MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

evidence

Some sceptics are convinced that, in alternative medicine, there is no evidence. This assumption is wrong, I am afraid, and statements of this nature can actually play into the hands of apologists of bogus treatments: they can then easily demonstrate the sceptics to be mistaken or “biased”, as they would probably say. The truth is that there is plenty of evidence – and lots of it is positive, at least at first glance.

Alternative medicine researchers have been very industrious during the last two decades to build up a sizable body of ‘evidence’. Consequently, one often finds data even for the most bizarre and implausible treatments. Take, for instance, the claim that homeopathy is an effective treatment for cancer. Those who promote this assumption have no difficulties in locating some weird in-vitro study that seems to support their opinion. When sceptics subsequently counter that in-vitro experiments tell us nothing about the clinical situation, apologists quickly unearth what they consider to be sound clinical evidence.

An example is this prospective observational 2011 study of cancer patients from two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (HG; n = 259), and one cohort with conventionally treated cancer patients (CG; n = 380). Its main outcome measures were the change of quality life after 3 months, after one year and impairment by fatigue, anxiety or depression. The results of this study show significant improvements in most of these endpoints, and the authors concluded that we observed an improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment.

Another, in some ways even better example is this 2005 observational study of 6544 consecutive patients from the Bristol Homeopathic Hospital. Every patient attending the hospital outpatient unit for a follow-up appointment was included, commencing with their first follow-up attendance. Of these patients 70.7% (n = 4627) reported positive health changes, with 50.7% (n = 3318) recording their improvement as better or much better. The authors concluded that homeopathic intervention offered positive health changes to a substantial proportion of a large cohort of patients with a wide range of chronic diseases.

The principle that is being followed here is simple:

  • believers in a bogus therapy conduct a clinical trial which is designed to generate an apparently positive finding;
  • the fact that the study cannot tell us anything about cause and effect is cleverly hidden or belittled;
  • they publish their findings in one of the many journals that specialise in this sort of nonsense;
  • they make sure that advocates across the world learn about their results;
  • the community of apologists of this treatment picks up the information without the slightest critical analysis;
  • the researchers conduct more and more of such pseudo-research;
  • nobody attempts to do some real science: the believers do not truly want to falsify their hypotheses, and the real scientists find it unreasonable to conduct research on utterly implausible interventions;
  • thus the body of false or misleading ‘evidence’ grows and grows;
  • proponents start publishing systematic reviews and meta-analyses of their studies which are devoid of critical input;
  • too few critics point out that these reviews are fatally flawed – ‘rubbish in, rubbish out’!
  • eventually politicians, journalists, health care professionals and other people who did not necessarily start out as believers in the bogus therapy are convinced that the body of evidence is impressive and justifies implementation;
  • important health care decisions are thus based on data which are false and misleading.

So, what can be done to prevent that such pseudo-evidence is mistaken as solid proof which might eventually mislead many into believing that bogus treatments are based on reasonably sound data? I think the following measures would be helpful:

  • authors should abstain from publishing over-enthusiastic conclusions which can all too easily be misinterpreted (given that the authors are believers in the therapy, this is not a realistic option);
  • editors might consider rejecting studies which contribute next to nothing to our current knowledge (given that these studies are usually published in journals that are in the business of promoting alternative medicine at any cost, this option is also not realistic);
  • if researchers report highly preliminary findings, there should be an obligation to do further studies in order to confirm or refute the initial results (not realistic either, I am afraid);
  • in case this does not happen, editors should consider retracting the paper reporting unconfirmed preliminary findings (utterly unrealistic).

What then can REALISTICALLY be done? I wish I knew the answer! All I can think of is that sceptics should educate the rest of the population to think and analyse such ‘evidence’ critically…but how realistic is that?

Has it ever occurred to you that much of the discussion about cause and effect in alternative medicine goes in circles without ever making progress? I have come to the conclusion that it does. Here I try to illustrate this point using the example of acupuncture, more precisely the endless discussion about how to best test acupuncture for efficacy. For those readers who like to misunderstand me I should explain that the sceptics’ view is in capital letters.

At the beginning there was the experience. Unaware of anatomy, physiology, pathology etc., people started sticking needles in other people’s skin, some 2000 years ago, and observed that they experienced relief of all sorts of symptoms.When an American journalist reported about this phenomenon in the 1970s, acupuncture became all the rage in the West. Acupuncture-fans then claimed that a 2000-year history is ample proof that acupuncture does work.

BUT ANECDOTES ARE NOTORIOUSLY UNRELIABLE!

Even the most enthusiastic advocates conceded that this is probably true. So they documented detailed case-series of lots of patients, calculated the average difference between the pre- and post-treatment severity of symptoms, submitted it to statistical tests, and published the notion that the effects of acupuncture are not just anecdotal; in fact, they are statistically significant, they said.

BUT THIS EFFECT COULD BE DUE TO THE NATURAL HISTORY OF THE CONDITION!

“True enough”, grumbled the acupuncture-fans and conducted the very first controlled clinical trials. Essentially they treated one group of patients with acupuncture while another group received conventional treatments as usual. When they analysed the results, they found that the acupuncture group had improved significantly more. “Now do you believe us?”, they asked triumphantly, “acupuncture is clearly effective”.

NO! THIS OUTCOME MIGHT BE DUE TO SELECTION BIAS. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT.

The acupuncturists felt slightly embarrassed because they had not thought of that. They had allocated their patients to the treatment according to patients’ choice. Thus the expectation of the patients (or the clinician) to get relief from acupuncture might have been the reason for the difference in outcome. So they consulted an expert in trial-design and were advised to allocate not by choice but by chance. In other words, they repeated the previous study but randomised patients to the two groups. Amazingly, their RCT still found a significant difference favouring acupuncture over treatment as usual.

