MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bogus claims

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.

Since homeopathy was invented by Samuel Hahnemann about 200 years ago, a steadily growing group of critics have raised their voices more and more loudly. Usually they come from doctors or scientists and only rarely from the legal profession.

Yet, there are exceptions: an Australian barrister and professor of law has published an analysis of “a series of criminal, civil, disciplinary and coronial decisions from difference countries in relation to homeopathic medicine where outcomes have been tragic”. He concludes that “there is an urgent need for reflection and response within the health sector generally, consumer protection authorities, and legal policy-makers about the steps that should be taken to provide community protection from dangerous homeopathic practice”.

He also questions whether homeopathy can ever be registered alongside other health care professionals:

“Until such time as homoeopathy can scientifically justify its fundamental tenets,… it cannot be said that its claims for therapeutic efficacy can be justifiable. This leaves the profession not just exposed to criticisms,… but potentially open to consumer protection actions directed toward whether its representations are false, misleading and deceptive, to civil litigation when its promises have not been fulfilled, and especially when persons have died, and to criminal actions in respect of the financial advantage that is obtained by its practitioners from their representations.

The distressing cases referred to here which led to avoidable deaths and the multiple accusations leveled against homoeopathy require of the profession at least a formal repudiation of the practitioners concerned… In addition, they demand an unequivocal response that homoeopathy will discipline its own in a robust and open way. If the profession is to acquire any scientific credibility, which is difficult to conceive of, the deaths to which homoeopathy has contributed…also require that homoeopathy actively generate a defensible research basis that justifies its claims to efficacy of outcome for its patients. It is only then that the claims of the medical establishment that homoeopathy is a dangerous and too often a lethal form of quackery will be able to be contested rationally. In the meantime, it is timely to consider further the status that homoeopathy has within the general and health care communities and whether that status can be scientifically, ethically or legally justified”.

I believe this legal view to be highly significant. The persistent criticism from skeptics, concerned scientists and doctors has rarely been translated into decisions about health care provision. Homeopaths tended to respond to our criticism by producing anecdotes, unconvincing or cherry-picked data or by producing outright lies, for instance in relation to the “Swiss government’s report” on homeopathy.

In this context, it is worth noting that, in some countries, homeopaths who have no medical qualifications have been accused to practice medicine without a licence. The case of Dana Ullman in the US is probably the most spectecular such incident; this is how one pro-homeopathy site describes it:

Dana is perhaps the person who has done the most for homeopathy since his court case in that he pursues the evangelism of homeopathy through the NCH and his mail order company… He prescribed homeopathic medicine and was arrested for practicing medicine without a license. But he won an important settlement in 1977 in the Oakland Municipal Court in which the court allowed his practice under two stipulations:

  1. that he did not diagnose or treat disease and that he refers to medical doctors for the diagnosis and treatment of disease;
  2. that he makes contracts with his patients that clearly define his role as a non-medical homeopathic practitioner and the patient’s role in seeking his care.

But such cases are not the only occasions for lawyers to look at homeopathy. Recently there has been a class action against the Boiron, the world’s largest manufacturer of homeopathic preparations. It was alleged that Boiron made bogus claims for one of its remedies, and there was a settlement worth millions of dollars. Similar cases  are likely to follow, e.g.:

  • Nelsons Homeopathy (Rescue Remedy, Bach Original Flower Remedies, Pure & Clear, Arnileve, H+Care)
  • CVS Homeopathic Products (Flu Relief, Cold Relief, Cold Remedy, Ear Pain Relief)
  • Nature’s Innovation (Naturasil Skin Tags, Bed Bug Patrol, Naturasil Scabies)
  • Boericke & Tafel Cold/Flu
  • Homeolab USA (Kids Relief Cough & Cold)

In June 2003, a British High Court Judge ordered two mothers to ensure that their daughters are appropriately vaccinated. The ruling concerned two separate cases brought by fathers who wanted their daughters immunized despite opposition by the girls’ unwed mothers

The fact that, in the UK and other countries, homeopathic placebos are still being sold as “vaccines” for the prevention of serious, life-threatening infections is, in my view nothing short of a scandal. The fact that a leading figure at Ainsworth actively misleads the public about these products is an outrage. It is high time therefore that the legal profession looks seriously at the full range of issues related to homeopathy with a view of stopping the dangerous nonsense.

