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

informed consent

The World Federation of Chiropractic (WFC) claim to have been at the forefront of the global development of chiropractic. Representing the interests of the profession in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions. Now, the WFC have formulated 20 principles setting out who they are, what they stand for, and how chiropractic as a global health profession can, in their view, impact on nations so that populations can thrive and reach their full potential. Here are the 20 principles (in italics followed by some brief comments by me in normal print):

1. We envision a world where people of all ages, in all countries, can access the benefits of chiropractic.

That means babies and infants! What about the evidence?

2. We are driven by our mission to advance awareness, utilization and integration of chiropractic internationally.

One could almost suspect that the drive is motivated by misleading the public about the risks and benefits of spinal manipulation for financial gain.

3. We believe that science and research should inform care and policy decisions and support calls for wider access to chiropractic.

If science and research truly did inform care, it would soon be chiropractic-free.

4. We maintain that chiropractic extends beyond the care of patients to the promotion of better health and the wellbeing of our communities.

The best example to show that this statement is a politically correct platitude is the fact that so many chiropractors are (educated to become) convinced that vaccinations are undesirable or harmful.

5. We champion the rights of chiropractors to practice according to their training and expertise.

I am not sure what this means. Could it mean that they must practice according to their training and expertise, even if both fly in the face of the evidence?

6. We promote evidence-based practice: integrating individual clinical expertise, the best available evidence from clinical research, and the values and preferences of patients.

So far, I have seen little to convince me that chiropractors care a hoot about the best available evidence and plenty to fear that they supress it, if it does not enhance their business.

7. We are committed to supporting our member national associations through advocacy and sharing best practices for the benefit of patients and society.

Much more likely for the benefit of chiropractors, I suspect.

8. We acknowledge the role of chiropractic care, including the chiropractic adjustment, to enhance function, improve mobility, relieve pain and optimize wellbeing.

Of course, you have to pretend that chiropractic adjustments (of subluxations) are useful. However, evidence would be better than pretence.

9. We support research that investigates the methods, mechanisms, and outcomes of chiropractic care for the benefit of patients, and the translation of research outcomes into clinical practice.

And if it turns out to be to the detriment of the patient? It seems to me that you seem to know the result of the research before you started it. That does not bode well for its reliability.

10. We believe that chiropractors are important members of a patient’s healthcare team and that interprofessional approaches best facilitate optimum outcomes.

Of course you do believe that. Why don’t you show us some evidence that your belief is true?

11. We believe that chiropractors should be responsible public health advocates to improve the wellbeing of the communities they serve.

Of course you do believe that. But, in fact, many chiropractors are actively undermining the most important public health measure, vaccination.

12. We celebrate individual and professional diversity and equality of opportunity and represent these values throughout our Board and committees.

What you should be celebrating is critical assessment of all chiropractic concepts. This is the only way to make progress and safeguard the interests of the patient.

13. We believe that patients have a fundamental right to ethical, professional care and the protection of enforceable regulation in upholding good conduct and practice.

The truth is that many chiropractors violate medical ethics on a daily basis, for instance, by not obtaining fully informed consent.

14. We serve the global profession by promoting collaboration between and amongst organizations and individuals who support the vision, mission, values and objectives of the WFC.

Yes, those who support your vision, mission, values and objectives are your friends; those who dare criticising them are your enemies. It seems far from you to realise that criticism generates progress, perhaps not for the WFC, but for the patient.

15. We support high standards of chiropractic education that empower graduates to serve their patients and communities as high value, trusted health professionals.

For instance, by educating students to become anti-vaxxers or by teaching them obsolete concepts such as adjustment of subluxation?

16. We believe in nurturing, supporting, mentoring and empowering students and early career chiropractors.

You are surpassing yourself in the formulation of platitudes.

17. We are committed to the delivery of congresses and events that inspire, challenge, educate, inform and grow the profession through respectful discourse and positive professional development.

You are surpassing yourself in the formulation of platitudes.

18. We believe in continuously improving our understanding of the biomechanical, neurophysiological, psychosocial and general health effects of chiropractic care.

Even if there are no health effects?!?

19. We advocate for public statements and claims of effectiveness for chiropractic care that are honest, legal, decent and truthful.

Advocating claims of effectiveness in the absence of proof of effectiveness is neither honest, legal, decent or truthful, in my view.

