MD, PhD, FMedSci, FSB, FRCP, FRCPEd

informed consent

In many countries, consumers seem to be fond of consulting chiropractors – mostly for back pain, but also for other conditions. I therefore think it is might be a good and productive idea to give anyone who is tempted to see a chiropractor some simple, easy to follow advice. Here we go:

  1. Ask your chiropractor what he/she thinks about the chiropractic concept of subluxation. This is the chiropractors’ term (real doctors use the word too but understand something entirely different by it) for an imagined problem with your spine. Once they have diagnosed you to suffer from subluxation, they will persuade you that it needs correcting which is done by spinal manipulation which they tend to call ‘adjustments’. There are several important issues here: firstly subluxations do not exist outside the fantasy world of chiropractic; secondly chiropractors who believe in subluxation would diagnose subluxation in about 100% of the population – also in individuals who are completely healthy. My advice is to return straight back home as soon as the chiropractor admits he believes in the mystical concept of subluxation.
  2. Ask your chiropractor what he/she thinks of ‘maintenance care’. This is the term many chiropractors use for indefinite treatments which do little more than transfer lots of cash from your account to that of your chiropractor. There is no good evidence to show that maintenance care does, as chiropractors claim, prevent healthy individuals from falling ill. So, unless you have the irresistible urge to burn money, don’t fall for this nonsense. You should ask your chiropractor how long and frequent your treatment will be, what it will cost, and then ask yourself whether it is worth it.
  3. Run a mile, if the chiropractor wants to manipulate your neck (which most will do regardless of whether you have neck-pain, some even without informed consent). Neck manipulation is associated with very serious complications; they are usually caused by an injury to an artery that supplies parts of your brain. This can cause a stroke and even death. Several hundred such cases have been documented in the medical literature – but the true figure is almost certainly much larger (there is still no system in place to monitor such events).
  4. Run even faster, if the chiropractor wants to treat your children for common paediatric conditions. Many chiropractors believe that their manipulations are effective for a wide range of health problems that kids frequently suffer from. However, there is not a jot of evidence that these claims are true.
  5. Be aware that about 50% of all patients having chiropractic treatments will suffer from side effects like pain and stiffness. These symptoms usually last for 2-3 days and can be severe enough to impede your quality of life. Ask yourself whether the risk is outweighed by the benefit of chiropractic.
  6. Remember that there is no good evidence that chiropractors can treat any condition effectively other than lower back pain (and even for that condition the evidence is far from strong). Many chiropractors claim to be able to treat a plethora of non-spinal conditions like asthma, ear infection, gastrointestinal complaints, autism etc. etc. There is no good evidence that these claims are correct.
  7. Distrust the advice given by many chiropractors regarding prescribed medications, vaccinations or surgery. Chiropractic has a long history of warning their patients against all sorts of conventional treatments. Depending on the clinical situation, following such advice can cause very serious harm.

I am minded to write similar posts for all major alternative therapies (this will not make me more popular with alternative therapists, but I don’t mind all that much) – provided, of course, that my readers find this sort of article useful. So, please do give me some feedback.

‘Healing, hype or harm? A critical analysis of complementary or alternative medicine’ is the title of a book that I edited and that was published in 2008. Its publication date coincided with that of ‘Trick or Treatment?’ and therefore the former was almost completely over-shadowed by the latter. Consequently few people know about it. This is a shame, I think, and this post is dedicated to encouraging my readers to have a look at ‘Healing, hype or harm?’

One reviewer commented on Amazon about this book as follows: Vital and informative text that should be read by everyone alongside Ben Goldacre’s ‘Bad Science’ and Singh and Ernt’s ‘Trick or Treatment’. Everyone should be able to made informed choices about the treatments that are peddled to the desperate and gullible. As Tim Minchin famously said ‘What do you call Alternative Medicine that has been proved to work? . . . Medicine!’

This is high praise indeed! But I should not omit the fact that others have commented that they were appalled by our book and found it “disappointing and unsettling”. This does not surprise me in the least; after all, alternative medicine has always been a divisive subject.

