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

malpractice

I was alerted to an interview published in an anthroposophical journal with Prof. Dr. med. Harald Matthes. He is the clinical director of the ‘Gemeinschaftskrankenhauses Havelhöhe‘, a hospital of anthroposophic medicine in Berlin where apparently some COVID-19 patients are presently being treated. Anthroposophic medicine is a medical cult created by the mystic, Rudolf Steiner, about 100 years ago that lacks a basis in science, facts or common sense. Here is the two passages from that interview that I find most interesting (my translation/explanation is below):

Es gibt bisher kein spezifisches Covid-19 Medikament aus der konventionellen Medizin. Remdesivir führt in Studien zu keinem signifikant verbesserten Überleben, sondern lediglich zu einer milden Symptomreduktion. Die anfänglich große Studie vor allem an Universitätskliniken mit Hydrochloroquin und Azithromycin erbrachte sogar eine Steigerung der Todesrate. Daher haben anthroposophische Therapiekonzepte mit Steigerung der Selbstheilungskräfte eine große Bedeutung erfahren. Wichtige anthroposophische Arzneimittel waren dabei das Eisen als Meteoreisen oder als Ferrum metallicum praep., der Phosphor, das Stibium sowie das Cardiodoron® und Pneumodoron®, aber auch Bryonia (Zaunrübe) und Tartarus stibiatus (Brechweinstein). Die Erfolge waren sehr gut, da in Havelhöhe bisher kein Covid-19 Patient verstorben ist, bei einer sonstigen Sterblichkeit von ca. 30% aller Covid-19-Intensivpatienten…

100 Jahre Bazillentheorie und die Dominanz eines pathogenetischen Medizinkonzeptes haben zu der von Rudolf Steiner bereits 1909 vorausgesagten Tyrannei im Sozialen geführt. Der Mensch hat ein Mikrobiom und Virom, das unverzichtbar für seine Immunität ist und von der Quantität mächtiger als der Mensch selbst (Mikrobiom 1014 Bakterien mit ca. 1200 Spezies z.B. im Darm bei nur 1012 Körperzellen).

Matthes explains that, so far, no medication has been demonstrated to be effective against COVID-19 infections. Then he continues: “This is the reason why anthroposophic therapies which increase the self-healing powers have gained great importance”, and names the treatments used in his hospital:

  • Meteoric Iron (a highly diluted anthroposophic remedy based on iron from meteors),
  • Ferrum metallicum praep. (a homeopathic/anthroposophic remedy based on iron),
  • Phosphor (a homeopathic remedy based on phosphor),
  • Stibium (a homeopathic remedy based on antimony),
  • Cardiodoron (a herbal mixture used in anthroposophical medicine),
  • Pneumodoron (a herbal mixture used in anthroposophical medicine containing).

Matthes also affirms (my translation):

“The success has so far been very good, since no COVID-19-patient has died in Havelhöhe – with a normal mortality of about 30% of COID_19 patients in intensive care…

100 years of germ theory and the dominance of a pathogenetic concept of medicine have led to the tyranny in the social sphere predicted by Rudolf Steiner as early as 1909. Humans have a microbiome and virom that is indispensable for their immunity and more powerful in quantity than humans themselves (microbiome 1014 bacteria with about 1200 species e.g. in the intestine with only 1012 somatic cells)…”

_________________

The first 4 remedies listed above are highly diluted and contain no active molecules. The last two are less diluted and might therefore contain a few active molecules but in sub-therapeutic doses. Crucially, none of the remedies have been shown to be effective for any condition.

The germ theory of disease which Matthes mentions is, of course, a bit more than a ‘theory’; it is the accepted scientific explanation for many diseases, including COVID-19.

I have cold sweats when I think of anthroposophical doctors who seem to take it less than seriously, while treating desperately ill COVID-19 patients. If I were allowed to ask just three questions to Matthes, I think, it would be these:

  1. How did you obtain fully informed consent from your patients, including the fact that your remedies are unproven and implausible?
  2. If you think your results are so good, are you monitoring them closely to publish them urgently, so that other centres might learn from them?
  3. Do you feel it is ethical to promote unprovn treatments during a health crisis via a publicly available interview before your results have been formally assessed and published?

Acupuncture-moxibustion therapy (AMT) is a so-called alternative medicine (SCAM) that has been used for centuries in treatment of numerous diseases. Some enthusiasts even seem to advocate it for chemotherapy-induced leukopenia (CIL)  The purpose of this review was to evaluate the efficacy and safety of acupuncture-moxibustion therapy in treating CIL.

Relevant studies were searched in 9 databases up to September 19, 2020. Two reviewers independently screened the studies for eligibility, extracted data, and assessed the methodological quality of selected studies. Meta-analysis of the pooled mean difference (MD) and risk ratio (RR) with their respective 95% confidence intervals (CI) were calculated.

Seventeen studies (1206 patients) were included, and the overall quality of the included studies was moderate. In comparison with medical therapy, AMT has a better clinical efficacy for CIL (RR, 1.24; 95% CI, 1.17-1.32; P < 0.00001) and presents advantages in increasing leukocyte count (MD, 1.10; 95% CI, 0.67-1.53; P < 0.00001). Also, the statistical results show that AMT performs better in improving the CIL patients’ Karnofsky performance score (MD, 5.92; 95% CI, 3.03-8.81; P < 0.00001).

The authors concluded that this systematic review and meta-analysis provides updated evidence that AMT is a safe and effective alternative for the patients who suffered from CIL.

A CIL is a serious complication. If I ever were afflicted by it, I would swiftly send any acupuncturist approaching my sickbed packing.

But this is not an evidence-based attitude!!!, I hear some TCM-fans mutter. What more do you want that a systematic review showing it works?