20. We commit to an EPIC future for chiropractic: evidence-based, people-centered, interprofessional and collaborative.

And what do you propose to do with the increasing mountain of evidence suggesting that your spinal adjustments are not evidence-based as well as harmful to the health and wallets of your patients?

________________________________________________________________

What do I take out of all this? Not a lot!

Perhaps mainly this: the WFC is correct when stating that, in the interests of the profession in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions. What is missing here is a small but important addition to the sentence: in the interests of the profession and against the interest of patients, consumers or public health in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions.

Another presentation from the 2nd OFFICIAL SIPS CONFERENCE ON PLACEBO STUDIES caught my eye. As it is not available on-line, I have copied here the unabbreviated abstract:

Open-label placebo vs. conventional and alternative medicine – An online study on expected effectiveness 1. Marcel Wilhelm. Philipps-University Marburg, Marburg, Germany. 2. Winfried Rief. Philipps-University Marburg, Marburg, Germany. 3. Frank Euteneuer. Medical School Berlin, Berlin, Germany.

Background: Treatment expectations are a key mechanism in placebo effects. Optimizing these expectations is a main goal in placebo designs but is often based on deception. To address ethical concerns, open-label placebo treatments seem to be effective without deception, although the role of expectations for their effect is rather unclear. Methods: Participants (N=253) who occasionally suffer from headaches were recruited online and randomized to receive one of three hypothetical descriptions of a doctor-patient-situation in which a certain headache treatment is prescribed: 1) conventional medicine, 2) open-label placebo, 3) alternative medicine (homeopathy). Subsequently, participants rated how strongly they expect that the given treatment can be effective. Results: One-way ANOVA revealed differences in expected effectiveness between groups. The highest expected effectiveness occurred in the conventional medicine group, the lowest in the open-label placebo group as well as in the homeopathy group. Potential moderators are discussed, e.g., socioeconomic variables, health literacy, locus of control. Conclusions: Participants expect lower effectiveness of treatment if they are truthfully informed about the inertness of a prescribed treatment (open-label placebo). While the descriptions were otherwise identical, the homeopathy group also scored lower levels of expectancy compared to conventional medicine. Homeopathy can be interpreted as a placebo prescription with deception as it does not contain pharmacologically active substances. The expected effectiveness in the homeopathy group did not differ from open-label placebo. These results suggest that prescribing a placebo while truthfully informing about placebo effects seems to be as feasible as to prescribe homeopathy regarding the expected effectiveness.

I am not sure what these results indicate. However, the fact that the authors describe homeopathy as a ‘placebo prescription with deception’ is definitely interesting.

I wonder whether homeopaths agree.

An article in the ‘Chronicle of Chiropractic’ defends the currently much debated chiropractic care for children. It is authored by ‘ChiroFuture‘, a Risk Purchasing Group founded by chiropractors. Here is the unabridged article (the references were added by me and refer to my comments below):

The chiropractic care of children has been the subject of increased media attention and scrutiny following decisions by chiropractic regulatory boards in Europe, Australia and Canada. These decisions were not based on science, research or data but rather a purposeful misrepresentation of the concept of evidence informed practice (1) and its application coupled with compelled speech.

As with the chiropractic care of adults, an evidence informed perspective (2) respects the needs and wants of parents for the care of their child, the published research evidence and the clinical expertise of chiropractors in the care of children.

ChiroFutures Malpractice Program does not base its malpractice insurance rates on the age of the patients a chiropractor sees.  In fact, we are not aware of any actuarial data showing an increase in adverse events from the tens of millions of pediatric chiropractic visits per year (3). The vast majority of claims or incidents alleging chiropractic negligence involve adult patients (4).

What chiropractors do is minimally invasive and typically nothing else but their hands are used to gently ease any obstruction to the functioning of the patient’s nervous system (5). Since the nervous system controls and coordinates all functions of the body it is important to be sure it is functioning as best it can with no obstructions and no matter the disease afflicting the patient.

State and provincial laws, federal governments, international, national and state chiropractic organizations and chiropractic educational institutions all support the role and responsibility of chiropractors in the management of children’s health (6). The rationale for chiropractic care of children is supported by published protocols that are safe, efficacious, and valid (7). The scientific literature is sufficiently supportive of the usefulness of these protocols in regard to the chiropractic care of children (8).