The book was written by a total of 17 authors and covers many important aspects of alternative medicine. Some of its most famous contributors are Michael Baum, Gustav Born, David Colquhoun, James Randi and Nick Ross. Some of the most important subjects include:

  • Compassion
  • Quackademia
  • Impartiality
  • Ethics
  • Politics
  • Holism
  • Vitalism
  • Placebo

As already mentioned, our book is already 6 years old; however, this does not mean that it is now out-dated. The subject areas were chosen such that it will be timely for a long time to come. Nor does this book reflect one single point of view; as it was written by over a dozen different experts with vastly different backgrounds, it offers an entire spectrum of views and attitudes. It is, in a word, a book that stimulates critical thinking and thoughtful analysis.

I sincerely think you should have a look at it… and, in case you think I am hoping to maximise my income by telling you all this: all the revenues from this book go to charity.

The purpose of this paper by Canadian chiropractors was to expand practitioners’ knowledge on areas of liability when treating low back pain patients. Six cases where chiropractors in Canada were sued for allegedly causing or aggravating lumbar disc herniation after spinal manipulative therapy were retrieved using the CANLII database.

The patients were 4 men and 2 women with an average age of 37 years. Trial courts’ decisions were rendered between 2000 and 2011. The following conclusions from Canadian courts were noted:

  1. informed consent is an on-going process that cannot be entirely delegated to office personnel;
  2. when the patient’s history reveals risk factors for lumbar disc herniation the chiropractor has the duty to rule out disc pathology as an aetiology for the symptoms presented by the patients before beginning anything but conservative palliative treatment;
  3. lumbar disc herniation may be triggered by spinal manipulative therapy on vertebral segments distant from the involved herniated disc such as the thoracic spine.

The fact that this article was published by chiropractors seems like a step into the right direction. Disc herniations after chiropractic have been reported regularly and since many years. It is not often that I hear chiropractors admit that their spinal manipulations carry serious risks.

And it is not often that chiropractors consider the issue of informed consent. One the one hand, one hardly can blame them for it: if they ever did take informed consent seriously and informed their patients fully about the evidence and risks of their treatments as well as those of other therapeutic options, they would probably be out of business for ever. One the other hand, chiropractors should not be allowed to continue excluding themselves from the generally accepted ethical standards of modern health care.

It almost goes without saying that alternative practitioners contribute importantly to the ‘sea of misinformation’ about alternative medicine. Again, I could write books about this subject but have to refrain myself and therefore will merely put quick spotlights on several types of practitioners, mostly drawing from my own research on these subjects.

Acupuncturists

A survey of more than 9000 patients of U.K. non-medically trained acupuncturists showed that a considerable number had received advice from their therapists about prescribed medicines. Since these acupuncturists hold no medical qualifications, they are not qualified to issue such advice. It is therefore clear to me that the advice given is likely to be misleading. In 2000, we directly asked the U.K. acupuncturists’ advice about electro-acupuncture treatment for smoking cessation, a treatment which we previously had identified to be ineffective. The advice we received was frequently not based on current best evidence and some of it also raised serious safety concerns (Schmidt, K., & Ernst, E. Internet advice by acupuncturists—a risk factor for cardiovascular patients? Perfusion,2002, 15: 44-50. Article not Medline-listed).

Chiropractors

Many chiropractors from the UK and other countries make unsustainable therapeutic claims on their websites. In 2002, at the height of the ‘‘MMR scare’’ in Britain, we conducted a study revealing that a sizable proportion of U.K. chiropractors advised mothers against having the measles-mumps-rubella (MMR) jab for their children. A survey of the U.K. chiropractors demonstrated that an alarming percentage of the U.K. chiropractors fail to provide advice about the risks of spinal manipulation before commencing treatment. As these risks are, in fact, considerable, this behaviour amounts to misinformation and is an obvious violation of medical ethics.

