MD, PhD, FMedSci, FSB, FRCP, FRCPEd

Informed consent is a basic ethical principle and a precondition for any medical or surgical procedure (e. g. a therapeutic intervention or a diagnostic test). Essentially, there are 4 facets of informed consent:

  1. the patient must have decision-making capacity,
  2. the patient’s decision must be free from coercion or manipulation,
  3. all relevant information must be disclosed to the patient,
  4. the patient must not merely be told but must understand what he/she has been told.

It seems to me that points 1, 2 and 4 are more or less the same in alternative as in conventional medicine. Point 3, however, has fundamentally different implications in the two types of healthcare.

What is meant by ‘all relevant information’? There seems to be general agreement that this should include the following elements:

  1. the indication,
  2. the nature of the procedure,
  3. its potential benefits,
  4. its risks,
  5. other options for the proposed procedure, including the option of doing nothing at all.

If we carefully consider these 5 elements of ‘all relevant information’, we soon realise why there might be profound differences between alternative and conventional medicine. These differences relate not so much to the nature of the procedures but to the competence of the clinicians.

At medical school, doctors-to-be learn the necessary facts that should enable them to adequately deal with the 5 elements listed above. (This does not necessarily mean that, in conventional medical or surgical practice, informed consent is always optimal. But there is little doubt that, in theory, it could be optimal.)

By contrast, alternative practitioners have not normally been to medical school and will have gone through an entirely different type of training. Therefore, the question arises whether – even in theory – they are able to transmit to their patients all essential information as outlined above.

Let’s try to address this question by looking at concrete cases: a patient with frequent headaches consults an alternative practitioner for help. For the sake of argument, the practitioner could be:

  • a chiropractor,
  • an acupuncturist,
  • a homeopath,
  • a naturopath,
  • a traditional herbalist.

Are these alternative practitioners able to convey all the relevant information to their patient before starting their respective treatments?

THE CHIROPRACTOR

  1. Can he provide full information on the indication? In all likelihood he would treat the headache as though it was caused by a spinal subluxation. If our patient were suffering from a brain tumour, for instance, this might dangerously delay the diagnosis.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? Many chiropractors deny any risk of spinal manipulation.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? Probably yes for cervicogenic headache. No for most other differential diagnoses.

THE TRADITIONAL ACUPUNCTURIST

  1. Can he provide full information on the indication? The patient might be treated for an assumed ‘energy blockage’; other diagnoses might not be given adequate consideration.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? Perhaps.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No

THE CLASSICAL HOMEOPATH

  1. Can he provide full information on the indication? No, for a classical homeopath, the totality of the symptoms is the only valid diagnosis.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? Doubtful.
  4. Can he explain its risks? Doubtful.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No.

THE NATUROPATH

  1. Can he provide full information on the indication? Doubtful.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? Doubtful.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No.

THE TRADITIONAL HERBALIST

  1. Can he provide full information on the indication? No.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? He is likely to have a too optimistic view on this.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No.

The answers provided above are based on my experience of more than 20 years with alternative practitioners; I am aware of the degree of simplification required to give short, succinct replies. The answers are, of course, assumptions as well as generalisations. There may well be individual practitioners who would do better (or worse) than the fictitious average I had in mind when answering the questions. Moreover, one would expect important national differences.

If my experience-based assumptions are not totally incorrect, their implications could be most significant. In essence they suggest that, in alternative medicine, fully informed consent can rarely, if ever, be provided. In turn, this means that the current practice of alternative medicine cannot be in line with the most fundamental requirements of medical ethics.

There is very little research on any of these  issues, and thus hardly any reliable evidence. Therefore, this post is simply meant as a deliberately provocative essay to stimulate debate – debate which, in my view, is urgently required.

 

6 Responses to Informed consent in alternative medicine?

  • “Debate is urgently required” – couldn’t agree more. Which is why I wrote ‘Real Secrets of Alternative Medicine’ (available from Amazon and Kindle).

    The concept of patient autonomy and informed consent is an important component of the GMC’s ‘Good Medical Practice’ which states that, “The doctor uses specialist knowledge and experience and clinical judgement, and the patient’s views and understanding of their condition, to identify which investigations or treatments are likely to result in overall benefit for the patient. The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. …Before accepting a patient’s consent, you must consider whether they have been given the information they want or need, and how well they understand the details and implications of what is proposed. This is more important than how their consent is expressed or recorded.”