I beg to differ. Why? Because the ‘evidence’ is hardly what critical thinkers can accept as evidence. Have a look at the list of the primary studies included in this review:

  1. Lin Z. T., Wang Q., Yu Y. N., Lu J. S. Clinical observation of post-chemotherapy-leukopenia treated with ShenMai injectionon ST36. World Journal of Integrated Traditional and Western Medicine2010;5(10):873–876. []
  2. Wang H. Clinical Observation of Acupoint Moxibustion on Leukopenia Caused by Chemotherapy. Beijing, China: Beijing University of Chinese Medicine; 2011. []
  3. Fan J. Y. Coupling of Yin and Yang between Ginger Moxibustion Improve the Clinical Effect of the Treatment of Chemotherapy Adverse Reaction. Henan, China: Henan University of Chinese Medicine; 2013. []
  4. Lu D. R., Lu D. X., Wei M., et al. Acupoint injection with addie injection for patients of nausea and vomiting with cisplatin induced by chemotherapy. Journal of Clinical Acupuncture and Moxibustion2013;29(10):33–38. []
  5. Yang J. E. The Clinical Observation on Treatment of Leukopenia after Chemotherapy with Needle Warming Moxibustion. Hubei, China: Hubei University of Chinese Medicine; 2013. []
  6. Fu Y. H., Chi C. Y., Zhang C. Y. Clinical effect of acupuncture and moxibustion on leukopenia after chemotherapy of malignant tumor. Guide of China Medicine2014;12(12) []
  7. Wang J. N., Zhang W. X., Gu Q. H., Jiao J. P., Liu L., Wei P. K. Protection of herb-partitioned moxibustion on bone marrow suppression of gastric cancer patients in chemotherapy period. Chinese Archives of Traditional Chinese Medicine2014;32(12):110–113. []
  8. Zhang J. The Clinical Research on Myelosuppression and Quality of Life after Chemotherapy Treated by Grain-Sized Moxibustion. Nanjing, China: Nanjing University of Chinese Medicine; 2014. []
  9. Tian H., Lin H., Zhang L., Fan Z. N., Zhang Z. L. Effective research on treating leukopenia following chemotherapy by moxibustion. Clinical Journal of Chinese Medicine2015;7(10):35–38. []
  10. Hu G. W., Wang J. D., Zhao C. Y. Effect of acupuncture on the first WBC reduction after chemotherapy for breast cancer. Beijing Journal of Traditional Chinese Medicine2016;35(8):777–779. []
  11. Zhu D. L., Lu H. Y., Lu Y. Y., Wu L. J. Clinical observation of Qi-blood-supplementing needling for leukopenia after chemotherapy for breast cancer. Shanghai Journal of Acupuncture and Moxibustion2016;35(8):964–966. []
  12. Chen L, Xu G. Y. Observation on the prevention and treatment of chemotherapy-induced leukopenia by moxibustion therapy. Zhejiang Journal of Traditional Chinese Medicine2016;51(8):p. 600. []
  13. Mo T., Tian H., Yue S. B., Fan Z. N., Zhang Z. L. Clinical observation of acupoint moxibustion on leukocytopenia caused by tumor chemotherapy. World Chinese Medicine2016;11(10):2120–2122. []
  14. Nie C. M. Nursing observation of acupoint moxibustion in the treatment of leucopenia after chemotherapy. Today Nurse2017;4:93–95. []
  15. Wang D. Y. Clinical Research on Post-chemotherapy-leukopenia with Spleen-Kidney Yang Deficiency in Colorectal Cancer Treated with Point-Injection. Yunnan, China: Yunnan University of Chinese Medicine; 2017. []
  16. Gong Y. Q, Zhang M. Q, Zhang B. C. Prevention and treatment of leucocytopenia after chemotherapy in patients with malignant tumor with ginger partitioned moxibustion. Chinese Medicine Modern Distance Education of China2018;16(21):135–137. []
  17. Li Z. C., Lian M. J., Miao F. G. Clinical observation of fuzheng moxibustion combined with wenyang shengbai decoction in the treatment of 80 cases of leukopenia after chemotherapy. Hunan Journal of Traditional Chinese Medicine2019;35(3):64–66. []

Notice anything peculiar?

  • The studies are all from China where data fabrication was reported to be rife.
  • They are mostly unavailable for checking (why the published adds links that go nowhere is beyond me).
  • Many do not look at all like randomised clinical trials (which, according to the authors, was an inclusion criterion).
  • Many do not look as though their primary endpoint was the leukocyte count (which, according to the authors, was another inclusion criterion).

Intriguingly, the authors conclude that AMT is not just effective but also ‘safe’. How do they know? According to their own data extraction table, most studies failed to mention adverse effects. And how exactly is acupuncture supposed to increase my leukocyte count? Here is what the authors offer as a mode of action:

Based on the theory of traditional Chinese medicine (TCM), CIL belongs to the category of consumptive disease, owing to the exhaustion of genuine qi in the zang-fu viscera and the insufficiency of kidney essence and qi-blood. Researchers believe that there is an intimate association between the occurrence of malignant tumors and the deficiency of genuine qi. During attacking the cancer cells, chemotherapeutics also damaged the function of zang-fu viscera and qi-blood, leading to CIL. According to the theory of TCM and meridian, acupuncture-moxibustion is an ancient therapeutic modality that may be traced back more than 3500 years in China. Through meridian conduction, acupuncture-moxibustion therapy stimulates acupoints to strengthen the condition of zang-fu viscera and immune function, supporting genuine qi to improve symptoms of consumption.

I think it is high time that we stop tolerating that the medical literature gets polluted with such nonsense (helped, of course, by journals that are beyond the pale) – someone might actually believe it, in which case it would surely hasten the death of vulnerable patients.

The Center for Science in the Public Interest*** (CSPI) announced its agreement with Boiron to improve the labeling on the homeopathic products manufactured by Boiron and sold under the Boiron or other private label brands. The agreement covers the labeling for over 50 homeopathic products.

