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

alternative medicine

Can anyone think of celebrities promoting conventional treatments? Jane Fonda advertising blood pressure control?  Brad Pit advocating early intervention after stroke? Boris Johnson making sure that diabetics check their metabolic control? Angelina Jollie suggesting that we all immunise our kids?  Well, I cannot – not many anyway. But I certainly could list numerous VIPs doing their very best to promote quackery and anti-vaccination propaganda.

We may smile about such vain attempts to catch the lime-light, but the influence of celebrities on consumers’ behaviour might be huge and detrimental. It is difficult to estimate, and I am not aware of much reliable research data in this area. But my instinct tells me that, in the realm of alternative medicine, the ‘celebrity-factor’ is a very strong determinant of alternative medicine usage, and one that significantly contributes to the ‘sea of misinformation’ in this area.

With one of our research projects at Exeter, we wanted to identify reports on celebrities’ use of alternative medicine. We searched our department’s extensive data files, the Internet via the Google search engine, and the UK popular press via LexisNexis using the search terms “celebrity”, “alternative medicine” and “complementary medicine”. We considered articles published during 2005 and 2006 for inclusion in our study.

Using this strategy, we identified 38 celebrities using a wide range of alternative medicine interventions. Homeopathy, acupuncture and Ayurveda were the most popular modalities. The conclusion we drew from this investigation was that there may be many reasons why consumers use alternative medicine, and wanting to imitate their idols is one of them.

Some pro-alternative sites even boast with the fact that celebrities use quackery: Oprah is into it; so are Madonna, Uma and Gwyneth. No, it’s not a club for high-profile women with unique names. It’s alternative medicine. As ABC News describes, alternative medicine remains an option outside of “standard care” practices that physicians employ. But it has had a sweeping effect on the country, and celebrities have played a role in its popularity.

This, I think, indicates that celebrities are being used as a marketing tool for the alternative medicine industry. Both seem to feed of each other: the industry turns the celebrity endorsements into profit, and the celebrities turn the interest of the press into the all-important fame needed for remaining a celebrity. If a star displays her shapely back in a low-cut dress, nobody bats an eyelash; if, however, her back is covered with marks from today’s cupping-therapy, the press goes crazy – and, as a consequence, cupping therapy experiences a boost. The fact that there is no good evidence for this treatment becomes entirely irrelevant, and so is the fact that thousands of people will hence forward waste their money on ineffective treatments, some of them possibly even losing valuable time for curing a life-threatening disease.

Who wants such a pedestrian thing as evidence? We are in the realm of the high-fliers who cannot be bothered with such trivialities – unless, of course, they are really ill, in which case they will not consult their local quack but use the best conventional medicine on offer. Has anyone heard of a member of the Royal family being rushed to a homeopathic hospital when acutely ill?

In my experience, a VIP’s conviction in promoting quackery is inversely correlated to his expertise and intelligence. Prince Charles seems to want the entire British nation to be force-fed on quackery – anything from Gerson diet to homeopathy. He knows virtually nothing about medicine, but makes up for this deficit through a strong and quasi-religious belief in quackery. Scientists tend to laugh about his quest and might say with a slightly pitiful smile “but he is full of good will!”. Yet I am not sure that it is all that funny, nor am I convinced that good will is enough. Misleading the public about matters of health care is not amusing. And good will and conviction render quacks not less but more dangerous.

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)
Biliary colic
Depression (including depressive neurosis and depression following stroke)
Dysentery, acute bacillary
Dysmenorrhoea, primary
Epigastralgia, acute (in peptic ulcer, acute and chronic gastritis, and gastrospasm)
Facial pain (including craniomandibular disorders)
Headache
Hypertension, essential
Hypotension, primary
Induction of labour
Knee pain
Leukopenia
Low back pain
Malposition of fetus, correction of
Morning sickness
Nausea and vomiting
Neck pain
Pain in dentistry (including dental pain and temporomandibular dysfunction)
Periarthritis of shoulder
Postoperative pain
Renal colic
Rheumatoid arthritis
Sciatica
Sprain

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!

