Black salve is a paste for external use made from a variable mixture of herbal and non-herbal ingredients. It usually contains bloodroot and/or chaparral and/or zinc chloride which are all ingredients that render the products corrosive. This means black salve destroys living cells that come in contact with it.
Black salve is said to originate from native American tribes who used the paste as a treatment for various conditions. It was adopted by conventional medicine during the Victorian era as a treatment for a range of skin problems, including skin cancers. When effective treatments became available, it became obsolete.
Black salve was recently re-discovered by some practitioners of so-called alternative medicine (SCAM) who now recommend it as a natural treatment for various skin conditions, including cancer. Black salve is readily available, for instance, via the Internet. Several national regulators have issued warnings to consumers not to use it. Consumers have little means of telling what is the nature, quality or strength of the black salve they might be purchasing.
No compelling evidence exists that black salve is efficacious for any condition, especially not for any type of skin cancer. Rigorous clinical trials testing its efficacy are not available. A recent review of the published evidence concluded as follows: Black salve is not a natural therapy. It contains significant concentrations of synthetic chemicals. Black salve does not appear to possess tumour specificity with in vitro and in vivo evidence indicating normal cell toxicity. Black salve does appear to cure some skin cancers, although the cure rate for this therapy is currently unknown. The use of black salve should be restricted to clinical research in low risk malignancies located at low risk sites until a better understanding of its efficacy and toxicity is developed. Where a therapy capable of harm is already being used by patients, it is ethically irresponsible not to study and analyse its effects. Although cautionary tales are valuable, black salve research needs to move beyond the case study and into the carefully designed clinical trial arena. Only then can patients be properly informed of its true benefits and hazards.
Due to its erosive nature, black salve burns away the tissue with which it comes into contact. Numerous case reports of the resulting deformations have been published., Many horrendous pictures of patients maimed by their use of black salve are available on the Internet and give a dramatic impression of the harm caused. Black salve is unquestionably a treatment that can cause considerable damage and should be regarded as unsafe. One paper concluded that it is vital that members of the public are aware of the potential effects and toxicity of commercial salve products.
In conclusion, black salve is not of proven efficacy as a treatment of any condition. It is well documented to cause much harm. Its use should be discouraged. Practitioners who employ or recommend it are, in my view, irresponsible to the extreme.
 Croaker A, King GJ, Pyne JH, Anoopkumar-Dukie S, Liu L. A Review of Black Salve: Cancer Specificity, Cure, and Cosmesis. Evid Based Complement Alternat Med. 2017;2017:9184034. doi:10.1155/2017/9184034
 Ong NC, Sham E, Adams BM. Use of unlicensed black salve for cutaneous malignancy. Med J Aust. 2014;200(6):314. doi:10.5694/mja14.00041
 Saltzberg F, Barron G, Fenske N. Deforming self-treatment with herbal “black salve”. Dermatol Surg. 2009;35(7):1152-1154. doi:10.1111/j.1524-4725.2009.01206.x
 Lim A. Black salve treatment of skin cancer: a review. J Dermatolog Treat. 2018;29(4):388-392. doi:10.1080/09546634.2017.1395795
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.  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.  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,  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. 
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.”)  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  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?  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.
 Such as from the Victoria Dept of Health at https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/ayurveda
 Health Care Complaints Act 1993 https://www.legislation.nsw.gov.au/view/html/inforce/current/act-1993-105
… The global market for alternative and complementary medicines is projected to experience substantial growth in the next few years. The rising expenditure of the healthcare facilities is considered as the major factor that is likely to encourage the growth of the overall market in the coming years. In addition, the increasing number of initiatives being taken by Governments across the globe to promote alternative and complementary medicines is projected to accelerate the market’s growth. Thanks to these factors, the global alternative and complementary medicine market is likely to exhibit a promising growth rate in the near future.
A significant rise in the number of initiatives by NGOs and government organizations to encourage the use of alternative and complementary medicines is estimated to bolster global market in the near future. In addition to this, technological advancements in this field and the rising inclination of consumers towards these medicines and practices are likely to offer lucrative growth opportunities for the leading players operating in the alternative and complementary medicine market across the globe. However, the lack of scientific results is expected to hamper the overall growth of the market in the next few years…
From a regional perspective, Europe is considered as one of the leading segment, thanks to the significant revenue contribution in the last few years. This region is expected to account for a large share of the global alternative and complementary medicine market with the rising use of botanicals. In addition to this, the increasing awareness among consumers regarding the availability of effective alternative and complementary medicines and the benefits they offers are expected to encourage the growth of the Europe market in the coming years.
