I have said it so often that I hesitate to state it again: an uncritical researcher is a contradiction in terms. This begs the question as to how critical the researchers of alternative medicine truly are. In my experience, most tend to be uncritical in the extreme. But how would one go about providing evidence for this view? In a previous blog-post, I have suggested a fairly simple method: to calculate an index of negative conclusions drawn in the articles published by a specific researcher. This is what I wrote:
If we calculated the percentage of a researcher’s papers arriving at positive conclusions and divided this by the percentage of his papers drawing negative conclusions, we might have a useful measure. A realistic example might be the case of a clinical researcher who has published a total of 100 original articles. If 50% had positive and 50% negative conclusions about the efficacy of the therapy tested, his trustworthiness index (TI) would be 1.
Depending on what area of clinical medicine this person is working in, 1 might be a figure that is just about acceptable in terms of the trustworthiness of the author. If the TI goes beyond 1, we might get concerned; if it reaches 4 or more, we should get worried.
An example would be a researcher who has published 100 papers of which 80 are positive and 20 arrive at negative conclusions. His TI would consequently amount to 4. Most of us equipped with a healthy scepticism would consider this figure highly suspect.
So how would alternative medicine researchers do, if we applied this method for assessing their trustworthiness? Very poorly, I fear – but that is speculation! Let’s see some data. Let’s look at one prominent alternative medicine researcher and see. As an example, I have chosen Professor George Lewith (because his name is unique which avoids confusion with researchers), did a quick Medline search to identify the abstracts of his articles on alternative medicine, and extracted the crucial sentence from the conclusions of the most recent ones:
- The study design of registered TCM trials has improved in estimating sample size, use of blinding and placebos
- Real treatment was significantly different from sham demonstrating a moderate specific effect of PKP
- These findings highlight the importance of helping patients develop coherent illness representations about their LBP before trying to engage them in treatment-decisions, uptake, or adherence
- Existing theories of how context influences health outcomes could be expanded to better reflect the psychological components identified here, such as hope, desire, optimism and open-mindedness
- …mainstream science has moved on from the intellectual sterility and ad hominem attacks that characterise the sceptics’ movement
- Trustworthy and appropriate information about practitioners (e.g. from professional regulatory bodies) could empower patients to make confident choices when seeking individual complementary practitioners to consult
- Comparative effectiveness research is an emerging field and its development and impact must be reflected in future research strategies within complementary and integrative medicine
- The I-CAM-Q has low face validity and low acceptability, and is likely to produce biased estimates of CAM use if applied in England, Romania, Italy, The Netherlands or Spain
- Our main finding was of beta power decreases in primary somatosensory cortex and SFG, which opens up a line of future investigation regarding whether this contributes toward an underlying mechanism of acupuncture.
- …physiotherapy was appraised more negatively in the National Health Service than the private sector but osteopathy was appraised similarly within both health-care sectors
This is a bit tedious, I agree, so I stop after just 10 articles. But even this short list does clearly indicate the absence of negative conclusions. In fact, I see none at all – arguably a few neutral ones, but nothing negative. All is positive in the realm of alternative medicine research then? In case you don’t agree with that assumption, you might prefer to postulate that this particular alternative medicine researcher somehow avoids negative conclusions. And if you believe that, you are not far from considering that we are being misinformed.
Alternative medicine is not really a field where one might reasonably expect that rigorous research generates nothing but positive results; even to expect 50 or 40% of such findings would be quite optimistic. It follows, I think, that if researchers only find positives, something must be amiss. I have recently demonstrated that the most active research homeopathic group (Professor Witt from the Charite in Berlin) has published nothing but positive findings; even if the results were not quite positive, they managed to formulate a positive conclusion. Does anyone doubt that this amounts to misinformation?
So, I do have produced at least some tentative evidence for my suspicion that some alternative medicine researchers misinform us. But how precisely do they do it? I can think of several methods for avoiding publishing a negative result or conclusion, and I fear that all of them are popular with alternative medicine researchers:
- design the study in such a way that it cannot possibly give a negative result
- manipulate the data
- be inventive when it comes to statistics
- home in on to the one positive aspect your generally negative data might show
- do not write up your study; like this nobody will ever see your negative results
And why do they do it? My impression is that they use science not for testing their interventions but for proving them. Critical thinking is a skill that alternative medicine researchers do not seem to cultivate. Often they manage to hide this fact quite cleverly and for good reasons: no respectable funding body would give money for such an abuse of science! Nevertheless, the end-result is plain to see: no negative conclusions are being published!
