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

evidence

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In staunch defiance of the evidence and common sense, Prince Charles has long defended homeopathy. Apparently, he not only uses it himself but also employs it for his animals. Claiming that his cattle don’t know about placebo effects, he seems convinced it works better than a placebo. Homeopaths are naturally delighted to have his royal support, not least the ones from India where homeopathy has been hugely popular for many years.

From the beginning of the pandemic, many Indian enthusiasts have claimed that homeopathy can effectively prevent and treat COVID-19 infections. In parts of India, homeopathy was thus employed on a population basis in an attempt to prevent the spread of the disease. There were voices that warned of a disaster but the  Indian enthusiasm for homeopathy as an effective anti-COVID-19 therapy won the day.Image

When Prince Charles fell ill with COVID-19, Indian officials did not hesitate to claim that his quick recovery was due to the homeopathic treatment he had received. Charles’ officials denied this but in India, the story was reported widely and lent crucial support to the myth that homeopathy would provide a solution to the pandemic. Subsequently, Indian officials began to rely even more on the alleged power of homeopathy.

Today, the consequences of these actions are becoming tragically visible: With more than 15 million confirmed cases, India is experiencing a catastrophic tsunami of COVID-19 infections. Its healthcare system is close to collapse, and the high prevalence of the virus provides dangerously fertile grounds for the development of mutants. One does not need to be a clairvoyant to predict that, in turn, these will cause problems on a global basis.

Why am I telling you all this?

I think this depressing sequence of events shows in exemplary fashion what damage ill-informed VIP support for an ineffective therapy can do. Many people tend to feel that Charles’ passion for homeopathy might perhaps be laughable but is essentially harmless. I beg to differ. I am not saying that Charles instructed Indian officials to employ homeopathy the way they did. I am even emphasizing that Charles’ officials denied that homeopathy had anything to do with his speedy recovery after his illness. But I am saying that Charles’ life-long promotion of homeopathy combined with his quick recovery motivated Indian officials, even more, to ignore the evidence and decide to heavily rely on homeopathy.

This decision has cost uncounted lives and will cause many more in the near future. I submit that the seemingly harmless promotion of unproven or disproven treatments such as homeopathy can be a deadly dangerous game indeed.

 

In Germany, homeopathy had a free ride for a very long time. In recent years, however, several doctors, pharmacists, scientists, etc. have started opposing the fact that the public has to pay for ineffective treatments such as homeopathics. As a consequence, homeopaths have begun to fight back. The weapons they chose are often not the most subtle. Now they seem to have reached a new low; the Board of the German Central Association of Homeopathic Physicians (DZVhÄ) has sent an open letter to the Board of the German Society of Internal Medicine (DGIM) and to the participating colleagues of the 127th Congress of the DGIM from April 17 – 20, 2021 in an attempt to stop an invited lecture of a critic of homeopathy.

Here is my translation of the letter:

Dear colleagues on the board of the DGIM,

We were very surprised to read that an ENT colleague will speak on homeopathy at the 127th Congress of Internal Medicine. Dr. Lübbers is known up and down the country as a media-active campaigner against homeopathy. His “awakening experience” he had, according to his own account, when he had to fish homeopathic pills out of the ear of a child with otitis, since then he is engaged – no: not for better education, in the mentioned case of the parents or other users – against the method homeopathy (which was certainly not “guilty” of the improper application!).

It has surely not escaped you that in all media again and again only a small handful of self-proclaimed “experts” – all from the clique of the skeptic movement! – are heard on the subject of homeopathy. A single (!) fighter against homeopathy is a physician who completed her training in homeopathy and practices for a time as a homeopath. All the others come from non-medical and other occupational groups. In contrast, there are several thousand medical colleagues throughout Germany who stand on the ground of evidence-based medicine, have learned conventional medicine, implement it in their practices, and have completed a recognized continuing education program in homeopathy.

In the German Central Association of Homeopathic Physicians – the oldest medical professional association in Germany – 146 qualified internists are currently registered as members, in addition to numerous other medical specialists, all of whom are actively practicing medicine.

Question: Why does the German Society for Internal Medicine invite an ENT specialist, of all people, who lectures on homeopathy without any expertise of his own? Why not at least a specialist colleague in internal medicine? Or even a colleague who could report on the subject from her own scientific or practical experience? For example, on the topic of “hyperaldosteronism,” would you also invite a urologist or orthodontist? And if so, why?

Dear Board of Directors of the DGIM: As an honorary board member of the German Central Association of Homeopathic Physicians e.V.. (DZVhÄ) – and a specialist in internal medicine – I am quite sure that we could immediately name several colleagues with sufficient expertise as homeopathically trained and experienced internists, if you are really interested in a solid and correct discourse on the subject of homeopathy. Under the above-mentioned circumstances, there is, of course, rather the suspicion that it should not be about, but rather exclusively against homeopathy.

If it is planned for a later congress, e.g. in 2022, to deal again with the topic of homeopathy in a truly professionally well-founded and possibly even more balanced form: please contact us at any time! As medical colleagues, we are very interested in a fair and unprejudiced professional discourse.

Yours sincerely

Dr. med. Ulf Riker, Internist – Homeopathy – Naturopathy

2nd chairman DZVhÄ / 1st chairman LV Bayern

________________

What are Riker and the DZVhÄ trying to say with this ill-advised, convoluted, and poorly written letter?

