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

progress

Subluxation is … a displacement of two or more bones whose articular surfaces have lost, wholly or in part, their natural connection. (D. D. Palmer, 1910)

The definition of ‘subluxation’ as used by chiropractors differs from that in conventional medicine where it describes a partial dislocation of the bony surfaces of a joint readily visible via an X-ray. Crucially, a subluxation, as understood in conventional medicine, is not the cause of disease. Spinal subluxations, according to medical terminology, are possible only if anatomical structures are seriously disrupted.

Subluxation, as chiropractors understand the term, has been central to chiropractic from its very beginning. Despite its central role in chiropractic, its definition is far from clear and has changed significantly over time.

DD Palmer (the guy who invented chiropractic) was extremely vague about most of his ideas. Yet, he remained steadfast about his claims that 95% of all diseases were due to subluxations of the spine, that subluxations hindered the flow of the ‘innate intelligence’ which controlled the vital functions of the body. Innate intelligence or ‘inate’, he believed, operated through the nerves, and subluxated vertebra caused pinched nerves, which in turn blocked the flow of the innate and thus led to abnormal function of our organs. For Palmer and his followers, subluxation is the sole or at least the main cause of all diseases (or dis-eases, as Palmer preferred).

Almost exactly 4 years ago, I published this post:

Is chiropractic subluxation a notion of the past? SADLY NOT! 

In it, I provided evidence that – contrary to what we are often told – chiropractors remain fond of the subluxation nonsense they leant in school. This can be shown by the frequency by which chiropractors advertise on Twitter the concept of chiropractic subluxation.

Today, I had another look. The question I asked myself was: has the promotion of the obsolete subluxation concept by chiropractors subsided?

The findings did not surprise me.

Even a quick glance reveals that there is still a plethora of advertising going on that uses the subluxation myth. Many chiros use imaginative artwork to get their misleading message across. Below is a small selection.

Yes, I know, this little display is not very scientific. In fact, it is a mere impression and does not intend to be anything else. So, let’s look at some more scientific data on this subject. Here are the last 2 paragraphs from the chapter on subluxation in my recent book on chiropractic:

A 2018 survey determined how many chiropractic institutions worldwide still use the term in their curricula.[1] Forty-six chiropractic programmes (18 from US and 28 non-US) participated. The term subluxation was found in all but two US course catalogues. Remarkably, between 2011 and 2017, the use of subluxation in US courses even increased. Similarly, a survey of 7455 US students of chiropractic showed that 61% of them agreed or strongly agreed that the emphasis of chiropractic intervention is to eliminate vertebral subluxations/vertebral subluxation complexes.[2]

Even though chiropractic subluxation is at the heart of chiropractic, its definition remains nebulous and its very existence seems doubtful. But doubt is not what chiropractors want. Without subluxation, spinal manipulation seems questionable – and this will be the theme of the next chapter.

[1] https://chiromt.biomedcentral.com/articles/10.1186/s12998-018-0191-1

[2] https://www.ncbi.nlm.nih.gov/pubmed/25646145

In a nutshell: chiros cannot give up the concept of subluxation because, if they did, they would be physios except with a much narrower focus.

Health Canada is a government agency responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health risks. Health Canada regulates consumer health products that are sold directly to consumers and do not require a prescription or the oversight of a health care professional. In the past, Health Canada has approved more than 8,500 homeopathic products. A recent survey by Health Canada showed that 11% of parents and guardians believe that alternative practices such as homeopathy or naturopathy can replace vaccines.

Now, Health Canada is proposing changes to the labelling and evidence requirements for homeopathic products, as part of the proposed guidance document: Labelling Requirements for Natural Health Products. These changes would require that all homeopathic products that are sold over the counter include on the front panel of their label the statement “This claim is based on traditional homeopathic references and not modern scientific evidence.” Health Canada is also consulting on the introduction of risk-based evidence standards for homeopathic products, which would align requirements with those of other natural health products. The public consultation opens June 26, 2021 and closes September 4, 2021. For more information on how to participate, visit Consultation – Proposed Amendments to the Natural Health Products Regulations.

I hope you agree with me that it might be worth participating in this public consultation with a view of preventing regulations that could open the door to quackery in Canada. So, please do have a look at the documents and make sure that Canadian consumers are adequately protected.

