MD, PhD, FMedSci, FSB, FRCP, FRCPEd

quackery

Whenever we consider alternative medicine, we think of therapeutic interventions and tend to forget that alternative practitioners frequently employ diagnostic methods which are alien to mainstream health care. Acupuncturists, iridologists, spiritual healers, massage therapists, reflexologists, applied kinesiologists, homeopaths, chiropractors, osteopaths and many other types of alternative practitioners all have their very own ways of diagnosing what might be wrong  with their patients.

The purpose of a diagnostic test or technique is, of course, to establish the presence or absence of an abnormality, condition or disease. Conventional doctors use all sorts of validated diagnostic methods, from physical examination to laboratory tests, from blood pressure measurements to X-rays. Alternative practitioners use mostly alternative methods for arriving at a diagnosis, and we should ask: how reliable are these techniques?

Anyone trying to answer this question, will be surprised to find how very little reliable information on this topic exists. Scientific tests of the validity of alternative diagnostic tests are a bit like gold dust. And this is why a recently published article is, in my view, of particular importance and value.

The aim of this study was to evaluate the inter-rater reliability of pulse-diagnosis as performed by Traditional Korean Medicine (TKM) clinicians. A total 658 patients with stroke who were admitted into Korean oriental medical university hospitals were included. Each patient was seen by two TKM-experts for an examination of the pulse signs – pulse diagnosis is regularly used by practitioners of TKM and Traditional Chinese Medicine (TCM), and is entirely different from what conventional doctors do when they feel the pulse of a patient. Inter-observer reliability was assessed using three methods: simple percentage agreement, the kappa value, and the AC(1) statistic. The kappa value indicated that the inter-observer reliability in evaluating the pulse signs ranged from poor to moderate, whereas the AC(1) analysis suggested that agreement between the two experts was generally high (with the exception of ‘slippery pulse’). The kappa value indicated that the inter-observer reliability was generally moderate to good (with the exceptions of ‘rough pulse’ and ‘sunken pulse’) and that the AC(1) measure of agreement between the two experts was generally high.

Based on these findings, the authors drew the following conclusion: “Pulse diagnosis is regarded as one of the most important procedures in TKM… This study reveals that the inter-observer reliability in making a pulse diagnosis in stroke patients is not particularly high when objectively quantified. Additional research is needed to help reduce this lack of reliability for various portions of the pulse diagnosis.”

This indicates, I think, that the researchers (who are themselves practitioners of TCM!) are not impressed with the inter-rater reliability of the most commonly used diagnostic tool in TCM/TKM. Imagine this to be true for a commonly used test in conventional medicine; imagine, for instance, that one doctor measuring your blood pressure produces entirely different readings than the next one. Hardly acceptable, don’t you think?

And, of course, inter-rater reliability would be only one of several preconditions for their diagnostic methods to be valid. Other essential preconditions for diagnostic tests to be of value are their specificity and their sensitivity; do they discriminate between healthy and unhealthy, and are they capable of differentiating between severely abnormal findings and those that are just a little out of the normal range?

Until we have answers to all the open questions about each specific alternative diagnostic method, it would be unwise to pretend these tests are valid. Imagine a doctor prescribing a life-long anti-hypertensive therapy on the basis of a blood pressure reading that is little more than guess-work!

Since non-validated diagnostic tests can generate both false positive and false negative results, the danger of using them should not be under-estimated. In a way, invalid diagnostic tests are akin to bogus bomb-detectors (which made headlines recently): both are techniques to identify a problem. If the method generates a false positive result, an alert will be issued in vain, people will get anxious for nothing, time and money will be lost, etc. If the method generates a false negative result, we will assume to be safe while, in fact, we are not. In extreme cases, such an error will cost lives.

It is difficult to call those ‘experts’ who advocate using such tests anything else than irresponsible, I’d say. And it is even more difficult to have any confidence in the treatments that might be administered on the basis of such diagnostic methods, wouldn’t you agree?

The developed world is in the middle of a major obesity epidemic. It is predicted to cause millions of premature deaths and billions of dollars, money that would be badly needed elsewhere. The well-known method of eating less and moving more is most efficacious but sadly not very effective, that is to say people do not easily adopt and adhere to it. This is why many experts are searching for a treatment that works and is acceptable to all or at least most patients.

Entrepreneurs of alternative medicine have long jumped on this band waggon. They have learnt that the regulations are lax or non-existent, that consumers are keen to believe anything they tell them and that the opportunities to make a fast buck are thus enormous. Today, they are offering an endless array of treatments which are cleverly marketed, for instance via the Internet.

