MD, PhD, FMedSci, FSB, FRCP, FRCPEd

misleading consumers

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In my last post, I claimed that researchers of alternative medicine tend to be less than rigorous. I did not link this statement to any evidence at all. Perhaps I should have at least provided an example!? As it happens, I just came across a brand new paper which nicely demonstrates what I meant.

According to its authors, this non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug. They treated 1050 outpatients suffering from common cold with a commercially available homeopathic remedy for 8 days. The study was conducted in 64 German outpatient practices of medical doctors trained in CAM. Tolerability, compliance and the treatment effects were assessed by the physicians and by patient diaries. Adverse events were collected and assessed with specific attention to homeopathic aggravation and proving symptoms. Each adverse effect was additionally evaluated by an advisory board of experts.

The physicians detected 60 adverse events from 46 patients (4.4%). Adverse drug reactions occurred in 14 patients (1.3%). Six patients showed proving symptoms (0.57%) and only one homeopathic aggravation (0.1%) appeared. The rate of compliance was 84% for all groups. The global assessment of the treatment effects resulted in the verdict “good” and “very good” in 84.9% of all patients.

The authors concluded that the homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity.

So why do I think this is ‘positively barmy’?

The study had no control group. This means that there is no way anyone can attribute the observed ‘treatment effects’ to the homeopathic remedy. There are many other phenomena that may have caused or contributed to it, e. g.:

  • a placebo effect
  • the natural history of the condition
  • regression to the mean
  • other treatments which the patients took but did not declare
  • the empathic encounter with the physician
  • social desirability

To plan a study with the aim as stated above and to draw the conclusion as cited above is naïve and unprofessional (to say the least) on the part of the researchers (I often wonder where, in such cases, the boundary between incompetence and research misconduct might lie). To pass such a paper through the peer review process is negligent on the part of the reviewers. To publish the article is irresponsible on the part of the editor.

In a nut-shell: COLLECTIVELY, THIS IS ‘POSITIVELY BARMY’!!!

Lyme disease, also known as Lyme borreliosis, is an infectious disease caused by Borrelia infection transmitted by ticks. The most common early sign is an expanding area of redness beginning at the site of a bite about a week after a tick-bite. Fever, tiredness and headaches often follow. Later stages are characterised by more severe and remarkably variable illness.

Patients with medically unexplained or vague symptoms are sometimes told that they suffer from Lyme disease. These patients are commonly targeted by providers of alternative therapies who promise hope by claiming that their particular brand of quackery is effective for this chronic condition.

A recent review was designed to identify and characterize the range of unorthodox alternative therapies advertised to patients with a diagnosis of Lyme disease.

Internet searches using the Google search engine were performed to identify the websites of clinics and services that marketed non-antimicrobial therapies for Lyme disease. Subsequently the PubMed search engine was employed to identify any scientific studies evaluating such treatments for Lyme disease. Websites were included in this review, if they advertised a commercial, non-antimicrobial product or service that specifically mentioned utility for Lyme disease. Websites with patient testimonials (such as discussion groups) were excluded unless the testimonial appeared as marketing on a commercial site.

More than 30 different alternative treatments were identified. They fell into several broad categories: these included oxygen and reactive oxygen therapy; energy and radiation-based therapies; nutritional therapies; chelation and heavy metal therapies; and biological and pharmacological therapies ranging from certain medications without recognized therapeutic effects on Borrelia burgdorgeri to stem cell transplantation. The review of the medical literature did not substantiate efficacy or, in most cases, any rationale for the advertised treatments.

The authors concluded that providers of alternative therapies commonly target patients who believe they have Lyme disease. The efficacy of these unconventional treatments for Lyme disease is not supported by scientific evidence, and in many cases they are potentially harmful.

Being a bacterial infection, Lyme disease can be successfully treated with oral or intra-venous antibiotics. But, of course, patients need to have the infection in order to benefit from antibiotic treatment. Those patients who don’t are easy targets for charlatans promising help from bogus treatments. It seems that an entire, profitable industry has developed around this situation.

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/.

As I grew up in Germany, it was considered entirely normal that I was given homeopathic remedies when ill. I often wondered whether, with the advent of EBM, this has changed. A recent paper provides an answer to this question.

In this nationwide German survey, data were collected from 3013 children on their utilization of medicinal products, including homeopathic and other alternative remedies.

In all, 26% of the reported 2489 drugs were from the realm of alternative medicine. The 4-week prevalence for homeopathy was 7.5%. Of the drugs identified as alternative, 53.7% were homeopathic remedies, and 30.8% were herbal drugs. Factors associated with higher medicinal use of alternative remedies were female gender, residing in Munich, and higher maternal education. A homeopathy user utilized on average homeopathic remedies worth EUR 15.28. The corresponding figure for herbal drug users was EUR 16.02, and EUR 18.72 for overall medicinal CAM users. Compared with data from 4 years before, the prevalence of homeopathy use had declined by 52%.

