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

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Proponents of SCAM like to think that anyone who is critical of SCAM must be a defender of conventional medicine or worse a pharma shill. One can point out the ridiculousness of this claim until the cows come home, it nevertheless pops up relentlessly.

Personally, I am aware of (and have experienced) the many shortcomings of conventional medicine and applaud the various initiatives to improve it. Take this press release about 10 worst actions in US conventional medicine of 2019, for instance:

The Lown Institute released the 3rd Annual Shkreli Awards, a list of the top ten worst actors in health care from the past year, named for the infamous “pharma bro” Martin Shkreli… The top ten Shkreli Awards went to:

10. The cancer doctor who hid millions in industry gifts, then got a “dream job” at a cancer drug company.

9. The hospital that kept a vegetative patient on life support to boost transplant survival rates.

8. The doctors, telemedicine company employees, and genetic testing lab employees who bilked Medicare for $2.1 billion in a genetic cancer test scam.

7. The psychiatric hospitals that held patients against their will and drugged children.

6. The hospital that pressured cardiologists to keep referring pediatric patients for surgery in-house despite disturbingly high mortality rates.

5. The pharma executive who said, “addicts are to blame for their opioid addiction.”

4. The private equity firm that took over nursing homes, leading to a surge of neglected and abused residents.

3. The hospital that used a technicality to force a $900,000 medical bill on a new mother, who was also a hospital employee.

2. The private equity firms that spent $28 million to defeat “surprise billing” legislation, as medical debt skyrockets.

1. Several hospitals which claimed to care about patients but nevertheless sued them, garnished wages, and seized houses.

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What, you do not believe me that I regularly point out the shortcomings of conventional medicine? In this case, let me show you the introduction of a chapter dedicated to this topic from one of my books:

All too often, the failings of modern medicine seem as obvious as they seem inexcusable. It is thus understandable that some disappointed patients seek help and compassion from homeopaths. Seen from this perspective, the current popularity of homeopathy indicates that many patients are not satisfied with what conventional medicine offers. In other words, the current boom in homeopathy can be seen as a poignant criticism of certain aspects of modern health care.

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And why do I not dedicate more posts to the failures of conventional medicine? Because I am a pharma shill? No, because the topic of this blog was, is and will remain so-called alternative medicine (SCAM).

Why?

Because of two main reasons:

  1. In conventional medicine there are already many excellent initiatives (like the one mentioned above) to expose shortcomings, while in SCAM there are only relatively few.
  2. My expertise is in SCAM.

Please allow me to quote from yet another paper that I published 20 years ago. It is a very brief comment on an article by Kaptchuk and Eisenberg which discussed the reasons for the considerable popularity of SCAM. In it, they stated that the attraction of alternative medicine is related to the power of its underlying shared beliefs and cultural assumptions. The fundamental premises are an advocacy of nature, vitalism, “science,” and spirituality. These themes offer patients a participatory experience of empowerment, authenticity, and enlarged self-identity when illness threatens their sense of intactness and connection to the world.

This failed to convince me and I decided to offer an alternative view. Here is the relevant passage:

…  I would like to expand on a much more profane possible reason for the prevalence of alternative medicine. U.S. sales data of BMW cars (used as a marker of affluence) were obtained from the BMW head office in Munich, Germany. These data were correlated with both U.S. consumer use of herbal remedies and sales figures from the U.S. herbal mass market. Both latter data sets were taken from a recent overview of the U.S. herbal market. The correlation coefficients were impressive (r = 0.870 and r = 0.929, respectively).

Of course, correlations of this type do not imply a causal relation. Nevertheless, they do put affluence into the realm of factors to be considered seriously as explanations for the currently high prevalence of complementary medicine.

What I tried to imply in my comment is simple: many consumers in countries such as the US are well-off. Some seem to have so much money that they don’t know anymore what to do with it. Thus they spend it on all sorts of nonsense – some even spend it on SCAM! This was true, I think, 20 years ago – and it is true today.

I think that, during the last 20 years, this hypothesis has received much support – just think of our favourite SCAM merchant, Gwyneth Paltrow laughing all the way to the bank!

We were all born stupid, but it requires continuously hard work to remain dumb. A SCAM-obsessed, belligerent twit – the type we regularly encounter in the comments section of this blog – is not born but evolves during years of agonisingly tough work. At least, this is my impression. Certain traits (e. g. lack of self-doubt, bloody-mindedness, arrogance, egoism) might help, but the rest is a development that must follow certain steps.

THE INITIATION

An event is needed to start it all off. Often this is a very personal experience such as an illness which is unsuccessfully diagnosed and treated by a series of ungifted physicians. Eventually, our man (less frequently woman) comes across one particular SCAM. He tries it and his aliment subsequently is much-improved. Understandably, he is impressed and, unable to think critically, becomes a proponent of this particular SCAM.

