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

commercial interests

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The Lightning Process  (LP) is a commercial programme developed by Phil Parker based on ideas from osteopathy, life coaching and neuro-linguistic programming. It has been endorsed by celebrities like Martine McCutcheon and Esther Rantzen, who credits it for her daughter’s recovery from ME. Parker claims that LP works by teaching people to use their brain to “stimulate health-promoting neural pathways”. One young patient once described it as follows: “Whenever you get a negative thought, emotional symptom, you are supposed to turn on one side and with your arm movements in a kind if stop motion, just say STOP very firmly and that is supposed to cut off the adrenaline response.”

Allegedly, the LP teaches individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns and physical movements with the aim of improving a more appropriate response to situations. The LP involves three group sessions on consecutive days where participants are taught theories and skills, which are then practised through simple steps, posture and coaching.

A few days ago, someone asked my help writing to me: Norwegian newspaper is attacking patients for objecting to a clinical trial of the lightning process which is horrible quackery. LP is being backed by some people in Norwegian health authorities. Could you bring attention to how disgraceful this is please? I promised to look into it. Hence this post.

My searches located just one single trial. It seems to be the only controlled clinical study available. Here it is:

Design: Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.

Setting: Specialist paediatric CFS/ME service.

Patients: 12-18 year olds with mild/moderate CFS/ME.

Main outcome measures: The primary outcome was the the 36-Item Short-Form Health Survey Physical Function Subscale (SF-36-PFS) at 6 months. Secondary outcomes included pain, anxiety, depression, school attendance and cost-effectiveness from a health service perspective at 3, 6 and 12 months.

Results: We recruited 100 participants, of whom 51 were randomised to SMC+LP. Data from 81 participants were analysed at 6 months. Physical function (SF-36-PFS) was better in those allocated SMC+LP (adjusted difference in means 12.5(95% CI 4.5 to 20.5), p=0.003) and this improved further at 12 months (15.1 (5.8 to 24.4), p=0.002). At 6 months, fatigue and anxiety were reduced, and at 12 months, fatigue, anxiety, depression and school attendance had improved in the SMC+LP arm. Results were similar following multiple imputation. SMC+LP was probably more cost-effective in the multiple imputation dataset (difference in means in net monetary benefit at 12 months £1474(95% CI £111 to £2836), p=0.034) but not for complete cases.

Conclusion: The LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME.

The trial was designed as an ‘A+B versus B’ study which practically always generates a positive outcome. It did not control for placebo effects and is, in my humble view, worthless and arguably unethical. It certainly does not warrant the conclusion that LB is effective or cost-effective.

I do not doubt that the LP-children improved, but I see no reason to believe that this had anything to do with LP. It could have been (and most likely was) caused by the intense attention that these kids received over three days. Giving them a daily ice-cream and some kindness might (and probably would) have produced even better outcomes.

So, what do we call a therapy for which numerous, far-reaching claims are being made, which is based on implausible assumptions, which is unproven, and for which people have to pay dearly?

The last time I looked, it was called quackery.

Have you ever noticed that, according to its proponents, many forms of so-called alternative medicine (SCAM) must be applied a long time before there is a noticeable benefit?

As so often, homeopathy is a good example. If you consult a homeopath, she will, in all likelihood, explain that it would be unwise to expect immediate effects. The treatment needs to be taken for weeks; perhaps she even needs to change the prescription once or twice. And the longer you have suffered from your illness, the longer it will take to get rid of it. Sometimes it takes years!

Those homeopathy-fans who have experienced instant effects will, of course, disagree. But these cases are almost certainly due to the placebo response which is known to be fast. The majority of patients will be told to persevere and show patience.

And unquestionably some patients will eventually experience a reduction of symptoms. Thus the homeopaths is proven correct: homeopathy takes time to work!

But hold on, how plausible is this explanation?

Let’s assume a child is cured of asthma after many months of religiously taking the prescribed homeopathic remedies. Is the cure due to the treatment, or might there be other phenomena at play? The most obvious explanation by far is the fact that children frequently grow out of diseases like asthma. So, this and other self-limiting conditions are not good examples.

What about a disease that is clearly not self-limiting? What about a MS patient who feels much improved after taking his homeopathic remedies for three months? Again, the best explanation for the improvement would be the natural history of the disease. The severity of the symptoms of many conditions fluctuate in such a way that there will be periods of relative well-being followed by deterioration.

