Edzard Ernst

MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

Researchers from the ‘Complementary and Integrative Medicine Research, Primary Medical Care, University of Southampton’ conducted a study of Professional Kinesiology Practice (PKP) What? Yes, PKP! This is a not widely known alternative method.

According to its proponents, it is unique and a complete kinesiology system… It was developed by a medical doctor, Dr Bruce Dewe and his wife Joan Dewe in the 1980s and has been taught since then in over 16 countries around the world with great success… Kinesiology is a unique and truly holistic science and on the cutting edge of energy medicine. It uses muscle monitoring as a biofeedback system to identify the underlying cause of blockage from the person’s subconscious mind via the nervous system. Muscle monitoring is used to access information from the person’s “biocomputer”, the brain, in relation to the problem or issue and also guides the practitioner to find the priority correction in order to stimulate the person’s innate healing capacity and support their physiology to return to normal function. Kinesiology is unique as it looks beyond symptoms. It recognizes the flows of energy within the body not only relate to the muscles but to every tissue and organ that make the human body a living ever changing organism. These energy flows can be evaluated by testing the function of the muscles, which in turn reflect the body’s overall state of structural, chemical, emotional and spiritual balance. In this way kinesiology taps into energies that the more conventional modalities overlook and helps remove all the guesswork, doubt and hard work of subjective diagnostics. This is a revolutionary way to communicate with the body/mind connection. Through muscle monitoring and the use of over 300 fingermodes we can detect and correct the cause of the problem and effect a long lasting change for better health and wellbeing. Our posture could be considered to be the visual display unit from our internal bio-computer. Our posture / life energy improves as we upgrade the way we respond to life’s constant challenges and demands.

You do not understand? Let me make it crystal clear by citing another PKP-site:

PKP is a phenomenological practice – this means practitioners use manual muscle testing to demonstrate to the client how much or how little they are able to move in relation to their problem. PKP practitioners have tests for more than 100 muscles, and dozens of other tests that they do so they can clearly show you how your movement is affected by your problem. This muscle story shows a person how their life is unfolding, and it also helps to guide on how to transcend the situation and design a future which is more in alignment with nature and the laws of the cosmos… PKP is about living life more wisely.

In case you still have not understood what PKP is, you might have to watch this youtube clip. And now that everyone knows what it is, let us have a look at the new study.

According to its authors, it was an exploratory, pragmatic single-blind, 3-arm randomised sham-controlled pilot trial with waiting list control (WLC) which was conducted in the setting of a UK private practice. Seventy participants scoring ≥4 on the Roland and Morris Disability Questionnaire (RMDQ) were randomised to real or sham PKP receiving one treatment weekly for 5 weeks or a WLC. WLC’s were re-randomised to real or sham after 6 weeks. The main outcome measure was a change in RMDQ from baseline to end of 5 weeks of real or sham PKP.

The results show an effect size of 0.7 for real PKP which was significantly different to sham. Compared to WLC, both real and sham groups had significant RMDQ improvements. Practitioner empathy (CARE) and patient enablement (PEI) did not predict outcome; holistic health beliefs (CAMBI) did, though. The sham treatment appeared credible; patients did not guess treatment allocation. Three patients reported minor adverse reactions.

From these data, the authors conclude that real treatment was significantly different from sham demonstrating a moderate specific effect of PKP; both were better than WLC indicating a substantial non-specific and contextual treatment effect. A larger definitive study would be appropriate with nested qualitative work to help understand the mechanisms involved in PKP.

So, PKP has a small specific effect in addition to generating a sizable placebo-effect? Somehow, I doubt it! This was, according to its authors, a pilot study. Such an investigation should not evaluate the effectiveness of a treatment but the feasibility of the protocol. Even if we disregard this detail, I assume that the results indicate the effects of PKP to be essentially due to placebo. The small effect which the authors label as “specific” is, in my view, almost certainly caused by residual confounding and hidden biases.

One could also go one step further and say that any treatment that is shrouded in pseudo-scientific language and has zero plausibility is an ill-conceived candidate for a clinical trial of this nature. If it should be tested at all – and thus cost money, effort and patient-participation – a rigorous study should be designed and conducted not by apologists of the intervention but by more level-headed scientists.

In 2010, NICE recommended acupuncture for chronic low back pain (cLBP). Acupuncturists were of course delighted; the British Acupuncture Council, for instance, stated that they fully support NICE’s (National Institute for Health and Clinical Excellence) decision that acupuncture be made available on the NHS for chronic lower back pain. Traditional acupuncture has been used for over 2,000 years to alleviate back pain and British Acupuncture Council members have for many many years been successfully treating patients for this condition either in private practice or working within the NHS. In effect, therefore, these new guidelines are a rubber stamp of the positive work already being undertaken as well as an endorsement of the wealth of research evidence now available in this area.

More critical experts, however, tended to be surprised about this move and doubted that the evidence was strong enough for a positive recommendation. Now a brand-new meta-analysis sheds more light on this important issue.

Its aim was to determine the effectiveness of acupuncture as a therapy for cLBP. The authors found 13 RCTs which matched their inclusion criteria. Their results show that, compared with no treatment, acupuncture achieved better outcomes in terms of pain relief, disability recovery and better quality of life. These effects were, however, not observed when real acupuncture was compared to sham acupuncture. Acupuncture achieved better outcomes when compared with other treatments. No publication bias was detected.