BUT THIS DIFFERENCE COULD BE CAUSED BY A PLACEBO-EFFECT!

Now the acupuncturists were in a bit of a pickle; as far as they could see, there was no good placebo for acupuncture! Eventually some methodologist-chap came up with the idea that, in order to mimic a placebo, they could simply stick needles into non-acupuncture points. When the acupuncturists tried that method, they found that there were improvements in both groups but the difference between real acupuncture and placebo was tiny and usually neither statistically significant nor clinically relevant.

NOW DO YOU CONCEDE THAT ACUPUNCTURE IS NOT AN EFFECTIVE TREATMENT?

Absolutely not! The results merely show that needling non-acupuncture points is not an adequate placebo. Obviously this intervention also sends a powerful signal to the brain which clearly makes it an effective intervention. What do you expect when you compare two effective treatments?

IF YOU REALLY THINK SO, YOU NEED TO PROVE IT AND DESIGN A PLACEBO THAT IS INERT.

At that stage, the acupuncturists came up with a placebo-needle that did not actually penetrate the skin; it worked like a mini stage dagger that telescopes into itself while giving the impression that it penetrated the skin just like the real thing. Surely this was an adequate placebo! The acupuncturists repeated their studies but, to their utter dismay, they found again that both groups improved and the difference in outcome between their new placebo and true acupuncture was minimal.

WE TOLD YOU THAT ACUPUNCTURE WAS NOT EFFECTIVE! DO YOU FINALLY AGREE?

Certainly not, they replied. We have thought long and hard about these intriguing findings and believe that they can be explained just like the last set of results: the non-penetrating needles touch the skin; this touch provides a stimulus powerful enough to have an effect on the brain; the non-penetrating placebo-needles are not inert and therefore the results merely depict a comparison of two effective treatments.

YOU MUST BE JOKING! HOW ARE YOU GOING TO PROVE THAT BIZARRE HYPOTHESIS?

We had many discussions and consensus meeting amongst the most brilliant brains in acupuncture about this issue and have arrived at the conclusion that your obsession with placebo, cause and effect etc. is ridiculous and entirely misplaced. In real life, we don’t use placebos. So, let’s instead address the ‘real life’ question: is acupuncture better than usual treatment? We have conducted pragmatic studies where one group of patients gets treatment as usual and the other group receives acupuncture in addition. These studies show that acupuncture is effective. This is all the evidence we need. Why can you not believe us?

NOW WE HAVE ARRIVED EXACTLY AT THE POINT WHERE WE HAVE BEEN A LONG TIME AGO. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT. YOU OBVIOUSLY CANNOT DEMONSTRATE THAT ACUPUNCTURE CAUSES CLINICAL IMPROVEMENT. THEREFORE YOU OPT TO PRETEND THAT CAUSE AND EFFECT ARE IRRELEVANT. YOU USE SOME IMITATION OF SCIENCE TO ‘PROVE’ THAT YOUR PRECONCEIVED IDEAS ARE CORRECT. YOU DO NOT SEEM TO BE INTERESTED IN THE TRUTH ABOUT ACUPUNCTURE AT ALL.

In 1747, James Lind conducted what may well be the first documented controlled clinical trial in the history of medicine. He treated a small group of healthy sailors with a range of different remedies to see whether one of these regimen might be effective in preventing scurvy. The results showed that lemon and lime juice – effectively vitamin C – did the trick. This trial changed the world: it saved tens of thousands of lives, gave Britain the advantage at sea needed to become a dominant empire, and set medicine on the track to eventually become evidence-based.

Of course, Lind did not know that the effective principle in his lemon/lime juice was vitamin C. The Hungarian physiologist Albert Szent-Gyorgyi discovered vitamin C only ~200 years later and received the Nobel Prize for it in 1937. Since then, research has been buoyant, and vitamin C has been advocated for almost every condition one can think of. Looking at some of the claims made for it, I get the impression that more charlatans have jumped on the vitamin C band-waggon than the old vehicle can support. In alternative medicine, high-dose IV vitamin C is a popular variation of Lind’s concept, not least for the treatment of cancer.

Researchers from the NIH in the US surveyed attendees at annual CAM Conferences in 2006 and 2008, and determined sales of intravenous vitamin C by major U.S. manufacturers/distributors. They also queried practitioners for adverse effects, compiled published cases, and analyzed FDA’s Adverse Events Database. Of 199 survey respondents (out of 550), 172 practitioners had administered IV vitamin C to 11,233 patients in 2006 and to 8876 patients in 2008. The average dose was 28 grams every 4 days, with a mean of 22 treatments per patient. Estimated yearly doses used (as 25g/50ml vials) were 318,539 in 2006 and 354,647 in 2008. Manufacturers’ yearly sales were 750,000 and 855,000 vials, respectively. Common reasons for treatment included infection, cancer, and fatigue. Of 9,328 patients for whom data was available, 101 had adverse effects, mostly minor, including lethargy/fatigue in 59 patients, change in mental status in 21 patients and vein irritation/phlebitis in 6 patients. Publications documented serious adverse events, including two deaths. The FDA Adverse Events Database was uninformative.

The authors of this paper conclude that high dose IV vitamin C is in unexpectedly wide use by CAM practitioners. Other than the known complications of IV vitamin C in those with renal impairment or glucose 6 phosphate dehydrogenase deficiency, high dose intravenous vitamin C appears to be remarkably safe. Physicians should inquire about IV vitamin C use in patients with cancer, chronic, untreatable, or intractable conditions and be observant of unexpected harm, drug interactions, or benefit.

