MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bogus claims

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One of the UK’s most ardent promoters of outright unproven and disproven therapies must be Dr Michael Dixon. He has repeatedly and deservedly received a mention on this blog. Steven Novella even called him once a ‘pyromaniac in a field of (integrative) straw men’. This is because Steven felt that Dixon uses phony arguments to promote dodgy therapies. If you find this hard to believe (after all Dixon is a GP who heads important organisations such as the NHS Alliance and the College of Medicine), just look at him dabbling in spiritual healing. Unusual, to say the least, I’d say. If you want to learn more about the strange Dr Dixon, you should read my memoir where he makes several remarkable appearances.

I always delight when I stumble over something that one of my former co-workers (yes, Dixon and I did collaborate for many years) has said to the press. This is why an otherwise silly article in the Daily Mail (yes, I know!) caught my attention; here is the relevant section: Dr Mike Dixon, a GP in Cullompton, Devon, and chairman of the College of Medicine, says he is a ‘fan’ of herbal medicines because they are ‘safe, help to encourage self-care by patients and, in cases such as mint and aloe vera, can be grown by the patients themselves, making them virtually free’.

As I already pointed out, Dixon does tend to promote bizarre concepts. The generalisation that herbal remedies are safe is not just bizarre, it also put the public at risk. One does not need to search long to find an article that makes this clear:

Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.

Dixon once told me that GPs do not any longer read scientific papers. I think, however, that he should start doing so before the next time he misinform the public and endangers the health of vulnerable people.

The task of UK Clinical Commissioning Groups (CCGs) is to ensure NHS funds are spent as effectively and responsibly as possible. This is particularly important in the current financial climate, as NHS budgets are under enormous pressure. For that reason, The Good Thinking Society (GTS, a pro-science charity) invited Liverpool CCG to reconsider whether the money (~ £ 30,000 pa) they spend on homeopathy represents good service to the public. Recently the CCG agreed to make a fresh decision on this contentious issue.

The GTS would prefer to see limited NHS resources spent on evidence-based medicine rather than on continued funding of homeopathy which, as readers of this blog will know, has repeatedly failed to demonstrate that it is doing more good than harm. It is encouraging to see Liverpool CCG take a first step in the right direction by agreeing to properly consider the best evidence and expertise on this issue.

Supporters of homeopathy frequently cite the concept of patient choice and claim that, if patients want homeopathy, they should have it free on the NHS. The principle is obviously important, but it is crucial that this choice is an informed one. The best evidence has conclusively shown that homeopathy is not an effective treatment, and to continue to offer ineffective treatments under the guise of patient choice raises troubling questions about the important concept of informed choice, and indeed of informed consent as well as medical ethics.

The GTS were represented by Salima Budhani and Jamie Potter of Bindmans LLP. Salima said: “This case underlines the necessity of transparent and accountable decision making by the controllers of health budgets, particularly in the light of the current financial climate in the NHS. CCGs have legal obligations to properly consider relevant evidence, as well as the views of experts and residents, in deciding how precious NHS resources are to be spent. It is essential that commissioning decisions are rational and evidence-based. Liverpool CCG’s decision to reconsider its position on the funding of homeopathy in these circumstances is to be welcomed.

“Our client has also called upon the Secretary of State for Health to issue guidance on the funding of homeopathy on the NHS. Public statements by the Secretary of State indicate that he does not support ongoing funding, yet he has so far declined to ask NICE to do any work on this issue. The provision of such guidance would be of significant benefit to CCGs in justifying decisions to terminate funding.”

Commenting on their decision, a Liverpool CCG spokesperson said: “Liverpool CCG currently resources a small homeopathy contract to the value of £30,000 per year that benefits a small number of patients in the city who choose to access NHS homeopathy care and treatment services. The CCG has agreed with the Good Thinking Society to carry out further engagement with patients and the general public to inform our future commissioning intentions for this service.”

Over the last two decades, prescriptions fulfilled in community pharmacies for homeopathy on the NHS in England have fallen  by over 94% and homeopathic hospitals have seen their funding reallocated. This reduction indicates that the majority of doctors and commissioning bodies have acted responsibly by terminating funding for homeopathic treatments.

The GTS are currently fundraising in order to fund further legal challenges – donate now to support our campaign at justgiving.com/Good-Thinking-Society-Appeal/.