There are at least two further implications of the fact that alternative medicine researchers misinform the public. The first concerns the academic centres in which these researchers are organised. If a prestigious university accommodates a research unit of alternative medicine, it gives considerable credence to alternative medicine itself. If the research that comes out of the unit is promotional pseudo-science, the result, in my view, amounts to misleading the public about the value of alternative medicine.
The second implication relates to the journals in which researchers of alternative medicine prefer to publish their articles. Today, there are several hundred journals specialised in alternative medicine. We have shown over and over again that these journals publish next to nothing in terms of negative results. In my view, this too amounts to systematic misinformation.
My conclusion from all this is depressing: the type of research that currently dominates alternative medicine is, in fact, pseudo-research aimed not at rigorously falsifying hypotheses but at promoting bogus treatments. In other words alternative medicine researchers crucially contribute to the ‘sea of misinformation’ in this area.
Numerous charities in the UK, US and elsewhere abuse their charitable status to misinform the pubic about alternative medicine. As the BMJ today published an article on one this organisation, I have chosen HOMEOPATHS WITHOUT BORDERS as an example – from a disturbingly vast choice, I hasten to add.
Sounds good, doesn’t it? HOMEOPATHS WITHOUT BORDERS (HWB). Unless, of course, you happen to know that this organisation has nothing whatsoever to do with the much-admired ‘Medicine without Borders’. HWB and its numerous national branches promote the use of homeopathic remedies worldwide, particularly in disaster-stricken and extremely poor areas. On their website, they state: When disaster strikes or in times of crisis, homeopathy can provide effective treatment for acute anxiety and the after effects of shock and trauma. No, no, no! Homeopathy is a placebo-therapy; it is not effective for anxiety or anything else, crisis or no crisis.
To get an impression about their activities, here are HWB’s projects for 2013:
- We plan to train as many as 40 additional Homeopathe Communautaires in 2013.
- We’ll support the Homeopathe Communautaires as they grow with study groups and ongoing clinical support provided by our volunteer homeopaths.
- The 2012 graduates of the Fundamentals program will become teachers, moving HWB toward achieving our vision of Haitians teaching Haitians.
- We hope to bring continuing homeopathic medical care to the people of Haiti, reaching nearly three times as many people as we did in 2012.
- We plan to initiate a training program in 2013 for Haitian midwives and birth attendants for homeopathic therapeutics in pregnancy, delivery and postpartum care.
All of this looks to me as though HWB should be re-named into HOMEOPATHS WITHOUT SCRUPLES! Under the guise of some humanitarian activity, they seem to promote misinformation about a disproven treatment for some of the most vulnerable people in the world. I cannot imagine many things that are more despicable than that.
David Shaw, senior research fellow, Institute for Biomedical Ethics, University of Basel, Switzerland, has just published the above-mentioned BMJ-article on HWB. He discloses their activities as deeply unethical and concludes: Despite Homeopaths Without Borders’ claims to the contrary, “homeopathic humanitarian help” is a contradiction in terms. Although providing food, water, and solace to people in areas affected by wars and natural disasters certainly constitutes valuable humanitarian work, any homeopathic treatment deceives patients into thinking they are receiving real treatment when they are not. Furthermore, training local people as homeopaths in affected areas amounts to exploiting vulnerable people to increase the reach of homeopathy. Much as an opportunistic infection can take hold when a person’s immune system is weakened, so Homeopaths Without Borders strikes when a country is weakened by a disaster. However, infections are expunged once the immune system recovers but Homeopaths Without Borders’ methods ensure that homeopathy persists in these countries long after the initial catastrophe has passed. Homeopathy is neither helpful nor humanitarian, and to claim otherwise to the victims of disasters amounts to exploitation of those in need of genuine aid.
I strongly recommend reading the article in full.
And lastly: can I encourage readers to post their experience with and knowledge of other woo-infested charities, please?
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!
One would have thought that, after losing their libel case against Simon Singh, chiropractors across the world might have got their act together and stopped claiming that their ‘bogus’ treatments are effective for conditions that lack both supporting evidence and scientific rationale. However, our investigation which was carried out in 2010, well after the libel action and the embarrassing defeat for chiropractors, sadly suggests otherwise.
It was aimed at determining the frequency of claims of chiropractors and their associations to treat a range of pre-defined conditions: asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash as examples of indications not supported by sound evidence, and lower back pain as an example of a condition supported by some evidence.
For this purpose, we conducted a review of 200 websites of individual chiropractors and 9 websites of chiropractic associations from Australia, Canada, New Zealand, the United Kingdom, and the United States between 1 October 2008 and 26 November 2008. Our outcome measure was either direct or indirect claims regarding the eight above-named conditions.