INITIAL ‘RESEARCH’

Next our man takes the (not entirely irrational) step of reading all he can find about his newly discovered SCAM. Not having a science background, he falls for the plethora of uncritical BS that pollute the Internet. The more he reads, the more confident he becomes that SCAM is quite simply wonderful. And the more he studies, the clearer he realises that the news about the wonders of SCAM is being suppressed by the pharma/establishment mafia which is keen to hide the knowledge about SCAM for fear of losing their profits, jobs and income.

LOATHING

Naturally this insight triggers increasing resentment. How dare they suppress the information that would save thousands from suffering? How do they manage to sleep at night knowing that they are viciously hindering progress? Our man started his SCAM-journey by being mildly critical of conventional medicine (which could of course be a good thing). Now this sentiment is fast turning into a deep loathing. He is unable to see a single good point about conventional healthcare and he is becoming convinced that all who are engaged in it are cynically out to harm their fellow human beings. Consequently, he is less and less able to engage in a meaningful discussion with anyone who is not of his opinion.

THE DECISION

Our man arrives at the point where he makes a conscious decision to reject any information that contradicts his by now ‘superior’ knowledge of health, medicine, science and SCAM. He has seen clearly that such information is false, biased or misleading. The people who call themselves experts are bought by Big Pharma and cannot be trusted. They control the medical press where they publish their evidence. Yet, our ignoramus knows that their evidence is false and their science is corrupt. Reliable evidence, our man decides, is defined as evidence supporting his views. People who disagree with him are his personal enemies.

ADVANCED ‘RESEARCH’

Instead of reading any of the many papers that contradict his thinking, our man decides to dig deeper and deeper into BS. He now conducts ‘in-depth research’ by concentrating purely on what his gurus have put on the internet and published in their books. Peer review is not necessary; in conventional science, it is merely a smokescreen to hide the corrupt machinations of the establishment. In other words, our man has firmly established his home on ‘mount stupid’ (see below) and has turned into the belligerent fool we sometimes encounter on this blog. His over-confidence prevents him from descending into the ‘valley of despair’.

THE FOCUS

What he needs now is a pair of blinkers which allows our simpleton to eliminate all the disturbing information from ‘the enemy’. He now focusses on all the material that confirms his opinions. Any facts that might contradict them are denounced as propaganda from the ‘status quo’ and thus ignored. Accepted knowledge from the areas of physiology, pathology, pharmacology, etc. is pushed aside as just another bit of fake news from the medical mafia. He is unable to move on by learning; all he does is confirm his prior belief though a semblance of research. At this stage, our dimwit considers himself now a leading expert in his SCAM. His near-total lack of understanding of related issues and fields has become irrelevant. His self-confidence is at its peak, while his knowledge stagnates.

THE MISSION

Our belligerent ignoramus is full of anger about the fact that his supreme expertise is not taken seriously outside the echo chamber of his SCAM. He thus decides to go on a mission and preach the gospel wherever he can find a platform. Others may politely caution him pointing out that he might have misunderstood many of the basic principles involved. He is, however, unperturbed and proud of the half-knowledge that he managed to acquire during the process he calls research. Confronted with the repeated rejection of his bizarre notions, he eventually gets aggressive and starts insulting those who fail to follow his delusions. His mission is preaching the gospel of SCAM and, for that purpose, all means are necessary and allowed.

Our cantankerous twit has developed a serious neurosis. Nothing can free him from his paranoid obsessions and conspiracy theories. One by one, his opponents realise the extent of his problems and abandon discussing with him. This merely confirms his prior belief that, on this blog, everyone is in the pocket of Big Pharma. Deeply disgusted he stops debating and looks for another forum where, at least for a while, he can display his profound ignorance.

Carbon 60 has recently been promoted by some commentators on this blog. Their claim seems to be that it is the best thing since sliced bread. So, what should we make of carbon 60 as a dietary supplement?

Here is my attempt to provide a brief summary:

The endogenous production of reactive oxygen species (ROS) is a consequence of basal cellular respiration. At a moderate level, ROS are involved in cell signalling and required for biochemical energetics of life. When ROS overwhelm the cellular anti-oxidant defence system, oxidative stress can cause damage to cellular proteins, lipids and nucleic acids. Oxidative stress has been implicated in the pathogenesis of atherosclerosis, neurodegeneration, cancer and musculoskeletal conditions. Therefore, it might be of therapeutic value to relieve the oxidative stress by neutralising ROS with extrinsic anti-oxidants. One potentially potent anti-oxidants is ‘carbon 60’ (also called Fullerene 60).

But what exactly is carbon 60?