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.

Vaccinations are unquestionably amongst the biggest achievements in the history of medicine. They have prevented billions of diseases and saved millions of lives. Despite all this, there has been an irritatingly vocal movement protesting against immunizations and thus jeopardising the progress made. Kata summarized the notions and tactics of these activists and identified the following ‘common anti-vaccination tropes‘ from searching relevant sites on the internet:

1 I am not anti-vaccine, I am pro-safe vaccine.

2 Vaccines are toxic.

3 Vaccines should be 100% safe.

4 You cannot prove that vaccines are safe.

5 Vaccines did not save us.

6 Vaccines are not natural.

7 I am an expert in my own child.

8 Galileo was persecuted too.

9 Science has been wrong before.

10 So many people simply cannot be wrong.

11 You must be in the pocket of BIG PHARMA.

12 I do not believe that the problems after vaccination occur coincidentally.

And what has this to do with alternative medicine, you may well ask?

In my experience, many of the arguments resonate with those of alternative medicine enthusiasts. Moreover, there is a mountain of evidence to show that many practitioners of alternative medicine are an established and important part of the anti-vax movement; in particular, homeopaths, chiropractors, naturopaths and practitioners of anthroposophic medicine are implicated.

The literature on this topic is vast, so I am spoilt for choice in providing an example. The one that I have selected is by Kate Birch, a mother who apparently found homeopathy so effective for her children that she decided to become a homeopath. Her book “Vaccine Free. Prevention & treatment of infectious contagious disease with homeopathy” provides details about the “homeopathic prevention and treatment” of the following diseases:

Rabies

Tetanus

Polio

Diphtheria

Whooping cough

Mumps

Scarlet fever

Streptococcus A

Roseola

Rocky Mountain spotted fever

Measles

German measles

Chickenpox

Smallpox

Anthrax

Plague

Haemophilus influencae

Otitis media

Influenza

Mononucleosis

Pneumonia

Tuberculosis

Conjunctivitis

Herpes simplex type 1 and 2

Genital warts

Gonorrhoea

Syphilis

AIDS/HIV

Hepatitis A, B, and C

Yellow fewer

Dengue fever

Malaria

Typhoid

Typhus

Cholera

While copying this list from her book, I became so angry that I was about to write something that I might later regret. It is therefore better to end this post abruptly. I leave it to my readers to comment.

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!

 

 

The question whether spinal manipulation is an effective treatment for infant colic has attracted much attention in recent years. The main reason for this is, of course, that a few years ago Simon Singh had disclosed in a comment that the British Chiropractic Association (BCA) was promoting chiropractic treatment for this and several other childhood condition on their website. Simon famously wrote “they (the BCA) happily promote bogus treatments” and was subsequently sued for libel by the BCA. Eventually, the BCA lost the libel action as well as lots of money, and the entire chiropractic profession ended up with enough egg on their faces to cook omelets for all their patients.

At the time, the BCA had taken advice from several medical and legal experts; one of their medical advisers, I was told, was Prof George Lewith. Intriguingly, he and several others have just published a Cochrane review of manipulative therapies for infant colic. Here are the unabbreviated conclusions from their article:

The studies included in this meta-analysis were generally small and methodologically prone to bias, which makes it impossible to arrive at a definitive conclusion about the effectiveness of manipulative therapies for infantile colic. The majority of the included trials appeared to indicate that the parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not, based on contemporaneous crying diaries, and this difference was statistically significant. The trials also indicate that a greater proportion of those parents reported improvements that were clinically significant. However, most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias, the results did not reach statistical significance. Further research is required where those assessing the treatment outcomes do not know whether or not the infant has received a manipulative therapy. There are inadequate data to reach any definitive conclusions about the safety of these interventions”

Cochrane reviews also carry a “plain language” summary which might be easier to understand for lay people. And here are the conclusions from this section of the review:

The studies involved too few participants and were of insufficient quality to draw confident conclusions about the usefulness and safety of manipulative therapies. Although five of the six trials suggested crying is reduced by treatment with manipulative therapies, there was no evidence of manipulative therapies improving infant colic when we only included studies where the parents did not know if their child had received the treatment or not. No adverse effects were found, but they were only evaluated in one of the six studies.