“Working well for him…” That was the response to my tweet yesterday about cupping for Olympic swimmers. I had tweeted this picture showing one swimmer’s cupping marks (similar signs currently are currently being displayed by several competitors in Tokyo).

I had added to the tweet my post from 2018 which failed to show that cupping is an effective means of improving athletic performance.

The response ‘WORKING WELL FOR HIM..’ irritated me (not that it has the slightest importance) and made me think how prone we all are to find causal relationships where there are, in fact, none (which might have more importance). I feel that we must, as intelligent humans, do more to fight this reflex.

In 2008, just before Simon Singh and I published ‘TRICK OT TREATMENT?‘, I broke my left shoulder. It was stupid, painful, unpleasant, and most annoying. Yet, it coincided with a very nice publishing success: our book received plenty of praise and was translated into about 20 languages.

So, should we recommend to all authors who are about to publish a book that they break their left shoulder? I think we can probably agree that this would be absurd.

But why do many people who see the cupping-marked Olympic athletes think that cupping is WORKING WELL FOR THEM? I know, it is tempting to think that they know best, and they must have tested it, etc. But why not rather consult the evidence? Why not rather question the plausibility of cupping as a means to improve performance? Why not rather consider that athletes do all sorts of weird, irrational things that make them feel a little more secure?

Frankly, the evidence that breaking your arm makes you publish a decent book is just as sound as the evidence that cupping improves the speed of swimmers. My advice, therefore, is to resist quick thinking where slow thinking including asking probing questions and consulting the evidence is indicated.

 

 

Ever wondered what homeopathy truly is?

Who better to ask than Boiron?

On their website, Boiron (the largest manufacturer of homeopthics) explains:

Homeopathy is a therapeutic method that uses natural substances to relieve symptoms. It derives from the Greek words homeo, meaning “similar,” and pathos, meaning “suffering” (such as the pathology of a disease). Homeopathy operates on a “like cures like” principle that has been used empirically for more than 200 years and continues to be confirmed in pharmacological research and clinical studies.

What this means is a person suffering from symptoms can be treated by microdoses of a substance capable of producing similar symptoms in a healthy person. It is said that homeopathic medicines stimulate the body’s physiological reactions that restore health. This is accomplished with a very low risk of side effects due to the use of microdoses.

Homeopathy in Action

An example of how homeopathic medicines work is the similarity of symptoms between allergies and chopping onions. When you cut into an onion, your eyes will water and your nose runs. If similar symptoms appear after contact with pollen or a pet, the homeopathic medicine most appropriate to treat these symptoms is made from a tiny amount of onion. Instead of masking symptoms, the medicine sends the body a signal to help it rebalance and heal.

The Benefits of Homeopathy and You

A natural choice. The active ingredients in homeopathic medicines are made from diluted extracts of plants, animals, minerals, or other raw substances found in nature.

For everyday use. Similar to other over-the-counter (OTC) medicines, homeopathic medicines can be used to relieve symptoms of a wide range of common health conditions such as allergies, coughs, colds, flu, stress, arthritis pain, muscle pain, and teething.

Safe and reliable. Homeopathy has been used for more than 200 years, building a remarkable safety record and generating a great body of knowledge. Homeopathic medicines do not mask symptoms, are not contraindicated with pre-existing conditions, and are not known to interact with other medications or supplements, making them one of the safest choices for self-treatment.

Rigorous standards. Homeopathic medicines are manufactured according to the highest standards, complying with U.S. Food and Drug Administration regulations and the Homeopathic Pharmacopoeia of the United States (HPUS).

More choices and preferences. Homeopathic medicines are available in a variety of dosage forms such as gels, ointments, creams, syrups, eye drops, tablets, and suppositories.

_________________________

Are you pleased with this explanation?

No?

One must not be too harsh with Boiron and forgive them their errors; a powerful conflict of interest might have clouded their views. Therefore, I shall now take the liberty to edit and update their text ever so slightly.

Homeopathy is an obsolete method that used all sorts of substances in the misguided hope to relieve symptoms. The word derives from the Greek words homeo, meaning “similar,” and pathos, meaning “suffering” (such as the pathology of a disease). Homeopathy was alleged to operate on a “like cures like” principle that had been used empirically for more than 200 years but was refuted by pharmacological research, clinical studies and more.