The authors conclude that acupuncture is an effective treatment for chronic low back pain, but this effect is likely to be produced by the nonspecific effects of manipulation.

In plain English, this means that the effects of acupuncture on cLBP are most likely due to placebo. Should NICE be recommending placebo-treatments and have the tax payer foot the bill? I think I can leave it to my readers to answer this question.

Believe it or not, I started my medical career in homeopathy, to be more exact, in the ‘Krankenhaus fuer Naturheilweisen’ in Munich. That was directly after studying medicine almost 40 years ago. I am not ashamed to admit that I was impressed (show me a doctor who is not balled over with his/her first clinical post and I show you a person without compassion who should have chosen another profession). I stayed about half a year in this hospital and then moved on to lots of other things.

So, how has homeopathy cured me?

In medical school, I am afraid to say, we did not learn critical thinking, not even one iota of it! When I started working, and saw several patients who did get better after taking my homeopathic remedies, I was fascinated. Back in medical school, our pharmacology professor used to go apoplectic when anyone mentioned homeopathy, and I thus knew very well that there was no way it could possibly work. But it did!!! My patients did improve! I had seen it with my own eyes!

This discrepancy needed an explanation. Years later, it became my job to apply science to alternative medicine, and I picked up the subject roughly where I had left it more than a decade before. Now, we did systematic research and published dozens of papers on homeopathy. Even though I started this work slightly on the ‘pro- homeopathic foot’, in the end, the discrepancy between the scientific evidence and the anecdotal observations of millions of patients and homeopaths and myself dissolved into thin air: homeopathic remedies are pure placebos, and there is no discrepancy at all between evidence and anecdote.

Patients can improve for all sorts of reasons:

1) the natural history of the condition

2) placebo effects

3) other treatments they fail to tell their doctor about

4) because the clinician is nice and compassionate

etc. etc.

These are, of course, pretty obvious insights. Yet, remarkably, doctors and other clinicians of all specialities very rarely have them, in my experience. When a patient gets better after our treatments (homeopathic or otherwise), we almost automatically assume that our interventions did the trick. Few of us have the courage to admit that this is only one of many explanations.

To accurately differentiate between effects of the treatment per se and the host of context effects which can mimic them, we need critical thinking. The lack of critical thinking in health care is, I think, like an illness which hinders progress. AND IT WAS HOMEOPATHY THAT CURED ME FROM IT.

Hot flushes are a big problem; they are not life-threatening, of course, but they do make life a misery for countless menopausal women. Hormone therapy is effective, but many women have gone off the idea since we know that hormone therapy might increase their risk of getting cancer and cardiovascular disease. So, what does work and is also risk-free? Acupuncture?

Together with researchers from Quebec, we wanted to determine whether acupuncture is effective for reducing hot flushes and for improving the quality of life of menopausal women. We decided to do this in form of a Cochrane review which was just published.

We searched 16 electronic databases in order to identify all relevant studies and included all RCTs comparing any type of acupuncture to no treatment/control or other treatments. Sixteen studies, with a total of 1155 women, were eligible for inclusion. Three review authors independently assessed trial eligibility and quality, and extracted data. We pooled data where appropriate.

Eight studies compared acupuncture versus sham acupuncture. No significant difference was found between the groups for hot flush frequency, but flushes were significantly less severe in the acupuncture group, with a small effect size. There was substantial heterogeneity for both these outcomes. In a post hoc sensitivity analysis excluding studies of women with breast cancer, heterogeneity was reduced to 0% for hot flush frequency and 34% for hot flush severity and there was no significant difference between the groups for either outcome. Three studies compared acupuncture with hormone therapy, and acupuncture turned out to be associated with significantly more frequent hot flushes. There was no significant difference between the groups for hot flush severity. One study compared electro-acupuncture with relaxation, and there was no significant difference between the groups for either hot flush frequency or hot flush severity. Four studies compared acupuncture with waiting list or no intervention. Traditional acupuncture was significantly more effective in reducing hot flush frequency, and was also significantly more effective in reducing hot flush severity. The effect size was moderate in both cases.

For quality of life measures, acupuncture was significantly less effective than HT, but traditional acupuncture was significantly more effective than no intervention. There was no significant difference between acupuncture and other comparators for quality of life. Data on adverse effects were lacking.

Our conclusion: We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.

I still have to meet an acupuncturist who is not convinced that acupuncture is not an effective treatment for hot flushes. You only need to go on the Internet to see the claims that are being made along those lines. Yet this review shows quite clearly that it is not better than placebo. It also demonstrates that studies which do suggest an effect do so because they fail to adequately control for a placebo response. This means that the benefit patients and therapists observe in routine clinical practice is not due to the acupuncture per se, but to the placebo-effect.

And what could be wrong with that? Quite a bit, is my answer; here are just 4 things that immediately spring into my mind:

1) Arguably, it is dishonest and unethical to use a placebo on ill patients in routine clinical practice and charge for it pretending it is a specific and effective treatment.

2) Placebo-effects are unreliable, small and usually of short duration.

3) In order to generate a placebo-effect, I don’t need a placebo-therapy; an effective one administered with compassion does that too (and generates specific effects on top of that).

4) Not all placebos are risk-free. Acupuncture, for instance, has been associated with serious complications.