If we read it carefully, this article seems to confirm that there is no reliable evidence to suggest that manipulative therapies are effective for infant colic. In the analyses, the positive effect disappears, if the parents are properly blinded;  thus it is due to expectation or placebo. The studies that seem to show a positive effect are false positive, and spinal manipulation is, in fact, not effective.

The analyses disclose another intriguing aspect: most trials failed to mention adverse effects. This confirms the findings of our own investigation and amounts to a remarkable breach of publication ethics (nobody seems to be astonished by this fact; is it normal that chiropractic researchers ignore generally accepted rules of ethics?). It also reflects badly on the ability of the investigators of the primary studies to be objective. They seem to aim at demonstrating only the positive effects of their intervention; science is, however, not about confirming the researchers’ prejudices, it is about testing hypotheses.

The most remarkable thing about the new Cochrane review  is, I think, the in-congruence of the actual results and the authors’ conclusion. To a critical observer, the former are clearly negative but  the latter sound almost positive. I think this begs the question about the possibility of reviewer bias.

We have recently discussed on this blog whether reviews by one single author are necessarily biased. The new Cochrane review has 6 authors, and it seems to me that its conclusions are considerably more biased than my single-author review of chiropractic spinal manipulation for infant colic; in 2009, I concluded simply that “the claim [of effectiveness] is not based on convincing data from rigorous clinical trials”.

Which of the two conclusions describe the facts more helpfully and more accurately?

I think, I rest my case.

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.

Craniosacral therapy (CST), which, confusingly, is sometimes also called ‘cranial osteopathy’, was invented less than half a century ago by an osteopath. He thought that the spinal fluid is pulsating, the cranial bones are sufficiently movable to enable a therapist feel this pulse from the outside, and that it is possible to influence this process with very gentle manual manipulations which, in turn, would restore health in sick individuals. According to the inventor, the CST-practitioner uses his or her own hands to evaluate the craniosacral system by gently feeling various locations of the body to test for the ease of motion and rhythm of the   fluid pulsing around the brain and spinal cord. Soft-touch techniques are then used to release restrictions in any tissues influencing the craniosacral system.

But how does CST work? Let’s ask a practitioner who surely must know best:

When a self-development issue is linked to the illness, it is enough for that issue to be acknowledged by the client (without any further discussion unless the client desires it) for the body to release the memory of that issue – sensed by the therapist as tightness, tension, inertia within the body’s systems – so that the healing can proceed.

Several treatment sessions may still be needed, especially if the condition is a long lasting one. Our bodies’ self healing mechanisms rely on a combination of the various fluid systems of the body (blood and lymph flow and the fluid nature of the cells making up all the organs and systems within our bodies) and the body’s energy fields. Our hearts generate their own electrical signal independently of the control of our brains. Such signals travel around the body through the blood and other fluid systems. Blood is an excellent conductor of electricity and, when electricity flows through a conductor, magnetic fields are created. It is with these fields that the craniosacral therapist works.

These same fields store the memory of the events of our life – rather like the hard disk on a computer – but these memories can only be accessed when the underlying Body intelligence ‘decides’ it is needed as part of the healing process. There is absolutely no danger, therefore, of more being revealed than is strictly necessary to encourage the client back onto their self development route and to enable healing to take place.

To many desperate patients or distressed parents of ill children – CST is often advocated for children, particularly those suffering from cerebral palsy – this sort of lingo might sound impressive; to anyone understanding a bit of physiology, anatomy etc. it looks like pure nonsense. CST has therefore been considered by most independent experts to be on the lunatic fringe of alternative medicine.

Of course, this does not stop proponents to make and publicise big therapeutic claims for CST; it would be quite difficult to think of a condition that some CST-practitioner does not claim to cure or alleviate. One UK organisation boldly states that any symptom a patient may present with will improve in the hands of one of their members; in the eyes of its proponents, CST clearly is a panacea.

But, let’s be fair, the fact that it is implausible does not necessarily mean that CST is useless. The theory might be barmy and wrong, yet the treatment might still be effective via a different, as yet unknown mechanism. What we need to decide is evidence from clinical trials.

Recently, I have evaluated the findings from all randomised clinical trials of CST. I was pleasantly surprised to find that 6 such trials had been published, one would not normally expect so many studies of something that seems so utterly implausible. Far less impressive was the fact that the quality of the studies was, with the exception of one trial, deplorably poor.

