MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

informed consent

Needle acupuncture in small children is controversial, not least because the evidence that it works is negative or weak, and because small children are unable to consent to the treatment. Yet it is recommended by some acupuncturists for infant colic. This, of course, begs the questions:

  1. Does the best evidence tell us that acupuncture is effective for infant colic?
  2. Are acupuncturists who recommend acupuncture for this condition responsible and ethical?

This systematic review and a blinding-test validation based on individual patient data from randomised controlled trials was aimed to assess its efficacy for treating infantile colic. Primary end-points were crying time at mid-treatment, at the end of treatment and at a 1-month follow-up. A 30-min mean difference (MD) in crying time between acupuncture and control was predefined as a clinically important difference. Pearson’s chi-squared test and the James and Bang indices were used to test the success of blinding of the outcome assessors [parents].

The investigators included three randomised controlled trials with data from 307 participants. Only one of the included trials obtained a successful blinding of the outcome assessors in both the acupuncture and control groups. The MD in crying time between acupuncture intervention and no acupuncture control was -24.9 min at mid-treatment, -11.4 min at the end of treatment and -11.8 min at the 4-week follow-up. The heterogeneity was negligible in all analyses. The statistically significant result at mid-treatment was lost when excluding the apparently unblinded study in a sensitivity analysis: MD -13.8 min. The registration of crying during treatment suggested more crying during acupuncture.

The authors concluded that percutaneous needle acupuncture treatments should not be recommended for infantile colic on a general basis.

The authors also provide this further comment: “Our blinding test validated IPD meta-analysis of minimal acupuncture treatments of infantile colic did not show clinically relevant effects in pain reduction as estimated by differences in crying time between needle acupuncture intervention and no acupuncture control. Analyses indicated that acupuncture treatment induced crying in many of the children. Caution should therefore be exercised in recommending potentially painful treatments with uncertain efficacy in infants. The studies are few, the analysis is made on small samples of individuals, and conclusions should be considered in this context. With this limitation in mind, our findings do not support the idea that percutaneous needle acupuncture should be recommended for treatment of infantile colic on a general basis.”

So, returning to the two questions that I listed above – what are the answers?

I think they must be:

  1. No.
  2. No.

The literature on malpractice in medicine is huge: more than 33 000 articles listed in Medline. By contrast, the literature on malpractice in alternative medicine hardly exists. An exception is this recent article. I therefore thought I share it with you and provide a few comments:

START OF QUOTE

According to the (US) National Practitioner Data Bank, between September 1, 1990 and January 29, 2012, a total of 5,796 chiropractic medical malpractice reports were filed. Lawsuits with the highest payouts in any medical field are related to misdiagnosis, failure to diagnose and delayed diagnosis of a severe medical condition.

Common reasons for chiropractic malpractice lawsuits:

Chiropractor causes stroke: Numerous cases have been documented in which a patient suffers a stroke after getting his or her neck manipulated, or adjusted. Especially forceful rotation of the neck from side to side can overextend an artery that runs along the spine, which can result in a blockage of blood flow to the brain. Strokes are among the most serious medical conditions caused by chiropractic treatment, and can result in temporary or permanent paralysis, and even death.

Herniated disc following adjustment: Although many patients seek the medical attention of a chiropractor after they have experienced a herniated disc, chiropractors can actually be the cause of the problem. Usually a herniated disc is caused by wear and tear, but a sudden heavy strain, increased pressure to the lower back or twisting motions can cause a sudden herniated disc. The stress that chiropractors exercise in their adjustments have been known to be the root cause of some herniated discs.

Sexual misconduct: The American Chiropractic Association has assembled a code of ethics “based upon the acknowledgement that the social contract dictates the profession’s responsibilities to the patient, the public and the profession.” Sexual misconduct is among the top ten reasons that patients file lawsuits against chiropractors. Often, chiropractic practices are unfamiliar to many new patients and can be misinterpreted as inappropriate even though they are absolutely normal, so it is important that patients familiarize themselves with common chiropractic methods of healing.

END OF QUOTE

In this context, a study of chiropractic from Canada might be interesting. It highlights the conclusions from Canadian courts: informed consent is an ongoing process that cannot be entirely delegated to office personnel… A further study showed that valid consent procedures are either poorly understood or selectively implemented by chiropractors. Arguably, not obtaining informed consent amounts to malpractice.