What it suggested was that a person suffering from symptoms might be treated by the absence of a substance capable of producing similar symptoms in a healthy person. It was said that homeopathic medicines stimulate the body’s physiological reactions that restore health. These assumptions proved to be erroneous.

Homeopathy in Action

An example of how homeopathic medicines were supposed to work is the similarity of symptoms between allergies and chopping onions. When you cut into an onion, your eyes will water and your nose runs. If similar symptoms appear after contact with pollen or a pet, the homeopathic medicine most appropriate to treat these symptoms was assumed to be made with the memory of an onion. These ideas were never proven and had no basis in science.

The Alleged Benefits of Homeopathy

A natural choice. The active ingredients in homeopathic medicines were often made from diluted extracts of plants, animals, minerals, or other raw substances found in nature. The appeal to nature is, however, misleading: firstly the typical remedy did not contain anything; secondly, some remedies were made from synthetic substances (e. g. Berlin wall) or no substances (e. g. X-ray).

For everyday use. Similar to other over-the-counter (OTC) medicines, homeopathic medicines were promoted to relieve symptoms of a wide range of common health conditions such as allergies, coughs, colds, flu, stress, arthritis pain, muscle pain, and teething. These claims could never be verified and are therefore bogus.

Safe and reliable. Homeopathy had been used for more than 200 years. During all these years, no reliable safety record or body of knowledge had been forthcoming. Homeopathic medicines do not mask symptoms, are not contraindicated with pre-existing conditions, and are not known to interact with other medications or supplements. In fact, they have no effects whatsoever beyond placebo.

Rigorous standards. Homeopathic medicines were said to be manufactured according to the highest standards, complying with U.S. Food and Drug Administration regulations and the Homeopathic Pharmacopoeia of the United States (HPUS). This guaranteed that they were devoid of any active ingredient and made them pure placebos.

More choices and preferences. Homeopathic medicines were available in a variety of dosage forms such as gels, ointments, creams, syrups, eye drops, tablets, and suppositories. This means they offered a range of placebos to chose from.

In case, Boiron feels like adopting my updated, evidence-based version of their text, I am sure we can come to an agreement based on an adequate fee.

Prof Harald Walach has had a few rough weeks. First, he published his paper suggesting that Covid vaccinations do more harm than good which was subsequently retracted as flawed, if not fraudulent. Next, he published a paper showing that children are put in danger when wearing face masks suggesting that “decision-makers weigh the hard evidence produced by these experimental measurements accordingly, which suggest that children should not be forced to wear face masks.” Now, the journal put out the following announcement about it:

The Research Letter, “Experimental Assessment of Carbon Dioxide Content in Inhaled Air With or Without Face Masks in Healthy Children: A Randomized Clinical Trial,” by Harald Walach, PhD, and colleagues published online in JAMA Pediatrics on June 30, 2021,1 is hereby retracted.

Following publication, numerous scientific issues were raised regarding the study methodology, including concerns about the applicability of the device used for assessment of carbon dioxide levels in this study setting, and whether the measurements obtained accurately represented carbon dioxide content in inhaled air, as well as issues related to the validity of the study conclusions. In their invited responses to these and other concerns, the authors did not provide sufficiently convincing evidence to resolve these issues, as determined by editorial evaluation and additional scientific review. Given fundamental concerns about the study methodology, uncertainty regarding the validity of the findings and conclusions, and the potential public health implications, the editors have retracted this Research Letter.

To make things even worse, Walach’s University fired him because of his fraudulent anti-vax research. Poznan University of Medical Sciences tweeted on 6 July:

We wish to emphasize that the claims included in dr Harald Walach’s recent article in @Vaccines_MDPI do not represent the position of @PUMS_tweets . We find that the article lacked scientific diligence and proper methodology. Dr. Walach’s affiliation with PUMS was now terminated. Throughout the pandemic PUMS has actively promoted vaccination programs, offering scientific expertise in the media, broadcasting seminars, and reported on progress of the vaccination program. We consider vaccinations as the paramount tool in the global fight against the pandemic. We consider vaccinations as the paramount tool in the global fight against the #pandemic. Over 85% of our own academic community has already been vaccinated with support and encouragement from the University.