Furthermore, with the rising popularity of medical tourism, the alternative and complementary medicine market in Asia Pacific is projected to witness a steady growth in the next few years. Moreover, the presence of a large number of new players operating in this region is likely to offer promising growth opportunities over the forecast period. The Middle East and Africa segment is anticipated to experience a healthy growth in the alternative and complementary medicine market in the near future.
The global market for alternative and complementary medicines is presently at a highly competitive stage and is predicted to experience an intense level of competition among the leading players in the coming years. The prominent players in the market are focusing on the expansion of the product portfolio so as to attract a large number of consumers across the globe. This is likely to help them in creating a brand name and acquiring a leading position in the global market. Some of the leading players operating in the alternative and complementary medicine market across the globe are Herb Pharm, Yoga Tree, Quantum Touch Inc., Helio USA Inc., Pure encapsulations, Inc., Pacific Nutritional Inc., Deepure Plus, Herbal Hills, Iyengar Yoga Institute, The Healing Company, and Nordic Naturals.
Yes, I know, this is little more than hot air mixed with platitudes and advertisements to purchase the full report. I used to buy such documents for my department and research but was invariably disappointed. They provide are expensive and of very little of value.
Yet, one thing has been confirmed over the years: the prediction of steady growth of the SCAM-industry is rarely wrong (certain sections, such as homeopathy, have been shrinking in some regions, but the industry as a whole is financially healthy). The scientific evidence seems to get less and less convincing, yet consumers buy more and more of these products. They may do little good and have the potential to cause quite a bit of harm, but consumers continue to waste their money on them.
The question is: why?
There are, of course, many reasons. An important one is that the gullible public wants to believe in SCAM, and the SCAM-industry is highly skilled in misleading us. What is worse: many governments, instead of limiting the damage, are mildly or even overtly supportive of the SCAM-industry.
Whenever I contemplate this depressing state of affairs, I realise that my blog is important. It is only a drop in the ocean, I know, but still…
We probably all think we know what is meant by ‘pseudo-science’. But, in fact, the more you think about it, the less certain you are likely to become. Many very smart people have tried shed some light on this question and, in the end, had to admit that it is far from clear.
In his book ‘Decision Making and Rationality in the Modern World‘, Keith Stanovich makes a fresh attempt to tackle the problem. Here is a list of criteria that he deems important:
• The use of psychobabble – words that sound scientific, but are used incorrectly, or in a misleading manner. For example, “energy therapies” for psychological problems are often premised on biofeedback, meridian lines, quantum energies, and a host of other concepts that may sound impressive, but lack evidence.
• A substantial reliance on anecdotal evidence. Evidence for pseudoscience is typically anecdotal and consequently difficult to verify. For a class example, instructors may want to show students the Q-Ray bracelet website 1 and read the many quotes submitted by Q-Ray users. Although the quotes sound compelling, there is no scientific evidence to support any claims attached to them. In fact, the Q-Ray company lost a lawsuit in 2011 and was ordered to refund over $11 million dollars to people who purchased a Q-Ray bracelet.
• Extraordinary claims in the absence of extraordinary evidence (Truzzi, 1978; Sagan, 1995). In pseudosciences, assertions are often highly implausible in light of existing knowledge yet are not backed by convincing evidence. For a class example, instructors may wish to describe how infomercials promoting Q-Ray bracelets state that the “bracelet rips [pain] right out of the body 2.” and are “designed to optimize your natural positive energy 1.”
• Unfalsifiable claims – Most pseudoscientific claims are incapable of being refuted in principle. For example, proponents of traditional Chinese medicine (TCM) believe the human body has an invisible energy force called Qi (Zollman and Vickers, 1999). Qi is a crucial component of TCM, even though it cannot be measured or tested scientifically.
• An absence of connectivity to other research (Stanovich, 2010). Connectivity refers to the extent to which assertions build on extant knowledge. For example, homeopathic practitioners state that homeopathic treatments become stronger as they become more dilute, and that water has memory. Both of these claims run counter to established scientific knowledge (Singh and Ernst, 2008).
• Absence of adequate peer review. Peer review is far from perfect, but it is a key safeguard against error. Instructors may wish to encourage students to contrast the claims advanced by the authors of peer-reviewed versus non-peer-reviewed articles.