In our book, this is what we conclude about informed consent by alternative therapists in general: Genuine informed consent is unattainable for most CAM modalities. This presents a serious and intractable ethical problem for CAM practitioners. Attempts to square this circle by watering down or redefining the criteria for informed consent are ethically indefensible. The concept of informed consent and its centrality in medical ethics therefore renders most CAM practice unacceptable. Conventional healthcare subscribes to the ethical principle ‘no consent, no treatment’: we are not aware of the existence of any good reasons to excuse CAM from this dictum.

I fear that, if we were to count the lack of informed consent by chiropractors (and other alternative practitioners) as malpractice, the numbers would be astronomical. Or, to put it differently, the often-cited relatively low malpractice rate in chiropractic is due to the omission of the vast majority of malpractice cases.

My previous post was about the question whether lay-homeopaths can practise homeopathy without breaking their code of ethics. The answer was NO, because they lack most of the skills needed to obtain informed consent.

What about doctor homeopaths?

Can they practice homeopathy ethically?

Doctors are, of course, also obliged to follow their ethical code, and that means they too must obtain informed consent from their patients before starting a therapy. This is, for instance, what the UK General Medical Council tells their members:

You must give patients the information they want or need about:

  1. the diagnosis and prognosis
  2. any uncertainties about the diagnosis or prognosis, including options for further investigations
  3. options for treating or managing the condition, including the option not to treat
  4. the purpose of any proposed investigation or treatment and what it will involve
  5. the potential benefits, risks and burdens, and the likelihood of success, for each option; this should include information, if available, about whether the benefits or risks are affected by which organisation or doctor is chosen to provide care
  6. whether a proposed investigation or treatment is part of a research programme or is an innovative treatment designed specifically for their benefit4 
  7. the people who will be mainly responsible for and involved in their care, what their roles are, and to what extent students may be involved
  8. their right to refuse to take part in teaching or research
  9. their right to seek a second opinion
  10. any bills they will have to pay
  11. any conflicts of interest that you, or your organisation, may have
  12. any treatments that you believe have greater potential benefit for the patient than those you or your organisation can offer.

You should explore these matters with patients, listen to their concerns, ask for and respect their views, and encourage them to ask questions.

You should check whether patients have understood the information they have been given, and whether or not they would like more information before making a decision. You must make it clear that they can change their mind about a decision.

Following the 8 points from my previous post (I am trying to apply the same criteria to both types of homeopaths), a medical homeopath might tell her patient (whose stomach pain turns out to be caused, let’s assume, by a stomach ulcer) roughly this:

  1. The tests show that you are suffering from stomach ulcer.
  2. The natural history of this condition is usually benign, but it needs effective treatment; if not, the problem would become serious.
  3. Conventional medicine has several effective therapeutic options.
  4. I nevertheless propose to treat you with a homeopathic remedy.
  5. There is no good evidence that it will work beyond a placebo effect.
  6. The remedy is harmless, but not giving you an effective treatment might cause considerable harm.
  7. The cost of the consultation is £80, and the remedy will cost you around £15.
  8. I suggest you come again in a week or two; perhaps we need quite a few consultations altogether.

Again, as with the lay-homeopath from my previous post, any sensible patient would walk away without accepting the treatment. This means that our doctor homeopath can only practice homeopathy, if she does not inform her patient about points 5 and 6. In other words, doctors who practice homeopathy cannot obtain adequately informed consent. We have recently seen a real case of this happening and ending in the death of the patient.

Of course, the homeopath might send her patient to a specialist; or she might decide to administer a conventional therapy herself. Either way, she would not be practising homeopathy.

The dilemma is real, yet it is rarely considered. Here is a short passage from our book where we discuss the ethics of alternative medicine in full detail:

Genuine informed consent is unattainable for most CAM modalities. This presents a serious and intractable ethical problem for CAM practitioners. Attempts to square this circle by watering down or redefining the criteria for informed consent are ethically indefensible. The concept of informed consent and its centrality in medical ethics therefore renders most CAM practice unacceptable. Conventional healthcare subscribes to the ethical principle ‘no consent, no treatment’; we are not aware of the existence of any good reasons to excuse CAM from this dictum.

As I said, the ethical practice of homeopathy is a practical impossibility.

Or do you think I got this wrong?

I am not a regular reader of the ‘HALTERNER ZEITUNG’, I have to admit; but this article from the paper came to me because of my interest in homeopathy. It tells a tragic story of a German women who paid dearly for consulting a homeopath.

