Ever since I published a post about the irresponsible and aggressive advertising campaign of LYMA (“the world’s 1st super-supplement”), I am pursued by them with emails informing me about the wonders of this supplement. Here is one I received recently:
Here at LYMA we are firm believers that optimal productivity depends on good quality sleep and your day is only as good as the previous night.
Suffering from bad sleep is debilitating whether it’s ourselves or we’re watching someone we love suffer, the search for good rest is something we’re all united in.
Energy levels, positive mindset and strong cognitive function all come from sleep, which is why we spent so long formulating the LYMA supplement. Our patented KSM-66® Ashwagandha is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world. The hefty combination of purity and potency make it unrivalled in its ability to reduce inflammation, neutralise anxiety and promote deep, restful sleep, night after night.
Thousands of customers have told us that after years of bad sleep, they’re finally getting the rest they need and feeling transformed as a result. In fact, it’s one of the very first benefits most people notice. We’re happy to hear it.
And the knock-on effects of a good night’s sleep in how we feel, how we perform and our overall health are far reaching. Which is why we are so delighted to welcome Michael Grandner, world-renowned sleep expert and Director of the Behavioural Sleep Medicine Clinic, Arizona to the LYMA team.
Michael is one of the most cited sleep experts in the world and has himself published over 175 articles on issues relating to sleep and health. We plan on tapping into every area of his expertise to understand our own sleep habits and how we can all become the best at rest.
To introduce Michael to the LYMA community we’re hosting a seminar dedicated to understanding sleep on Tuesday 22nd June…
I was tempted to discard all this as rather pathetic advertising hype. But then I had second thoughts. This text does after all make several medical claims, and the question is: ARE THEY SUPPORTED BY EVIDENCE?
It claims that KSM-66® Ashwagandha:
- is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world.
- That the hefty combination of purity and potency makes it unrivalled in its ability to reduce inflammation.
- That the product neutralises anxiety.
- That it promotes deep, restful sleep, night after night.
I ran a few searches to find out whether there is any sound evidence for any of these claims.
- There seem to be several supplements that contain,KSM-66® Ashwagandha’. The impression that LYMA is the only one is thus wrong. Zero toxicity must also be wrong; not even water has zero toxicity. In fact, epigastric pain/discomfort and loose stools were reported as most common (>5%); and giddiness, drowsiness, hallucinogenic, vertigo, nasal congestion (rhinitis), cough, cold, decreased appetite, nausea, constipation, dry mouth, hyperactivity, nocturnal cramps, blurring of vision, hyperacidity, skin rash and weight gain have all been associated with the herbal remedy. Moreover, if it is true that Ashwagandha stimulates the immune system, it might cause problems for people with autoimmune diseases.
- I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha reduces inflammatory conditions in humans.
- I found a study concluding that Ashwagandha given as an adjunct offered some potential advantages as a safe and effective adjunctive therapy to SSRIs in GAD. Yet, I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha as a single supplement reduces anxiety in otherwise healthy individuals.
- A 2021 study suggested that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Yet the authors cautioned that additional clinical trials are required to generalize the outcome.
So, what does that tell us?
It could mean that:
- My searches were not sufficiently thorough and that I have missed compelling evidence. If so, I would appreciate, if the LYMA promoters would show me their evidence so that I can assess it.
- The LYMA people are irresponsible and mislead the public with untenable claims.
I am looking forward to their response.
By guest blogger Michael Scholz
For several years, the “flower essences” invented by Dr. Edward Bach had a difficult time in the European Union and especially Germany. The manufacturers were regularly taken to court for violating the EU Health Claim Regulation. This now culminates in the fact that the manufacturer, Nelsons, who sells the “Original Bach Flowers” in Germany, was forced to rename its popular “Rescue” remedies.
The “Rescue” remedies were promoted with statements such as “calm and strong through the day” and “recommended use in emotionally exciting situations, e.g. at work” or to “face emotional challenges”. The competitor, Annoyax Nutripharm, regarded this as a health-related statement that is prohibited according to the EU Health Claim Regulation. Since the “Bach Flower Remedies” are not considered to be medicinal products in Germany, they are treated as food supplements, according to a ruling by the Oberlandesgericht (Higher Regional Court) Hamburg in 2007.