We found evidence that 95% chiropractor websites made unsubstantiated claims regarding at least one of these conditions. Four of the 9 (44%) associations made justified claims about lower back pain. All 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were also made about asthma, ear infection/earache/otitis media, neck pain.
We concluded that the majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.
Criticism regarding unsubstantiated claims have been raised even from within the profession of chiropractors (albeit very, very rarely); two chiropractors suggested that they are “evidence of a lack of professionalism and of quackery” that have evolved within a “tradition of dogma, fallacious reasoning, and unconventional attitudes about research and science”. I quite agree; instead of self-critical attitudes, chiropractors seem to develop a pathological state of denial.
The codes of ethics of chiropractors vary, of course, from nation to nation, but they tend to agree that information used must be factual and verifiable and should not be misleading or inaccurate. Unsubstantiated claims such as those disclosed by our investigation thus violate the rules of these codes. More importantly perhaps, they also misinform unsuspecting consumers and put public health at risk. This has now been going on for such a long time that it truly is embarrassing – not just for chiropractors (who seem to be immune to embarrassment) but to regulators and even to society at large who tolerates such abuse at the hands of the chiropractic profession.
Considering more recent events in the realm of chiropractic, it seems highly unlikely that the situation is going to improve any time soon. Misinformation in the name of maximising income , it often seems to me, is what chiropractic is really about.
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.
The UK ‘Society of Homeopaths’ (SoH) is the largest professional organisation of UK non-doctor, so-called lay- homeopaths. On their website, the SoH made very specific claims about homeopathy; in particular, they listed conditions for which homeopathy had allegedly been proven to be effective. These claims have now thoroughly been debunked, and the evidence the SoH produced in support of their claims has been shown to be misleading, cherry-picked or misinterpreted.
I have no idea who conducted the above-named investigation and made a youtube video of it, but I think it is essentially correct and well worth watching. My own experiences with the SoH relate mainly to two encounters.
The first was a complaint I made about one of their high-ranking officers, Ralf Jeutter. He had been promotiong homeopathic vaccinations on his website (needless to stress, I think, that there is no evidence to support the notion that homeopathic vaccinations are effective). As I felt that the SoH dragged their feet pursuing my complaint, I had to send several reminders. Eventually, they considered it and concluded that Reuter had done nothing wrong. This, presumably, is the reason why, even today, he can state on his website that Homeopathy is used to help individuals in dealing better with kinds of infections such as leptospirosis, meningitis and cholera. All is fine, it seems as long as a disclaimer is added: Any information obtained here is not to be construed as medical OR legal advice. The decision to vaccinate and how you implement that decision is yours and yours alone. The evidence for the efficacy of homeopathic immunisation is ‘anecdotal’. That means it is based on individuals’ reports past and present.
My second encounter with the SoH relates to my 2010 analysis of the SoH code of ethics and their adherence to it. The code demanded that:
- ‘all speculative theories will be stated as such and clearly distinguished’
- ‘no advertising may be used which expressly or implicitly claims to cure named diseases’
- ‘Advertising shall not be false, fraudulent, misleading, deceptive, extravagant or sensational.’
Encouraged by these assurances, I decided to study the websites of some members of the SoH, and soon discovered numerous and very obvious violations of the above-mentioned imperatives. In an attempt to find the root of these transgressions, I scrutinised the SoH’s own website where I found a multitude violations on all levels of the SoH’s own code of ethics. Many of the violations related to claims which were not supported by evidence. In other words, the largest professional UK organisation of lay- homeopaths misled the public in several rather devious ways:
they pretended to adhere to a code of ethics which forbids members to mislead the public
SoH -members nevertheless did mislead the public in ways that public health at risk
and they did so not least because the SoH followed exactly the same strategy
thus the SoH violated its own code of ethics to the detriment of public health.
My analysis was conducted a while ago, and some might hope that the SoH has stopped systematically misleading the public. This hope, however, is harshly disappointed when you watch the brand-new video entitled TESTING HOMEOPATHY mentioned above. As the SoH is about to celebrate 35 years of wisdom, courage, knowledge and prosperity, I do wonder whether this should not be 35 years of dangerously misleading the public.
What do you think?
In my last post and several others before, I have stated that consumers are incessantly being mislead about the value of alternative medicine. This statement requires evidence, and I intend to provide it – not just in one post but in a series of posts following in fast succession.
I start with an investigation we did over a decade ago. Its primary aim was to determine which complementary therapies are believed by their respective representing UK professional organizations to be suited for which medical conditions.
