MD, PhD, FMedSci, FSB, FRCP, FRCPEd

medical ethics

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Medical ethics comprise a set of rules and principles which are essential for all aspects of medicine, including of course research. The main issues are:

  • Respect for autonomy – patients must have the right to refuse or choose their treatments.
  • Beneficence – researchers and clinicians must act in the best interest of the patient.
  • Non-maleficence – the expected benefits of interventions must outweigh their risks.
  • Justice – the distribution of health resources must be fair.
  • Respect for persons – patients must be treated with dignity.
  • Truthfulness and honesty – informed consent is an essential element in research and clinical practice.

While all of this has long been fairly standard in conventional health care, it is often neglected in alternative medicine. It is therefore timely to ask, how much of research in the realm of alternative medicine abides by the rules of medical ethics?

After more than two decades of involvement in this sector, I have serious and growing concerns. The subject is, of course complex, but the way I see it, in alternative medicine there are two main areas where medical ethics are violated with some regularity.

  1. Nonsensical research projects
  2. Lack of informed consent

NONSENSICAL RESEARCH PROJECTS

At best, nonsensical research is a waste of precious resources, at worst it violates the beneficence principle. In alternative medicine, nonsensical research seems to happen ad nauseam. Regular readers of this blog will have seen plenty of examples of such abuse – for instance, if researchers conduct a clinical trial of chiropractic spinal manipulation for improving the singing voices of choir singers, or homeopaths test whether their remedies enhance female fertility. Often, nonsensical research happens when naïve enthusiasts decide to dabble a bit in science in order to promote their trade – but without realising that research would require a minimum of education.

But there are other occasions when it seems that the investigators know only too well what they are doing. Take for instance the plethora of ‘pragmatic’ trials which are currently so much ‘en vogue’ in alternative medicine. They can be designed in such a way that their results must produce what the researchers intended to show; the ‘A+B versus B’ study design is a prominent and obvious example of this type of abuse which I have repeatedly written about on this blog.

I use the term ‘abuse’ intentionally, because that is precisely what it is, in my view. Nonsensical research abuses the willingness of patients to participate by misleading them that it is a worthwhile sacrifice. In reality it is an unethical attempt to generate findings that can mislead us all. Moreover, it gives science a bad name and can lead to patients’ unwillingness to take part in research that does need doing. The damage done by nonsensical research projects is therefore immeasurable.

INFORMED CONSENT

Informed consent is essential in research for protecting the interests of the volunteering patients. When a clinical trial is first conceived, the researchers need to work out all the details, write a protocol and submit it to their ethics committee. Their submission has to give evidence that all the participating patients have given informed consent in writing before they are enrolled into the study. That means, they have to be told the essential details about what might happen to them during the trial.

In a placebo-controlled trial of homeopathy, for instance, they might be told that they will receive either a homeopathic remedy or a placebo during the study period. They might also be informed that there is some encouraging evidence that the former works, and that the trial is designed to define to what extend this is so. Generating this knowledge, they might further be told, will help future patients and will be an important contribution to improving health care. Based on such phraseology, the ethics committee is likely to allow the study to go ahead, and patients are likely to agree to take part.

But, of course, this information is less than truthful. An honest and full information for patients would need to include the following points:

  • you will receive either a homeopathic remedy or a placebo,
  • the former contains no active molecules and the totality of the most reliable evidence does not show that it works for your condition,
  • this means that you will receive either a homeopathic or a conventional placebo,
  • neither of these can possibly help your condition,
  • the study can therefore not advance our knowledge in any way,
  • during the trial your condition will remain untreated which is likely to increase your suffering unnecessarily.

If any research team would truthfully disclose this information, no ethics committee would pass their protocol. If by some weird mistake they did, no patients would volunteer to participate in the study.

