Edzard Ernst

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

As often mentioned in previous posts, the ‘Heilpraktiker’ is a recognized healthcare professional in Germany that was established during the Third Reich. Despite the fact that a Heilpraktiker doesn’t necessarily undergo any meaningful medical training, they are permitted to do almost all the treatments a medically trained practitioner can carry out. This situation has created a two-tier healthcare system in Germany which many experts find unacceptable. Reports of patients being seriously harmed are reported with depressing regularity.

It has been reported that a German woman suffering from cancer discontinued her conventional oncological treatments and had herself treated with preparations made from snake venom. After she died of her cancer, the practitioner of so-called alternative medicine (SCAM), a Heilpraktiker, was ordered to pay compensation for pain and suffering. The practitioner must now pay 30,000 Euros in compensation for pain and suffering to her son. This was decided by a court in Munich in a landmark ruling on Thursday. The boy’s father had originally demanded 170,000 Euros.

The deceased patient had been suffering from cervical cancer with a good prognosis. She decided to abandon radiation and chemotherapy and instead opted for preparations made from snake venom, which she received from her SCAM practitioner.

“The defendant did not actively advise her patient to discontinue the life-saving radiation therapy,” the court found, but “she did not oppose her decision, which as a Heilpraktiker would have been her duty.” In the court’s view, the Heilpraktiker should have advised her patient to resume chemotherapy. “This continued omission by the defendant over a period of weeks was irresponsible and, from the point of view of a responsible healthcare practitioner, utterly incomprehensible.” In addition to damages for pain and suffering, the Heilpraktiker was ordered to pay damages for lost child support, among other things. The court did not allow an appeal against the verdict.

The case seems unusual in that the court found a SCAM practitioner guilty not because of administering a bogus or harmful treatment, but because of failing to provide essential advice. This could have consequences for many legal cases in the future.

If I understand it correctly, it means that, according to German law, healthcare practitioners can be held responsible not just for what they were doing, but also for what they were not doing, and that this form of neglect extends not just to treatments and procedures, but also to advice. If that is true, a German homeopath treating an asthma patient, for instance, could be sued if he fails to advise that his patient also takes essential conventional medications.

It would be valuable to have the opinion of legal experts on this point and on the question of how the law in other counties would apply in such matters.

The Chinese have made several attempts to persuade us that their traditional remedies are effective for COVID-19 infections. Here is yet another one. This review summarised the evidence of the therapeutic effects and safety of Chinese herbal medicine (CHM) used with or without conventional western therapy for COVID-19. All clinical studies of the therapeutic effects and safety of CHM for COVID-19 were included. The authors

  • summarized the general characteristics of included studies,
  • evaluated the methodological quality of the randomized controlled trials (RCTs) using the Cochrane risk of bias tool,
  • analyzed the use of CHM,
  • used Revman 5.4 software to present the risk ratio (RR) or mean difference (MD) and their 95% confidence interval (CI) to estimate the therapeutic effects and safety of CHM.

A total of 58 clinical studies were identified including;

  • 10 RCTs,
  • 1 non-randomized controlled trials,
  • 11 retrospective studies with a control group,
  • 12 case-series,
  • 24 case-reports.

All of the studies had been performed in China. No RCTs of high methodological quality were identified. The most frequently tested oral Chinese patent medicine, Chinese herbal medicine injection, or prescribed herbal decoction were:

  • Lianhua Qingwen granule/capsule,
  • Xuebijing injection,
  • Maxing Shigan Tang.

The pooled analyses showed that there were statistical differences between the intervention group and the comparator group (RR 0.42, 95% CI 0.21 to 0.82, six RCTs; RR 0.38, 95% CI 0.23 to 0.64, five retrospective studies with a control group), indicating that CHM plus conventional western therapy appeared to be better than conventional western therapy alone in reducing aggravation rate.

In addition, compared with conventional western therapy, CHM plus conventional western therapy had the potential advantages in increasing the recovery rate and shortening the duration of fever, cough, and fatigue, improving the negative conversion rate of nucleic acid test, and increasing the improvement rate of chest CT manifestations and shortening the time from receiving the treatment to the beginning of chest CT manifestations improvement.

For adverse events, the pooled data showed that there were no statistical differences between the CHM and the control groups.

The authors concluded that current low certainty evidence suggests that there maybe a tendency that CHM plus conventional western therapy is superior to conventional western therapy alone. The use of CHM did not increase the risk of adverse events.

One of the principles to remember here is this: RUBBISH IN, RUBBISH OUT. If you meta-analyze primary data that are rubbish, your findings can only be rubbish as well.

