MD, PhD, FMedSci, FSB, FRCP, FRCPEd

Monthly Archives: July 2013

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.

Research is essential for progress, and research in alternative medicine is important for advancing alternative medicine, one would assume. But why then do I often feel that research in this area hinders progress? One of the reasons is, in my view, the continuous drip, drip, drip of misleading conclusions usually drawn from weak studies. I could provide thousands of examples; here is one recently published article chosen at random which seems as good as any other to make the point.

Researchers from the Department of Internal and Integrative Medicine, Faculty of Medicine, University of Duisburg-Essen, Germany set out to investigate associations of regular yoga practice with quality of life and mental health in patients with chronic diseases. Using a case-control study design, 186 patients with chronic diseases who had elected to regularly practice yoga were selected and compared to controls who had chosen to not regularly practice yoga. Patients were matched individually on gender, main diagnosis, education, and age. Patients’ quality of life, mental health, life satisfaction, and health satisfaction were also assessed. The analyses show that patients who regularly practiced yoga had a significantly better general health status, a higher physical functioning, and physical component score  on the SF-36 than those who did not.

The authors concluded that practicing yoga under naturalistic conditions seems to be associated with increased physical health but not mental health in chronically diseased patients.

Why do I find these conclusions misleading?

In alternative medicine, we have an irritating abundance of such correlative research. By definition, it does not allow us to make inferences about causation. Most (but by no means all) authors are therefore laudably careful when choosing their terminology. Certainly, the present article does not claim that regular yoga practice has caused increased physical health; it rightly speaks of “associations“. And surely, there is nothing wrong with that – or is there?

Perhaps, I will be accused of nit-picking, but I think the results are presented in a slightly misleading way, and the conclusions are not much better.

Why do the authors claim that patients who regularly practiced yoga had a significantly better general health status, a higher physical functioning, and physical component score  on the SF-36 than those who did not than those who did not? I know that the statement is strictly speaking correct, but why do they not write that “patients who had a significantly better general health status, a higher physical functioning, and physical component score  on the SF-36 were more likely to practice yoga regularly”? After all, this too is correct! And why does the conclusion not state that better physical health seems to be associated with a greater likelihood of practicing yoga?

The possibility that the association is the other way round deserves serious consideration, in my view. Is it not logical to assume that, if someone is  relatively fit and healthy, he/she is more likely to take up yoga (or table-tennis, sky-diving, pole dancing, etc.)?

It’s perhaps not a hugely important point, so I will not dwell on it – but, as the alternative medicine literature is full with such subtly  misleading statements, I don’t find it entirely irrelevant either.

According to its proponents, Vibrational Medicine (VM) is a healing system that uses the ancient art of dowsing to identify the cause of a disease (or dis-harmony in the body). This therapy is a meeting of eastern and western forms of healing since we often use a western understanding of the body and how it functions and combine this with the eastern practice of rebalancing energies within the body to bring about healing. Sometimes the actual cause of a disease can appear to be far removed from the apparent symptoms when taking the western viewpoint. However everything is connected and especially so within the body. The body is always striving to heal itself but sometimes it can get ‘blocked’. These ‘blocks’ can be caused by many things including biochemicals, toxins, emotions, viruses, parasites or bacteria. The main aim of vibrational medicine is to clear these ‘blocks’ to allow the body to function correctly.

I am intrigued and surprised; for instance, I had no idea that there is such a thing as a western understanding of the body and how it functions. But what does this mean? How does VM work? The answer seems simpler than you may have thought: VM works by rebalancing the minute vibrational frequencies that make up the energy field within the atoms, molecules, organs and systems within the body. A block or a disharmony within the body can be thought of as being like an orchestra with an instrument that is not tuned correctly. The remedies  applied are then ‘re-tuning’ the body’s energy so that the body (the orchestra) plays a more harmonious tune again.

I see, that is impressive! And what diseases can be treated with VM? Don’t tell me it is a panacea! Yes, it is: Because vibrational medicine can work on many levels within the body (for instance it can work on the aura and chakras, the cellular level or it can work on particular organs or systems within the body) it can therefore be used to treat any condition that affects the mind or body of any person or animal.