The last point is interesting also in the context of our finding that the RCTs analysed failed to mention adverse-effects. This is a phenomenon we observe regularly in studies of alternative medicine: trialists tend to violate the most fundamental rules of research ethics by simply ignoring the need to report adverse-effects. In plain English, this is called ‘scientific misconduct’. Consequently, we find very little published evidence on this issue, and enthusiasts claim their treatment is risk-free, simply because no risks are being reported. Yet one wonders to what extend systematic under-reporting is the cause of that impression!

So, what about the legion of acupuncturists who earn a good part of their living by recommending to their patients acupuncture for hot flushes?

They may, of course, not know about the evidence which shows that it is not more than a placebo. Would this be ok then? No, emphatically no! All clinicians have a duty to be up to date regarding the scientific evidence in relation to the treatments they use. A therapist who does not abide by this fundamental rule of medical ethics is, in my view, a fraud. On the other hand, some acupuncturists might be well aware of the evidence and employ acupuncture nevertheless; after all, it brings good money! Well, I would say that such a therapist is a fraud too.

In a recent comment, US chiropractors stated that there is a growing recognition within the profession that the practicing chiropractor must be able to do the following: formulate a searchable clinical question, rapidly access the best evidence available, assess the quality of that evidence, determine if it is applicable to a particular patient or group of patients, and decide if and how to incorporate the evidence into the care being offered. In a word, they believe, that evidence-based chiropractic is possible, perhaps even (almost) a reality. For evidence-based practice to penetrate and transform a profession, the penetration must occur at two levels, they explain. One level is the degree to which individual practitioners possess the willingness and basic skills to search and assess the literature.

The second level, the authors explain, relates to whether the therapeutic interventions commonly employed by a particular health care discipline are supported by clinical research. The authors believe that a growing body of randomized controlled trials provides evidence of the effectiveness and safety of manual therapies. Is this really true, I wonder.

In support of these fairly bold statements, they cite a paper by Bronfort et al which, in their view, is currently the most comprehensive review of the evidence for the efficacy of manual therapies. According to these authors, the ‘Bronfort-report’ stated that evidence is inconclusive for pneumonia, stage 1 hypertension, pre-menstrual syndrome, nocturnal enuresis, and otitis media. The authors also believe that it is unlikely manipulation of the neck is causally related to stroke.

When I read this article, I could not stop myself from giggling. It seems to me that it provides pretty good evidence for the fact that the chiropractic profession is nowhere near reaching the stage where anyone could reasonably claim that chiropractors practice evidence-based medicine – not even the authors themselves seem to abide by the rules of evidence-based medicine! If they had truly been able to access the best evidence available and assess the quality of that evidence surely they would not have (mis-) quoted the ‘Bronfort-report’.

Bronfort’s overview was commissioned by the General Chiropractic Council, it was hastily compiled by ardent believers of chiropractic, published in a journal that non-chiropractors would not touch with a barge pole, and crucially it lacks some of the most important qualities of an unbiased systematic review. In my view, it is nothing short of a white-wash and not worth the paper it was printed on. Conclusions, such as the evidence regarding pneumonia, bed-wetting and otitis is inconclusive are just embarrassing; the correct conclusion is that the evidence fails to be positive for these and most other indications.

Similarly, if the authors had really studied and quoted the best evidence, how on earth could they have stated that manipulation of the neck cannot cause a stroke? The evidence for that is fairly overwhelming, and the only open question here is, how often do such complications occur? And even the biased ‘Bronfort-report’ states: Adverse events associated with manual treatment can be classified into two categories: 1) benign, minor or non-serious and 2) serious. Generally those that are benign are transient, mild to moderate in intensity, have little effect on activities, and are short lasting. Most commonly, these involve pain or discomfort to the musculoskeletal system. Less commonly, nausea, dizziness or tiredness are reported. Serious adverse events are disabling, require hospitalization and may be life-threatening. The most documented and discussed serious adverse event associated with spinal manipulation (specifically to the cervical spine) is vertebrobasilar artery (VBA) stroke. Less commonly reported are serious adverse events associated with lumbar spine manipulation, including lumbar disc herniation and cauda equina syndrome.

Evidence-based practice? Who are these chiropractors kidding? This article very neatly reflects the exact opposite. It ignores hundreds of peer-reviewed papers which are critical of chiropractic. The best one can do with this paper, I think, is to use it as a hilarious bit of involuntary humour or as a classic example of cherry-picking.

Come to think of it, chiropractic and evidence-based practice are contradictions in terms. Either a therapist claims to adjust mystical subluxations, in which case he/she does not practice evidence-based medicine. Or he/she practices evidence-based medicine, in which case adjusting mystical subluxations cannot be part of their therapeutic repertoire.

Towards the end of the article, we learn further fascinating things: the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article – oh, really?!?! Furthermore, we are told that this ‘research’ was funded by the ‘National Center of Complementary and Alternative Medicine’ (NCCAM) of the National Institutes of Health.

Can it be true? Does the otherwise most respectable NIH really give its name for such overt nonsense? Yes, it is true, and it is by no means the first time. In fact, our analysis shows that, when it comes to chiropractic, this organisation has sponsored almost nothing but utter rubbish, and our conclusion was blunt: the criticism repeatedly aimed at NCCAM seems justified, as far as their RCTs of chiropractic is concerned. It seems questionable whether such research is worthwhile.