I find these results somewhat worrying. Desperate cancer patients are constantly being told that they can fight the disease with high-dose vitamin C, for instance on the >9 million (!) websites on this subject. One site, for instance, leaves little doubt about the efficacy of vitamin C as a treatment for cancer: First shown to be a powerful anti-cancer agent in 1971, it wasn’t until 20 years later that vitamin C started to be accepted by the mainstream medical profession. Eating a vitamin C-rich diet substantially reduces the risk of cancer, and high intakes – above 5000mg a day (the equivalent of 100 oranges) – substantially increases the life expectancy of cancer patients.

Statements like this one give false hope to cancer patients which is unethical and cruel and might hasten the death of many. The reality is quite different and provides little reason for such hope. Here are just a few conclusions from recent scientific analyses on this or closely related topics:

post-diagnosis vitamin C supplementation at the level observed in our population was not associated with survival

Evidence is insufficient to prove the presence or absence of benefits from use of multivitamin and mineral supplements to prevent cancer and chronic disease

We could not find evidence that antioxidant supplements prevent gastrointestinal cancers. On the contrary, they seem to increase overall mortality. The potential cancer preventive effect of selenium should be studied in adequately conducted randomised trial

The question whether the regular intake of high doses of vitamin C have a preventative effect for certain cancers is currently open. But there is no good reason to suggest that high dose IV vitamin C is an effective treatment for any cancer. To pretend otherwise, as so many alternative practitioners seem to do, is less than responsible – in fact, it is a hallmark for cancer quackery.

As I write these words, I am travelling back from a medical conference. The organisers had invited me to give a lecture which I concluded saying: “anyone in medicine not believing in evidence-based health care is in the wrong business”. This statement was meant to stimulate the discussion and provoke the audience who were perhaps just a little on the side of those who are not all that taken by science.

I may well have been right, because, in the coffee break, several doctors disputed my point; to paraphrase their arguments: “You don’t believe in the value of experience, you think that science is the way to know everything. But you are wrong! Philosophers and other people, who are a lot cleverer than you, tell us that science is not the way to real knowledge; and in some forms of medicine we have a wealth of experience which we cannot ignore. This is at least as important as scientific knowledge. Take TCM, for instance, thousands of years of tradition must mean something; in fact it tells us more than science will ever be able to. Qi-energy, for instance, is a concept based on experience, and science is useless at verifying it.”

I disagreed, of course. But I am afraid that I did not convince my colleagues. The appeal to tradition is amazingly powerful, so much so that even well-seasoned physicians fall for it. Yet it nevertheless is a fallacy, I am sure.

So what does experience tell us, how is it generated and why should it be unreliable?

On the level of the individual, experience emerges when a clinician makes similar observations several times in a row. This is so persuasive that few doctors are immune to the phenomenon. Let’s assume the experience is about acupuncture, more precisely about acupuncture for smoking cessation. The acupuncturist presumably has learnt during his training that his therapy works for that indication via stimulating the flow of Qi, and promptly tries it on several patients. Some of them come back for more and report that they find it easier to give up cigarettes after consulting him. This happens repeatedly, and our clinician forthwith is convinced – in fact, he knows – that acupuncture is effective for smoking cessation.

If we critically analyse this scenario, what does it tell us? It tells us very little of relevance, I am afraid. The scenario is entirely compatible with a whole host of explanations which have nothing to do with the effects of acupuncture per se:

  • Those patients who did not manage to stop smoking might not have returned. Only seeing his successes without his failures, the acupuncturist would have got the wrong end of the stick.
  • Human memory is selective such that the few patients who did come back and reported failure might easily get forgotten by the clinician. We all remember the good things and forget the disappointments, particularly if we are clinicians.
  • The placebo-effect might have played a dirty trick on the experience of our acupuncturist.
  • Some patients might have used nicotine patches that helped him to stop smoking without disclosing this fact to the acupuncturist who then, of course, attributed the benefit to his needling.
  • The acupuncturist – being a very kind and empathetic clinician – might have involuntarily induced some of his patients to show kindness in return and thus tell porkies about their smoking habits which would have created a false positive impression about the effectiveness of his treatment.
  • Being so empathetic, the acupuncturists would have provided lots of encouragement to stop smoking which, in some patients, might have been sufficient to kick the habit.

 

The long and short of all this is that our acupuncturist gradually got convinced by this interplay of factors that Qi exists and that acupuncture is an ineffective treatment. Hence forth he would bet his last shirt that he is right about this – after all, he has seen it with his own eyes, not just once but many times. And he will doubt anyone who shows him evidence that says otherwise. In fact, he is likely become very sceptical about scientific evidence in general – just like the doctors who talked to me after my lecture.

On a population level, such experience will be prevalent in not just one but most acupuncturists. Our clinician’s experience is certainly not unique; others will have made it too. In fact, as an acupuncturist, it is hard not to make it. Acupuncturists would have told everyone else about it, perhaps reported it on conferences or published it in articles or books. Experience of this nature is passed on from generation to generation, and soon someone will be able to demonstrate that acupuncture has been used ’effectively’ for smoking cessation since decades or centuries. The creation of a myth out of unreliable experience is thus complete.

Am I saying that experience of this nature is always and necessarily wrong or useless? No, I am not. It can be and often is correct. But, at the same time, it is frequently incorrect. It can serve as a valuable indicator but not more. Experience is not a tool for reliably informing us about the effectiveness of medical interventions. Experience based-medicine is an obsolete pseudo-medicine burdened with concepts that are counter-productive to optimal health care.

Philosophers and other people who are much cleverer than I am have been trying for some time to separate good from bad science and evidence from experience. Most recently, two philosophers, MASSIMO PIGLIUCCI and MAARTEN BOUDRY, commented specifically on this problem in relation to TCM. I leave you with some extensive quotes from what they wrote.