Since many years, my research team are involved in a programme of assessing the alternative slimming aids mostly through systematic reviews and occasionally also through conducting our own clinical trials. Our published analyses include the following treatments:

Phaseolus vulgaris

Supplements containing conjugated linoleic acid

Green tea

Garcinia extracts

Calcium supplements

Chromium picolinate

Guar gum

Chitosan

Acupuncture

There are, of course, many more but, for most, no evidence exist at all. The treatments listed above have all been submitted to clinical trials. The results show invariably that the outcomes were not convincingly positive: either there were too few data, or there were too many flaws in the studies, or the weight reduction achieved was too small to be clinically relevant.

Our latest systematic review is a good example; its aim was to evaluate the evidence from randomized controlled trials (RCTs) involving the use of the African Bush Mango, Irvingia gabonensis, for body weight reduction in obese and overweight individuals. Three RCTs were identified, and all had major methodological flaws. All RCTs reported statistically significant reductions in body weight and waist circumference favoring I. gabonensis over placebo. They also suggested positive effects of I. gabonensis on blood lipids. Adverse events included headache and insomnia. Despite these apparently positive findings, our conclusions had to be cautious: “Due to the paucity and poor reporting quality of the RCTs, the effect of I. gabonensis on body weight and related parameters are unproven. Therefore, I. gabonensis cannot be recommended as a weight loss aid. Future research in this area should be more rigorous and better reported.”

People who want to loose weight are often extremely desperate and ready to try anything. They are thus easy victims of the irresponsible promises that are being made on the Internet and elsewhere. Despite the overwhelmingly evidence to the contrary, consumers are led to believe that alternative slimming aids are effective. What is more, they are also misled to assume they are risks-free. This latter assumption is false too: apart from the harm done to the patient’s bank account, many alternative slimming aids are associated with side-effects which, in some cases, are  serious and can even include death.

The conclusion from all this is short and simple: alternative slimming aids are bogus.

The ‘Samueli Institute’ might be known to many readers of this blog; it is a wealthy institution that is almost entirely dedicated to promoting the more implausible fringe of alternative medicine. The official aim is “to create a flourishing society through the scientific exploration of wellness and whole-person healing“. Much of its activity seems to be focused on military medical research. Its co-workers include Harald Walach who recently was awarded a rare distinction for his relentless efforts in introducing esoteric pseudo-science into academia.

Now researchers from the Californian branch of the Samueli Institute have published an articles whic, in my view, is another landmark in nonsense.

Jain and colleagues conducted a randomized controlled trial to determine whether Healing Touch with Guided Imagery [HT+GI] reduced post-traumatic stress disorder (PTSD) compared to treatment as usual (TAU) in “returning combat-exposed active duty military with significant PTSD symptoms“. HT is a popular form of para-normal healing where the therapist channels “energy” into the patient’s body; GI is a self-hypnotic from of relaxation-therapy. While the latter approach might be seen as plausible and, at least to some degree, evidence-based, the former cannot.

123 soldiers were randomized to 6 sessions of HT+GI, while the control group had no such therapies. All patients also received standard conventional therapies, and the treatment period was three weeks. The results showed significant reductions in PTSD symptoms as well as depression for HT+GI compared to controls. HT+GI also showed significant improvements in mental quality of life and cynicism.

The authors concluded that HT+GI resulted in a clinically significant reduction in PTSD and related symptoms, and that further investigations of biofield therapies for mitigating PTSD in military populations are warranted.

The Samueli Institute claims to “support science grounded in observation, investigation, and analysis, and [to have] the courage to ask challenging questions within a framework of systematic, high-quality, research methods and the peer-review process“. I do not think that the above-named paper lives up to these standards.

As discussed in some detail in a previous post, this type of study-design is next to useless for determining whether any intervention does any good at all: A+B is always more than B alone! Moreover, if we test HT+GI as a package, how can we conclude about the effectiveness of one of the two interventions? Thus this trial tells us next to nothing about the effectiveness of HT, nor about the effectiveness of HT+GI.

Previously, I have argued that conducting a trial for which the result is already clear before the first patient has been recruited, is not ethical. Samueli Institute, however, claims that it “acts with the highest respect for the public it serves by ensuring transparency, responsible management and ethical practices from discovery to policy and application“. Am I the only one who senses a contradiction here?

Perhaps other research in this area might be more informative? Even the most superficial Medline-search brings to light a flurry of articles on HT and other biofield therapies that are relevant.