 

Imagine: you consult your doctor and he says:  “I am so sorry, but I have bad news: the tests have shown that you have cancer”. You go home and feel as though someone has hit you with a sledge hammer. You cry a lot and your thoughts go round in circles. A complete nightmare unfolds; you sometimes think you are dreaming but reality soon catches up with you.

A few days later, you have an appointment with the oncologist who explains the treatment plan. You feel there is no choice and you agree to it. After the first chemotherapy, you lose your hair, your well-being, your dignity, your control and your patience – time to investigate what else there is on offer. There must be an alternative!

By then lots of well-wishers will have mentioned to you that the conventional route is but one of many: there are, in fact, alternatives!!! You go on the internet and find not just a few, you find millions of website promoting hundreds of solutions – anything from diets to herbal remedies, from homeopathy to faith-healing. All are being promoted as cures for your cancer, and all are free of those nasty side-effects which make your life hell at the moment. You think “there is a choice after all”.

Who would not be tempted by these options advertised in the most glorious terms? Who would not begin to distrust the oncologists who kindly but firmly insist that ‘alternative cancer cures’ are bogus? Who would not want to get rid of the cancer and the side-effects in one genial master-stroke?

Cancer patients yearn for hope and are extremely vulnerable to such influences.  I do not know a single one who, faced with the diagnosis and all it entails, has not looked at the ‘alternatives’. This is why it would be so very important that the websites informing patients and their carers convey accurate and responsible information. But do they?

One of our research projects at Exeter had been aimed at assessing the quality of the websites advising patients on alternative treatments for cancer. For this purpose, we evaluated a total of 32 sites which cancer patients were most likely to consult according to pre-defined criteria – in other words, we assessed the most frequented websites for cancer.

Our results were shocking: many of these sites were of poor quality and most of them recommended a plethora of unproven treatments for cancer, most frequently herbal remedies, diets and mind-body therapies. In our estimation, at least three of them were outright dangerous and had the potential to harm patients.

The level of misinformation in this area is sickening. Patients are being sold false hope by the truck-load. Yet they deserve better; they deserve impartial information on their illness and the best treatment for it – cancer patients especially so. What they get instead is a total disgrace: commercially driven lies about ‘treatments’ which are not just unproven but which would, if used as instructed, hasten their death. Some alternative therapies have potential for palliative and supporting care, BUT NONE OFFER A CURE OR A REDUCTION OF THE TUMOR BURDEN OR A CHANGE IN THE NATURAL HISTORY OF THE DISEASE.

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?

Quite a few people seem to be amazed about the amount of work and the enthusiasm I invest into this blog. To be honest, I am amazed too. Why do I do it? And why do I do it in the way I do it?

I am sure that my critics have a choice of answers at the ready; in one way or another, the following theories have been put forward:

  1. I was bought by the pharmaceutical industry.
  2. I have had a bad experience with one or several alternative practitioners.
  3. I want to get rich and/or famous.
  4. I feel that conventional medicine is flawless
  5. I don’t know what I am writing about.

None of these notions is remotely true, of course.

Big Pharma has never approached me, and so far nobody at all has ever tried to influence the contents of my posts. I never had a bad personal experience with alternative medicine; on the contrary, I had several quite positive ones. The blog does not earn me money; it even costs a little to run it, and nobody other than I pay for it. I do not think that fame is something one can achieve through doing a blog, and I certainly do not aim at doing so. Sadly, I know only too well about the many flaws in conventional medicine; it is often far from perfect but at least it makes progress; alternative medicine, by contrast, seems almost entirely static. As I have studied most aspects of alternative medicine for two decades and published more than any other person on this subject, I think the allegation of incompetence might be a bit far-fetched.

So, why then?