The conditions treated in the trials were diverse: cerebral palsy, migraine, fibromyalgia and infant colic. All the badly-flawed studies reported positive results. The only rigorous trial was the one with children suffering from cerebral palsy – and here the findings were squarely negative. The conlusion of my review was blunt and straight forward: “the notion that CST is associated with more than non-specific effects is not based on evidence from rigorous randomised clinical trials“. This is a polite and scientific way of saying that CST is bogus.

Why should this matter? CST is popular, particularly for children. It is a very gentle technique, and some might argue that no harm [apart from the cost] can be done; on the contrary, the gentle touch  might even calm over-excited children and could thus be helpful. Who then cares that it has no specific therapeutic effects?

Few people would argue against the potential benefits of gentle touch or other non-specific effects. But we should realise that, for achieving them, we do not need CST or other placebo-treatments. An effective therapy that is given with compassion and empathy will do the same trick; and, in addition, it will also generate specific therapeutic effects.

What follows is simple: administering CST or other bogus treatments [by this, I mean a treatment for which claims are being made that are not supported by sound evidence] means preventing the patient from profiting from the most important element of any good treatment. In such cases, patients will not be treated adequately which can not just cost money but, in extreme cases, also lives.

In a nutshell: 1) ineffective therapies, such as CST, may seem harmless but, through their ineffectiveness, they constitute a serious threat to our health; 2) bogus treatments become bogus through the false claims which are being made for them; 3) seriously flawed studies can be worse than none at all: they generate false positive results and send us straight up the garden path.

Guest post by Louise Lubetkin

A while ago this sardonic little vignette, titled Medicine Through the Ages, was doing the rounds on the Internet:

2000 B.C. – Here, eat this root.
1000 A.D. – That root is pagan. Here, say this prayer.
1750 A.D. – That prayer is superstition. Here, drink this potion.
1900 A.D. – That potion is snake oil. Here, swallow this pill.
1985 A.D. – That pill is ineffective. Here, take this antibiotic.
2000 A.D. – That antibiotic is unnatural. Here, eat this root.

We seem to have come full circle. The idea of health as a personal goal, something that can be achieved by taking nutritional supplements such as herbal preparations, vitamins and minerals, is a fundamental tenet of alternative medicine. Consequently the rise of alternative medicine has been accompanied by a parallel rise in the use of dietary supplements.

Most people assume that dietary supplements, like pharmaceuticals, are thoroughly tested before being allowed onto the market, and that in any case because they are “natural” they are ipso facto safe.

Neither assumption is correct.

First of all, it is a great mistake to assume that all “natural” substances are harmless and therefore fit for consumption. (Fugu anyone? Perhaps with some sautéed Amanita mushrooms?) Secondly, unlike pharmaceuticals, which must undergo protracted pre-market testing for safety and efficacy, dietary supplements need not undergo even rudimentary testing before being sold over the counter to the public.

Supplement usage is at an all-time high. Currently, almost 50 percent of us regularly take supplements. The older you are, the more likely you are to take them: usage climbs to 70 percent amongst people 70 years and older. Similarly, the more formal education you have had, and the higher your income level, the more likely you are to be a regular consumer of dietary supplements.

Our collective enthusiasm for taking supplements has undoubtedly done considerably more for the health of the supplement industry than it has for that of the public. There is mounting research evidence to suggest that taking dietary supplements may neither be as safe nor beneficial to health as has previously been assumed (more on this in another post). Nevertheless, physicians seem to be just as vulnerable as the rest of us to the blandishments of the supplement industry. According to one study published in the Journal of Nutrition, 75 percent of dermatologists, 73 percent of orthopedists and 57 percent of cardiologists reported personally using dietary supplements. An earlier study by the same research group found that a staggering 79 percent of physicians and 82 percent of nurses reported recommending dietary supplements to their patients. Of course the fact that supplements come with a personal recommendation by a physician only serves to reinforce the public’s ill-founded presumption of safety.

The manufacture and sale of supplements is a hugely profitable business, generating more than $25 billion in annual sales and contributing an estimated $60 billion to the US economy. While most other industries have languished during the current economic downturn, the supplement industry has grown steadily:  overall, between 2008 and 2012, sales of supplements rose by 31.7 percent.

(Ironically, the huge popularity of these so-called “natural” health products has not escaped the notice of agribusiness and pharmaceutical giants such as Kellogg’s, Pfizer, Monsanto and others, all of which have now begun manufacturing and marketing nutritional supplements of their own.)