Let me try to put his points a little clearer:

  • They are upset that the congress of internists invited a non-homeopath to give a lecture about homeopathy.
  • The person in question, Dr. Lübbers, is an ENT specialist and, like all other German critics of homeopathy (apart from one, Dr. Grams), does not understand homeopathy.
  • There are thousands of physicians who do understand it and are fully trained in homeopathy.
  • They would therefore do a much better job in providing a lecture.
  • So, would the German internists please invite homeopaths for their future meetings?

And what is Riker trying to achieve?

  • It seems quite clear that he aims to prevent criticism of homeopathy.
  • He wishes to replace it with pro-homeopathy propaganda.
  • Essentially he wants to stifle free speech, it seems to me.

To reach these aims, he does not hesitate to embarrass himself by sending and making publicly available a very stupid letter. He also behaves in a most unprofessional fashion and does not mind putting a few untruths on paper.

Having said that, I will admit that they are in good company. Hahnemann was by all accounts a most intolerant and cantankerous chap himself. And during the last 200 years, his followers have given ample evidence that critical thinking has remained an alien concept for them. Consequently, such behavior seems not that unusual for German defenders of homeopathy. In recent times they have:

Quite a track record, wouldn’t you agree?

But, I think, attempting to suppress free speech beats it all and must be a new low in the history of homeopathy.

 

Absurd claims about spinal manipulative therapy (SMT) improving immune function have increased substantially during the COVID-19 pandemic. Is there any basis at all for such notions?

The objective of this systematic review was to identify, appraise, and synthesize the scientific literature on the efficacy and effectiveness of SMT in preventing the development of infectious disease or improving disease-specific outcomes in patients with infectious disease and to examine the association between SMT and selected immunological, endocrine, and other physiological biomarkers.

A literature search of MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, the Index to Chiropractic Literature, the Cochrane Central Register of Controlled Trials, and Embase was conducted. Randomized clinical trials and cohort studies were included. Eligible studies were critically appraised, and evidence with high and acceptable quality was synthesized using the Synthesis Without Meta-Analysis guideline.

A total of 2593 records were retrieved; after exclusions, 50 full-text articles were screened, and 16 articles reporting the findings of 13 studies comprising 795 participants were critically appraised. No clinical studies were located that investigated the efficacy or effectiveness of SMT in preventing the development of infectious disease or improving disease-specific outcomes among patients with infectious disease. Eight articles reporting the results of 6 high- and acceptable-quality RCTs comprising 529 participants investigated the effect of SMT on biomarkers. Spinal manipulative therapy was not associated with changes in lymphocyte levels or physiological markers among patients with low back pain or participants who were asymptomatic compared with sham manipulation, a lecture series, and venipuncture control groups. Spinal manipulative therapy was associated with short-term changes in selected immunological biomarkers among asymptomatic participants compared with sham manipulation, a lecture series, and venipuncture control groups.

The authors concluded that no clinical evidence was found to support or refute claims that SMT was efficacious or effective in changing immune system outcomes. Although there were limited preliminary data from basic scientific studies suggesting that SMT may be associated with short-term changes in immunological and endocrine biomarkers, the clinical relevance of these findings is unknown. Given the lack of evidence that SMT is associated with the prevention of infectious diseases or improvements in immune function, further studies should be completed before claims of efficacy or effectiveness are made.

I fully agree with the data as summarised in this paper. Yet, I find the conclusions a bit odd. The authors of this paper are chiropractors who declare the following conflicts of interest: Dr Côté reported receiving grants from the College of Chiropractors of British Columbia during the conduct of the study and grants from the Canadian Chiropractic Research Foundation, travel expenses from the World Federation of Chiropractic, and personal fees from the Canadian Chiropractic Protective Association outside the submitted work. Dr Cancelliere reported receiving grants from the Canadian Chiropractic Research Foundation outside the submitted work. Dr Mior reported receiving grants from the College of Chiropractors of British Columbia during the conduct of the study and grants from the Canadian Chiropractic Association and the Ontario Chiropractic Association outside the submitted work. Dr Hogg-Johnson reported receiving grants from the College of Chiropractors of British Columbia during the conduct of the study and grants from the Canadian Chiropractic Research Foundation outside the submitted work. No other disclosures were reported. The research was supported by funding from the College of Chiropractors of British Columbia to Ontario Tech University, the Canada Research Chairs program (Dr Côté), and the Canadian Chiropractic Research Foundation (Dr Cancelliere).

Would authors independent of chiropractic influence have drawn the same conclusions? I doubt it! While I do appreciate that chiropractors published these negative findings prominently, I feel the conclusions could easily be put much clearer:

There is no clinical evidence to support claims that SMT is efficacious or effective in changing immune system outcomes. Further studies in this area are not warranted.

Low back pain must be one of the most frequent reasons for patients to seek out some so-called alternative medicine (SCAM). It would therefore be important that the information they get is sound. But is it?

The present study sought to assess the quality of web-based consumer health information available at the intersection of LBP and CAM. The investigators searched Google using six unique search terms across four English-speaking countries. Eligible websites contained consumer health information in the context of CAM for LBP. They used the DISCERN instrument, which consists of a standardized scoring system with a Likert scale from one to five across 16 questions, to conduct a quality assessment of websites.

Across 480 websites identified, 32 were deemed eligible and assessed using the DISCERN instrument. The mean overall rating across all websites 3.47 (SD = 0.70); Summed DISCERN scores across all websites ranged from 25.5-68.0, with a mean of 53.25 (SD = 10.41); the mean overall rating across all websites 3.47 (SD = 0.70). Most websites reported the benefits of numerous CAM treatment options and provided relevant information for the target audience clearly, but did not adequately report the risks or adverse side-effects adequately.