Upper spinal manipulation, the signature-treatment of many chiropractors is by no means free of serious risks. Most chiropractors negate this, but can any reasonable person deny it? Neurosurgeons from New York have just published an interesting case-report in this context:

A 45 year old male with presented to his internist with a two-week history of right sided neck pain and tenderness, accompanied by tingling in the hand. The internists’ neurological examination revealed nothing abnormal, except for a decreased range of motion of the right arm. He referred the patient to a chiropractor who performed plain X-rays which apparently showed “mild spasm” (how anyone can see spasm on an X-ray is beyond me!). No magnetic resonance imaging study was done.

The chiropractor proceeded manipulating the patient’s neck on two successive days. By the morning of the third visit, the patient reported extreme pain and difficulty walking. Without performing a new neurological examination or obtaining a magnetic resonance study, the chiropractor manipulated the patient’s neck for a third time.

Thereafter, the patient immediately became quadriplegic. Despite undergoing an emergency C5 C6 anterior cervical diskectomy/fusion to address a massive disc found on the magnetic resonance scan, the patient remained quadriplegic. There seemed to be very little doubt that the quadriplegia was caused by the chiropractic spinal manipulation.

The authors of this report also argue that a major point of negligence in this case was the failure of both the referring internist and chiropractor to order a magnetic resonance study of the cervical spine prior to the chiropractic manipulations. In his defence, the internist claimed that there was no known report of permanent quadriplegia resulting from neck manipulation in any medical journal, article or book, or in any literature of any kind or on the internet. Even the quickest of literature searches discloses this assumption to be wrong. The first such case seems to have been published as early as 1957. Since then, numerous similar reports have been documented in the medical literature.

The internist furthermore claimed that the risk of this injury must be vanishingly small given the large numbers of manipulations performed annually. As we have pointed out repeatedly, this argument is pure speculation; under-reporting of such cases is huge, and therefore exact incidence figures are anybody’s guess.

The patient sued both the internist and the chiropractor, and the total amount of the verdict was $14,596,000.00 the internist’s liability was 5% ($759,181.65).

Massage is an agreeable and pleasant treatment. It comes in various guises and, according to many patients’ experience, it relaxes both the mind and the body. But does it have therapeutic effects which go beyond such alleged benefits?

There is a considerable amount of research to test whether massage is effective for some conditions, including depression. In most instances, the evidence fails to be entirely convincing. Our own systematic review of massage for depression, for instance, concluded that there is currently a lack of evidence.

This was ~5 years ago – but now a new trial has emerged. It was aimed at determining whether massage therapy reduces symptoms of depression in subjects with human immunodeficiency virus (HIV) disease. Subjects were randomized into one of three groups to receive either Swedish massage (the type that is best researched amongst the many massage-variations that exist), or touch, or no such interventions. The treatment period lasted for eight weeks. Patients had to be at least 16 years of age, HIV-positive, suffering from a major depressive disorder, and on a stable neuropsychiatric, analgesic, and antiretroviral regimen for > 30 days with no plans to modify therapy for the duration of the study. Approximately 40% of the subjects were taking antidepressants, and all subjects were judged to be medically stable.

Patients in the Swedish massage and touch groups visited the massage therapist for one hour twice per week. In the touch group, a massage therapist placed both hands on the subject with slight pressure, but no massage, in a uniform distribution in the same pattern used for the massage subjects.

The primary and secondary outcome measures were the Hamilton Rating Scale for Depression score and the Beck Depression Inventory. The results showed that, compared to no intervention and/or touch, massage significantly reduced the severity of depression at week 4, 6 and 8.

The authors’ conclusion is clear: The results indicate that massage therapy can reduce symptoms of depression in subjects with HIV disease. The durability of the response, optimal “dose” of massage, and mechanisms by which massage exerts its antidepressant effects remain to be determined.

Clinical trials of massage therapy encounter formidable problems. No obvious funding source exists, and the expertise to conduct research is minimal within the realm of massage therapy. More importantly, it is difficult to find solutions to the many methodological issues involved in designing rigorous trials of massage therapy.

One such issue is the question of an adequate control intervention which might enable to blind patients and thus account for the effects of placebo, compassion, attention etc. The authors of the present trial have elegantly solved it by creating a type of sham treatment which consisted of mere touch. However, this will only work well, if patients can be made to believe that the sham-intervention was a real treatment, and if somehow the massage therapist is prevented to influence the patients through verbal or non-verbal communications. In the current trial, patients were not blinded, and therefore patients’ expectations may have played a role in influencing the results.

Despite this drawback, the study is one of the more rigorous investigations of massage therapy to date. Its findings offer hope to those patients who suffer from depression and who are desperate for an effective and foremost safe treatment to ease their symptoms.

My conclusion: the question whether massage alleviates depression is intriguing and well worth further study.

The NHS tells us that our “choices include more than just which GP or hospital to use. You also have choices about your treatment decisions…”  In most other countries, similarly confusing statements about PATIENT CHOICE are being made almost on a daily basis, often by politicians who have more ambition to win votes than to understand the complex issues at hand. Consequently, patients and consumers might be forgiven to assume that PATIENT CHOICE means we are all invited to indulge in the therapy we happen to fancy, while society foots the bill. Certainly, proponents of alternative medicine are fond of the notion that the principle of PATIENT CHOICE provides a ‘carte blanche’ for everyone who wants it to have homeopathy, Reiki, Bach Flower Remedies, crystal healing, or other bogus treatments – paid for, of course, by the taxpayer.

