MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Monthly Archives: September 2020

Opioid over-use has become a huge problem, particularly in the US. Proponents of complementary and alternative medicine (CAM) – or so-called alternative medicine (SCAM) as I prefer to call it these days – have been keen to suggest that they have a solution to this problem. But is this really true? So far, the evidence was slim, to say the least.

This systematic review evaluated the effectiveness of the integrative medicine (IM) approach or any of the CAM therapies to reduce or cease opioid use in CP patients.

The electronic searches yielded 5,200 citations. Twenty-three studies were selected. Eight studies were randomized controlled trials, 7 were retrospective studies, 4 studies were prospective observational, 3 were cross-sectional, and one was quasi-experimental. The majority of the studies showed that opioid use was reduced significantly after using IM. Cannabinoids were among the most commonly investigated approaches in reducing opioid use, followed by multidisciplinary approaches, cognitive-behavioural therapy (CBT), and acupuncture. The majority of the studies had limitations related to sample size, duration, and study design.

The authors concluded that there is a small but defined body of literature demonstrating positive preliminary evidence that the IM approach including CAM therapies can help in reducing opioid use. As the opioid crisis continues to grow, it is vital that clinicians and patients be adequately informed regarding the evidence and opportunities for IM/CAM therapies for CP.

The authors who are from the Canadian College of Naturopathic Medicine in Ontario, Canada (and who claim to have no conflict of interest) seem to have forgotten to discuss some not so unimportant details and questions:

  • Why did they include studies with extremely weak designs in their review (such studies are likely to produce false positive findings)?
  • Why did they consider treatments such as CBT as CAM (most experts would characterise them as conventional psychological therapies)?
  • Why did they not conduct a separate analysis of the RCT-evidence (is it because that would not have generated the result they wanted?)?

My reading of the RCTs – the only type of study that might give a reliable answer to the question posed- is that they do not show a opioid-sparing effect of CAM use, particularly if we eliminate those studies that tested treatments which are not truly CAM. In any case, as I have said several times before, the way to avoid over-prescribing opioid is not through using more therapies of doubtful effectiveness but through prescribing less opioids. And to achieve that, doctors should just do what they learnt in medical school (at least I did all those years ago).

In so-called alternative medicine (SCAM), there are few notions more difficult to argue against than this one:

I KNOW IT WORKS BECAUSE I HAVE EXPERIENCED IT MYSELF!

Yet, it is this notion that we most often encounter when discussing with proponents of SCAM. To argue against it often gets an emotional response, not least because the SCAM proponent feels that we are implying that (s)he is either lying or stupid or both. Therefore, it is important, I feel, to keep on addressing this issue. So, let me once again explain why ineffective treatments often appear to be effective.

To make this less boring, let’s consider a concrete case, one where nobody (well, almost nobody) will get emotionally involved. Let’s consider a patient who has been suffering from recurring pain of an undiagnosed origin and experiences benefit after crystal healing, a form of SCAM for which there truly is not a jot of evidence.

Why then does (s)he experience less pain after consulting her crystal healer?

There is a myriad of reasons, and in this post I will borrow some from the literature of psychology:

  1. The patient might think his/her pain is less frequent without actual change; recall bias.
  2. The healer might have provided an explanation for the pain which the patient experiences as a symptomatic improvement.
  3. The healer could have convinced him/her that his/her pre-treatment pain was worse than it truly was; recall bias.
  4. The patient might report improvement in accord with what (s)he believes to be the healer’s hope and expectation; social desirability.
  5. The patient is prone to preferentially remembering improvements as opposed to worsening; recall bias.
  6. Patients might interpret ambiguous changes in symptoms as indications of improvement.
  7. Many symptoms disappear or improve on their own; natural history of the disease.
  8. Many symptoms fluctuate; natural history of the disease.
  9. Extremes become less extreme on re-testing; the phenomenon of ‘regression towards the mean’.
  10. Patients employ several therapies simultaneously and later misattribute an improvement to one treatment.
  11. Patients expect to improve; the placebo-effect.
  12. Patients are conditioned to improve; the placebo-effect.
  13. Improvement owing to enthusiasm of receiving a new intervention; the novelty effect.
  14. Improvement owing to enthusiasm of receiving an exotic therapy.
  15. Improvement due to the compassionate care and attention received.
  16. Improvement due to the time spent with the healer.
  17. Improvement due to the effort and resources invested by the patient.