Those contending that there is no evidence supporting the safety and efficacy of the chiropractic care of children demonstrate a complete disregard for the evidence and scientific facts related to the chiropractic care of children (9).

ChiroFutures encourages and supports a shared decision making process between doctors (10) and patients regarding health needs. As a part of that process, patients have a right to be informed about the state of their health as well as the risks, benefits and alternatives related to care. Any restriction on that dialogue or compelled statements inconsistent with the doctrine of informed consent present a threat to public health (11).

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Here are my comments:

  1. Why ‘evidence informed’ and not evidence-based’? The term ‘evidence informed’ is popular with SCAM practitioners. Barratt and Hodson noted, “The evidence-informed practitioner carefully considers what research evidence tells them in the context of a particular child, family or service, and then weighs this up alongside knowledge drawn from professional experience and the views of service users to inform decisions about the way forward.”  This seems to imply that the two terms are synonymous. However, in reality they are not.
  2. Does that mean that ‘evidence-informed’ is defined as the practice wanted by patients, regardless of the evidence?
  3. There is no post-marketing surveillance in chiropractic. Therefore we do not have reliable data on adverse events.
  4. That might be true but it is unclear what it tells us. It might simply mean that chiropractors treat more adults than children.
  5. There is no good evidence to show that the function of the nervous system can be enhanced by manual therapy.
  6. Provincial laws and federal governments might tolerate but I don’t think they ‘support’ the role and responsibility of chiropractors. That chiropractic organisations support it surprises nobody.
  7. This sentence does not make sense to me. The facts, however, are clear: there is no sound rational for chiropractic manipulations and they are neither efficacious nor totally safe for children.
  8. The scientific evidence does not show that chiropractic care is effective for any paediatric condition.
  9. I think the complete disregard is shown not by critics but by the authors of these lines.
  10. Calling chiropractors ‘doctors’ gives the impression they have  been to medical school and is therefore misleading the public.
  11. The threat to public health are those chiropractors who advise parents not to immunise their children.

Perhaps ChiroFuture need to brush up on their knowledge of the evidence. Chiropractic has no place in the healthcare of children. Parents should be warned!

As most of us know, the use of so-called alternative medicine (SCAM) can be problematic; its use in children is often most problematic:

In this context, the statement from the ‘Spanish Association Of Paediatrics Medicines Committee’ is of particular value and importance:

Currently, there are some therapies that are being practiced without adjusting to the available scientific evidence. The terminology is confusing, encompassing terms such as “alternative medicine”, “natural medicine”, “complementary medicine”, “pseudoscience” or “pseudo-therapies”. The Medicines Committee of the Spanish Association of Paediatrics considers that no health professional should recommend treatments not supported by scientific evidence. Also, diagnostic and therapeutic actions should be always based on protocols and clinical practice guidelines. Health authorities and judicial system should regulate and regularize the use of alternative medicines in children, warning parents and prescribers of possible sanctions in those cases in which the clinical evolution is not satisfactory, as well responsibilities are required for the practice of traditional medicine, for health professionals who act without complying with the “lex artis ad hoc”, and for the parents who do not fulfill their duties of custody and protection. In addition, it considers that, as already has happened, Professional Associations should also sanction, or at least reprobate or correct, those health professionals who, under a scientific recognition obtained by a university degree, promote the use of therapies far from the scientific method and current evidence, especially in those cases in which it is recommended to replace conventional treatment with pseudo-therapy, and in any case if said substitution leads to a clinical worsening that could have been avoided.

Of course, not all SCAM professions focus on children. The following, however, treat children regularly:

  • acupuncturists
  • anthroposophical doctors
  • chiropractors
  • craniosacral therapists
  • energy healers
  • herbalists
  • homeopaths
  • naturopaths
  • osteopaths

I believe that all SCAM providers who treat children should consider the above statement very carefully. They must ask themselves whether there is good evidence that their treatments generate more good than harm for their patients. If the answer is not positive, they should stop. If they don’t, they should realise that they behave unethically and quite possibly even illegally.

The three-year old Noah was diagnosed with acute lymphoblastic leukaemia, a blood cancer with a very good prognosis when treated (~85% of all children affected can be completely cured and expect to live a normal life). The child was admitted to hospital and, initially, chemotherapy was started. But the treatment was not finished, because the parents took their child home prematurely. The mother, a 22-year-old ‘holistic birth attendant’, had been against conventional treatments from the start. She nevertheless agreed to the first two rounds of chemotherapy — “because they can get a medical court order to force you to do it anyways for a child with his diagnosis”.