When I decided to become a doctor I, like most medical students, did so mainly to help suffering individuals. When I became a researcher, I felt more removed from this original ideal. Yet I told myself that, by conducting research, I might eventually contribute to a better health care of tomorrow. Helping suffering patients was still firmly on the agenda. But then I realised that my articles in peer-reviewed medical journals somehow missed an important target: in alternative medicine, one ought to speak not just to health care professionals but also to consumers and patients; after all, it is they who often make the therapeutic decisions in this area.

Once I had realised this, I started addressing the general public by writing for The Guardian and other newspapers, giving public lectures and publishing books for a lay audience, like TRICK OR TREATMENT…The more I did this sort of thing, the more I noticed how important this activity was. And when a friend offered to help me set up a blog, I did not hesitate for long.

So, the reason for my enthusiasm for this blog turns out to be the same as the one that enticed me to go into medicine in the first place. I do believe that it is helpful for consumers to know the truth about alternative medicine. Considering the thousands of sources of daily misinformation in this area, there is an urgent need for well-informed, critical information. By providing it, I am sure I can assist people to make better therapeutic decisions. In a way, I am back where I started all those years ago: hoping to help suffering patients in the most direct way my expertise allows.

Realgar, a commonly used traditional Chinese medicine, has – according to the teachings of Traditional Chinese Medicine (TCM) – acrid, bitter, warm, and toxic characteristics and is affiliated with the Heart, Liver and Stomach meridians. It is used internally against intestinal parasites and treat sore throats, and is applied externally to treat swelling, abscesses, itching, rashes, and other skin disorders.

Chemically, it is nothing other than arsenic sulphide. Despite its very well-known toxicity, is thought by TCM-practitioners to be safe, and it has been used in TCM under the name ‘Xiong Huang’ for many centuries. TCM-practitioners advise that the typical internal dose of realgar is between 0.2 and 0.4 grams, decocted in water and taken up to two times per day. Some practitioners may recommend slightly higher doses (0.3-0.9 grams). Larger doses of realgar may be used if it is being applied topically.

Toxicologists from Taiwan report a case of fatal realgar poisoning after short-term use of a topical realgar-containing herbal medicine.

A 24-year-old man with atopic dermatitis had received 18 days of oral herbal medicine and realgar-containing herbal ointments over whole body from a TCM-practitioner. Seven days later, he started to develop loss of appetite, dizziness, abdominal discomfort, an itching rash and skin scaling. Subsequently he suffered generalized oedema, nausea, vomiting, decreased urine amount, diarrhoea, vesico-oedematous exanthemas, malodorous perspiration, fever, and shortness of breath.

He was taken to hospital on day 19 when the dyspnoea became worse. Toxic epidermal necrolysis complicated with soft tissue infection and sepsis were then diagnosed. The patient died shortly afterwards of septic shock and multiple organ failure. Post-mortem blood arsenic levels were elevated at 1225 μg/L. The analysis of the patient’s herbal remedies yielded a very high concentration of arsenic in three unlabelled realgar-containing ointments (45427, 5512, and 4229 ppm).

The authors of this report concluded that realgar-containing herbal remedy may cause severe cutaneous adverse reactions. The arsenic in realgar can be absorbed systemically from repeated application to non-intact skin and thus should not be extensively used on compromised skin.

The notion that a treatment that ‘has stood the test of time’ must be safe and effective is very wide-spread in alternative medicine. This, we often hear, applies particularly to the external use of traditional remedies – what can be wrong with putting a traditional Chinese herbal cream on the skin?? This case, like so many others, should teach us that this appeal to tradition is a classical and often dangerous fallacy. And the ‘realgar-story’ also suggests that, in TCM, the ‘learning-curve’ is very flat indeed.

Chinese and Ayurvedic remedies are often contaminated with toxic heavy metals. But the bigger danger seems to be that some of these traditional ‘medicines’ contain such toxins because, according to ‘traditional wisdom’, these constituents have curative powers. I think that, until we have compelling evidence that any of these treatments do more good than harm, we should avoid taking them.

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:

  1.  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’.
  2.  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.
  3.  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.
  4.  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.

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