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Regulation of complementary therapists 'may harm patients'

03 Dec 09

Statutory regulation of herbalists and Chinese medicine practitioners is ‘completely inappropriate’ and will put patients at risk, according to doctors' leaders.

In comments that put the college on a direct collision course with the Government and prominent pressure groups, the Royal College of Physicians said plans to extend regulation would legitimise therapies that have no proven benefit.

Alternative medicine practitioners are currently subject to voluntary regulation by the Complementary and Natural Healthcare Council, but this system has been criticised as ‘misleading and dangerous’.

The Government plans to introduce statutory regulation for acupuncturists, herbalists and Chinese and other traditional medicine practitioners before new EU rules on the supply of complementary therapies come into force in 2011.

As part of a consultation on the plans that closed last month, the RCP has weighed in with a strongly worded response – seen by Pulse – saying those offering ‘unproven’ complementary medicines should not be allowed the status of a regulated profession.

‘This approach would be completely inappropriate for those “disciplines” of complementary therapy whose therapies are neither of proven benefit nor appropriately tested,' reads the response.

‘Extending the imprimatur of statutory regulation analogous to that applied to medical, nursing, dentistry, and physiotherapy, to practitioners whose therapies are neither of proven benefit nor appropriately tested, has the potential to increase the possibility of harm.'

The RCP said it supported statutory regulation of acupuncture, but not for other complementary therapies: ‘Herbal and traditional medicine which are largely or completely of unproven benefit should be regulated in terms of consumer protection,’ the statement says.

The comments are in direct opposition to those issued by the Prince of Wales’ Foundation for Integrated Health this week.

A spokesperson for the foundation said patients will be ‘abandoned to quackery’ unless the Government introduces statutory regulation of herbal medicine.

The EU rules due to be introduced in 2011 dictate that only statutory registered professionals will be able to prescribe herbal medicines. The foundation argues this will result in patients seeking ‘bogus’ practitioners to access herbal medicines.

Readers' comments

  • Edzard Ernst | 03 Dec 09

    The thing about the proposed regulation which makes it, I think, utterly unacceptable is the fact that it does not include a committment to evidence-based practice. All other statutorily regulated healthcare professions in the UK have such an obligation. Thus the proposed regulation would de facto introduce an unprecedented double standard.

  • vincent marks | 03 Dec 09

    I am delighted that the Royal College has done what it was set up to do - namely to protect us from quackery. The use of acupuncture as a debonafide (roughly corresponding to placebo) treatment by registered medical practioners who know what they are about and have treated the patient's symptoms/worries/complaints to the best of their ability is acceptable until a more specific, pathology-evidence-based treatment becomes available.

  • Steve Scrutton | 03 Dec 09

    EE continues to talk about evidence base on the presumption that conventional medicine has one, but that no other medical therapy has. So can EE tell us about the evidence base for conventional medicine, and how that evidence base stands up to the two primary functions of 'evidence based medicine' - safety and efficacy. In particular, does EE believe that Pharma drugs are safe because they have been scientifically proven, having undergone rigorous safety testing, and have been approved as 'safe' by the MHRA and FDA. A moment's reflection should suggest that this cannot be so, as Pharma drugs are now one of the leading causes of death - it has been estimated up to 100,000 people in the USA every year. If EE wants to question the evidence base of CAM therapies, he needs first to question the validity of the evidence base of conventional medicine, that would seem entirely unable to predict drug consequences, at least not until large numbers of people have suffered adverse reactions. For decades now, drugs routinely sanctioned by MHRA, the FDA, and other licensing bodies, have been found to be ineffective, or harmful, or even lethal. Patients are prescribed drugs, often for years, only to find that their health has not been enhanced, but jeopardised? The only sensible conclusion is that the 'evidence base' for conventional drugs is of little value to the patients who take them. EE's constant assertion that CAM therapies need to be evidenced based is quite right. However, despite what he says, it does exist - although more is required. But his case would be enhanced if he was able to justify the 'evidence base' for conventional drugs. I suspect he is unlikely ever to do so.

