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

alternative therapist

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Many chiropractors seem to view the present pandemic as a business opportunity and make no end of false claims to attract customers. This has now been outlawed in the US. Medscape reported that a US district court will decide whether a chiropractor who is charged with 10 counts of making false marketing claims related to COVID-19 will be the first person convicted under a new federal law.

On his website, chiropractor ‘Dr.’ Eric Neptune advertises his services as follows:

Have you ever been told by your medical doctor that you or a member of your family had a specific disease, syndrome, or sickness? Did your doctor then recommend a drug or surgery to fix the issue, or tell you that you would have to live with it for the rest of your life? If so, you are not alone!

Nepute Wellness Center is unlike any medical clinic you may have been to. The clinic team is focused on finding and fixing the CAUSE of your problem vs. seeking out and treating only the SYMPTOMS. Nepute Wellness Center is equipped with state-of-the-art diagnostic equipment and testing, as well as medical doctors, nurses, and chiropractors who have been uniquely trained to treat your whole body, regardless of age, and return your body to a healthy balance so that it can heal itself the way God intended.

If you are tired of trying to treat your symptoms using prescription and over-the-counter pills, or even considering surgery, then Nepute Wellness Center may be right for you! Or like many, you want to be proactive with your health and prevent sickness and disease before you begin to suffer any symptoms, allowing you to live the full life you deserve, then make Nepute Wellness Center your partner in health!

Already over a year ago, Eric Nepute, the owner of Quickwork, based in St. Louis, Missouri, managed to make headlines. He had recorded a video that racked up more than 21 million views and suggested that drinking tonic water would prevent COVID-19 infections. Now, Mr. Neptune is the first person charged by the Federal Trade Commission (FTC) under the new COVID- 19 Consumer Protection Act. His company which has several locations in St. Louis County advertised its vitamin D and zinc products on social media and the internet as drugs that could treat or prevent COVID-19 claiming that their products are “more effective than the available COVID-19 vaccines”.

The FTC warned Nepute’s company in May 2020 about making unsubstantiated claims for other products regarding efficacy against COVID-19 and advised him to immediately stop making claims that were not supported by scientific evidence. However, Nepute seemed undeterred.

The FTC is seeking to fine Nepute and Quickwork up to US$43,792 for each violation of the COVID-19 Consumer Protection Act. In addition, the FTC seeks to bar the company from making health claims unless they are true and can be substantiated by scientific evidence.

Through his attorney, Neptune told the local NBC TV news affiliate, “I feel that I have not done anything wrong. I encourage everyone to live a healthy lifestyle during this unprecedented time. My attorneys are reviewing the complaint and I have no further comments at this time.”

If you ask me, it is time that all counties make the publication of false medical claims illegal as well – not just those made by chiros, and not just those related to COVID-19 either.

 

In 2008, the British Chiropractic Association sued Simon Singh because he disclosed that they were promoting chiropractic for infant colic. The BCA lost the case, plenty of money, and all its reputation. Ever since the issue is a very sore point for chiropractic pride. The data show that Simon was quite correct in stating that they are happily promoting bogus treatments without a jot of evidence. Here for instance is my systematic review:

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

But chiropractors steadfastly refuse to accept defeat and keep on trying to find positive results. Now Danish chiropractors have made another attempt.

The purpose of this study is to evaluate the effect of chiropractic care on infantile colic. This multicenter, single-blind randomized controlled trial was conducted in four Danish chiropractic clinics, 2015–2019. Information was distributed in the maternity wards and by maternal and child health nurses. Children aged 2–14 weeks with unexplained excessive crying were recruited through home visits and randomized (1:1) to either chiropractic care or control group. Both groups attended the chiropractic clinic twice a week for 2 weeks. The intervention group received chiropractic care, while the control group was not treated. The parents were not present in the treatment room and unaware of their child’s allocation.

The primary outcome was change in daily hours of crying before and after treatment. Secondary outcomes were changes in hours of sleep, hours being awake and content, gastrointestinal symptoms, colic status and satisfaction. All outcomes were based on parental diaries and a final questionnaire.

Of 200 recruited children, 185 completed the trial (treatment group n = 96; control group n = 89). Duration of crying in the treatment group was reduced by 1.5 h compared with 1 h in the control group (mean difference − 0.6, 95% CI − 1.1 to − 0.1; P = 0.026), but when adjusted for baseline hours of crying, age, and chiropractic clinic, the difference was not significant (P = 0.066). The proportion obtaining a clinically important reduction of 1 h of crying was 63% in the treatment group and 47% in the control group (p = 0.037), and NNT was 6.5. We found no effect on any of the secondary outcomes.

The authors concluded that excessive crying was reduced by half an hour in favor of the group receiving chiropractic care compared with the control group, but not at a statistically significant level after adjustments. From a clinical perspective, the mean difference between the groups was small, but there were large individual differences, which emphasizes the need to investigate if subgroups of children, e.g. those with musculoskeletal problems, benefit more than others from chiropractic care.