… pointing out that some traditional Chinese remedies (like drinking fresh turtle blood to alleviate cold symptoms) may in fact work, and therefore should not be dismissed as pseudoscience… risks confusing the possible effectiveness of folk remedies with the arbitrary theoretical-metaphysical baggage attached to it. There is no question that some folk remedies do work. The active ingredient of aspirin, for example, is derived from willow bark…

… claims about the existence of “Qi” energy, channeled through the human body by way of “meridians,” though, is a different matter. This sounds scientific, because it uses arcane jargon that gives the impression of articulating explanatory principles. But there is no way to test the existence of Qi and associated meridians, or to establish a viable research program based on those concepts, for the simple reason that talk of Qi and meridians only looks substantive, but it isn’t even in the ballpark of an empirically verifiable theory.

…the notion of Qi only mimics scientific notions such as enzyme actions on lipid compounds. This is a standard modus operandi of pseudoscience: it adopts the external trappings of science, but without the substance.

…The notion of Qi, again, is not really a theory in any meaningful sense of the word. It is just an evocative word to label a mysterious force of which we do not know and we are not told how to find out anything at all.

Still, one may reasonably object, what’s the harm in believing in Qi and related notions, if in fact the proposed remedies seem to help? Well, setting aside the obvious objections that the slaughtering of turtles might raise on ethical grounds, there are several issues to consider. To begin with, we can incorporate whatever serendipitous discoveries from folk medicine into modern scientific practice, as in the case of the willow bark turned aspirin. In this sense, there is no such thing as “alternative” medicine, there’s only stuff that works and stuff that doesn’t.

Second, if we are positing Qi and similar concepts, we are attempting to provide explanations for why some things work and others don’t. If these explanations are wrong, or unfounded as in the case of vacuous concepts like Qi, then we ought to correct or abandon them. Most importantly, pseudo-medical treatments often do not work, or are even positively harmful. If you take folk herbal “remedies,” for instance, while your body is fighting a serious infection, you may suffer severe, even fatal, consequences.

…Indulging in a bit of pseudoscience in some instances may be relatively innocuous, but the problem is that doing so lowers your defenses against more dangerous delusions that are based on similar confusions and fallacies. For instance, you may expose yourself and your loved ones to harm because your pseudoscientific proclivities lead you to accept notions that have been scientifically disproved, like the increasingly (and worryingly) popular idea that vaccines cause autism.

Philosophers nowadays recognize that there is no sharp line dividing sense from nonsense, and moreover that doctrines starting out in one camp may over time evolve into the other. For example, alchemy was a (somewhat) legitimate science in the times of Newton and Boyle, but it is now firmly pseudoscientific (movements in the opposite direction, from full-blown pseudoscience to genuine science, are notably rare)….

The borderlines between genuine science and pseudoscience may be fuzzy, but this should be even more of a call for careful distinctions, based on systematic facts and sound reasoning. To try a modicum of turtle blood here and a little aspirin there is not the hallmark of wisdom and even-mindedness. It is a dangerous gateway to superstition and irrationality

I regularly used to ask alternative practitioners what diseases they are good at treating. In fact, we once ran an entire research project dedicated to this question and found that their own impressions were generally based on wishful thinking rather than on evidence. The libel case of the BCA versus Simon Singh then brought this issue into the focus of the public eye, and consequently several professional organisations of alternative practitioners seem to have advised their members to be cautious about making unsubstantiated therapeutic claims. This could have been an important step into the right direction – unless, of course, a clever trick had not been devised to bypass the need for evidence. Today, when I ask alternative practitioners ‘what do you treat effectively?’ I tend to get answers like:

  • Alternative practitioners, unlike conventional clinicians, do not treat diseases.
  • I treat the whole person, not just the disease.
  • I treat people and their specific set of signs and symptoms, rather than disease labels (this actually is a quote from the comments section of one of my recent posts).
  • I focus on the totality of the symptoms; disease labels are irrelevant in the realm of my therapy.
  • Chiropractors adjust subluxations which are the root cause for most diseases.
  • Acupuncturists re-balance life energies which is a precondition for healing to commence irrespective of the disease.
  • Homeopaths treat the totality of symptoms so that the patient’s vital force can do the healing.
  • etc. etc.

All of these statements are deeply rooted in the long obsolete notions of vitalism, i.e. the assumption that a vital energy flows in all living organisms and is responsible for our health irrespective of the disease we happen to suffer from. But what do the answers to my question ‘what do you treat?’ really mean? If we analyse the above responses critically, they seem to imply that:

  1. Conventional clinicians do not treat patients but merely disease labels.
  2. Alternative practitioners can successfully treat any disease or condition.

Ad 1 In my view, it is arrogant and grossly unfair to claim that alternative practitioners work holistically, while conventional health care professionals do not. I have pointed out repeatedly that any good medicine always has been and always will be holistic. High-jacking holism as a specific characteristic for alternative medicine is misleading and an insult to all conventional clinicians who do their best to practice good medicine.

Ad 2 By claiming that they treat the whole person irrespective of her disease, alternative practitioners effectively try to give themselves a ‘carte blanche’ for treating any disease or any condition or any symptom. If a child has asthma, a chiropractor will find a subluxation, adjust it with spinal manipulation, and claim that the child’s condition will improve as a consequence of his treatment – NEVER MIND THE EVIDENCE. If a person wants to give up smoking, an acupuncturist will use acupuncture to re-balance her yin and yang claiming that this intervention will make smoking cessation more successful – NEVER MIND THE EVIDENCE. If a patient suffers from cancer, a homeopath might find a remedy that promotes her vital energy claiming that the cancer will subsequently be cured – NEVER MIND THE EVIDENCE which in all of the three cases is negative.