As it is strictly forbidden to advertise food supplements with health-related claims that are unproven, Annoyax Nutripharm filed a lawsuit against Nelsons that all the way to the Bundesgerichtshof (Federal High Court of Justice) in Karlsruhe. Since the case concerned European law, the judges in Karlsruhe referred it to the European Court of Justice in Luxemburg.
The judges wanted two questions clarified: 1. Are the “Rescue” remedies to be regarded simply as Brandy due to their alcohol content of 27%? (in which case, health-related claims would be strictly forbidden). 2. Does the product’s name “Rescue” itself constitute a violation of the Health Claims Regulation?
The Luxemburg judges ruled “No” and “Yes”. “No”, it is not Brandy, although the „essences“ consist of a considerable quantity of alcohol, the recommended dose is too small to be intoxicating. But “Yes”, the term “Rescue” does indeed violate the Health Claim Regulation. So the plaintiff won – and what is the result?
When the Health Claims Regulation was enacted in 2005, a transition period until 2022 was established. This applied to all products that were sold using the same brand name and composition before 2005. This now gave the defendant – Nelsons – the opportunity to use Edward Bach’s 135th anniversary for launching an advertising campaign that praises the court-ordered renaming as „modernization“ for the 21st century. And as you see, the new name is a paragon of creativity, innovation & modernism, indeed (//irony:off): “Rescue” becomes – drum roll – “Rescura”. Yes, I looked just like that too…
This pyrrhic victory for the plaintiffs shows how important it is to protect the European citizens against misleading advertising. And – far more important – it is now established through a ruling of the Federal High Court of Justice that “Bach Flowers” are an esoterical concept devoid of medical evidence.
We live in truly grim times! Let me therefore try to cheer you up a little. Here is a story that might make you smile.
In 1981, I moved back from London to Munich. While still in London, I had written an article on garlic for a German medical journal. It was published just as we arrived in our new home. Here is it’s English abstract:
Garlic has had a firm place in folk medicine since ancient times. More recent results are summarized here which show that extracts of the plant have an antimicrobial action, they are capable of lowering blood cholesterol and of reducing secondary vascular changes. They raise fibrinolytic activity and inhibit thrombocyte aggregation. Therefore the plant contains highly active therapeutic principles which appear to be particularly suitable for prophylaxis of arteriosclerosis.
Yes, you are quite right, this paper is nothing to write home about. So, why do I consider it ‘most consequential‘? Here is what happened:
My wife and I had barely arrived in our new home, when a man phoned (he had gone to a lot of trouble to find my number) and said: “I know you are the leading expert on garlic; I urgently need to talk to you”. Never correct a man’s mistake, if it’s in your favour, I thought, and we made an appointment for a meeting at the Munich train station hotel.
When I met him a few days later, he ordered me a coffee (which later I had to pay for) and explained that he had worked his whole life (he was about 50, I guessed) for the pharmaceutical industry and had now decided that this was enough. He thus planned to set up his own pharmaceutical company. He already had a photocopy machine in his basement, he proudly told me, and a wife who was willing to work as hard as he was. Specifically, his plan was to launch a garlic pill, and for that he needed my advice. I told him what he wanted to know, and we parted after about two hours promising to stay in contact.
The man’s name was Kuno Lichtwer.
During the weeks that followed, he often phoned me to pick my brain. One day, he told me that he had everything in place: he had found a supplier of the materials, a manufacturer to produce the pills and even registered a name for it:
Then he popped the question that was foremost on his mind: ‘What do you think, Dr Ernst, should I risk it and go ahead with this or not?’. I had started to like that man; he was going to lose all his savings on a crazy idea, I felt. So, I told him: ‘If I were you, I would not do it. There are already plenty of garlic pills on the market. You are risking to lose everything.’ Then there was a long pause; eventually, he thanked me for my honest advice and hung up.