And what, if we are dealing with a disease that normally gets progressively worse over time, if untreated ? What if a cancer patient claims to be cured after months of homeopathic therapy? Such cases do not exist! The few such ‘cures’ that have been reported have explanations that are unrelated to homeopathy. They are due to one of the three phenomena:

  • false diagnosis,
  • concomitant treatments,
  • spontaneous recovery.

It turns out that the notion of homeopathy (or any other SCAM) requiring a long period of time until the benefit kicks in is mostly a myth.

Well, perhaps not entirely!

The benefit of SCAM does unquestionably need time before a significant benefit ($$$, £££) for the SCAM provider kicks in. So, let’s not sneer at the notion. Let’s be positive. Let’s recognise the reason why the myth is being kept alive. We all must make a living!

 

SIMILE is the newsletter of ‘The Faculty of Homeopathy’ which is the professional organisation of doctor homeopaths in the UK. Readers of this blog might know about SIMILE because I once published a post about it. Two years ago, the late Dr Peter Fisher (then the Queen’s homeopath) used SIMILE to re-publish a serious lie about me:

A prepublication draft [of the Smallwood report] was circulated for comment with prominent warnings that it was confidential and not to be shared more widely (I can personally vouch for this, since I was one of those asked to comment). Regrettably, Prof Ernst did precisely this, leaking it to The Times who used it as the basis of their lead story. The editor of The Lancet, Richard Horton, certainly no friend of homeopathy, promptly denounced Ernst for having “broken every professional code of scientific behaviour”.

Sir Michael Peat, the Prince of Wales’ Principal Private Secretary, wrote to the vice chancellor of Exeter University protesting at the leak, and the university conducted an investigation. Ernst’s position became untenable, funding for his department dried up and he took early retirement. Thirteen years later he remains sore; in his latest book More Harm than Good? he attacks the Prince of Wales as “foolish and immoral”.

At the time, I complained and SIMILE (not Fisher) apologised unreservedly.

The current (May 2020) issue of SIMILE carries the following article. I find it quite humorous and therefore take the liberty of copying it here for you:

Every year in Austria a sceptic group called the Society for the Scientific Investigation of Parasciences (GWUP) announces the winner of the Golden Board in Front of the Head Award for what they deem as “unscientific nonsense”. Their award frequently goes to a representative of Austria’s homeopathy community.

However, it now appears Austrian homeopaths have turned the tables on their antagonists by bestowing the 2019 Award for pseudoscience to the GWUP.

But what seems on the surface to be a light hearted tit-for-tat gesture is in truth an attempt to raise questions about who these sceptic groups represent and their real aims.

The Austrian Society of Medical Homeopathy and the Veterinary Society for Homeopathy justify the award on the grounds that the GWUP is trying to agitate against complementary medicine and homeopathy without disclosing their true motives and donors. They say that under the guise of science and purported “scientific truths” these “all-knowing” activists, many of whom are without any medical qualifications, deliberately misrepresent scientific studies that support the efficacy of homeopathy beyond placebo.

The homeopaths accuse the sceptic group of fanatical and aggressive lobbying and media work to discredit proven methods of complementary medicine, which are successfully used by a large number of people around the world. Their aim, claim the homeopaths, is to position complementary medicine in an “esoteric, frivolous corner, to curtail plurality and freedom of choice in healthcare, and to hinder progress towards inclusive medicine”.

As we can see, SIMILE learnt an important lesson: they now tell lies in a way that does no loner put them in the firing line. Instead they report then as said by someone else:

  • GWUP is trying to agitate against complementary medicine and homeopathy without disclosing their true motives and donors = lie No 1
  • under the guise of science and purported “scientific truths” these “all-knowing” activists, many of whom are without any medical qualifications, deliberately misrepresent scientific studies that support the efficacy of homeopathy beyond placebo = lie No 2
  • fanatical and aggressive lobbying and media work to discredit proven methods of complementary medicine = lie No 3
  • position complementary medicine in an “esoteric, frivolous corner, to curtail plurality and freedom of choice in healthcare, and to hinder progress towards inclusive medicine” = lie No 4

Congratulation guys!

You have managed to find a way which enables you to promote untruth and shelter yourselves from considering criticism. You have, in other words, continued the age-old homeopathic tradition of effectively avoiding critical thinking.

Spermidine is a polyamine which is a natural component of our cells. It has its name from the fact that it was first found in sperm. It can also be found in varying concentrations in different fruits, vegetables, meat and cheese. About one third of the spermidine levels in our body is produced by our own cells, the rest is absorbed through food and certain bacteria found in our digestive tract. A balanced diet can therefore help maintain high levels of spermidine.