This seems to be a rigorous trial. However, I don’t quite understand why the authors even mention that, before adjusting, the results seemed to favor chiropractic. This only makes a squarely negative study look positive! Why would anyone want to do that? Could this perhaps hint at a reason for this odd behavior? “The study was primarily funded by the Foundation for Chiropractic Research and Postgraduate Education.”

On 17/2/2020 I posted this article:

The drop in cases and deaths due to COVID-19 infections in India has been attributed to India’s national policy of using homeopathy. Early in the epidemic, the national “Ministry of AYUSH, recommended the use of Arsenic album 30 as preventive medicine against COVID-19. Its prophylactic use has been advised in states like Karnataka, Tamil Nadu, Kerala, and Maharashtra. The ‘OFFICIAL HOMEOPATHY RESOURCE’ is now claiming that homeopathy is the cause of the observed outcome…

If you click on the link, you will find that the OFFICIAL HOMEOPATHY RESOURCE has now removed the original. No problem! Thanks to Alan Henness, we can still access it; he announced in a tweet that he has archived a copy. So, here is the full article again:

India’s National Policy of Using Homeopathic Medicine To Prevent COVID is Dramatically Working

A dramatic plunge in cases and deaths of COVID in India can be attributed to India’s national policy of using homeopathy.

Early in the epidemic, the national “Ministry of AYUSH, (medical alternatives), in its guidelines, issued an advisory to states across India recommending the use of a traditional homeopathic drug, Arsenic album 30 as a form of preventive medicine against COVID-19. Its prophylactic use has been advised in states like Karnataka, Tamil Nadu, Kerala and Maharashtra and in some places, it has been used in high-risk areas. In places like Bhopal, claims were raised when doctors said that mild COVID cases were successfully treated with homeopathy.” [Times of India]

And now the results of that policy and use are clear, even though scientists in the conventional paradigm are mystified as to why the drop is so dramatic. They know nothing about homeopathy and its history of successfully treating epidemics.

India has a population of 1 billion, 300 million people. Relative to this massive population the number of cases per day and especially the number of deaths per day are now exceptionally low. According to the Daily Mail:

“Scientists are trying to work out why coronavirus cases in India are falling when at one point it looked like the country might overtake the US as the worst-hit nation.
In September the country was reporting some 100,00 new cases per day, but that went into decline in October and is now sitting at around 10,000 per day – leaving experts struggling to explain why.”

But why?

Why did the original disappear?

The reason seems obvious:

Saturday’s official toll recorded another 2,600 deaths and 340,000 new infections in India, bringing the total number of cases to 16.5 million, second only to the US. There have been 190,000 deaths attributed to Covid in India since the start of the pandemic. These figures are dramatic but most likely they are gross underestimates of the truth.

The egg on the face of homeopathy gets bigger if we consider things like the COVID-19 advice from ‘HOMEOPATHY INTERNATIONAL’, or the fact that UK’s biggest provider of homeopathy training encouraged the use of homeopathic potions made with phlegm to protect against and treat Covid-19. The egg finally turns into a veritable omelette, once we learn that the leading academic journal in homeopathy, HOMEOPATHY, promoted the idea that homeopathic have a place in the fight against the pandemic – not just once but repeatedly – and that the leading UK homeopath, Elizabeth Thompson, recommended homeopathy for COVID-19 infections after herself falling ill with the virus.

No, I do not feel the slightest tinge of Schadenfreude, about all this. I am writing about it because I still hope that it will prevent some people from risking their health with useless therapies and perhaps even stop some charlatans to make ridiculously irresponsible claims about them.  So, please do me a favor and heed my message:

The promotion of homeopathy and other ineffective therapies costs many lives!

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.

 

The General Chiropractic Council’s (GCC) Registrant Survey 2020 was conducted in September and October 2020. Its aim was to gain valuable insights into the chiropractic profession to improve the GCC’s understanding of chiropractic professionals’ work and settings, qualifications, job satisfaction, responsibilities, clinical practice, future plans, the impact of the COVID-19 pandemic on practice, and optimism and pessimism about the future of the profession.

The survey involved a census of chiropractors registered with the GCC. It was administered online, with an invitation email was sent to every GCC registrant, followed by three reminders for those that had not responded to the survey. An open-access online survey was also available for registrants to complete if they did not respond to the mailings. This was promoted using the GCC website and social media channels. In total, 3,384 GCC registrants were eligible to take part in the survey. A fairly miserable response rate of 28.6% was achieved.