All one needs to know about the primary data entered into the present analysis is that there were no rigorous RCTs… not one! That means the evidence is, as the authors rightly but modestly conclude of LOW CERTAINTY. My conclusions would have been a little different:

  1. In terms of safety, the dataset is too small and unreliable to make any judgment.
  2. In terms of efficacy, there is no sound data that CHM has a positive effect.

This study was aimed at determining the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors.

The Personalized Electroacupuncture vs Auricular Acupuncture Comparativeness Effectiveness (PEACE) trial is a randomized clinical trial that was conducted from March 2017 to October 2019 (follow-up completed April 2020) across an urban academic cancer center and 5 suburban sites in New York and New Jersey. Study statisticians were blinded to treatment assignments. The 360 adults included in the study had a prior cancer diagnosis but no current evidence of disease, reported musculoskeletal pain for at least 3 months, and self-reported pain intensity on the Brief Pain Inventory (BPI) ranging from 0 (no pain) to 10 (worst pain imaginable).

Patients were randomized 2:2:1 to:

  1. electroacupuncture (n = 145),
  2. auricular acupuncture (n = 143),
  3. or usual care (n = 72).

Intervention groups received 10 weekly sessions of electroacupuncture or auricular acupuncture. Ten acupuncture sessions were offered to the usual care group from weeks 12 through 24.

The primary outcome was a change in the average pain severity score on the BPI from baseline to week 12. Using a gatekeeping multiple-comparison procedure, electroacupuncture and auricular acupuncture were compared with usual care using a linear mixed model. Noninferiority of auricular acupuncture to electroacupuncture was tested if both interventions were superior to usual care.

Among 360 cancer survivors (mean [SD] age, 62.1 [12.7] years; mean [SD] baseline BPI score, 5.2 [1.7] points; 251 [69.7%] women; and 88 [24.4%] non-White), 340 (94.4%) completed the primary end point. Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12. Noninferiority of auricular acupuncture to electroacupuncture was not demonstrated. Adverse events were mild; 15 of 143 (10.5%) patients receiving auricular acupuncture and 1 of 145 (0.7%) patients receiving electroacupuncture discontinued treatments due to adverse events (P < .001).

The authors of this study concluded that, in this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture and auricular acupuncture produced greater pain reduction than usual care. However, auricular acupuncture did not demonstrate noninferiority to electroacupuncture, and patients receiving it had more adverse events.

I think the authors made a mistake in formulating their conclusions. Perhaps they allow me to correct it:

In this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture plus usual care and auricular acupuncture plus usual care produced greater pain reduction than usual care alone.

I know, I must sound like a broken record, but – because it followed the often-discussed ‘A+B versus B’ design – this study does simply not show what the authors conclude. In fact, it tells us very little about any effects caused by the two acupuncture versions per se. The study does not control for placebo effects and therefore its results are consistent with acupuncture itself having no effect at all.

Here is an attempt at explaining the ‘A+B versus B’ study design I posted previously:

As regularly mentioned on this blog, there are several ways to design a study such that the risk of producing a negative result is minimal. The most popular one in SCAM research is the ‘A+B versus B’ design…

Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual alone, and the former is therefore more than likely to produce a better result. This will be true, even if acupuncture is a pure placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.

Imagine the two interventions had been a verbal encouragement or pat on the shoulder or a pat on the right shoulder for group 1 and one on the left for group 2. The findings could well have been very similar. To provide evidence that acupuncture PRODUCES PAIN REDUCTION, we need proper tests of the hypothesis. And to ‘determine the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors’, we need a different methodology.

This is, of course, all very elementary. Nothing elaborate or complicated! Scientists know it; editors know it; reviewers know it. Or at least they should know it. Therefore, I am at a loss trying to understand why even journals of high standing publish IMPROPER tests, better known as pseudo-science.

It is hard not to conclude that they deliberately try to mislead us.

I am currently working on a project that involves studying a lot of what our heir to the throne – or is the ‘the heir to our throne? – as done, said and written about so-called alternative medicine (SCAM). Unavoidably, this meant reading his 2010 book HARMONY, A NEW WAY OF LOOKING AT OUR WORLD. In it, Prince Charles states that “… I cannot bear to see people suffer unnecessarily when, so often, a complementary treatment can be beneficial…” This is a statement that Charles has made several times before.

Each time I come across it, I have to think of some of my own patients. It’s a long time since I was a clinician, yet one patient, in particular, often comes to my mind.

