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

EBM

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I recently saw a tweet by a German homeopath stating that ‘homeopathy is 100% experienced based medicine’. It made me think and realise that there is not just one EBM, there are, in fact, at least three EBMs!

  1. Experience based medicine
  2. Eminence based medicine
  3. Evidence based medicine

I will start with the type which I encountered first when studying medicine all those years ago.

EMINENCE BASED MEDICINE

German healthcare was at the time – 1970s – deeply steeped in this variety of EBM. What the professor said was right, and there was no discussion about it. I don’t even know how my teachers would have reacted, if we had challenged their wisdom, because nobody ever did; it just did not occur to us.

Personally, I never got along too well with this type of EBM. I found it stifling, and this feeling might have contributed to my first ‘escape’ to England in 1979. In the UK, I felt, things were refreshingly different (see also my recent obituary of my former boss).

EXPERIENCE BASED MEDICINE

So-called alternative medicine (SCAM) is almost entirely based on this type of EBM. Practitioners of SCAM pride themselves of their experience and are convinced that it outweighs evidence any time. They rarely miss an occasion to stress that their treatment as stood the test of time. And as such it does not require evidence; if SCAM did not work, it would not have survived all these years.

Little do they know that the appeal to tradition is a logical fallacy. And little do they care that the long tradition of their SCAMs might just signal how obsolete their treatments truly are. Hundreds (homeopathy) or thousands (acupuncture) of years ago, we had little knowledge about physiology, pathology, etc., and clinicians had to make do with the little that got. Seen in this light, experience based medicine is a negative label that indicates the fact that the treatments are likely to be obsolete and out-dated.

EVIDENCE BASED MEDICINE

Providers of SCAM have a deeply rooted dislike for the word evidence. The reason is simple: their SCAMs are usually very shy on evidence; little wonder that they like to focus on experience instead. Yet, try to explain the concept of evidence to someone neutral like a barman, for instance – whenever I made this attempt, I was interrupted by him saying: ‘Hold on, are you saying that before EBM you did not depend on evidence? This is frightening! What on earth did you rely on then?’

It is indeed not logical to rely on eminence or on experience, in my view. And therefore, I have stopped explaining EBM to people who have common sense, like my barman. Let’s try something else instead: imagine you are seriously ill and are able to chose between three clinician who are each the leading head in their type of EMB.

THE EMINENCE IS A PROFESSOR MANY TIMES OVER AND SIMPLY KNOWS THAT HE IS ALWAYS RIGHT

Personally, I would run a mile. I have seen too many of those blundering through the wards of university hospitals. He never makes a mistake, except that things do go wrong quite often; and when they do, it is the fault of some underling, of course.

THE EXPERIENCED CLINICIAN WITH YEARS OF PRACTICE WHO HAS SEEN IT ALL AND HAS ALL THE ANSWERS

With a bit of bad luck, he might be a homeopath. He will tell you endlessly of cases that were similar to yours. Occasionally, there was an aggravation (which, of course, is a good sign in his view), but in the end he cured them all with his treatments that had stood the test of time. He has excellent bedside manners, a lot of charisma, and is a good listener. Who was it that said: “the three most dangerous words in medicine are IN MY EXPERIENCE”?

Yes, you guessed it: run and don’t turn back!

THE CLINICIAN WHO KNOWS WHAT THE CURRENT BEST EVIDENCE HAS TO OFFER

He might not be all that charismatic, perhaps he even is a bit abrupt. But he will know the latest developments and weigh the risks of all therapeutic options against their benefits.

But hold on, my barman would interrupt at this point, this is not either or. One can have both experience and evidence!

I told you my barman was clever. The definition of evidence based medicine is not healthcare based on up-to date knowledge, it is the integration of best research evidence with clinical expertise and patient values. It thus rests on three pillars: external evidence, ideally from systematic reviews, the clinician’s experience, and the patient’s preferences.

Therefore, my barman and I agree that eminence based medicine is highly questionable, experience based medicine can be outright dangerous, and evidence based medicine is the only EBM version that does make sense.

 

 

I wish people would think a bit before naming things! What is ‘natural health’? Is it the opposite of ‘unnatural health’ or of ‘natural illness’? But who am I to question the terminology of the NHS? I am not even a native English speaker!

Therefore, let me rather look at what this oddly-named school does. Here is how the ‘NHS Natural Health School‘ explain their work:

The NHS Natural Health School has been developed to meet the standards of practice, and experience that are essential for complementary therapists wishing to treat patients within an NHS healthcare setting. The school offers a wide range of approved and accredited courses, taught by highly qualified and clinically skilled lecturers who are experienced in working clinically within NHS Healthcare settings and providing complementary therapy treatments for patients with a range of complex needs including cancer diagnosis. By welcoming you into the multi-disciplinary care team, we not only prepare you as a confident, competent practitioner ready to meet the needs of a demanding industry, but we are able to support the provision of specialist care for a wide range of patients and clients who otherwise would miss out on beneficial treatments.