On Boiron’s Oscillococcinum and two similar products, Boiron will substantially increase the prominence of the words “Homeopathic Medicine” on the front of the box and the disclaimer on the back of the box that says the product’s uses have not been evaluated by the Food and Drug Administration (FDA). These changes will make it easier for consumers to identify that the products are homeopathic products, and are not FDA approved over-the-counter medicines.

For all of the other homeopathic products manufactured by Boiron, consumers will receive much more information on the packages. In addition to increasing the prominence of the words “Homeopathic Medicine,” a new disclaimer in large and contrasting font will be added to the back of the package (endorsed by the American Association of Homeopathic Pharmacists) stating: “Claims based on traditional homeopathic practice, not accepted medical evidence, and not FDA evaluated.”…

“The labeling changes that Boiron has agreed to on all the products covered by the agreement will help consumers more clearly identify that these are homeopathic products and are not FDA approved over-the-counter medicines that have been scientifically proven to be safe and effective,” said CSPI litigation director Lisa Mankofsky. “In addition, the vast majority of the covered homeopathic products will bear a disclaimer clarifying that they are based on traditional homeopathic practice, not accepted medical evidence, and not FDA evaluated. We think that consumers will find this labeling change important when choosing a remedy. We encourage other manufacturers to similarly make their labels more transparent and clear for consumers.”

Bravo!

Clearly a step into the right direction!

But it’s a small step only. It is a long way short of what Dylan Evans suggestied in his book ‘Placebo‘, first published in 2004:

Warning: this product is a placebo. It will work only if you believe in homeopathy, and only for certain conditions such as pain and depression. Even then, it is not likely to be as powerful as orthodox drugs. You may get fewer side-effects from this treatment than from a drug, but you will probably also get less benefit.

***The Center for Science in the Public Interest is perhaps the oldest independent, science-based consumer advocacy organization with an impressive record of accomplishments and a clear and ambitious agenda for improving the food system to support healthy eating.

Misinformation by chiropractors is unfortunately nothing new and has been discussed ad nauseam on this blog. It is tempting to ask whether chiropractors have lost (or more likely never had) the ability to ditinguish real information from misinformation or substantiated from unsubstantiated claims. During the pandemic, the phenomenon of chiropractic misinformation has become even more embarrassingly obvious, as this new article highlights.

Chiropractors made statements on social media claiming that chiropractic treatment can prevent or impact COVID-19. The rationale for these claims is that spinal manipulation can impact the nervous system and thus improve immunity. These beliefs often stem from nineteenth-century chiropractic concepts. The authors of the paper are aware of no clinically relevant scientific evidence to support such statements.

The investigators explored the internet and social media to collect examples of misinformation from Europe, North America, Australia and New Zealand regarding the impact of chiropractic treatment on immune function. They discussed the potential harm resulting from these claims and explore the role of chiropractors, teaching institutions, accrediting agencies, and legislative bodies.

The authors conclude as follows: In this search of public media in Europe, North America, New Zealand, and Australia, we discovered many cases of misinformation. Claims of chiropractic treatment improving immunity conflict with the advice from authorities and the scientific consensus. The science referenced by these claims is missing, flawed or has no clinical relevance. Consequently, their claims about clinical effectiveness are spurious at best and misleading at worst. However, our examples cannot be used to make statements about the magnitude of the problem among practitioners as our samples were not intended to be representative. For that reason, we also did not include an analysis of the arguments provided in the various postings. In view of the seriousness of the topic, it would be relevant to conduct a systematic study on a representative sample of public statements, to better understand these issues. Our search illustrates the possible danger to public health of misinformation posted on social media and the internet. This situation provides an opportunity for growth and maturation for the chiropractic profession. We hope that individual chiropractors will reflect on and improve their communication and practices. Further, we hope that the chiropractic teaching institutions, regulators, and professional organisations will always demonstrate responsible leadership in their respective domains by acting to ensure that all chiropractors understand and uphold their fiduciary duties.

Several previous papers have found similar things, e.g.: Twitter activity about SMT and immunity increased during the COVID-19 crisis. Results from this work have the potential to help policy makers and others understand the impact of SMT misinformation and devise strategies to mitigate its impact.

The pandemic has crystallised the embarrassment about chiropractic false claims. Yet, the phenomenon of chiropractors misleading the public has long been known and arguably is even more important when it relates to matters other than COVID-19. Ten years ago, we published this paper:

Background: Some chiropractors and their associations claim that chiropractic is effective for conditions that lack sound supporting evidence or scientific rationale. This study therefore sought to determine the frequency of World Wide Web claims of chiropractors and their associations to treat, asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence).

Methods: A review of 200 chiropractor websites and 9 chiropractic associations’ World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States was conducted between 1 October 2008 and 26 November 2008. The outcome measure was claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment.

Results: We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain,

Conclusions: The majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.

It makes it clear that the misleading information of chiropractors is a serious problem. And I find it disappointing to see that so little has been done about it, and that progress seems so ellusive.

This, of course, begs the question, where does all this misinformation come from? The authors of the new paper stated that beliefs often stem from nineteenth-century chiropractic concepts. This, I believe, is very true and it gives us an important clue. It suggests that, because it is good for business, chiro schools are still steeped in obsolete notions of pseudo- and anti-science. Thus, year after year, they seem to churn out new generations of naively willing victims of the Dunning Kruger effect.

We have often heard it said on this blog and elsewhere that chiropractors are making great strides towards reforming themselves and becoming an evidence-based profession. In view of the data cited above, this does not ring all that true, I am afraid. Is the picture that emerges not one of a profession deeply embroiled in BS with but a few fighting a lost battle to clean up the act?

One of my last posts re-ignited the discussion about the elementary issue of informed consent, specifically about informed consent for chiropractors. As it was repeatedly claimed that, in Australia, informed consent is a legal requirement for all chiros, I asked on Wednesday 11 November 2020 at 07:12

FOUR QUESTIONS TO DC + CRITICAL CHIRO (CC):

1) what does the law say about informed consent for Australian chiros?
2) what info exactly do you have to provide?
3) who monitors it?
4) what published evidence do we have about compliance?

CC then posted this reply:

Here we go again you demand evidence while providing little if any for your own assumptions (poor case studies do not count. The pleural of anecdote does not equal evidence whether it’s from chiro’s or you).
We have been over this many times over many years, I cite research/provide links yet you still find it challenging to take it onboard. It is human nature to feel obligated once making a public statement to defend it no matter how much evidence is sent your way. So not surprising.

“1) what does the law say about informed consent for Australian chiros?”
It is all freely available on the national regulators website (as you know and as I have referenced in the past):
https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx
https://www.chiropracticboard.gov.au/Search.aspx?q=Informed+consent
Some research by chiropractors on this topic (cited many times in the past):
Risk Management for Chiropractors and Osteopaths. Informed consent
A Common Law Requirement (2004):
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2051308/
Quick advanced PubMed with filters set to “Chiropractic” AND “Informed consent”.
https://www.ncbi.nlm.nih.gov/pmc/?term=(Chiropractic)+AND+Informed+consent
Not rocket science
Latest paper that you wrote an ill informed blog on and the comments were not going as you expected (So I expected you to double down like Donald Trump with a new blog within days. Your getting predictable).
https://chiromt.biomedcentral.com/articles/10.1186/s12998-020-00342-5
This paper questions the legal implications of vertebral subluxations with high powered legal input and is a broadside by evidence based chiropractors against vitalistic chiropractors. You respond a snide fantasy informed consent dialogue when you should be supporting the authors:
https://edzardernst.com/2020/11/informed-consent-why-chiropractors-dont-like-it/

“2) what info exactly do you have to provide?”
“4) what published evidence do we have about compliance?”
We have discussed this as well. It is a common law requirement for every profession and is checked upon re-registration by AHPRA every year and by the professional indemnity insurers every year. No informed consent, no registration and no professional indemnity insurance.
Checked AHPRA’s panel decisions and went back 5 YEARS and found ONE decision relating to informed consent:
https://www.ahpra.gov.au/Publications/Panel-decisions.aspx

“3) who monitors it?”
Another of your tired old arguments that we have discussed many times over the years.
In the UK there is the “‘Chiropractic Reporting and Learning System’ (CRLS)” but this is set up by the association representing chiropractors and not the registration board that advocates for patients. Right idea and step in the right direction, wrong organization.
Here years ago there was a trial of an adverse event reporting system in a Melbourne emergency department systematically collected relevant AE information on all professions which was sent to the relevant board for investigation.
It was supported by doctors and chiropractors while physio’s were not involved. A doctor involved told me it was killed off by ER doctors who “snivelled” about the extra paperwork.
There is no AE reporting system for physio’s, chiro’s, osteo’s, GP’s in private practice etc.
Over the years you have harped on and on about this topic as if it is a failing purely of the chiropractic profession when we have supported initiatives for its implementation.
You have also kept up with the research even commenting on an chiropractic researcher on AE’s Charlotte Leboeuf-Yde (who you highly regard) yet ignored until you could take issue with two sentences written in a blog then you wrote this hatchet blog:
https://edzardernst.com/2017/04/we-have-an-ethical-legal-and-moral-duty-to-discourage-chiropractic-neck-manipulations/
So you are asking for evidence yet willfully ignore an author who “I have always thought highly of Charlotte’s work”.

Stop the cynical cherry picked blogs and start supporting the researchers and reformers otherwise you are just someone standing on the sidelines blindly throwing grenades. You do not care who you hit or the damage you do to the chiropractors leading the reform you demand yet consistently fail to support.

____________________________________

I thought the tone of this response was oddly aggressive and found that CC had failed to understand some of my questions. Yet the link to the chiro’s code of conduct https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx was useful. This is what it says about informed consent:

3.5 Informed consent
Informed consent is a person’s voluntary decision about healthcare that is made with knowledge and understanding of the benefits and risks involved. A useful guide to the information that chiropractors need to give to patients is available in the National Health and Medical Research Council (NHMRC) publication General guidelines for medical practitioners in providing information to patients.3 The NHMRC guidelines cover the information that chiropractors should provide about their proposed management or approach, including the need to provide more information where the risk of harm is greater and likely to be more serious, and advice about how to present information. Good practice involves:
a) providing information to patients in a way they can understand before asking for their consent
b) providing an explanation of the treatment/care recommended, its likely duration, expected benefits and cost, any alternative(s) to the proposed care, their relative risks/benefits, as well as the likely consequences of no care
c) obtaining informed consent or other valid authority before undertaking any examination or investigation, providing treatment/care (this may not be possible in an emergency) or involving patients in teaching or research, including providing information on material risks
 d) consent being freely given, without coercion or pressure
 e) advising patients, when referring a patient for investigation or treatment/ care, that there may be additional costs, which they may wish to clarify before proceeding
 f) obtaining (when working with a patient whose capacity to give consent is or may be impaired or limited) the consent of people with legal authority to act on behalf of the patient, and attempting to obtain the consent of the patient as far as practically possible
 g) being mindful of additional informed consent requirements when supplying or prescribing products not approved or made in Australia, and
h) documenting consent appropriately, including considering the need for written consent for procedures that may result in serious injury or death.
_______________________________________
This does indeed clarify some of my questions. Related to the fictional patient with neck pain who consults a chiropractor in my previous post, this means the chiro must inform the patient that:
  • the chiro suggests a manipulation of the neck;
  • this often involves forcing a spinal joint beyond its physiological range of motion;
  • the treatment will be short but needs repeating several times during the coming weeks;
  • the expected benefits are a reduction of pain and improvement of motion;
  • the total cost of the treatment series will be xy;
  • there are many other treatment options for neck pain;
  • most of these have a better risk/benefit profile than neck manipulation;
  • having no treatment for neck pain at all is likely to lead to full resolution of the problem over time.

Apart from any doubts that chiropractors would actually comply with these requirements, the question remains: is the listed information sufficient? Does it outline a truly a fully informed consent? I think that essential aspects of informed consent are missing.

  • The code does not explicidly require an explanation about the possible harms of spinal manipulation (i.e. 50% of all patients will suffer mild to moderate adverse effects lasting 2-3 days, and occasionally patients will have a stroke of which some have died).
  • Moreover, the code mentions EXPECTED benefits, but not benefits supported by evidence. Chiros may well EXPECT their treatment to work, but what does the evidence show? As often discussed on this blog, the evidence is negative or very week, depending how you want to interpret it. The code does not require a chiro to inform his patients about this fact.

So, the way I see it, the code does not expressedly demand the chiro to explain his patient that the treatment he is being asked to consent to is

  1. not supported by sound evidence for effectiveness,
  2. nor that the treatment is burdened with significant risks.

And what about the other questions listed above? An Australian chiropractor who will remain anonymous gave me the following answers:

Who monitors Informed Consent?
 
The short answer here is nobody monitors informed consent.  Typically informed consent is a side issue whenever a negligence claim is made.  Similarly, clinical records are a side issue as well.   Thus, when a patient alleges they were injured a complaint is lodged.  As part of the investigation consideration is given regarding the consent process.  If the analysis determines that the adverse outcome was maloccurence rather than negligence  but valid consent was not obtained, the practitioner will still face disciplinary action. 
 
As we are all too well aware, the Boards show little or no desire to be proactive.  I have yet to see any results from the pilot advertising audit project which began approximately 2 years ago.
 
What published evidence have we ab​out compliance?
 
Good question.  To my knowledge Langworthy & Flemming’s 2005 paper is the only one looking at compliance.  Their results suggest that the majority of respondents would be unable to successfully defend a negligence in consent liability charge.  In my experience providing expert opinions in Australian cases, valid consent was not obtained in a single case.  The most bizarre case had the practitioner their expert argue that consent obtained 7 years prior to the injury was still valid.  
 
Langworthy J.M., Cambron J. Consent: its practices and implications in United Kingdom and the United States chiropractic practice. J Manip Physiol Ther. 2007;(6):419–431.

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Yet, Australian chiropractors claim that they abide by the ethical imperative of informed consent. Are they taking the Mickey?

Perhaps not. Perhaps they are merely trying to make sure they do not lose the majority of their clientele. As I already pointed out in my previous post, fully informed consent would make most chiropractic patients turn round and run a mile.

Vitamin D and Omega-3 supplements help the elderly avoid Covid-19 infection by boosting their immune systems, study claims. Yes, that was the headline in the DAILY MAIL on 11/11/2020. Naturally, I found this interesting. So, I looked up the original paper. Here is its abstract:

Importance: The benefits of vitamin D, omega-3 fatty acids, and exercise in disease prevention remain unclear.

Objective: To test whether vitamin D, omega-3s, and a strength-training exercise program, alone or in combination, improved 6 health outcomes among older adults.

Design, setting, and participants: Double-blind, placebo-controlled, 2 × 2 × 2 factorial randomized clinical trial among 2157 adults aged 70 years or older who had no major health events in the 5 years prior to enrollment and had sufficient mobility and good cognitive status. Patients were recruited between December 2012 and November 2014, and final follow-up was in November 2017.

Interventions: Participants were randomized to 3 years of intervention in 1 of the following 8 groups: 2000 IU/d of vitamin D3, 1 g/d of omega-3s, and a strength-training exercise program (n = 264); vitamin D3 and omega-3s (n = 265); vitamin D3 and exercise (n = 275); vitamin D3 alone (n = 272); omega-3s and exercise (n = 275); omega-3s alone (n = 269); exercise alone (n = 267); or placebo (n = 270).

Main outcomes and measures: The 6 primary outcomes were change in systolic and diastolic blood pressure (BP), Short Physical Performance Battery (SPPB), Montreal Cognitive Assessment (MoCA), and incidence rates (IRs) of nonvertebral fractures and infections over 3 years. Based on multiple comparisons of 6 primary end points, 99% confidence intervals are presented and P < .01 was required for statistical significance.

Results: Among 2157 randomized participants (mean age, 74.9 years; 61.7% women), 1900 (88%) completed the study. Median follow-up was 2.99 years. Overall, there were no statistically significant benefits of any intervention individually or in combination for the 6 end points at 3 years. For instance, the differences in mean change in systolic BP with vitamin D vs no vitamin D and with omega-3s vs no omega-3s were both -0.8 (99% CI, -2.1 to 0.5) mm Hg, with P < .13 and P < .11, respectively; the difference in mean change in diastolic BP with omega-3s vs no omega-3s was -0.5 (99% CI, -1.2 to 0.2) mm Hg; P = .06); and the difference in mean change in IR of infections with omega-3s vs no omega-3s was -0.13 (99% CI, -0.23 to -0.03), with an IR ratio of 0.89 (99% CI, 0.78-1.01; P = .02). No effects were found on the outcomes of SPPB, MoCA, and incidence of nonvertebral fractures). A total of 25 deaths were reported, with similar numbers in all treatment groups.

Conclusions and relevance: Among adults without major comorbidities aged 70 years or older, treatment with vitamin D3, omega-3s, or a strength-training exercise program did not result in statistically significant differences in improvement in systolic or diastolic blood pressure, nonvertebral fractures, physical performance, infection rates, or cognitive function. These findings do not support the effectiveness of these 3 interventions for these clinical outcomes.

Speachless?

Me too!

The study has noting to do with COVID-19 and very little with infections. The bit about infections shows almost the opposite of what the MAIL claims. So, where does the notion stipulated in the headline come from?

The MAIL article gives the answer: Professor Heike Bischoff-Ferrari from Zurich University in Switzerland, who led the latest study, said: ‘Our findings suggest supplementation of vitamin D and omega-3s in adults aged 70 or older who lead an active lifestyle and have no pre-existing conditions does not provide any benefits when it comes to bone health, memory and muscle function. ‘However, we believe there is an effect on infections – such as Covid-19.’  

I would not be surprised, if the last sentence in the quote was taken out of context.

I would not be surprised, if this is the worst health related article in the DAIL MAIL this year.

And, by Jove, there are plenty to choose from.

And why do I report all this?

As I have pointed out before, I believe that journalists have a lot to answer for when it comes to misleading the public about so-called alternative medicine (SCAM):

My hope is that, by reminding them of their ‘errors’ every now and then, I might contribute to some progress.

Yes, I know, I am an incurable optimist!

I was alerted to an outstanding article by an unusual author, a law firm, on the subject of chiropractic. Allow me to quote a few passages from it (without changing a word or adding a comment):

When Katie May passed away suddenly from a stroke at just 34 years old, it was initially ruled an accident. After further investigation, a coroner determined the stroke that claimed the model and single mother’s life was caused by injuries sustained during neck manipulation by a chiropractor. And Ms. May is not the first to be affected by this seemingly harmless procedure…

What health issues can be caused by chiropractic manipulation?

Chiropractors typically use their hands to apply pressure to joints, aiming to help alleviate pain and improve body function. This is referred to as a chiropractic adjustment.

Adjustments are commonly performed for neck and/or back pain. Although the Mayo Clinic says the risk of a serious complication is relatively small, these complications can include:

  • A herniated disk, or worsening of an existing herniated disk
  • Compression of nerves in the lower spinal column
  • Stroke, which can result in paralysis or death

The last item on this list is particularly concerning.

Patients who receive neck manipulation are at risk for a stroke caused by vertebral artery dissection. Located in the neck, the vertebral arteries supply blood to the brain and can be torn by stretching and sudden force applied during a neck adjustment.

Studies have shown that vertebral artery dissection occurs in approximately 1 in 100,000 people and can be caused by something as simple as cracking your neck.

How could a chiropractor be responsible for a patient’s injury?

Although the risk of being seriously injured by a chiropractor is low, tragic accidents can and do happen. If you or a loved one believe you have been the victim of medical malpractice, please contact an experienced personal injury attorney.

Explaining how an injury or medical error occurred will help your attorney determine the potential liability of a chiropractor and any other involved parties. A chiropractor’s liability could fall into a legal category such as:

  • Failure to Diagnose a Medical Condition – The chiropractor breaches a duty of care to their patients by failing to diagnose an underlying medical condition. This could occur when a patient reveals or exhibits symptoms of a severe issue, such as a stroke, and is not referred for appropriate medical attention.
  • Lack of Informed Consent – A patient is treated without being properly informed of the potential risks or side effects, and experiences an injury from that treatment.
  • Negligent Manipulation – The patient’s body is adjusted by the chiropractor in such a way that it causes a new injury or worsens an existing injury. This could also include manipulation of a patient who is pregnant and goes into premature labor.
  • Chiropractic Induced Injury – A patient suffers injury, permanent irreversible damage such as paralysis or wrongful death as the direct result of a chiropractic manipulation.

To find out whether or not you may have a case, please discuss your concerns with a qualified personal injury attorney.

What should I do if I think I have been injured by chiropractic manipulation?

A personal injury attorney can help recover compensation for victims of medical malpractice, including those who have experienced a chiropractic injury. Surviving loved ones can also pursue their case after a family member’s wrongful death.

An attorney will help you collect documents, photos and other items pertaining to your case – but staying organized early in the process will be helpful. Try to preserve important documents, such as:

  • Photographs before and after treatment
  • Medical records and medical bills
  • Receipts, appointment confirmations and other paperwork from your chiropractor

There is a time limit to file a medical malpractice lawsuit, referred to as a statute of limitations…

The issue of informed consent has made regular appearances on this blog. It is important and has many intriguing aspects, particularly for so-called alternative medicine (SCAM). On the one hand, it is a ‘conditio sine qua non’ for any form of healthcare, while, on the other hand, it is a near impossibility in SCAM practice.

In this new article published in a chiro-journal, the authors review the origins of informed consent and trace the duty of disclosure and materiality through landmark medical consent cases in four common law (case law) jurisdictions. The duty of disclosure has evolved from a patriarchal exercise to one in which patient autonomy in clinical decision making is paramount. Passing time has seen the duty of disclosure evolve to include non-medical aspects that may influence the delivery of care. The authors argue that a patient cannot provide valid informed consent for the removal of vertebral subluxation. Further, vertebral subluxation care cannot meet code of conduct standards because it lacks an evidence base and is practitioner-centered.

The uptake of the expanded duty of disclosure has been slow and incomplete by practitioners and regulators. The expanded duty of disclosure has implications, both educative and punitive for regulators, chiropractic educators and professional associations. The authors discuss how practitioners and regulators can be informed by other sources such as consumer law. For regulators, reviewing and updating informed consent requirements is required. For practitioners it may necessitate disclosure of health status, conflict of interest when recommending “inhouse” products, recency of training after attending continuing professional development, practice patterns, personal interests and disciplinary findings.

The authors conclude that, ultimately such matters are informed by the deliberations of the courts. It is our opinion that the duty of a mature profession to critically self-evaluate and respond in the best interests of the patient before these matters arrive in court.

In their paper, the authors also provide a standard list of items required for ‘informed’ consent:

(1) emphasizing the patient’s role in shared decision-making

(2) disclosure of information

a. explaining the patient’s medical status including diagnosis and prognosis

b. describing the proposed diagnostic and therapeutic intervention, including the likelihood and effect of associated risks and benefits of the proposed action, including material risks

c. discussing alternatives to the proposed intervention, including doing nothing

(3) prompting and answering patient questions related to the proposed course of action (NB. this involves probing for understanding, not simply asking ‘do you have any questions’), and

(4) eliciting the patient’s preference (usually by signature). (NB. A signed form is not consent. The conversation between the clinician and the patient or carer is the true process of obtaining informed consent. The signature on the consent form is proof that the conversation took place and that the patient understood and agreed.)

The authors of this article – I do commend it to all chiropractors – take a mostly judicial view of informed consent (for an ethical perspective on the subject, I recommend our book). They do not discuss, whether chiropractors do, in fact, adhere to the ethical imperative of informed consent. As I have stated before, there is not much research on this issue. But the little that does exist fails to show that chiropractors care much about it.

But why?

If it’s an ethical imerative, why do chiropractors not abide by it?

The answer to this question is not difficult to find. Just imagine a conversation between a chiropractor (C) and a patient with neck pain (P):

  • P: What’s your diagnisis?
  • C: You are suffering from acute neck pain.
  • P: Thanks, that much was clear to me. What do you suggest I do?
  • C: I will perform a manipulation of your neck, if you agree.
  • P: Why would this help?
  • C: It can realign the vertebrae that are out of place, simply put.
  • P: And my pain will disappear?
  • C: Sometimes it does, yes.
  • P: But will it disappear quicker than without manipulation.
  • C: Some of the evidence says so.
  • P: Ok, but what does the most reliable evidence say?
  • C: It is not entirely clear cut.
  • P: Hmm, that does not sound too good.
  • P: So, tell me, are there any risks?
  • C: About 50% of patients suffer from minor to moderate pain for 2-3 days afterwards.
  • P: That’s a lot!
  • P: Anything else?
  • C: In some cases, neck manipulation was followed by a stroke.
  • P: Gee that’s bad; how often has this happened?
  • C: We know of about 500 such cases.
  • P: Heavens!
  • C: Now, do you want the treatment or not?
  • P: How much will you charge?
  • C: Only 60 Euros per session.
  • P: You mean I have to come back for more, each time risking a stroke?
  • C: Well… You don’t have to.
  • P: Thanks for the info; I am off. Cherio!

I rest my case. 

 

If you think that the papers published on SCAM for humans are bad, you should have a look at those in the veterinary sector. Take for instance this article from the AHVMA (American Holistic Veterinary Medical Association) Journal:

Evidence demonstrates that acupuncture and herbal medicine are useful and effective for the treatment of seizures. In the perspective of Traditional Chinese Veterinary Medicine (TCVM), seizures in dogs and cats can be classified into 6 patterns:

  1. Obstruction by WindPhlegm,
  2. Internal Profusion of Phlegm-Fire,
  3. Stagnation of Blood,
  4. Liver Blood Deficiency,
  5. Liver/Kidney Yin Deficiency,
  6. Yin Deficiency with Blood Deficiency.

This article focuses on how to differentiate and treat these patterns using herbal medicine and acupuncture. An overview of clinical trials is provided, and case examples are also included.

The authors from the ‘Equine Acupuncture Center/University of Florida, USA, concluded that the combination of TCVM and Western medicine (WM) can be an effective therapeutic approach to control seizures and epilepsy. WM is effective for initial control of severe seizures and in identification of the cause of the disease. TCVM can be effectively used for the treatment of milder cases and to help control seizures in those patients that fail to respond to WM. 

Having done some research into acupuncture for animals myself, I was particularly interested in this aspect of the paper – interested and disappointed, I have to admit. The sad truth is that, despite the opimistic conclusions of the authors, there is no sound evidence. As no good evidence has emerged since, our own systematic review of 2006 (which was not cited by the authors of the above article) still holds true:

Acupuncture is a popular complementary treatment option in human medicine. Increasingly, owners also seek acupuncture for their animals. The aim of the systematic review reported here was to summarize and assess the clinical evidence for or against the effectiveness of acupuncture in veterinary medicine. Systematic searches were conducted on Medline, Embase, Amed, Cinahl, Japana Centra Revuo Medicina and Chikusan Bunken Kensaku. Hand-searches included conference proceedings, bibliographies, and contact with experts and veterinary acupuncture associations. There were no restrictions regarding the language of publication. All controlled clinical trials testing acupuncture in any condition of domestic animals were included. Studies using laboratory animals were excluded. Titles and abstracts of identified articles were read, and hard copies were obtained. Inclusion and exclusion of studies, data extraction, and validation were performed independently by two reviewers. Methodologic quality was evaluated by means of the Jadad score. Fourteen randomized controlled trials and 17 nonrandomized controlled trials met our criteria and were, therefore, included. The methodologic quality of these trials was variable but, on average, was low. For cutaneous pain and diarrhea, encouraging evidence exists that warrants further investigation in rigorous trials. Single studies reported some positive intergroup differences for spinal cord injury, Cushing’s syndrome, lung function, hepatitis, and rumen acidosis. These trials require independent replication. On the basis of the findings of this systematic review, there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.

The AHVMA-article becomes wholly farcical, once we see the heading the AHVMA-journal has given it:

SCIENTIFIC REVIEW

The AHVMA-journal is the official publication of the American Holistic Veterinary Medical Association, according to their own statement, is the mindful leader elevating the veterinary professional through innovation, education, and advocacy of integrative medicine.

One stated objective of the AHVMA is to advance and educate in the science and art of holistic veterinary medicine. If their new ‘scientific review’ is anything to go by, they seem to have a most bizarre view about science. The question that occurred to me while reading the paper was this: are they not promoting animal abuse, a term defined as any use or treatment of animals that seems unnecessarily cruel, regardless of whether the act is against the law?

 

I know of one patient who turned to the Gerson Therapy having been told that she was suffering from terminal cancer and would not survive another course of chemotherapy. Happily, seven years later she is alive and well. So therefore it is vital that, rather than dismissing such experiences, we should further investigate the beneficial nature of these treatments.

HRH The Prince of Wales (2004)

I was reminded of this embarrassing (because displaying profound ignorance) quote when I looked at the website of the ‘GERSON SUPPORT GROUP UK‘ where it is prominently cited. Under the heading ‘SCIENCE & CLINICAL RATIONAL’ the site offers a long article about the Gerson therapy (GT). Allow me to show you a few quotes from it:

Dr Max Gerson’s therapy is based on the belief that insufficient nutrients within the cells and an accumulation of toxins in the tissues lead to a breakdown in healthy cellular function which, if left unchecked, can trigger cancer.

That is interesting, I find, because the statement clearly admits that the GT is not an evidence-based therapy but a belief-based treatment.

The therapy that he developed uses a restrictive, plant-based diet and specific supplements to boost healthy cellular function; and various detoxification procedures, including coffee enemas, to eliminate waste products.

The claims hidden in this sentence remain unproven. There is no evidence that cellular fuction is boosted, nor that the procedures eliminate toxins.

… we only need to look at communities across the globe which exist in a pre-industrialised state to see that, whilst they might be more likely to die from pneumonia or tuberculosis, rates of degenerative illness are a fraction of those in the ‘developed‘ world. The age-adjusted death rate from breast cancer is less than 2 per 100,000 of the population in Thailand, Sri Lanka and El Salvador and around 33 per 100,000 in the UK, US, The Netherlands and numerous other affluent, Western countries.

Correlation is not causation! Pre-industrial societies also watch less TV, eat less ice-cream, read less fashion magazines, etc., etc. Are these habits also the cause of cancer?

… migrant studies show that within two generations the cancer rates of migrants increase rapidly towards Western rates, again underlining the assertion that cancer is caused primarily by diet and lifestyle rather than ‘faulty’ genes.

In no way is this an argument for eating raw vegetable and taking your coffee via the rectum.

In the German scientific golden age of the 1920s and 30s…

Golden age for what, for fascists?

Gerson had used a restricted diet to cure himself of migraines. He then helped another patient to reverse tuberculosis, and many others to reverse a variety of degenerative illnesses, all by similar means. He later developed his therapy to the point where he was able to help individuals reverse cancer. 

In this case, Max Gerson was ignorant of the fact that experience and evidence are two fundamentally different things.

Max Gerson developed his therapy in an iterative way, starting with a restrictive plant-based diet, adding vitamins, minerals and enzymes to encourage the oxygenation of the cells and then introducing the coffee enemas to aid detoxification of waste products. What is fascinating is that science has subsequently explained the mechanism of action behind some of his theories. (See Biochemical Basis to the Therapy).

Science has not explained the mechanism of action, not least because the action has never been verified. There are no robust clinical trials of Gerson’s therapy. Evidently, 100 years were not enough to conduct any – or perhaps the proponents know only too well that they would not generate the results they hoped?

Equally interesting is that in 2012 Dr Thomas Seyfried published the results of many years research in Cancer as a Metabolic Disease. 

Really? On Medline, I find only two cancer-related papers for Seyfried T. 2012:

Thus, nearly a century after their original proposition that the fundamental cause of cancer was faulty cellular metabolism, it seems that doctors Otto Warburg and Max Gerson might be vindicated.

No, to ‘vindicate’ a therapeutic suggestion one needs several rigorous clinical trials. And for the GT, they remain absent.

_______________________________

So, what does the GT amount to?

  • proponents had ~100 years to produce evidence;
  • they failed to do so;
  • thus the therapy is at best unproven;
  • it is also biologically implausible;
  • moreover, it is expensive;
  • crucially it is not free of serious adverse effects;
  • it is promoted only by those who seem to make money from it.

The only controlled clinical trial of a Gerson-like therapy that I know of is this one (rarely cited by Gerson fans):

Conventional medicine has had little to offer patients with inoperable pancreatic adenocarcinoma; thus, many patients seek alternative treatments. The National Cancer Institute, in 1998, sponsored a randomized, phase III, controlled trial of proteolytic enzyme therapy versus chemotherapy. Because most eligible patients refused random assignment, the trial was changed in 2001 to a controlled, observational study.

METHODS

All patients were seen by one of the investigators at Columbia University, and patients who received enzyme therapy were seen by the participating alternative practitioner. Of 55 patients who had inoperable pancreatic cancer, 23 elected gemcitabine-based chemotherapy, and 32 elected enzyme treatment, which included pancreatic enzymes, nutritional supplements, detoxification, and an organic diet. Primary and secondary outcomes were overall survival and quality of life, respectively.

RESULTS

At enrollment, the treatment groups had no statistically significant differences in patient characteristics, pathology, quality of life, or clinically meaningful laboratory values. Kaplan-Meier analysis found a 9.7-month difference in median survival between the chemotherapy group (median survival, 14 months) and enzyme treatment groups (median survival, 4.3 months) and found an adjusted-mortality hazard ratio of the enzyme group compared with the chemotherapy group of 6.96 (P < .001). At 1 year, 56% of chemotherapy-group patients were alive, and 16% of enzyme-therapy patients were alive. The quality of life ratings were better in the chemotherapy group than in the enzyme-treated group (P < .01).

CONCLUSION

Among patients who have pancreatic cancer, those who chose gemcitabine-based chemotherapy survived more than three times as long (14.0 v 4.3 months) and had better quality of life than those who chose proteolytic enzyme treatment.

Considering all this, I believe, it would be hard to name a cancer quackery that is less credible than the GT.

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