Reality is, however, very different. Anyone who has actually tried to choose his/her hospital will know that this is far from easy. And deciding what treatment one might employ for this or that condition is even less straight forward. Choice, it turns out, is a big word, but often it is just that: a word.

Yet politicians love their new mantra of PATIENT CHOICE; it is politically correct as it might give the taxpayer the impression that he/she is firmly installed in the driving seat. Consequently PATIENT CHOICE has become a slogan that is used to score points in public debates but that, in fact, is frequently next to meaningless. More often than not, the illusion of being in control has to serve as a poor substitute for actually being in control.

To imply that patients should be able to choose their treatment has always struck me as a little naïve, particularly in the way this is often understood in the realm of alternative medicine. Imagine you have a serious condition, say cancer: after you have come over the shock of this diagnosis, you begin to read on the Internet and consider your options. Should you have surgery or faith healing, chemotherapy or homeopathy, radiotherapy or a little detox?

Clearly PATIENT CHOICE, as paid for by society, cannot be about choosing between a realistic option and an unrealistic one. It must be confined to treatments which have all been shown to be effective. Using scarce public funds for ineffective treatments is nothing short of unethical. If, for a certain condition, there happen to be 10 different, equally effective and safe options, we may indeed have a choice. Alas, this is not often the case. Often, there is just one effective treatment, and in such instances the only realistic choice is between accepting or rejecting it.

And, anyway, how would we know that 10 different treatments are equally effective and safe? After going on the Internet and reading a bit about them, we might convince ourselves that we know but, in fact, very few patients have sufficient knowledge for making complex decisions of this nature. We usually need an expert to help us. In other words, we require our doctor to guide us through this jungle of proven benefits and potential risks.

Once we accept this to be true, we have arrived at a reasonable concept of what PATIENT CHOICE really means in relation to deciding between two or more treatments: the principle of shared decision making. And this  is a  fundamentally different concept from the naïve view of those alternative medicine enthusiasts who promote the idea that PATIENT CHOICE opens the door to opting for any unproven or disproven pseudo-therapy.

To be meaningful, ethical and responsible, choice needs to be guided by sound evidence – if not, it degenerates into irresponsible arbitrariness, and health care deteriorates into some kind of Russian roulette. To claim, as some fans of alternative medicine do, that the principle of PATIENT CHOICE gives everyone the right to use unproven treatments at the expense of the taxpayer is pure nonsense. But some extreme proponents of quackery go even further; they claim that the discontinuation of payment for treatments that have been identified as ineffective amounts to a dangerous curtailment of patients’ rights. This, I think, is simply a cynical attempt to mislead the public for the selfish purpose of profit.

Guest post by Louise Lubetkin

Those who recognize and appreciate a fine example of pseudoscientific baloney when they see one know that there is no richer seam, no more inexhaustible source, than the bustling, huckster-infested street carnival that is alternative medicine. There one can find intellectual swindlers in abundance, all offering outrageously implausible claims with the utmost earnestness and sincerity. But the supreme prize, the Fabergé egg found buried among the bric-a-brac, surely belongs to that most convincing of illusionists, the physician reborn as an ardent advocate of alternative medicine.

Why would any physician, exhaustively trained in the basic sciences that underpin every aspect of medical practice, decide to toss aside the entire canon in favor of a return to blatant mumbo jumbo?

There can be only two possible explanations, and they’re mutually exclusive.

First is the unsavory possibility that the physician who embraces alternative medicine is a cynical charlatan who knows full well that what is being offered is worthless, but sees it as a path to a more lucrative form of practice that is largely paid for out of pocket, in cash, requiring no tedious insurance company paperwork and avoiding the unpleasant possibility of Medicare audits.

And then there is the opposite explanation: the physician has actually become a true believer, in which case the wholesale rejection of his or her scientific training is essential in order to resolve the uneasy tension between what the physician knows to be fundamentally true and what he or she ardently believes and wishes were true. The two are diametrically opposed: one is a system of thinking in which each component has been painstakingly validated, assessed and reassessed over time, and revised where necessary with the emergence of new knowledge. The other is a simply a belief system founded on faith and wishful thinking.

Alternative medicine, particularly in the realm of cancer, has a long history of attracting people who are seduced by simplistic explanations of this dauntingly implacable and hugely complex constellation of diseases and become gripped by a messianic conviction that this is the true path to a cure. Never mind that such explanations have usually been around for a very long time and have been repeatedly debunked in carefully conducted studies. There is usually an element of paranoia involved: they see themselves as martyrs and explain the medical profession’s indifference to this revolutionary truth as a conspiracy designed to maintain a profitable status quo by silencing dissidents, especially when they arise from within the medical profession itself.

Which of these explanations is the correct one in any particular situation is not always easy to discern. Take the case of Nicholas James Gonzalez, M.D., a New York physician turned alternative practitioner whose practice focuses largely on the treatment of advanced cancer by nutritional means.

THE ORIGINS OF GONZALEZ’S TREATMENT

Gonzalez presents himself as a true believer who became a convert to alternative medicine after coming across the work of William Donald Kelley, D.D.S., a Texas orthodontist who had his own Damascene conversion when his doctors told him that he was dying of pancreatic cancer and that there was nothing more that they could do for him. Undeterred, Kelley claimed that he had cured himself by means of a rigorous diet combined with frequent self-administered coffee enemas. After thus miraculously dragging himself (and his enema bucket) back from the banks of the River Styx, Kelley decided to abandon straightening children’s teeth in favor of treating people with advanced cancer – perhaps not the most logical career move, to be sure, but Texas is Texas.