The claim of alternative practitioners to not treat disease labels but the whole patient is doubtlessly attractive to consumers and it is also extremely good for business. On closer inspection, however, it turns out to be a distraction from the fact that alternative practitioners treat everything and anything, usually without the slightest evidence that their interventions generates more good than harm. It allows alternative practitioners to live in a fool’s paradise of quackery where they believe themselves to be protected from any challenges and demands for evidence.

One cannot very well write a blog about alternative medicine without giving full credit to the biggest and probably most determined champion of quackery who ever hugged a tree. Prince Charles certainly has done more than anyone else I know to let unproven treatments infiltrate real medicine. To honour his unique achievements, I am here presenting a fictitious interview with him. It never did take place, of course, and the questions I put to him are pure imagination. However, the ‘answers’ are in a way quite real: they have been taken unaltered from various speeches he made and articles he wrote. To avoid being accused of using dodgy sources which might have quoted him inaccurately or sympathetically, I have exclusively used HRH’s very own official website as a source for his comments. It seems safe to assume that HRH identifies with them more fully than with the many other statements he made on this subject.

I have not changed a single word in his statements and I have tried to avoid quoting him out of context; I did, however, take the liberty of putting sentences side by side which do not always originate from the same speech or article, i.e. I have used quotes from different communications to appear as though they originally were in sequence. It will be clear from the text that the fictitious interview is dated before Charles’ Foundation folded because of money laundering and fraud.

It is, of course, hugely tempting to comment on the various statements by Charles. However, I have resisted this temptation; I wanted the reader to enjoy his wisdom in its pure and unadulterated beauty. Anyone who feels like it will have plenty of opportunity to post comments, if they so wish.

To make clear what is what, my questions appear in italics, while his ‘answers’ are in Roman typeface.

 

Q I believe you have no training in science or medicine; yet you have long felt yourself expert enough to champion bizarre forms of therapies which many of our readers might call quackery.

As you know by now, this is an area to which I attach the greatest importance and where I have tried to make a particular contribution. For many years, the NHS has found complementary medicine an uncomfortable bedfellow – at best regarded as ‘fringe’ and in some quarters as ‘quack’; never viewed as a substitute for conventional medicine and rarely as a genuine partner in providing therapy.

I look back to the rather “lukewarm” response I received in 1983 as President of the British Medical Association when I first spoke about integration and complementary and alternative medicine. We have clearly travelled a very long way since that time.

Q Alternative medicine is mainly used by those who can afford it; at present, little of it is available on the NHS. Why do you want to change this situation? 

The very popularity of non-conventional approaches suggests that people are either dissatisfied with the kind of orthodox treatment they are receiving, or find genuine relief in such therapies. Whatever the case, it is only reasonable to try to identify the factors that are contributing to their increased use. And if advantages are found, clearly they should not be limited only to those people who can pay, but should be made more widely available on the NHS.

Q If with a capital “I”?

I believe it is because complementary and alternative approaches to healthcare bring a different emphasis to bear which often unlocks an individual’s inner resources to aid recovery or help to manage living with a serious chronic illness. It is also because complementary and alternative therapies often offer more effective and less intrusive ways of treating illness.

Q Really? Are you sure that they are more effective that conventional treatments? What is your evidence for that?

In 1997 the Foundation for Integrated Medicine, of which I am the president and founder, identified research and development based on rigorous scientific evidence as one of the keys to the medical establishment’s acceptance of non-conventional approaches. I believed then, as I do now, that the move to a more integrated provision of healthcare would ultimately benefit patients and their families.

Q But belief is hardly a good substitute for evidence. In this context, it is interesting to note that chiropractors and osteopaths received the same status as doctors and nurses in the UK. Is this another of your achievements? Was it based on belief or on evidence?

True healing is a synergy that comes not by courtesy of a medical diploma.

Q What do you mean?

As we know, the professions of Osteopathy and Chiropractice are now regulated in the same way as doctors and dentists, with their own Acts of Parliament. I’m very proud to have played a tiny role in trying to push for that Act of Parliament over the years. It has also been reassuring to see the progress being made by the other main complementary professions and I look forward to the further development of regulatory frameworks enabling high standards of training, clinical practice and professional behaviour.

Q Some might argue that statutory regulation made them not more professional but merely improved their status and thus prevented asking question about evidence. Why did they need to be regulated in that way?

The House of Lord’s Select Committee Report on Complementary and Alternative Medicine in 2000, quite sensibly recommended that only complementary professions which were statutorily regulated, or which had well-established arrangements for voluntary self-regulation, should be made available through the NHS.

Q Integrated healthcare seems to be your new buzz-word, what does it mean? Is it more than a passing fad?

Integrated Healthcare is, I believe, here to stay. The public want it and need it. It is not a takeover of the orthodox by CAM or the other way around, but is rather the bringing together of the best from both for the ultimate benefit of the patient.

Q Your lobby-group, Foundation for Integrated Medicine, what has it ever done to justify its existence?

In 1997 the steering group of The Foundation for Integrated Medicine (FIM), of which I am proud to be president, published a discussion document ‘Integrated Healthcare – A Way Forward for the Next Five Years?’

Q Sorry to interrupt, but if so many people are already using them, why do you feel compelled to promote unproven treatments even more? Why is ‘a way forward’ in promotion actually needed? Why did we need a lobby group like FIM?

Homoeopaths, osteopaths, reflexologists, acupuncturists, T’ai chi instructors, art therapists, chiropractors, herbalists and aromatherapists: these practitioners were working alongside NHS colleagues in acute hospitals, on children’s wards, in nursing homes and in particular in primary healthcare, in GP practices and health clinics up and down the country.