I have chosen here the example of homeopathy (because most readers will understand it quite easily), but I could have used almost any other alternative treatment. The issues are identical or very similar: informed consent is usually misinformed consent. If it were fully and truthfully informed, it would neither pass the hurdle of the essential ethics approval nor would it lend itself to recruiting sufficiently large numbers of patients.

CONCLUSION

There are, I think, very serious concerns about the ethical standards in alternative medicine research. I have been banging on about these issues since many years (for instance here and here and here and here). Predictably, this did not find much resonance in the realm of alternative medicine. Regrettably, very few ethicists have so far taken this subject seriously; they seem to feel that these problems are trivial compared to the important issues medical ethics face in conventional health care. I remain unconvinced that this is true and believe it is high time to systematically address the ethics of alternative medicine.

Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:

The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).

Conclusions

Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.

Let us be clear about what has happened here. I think, the events can be summarised as follows:

  • the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
  • they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
  • the question raises, what should the researchers give to the control group?
  • someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
  • the researchers are impressed and ask: but what precisely could we use?
  • let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
  • another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
  • the team is in agreement,
  • Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
  • a protocol is written,
  • ethics approval is obtained,
  • the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.

And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.

BOB’S YOUR UNCLE!

EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.

When I come across a study with the aim to “examine the effectiveness of acupuncture to relieve symptoms commonly observed in patients in a hospice program” my hopes are high. When I then see that its authors are from the ‘New England School of Acupuncture’, the ‘All Care Hospice and the ‘Tufts University School of Medicine, Boston, my hopes for a good piece of science are even higher. So, let’s see what this new paper has to offer.

A total of 26 patients participated in this acupuncture ‘trial’, receiving a course of weekly treatments that ranged from 1 to 14 weeks. The average number of treatments was five. The Edmonton Symptom Assessment Scale (ESAS) was used to assess the severity of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and dyspnoea. A two-tailed, paired t test was applied to the data to compare symptom scores pre- versus post-acupuncture treatment. Patients enrolled in All Care Hospice’s home care program were given the option to receive acupuncture to supplement usual care offered by the hospice team. Treatment was provided by licensed acupuncturists in the patient’s place of residence.

The results indicated that 7 out of 9 symptoms were significantly improved with acupuncture, the exceptions being drowsiness and appetite. Although the ESAS scale demonstrated a reduction in symptom severity post-treatment for both drowsiness and appetite, this reduction was not found to be significant.

At tis stage, I have lost most of my hopes for good science. This is not a ‘trial’ but a glorified case-series. There is no way that the stated aim can be pursued with this type of methodology. There is no reason whatsoever to assume that the observed outcome can be attributed to acupuncture; the additional attention given to these patients is but one of several factors that are quite sufficient to explain their symptomatic improvements.

This is yet another disappointment then from the plethora of ‘research’ into alternative medicine that, on closer inspection, turns out to be little more than thinly disguised promotion of quackery. These days, I can bear such disappointments quite well – after all, I had many years to get used to them. What I find more difficult to endure is the anger that overcomes me when I read the authors’ conclusion: Acupuncture was found to be effective for the reduction and relief of symptoms that commonly affect patient QOL. Acupuncture effectively reduced symptoms of pain, tiredness, nausea, depression, anxiety, and shortness of breath, and enhanced feelings of well-being. More research is required to assess the long-term benefits and symptom reduction of acupuncture in a palliative care setting.

This is not disappointing; in my view, this is scientific misconduct by

  • the authors,
  • the institutions employing the authors,
  • the ethics committee that has passed the ‘research’,
  • the sponsors of the ‘research’,
  • the peer-reviewers of the paper,
  • the journal and its editors responsible for publishing this paper.

The fact that this sort of thing happens virtually every day in the realm of alternative medicine does not render this case less scandalous, it merely makes it more upsetting.

One of the questions that I hear regularly is: ‘What happened to your research unit at Exeter?’ Therefore it might be a good idea to put the full, shameful story on this blog.