Probably the most famous of Kelley’s patients was the actor Steve McQueen, who, in the advanced stages of mesothelioma, turned to the erstwhile orthodontist in search of a cure. Not surprisingly, McQueen died despite Kelley’s ministrations, an unfortunate turn of events which Kelley rationalized away by claiming that he had in fact successfully cured McQueen, but that the medical establishment had subsequently had McQueen murdered in order to prevent him “blowing the lid off the cancer racket.”

But back to Gonzalez.

Like Kelley before him, Gonzalez bases his treatment on the work of James Beard, a long-dead Scottish embryologist who, more than 100 years ago, put forward the notion that all cancer was caused by wayward cells called trophoblasts. Trophoblasts are the cells which organize around the developing embryo very early in pregnancy, and which ultimately give rise to the placenta. Beard, of course, lived and died long before the advent of electron microscopy, the unraveling of the structure of DNA and a myriad other crucial discoveries that have helped to elucidate the hugely complex phenomenon that is collectively referred to as cancer. While his observations concerning the similarities between the invasiveness of cancer and the ability of the primitive placenta to tunnel its way into the uterine wall were undoubtedly astute, they are inadequate to explain what is now known about the etiology and progression of cancer.

Having observed that the placenta’s invasion of the uterine wall ceased at the very moment that the fetal pancreas became active, he took a leap of faith and postulated that it was the fetal pancreatic enzymes that were responsible for arresting the growth and invasion of the trophoblast layer. Beard went further, suggesting that quite apart from their role in digestion, pancreatic enzymes actually represent the body’s main defense against cancer, and therefore it should be possible to control cancer by administering large quantities of pancreatic enzymes.

This hundred-year-old hypothesis forms the cornerstone of the cancer treatment program devised by Gonzalez. (It should also be mentioned that Gonzalez doesn’t limit himself to the treatment of cancer, but uses the same methodology for treating a range of chronic degenerative diseases, including multiple sclerosis, presumably on the assumption that wayward trophoblasts are responsible for these, also, although it is difficult to imagine exactly how.)

Beard rightly surmised that pancreatic enzymes could not be successfully administered by mouth because the acid environment of the stomach would inactivate them immediately. Furthermore, being proteins themselves, any orally administered pancreatic enzymes would be quickly broken down by the gastric enzyme pepsin. Beard therefore advocated administering the enzymes by hypodermic injection.

In this, and in other ways, Beard seems to have been considerably more circumspect about his theory and its therapeutic implications than his modern day acolytes. It is interesting to note that he conspicuously refrained from making any claim that his method was a cure for cancer. A contemporary account of the public debate over Beard’s theory of cancer origins and treatment, which appeared in 1907 in the New York Times, is available here.

Much has happened since Beard’s day, it’s true, but gastric physiology and the essentials of protein digestion have not changed an iota. Pepsin is still pepsin, and the stomach is still awash in acid. Nevertheless, Gonzalez insists that the oral route is perfectly adequate. This odd departure from otherwise strict historical orthodoxy may have more to do with regulatory issues than pharmacokinetics: the type of enzymes he uses are viewed as dietary supplements by the Food and Drug Administration (FDA) rather than as prescription drugs, and are therefore unregulated.

GONZALEZ’S TREATMENT

In addition to pancreatic enzymes taken by mouth, Gonzalez prescribes a restrictive diet (which, even for those whom be pronounces to be obligate vegetarians, includes raw liver), and a staggering number of nutritional supplements which patients must take at regular intervals throughout the day and night.

The dietary guidelines he issues to his patients contain an amazing array of obviously unsound statements which bespeak not only a total abandonment of logical thinking on the part of their author, but also a casual disregard for objective fact, as though the solid benchmarks of physiology and biochemistry, such as pH, were just another narrative.

And then of course there’s the obligatory detoxification, without which no alternative treatment regimen could possibly be considered complete. But beyond its role as a doctrinal tenet, the notion that the body is inadequate to the task of handling its own waste holds a special utility for the practitioner of alternative cancer treatment. By insisting on regular and vigorous detoxification, the practitioner can reinforce the idea that the treatment regime – in this case, the pancreatic enzyme barrage – is working so well that the patient’s liver and bloodstream are in danger of being overrun by waste products from tumor breakdown. This must be a great boost to a patient in the advanced stages of cancer who is grimly contemplating his umpteenth coffee enema of the week and struggling to swallow another round of 30 supplement pills. However, most self-respecting physicians and patients would surely like to have that comforting assertion about massive tumor destruction confirmed with some kind of objective test such as imaging. And if the liver is really so hobbled by its task that it has to be supported by regular retrograde sluicing with tepid coffee, perhaps a few blood tests of liver function might be in order? It appears that such considerations are purely for pedants and infidels: real believers have no need for such niceties.