Q Exactly! Why then even more promotion of unproven treatments?

All well and good, perhaps, but if there are advantages in this approach, clearly they should not be limited only to those who can pay.

Q Yes, if again with a capital “I”, presumably . Anyway, do you believe these therapies should be tested like other treatments?

One of the obstacles always raised is that it is very difficult to trial complementary therapies in the rigorous randomised way that mainstream medicine deems to be the gold standard. This is ironic as there are, of course, un-evaluated orthodox practices which continue to be funded by the NHS.

Q Are you an expert on research methodology as well?

At the same time, we should be mindful that clinically controlled trials alone are not the only pre-requisites to apply a healthcare intervention. Consumer-based surveys can explore WHY people choose complementary and alternative medicine and tease out the therapeutic powers of belief and trust

These “rationalist selves” would be enormously relieved to see the effectiveness of these treatments proven through the “double-blind randomized controlled trial” – the gold-standard of medical research. However, we know that some complementary and alternative medicine disciplines (and indeed other forms of medical or surgical intervention) do not lend themselves to this research method.

Q Are you sure? This sounds like something someone who is ignorant of research methodology has told you.

… it has been suggested that we need a research method for complementary treatment that is, to use that awful expression, “fit for purpose”. Something that is entirely practical – what has been called “applied” research – which takes into account the whole person and the whole treatment as it is actually given in the surgery or the hospital. Something that might offer us a better idea of the cost-effectiveness of any given approach. It would also help to provide the right sort of evidence that health service commissioners require when they decide which services they wish to commission for their patients.

Q Hmm – anyway, would you promote unproven treatments even for serious conditions like cancer?

Two surveys have indicated that up to eighty per cent of cancer patients try alternative or complementary treatments at some stage following diagnosis and seventy-five per cent of patients would like to see complementary medicine available on the N.H.S.

Q Yes, but why the promotion?

There is a major role for complementary medicine in bowel cancer – as a support to more conventional approaches – in helping to prevent it through lifestyle changes, helping to boost our immune systems and in helping sufferers to come to terms with, and maintain, a sense of control over their own lives and wellbeing. My own Foundation For Integrated Medicine is, for example, involved in finding ways to integrate the best of complementary and alternative medicine.

Q And what do you understand by “the best”? In medicine, this term should mean “the most effective”, shouldn’t it?

Many cancer patients have turned to an integrated approach to managing their health, finding complementary therapies such as acupuncture, aromatherapy, reflexology and massage therapy extremely therapeutic. I know of one patient who turned to Gerson Therapy having been told that she was suffering from terminal cancer, and would not survive another course of chemotherapy. Happily, seven years later she is alive and well. So it is therefore vital that, rather than dismissing such experiences, we should further investigate the beneficial nature of these treatments.

Q Gerson? Is it ethical to promote an unproven starvation diet for cancer? 

…many patients use and believe in Gerson Therapy, yet more evidence needs to be available as to who might benefit or what adverse effects there might be. But, surely, we need to take a wider view of the most appropriate types of research methodology – a wider view of what research will help patients.

Q You are a very wealthy man; will you put your own money into the research that you regularly demand?

Complementary medicine is gaining a toehold on the rockface of medical science.

Q I beg your pardon.

Complementary medicine’s toehold is literally that, and it’s an inescapable fact that clinical trials, of the calibre that medical science demands, cost money. Figures from the Department of Complementary Medicine at the University of Exeter show that less than 8p out of every £100 of NHS funds for medical research was spent on complementary medicine. In 1998-99 the Medical Research Council spent no money on it at all, and in 1999 only 0.05% of the total research budget of UK medical charities went to this area.

Q HmmNature; you are very fond of all things natural, aren’t you?

The garden is designed to remind people of our interconnectedness with Nature and of the beneficial medicinal properties She provides through countless plants, flowers and trees. Throughout the 20th century so much ancient, accumulated, traditional wisdom has been thrown away – whether in the fields of medicine, architecture, agriculture or education. The baby was thrown out with the bathwater, so this garden is designed to bring the baby back again and to remind us of that priceless, traditional knowledge before we lose that rich store of Nature’s healing gifts for the benefit of our descendants.

When you think about it, what on earth is the point of throwing away our lifeline; of abandoning the priceless knowledge and wisdom accumulated over 1,000’s of years relating to the treatment of the human condition by natural means? It is sheer folly it seems to me to forget that we are a part of Nature and to imagine we can survive on this Earth as if we were merely a mechanical process divorced from, and in opposition to, the unity of the world around us.

Q …and herbalism?

Medical herbalists talk about ‘synergy’, the result of a complex mix of active ingredients in a plant that create a more powerful therapeutic effect together than if isolated. It’s a concept that has a wider application. As the 17th century poet John Donne famously wrote, “No man is an Island, entire of itself; every man is a piece of the Continent, a part of the main.”

Q I am not sure I understand; what does that mean?

Medical herbalists, who make up their own preparations from combinations of fresh or dried plants, believe that this mix within individual herbs as well as in traditional mixtures of plant medicines creates what is called synergy, in which all the chemical components contribute to the remedy’s specific therapeutic effects.

At a time when farmers everywhere are struggling to make ends meet, the development of a natural pharmacy of organically grown herbs offers an alternative means of earning a living. Yet without protective measures, herbs are easily adulterated or their quality compromised.

Q …and homeopathy?

I went to open the new Glasgow Homeopathic Hospital for instance a couple of years ago, I met a whole lot of students who were studying homeopathy, I think, and I’ve never forgotten when they said to me ‘Are you interested in homeopathy’ and I thought – I don’t know, why do I bother?

Q And why exactly do you bother, if I may ask?