  • james may | 03 Dec 09

    I agree with Ernst. The reason for the double standard would seem to be that CAM is popular, and regulating it would win votes by giving legitimacy to the illegitimate: this has a politician's best interests at heart rather than patients.

  • Andrew Bamji | 03 Dec 09

    How can you regulate a 'therapy' that neither works nor has any scientific basis? I have no quibble with the mechanical therapies that certainly may have an evidence base, but regulation implies acceptance of principle, and from that will follow an obligation to prescribe, at enormous and unwarranted cost. This makes no sense in a cash-strapped NHS if the consequence is that effective treatments become unavailable because of the competition.

  • Sean Ellis | 03 Dec 09

    The RCP's stand makes sense to me. Why do we need separate standards for different 'traditions' of medicine? A given treatment either works according to our standards for effective care, or it doesn't. Steve Scrutton's observations about safety of conventional drugs are, in my opinion, flawed. It is true that nothing is perfect, but the same can be said of CAM interventions. He fails to take into account the much larger numbers of serious illnesses being treated by conventional drugs than by alternative interventions. Even if true, it would still not magically make CAM medicines safer than conventional medicines. What are the corresponding rates of death and serious complication for similar cohorts with similar conditions, under CAM therapies? With no data offered, they could quite easily be an order of magnitude worse. Also, conventional medicine acknowledges its flaws and withdraws treatments when they have been shown to be useless or dangerous. How many times has this happened for CAM interventions?

  • Michael Baum | 03 Dec 09

    As I've said before and I'll say again, the proposed regulation is nothing more than approving witchcraft providing the practitioner has a diploma from Hogwarts and that the bat's wings employed in their brew are sterile.

  • Les Rose | 03 Dec 09

    Steve Scrutton trots out the usual distortions about evidence for proper medicines. What matters is risk:benefit ratio. Yes, there is risk attached to treatment, but the alleged 100,000 drug-associated deaths result from many millions of prescriptions. The real risk is a very small fraction of a percent. Not acceptable, and we have to improve on that, but it's associated with real benefit. Drug development isn't perfect, but most of the time it works. How on earth does Scrutton think we rendered smallpox extinct? How did we close all the TB sanatoria? It sure as hell wasn't with herbs or Chinese quackery. Name me one significant and verified impact on public health resulting from the use of CAM. Go on - try. In any case, the tu quoque fallacy is a cheap argument.

  • Les Rose | 03 Dec 09

    But of course the RCP is wrong about acupuncture. The point is not whether it works, it is whether the regulation demands evidence that it works. Even if we had very good evidence of efficacy (and the evidence is looking shakier as time goes on) we should still demand evidence-based practice.

  • Andrew Sikorski - WADHURST | 03 Dec 09

    In China Western medicine is used alongside traditional techniques and regular exercise in the form of Tai Chi is universal. In Europe homeopathy sits side by side with herbal tinctures and conventional medication on the shelves of pharmacies. In the UK scientists embark on telling patients what their doctors should be allowed to do to them preaching EBM. We are encouraged to follow a Mediterranean diet, but not the Mediterranean lifestyle. The best EBM would be studying N=1 trials with the particular patient to see what suits their needs best and provides an optimum outcome. Rarely does my patient match the inclusion criteria of a single study, let alone amalgamated studies included in met-analyses. Yet I am heartened by the research which suggests there is an inbuilt healing system within us all and judiciously following Hippocrates' dictat 'primo (primum) non nocere' we can assist a person in returning to their optimum state of health using pharmaceutical, surgical, complementary techniques alongside the non-specific effects of a person consulting someone considered a healer/ doctor (Latin origin teacher) in a consultation. Paradoxically, without a healer operative, the surgical, pharmaceutical and complementary interventions are rendered inoperative. Regretably there appears no alternative, once born, to dying. The manner in which the intervening gap is spent is all we can hope to influence. The Royal College of General Practice motto gives a clue as to how we can proceed: 'scientia cum caritas' - COMPASSION with science. 'The people' may be seeking compassion in complementary medicine through an innate awareness of what they require to get better. How long will conventional medicine take before seeking out this critical ingredient? Can scientists ever bear to share their bed with this elusive component of healing? Practicing clinicians do so daily.