Osteopaths

With osteopaths, it is a very similar story; the main difference is that there are far less investigations than for chiropractors. This may be due to the fact that, in the US, osteopaths are not alternative but conventional clinicians with much the same training and skills as proper doctors. But in Europe, they are strictly alternative and make as many bogus claims as chiropractors. Systematic investigations are rare, but I only need to remind us of my recent blog-post where I pointed out that:

Most osteopaths treat children for a wide range of conditions and claim that their interventions are helpful. They believe that children are prone to structural problems which can be corrected by their interventions. Here is an example from just one of the numerous promotional websites on this topic:

STRUCTURAL  PROBLEMS, such as those affecting the proper mobility and function of the  body’s framework, can lead to a range of problems. These may include:

  • Postural – such as scoliosis
  • Respiratory  – such as asthma
  • Manifestations of brain  injury – such as cerebral palsy and spasticity
  • Developmental  – with delayed physical or intellectual progress, perhaps triggering learning  behaviour difficulties
  • Infections – such  as ear and throat infections or urinary disturbances, which may be recurrent.

OSTEOPATHY can assist in the prevention of health problems, helping children to make a smooth  transition into normal, healthy adult life.

Herbalists

Encouraging evidence exists for some specific herbs in the treatment of some specific conditions. Yet, virtually no good evidence exists to suggest that the prescriptions of individualized herbal mixtures by traditional herbalists across the globe generate more good than harm. Despite this lack of evidence, herbalists do not seem to offer this information voluntarily to his or her patients. When we directly asked the UK herbalists for advice on a clinical case, we found that it was ‘‘misleading at best and dangerous at worst’’ . In other words, herbalists misinform their patients and the public about the value of their treatments.

Homeopaths

Many non-medically trained homeopaths advise their clients against the immunization of children. Instead, these practitioners often recommend using ‘‘homeopathic vaccinations’’ for which no good evidence exists. For instance, the vice-chair of the board of directors of ‘‘The Society of Homeopaths’’ had a site with the following statements: ‘‘Homeopathic alternatives to children’s immunisation are now available.’’ ‘‘Our clinic offers alternative immunisation programmes for the whole family.’’ Such statements amounts to misinformation which puts children’s health at risk.

Other alternative practitioners

I have chosen the above-listed professions almost at random and could have selected any other type as well. Arguably, all alternative practitioners who employ unproven treatments – and that must be the vast majority – misinform their patients to some extend. The only way to avoid this is to say: ‘look, I am going to give you a therapy for which there is no good evidence – I hope you don’t mind’. If they did that, they would be out of business in a flash. It follows, I think, that being in business is tantamount to misleading patients.

And there is, of course, another way of misinforming patients which is often forgotten yet very important: withholding essential information. In all of health care, informed consent is a ‘sine qua non’. Alternative practitioners very rarely obtain informed consent from their patients. The reason seems obvious (see above). I would argue that not informing people when they should be informed is a form of misinformation.

In this context, it is worth mentioning an investigation we did in 2009: We obtained the ethical codes of the following bodies: Association of Naturopathic Practitioners, Association of Traditional Chinese Medicine (UK), Ayurvedic Practitioners Association, British Acupuncture Council, Complementary and Natural Healthcare Council, European Herbal Practitioners Association, General Chiropractic Council, General Osteopathic Council, General Regulatory Council for Complementary Therapies, National Institute of Medical Herbalists, Register of Chinese Herbal Medicine, Society of Homeopaths, UK Healers, Unified Register of Herbal Practitioners. We then extracted the statements from these codes referring to evidence-based practice (EBP). The results showed that only the General Chiropractic Council, the General Osteopathic Council and the General Regulatory Council for Complementary Therapies oblige their members to adopt EBP.

Conclusion

It seems that misinformation is an alternative practitioner’s daily bread. Without it, alternative therapists would need to confine their practice to the few treatments/conditions for which the evidence is positive. If they ever followed this strategy, they would hardly be able to earn a living.