The authors concluded that despite some high-quality resources identified, our findings highlight the varying quality of consumer health information available online at the intersection of LBP and CAM. Healthcare providers should be involved in the guidance of patients’ online information-seeking.

In the past, I have conducted several similar surveys, for instance, this one:

Background: Low back pain (LBP) is expected to globally affect up to 80% of individuals at some point during their lifetime. While conventional LBP therapies are effective, they may result in adverse side-effects. It is thus common for patients to seek information about complementary and alternative medicine (CAM) online to either supplement or even replace their conventional LBP care. The present study sought to assess the quality of web-based consumer health information available at the intersection of LBP and CAM.

Methods: We searched Google using six unique search terms across four English-speaking countries. Eligible websites contained consumer health information in the context of CAM for LBP. We used the DISCERN instrument, which consists of a standardized scoring system with a Likert scale from one to five across 16 questions, to conduct a quality assessment of websites.

Results: Across 480 websites identified, 32 were deemed eligible and assessed using the DISCERN instrument. The mean overall rating across all websites 3.47 (SD = 0.70); Summed DISCERN scores across all websites ranged from 25.5-68.0, with a mean of 53.25 (SD = 10.41); the mean overall rating across all websites 3.47 (SD = 0.70). Most websites reported the benefits of numerous CAM treatment options and provided relevant information for the target audience clearly, but did not adequately report the risks or adverse side-effects adequately.

Conclusion: Despite some high-quality resources identified, our findings highlight the varying quality of consumer health information available online at the intersection of LBP and CAM. Healthcare providers should be involved in the guidance of patients’ online information-seeking.

Or this one:

Background: Some chiropractors and their associations claim that chiropractic is effective for conditions that lack sound supporting evidence or scientific rationale. This study therefore sought to determine the frequency of World Wide Web claims of chiropractors and their associations to treat, asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence).

Methods: A review of 200 chiropractor websites and 9 chiropractic associations’ World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States was conducted between 1 October 2008 and 26 November 2008. The outcome measure was claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment.

Results: We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain,

Conclusions: The majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.

The findings were invariably disappointing and confirmed those of the above paper. As it is nearly impossible to do much about this lamentable situation, I can only think of two strategies for creating progress:

  1. Advise patients not to rely on Internet information about SCAM.
  2. Provide reliable information for the public.

Both describe the raison d’etre of my blog pretty well.

Recently, I came across a newspaper asking: “Which vaccine do you trust most?” It turned out that there was a clear favourite according to public opinion. In the present climate of heated debates about COVID vaccines, this seems to make sense.

Or doesn’t it?

What determines public opinion?

There are probably many determinants, but most are dominated by what the public is being told about a subject. If, for instance, the press incessantly reports bad things about a certain vaccine and mostly good news about another, public opinion will reflect exactly that.

What I am trying to point out is this: the man and woman in the street have no expertise in vaccines. They mostly think what they are being told about them. So, public opinion is largely determined by journalists who write about the subject. If then a newspaper presents the public opinion about a vaccine, it is all but a foregone conclusion. The paper might as well just repeat what they have been telling their readers. By presenting a ‘public opinion’ about vaccines they actually go one step further: they amplify their own opinion by pretending it is not of their making but that of the public.

All this seems fairly obvious, once you start thinking about it.

So, why do I go on about it?

If this phenomenon occurs with vaccines, it also occurs with other issues, for instance, so-called alternative medicine (SCAM). We often hear that the public is in favour of this or that type of SCAM. It is supposed to convince us and politicians that SCAM is good. If thousands or even millions are in favour of it, it must be good! Who am I to disagree with the public?

But, as we have just seen with the example of the vaccines, public opinion is merely a reflection of what the press tells people. The man and the woman in the street are not competent to reliably estimate the risk-benefit ratios of St John’s wort, Arnica, glucosamine, acupuncture, etc. etc. They can judge such issues as little as they can judge the risk-benefit balance of a vaccine. They rely on information from the outside, and that information usually reaches them by the press.

What am I aiming at?

Public opinion sounds impressive, and in the realm of SCAM, it often determines much. If the public opinion is in favour of homoeopathy, for instance, politicians are likely to lend their support to it. Yet, public opinion is just OPINION! It cannot be used as an indicator for the efficacy or safety of medical interventions, and it cannot be the reason for using or rejecting them.

It follows, I think, that journalists have a huge responsibility to inform the public correctly on SCAM (and any other matter). On this blog, we have seen numerous instances of journalists who could have done better, e.g.:

Public opinion, it seems to me, can only be meaningful, if the information fed to the public is sound. And when it comes to SCAM, this condition is often not met.

 

 

After yesterday’s post entitled ‘What does a holistic doctor do that a traditional doctor doesn’t?‘, I thought it would only be fair to turn the question around and ask: What does a proper doctor do that a holistic healer doesn’t? The answers will upset a lot of practitioners of alternative medicine (SCAM), but so be it.

So, what does a proper doctor do that a holistic healer doesn’t?

I suggest several answers and hope that the readers of this blog will contribute to further points. Many of them center around safeguarding the public:

  • Proper doctors avoid confusing or misleading the public with titles they do not have.
  • They do have rigorous education and training.
  • They avoid making false therapeutic claims.
  • They adhere to the ethical standards of their profession.
  • They resist the temptation to advertise their services to the consumer.
  • They do their best to identify the cause of their patient’s symptoms.
  • They treat the causes of disease whenever possible.
  • They avoid pretending that they always have all the answers.
  • They abide by the rules of evidence-based medicine.
  • They are aware that almost any effective treatment comes with adverse effects.
  • They try to keep abreast with the rapid advances in medicine.
  • They know that a patient is more than a diagnostic label.
  • They try to treat patients holistically.