There has been a flurry of research into spermidine, not least because epidemiologic evidence supports to the concept that nutrition rich in spermidine is linked to increased survival in humans. Unsurprisingly, many spermidine supplements are now available for sale (at around £50 for one month’s supply). In order to check whether there is any clinical evidence to suggest that they are effective, I ran a quick Medline search for placebo-controlled, double-blind RCTs. I found 4 such studies; here are their abstracts:

1st study

Introduction: Nutritional intervention with the natural polyamine spermidine, an autophagy-enhancing agent, can prevent memory loss in aging model organisms. This is the first human study to evaluate the impact of spermidine supplementation on memory performance in older adults at risk for the development of Alzheimer’s disease.

Methods: Cognitively intact participants with subjective cognitive decline (n = 30, 60-80 years of age) were included in this three-months, randomized, placebo-controlled, double-blind Phase IIa pilot trial with a spermidine-rich plant extract supplement. Effects of intervention were assessed using the behavioral mnemonic similarity task, measured at baseline and post-intervention visits. Data analysis was focused on reporting and interpreting effectiveness based on effect sizes.

Results: Memory performance was moderately enhanced in the spermidine group compared with placebo at the end of intervention [contrast mean = .17, 95% confidence interval (CI): -.01, .35, Cohen’s d = .77, 95% CI: 0, 1.53]. Mnemonic discrimination ability improved in the spermidine-treated group with a medium effect size (mean difference = -.11, 95% CI: -.19, -.03, Cohen’s d = .79, 95% CI: .01, 1.55). A similar effect was not found in the placebo-treated group (mean difference = .07, 95% CI: -.13, .27, Cohen’s d = -.20, 95% CI: -.94, .54).

Discussion: In this pilot trial, nutritional spermidine was associated with a positive impact on memory performance in older adults with subject cognitive decline. The beneficial effect might be mediated by stimulation of neuromodulatory actions in the memory system. A follow-up Phase IIb randomized controlled trial will help validate the therapeutic potential of spermidine supplementation and delineate possible neurophysiological mechanisms of action.

2nd study

Supplementation of spermidine, an autophagy-inducing agent, has been shown to protect against neurodegeneration and cognitive decline in aged animal models. The present translational study aimed to determine safety and tolerability of a wheat germ extract containing enhanced spermidine concentrations. In a preclinical toxicity study, supplementation of spermidine using this extract did not result in morbidities or changes in behavior in BALBc/Rj mice during the 28-days repeated-dose tolerance study. Post mortem examination of the mice organs showed no increase in tumorigenic and fibrotic events. In the human cohort (participants with subjective cognitive decline, n=30, 60 to 80 years of age), a 3-month randomized, placebo-controlled, double-blind Phase II trial was conducted with supplementation of the spermidine-rich plant extract (dosage: 1.2 mg/day). No differences were observed between spermidine and placebo-treated groups in vital signs, weight, clinical chemistry and hematological parameters of safety, as well as in self-reported health status at the end of intervention. Compliance rates above 85% indicated excellent tolerability. The data demonstrate that spermidine supplementation using a spermidine-rich plant extract is safe and well-tolerated in mice and older adults. These findings allow for longer-term intervention studies in humans to investigate the impact of spermidine treatment on cognition and brain integrity.

3rd study

Recently, it was demonstrated that spermidine-induced autophagy reduces the risk of cardiovascular disease in mice. Intestinal bacteria are a major source of polyamines, including spermidine. We previously reported that the intake of both Bifidobacterium animalis subsp. lactis (Bifal) and arginine (Arg) increases the production of putrescine, a spermidine precursor, in the gut. Here, we investigated the effects of Bifal and Arg consumption on endothelial function in healthy subjects. Healthy individuals with body mass index (BMI) near the maximum value in the “healthy” range (BMI: 25) (n = 44) were provided normal yogurt containing Bifal and Arg (Bifal + Arg YG) or placebo (normal yogurt) for 12 weeks in this randomized, double-blinded, placebo-controlled, parallel-group comparative study. The reactive hyperemia index (RHI), the primary outcome, was measured using endo-peripheral arterial tone (EndoPAT). The change in RHI from week 0 to 12 in the Bifal + Arg YG group was significantly higher than that in the placebo group, indicating that Bifal + Arg YG intake improved endothelial function. At week 12, the concentrations of fecal putrescine and serum putrescine and spermidine in the Bifal + Arg YG group were significantly higher than those in the placebo group. This study suggests that consuming Bifal + Arg YG prevents or reduces the risk of atherosclerosis.