Alternative medicine has the image of being gentle and risk-free; it is therefore frequently used for children. German experts have just published an important article on this rather controversial topic.

They performed a systematic synthesis of all Cochrane reviews in paediatrics assessing the efficacy, clinical implications and limitations of alternative medicine use in children. The main outcome variables were: percentage of reviews concluding that a certain intervention provides a benefit, percentage of reviews concluding that a certain intervention should not be performed, and percentage of studies concluding that the current level of evidence is inconclusive. A total of 135 reviews were included – most from the United Kingdom (29), Australia (24) and China (24). Only 5 (3.7%) reviews gave a recommendation in favour of a certain intervention; 26 (19.4%) issued a conditional positive recommendation. The 5 positive recommendations were:

1) Calcium supplements during pregnancy for prevention of hypertension and related conditions

2) Creatinine supplements for treating muscular disorders

3) Zinc supplements for prevention of pneumonia

4) Probiotics for prevention of upper respiratory infections

5) Acupuncture for prevention of post-operative nausea and vomiting

Nine (6.6%) reviews concluded that certain interventions should not be performed. Ninety-five reviews (70.3%) were inconclusive. The proportion of inconclusive reviews increased over time. The three most common criticisms of the quality of the primary studies included were: more research needed (82), low methodological quality (57) and small number of study participants (48).

The authors concluded: Given the disproportionate number of inconclusive reviews, there is an ongoing need for high quality research to assess the potential role of CAM in children. Unless the study of CAM is performed to the same science-based standards as conventional therapies, CAM therapies risk being perpetually marginalised by mainstream medicine.

As it happens, we published a very similar review two years ago. At the time (and using slightly different inclusion criteria), we identified a total of 17 systematic reviews. They related to acupuncture, chiropractic, herbal medicine, homeopathy, hypnotherapy, massage and yoga. Results were unconvincing for most conditions, but there was some evidence to suggest that acupuncture may be effective for postoperative nausea and vomiting, and that hypnotherapy may be effective in reducing procedure-related pain. Most of the reviews failed to mention the incidence of adverse effects of the alternative treatments in question. Our conclusions were as follows: “Although there is some encouraging evidence for hypnosis, herbal medicine and acupuncture, there is insufficient evidence to suggest that other CAMs are effective for the treatment of childhood conditions. Many of the systematic reviews included in this overview were of low quality, as were the randomised clinical trials within those reviews, further reducing the weight of that evidence. Future research in CAM for children should conform to the reporting standards outlined in the CONSORT and PRISMA guidelines.”

Treating children with unproven or dis-proven therapies is even more problematic than treating adults in this way. The main reason is that children cannot give informed consent. Thus alternative medicine for children can open difficult ethical questions, and sometimes I wonder where the line is between the application of bogus treatments and child-abuse. Examples are parents who opt for homeopathic vaccinations instead of conventional ones, or paediatric cancer patients who are being treated with bogus alternatives such as laetrile.

Why would parents not want the most effective therapy for their children? Why would anyone opt for dubious alternatives? The main reason, I think, must be misinformation. Parents who use alternative medicine are convinced they are effective and safe because they have been misinformed. We only need to google ALTERNATIVE MEDICINE to see for ourselves what utter nonsense and dangerous rubbish is being promoted under this umbrella.

Misinformation is the foremost reason why well-meaning parents (mis-) treat their children with alternative medicine. The results can be disastrous. Misinformation can kill!

Daniels and Vogel recently published an article entitled “Consent in osteopathy: A cross sectional survey of patients’ information and process preferences” (INTERNATIONAL JOURNAL OF OSTEOPATHIC MEDICINE 2012, 15:3, p.92-102). It addresses an important yet woefully under-researched area.

I find most laudable that two osteopaths conduct research into medical ethics; but the questions still are, does the article tell us anything worth knowing and is it sufficiently rigorous and critical? As the journal does not seem to be available on Medline, I cannot provide a link. I therefore take the liberty of quoting the most important bits from directly the abstract here.