Here are 6 results that I found noteworthy:

  • Registrants who worked in clinical practice were asked if performance was monitored at any of the clinical practices they worked at. Just over half (55%) said that it was and a third (33%) said it was not. A further 6% said they did not know and 6% preferred not to say. Of those who had their performance monitored, only 37% said that audits of clinical care were conducted.
  • Registrants working in clinical practice were asked if any of their workplaces used a patient safety incident reporting system. Just under six in ten (58%) said at least one of them did, whilst 23% said none of their workplaces did. A further 12% did not know and 7% preferred not to say.
  • Of the 13% who said they had a membership of a Specialist Faculty, a third (33%) said it was in paediatric chiropractic, 25% in sports chiropractic, and 16% in animal chiropractic. A further 13% said it was in pain and the same proportion (13%) in orthopaedics.
  • Registrants who did not work in chiropractic research were asked if they intended to work in that setting in the next three years. Seven in ten (70%) said they did not intend to work in chiropractic research in the next three years, whilst 25% did not know or were undecided. Only 5% said they did intend to work in chiropractic research.
  • Registrants were also asked how easy it is to keep up to date with recommendations and advances in clinical practice. Overall, two-thirds (67%) felt it was easy and 30% felt it was not.
  • Registrants were asked in the survey whether they felt optimistic or pessimistic about the future of the profession over the next three years. Overall, half (50%) said they were optimistic and 23% were pessimistic. A further 27% said they were neither optimistic nor pessimistic.

Perhaps even more noteworthy are those survey questions and subject areas that might have provided interesting information but were not included in the survey. Here are some questions that spring into my mind:

  • Do you believe in the concept of subluxation?
  • Do you treat conditions other than spinal problems?
  • How frequently do you use spinal manipulations?
  • How often do you see adverse effects of spinal manipulation?
  • Do you obtain informed consent from all patients?
  • How often do you refer patients to medical doctors?
  • Do you advise in favour of vaccinations?
  • Do you follow the rules of evidence-based medicine?
  • Do you offer advice about prescribed medications?
  • Which supplements do you recommend?
  • Do you recommend maintenance treatment?

I wonder why they were not included.

 

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.

On ‘healthline’, I came across an article entitled ‘What Does a Holistic Doctor Do?‘ which I found intriguing. It explained to me the
Principles of holistic medicine 

Holistic medicine is based on several core values:

  • good health is a combination of physical, emotional, mental, spiritual, and social wellness
  • prevention first, treatment second
  • disease is caused by a problem with the whole body, rather than a single event or body part
  • the goal of treatment is to fix the underlying cause of disease, instead of just improving the symptoms
  • treatment involves a wide range of options, including education, self-care, CAM, and traditional medicine
  • a person is not defined by their condition
  • the relationship between a doctor and the person being treated determines the treatment outcome
And after this overdose of misleading and somewhat annoying platitudes, the author addressed a question that I had been wondering about for years:
What does a holistic doctor do that a traditional doctor doesn’t?

Generally, traditional doctors treat symptoms. They provide medical solutions to alleviate a disease.

A holistic doctor treats the body as one. They aim to find the cause behind the disease, instead of just fixing the symptoms. This could require multiple therapies.

For example, if you have eczema, a medical doctor may give you a prescription cream. But a holistic doctor may suggest dietary and lifestyle changes. The holistic doctor might also recommend using the cream, plus natural home remedies like oatmeal baths.

So, now we know!

This could, of course, be just laughable if it were not perpetuating such common misconceptions. And as this sort of BS is so common, I feel obliged to carry on exposing it. Let me, therefore, correct the main errors in the short paragraph:

  1. ‘Traditional doctors’ are just doctors, proper doctors; holistic healers often give themselves the title ‘doctor’ but, unless they have been to medical school, they are not doctors.
  2. ‘Doctors treat symptoms’; yes, they do. But whenever possible, they treat the cause too. Therefore they do what is possible to identify the cause. And during the last 150 years or so, they have become reasonably good at this task.
  3. ‘A holistic doctor treats the body as one.’ That’s what they claim. But in reality, they are often not trained to do so. The body is mighty complex, and many holistic practitioners are simply not trained for coping with this complexity.
  4. ‘They aim to find the cause behind the disease’. They might well aim at that, but if they are not fully trained doctors, this is an impossible aim, and they merely end up finding what they have been taught about the cause of disease. An imbalance of Yin and Yang is the imagined cause of disease in TCM, and for many chiropractors, a subluxation is the cause of disease. But such assumptions are not facts; it is merely wishful thinking which get in the way of finding true causes of disease.
  5. Eczema happens to be a superb example (thank you ‘helpline’). The oatmeal bath of the holistic practitioner is at best a symptomatic treatment. This is why a proper doctor aims to find the cause of eczema which could be an allergy, for instance. Having identified it, the doctor would then advise how to avoid the allergen. If that is possible, further treatment might not be even necessary.

When practitioners are elaborating on their concept of holism, one often only needs to read on to find that those who pride themselves on holism are, in fact, the victims of multiple errors (or perhaps they use the holism gimmick only as a sales strategy, because consumers fall easily for this ‘bait and switch’). And those doctors who are accused of lacking holism are, in fact, more likely to be holistic than the so-called holists.

 

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.

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.

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: e.weatherley-jones@sheffield.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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