  • Peter Flegg | 03 Dec 09

    I just don't understand the straw-man logic in Steve Scrutton's argument. He seems to be suggesting that since not all conventional medical treatment is evidence-based that we should allow any old quack nostrum to be given the seal of official regulatory approval. Clearly this is muddled thinking. Well done to the Royal College of Physicians for their stance on this matter.

  • Edzard Ernst | 04 Dec 09

    SS seems to neglect a very basic fact: it is not the absolute risk that determines the value of an intervention but the balance of its benefits versus its risks. And is mainstream medicine more evidence-based than CAM? The answer has to be an unreserved yes.

  • Selva Rasaiah | 05 Dec 09

    Interesting that Hippocrates is brought up here - he was described by Garrison as 'ever on the lookout for sources of error, and the essence of scientific spirit' - I am sure he would be an advocate of evidence-based medicine today.

  • Matthew Gothill - Bristol | 06 Dec 09

    An interesting debate. In order to justify preventing patients from exercising a free choice of therapy and practitioner, it seems to me that there should be a public consensus that there is a robust evidence base pointing to significant harm (and not just absence of demonstrable benefit) arising from the use of CAM. If this evidence exists I would be interested to learn about it. Absence of evidence is not evidence of absence. On the other hand, perjorative language such as 'quack' and 'witchcraft' does not come from the lexicon of EBM and its use leads me to question the objectivity and motivation of those who use it.