In the realm of homeopathy there is no shortage of irresponsible claims. I am therefore used to a lot – but this new proclamation takes the biscuit, particularly as it currently is being disseminated in various forms worldwide. It is so outrageously unethical that I decided to reproduce it here [in a slightly shortened version]:

“Homeopathy has given rise to a new hope to patients suffering from dreaded HIV, tuberculosis and the deadly blood disease Hemophilia. In a pioneering two-year long study, city-based homeopath Dr Rajesh Shah has developed a new medicine for AIDS patients, sourced from human immunodeficiency virus (HIV) itself.

The drug has been tested on humans for safety and efficacy and the results are encouraging, said Dr Shah. Larger studies with and without concomitant conventional ART (Antiretroviral therapy) can throw more light in future on the scope of this new medicine, he said. Dr Shah’s scientific paper for debate has just been published in Indian Journal of Research in Homeopathy…

The drug resulted in improvement of blood count (CD4 cells) of HIV patients, which is a very positive and hopeful sign, he said and expressed the hope that this will encourage an advanced research into the subject. Sourcing of medicines from various virus and bacteria has been a practise in the homeopathy stream long before the prevailing vaccines came into existence, said Dr Shah, who is also organising secretary of Global Homeopathy Foundation (GHF)…

Dr Shah, who has been campaigning for the integration of homeopathy and allopathic treatments, said this combination has proven to be useful for several challenging diseases. He teamed up with noted virologist Dr Abhay Chowdhury and his team at the premier Haffkine Institute and developed a drug sourced from TB germs of MDR-TB patients.”

So, where is the study? It is not on Medline, but I found it on the journal’s website. This is what the abstract tells us:

“Thirty-seven HIV-infected persons were registered for the trial, and ten participants were dropped out from the study, so the effect of HIV nosode 30C and 50C, was concluded on 27 participants under the trial.

Results: Out of 27 participants, 7 (25.93%) showed a sustained reduction in the viral load from 12 to 24 weeks. Similarly 9 participants (33.33%) showed an increase in the CD4+ count by 20% altogether in 12 th and 24 th week. Significant weight gain was observed at week 12 (P = 0.0206). 63% and 55% showed an overall increase in either appetite or weight. The viral load increased from baseline to 24 week through 12 week in which the increase was not statistically significant (P > 0.05). 52% (14 of 27) participants have shown either stability or improvement in CD4% at the end of 24 weeks, of which 37% participants have shown improvement (1.54-48.35%) in CD4+ count and 15% had stable CD4+ percentage count until week 24 week. 16 out of 27 participants had a decrease (1.8-46.43%) in CD8 count. None of the adverse events led to discontinuation of study.

Conclusion: The study results revealed improvement in immunological parameters, treatment satisfaction, reported by an increase in weight, relief in symptoms, and an improvement in health status, which opens up possibilities for future studies.”

In other words, the study had not even a control group. This means that the observed ‘effects’ are most likely just the normal fluctuations one would expect without any clinical significance whatsoever.

The homeopathic Ebola cure was bad enough, I thought, but, considering the global importance of AIDS, the homeopathic HIV treatment is clearly worse.

The Paleo diet is based on the evolutionary discordance hypothesis, according to which departures from the nutrition and activity patterns of our hunter-gatherer ancestors have contributed greatly and in specifically definable ways to the endemic chronic diseases of modern civilization. The assumption is that during the Paleolithic era — a period lasting around 2.5 million years that ended about 10,000 years ago with the advent of agriculture and domestication of animals — humans evolved nutritional needs specific to the foods available at that time, and that the nutritional needs of modern humans remain best adapted to the diet of their Paleolithic ancestors. Today’s humans are said to be not well adapted to eating foods such as grain, legumes, and dairy, and in particular the high-calorie processed foods. Proponents claim that modern humans’ inability to properly metabolize these comparatively new types of food has led to modern-day problems such as obesity, heart disease, and diabetes. They furthermore claim that followers of the Paleolithic diet may enjoy a longer, healthier, more active life.

The Paleo Diet is alleged to work by two fundamental principles:

  •  Put the optimal nutrition into your body.
  •  Reduce or eliminate toxins and “interference”.

And what are the results, as claimed by those who promote (and profit from) the Paleo diet? The alleged benefits include:

  • Leaner, Stronger Muscles
  • Increased Energy
  • Significantly More Stamina
  • Clearer, Smoother Skin
  • Weight Loss Results
  • Better Performance and Recovery
  • Stronger Immune System
  • Enhanced Libido
  • Greater Mental Clarity
  • No More Hunger/Cravings
  • Thicker, Fuller Hair
  • Clear Eyes

Critics of the Paleo diet point towards abundant evidence that paleolithic humans did, in fact, eat grains and legumes. They also stress that humans are much more nutritionally flexible than previously thought, that the hypothesis that Paleolithic humans were genetically adapted to specific local diets is unproven, that the Paleolithic period was extremely long and saw a variety of forms of human settlement and subsistence in a wide variety of changing nutritional landscapes, and that currently very little is known for certain about what Paleolithic humans ate.