Several trials have indeed produces promissing evidence suggesting positive effects of such treatments on anxiety and other symptoms. But the data are far from uniform, and most investigations are wide open to bias. The more rigorous studies seem to suggest that these interventions are not effective beyond placebo. Our review demonstrated that “the evidence is insufficient” to suggest that reiki, another biofield therapy, is an effective treatment for any condition.

Another study showed that tactile touch led to significantly lower levels of anxiety. Conventional massage may even be better than HT, according to some trials. The conclusion from this body of evidence is, I think, fairly obvious: touch can be helpful (most clinicians knew that anyway) but this has nothing to do with energy, biofields, healing energy or any of the other implausible assumptions these treatments are based on.

I therefore disagree with the authors’ conclusion that “further investigation into biofield therapies… is warranted“. If we really want to help patients, let’s find out more about the benefits of touch and let’s not mislead the public about some mystical energies and implausible quackery. And if we truly want to improve heath care, as the Samueli Institute claims, let’s use our limited resources for research which meaningfully contributes to our knowledge.

According to Wikipedia, Gua sha involves repeated pressured strokes over lubricated skin with a smooth edge placed against the pre-oiled skin surface, pressed down firmly, and then moved downwards along muscles or meridians.This intervention causes bleeding from capillaries and sub-cutaneous blemishing which usually last for several days. According to a recent article on Gua Sha, it is a traditional healing technique popular in Asia and Asian immigrant communities involving unidirectional scraping and scratching of the skin until ‘Sha-blemishes’ appear.

Gua Sha paractitioners make far-reaching therapeutic claims, e.g.” Gua Sha is used whenever a patient has pain whether associated with an acute or chronic disorder… In addition to resolving musculo skeletal pain, Gua Sha is used to treat as well as prevent common cold, flu, bronchitis, asthma, as well as any chronic disorder involving pain, congestion of Qi and Blood“. Another source informs us that ” Gua Sha is performed to treat systemic toxicity, poor circulation, physical and  emotional stress, and migraines. Gua Sha healing promotes the flow of Qi  (energy) and blood throughout the body for overall health“.

Gua Sha “blemishes” can look frightful – more like the result of torture than of treatment. Yet with our current craze for all things exotic in medicine, Gua Sha is becoming popular also in Western countries. One German team has even published several RCTs of Gua Sha.

This group treated 40 patients with neck pain either with Gua Sha or locally applied heat packs. They found that, after one week, the pain was significantly reduced in the former compared to the latter group. The same team also published a study with 40 back or neck-pain patients who either received a single session of Gua Sha or were left untreated. The results indicate that one week later, the treated patients had less pain than the untreated ones.

My favoutite article on the subject must be a case report by the same German research team. It describes a woman suffering from chronic headaches. She was treated with a range of interventions, including Gua Sha – and her symptoms improved. From this course of events, the authors conclude that “this case provides first evidence that Gua Sha is effective in the treatment of headaches”

The truth, of course, is that neither this case nor the two RCTs provide any good evidence at all. The case-report is, in fact, a classic example of drawing hilariously over-optimistic conclusions from data that are everything but conclusive. And the two RCTs  just show how remarkable placebo-effects can be, particularly if the treatment is exotic, impressive, involves physical touch, is slightly painful and raises high expectations.

My explanation for the observed effects after Gua Sha is quite simple: imagine you have a headache and accidentally injure yourself – say you fall off your bike and the tarmac scrapes off an area of skin on your thigh. This hurts quite a bit and distracts you from your headache, perhaps even to such an extend that you do not feel it any more. As the wound heals, it gets a bit infected and thus hurts for several days; chances are that your headache will be gone for that period of time. Of course, the Gua Sha- effect would be larger because the factors mentioned above (exotic treatment, expectation etc.) but essentially the accident and the treatment work via similar mechanisms, namely distraction and counter-irritation. And neither Gua Sha nor injuring yourself on the tarmac are truly recommendable therapies, in my view.

But surely, for the patient, it does not matter how she gets rid of her headache! The main point is that Gua Sha works! In a way, this attitude is understandable – except, we do not need the hocus pocus of meridians, qi, TCM, ancient wisdom etc. nor do we need to tolerate claims that Gua Sha is “serious medicine” and has any specific effects whatsoever. All we do need is to apply some common sense and then use any other method of therapeutic counter-irritation; that might be more honest, safer and would roughly do the same trick.