Courses include supervised clinical placements across hospital and community healthcare settings. All proceeds raised from the courses are reinvested into the Harrogate Hospital and Community Charity’s SROMC Complementary Therapy Fund to ensure the financial sustainability of the HDFT NHS Trust Complementary Therapy Service. For more information on the courses and education available please click the courses link above.

Naturally, I am intrigued and have a look at their courses. They include shiatsu, holistic massage and reflexology. Having published several papers on the latter, it is of particular interest to me. Reflexologists have maps of the sole of the foot where all the body’s organs are depicted. Numerous such maps have been published and, embarrassingly, they do not all agree with each other as to the location of the organs on the sole of the feet. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs.  Here is what the NHS Natural Health School advertise about their reflexology course:

A combination of theory and practical modules designed to equip the learner with the skills required to provide Reflexology treatments for a wide range of clients. On successful completion of the course you will be able to register with the relevant regulatory and professional associations and gain full insurance to practice.

Course content includes;

  • Explore the history and origins of Reflexology
  • Explore the use of various mediums used in treatment including waxes, balms, powders and oils
  • Explore the philosophy of holism and its role within western bio medicine
  • Reading the feet/hands and mapping the reflex points
  • Relevant anatomy, physiology and pathology
  • Managing a wide range of conditions
  • Legal implications
  • Cautions and contraindications
  • Assessment and client care
  • Practical reflexology skills and routines
  • Treatment planning

Assessment: You will produce evidence of 30 reflexology treatments. An additional assessment of your competence will determine your readiness to undertake 72 in-depth case studies and complete a practical assessment.

Course Duration: Attendance is required at 8 Reflexology technical days over 12 months, during which time you will demonstrate a minimum of 100 practical hours.

Special Notes: The core modules; Anatomy, Physiology and Pathology, Business Practice and Principles and Practice of Complementary Therapy are normally completed concurrently as part of the diploma.

Learners who already have a Level 3 diploma in a complementary therapy may be exempt from the core modules.

A first aid certificate is required prior to completion of the diploma.

Fascinating! Personally I am most intrigued about the module on anatomy, physiology and pathology, because all of the three squarely contradict what reflexologists believe. But I wonder even more why there is no mention of the evidence. Have they forgotten to mention it? Unlikely; their other courses on SCAMs such as aromatherapy, holistic massage or shiatsu have similar omissions. Or does the ‘NHS Natural Health School’ not think that evidence matters to ‘competent practitioners’ of the NHS? Or perhaps this is where ‘natural health’ is different from unnatural health?

No, silly me! The reason clearly lies elsewhere: the evidence fails to show that reflexology generates more good than harm. So, the clever people from the ‘NHS Natural Health School’ decided to hide it discretely. Shrewd move! Albeit slightly embarrassing as well as just a little unethical, particularly for the NHS Harrogate, I’d say.

Just in case some readers do wonder nonetheless what the evidence does tell us about reflexology, here is the summary table from my recent book:

PLAUSIBILITY Negative
EFFICACY Negative
SAFETY Positive
COST Debatable
RISK/BENEFIT BALANCE negative

I cannot help but being reminded of something I stated many times before: EVEN THE MOST PROPER TEACHING OF NONSENSE CAN ONLY RESULT IN NONSENSE.

It is hard to deny that many practitioners of so-called alternative medicine (SCAM) advise their patients to avoid ‘dangerous chemicals’. By this they usually mean prescription drugs. If you doubt how strong this sentiment often is, you have not followed the recent posts and the comments that regularly followed. Frequently, SCAM practitioners will suggest to their patients to not take this or that drug and predict that patients would then see for themselves how much better they feel (usually, they also administer their SCAM at this point).

Lo and behold, many patients do indeed feel better after discontinuing their ‘chemical’ medicines. Of course, this experience is subsequently interpreted as a proof that the drugs were dangerous: “I told you so, you are much better off not taking synthetic medicines; best to use the natural treatments I am offering.”

But is this always interpretation correct?

I seriously doubt it.

Let’s look at a common scenario: a middle-aged man on several medications for reducing his cardiovascular risk (no, it’s not me). He has been diagnosed to have multiple cardiovascular risk factors. Initially, his GP told him to change his life-style, nutrition and physical activity – to which he was only moderately compliant. Despite the patient feeling perfectly healthy, his blood pressure and lipids remained elevated. His doctor now strongly recommends drug treatment and our chap soon finds himself on statins, beta-blockers plus ACE-inhibitors.

Our previously healthy man has thus been turned into a patient with all sorts of symptoms. His persistent cough prompts his GP to change the ACE-inhibitor to a Ca-channel blocker. Now the patients cough is gone, but he notices ankle oedema and does not feel in top form. His GP said that this is nothing to worry about and asks him to grin and bear it. But the fact is that a previously healthy man has been turned into a patient with reduced quality of life (QoL).