All these phenomena (and several more, I am sure) work in concert and can generate a clinical outcome that makes ineffective therapies and even slightly harmful treatments appear to be effective. In any single case, it is impossible to decide what precisely brought about the improvement. The only way to make sure that the specific effects of the treatment (in my example the crystal therapy) was involved is to conduct one (better several) controlled clinical trials.

It would be interesting, I thought, to get some information on what type of books on so-called alternative medicine (SCAM) are being most frequently sold and read in different countries. In particular, it would be relevant to see how many of them are books that one might recommend.

But how would one go about researching this?

The simplest solution, I guessed, would be to go on the Amazon sites of various countries and have a look. And that’s precisely what I did a few days ago. I decided to scan the first 100 books that are listed under ‘alternative medicine’ and pick out the ones that are non-promotional, factual or critical. I did this little research in 4 countries: USA, UK, France and Germany.

Here are my findings:

1 USA

Not one of the 100 books seems to offer a critical assessment of SCAM. That means the percentage of what I might call recommendable books (books that do not promote unproven or disproven SCAMs to the unsuspecting public) seems to be precisely zero.

2 UK

On place 6, I was delighted to find my recent book Alternative Medicine: A Critical Assessment of 150 Modalities. On place 14 was You Are the Placebo: Making Your Mind Matter. And on place 70 Trick or Treatment?: Alternative Medicine on Trial.

That makes the percentage 3.

3 FRANCE

Surprisingly, there are hardly any books in French listed in the SCAM category. Place 4 is my SCAM: So-Called Alternative Medicine, place 7 More Harm than Good?: The Moral Maze of Complementary and Alternative Medicine, place 9 Trick or Treatment: The Undeniable Facts about Alternative Medicine, and place 64 Killing Us Softly: The Sense and Nonsense of Alternative Medicine.

The percentage is thus 4.

4 GERMANY

Not a single book met the inclusion criteria which makes the percentage a proud zero.

____________

In 1998, we assessed for the first time books on SCAM ( Int J Risk Safety Med 1998, 11: 209-215. [the article is not Medline-listed]). We chose a random sample of 6 such books published in 1997, and assessed their contents according to pre-defined criteria. The findings showed that the advice given in these volumes was frequently misleading, not based on good evidence and often inaccurate. If followed, it would have caused significant harm to patients.

In 2006, we conducted a similar investigation which we then reported in the first and second editions of our book THE DESKTOP GUIDE TO COMPLEMENTARY AND ALTERNATIVE MEDICINE (now out of print, but the German and French translations are still available, I think). This time, we selected 7 best-sellers in SCAM and scrutinised them in much the same way. Our findings showed that almost every form of SCAM was recommended for almost every condition. There was no agreement between the 7 books which SCAM might be effective for which condition. Some treatments were even named as indications for a certain condition in one book, while, in other books, they were listed as contra-indications for the same problem. A bewildering plethora of treatments was recommended for most conditions, for instance:

  • addictions: 120 different SCAMs
  • arthritis: 131 different SCAMs
  • asthma: 119 different SCAMs
  • cancer: 133 different SCAMs
  • etc. etc.

Even though, it included a much larger range of SCAM books, I do not consider my new investigation into this area to be a reliable piece of research. There are many reasons why, it can provide merely a very rough impression, e.g.:

  • The lists included lots of misclassifications, i. e. books that have nothing to do with SCAM.
  • Nobody seems to know by what rank order Amazon lists these books; I had hoped that it would be by sales figures, but I am not sure that this is so.
  • Amazon is just one of many book sellers.
  • My categorising can be criticised for being highly subjective.

Nonetheless, this little exercise, together with my previous research, might tell us something valuable after all. There are now between 30 000 and 60 000 SCAM books listed on the national Amazon sites, and even the most useless forms of SCAM are thus being promoted as though they were evidence-based forms of healthcare. Consumer demand for SCAM books is evidently substantial. The vast majority of these books are dangerously uncritical.

I believe that consumers deserve better.

The definitions of a quack as used in healthcare vary somewhat:

Richard Lanigan, in his post entitled Skeptics like Edzard Ernst remind me of Humpty Dumpty in their use of words. They make them up as they go along prefers the the definition from the Oxford dictionary: “a person who dishonestly claims to have special knowledge and skill in some field, typically medicine” (actually, the version of the Oxford dictionary I accessed defines a quack not quite like this but as a person who dishonestly claims to have medical knowledge or skills).

