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

medical ethics

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This image caught my eye on facebook. It links to an article that makes a multitude of claims for a dietary supplement by the name of ‘smarter curcumin’:

Promotes Comfort & Flexibility

Studies have shown that curcumin may work by reducing certain key inflammation-promoting enzymes in the body. In some studies curcumin performed well in promoting comfort and flexibility without the side-effects; providing a natural supplement alternative. Athletes and weekend warriors alike are also using it for muscle and joint health recovery, too.

Supports Healthy Joints

Antioxidants play a role in keeping our joints healthy. Your body uses antioxidants to combat free radicals. Free radicals are unstable particles that are created as a result of millions of chemical reactions in the body. They can cause oxidative stress and damage on a cellular level. When scientists examine the blood and joint fluid of patients that are suffering with joint discomfort, often times there is an increased activity of free radicals and lower levels of antioxidants. Curcumin being rich in antioxidants, can give you a healthy supply.

Age-Reducing Beauty – Skin, Hair, and Body

Curcumin, being a very powerful natural antioxidant, helps reduce and neutralize free radicals, which damage and destroy your cells and DNA causing accelerated aging. Since most ageing disorders are driven by oxidative stress, this makes curcumin a very important daily supplement for aging adults.

Healthy Immune Balance

Your immune system is a network of various organs, tissues, and cells that work together to protect your body. Curcumin not only helps to enhance the responses of certain antibodies and cells within the immune system but may also help downregulate the expression of certain proinflammatory substances.

Promotes Cardio Health

A healthy heart consists of many factors, especially eating healthy and routine exercise. Adding curcumin as part of your healthy diet may have many benefits to protect your heart. Oxidized LDL (Low-density lipoprotein) particles (that have been disrupted by free radicals) may produce inflammation in the cardiovascular system. Studies suggest that the antioxidant effects of curcumin can help fight those free radicals.

Improves Digestion

Curcumin has been shown to calm the digestive system, helping to relieve gas, bloating, and other stomach and bowel issues. It works differently than probiotics or enzymes – naturally soothing the gut, and reducing the overproduction of acid.

Support Liver Health

Your liver plays an important role in stabilizing and balancing the maintenance of your body. The health of your liver can be directly related to oxidative stress and proinflammatory substances. Curcumin may help boost antioxidant defenses to help the liver detoxify and restore balance.

Supports Brain Health

The connection between inflammation and cognitive health cannot be overstated. Neurons are especially susceptible to inflammation and the release of inflammatory compounds in the body can be neurotoxic. Curcumin may help protect those precious brain cells.

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What fascinates me here is not so much the plethora of therapeutic claims. As far as I can see, most of them are not supported by what I would call good evidence. But I have grown so used to bogus claims in SCAM, that they rarely make me bat an eyelash.

What fascinates me most is the extraordinary picture evidently designed to attract our attention. Many people might have no idea what it depicts, other than a running leopard in a strange environment. Others will realise that the environment is an artery, and the chasing animal therefore seems to imply that the supplement enhances arterial blood flow.

But why? There is no evidence that curcumin has this effect, and the above therapeutic claims are largely unrelated to improvements of the blood circulation.

The artery is filled with red cells in their typical disc shape. It is, however, a shape red cells never have while submitted to flow in arteries. While circulating, they tend to attain a parachute-like shape:

Image result for red cell, parachute shape,

 

Red cells form a disc shape only when they are motionless. Perhaps the picture really implies that curcumin generates a stagnation of blood flow? No, this is also not in line with reality; in stagnant blood, red cells aggregate and look like this:

So, you see why this image is puzzling. It seems to be aimed at people who are aware that it depicts something medical, yet too ignorant to realise that almost everything is wrong with it.

And why would anyone design an image like this? Could it be that only people naïve enough to think this picture makes any sense are likely to believe the tall tales offered in the text?

One of the favourite arguments of proponents of so-called alternative medicine (SCAM) is that conventional medicine is amongst the world’s biggest killers. The argument is used cleverly to discredit conventional medicine and promote SCAM. It has been shown to be wrong many times, but it nevertheless is much-loved by SCAM enthusiasts and thus refuses to disappear. Perhaps this new and important review might help instilling some realism into this endless discussion? Here is its abstract:

Objective To systematically quantify the prevalence, severity, and nature of preventable patient harm across a range of medical settings globally.

Design Systematic review and meta-analysis.

Data sources Medline, PubMed, PsycINFO, Cinahl and Embase, WHOLIS, Google Scholar, and SIGLE from January 2000 to January 2019. The reference lists of eligible studies and other relevant systematic reviews were also searched.

Review methods Observational studies reporting preventable patient harm in medical care. The core outcomes were the prevalence, severity, and types of preventable patient harm reported as percentages and their 95% confidence intervals. Data extraction and critical appraisal were undertaken by two reviewers working independently. Random effects meta-analysis was employed followed by univariable and multivariable meta regression. Heterogeneity was quantified by using the I2 statistic, and publication bias was evaluated.

Results Of the 7313 records identified, 70 studies involving 337 025 patients were included in the meta-analysis. The pooled prevalence for preventable patient harm was 6% (95% confidence interval 5% to 7%). A pooled proportion of 12% (9% to 15%) of preventable patient harm was severe or led to death. Incidents related to drugs (25%, 95% confidence interval 16% to 34%) and other treatments (24%, 21% to 30%) accounted for the largest proportion of preventable patient harm. Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery; regression coefficient b=0.07, 95% confidence interval 0.04 to 0.10).

Conclusions Around one in 20 patients are exposed to preventable harm in medical care. Although a focus on preventable patient harm has been encouraged by the international patient safety policy agenda, there are limited quality improvement practices specifically targeting incidents of preventable patient harm rather than overall patient harm (preventable and non-preventable). Developing and implementing evidence-based mitigation strategies specifically targeting preventable patient harm could lead to major service quality improvements in medical care which could also be more cost effective.

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One in 20 patients is undoubtedly an unacceptably high proportion, but it is nowhere close to some of the extraordinarily alarming claims by SCAM enthusiasts. And, as I try regularly to remind people, the harm must be viewed in relation to the benefit. For the vast majority of conventional treatments, the benefits outweigh the risks. But, if there is no benefit at all – as with some form of SCAM – a risk/benefit balance can never be positive. Moreover, many experts work hard and do their very best to improve the risk/benefit balance of conventional healthcare by educating clinicians, maximising the benefits, minimising the risks, and filling the gaps in our current knowledge. Do equivalent activities exist in SCAM? The answer is VERY FEW?

The effectiveness of spinal manipulative therapy (SMT) for improving athletic performance in healthy athletes (or anything else for that matter) is unclear. The objective of this systematic review was to systematically review the literature on the effect of SMT on performance-related outcomes in asymptomatic adults.

The authors searched electronic databases from 1990 to March, 2018. Inclusion criteria was any study examining a performance-related outcome of SMT in asymptomatic adults. Methodological quality was assessed using the SIGN criteria. Studies with a low risk of bias were considered scientifically admissible for a best evidence synthesis.

Of 1415 articles screened, 20 studies had low risk of bias, seven were randomized crossover trials, 10 were randomized controlled trials (RCT) and three were RCT pilot trials. Four studies showed SMT had no effect on physiological parameters at rest or during exercise. There was no effect of SMT on scapular kinematics or transversus abdominus thickness. Three studies identified changes in muscle activation of the upper or lower limb, compared to two that did not. Five studies showed changes in range of motion (ROM). One study showed an increase lumbar proprioception and two identified changes in baropodometric variables after SMT. Sport-specific studies showed no effect of SMT except for a small increase in basketball free-throw accuracy.

The authors, who are all affiliated to the Canadian Memorial Chiropractic College, concluded that the preponderance of evidence suggests that SMT in comparison to sham or other interventions does not enhance performance-based outcomes in asymptomatic adult population. All studies are exploratory with immediate effects. In the few studies suggesting a positive immediate effect, the importance of such change is uncertain. Further high-quality performance specific studies are required to confirm these preliminary findings.

I think, this says it (almost) all: yet another lucrative claim made by many chiropractors and osteopaths turns out to be not backed up by good evidence. The only thing worth adding is the fact that only 4 of the studies mentioned adverse effects. This means the vast majority of studies failed to comply with this basic requirement of research ethics – and this really says it all!

Chiropractors often claim that they are working tirelessly towards increasing public health. But how seriously should we take such claims?

The purpose of this study was to investigate weight-loss interventions offered by Canadian chiropractors. It is a secondary analysis of data from the Ontario Chiropractic Observation and Analysis STudy (Nc = 42 chiropractors, Np = 2162 patient encounters). Its results show that around two-thirds (61.3%) of patients who sought chiropractic care were either overweight or had obesity. Very few patients had weight loss managed by their chiropractor. Among patients with body mass index equal to or greater than 18.5 kg/m2, guideline recommended weight management was initiated or continued by Ontario chiropractors in only 5.4% of encounters. Chiropractors did not offer weight management interventions at different rates among patients who were of normal weight, overweight, or obese (P value = 0.23). Chiropractors who graduated after 2005 who may have been exposed to reforms in chiropractic education to include public health were significantly more likely to offer weight management than chiropractors who graduated between 1995 and 2005.

The authors concluded that the prevalence of weight management interventions offered to patients by Canadian chiropractors in Ontario was low. Health care policy and continued chiropractic educational reforms may provide further direction to improve weight-loss interventions offered by doctors of chiropractic to their patients.

This paper seems to confirm my suspicion that the claim of chiropractors working for public heath is little more than an advertising gimmick. If we also consider the often negative attitude of chiropractors towards vaccination, the claim even deteriorates into a sick joke. Chiropractors, I have previously argued, are undermining public health and are being educated to become a danger to public health.

The NHS England has stopped paying for homeopathy in 2017. France has just announced to do likewise. What about Germany, the homeland of homeopathy?  

In Germany there are about 150,000 doctors, and around 7,000 specialize in homeopathy. Multiple surveys confirm that Germans do like their SCAMs, particularly homeopathy. Two examples:

  • A 2016 cross-sectional analysis conducted among all patients being referred to the Department of Internal and Integrative Medicine at Essen, Germany, over a 3-year period showed that 35% of the 2,045 respondents reported having used homeopathy for their primary medical complaint.  359 (50.2%) patients reported benefits and 15 (2.1%) reported harm.
  • More recently, a questionnaire survey concerning current and lifetime use of SCAM was distributed to German adults with autism spectrum disorder (ASD). The results suggested that 45% of the respondents were currently using or had used at least one SCAM modality in their life. Homeopathy and acupuncture were most frequently used SCAMs, followed by mind-body interventions.

But since a few years, the German opposition to homeopathy has become much more active. In particular the INH, the GWUP, and the Muensteraner Kreis have been instrumental in informing the public about the uselessness and dangers of homeopathy. The press has now taken up this message and, as this article explains, now the debate about homeopathy has finally reached the political level.

The head of the main doctors’ association and the SPD’s health specialist have called for an end to refunds for homeopathy treatments in Germany. The head of the National Association of Statutory Health Insurance Physicians (KBV), which represents 150,000 doctors and psychotherapists in Germany, recently urged health insurance companies to stop funding homeopathic services. “There is insufficient scientific evidence for the efficacy of homeopathic procedures,” Andreas Gassen told the Rheinische Post. “If people want homeopathic remedies, they should have them — but not at the expense of the community.

Gassen’s comments follow those of the Social Democrat (SPD) health issues specialist and lawmaker Karl Lauterbach who has pressed for a law banning refunds for homeopathy. “We have to talk about it in GroKo,” Lauterbach said earlier this month, suggesting a discussion in the government grand coalition. He said the benefits paid for by insurers should be medically and economically sensible. He has the support of the Federal Joint Committee which decides on what is covered by payments from the statutory health funds.

So, what is going to happen?

As I have written previously, one can only be sure of this:

  • The German homeopathy lobby will not easily give up; after all, they have half a billion Euros per year to lose.
  • They will not argue on the basis of science or evidence, because they know that neither are in their favour.
  • They will fight dirty and try to defame everyone who stands in their way.
  • They will use their political influence and their considerable financial power.

AND YET THEY WILL LOSE!

Not because we are so well organised or have great resources – in fact, as far as I can see, we have none – but because, in medicine, the evidence is invincible and will eventually prevail. Progress might be delayed, but it cannot be halted by those who cling to an obsolete dogma.

 

 

Treating children is an important income stream for chiropractors and osteopaths. There is plenty of evidence to suspect that their spinal manipulations generate more harm than good; on this blog, we have discussed this problem more often than I care to remember (see for instance here, here, here, here and here). Yet, osteopaths and chiropractors carry on misleading parents to abuse their children with ineffective and dangerous spinal manipulations. A new and thorough assessment of the evidence seems to confirm this suspicion.

This systematic review evaluated the evidence for effectiveness and harms of specific SMT techniques for infants, children and adolescents. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1-18 years), were included to determine effectiveness.

Of the 1,236 identified studies, 26 studies were eligible. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication and treatment comparison were scarce. The results showed that:

  • Due to very low quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis.
  • Five case reports described severe harms after HVLA manipulations in 4 infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children, and could be interpreted as side effect of treatment.

The authors concluded that due to very low quality of the evidence, the effectiveness of gentle, low-velocity mobilizations in infants and HVLA manipulations in children and/or adolescents is uncertain. Assessments of intermediate outcomes are lacking in current pediatric SMT research. Therefore, the relationship between specific treatment and its effect on the hypothesized spinal dysfunction remains unclear. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique. Although scarcely reported, HVLA manipulations in infants and young children could lead to severe harms. Severe harms were likely to be associated with unexamined or missed underlying medical pathology. Nevertheless, there is a need for high quality research to increase certainty about effectiveness and safety of specific SMT techniques in infants, children and adolescents. We encourage conduction of controlled studies that focus on the effectiveness of specific SMT techniques on spinal dysfunction, instead of concluding about SMT as a general treatment approach. Large observational studies could be conducted to monitor the course of complaints/symptoms in children and to gain a greater understanding of potential harms.

The situation regarding spinal manipulation for children might be summarised as follows:

  1. Spinal manipulations are not demonstrably effective for paediatric conditions.
  2. They can cause serious direct and indirect harm.
  3. Chiropractors and osteopaths are not usually competent to treat children.
  4. They nevertheless treat children regularly.

In my view, this is unethical and can amount to child abuse.

It is not that long ago that I published a post entitled HOMEOPATHY IN FRANCE: A TRIUMPH OF PROFIT OVER REASON. Today, I am pleased to post one with the reverse title.

It has taken a few years (compared to the UK where it has taken a few decades, it was nevertheless fast), but now it is done. Very briefly, this is what happened:

  • In 2014, our book was published in French. I might be fooling myself, but I do hope that it helped starting a ball rolling in France where, up to then, homeopathy had enjoyed a free ride.
  • Subsequently, French sceptics began raising their voices against quackery in general and homeopathy in particular.
  • In 2018, they got organised and 124 doctors published an open letter criticising the use of alternative medicine as dangerous practised by charlatans of all kinds.
  • In the same year, the Collège National des Généralistes Engseignants, the national association for teaching doctors, pointed out that there was no rational justification for the reimbursement of homeopathics nor for the teaching of homeopathy in medical schools stating that It is necessary to abandon these esoteric methods, which belong in the history books.
  • Also in 2018, the University of Lille announced its decision to stop its course on homeopathy. The faculty of medicine’s dean, Didier Gosset, said: It has to be said that we teach medicine based on proof – we insist on absolute scientific rigour – and it has to be said that homeopathy has not evolved in the same direction, that it is a doctrine that has remained on the margins of the scientific movement, that studies on homeopathy are rare, that they are not very substantial. Continuing to teach it would be to endorse it.
  • In 2019, the French Academies of Medicine and Pharmacy have published a document entitled ‘L’homéopathie en France : position de l’Académie nationale de médecine et de l’Académie nationale de pharmacie’. It stated that L’homéopathie a été introduite à la fin du XVIIIe siècle, par Samuel Hahnemann, postulant deux hypothèses : celle des similitudes (soigner le mal par le mal) et celle des hautes dilutions. L’état des données scientifiques ne permet de vérifier à ce jour aucune de ces hypothèses. Les méta-analyses rigoureuses n’ont pas permis de démontrer une efficacité des préparations homéopathiques. The academies concluded that no French university should offer degrees in homeopathy, and that homeopathy should no longer be funded by the public purse: “no homeopathic preparation should be reimbursed by Assurance Maladie [France’s health insurance] until the demonstration of sufficient medical benefit has been provided. No university degree in homeopathy should be issued by medical or pharmaceutical faculties … The reimbursing of these products by the social security seems aberrant at a time when, for economic reasons, we are not reimbursing many classic medicines because they are more or less considered to not work well enough …”
  • Only weeks later, the French health regulator (HAS) has recommended with a very large majority (only one vote against) for the discontinuation of the reimbursement of homeopathic products.
  • The health minister, Agnès Buzyn, announced “Je me tiendrai à l’avis de la Haute Autorité de santé”.
  • Consequently, the powerful French homeopathy lobby created political pressure in multiple ways, including a petition with over 1000000 signatures and the last minute press-release below.

It is important, I think, to use this occasion for considering the main arguments of the homeopathy lobby in their defence of homeopathy.

  1. Homeopathy is effective. This argument is demonstrably false and can only be made, if one abuses the published evidence. One way to demonstrate this is to look at the official verdicts from around the globe.
  2. Homeopathy may only be a placebo, but it prevents patients taking dangerous drugs instead. This argument is tricky but wrong. If patients are ill, they need an effective therapy and not homeopathy. If they are not ill, they need reassurance and not a placebo. We need to educate the public and doctors to understand this simple message rather than pulling wool over their eyes.
  3. Discontinuing homeopathy is an undesirable curtailment of our freedom of choice. This is a pseudo-argument, because nobody forbids anyone using homeopathy. All we advocate is that the public purse should only pay for effective treatments. Any other strategy means that we jeopardise funds for effective therapies.
  4. Homeopathy employs over 1000 workers, and any cut in reimbursement would jeopardise these jobs. This argument is also tricky (and it is probably the one that created a headache for politicians). It is, however, spurious. Firstly, job preservation is only a good thing, if the jobs in question are worth preserving. If they serve no good service to the public, they are probably not worth preserving. (We don’t need to all start smoking, for instance, in order to preserve the jobs in the tobacco industry.) Secondly, the argument contradicts the other arguments of the homeopathy lobby. If homeopathy were effective and helpful, people would carry on buying homeopathics regardless of any cut in reimbursement. Thirdly, I suspect the figure of > 1000 will turn out to be hugely exaggerated. Fourthly, arguments of this kind are deeply regressive; they have historically stood in the way of progress whenever an innovation was inescapable (think of the industrial revolution, for instance), and they have never succeeded.

To contemplate these arguments carefully is important, I feel, because this will help other rational thinkers to fight for progress, optimal healthcare and good science. There is still plenty of quackery out there. So, let’s celebrate the French triumph (à votre santé, Agnès Buzyn!!!) – and then roll up our sleeves and get cracking!

George Vithoulkas, has been mentioned on this blog repeatedly. He is a lay homeopath – one that has no medical background – and has, over the years, become an undisputed hero within the world of homeopathy. Yet, Vithoulkas’ contribution to homeopathy research is perilously close to zero. Judging from a recent article in which he outlines the rules of rigorous research, his understanding of research methodology is even closer to zero. Here is a crucial excerpt from this paper intercepted by a few comment from me in brackets and bold print.

Which are [the] homoeopathic principles to be respected [in clinical trials and meta-analyses]?

1. Homoeopathy does not treat diseases, but only diseased individuals. Therefore, every case may need a different remedy although the individuals may be suffering from the same pathology. This rule was violated by almost all the trials in most meta-analyses. (This statement is demonstrably false; there even has been a meta-analysis of 32 trials that respect this demand)

2. In the homoeopathic treatment of serious chronic pathology, if the remedy is correct usually a strong initial aggravation takes place []. Such an aggravation may last from a few hours to a few weeks and even then we may have a syndrome-shift and not the therapeutic results expected. If the measurements take place in the aggravation period, the outcome will be classified negative. (Homeopathic aggravations exist only in the mind of homeopaths; our systematic review failed to find proof for their existence.)

This factor was also ignored in most trials []. At least sufficient time should be given in the design of the trial, in order to account for the aggravation period. The contrary happened in a recent study [], where the aggravation period was evaluated as a negative sign and the homoeopathic group was pronounced worse than the placebo []. (There are plenty of trials where the follow-up period is long enough to account for this [non-existing] phenomenon.)

3. In severe chronic conditions, the homoeopath may need to correctly prescribe a series of remedies before the improvement is apparent. Such a second or third prescription should take place only after evaluating the effects of the previous remedies []. Again, this rule has also been ignored in most studies. (Again, this is demonstrably wrong; there are many trials where the homeopath was able to adjust his/her prescription according to the clinical response of the patient.)

4. As the prognosis of a chronic condition and the length of time after which any amelioration set in may differ from one to another case [], the treatment and the study-design respectively should take into consideration the length of time the disease was active and also the severity of the case. (This would mean that conditions that have a short history, like post-operative ileus, bruising after injury, common cold, etc. should respond well after merely a short treatment with homeopathics. As this is not so, Vithoulkas’ argument seems to be invalid.)

5. In our experience, Homeopathy has its best results in the beginning stages of chronic diseases, where it might be possible to prevent the further development of the chronic state and this is its most important contribution. Examples of pathologies to be included in such RCTs trials are ulcerative colitis, sinusitis, asthma, allergic conditions, eczema, gangrene rheumatoid arthritis as long as they are within the first six months of their appearance. (Why then is there a lack of evidence that any of the named conditions respond to homeopathy?)

In conclusion, three points should be taken into consideration relating to trials that attempt to evaluate the effectiveness of homoeopathy.

First, it is imperative that from the point of view of homoeopathy, the above-mentioned principles should be discussed with expert homoeopaths before researchers undertake the design of any homoeopathic protocol. (I am not aware of any trial where this was NOT done!)

Second, it would be helpful if medical journals invited more knowledgeable peer-reviewers who understand the principles of homoeopathy. (I am not aware of any trial where this was NOT done!)

Third, there is a need for at least one standardized protocol for clinical trials that will respect not only the state-of-the-art parameters from conventional medicine but also the homoeopathic principles []. (Any standardised protocol would be severely criticised; a good study protocol must always take account of the specific research question and therefore cannot be standardised.)

Fourth, experience so far has shown that the therapeutic results in homeopathy vary according to the expertise of the practitioner. Therefore, if the objective is to validate the homeopathic therapeutic modality, the organizers of the trial have to pick the best possible prescribers existing in the field. (I am not aware of any trial where this was NOT done!)

Only when these points are transposed and put into practice, the trials will be respected and accepted by both homoeopathic practitioners and conventional medicine and can be eligible for meta-analysis.

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I suspect what the ‘GREAT VITHOULKAS’ really wanted to express are ‘THE TWO ESSENTIAL PRINCIPLES OF HOMEOPATHY RESEARCH’:

  1. A well-designed study of homeopathy can always be recognised by its positive result.
  2. Any trial that fails to yield a positive finding is, by definition, wrongly designed.

A few days ago, I reported that the German homeopathy manufacturer Hevert has taken legal action against German critics of homeopathy. This caused a storm of protests on twitter, in the press and even on TV. Hevert has remained silent in all this, but now a spokesperson and part owner of the firm, Mr Mathias Hevert, has given an interview to ‘Pharma Relations’ in an attempt to explain and justify Hevert’s position.

The interview does not tell us much, except for one particular passage:

Frau Grams hat sich meines Wissens nach gar nicht konkret auf die Produkte der Firma Hevert bezogen. Warum fühlten Sie sich dennoch aufgerufen, sozusagen stellvertretend für die Branche juristische Schritte einzuleiten?

Da homöopathische Arzneimittel neben pflanzlichen und schulmedizinischen Präparaten einen wichtigen Teil des breiten Hevert-Sortiments darstellen, fühlen wir uns bereits seit der Firmengründung 1956 eng mit der durch Pastor Emanuel Felke begründeten Komplexmittel-Homöopathie verbunden. Seit Monaten beobachten wir, wie die Homöopathie von Meinungsbildnern in den Sozialen Medien, der Presse und dem Fernsehen undifferenziert und ohne wissenschaftliche Grundlage denunziert wird. In Großbritannien wurden bereits einflussreiche Lobbygruppen aktiv, um die Homöopathie als Ganzes und ohne differenzierte Betrachtung der Datenlage zu verunglimpfen. Mit ihren Bemühungen schafften sie es sogar, die Politik zu gesetzlichen Einschränkungen des Feldes zu drängen. Um ähnliches in Deutschland – dem Mutterland der Homöopathie – zu verhindern, geht Hevert entschlossen gegen ungerechtfertigte und nicht fundierte Diskreditierungen der Homöopathie durch Lobbygruppen und andere Meinungsbildner vor.

Here is my translation of the bit that concerns me:

Q: Frau Grams has, as far as I know, not even concretely referred to the products of Hevert. Why do you still feel compelled to start legal procedures, so to speak for the sector?

A: … We observe since months how homeopathy is being denounced in an undifferentiated manner and without a scientific basis by opinion leaders in social media, the press, an on TV. In England, influential lobby groups have been active to denigrate homeopathy as a whole and without differentiated consideration of the data. Through their efforts, they have even managed to force politicians to implement legal restrictions in this area…

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I must admit, I find this response quite extraordinary!

I am not aware of anyone or any group in England denigrating homeopathy without differentiated consideration of the data. All we did was to point out what the best available evidence tells us, exercise our critical thinking abilities, and report facts. And I do strongly object anyone claiming otherwise. In fact, I ask myself whether the above remarks by a representative of a manufacturer of homeopathics are not libellous and thus actionable.

What do you think?

PS

But perhaps I have misunderstood something; in this case, could Mr Hevert please name the UK critics he had in mind when he made these comments?

This press-release caught my attention:

Following the publication in Australia earlier this year of a video showing a chiropractor treating a baby, the Health Minster for the state of Victoria called for the prohibition of chiropractic spinal manipulation for children under the age of 12 years. As a result, an independent panel has been appointed by Safer Care Victoria to examine the evidence and provide recommendations for the chiropractic care of children.