Here is an excerpt – as it is in German, I will sum up the essence of the story below in English.

_______________________________________________________________________________________________

…Die traurige Geschichte beginnt im Jahr 2012. Die später verstorbene Frau aus Haltern lässt sich von ihrer Ärztin wegen Heiserkeit behandeln und bekommt homöopathische Mittel. Rund zehn Monate später wechselt die Seniorin den Arzt und muss umgehend ins Krankenhaus: Luftröhrenschnitt, Kehlkopf-Entfernung, Krebs. Die Frau verstirbt nach vierjähriger Leidenszeit.

Für Schwester und Tochter war das nicht nur ein Schock, sie machen der Ärztin nun auch schwere Vorwürfe. Aus ihrer Sicht hätte praktisch sofort eine Überweisung zu einem HNO-Arzt und damit eine schulmedizinische Behandlung erfolgen müssen.

Genau das habe die Patientin aber nicht gewollt, sagte die Ärztin. „Sie hat sich immer dagegen gewehrt.“ Angeblich soll das auch dokumentiert sein. Doch auch das ist umstritten. Die Hinterbliebenen werfen der Ärztin nämlich vor, die Unterlagen gefälscht zu haben.

150.000 Euro haben sie als Schmerzensgeld eingeklagt. Dafür sah die Medizinkammer zum jetzigen Zeitpunkt jedoch keine Grundlage. „Die Haftung ist vollkommen offen“, sagte Richter Norbert Schalla.

Man wolle die Leiden der Frau zwar nicht in Abrede stellen. Die Frage sei jedoch, inwieweit die Behandlung eines krankheitsbedingten Leidens tatsächlich verzögert worden sei. „Wir müssten erstens eine Pflichtverletzung und zweitens die Kausalität feststellen“, so Schalla. Beides sei aber außerordentlich schwierig, weil es außer der Ärztin keine Zeugen gebe.

Trotzdem hatten die Richter am Essener Landgericht am Ende eine „Goodwill-Zahlung“ vorgeschlagen, um einen möglicherweise jahrelangen Rechtsstreit zu verhindern. „Manchmal ist es besser, zu einem Abschluss zu kommen, damit man seinen inneren Frieden wiederfinden kann.“

Genau so hat es die Ärztin am Ende wohl auch gesehen. Ob die 10.000 Euro aber wirklich gezahlt werden, hängt allerdings noch von ihrer Haftpflicht-Versicherung ab. Die kann in den nächsten zwei Wochen noch ihr Veto einlegen.

Auch die Hinterbliebenen können die Einigung noch immer widerrufen. Sie müssen von dem Geld nämlich 94 Prozent der Prozesskosten tragen.

_______________________________________________________________________________________________

Here is my summary:

  • An elderly woman with a sore throat consults her doctor who happens to be a homeopath.
  • The doctor prescribes homeopathic remedies.
  • The homeopathic treatment continues for months, evidently without success.
  • 10 months later, the patient changes her doctor, and her new physician sends her straight away into hospital.
  • There she is diagnosed with throat cancer.
  • After 4 years of suffering, the woman dies.
  • The patients relatives sue the homeopath for the relatively modest sum of 150 000 Euros.
  • The homeopath claims that the old woman had refused to be referred to a specialist and that the case notes provide proof for that claim.
  • The relatives suspect that the case notes have been altered retrospectively.
  • The judge suggest a ‘good will’ payment of 10 000 Euro.
  • The homeopath accepts, but it remains unclear whether the insurance agrees to pay this sum.
  • The relatives have to pay 94% of the costs for the court proceedings.

_______________________________________________________________________________________________

Anyone who claims that homeopathy is harmless should remember this story. Similar (but hopefully less dramatic) things happen almost every time a homeopath treats a patient, we argue in our book. The practice of homeopathy is by and large medical neglect. Because homeopathy is employed mostly for minor, self-limiting conditions, the neglect usually remains invisible. However, as soon as homeopath venture to treat serious diseases, the neglect (the deliberate treatment of a disease with an ineffective therapy) becomes obvious.

We recently discussed the deplorable case of Larry Nassar and the fact that the ‘American Osteopathic Association’ stated that intravaginal manipulations are indeed an approved osteopathic treatment. At the time, I thought this was a shocking claim. So, imagine my surprise when I was alerted to a German trial of osteopathic intravaginal manipulations.