After the complaint by Prince Charles’ secretary to my Vice Chancellor alleging that I had breached confidentiality over the Smallwood report, my University conducted a 13 months investigation into my actions. At the end of it, I was declared innocent as charged (it should have been clear from a 10 minute discussion that I had done nothing wrong: I had not disclosed any information from the report, and even if I had, it would have been a matter of public interest and medical ethics to blow the whistle. However, the Vice Chancellor never once bothered to talk to me.). Subsequently, all support that I had once enjoyed broke down, my staff’s contracts were terminated, and I eventually had to take early retirement (full details of this part of the story can be found in ‘A SCIENTIST IN WONDERLAND’).

A few months later, a new dean was appointed at my medical school. The new man seemed to have a lot more understanding for my situation than his predecessor. Provided that I accept to go into early retirement, he offered to re-employ me for one year (half time) to help him find a successor for my position.

I did accept because, above everything, I wanted to prevent the closure of my unit. We then developed criteria for advertising the post and conducted two rounds of advertisements. Several candidates applied but none them seemed suited in our view. Eventually we did find several experts who were promising; one even came to Exeter from abroad and had detailed talks with the dean and several other people.

However, Exeter was unwilling to equip my potential successor with any funds to speak of. The suggestion was to appoint the new chair with the onus to raise all the necessary funds himself. This is a proposition that no well-qualified academic at the professorial level can possibly find attractive. Consequently, the candidates all declined.

Meanwhile, there had been an initiative by several altruistic UK public figures and friends to raise funds for the new chair and thus save my unit from closure. Sadly, however, these activities did not generate in the necessary cash. When my year of half-time re-employment had expired, I left Exeter and my unit disappeared for good.

To the present day, I am not at all sure what the true intentions of Exeter had been during this final stage.

  • Was I offered re-employment simply to keep me sweet?
  • Did they fear that I would otherwise sue them or cause a public scandal?
  • Did they truly believe they could find a suitable successor?
  • If so, why did they not put up the money?

I do not expect to ever find conclusive answers for any of these questions. However, I do know what, in an ideal world, should have become of my unit. If it had been for me to decide, I would have equipped the chair with the necessary core funds and appointed an ethicist with a documented interest in alternative medicine as the new professor. I see two main reasons for this perhaps less than obvious choice:

  • In my experience, Exeter would greatly benefit from an ethicist to give them guidance on a range of matters.
  • After two decades of being involved in alternative medicine research, I have become convinced that this field foremost needs the input of a critical ethicist.

In case either of these last two statements puzzles you, I recommend you read ‘A SCIENTIST IN WONDERLAND’.

Sanevax is a US organisation that claims to promote only Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine. Our primary goal is to provide the information necessary for you to make informed decisions regarding your health and well-being. We also provide referrals to helpful resources for those unfortunate enough to have experienced vaccine-related injuries. Recently they seem to have become active in the UK as well; even in my rural neck of the woods, I found a poster that claimed the following:

The side effects experienced by some girls [following HPV vaccination] have been severe and long lasting and include:

  • persistent headaches
  • persistent sore throat
  • ME
  • problems with eyes and vision
  • muscle aches
  • muscle weaknesses/twitches
  • numbness of limbs
  • pins and needles/tingling
  • joint pains
  • chest pains
  • breathing problems
  • racing heart or palpitations
  • sensitive to light or noise
  • cold hands and feet
  • abdominal pain
  • skin problems and rashes
  • memory impairment
  •  concentration problems
  • difficulty multi-tasking
  • difficulty taking in information
  • dizziness
  • fainting
  • postural orthostatic tachycardia syndrome
  • seizures
  • persistent nausea and vomiting
  • acid reflux
  • new allergies
  • menstrual problems/ changes to menstrual cycle
  • difficulty regulating body temperature
  • excessive sweating
  • frequent urination
  • insomnia or change of body clock
  • autoimmune diseases, e. g. autoimmune encephalitis. Raynaud’s disease, rheumatoid arthritis, thyroid.