No, I am wrong! I forgot something important: it would not be nearly as lucrative for the TCM-practitioner.

On the last day of the year, is time to contemplate the achievements and failures of the past 12 months and think about the future. For me, it is also the moment to once again place my tongue in my cheek, empathise with my opponents and think of what they might hope for in the coming year.

Here is a brief yet somewhat ambitious expose of what I came up with: the charlatan’s wish list for 2013.

1 Let the Daily Mail and similar publications continue to promote uncritical thinking and bogus claims for alternative medicine.

2 Make sure that politicians remain blissfully ignorant of all matters related to science.

3 Let the anecdote continue to reign over evidence, for instance, in the popular press.

4 Regulate alternative practitioners such that they benefit from the added status without any obligation to abide by the generally accepted rules of evidence-based practice.

5 Prevent the closure of more homeopathic hospitals.

6 Ensure that the public continues to be mislead about nonsensical scams such as “integrated medicine”.

7 Increase the influence of Prince Charles in the realm of health care.

8 Give Royal status to the ‘College of Medicine’.

9 Appoint Dr Michael Dixon, chair of the ‘NHS-Alliance’ and the above-named “college”, as advisor to the government.

10 Introduce more post-modern thinking into health care; after all, there is more than one way of knowing!

11 Defame all those terrible sceptics who always doubt our claims.

12 Cherish double standards in medicine; they are essential for our survival!

13 Make sure researchers of alternative medicine use science not for testing but for proving the value of alternative therapies.

14 Continue to allow promotion of alternative medicine to masquerade as research.

15 Ensure that all our celebrity clients tell every journalist how young they look thanks to alternative medicine.

16 Let ‘Duchy’s Original detox Tincture’ become a financial success – Charles needs the added income for promoting quackery.

17 Open more woo-institutes in academia to spread the gospel of belief-based medicine.

18 Prevent anyone from finding out that many of us break even the most fundamental rules of medical ethics in our daily practice.

I am aware that the list is probably not nearly complete, and I invite everyone to add items of importance. Happy New Year!

 

 

In these austere and difficult times, it must be my duty, I think, to alert my fellow citizens to a possible source of additional income which almost anyone can plug into: become a charlatan, and chances are that your economic hardship is a memory from the past. To achieve this aim, I [with my tongue firmly lodged in my cheek] suggest a fairly straight forward step by step approach.

1. Find an attractive therapy and give it a fantastic name

Did I just say “straight forward”? Well, the first step isn’t that easy, after all. Most of the really loony ideas turn out to be taken: ear candles, homeopathy, aura massage, energy healing, urine-therapy, chiropractic etc. As a true charlatan, you want your very own quackery. So you will have to think of a new concept.

Something truly ‘far out’ would be ideal, like claiming the ear is a map of the human body which allows you to treat all diseases by doing something odd on specific areas of the ear – oops, this territory is already occupied by the ear acupuncture brigade. How about postulating that you have super-natural powers which enable you to send ‘healing energy’ into patients’ bodies so that they can repair themselves? No good either: Reiki-healers might accuse you of plagiarism.

But you get the gist, I am sure, and will be able to invent something. When you do, give it a memorable name, the name can make or break your new venture.

2. Invent a fascinating history

Having identified your treatment and a fantastic name for it, you now need a good story to explain how it all came about. This task is not all that tough and might even turn out to be fun; you could think of something touching like you cured your moribund little sister at the age of 6 with your intervention, or you received the inspiration in your dreams from an old aunt who had just died, or perhaps you want to create some religious connection [have you ever visited Lourdes?]. There are no limits to your imagination; just make sure the story is gripping – one day, they might make a movie of it.

3. Add a dash of pseudo-science

Like it or not, but we live in an age where we cannot entirely exclude science from our considerations. At the very minimum, I recommend a little smattering of sciency terminology. As you don’t want to be found out, select something that only few experts understand; quantum physics, entanglement, chaos-theory and Nano-technology are all excellent options.

It might also look more convincing to hint at the notion that top scientists adore your concepts, or that whole teams from universities in distant places are working on the underlying mechanisms, or that the Nobel committee has recently been alerted etc. If at all possible, add a bit of high tech to your new invention; some shiny new apparatus with flashing lights and digital displays might be just the ticket. The apparatus can be otherwise empty – as long as it looks impressive, all is fine.