Here is the full and unaltered abstract of the study:

Introduction: 50 to 80% of pregnant women suffer from low back pain (LBP) or pelvic pain (Sabino und Grauer, 2008). There is evidence for the effectiveness of manual therapy like osteopathy, chiropractic and physiotherapy in pregnant women with LBP or pelvic pain (Liccardione et al., 2010). Anatomical, functional and neural connections support the relationship between intrapelvic dysfunctions and lumbar and pelvic pain (Kanakaris et al., 2011). Strain, pressure and stretch of visceral and parietal peritoneum, bladder, urethra, rectum and fascial tissue can result in pain and secondary in muscle spasm. Visceral mobility, especially of the uterus and rectum, can induce tension on the inferior hypogastric plexus, which may influence its function. Thus, stretching the broad ligament of the uterus and the intrapelvic fascia tissue during pregnancy can reinforce the influence of the inferior hypogastric plexus. Based on above facts an additional intravaginal treatment seems to be a considerable approach in the treatment of low back pain in pregnant women.
Objective: The purpose of this study was to compare the effect of osteopathic treatment including intravaginal techniques versus osteopathic treatment only in females with pregnancy-related low back pain.
Methods: Design: The study was performed as a randomized controlled trial. The participants were randomized by drawing lots, either into the intervention group including osteopathic and additional intravaginal treatment (IV) or a control group with osteopathic treatment only (OI). Setting: Medical practice in south of Germany.
Participants 46 patients were recruited between the 30th and 36th week of pregnancy suffering from low back pain.
Intervention Both groups received three treatments within a period of three weeks. Both groups were treated with visceral, mobilization, and myofascial techniques in the cervical, thoracic and lumbar spine, the pelvic and the abdominal region (American Osteopathic Association Guidelines, 2010). The IV group received an additional treatment with intravaginal techniques in supine position. This included myofascial techniques of the M. levator ani and the internal obturator muscles, the vaginal tissue, the pubovesical and uterosacral ligaments as well as the inferior hypogastric plexus.
Main outcome measures As primary outcome the back pain intensity was measured by Visual Analogue Scale (VAS). Secondary outcome was the disability index assessed by Oswestry-Low-Back-Pain-Disability-Index (ODI), and Pregnancy-Mobility-Index (PMI).
Results: 46 participants were randomly assigned into the intervention group (IV; n = 23; age: 29.0 ±4.8 years; height: 170.1 ±5.8 cm; weight: 64.2 ±10.3 kg; BMI: 21.9 ±2.6 kg/m2) and the control group (OI; n = 23; age: 32.0 ±3.9 years; height: 168.1 ±3.5 cm; weight: 62.3 ±7.9 kg; BMI: 22.1 ±3.2 kg/m2). Data from 42 patients were included in the final analyses (IV: n=20; OI: n=22), whereas four patients dropped out due to general pregnancy complications. Back pain intensity (VAS) changed significantly in both groups: in the intervention group (IV) from 59.8 ±14.8 to 19.6 ±8.4 (p<0.05) and in the control group (OI) from 57.4 ±11.3 to 24.7 ±12.8. The difference between groups of 7.5 (95%CI: -16.3 to 1.3) failed to demonstrate statistical significance (p=0.93). Pregnancy-Mobility-Index (PMI) changed significantly in both groups, too. IV group: from 33.4 ±8.9 to 29.6 ±6.6 (p<0.05), control group (OI): from 36.3 ±5.2 to 29.7 ±6.8. The difference between groups of 2.6 (95%CI: -5.9 to 0.6) was not statistically significant (p=0.109). Oswestry-Low-Back-Pain-Disability-Index (ODI) changed significantly in the intervention group (IV) from 15.1 ±7.8 to 9.2 ±3.6 (p<0.05) and also significantly in the control group (OI) from 13.8 ±4.9 to 9.2 ±3.0. Between-groups difference of 1.3 (95%CI: -1.5 to 4.1) was not statistically significant (p=0.357).
Conclusions: In this sample a series of osteopathic treatments showed significant effects in reducing pain and increasing the lumbar range of motion in pregnant women with low back pain. Both groups attained clinically significant improvement in functional disability, activity and quality of life. Furthermore, no benefit of additional intravaginal treatment was observed.