4th study

Background: Spermidine has been shown both in vitro and in mice models to have an anagen-prolonging effect on hair follicles (HFs).

Objectives: To evaluate the effects of a spermidine-based nutritional supplement on the anagen phase of HFs in healthy human subjects in a randomized, double-blind, placebo-controlled trial.

Methods: One hundred healthy males and females were randomized to receive a tablet containing a spermidine-based nutritional supplement or a placebo once daily for 90 days. At the beginning and the end of the treatment period, 100 HFs were plucked and subjected to microscopic evaluation to determine the number of anagen V-VI HFs, and immunohistochemical examination was performed to quantify the Ki-67 and c-Kit levels in the hair bulbs. Pull test was performed after three and six months.

Results: The spermidine-based nutritional supplement increased the number of anagen V-VI HFs after three months of treatment, accompanied by increased Ki-67, a marker for cellular proliferation, and decreased c-Kit, a marker for apoptosis, levels. All results were also significantly better when compared to the placebo group. The pull test remained negative after six months in all patients receiving the spermidine supplement, while 68% of the subjects in the placebo group had a positive pull test.

Conclusions: This preliminary study shows that a spermidine-based nutritional supplement can prolong the anagen phase in humans, and therefore might be beneficial for hair loss conditions. Further studies are needed to evaluate its effects in specific different clinical settings.

_____________________

Convinced?

I could certainly do with a few more hair on my head.

And living longer with less cognitive decline would also be not a bad prospect.

Do I therefore rush to the next health food shop to buy a spermidine supplement?

No.

Yes, the evidence – particularly the pre-clinical one – is fascinating. But it seems to me that a normal diet will provide all the spermidine I need (and for £50 I can buy a lot of good food).

THE HINDU reported on 22 May the following amazing story:

A corporator from Borivali, Riddhi Khursange, has distributed 10,000 bottles of Arsenicum Album 30, the homoeopathy medicine that was recommended by Ministry of AYUSH as a prophylactic for COVID-19. Another corporator from Ghatkopar, Pravin Chheda, has bought 25,000 bottles and has distributed over 7,100 in the past four days…

“The AYUSH Ministry must have based their claims on the benefits of the medication. The municipal corporation has also approved it for distribution,” said Mr. Chheda, who aims to distribute one lakh vials. He said all his family members have taken the three-day dose.

While the recommendation from AYUSH was issued on March 6, the Brihanmumbai Municipal Corporation (BMC) on May 8 issued a circular that 20 lakh people, including those in quarantine centres, will get the medicine.

Some experts, however, do not agree with such random, mass distribution. Also known as Ars Alb, the medication was termed as genus epidemicus (homoeopathy medicine indicated for an epidemic) during the H1N1 outbreak of 2008-2009. “Back then, Ars Alb proved extremely beneficial. But the current claim of AYUSH Ministry has not been backed by the process of genus epidemicus,” said Dr Bahubali Shah, former president of the Maharashtra Council of Homoeopathy.

“Another major problem is this general mass distribution of the medicine without an attempt to collect data on efficacy. There has to be a proper distribution protocol and a protocol for analysis. Right now, corporators, NGOs, the BMC and everyone who can get their hands on the medication are distributing it without any record-keeping,” he said.

Well-known chest physician, Dr. Zarir Udwadia, who is part of the State’s COVID-19 task force, said any alternative treatment still has to undergo a trial. “In my opinion, it should not be added on ad hoc,” said Dr. Udwadia.

The State government has set up a new committee to exclusively look at AYUSH remedies. Dr. T.P. Lahane, who is a part of the committee, said a meeting was planned on Thursday evening to discuss various options.

Meanwhile, a trial on 44 COVID-19 patients in Agra has shown that a homoeopathy medicine called Bryonia Alba was more beneficial than Ars Alb. “We have submitted our findings to Central Council of Homoeopathy and are now enrolling more patients for a bigger trial,” said Dr. Pradeep Gupta, principal of the Naiminath Homeopathy College and Hospital, who is conducting the trial.

He said 22 patients were given a placebo while 22 others were given homoeopathy medicines, Bryonia Alba, Ars Alb and Gelsemium. “19 patients who had fever, cough and weakness, responded to Bryonia within the first three days, two patients who had respiratory distress were first given Ars Alb, which relieved the breathing discomfort, but they had to be put on Bryonia Alba to relieve their fever and cough. Only one patient who came in with drowsiness was first given Gelsemium, but later put on Bryonia Alba for other symptoms,” said Dr. Gupta.