How utterly miraculous! But in case you find this too vague and not sufficiently technical, here is a more scientific explanation from a different source:  The  term ‘vibrational’ is connected to the field of Quantum Physics where it is  found that all living beings (people, animals and plants) have a unique  vibrational frequency or energy field.   Kilian photography is one of several scientific methods which have  illustrated the existence of this field.   If one picks a leaf from a tree and applies a high voltage to its energy  field, it can be photographed and observed.   As the leaf dies the field becomes smaller until it disappears when it  is dead.  Also, a ‘quantum’ of energy is  released by an atom when it reaches a stable state.  This is unique to that particular atom.

I did suspect that quantum physics had to be involved. This is as good as it gets! I am sure you are as fascinated as I am and keen to learn more. The exciting news is that, at the Scottish School of Vibrational Medicine, you can complete your knowledge to diploma-level: This course will cover the major range of topics covered in the course of obtaining the Diploma in Vibrational Medicine and is a “broad brush” coverage of the whole course. During the course specialist and unique Homeopathic remedies will be used and students will take some remedies home with them to try at leisure the working of these remedies.

Now I understand; VM seems to be a bit of homeopathy, naturopathy, spiritual healing all mixed together. Sounds convincing – wait until our Health Secretary hears about this one! The NHS might never be the same again.

What is a competent homeopath? This intriguing question was addressed in a recent article by researchers from the Department of Public Health, School of Health and Related Research, University of Sheffield, UK, and the Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, Norway. Non-homeopaths would probably argue that either a clinician is competent or he/she is a homeopath; being a competent homeopath seems like a contradiction in terms. So, is is interesting to see what these authors had to say on the subject.

They started by pointing out that homeopathy is unregulated in most European countries, it is therefore not clear, in their view, what it means to be a “competent homeopath”. To clarify this issue, they decided to conduct a small survey investigating homeopathy-educators’ views on what a “competent homeopath” might be and what homeopaths might require in their education. They did a qualitative study based on grounded theory methodology involving telephone interviews with 17 homeopathy-educators from different schools in 10 European countries. The main questions asked were “What do you think is necessary in order to educate and train a competent homeopath?” and “How would you define a competent homeopath?

The results indicate that the homeopathy-educators defined a “competent homeopath” as a professional who, through his/her knowledge and skills together with an awareness of his/her bounds of competence, is able to help his/her patients in the best way possible. This is achieved through the processes of study and self-development, and is supported by a set of basic resources. Becoming and being a “competent homeopath” is underpinned by a set of basic attitudes. These attitudes include course providers and teachers being student-centred, and students and homeopaths being patient-centred. Openness on the part of students is important to learn and develop themselves, on the part of homeopaths when treating patients, and for teachers when working with students. Practitioners have a responsibility towards their patients and themselves, course providers and teachers have responsibility for providing students with effective and appropriate teaching and learning opportunities, and students have responsibility for their own learning and development (in order to avoid confusion or misinterpretation, I have copied this section almost verbatim from the abstract).

The authors consider that, according to homeopathy-educators’ understanding, basic resources and processes contribute to the development of a competent homeopath, who possesses certain knowledge and skills, all underpinned by a set of basic attitudes. And they conclude that this study proposes a substantive theory to answer what homeopathy educators believe a competent homeopath is and what it takes to be educated and trained to become one. The model suggests that certain basic resources and educational and self-developmental processes contribute to developing knowledge and skills necessary to be competent homeopaths. It also pinpoints underlying attitudes needed in the education as well as the clinical practice of competent homeopaths.

I find two things particularly striking in this text which I have copied almost unchanged from the abstract of the original paper (the full text is hardly more illuminating).

Firstly, these statements tell me virtually nothing that is specific to homeopathy. In my view, they are merely a bonanza of platitudes without much real meaning. We could substitute almost any other health care profession for “homeopath”, and the text would still be applicable in a very general and politically correct sort of way. I see nothing here that is specific to homeopathy.

Secondly, according to the findings of this survey, a “competent homeopath” does not seem to have much need for evidence. With virtually every other health care profession I know, one would expect a very strong emphasis on the need for the competent clinician to abide by the rules of evidence-based medicine. Not so in homeopathy!

Why? The answer seems obvious: if a clinician practices evidence-based medicine, he/she cannot possibly practice homeopathy – the evidence shows that homeopathy is a placebo-therapy. So, here we have it: a competent homeopath has to be a contradiction in terms because either someone practices homeopathy or he/she practices evidence-based medicine. Doing both at the same time is simply not possible.

