informed consent
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:
‘Complementary & Alternative Medicine’ (CAM): Ethical And Policy Issues.
Pharmacists and homeopathic remedies.
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.
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.
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:
- the patient must have decision-making capacity,
- the patient’s decision must be free from coercion or manipulation,
- all relevant information must be disclosed to the patient,
- 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:
- the indication,
- the nature of the procedure,
- its potential benefits,
- its risks,
- 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
- 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.
- Can he explain the nature of the procedure? Yes.
- Can he explain its potential benefits? He is likely to have a too optimistic view on this.
- Can he explain its risks? Many chiropractors deny any risk of spinal manipulation.
- 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
- 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.
- Can he explain the nature of the procedure? Yes.
- Can he explain its potential benefits? He is likely to have a too optimistic view on this.
- Can he explain its risks? Perhaps.
- Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No
THE CLASSICAL HOMEOPATH
- Can he provide full information on the indication? No, for a classical homeopath, the totality of the symptoms is the only valid diagnosis.
- Can he explain the nature of the procedure? Yes.
- Can he explain its potential benefits? Doubtful.
- Can he explain its risks? Doubtful.
- Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No.
THE NATUROPATH
- Can he provide full information on the indication? Doubtful.
- Can he explain the nature of the procedure? Yes.
- Can he explain its potential benefits? He is likely to have a too optimistic view on this.
- Can he explain its risks? Doubtful.
- Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No.
THE TRADITIONAL HERBALIST
- Can he provide full information on the indication? No.
- Can he explain the nature of the procedure? Yes.
- Can he explain its potential benefits? He is likely to have a too optimistic view on this.
- Can he explain its risks? He is likely to have a too optimistic view on this.
- 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.
Medical ethics are central to any type of healthcare – and this includes, of course, alternative medicine. The American Medical Association (AMA) have just published their newly revised code of ethics, AMA Principles of Medical Ethics.
It has long been my impression that, in alternative medicine, ethics receive no or far too little attention. Some alternative practitioners thrive to be able to call themselves ‘physicians’. Therefore, it seems interesting to ask whether they would also be able to comply with the ethical duties of a physician as outlined by the AMA.
The following 9 points are taken without change from the new AMA code; in brackets I have put my own, very brief comments pertaining to alternative practitioners. There is much more to be said about each of these points, of course, and I encourage my readers to do so in the comments section.
- A physician shall be dedicated to providing competent medical care, with compassion and respect for human dignity and rights. [Most alternative practitioners use unproven treatments; I doubt whether this can be called ‘competent medical care’.]
- A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities. [Treating patients with unproven therapies in the absence of fully informed consent is arguably unprofessional, dishonest and deceptive. Crucially, alternative practitioners never object to even the worst excesses of quackery that occur in their realm.]
- A physician shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient. [Treatment with unproven therapies can hardly be in the best interest of the patient.]
- A physician shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences and privacy within the constraints of the law. [The right of patients includes full informed consent which is, according to my impression, rare in alternative medicine.]
- A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated. [Alternative medicine is frequently out of line with or even opposed to medical knowledge.]
- A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care.
- A physician shall recognize a responsibility to participate in activities contributing to the improvement of the community and the betterment of public health. [Some activities of some alternative practitioners are directly opposed to public health, for instance when they advise against immunising children.]
- A physician shall, while caring for a patient, regard responsibility to the patient as paramount. [Arguably this is not possible when using unproven therapies.]
- A physician shall support access to medical care for all people. [Some alternative practitioners advise their patients against accessing conventional healthcare.]
As I stated above, medical ethics are neglected in alternative medicine. The 9 points of the AMA together with my comments go some way towards explaining why this is so. If ethical principles were applied to alternative medicine, much of it would have to stop instantly.
Seasonal allergic rhinitis (hay fever) is a common condition which can considerably reduce the quality of life of sufferers. Homeopathy is often advocated – but does it work?
A new study was meant to be an “assessment of the clinical effectiveness of homeopathic remedies in the alleviation of hay fever symptoms in a typical clinical setting.”
The investigator performed a ‘clinical observational study’ of eight patients from his private practice using Measure Yourself Medical Outcome Profile (MYMOP) self-evaluation questionnaires at baseline and again after two weeks and 4 weeks of individualized homeopathic treatment which was given as an add-on to conventional treatments.
The average MYMOP scores for the eyes, nose, activity and wellbeing had improved significantly after two and 4 weeks of homeopathic treatment. The overall average MYMOP profile score at baseline was 3.83 (standard deviation, SD, 0.78). After 14 and 28 days of treatment the average score had fallen to 1.14 (SD, 0.36; P<0.001) and 1.06 (SD, 0.25; P<0.001) respectively.