Noah’s parent treated their sons with a number of home remedies:

  • Rosemary,
  • colloidal silver,
  • Reishi mushroom tea,
  • Apricot seeds,
  • and other forms of SCAM.

After the child had gone missing, the police issued an alert:

“On April 22, 2019 the parents failed to bring in the child to a medically necessary hospital procedure. The parents have further refused to follow up with the life saving medical care the child needs.”

In a matter of hours, the parents and their child were found. Noah was then taken from his parents and was “now being medically treated,” the sheriff’s office stated. The parents, meanwhile, were being investigated on suspicion of child neglect.

They insist that they were merely trying to give their son alternative medical care, accusing the police and medical officials of stripping them of the right to choose their own treatment plan for their son. Their supporters call the state’s decision to take custody of Noah a “medical kidnapping”. Medical kidnapping is defined as the State taking away children from their parents so that the children can receive medical or surgical care which the parents would otherwise not allow to be administered.

“We’re not trying to refuse any kind of treatment,” the parents told reporters. “They think we’re refusing treatment all around, putting him in danger, trying to kill him. But not at all. We’re trying to save him.” An organization fighting on behalf of the parents, the Florida Freedom Alliance, which also supports “vaccine freedom,” argues that the couple should be entitled to “medical freedom” and freedom from “medical kidnappings.”

Who is right and who is wrong?

Are medical kidnappings legal?

I am, of course, not sure about the legalities. But I am fairly certain about the evidence in the above case:

  1. Noah’s condition is treatable, and in all likelihood he would be cured, if treated according to current oncological standards. This view was also confirmed by the oncologist who is in charge of treating him in hospital.
  2. None of the treatments mentioned by the parents are effective. In fact, alternative cancer cures are a myth; they do not exist and they will never exist. Once a treatment shows promise, it would be scientifically investigated. And, if the results are positive, it would become mainstream quicker than I can climb a tree.

Ethically Noah’s case could not be clearer: the child’s life must be saved, whether with the support of his parents or not. However strongly parents might feel about their under-age kids’ care, they do not own their children and must not be allowed to cause them significant harm.

In 1995, Dabbs and Lauretti reviewed the risks of cervical manipulation and compared them to those of non-steroidal, anti-inflammatory drugs (NSAIDs). They concluded that the best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. This article must be amongst the most-quoted paper by chiropractors, and its conclusion has become somewhat of a chiropractic mantra which is being repeated ad nauseam. For instance, the American Chiropractic Association states that the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation.

As far as I can see, no further comparative safety-analyses between cervical manipulation and NSAIDs have become available since this 1995 article. It would therefore be time, I think, to conduct new comparative safety and risk/benefit analyses aimed at updating our knowledge in this important area.

Meanwhile, I will attempt a quick assessment of the much-quoted paper by Dabbs and Lauretti with a view of checking how reliable its conclusions truly are.

The most obvious criticism of this article has already been mentioned: it is now 23 years old, and today we know much more about the risks and benefits of these two therapeutic approaches. This point alone should make responsible healthcare professionals think twice before promoting its conclusions.

Equally important is the fact that we still have no surveillance system to monitor the adverse events of spinal manipulation. Consequently, our data on this issue are woefully incomplete, and we have to rely mostly on case reports. Yet, most adverse events remain unpublished and under-reporting is therefore huge. We have shown that, in our UK survey, it amounted to exactly 100%.

To make matters worse, case reports were excluded from the analysis of Dabbs and Lauretti. In fact, they included only articles providing numerical estimates of risk (even reports that reported no adverse effects at all), the opinion of exerts, and a 1993 statistic from a malpractice insurer. None of these sources would lead to reliable incidence figures; they are thus no adequate basis for a comparative analysis.

In contrast, NSAIDs have long been subject to proper post-marketing surveillance systems generating realistic incidence figures of adverse effects which Dabbs and Lauretti were able to use. It is, however, important to note that the figures they did employ were not from patients using NSAIDs for neck pain. Instead they were from patients using NSAIDs for arthritis. Equally important is the fact that they refer to long-term use of NSAIDs, while cervical manipulation is rarely applied long-term. Therefore, the comparison of risks of these two approaches seems not valid.