    A registered medical practitioner who does not comply might be struck off. Camists (who practice camisty), whether they style themselves as ‘doctor’ or not (as some chiropractors do) have no such ethical qualms, and indeed, the very nature of their practice is to mislead patients as to exactly what their practices involve.
    Most camists claim their practices of pills, pummelling, pricking and provision of preternatural powers affect specific conditions, but provide no plausible evidence in support. Patients do not understand this. Camists do not properly explain.

    The GMC was founded to protect patients. That is why camistry is ‘Alternative’. That is why patients must beware. That is why the media more generally should be more conscientious about properly informing the public, and should encourage debate, not promulgate delusion.

    • An interesting conundrum not wholly expanded by either Rawlins of Ernst who appear to assume that “competence” in allopathy suggests sufficiency of understanding of the potential effects (positive and negative) of any medication meted out to the unsuspecting patient.
      In fact it is widely perceived that most drugs do not work on most patients (and some do incredible harm), percentages have been debated for decades not least by Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline (GSK), who said fewer than half of the patients prescribed some of the most expensive drugs actually derived any benefit from them.
      This creates a quandary for GPs, nurses and medical specialists who often have no idea which prescription may or may not work on which patient, or which patient may actually be harmed. It is very uncommon to hear any medic inform a patient “this drug I am prescribing is more unlikely to work for you than likely to work so please come back and let be try another if you see no benefit; also it is highly probable you may get side effects, some extremely serious, so you must inform me of that also if you suspect an adverse reaction”.

      • It is very uncommon to hear any medic inform a patient “this drug I am prescribing is more unlikely to work for you than likely to work so please come back and let be try another if you see no benefit; also it is highly probable you may get side effects, some extremely serious, so you must inform me of that also if you suspect an adverse reaction”.
        perhaps – but what you do hear regularly is
        1) you are suffering from XY
        2) this treatment has been shown to be efficacious for this condition
        3) there are several other options such as…
        4) I advise to use the option mentioned because…
        5) you must know that there are risks; there are the frequent ones which are all minor… these are the serious ones which are very rare…
        6) please come and see me as soon as you notice any of these side-effects
        7) for now we make an appointment in … days to see whether the treatment has the desired effect.
        HOW OFTEN DO YOU HEAR STUFF LIKE THAT FROM AN ALTMED PRACTITIONER?
        4)

        • Edzard, I think you look through rose-tinted spectacles.

          1) A retired GP recently remarked, when asked how be managed to diagnose his patients, “I’d no idea what was wrong with 90% of them”..
          Another GP remarked to me, I don’t believe viral that disorders are very prevalent but must admit that during my night calls last evening I probably told 12 of the 13 patients I saw “its probably a virus”..”

          2) Most GPs I know merely hand a prescription to a patient and the pharmacist fills it. If asked what it is, how it works, what it was given for (especially when added to 10 others the elderly patient is already prescribed) the GP usually fails to give a meaningful response. It seems all too common nowadays that patients are asked by GPs what medication they would like, especially those who might have “googled” their own illness..

          3) I don’t believe that options are EVER given to the average patient by the average GP.

          4) ditto

          5) Virtually never heard from the average GP.

          6) ditto

          7) Used to be commonly heard 40 years ago, nowadays rarely ever.

          You are more likely to hear the 7 kinds of comment from alt med practitioners (than GPs and some medical specialists) especially herbalists, homeopaths and acupuncturists.

          I think that any objective research asking the “average patient” about their “average GP” would echo my own observations on those 7 important considerations.

        • And how often do we hear, for example, an acupuncturist who is ‘just renting a room in an alt-med clinic’, say to their clients: “For your specific condition, I recommend that you book an appointment with the Reiki practitioner who works in this clinic. Oh, don’t worry, neither the clinic nor myself will bill you for this appointment with me: it is totally our fault for not adequately assessing your health condition, and obtaining your informed consent, *before* we started charging you for treatment.”

          Integrated medicine it is not! It is nothing other than despicable quackery.

  • Common Law requirement here since 2000! What it must contain is clearly spelled out for all professions! Informed consent is checked every year by the registration board and my professional indemnity insurer!
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2051308/?tool=pmcentrez
    Every patient since 1995 in my practice! Informed Consent form is on its 6th revision.
    @FrankCollins would also appreciate that I include natural history and regression to the mean in my informed consent with chronic pain patients which make up the bulk of my medical referrals!

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