Weeks later he phoned again to tell me that he had truly appreciated my brutally direct advice, thought long and hard about it, but went ahead with his plan anyway. Would I now accept the position of ‘medical advisor’ to Lichwer Pharma? I was surprised, but accepted this new post. Thereafter, I advised him the best I could. We even conducted and published the very first clinical trial with his product. It was a rather flimsy study (we had no funds at all), but did suggest a positive result.
Each time Mr Lichtwer called me, he was elated; things were not just going well, they were booming! He was evidently hugely gifted in promoting KWAI. Then he invited me several times to come to Berlin where Lichtwer Pharma was based for business meetings. Proudly, he showed me that meanwhile his firm had moved out of his basement into a proper building. The next I knew was that he had a dozen employees. Lichtwer seemed unstoppable. This went on for 2 or 3 years, if I remember correctly.
During all this time, we had never talked about money, and my work for him had always been unpaid – that is, until one day just before Christmas he phoned and explained that he had moved his firm to yet a bigger building and hired yet more staff. He also realised that I deserved some renumeration for my advice; therefore, he had put a cheque in the post. When I told my wife about it, we both celebrated in anticipation of the substantial windfall. Two days later, his letter arrived. He very kindly thanked me for years of work and included a cheque of 500 DM (about 150 DM per year of work). A few months later, his firm had grown so big that a full time medical and research director was badly needed. He informed me that he had found a highly experienced expert and invited me to meet the new man, Prof Schulz.
No, I did not feel hard done by! On the contrary, I was happy that my prediction had been grossly wrong and that my friend Kuno was doing so well. In addition, I was also relieved, because my research at the University did not give me nearly enough time to look adequately after the now substantial firm of Lichtwer Pharma.
Thereafter, Lichtwer’s garlic pill went from strength to strength. Several larger studies confirmed our initial results that garlic positively influenced blood lipids (in 2000, our systematic review concluded: The available data suggest that garlic is superior to placebo in reducing total cholesterol levels. However, the size of the effect is modest, and the robustness of the effect is debatable. The use of garlic for hypercholesterolemia is therefore of questionable value). One day, I read somewhere that KWAI had become the most consumed pill in Germany (even beating Aspirin). Then Lichtwer Pharma went international and added several further herbal products to its portfolio. In 1991, Lichtwer Pharma was estimated to be worth 100 Million DM. Several years later, the firm had almost 400 employees and a yearly turnover of 353 Million DM.
To his credit, Kuno Lichtwer never entirely forgot me. When I had moved to the UK, he even came to Exeter, was entertained by my University, and made a donation of £100 000 towards a ‘Lichtwer Research Fellowship’ for my department. I am not sure whether Kuno Lichtwer is still alive. If he is, he would probably agree that, had I offered him 10 000 DM of my savings during our 1st meeting in 1981 (he did hint at that possibility), he would have gladly made me a partner in his enterprise.
But, as they say: money is not everything.
And a good story to tell is also not bad.
This study assessed the patterns of dietary supplement usage among cancer survivors in the United States in a population-based setting. National Health and Nutrition Examination Survey (NHANES) datasets (1999-2016) were accessed, and adult respondents (≥ 20 years old) with a known status of cancer diagnosis and a known status of dietary supplements intake were included. Multivariable logistic regression analysis was then used to assess factors associated with dietary supplements intake. Moreover, and to evaluate the impact of dietary supplements on overall survival among respondents with cancer, multivariable Cox regression analysis was conducted.
A total of 49,387 respondents were included in the current analysis, including a total of 4,575 respondents with cancer. Among respondents with cancer, 3,024 (66.1%) respondents reported the use of dietary supplements; while 1,551 (33.9%) did not report the use of dietary supplements. Using multivariable logistic regression analysis, factors associated with the use of dietary supplements included:
- older age (OR: 1.028; 95% CI: 1.027-1.030);
- white race (OR for black race vs. white race: 0.67; 95% CI: 0.63-0.72);
- female gender (OR for males vs. females: 0.56; 95% CI: 0.53-0.59),
- higher income (OR: 1.13; 95% CI: 1.11-1.14),
- higher educational level (0.59; 95% CI: 0.56-0.63),
- better self-reported health (OR: 1.36; 95% CI: 1.17-1.58),
- health insurance (OR: 1.35; 95% CI: 1.27-1.44),
- history of cancer (OR: 1.20; 95% CI: 1.10-1.31).