As I said, this is truly unlucky …

.. or perhaps not?

Come to think of it, it is lucky when pseudo-science and fraud are called out. It means that the self-cleaning mechanisms of science are working and we are protected from the harm done by charlatans.

Recently, I received this comment from a reader:

Edzard-‘I see you do not understand much of trial design’ is true BUT I wager that you are in the same boat when it comes to a design of a trial for LBP treatment: not only you but many other therapists. There are too many variables in the treatment relationship that would allow genuine , valid criticism of any design. If I have to pick one book of the several listed elsewhere I choose Gregory Grieve’s ‘Common Vertebral Joint Problems’. Get it, read it, think about it and with sufficient luck you may come to realize that your warranted prejudices against many unconventional ‘medical’ treatments should not be of the same strength when it comes to judging the physical therapy of some spinal problems as described in the book.

And a chiro added:

EE: I see that you do not understand much of trial design

Perhaps it’s Ernst who doesnt understand how to research back pain.

“The identification of patient subgroups that respond best to specific interventions has been set as a key priority in LBP research for the past 2 decades.2,7 In parallel, surveys of clinicians managing LBP show that there are strong views against generic treatment and an expectation that treatment should be individualized to the patient.6,22.”

Journal of Orthopaedic & Sports Physical Therapy
Published Online:January 31, 2017Volume47Issue2Pages44-48

Do I need to explain why the Grieve book (yes, I have it and yes, I read it) is not a substitute for evidence that an intervention or technique is effective? No, I didn’t think so. This needs to come from a decent clinical trial.

And how would one design a trial of LBP (low back pain) that would be a meaningful first step and account for the “many variables in the treatment relationship”?

How about proceeding as follows (the steps are not necessarily in that order):

  • Study the previously published literature.
  • Talk to other experts.
  • Recruit a research team that covers all the expertise you need (and don’t have yourself).
  • Formulate your research question. Mine would be IS THERAPY XY MORE EFFECTIVE THAN USUAL CARE FOR CHRONIC LBP? I know LBP is but a vague symptom. This does, however, not necessarily matter (see below).
  • Define primary and secondary outcome measures, e.g. pain, QoL, function, as well as the validated methods with which they will be quantified.
  • Clarify the method you employ for monitoring adverse effects.
  • Do a small pilot study.
  • Involve a statistician.
  • Calculate the required sample size of your study.
  • Consider going multi-center with your trial if you are short of patients.
  • Define chronic LBP as closely as you can. If there is evidence that a certain type of patient responds better to the therapy xy than others, that might be considered in the definition of the type of LBP.
  • List all inclusion and exclusion criteria.
  • Make sure you include randomization in the design.
  • Randomization should be to groups A and B. Group A receives treatment xy, while group B receives usual care.
  • Write down what A and B should and should not entail.
  • Make sure you include blinding of the outcome assessors and data evaluators.
  • Define how frequently the treatments should be administered and for how long.
  • Make sure all therapists employed in the study are of a high standard and define the criteria of this standard.
  • Train all therapists of both groups such that they provide treatments that are as uniform as possible.
  • Work out a reasonable statistical plan for evaluating the results.
  • Write all this down in a protocol.

Such a trial design does not need patient or therapist blinding nor does it require a placebo. The information it would provide is, of course, limited in several ways. Yet it would be a rigorous test of the research question.

If the results of the study are positive, one might consider thinking of an adequate sham treatment to match therapy xy and of other ways of firming up the evidence.

As LBP is not a disease but a symptom, the study does not aim to include patients that all are equal in all aspects of their condition. If some patients turn out to respond better than others, one can later check whether they have identifiable characteristics. Subsequently, one would need to do a trial to test whether the assumption is true.

Therapy xy is complex and needs to be tailored to the characteristics of each patient? That is not necessarily an unsolvable problem. Within limits, it is possible to allow each therapist the freedom to chose the approach he/she thinks is optimal. If the freedom needed is considerable, this might change the research question to something like ‘IS THAT TYPE OF THERAPIST MORE EFFECTIVE THAN THOSE EMPLOYING USUAL CARE FOR CHRONIC LBP?’