END OF QUOTE

My first thoughts after reading this were: how on earth did the investigators get this past an ethics committee? It cannot be ethical, in my view, to allow osteopaths (in Germany, they have no relevant training to speak of) to manipulate women intravaginally. How deluded must an osteopath be to plan and conduct such a trial? What were the patients told before giving informed consent? Surely not the truth!

My second thoughts were about the scientific validity of this study: the hypothesis which this trial claims to be testing is a far-fetched extrapolation, to put it mildly; in fact, it is not a hypothesis, it’s a very daft idea. The control-intervention is inadequate in that it cannot control for the (probably large) placebo effects of intravaginal manipulations. The observed outcomes are based on within-group comparisons and are therefore most likely unrelated to the treatments applied. The conclusion is as barmy as it gets; a proper conclusion should clearly and openly state that the results did not show any effects of the intravaginal manipulations.

In summary, this is a breathtakingly idiotic trial, and everyone involved in it (ethics committee, funding body, investigators, statistician, reviewers, journal editor) should be deeply ashamed and apologise to the poor women who were abused in a most deplorable fashion.

The RCC is a relatively new organisation. It is a registered charity claiming to promote “professional excellence, quality and safety in chiropractic… The organisation promotes and supports high standards of education, practice and research, enabling chiropractors to provide, and to be recognised for providing, high quality care for patients.”

I have to admit that I was not impressed by the creation of the RCC and lately have not followed what they are up to – not a lot, I assumed. But now they seem to plan a flurry of most laudable activities:

The Royal College of Chiropractors is developing a range of initiatives designed to help chiropractors actively engage with health promotion, with a particular focus on key areas of public health including physical activity, obesity and mental wellbeing.

Dr Mark Gurden, Chair of the RCC Health Policy Unit, commented:

“Chiropractors are well placed to participate in public health initiatives. Collectively, they have several million opportunities every year in the UK to support people in making positive changes to their general health and wellbeing, as well as helping them manage their musculoskeletal health of course.

Our recent AGM & Winter Conference highlighted the RCC’s intentions to encourage chiropractors to engage with a public health agenda and we are now embarking on a programme to:

  • Help chiropractors recognise the importance of their public health role;
  • Help chiropractors enhance their knowledge and skills in providing advice and support to patients in key areas of public health through provision of information, guidance and training;
  • Help chiropractors measure and recognise the impact they can have in key areas of public health.

To take this work forward, we will be exploring the possibility of launching an RCC Public Health Promotion & Wellbeing Society with a view to establishing a new Specialist Faculty in due course.”

END OF QUOTE

A ‘Public Health Promotion & Wellbeing Society’. Great!

As this must be new ground for the RCC, let me list a few suggestions as to how they could make more meaningful contributions to public health:

  • They could tell their members that immunisations are interventions that save millions of lives and are therefore in the interest of public health. Many chiropractors still have a very disturbed attitude towards immunisation: anti-vaccination attitudes still abound within the chiropractic profession. Despite a growing body of evidence about the safety and efficacy of vaccination, many chiropractors do not believe in vaccination, will not recommend it to their patients, and place emphasis on risk rather than benefit. In case you wonder where this odd behaviour comes from, you best look into the history of chiropractic. D. D. Palmer, the magnetic healer who ‘invented’ chiropractic about 120 years ago, left no doubt about his profound disgust for immunisation: “It is the very height of absurdity to strive to ‘protect’ any person from smallpox and other malady by inoculating them with a filthy animal poison… No one will ever pollute the blood of any member of my family unless he cares to walk over my dead body… ” (D. D. Palmer, 1910)
  • They could tell their members that chiropractic for children is little else than a dangerous nonsense for the sake of making money. Not only is there ‘not a jot of evidence‘ that it is effective for paediatric conditions, it can also cause serious harm. I fear that this suggestion is unlikely to be well-received by the RCC; they even have something called a ‘Paediatrics Faculty’!
  • They could tell their members that making bogus claims is not just naughty but hinders public health. Whenever I look on the Internet, I find more false than true claims made by chiropractors, RCC members or not.
  • They could tell their members that informed consent is not an option but an ethical imperative. Actually, the RCC do say something about the issue: The BMJ has highlighted a recent UK Supreme Court ruling that effectively means a doctor can no longer decide what a patient needs to know about the risks of treatment when seeking consent. Doctors will now have to take reasonable care to ensure the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. Furthermore, what counts as material risk can no longer be based on a responsible body of medical opinion, but rather on the view of ‘a reasonable person in the patient’s position’. The BMJ article is available here. The RCC feels it is important for chiropractors to be aware of this development which is relevant to all healthcare professionals. That’s splendid! So, chiropractors are finally being instructed to obtain informed consent from all their patients before starting treatment. This means that patients must be told that spinal manipulation is associated with very serious risks, AND that, in addition, ~ 50% of all patients will suffer from mild to moderate side effects, AND that there are always less risky and more effective treatments available for any condition from other healthcare providers.
  • The RCC could, for the benefit of public health, establish a compulsory register of adverse effects after spinal manipulations and make the data from it available to the public. At present such a register does not exist, and therefore its introduction would be a significant step in the right direction.
  • The RCC could make it mandatory for all members to adhere to the above points and establish a mechanism of monitoring their behaviour to make sure that, for the sake of public health, they all do take these issues seriously.