Scary? Yes, I think so – I am always afraid of people who write about health and think that THYROID is a side effect!

Elsewhere the connection to alternative medicine becomes more obvious and the mission of Sanevax gets a little clearer. However, the claims are similar:

The most common side effects of HPV vaccines are pain, swelling, itching, bruising and redness at the injection site, headache, fever, nausea, dizziness, vomiting and fainting.

The following side effects are less common, but more dangerous:

*Difficulty breathing, shortness of breath or wheezing (bronco spasm)
*Hives and/or rash
*Swollen glands (neck, armpit, or groin)
*Joint, leg, or chest pain
*Unusual tiredness, weakness, lethargy, brain fog, or confusion
*Chills
*Generally feeling unwell
*Aching muscles and/or muscle weakness
*Difficulty keeping food down, vomiting or stomach ache
*Seizures
*Shortness of breath
*Chest pain
*Bad stomach pain
*Skin infection
*Bleeding or bruising more easily than normal

This list is by no means comprehensive; it is taken directly from HPV patient Product Information inserts. Many young girls from around the world have experienced many more severe events after HPV vaccination. For the health and safety of the children in your care, please be alert to any changes in your student’s health and behavior post-vaccination.

Should a student experience any of the less common side effect symptoms even months after vaccination, please alert their parents to the possibility that the student may be exhibiting a vaccine reaction, so they can consult their physician for proper medical care.

Now I am not just scared, I am positively alarmed. This makes the HPV vaccine look like something to be avoided at all cost. In this state of alarm, I do a quick search for published evidence. My findings make me concerned again – this time not about the vaccination but about Sanevax. The Sanevax text is in stark contradiction to the published information on this issue. The most recent article I could find stated that serious adverse events such as adverse pregnancy outcomes, autoimmune diseases (including Guillain-Barre Syndrome and multiple sclerosis), anaphylaxis, venous thromboembolism, and stroke, were extensively studied, and no increase in the incidence of these events was found compared with background rates.

This makes me wonder, who is trying to mislead us here? Are we duped into ignorance by scientists bought by BIG PHARMA, or should we perhaps re-name ‘Sanevax’ into INSANE ANTI-VAX?

I think I know the answer, but I would like to hear your views.

For ‘my’ journal FACT, I review all the new articles that have emerged on the subject of alternative medicine on a monthly basis. Here are a few impressions and concerns that this activity have generated:

  • The number of papers on alternative medicine has increased beyond belief: between the year 2000 and 2010, there was a slow, linear increase from 335 to 610 Medline-listed articles; thereafter, the numbers exploded to 1189 (2011), 1674 (2012) and 2236 (2013).
  • This fast growing and highly lucrative ‘market’ has been cornered mainly by one journal: ‘EVIDENCE BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE’ (EBCAM), a journal that I mentioned several times before (see here, for instance). In 2010, EBCAM published 76 papers, while these figures increased to 546, 880 and 1327 during the following three years.
  • Undeniably, this is big business, as authors have to pay tidy sums each time they get published in EBCAM.
  • The peer-review system of EBCAM is farcical: potential authors who send their submissions to EBCAM are invited to suggest their preferred reviewers who subsequently are almost invariably appointed to do the job. It goes without saying that such a system is prone to all sorts of serious failures; in fact, this is not peer-review at all, in my opinion, it is an unethical sham.
  • As a result, most (I estimate around 80%) of the articles that currently get published on alternative medicine are useless rubbish. They tend to be either pre-clinical investigations which never get followed up and are thus meaningless, or surveys of no relevance whatsoever, or pilot studies that never are succeeded by more definitive trials, or non-systematic reviews that are wide open to bias and can only mislead the reader.
  • Nowadays, very few articles on alternative medicine are good enough to get published in mainstream journals of high standing.