So, the theories behind the Paleo diet are flimsy and naïve; the most crucial question, however, is does it work?

Overall there is little solid evidence; unsurprisingly, some studies have shown that cardiovascular risk factors can be positively influenced, for instance, in patients with diabetes. But the more specific claims, like the ones above, are not supported by good clinical evidence.

It seems that, yet again, less than responsible entrepreneurs have jumped on a popular band-wagon to exploit the often hopelessly gullible public.

My memoir ‘A SCIENTIST IN WONDERLAND’  has already brought many surprises (and about 20 most flattering reviews). A few days ago, the German version was published entitled ‘NAZIS, NADELN UND INTRIGEN’ (people who have not read it might find this title puzzling). The German publisher reported that the first print-run was sold out in the first 4 days.

In order to tempt you to read my memoir, I publish here the final section of the book which affirms that the link between my rather diverse experiences boils down to ethics.

…the most important link between my research into alternative medicine and that related to the Third Reich was that of medical ethics.

It should be axiomatic that ethics is indispensable to the practice of medicine, and is not something that can just be switched off at will. No branch of health care, including alter-native medicine, can be considered exempt from it. But the subject of ethics is seldom even considered in alternative medicine; many alternative practitioners have never been taught medical ethics, and where training in this area does exist, it tends to be at best superficial. There are thousands of books on alternative medicine but hardly more than a handful cover the subject of medical ethics in any depth. It is perhaps not surprising, therefore, that the principles of medical ethics are routinely ignored and frequently violated by promoters of alternative medicine.

Medical ethics seem to me to be violated, for example: when homeopaths prescribe or recommend homeopathic vaccinations for which there is not a shred of evidence; when chiropractors or other alternative practitioners happily promote bogus treatments for children with asthma or other serious conditions; when practitioners fail to obtain informed consent before commencing their treatments; when Prince Charles sells his “detox tincture” which is unable to eliminate poisons from your body, merely cash from your purse; when quacks inveigle desperate cancer patients by pretending they have found a cure; when pharmacists sell Bach Flower Remedies or other glorified placebos; when applied kinesiologists, iridologists, etc. claim that their baseless diagnostic tests are able to identify serious diseases; when pseudoscientists claim that certain alternative therapies are evidence-based because they managed to generate a false positive result purely by cherry-picking or massaging their data; when politicians who lack even the most basic understanding of science publicly support quackery, proclaiming that it is evidence-based.

And so on, and so on.

Some might criticize me here for claiming the moral high ground. But if I do so, it is for a good reason. Medical consultations are intrinsically unequal, with the clinician occupying a position of considerable power over often highly vulnerable patients. This places an important ethical onus on the caregiver to assist patients in making informed choices—an imperative and a trust that is breached each and every time that unproven nostrums born of ideology and wishful thinking are offered to people with assertions that they are an effective, valid approach to the treatment of disease.

When science is abused, hijacked or distorted in order to serve political or ideological belief systems, ethical standards will inevitably slip. The resulting pseudoscience is a deceit perpetrated on the weak and the vulnerable. We owe it to ourselves, and to those who come after us, to stand up for the truth, no matter how much trouble this might bring.

Today, I look back at the often stormy past from the peaceful vantage point of my retirement with a mixture of satisfaction and incredulity. The doctor and scientist may still be full of questions, but the musician in me breathes a sigh of relief that the performance, with all its impossible demands and fiendishly difficult passages, is finally over.