For patients in Agra, Bryonia Alba seems to be the genus epidemicus, he said. Dr. Gupta has now written to the Maharashtra government to conduct a similar trial on patients here.

Are they serious?

To me this sounds as though some amateurs are playing doctor and scientist.

I am sure we will have some homeopathy fans pointing out that India is doing very well in the pandemic and that this must be due to the widespread use of homeopathy. To this I answer that firstly India is sadly no longer doing all that well, and secondly that proof of efficacy requires more than speculation. They will reply that homeopathy has proven itself in many previous epidemics. And I will counter that this is just wishful thinking.

So, will the current pandemic finally provide the proof that homeopathy works?

No!

And the Indian homeopaths seem to be doing their utmost to obscure the picture in their hope that, in the end, they can nevertheless claim victory out of a shameful defeat.

Guest post by: Loretta Marron

In March 1991, the Australian College of Allergy published an article in the Medical Journal of Australia (MJA) about a ‘bioresonance’ device for allergy testing. Titled “VEGA testing in the diagnosis of allergic conditions”, it stated that it was “an unorthodox method of diagnosing allergic and other diseases” with “no established scientific basis” and “no controlled trials to support its usefulness”.

The article raised concerns that this test “may lead to inappropriate treatment and expense to the patient and community”. VEGA is one of nearly 30 ‘energy medicine’ devices, some of which continue to cite Therapeutic Goods Administration (TGA) ‘listing numbers’.

Sometime costing more than $34,000, the sponsors tell practitioners that they can earn up to $150,000 annually with these computerised devices. Referring to ‘bioresonance’ as “the medicine of the future”, they claim that all toxins, viruses and bacteria have unique ‘frequency patterns’, which, when ‘neutralised’ by the device, restore the patient to health. They may also claim that it can cure addictions to alcohol, cocaine, crack, nicotine, heroin, opiates, cannabis, spice, ‘legal highs’ and other medications. Some claim that it can cure cancer, hay fever, allergies, auto-immune diseases, behavioural problems, smoking addiction and that they can kill parasites – the list goes on.

The devices are ‘based’ on acupuncture, homeopathy and ‘quantum physics’. More than 60 reviews in the Cochrane Collaboration (the ‘Gold Standard’ for evidence-based Medicine), have failed to find robust evidence for clinically significant outcomes for acupuncture for any disease or disorders. The National Health & Medical Research Council concluded, “there are no health conditions for which there is reliable evidence that homeopathy is effective” and quantum physics “is not at work”. In February 2020, nearly 30 years after that MJA article, the TGA’s cancellation of two of these devices saw the last of them removed from their register, but not from permissible advertising or practice.

From 2014 to 2018, Friends of Science in Medicine (FSM) had repeatedly written letters and submissions to the TGA asking for these devices to be investigated. Meeting with the national manager in 2016, we were told that these devices could not be cancelled because they were ‘biofeedback’ devices, which had a legitimate place in health care. In 2018, FSM sourced comments from informed experts here and overseas. These disputed the ‘biofeedback’ claim. FSM sent screenshots from more than 200 websites to the TGA advertising complaints. In 2019, after issuing a warning on bioresonance, the TGA closed the complaints and commenced an ‘education campaign’. They also engaged a credible Australian scientific organisation to review the evidence provided by eight ‘sponsors’ of 12 bioresonance’ devices listed in the Australian Register of Therapeutic Goods).

All devices have now been cancelled by their sponsors or by the TGA. The ‘education campaign’ continues. Even though the devices are still widely used, and courses still being run, FSM considers this a modestly satisfactory outcome.

Informed opinions:

Biofeedback:

o Michelle G Aniftos BCN, FCCLP, QEEGD, MEd, MPsych (Clinical), GradCertClinNeurophysiology, Fellow, Biofeedback Certification International Alliance, &

o Dr Tania M. Slawecki, PhD. Energy and the Environment Laboratory (formerly Materials Research Lab), Penn State University, USA (Author of “How to Distinguish Legitimate Biofeedback/Neurofeedback Devices”;

Electronic devices:

o Dr Stephen J Roberts, BSc ARCS DIC PhD. Consultant on electronic devices;

Psychology:

o Emeritus Professor Joseph P Forgas, AM, DPhil, Dsc (Oxford), FASSA, Scientia Professor, Psychology, UNSW &