At this stage, I can hear some readers shout in anger:

  • Ahh, but that is rubbish!
  • I know doctors who are not at all like that!
  • You are idealizing your profession!
  • This is little more than wishful thinking!

Yes, I know that many patients are disappointed and have had a bad experience with conventional medicine. That is one of the reasons many try SCAM. I know that many doctors occasionally fail to live up to the ideal that I depicted above. And I fear that some do so more often than just occasionally.

This is regrettable and occasionally it is unacceptable. Medicine is populated not by perfect people; it is run by humans like you and me. Humans are fallible. Doctors have bad days just like you and me. If that happens regularly, we need to address the problems that may the cause of the deficit. If necessary, the case has to go before a disciplinary hearing. There are thousands of experts who are dedicated to improving healthcare in the hope of generating progress.

The point I was trying to make is that there is such a thing as an ideal physician. It relies on:

  • rigorous training,
  • ethical codes,
  • post-graduate education,
  • supervision,
  • governance,
  • swift disciplinary procedures,
  • advances brought about through colossal research efforts,
  • etc., etc.

Do ‘holistic healers’ offer all of these safeguards?

The sad answer is no.

For those who disagree, let’s briefly look at a recent example.

John Lawler died in 2017 after being treated by a chiropractor (as discussed on this blog before).

  • Mr. Lawler died because of a tear and dislocation of the C4/C5 intervertebral disc caused by a considerable external force.
  • The pathologist’s report also showed that the deceased’s ligaments holding the vertebrae of the upper spine in place were ossified.
  • This is a common abnormality in elderly patients and limits the range of movement of the neck.
  • There was no adequately informed consent by Mr. Lawler.
  • Mr. Lawler seemed to have been under the impression that the chiropractor, who used the ‘Dr’ title, was a medical doctor.
  • There is no reason to assume that the treatment of Mr. Lawler’s neck would be effective for his pain located in his leg.
  • The chiropractor used an ‘activator’ that applies only little and well-controlled force. However, she also employed a ‘drop table’ which applies a larger and not well-controlled force.

As far as I can see, most of the safeguards and standards that apply to conventional medicine were not in place to safeguard Mr. Lawler. And that includes a timely disciplinary hearing of the case. Mr. Lawler died in 2017! The CCG has been dragging its feet ever since, and, as far as I know, the chiropractor was meanwhile allowed to practise. The HEARING BEFORE THE PROFESSIONAL CONDUCT COMMITTEE OF THE GENERAL CHIROPRACTIC COUNCIL has now been scheduled to commence on 19 April 2021.

I know, it’s just an example. But it should make us think.

In the world of homeopathy, Prof Michael Frass is a famous man. He is the First Chairman of the Scientific Society for Homeopathy (WissHom), the president of the Umbrella organization of Austrian Doctors for Holistic Medicine, and the Vicepresident of the Doctors Association for Classical Homeopathy. Frass has featured on this blog before, not least because he has published numerous studies of homeopathy, none of which has ever failed to produce a positive result

This is not just remarkable, in my view, it defies logic and the laws of nature. Even if homeopathy were a supremely effective therapy – a very broad consensus holds that it is not! – one would occasionally expect some negative results. No treatment works under all circumstances

… that is no treatment except homeopathy, according to Frass.

Recently Frass amazed even the world of oncology by publishing a study suggesting that homeopathy can prolong the survival of lung cancer patients. Every oncologist I know was flabbergasted.

Can this be true? This is the question, many people have been asking for some time in relation to Frass’s research.

In my quest to shine more light on it, I was recently alerted to an article by the formidable Austrian investigative journalist, Alwin Schönberger. In 2015, he came across a press release announcing that “HOMEOPATHY HAD BEEN PROVEN TO WORK AFTER ALL” (strikingly similar to one issued in 2018). It came from Austria’s leading manufacturer who was giving an award to an apparently outstanding thesis supervised by Frass. Even today, this piece of research has not been published in the peer-reviewed literature.

Yet, after some difficulties, Schönberger managed to obtain a copy. What he found was surprising, and he thus published his findings in the respected Austrian journal ‘Profil’ (2. Mai 2015 • profil 22).

Frass’s student had been given the task to systematically review all the homeopathy trials published between 2008 and 2012. Contrary to the hype of the press release, the meta-analysis merely suggested a very small effect. When digging deeper, Schönberger found several inconsistencies and mistakes in the analysis. They all were such that they produced a false-positive picture for homeopathy. Upon their correction, homeopathy turned out to be no longer significantly superior to placebo. Frass was then interviewed about it and claimed that the inconsistencies were only ‘errors’ but insisted that homeopathy is not a placebo therapy.

Yes, of course, errors happen in research. But if they all go in one direction and if that direction coincides with the interests of the researchers, we have the right, perhaps even the duty, to be suspicious. The questions that arise from this story are, I think, as follows:

  • Have the errors been corrected?
  • Are there perhaps other errors in Frass’s research?
  • Can we trust anything that Frass says?
  • Is it time to consider an official investigation into Frass’s studies of homeopathy?