By allowing patients treatment choice, negative emotions can, in part, be alleviated. Many complementary practitioners provide time, empathy, hope and reassurance – skills that are referred to as the “human effect” – which can improve the confidence of cancer patients, alter mindsets and produce major positive changes in the immune system. As a result the “human effect” can greatly prolong life: it has been demonstrated that in a variety of cancers, such as breast cancer, that attitude of mind can not only raise the quality of life but in some cases can even prolong life. At the same time, we need specific treatments that are designed to improve the quality of patients’ lives, and to provide relief from the unpleasant symptoms of cancer – anxiety; pain; sleeplessness; skin irritation; poor appetite; nausea and depression, to name but a few.

Q At heart you seem to be a vitalist who believes in a vital force or energy that interconnects anything with everything and determines our health.

Research in the new field of psychoneuroimmunology – or mind-body medicine as it is sometimes called – is discovering that there is a constant interplay between our emotions, thoughts and actions and our body systems. It seems that the food we eat, the air we breathe, the exercise we take, our relationships with other people, all have a direct bearing on our health and natural healing processes. Complementary medicine has always known this and I believe it is one of the reasons for its enormous popularity.

Q Clarence House made several statements assuring the British public that you never overstep your constitutional role by trying to influence health politics; they were having us on, weren’t they?

A few days ago I launched an initiative to promote the provision of more complementary medicine in the NHS. For many years I have been working towards this goal.

Q Does that mean these statements were wrong?

I am convinced there is no better moment than now to create a real integration of our healthcare, particularly when there is talk of a Patient-Centred NHS. So much ill-health and disease is due to the misery, stress and alienation we see in our community.

CAM-Cancer is short for a project entitled “Concerted Action for Complementary and Alternative Medicine Assessment in the Cancer Field”. Originally funded by the European Commission, it is now hosted by the National Information Center for Complementary and Alternative Medicine (NIFAB) at the University of Tromsø, Norway.

Our executive Committee is very international and, in my view, fairly balanced; it consists of the following experts:

  • Prof Vinjar Fønnebø, The Norwegian National Research Center in CAM
  • Prof Thomas Cerny, Kantonsspital St Gallen, Switzerland
  • Prof Edzard Ernst, University of Exeter, UK
  • Dr Markus Horneber, Department of Oncology/Hematology, Klinikum Nuernberg, Germany
  • Dr Christine Paludan-Müller, Danish Cancer Society

Our work consists mainly of conducting and updating systematic reviews of treatments often used by cancer patients and providing them for free via the Internet. To date, we have concluded more than 60 such projects and they are all available for anyone to study. I have previously reported about our results in the area of herbal medicine. Today, I will briefly mention those on mind-body interventions.

The Internet is awash with information on the effectiveness of such treatments which is not always accurate, and even top-journals publish reviews which paint a rather optimistic picture: Mind-body therapies categorized as CAM could potentially serve as a positive platform from which providers could discuss CAM and even link survivor subgroups to services that may, at least, partly address unmet psychosocial needs. This would be especially relevant for survivor subgroups that have a cultural bias toward CAM. The mind-body therapies reviewed in this article have some supportive evidence and a rationale for use in cancer survivors. Although data on efficacy and mechanisms of action of mind-body therapies are incomplete and inconclusive, the potential benefits of using these therapies in survivor care plans warrant consideration.

By contrast, our reviews seem far less positive. Here are the key sentences describing the evidence of the four mind-body therapies that we at ‘CAM cancer’ have so far tackled.

  • Based on one clinical trial and two pilot studies, it is not possible to draw conclusions about the effectiveness of autogenic therapy for people with cancer
  • There is presently a lack of good quality, single-intervention trials, so it is not possible to draw clear conclusions about the efficacy of biofeedback for people with cancer
  • Existing evidence suggests that hypnotherapy may reduce cancer therapy related pain, anticipatory nausea and vomiting, and anxiety
  • There is insufficient evidence for the effectiveness of PMR for cancer patients suffering from pain, anxiety, depression, sleep disorders and chemotherapy-induced nausea

The question is, what precisely does that mean? I think this evidence is compatible with several interpretations:

  1. Mind-body therapies are generally over-rated but not really that helpful.
  2. They are effective, but the research is in its infancy and currently fails to document their value adequately.
  3. Some mind-body therapies are effective, while others are not.

At present, it is impossible to tell which interpretation is correct. What is clear, however, is the fact that ‘CAM-Cancer’ is a source that tries its utmost to inform people accurately while doing everything possible to minimise bias.

It is time, I think, to call an end to this series of articles on ‘drowning in a sea of misinformation’. Not that I have covered every contributor to and aspect of it. On the contrary, I could have carried on for another couple of weeks writing a post every day as I did during the last 15 days. But it was getting a bit boring – at least for me. So, for the last post, I have decided to briefly discuss politicians. In my view, they are crucially important in this context, as they create the general atmosphere and framework in which all the other mis-informers can thrive.

Peter Hain (Labour) is a campaigner for homeopathy and wants to see it widely used on the NHS. He was quoted as saying: “I first came to know about homeopathy through my son who as a baby suffered from eczema. He had it a couple of years but with conventional treatment the eczema was getting progressively worse and at the age of four he also developed asthma. We turned to homeopathy out of desperation and were stunned with the positive results. Since then I have used homeopathy for a wide variety of illnesses, but I rely on arnica as it’s excellent for treating the everyday bruises and shocks to the system we face. My view is that homeopathy and conventional medicines must remain side by side under the NHS to offer the best to patients”

Politicians who put anecdote before evidence do worry me quite a bit, I have to admit; by doing this, they provide us with strong evidence that they would be wise to keep their mouth shut when it comes to matters of science and medicine. But Hain is in good company: Jeremy Hunt (conservative), the current Secretary for Health, signed the following Early Day Motion in 2007: That this House welcomes the positive contribution made to the health of the nation by the NHS homeopathic hospitals; notes that some six million people use complementary treatments each year; believes that complementary medicine has the potential to offer clinically-effective and cost-effective solutions to common health problems faced by NHS patients, including chronic difficult to treat conditions such as musculoskeletal and other chronic pain, eczema, depression, anxiety and insomnia, allergy, chronic fatigue and irritable bowel syndrome; expresses concern that NHS cuts are threatening the future of these hospitals; and calls on the Government actively to support these valuable national assets.