More importantly, Richard claims in an oddly incoherent post that not the chiropractors but the critics of chiropractic are are the true quacks:

It would appear “quacks” are people who pretend to have expertise in subjects they know little about, presumably subjects like, chiropractic medicine or acupuncture. I practice chiropractic, I dont diagnose or treat illness or disease, I dont make medical claims. You may not like chiropractic or understand it, however practicing chiropractic would not appear to conform to the definition of “quackery”, however claiming to have “special knowledge” about chiropractic and having only been trained as a medical practitioner may in fact make you a “quack” professor Ernst. All I do is maintain movement in spinal joints that become stiff from sedentary lifestyles, movement effects function of mechano receptors(nerves) in spinal joints. You may not believe that is possible, you may not believe maintaining joint function is important or that it effects wellbeing, you are perfectly entitled to your opinion, however I am not so confident of you depth and breath knowledge in anatomy and physiology. You might start by asking, why joints were immobility post surgery in the 80s and now post surgical treatment is all about maintaining joint motion as chiropractors have been advocating for years.

If I understand this correctly, this means: any non-chiropractor who criticises chiropractic is a quack. Moreover, it means that, as chiropractic is very rarely criticised by a chiropractor, chiropractors cannot be quacks.

I find this fascinating. It amounts to the legitimisation of any healthcare profession, however bizarre, unproven, disproven or dangerous their practice might be:

  • crystal therapists cannot be accused of quackery, because only their kind understand their business;
  • rebirthing practitioners cannot be accused of quackery, because only their kind understand their business;
  • applied kinesiologists cannot be accused of quackery, because only their kind understand their business;
  • bioresonance practitioners cannot be accused of quackery, because only their kind understand their business;
  • Bach flower therapists therapists cannot be accused of quackery, because only their kind understand their business;
  • colour therapists cannot be accused of quackery, because only their kind understand their business;
  • colon therapists cannot be accused of quackery, because only their kind understand their business;
  • dowsers cannot be accused of quackery, because only their kind understand their business;
  • ear candle practitioners cannot be accused of quackery, because only their kind understand their business;
  • feng shui practitioners cannot be accused of quackery, because only their kind understand their business;
  • faith healers cannot be accused of quackery, because only their kind understand their business;
  • gua sha practitioners cannot be accused of quackery, because only their kind understand their business;
  • iridologists cannot be accused of quackery, because only their kind understand their business;
  • homeopaths cannot be accused of quackery, because only their kind understand their business;
  • naprapathy therapists cannot be accused of quackery, because only their kind understand their business;
  • neurolinguistic programmers cannot be accused of quackery, because only their kind understand their business;
  • osteopaths cannot be accused of quackery, because only their kind understand their business;
  • pranic healers cannot be accused of quackery, because only their kind understand their business;
  • psychic surgeons cannot be accused of quackery, because only their kind understand their business;
  • radionics practitioners cannot be accused of quackery, because only their kind understand their business;
  • reflexologists cannot be accused of quackery, because only their kind understand their business;
  • Reiki masters cannot be accused of quackery, because only their kind understand their business;
  • shiatsu practitioners cannot be accused of quackery, because only their kind understand their business;
  • therapeutic touchers cannot be accused of quackery, because only their kind understand their business;
  • vaginal steamers cannot be accused of quackery, because only their kind understand their business;
  • etc, etc.

I can, of course, easily see why Richard Lanigan would like this concept to be true. Alas, Richard (and all the other SCAM-enthusiasts who make similar arguments), it does not work like this! A quack might be defined as listed above or in many other ways. But, in so-called alternative medicine (SCAM), a quack foremost is a person who habitually misleads the public by making claims that are not supported by sound evidence. And as some wise guy once observed: honest conviction renders a quack only more dangerous. As to the professional background of a quack:

I do not care a hoot!

I have done my best to disclose quackery no matter whether it came from a medic or a SCAM-practitioner, a physio or a nurse, an entrepreneur or a fruitcake, an evangelist or a politician, royalty or commoner. And, believe me, Richard (plus all the other SCAM-enthusiasts who make similar arguments), I will carry on doing so, whether it fits into your little scheme of wishful thinking or not.