I do realise that the RCC may not currently have the expertise and know-how to adopt my suggestions, as these issues are rather new to them. To support the RCC in their praiseworthy endeavours, I herewith offer to give one or more evidence-based lectures on these subjects (at a date and place of their choice) in an attempt to familiarise the RCC and its members with these important aspects of public health. I also realise that the RCC may not have the funds to pay professorial lecture fees. Therefore, in the interest of both progress and public health, I offer to give these lectures for free.

I can be contacted via this blog.

In 2017, Medline listed just over 1800 articles on ‘complementary alternative medicine’. If you find this number impressively high, consider that, for ‘surgery’ (a subject that has often been branded as less that active in conducting research), there were almost 18 000 Medline-listed papers.

So, the research activity in CAM is relatively small. Vis a vis the plethora of open questions, this inactivity is perhaps lamentable. What I find much more regrettable, however, is the near total lack of investigations into the ethical issues in CAM. In 2017, there were just 11 articles on Medline on ‘ethics and CAM’ (24393 articles on ‘ethics and surgery’).

One of the 11 papers that tackled the ethics directly and that was (in my opinion) one of the best is this article. Here is its concluding paragraph:

When we encounter patients who use or consider the use of complementary and/or alternative medicine, we should respect their autonomy while also fulfilling our obligations of beneficence and nonmaleficence. Physicians should become more knowledgeable about research on CAM therapies and approach discussions in an open, nonjudgmental manner to enhance patient trust. In situations where there is little risk of harm and the possibility of benefit, supporting a patient in their interest in complementary therapies can strengthen the patient-physician relationship. However, when a patient’s desire to utilize alternative therapies poses a health risk, physicians have the ethical obligation to skillfully counsel the patient toward those therapies that are medically appropriate.

I have had a long-lasting and keen interest in the ethics of CAM which resulted in the publication of many papers. Here is a selection:

Problems with ethical approval and how to fix them: lessons from three trials in rheumatoid arthritis.

‘Complementary & Alternative Medicine’ (CAM): Ethical And Policy Issues.

Pharmacists and homeopathic remedies.

No obligation to report adverse effects in British complementary and alternative medicine: evidence for double standards.

Homeopathy, a “helpful placebo” or an unethical intervention?

Advice offered by practitioners of complementary/ alternative medicine: an important ethical issue.

The ethics of British professional homoeopaths.

Evidence-based practice in British complementary and alternative medicine: double standards?

Ethics of complementary medicine: practical issues.

The ethics of chiropractic.

Reporting of ethical standards: differences between complementary and orthodox medicine journals?

Informed consent: a potential dilemma for complementary medicine.

Ethical problems arising in evidence based complementary and alternative medicine.

Complementary medicine: implications for informed consent in general practice.

Ethics and complementary and alternative medicine.

Research ethics questioned in Qigong study.

Informed consent in complementary and alternative medicine.

The ethics of complementary medicine.

For most of the time conducting this research, I felt that I was almost alone in realising the importance of this topic. And all this time, I was convinced that the subject needed more attention and recognition. Therefore, I teamed up with with the excellent ethicist Kevin Smith from the University of Dundee, and together we spent the best part of 2017 writing about it.

Our book is entitled ‘MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE’ and will be published shortly by Springer.

Product Details

It is an attempt to highlight some of the most important topics in this broad and under-researched area. While working on it, I was continually struck by the fact that most of the issues we have been struggling with on this blog are, in the final analysis, ethical by nature.