The Telegraph today reports that, despite relentless lobbying from the Prince of Wales, UK  herbalists will not, after all, be regulated by statute. Here are the most important statements from this article:

Prof David Walker, deputy chief medical officer, said he had taken the decision because there was insufficient evidence that the alternative therapy works, making it impossible to set standards of good practice. Three years ago ministers had pledged to bring in an official register of practitioners of herbal and Chinese medicines, which would see therapists regulated alongside other health workers, such as physiotherapists and speech therapists…But ministers blocked the proposals, instead setting up a new committee, led by the NHS deputy chief medical officer – which has now ruled against statutory regulation. The decision came despite lobbying from Prince Charles, a keen advocate of complementary medicines, and a supporter of regulation, who held a meeting with Jeremy Hunt in 2013 in which his concerns were raised…Prof Walker said that although most herbal practitioners were in favour of regulation, those opposed to it feared it would “confer an inappropriate level of legitimacy on herbal practice which was poorly supported by scientific evidence.” He said the decision to rule against regulation was “undoubtedly the most contentious area” addressed by the working party, which also looked at the safety of herbal medicine products. Instead, the report calls for a review of all ingredients sold in such medicines, to check their safety, with a “voluntary register” for practitioners who use them. It says there is too little evidence to show that herbal medicines improve health outcomes, making it “difficult to establish the boundaries of good practice” in regulating practitioners. It also says there is very little understanding of the risks posed to patients from current practices in herbal medicine…Prof Walker’s recommendation has triggered an immediate rift among the 26 members of his working party. Twelve members of the working party have written to Dr Dan Poulter, health minister, alleging that the decision will put the safety of the public at risk, because anyone will be able to promote themselves as an expert in herbal medicine, without any training. Research suggests around three million Britons a year consult herbal practitioners, operating in shops, online and in private clinics, with up to one in 12 of all adults using a herbal medicine at some stage. Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, said the decision not to regulate practitioners could put the public at risk from rogue operators, with no training. The herbal practitioner, who was a member of the DoH working party, said: “We are deeply disappointed by this. We feared this issue was going to be kicked into the long grass, by quietly putting something out just before the election – and that is exactly what has happened.” He said the public needed the reassurance of statutory regulation, to know that any herbal doctor who is practising had received some training. The association disputed claims there was insufficient evidence to show that herbal medicines worked, saying that several trials had shown its impact for a number of conditions, but that the sector had less money than the pharmaceutical industry had to undertake mass research. The report says that although ministers promised “some form of regulation of herbal practitioners” this only committed the working party to consider the options, and that the introduction of regulation would require the sector to be “more science and evidence-based”.

Perhaps I should first state that I was not involved in any way in this process. Furthermore, I must say that I do think it is the right decision. To understand it better, I need to refer to several previous posts: yes, some herbal medicines are demonstrably effective. But the regulation in question is NOT about herbal medicines; it is about herbal practitioners, and the two are not necessarily related. UK herbal practitioners practice within a range of  traditions including traditional European herbalism, TCM, or other schools of thought. They differ vastly but have one characteristic in common: they individualise their prescriptions according to the specific characteristics of the patient. Thus they would rarely prescribe the evidence-based herbal medicines but mix up prescriptions composed of several herbal ingredients. The problems with this approach are numerous:

  • there is no good evidence that this approach of individualised herbalism is effective;
  • the safety of the herbs used by traditional herbalists is often unknown;
  • traditional herbalists tend to use obsolete diagnostic techniques, false-positive and false-negative diagnoses are thus inevitable;
  • some of the herbal mixtures have been shown to be contaminated with toxic ingredients;
  • some mixtures are adulterated with powerful prescription drugs;
  • the herbal ingredients could interact with each other in an unpredictable manner;
  • the herbal mixtures might interact with prescribed drugs.

The long and short of it is that nobody knows whether the treatments of traditional herbalists generate more good than harm. Regulating these professions by statute would merely give them a level of credibility that they do not deserve. As with the regulation of chiropractors or osteopaths in the UK, the regulation of herbalists would simply misled the public about the value of traditional herbalism, and it most likely would have prompted the herbalists to happily rest on their assumed merits claiming that their effectiveness and safety has been officially acknowledged and is therefore no longer in doubt.

In a nutshell: THE ‘PROPER’ REGULATION OF NONSENSE GENERATES PROPER NONSENSE

The other day, I received a request from THE GUARDIAN: could I write a piece on homeopathy in relation to the Australian report which had just come out; they gave me ~700 words and all of 3 hours to do it. I had an extremely busy day, but accepted the challenge nevertheless.

My article was published the next day and the ‘headliner’ at THE GUARDIAN had elected to call it There is no scientific case for homeopathy: the debate is over.

What followed was a flurry of debate – well over 2200 comments – which was more than a little ironic, considering the headline.

Essentially, my article had repeated the well-rehearsed arguments which have so often been made on this blog and elsewhere:

Our trials failed to show that homeopathy is more than a placebo.

Our reviews demonstrated that the most reliable of the 230 or so trials of homeopathy ever published are also not positive.