Carbon 60 is a molecule composed of 60 carbon atoms arranged in a sphere, and is also known as a buckyball, a cluster of sixty carbon atoms in the shape of a ball, also known as buckminsterfullerene. The carbon atoms in C60 fullerene are linked to three adjacent carbon atoms by strong covalent bonds, and form a spherical pattern of 20 hexagons and 12 pentagons, also known as a truncated icosahedron. The C60 molecule is around 0.7 to 1 nanometres in diameter. Most carbon 60 is manufactured in the laboratory, using an electric arc between two carbon electrodes to create a soot from which the carbon 60 fullerene molecules can be extracted. Tweaking the soot-creating conditions also allows carbon nanotubes to be created instead of C60 buckyballs.

The medicinal properties of carbon 60 currently are the subject of much hype. One website lists 12 amazing health benefits of carbon 60.

#1 May Increase Longevity

#2 Scavenges Free Radicals

#3 May Promote Less Bodily Stiffness and Happier Joints

#4 Seems to Improve Immune Function

#5 Possibly Supports Brain Health

#7 Promotes Cleanliness & Supports Good Hygiene

#8 Might Help You Maintain an Even Waistline

#9 Might Be Useful As A Chemo Support Supplement

#10 Possible UV Protection

#11 Might Enhance Your Skincare Routine

#12 Could Prove Helpful As A Support for Male Infertility Treatments

Is there any evidence to justify these claims? My ‘rough and ready’ searches found just two clinical trials:

Trial No 1

Highly purified and organic solvent-free fullerene-C60 was dissolved, at nearly saturated concentration of 278 ppm, in squalane prepared from olive oil, which is designated as LipoFullerene (LF-SQ) and was examined for usage as a cosmetic ingredient with antioxidant ability. The aim of this study was to assess the anti-wrinkle formation efficacy of LF-SQ in subjects. A total of 23 Japanese women (group I: age 38.9 +/- 3.8, n = 11, group II; age 39.4 +/- 4.3, n = 12) were enrolled in an 8-week trial of LF-SQ blended cream in a randomized, matched pair double-blind study. The LF-SQ cream was applied twice daily on the right or left half of the face, and squalane blended cream (without fullerene-C60) was applied as the placebo on another half of the face. As clinical evaluations of wrinkle grades, visual observation and photographs, and silicone replicas of both crow’s feet areas were taken at baseline (0 week) and at 4th and 8th weeks. Skin replicas were analyzed using an optical profilometry technique. The wrinkle and skin-surface roughness features were calculated and statistically analyzed. Subsequently, trans-epidermal water loss (TEWL), moisture levels of the stratum corneum, and visco-elasticity (suppleness: RO and elasticity: R7) were measured on cheeks by instrumental analysis. LF-SQ cream enhanced the skin moisture and the anti-wrinkle formation. LF-SQ cream that was applied on a face twice daily was not effective at 4th week, but significantly more effective than the placebo at 8th week (p < 0.05) without severe side effects. The roughness-area ratio showed significant improvement (p < 0.05) at 8th week with LF-SQ cream as compared to 0 week with LF-SQ cream, but no significant difference was detected between LF-SQ cream and the placebo. We suggest that LF-SQ could be used as an active ingredient for wrinkle-care cosmetics.

Trial No 2

Oxidative stress plays a major role in acne formation, suggesting that oxygen radical scavengers are potential therapeutic agents. Fullerene is a spherical carbon molecule with strong radical sponge activity; therefore, we studied the effectiveness of fullerene gel in treating acne vulgaris. We performed an open trial using a fullerene gel twice a day; at 4 and 8 weeks, the mean number of inflammatory lesions (erythematous papules and pustules) significantly (P < 0.05) decreased from 16.09 ± 9.08 to 12.36 ± 7.03 (reduction rate 23.2%) and 10.0 ± 5.62 (reduction rate 37.8%), respectively. The number of pustules, consisting of accumulation of neutrophils, was significantly (P < 0.05) decreased from 1.45 ± 1.13 to 0.18 ± 0.60 (reduction rate 87.6%), and further in vitro assays of sebum production in hamster sebocytes revealed that 75 μM polyvinylpyrrolidone-fullerene inhibits sebum production, suggesting that fullerene suppresses acne through decreasing neutrophil infiltration and sebum production. After treatment for 8 weeks, the water content of the skin significantly (P < 0.05) increased from 51.7 ± 7.9 to 60.4 ± 10.3 instrumental units. Therefore, the fullerene gel may help in controlling acne vulgaris with skin care benefit.

So, would you buy a supplement of carbon 60? There are many products to chose from. Yet, many readers of this blog might hesitate: not only is the evidence hardly anything to write home about, but also the price tags are eye-watering (~£40/100ml of oil enriched with carbon 60).