It hardly is a secret: we have a growing problem with obesity. Worldwide it is predicted to cause millions of premature deaths – unless, of course, we come up with a safe and effective treatment that patients find acceptable.

Many herbal remedies are being promoted as the solution to this serious problem. My team looked at the evidence for such treatments in much detail. Sadly the results were less than impressive.

But now, there seems to be new hope! Two recent studies of a specific herbal mixture report amazingly good results – or are they perhaps too good to be true?

Stern JS, Peerson J, Mishra AT, Sadasiva Rao MV and Rajeswari KP from the Department of Nutrition and the Department of Internal Medicine, University of California Davis, have just published an RCT in 60 subjects with body mass index (BMI) between 30 and 40 kg/square meter. Participants received either 400 mg herbal capsules with extracts from Sphaeranthus indicus and Garcinia mangostana or 400 mg placebo capsules twice daily. During the study period, participants consumed a standard diet (2,000 kcal per day) and walked 30 min 5 days per week.

After 8 weeks of this treatment, significant reductions in body weight (3.7 kg), BMI (1.6 kg/m2), and waist circumference (5.4 cm) were observed in the herbal group compared with placebo. Additionally, a significant increase in serum adiponectin concentration was found in the herbal group versus placebo. Adverse events were mild and were equally distributed between the two groups.

The authors’ conclusion leave no doubt: Supplementation with the herbal blend resulted in a greater degree of weight loss than placebo over 8 weeks.

As our own review had suggested that extracts of Garcinia cause small short-term weight reductions, the results did not come as a complete surprise to me. What did strike me as odd, however, was the fact that almost simultaneously another article was published. It was authored by Stern JS, Peerson J, Mishra AT, Mathukumalli VS and Konda PR from the Department of Nutrition, University of California-Davis, and it reported the pooled data from the above plus another, similarly designed trial.

The two studies together enrolled 100 patients who were treated either with the same herbal formula or with placebo. All subjects received 2000 kcal/day throughout the study and walked 5 days a week for 30 min. The primary outcome was the reduction in body weight. Secondary outcomes were reductions in BMI and in waist and hip circumference. Serum glycaemic, lipid, and adiponectin levels were also measured. Ninety-five subjects completed the trials, and the data from these two studies were pooled and analysed.

At study conclusion (8 weeks), statistically significant reductions in body weight (5.2 kg), BMI (2.2 kg/m2), as well as waist (11.9 cm) and hip circumferences (6.3 cm) were observed in the pooled herbal groups compared with placebo. A significant increase in serum adiponectin concentration was also found in the herbal groups versus placebo at study conclusion along with reductions in fasting blood glucose (12.2%), cholesterol (13.8%), and triglyceride (41.6%) concentrations. No changes were seen across organ function panels, multiple vital signs, and no major adverse events were reported. The minor adverse events were equally distributed between the two groups.

And what should be odd about that? Authors are entitled to pool the data of two of their own trials! Yes, of course, but what confuses me is the fact that the data from the second study of 40 patients cannot be found anywhere. I would have liked to see how it is possible that the results from just 40 more patients (actually just 35 seemed to have been included in the analysis) raise the average weight loss from 3.7 kg in the first RCT to a remarkable 5.2 kg in the two RCTs together. As a rough estimate, this means that, in the second trial, patients who took the herbal mixture must have lost about one kilo per week more than those who were on placebo. If true, this outcome is pretty sensational! It could signal the end of the obesity epidemic. It would also mean that the manufacturer of this herbal wonder mixture stands to earn billions.

Considering the potential importance of these findings, I would also like to know what precisely the Californian researchers’ involvement has been in these two studies. In the second article they state that: The two clinical trials were performed at Alluri Sitarama Raju Academy of Medical Sciences (ASRAM), Eluru, Andhra Pradesh, India from November 2009 to April 2010 (clinical trial registration number: ISRCTN45078827) and from March 2010 to July 2010 (clinical trial registration number: ISRCTN52261953). I find this puzzling.

Moreover, it would be interesting to learn what happened to the following co-authors of the first study: Sadasiva, Rao MV and Rajeswari KP. As authors of the largest of the two trials, I would have thought their names would have to be included in the article reporting the pooled data of the two studies.

Call me sceptical, perhaps even cynical, but I do wonder about trials which seem to beg so many intriguing questions. In case you want to know who funded these studies and who thus stands to make the above-named billions, the answer is provided in the second paper: This work was supported by an unrestricted grant from InterHealth Nutraceuticals Inc., Benicia, CA, to J.S.S.