• Lack of self-correction. Pseudosciences frequently persist despite refutation. Often, proponents of pseudoscience will use the idea that since the treatment or idea has been used for thousands of years it must be correct (e.g., astrology), an error often called the ad antiquetem fallacy (or, argument from antiquity).
Yes, I know, nothing fundamentally new here. Nonetheless, I thought the list was thought-provoking, particularly as it harps back to themes which we have discussed regularly on this blog. Stanovich’s list is certainly not comprehensive. Feel free, if you think you can add new aspects to the features that characterise pseudoscience.
It would be interesting, I thought, to get some information on what type of books on so-called alternative medicine (SCAM) are being most frequently sold and read in different countries. In particular, it would be relevant to see how many of them are books that one might recommend.
But how would one go about researching this?
The simplest solution, I guessed, would be to go on the Amazon sites of various countries and have a look. And that’s precisely what I did a few days ago. I decided to scan the first 100 books that are listed under ‘alternative medicine’ and pick out the ones that are non-promotional, factual or critical. I did this little research in 4 countries: USA, UK, France and Germany.
Here are my findings:
Not one of the 100 books seems to offer a critical assessment of SCAM. That means the percentage of what I might call recommendable books (books that do not promote unproven or disproven SCAMs to the unsuspecting public) seems to be precisely zero.
On place 6, I was delighted to find my recent book Alternative Medicine: A Critical Assessment of 150 Modalities. On place 14 was You Are the Placebo: Making Your Mind Matter. And on place 70 Trick or Treatment?: Alternative Medicine on Trial.
That makes the percentage 3.
Surprisingly, there are hardly any books in French listed in the SCAM category. Place 4 is my SCAM: So-Called Alternative Medicine, place 7 More Harm than Good?: The Moral Maze of Complementary and Alternative Medicine, place 9 Trick or Treatment: The Undeniable Facts about Alternative Medicine, and place 64 Killing Us Softly: The Sense and Nonsense of Alternative Medicine.
The percentage is thus 4.
Not a single book met the inclusion criteria which makes the percentage a proud zero.
In 1998, we assessed for the first time books on SCAM ( Int J Risk Safety Med 1998, 11: 209-215. [the article is not Medline-listed]). We chose a random sample of 6 such books published in 1997, and assessed their contents according to pre-defined criteria. The findings showed that the advice given in these volumes was frequently misleading, not based on good evidence and often inaccurate. If followed, it would have caused significant harm to patients.
In 2006, we conducted a similar investigation which we then reported in the first and second editions of our book THE DESKTOP GUIDE TO COMPLEMENTARY AND ALTERNATIVE MEDICINE (now out of print, but the German and French translations are still available, I think). This time, we selected 7 best-sellers in SCAM and scrutinised them in much the same way. Our findings showed that almost every form of SCAM was recommended for almost every condition. There was no agreement between the 7 books which SCAM might be effective for which condition. Some treatments were even named as indications for a certain condition in one book, while, in other books, they were listed as contra-indications for the same problem. A bewildering plethora of treatments was recommended for most conditions, for instance:
- addictions: 120 different SCAMs
- arthritis: 131 different SCAMs
- asthma: 119 different SCAMs
- cancer: 133 different SCAMs
- etc. etc.
Even though, it included a much larger range of SCAM books, I do not consider my new investigation into this area to be a reliable piece of research. There are many reasons why, it can provide merely a very rough impression, e.g.:
- The lists included lots of misclassifications, i. e. books that have nothing to do with SCAM.
- Nobody seems to know by what rank order Amazon lists these books; I had hoped that it would be by sales figures, but I am not sure that this is so.
- Amazon is just one of many book sellers.
- My categorising can be criticised for being highly subjective.
Nonetheless, this little exercise, together with my previous research, might tell us something valuable after all. There are now between 30 000 and 60 000 SCAM books listed on the national Amazon sites, and even the most useless forms of SCAM are thus being promoted as though they were evidence-based forms of healthcare. Consumer demand for SCAM books is evidently substantial. The vast majority of these books are dangerously uncritical.
I believe that consumers deserve better.
The definitions of a quack as used in healthcare vary somewhat:
- ignorant, misinformed, or dishonest practitioner of medicine
- untrained person who pretends to be a physician and dispenses medical advice and treatment
- people who claim to be skilled in medicine but are not
- person who dishonestly pretends to have medical skills or knowledge
- one who misrepresents ability and experience in diagnosis and treatment of disease or the effects to be achieved by treatment
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? 