Here is a so-called alternative medicine (SCAM) that might be new to you – it certainly was to me: etiopathy. Founded in 1963 by the French Christian Trédaniel, etiopathy is a method of reasoning to determine the causes of a health problem and remove them acting on them. Etiopathy seems particularly popular in France, but is now slowly making inroads also elsewhere.

What is it?

This article explains it quite well:

Etiopathy is an alternative medicine which aims to treat everyday ailments without medication, using only manual techniques. Although it has been around for many years, the discipline is only just beginning to find its feet. It is a recognised health profession in several European countries, although there are not many practitioners.

The word etiopathy comes from the Greek word “aïtia”, which means “cause” and “pathos”, which means “suffering”. In short, etiopathy prioritises trying to find the cause for a pathology rather than getting rid of its symptoms.

The ethos of etiopathy is that the only way to prevent a problem from recurring is to treat it at the cause. According to this approach, if we don’t go back to the true source of the problem, patients run the risk of relapse.

The emphasis on diagnosis in etiopathy allows practitioners to treat the majority of common pathologies, thanks to an exclusively manual treatment approach, involving massage of particular points and thus avoiding medication and side effects. Obviously, an etiopath will immediately refer the patient on if they feel that the support of another health professional is required.

Etiopathy can be used to complement classic medical treatment, to help treat fairly benign problems such as:

  • joint problems (sprains, strains, tendonitis, carpal tunnel syndrome, tarsal tunnel syndrome, etc.)
  • respiratory or ENT problems (asthma, colds, coughs, sinusitis, rhinitis, rhinopharyngitis, etc.)
  • vertebral problems (neuralgia, torticollis, lumbago, chronic lower back pain, etc.)
  • problems during pregnancy (nausea, vomiting, sciatica) and preparation for giving birth
  • digestive problems (bloating, aerophagia, gastro-oesophageal reflux, constipation, diarrhea, etc.)
  • urinary problems (cystitis, prostate problems, incontinence, etc.)
  • gynaecological problems (painful periods, infertility, menopause, organ prolapse, etc.)
  • circulation problems (palpitations, tightness in the chest, heavy legs, Raynaud’s syndrome, etc.)
  • general health problems (migraines, insomnia, anxiety, shingles, etc.)

The goal of etiopathy is to reduce the risk of developing chronic problems or to find a natural solution to avoid surgical intervention.

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Big claims indeed!

But what about plausibility?

What about the evidence?

None!

Naught!

Zero!

Zilch!

Zippo!

Conclusion: etiopathy is a SCAM like many others – plenty of hot air, fantasy and hype combined with an absence of science, evidence and  data.

Having mentioned the report on chiropractic for children by SAVER CARE VICTORIA (SCV) several times before, I now better reveal its contents. Here are important excerpts from it, but I encourage everyone to read the full document:

Review of evidence of harm

An extensive search was undertaken to identify evidence of harm sustained by children who had received spinal manipulation. This included a literature review by Cochrane Australia, capture of patient complaints and practitioner notification data from Australian complaints and regulatory agencies, capture of Australian insurance claim data from the primary insurers for registered chiropractors, and stakeholder feedback from both online consultations. This extensive search identified very little evidence of patient harm occurring in Australia. In particular, there were no patient complaints or practitioner notifications that arose from significant harm to a child following spinal manipulation.

Three individual case reports were the only evidence of serious harm identified. Each of these reports related to spinal manipulative techniques performed outside of Australia and not limited to chiropractors. The practices described in these reports are not reflective of Australian chiropractic techniques. This does not mean spinal manipulation in children is not associated with any risk of any adverse effects. An extensive literature review did identify transient or minor adverse events but the prevalence was very low, albeit possibly more common in very young children.

There are two principle reasons why the search did not find strong evidence of harm in Australia. First, it is unlikely that spinal manipulation, as defined within the scope of the review, is a technique that is being routinely applied in Australia to young children or those with an immature spine. Second, skilled chiropractic care requires the practitioner to modify the force applied based on the age and developmental stage of the child. This means that children, particularly very young children, under the care of an Australian chiropractor are not likely to be receiving high impact manipulations.

Nonetheless, it is clear that spinal manipulation in children is not wholly without risk. Any risk associated with care, no matter how uncommon or minor, must be considered in light of any potential or likely benefits. This is particularly important in younger children, especially those under the age of 2 years in whom minor adverse events may be more common.

Review of evidence of effectiveness

SCV commissioned Cochrane Australia to undertake a systematic review of the effectiveness and safety of spinal manipulation of children under 12 years for any condition or symptom, irrespective of the profession providing treatment.

The major finding of this review is that the evidence base for spinal manipulation in children is very poor. In particular, no studies have been performed in Australia.

Specifically, the comprehensive review of the literature failed to identify any strong evidence for the effectiveness of spinal manipulation for a variety of conditions for which children are widely offered chiropractic manipulations. These conditions included colic, enuresis, back/neck pain, headache, asthma, otitis media, cerebral palsy, hyperactivity and torticollis.

There was low certainty (weak) evidence that spinal manipulation may be beneficial for modestly reducing crying time in children with colic, or for reducing the number of wet nights in children with enuresis. For both conditions the evidence was also consistent with either no or worsening effects.

For the other conditions – headache, asthma, otitis media, cerebral palsy, hyperactivity, and torticollis – there was no evidence that spinal manipulation was effective.

Based on this review of effectiveness, spinal manipulation of children cannot be recommended for:

  • headache
  • asthma
  • otitis media
  • cerebral palsy
  • hyperactivity disorders
  • torticollis.

The possible, but unlikely, benefits of spinal manipulation in the management of colic or enuresis should be balanced by the possibility, albeit rare, of minor harm.

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As pointed out repeatedly, one reason for not finding many reports of adverse effects might be very simple: UNDER-REPORTING! In any case, no good evidence for benefit + a finite risk = a negative risk/benefit balance. And a negative risk/benefit balance, of course, means that we should advise against chiropractic spinal manipulation for children. I am pleased to report that SCV agree; their 1st recommendation is: spinal manipulation … should not be provided to children under 12 years of age.

When I worked as a junior doctor in a homeopathic hospital, this is what I was told in no uncertain terms: children are ideal patients of homeopathy, because they respond particularly well to it. Most books on the subject confirm this message. The reason for the assumption is as simple as it is simplistic: children are relatively unspoilt by conventional drugs that can hinder the effects of homeopathy.

Many years later, when we conducted one of our clinical trials of homeopathy, we opted for a study with children, because all homeopaths believe in this dogma. For the same reason, it made (homeopathic) sense for the paediatricians of my former medical school (LMU Munich) to run a homeopathic clinic for decades. Not just that, they also taught homeopathy to medical students.

In the course of doing this for such a long time, they did their research and, of course, gathered tons of experience. And what does this wisdom and insight collected over decades reveal? Does it confirm the dogma that kids are excellent homeopathy-responders? Or perhaps does it reject the notion?

The question has just been definitively answered by a (well-hidden) remark in an announcement from the university paediatrics department entitled Integrative Pädiatrie. The original text is below; for those who don’t read German, I will translate:

Our healthcare for children is devoted to a holistic approach which considers biological and psychosocial dimensions of health and disease.

We see positive potential in the use of music, art and humour. Methods from integrative medicine such as mind/body therapies or integrative movement therapy can have curative effects. These and other methods are also being tested in scientific studies.

Homeopathic remedies, however, are not being used in Hanauer’s Paediatric Hospital because, after 200 years of research, it has become clear that the basis of homeopathy is not in accordance with the modern concepts of the natural sciences.

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Unsere Medizin für kranke Kinder ist einer ganzheitlichen Sicht verpflichtet, die neben den biologischen auch psychosoziale Dimensionen von Gesundheit und Krankheit berücksichtigt.

Wir sehen das positive Potential durch den Einsatz von Musik, Kunst oder Humor.  Auch Methoden der “Integrativen Medizin”, wie zum Beispiel die “mind-body-Medizin” oder die Technik der integrativen Bewegungstherapie können eine heilende Wirkung haben. Diese und andere Methoden werden zum Teil auch in wissenschaftlichen Studien geprüft.

Homöopathische Arzneimittel kommen im Dr. von Haunerschen Kinderspital hingegen nicht zum Einsatz, da sich nach über 200 Jahren wissenschaftlicher Forschung klar herausgestellt hat, dass ihre Grundlagen nicht mit dem modernen Verständnis der Naturwissenschaft in Einklang zu bringen sind.

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Let’s be clear what exactly the last paragraph means:

  • This institution has bee open to homeopathy for a very long time.
  • They treated children homeopathically.
  • They conducted research in homeopathy.
  • They taught homeopathy to medical students.
  • Eventually, they could no longer ignore what was before their eyes.
  • They stopped using homeopathy.
  • And they discontinued their course of homeopathy.

Why?

Because highly diluted homeopathic remedies are pure placebos – and that is true for children, adults and even animals.

The Sueddeutsche Zeitung reported yesterday that the Bavarian government has given the go-ahead to a major study of homeopathy, and Die Zeit published a similar article. For those who read German, I append the text from the SZ below. For those who don’t, let me give a short summary.

The study is aimed at clarifying whether the use of homeopathic remedies can reduce the use of antibiotics in humans and animals. The vote was carried because of the CDU delegates being in favour. The debate of the project was, however, controversial. Critics stressed that, at best, the study is superfluous and pointed out that the project is negligent because it implies that homeopathics might be effective, whereas the evidence shows the opposite. A SPD delegate stated that he is ‘open moth’, homeopathy works because of the doctor-patient contact and not because of its remedies which are pure placebos.

The project was tabled because some people had worried about antibiotic resistance and felt that homeopathy might be an answer. Some CSU delegates stated that in ENT medicine, there is evidence that homeopathics can reduce the use of antibiotics. Even in cases of severe sepsis, there was good evidence, they claimed.

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Mit einer medizinischen Studie soll die Staatsregierung klären, ob durch homöopathische Mittel der Einsatz von Antibiotika reduziert werden kann. Dies hat der Landtag am Donnerstag mit den Stimmen der Regierungsfraktionen von CSU und Freien Wählern beschlossen. Bei der namentlichen Abstimmung votierten 120 Abgeordnete für den Antrag und damit acht mehr, als die Koalition selbst stellt. Im Plenum löste der Antrag, der im Zusammenhang mit weiteren Maßnahmen gegen sogenannte multiresistente Keime besprochen wurde, teils kontroverse Debatten aus. Kritiker der Homöopathie betonten, dass die Studie bestenfalls überflüssig sei.

“Das Vorhaben der bayerischen Staatsregierung ist fahrlässig, weil es bereits mit der Fragestellung suggeriert, dass homöopathische Mittel wie Globuli multiresistente Keime bekämpfen könnten”, sagte Dominik Spitzer (FDP). Bisher habe keine wissenschaftliche Studie beweisen können, dass homöopathische Mittel allein gegen Beschwerden wirkten.

Auch die SPD-Abgeordnete Ruth Waldmann hatte bereits vor der Debatte zum Ansinnen der CSU gesagt: “Da bleibt einem der Mund offen stehen.” Wenn an Homöopathie “wirklich nachweislich etwas wirkt, dann ist es der Anteil der sprechenden Medizin, der ganzheitliche Blick auf die Patienten”. Das tue vielen Menschen gut. “Und da bin ich auch dafür, das den Leuten zu lassen”, betonte Waldmann. “Aber bei schwerer Sepsis auch nur daran zu denken, diese Kügelchen womöglich anstelle von Antibiotika zu verabreichen”, das könne sie nicht mehr nachvollziehen.

Die CSU-Landtagsfraktion hatte ein Paket von insgesamt fünf Anträgen eingereicht, mit denen sie erreichen will, dass es weniger Todesfälle durch multiresistente Keime gibt. Dazu gehöre es, im Alltag den Antibiotika-Einsatz zu reduzieren, auch in der Landwirtschaft. Fahrlässig eingesetzte Antibiotika werden von Forschern mit als Grund dafür genannt, dass Krankheitserreger resistent werden. In einem dieser Anträge wird die Staatsregierung aufgefordert, per Studie untersuchen zu lassen, wie der Antibiotika-Einsatz reduziert werden kann – und ob dabei womöglich auch homöopathische Präparate eine “positive Rolle” spielen.

Im Bereich der Hals-Nasen-Ohren-Erkrankungen, so die CSU-Abgeordneten, hätten Studien aufzeigen können, “dass durch den Einsatz klassischer Homöopathie sowohl ein Einsatz von Antibiotika vermieden als auch eine Verbesserung der individuellen Infektabwehr erreicht werden konnte”. Auch an schwer septischen Patienten – also Patienten, bei denen das körpereigene Abwehrsystem bereits die Organe und das Gewebe schädigte – habe eine Studie Hinweise darauf gebracht, dass eine homöopathische Behandlung “eine nützliche Behandlungsmethode” darstellen könne.

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The notion that there might be good evidence for the efficacy of homeopathy in ENT and sepsis is clearly mistaken. On this blog, we have even discussed a tragic case of a child dying because of this erroneous belief. Homeopathy does not work in humans nor in animals as an alternative to antibiotics. And, of course, the notion that there is good, reproducible evidence to show that homeopathy effectively cures sepsis is a most dangerous fallacy. (There have been some experiments along these lines in the Dachau concentration camp, but they cannot seriously mean that!)

As far as I know it is as yet unclear what the precise research questions of the Bavarian project are, how much money will be spent on it (I saw a mention of 400 000 Euros), who is going to conduct the research, etc. No doubt, we will learn all this in due course. Meanwhile, if I may be so bold as to recommend someone for designing the research, I can think of nobody better suited than the only person who truly believes that it can produce a positive result: PRINCE CHARLES.

The Federation of European Academies of Medicine (FEAM) and the European Academies’ Science Advisory Council have issued a joint statement today urging the World Health Organisation (WHO) to clarify how Traditional Chinese Medicine (TCM) and other so-called alternative medicines (SCAMs) should be used.

As we discussed previously, the WHO has included TCM diagnoses in the International Classification of Diseases (ICD). The WHO claim this is not an endorsement, but experts point out that the move will promote TCM and mislead the public into thinking that TCM is safe and effective. Thus consumers might use it as an alternative for effective treatments of serious conditions, in which case they would endanger their lives.