Alternative medicine:

o Emeritus Professor Edzard Ernst MD, PhD, FMed Sci, FSB, FRCP, FRCP(Edin)

Their comments include the following:

· Ms Aniftos: “Having reviewed the specifications of the BICOM device, I find that its inclusion on the ARTG as a ‘biofeedback device’ is erroneous”;

· Dr Slawecki: “the BICOM device does not fit the criteria of a legitimate biofeedback device”;

· Dr Roberts: “The claims of how the BICOM and CyberScan work are preposterous.”Quantum physics” is not at work”;

· Professor Forgas: “The BICOM is NOT a biofeedback device and should be cancelled”; “The description of this device makes it crystal clear that it cannot possibly have any effective diagnostic or therapeutic function, and certainly has nothing at all to do with biofeedback.

“The claims made for the device amount to the worst kind of psychological manipulation, and their sole purpose is to mislead and exploit vulnerable people for financial gain. As a civilised society, we should not allow this kind of immoral exploitation to continue and the device should be banned forthwith”;

· Professor Ernst: “Bioresonance is not biologically plausible, not of proven effectiveness, potentially harmful and associated with exorbitant costs. I cannot recommend it for anyone or any purpose”.

As mentioned before, the US ‘Agency for Healthcare Research and Quality (AHRQ) have published a most comprehensive review update entitled ‘Noninvasive Nonpharmacological Treatment for Chronic Pain‘. It followed the AHRQ Methods Guide for Effectiveness and Comparative Effectiveness. The conditions included were:

  • Chronic low back pain
  • Chronic neck pain
  • Osteoarthritis (knee, hip, hand)
  • Fibromyalgia
  • Chronic tension headache

 

Here are the main findings related to spinal manipulation:

LOW BACK PAIN

  • Spinal manipulation was associated with small improvements compared with sham manipulation, usual care, an attention control, or a placebo intervention in short-term (3 trials) and intermediate-term (3 trials) function (strength of evidence : low). There was no difference between spinal manipulation versus sham manipulation, usual care, an attention control, or a placebo intervention in short-term pain (3 trials), but manipulation was associated with a small improvement compared with controls on intermediate-term pain (3 trials) (SOE: low for short term, moderate for intermediate term).

CHRONIC TENSION HEADACHE

  • Spinal manipulation therapy was associated with small improvements in function and moderate improvements in pain compared with usual care over the short term in one trial (: low). Approximately a quarter of the patients had comorbid migraine.

HARMS

It was noted that many trails failed to report on adverse effects (AEs). Non- serious AEs reported included mild to moderate increase in pain, local discomfort and tiredness (2 RCTs).

___________________

Hardly impressive, is it?

Yet, some chiropractors treating chronic pain claim they practice Evidence-based medicine. This review seems to disclose this claim as bogus. What chiropractors do practice on virtually all patients is spinal manipulation which generates more harm than it produces benefit.

Please note yet again that:

  • many chiro trials fail to mention AEs (thus violating research ethics),
  • clinical trials are always too small to give a reliable impression about safety,
  • no post-marketing surveillance exists in chiropractic,
  • we thus have to rely mostly on case reports and similar articles,
  • and the collective evidence from such reports shows quite clearly that spinal manipulations are not safe,
  • chiropractors tend to deny all of the above,
  • this is because they have a monumental conflict of interest.

Can I invite you to join me in a little thought experiment?

Think of a totally useless therapy. I would suggest homeopathy but there are always some who would disagree with this classification. I need a TOTALLY useless therapy, and one where we ALL can agree on the label.

What about ‘Potentised Toe-Nail Powder’ (PoToNaPo)?

PoToNaPo is made from nail clippings, thoroughly sterilised, ground to a powder, serially diluted and potentised. Does anyone claim this remedy to be effective for any condition?

No?

Splendid!

So, we all agree that PoToNaPo is completely ineffective.

Now imagine some charlatan claiming that PoToNaPo is a highly effective cancer cure. Let’s furthermore imagine that he is very successful with his claim.

(No, this is not far fetched! Think of Laetrile, Essiac, etc.)

Imagine our charlatan makes millions with PoToNaPo.

There would soon be some opposition to his quackery. The FDA would issue a statement that PoToNaPo is unproven. Perhaps the NEJM would publish an editorial saying something similar. Ethicists would frown publicly. And many sceptics would head to the pubs where clever guys would give talks about ‘the scandal of PoToNaPo’.