The wording here is remarkable, I think: “…believes that complementary medicine has the potential to offer clinically-effective and cost-effective solutions to common health problems faced by NHS patients…” What is this supposed to mean? Health politics based on believe??? What it, in fact, implies is that there is merely belief but no evidence. Bravo! This looks like an own-goal to me.

And there are many, many more politicians who seem to prefer belief over evidence – not just in the UK but in virtually every country; our US friends would probably want me to mention Senator Tom Harkin who is responsible for spending billions of tax-payers’ dollars on researching implausible concepts with flawed studies. To make things worse, it is not just individual politicians who promote woo, as far as I can see, most political parties have a group of members promoting pseudo-science.

But why? Why do so many politicians misinform their voters about the values of unproven and disproven treatments? And I do not mean those members of parliament who nobody seems to be able to take seriously, like David Tredenick; I mean otherwise respectable politicians with real influence. Should they not be the first to insist on reliable evidence? Do they not have a mandate and an ethical/moral obligation to do so?

Call me cynical, but I have come to the conclusion that the answer is actually quite simple. Politicians need to be (re-)elected, and therefore they have to run with whatever subject is popular – and, like it or not, alternative medicine is popular. Politicians rarely take a reasonably long view on health care (in fact, very few understand the first thing about science or medicine); their perspective has exactly the same length as the current legislative period. They usually do not even attach much importance to alternative medicine; after all, it only amounts to a tiny fraction of the total health care budget.

Tony Blair (Labour) is as good an example as any other politician; in relation to homeopathy, he is quoted saying: I think that most people today have a rational view about science and my advice to the scientific community would be fight the battles you need to fight. I wouldn’t bother fighting a great battle over homeopathy – there are people who use it, people who don’t use it, it is not going to determine the future of the world, frankly. What will determine the future of the world however, is the scientific community explaining for example the science of genetics and how it develops, or the issue to do with climate change and so on.

Sounds reasonable? Almost, but not quite. Firstly, if people employ homeopathy to protect themselves from infectious diseases like malaria, typhus, TB, AIDS etc., or if people believe those charlatans who promote it as an effective cure for life-threatening conditions, we do have a serious public health issue at hand. Secondly, why should the vast majority of health care professionals bend over backwards to do their very best implementing the concepts of EBM, if homeopathy is being given a free ride to continue existing in a virtual universe of belief-based medicine? Thirdly, how on earth can scientists possibly explain “the science of genetics and how it develops, or the issue to do with climate change”, if they lack the skill, courage, power or honesty to adequately respond to harmful quackery masquerading as medicine?

It is not difficult to criticise politicians but what might be the way forward and out of this mess? Because of the central role they play in all this, I think that it would be important that those politicians who take up posts in science-based areas be adequately educated and trained in science. I know this may sound naïve, but I think it would be an essential step towards avoiding politicians regularly making fools of themselves, misinforming the public and misguiding important decisions which might affect all of us.

If my health insurance pays for this treatment, it must be scientifically tested and proven. The ‘appeal to authority’ is powerful indeed, and I imagine that many consumers fall for this argument. But it is a fallacy! Health insurances are misinforming us for commercial benefit.

In 2007, I published an analysis of German health insurance companies’ policies regarding bogus treatments (MMW 2006, 149: 55-56 [the paper is in German and unfortunately not Medline-listed]). For this purpose, I had selected three popular alternative modalities: Bach flower remedies, Schuessler salts, and kinesiology all of which are, of course, not supported by sound evidence nor by biological plausibility. What emerged from this evaluation was shocking: of the 13 companies analysed, 9 paid for Bach flower remedies, 7 for kinesiology and 9 for Schuessler salts.

If you now think ‘ah yes, those Germans are obsessed with alternative medicine’, think again. The situation in most other countries is not much better; health insurances go for alternative medicine as though there is no tomorrow. A review from the US concluded that the number of people using CAM insurance benefits was substantial; the effect on insurance expenditures was modest. Because the long-term trajectory of CAM cost under third-party payment is unknown, utilization of these services should be followed. And apparently this is by no means confined to human health; recently someone tweeted that he had a very hard time finding a pet-insurance which did not offer to cover woo.

A few years after the above-mentioned publication, I was invited to speak at an international meeting of health insurers. I told the delegates in no uncertain terms that most of what they were offering to their clients in terms of alternative medicine was either unproven or disproven. There was stunned silence during the official discussion period, and I asked myself whether I had impolitely embarrassed my hosts. Then came the tea break, and one high-level representative of an insurance company after the other came to me to chat. Essentially, they all said: “We are well aware of the facts and the evidence you reviewed in your lecture; most of these treatments are useless, of course. But we have to offer them to our customers because we need to be competitive.”

In other words, health insurers, who normally are keen to keep their costs down, do not mind to pay for treatments which they know are ineffective simply because they use it as some sort of an advertising gimmick. In doing so they say or imply that these treatments do work. I think this is not just wrong and short-sighted, it is unethical and it significantly contributes to the ‘sea of misinformation’.

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!

 

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories