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

malpractice

Prof. Shailendra Ramchandra Vishampayan is the 1st author of the paper we discussed yesterday. He was kind enough to repeatedly join us in the comments section, and I was therefore keen to learn more about him. On his website, he says about himself that he is a renowned academician and famous homeopath, enriched with decades of ideal experiences and quality services. He is registered medical practitioner (M.D), performs all the duties of registered medical practitioner following the law of land in India. Globally he is considered as homeopath and known as “Dr.V”. He is a registered member of Society of Homeopaths (overseas).

Dr. V, is a practicing homeopath with clinical experience of over 20 years. In course of his years of practice he had successfully helped more than 250 happy families globally, with various kinds of cases like thyroid, immune compromised, epilepsy, endocrine disorders, paediatric, gynaecological disorders addictions, psychiatric disorder, children with special needs, pets and plants.

He is famous for his path breaking concept and novel idea of creating an organization called ‘Folk Homeopathy ‘, which is dedicated to professional enrichment of homeopathic practitioners helping them to improve their clinical acumen with spot on prescription.

His practical approach in solving cases has earned him accolades and fame throughout the globe.

Dr. V is the author of ‘Kinder Garten Materia Medica’ a reference book for beginners widely used by homeopathic students in India. It is a book with unique combination of pictorial and pneumonic.

He is a Professor (PG) at D.Y.Patil Homeopathy Medical College (Pune). He has a teaching experience of over 16 years in teaching UG and PG. He has drawn large number of followers through webinars which is accessible throughout the globe. He has given more than 50 international seminar ,workshops and webinars in countries like USA, Ireland, Malaysia, with presentations on Homeopathic approach to female hormonal imbalance cases at OMICS Conference of Alternative Medicine, presentation on Psychiatric cases at Asian Homeopathic League. And various presentation at University of Cyberjaya, Malaysia, California Homeopathic Medical society, San Diego and also at Corte Madera, 98th FOH Congress, Liverpool and Kinvara Co Galway, Ireland.

And on the same site, we also learn that ‘Dr V’ is particularly adept at treating diabetes:

India is now considered as the diabetes capital of the world. Approximately 8.7 percent of Indians between the age of 20 to 70 years are diabetic. This translates to approximately 62.5 million diabetics living in India, according to estimates by the World Health Organisation (W.H.O.) The economic burden of managing this disease is also substantial since this is a combination of cost of treatment and loss of productivity in such a high number of diabetics. Diabetes can affect multiple organ systems resulting in a wide range of serious issues in patients. Many of these complications in a diabetic do not have any specific treatment with conventional medicines. However, an indication of the popularity of homeopathy amongst diabetics is that the doctors at our clinic treat approximately two hundred cases of diabetes or diabetes related issues every day. We have, in fact, developed specific diabetes management protocols for patients based on the experience of thousands of cases we have seen over four decades.

This is interesting, I thought, and conducted a few Medline searches to see whether there is any evidence to show that homeopathy is an effective therapy for diabetes. I am afraid, I found no papers of ‘Dr V’ to suggest such an effect. But what I did find was certainly fascinating.

Last year, Italian diabetologists published an review entitled ‘Alternative treatment or alternative to treatment? A systematic review of randomized trials on homeopathic preparations for diabetes and obesity‘. Here is what they reported:

The searches failed to retrieve any trial comparing homeopathic remedies with placebo or any active drug for the treatment of either diabetes or obesity.

These authors commented that

… if homeopathy is used as an alternative to available and effective treatments, the consequences can be catastrophic, particularly in some conditions such as insulin-requiring diabetes. In conclusion, there is no scientific evidence on efficacy and no demonstration of safety of homeopathy in diabetes and obesity…

I agree with my Italian colleagues and I have previously expressed this view bluntly; I even entitled one of my posts ‘This is how homeopathy could kill millions‘.

‘Dr V’ will probably point out that he is a fully qualified doctor and uses homeopathy merely as an adjunct to conventional anti-diabetic treatments; thus he kills nobody.

I certainly hope this is so! But, even in this case, I must still ask: WHERE IS THE EVIDENCE THAT HOMEOPATHY IS AN EFFECTIVE ADJUNCT TO CONVENTIONAL MEDICINE?

Indian homeopaths published a remarkable article in the journal ‘HOMEOPATHY’ proposing Mercurius solubilis as genus epidemicus for the current pandemic. Here it is:

From mid-June to mid-July 2020, our team of homeopathic doctors treated 104 patients in two COVID treatment centers—Pandit Bhimsen Joshi Hospital and Sheth P.V. Doshi Hospital—on the outskirts of Mumbai, India, with adjuvant homeopathy. It was observed by the patients, hospital staff, and the management that those patients on adjuvant homeopathy were discharged 3 to 7 days earlier than other comparable patients in the same wards, allowing us gradually to accommodate more severely ill patients who required oxygen, continuous positive airway pressure, or a ventilator.

Twenty-five different homeopathic medicines in total were prescribed to the patients, each receiving individualized treatment according to his or her symptoms. After collecting 143 clinical and individualizing (homeopathic) symptoms of 104 patients and converting those symptoms into rubrics, we repertorized the combined data with the help of the software Hompath, with an aim to arrive at a genus epidemicus. We observed that the medicine Merc Sol was at the top of the combined repertorization chart. After reviewing repertory sheets of all 104 patients, we discovered that Merc Sol was at the fourth or fifth place of all individual repertorization charts as well.

To substantiate our deduction, we studied the Materia Medica of Merc Sol from the original provings of Hahnemann[1] and other sourcebooks.[2] [3] [4] We also searched research articles and case studies about toxicological effects of mercury.[5] [6] [7] [8] These showed that acute exposure to mercury produces an acute respiratory distress syndrome-like presentation, a picture similar to the COVID symptomatology. Moreover, anosmia, aphthae, gastrointestinal and ocular manifestations that are seen in patients with COVID-19 were produced also by mercury the toxin and mercury the homeopathy-proved medicine. This finding is in accordance with the homeopathic Law of Similars: a substance producing a symptom in a healthy person is able to cure a similar symptom in a sick person.

To confirm our hypothesis, we identified 13 common symptoms of Merc Sol, such as indented tongue, salivation, perspiration, and night aggravation, which were present in various intensities in the previously treated 104 patients. We created a 13-point questionnaire and, after obtaining suitable Ethics Committee approval and individual informed consent from the patients, we evaluated 68 further patients in the above-mentioned COVID hospitals. People with at least eight confirmed symptoms from the questionnaire were prescribed Merc Sol 200c thrice a day for a week. In our 2-week study at both the locations, we observed a speedy recovery and a hospital stay reduction by 5 to 7 days in all the 68 patients when Merc Sol was used along with the standard Indian Council of Medical Research clinical protocol. Many of them were not newly admitted patients but were those who exceeded the mandatory minimum hospital stay. We are now using Merc Sol as a preventive medicine for over 1,000 people in a COVID hot-spot area in Powai, Mumbai, with the expressed permission of local authorities.

Following the Hahnemannian method of arriving at a genus epidemicus [9] (§ 99–103), and deducing it from the combined data of symptoms of more than 100 patients, we arrived at the conclusion that Merc Sol, “the deceitful malefic mercury” known for various symptomatic presentations and tissue destruction, is genus epidemicus of this pandemic. Our efforts are in accordance with the logic of homeopathy proffered by Dr. Stuart Close[10]: exact observation, correct interpretation, rational explanation, and scientific construction.

We now appeal to the global homeopathy community to test our findings in their respective areas, designing specific research projects to explore the utility of Mercurius solubilis in the COVID-19 pandemic as genus epidemicus.

If it were not such a serious matter, I might joke that everyone with a dental amalgam filling must be protected from COVID-19. But it is rather too serious to make fun, I am afraid. Therefore, I will just point out to all those homeopaths across the globe who follow their Indian colleagues’ appeal something rather basic: it is bad science to confirm their hypothesis. Science works by falsifying hypotheses. And a proper hypothesis needs, of course, more that the implausible hunches of some evangelic believers in the homeopathic cult.

Guest post by Ken McLeod

‘Ayurvedic Medicine,’ or Ayurveda, is an alternative medicine system which originated in India as long as 5,000 years ago, according to its proponents.  Science-based medicine refers to it  as pseudoscientific and the Indian Medical Association (IMA) characterises  it as quackery. [1] Ayurvedic practitioners claim that its popularity through the ages vindicates it as safe and effective.

That last bit is of course the appeal to antiquity, or the appeal to tradition (also known as argumentum ad antiquitatem. [2] This proposes that if something was supported by people for a long time it must be valid.   That is bunkum; many ancient ideas have long since been discredited; the Earth is not flat, no matter for how long people thought it was.

Nevertheless, ‘Ayurvedic Medicine’ has many practitioners and supporters in the supposedly rational West, including Bondi Junction here in Australia.  Despite the many warnings about it, [3] people still go to practitioners, and occasionally they are injured.

One such injury and the consequent complaint to the New South Wales regulator, the Health Care Complaints Commission, (HCCC), has resulted in a Public Warning dated 18 September concerning levels of heavy metals in Ayurvedic Medication.  [4]

The HCCC said:

‘The NSW Health Care Complaints Commission is concerned about a complaint received regarding the prescription of “Manasamithra Vatika,” (Manasamitram Pills) an Ayurvedic medication.

‘The complaint related to prescription of this medication to a child for treatment of autism.

‘This medication was found to contain concerning levels of lead and other heavy metals.’

That’s all very bland, no headlines there.  But then it got into:

“The Commission strongly urges those individuals seeking alternative therapies to be vigilant in their research prior to proceeding with any natural therapy medications or medicines and to discuss any such proposed therapies with their treating registered health practitioner.”

Not so bland there; that’s very comprehensive; ‘any natural therapy medications or medicines’ and ‘discuss any such proposed therapies with their treating registered health practitioner.” ‘Note the HCCC’s emphasis on “registered.”  That rules out Ayurvedic Medicine practitioners, homeopaths, and other assorted cranks; go to a real doctor.

Surely that is headline material; a regulator responsible for promoting the health of citizens warns them to go to real doctors before going to these quacks.

Then it gets better, (or worse if you are an Ayurvedic Medicine practitioner).  At the same time the HCCC issued an Interim Prohibition Order against Mr Rama Prasad (“Ayurveda Doctor Rama Prasad.”) [5] The HCCC’s Order says:

‘The NSW Health Care Complaints Commission (“the Commission”) is currently investigating Mr Rama Prasad in relation to his prescribing of the Ayurvedic Medication “Manasamithra Vatika” (Manasamitram Pills) to both children and adults and about his claims that his treatments can reverse several aspects of autism in children.

‘The Ayurvedic Medication “Manasmithra Vatika” (Manasamitram Pills) was found to contain elevated levels of lead and other heavy metals.

‘One case with mildly elevated blood level was notified to the South Eastern Sydney Public Health Unit after consuming this product.

‘Clients residing in NSW who are considered to have been placed at possible risk have now been contacted by NSW Health public health personnel.

‘The Commission has issued an interim prohibition order in relation to Mr Rama Prasad, under section 41AA of the Health Care Complaints Act 1993 (‘The Act’). Mr Prasad is currently prohibited from providing any health services, either in paid employment or voluntarily, to any member of the public.

‘This interim prohibition order will remain in force for a period of eight weeks and may be renewed where appropriate in order to protect the health or safety of the public.’

That should send chills down the spine of any Ayurvedic Medicine practitioner.  A complete Prohibition Order ordering Prasad not to engage in providing any health service as defined in the Act  [6] for eight weeks, which may be renewed or even made permanent, depending on what the investigation finds.  The Act includes a comprehensive list of activities that comprise a ‘health service’:

‘health service includes the following services, whether provided as public or private services:

  • (a)  medical, hospital, nursing and midwifery services,
  • (b)  dental services,
  • (c)  mental health services,
  • (d)  pharmaceutical services,
  • (e)  ambulance services,
  • (f)  community health services,
  • (g)  health education services,
  • (h)  welfare services necessary to implement any services referred to in paragraphs (a)–(g),
  • (i)  services provided in connection with Aboriginal and Torres Strait Islander health practices and medical radiation practices,
  • (j)  Chinese medicine, chiropractic, occupational therapy, optometry, osteopathy, physiotherapy, podiatry and psychology services,
  • (j1)  optical dispensing, dietitian, massage therapy, naturopathy, acupuncture, speech therapy, audiology and audiometry services,
  • (k)  services provided in other alternative health care fields,
  • (k1)  forensic pathology services,’

Note the inclusion of ‘health education.’  This is where so many cranks fall foul of the law;  setting yourself up as a health educator makes you subject to the Act.   Even if you claim to be a master chef, homeopath or Ayurvedic Medicine Practitioner, you are not exempt.

It’s early days yet in this particular saga, and there are many questions to be answered, for example:

  • – How did this “medicine” get past Australia’s Therapeutic Goods Administration, (Australia’s equivalent to the US FDA)?
  • – Did the TGA list or register it?
  • – If not why not? If it was who is responsible?
  • – Was this detected only after a child was so sickened that they were taken to hospital?
  • – Why is the practitioner concerned still advertising his Ayurvedic medicine courses? [7]  Is this a breach of his Prohibition Order which prohibits ‘health education services’?’

So stay tuned for updates as this case progresses.  In the meantime note that an Australian Health regulator is advising the public to seek advice from real doctors before going to alternative therapists, including ‘Ayurvedic Medicine’ practitioners.  That is a real headline.

[1] https://en.wikipedia.org/wiki/Ayurveda

[2] https://en.wikipedia.org/wiki/Appeal_to_tradition

[3] Such as from the Victoria Dept of Health at https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/ayurveda

[4] https://www.hccc.nsw.gov.au/decisions-orders/public-statements-and-warnings/public-warning-under-s94a-of-the-health-care-complaints-act-concerning-levels-of-heavy-metals-in-ayurvedic-medication

[5] https://www.hccc.nsw.gov.au/decisions-orders/media-releases/2020/mr-rama-prasad-ayurveda-doctor-rama-prasad-interim-prohibition-order

[6] Health Care Complaints Act 1993 https://www.legislation.nsw.gov.au/view/html/inforce/current/act-1993-105

[7] https://www.enlightenedevents.com.au/events/certificate-in-clinical-ayurveda-dr-rama-prasad

On this blog, I have discussed the adverse events (AEs) of spinal manipulative therapy (SMT) with some regularity, and we have seen that ~ 50% of patients who receive SMT from a chiropractor experience some kind of AE. In addition there are many serious complications. In my book, I discuss, apart from the better-known vascular accidents followed by a stroke or death, the following:

  • atlantoaxial dislocation,
  • cauda equina syndrome,
  • cervical radiculopathy,
  • diaphragmatic paralysis,
  • disrupted fracture healing,
  • dural sleeve injury,
  • haematoma,
  • haematothorax,
  • haemorrhagic cysts,
  • muscle abscess,
  • muscle abscess,
  • myelopathy,
  • neurologic compromise,
  • oesophageal rupture
  • pneumothorax,
  • pseudoaneurysm,
  • soft tissue trauma,
  • spinal cord injury,
  • vertebral disc herniation,
  • vertebral fracture,
  • central retinal artery occlusion,
  • nystagmus,
  • Wallenberg syndrome,
  • ptosis,
  • loss of vision,
  • ophthalmoplegia,
  • diplopia,
  • Horner’s syndrome.

Considering this long list, we currently have far too little reliable information. A recent publication offers further information on this important topic.

The aim of this study was to identify beliefs, perceptions and practices of chiropractors and patients regarding benign AEs post-SMT and potential strategies to mitigate them. Clinicians and patients from two chiropractic teaching clinics were invited to respond to an 11-question survey exploring their beliefs, perceptions and practices regarding benign AEs post-SMT and strategies to mitigate them.

A total of 39 clinicians (67% response rate) and 203 patients (82.9% response rate) completed the survey. The results show that:

  • 97% of the chiropractors believed benign AEs occur.
  • 82% reported their own patients have experienced an AE.
  • 55% of the patients reported experiencing benign AEs post-SMT, with the most common symptoms being pain/soreness, headache and stiffness.
  • 61.5% of the chiropractors reported trying a mitigation strategy with their patients.
  • Yet only 21.2% of patients perceived their clinicians had tried any mitigation strategy.
  • Chiropractors perceived that patient education is most likely to mitigate benign AEs, followed by soft tissue therapy and/or icing after SMT.
  • Patients perceived stretching was most likely to mitigate benign AEs, followed by education and/or massage

 

The authors concluded that this is the first study comparing beliefs, perceptions and practices from clinicians and patients regarding benign AEs post-SMT and strategies to mitigate them. This study provides an important step towards identifying the best strategies to improve patient safety and improve quality of care.

The question that I have often asked before, and I am bound to ask again after seeing such results, is this:

If there were a drug that causes temporary pain/soreness, headache and stiffness in 55% of all patients (plus an unknown frequency of a long list of serious complications), while being of uncertain benefit, do you think it would still be on the market?

 

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.

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

When chiropractors try to play medical doctors, their patients are in danger. When they try to play epidemiologists, we might all be in danger. Already in April 2020, the Australian ‘Patrons of Chiropractic Science’ issued a press release on COVID 19 stating:

Good function of the body’s joints, particularly within the spine, may improve neurological function, which is important for an effective natural immune system. Treatment by a qualified and experienced chiropractor offers one of the most effective methods to improve and maintain good spinal joint function. The chiropractic profession attends to many patients, and like all other health workers, the profession truly cares for the welfare of every individual.

Now they have gone further. Their press release of 18/8/2020 states amongst other things:

  • Approximately 1.5% of those infected with SARS-CoV-2 may die; all people with a compromised immune system, that being the aged or those suffering a co-morbidity;
  • 98.5% of those infected with the COVID-19 virus suffer either no symptoms, mild symptoms or treatable symptoms no worse than seasonal influenza;
  • COVID-19 positive test numbers are largely irrelevant, as 98.5% of those testing positive will simply develop natural immunity and recover as the virus moves through the population. Recent studies by the UK based Centre for Evidence Based Medicine confirms increased COVID testing is the primary reason for increased case numbers, which have little relationship to mortality. The focus on case numbers is again designed to engender public fear and compliance;

Patrons of Chiropractic Science demands that the Victorian Government and its senior health officials cease distorting facts, stop blaming Victorian non-compliance for the increased positive testing numbers, and assume full responsibility for the aged care deaths and the current economic damage.

Simple facts: it is critical and more effective to isolate and protect the high-risk groups, effectively quarantine return travellers, but cease the illogical isolation of the vast majority of the population who are not at risk as the virus naturally circulates, and allow them to recommence working to save many businesses and initiate economic recovery.

________________________________

Implying that regular chiropractic manipulations improve immunity or protect people from the corona virus is bad enough. But the new press release is worse:

  1. It is not true that only people with impaired immune systems, of old age, or affected by other diseases die of COVID 19.
  2. It is not true that all of the 98.5% who do not die have treatable symptoms not worse than a flu; an undefined percentage of the survivors suffer from very severe and sometimes long-lasting conditions.
  3. It is not true that 98.5% of those testing positive will simply develop natural immunity and recover; many will not recover completely, and the question whether mildly affected individuals develop immunity and for how long is as yet unanswered.
  4. It is not true that COVID testing results are unrelated to mortality; the figures need, of course, careful interpretation; the percentage of positive tests per number of tests done, for instance, should be independent of the frequency of testing.
  5. It is not true that the vast majority of the population are not at risk, if the virus were to circulate naturally.

All this looks to me as though the ‘Patrons of Chiropractic Science’ are in urgent need of learning some science. Meanwhile, it would be most helpful, if they could keep quiet.

For many years, ‘HOMEOPATHY‘ (the ‘flag-ship’ journal of homeopathy which started its life in 1911 as THE BRITISH JOURNAL OF HOMOEOPATHY) was edited by Peter Fisher. When Peter fired me from its editorial board, it arguably lost its only expert who was critical of homeopathy. Then the journal was transferred from Elsevier to Thieme. When Peter tragically died, the journal lost its editor who, despite everything, had at least tried to keep the most dangerous loons within the homeopathy cult at bay.

Now, under the new editor, this seems no longer possible. The current issue of HOMEOPATHY holds several papers about the role of homeopathy in the present pandemic:

First paper entitled ‘The COVID-19 Pandemic: A View from New York City’

This article provides a view of homeopathic clinical practice in the New York City area in the first few months of 2020 as the coronavirus disease 2019 (COVID-19) pandemic began to evolve in the United States. Key symptoms used to generate a short list of potentially curative remedies are given, and the pandemic syndrome is viewed as appearing in stages or as having various clinical manifestations each with its own main remedy. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is briefly described, as are the preliminary presenting signs and symptoms of COVID-19 infection. Several clinical examples are given, some with positive laboratory confirmation.

Second paper entitled The Hydra-Headed Coronaviruses: Implications of COVID-19 for Homeopathy

Successful homeopathic prescriptions are based on careful individualization of symptoms, either for an individual patient or collectively in the case of epidemic outbreaks. The ongoing COVID-19 pandemic was initially represented as a severe acute respiratory illness, with eventual dramatic complications. However, over time it revealed to be a complex systemic disease with manifestations derived from viral-induced inflammation and hypercoagulability, thus liable to affect any body organ or system. As a result, clinical presentation is variable, in addition to variations associated with several individual and collective risk factors. Given the extreme variability of pathology and clinical manifestations, a single, or a few, universal homeopathic preventive Do not split medicine(s) do not seem feasible. Yet homeopathy may have a relevant role to play, inasmuch as the vast majority of patients only exhibit the mild form of disease and are indicated to self-care at home, without standard monitoring, follow-up, or treatment. For future pandemics, homeopathy agencies should prepare by establishing rapid-response teams and efficacious lines of communication.

Third paper entitled The Experience of an Italian Public Homeopathy Clinic during the COVID-19 Epidemic, March-May 2020

During the COVID-19 epidemic in Italy, hospital outpatient clinics progressively decreased their activities; in March 2020 they were closed except for emergencies. During this period, the activities of the public Homeopathy Outpatient Clinic of Lucca aimed at guaranteeing therapeutic continuity to patients by means of telephone or video consultations, and searching for homeopathic medicines that best responded to early COVID-19 symptoms. In March 2020, the Complementary Medicine Working Group participated in the organization of a mission of COVID-19 Chinese experts for the online training of professionals working in the Tuscan Healthcare System. The medical staff of the Lucca Clinic also cooperated in telephone health surveillance of infected patients at home, seroprevalence investigations using the capillary blood rapid test, and the implementation of the CLIFICOL (Clinical Files Collection) project.

Why is this a regrettable development?

In my mind, there is little doubt that homeopathy has no role to play in the current pandemic. To state or imply otherwise is not just false but dangerous. It endangers the lives of millions.

Others might see it differently and argue that it is not a bad thing at all. By coming out on the side of the loons within homeopathy, the ‘flag-ship’ journal of homeopathy has done a favour to rational healthcare: it has demonstrated beyond reasonable doubt that HOMEOPATHY (both the journal and the cult) cannot be taken seriously and can therefore be safely discarded to the waste-basket of medical history.

Steiner with his wife (right) and Ita Wegman, his lover (left).

Anthroposophic medicine was founded by Steiner and Ita Wegman in the early 20th century. Currently, it is being promoted as an extension of conventional medicine. Proponents claim that “its unique understanding of the interplay among physiological, soul and spiritual processes in healing and illness serves to bridge allopathy with naturopathy, homeopathy, functional/nutritional medicine and other healing systems.” Its value has repeatedly been questioned, and clinical research in this area is often less than rigorous.

Anthroposophic education was developed in the Waldorf school that was founded by Steiner in 1919 to serve the children of employees of the Waldorf-Astoria cigarette factory in Stuttgart, Germany. Pupils of Waldorf or Steiner schools, as they are also frequently called, are encouraged to develop independent thinking and creativity, social responsibility, respect, and compassion.

Waldorf schools implicitly infuse spiritual and mystic concepts into their curriculum. Like some other alternative healthcare practitioners – for instance, doctors promoting integrative medicine, chiropractors, homeopaths and naturopaths – some doctors of anthroposophic medicine take a stance against childhood immunizations. In a 2011 paper, I summarised the evidence which showed that in the UK, the Netherlands, Austria and Germany, Waldorf schools have been at the centre of measles outbreaks due to their stance regarding immunisations.

More recently, a study evaluated trends in rates of personal belief exemptions (PBEs) to immunization requirements for private kindergartens in California that practice alternative educational methods. The investigators used California Department of Public Health data on kindergarten PBE rates from 2000 to 2014 to compare annual average increases in PBE rates between schools.

Alternative schools had an average PBE rate of 8.7%, compared with 2.1% among public schools. Waldorf schools had the highest average PBE rate of 45.1%, which was 19 times higher than in public schools (incidence rate ratio = 19.1; 95% confidence interval = 16.4, 22.2). Montessori and holistic schools had the highest average annual increases in PBE rates, slightly higher than Waldorf schools (Montessori: 8.8%; holistic: 7.1%; Waldorf: 3.6%).

The authors concluded that Waldorf schools had exceptionally high average PBE rates, and Montessori and holistic schools had higher annual increases in PBE rates. Children in these schools may be at higher risk for spreading vaccine-preventable diseases if trends are not reversed.

As the world is hoping for the arrival of an effective vaccine against the corona virus, these figures should concern us.

When I discuss published articles on this blog, I usually focus on recent papers. Not so today! Today I write about a small study we published 17 years ago. It was conducted in Canada by researchers whom I merely assisted in designing the protocol and interpreting the findings.

They trained 8 helpers to pretend being customers of health food stores. They entered individually into assigned stores; the helpers had been informed to browse in the store until approached by an employee. At this time they would declare that their mother has breast cancer. They disclosed information on their mother’s condition, use of chemotherapy (Tamoxifen) and physician visits, only if asked. The helpers would then ask what the employee recommend for this condition. They followed a structured, memorized, pretested questionnaire that asked about product usage, dosage, cost, employee education and product safety or potential for drug interactions.

The helpers recorded which products were recommended by the health food store employees, along with the recommended dose and price per product as well as price per month. Additionally, they inquired about where the employee had obtained information on the recommended products. They also noted whether the employees referred them on to SCAM practitioners or recommended that they consult a physician. Full notes on the encounters were written immediately after leaving the store.

The findings were impressive. Of the 34 stores that met our inclusion criteria, 27 recommended SCAMs; a total of 33 different products were recommended. Here are some further findings:

  • Essiac was recommended most frequently.
  • The mean cost of the recommended products per month was $58.09 (CAD) (minimum $5.28, median $32.99, maximum $600).
  • Twenty-three employees (68%) did not ask whether the patient took prescription medications.
  • Fifteen (44%) employees recommended visiting a healthcare professional; these included: naturopaths (9), physicians (5) and nutritionists (1).
  • Health food store employees relied on a variety of sources of information. Twelve employees (35%) said they had received their information from books, 5 (15%) from a supplier, 3 (9%) had formal education in SCAM, 2 (6%) had in-store training, and 12 (35%) did not disclose their sources of information.

Since our paper has been published, several other investigations have addressed similar issues. Here are a few excerpts:

But why do I mention all this today?

The answer is that firstly, I think it is important to warn consumers of the often dangerous advice they might receive in HFSs. Secondly, I feel it would worthwhile to do further research, check whether the situation has changed and repeat a similar study today. Ideally, a new investigation should be conducted in different locations comparing several countries. If you have the possibility to plan and conduct such an experiment, please drop me a line.

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