Studies with animals confirmed the results obtained on humans.

Surveys and case reports suggested that homeopathy can be dangerous.

The claims made by homeopaths to cure conditions like cancer, asthma or even Ebola were bogus.

The promotion of homeopathy is not ethical.

The comments that followed were mixed, of course; those that disagreed with me used a range of counter-arguments; in no specific order, these were the following:

  1. For several reasons, I cannot be trusted.
  2. I even once stated that I have treated my wife homeopathically.
  3. The Australian report was neither thorough nor reliable.
  4. The Australian expert panel were bought by Big Pharma.
  5. Homeopathic treatment must be individualised and can therefore not be tested in RCTs.
  6. Just because we don’t understand how homeopathy works, we should not conclude that it is ineffective.
  7. 200 years of positive experience with homeopathy clearly prove that it works.
  8. The huge popularity of homeopathy worldwide demonstrated its effectiveness.
  9. The fact that some very clever people support homeopathy shows that it works.
  10. Homeopathy works in animals and little children, therefore it cannot be just a placebo.
  11. The Queen and my aunt Doris use homeopathy.
  12. Placebos work.
  13. Patients must be able to choose; patient choice is an important principle in all health care.
  14. There’s more to evidence than just RCTs.
  15. Homeopathy works like vaccines.

With such an abundance of counter-arguments, the debate is clearly NOT over! Or is it? Let’s see how solid the arguments really are.

1) I cannot be trusted

Ad hominem attacks are no arguments at all; they are merely a sign that the person using them has no real arguments left.

2) I treated my wife homeopathically

This is true. At one stage in my life, I treated anyone who couldn’t run fast enough to escape me with homeopathy. What does that show? It simply shows that I can make mistakes too.

3) The Australian report was flawed

Perhaps it was not entirely faultless (no report ever is), but it certainly was rigorous – more so than any previous document in the entire history of homeopathy. If it excluded certain types of evidence, like the observational studies (which are so much loved by homeopaths), it did so because such data are wide open to bias.

4) The panel was not independent

Yes, it was! It even included a homeopath. The Australian National Health and Medical Research Council is internationally highly respected, and to defame it without evidence is, in a way, just another ad hominem attack.

5) Homeopathy must be individualised

This is a half-truth: classical homeopathy is mostly individualised, but lots of homeopathic prescribing is not individualised. And in any case, we have recently seen how totally unconvincing the results of strictly individualised trials of homeopathy are. This argument turns out to be a red herring.

6) We currently don’t understand how homeopathy works

What we do understand perfectly well, however, is the fact that no explanation exists which would not require throwing over board big chunks of the laws of nature. But even if we accepted that the mode of action is unknown, this would not change the lack of homeopathy’s clinical effectiveness. Lots of treatments work without us understanding how.

7) Experience shows it works

Experience is a very unreliable indicator of effectiveness; there are simply far too many confounders such as placebo effects, regression towards the mean or natural history of the disease. This is why we need evidence to be sure, and historically medicine finally started making progress when this lesson had been learnt.

8) The amazing popularity of homeopathy is proof of its effectiveness

This is the ‘argumentum ad populum’ fallacy. Think of the popularity of blood-letting to see how wrong this argument can be.

9) Homeopathy is backed by some very clever people

So what? Clever people are not always correct – look at me (just joking!)

10) Homeopathy works in animals and little children which proves that it is more than a placebo

First, animals and children do also show placebo-responses.

Second, the animal owner/parent might respond to placebo and thus mimic a placebo-response in the patient.

Third, the evidence for homeopathy is not positive neither in animals nor in children.

11) The Queen swears by homeopathy

Yes, so much so that, as soon as she is really ill, she makes use of what the very best of conventional medicine has to offer.

12) Placebos work

For sure! But that does not mean that we should prescribe placebos. If an effective treatment is given with compassion and empathy, the patient will also profit from a placebo effect – in addition to the effect of the treatment. Merely administering placebos means withholding the latter and is thus not in the best interest of the patient.

13) Patient choice

Yes, patient choice is important. However, it only applies to the choice between treatments that are demonstrably effective – if not choice becomes arbitrariness.

14) Evidence is more than just RCTs

True, there are many study designs other than RCTs. They all have their place in research – but when the research question is to test whether a treatment is effective beyond placebo, they are all open to different types of bias. The one that minimises bias best and thus produces more reliable findings than any other study design is the placebo-controlled, double-blind RCT.