And then there are the supplements, in staggering quantities and bewildering combinations:

Five times during your waking hours take:

  • 16 pancreas glandular tissue
  • 1 magnesium citrate 60mg

With two doses of pancreas glandular take

  • 2 chicken collagen type II

During breakfast and dinner (twice daily) take:

  • 1 amino acids
  • 1 Calsym (vitamin D3 and calcium carbonate)
  • 1 thyroid (sic)
  • 1 vitamin E 100 IU

During each meal (3 times daily) take:

  • 1 adrenal glandular
  • 2 vitamin C
  • 1 Atlantic kelp
  • 2 Formula #1 (sic)
  • 1 liver
  • 1 lung
  • 2 magnesium citrate 60mg
  • 1 digest aid
  • 1 multivitamin
  • 1 multimineral
  • 3 pancreas glandular tissue
  • 3 thymus glandular tissue
  • 1 vitamin 400 IU

During lunch only take:

  • 1 beta carotene 25,000
  • 1 copper gluconate
  • 1 potassium citrate
  • 1 vitamin A 10,000 (which incidentally is twice the recommended daily allowance)

At bedtime take:

  • 2 iron
  • 2 magnesium citrate 60mg
  • 4 RNA/DNA (sic)

At 3:30am take:

  • 16 pancreas glandular tissue

The patient following such a program would take 187 supplement pills daily. Regardless of the dosage of active ingredients involved, the sheer volume and weight of excipients that are ingested during any one 24 hour period is surely something to take into account, especially in a patient debilitated by the ravages of advanced cancer. In a regimen that puts such emphasis on detoxification this is a curious departure indeed.

But onward.

THE EVIDENCE

In 1999, Gonzalez published a paper in the journal Nutrition and Cancer (abstract here) claiming that he had achieved significantly increased survival in 11 patients with inoperable pancreatic cancer by treating them with what he described as “an aggressive nutritional therapy with large doses of pancreatic enzymes.”

Now bear in mind that pancreatic cancer is one of the most aggressive and deadly of all malignancies. The majority of people with pancreatic adenocarcinoma, which is by far the commonest form of pancreatic cancer, die within a few months of their diagnosis; only one in five patients survive the first year, and just four percent of patients live five years beyond diagnosis.

So when Gonzalez published his paper asserting that 9 of the 11 patients (81%) whom he had treated with this regimen survived one year, while 5 (45%) survived two years, and the remaining 4 patients were still alive and holding their own at the 3 year mark, people sat up and took notice.

Despite the fact that this was a very small study, and rife with biases (not least, an obvious selection bias: a further 12 patients who were unable to comply fully with the treatment were excluded from the analysis), it was sufficiently positive a report in an otherwise unrelievedly gloomy prognostic landscape that it prompted further investigation. Ultimately a full-fledged phase III clinical trial comparing Gonzalez’ nutritional protocol to the standard chemotherapy regimen in pancreatic cancer patients was sponsored by the National Institutes of Health and was carried out at Columbia University.

Perhaps not surprisingly, the trial turned out to be hugely contentious and very unorthodox. As a means of eliminating experimental bias, clinical trials are typically “blinded” and randomized – i.e., they are carefully designed so that patients are randomly assigned to one group or the other, and neither the patients nor the physicians know which treatment they are receiving. But in this case there was no way that the trial could be randomized or blinded. Patients could choose whether to undergo chemotherapy or to be assigned to the Gonzalez protocol group, so both they and the investigating physicians knew what treatment they were getting from the beginning.

When it became apparent, as it quickly did, that the results were not going to reflect well on his treatment protocol. Gonzalez began clamoring loudly for an investigation, claiming that the clinical trial had been deliberately rigged to discredit him. (Those interested in the background to the clinical trial, including a very thorough discussion of its ethical and scientific implications, can read about it in several installments, titled “The Ethics of CAM Trials” (parts I-V), here.)

The results of the clinical trial were reported in a paper published in October, 2009, in the Journal of Clinical Oncology (article here). To summarize the results, the 32 patients who underwent traditional chemotherapy lived more than three times as long (14 months vs 4.3 months), and had a measurably better quality of life, including less pain than those treated by the Gonzalez protocol – and since pancreatic cancer is notoriously painful, this is a hugely important consideration in any treatment, regardless of whether or not it extends survival.

But perhaps the most extraordinary and disturbing aspect of the paper was this paragraph, in the Methods section, describing the Gonzalez protocol:

“The enzyme treatment included orally ingested proteolytic enzymes, nutritional supplements, detoxification, and an organic diet (unaltered from the pilot study). Patients received three pancreatic enzyme and two magnesium citrate capsules with each meal. The patients also took specified numbers of capsules with magnesium citrate and Papaya Plus every 4 hours on an empty stomach. The dose for patients with stage II disease was 69 enzyme capsules, and the dose for patients with stages III or IV was 81 capsules per day. After day 16, patients had a 5-day rest period and then resumed treatment on day 22. Treatment could be adjusted by the physician and could be increased for cancer progression. A diet that required at least 70% of the food to be raw or minimally cooked was required. All food was organic. Prescribed detoxification procedures included coffee enemas twice each day; skin brushing and cleansing; salt and soda baths; and a liver flush, clean sweep, and purging.”

Excuse me? A liver flush? What is that, exactly? And could someone please explain what is meant by “a clean sweep”? And purging? If it’s not an indelicate question, might we be told exactly what that consists of?

How this extraordinary paragraph found its way into print, unchallenged, in the venerable Journal of Clinical Oncology is unfathomable. Why didn’t the editors, or the authors, for that matter, feel that it might be useful – in fact, essential – to (a) append an explanation of exactly what was meant by these terms, and (b) to include some kind of rationale for their use?