  • Vivienne Crawford | 07 Dec 09

    I don't normally waste time on blogs, but Michael Baum's comments (above) are as breath-taking in their arrogance as they are in their ignorance. I'm reminded that EBM was developed in the first place because it was found that doctors mostly didn't bother to read. The year in which a doctor graduated could be accurately determined simply by studying their prescription habits. But surely, before we deliver opinions which significantly affect both the population's health, and the right of free citizens to make informed choices about what they put into their bodies, we have a moral responsibility actually to know what we're talking about? I've just spent the afternoon reading articles in peer-reviewed journals of oncology, allergy, geriatrics and respiratory medicine, all of which focus on the beneficial physiological effects of various plants, or individual constituents thereof. Detailed information about their mechanisms of action is readily available. In what sense, then, is this to be described as 'witchcraft'? If Thymus spp. contain high levels of phenolic compounds, is their antiseptic property magical? Manifestly, it is not. It is measureable by ordinary scientific methods. As a medical herbalist, I too subscribe to the (Latinised) Hippocratic dictum 'Primum non nocere'. It is for that reason that I strongly support regulation. That would perhaps bring to an end the dangerously random selling of herbs over the internet, or by salespeople in so-called 'health food' shops, and the import of herbal products from China where quality control is lamentable. In my practice, I use only organic dried herbs, and tinctures made from organic herbs steeped in organic alcohol and/or pure water in an appropriately sterile environment. My medicine is as pure and natural as it can possibly be. My (British) suppliers are regulated and inspected - and more recently, licensed by the MHRA. My clinical case history-taking doesn't focus simply on a presenting symptom, but includes detailed attention to a patient's lifetime medical history, along with their diet, medication and lifestyle as well as some assessment of their consitutional tendencies. I perform orthodox physical examinations, such as palpation, or sensory nerve testing, where appropriate and checking pulse and BP is routine. Sometimes, I judge that herbal medicine is not the most appropriate therapy. I may suggest to patients that they see their GP in order to have insulin or thyroid hormone levels checked, or advise that physical manipulation is required. Properly trained and regulated herbalists can effectively function as gate-keepers and direct access to the most appropriate treatment path for an individual patient. I am fully aware that herbal medicine is not a panacea - where a hip replacement is required, herbal medicine cannot be a substitute. Yet I also know from empirical experience, now supported by scientific evidence, that some herbs are equal or superior to chemical drugs in the treatment particularly of the digestive (Filipendula ulmaria, for instance, is an effective antacid which does not damage membranes or cause bleeding), and the gynecological systems. Herbs supply the body not with pre-formed artificial compounds, but with the building blocks the body needs to supply the correct amount of end substance. This is a much more sensitive medicine, which allows the body's own feedback systems to direct the process. In contrast, I refer to HRT (cf the Million Women survey) as an example of a pharmaceutical bludgeon. The NHS must necessarily practise population-based medicine, using standardised formulas which are 'good-enough' therapy for many patients. There is insufficent clean land in the world - particularly in Europe - for herbs to be grown in massive quantity. For that reason, we will always need laboratory-created analogues of natural substances. And given the industrial scale on which medicine is practised, doctors can't give each patient an hour, as herbalists do. But it doesn't follow that we must therefore prohibit individualised treatment with plant medicines for those citizens who choose it. The question of evidence is the stumbling block for many. I would remind readers that empirical evidence has a value. Physicians formerly proceeded on close observation of their patients and sound knowledge of their Materia medica. Can modern doctors claim the same? My emails from the MHRA constantly revise information a bout new medicines. JAMA et al have conceded in recent articles that orthodox medicine is dominated by Big Pharma, whose studies are hardly objective. The Cochrane meta--analyses are a shambles so far as herbs are concerned. To take Hypericum as an example: studies using different doses of the whole herb, or of isolated consituents, are conflated in such a confused manner that no clear conclusion could be derived. Further, scientific opinion has asserted at different times that hyperforin andd then hypericin was the 'active ingredient': the latest finding is that an anti-oxidant needs to be administered concurrently for bioavilability. Herbalists, in the interim, have been using the whole-plant extract - containing hyperforin, hypericin, anti-oxidants, substances which assist liver function via the P450 cytochrome enzymes etc - to good effect. So my attitude to scientific evidence is that it's interesting and often useful, but isn't yet sufficiently well developed for my practice to depend upon it. I rely on the apprenticeships I have served with practitioners, on the enormous legacy of herbal knowlege collected all over the world for millennia, available in libraries, and on my own observations over decades, supplemented by new findings published in both clinical & other scientific journals. What your correspondents don't seem to recognise is that many herbs function as sources of essential nutrients: they're on the border between food and medicine. The class of adaptogenic herbs -w hich doesn't exist in pharmaceutical form -regulate and improve physiological function in a general, non-site specific, manner. Few herbs are dangerous per se (those which are are known, and their use requires skill and training: I believe they should be available only to regulated practitioners) but many are inadvisable for particular individuals, or they are contra-indicated for certain conditions, or along with some orthodox drugs. Again, this suggests not a blanket ban, but their prescription in the context of a consultation with a trained practitioner. I spent many years in universities (including University College London and Harvard - neither establishment known for giving degrees in 'Woo') where I was trained to think rigorously, and critically. Is it too much to hope that orthodox healthcare practitioners will do likewise, and not simply base their opinions on ill-informed prejudice and a superstitious belief in the products of the pharmaceutical companies? I hope this has been a useful contribution to the discussion, and I welcome any rational response.

  • Peter Conway | 13 Dec 09

    What a poorly researched report by Mr Praities. The Complementary and Natural Healthcare Council only includes a few 'CAM' therapies. It does not include acupuncture, herbal medicine and traditional medicine. (And the phrase 'subject to voluntary' is an obvious oxymoron - does anybody proof read this stuff?). The EU rules to be introduced in 2011 do not refer to 'complementary therapies' but specifically to herbal products - the act in question is called the Traditonal Herbal Medicinal Products Directive. However, it DOES NOT 'dictate that only statutorily registered professionals will be able to prescribe herbal medicines' and Pulse should take care not to spread such misinformation. Mr Praities has seen the RCP report (and so have I) but what about everyone else? When will the RCP make this shoddy piece of work public? (It isn't on their website - but a page proudly claiming their herbal heritage is!). Oh - and compare it with the FIH response and you will see why the term 'shoddy' is justified. The RCP does not seem to have researched their response very well - or to have taken on board the report of the Working Group on Extending Professional Regulation, which advised that: 'When considering all the factors at play that drive professional and occupational groups to seek regulation the Working Group recommends that safety of patients and the public, as well as enhancing effective, high quality, and respectful care, are the legitimate benefits to be considered in assessing whether to extend professional and occupational regulation. The Working Group felt that respect, respectability, status and legitimacy was earned from the public rather than conferred by statutory regulation.' Just a year ago the RCP wrote to the Government in support of statutory regulation for acupuncture, herbal medicine and traditional medicine. The MHRA and the Health Professions Council, amongst many others, still support this regulation - so why has the RCP changed its mind? I think we should be told.