15) Homeopathy works like vaccines

No! The ‘like cures like principle’ appears to be similar to the principles of vaccination, but this appearance is misleading. Vaccines contain small amounts of active material, while the typical homeopathic remedy doesn’t. Vaccines use the substance that causes the illness, e. g. (parts of) a virus, while homeopathy doesn’t.

So, is there still a debate? Obviously there is – the Guardian headliner was wrong – but it is a debate without reasonable arguments. And in the public domain, the debate is dominated by enthusiasts who endlessly repeat nonsensical notions which have been shown to be wrong over and over again.

In a nutshell:

Yes, there continues to be a debate.

No, there is no reasonable debate.

 

According to Bloomberg Markets, A Nelson & Co Ltd. manufactures and markets natural healthcare products. The company offers arnica creams that provide natural first aid for bruises; plant and flower based remedies that help in managing the emotional demands of everyday life; and over-the-counter homeopathic medicines for everyday ailments, such as relief from travel sickness and relief for the symptoms of hay fever. It also provides hemorrhoid relief creams and soothing hygienic wipes; anti-blemish range products for various skin types and age groups; multi-purpose cream that helps to soothe and restore skin; iron supplements; teething granules that provide relief from the symptoms and discomfort of teething; a range of creams, ointments, and sprays for a range of common skin conditions/complaints; and a range of commonly used herbal remedies. The company offers products for ailments, including aches and pains, mild anxiety, babies and children, colds and minor infections, digestion, emotional health, energy, everyday stresses, first aid, getting older, pets, quit smoking, skin, sleep, travel, and women’s health. It also operates a clinic; and a pharmacy that offers homeopathy and complementary healthcare products. The company offers its products through its pharmacy in the United Kingdom; and distributors in Europe, Latin America, and internationally. It also serves customers online. The company was formerly known as Armbrecht, Nelson & Co. The company was founded in 1860 and is based in London, United Kingdom with subsidiary offices in Boston, Massachusetts; and Hamburg, Germany. A Nelson & Co Ltd. operates as a subsidiary of Nelson and Russell Holdings Ltd.

In the journal ‘Chemist and Druggist’ we find an article informing us that, in 1930, Nelsons Homeopathic Pharmacy was approached by Dr Edward Bach who wanted help making and selling his products. He had created 38 flower remedies to rebalance emotions and later created an emergency remedy, a combination of five flower remedies that became Rescue. The relationship between Nelsons and the Dr Edward Bach Centre, based at Dr Bach’s former home at Mount Vernon in Oxfordshire, continues to this day and both the Bach Original Flower Remedies and Rescue are key ranges for Nelsons.

Nelson’s homeopathic pharmacy has a proud history:

Ernst Louis Armbrecht, a German pharmacist and disciple of Samuel Hahnemann, came to London and founded Nelsonsin 1860. Since then, Nelsons has been supplying homeopathic medicines. “Our wish today” they state “is the same as 152 years ago: to make homeopathy accessible and to provide the highest standards of medicine and advice.”

The highest standards of medicine and advice? It seems that the Advertising Standards Authority (ASA) disagrees. A recent ASA Adjudication on A Nelson & Co Ltd deals with an advertisement by Nelsons for ‘Bach Rescue Night’ which stated “I CAN’T SWITCH OFF…The RESCUE NIGHT range helps your mind switch off, so you can enjoy a natural night’s sleep”

A freelance health writer had challenged whether the claims “I can’t switch off … Rescue Night range helps your mind switch off, so you can enjoy a natural night’s sleep” was an authorised health claim in the EU Register of Nutrition and Health Claims for Foods (the EU Register).

The ASA noted that, according to EC Regulation 1924/2006 on Nutrition and Health Claims made on Foods (the Regulation), which was reflected in the CAP Code, only health claims which appeared on the list of authorised health claims (the Register) could be made in ads promoting foods, including food supplements. Health claims were defined as those that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health.

The ASA furthermore stated: We acknowledged Rescue Remedy’s assertion that their ad had not made specific claims to aid sleep or that it improved sleep. However, we considered that the use of visuals such as a crescent moon and stars on a dark background, that the letter ‘O’ in the word “OFF” resembled a simple on/ off light switch image, the text “… you can enjoy a natural night’s sleep” and the name of the product “Rescue Night” was likely to give the impression to consumers that it was a product that would aid sleep or that it would help consumers fall asleep easily. We understood that ‘unwanted thoughts’ was one reason why consumers might find it difficult to get to sleep and, again, considered this added to the impression that the product would contribute positively to sleep. We therefore considered that the ad made a health claim related to sleep involving a food item.