The role of the panel is to (a) examine and assess the available evidence, including information from consumers, providers, and other stakeholders, for the use of spinal manipulation by chiropractors on children less than 12 years of age and (b) provide recommendations regarding this practice to the Victorian Minister for Health.
Members of the public and key stakeholders, including the WFC’s member for Australia, the Australia Chiropractors Association (AusCA), were invited to submit observations. The AusCA’s submission can be read here

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This submission turns out to be lengthy and full of irrelevant platitudes, repetitions and nonsense. In fact, it is hard to find in it any definitive statements at all. Here are two sections (both in bold print) which I found noteworthy:

1. There is no need to restrict parental or patient choice for chiropractic care for children under 12 years of age as there is no evidence of harm. There is however, expressed outcome of benefit by parents70 who actively choose chiropractic care for their children … 

No evidence of harm? Really! This is an outright lie. Firstly, one has to stress that there is no monitoring system and that therefore we simply do not learn about adverse effects. Secondly, there is no reason to assume that the adverse effects that have been reported in adults are not also relevant for children. Thirdly, adverse effects in children have been reported; see for instance here. Fourthly, we need to be aware of the fact that any ineffective therapy causes harm by preventing effective therapies from being applied. And fifthly, we need to remember that some chiropractors harm children by advising their parents against vaccination.

2. Three recent systematic reviews have focused on the effectiveness of manual therapy for paediatric conditions. For example, Lanaro et al. assessed osteopathic manipulative treatment for use on preterm infants. This systematic review looked at five clinical trials and found a reduction of length of stay and costs in a large population of preterm infants with no adverse events (96).

Carnes et al.’s 2018 systematic review focused on unsettled, distressed and excessively crying infants following any type of manual therapy. Of the seven clinical trials included, five involved chiropractic manipulative therapy; however, meta-analyses of outcomes were not possible due to the heterogeneity of the clinical trials. The review also analysed an additional 12 observational studies: seven case series, three cohort studies, one service evaluation survey, and one qualitative study. Overall, the systematic review concluded that small benefits were found. Additionally, the reporting of adverse events was low. Interestingly, when a relative risk analysis was done, those who had manual therapy were found to have an 88% reduced risk of having an adverse event compared to those who did not have manual therapy (97).

A third systematic review by Parnell Prevost et al. in 2019 evaluated the effectiveness of any paediatric condition following manual therapy of any type and summarizes the findings of studies of children 18 years of age or younger, as well as all adverse event information. While mostly inconclusive data were found due to lack of high-quality studies, of the 32 clinical trials and 18 observational studies included, favourable outcomes were found for all age groups, including improvements in suboptimal breastfeeding and musculoskeletal conditions. Adverse events were mentioned in only 24 of the included studies with no serious adverse events reported in them (98).

(96) Lanaro D, Ruffini N, Manzotti A, Lista G. Osteopathic manipulative treatment showed reduction of length of stay and costs in preterm infants: A systematic review and meta-analysis. Medicine (Baltimore). 2017; 96(12):e6408 10.1097/MD.0000000000006408.

(97) Carnes D, Plunkett A, Ellwood J, Miles C. Manual therapy for unsettled, distressed and excessively crying infants: a systematic review and meta-analyses. BMJ Open 2018;8:e019040. doi:10.1136/bmjopen-2017-019040.

(98) Parnell Prevost et al. 2019.

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And here are my comments:

(96) Lanaro et al is about osteopathy, not chiropractic (4 of the 5 primary trials were by the same research group).

(97) The review by Carnes et al has been discussed previously on this blog. This is what I wrote about it at the time:

The authors concluded that some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

For several reasons, I find this review, although technically sound, quite odd.

Why review uncontrolled data when RCTs are available?

How can a qualitative study be rated as high quality for assessing the effectiveness of a therapy?

How can the authors categorically conclude that there were benefits when there were only 4 RCTs of high quality?

Why do they not explain the implications of none of the RCTs being placebo-controlled?

How can anyone pool the results of all types of manual therapies which, as most of us know, are highly diverse?

How can the authors conclude about the safety of manual therapies when most trials failed to report on this issue?

Why do they not point out that this is unethical?

My greatest general concern about this review is the overt lack of critical input. A systematic review is not a means of promoting an intervention but of critically assessing its value. This void of critical thinking is palpable throughout the paper. In the discussion section, for instance, the authors state that “previous systematic reviews from 2012 and 2014 concluded there was favourable but inconclusive and weak evidence for manual therapy for infantile colic. They mention two reviews to back up this claim. They conveniently forget my own review of 2009 (the first on this subject). Why? Perhaps because it did not fit their preconceived ideas? Here is my abstract:

Some chiropractors claim that spinal manipulation is an effective treatment for infant colic. This systematic review was aimed at evaluating the evidence for this claim. Four databases were searched and three randomised clinical trials met all the inclusion criteria. The totality of this evidence fails to demonstrate the effectiveness of this treatment. It is concluded that the above claim is not based on convincing data from rigorous clinical trials.