Using multivariable Cox regression analysis and within the subgroup of respondents with a history of cancer, the use of dietary supplements was not found to be associated with a difference in overall survival (HR: 1.13; 95% CI: 0.98-1.30).
The authors concluded that dietary supplement use has increased in the past two decades among individuals with cancer in the United States, and this increase seems to be driven mainly by an increase in the use of vitamins. The use of dietary supplements was not associated with any improvement in overall survival for respondents with cancer in the current study cohort.
Many cancer patients, when they first get diagnosed, are tested for vitamin D levels and found to be low or borderline. Consequently, they get a prescription for supplements. Other than this, there is rarely an indication to take any vitamins or other dietary supplements. Yet, cancer patients take them because they think these ‘natural’ preparations can do no harm (and because the industry can be persuasive [there is big money at stake] and the odd breed of ‘integrated’ oncologists might even recommend them). Sadly, this assumption is not correct. The biggest danger, in my view, is the possibility of supplements to interact with one of the many drugs that cancer patients need to take. So, in a way, it is reassuring that, on average, there is no detrimental effect on overall survival.
The paper will probably also reignite the perennial discussion about the effects of vitamin C on the natural history of cancer. My understanding is that there is none (and this verdict seems to be supported by the findings reported here). But I am, of course, aware that this is a ‘hot potato’ and that some readers will think differently. To them I say: please show me the evidence.
I have to thank one of our regular commentators for inspiring me to write this post. He recently contributed this insight about homeopathic provings:
If you didn’t experience anything from a proving you didn’t perform it properly.
It is an argument that, in different forms and shapes, I have heard very often. Essentially it holds that, if an investigation or a test fails to produce the desired result, the methodology must have been faulty. Donald Trump is, I fear, about to use it in the upcoming US election: if he is voted out, he will claim that there was too much fraud going on. Therefore, he cannot accept the result as valid. Thus it is his democratic duty to remain in post, he is likely to claim.
In medicine, the argument has been popular since millennia. In our book TRICK OR TREATMENT?, we recount the story of blood letting. Based on the doctrine of the 4 humours, it was believed for centuries to be a panacea. If someone died after losing litres of blood to the believers in the doctrine, the assumption was not that he had been bled to death, but that he had sadly not received enough of the ‘cure all’. Eventually, some bright chap had the novel idea of running a rigorous test of blood-letting, and it turned out that the patients who had received the treatment had a worse chance of survival than those who had escaped it. Aaaahhh !!!, shouted the blood-letters, this shows that the concept of the scientific test is flawed.
Checking the methodological rigour of clinical studies (or homeopathic provings) can be a tricky and tedious business. It requires proper learning and experience – qualities that SCAM fanatics rarely possess. Amongst other things, one needs to know about:
- trial design,
- sources of bias,
- and the many tricks people use to hide flaws in published studies.
This is not easy and it takes time – lots of time – to acquire the necessary skills. Having discussed such issues with enthusiasts of so-called alternative medicine (SCAM) for decades, I realise that it would be unrealistic to expect of them to spend all this time learning all these complicated things (they have to make a living, you know!). I therefore propose an entirely new and much simpler method of differentiating between valid and invalid research of SCAM. It rests on merely 2 golden rules:
- Any research methodology is valid, if it produces the desired result.
- Any research methodology is invalid, if it fails to produce the desired result.
In analogy to these two rules, one can easily extrapolate further. For instance, one can state that:
- any person who generates or promotes the desired result is honest;
- any person who contradicts the desired result is corrupt (bought by ‘Big Pharma’).
I am sure my readers all see the beauty of this revolutionary, new system: it’s easy to learn, practical to apply, it avoids controversy and it takes full account of the previously much-neglected needs of the SCAM fraternity.