We understood that some Bach Flower Remedies contained levels of alcohol which would preclude them from bearing health claims altogether, however, we noted that Bach Rescue Night was alcohol free. We acknowledged Rescue Remedy’s points regarding EFSA and ‘on hold’ claims for botanicals. We understood that ‘on hold’ claims for such botanicals could be used in marketing, provided such use had the same meaning as the proposed claim and they were used in compliance with applicable existing national provisions (in this case the CAP Code). However, Rescue Remedy did not provide evidence that relevant proposed claims for white chestnut, or any of the other product ingredients were ‘on hold’. Nevertheless, we understood that there were no ‘on hold’ claims entered onto the Register for white chestnut or the other product ingredients. Furthermore, ‘on hold’ claims should also be supported with adequate substantiation which we did not receive.

Because the ad made health claims relating to Bach Rescue Night as a sleep aid and we had not seen evidence that relevant claims for the botanical ingredients contained in the product were ‘on hold’, we concluded that the ad breached the Code.

The ad breached CAP Code (Edition 12) rules 15.1, 15.1.1 and 15.7 (Food, food supplements and associated health or nutritional claims).

The ASA ruled that the ad must not appear again in its current form. We told A Nelson & Co Ltd t/a rescueremedy.co.uk not to make health claims for botanical ingredients if they did not comply with the requirements of the Regulation.

I am afraid that such a ruling will have very little effect on the sale of Bach Flower Remedies. In case you have any doubt, I should mention that these inventions of Dr Bach are not supported by good evidence. Here is the abstract of my systematic review on the subject:

Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.

Bach Flower Remedies have no effect whatsoever!

Come to think of it, this is not entirely true: they obviously keep the ASA busy, they exploit the gullible public, and they are clearly good for the cash flow at Nelson’s.

Henry Louis Mencken (1880-1956) was an outspoken American journalist, essayist and literary critic famous for his vitriolic attacks on what he considered to be the hypocrisy of much of American life. In 1924, he published an essay on chiropractic which, I think, is still poignant today. I take the liberty of reproducing here in a slightly abbreviated form.

This preposterous quackery [chiropractic] flourishes lushly in the back reaches of the Republic, and begins to conquer the less civilized folk of the big cities. As the old-time family doctor dies out in the country towns, with no competent successor willing to take over his dismal business, he is followed by some hearty blacksmith or ice-wagon driver, turned into a chiropractor in six months, often by correspondence… [Chiropractic] pathology is grounded upon the doctrine that all human ills are caused by pressure of misplaced vertebrae upon the nerves which come out of the spinal cord — in other words, that every disease is the result of a pinch. This, plainly enough, is buncombe. The chiropractic therapeutics rest upon the doctrine that the way to get rid of such pinches is to climb upon a table and submit to a heroic pummeling by a retired piano-mover. This, obviously, is buncombe doubly damned.

…Any lout with strong hands and arms is perfectly equipped to become a chiropractor. No education beyond the elements is necessary. The takings are often high, and so the profession has attracted thousands of recruits — retired baseball players, work-weary plumbers, truck-drivers, longshoremen, bogus dentists, dubious preachers, cashiered school superintendents. Now and then a quack of some other school — say homeopathy — plunges into it. Hundreds of promising students come from the intellectual ranks of hospital orderlies.

…[The chiropractor’s] trade is mainly with ambulant patients; they must come to his studio for treatment. Most of them have lingering diseases; they tour all the neighborhood doctors before they reach him. His treatment, being nonsensical, is in accord with the divine plan. It is seldom, perhaps, that he actually kills a patient, but at all events he keeps any a worthy soul from getting well.

…But chiropractic, of course, is not perfect. It has superb potentialities, but only too often they are not converted into concrete cadavers. The hygienists rescue many of its foreordained customers, and, turning them over to agents of the Medical Trust, maintained at the public expense, get them cured. Moreover, chiropractic itself is not certainly fatal: even an Iowan with diabetes may survive its embraces. Yet worse, I have a suspicion that it sometimes actually cures. For all I know (or any orthodox pathologist seems to know) it may be true that certain malaises are caused by the pressure of vagrant vertebra upon the spinal nerves. And it may be true that a hearty ex-boilermaker, by a vigorous yanking and kneading, may be able to relieve that pressure. What is needed is a scientific inquiry into the matter, under rigid test conditions, by a committee of men learned in the architecture and plumbing of the body, and of a high and incorruptible sagacity. Let a thousand patients be selected, let a gang of selected chiropractors examine their backbones and determine what is the matter with them, and then let these diagnoses be checked up by the exact methods of scientific medicine. Then let the same chiropractors essay to cure the patients whose maladies have been determined. My guess is that the chiropractors’ errors in diagnosis will run to at least 95% and that their failures in treatment will push 99%. But I am willing to be convinced.