Objective: To explore and describe patients’ preferences of consent procedures in a sample of UK osteopathic patients.

Methods: A cross sectional survey using a new questionnaire was performed incorporating paper and web-based versions of the instruments. 500 copies were made available, (n = 200) to patients attending the British School of Osteopathy (BSO) clinic, and (n = 300) for patients attending 30 randomly sampled osteopaths in practice. Quantitative data were analysed descriptively to assess patient preferences; non-parametric analyses were performed to test for preference difference between patients using demographic characteristics.

Results: 124 completed questionnaires were returned from the BSO sample representing a 41% response rate. None were received from patients attending practices outside of the BSO clinic. The majority (98%) of patient respondents thought that having information about rare yet potentially severe risks of treatment was important. Patients’ preferred to have this information presented during the initial consultation (72%); communication method favoured was verbal (90%). 99% would like the opportunity to ask questions about risks, and all respondents (100%) consider being informed about their current diagnosis as important.

Conclusion: Patients endorse the importance of information exchange as part of the consent process. Verbal communication is very important and is the favoured method for both receiving information and giving consent. Further research is required to test the validity of these results in practice samples

The 0% response-rate in patients from non-BSO practices is, of course, remarkable and not without irony. In my view, it highlights better than anything else the fact that informed consent rarely appears on the osteopathic radar screen. In a way, this increases the praise we should give the two authors for tackling the issue.

The central question of the survey is whether patients want to know about the risks of osteopathy. This is more than a little bizarre: informed consent is not an option, it is a legal, moral and ethical obligation. It seems therefore odd to ask the question “do you want to learn about the risks which you are about to be exposed to?”

Even odder is, I think, the second question “when do you want to receive this information?” It goes without saying that informed consent has to happen before the intervention! This is what, common sense tells us, the law dictates and ethical codes prescribe.

There is general agreement amongst health care professionals and ethicist that verbal consent does suffice in most therapeutic situations, that patients must have the opportunity to ask questions, and that informed consent also extends to diagnostic issues. So, the questions referring to these issues are also a bit strange or naive, in my view.

The article might be revealing mostly by what it does not address rather than by what it tells us. It would be really valuable to know the percentage of osteopaths who abide by the legal, moral and ethical imperative of informed consent in their daily practice. To the best of my knowledge, this information is not available [if anyone has such information, please let me know and provide the reference]. Assuming that it is similar to the percentage of UK chiropractors who obtain informed consent, it might be seriously wanting: only 45% of them routinely obtain informed consent from their patients.

Another issue that, in my view, would be relevant to clarify is the nature of the information provided by osteopaths to patients, other than that of serious risks associated with spinal manipulation/mobilisation. Do they tell their patients about the evidence suggesting that osteopathy does (not) work for the condition at hand? Do they elaborate on non-osteopathic treatments for that disease? I fear that the answers to these questions might well be negative.

Imagine a patient being told that there is no good evidence for effectiveness of osteopathy, that the possibility of some harm exists, and that other interventions might actually do more good than harm than what the osteopath has to offer. How likely is it that this patient would agree to receiving osteopathic treatment?

For most alternative practitioners, including osteopaths, informed consent and most other important ethical issues have so far remained highly uncomfortable areas. This may have a good and simple reason: they have the potential to become real and serious threats to their current practice and business. I suspect this is why there is so very little awareness of and research into the ethics of alternative medicine: “best not to wake sleeping lions”, seems to be the general attitude.

The survey by Daniels and Vogel, even though it touches upon an important topic, avoids the truly pertinent questions. It therefore looks to me a bit like a fig leaf shamefully hiding an area of potential embarrassment.

And where do we go from here? I predict that the current strategy of alternative practitioners to ignore and violate medical ethics as much as possible will not be tolerated for much longer. Double standards in health care cannot and should not survive. The sooner we begin addressing some of these uncomfortable questions with rigorous research, the better – perhaps not for the practitioner but certainly for the patient.

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