Moreover, when comparing the risks between cervical manipulation and NSAIDs, Dabbs and Lauretti seemed to have used incidence per manipulation, while for NSAIDs the incidence figures were bases on events per patient using these drugs (the paper is not well-constructed and does not have a methods section; thus, it is often unclear what exactly the authors did investigate and how). Similarly, it remains unclear whether the NSAID-risk refers only to patients who had used the prescribed dose, or whether over-dosing (a phenomenon that surely is not uncommon with patients suffering from chronic arthritis pain) was included in the incidence figures.

It is worth mentioning that the article by Dabbs and Lauretti refers to neck pain only. Many chiropractors have in the past broadened its conclusions to mean that spinal manipulations or chiropractic care are safer than drugs. This is clearly not permissible without sound data to support such claims. As far as I can see, such data do not exist (if anyone knows of such evidence, I would be most thankful to let me see it).

To obtain a fair picture of the risks in a real life situation, one should perhaps also mention that chiropractors often fail to warn patients of the possibility of adverse effects. With NSAIDs, by contrast, patients have, at the very minimum, the drug information leaflets that do warn them of potential harm in full detail.

Finally, one could argue that the effectiveness and costs of the two therapies need careful consideration. The costs for most NSAIDs per day are certainly much lower than those for repeated sessions of manipulations. As to the effectiveness of the treatments, it is clear that NSAIDs do effectively alleviate pain, while the evidence seems far from being conclusively positive in the case of cervical manipulation.

In conclusion, the much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim.

 

The researcher who proves that highly diluted homeopathics work beyond placebo might be in for a Nobel Prize. The scientist who finds a cure for addictions probably also deserves one. The investigator who does both might get two Nobels. The question is, do these Brazilian homeopaths fulfil these criteria?

Their study investigated the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting. A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence. The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group). The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were recorded in both groups.

The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% compared to 29.8% in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients’ appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group.

The authors concluded that a psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention.

I am glad that the authors mention the high dropout rate which clearly is a serious limitation of this fascinating trial. Had they analysed the data according to an intention to treat analysis – which, I think, would have been a better statistical approach – the results would almost certainly have been negative.

But there are other puzzling issues about this study:

  • The authors say they used homeopathic remedies. I think, however, that this is not the case. Homeopathy is defined as a therapy that follows the ‘like cures like’ principle. If the remedy is based on the causative agent, as in the case of the present study, it follows a different principle (identical cures identical) and is not called homeopathy but isopathy (here an explanation from my book: “Isopathy is the use of potentised remedies which are derived from the causative agent of the disease that is being treated. It thus does not follow the supreme law of homeopathy; instead of ‘like cures like’, instead it postulates that identical cures identical. An example of isopathy is the use of potentised grass pollen to treat patients suffering from hay fever. Some of the methodologically best trials that generated a positive result were done using isopathy; they therefore did not test homeopathy and its principal assumption, the ‘like cures like’ theory. They are nevertheless regularly used by proponents of homeopathy to argue that homeopathy is effective”). This means that the above trial does, in fact, NOT test the defining principle of homeopathy.
  • Moreover, I fail to understand why the authors called their trial a PILOT study. It does not explore the feasibility of a more definitive trial, but tests the effectiveness of the intervention. It is thus NOT a pilot study.
  • I cannot help being suspicious of authors who, based on an extremely implausible, such as homeopathy, publish one paper after the next with positive or encouraging results.
  • I am also puzzled by the fact that, in 2012 and 2013, the authors have published two previous studies along the same lines that produced encouraging results. Surely 6/5 years are a long enough period for INDEPENDENT replications to be carried out and published. And surely, a finding like this would have been replicated several times by now.
  • I furthermore find it odd that the authors chose to publish their findings in the JOURNAL OF INTEGRATIVE MEDICINE. This is a 3rd class journal read only by those who promote alternative therapies. The notion that a treatment of addiction has finally be found should appear in journals like SCIENCE, NATURE, NEJM, etc.
  • Considering the extremely low prior probability of their hypothesis, the authors should perhaps have not used the conventional 5% probability threshold, but one two dimensions lower.
  • I have not found a statement regarding informed consent of the study participants.

So, are these Brazilian homeopaths likely to be on the next list of Nobel laureates?

I have my doubts.

What do you think?

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?

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