Prof George Griffin, the president of FEAM, was quoted saying “We don’t give drugs and surgical treatments unless there is real evidence that they work and do no damage and basically the feeling is that most of the traditional Chinese medicine drugs are unregulated. They are not tested properly for toxicity. They probably vary greatly between batches produced, for example seaweed, which is the latest, and they may be harmful. The other side of the equation is that they may be deluding patients into thinking they are taking appropriate therapies for serious disease.”

“Multiple risks of harm from herbal ingredients have been documented,” the joint statement warns. Sometimes herbal remedies have been adulterated with chemicals. Interaction with conventional drugs can be a serious threat. And acupuncture, they will say, “is not necessarily harmless”. A review in 2017 as well as numerous papers discussed on this blog (for instance here and here) found injuries to vital organs, infections and other adverse reactions.

Although those who use SCAM are being misled to think of them as originating from small scale enterprises, globally it is big business. “The production and delivery of TCM has become a large industry with estimates of $60bn [£46.5bn] a year and an annual growth rate above 10%,” says the statement.

The statement authors “urge the European Commission and member states to do more to ensure that all medical products and procedures are subject to an appropriate level of evaluation for quality, safety and efficacy consistent with standardised testing procedures”.

Here are further important points from the statement:

  • We agree with the underlying principle that the proponents of TCM and other CAM should be invited to seek the same rigorous assessment as is applied to innovative, evidence-based medicines (from state-of-the-art clinical trials) developed and regulated worldwide.
  • We accept that WHO has tried to make clear that their chapter in ICD-11 on TCM does not refer to, nor endorse, any specific form of treatment (Anon 2019a). However, because of the perceived encouragement created by ICD-11 inclusion of  TCM as a core principle and system of medicine, the qualification may be misconstrued or ignored.
  • We agree that there have been examples where traditional medicine, Chinese or otherwise, has been subjected to thorough preclinical investigation and proven in rigorous clinical trials to contribute significant health benefit. The example of artemisinin therapy for malaria is notable (WHO, 2015). The success of artemisinin as an anti-malaria agent is due to meticulous research in pharmacognosy and medicinal chemistry, combined with clinical trials. Many of the artemisia TCM preparations tested originally had little reproducibility of activity. The compound that has been approved by medicinal product agencies is a chemically modified version of the naturally occurring molecule in order to improve its pharmacokinetic properties. It is well known that many natural products have significant pharmacological activities and provided the basis for much of modern medicine. And, there may be many more such leads to therapeutic benefit. But, none of this means that other claims can be accepted uncritically, even if the objective to ensure access for all to the benefits of medicine is worthy.
  • European patients may be encouraged to self-administer unregulated products or seek unregulated diagnostic procedures outside of the remit and responsibility of public health services. This raises issues for efficacy, particularly if patients delay seeking evidence-based healthcare. There are also serious safety concerns. Multiple risks of harm from herbal ingredients have been documented (e.g. see Byard et al. 2017; Zhou et al. 2019) and in the absence of an approved framework for quality and formulation, adulteration and dose variation may bring additional health risks (Ching et al. 2018). Interaction with other medications is,
    additionally, a serious threat. It is also noteworthy that, contrary to common assumptions, acupuncture is not necessarily harmless (Chan et al. 2017). It is not our present purpose to review the evidence on TCM or to make judgement on particular practices, rather to emphasise the need for consistency in applying common standards to all of medicine. Although there is a very large literature on TCM, we note that clinical studies often fail to meet expected methodological criteria and highquality evidence is often lacking (for example as concluded from a systematic review of the literature on use of Chinese herbal medicines for rheumatoid arthritis, Pan et al. 2017). Follow-up surveillance and procedures for assessing liability, where necessary, may also be weak.
  • European patients may be encouraged to seek diagnosis according to the proffered TCM precepts through public health services, thereby causing additional pressures on limited resources. It is likely that there will be increasing demands for these services across the EU. The European Commission, the EMA and Member State health authorities must revisit their regulatory strategies to ensure that appropriate, evidence-based patient information is readily accessible.
  •  There should be consistent proof underlying the regulatory requirements for scrutiny to demonstrate efficacy, safety and quality for all products and practices for human medicine. There must be verifiable and objective evidence, commensurate with the nature of the claims being made. In the absence of such evidence, a product should be neither approvable nor registrable by national regulatory agencies for the designation medicinal product. The current EU Directive on Traditional Herbal Medical Products (Directive 2004/24/EC amending Directive 2001/83/EC) was established to provide a simplified regulatory approval process for traditional herbal medicines, and national procedures are overseen by the national competent authorities. However, designated categories within this legislation allow treatment based on traditional or well-established use in the absence of robust evidence. Medicinal herbal products registered by the European Medicines Agency for traditional use have the requirement of “bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years in the Community”5. Thus, the regulation is essentially to ensure that the product is harmless and there is no real requirement for demonstration of effect. As recommended in our previous assessment of homeopathy (EASAC, 2017) it would now be timely to reassess the validity and value of continuing to allow these simpler regulatory approval categories to apply.
  • Diagnostic procedures should also be evidence-based and include validated diagnostic instruments to provide objective, reliable, reproducible assessment and reduce inter-rater variability. Whatever the diagnostic approach utilised, practitioners should be appropriately trained and audited by professional bodies.
  • Similarly, use of other TCM procedures such as acupuncture should be evidence-based to demonstrate efficacy and safety, and subject to professional standards.
  • Evidence-based public health systems and medical insurance systems should not reimburse products and practices unless they are demonstrated to be efficacious and safe by rigorous pre-marketing testing: a robust evidence base is essential for all medicines.
  • The composition of standardised TCM remedies should be labelled in a similar way to other health products. That is, there should be an accurate, clear, verifiable and simple description of the ingredients and their amounts present in the formulation. TCM diagnostic and therapeutic procedures should, likewise, be clearly explained in patient information literature.
  • Advertising and marketing of TCM products and services must conform to established standards of accuracy and clarity6. Promotional claims for efficacy, safety and quality should not be made without demonstrable and reproducible evidence