4. Do not forget a dose of ancient wisdom

With all this science – sorry, pseudo-science – you must not forget to remain firmly grounded in tradition. Your treatment ought to be based on ancient wisdom which you have rediscovered, modified and perfected. I recommend mentioning that some of the oldest cultures of the planet have already been aware of the main pillars on which your invention today proudly stands. Anything that is that old has stood the test of time which is to say, your treatment is both effective and safe.

5. Claim to have a panacea

To maximise your income, you want to have as many customers as possible. It would therefore be unwise to focus your endeavours on just one or two conditions. Commercially, it is much better to affirm in no uncertain terms that your treatment is a cure for everything, a panacea. Do not worry about the implausibility of such a claim. In the realm of quackery, it is perfectly acceptable, even common behaviour to be outlandish.

6. Deal with the ‘evidence-problem’ and the nasty sceptics

It is depressing, I know, but even the most exceptionally gifted charlatan is bound to attract doubters. Sceptics will sooner or later ask you for evidence; in fact, they are obsessed by it. But do not panic – this is by no means as threatening as it appears. The obvious solution is to provide testimonial after testimonial.

You need a website where satisfied customers report impressive stories how your treatment saved their lives. In case you do not know such customers, invent them; in the realm of quackery, there is a time-honoured tradition of writing your own testimonials. Nobody will be able to tell!

7. Demonstrate that you master the fine art of cheating with statistics

Some of the sceptics might not be impressed, and when they start criticising your ‘evidence’, you might need to go the extra mile. Providing statistics is a very good way of keeping them at bay, at least for a while. The general consensus amongst charlatans is that about 70% of their patients experience remarkable benefit from whatever placebo they throw at them. So, my advice is to do a little better and cite a case series of at least 5000 patients of whom 76.5 % showed significant improvements.

What? You don’t have such case series? Don’t be daft, be inventive!

8. Score points with Big Pharma

You must be aware who your (future) customers are (will be): they are affluent, had a decent education (evidently without much success), and are middle-aged, gullible and deeply alternative. Think of Prince Charles! Once you have empathised with this mind-set, it is obvious that you can profitably plug into the persecution complex which haunts these people.

An easy way of achieving this is to claim that Big Pharma has got wind of your innovation, is positively frightened of losing millions, and is thus doing all they can to supress it. Not only will this give you street cred with the lunatic fringe of society, it also provides a perfect explanation why your ground-breaking discovery has not been published it the top journals of medicine: the editors are all in the pocket of Big Pharma, of course.

9. Ask for money, much money

I have left the most important bit for the end; remember: your aim is to get rich! So, charge high fees, even extravagantly high ones. If your treatment is a product that you can sell (e.g. via the internet, to escape the regulators), sell it dearly; if it is a hands-on therapy, charge heavy consultation fees and claim exclusivity; if it is a teachable technique, start training other therapists at high fees and ask a franchise-cut of their future earnings.

Over-charging is your best chance of getting famous – or have you ever heard of a charlatan famous for being reasonably priced?  It will also get rid of the riff-raff you don’t want to see in your surgery. Poor people might be even ill! No, you don’t want them; you want the ‘worried rich and well’ who can afford to see a real doctor when things should go wrong. But most importantly, high fees will do a lot of good to your bank account.

 

Now you are all set. However, to prevent you from stumbling at the first hurdle, here are some handy answers to the questions you inevitably will receive from sceptics, this nasty breed that is never happy. The answers are not designed to convince them but, if voiced in public, they will ensure that the general opinion is on your side – and that’s what is paramount in the realm of quackery.

Q: Your treatment can cause considerable harm; do you find that responsible?

A: Harm? Do you know what you are talking about? Obviously not! Every year, hundreds of thousands die because of the medicine they received from mainstream doctors. This is what I call harm!

Q: Experts say that your treatment is not biologically plausible, what is your response?

A: There are many things science does not yet understand and many things that it will never understand. In any case, there are other ways of knowing, and science is but one of them.

Q: Where are the controlled trials to back up your claim?

A: Clinical trials are of very limited value; they are far too small, frequently biased and never depict the real life situation. This is why many experts now argue for better ways of showing the value of medical interventions.

Q: Professor Ernst recently said that your therapy is unproven, is that true?

A: This man cannot be trusted; he is in the pocket of the pharmaceutical industry! He would say that, wouldn’t he?

Anyway, did you know that only 15% of conventional therapies actually are evidence-based?

Q: Why is your treatment so expensive?

A: Years of training, a full research programme, constant audits, compliance with regulations, and a large team of co-workers – do you think that all of this comes free? Personally, I would treat all my patients for free (and often do so) but I have responsibilities to others, you know.

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