Yes, I know what you will say: homeopathic remedies are all nothing but diluted water. But the ‘diluted water’ remedies that this post is about are different. Even their starting material – homeopaths call it mother tincture – is nothing but water. And what is more, homeopaths are so fond of these ‘diluted water’ remedies that they have more than one of it! One might think that water is water, especially, if you dilute it endlessly with pure distilled water. This may be true for most of us, but not for homeopaths – FAR FROM IT!

Here I present you those commercially available ‘diluted water’ remedies that I have found (I am fairly sure there are more, if you search more thoroughly than I did):

I don’t know about you, but I was impressed to find this big a variety of water – better than in a three-star restaurant! My favourite is not the water from my place of birth, Wiesbaden, but LORDES WATER. I am sure you will ask me what all these waters are used for. Lourdes water is the only water remedy for which we can tell with any degree of certainty:

  • The original Lourdes water is supposed to heal patients of all ills.
  • Now, please apply the ‘like cures like’ hypothesis of homeopathy to this fact.
  • The result is clear: homeopathic Lourdes water is supposed to give you all diseases known to mankind.

And then some nutters try to tell you that homeopathy is not dangerous!!! 

Dr Mathias Rath, the German born purveyor of multiple food supplements, and his organisation puzzle me a great deal. As previously reported, the ‘Dr Rath Foundation’ published an article about me. In it, the author got my name right, but not much more. Here is its opening passage [the numbers in square brackets refer to my comments below].

Professor Edzard Ernst: A Career Built On Discrediting Natural Health Science? [1]

Professor Edzard Ernst, a retired German [2] physician and academic, has recently [3] become a prominent advocate of plans that could potentially outlaw [4] the entire profession of naturopathic doctors [5] in Germany. Promoting the nonsensical idea that naturopathic medicine somehow poses a risk to public health, Ernst attacks its practitioners as supposedly having been educated in “nonsense” [6]. Tellingly, however, given that he himself has seemingly not published even so much as one completely original scientific trial of his own [7], Ernst’s apparent attempts to discredit natural healthcare approaches are largely reliant instead on his analysis or review of handpicked negative studies carried out by others [8].

  1. When I was appointed at Exeter to research alternative medicine in 1993, I had already been a full professor at Hannover, Germany and subsequently at Vienna, Austria. If anything, coming to Exeter was a big step down in terms of ‘career’, salary, number of co-workers etc. (full details in my memoir)
  2. I am German-born, became an Austrian citizen in 1990, and since 2000 I am a British national.
  3. I have been critical about the German ‘Heilpraktiker’ for more than 20 years.
  4. This refers to the recent ‘Muensteraner Memorandum’ which is the work of an entire team of multidisciplinary experts and advocates reforming this profession.
  5. ‘Heilpraktiker’ are certainly not doctors; they have no academic or medical background.
  6. This is correct, and I stand by my statement that educating people in vitalism and other long-obsolete concepts is pure nonsense.
  7. Since I am researching alternative medicine, I have conducted and published about 40 ‘scientific trials’, and before that time (1993) I have published about the same number again in various other fields.
  8. This refers to systematic reviews which, by definition, include all the studies available on a defines research question, regardless of their conclusion (their aim is to minimise random and selection biases)  .

Rath states about himself that “Dr. Rath heads a research and development institute in nutritional and Cellular Medicine. His institute is conducting basic research and clinical studies to scientifically document the health benefits of micronutrients in fighting a multitude of diseases.”

But this is equally puzzling.

Firstly, because research does not aim ‘to scientifically document the health benefits of ‘ anything; it is for testing hypotheses; Rath surely must know that. Secondly, on Medline, I find dozens of publications by Rath. These refer mostly to mechanistic in-vitro or animal studies about the mode of action of vitamins and other natural compounds.

But ‘clinical studies‘?

None!

Hold on! My Medline searches did deliver one clinical trial – just one – (Rath himself lists more, but they seem to be meaningless observational studies without a control group). It was published as an abstract on his own website. Here is the abstract:

Healing of bone fractures is a prolonged process that can be affected by nutrition. Our objective was to critically evaluate the effect of supplementation with an essential nutrient complex, containing ascorbic acid, lysine, proline, and vitamin B6 on healing time of tibial fractures.