None of this would have been possible had it not been for the 1994 enactment by the US Congress of the Dietary Supplement Health and Education Act (DSHEA), an extraordinarily ill-conceived piece of legislation that drastically weakened the FDA’s regulatory control over vitamins, minerals, herbal, botanical and other “traditional” medical products. Prior to DSHEA, these products were classified as drugs and were therefore subject to FDA regulation. By reclassifying them as foods rather than drugs DSHEA effectively removed dietary supplements from FDA regulatory oversight. As a result, supplement manufacturers became exempt from any obligation to perform pre-market testing for purity, safety or effectiveness, and it became infinitely harder for the FDA to detect unsafe products and quickly remove them from the market.

While the FDA does have the authority to insist that manufacturers refrain from making unsubstantiated health claims, it no longer has the power to mandate removal of unsafe products from the market without first clearing the almost insurmountable legal hurdle of proving significant risk. In other words, DSHEA inverts the responsibility for ensuring safety. Before the FDA can act, consumers must first be harmed sufficiently seriously, and in sufficient numbers, to trigger an investigation.

In one fell legislative swoop, DSHEA dished up a profit bonanza to the supplement industry while simultaneously robbing the public of any meaningful protection. Thus disencumbered of all but token regulation, the dietary supplement industry quickly burgeoned. In 1994, when DSHEA was enacted, there were just 4,000 dietary supplements on the market. Today there are more than 75,000.

The brave new world spawned by DSHEA is well exemplified by the ephedra case. Herbal weight loss supplements containing the plant alkaloids ephedra and ephedrine were linked to a string of over 150 deaths and countless other serious adverse events. Metabolife, the manufacturer of the supplement, received 15,000 complaints of adverse events – including deaths – related to the product, yet was under no obligation to alert the FDA, and (not surprisingly) chose not to do so.

It took a full 10 years of intense legal fighting for the FDA to succeed in getting ephedra-containing supplements removed from the market. Undeterred, powerful industry lobbying groups and vociferous opponents of regulation mounted a successful appeal challenging the legality of the FDA ban, and ephedra supplements once again went on sale in several states. The ruling against FDA was eventually overturned on appeal and the ephedra ban was upheld, but the cost, difficulty and duration of the legal process of restricting access to this dangerous “natural” supplement was staggering. Yet even now, despite the FDA’s hard-won ban on ephedra, it is perfectly legal to buy ephedrine hydrochloride – an extract of ephedra – over the counter in the US, where it is marketed for sale without prescription as a bronchodilator and nasal decongestant. The only restriction on its sale is that it must be presented in pill form with dosage not exceeding 8mg, and the label cannot promote it as a weight loss aid – a restriction which can be sidestepped with the greatest of ease, as this website, with the in-your-face domain name ephedrinediet.org, vividly demonstrates.

Perhaps not surprisingly, the ephedra case is the only time the FDA has attempted to force the removal of a dangerous supplement from the market. Hamstrung by DSHEA, the FDA can do little more than exert its limited authority over the wording on supplement labels to ensure that manufacturers make no explicit claims that their products may be used prevent, cure or treat a specific disease. However, the lack of seriousness with which an increasingly confident supplement industry takes the FDA and its semantic policing powers is well illustrated by the following statement which appears in a recent report published by the Natural Products Foundation, an industry umbrella and lobbying group:

Healthy consumers use supplements to decrease their risk of heart disease, boost their immune systems, prevent vision loss, build strong bones, or prevent birth defects. Less healthy or ill consumers turn to supplements as an alternative to traditional medical treatments, to either complement prescription drugs they may be taking or substitute supplements for prescription drugs they either cannot afford or do not trust.

There are encouraging signs that concern about the dangers posed by an largely unregulated supplement industry may at last be growing, although industry and grass-roots opposition to attempts to repeal DSHEA have been well organized, well funded and vociferous. Even so, in 2007, largely as a result of public unease over the FDA’s protracted struggle to ban ephedra, DSHEA was amended to make reporting of serious adverse events such as death, life-threatening emergencies, inpatient hospitalizations or significant, persistent incapacities, mandatory. As a result of this amendment, in the first 9 months of 2008 alone, the FDA received almost 600 reports of serious adverse events arising from the use of dietary supplements. Moreover, the FDA believes that adverse events are being seriously under-reported, and that the annual number of supplement-related adverse events in the US is close to 50,000.