So, do I think that we have finally identified a safe and effective treatment to combat the worldwide epidemic of obesity? Well….

Did I previously imply that osteopaths are not very research-active? Shame on me!

Here are two brand-new studies by osteopaths and they both seem to show that their treatments work.

Impressed?

Well, perhaps we better have a closer look at them before we start praising osteopathic research efforts.

THE FIRST STUDY

Researchers from the ‘European Institute for Evidence Based Osteopathic Medicine’ in Chieti, Italy, investigated the effect of  osteopathic manipulative therapy (OMT) on the length of hospital-stay (LOHS) in premature infants. They conducted an RCT on 110 preterm newborns admitted to a single specialised unit. Thus the subjects with a gestational age between 28 and 38 weeks were randomized to receive either just routine care, or routine care with OMT for the period of hospitalization. Endpoints were differences in LOHS and daily weight gain. The results showed a mean difference in LOHS between the OMT and the control group: -5.906 days (95% C.I. -7.944, -3.869; p<0.001). However, OMT was not associated with any change in daily weight gain.

The authors’ conclusion was bold: OMT may have an important role in the management of preterm infants hospitalization.

THE SECOND STUDY

The second investigation suggested similarly positive effects of OMT on LOHS in a different setting. Using a retrospective cohort study, US osteopaths wanted to determine whether there is a relationship between post-operative use of OMT and post-operative outcomes in gastrointestinal surgical patients, including time to flatus, clear liquid diet, and bowel movement [all indicators for the length of the post-operative ileus] as well as LOHS. They thus assessed the records of 55 patients who underwent a major gastrointestinal operation in a hospital that had been routinely offering OMT to its patients. The analyses showed that 17 patients had received post-operative OMT and 38 had not.The two groups were similar in terms of all variables the researchers managed to assess. The time to bowel movement and to clear liquid diet did not differ significantly between the groups. The mean time to flatus was 4.7 days in the non-OMT group and 3.1 days in the OMT group (P=.035). The mean post-operative hospital LOHS was also reduced significantly with OMT, from 11.5 days in the non-OMT group to 6.1 days in the OMT group (P=.006).

The authors concluded that OMT applied after a major gastrointestinal operation is associated with decreased time to flatus and decreased postoperative hospital LOHS.

WHAT SHOULD WE MAKE OF THESE RESULTS?

Some people may have assumed that OMT is for bad backs; these two studies imply, however, that it can do much more. If the findings are correct, they have considerable implications: shortening the time patients have to spend in hospital would not only decrease individual suffering, it would also save us all tons of money! But do these results hold water?

The devil’s advocate in me cannot help but being more than a little sceptical. I fail to see how OMT might shorten LOHS; it just does not seem plausible! Moreover, some of the results seem too good to be true. Could there be any alternative explanations for the observed findings?

The first study, I think, might merely demonstrate that more time spent handling  premature babies provides a powerful developmental stimulus. Therefore the infants are quicker ready to leave hospital compared to those children who did not receive this additional boost. But the effect might not at all be related to OMT per se; if, for instance, the parents had handled their children for the same amount of time, the outcome would probably have been quite similar, possibly even better.

The second study is not an RCT and therefore it tells us little about cause and effect. We might speculate, for instance, that those patients who elected to have OMT were more active, had lived healthier lives, adhered more rigorously to a pre-operative diet, or differed in other variables from those patients who chose not to bother with OMT. Again, the observed difference in the duration of the post-operative ileus and consequently the LOHS would be entirely unrelated to OMT.

I suggest therefore to treat these two studies with more than just a pinch of salt. Before hospitals all over the world start employing osteopaths right, left and centre in order to shorten their average LOHS, we might be well advised to plan and conduct a trial that avoids the pitfalls of the research so far. I would bet a fiver that, once we do a proper independent replication, we will find that both investigations did, in fact, generate false positive results.

My conclusion from all this is simple: RESEARCH CAN SOMETIMES BE MISLEADING, AND POOR QUALITY RESEARCH IS ALMOST INVARIABLY MISLEADING.

A recently published study by Danish researchers aimed at comparing the effectiveness of a patient education (PEP) programme with or without the added effect of chiropractic manual therapy (MT) to a minimal control intervention (MCI). Its results seem to indicate that chiropractic MT is effective. Is this the result chiropractors have been waiting for?