The consequences of these fairly recent developments are serious:

  • Conventional scientists and clinicians must get the impression that there is little research activity in alternative medicine (while, in fact, there is lots) and that the little research that does emerge is of poor quality.
  • Consequently alternative medicine will be deemed by those who are not directly involved in it as trivial, and the alternative medicine journals will be ignored or even become their laughing stock.
  • At the same time, the field of alternative medicine and its proponents (the only ones who might actually be reading the plethora of rubbish published in alternative medicine journals) will get more and more convinced that their field is supported by an ever- abundance of peer-reviewed, robust science.
  • Gradually, they will become less and less aware of the standards and requirements that need to be met for evidence to be called reliable (provided they ever had such knowledge in the first place).
  • They might thus get increasingly frustrated by the lack of acceptance of their ‘advances’ by proper scientists – an attitude which, from their perspective, must seem unfair, biased and hostile.
  • In the end, conventional and alternative medicine, rather than learning from each other, will move further and further apart.
  • Substantial amounts of money will continue to be wasted for research into alternative medicine that, whenever assessed critically, turns out to be too poor to advance healthcare in any meaningful way.
  • The ones who medicine should be all about, namely the patients who need our help and rely on the progress of research, are not well served by these developments.

In essence this suggests, I think, that alternative medicine is ill-advised and short-sighted to settle for standards that are so clearly below those generally deemed acceptable in medicine. Similarly, conventional medicine does a serious disfavour to progress and to us all, if it ignores or tolerates this process.

I am not at all sure how to reverse this trend. In the long-term, it would require a change of attitude that obviously is far from easy to bring about. In the short-term, it might help, I think, to de-list journals from Medline that are in such obvious conflict with publication ethics.

‘Doctor’ Don Harte is former medical student who prematurely left medical school and currently works as a chiropractor in California. He, has served on the Boards of the World Chiropractic Association and the Council on Chiropractic Practice. He has published extensively; on his website, he offers a list of his articles:

His website also reveals that Harte views chiropractic as a ‘cure all’ and believes that the “Vertebral Subluxation Complex (VSC) is THE most serious threat to your health and well-being.”

Harte is not impressed with conventional medicine: “Virtually everyone has lost loved ones to medical mistakes and indifference. I, myself, count my father, my favorite uncle and two cousins amongst this unnecessary medical death toll. Though people concoct all kinds of charges against Chiropractic, nobody knows of any deaths from Chiropractic, because there just aren’t any. You might want to read the article that I wrote on this subject in the San Francisco Chronicle, “Where is the Danger in Chiropractic.”

In particular, Harte is no friend of immunisation. Here are some of the things he has been quoted as saying recently about the subject:

  • He charged the media with “an evil bigotry” in relation to vaccination.
  • He said that “The mass media refuses to acknowledge the existence of vaccine-injured children. This is quite a trick, since we are talking millions of children.”
  • He explained that “their whole con game relies on fear, trying to convince you that you and your children have nothing inside to protect them from all those evil germs. That you need their HOLY WATER, the vaccines, or you will die.” Once again, Harte charged the California Governor and the legislature “as Destroyers of the family, as Enemies of liberty, as CHEMICAL CHILD MOLESTERS.”
  • He claimed that “His (Mr J Coleman’s) son, Otto, who was paralyzed by a vaccine reaction, was there, in his wheelchair; as were other vaccine-damaged children. Some participants held up photos of their children who had died from vaccines.” And he said, “There were no photos of these children, nor any mention of them in news accounts. Establishment media refuses to put a human face on the suffering caused by vaccinations. I don’t know whether to call them ‘chicken’ or ‘evil.’”
  • Harte also stated that “The claim that non-vaccinated children are a threat to Rhett has ZERO scientific basis. First of all, less-vaccinated and non-vaccinated kids tend to be healthier. And more specifically, children recently vaccinated with live virus vaccines will shed viruses, and thus, be contagious, for up to 28 days.”
  • “Here we have a case,” explained Harte, “of one boy held up as a potential victim of unvaccinated or less-vaccinated children, who has had, in reality, no harm done by those children. The millions of children who have endured great harm, up to and including paralysis and death, are ignored. This is not science, nor is it reputable news reporting nor reputable public policy. It is naked propaganda, paid for by Big Pharma.”