Perhaps it will take another ephedra disaster to make us rethink DSHEA, take the handcuffs off the FDA and begin looking more critically at the notion that dietary supplements are intrinsically beneficial and harmless.

In the meantime, here’s the 2013 addendum to Medicine Through the Ages:

2000 A.D. – That antibiotic is unnatural. Here, eat this root.

2013 A.D. – Has that root been assayed for adulterants, standardized for potency and purity? Has that root been approved by the FDA following clinical trials to establish dosage, efficacy and safety? Is the use of that root use evidence-based? Is it safe to take that root concurrently with other roots? Are there any contraindications? My diet already contains roots; will taking more be too much?

There are few subjects in the area of alternative medicine which are more deceptive than the now fashionable topic of “integrated medicine” (or integrative medicine, healthcare etc.). According to its proponents, integrated medicine (IM) is based mainly on two concepts. The first is that of “whole person care”, and the second is often called “the best of both worlds”.  Attractive concepts, one might think – why then do I find IM superfluous, deeply misguided and plainly wrong?

Whole patient care or holism

Integrated healthcare practitioners, we are being told, do not just treat the physical complaints of a patient but look after the whole individual: body, mind and soul. On the surface, this approach seems most laudable. Yet a closer look reveals major problems.

The truth is that all good medicine is, was, and always will be holistic: today’s GPs, for instance, should care for their patients as whole individuals dealing the best they can with physical problems as well as social and spiritual issues. I said “should” because many doctors seem to neglect the holistic aspect of care. If that is so, they are, by definition, not good doctors. And, if the deficit is wide-spread, we should reform conventional healthcare. But delegating holism to IM-practitioners would be tantamount to abandoning an essential element of good healthcare; it would be a serious disservice to today’s patients and a detriment to the healthcare of tomorrow.

It follows that the promotion of IM under the banner of holism is utter nonsense. Either it is superfluous because it misleads patients into believing holism is an exclusive feature of IM, while, in fact, it is a hallmark of any good healthcare. Or, if holism is neglected or absent in a particular branch of conventional medicine, it detracts us from the important task to remedy this deficit. We simply must not allow a core value of medicine to be highjacked.

The best of both worlds

The second concept of IM is often described as “the best of both worlds”. Proponents of IM claim to use the “best” of the world of alternative medicine and combine it with the “best” of conventional healthcare. Again, this concept looks commendable at first glance but, at closer inspection, serious doubts emerge.

They hinge, in my view, on the use of the term “best”. We have to ask, what does “best” stand for in the context of healthcare? Surely it cannot mean the most popular or fashionable – and certainly “best” is not by decree of HRH Prince Charles. Best can only signify “the most effective” or more precisely “being associated with the most convincingly positive risk/benefit balance”.

If we understand “the best of both worlds” in this way, the concept becomes synonymous with the concept of evidence-based medicine (EBM) which represents the currently accepted thinking in healthcare. According to the principles of EBM, treatments must be shown to be safe as well as effective. When treating their patients, doctors should, according to EBM-principles, combine the best external evidence with their own experience as well as with the preferences of their patients.

If “the best of both worlds” is synonymous with EBM, we clearly don’t need this confusing duplicity of concepts in the first place; it would only distract from the auspicious efforts of EBM to continuously improve healthcare. In other words, the second axiom of IM is as nonsensical as the first.

The practice of integrated medicine

So, on the basis of these somewhat theoretical considerations, IM is a superfluous, misleading and counterproductive distraction. But the most powerful argument against IM is really an entirely practical one: namely the nonsensical, bogus and dangerous things that are happening every day in its name and under its banner.

If we look around us, go on the internet, read the relevant literature, or walk into an IM clinic in our neighbourhood, we are sure to find that behind all these politically correct slogans of holism and” best of all worlds” there is the coal face of pure quackery.Perhaps you don’t believe me, so go and look for yourself. I promise you will discover any unproven and disproven therapy that you can think of, anything from crystal healing to Reiki, and from homeopathy to urine-therapy.

What follows is depressingly simple: IM is a front of half-baked concepts behind which boundless quackery and bogus treatments are being promoted to unsuspecting consumers.

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