For this purpose, we sent out 223 questionnaires to CAM organizations representing a single CAM therapy (yes, amazingly that many such institutions exist just in the UK!). They were asked to list the 15 conditions which they felt benefited most from their specific CAM therapy, as well as the 15 most important contra-indications, the typical costs of initial and any subsequent treatments and the average length of training required to become a fully qualified practitioner. The conditions and contra-indications quoted by responding CAM organizations were recorded and the top five of each were determined. Treatment costs and hours of training were expressed as ranges.
Only 66 questionnaires were returned. Taking undelivered questionnaires into account, the response rate was 34%. Two or more responses were received from CAM organizations representing twelve therapies: aromatherapy, Bach flower remedies, Bowen technique, chiropractic, homoeopathy, hypnotherapy, magnet therapy, massage, nutrition, reflexology, Reiki and yoga.
The top seven common conditions deemed to benefit from all twelve therapies, in order of frequency, were: stress/anxiety, headaches/migraine, back pain, respiratory problems (including asthma), insomnia, cardiovascular problems and musculoskeletal problems. It is perhaps important at this stage to point out that some of these conditions are serious, even life-threatening. Aromatherapy, Bach flower remedies, hypnotherapy, massage, nutrition, reflexology, Reiki and yoga were all recommended as suitable treatments for stress/anxiety. Aromatherapy, Bowen technique, chiropractic, hypnotherapy, massage, nutrition, reflexology, Reiki and yoga were all recommended for headache/migraine. Bowen technique, chiropractic, magnet therapy, massage, reflexology and yoga were recommended for back pain. None of the therapies cost more than £60 for an initial consultation and treatment. No correlation between length of training and treatment cost was noted.
I think, this article provides ample evidence to show that, at least in the UK, professional organisations of alternative medicine readily issue statements about the effectiveness of specific alternative therapies which are not supported by evidence. Several years later, Simon Singh noted that phenomenon in a Guardian-comment and wrote about the British Chiropractic Association “they happily promote bogus claims”. He was famously sued for libel but won the case. Simon had picked the BCA merely by chance. The frightening thought is that he could have targeted any other of the 66 organisations from our investigation: they all seem to promote bogus claims quite happily.
Several findings from our study stood out for being particularly worrying: according to the respective professional organisation, Bach Flower Remedies were deemed to be effective for cancer and AIDS, for instance. If their peers put out such irresponsible nonsense, we should not be amazed at the claims made by the practitioners. And if the practitioners tell such ‘tall tales’ to their clients, to journalists and to everyone else, how can we be amazed that we seem to be drowning in a sea of misinformation?
Can one design a clinical study in such a way that it looks highly scientific but, at the same time, has zero chances of generating a finding that the investigators do not want? In other words, can one create false positive findings at will and get away with it? I think it is possible; what is more, I believe that, in alternative medicine, this sort of thing happens all the time. Let me show you how it is done; four main points usually suffice:
- The first rule is that it ought to be an RCT, if not, critics will say the result was due to selection bias. Only RCTs have the reputation of being ‘top notch’.
- Once we are clear about this design feature, we need to define the patient population. Here the trick is to select individuals with an illness that cannot be quantified objectively. Depression, stress, fatigue…the choice is vast. The aim must be to employ an outcome measure that is well-accepted, validated etc. but which nevertheless is entirely subjective.
- Now we need to consider the treatment to be “tested” in our study. Obviously we take the one we are fond of and want to “prove”. It helps tremendously, if this intervention has an exotic name and involves some exotic activity; this raises our patients’ expectations which will affect the result. And it is important that the treatment is a pleasant experience; patients must like it. Finally it should involve not just one but several sessions in which the patient can be persuaded that our treatment is the best thing since sliced bread – even if, in fact, it is entirely bogus.
- We also need to make sure that, for our particular therapy, no universally accepted placebo exists which would allow patient-blinding. That would be fairly disastrous. And we certainly do not want to be innovative and create such a placebo either; we just pretend that controlling for placebo-effects is impossible or undesirable. By far the best solution would be to give the control group no treatment at all. Like this, they are bound to be disappointed for missing out a pleasant experience which, in turn, will contribute to unfavourable outcomes in the control group. This little trick will, of course, make the results in the experimental group look even better.
That’s about it! No matter how ineffective our treatment is, there is no conceivable way our study can generate a negative result; we are in the pink!
Now we only need to run the trial and publish the positive results. It might be advisable to recruit several co-authors for the publication – that looks more serious and is not too difficult: people are only too keen to prolong their publication-list. And we might want to publish our study in one of the many CAM-journals that are not too critical, as long as the result is positive.