We all know it would happen, because it has happened with PoToNaPo-like remedies many times before.

______________

Now imagine a different scenario, namely one in which our charlatan does not claim that PoToNaPo is a cancer cure; imagine instead he had claimed that PoToNaPo is a holistic medicine that boosts your well-being via re-balancing your vital energies which, in turn, helps with anxiety which in turn might have positive effects on things like mild chronic pain, depressive mood, tension headache, insomnia, erectile dysfunction and many more symptoms of daily life.

Let’s furthermore imagine that our charlatan is very successful with these claims.

No, this is not far fetched! Think of … well … think of any SCAM really.

Imagine the charlatan makes millions with PoToNaPo.

What would happen?

  • He would be invited to conferences on integrative medicine.
  • Become an honorary member/sponsor of the ‘College of Medicine and Integrated Health’.
  • He would be interviewed on the BBC.
  • The Daily Mail would publish advertorials.
  • HRH would perhaps invite him for tea.
  • Trump might hint that PoToNaPo cures virus infections.
  • Ainsworth might buy his patent.
  • There could even be a gong waiting for him.
  • And yes … some sceptics would mutter a bit, but the public would respond: what’s the harm?

We all know that things of this nature might happen, because they have happened before with PoToNaPo-like remedies.

__________________

So what’s the difference?

In both scenarios, our charlatan has marketed the same bogus remedy, PoToNaPo.

In both scenarios, he has made unsubstantiated, even fraudulent claims.

Why does he get plenty of stick in the 1st and becomes a hero in the 2nd case?

Yes, I know, the difference is the nature of the claims. But the invention, production, marketing and selling of a bogus treatment, the lying, the deceit, the fraud, the exploitation of vulnerable people are all the same.

Why then are we, as a society, so much kinder to the charlatan in the 2nd scenario?

I think we shouldn’t be; it’s not logical or consequent. I feel we should name, shame and punish both types of charlatans. They are both dangerous quacks, and it is our ethical duty to stop them.

END OF THOUGHT EXPERIMENT

 

The WHO have issued the following press-release:

The World Health Organization (WHO) welcomes innovations around the world including repurposing drugs, traditional medicines and developing new therapies in the search for potential treatments for COVID-19.

WHO recognizes that traditional, complementary and alternative medicine has many benefits and Africa has a long history of traditional medicine and practitioners that play an important role in providing care to populations. Medicinal plants such as Artemisia annua are being considered as possible treatments for COVID-19 and should be tested for efficacy and adverse side effects. Africans deserve to use medicines tested to the same standards as people in the rest of the world. Even if therapies are derived from traditional practice and natural, establishing their efficacy and safety through rigorous clinical trials is critical.

African governments through their Ministers of Health adopted a resolution urging Member States to produce evidence on the safety, efficacy and quality of traditional medicine at the Fiftieth Session of the WHO Regional Committee for Africa in 2000. Countries also agreed to undertake relevant research and require national medicines regulatory agencies to approve medicines in line with international standards, which include the product following a strict research protocol and undergoing tests and clinical trials. These studies normally involve hundreds of people under the monitoring of the national regulatory authorities and may take quite a few months in an expedited process.

WHO is working with research institutions to select traditional medicine products which can be investigated for clinical efficacy and safety for COVID-19 treatment. In addition, the Organization will continue to support countries as they explore the role of traditional health practitioners in prevention, control, and early detection of the virus as well as case referral to health facilities.

Over the past two decades, WHO has been working with countries to ensure safe and effective traditional medicine development in Africa by providing financial resources and technical support. WHO has supported clinical trials, leading 14 countries to issue marketing authorization for 89 traditional medicine products which have met international and national requirements for registration. Of these, 43 have been included in national essential medicines lists. These products are now part of the arsenal to treat patients with a wide range of diseases including malaria, opportunistic infections related to HIV, diabetes, sickle cell disease and hypertension. Almost all countries in the WHO African region have national traditional medicine policies, following support from WHO.

As efforts are under way to find treatment for COVID-19, caution must be taken against misinformation, especially on social media, about the effectiveness of certain remedies. Many plants and substances are being proposed without the minimum requirements and evidence of quality, safety and efficacy. The use of products to treat COVID-19, which have not been robustly investigated can put people in danger, giving a false sense of security and distracting them from hand washing and physical distancing which are cardinal in COVID-19 prevention, and may also increase self-medication and the risk to patient safety.