He had been a young man healthy, happily married, nice kids, good job, etc. Then one day, he was inattentive or distracted and drove his car full with his wife and kids across a red signal at an unguarded railway crossing. They were all killed instantly.

But almost miraculously, he survived and had just relatively minor injuries which we hoped to put right. So, his body was about to be fine, but his mind was not. Just before being dismissed from the hospital, he tried to commit suicide by jumping out of the 4th-floor window of his room. He survived that too, and we were looking after him and his multiple injuries. As he had lost a lot of blood, he received several blood transfusions. One had been infected and he contracted HIV. He did not survive.

Does Charles know what he is talking about?

How often does he see truly suffering patients?

Does he know that faked empathy might be seen as offensive?

On what evidential basis does he assume that so-called alternative medicine (SCAM) would bring any benefit to severely ill patients?

Does he assume to know better than the clinicians treating the ‘people suffering unnecessarily?

Does he realize that his words are an insult to those who actually do see patients suffer and empathize with them?

Does he know what it means to do everything possible to help patients?

Does he realize that this is achieved by employing the most effective treatments currently available?

Does he know that the most effective treatments would almost never include SCAM?

I am sorry, but sometimes Charles’s musings about SCAM do get under my skin.

It has been reported that the Middlesex University is cutting its ties with the UK’s biggest provider of homeopathy training after it peddled vaccine misinformation and encouraged the use of homeopathic potions made with phlegm to protect against and treat Covid-19. The Centre for Homeopathic Education (CHE) had been validated by the Middlesex University since 2004 and was the only UK homeopathy college to offer a University-accredited degree in homeopathy.

Now the CHE has been criticized for its “actively anti-scientific teaching”. Robbie Turner, a director at the Royal Pharmaceutical Society, said the unproven medicines being promoted by the college were “highly risky”. He added: “It is not just irresponsible, it’s downright dangerous.”

In webinars offered by the CHE Online, the lecturer Robin Murphy claimed the idea that vaccination was effective at eradicating disease was “delusional” and told students how to buy or make homeopathic “nosodes” made from bodily material of an infected Covid patient. He said the nosodes could help prevent and treat even the most severe cases of Covid, recommended their use among healthcare workers and carers exposed to the virus, and claimed he had helped administer the remedies to up to 200 people, including children. “I treated a 14-year-old girl and I gave her the nosode … she got fevers and chills. I followed up with mercury and between the nosode and mercury, that took care of the case,” he said.

In another case, Murphy said a client locked her son in his bedroom after he was exposed to Covid-19 to make him take the remedy. “If the husband comes home with a positive test and is sick … get the dose to everybody in the family,” Murphy said. “We’ve seen it work. A couple of my patients locked their son in the bedroom and wouldn’t let him come out. We gave him the remedies and everyone’s fine.”

He began the session with a “disclaimer”. “This is medical and historical information and blah blah blah and all this and that,” he said as the slide was shown. “This is for your own information … I feel we’re on solid ground to really help people like this.” Murphy is a regular lecturer at the CHE and director of the Lotus Health Institute in Virginia in the US. His other courses include one on 5G “toxicity”, promoting the debunked theory that 5G is dangerous.

Michael Marshall, project director at the Good Thinking Society, described claims that the vaccine “alternatives” were effective as “tremendously dangerous” and said it was “very concerning” that homeopaths were being taught their use by an accredited college. He said the teachings were “actively anti-science. For some people, the worst-case scenario is that they go on and contract and spread that disease. It fundamentally undermines public health messaging and puts the public at risk.”

The CHE was the largest homeopathy training provider in the UK providing a range of courses including, until last week, a bachelor of science degree validated by Middlesex. Under the 17-year partnership, the university — ranked 121st in the UK in the Good University Guide — would receive a £700 registration fee per student on the part-time, four-year course, and up to £3,500 went to the college in annual tuition fees.

A spokesperson for the University said it was “alarmed to hear about the allegations.”  Middlesex declared it is terminating the partnership with immediate effect.

Osteopathic manipulative treatment (OMT) is popular, but does it work? On this blog, we have often discussed that there are good reasons to doubt it.

This study compared the efficacy of standard OMT vs sham OMT for reducing low back pain (LBP)-specific activity limitations at 3 months in persons with nonspecific subacute or chronic LBP. It was designed as a prospective, parallel-group, single-blind, single-center, sham-controlled randomized clinical trial. 400 patients with nonspecific subacute or chronic LBP were recruited from a tertiary care center in France starting and randomly allocated to interventions in a 1:1 ratio.