A team of 42 authors from various disciplines (mostly medicine and philosophy) have published an appeal to broaden the definition of evidence. They reached several overlapping conclusions with implications for policy and practice in research and clinical care, which they summarised as follows:

1. ‘Evidence’ is typically evidence of causation. Common terms used in EBM, such as ‘intervention’, ‘outcome’ or ‘increased risk’, are relevant to evidence-based decision making only insofar as they point to causal matters: causal interventions and their effects. Although there is growing reluctance to make causal claims in areas of uncertainty, the correct response to such uncertainty is not to avoid talking about causation but instead to improve our methods of understanding it.

2. Establishing causation often requires the use of multiple methods since no single method will be universally applicable or perfect for this purpose. This means that statistical approaches, in particular randomised controlled trials and systematic reviews, cannot uncover all causally relevant information, contrary to their widespread assumed status as the universal gold standards of EBM.

3. An understanding of causal mechanisms can help to determine whether an intervention works (ie, its efficacy shown in experiment or effectiveness in clinical practice). In addition, we should strive to understand how an intervention works (ie, its mechanism) and how it can be made to work (ie, the conditions under which it works best). Understanding mechanisms is essential for both of these. For instance, a medical intervention that works experimentally might not do so when combined with a negatively interacting substance.

4. Although animal experiments can shed light on causal mechanisms, other types of evidence can add to our understanding. This is because causal mechanisms are complex, involving multiple causal interactions of various factors. These factors play roles in the effectiveness of the treatment and in interactions between the treatment and the individual patient.

5. Given the multiplicity of methods (cf 2) and a wide interpretation of what counts as a mechanism (cf 3 and 4), causation should be understood in non-reductionist terms. That is, the scope of relevant causal interactions extends beyond the molecular, pharmacological and physiological levels of interaction. Any thorough causal account should also include higher-level factors, such as the behaviour of tissues, whole organs and individuals, including psychological and social factors.

6. ‘Causal evidence’ should be extended to include different types of evidence, including case studies and case reports, which can in some cases provide valuable information for understanding causation and causal mechanisms. This is particularly important when dealing with rare disorders, marginal groups or outliers.

7. Patient narratives and phenomenological approaches are useful tools for looking beyond evidence such as symptoms and outcomes, and to elucidate the core causes or sources for chronic and unexplained conditions.

8. Causation has a non-negligible temporal aspect. Whether of long or short duration, a causal interaction cannot be fully understood from a ‘snapshot’, but requires both backwardlooking perspectives (towards the origin) and forward-looking perspectives (towards the outcome).

These points are well worth considering, in my view. As we have often discussed on this blog, causation is the key. The authors see their paper as a philosophical analysis that ought to have a direct impact on the practice of medicine. If we are to understand what is meant by ‘evidence’, what is the ‘best available evidence’ and how to apply it in the context of medicine, they write, we need to tackle the problem of causation head on. In practice, this means understanding the context in which evidence is obtained, as well as how the evidence might be interpreted and applied when making practical clinical decisions. It also means being explicit about what kind of causal knowledge can be gained through various research methods. The possibility that mechanistic and other types of evidence can be used to add value or initiate a causal claim should not be ignored. 

Their plea has much scope for being misunderstood by enthusiasts of so-called alternative medicine (SCAM). And I am keen to hear what you think about the 8 points raised here.

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