Professor Edzard Ernst, a retired German  physician and academic, has recently  become a prominent advocate of plans that could potentially outlaw  the entire profession of naturopathic doctors  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” . Tellingly, however, given that he himself has seemingly not published even so much as one completely original scientific trial of his own , 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 .
- 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)
- I am German-born, became an Austrian citizen in 1990, and since 2000 I am a British national.
- I have been critical about the German ‘Heilpraktiker’ for more than 20 years.
- This refers to the recent ‘Muensteraner Memorandum’ which is the work of an entire team of multidisciplinary experts and advocates reforming this profession.
- ‘Heilpraktiker’ are certainly not doctors; they have no academic or medical background.
- This is correct, and I stand by my statement that educating people in vitalism and other long-obsolete concepts is pure nonsense.
- 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.
- 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‘?
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.
Random double-blind placebo-controlled study
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.
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.
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:
- 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.
- 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).
- Why was it never properly published?
- Could it be because there was no ethics approval [none was mentioned in the LTTE]?
- Could it be because there was no informed consent [none was mentioned in the LTTE]?
- 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.
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
My new book has just been published. Allow me to try and whet your appetite by showing you the book’s introduction:
“There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking.” These words of Fontanarosa and Lundberg were published 22 years ago. Today, they are as relevant as ever, particularly to the type of healthcare I often call ‘so-called alternative medicine’ (SCAM), and they certainly are relevant to chiropractic.
Invented more than 120 years ago by the magnetic healer DD Palmer, chiropractic has had a colourful history. It has now grown into one of the most popular of all SCAMs. Its general acceptance might give the impression that chiropractic, the art of adjusting by hand all subluxations of the three hundred articulations of the human skeletal frame, is solidly based on evidence. It is therefore easy to forget that a plethora of fundamental questions about chiropractic remain unanswered.
I wrote this book because I feel that the amount of misinformation on chiropractic is scandalous and demands a critical evaluation of the evidence. The book deals with many questions that consumers often ask:
- How well-established is chiropractic?
- What treatments do chiropractors use?
- What conditions do they treat?
- What claims do they make?
- Are their assumptions reasonable?
- Are chiropractic spinal manipulations effective?
- Are these manipulations safe?
- Do chiropractors behave professionally and ethically?
Am I up to this task, and can you trust my assessments? These are justified questions; let me try to answer them by giving you a brief summary of my professional background.
I grew up in Germany where SCAM is hugely popular. I studied medicine and, as a young doctor, was enthusiastic about SCAM. After several years in basic research, I returned to clinical medicine, became professor of rehabilitation medicine first in Hanover, Germany, and then in Vienna, Austria. In 1993, I was appointed as Chair in Complementary Medicine at the University of Exeter. In this capacity, I built up a multidisciplinary team of scientists conducting research into all sorts of SCAM with one focus on chiropractic. I retired in 2012 and am now an emeritus professor. I have published many peer-reviewed articles on the subject, and I have no conflicts of interest. If my long career has taught me anything, it is this: in the best interest of consumers and patients, we must insist on sound evidence; not opinion, not wishful thinking; evidence.
In critically assessing the issues related to chiropractic, I am guided by the most reliable and up-to-date scientific evidence. The conclusions I reach often suggest that chiropractic is not what it is often cracked up to be. Hundreds of books have been published that disagree. If you are in doubt who to trust, the promoter or the critic of chiropractic, I suggest you ask yourself a simple question: who is more likely to provide impartial information, the chiropractor who makes a living by his trade, or the academic who has researched the subject for the last 30 years?
This book offers an easy to understand, concise and dependable evaluation of chiropractic. It enables you to make up your own mind. I want you to take therapeutic decisions that are reasonable and based on solid evidence. My book should empower you to do just that.
Alcohol-related hangover symptoms such as nausea, headache, stress and anxiety cause a considerable amount of harm and economic loss. Several so-called alternative medicines (SCAMs) are being recommended to alleviate hangovers. But, according to our systematic review, none has been shown to be convincingly effective:
Objective: To assess the clinical evidence on the effectiveness of any medical intervention for preventing or treating alcohol hangover.