 

 

When I yesterday reported about Charles’ new paper in a medical journal, I omitted to go into any sort of detail. Merely mumbling ‘this is bait and switch‘ and ‘there is no good evidence that social prescribing is effective‘, is not good enough. Charles deserves better! That’s why today I provide a more detailed analysis of what he wrote on social prescribing.

Social prescribing is a concept that emerged in the UK more than a decade ago [1]. It aims to connect patients to different types of community support, including social events, fitness classes, and social services. Trained professionals, often called link workers or community connections, work with healthcare providers to offer referrals to these types of support. Social prescribing largely exists to fill in healthcare treatment gaps. The basic medical treatment cannot address every concern. Primary care providers don’t always have enough time to get to know their patients and understand the complete picture of their lives.

For example, loneliness can cause stress, which can eventually affect sleep, nutrition, and physical health. Doctors may not be able to offer much help for this problem. That’s where link workers step in. They can provide more specialized support if someone struggles to meet basic wellness or social needs. They get to know a patient’s unique needs and help you take action to meet those needs by referring him or her to helpful resources in the community.[2]

Charles elaborated on social prescribing (or social prescription, as he calls it for some reason) as follows [the numbers in square brackets were added me and refer to my comments below]:

… For a long time, I have been an advocate of what is now called social prescription and this may just be the key to integrating the biomedical, the psychosocial and the environmental, as well as the nature of the communities within which we live and which have such an enormous impact on our health and wellbeing [1]. In particular, I believe that social prescription can bring together the aims of the health service, local authorities, and the voluntary and volunteer sector. Biomedicine has been spectacularly successful in treating and often curing disease that was previously incurable. Yet it cannot hold all the answers, as witnessed, for instance, by the increasing incidence of long-term disease, antibiotic resistance and opiate dependence [2]. Social prescription enables medicine to go beyond pills and procedures and to recognise the enormous health impact of the lives we lead and the physical and social environment within which we live [3]. This is precisely why I have spent so many years trying to demonstrate the vitally important psychosocial, environmental and financial added value of genuinely, sustainable urban planning, design and construction [4].

There is research from University College London, for instance, which shows that you are almost three times more likely to overcome depression if you have a hobby [5]. Social prescription enables doctors to provide their patients with a bespoke prescription that might help them at a time of need …

When we hear that a quarter of 14–16-year-old girls are self-harming and almost a third of our children are overweight or obese, it should make us realise that we will have to be a bit more radical in addressing these problems [5]. And though social prescription cannot do everything, I believe that, used imaginatively, it can begin to tackle these deep-rooted issues [6]. As medicine starts to grapple with these wider determinants of health [7], I also believe that medicine will need to combine bioscience with personal beliefs, hopes, aspirations and choices [8].

Many patients choose to see complementary practitioners for interventions such as manipulation, acupuncture and massage [9]. Surely in an era of personalised medicine, we need to be open-minded about the choices that patients make and embrace them where they clearly improve their ability to care for themselves? [10] Current NHS guidelines on pain that acknowledge the role of acupuncture and mindfulness may lead, I hope, to a more fruitful discussion on the role of complementary medicine in a modern health service [11]. I have always advocated ‘the best of both worlds’ [12], bringing evidence-informed [13] conventional and complementary medicine together and avoiding that gulf between them, which leads, I understand, to a substantial proportion of patients feeling that they cannot discuss complementary medicine with their doctors [14].

I believe it is more important than ever that we should aim for this middle ground [15]. Only then can we escape divisions and intolerance on both sides of the conventional/complementary equation where, on the one hand, the appropriate regulation of the proven therapies of acupuncture and medical herbalism [15] is opposed while, on the other, we find people actually opposing life-saving vaccinations. Who would have thought, for instance, that in the 21st century that there would be a significant lobby opposing vaccination, given its track record in eradicating so many terrible diseases and its current potential to protect and liberate some of the most vulnerable in our society from coronavirus? [16] …

My comments are as follows:

  1. Is Charles not a little generous to his own vision? Social prescribing is not nearly the same as the concept of integrated medicine which he has been pushing for years.
  2. There is no good evidence that social prescribing will reduce ‘of long-term disease, antibiotic resistance, and opiate dependence’.
  3. Here Charles produces a classic ‘strawman fallacy’. Medicine is much more than pills and procedures, and I suspect he knows it (not least because he uses proper medicine as soon as he is really ill).
  4. Charles has not so much ‘demonstrated’ the importance of ‘psychosocial, environmental and financial added value of genuinely, sustainable urban planning, design, and construction’ as talked about it.
  5. That does not necessarily mean that social prescribing is effective; correlation is not causation!
  6. There is no good evidence that social prescribing is effective against self-harm or obesity.
  7. Medicine has been trying to grapple with ‘wider issues’ for centuries.
  8. Medicine has done that for many years but we always had to be mindful of the evidence base. It would be unwise to adopt interventions without evidence demonstrating that they do more good than harm.
  9. Many patients also choose to smoke, drink, or sky-dive. Patient choice is no indicator of efficacy or harmlessness.
  10. Yes, we should embrace them where they clearly improve their ability to care for themselves. However, the evidence all too often fails to show that they improve anything.
  11. As we have seen, this discussion has been going on for decades and was not always helped by Charles.
  12. The best of both worlds can only be treatments that demonstrably generate more good than harm – and that’s called evidence-based medicine. Or, to put it bluntly: in medicine ‘best’ does not signify royal approval.
  13. ‘Evidence-informed’ is an interesting term. Proper medicine thrives to be evidence-based; royal medicine merely needs to be ‘evidence-informed’? This new term seems to imply that evidence is not all that important. Why? Perhaps because, for alternative medicine, it is largely not based on good evidence?
  14. If we want to bridge the gulf, we foremost require sound evidence. Today, plenty of such evidence is available. The problem is that it does often not show what Charles seems to think it shows.
  15. Even the best regulation of nonsense must result in nonsense.
  16. The anti-vaccination sentiments originate to an alarmingly large extent from the realm of alternative medicine.[4]