WHO welcomes every opportunity to collaborate with countries and researchers to develop new therapies and encourages such collaboration for the development of effective and safe therapies for Africa and the world.

________________________________

While this message – mostly directed towards Africa – seems very clear and reasonable, it is, at the same time, prone to be misunderstood. Here is an excerpt from an Ghana newspaper article commenting on the WHO initiative which demonstrates my point:

In the view of this newspaper, it stands to reason that, since the virus, was transmitted from animals, the best form of cure, is to use herbs.

We have abundance of the plant Madagascar is using to develop the cure. Medical doctors should stop seeing those practicing alternative medicine, as competitors.

The open hatred, and disdain by medical doctors, towards practitioners of alternative medicine, must be a cause for concern by all.

In the considered opinion of this newspaper, the government must bring the two together to work to avert any calamity.

The number of cases recorded so far, is a ticking time bomb. We cannot continue to treat it as business as usual, where traditional medicine practitioners, will claim to make a discovery, which will not be accepted by their counterpart who practice orthodox medicine.

If any country in Africa, should have been the first to announce a discovery of cure for coronavirus, using herbal remedy it should have been Ghana.

We can do a lot, if the two come together, instead of working at cross purpose.

This is how easily the crucial WHO message ‘the use of products to treat COVID-19, which have not been robustly investigated can put people in danger’ can be forgotten.

FIRST TEST

MAKE SURE IT WORKS

MAKE SURE IT’S REASONABLY SAFE

THEN USE IN ROUTINE CARE

Everything else is not going to be helpful!

During the last few months, I have done little else on this blog than trying to expose misinformation about COVID-19 in the realm of so-called alternative medicine (SCAM). However, the usefulness and accuracy of most viewed YouTube videos on COVID-19 have so far not been investigated. Canadian researchers have just published a very nice paper that fills this gap.

They performed a YouTube search on 21 March 2020 using keywords ‘coronavirus’ and ‘COVID-19’, and the top 75 viewed videos from each search were analysed. Videos that were duplicates, non-English, non-audio and non-visual, exceeding 1 hour in duration, live and unrelated to COVID-19 were excluded. Two reviewers coded the source, content and characteristics of included videos. The primary outcome was usability and reliability of videos, analysed using the novel COVID-19 Specific Score (CSS), modified DISCERN (mDISCERN) and modified JAMA (mJAMA) scores.

Of 150 videos screened, 69 (46%) were included, totalling 257 804 146 views. Nineteen (27.5%) videos contained non-factual information, totalling 62 042 609 views. Government and professional videos contained only factual information and had higher CSS than consumer videos (mean difference (MD) 2.21, 95% CI 0.10 to 4.32, p=0.037); mDISCERN scores than consumer videos (MD 2.46, 95% CI 0.50 to 4.42, p=0.008), internet news videos (MD 2.20, 95% CI 0.19 to 4.21, p=0.027) and entertainment news videos (MD 2.57, 95% CI 0.66 to 4.49, p=0.004); and mJAMA scores than entertainment news videos (MD 1.21, 95% CI 0.07 to 2.36, p=0.033) and consumer videos (MD 1.27, 95% CI 0.10 to 2.44, p=0.028). However, they only accounted for 11% of videos and 10% of views.

The authors concluded that over one-quarter of the most viewed YouTube videos on COVID-19 contained misleading information, reaching millions of viewers worldwide. As the current COVID-19 pandemic worsens, public health agencies must better use YouTube to deliver timely and accurate information and to minimise the spread of misinformation. This may play a significant role in successfully managing the COVID-19 pandemic.

I think this is an important contribution to our knowledge about the misinformation that currently bombards the public. It explains not only the proliferation of conspiracy theories related to the pandemic, but also the plethora of useless SCAM options that are being touted endangering the public.

The authors point out that the videos included statements consisting of conspiracy theories, non-factual information, inappropriate recommendations inconsistent with current official government and health agency guidelines and discriminating statements. This is particularly alarming, when considering the immense viewership of these videos. Evidently, while the power of social media lies in the sheer volume and diversity of information being generated and spread, it has significant potential for harm. The proliferation and spread of misinformation can exacerbate racism and fear and result in unconstructive and dangerous behaviour, such as toilet paper hoarding and mask stealing behaviours seen so far in the COVID-19 pandemic. Consequently, this misinformation impedes the delivery of accurate pandemic-related information, thus hindering efforts by public health officials and healthcare professionals to fight the pandemic.

Good work!

I suggest to critically evaluate the statements of some UK and US politicians next.

 

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