Data sources: Systematic searches on Medline, Embase, Amed, Cochrane Central, the National Research Register (UK), and ClincalTrials.gov (USA); hand searches of conference proceedings and bibliographies; contact with experts and manufacturers of commercial preparations. Language of publication was not restricted.
Study selection and data extraction: All randomised controlled trials of any medical intervention for preventing or treating alcohol hangover were included. Trials were considered if they were placebo controlled or controlled against a comparator intervention. Titles and abstracts of identified articles were read and hard copies were obtained. The selection of studies, data extraction, and validation were done independently by two reviewers. The Jadad score was used to evaluate methodological quality.
Results: Fifteen potentially relevant trials were identified. Seven publications failed to meet all inclusion criteria. Eight randomised controlled trials assessing eight different interventions were reviewed. The agents tested were propranolol, tropisetron, tolfenamic acid, fructose or glucose, and the dietary supplements Borago officinalis (borage), Cynara scolymus (artichoke), Opuntia ficus-indica (prickly pear), and a yeast based preparation. All studies were double blind. Significant intergroup differences for overall symptom scores and individual symptoms were reported only for tolfenamic acid, gamma linolenic acid from B officinalis, and a yeast based preparation.
Conclusion: No compelling evidence exists to suggest that any conventional or complementary intervention is effective for preventing or treating alcohol hangover. The most effective way to avoid the symptoms of alcohol induced hangover is to practise abstinence or moderation.
However, now we have new data; do they change our conclusion?
The aim of this study is to investigate the effect of the amino acid L-cysteine (an amino acid that is contained in most high-protein foods) on the alcohol/acetaldehyde related aftereffects. Voluntary healthy participants were recruited through advertisements. Volunteers had to have experience of hangover and/or headache. The hangover study was randomized, double-blind and placebo-controlled. Nineteen males randomly swallowed placebo and two differently dosed L-cysteine tablets. The alcohol dose was 1.5 g/kg, which was consumed during 3 h. The study involved 6 drinking sessions on subsequent Friday evenings which all started around 7pm and finished at 10pm.
The primary results based on correlational analysis showed that L-cysteine prevents or alleviates hangover, nausea, headache, stress and anxiety. For hangover, nausea and headache the results were apparent with the L-cysteine dose of 1200 mg and for stress and anxiety already with the dose of 600 mg.
The authors concluded that L-cysteine would reduce the need of drinking the next day with no or less hangover symptoms: nausea, headache, stress and anxiety. Altogether, these effects of L-cysteine are unique and seem to have a future in preventing or alleviating these harmful symptoms as well as reducing the risk of alcohol addiction.
The study was conducted in Finland where excessive drinking is apparently not a rarity. According to the study protocol, an 80kg man would have to drink 15 units of alcohol at 6 weekly occasions. This is an impressive amount, and one might wonder about the ethical implications of such a study.
More crucially, one might wonder whether the sample size was sufficiently large to draw such definitive conclusions. Looking at the graphs, it is easy to see that the average effects were determined by just a few data points. Personally, I would therefore feel uncomfortable with these conclusions and insist on further research before issuing far-reaching recommendations.
My discomfort would increase significantly considering that the sponsor of the study was the manufacturer of the L-cysteine supplement being tested, Catapult Cat Oy.
Misinformation seems to be everywhere and perhaps nowhere more intense than in so-called alternative medicine (SCAM). Correcting it is one of the main reasons/ambitions of this blog. But are such activities effective?
A meta-analysis estimated the efficacy of correcting health-related misinformation on social media. To better understand the causal relationship between exposure to corrective messages on social media and subsequent effects on health-related outcomes, the researchers restricted the meta-analysis to experimental studies that attempted to debunk health misinformation.
The findings indicate that correction can often mitigate the influence of misinformation but the size of the effect is usually small to moderate. The pooled effect was comparable with previous meta-analyses that focused on the correction of misinformation in contexts such as crime, politics, and science. The results provide no evidence of a so-called “boomerang” or backfire effect, whereby attempts to correct misinformation can unintentionally increase people’s acceptance of the falsehood.
The authors concluded that, although there is still much to be learned, the current study’s results are cause for optimism. The vast majority of corrective interventions are at least somewhat successful in diminishing the impact of misinformation, and our findings regarding moderating factors should inform future research into designing effective countermeasures. The continued efforts of the broader research community will only further refine our understanding of best practices to address the threat presented by health misinformation on social media.
What better motivator to carry on?