  • Peter Conway | 13 Dec 09

    Wow - so little science and rationality, so much ignorance, prejudice and intolerance. Most of the respondents on this blog seem to have caught a severe case of camophobia - an irrational intolerance of non-mainstream therapies. There's a tradtional remedy called Modus Vivendi that would help, but the tragedy is that your very condition prevents you from taking it. Very sad. Get well soon guys...

  • C A | 11 Mar 10

    Bravo Vivienne!! Well said.

  • Andrew Colombini - Balham | 26 Mar 10

    I am a qualified Acupuncturist and Traditional Chinese Medicine Practitioner. Regardless of what Prof. Colquhoun says about anti-scientific degrees, I can say that I spent 4 years as a very mature student studying Biochemistry, Physiology, Pathology, Pathophysiology, and Western Differential diagnosis, all this alongside the "witchcraft" of Chinese Medicine. I obtained a BSc. (Hons) degree and now practice Acupuncture in South West London. I am a member of the British Acupuncture Council. I am amazed at some of the anti cam views here. I agree with Peter Conway, it would appear that many participants in this blog are labelling ALL alternative medicine practitioners as dangerous quacks with little value for the unsuspecting public. They have lost sight of the real issues and can not see the wood for the trees. I treat patients who in most cases come to alternative medicine because they have had little or no success from Western Medicine. I recognise, as do many of my colleagues that patients who have tried everything and then revert to alternative medicine, with a "I might as well try this" attitude. As a member of the BAcC I follow their rules and regulations regarding our behaviour as a provider of healthcare. I do not use the title of Doctor, I always without exception take a full medical history, I ask for permission to communicate with the patient's GP in case I should see a red flag or find something that should be referred to a Medical professional. Most importantly I never use the word "cure", I explain that I can treat and possibly help with a particular condition, but I can not guarantee 100% success. Many of the conditions are idiopathic and/or WM has no "cure " This is all part of the legislation of our governing body. I recommend that around 6 sessions as a reasonable number of treatments to be able to ascertain whether we are making any progress, I use a MYMOP to try to measure this progress . I use sterile needles, and I work from a clinical environment. I have only the patient's interest at heart and if I was allowed to work in the NHS, I would willingly provide my services. Most patients that I see leave me satisfied with their treatment. If the patient believes they are better, who is anyone to tell them differently. I apologise for this long diatribe, but as a mature man with many years experience of life, I am astounded by the arrogance and ignorance of many of the anti cam lobbyists.

  • nigel shipston | 04 May 10

    You can regulate therapies even if there is no evidence base because regulation merely sets down standards of training and practice to ensure patient safety. GPs are free to advise patients if they feel complementary therapies have no proven benefit. Regulation would put no obligation on NHS Trusts and PCTs to provide therapies - only NICE guidance would. People seem to be verging on the hysterical when discussing CAM. Research and evidence to me is all about having a cool detached approach with scientific integrity. Nigel Shipston - acupuncturist.

  • Vipin Patel | 16 Aug 10

    Well over 600 million people rely and use ayurvedic medicines - is this not enough evidence!! Or can we assume that the medical profession is scared of competition. No doubt there are issues with some herbal medicines and practices then we can say the same about some of the allopathic medicines.


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