Design:

Random double-blind placebo-controlled study

Setting:
Dr. Jamdar Hospital, Jabalpur, India

Subjects and Intervention:
113 patients with unilateral displaced closed or grade I open tibial fractures were randomized to receive either standard care with placebo or with supplementation with an essential nutrient complex containing ascorbic acid, lysine, proline, and vitamin B6. Qualifying patients, on admission to the study, were clinically examined, radiographs of the affected limbs taken, fractures reduced under anesthesia, and above knee plaster casts applied. Radiographs were taken at each follow-up visit to confirm reduced alignment of fracture and proper callus formation.

Primary Outcome Measure:
The primary outcome measure was the number of weeks required for fracture to be healed. Healing was defined as absence of abnormal mobility at fracture site clinically, absence of pain elicited by stressing the fracture or by walking, and radiographic confirmation of callus formation.

Results:
Data analysis demonstrated reduced fracture-healing time associated with experimental supplementation. For PP analysis group, fracture healing time in 75% of the supplemented group of patients (N=21) was 17 weeks or less and 19 weeks or less in 75% of the placebo group patients (N=36). The percentage of patients with fractures healing in 10 weeks or less was 33.3% for the supplemented group and 11.1% for the placebo group. However, the difference in healing time between the two groups did not reach statistical significance.

Conclusion:
Results showed encouraging trends that fracture-healing time is reduced by supplementation with an essential nutrient complex containing ascorbic acid, lysine, proline, and vitamin B6. In addition, the nutrient supplemented participants reported improved feeling of well-being with use of the supplement.

This is odd in several ways:

  1. Even though the conclusions hide it quite well, the trial was in fact negative, i. e. it failed to show a significant difference between the verum and the placebo in the primary outcome measure.
  2. The trial was never published as a peer-reviewed full paper. The website refers to its publication as a ‘letter to the editor’ (LTTE) in the notorious JACM (a LTTE is not normally peer-reviewed).
  3. Why was it never properly published?
  4. Could it be because there was no ethics approval [none was mentioned in the LTTE]?
  5. Could it be because there was no informed consent [none was mentioned in the LTTE]?
  6. The LTTE mentions that a larger study with 200 patients is planned. This was 16 years ago, and to date there is no trace of such a trial.

Rath’s latest contribution to the world of science is a paper implying that his supplements could play a role in the fight against the present pandemic; it is entitled ‘Effective and safe global public health strategy to fight the COVID-19 pandemic: Specific micronutrient composition inhibits Coronavirus cell-entry receptor (ACE2) expression’. Here is the abstract which clearly shows that Rath has not a jot of clinical evidence:

Optimum micronutrient intake is the only scientifically proven way to improve general immune resistance against infections, a fact documented in every leading textbook of biology.  This study provides scientific evidence that, in addition, specific micronutrient compositions are powerful tools in the fight against the COVID-19 pandemic.

Both, SARS-CoV-2 – the virus that causes the current pandemic – and other coronaviruses enter body cells via a specific receptor, the Angiotensin-Converting-Enzyme 2 (ACE2). The ACE2 receptor is expressed by many cell types, including lung epithelial cells as well as endothelial cells of the vascular system.

Based on our earlier research that demonstrated that specific micronutrients can block several mechanisms of viral infections, we tested the efficacy of these natural compounds in suppressing the expression of the ACE2 receptor on human endothelial cells and small airway epithelial cells.

Our results show that a micronutrient composition comprising vitamin C as well as certain amino acids, polyphenols, and trace elements is able to suppress this viral ‘entry door’ into the body under both normal and inflammatory conditions, which are associated with infections.

Thus, vitamin-rich nutrition and micronutrient supplementation should be implemented as effective, safe and affordable public health strategies to fight the COVID-19 pandemic and help prevent future outbreaks.  Optimizing the micronutrient status of the entire population should form the basis for any global strategy to help prevent future pandemics across the world, including the developing nations.

The Wiki-page on Rath lists 10 (!) legal cases in which he has been involved. This looks like he easily sues people who disagree with his often bizarre views and sales techniques. Considering this suspicion, I better be careful what I say here. Therefore let me conclude by meekly repeating the title of this post which comes from my friend Ben Goldacre who, together with THE GUARDIAN won a famous and expensive legal battle against Rath:

Rath is an example of the worst excesses of the alternative therapy industry.

 

 

 

PS

What I like best about the many supplements sold by Rath is the footnote in the patient leaflets:

THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE

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