Six sessions (1 every 2 weeks) of standard OMT or sham OMT delivered by osteopathic practitioners. For both
experimental and control groups, each session lasted 45 minutes and consisted of 3 periods: (1) interview focusing on pain location, (2) full osteopathic examination, and (3) intervention consisting of standard or sham OMT. In both groups, practitioners assessed 7 anatomical regions for dysfunction (lumbar spine, root of mesentery, diaphragm, and atlantooccipital, sacroiliac, temporomandibular, and talocrural joints) and applied sham OMT to all areas or standard OMT to those that were considered dysfunctional.

The primary endpoint was the mean reduction in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index. Secondary outcomes were the mean reduction in LBP-specific activity limitations; mean changes in pain and health-related quality of life; number and duration of sick leave, as well as the number of LBP episodes at 12 months, and the consumption of analgesics and nonsteroidal anti-inflammatory drugs at 3 and 12 months. Adverse events were self-reported at 3, 6, and 12 months.

A total of 200 participants were randomly allocated to standard OMT and 200 to sham OMT, with 197 analyzed in each group; the median (range) age at inclusion was 49.8 (40.7-55.8) years, 235 of 394 (59.6%) participants were women, and 359 of 393 (91.3%) were currently working. The mean (SD) duration of the current LBP episode had been 7.5 (14.2) months. Overall, 164 (83.2%) patients in the standard OMT group and 159 (80.7%) patients in the sham OMT group had the primary outcome data available at 3 months.

The mean (SD) Quebec Back Pain Disability Index scores were:

  • 31.5 (14.1) at baseline and 25.3 (15.3) at 3 months in the OMT-group,
  • 27.2 (14.8) at baseline and 26.1 (15.1) at 3 months in the sham group.

The mean reduction in LBP-specific activity limitations at 3 months was -4.7 (95% CI, -6.6 to -2.8) and -1.3 (95% CI, -3.3 to 0.6) for the standard OMT and sham OMT groups, respectively (mean difference, -3.4; 95% CI, -6.0 to -0.7; P = .01). At 12 months, the mean difference in mean reduction in LBP-specific activity limitations was -4.3 (95% CI, -7.6 to -1.0; P = .01), and at 3 and 12 months, the mean difference in mean reduction in pain was -1.0 (95% CI, -5.5 to 3.5; P = .66) and -2.0 (95% CI, -7.2 to 3.3; P = .47), respectively. There were no statistically significant differences in other secondary outcomes. Four and 8 serious adverse events were self-reported in the standard OMT and sham OMT groups, respectively, though none was considered related to OMT.

The authors concluded that standard OMT had a small effect on LBP-specific activity limitations vs sham OMT. However, the clinical relevance of this effect is questionable.

This study was funded the French Ministry of Health and sponsored by the Département de la Recherche Clinique et du Développement de l’Assistance Publique-Hôpitaux de Paris. It is of exceptionally good quality. Its findings are important, particularly in France, where osteopaths have become as numerous as their therapeutic claims irresponsible.

In view of what we have been repeatedly discussing on this blog, the findings of the new trial are unsurprising. Osteopathy is far less well supported by sound evidence than osteopaths want us to believe. This is true, of course, for the plethora of non-spinal claims, but also for LBP. The French authors cite previously published evidence that is in line with their findings: In a systematic review, Rubinstein and colleagues compared the efficacy of manipulative treatment to sham manipulative treatment on LBP-specific activity limitations and did not find evidence of differences at 3 and 12 months (3 RCTs with 573 total participants and 1 RCT with 63 total participants). Evidence was considered low to very low quality. When merging the present results with these findings, we found similar standardized mean difference values at 3months (−0.11 [95% CI, −0.24 to 0.02]) and 12 months (−0.11 [95% CI, −0.33 to 0.11]) (4 RCTs with 896 total participants and 2 RCTs with 320 total participants).

So, what should LBP patients do?

The answer is, as I have often mentioned, simple: exercise!

And what will the osteopaths do?

The answer to this question is even simpler: they will find/invent reasons why the evidence is not valid, ignore the science, and carry on making unsupported therapeutic claims about OMT.

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.