Recently, I have received this message via the comments section of my blog:
“you’re actually an evil old nut-job Ed—been following your pharma ‘science’ bullshit for years—all opinion and ignorance and anti-science”
Don’t get me wrong, such attacks do not bother me – not any more. On the contrary, they amuse me. At one stage, I even started collecting them. Nowadays, I usually ignore them.
But this one is somewhat special. Therefore, I decided to analyse it a bit. The author essentially makes 9 claims:
- I am evil.
- I am old.
- I am a nut-job.
- I am called Ed.
- I conduct pharma science.
- I publish bullshit.
- All I state is opinion.
- I am ignorant.
- I am anti-science.
Yes, that’s quite a list. Let me try to tackle it one by one.
- Am I evil? I have had many ad hominem attacks before but, as far as I remember, nobody has yet alleged that I am evil. I looked it up, evil means: wicked · bad · wrong · morally wrong · wrongful · immoral · sinful · ungodly · unholy · foul · vile · base · ignoble · dishonorable · corrupt · iniquitous · depraved · degenerate · villainous · nefarious · sinister · vicious · malicious · malevolent · demonic · devilish · diabolic · diabolical · fiendish · dark · black-hearted · monstrous · shocking · despicable · atrocious · heinous · odious · contemptible · horrible · execrable · lowdown · stinking · dirty · shady · warped · bent · crooked · dastardly · black · egregious · flagitious · peccable. I am obviously the wrong person to judge, but I do not think that these attributes describe me all that well.
- Yes, I am old, 72 to be precise.
- Am I a nut-job? I looked that one up too. It’s a mentally unbalanced person. Call me biased, but I don’t think that this applies to me at all.
- No, I am not called Ed.
- I am not quite sure what ‘pharma science’ is supposed to mean, but one thing I do know for sure: since I research so-called alternative medicine (SCAM) – and that’s about 30 years now – I have not taken research funds from the pharmaceutical industry. And before I very rarely did.
- As I have published a sizable amount of papers and blog-posts, there must have been a bit of BS in some of it. But I do not think it can be much.
- All I state is opinion? Oh really! Opinion comes into blog-posts regularly; without it my stuff would be boring like hell. But ALL of it? I don’t think so.
- Am I ignorant? Yes, certainly; there are lots of things I don’t know, even in medicine. But in SCAM I do know quite a bit – even if I say so myself.
- Anti-science? That last allegation is probably the most far-fetched of them all. No, I am not anti-science, never have been and never will be.
So, Paul – the author of the comment preferred to remain anonymous and simply calls himself Paul – I have tried to give you credit where I could but, on the whole, I fear your ad hominem attack is yet another victory of reason over unreason. I thank you Paul for two reasons:
- firstly for the just-mentioned victory; it always feels good to be on a winning side,
- secondly for the stimulus and motivation to carry on doing what I have been doing for many years; your comment has shown me how much needed my work is in disclosing quackery, correcting errors, teaching critical thinking and responsibly informing the public.
… 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…
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
He is biased against it!
He cherry-picks the evidence!
He does not understand homeopathy!
If you are one of the many who believe such notions, please read on.
The website of the NHS England has a fairly detailed account of homeopathy. Here is the section entitled ‘What can we conclude from the evidence?‘ – but I recommend reading the full text:
There have been several reviews of the scientific evidence on the effectiveness of homeopathy.
The House of Commons Science and Technology Committee said there’s no evidence that homeopathy is effective as a treatment for any health condition.
There’s no evidence behind the idea that substances that cause certain symptoms can also help treat them.
Nor is there any evidence behind the idea that diluting and shaking substances in water can turn those substances into medicines.
The ideas that underpin homeopathy aren’t accepted by mainstream science, and aren’t consistent with long-accepted principles on the way the physical world works.
The Committee’s 2010 report on homeopathy said the “like cures like” principle is “theoretically weak”, and that this is the “settled view of medical science”.
For example, many homeopathic remedies are diluted to such an extent that it’s unlikely there’s a single molecule of the original substance remaining in the final remedy. In cases like these, homeopathic remedies consist of nothing but water.
Some homeopaths believe that, as a result of the succussion process, the original substance leaves an “imprint” of itself on the water. But there’s no known mechanism by which this can occur.