REFERENCES

[1] Brandling J, House W. Social prescribing in general practice: adding meaning to medicine. Br J Gen Pract. (2009) 59:454–6. doi: 10.3399/bjgp09X421085

[2] Social Prescribing: Definition, Examples, and More (healthline.com)

[3] Schmidt K, Ernst E. MMR vaccination advice over the Internet. Vaccine. 2003 Mar 7;21(11-12):1044-7. doi: 10.1016/s0264-410x(02)00628-x. PMID: 12559777.

The COMPLEMENTARY AND NATURAL HEALTHCARE COUNCIL describe themselves as follows:

We were set up by the government to protect the public. We do this by providing an independent UK register of complementary healthcare practitioners. Protection of the public is our sole purpose.

We set the standards that practitioners need to meet to get onto and then stay on the register. All CNHC registrants have agreed to be bound by the highest standards of conduct and have registered voluntarily. All of them are professionally trained and fully insured to practise.

We investigate complaints about alleged breaches of our Code of Conduct, Ethics and Performance. We impose disciplinary sanctions that mirror those of the statutory healthcare regulators.

We make the case to government and a wide range of organisations for the use of complementary healthcare to enhance the UK’s health and wellbeing. We raise awareness of complementary healthcare and seek to influence policy wherever possible to increase access to the disciplines we register.

At present, the CNHC are looking for new board members:

Are you interested in setting standards in the public interest? CNHC is the independent regulatory body for complementary healthcare practitioners, established in 2008 with support and funding from the Department of Health. Our public register of over 6,300 qualified therapists provides confirmation that individuals have met UK standards for safe and competent practice.

The Board meets for a half-day four times a year. In normal circumstances meetings are held in London. There is no remuneration but travel costs are reimbursed.

We have vacancies for one Lay and two Registrant Board members.

Although not essential, CNHC are particularly interested in applications from individuals with a background in financial management or accounting.

Deadline for applications is 26 March 2021. Interviews for a Lay member will be held via Zoom on 15 April and for Registrant members on 14 April.

Full information about the work of CNHC is available on our website.

I think it would be desirable for new members to be rational thinkers. I, therefore, encourage all skeptics and rationalists to apply via their website … but expect the job to be a challenge!

Guest post by Alan Henness

When I discovered a homeopath admitting on camera that she believed she and her fellow homeopaths had managed to unblind a triple-blinded homeopathy trial they were taking part in, I submitted a complaint to the journal that published the paper on the trial, the university of the researcher who had conducted the trial and the current university of the homeopath who had subsequently moved into research.

The paper concerned is the 2004 paper by Weatherley-Jones et al. A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome. This was published in the Journal of Psychosomatic Research.

The homeopath was Clare Relton, currently Senior Lecturer in Clinical Trials at the Centre for Primary Care and Public Health at Queen Mary University of London and Honorary Senior Research Fellow, School of Health and Related Research at the University of Sheffield.

She gave a presentation at the 2019 conference of the Homeopathy Research Institute. Billed as an International Homeopathy Research Conference, it was subtitled, Cutting edge research in homeopathy. The videos of the conference were sponsored by homeopathy manufacturing giant, Boiron.

My complaint email (see below) explains what I discovered and sets the context. As a result of the investigation by the journal, the current editor along with two former editors have just published a peer-reviewed paper on my complaint and their investigation:

When is lack of scientific integrity a reason for retracting a paper? A case study

Misconduct and unethical behaviour

It’s worth noting how serious the Journal of Psychosomatic Research considered the misconduct they identified by Relton and others. From the Results section of the paper:

We found the presentation by Dr. Relton disturbing on multiple grounds. This admission of unethical behavior calls her scientific integrity into question. The premise for her actions rests on an errant assumption widespread among clinicians, based on anecdotal experience, that one possesses an ultimate knowledge of what works and doesn’t work without the need for rigorous study. The history of medicine, unfortunately, has been littered by countless treatments that practitioners believed in and dispensed, only to be later found not beneficial or even harmful [4]. This underscores the importance of rigorous study for treatments where equipoise exists in the scientific community, as it arguably did for the use of homeopathy for chronic fatigue syndrome. Dr. Relton likely did not hold that equipoise herself, but if she had ethical concerns about the study, the appropriate action would have been to not participate in it. Instead, she purports to have enlisted colleagues to deliberately and systematically undermine the study.

In watching the presentation, the purpose of this admission seemed to be to discount the results of a rigorous but essentially negative study in the context of promoting her own ideas related to trial design. While we cannot know for certain that her motivation was to discount the results of this study, what she said clearly seeks to undermine the credibility of a trial whose results challenged her firmly held but untested beliefs about the benefit of a treatment that she had high allegiance to. Regardless of her intent or what actually happened during the trial, Dr. Relton’s presentation is ipso facto evidence of either an admitted prior ethical breach or is itself an ethical breach for the following reasons. Either she indeed undermined an ambitious effort to study of the efficacy of homeopathy for chronic fatigue syndrome, negating the work of all other investigators, study staff, and participants involved in the study as well as the investment of the public, or she is conducting a late and inappropriate attack on the study’s credibility. Her presentation certainly warrants formal censure from the scientific community, and this paper may contribute to that. Despite this clear indictment, after discussing and considering the complaint of Mr. Henness for several months, we ultimately decided not to retract the paper.