And then, of course, there’s the larger question of how the institutional review board at Columbia managed to sidestep the ethical issues inherent in approving a trial that was set up to compare the apples of standard treatment with the oranges of liver flushes and clean sweeps. If there was genuine clinical equipoise here we’re in deep, deep trouble.

You might think that this study, with its damning result, would be the end of it. But you’d be wrong. Gonzalez has written a book, a paranoid, self-exculpatory monologue, a martyr’s manifesto detailing what he perceives as his deliberate persecution at vast public expense by a pernicious cancer industry mafia whose goal is to silence him forever. (Presumably the hit man who got Steve McQueen was no longer available?)

So what are we to make of Gonzalez? Is he a cynical fraud or does he genuinely believe that coffee enemas, skin brushing and massive doses of supplements are capable of holding back the tsunami of cancer?

At the end of the day it hardly matters: either way, he’s a dangerous man.

Rudolf Steiner was a weird guy by any stretch of imagination. He was the founding father of anthroposophy, an esoteric “philosophy” that created a new dimension of obtrusiveness. Not only that, he also dabbled in farming methods, devised an educational technique and created an entire school of health care, called anthroposophical medicine. The leading product in its range of homeopathy-inspired “drugs” is a mistletoe-extract which is, according to Steiner, a cure for cancer. His idea was simple: the mistletoe plant is a parasite that lives off host trees sapping its resources until, eventually, it might even kill its host – just like cancer threatening the life of a human being!!!

So, what is more logical than to postulate that extracts from mistletoe are a cure for cancer? Medicine seems simple – particularly, if  you do not understand the first thing about it!

But here comes the odd thing: some ingredients from mistletoe do actually have anti-cancer properties. So, was the old Steiner an intuitive genius who somehow sensed that mistletoe would be a life-saver for cancer patients? Or is all this just pure luck? Or was it perhaps predictable?

Many plants produce molecules that are so toxic that they can kill (cancer) cells, and many conventional cancer drugs were originally derived from plants; the fact that mistletoe has some anti-cancer activity therefore comes as a surprise only to those who have little or no knowledge of phyto-pharmacology.

Ok, mistletoe might have some ingredients which possess pharmacological activity. But to claim that it is a cancer cure is still a huge leap of faith. This fact did not stop promoters of anthroposophical medicine to do just that.

Due to decades of clever promotion, it is now hard in many countries (including for instance Germany) to find cancer patients who have not tried mistletoe; indeed, selling mistletoe preparations to desperate cancer patients has become a mega-business.

But does it actually work?  Do these extracts achieve what proponents advertise?

The claims for mistletoe are essentially twofold:

1) Mistletoe cures cancer.

2) Mistletoe improves the quality of life (QoL) of cancer patients.

The crucial question clearly is: are these claims based on good evidence?

According to our own systematic review, the answer is NO. In 2003, we looked at all the clinical trials and demonstrated that some of the weaker studies implied benefits of mistletoe extracts, particularly in terms of quality of life. None of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. The current Cochrane review (of which I am not a co-author) concluded similarly : The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak.

But both reviews have one major weakness: they included all of the many available extracts of mistletoe – and one cannot deny that there are considerable differences between them. The market leader in this area is Weleda (avid readers of science blogs might remember that this firm has been mentioned before); they produce ISCADOR, the mistletoe extract that has been tested more than any other such preparation.

Perhaps it would be informative to focus specifically on this product then? A German team from the “Center for Integrative Medicine, Faculty of Health, University of Witten/Herdecke” has done just that; despite the fact that these authors are not really known for their critical analyses of anthroposophical medicine, their conclusion is also cautious: The analyzed studies give some evidence that Iscador treatment might have beneficial short-time effects on QoL-associated dimensions and psychosomatic self-regulation.

So, what is the bottom line? Sceptics would say that almost a century of research without a solid proof of efficacy is well and truly enough; one should now call it a day. Proponents of mistletoe treatment, however, insist: we need more and better studies. Well, there is more! A new RCT of Iscador has just been published.

It included chemotherapy-naive advanced non-small-cell lung cancer (NSCLC) patients to assess Iscador’s influence on chemotherapy-related adverse-effects and QoL. Patients with advanced NSCLC were randomised to receive chemotherapy alone or chemotherapy plus Iscador thrice weekly until tumour progression. Chemotherapy consisted of 21-day cycles of carboplatin combined with gemcitabine or pemetrexed. Seventy-two patients were enrolled of whom 65% were in stage IV, and 62% had squamous histology. Median overall survival in both groups was 11 months. Median time to tumour progression was not significantly different between the two groups. Differences in grade 3-4 haematological toxicity were not significant, but more control patients had chemotherapy dose reductions, grade 3-4 non-haematological toxicities, and hospitalisations.

The authors’ conclusion: No effect of Iscador could be found on quality of life or total adverse events. Nevertheless, chemotherapy dose reductions, severe non-haematological side-effects and hospitalisations were less frequent in patients treated with Iscador, warranting further investigation of Iscador as a modifier of chemotherapy-related toxicity.

So, does Steiner’s notion based on the weirdest of intuitions contain some kernel of truth? I am not sure. But for once I do agree with the proponents of mistletoe: we need more and better research to find out.

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