The 2010 report said: “We consider the notion that ultra-dilutions can maintain an imprint of substances previously dissolved in them to be scientifically implausible.”
Some people who use homeopathy may see an improvement in their health condition as the result of a phenomenon known as the placebo effect.
If you choose health treatments that provide only a placebo effect, you may miss out on other treatments that have been proven to be more effective.
Since 1948, homeopathy had been part of the NHS, there were 5 homeopathic NHS hospitals, and the costs for homeopathy were covered. Why would the NHS decision makers suddenly turn against it? They must have loved homeopathy for at least 4 reasons:
- It is inexpensive.
- It has support in high places.
- It did not cause any direct harm.
- It had many supporters who fought tooth and nail for it.
It is therefore hardly reasonable to assume that the NHS is biased against homeopathy. But, why do they now say that it is
- not effective beyond placebo,
- and can cause harm by making people miss out on effective therapies?
The answer is simple: BECAUSE THESE STATEMENTS ARE IN ACCORDANCE WITH THE OVERWHELMING MAJORITY OF THE BEST EVIDENCE AVAILABLE TO DATE.
So, here you are: the NHS now confirms what I (and many other experts) have been saying since years. And we all insist on the fact that this not because we are biased, stupid, uninformed, paid by BIG PHARMA, or want to deprive anyone of anything. We do it for one reason only:
BECAUSE IT’S THE TRUTH!
The purpose of this feasibility study was to:
(1) educate participants about the concept of Reiki,
(2) give participants the opportunity to experience six Reiki therapy sessions and subsequently assess outcomes on chronic pain,
(3) assess participants’ impression of and willingness to continue using and recommending Reiki therapy as adjunct for the treatment of chronic pain.
Using a prospective repeated measures pre- and postintervention design, a convenience sample of 30 military health care beneficiaries with chronic pain were educated about Reiki and received six 30-minute Reiki sessions over 2 to 3 weeks. Pain was assessed using a battery of pain assessment tools as well as assessment of impression of and willingness to share the concept of Reiki.
Repeated measures ANOVA analyses showed that there was significant decrease (P < 0.001) in present, average, and worst pain over the course of the six sessions with the most significant effect occurring up to the fourth session. When a variety of descriptor of pain was assessed, Reiki had a significant effect on 12 out of the 22 assessed, with the most significant effect on pain that was described as tingling/pins and needles (P = 0.001), sharp (P = 0.001), and aching (P = 0.001). Pain’s interference with general activity, walking, relationships, sleep, enjoyment of life, and stress significantly decreased (P < 0.001 to P = 0.002). Impression of improvement scores increased 27 % by session 6, and one’s knowledge about Reiki improved 43%. Eighty-one percent of the participants stated that they would consider scheduling Reiki sessions if they were offered with 70% desiring at least four sessions per month.
The authors concluded that 30-minute Reiki session, performed by a trained Reiki practitioner, is feasible in an outpatient setting with possible positive outcomes for participants who are willing to try at least four consecutive sessions. Reiki has the ability to impact a variety of types of pain as well as positively impacting those activities of life that pain often interferes with. However, education and the opportunity to experience this energy healing modality are key for its acceptance in military health care facilities as well as more robust clinical studies within the military health care system to further assess its validity and efficacy.
Where to begin?
- As a feasibility study, this trial should not evaluate outcome data; yet the paper focusses on them.
- To educate people one does certainly not require to conduct a study.
- That Reiki ‘is feasible in an outpatient setting‘ is obvious and does not need a study either.
- The finding that ‘Reiki had a significant effect’ is an unjustified and impermissible extrapolation; without a control group, it is not possible to determine whether the treatment or placebo-effects, or the regression towards the mean, or the natural history of the condition, or a mixture of these phenomena caused the observed outcome.
- The conclusion that ‘Reiki has the ability to impact a variety of types of pain as well as positively impacting those activities of life that pain often interferes with’ is quite simply wrong.
- The authors mention that ‘This study was approved by the U.S. Army Medical Research and Materiel Command Institutional Review Board’; I would argue that the review board must have been fast asleep.