Towards the end of their paper, the authors state that “this was a comprehensive and rigorously conducted review…” I beg to differ; it turned out to be uncritical and biased, in my view. And at the very end of the article, we learn a possible reason for this phenomenon: “CM had financial support from the National Council for Osteopathic Research from crowd-funded donations.”

(98) Parnell et al was easy to find despite the incomplete reference in the submission. This paper has also been discussed previously. Here is my post on it:

This systematic review is an attempt [at] … evaluating the use of manual therapy for clinical conditions in the paediatric population, assessing the methodological quality of the studies found, and synthesizing findings based on health condition.

Of the 3563 articles identified through various literature searches, 165 full articles were screened, and 50 studies (32 RCTs and 18 observational studies) met the inclusion criteria. Only 18 studies were judged to be of high quality. Conditions evaluated were:

      • attention deficit hyperactivity disorder (ADHD),
      • autism,
      • asthma,
      • cerebral palsy,
      • clubfoot,
      • constipation,
      • cranial asymmetry,
      • cuboid syndrome,
      • headache,
      • infantile colic,
      • low back pain,
      • obstructive apnoea,
      • otitis media,
      • paediatric dysfunctional voiding,
      • paediatric nocturnal enuresis,
      • postural asymmetry,
      • preterm infants,
      • pulled elbow,
      • suboptimal infant breastfeeding,
      • scoliosis,
      • suboptimal infant breastfeeding,
      • temporomandibular dysfunction,
      • torticollis,
      • upper cervical dysfunction.

Musculoskeletal conditions, including low back pain and headache, were evaluated in seven studies. Only 20 studies reported adverse events.

The authors concluded that fifty studies investigated the clinical effects of manual therapies for a wide variety of pediatric conditions. Moderate-positive overall assessment was found for 3 conditions: low back pain, pulled elbow, and premature infants. Inconclusive unfavorable outcomes were found for 2 conditions: scoliosis (OMT) and torticollis (MT). All other condition’s overall assessments were either inconclusive favorable or unclear. Adverse events were uncommonly reported. More robust clinical trials in this area of healthcare are needed.

There are many things that I find remarkable about this review:

      • The list of indications for which studies have been published confirms the notion that manual therapists – especially chiropractors – regard their approach as a panacea.
      • A systematic review evaluating the effectiveness of a therapy that includes observational studies without a control group is, in my view, highly suspect.
      • Many of the RCTs included in the review are meaningless; for instance, if a trial compares the effectiveness of two different manual therapies none of which has been shown to work, it cannot generate a meaningful result.
      • Again, we find that the majority of trialists fail to report adverse effects. This is unethical to a degree that I lose faith in such studies altogether.
      • Only three conditions are, according to the authors, based on evidence. This is hardly enough to sustain an entire speciality of paediatric chiropractors.

Allow me to have a closer look at these three conditions.

      1. Low back pain: the verdict ‘moderate positive’ is based on two RCTs and two observational studies. The latter are irrelevant for evaluating the effectiveness of a therapy. One of the two RCTs should have been excluded because the age of the patients exceeded the age range named by the authors as an inclusion criterion. This leaves us with one single ‘medium quality’ RCT that included a mere 35 patients. In my view, it would be foolish to base a positive verdict on such evidence.
      2. Pulled elbow: here the verdict is based on one RCT that compared two different approaches of unknown value. In my view, it would be foolish to base a positive verdict on such evidence.
      3. Preterm: Here we have 4 RCTs; one was a mere pilot study of craniosacral therapy following the infamous A+B vs B design. The other three RCTs were all from the same Italian research group; their findings have never been independently replicated. In my view, it would be foolish to base a positive verdict on such evidence.

So, what can be concluded from this?

I would say that there is no good evidence for chiropractic, osteopathic or other manual treatments for children suffering from any condition.

_________________________________________________________________

The ACA’s submission ends with the following conclusion:

The Australian Chiropractors Association (ACA) intent is to improve the general health of all Australians and the ACA supports the following attributes to achieve this:

      • The highest standards of ethics and conduct in all areas of research, education and practise
      • Chiropractors as the leaders in high quality spinal health and wellbeing
      • A commitment to evidence-based practice – the integration of best available research evidence, clinical expertise and patient values
      • The profound significance and value of patient-centred chiropractic care in healthcare in Australia.
      • Inclusiveness and collaborative relationships within and outside the chiropractic profession…

After reading through the entire, tedious document, I arrived at the conclusion that

THIS SUBMISSION CAN ONLY BE A CALL FOR THE PROHIBITION OF CHIROPRACTIC SPINAL MANIPULATION FOR CHILDREN.

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