They decided not to retract the paper but instead use it for ethical reflection. However, they concluded I had highlighted “undisputable evidence of scientific misconduct” by the homeopaths concerned:

When is lack of scientific integrity a reason for retracting a paper? A case study

Objective: The journal received a request to retract a paper reporting the results of a triple-blind randomized placebo-controlled trial. The present and immediate past editors expand on the journal’s decision not to retract this paper in spite of undisputable evidence of scientific misconduct on behalf of one of the investigators.

Methods: The editors present an ethical reflection on the request to retract this randomized clinical trial with consideration of relevant guidelines from the committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) applied to the unique contextual issues of this case.

Results: In this case, scientific misconduct by a blinded provider of a homeopathy intervention attempted to undermine the study blind. As part of the study, the integrity of the study blind was assessed. Neither participants nor homeopaths were able to identify whether the participant was assigned to homeopathic medicine or placebo. Central to the decision not to retract the paper was the fact that the rigorous scientific design provided evidence that the outcome of the study was not affected by the misconduct. The misconduct itself was thought to be insufficient reason to retract the paper.

Conclusion: Retracting a paper of which the outcome is still valid was in itself considered unethical, as it takes away the opportunity to benefit from its results, rendering the whole study useless. In such cases, scientific misconduct is better handled through other professional channels.

Ethical misconduct

The authors had additional ethical concerns:

Apart from the intention of ‘circumventing the blind’, there is another unethical aspect to the behavior of Dr. Relton, namely the fact that patients were systematically subject to an intervention (carcinosin administration) that was not part of the original research protocol and to which they did not consent as part of the study. Although the systematic administration of carcinosin was not part of the study protocol, it was administered only to patients taking part in the study, and because they took part in the study. Presumably, these patients were not properly informed, or maybe even misinformed, about the rationale of a double-blind trial design and/or the true reason for administrating carcinosin. Apparently, ‘deep listening and deep understanding’ does not necessarily need to be accompanied by an honest and open attitude towards patients that participate in research. Dr. Relton stated in her lecture ‘I’m not trained to be deceiving people’, but that is exactly what she did. Not only did she deceive patients, but also the researchers and study leaders that she is supposed to collaborate with as a colleague. [emphasis in original]

Sanctions

The authors said:

The authors are of the opinion that in case the misconduct was not conducted by or on behalf of the principal investigator – as is the case here -, the initiative for further action should lie with them. Not only is the principal investigator the one that was deceived, but they are in a better position to report the misconduct to the institution and funding body. If the principal investigator is responsible for the misconduct, the editor is probably the only one that can initiate further action, in which case the researcher’s institution should be informed and requested to take appropriate action.

It will be interesting to see what further action, if any, is taken by Weatherley-Jones as is suggested.

I had already brought my concerns to the attention of both the University of Sheffield and Queen Mary University of London. The former concluded:

This is to confirm that the University of Sheffield has now completed its assessment of this matter, and it has been agreed that it would not be appropriate for the University of Sheffield to undertake a research misconduct investigation of the allegation against Clare Relton, since she is not a current member of University staff, nor was she a member of staff at the time of the clinical trial in question.

In relation to the potential concerns about the reliability of the published research findings, the University is satisfied that the Journal of Psychosomatic Research is consulting with the authors and taking steps to address the concerns as appropriate. The University will therefore be taking no further action.

I received no response from Queen Mary University of London, despite their Principal being copied in on all the relevant correspondence.

I will be writing again to both and Weatherley-Jones now the paper has been published.

Acknowledgements

My thanks to Jess G. Fiedorowicz, Editor, Journal of Psychosomatic, for his thorough investigation of my complaint.


My complaint

Hi

The results of a trial were published in the Journal of Psychosomatic Research in 2004 (see attached copy):

A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome

doi:10.1016/S0022-3999(03)00377-5

Elaine Weatherley-Jones a,*, Jon P Nicholl a, Kate J Thomas a, Gareth J Parry a, Michael W McKendrickb, Stephen T Green b, Philip J Stanley c, Sean PJ Lynch d

a Medical Care Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK
b Communicable Diseases Directorate, Royal Hallamshire Hospital, Sheffield, UK
c Seacroft Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK
d St. James’s University Hospital, University of Leeds, Beckett Street, Leeds, UK

* Corresponding author. Tel.: +44-114-222-0744; fax: +44-114-222-0749.
E-mail address: [email protected]ac.uk (E. Weatherley-Jones)

The paper is indexed in PubMed here.

Elaine Weatherley-Jones is listed as the Corresponding author at the Medical Care Research Unit, School of Health and Related Research, University of Sheffield as are others.

One of the homeopaths involved in providing treatment was Clare Relton, currently Senior Lecturer in Clinical Trials at the Centre for Primary Care and Public Health at Queen Mary University of London.

The full list of those involved in providing treatment during the trial is given as:

The Homeopathic Trials Group: Homeopaths— Gill de Boer, MBChB, MFHom, Maryjoan Foster, RSHom, Susanne Hartley, RSHom, Jane Howarth, BRCPHom, Pat Mayborne RSHom, Georgina Ramsayer RSHom, Clare Relton, RSHom, Pat Strong, MBBS, MFHom, Angela Zajac, BSc, RSHom, BRCPHom.