To answer this question, we need to look at the trial and its methodology in more detail.

A total of 118 patients with clinical and radiographic unilateral hip osteoarthritis (OA) were randomized into one of three groups: PEP, PEP+ MT or MCI. The PEP was taught by a physiotherapist in 5 sessions. The MT was delivered by a chiropractor in 12 sessions, and the MCI included a home stretching programme. The primary outcome measure was the self-reported pain severity on an 11-box numeric rating scale immediately following the 6-week intervention period. Patients were subsequently followed for one year.

The primary analyses included 111 patients. In the PEP+MT group, a statistically and clinically significant reduction in pain severity of 1.9 points was noted compared to the MCI of 1.90. The number needed to treat for PEP+MT was 3. No difference was found between the PEP and the MCI groups. At 12 months, the difference favouring PEP+MT was maintained.

The authors conclude that for primary care patients with osteoarthritis of the hip, a combined intervention of manual therapy and patient education was more effective than a minimal control intervention. Patient education alone was not superior to the minimal control intervention.

This is an interesting, pragmatic trial with a result suggesting that chiropractic MT in combination with PEP is effective in reducing the pain of hip OA. One could easily argue about the small sample size, the need for independent replication etc. However, my main concern is the fact that the findings can be interpreted in not just one but in at least two very different ways.

The obvious explanation would be that chiropractic MT is effective. I am sure that chiropractors would be delighted with this conclusion. But how sure can we be that it would reflect the truth?

I think an alternative explanation is just as (possibly more) plausible: the added time, attention and encouragement provided by the chiropractor (who must have been aware what was at stake and hence highly motivated) was the effective element in the MT-intervention, while the MT per se made little or no difference. The PEP+MT group had no less than 12 sessions with the chiropractor. We can assume that this additional care, compassion, empathy, time, encouragement etc. was a crucial factor in making these patients feel better and in convincing them to adhere more closely to the instructions of the PEP. I speculate that these factors were more important than the actual MT itself in determining the outcome.

In my view, such critical considerations regarding the trial methodology are much more than an exercise in splitting hair. They are important in at least two ways.

Firstly, they remind us that clinical trials, whenever possible, should be designed such that they allow only one interpretation of their results. This can sometimes be a problem with pragmatic trials of this nature. It would be wise, I think, to conduct pragmatic trials only of interventions which have previously been proven to work.  To the best of my knowledge, chiropractic MT as a treatment for hip OA does not belong to this category.

Secondly, it seems crucial to be aware of such methodological issues and to consider them carefully before research findings are translated into clinical practice. If not, we might end up with  therapeutic decisions (or guidelines) which are quite simply not warranted.

I would not be in the least surprised, if chiropractic interest groups were to use the current findings for promoting chiropractic in hip-OA. But what, if the MT per se was ineffective, while the additional care, compassion and encouragement was? In this case, we would not need to recruit (and pay for) chiropractors and put up with the considerable risks chiropractic treatments can entail; we would merely need to modify the PE programme such that patients are better motivated to adhere to it.

As it stands, the new study does not tell us much that is of any practical use. In my view, it is a pragmatic trial which cannot readily be translated into evidence-based practice. It might get interpreted as good news for chiropractic but, in fact, it is not.

S.O. Hansson from the Royal Institute of Technology, Stockholm, Sweden recently published an interesting comment on the law regulating the labelling of homeopathic products. In it he points out that, in the European Union (EU), all pre-packaged food products must contain a list of ingredients and their quantities. The list should be “accurate, clear and easy to understand for the consumer.” Similar requirements apply to pharmaceutical drugs and products – with one notable exception: homeopathic preparations.

For such products, the ingredients need not be disclosed on the label, which should instead specify “the scientific name of the stock or stocks followed by the degree of dilution.” The degree of homeopathic dilutions is, in turn, given in an understandable jargon, such as “C60”, which actually describes a dilution of 1:10120.

The point Hansson is trying to make is that very few health care professionals and even fewer consumers would understand such abbreviations and jargon. This means that, manufacturers of homeopathic products are legally permitted to hide the fact from their customers that their remedies typically contain no active ingredient at all. Considering that homeopathic products are typically bought ‘over the counter’ (OTC), i.e. without interference from a health care professional, just like food products, the exemption seems most surprising.