My trial would obviously not answer all the open questions. Yet it would be a reasonable start for evaluating a therapy that has not yet been submitted to clinical trials. Subsequent trials could build on its results.

I am sure that I have forgotten lots of details. If they come up in discussion, I can try to incorporate them into the study design.

 

 

It has been reported that B.C.’s chiropractors are deeply divided about the future of their profession, disagreeing on everything from false advertising to the use of routine X-rays.

Chiropractors attending an extraordinary general meeting of the College of Chiropractors of B.C. were split nearly down the middle on a series of non-binding resolutions addressing actions the College has taken in recent years. By the narrowest of margins, with at most 54% support, the members voted in favor of the college’s moves to limit the use of diagnostic X-rays and ban claims that aren’t supported by scientific evidence. The question that remains is who represents the bulk of the profession in B.C. — chiropractors advocating for what they describe as evidence-based practice targeting the musculoskeletal system, or “vitalists” who argue that chiropractic treatment can help with everything from immunity to brain function.

The modernizers see it as “a deliberate attempt to take over the college by a small group of chiropractors with no respect or knowledge of regulation … funded by organizations out of the province and out of the country,” Victoria chiropractor Clark Konczak told the virtual meeting.

At issue was a series of policies the college introduced in the wake of what Konczak called “the smoothie episode.” He was referring to a video posted on Facebook in 2017 by the then-vice chair of the college’s board, Avtar Jassal, in which he falsely suggested fruit smoothies are better than vaccines at preventing the flu.

Earlier this year, the college introduced amendments that bar chiropractors from performing routine and repeat X-rays, saying radiography is only scientifically supported when there are red flags that something is seriously wrong. The policy change on X-rays was the flashpoint in the long-simmering tension within the profession. A group of chiropractors has filed a petition in B.C. Supreme Court, alleging the college is preventing them from providing “safe, ethical, and effective care to their patients.” Their legal action has backing from national and international vitalistic organizations. During the recent meeting, a group of chiropractors argued unsuccessfully for the new X-ray policy to be tossed. Some suggested that chiropractors who don’t perform X-rays as a matter of routine are actually harming their patients. Another extraordinary general meeting has been called for July 20 to vote on resolutions calling for the removal of four college board members.

As I have often pointed out, chiropractic is all about money. The ‘chiro-wars’ have been going on for quite a while now, and they are by no means confined to B. C. or Canada. In a nutshell, they suggest to me that a significant proportion of chiropractors prefer money to progress.

Bernie Garrett is a professor of nursing at the University of British Columbia. He is being mentioned here because he has written a book entitled THE NEW ALCHEMISTS which deals (mostly) with so-called alternative medicine (SCAM). It is a well-written, informative, critical, and evidence-based text that I can recommend wholeheartedly. It will be available in the UK on 29 July but you can pre-order it already.

On Amazon, It is being advertised with the following words:

How to identify and see through deceptive and unethical health marketing practices Health scams come in all shapes and sizes-from the suppression of side-effects from prescription drugs to the unproven benefits of ‘traditional’ health practices-taking advantage of the human tendency to assume good intentions in others. So how do we avoid being deceived? Professor of Nursing, Bernie Garrett explores real-world examples of medical malpractice, pseudo and deceptive health science, dietary and celebrity health fads, deception in alternative medicine and problems with current healthcare regulation, ending with a simple health-scam detection kit. And he looks at how these practices and ineffective regulations affect our lives.

The book is written for the interested layperson. But I am sure that healthcare professionals will like it too, not least because it is fully referenced. Its aim is to inform and prevent consumers from being deceived and exploited by charlatans, an aim shared with this blog – while reading the book, I often got the impression that Bernie Garrett might be a regular reader of my blog.

This does not mean that I did not learn a lot from reading Bernie’s book. On the contrary, there was a lot that I did not know before and that is worth knowing. For instance, were you aware that you can earn a ‘Doctor of Naturopathic Medicine, Advanced Diploma’ or Reiki master qualification for $ 12.99 in a 6-hour online course (if you want to know where you’ll have to get Bernie’s book)?  Well, I didn’t.

Yes, I did enjoy reading this book, and I share Bernie’s views on SCAM. In his overall conclusions, he writes: “The sad truth is, many health fraudsters are highly skilled manipulators, and do not always end up being held to account for their crimes, and many continue to profit from them.” Because this is so, it is good to have another splendid book that will help us in our struggle to inform the public responsibly.