Dr Relton gave a talk at the Conference in London of the Homeopathy Research Institute held 14 to 16 June 2019. The video of her talk has recently been published: https://www.hrilondon2019.org/films/#clip=eitxmhl1ilss. I have a copy of this video.

I invite you to watch all 30 minutes of it.

At about five minutes in, she begins to discuss the above trial, having just said she was a non-medical homeopath at the Wellforce Clinic in Sheffield. She is currently listed as Chair of Directors.

She then goes on to describe how she took part as one of the homeopaths in the trial and relates how she came up with “a cunning way of circumventing the blinding”.

I offer the following transcript of the segment of her talk where she discusses this (all transcription errors are mine):

Timestamp 05:12

So while I was still a homeopath in the Wellforce clinic, a researcher from the University of Sheffield which was actually only five minutes away from my clinic which was really handy came along and said, “I’ve got some money from Lord Sainsbury to do a trial of chronic fatigue syndrome of homoeopathy” and she described the design and I remember thinking, “not sure what that’s going to show”.

But anyway there were ten homeopaths recruited in Sheffield and Leeds and we saw patients with chronic fatigue syndrome.

A lot of us were getting patients with chronic fatigue syndrome anyway and particularly if they were never been well since glandular fever couple of doses of carcinosin 30 or 200 and they seem to make a really good recovery.

So we’re pretty confident about taking part in this trial.

So there were 130 or 140 patients recruited to the trial and then allocated to the homeopaths: there were five at our clinic and I was one of them.

Patients would arrive; you would do the normal thing, have the consultation with them. They seemed a bit standoffish, they were quite distant – I couldn’t work out why.

And then at the end of the consultation I had to say to them “well there’s a 50% chance that whatever I prescribe you is going to be a placebo”, which sort of sort of lowered the temperature in the in the in the Consulting room because you know they came because they have chronic fatigue; they came… didn’t come because they wanted to take part in an experimental game.

So we would ring the pharmacy up and tell them our prescription. Helios Pharmacy would then send out either placebo or the real remedy according to the allocation of the patient.

The patient would come back four weeks later and if they were better, great and if they weren’t it was really, really difficult. So, had I got the wrong prescription or were they on placebo?

So after about six months of this we started working out there was a cunning way of circumventing the blinding and we worked out, well if we give them all a dose of carcinosin they’re going to have some reaction: there’s going to be a dream there’s going to be some change and if when they come back at the second appointment they haven’t changed then we know they’re on placebo. So don’t bother doing all that trying to find the right remedy; just use all your other amazing skills you have as a homeopath: the deep listening we have the deep understanding of what we know about what’s toxic in our systems, about diet and counselling.

So that’s what we did. Because we’re homeopaths. We’re trained to treat people I’m not trained to be deceiving people. That’s what I do, that’s what I did then; that’s what all my colleagues did.

So ok, so the trial ended and at the end the results came out I’m sure quite a few of us are familiar with it.

There were two groups, so there was a group… everybody in the patient… everybody in the trial received treatment… a course of treatment by a homeopath and 50% of them received a placebo remedy 50% the real remedy, the verum.

And the results… both groups got better and the group that received the real remedy improved better than the group that received the placebo but was the difference clinically significant? Not quite. How many trials do we have that? So this trial was so much realisation, so many questions came out of my experience being inside, inside a double-blind placebo randomised controlled trial. What is seen as the… you know the… summit of evidence-based medicine in terms of rigorousness, I  just thought “what is this doing?” I don’t know what… I don’t know what this has shown.

This is what’s called an explanatory trial and I thought well it’s explaining nothing to me, apart from the fact that the system for designing and conducting randomised controlled trials at the moment isn’t working.

So lots of questions.

Timestamp 09:02

The paper states:

Patients were successfully blinded to their group allocation, and therefore we have assumed that whatever the reasons for nonresponse, they are the same for the treatment arm and the placebo arm and that the data are comparable. Therefore, intention to treat analyses was done on actual data plus imputed missing item data, but all unit missing data were excluded from analyses.

and:

Checking of double blinding showed that prediction of treatment group was made by neither homeopaths (j =. 07, P c.60) nor patients (j = 0.11, P c.48).

The trial was of a triple-blind design but there is no mention of the deliberate attempts to circumvent the blinding in the paper. The effects on participants by the actions – inadvertent or otherwise – of Relton and her colleagues are not considered and not known.

I believe the actions of Relton, the other four homeopaths at her clinic whom she clearly implicates in this circumvention of blinding, and possibly the remaining four homeopaths if they were all known to each other and in contact with each other since they were all in the same area of Leeds/Sheffield, compromised the trial design, rendered the results unreliable and seriously undermined the integrity of the paper and its conclusions. I do not believe it matters whether or not they were in fact able to circumvent the blinding, but it does matter that Relton and others believed they had because she admits it led to different behaviour on their part resulting in contamination of the results.

I believe the actions amount to misconduct.

I note additional criticism of this paper by Prof Edzard Ernst (see attached).

I ask that Sheffield University investigate this matter and that along with Queen Mary University of London and the Editor-in-chief of the Journal of Psychosomatic Research, Jess Fiedorowicz, MD, PhD, decide what actions to take. I ask that consideration is given to retracting this unsound paper.

Please consider this email as a formal complaint against Dr Clare Relton and others.

Please acknowledge receipt by return and keep me informed of your progress in investigating this matter and of your conclusions and outcome.

If you require any further information, please do not hesitate to contact me.

Best regards.
Alan Henness

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