The most OTC homeopathic remedies are in the “C30” potency; this signifies a dilution of 1: 1 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000. The likelihood that any potency higher than “C12” might contain a single molecule of active ingredient is very close to zero. In order to comprehend the degree of dilution in homeopathy more fully, a visual approach might be best: for it to have a reasonable chance to contain just one single molecule of active ingredient, a homeopathic pill in a “C30” potency would need to have a diameter roughly equal to the distance between the earth and the sun. Homeopathy is truly impossible to swallow.

If homeopathic manufacturers were obliged to provide a description that is “accurate, clear and easy to understand for the consumer”, it would need to state that any dilution beyond “C12” contains no active molecule. It seems clear that such accurate, clear and understandable information would discourage most consumers to spend their hard-earned money for such nonsense. It seems thus to be obvious that the EU exemption of homeopathic remedies from honest labelling protects the interests of the homeopathic industry.

But surely, this is deeply wrong. Regulations in health care are not supposed to protect commercial interests, they should protect the consumer. In my view, it is time to change such profoundly misguided EU-regulation – in the interest of honesty, single standards, transparency and foremost in the interest of the patient and the consumer.

A cult can be defined not just in a religious context, but also as a” usually nonscientific method or regimen claimed by its originator to have exclusive or exceptional power in curing a particular disease.” After ~20 years of researching this area, I have come to suspect that much of alternative medicine resembles a cult – a bold statement, so I better explain.

One characteristic of a cult is the unquestioning commitment of its members to the bizarre ideas of their iconic leader. This, I think, chimes with several forms alternative medicine. Homeopaths, for instance, very rarely question the implausible doctrines of Hahnemann who, to them, is some sort of a semi-god. Similarly, few chiropractors doubt even the most ridiculous assumptions of their founding father, D D Palmer who, despite of having been a somewhat pathetic figure, is uncritically worshipped. By definition, a cult-leader is idealised and thus not accountable to anyone; he (yes, it is almost invariably a male person) cannot be proven wrong by logic arguments nor by scientific facts. He is quite simply immune to any form of scrutiny. Those who dare to disagree with his dogma are expelled, punished, defamed or all of the above.

Cults tend to brain-wash their members into unconditional submission and belief. Likewise, fanatics of alternative medicine tend to be brain-washed, i.e. systematically misinformed to the extend that reality becomes invisible. They unquestioningly believe in what they have been told, in what they have read in their cult-texts, and in what they have learnt from their cult-peers. The effects of this phenomenon can be dramatic: the powers of discrimination of the cult-member are reduced, critical questions are discouraged, and no amount of evidence can dissuade the cult-member from abandoning even the most indefensible concepts. Internal criticism is thus by definition non-existent.

Like religious cults, many forms of alternative medicine promote an elitist concept. Cult-members become convinced of their superiority, based not on rational considerations but on irrational beliefs. This phenomenon has a range of consequences. It leads to the isolation of the cult-member from the rest of the world. By definition, critics of the cult do not belong to the elite; they are viewed as not being able to comprehend the subtleties of the issues at hand and are thus ignored or not taken seriously. For cult-members, external criticism is thus non-existent or invalid.

Cult-members tend to be on a mission, and so are many enthusiasts of alternative medicine. They use any conceivable means to recruit new converts. For instance, they try to convince family, friends and acquaintances of their belief in their particular alternative therapy at every conceivable occasion. They also try to operate on a political level to popularize their cult. They cherry pick data, often argue emotionally rather than rationally, and ignore all arguments which contradict their belief system.

Cult-members, in their isolation from society, tend to be assume that there is little worthy of their consideration outside the cult. Similarly, enthusiasts of alternative medicine tend to think that their treatment is the only true method of healing. Therapies, concepts and facts which are not cult-approved are systematically defamed. An example is the notion of BIG PHARMA which is employed regularly in alternative medicine. No reasonable person assumes that the pharmaceutical industry smells of roses. However, the exaggerated and systematic denunciation of this industry and its achievements is a characteristic of virtually all branches of alternative medicine. Such behaviour usually tells us more about the accuser than the accused.

There are many other parallels between a  cult and alternative medicine, I am sure. In my view, the most striking one must be the fact that any spark of cognitive dissonance in the cult-victim is being extinguished by highly effective and incessant flow of misinformation which often amounts to a form of brain-washing.

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