Withania somnifera, commonly known as Ashwagandha, is a plant belonging to the family of Solanaceae. It is widely used in Ayurvedic medicine. The plant is promoted as an immunomodulator, anti-inflammatory, anti-stress, anti-Parkinson, anti-Alzheimer, cardioprotective, neural and physical health enhancer, neuro-defensive, anti-diabetic, aphrodisiac, memory-boosting, and ant-cancer remedy. It contains diverse phytoconstituents including alkaloids, steroids, flavonoids, phenolics, nitrogen-containing compounds, and trace elements.

But how much of the hype is supported by evidence? Unsurprisingly, there is a shortage of good clinical trials. Yet, during the last few years, a surprising number of reviews of the accumulating evidence have emerged:

  • One review suggested that pre-clinical, as well as clinical studies, suggest the effectiveness of Withania somnifera (L.) against neurodegenerative disease.
  • A further review suggested a potential role of W. somnifera in managing diabetes.
  • A systematic review of 5 clinical trials found that W. somnifera extract improved performance on cognitive tasks, executive function, attention, and reaction time. It also appears to be well tolerated, with good adherence and minimal side effects.
  • Another systematic review included 4 clinical trials and reported significant improvements in serum hormonal profile, oxidative biomarkers, and antioxidant vitamins in seminal plasma. No adverse effects were reported in infertile men taking W. somnifera treatment.
  • Another review concluded that the root of the Ayurvedic drug W. somnifera (Aswagandha) appears to be a promising safe and effective traditional medicine for management of schizophrenia, chronic stress, insomnia, anxiety, memory/cognitive enhancement, obsessive-compulsive disorder, rheumatoid arthritis, type-2 diabetes and male infertility, and bears fertility promotion activity in females adaptogenic, growth promoter activity in children and as adjuvant for reduction of fatigue and improvement in quality of life among cancer patients undergoing chemotherapy.
  • A systematic review of 13 RCTs found that Ashwagandha supplementation was more efficacious than placebo for improving variables related to physical performance in healthy men and women.
  • Another systematic review concluded that Ashwagandha supplementation might improve the VO2max in athletes and non-athletes.

Impressed?

This certainly looks as though that this plant is worthy of further study. But I can never help feeling a bit skeptical when I hear of such a multitude of benefits without evidence for adverse effects (other than minor upset stomach, nausea, and drowsiness).

In 2020, a German court had ruled that pharmacies should be allowed to advertise homeopathic products by naming their alleged source materials, even if the dilution is so high that there is nothing in the products. An appeal against this was launched and it has now ended in defeat. The consequences for homeopathy could be far-reaching.

In homeopathy, it is customary to label and advertise products by naming the starting material or ‘mother tincture’. A German pharmacy thus named one of its products “HCG C30 globules” – HCG is a pregnancy hormone, C30 means it is diluted 30 times in the ratio 1:10o.  A group sued arguing that this was misleading.

The Darmstadt Regional Court first ruled that just because the original substance is no longer detectable does not mean that it is no longer present. And in any case, proponents of homeopathy would consider a high dilution to be important in order to reduce side effects. This ruling and the way it was justified caused considerable criticism. However, the plaintiff did not let up and appealed.

In the second instance, the Frankfurt Higher Regional Court (Case No. 6 U 49/20) took a completely different view of the matter. In the appeal hearing, it clarified first that advertisements for homeopathy address not only enthusiasts of homeopathy but the general public. Therefore, it must be in accordance with the general understanding of the population. And the public expects a product labeled “HCG” to actually contain the pregnancy hormone. If this ingredient cannot be detected, the product labeling would be misleading.

In essence, this means that all high potency homeopathic remedies (all beyond a C12) may no longer print the name of the mother tincture on the label. One can expect that this will seriously impact the sales of homeopathic products in Germany. This might re-open the discussion on the question of whether pharmacies should sell homeopathic preparations in the first place. As I have pointed out ad nauseam (e.g. here, here, and here), if pharmacists offer them to their customers pretending they are effective medicines, they violate their own ethical code. In other words, there is no place for homeopathy in pharmacies.

 

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