Where is there is such a committee to be found? I undertake to nominate it at ten minutes’ notice. The land swarms with men competent in anatomy and pathology, and yet not engaged as doctors. There are thousands of hospitals, with endless clinical material. I offer to supply the committee with cigars and music during the test. I offer, further, to supply both the committee and the chiropractors with sound wet goods. I offer, finally, to give a bawdy banquet to the whole Medical Trust at the conclusion of the proceedings.

I imagine that most chiropractors would find this comment rather disturbing. However, I do like it for several reasons:

  • it is refreshingly politically incorrect; today journalists seem to be obsessed with the notion of ‘balance’ thus often creating the impression that there are two valid sides to an issue where, in fact, there is only one;
  • it gets right at the heart of several problems which have plagued chiropractic from its beginning;
  • it even suggests a way to establishing the truth about the value of chiropractic which could easily been followed some 90 years ago;
  • finally it predicts a result of such a test – and I would not be surprised, if it turned out to be not far from the truth.

Please let me know what you think, regardless of whether you are a chiropractor or not.

Chinese proprietary herbal medicines (CPHMs) are a well-established and a hugely profitable part of Traditional Chinese Medicine (TCM) with a long history in China and elsewhere; they are used for all sorts of conditions, not least for the treatment of common cold. Many CPHMs have been listed in the ‘China national essential drug list’ (CNEDL), the official reference published by the Chinese Ministry of Health. One would hope that such a document to be based on reliable evidence – but is it?

The aim of a recent review was to provide an assessment on the potential benefits and harms of CPHMs for common cold listed in the CNEDL.

The authors of this assessment were experts from the Chinese ‘Centre for Evidence-Based Medicine’ and one well-known researcher of alternative medicine from the UK. They searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites from their inception to 31 March 2013 for clinical studies of CPHMs listed in the CNEDL for common cold.

Of the 33 CPHMs listed in the 2012 CNEDL for the treatment of common cold, only 7 had any type of clinical trial evidence at all. A total of 6 randomised controlled trials (RCTs) and 7 case series (CSs) could be included in the assessments.

All these studies had been conducted in China and published in Chinese. All of them were burdened with poor study design and low methodological quality, and all had to be graded as being associated with a very high risk of bias.

The authors concluded that the use of CPHMs for common cold is not supported by robust evidence. Further rigorous well designed placebo-controlled, randomized trials are needed to substantiate the clinical claims made for CPHMs.

I should state that it is, in my view, most laudable that the authors draw such a relatively clear, negative conclusion. This does certainly not happen often with papers originating from China, and George Lewith, the UK collaborator in this article, is also not known for his critical attitude towards alternative medicine. But there are other, less encouraging issues here to mention.

In the discussion section of their paper, the authors mention that the CNEDL has been approved by the Chinese Ministry of Public Health and is currently regarded as the accepted reference point for the medicines used in China. They also explain that the CNEDL was officially launched and implemented in August 2009. The CNEDL is now up-dated every 3 years, and its 2012 edition contains 520 medicines, including 203 CPHMs. The CPHMs listed in CNEDL cover 137 herbal remedies for internal medicine, 11 for surgery, 20 for gynaecology, 7 for ophthalmology, 13 for otorhinolaryngology and 15 for orthopaedics and traumatology.

Moreover, the authors inform us that about 3,100 medical and clinical experts had been recruited to evaluate the safety, effectiveness and costs of CPHMs. The selection process of medicines into CNEDL was strictly in accordance with the principle that they ‘must be preventive and curative, safe and effective, affordable, easy to use, think highly of both Chinese and Western medicine’. A detailed procedure for evaluation is, however, not available because the files are confidential.

The authors finally state that their paper demonstrates that the selection of CPHMs into the CNEDL is less likely to be ‘evidence-based’ and revealed the sharp contrast between the policy and priority given to by the Chinese government to Traditional Chinese Medicine(TCM).

This surely must be a benign judgement, if there ever was one! I would say that the facts disclosed in this review show that TCM seems to exist in a strange universe where commercial interests are officially allowed to reign supreme over patients’ interests and public health.

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