It seems that Harte is an altogether dangerous person.

Of course, chiropractors will (yet again) claim that Harte does in no way stand for chiropractic as a whole and that chiropractors are just as appalled by such dangerous anti-vaccination propaganda as we are. They will say he is just ‘a rotten apple’ within a mostly laudable profession.

But is that true? What have the professional bodies of chiropractic done against him and his hazardous views? Have they excluded or reprimanded him, or requested that he seeks treatment for what seems to be rampant paranoia?

The answer, I am afraid, is NO! What they did do instead was to name him, in 2006, as “Chiropractor of the Year” – an honour bestowed on him by the World Chiropractic Alliance.

Chiropractors are back pain specialists, they say. They do not pretend to treat non-spinal conditions, they claim.

If such notions were true, why are so many of them still misleading the public? Why do many chiropractors pretend to be primary care physicians who can take care of most illnesses regardless of any connection with the spine? Why do they continue to happily promote bogus treatments? Why do chiropractors, for instance, claim they can treat gastrointestinal diseases?

This recent narrative review of the literature, for example, was aimed at summarising studies describing the management of disorders of the gastrointestinal (GI) tract using ‘chiropractic therapy’ broadly defined here as spinal manipulation therapy, mobilizations, soft tissue therapy, modalities and stretches.

Twenty-one articles were found through searching the published literature to meet the authors’ inclusion criteria. The retrieved articles included case reports to clinical trials to review articles. The majority of articles chronicling patient experiences under chiropractic care reported that they experienced mild to moderate improvements in GI symptoms. No adverse effects were reported.

From this, the authors concluded that chiropractic care can be considered as an adjunctive therapy for patients with various GI conditions providing there are no co-morbidities.

I think, we would need to look for a long time to find an article with conclusions that are more ridiculous, false and unethical than these.

The old adage applies: rubbish in, rubbish out. If we include unreliable reports such as anecdotes, our finding will be unreliable as well. If we do not make this mistake and conduct a proper systematic review, we will arrive at very different conclusions. My own systematic review, for instance, of controlled clinical trials drew the following conclusion: There is no supportive evidence that chiropractic is an effective treatment for gastrointestinal disorders.

That probably says it all. I only want to add a short question: SHOULD THIS LATEST CHIROPRACTIC ATTEMPT TO MISLEAD THE PUBLIC BE CONSIDERED ‘SCIENTIFIC MISCONDUCT’ OR ‘FRAUD’?

I will state my position up front: THERE IS NO CHILDHOOD CONDITION FOR WHICH CHIROPRACTIC SPINAL MANIPULATION GENERATES MORE GOOD THAN HARM. What is more, I have published evidence (published herehere, here, and here, for instance) to support this statement. If you disagree with it, this is the place and time to do so – and please don’t forget to cite the evidence that supports your statements.

Given that there is very little reliable evidence in this area, I find it surprising that so many chiropractors continue to treat kids. Not true! I hear some chiropractors shout, we do not often treat children. Who is correct? Clearly, we need data to answer this question.

The objective of a new paper was to investigate characteristics of clinical chiropractic practice, including the age of pediatric patients, the number of reports of negative side effects (NSEs), the opinions of doctors of chiropractic on treatment options by patient age groups, the conditions seen and the number of treatment sessions delivered by conditions and by patient age.

An Internet cross-sectional survey was conducted in 20 European countries with 4109 chiropractors invited to reply. The 19 national associations belonging to the European Chiropractic Union and the Danish Chiropractic Association were asked to participate. Respondents were asked to self-report characteristics of their practices.