The author concluded as follows: Individualized homeopathic treatment was associated with significant alleviation of hay fever symptoms, enabling the reduction in use of conventional treatment. The results presented in this study can be considered as a step towards a pilot pragmatic study that would use more robust outcome measures and include a larger number of patients prescribed a single or a multiple homeopathic prescription on an individualized basis.
It is hard to name the things that are most offensively wrong here; the choice is too large. Let me just list three points:
- The study design is not matched to the research question.
- The implication that homeopathy had anything to do with the observed outcome is unwarranted.
- The conclusion that the results might lend themselves to develop a pilot study is meaningless.
The question whether homeopathy is an effective therapy for hay fever has been tested before, even in RCTs. It seems therefore mysterious why one needs to revert to tiny observational studies in order to plan a pilot, and even less for an assessment of effectiveness.
There are few conditions which are more time-dependent than hay fever. Any attempt of testing the effectiveness of medical interventions without a control group seems therefore not just questionable but wasteful. Clinical studies absorb resources; even if the author was happy to waste his time, he should not assume that he can freely waste the time, effort and availability of his patients.
Two final points, if I may:
- An observational study of homeopathy for hay-fever without a control group might be utterly useless but it is still an investigation that requires certain things. As far as I can see, this study did not even have ethics approval nor is there a mention of informed consent. Strictly speaking, this makes it an unethical study.
- If we allow research of this nature to take place and be published, we give clinical research a bad name and undermine the confidence of the public in science.
I am puzzled how such a paper could pass peer review and how an Elsevier journal could even consider publishing it.
Informed consent is an essential ethical precondition for any therapeutic intervention. This obviously cannot exclude alternative medicine. Yet, one gets the impression that alternative therapists systematically ignore informed consent. Chiropractors in the UK, for instance, have been shown to often take this issue more than a little light-heartedly.
The General Chiropractic Council (GCC) has issued guidance to its members about informed consent. Here is a passage from their website which I find particularly interesting:
The information you provide to the patient must be clear, accurate and presented in a way that the patient can understand… Patients must be fully informed about their care. You must not rely on a patient to ask questions about their care, the responsibility to fully inform patients about their care lies with you. When discussing with patients the expected outcomes of their care, chiropractors must fully discuss the risks as well as the benefits and explore with the patient what other factors they may see as relevant to making a decision.
When explaining risks, you must provide the patient with clear, accurate and up-to-date information about the risks of the proposed treatment and the risks of any reasonable alternative options, in a way that the patient can understand. You must discuss risks that occur often, those that are serious even if very unlikely and those that a patient is likely to think are important. You must encourage patients to ask questions, so that you can understand whether they have particular concerns that may influence their decision and you must answer honestly.
I have repeatedly written about the fact that, in alternative medicine, informed consent has remained an almost alien concept. Yet, there can be no doubt, it is an ethical imperative in ALL healthcare. The above guideline makes this perfectly clear. Essentially, it proscribes that a chiropractor has to inform each patient who is about to be treated with a spinal manipulation – virtually 100% of all patients consulting chiropractors – that:
- this treatment has not been shown to be effective for non-spinal conditions,
- for back and neck pain, it might help but not better than other conservative therapies,
- in about half of all patients, it leads to mild to moderate adverse effects that typically last 2-3 days and are severe enough to interfere with the patient’s quality of life,
- in an unknown number of patients, it might lead to severe complications, including stroke and death,
- there are other options for your problem that are more effective and/or less harmful.
The chiropractor then has to document the patient’s consent. Only then can he start treatments.
My question to the GCC is: have you tested how many patients would consent under these conditions?
I suspect the answer is No.
And my questions to UK chiropractors is: who is actually following these guidelines?
I suspect the answer is VERY FEW. If that were true, most chiropractors would violate their own ethical guidelines and could therefore be struck of the GCC’s register. Or did I get this wrong?
A 2016 article set out to define the minimum core competencies expected from a certified paediatric doctor of chiropractic using a Delphi consensus process. The initial set of seed statements and sub-statements was modelled on competency documents used by organizations that oversee chiropractic and medical education. The statements were then distributed to the Delphi panel, reaching consensus when 80% of the panelists approved each segment. The panel consisted of 23 specialists in chiropractic paediatrics from across the spectrum of the chiropractic profession. Sixty-one percent of panellists had postgraduate paediatric certifications or degrees, 39% had additional graduate degrees, and 74% were faculty at a chiropractic institution and/or in a postgraduate paediatrics program. The panel was initially given 10 statements with related sub-statements formulated by the study’s steering committee. On all 3 rounds of the Delphi process the panelists reached consensus; however, multiple rounds occurred to incorporate the valuable qualitative feedback received.