The authors concluded that CAM use among 15-year-old children in the GINIplus cohort is popular, but decreased noticeably compared with children from the same cohort at the age of 10 years. This is possibly mainly because German health legislation normally covers CAM for children younger than 12 years only.

The survey shows that homeopathy is still a major player in the health care of German children. From the point of view of a homeopath, this makes a lot of sense: children are supposed to respond particularly well to homeopathy. But is that really true? The short answer is NO.

Our systematic review of all relevant studies tells it straight: The evidence from rigorous clinical trials of any type of therapeutic or preventive intervention testing homeopathy for childhood and adolescence ailments is not convincing enough for recommendations in any condition.

In other words, the evidence is very much at odds with the practice. This begs the question, I think, HOW SHOULD WE INTERPRET THIS DISCREPANCY?

A few possibilities come into mind, and I would be grateful to hear from my readers which they think might be correct:

  • Homeopathy is used as a ‘benign placebo’ [clinicians know that most paediatric conditions are self-limiting and thus prefer to give placebos rather than drugs that can cause adverse effects].
  • Doctors prescribe homeopathy mainly because the kids’ parents insist on them.
  • Doctors believe that homeopathic remedies are more than just placebos [in which case they are clearly ill-informed].
  • German doctors do not believe in scientific evidence and prefer to rely on their intuition.
  • This high level of homeopathy usage misleads the next generation into believing in quackery.
  • It amounts to child abuse and should be stopped.

Twenty years ago, I published a short article in the British Journal of Rheumatology. Its title was ALTERNATIVE MEDICINE, THE BABY AND THE BATH WATER. Reading it again today – especially in the light of the recent debate (with over 700 comments) on acupuncture – indicates to me that very little has since changed in the discussions about alternative medicine (AM). Does that mean we are going around in circles? Here is the (slightly abbreviated) article from 1995 for you to judge for yourself:

“Proponents of alternative medicine (AM) criticize the attempt of conducting RCTs because they view this is in analogy to ‘throwing out the baby with the bath water’. The argument usually goes as follows: the growing popularity of AM shows that individuals like it and, in some way, they benefit through using it. Therefore it is best to let them have it regardless of its objective effectiveness. Attempts to prove or disprove effectiveness may even be counterproductive. Should RCTs prove that a given intervention is not superior to a placebo, one might stop using it. This, in turn, would be to the disadvantage of the patient who, previous to rigorous research, has unquestionably been helped by the very remedy. Similar criticism merely states that AM is ‘so different, so subjective, so sensitive that it cannot be investigated in the same way as mainstream medicine’. Others see reasons to change the scientific (‘reductionist’) research paradigm into a broad ‘philosophical’ approach. Yet others reject the RCTs because they think that ‘this method assumes that every person has the same problems and there are similar causative factors’.

The example of acupuncture as a (popular) treatment for osteoarthritis, demonstrates the validity of such arguments and counter-arguments. A search of the world literature identified only two RCTs on the subject. When acupuncture was tested against no treatment, the experimental group of osteoarthritis sufferers reported a 23% decrease of pain, while the controls suffered a 12% increase. On the basis of this result, it might seem highly unethical to withhold acupuncture from pain-stricken patients—’if a patient feels better for whatever reason and there are no toxic side effects, then the patient should have the right to get help’.

But what about the placebo effect? It is notoriously difficult to find a placebo indistinguishable to acupuncture which would allow patient-blinded studies. Needling non-acupuncture points may be as close as one can get to an acceptable placebo. When patients with osteoarthritis were randomized into receiving either ‘real acupuncture or this type of sham acupuncture both sub-groups showed the same pain relief.

These findings (similar results have been published for other AMs) are compatible only with two explanations. Firstly acupuncture might be a powerful placebo. If this were true, we need to establish how safe acupuncture is (clearly it is not without potential harm); if the risk/benefit ratio is favourable and no specific, effective form of therapy exists one might still consider employing this form as a ‘placebo therapy’ for easing the pain of osteoarthritis sufferers. One would also feel motivated to research this powerful placebo and identify its characteristics or modalities with the aim of using the knowledge thus generated to help future patients.

Secondly, it could be the needling, regardless of acupuncture points and philosophy, that decreases pain. If this were true, we could henceforward use needling for pain relief—no special training in or equipment for acupuncture would be required, and costs would therefore be markedly reduced. In addition, this knowledge would lead us to further our understanding of basic mechanisms of pain reduction which, one day, might evolve into more effective analgesia. In any case the published research data, confusing as they often are, do not call for a change of paradigm; they only require more RCTs to solve the unanswered problems.

Conducting rigorous research is therefore by no means likely to ‘throw out the baby with the bath water’. The concept that such research could harm the patient is wrong and anti-scientific. To follow its implications would mean neglecting the ‘baby in the bath water’ until it suffers serious damage. To conduct proper research means attending the ‘baby’ and making sure that it is safe and well.

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

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