Prince Charles has published his views on integrated health several times before in medical journals. In 2001, authored an editorial in the BMJ promoting his ideas around integrative medicine. Its title: THE BEST OF BOTH WORLDS.[1] This was followed in 2012 by an article in the JRSM where he expressed his views even more clearly.[2] Here is an excerpt: 

… By integrated medicine, I mean the kind of care that integrates the best of new technology and current knowledge with ancient wisdom. More specifically, perhaps, it is an approach to care of the patient which includes mind, body and spirit and which maximizes the potential of conventional, lifestyle and complementary approaches in the process of healing. Integrated health, on the other hand, represents an approach to individual and population health which respects and includes all health-related areas, such as the physical and social environment, education, agriculture and architecture…

… I have been attempting to suggest that it might be beneficial to develop truly integrated systems of providing health and care. That is, not simply to treat the symptoms of disease, but actively to create health and to put the patient at the heart of this process by incorporating those core human elements of mind, body and spirit…

This whole area of work – what I can only describe as an ‘integrated approach’ in the UK, or ‘integrative’ in the USA – takes what we know about appropriate conventional, lifestyle and complementary approaches and applies them to patients. I cannot help feeling that we need to be prepared to offer the patient the ‘best of all worlds’ according to a patient’s wishes, beliefs and needs. This requires modern science to understand, value and use patient perspective and belief rather than seeking to exclude them – something which, in the view of many professionals in the field, occurs too often and too readily…

Now, surely, is the time for us all to concentrate some real effort in these areas. We will need to do so by deploying approaches which, at their heart, retain the crucial bedrock elements of traditional and modern civilized health care – of empathy, compassion and the enduring values of the caring professions.

Now Charles has used the current health crisis to do it again. His new article has just been published in the RCP’s ‘Future Healthcare Journal’ [3]. Allow me to show you a crucial section from it:

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. 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. 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. 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.

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. Social prescription enables doctors to provide their patients with a bespoke prescription that might help them at a time of need (such as advice on housing and benefits) but which may also provide them with opportunities, hope and meaning by being able to engage in a range of physical, environmental and artistic activities, which resonate with where they are in their lives. Furthermore, social prescription has the potential not only to transform our understanding of what medicine is and does, but also to change the communities in which we all live. I understand, for instance, that alongside social-prescription link workers, there are now people responsible for redesigning and increasing the capacity of the local volunteer and voluntary sector, who can help to create a new social infrastructure and eventually, one might hope, communities that make us healthier rather than making us ill.

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. And though social prescription cannot do everything, I believe that, used imaginatively, it can begin to tackle these deep-rooted issues. As medicine starts to grapple with these wider determinants of health, I also believe that medicine will need to combine bioscience with personal beliefs, hopes, aspirations and choices.

Many patients choose to see complementary practitioners for interventions such as manipulation, acupuncture and massage. 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? 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. I have always advocated ‘the best of both worlds’, bringing evidence-informed 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.

I believe it is more important than ever that we should aim for this middle ground. 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 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?

The new article has, I think, all the hallmarks of having been written by Dr Michael Dixon (who has featured many times on this blog). Like the previous papers under Charles’ name, it is a simple ‘BAIT AND SWITCH’ affaire (Bait and switch is a morally suspect sales tactic that lures customers in with specific claims about the quality or low prices on items that turn out to be unavailable in order to upsell them on a similar, pricier item. It is considered a form of retail sales fraud, though it takes place in other contexts).

The bait, in this case, is ‘social prescribing’ (the new hobby horse of Dixon) and the switch is the good old so-called alternative medicine (SCAM). I have discussed social prescribing before, looked at the evidence, and concluded as follows:

The way I see it, it will be (and perhaps already is) used to smuggle bogus alternative therapies into the mainstream. In this way, it could turn out to serve the same purpose as did the boom in integrative/integrated medicine/healthcare: a smokescreen to incorporate treatments into medical routine which otherwise would not pass muster. If advocates of this approach, like Michael Dixon, subscribe to it, the danger of this happening is hard to deny.

The disservice to patients (and medical ethics) would then be obvious: diabetics unquestionably can benefit from a change of life-style (and to encourage them is part of good conventional medicine), but I very much doubt that they should replace their anti-diabetic medications with auto-hypnosis or other alternative therapies.

So, was I right with my prediction that social prescribing will be used to smuggle bogus alternative therapies into the mainstream?

Sadly, the answer seems to be YES.

 

REFERENCES

[1] The best of both worlds | The BMJ

[2] Hrh. Integrated health and post modern medicine. J R Soc Med. 2012 Dec;105(12):496-8. doi: 10.1258/jrsm.2012.12k095. Epub 2012 Dec 21. PMID: 23263785; PMCID: PMC3536513.

[3] HRH The Prince of Whales: A message from HRH The Prince of Wales, honorary fellow of the Royal College of Physicians. Future Healthcare Journal 2021 Vol 8, No 1: 5–7

 

PS

Charles new article has a footnote: Address for correspondence: Clarence House, London SW1A 1BA, UK

If you feel strongly about his message, please do write to him and let us know what his response is.

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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