The results of this process reveal that the Certified Paediatric Doctor of Chiropractic requires 8 sets of skills. (S)he will …
1) Possess a working knowledge and understanding of the anatomy, physiology, neurology, psychology, and developmental stages of a child. a) Recognize known effects of the prenatal environment, length of the pregnancy, and birth process on the child’s health. b) Identify and evaluate the stages of growth and evolution of systems from birth to adulthood. c) Appraise the clinical implications of developmental stages in health and disease, including gross and fine motor, language/communication, and cognitive, social, and emotional skills. d) Recognize normal from abnormal in these areas. e) Possess an understanding of the nutritional needs of various stages of childhood.
2) Recognize common and unusual health conditions of childhood. a) Identify and differentiate clinical features of common physical and mental paediatric conditions. b) Identify and differentiate evidence-based health care options for these conditions. c) Identify and differentiate clinical features and evidence-based health care options for the paediatric special needs population.
3) Be able to perform an age-appropriate evaluation of the paediatric patient. a) Take a comprehensive history, using appropriate communication skills to address both child and parent/ guardian. b) Perform age-appropriate and case-specific physical, orthopaedic, neurological, and developmental examination protocols. c) When indicated, utilize age-appropriate laboratory, imaging, and other diagnostic studies and consultations, according to best practice guidelines. d) Appropriately apply and adapt these skills to the paediatric special needs population. e) Be able to obtain and comprehend all relevant external health records.
4) Formulate differential diagnoses based on the history, examination, and diagnostic studies.
5) Establish a plan of management for each child, including treatment, referral to, and/or co-management with other health care professionals. a) Use the scientific literature to inform the management plan. b) Adequately document the patient encounter and management plan. c) Communicate management plan clearly (written, oral, and nonverbal cues) with both the child and the child’s parent/guardian. d) Communicate appropriately and clearly with other professionals in the referral and co-management of patients.
6) Deliver skilful, competent, and safe chiropractic care, modified for the paediatric population, including but not limited to: a) Manual therapy and instrument-assisted techniques including manipulation/adjustment, mobilization, and soft tissue therapies to address articulations and/or soft tissues. b) Physical therapy modalities. c) Postural and rehabilitative exercises. d) Nutrition advice and supplementation. e) Lifestyle and public health advice. f) Adapt the delivery of chiropractic care for the paediatric special needs population.
7) Integrate and collaborate with other health care providers in the care of the paediatric patient. a) Recognize the role of various health care providers in paediatric care. b) Utilize professional inter-referral protocols. c) Interact clearly and professionally as needed with health care professionals and others involved in the care of each patient. d) Clearly explain the role of chiropractic care to professionals, parents, and children.
8) Function as a primary contact, portal of entry practitioner who will. a) Be proficient in paediatric first aid and basic emergency procedures. b) Identify and report suspected child abuse.
9) Demonstrate and utilize high professional and ethical standards in all aspects of the care of paediatric patients and professional practice. a) Monitor and properly reports of effects/adverse events. b) Recognize cultural individuality and respect the child’s and family’s wishes regarding health care decisions. c) Engage in lifelong learning to maintain and improve professional knowledge and skills. d) Contribute when possible to the knowledge base of the profession by participating in research. e) Represent and support the specialty of paediatrics within the profession and to the broader healthcare and lay communities.
I find this remarkable in many ways. Let us just consider a few items from the above list of competencies:
Identify and differentiate evidence-based health care options… such options would clearly not include chiropractic manipulations.
Identify and differentiate clinical features and evidence-based health care options for the paediatric special needs population… as above. Why is there no mention of immunisations anywhere?
Perform age-appropriate and case-specific physical, orthopaedic, neurological, and developmental examination protocols. If that is a competency requirement, patients should really see the appropriate medical specialists rather than a chiropractor.
Establish a plan of management for each child, including treatment, referral to, and/or co-management with other health care professionals. The treatment plan is either evidence-based or it includes chiropractic manipulations.
Deliver skilful, competent, and safe chiropractic care… Aren’t there contradictions in terms here?
Manual therapy and instrument-assisted techniques including manipulation/adjustment, mobilization, and soft tissue therapies to address articulations and/or soft tissues. Where is the evidence that these treatments are effective for paediatric conditions, and which conditions would these be?
Clearly explain the role of chiropractic care to professionals, parents, and children. As chiropractic is not evidence-based in paediatrics, the role is extremely limited or nil.
Function as a primary contact, portal of entry practitioner… This seems to me as a recipe for disaster.
Demonstrate and utilize high professional and ethical standards in all aspects of the care of paediatric patients… This would include obtaining informed consent which, in turn, needs to include telling the parents that chiropractic is neither safe nor effective and that better therapeutic options are available. Moreover, would it not be ethical to make clear that a paediatric ‘doctor’ of chiropractic is a very far cry from a real paediatrician?
So, what should the competencies of a chiropractor really be when it comes to treating paediatric conditions? In my view, they are much simpler than outlined by the authors of this new article: I SEE NO REASON WHATSOEVER WHY CHIROPRACTORS SHOULD TREAT CHILDREN!