Once our article is in print, we can legitimately claim that our bogus treatment is evidence-based. With a bit of luck, other research groups will proceed in the same way and soon we will have not just one but several positive studies. If not, we need to do two or three more trials along the same lines. The aim is to eventually do a meta-analysis that yields a convincingly positive verdict on our phony intervention.
You might think that I am exaggerating beyond measure. Perhaps a bit, I admit, but I am not all that far from the truth, believe me. You want proof? What about this one?
Researchers from the Charite in Berlin just published an RCT to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress.
To prevent allegations of exaggeration, selective reporting, spin etc. I take the liberty of reproducing the abstract of this study unaltered:
Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion) or to no study intervention (waiting group). Primary outcome parameter was the difference to baseline on Cohen’s Perceived Stress Scale (CPSS) after 4 weeks between intervention and control.
Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years) were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years) to the control group. Adjusted CPSS differences after 4 weeks were -8.8 [95% CI: -10.8; -6.8] (mean 24.2 [22.2; 26.2]) in the intervention group and -1.0 [-2.9; 0.9] (mean 32.0 [30.1; 33.9]) in the control group, resulting in a highly significant group difference (P < 0.001).
Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up
This whole thing could just be a bit of innocent fun, but I am afraid it is neither innocent nor fun, it is, in fact, quite serious. If we accept manipulated trials as evidence, we do a disservice to science, medicine and, most importantly, to patients. If the result of a trial is knowable before the study has even started, it is unethical to run the study. If the trial is not a true test but a simple promotional exercise, research degenerates into a farcical pseudo-science. If we abuse our patients’ willingness to participate in research, we jeopardise more serious investigations for the benefit of us all. If we misuse the scarce funds available for research, we will not have the money to conduct much needed investigations. If we tarnish the reputation of clinical research, we hinder progress.
“Wer heilt hat recht”. Every German knows this saying and far too many believe it. Literally translated, it means THE ONE WHO HEALS IS RIGHT, and indicates that, in health care, the proof of efficacy of a treatment is self-evident: if a clinician administers a treatment and the patient improves, she was right in prescribing it and the treatment must have been efficacious. The only English saying which is vaguely similar (but rarely used for therapies) is THE PROOF OF THE PUDDING IS IN THE EATING, translated into a medical context: the proof of the treatment is in the clinical outcome.
The saying is German but the sentiment behind it is amazingly widespread across the world, particularly the alternative one. If I had a fiver for each time a German journalist has asked me to comment on this ‘argument’ I could probably invite all my readers for a beer in the pub. The notion seems to be irresistibly appealing and journalists, consumers, patients, politicians etc. fall for it like flies. It is popular foremost as a counter-argument against scientists’ objections to homeopathy and similar placebo-treatments. If the homeopath cured her patient, then she and her treatments are evidently fine!
It is time, I think, that I scrutinise the argument and refute it once and for all.
The very first thing to note is that placebos never cure a condition. They might alleviate symptoms, but cure? No!
The next issue relates to causality. The saying assumes that the sole reason for the clinical outcome is the treatment. Yet, if a patient’s symptoms improve, the reason might have been the prescribed treatment, but this is just one of a multitude of different options, e.g.:
- the placebo-effect
- the regression towards the mean
- the natural history of the condition
- the Hawthorne effect
- the compassion of the clinician
- other treatments that might have been administered in parallel
Often it is a complex mixture of these and possibly other phenomena that is responsible and, unless we run a proper clinical trial, we cannot even guess the relative importance of each factor. To claim in such a messy situation that the treatment given by the clinician was the cause of the improvement, is ridiculously simplistic and overtly wrong.
But that is precisely what the saying WER HEILT HAT RECHT does. It assumes a simple mono-causal relationship that never exists in clinical settings. And, annoyingly, it somewhat arrogantly dismisses any scientific evidence by implying that the anecdotal observation is so much more accurate and relevant.
The true monstrosity of the saying can be easily disclosed with a little thought experiment. Let’s assume the saying is correct and we adopt it as a major axiom in health care. This would have all sorts of terrible consequences. For instance, any pharmaceutical company would be allowed to produce colourful placebos and sell them for a premium; they would only need to show that some patients do experience some relief after taking it. THE ONE WHO HEALS IS RIGHT!
The saying is a dangerously misleading platitude. That it happens to be German and that the Germans remain so frightfully fond of it disturbs me. That the notion, in one way or another, is deeply ingrained in the mind of charlatans across the world is worrying but hardly surprising – after all, it is said to have been coined by Samuel Hahnemann.