coal face of health care. Scientists in their ivory towers have no idea about patient care and just want science for science sake. This is not how you help patients. Show some compassion man!
S: I do know about the importance of compassion and care, but here we are discussing an entirely different topic, namely tests the efficacy or effectiveness of treatments, not patient-care. Let’s focus on one issue at a time.
P: You cannot separate things in this way. We have to take a holistic view. Patients are whole individuals, and you cannot do them justice by running artificial experiments. Every patient is different; clinical trials fail to account for this fact and are therefore fairly irrelevant to us and to our patients. Real life is very different from your imagined little experiments, you know.
S: These are platitudes that are nonsensical in this context and do not contribute anything meaningful to the present discussion. You do not seem to understand the methodology or purpose of a clinical trial.
P: That is typical! Whenever you run out of arguments, you try to change the subject or throw a few insults at me.
S: Not at all, I thought we were talking about clinical trials evaluating the effectiveness of treatment X.
P: That’s right; and they do show that it is effective, provided you consider those which are truly well-done by experts who know about treatment X and believe in it.
S: Not true. Only if you cherry-pick the data will you be able to produce an overall positive result for treatment X.
P: In any case, the real world results of clinical practice show very clearly that it works. It would not have survived for so long, if it didn’t. Nobody can deny that, and nobody should claim that silly little trials done in artificial circumstances are more meaningful than a wealth of experience.
S: Experience has little to do with reliable evidence.
P: To deny the value of experience is just stupid and clearly puts you in the wrong. I have shown you plenty of reliable evidence but you just ignore everything I say that does not go along with your narrow-minded notions about science; science is not the only way of knowing or comprehending things! Stop being obsessed with science.
S: No, you show me rubbish data and have little understanding of science, I am afraid.
P: Here we go again! I have had about enough of that and your blinkered arguments. We are going in circles because you are ignorant and arrogant. I have tried my best to show you the light, but your mind is closed. I offer true insight and you pay me back with insults. You and your cronies are in the pocket of BIG PHARMA. You are cynical, heartless and not interested in the wellbeing of patients. Next you will tell me to vaccinate my kids!
S: I think this is a waste of time.
P: Precisely! Everyone who has followed this debate will see very clearly that you are obsessed with reductionist science and incapable of considering the suffering of whole individuals. You want to deny patients a treatment that really helps them simply because you do not understand how treatment X works. Shame on you!!!
One of the best-selling supplements in the UK as well as several other countries is evening primrose oil (EPO). It is available via all sorts of outlets (even respectable pharmacies – or is that supposedly respectable?), and is being promoted for a wide range of conditions, including eczema. The NIH website is optimistic about its efficacy: “Evening primrose oil may have modest benefits for eczema.” Our brand-new Cochrane review was aimed at critically assessing the effects of oral EPO or borage oil (BO) on the symptoms of atopic eczema, and it casts considerable doubt on this somewhat uncritical view.
Here is what we did: We searched six databases as well as online trials registers and checked the bibliographies of included studies for further references to relevant trials. We corresponded with trial investigators and pharmaceutical companies to identify unpublished and ongoing trials. We also performed a separate search for adverse effects. All RCTs investigating oral intake of EPO or BO for eczema were included.
Two experts independently applied eligibility criteria, assessed risk of bias, and extracted data. We pooled dichotomous outcomes using risk ratios (RR), and continuous outcomes using the mean difference (MD). Where possible, we pooled study results using random-effects meta-analysis and tested statistical heterogeneity.
And here is what we found: 27 studies with a total of 1596 participants met our inclusion criteria: 19 studies tested EPO, and 8 studies assessed BO. A meta-analysis of results from 7 studies showed that EPO failed to improve global eczema symptoms as reported by participants and doctors. Treatment with BO also failed to improve global eczema symptoms. 67% of the studies had a low risk of bias for random sequence generation; 44%, for allocation concealment; 59%, for blinding; and 37%, for other biases.
Our conclusions were clear: Oral borage oil and evening primrose oil lack effect on eczema; improvement was similar to respective placebos used in trials. Oral BO and EPO are not effective treatments for eczema.
The very wide-spread notion that EPO is effective for eczema and a range of other conditions was originally promoted by the researcher turned entrepreneur, D F Horrobin, who claimed that several human diseases, including eczema, were due to a lack of fatty acid precursors and could thus be effectively treated with EPO. In the 1980s, Horrobin began to sell EPO supplements without having conclusively demonstrated their safety and efficacy; this led to confiscations and felony indictments in the US. As chief executive of Scotia Pharmaceuticals, Horrobin obtained licences for several EPO-preparations which later were withdrawn for lack of efficacy. Charges of mismanagement and fraud led to Horrobin being ousted as CEO by the board of the company. Later, Horrobin published a positive meta-analysis of EPO for eczema where he excluded the negative results of the largest published trial, but included results of 7 of his own unpublished studies. When scientists asked to examine the data, Horrobin’s legal team convinced the journal to refuse the request.
The evidence for EPO is negative not just for eczema. To the best of my knowledge, there is not a single disease or symptom for which it demonstrably works. Our own review of the data concluded ” EPO has not been established as an effective treatment for any condition”
Our new Cochrane review might help to put this long saga to rest. In my view, it is a fascinating tale of a scientist being blinded by creed and ambition. The results of such errors can be dramatic. Horrobin misled all of us: patients, health care professionals, scientists, regulators, decision makers, businessmen. This caused unnecessary expense and set back research efforts in a multitude of areas. I find the tale also fascinating from other perspectives; for instance, it begs the question why so many ‘respectable’ manufacturers and retailers are still allowed to make money on EPO. Is it not time to debunk the EPO-myth and say it as clearly as possible: EPO helps only those who financially profit from misleading the public?