Of the 956 (23.3%) participating chiropractors, 921 reported 19821 pediatric patients per month. Children represented 8.1% of chiropractors’ total patient load over the last year. A total of 557 (534 mild, 23 moderate, and 0 severe) negative (adverse) side effects were reported for an estimated incidence of 0.23%. On the given treatment statements, chiropractors reported varying agreement and disagreement rates based on patient age. The 8309 answers on conditions were grouped into skeletal (57.0%), neurologic (23.7%), gastrointestinal (12.4%), infection (3.5%), genitourinary (1.5%), immune (1.4%), and miscellaneous conditions (0.5%). The number of treatment sessions delivered varied according to the condition and the patient age.

The authors of this survey concluded that this study showed that European chiropractors are active in the care of pediatric patients. Reported conditions were mainly skeletal and neurologic complaints. In this survey, no severe NSEs were reported, and mild NSEs were infrequent.

In my view, a more appropriate conclusion might be that MANY EUROPEAN CHIROPRACTORS ARE ACTIVE IN QUACKERY.

Placebo effects are important and often misunderstood. This is perhaps nowhere more true than in the realm of alternative medicine. Here they are often used to justify bogus treatments with the argument ‘I DON’T CARE HOW IT WORKS AS LONG AS IT DOES HELP PATIENTS, EVEN IF THIS SHOULD BE VIA A PLACEBO EFFECT’.

A recent article published in the prestigious NEJM sheds some light on these issues – all the more so, as one of its authors has a background as an advocate of alternative medicine. Here are a few passages from this paper which I think are particularly relevant:

… placebo effects are improvements in patients’ symptoms that are attributable to their participation in the therapeutic encounter, with its rituals, symbols, and interactions. These effects are distinct from those of discrete therapies and are precipitated by the contextual or environmental cues that surround medical interventions, both those that are fake and lacking in inherent therapeutic power and those with demonstrated efficacy…

So what have we learned about placebo effects to date, and what does our current understanding say about medicine?

First, though placebos may provide relief, they rarely cure. Although research has revealed objective neurobiologic pathways and correlates of placebo responses, the evidence to date suggests that the therapeutic benefits associated with placebo effects do not alter the pathophysiology of diseases beyond their symptomatic manifestations; they primarily address subjective and self-appraised symptoms…

Second, placebo effects are not just about dummy pills: the effects of symbols and clinician interactions can dramatically enhance the effectiveness of pharmaceuticals…

Third, the psychosocial factors that promote therapeutic placebo effects also have the potential to cause adverse consequences, known as nocebo effects. Not infrequently, patients perceive side effects of medications that are actually caused by anticipation of negative effects or heightened attentiveness to normal background discomforts of daily life in the context of a new therapeutic regimen…

… research on placebo effects can help explain mechanistically how clinicians can be therapeutic agents in the ways they relate to their patients in connection with, and separate from, providing effective treatment interventions. Of course, placebo effects are modest as compared with the impressive results achieved by lifesaving surgery and powerful, well-targeted medications. Yet we believe such effects are at the core of what makes medicine a healing profession.

So what about the claim that it is fine to use homeopathy, for instance, because it might help via a placebo effect? There are several reasons why this is not a good idea some of which are hinted at in the above article:

  1. placebo effects are not usually powerful,
  2. they are not normally long-lasting,
  3. they are not reliable,
  4. they are merely symptomatic,
  5. they are not always risk-free,
  6. they usually require deceiving patients, and that is not ethical,
  7. pretending that a bogus treatment is alright can undermine rationality in general,
  8. happily using bogus treatments because they generate placebo effects is a disincentive to find effective treatments,
  9. we do not need a placebo to generate placebo effects because any empathetic therapeutic encounter will do that too.

My conclusion is deliberately flippant and provocative: PLACEBO EFFECTS ARE TOO IMPORTANT TO LEAVE THEM TO QUACKS AND CHARLATANS.

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