My hope is that, in 2018, we will see many more high quality papers filling the almost total void of ethical perspectives on CAM. In my view, it is unquestionably an area that needs to be addressed with some urgency.

This is a fascinating new review of upper neck manipulation. It raises many concerns that we, on this blog, have been struggling with for years. I take the liberty of quoting a few passages which I feel are important and encourage everyone to study the report in full:

The Minister of Health, Seniors and Active Living gave direction to the Health Professions Advisory Council (“the Council”) to undertake a review related to high neck manipulation.

Specifically, the Minister directed the Council to undertake:

1) A review of the status of the reserved act in other Canadian jurisdictions,

2) A literature review related to the benefits to patients and risks to patient safety associated with the procedure, and

3) A jurisprudence review or a review into the legal issues that have arisen in Canada with respect to the performance of the procedure that touch upon the risk of harm to a patient.

In addition, the Minister requested the Council to seek written input on the issue from:

  • Manitoba Chiropractic Stroke Survivors
  • Manitoba Chiropractic Association
  • College of Physiotherapists of Manitoba
  • Manitoba Naturopathic Association
  • College of Physicians and Surgeons of Manitoba
  • other relevant interested parties as determined by the Council

… The review indicated that further research is required to:

  • strengthen evidence for the efficacy of cervical spinal manipulations (CSM) as a treatment for neck pain and headache, “as well as for other indications where evidence currently does not exist (i.e., upper back and should/arm pain, high blood pressure, etc.)”
  • establish safety and efficacy of CSM in infants and children
  • assess the risk versus benefit in consideration of using HVLA cervical spine manipulation, which also involve cost-benefit analyses that compare CSM to other standard treatments.

… the performance of “high neck manipulation” or cervical spine manipulation does present a risk of harm to patients. This risk of harm must be understood by both the patient and the practitioner.

Both the jurisprudence review and the research literature review point to the need for the following actions to mitigate the risk of harm associated with the performance of cervical spine manipulation:

  • Action One: Ensure that the patient provides written informed consent prior to initiating treatment which includes a discussion about the risk associated with cervical spine manipulation.
  • Action Two: Provide patients with information to assist in the early recognition of a serious adverse event.

Before starting to treat a patient, all health care professionals – including of course alternative practitioners – have to obtain informed consent. This is not optional but an ethical and legal imperative. Informed consent must usually include full information on:

  • the diagnosis
  • its natural history
  • the most effective treatment options available
  • the proposed therapy
  • its effectiveness
  • its risks
  • its cost
  • a rough treatment plan

Only when this information has been transmitted to and understood by the patient can informed consent be considered complete.

One could easily argue that, in alternative medicine, informed consent is a practical impossibility.

To explain why, let us consider two scenarios.

SCENARIO 1

A patient with fatigue and headaches consults a Reiki healer. The practitioner asks a few questions and proceeds to apply Reiki. The therapist has no means to obtain informed consent because:

  • he is not qualified to make diagnoses
  • he knows little about the natural condition of the patient
  • he is ignorant of the most effective treatment options
  • he is convinced that Reiki works but is unaware of the evidence

SCENARIO 2

A patient with fatigue and headaches consults a chiropractor. The chiropractor takes a history, conducts a physical examination, tells the patient that her headaches are due to spinal misalignments which he suggests to treat with spinal manipulations, and proceeds to apply his treatments. The chiropractor has no means to obtain informed consent because:

  • he has insufficient knowledge of other therapeutic options
  • he is biased as to the effectiveness of spinal manipulations
  • he believes that they are risk-free
  • he has an overt conflict of interest (he earns his money by applying his treatments)

In some respects, these might be extreme scenarios. They were chosen to explain why informed consent is rarely possible in the realm of alternative medicine. Put simply, informed consent requires knowledge that alternative practitioners almost never possess. I know this will sound chauvinistic, but it requires knowledge that normally only doctors have – I mean doctors who have been through medical school. Moreover, it requires a lack of financial interest such that the clinician is not in danger of loosing out on some income, if he advises his patient not to receive treatment from him. Finally, informed consent requires information about the treatment. Arguably, this should include explanations how it works. For many alternative therapies, this information is not available. If it is unavailable, informed consent is impossible.

If I am correct – and I am fully aware that many will think I am not – what implications would this have? If informed consent is usually not provided or even impossible, one cannot help but conclude that alternative medicine, as it is practised in most places today, is not ethical.

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.

 

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