This fact takes our man to a homeopath in the hope to restore his QoL (you see, it certainly isn’t me). The homeopath proceeds as outlined above: he explains that drugs are dangerous chemicals and should therefore best be dropped. The homeopath also prescribes homeopathics and is confident that they will control the blood pressure adequately. Our man complies. After just a few days, he feels miles better, his QoL is back, and even his sex-life improves. The homeopath is triumphant: “I told you so, homeopathy works and those drugs were really nasty stuff.”

When I was a junior doctor working in a homeopathic hospital, my boss explained to me that much of the often considerable success of our treatments was to get rid of most, if not all prescription drugs that our patients were taking (the full story can be found here). At the time, and for many years to come, this made a profound impression on me and my clinical practice. As a scientist, however, I have to critically evaluate this strategy and ask: is it the correct one?

The answer is YES and NO.

YES, many (bad) doctors over-prescribe. And there is not a shadow of a doubt that unnecessary drugs must be scrapped. But what is unnecessary? Is it every drug that makes a patient less well than he was before?

NO, treatments that are needed should not be scrapped, even if this would make the patient feel better. Where possible, they might be altered such that side-effects disappear or become minimal. Patients’ QoL is important, but it is not the only factor of importance. I am sure this must sound ridiculous to lay people who, at this stage of the discussion, would often quote the ethical imperative of FIRST DO NO HARM.

So, let me use an extreme example to explain this a bit better. Imagine a cancer patient on chemo. She is quite ill with it and QoL is a thing of the past. Her homeopath tells her to scrap the chemo and promises she will almost instantly feel fine again. With some side-effect-free homeopathy see will beat the cancer just as well (please, don’t tell me they don’t do that, because they do!). She follows the advice, feels much improved for several months. Alas, her condition then deteriorates, and a year later she is dead.

I know, this is an extreme example; therefore, let’s return to our cardiovascular patient from above. He too followed the advice of his homeopath and is happy like a lark for several years … until, 5 years after discontinuing the ‘nasty chemicals’, he drops dead with a massive myocardial infarction at the age of 62.

I hope I made my message clear: those SCAM providers who advise discontinuing prescribed drugs are often impressively successful in improving QoL and their patients love them for it. But many of these practitioners haven’t got a clue about real medicine, and are merely playing dirty tricks on their patients. The advise to stop a prescribed drug can be a very wise move. But frequently, it improves the quality, while reducing the quantity of life!

The lesson is simple: find a rational doctor who knows the difference between over-prescribing and evidence-based medicine. And make sure you start running when a SCAM provider tries to meddle with necessary prescribed drugs.

As reported on this blog, the Spanish minister of health want to change the EU law that governs homeopathy. Now the INH has taken action in support of this idea:

THE COMMENT

… the Spanish government … no longer wants to accept the medicinal status of homeopathy, wants to ban homeopathy from pharmacies and has already “discontinued” the first batch of homoeopathics which could not present a valid proof of efficacy upon request. England is currently performing a complete “blacklisting”, i.e. a process that means the end of any registration for homeopathic medication with a drug authority.

The EU Medicines Directive does not regulate in detail how exactly the member states deal with homeopathy in health care. However, it does fix two key points: It includes homeopathy in its definition of a medical drug and obliges the states to regulate a simplified registration procedure for homeopathy instead of the usual drug approval. If one seriously wants to dispute the status of homeopathic medicinal products (and thus their privileges), one cannot completely ignore EU law.

Spain knows that. At various levels (including that of the government), there are efforts to achieve a revision of the EU directive on medicinal products in the field of homeopathy. These efforts need support. The INH has therefore addressed the following letter to German MEPs, which is initially intended to provide basic information on the facts of the case and support Spain’s position in the expected discussion. This seems all the more necessary as the European homeopathic manufacturers and associations have for a long time maintained a lobby organisation directly in Brussels, which apparently has quite good material and personnel resources and whose task is to exert direct influence “on the spot”. We do not have such resources, but we do have the facts. And who knows – perhaps one or the other national government will even join Spain and become active in the EU?

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THE LETTER TO ALL GERMAN MEPs

7 August 2019

Homeopathy in the EU Medicines Directive

Dear Madam / Sir,

The European Medicines Directive (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use,  Official Journal of the European Community L 311, 28.11.2001) classifies homeopathic preparations as medicinal products and requires national governments to establish a simplified registration procedure outside the otherwise prescribed rules for marketing authorisation for pharmaceutical remedies.

However, the consensus of the worldwide scientific community has long since classified homeopathy as a specifically ineffective sham therapy, the spread and “popularity” of which have completely different bases than those of medical relevance (evidence). In many countries, this insight is now gaining acceptance. It will be in the well-understood interest of the public’s health to take consequences of this. The misguiding of the public that homeopathy is a form of therapy expressly recognised by the legislator and therefore endowed with the credit of efficacy and harmlessness may not be continued.

In this respect, the Kingdom of Spain is already campaigning for an amendment to European pharmaceutical law, which not only grants homeopathic preparations the status of medicinal products by definition, but also grants them the additional privilege of registration (see also http://www.europarl.europa.eu/doceo/document/E-8-2018-004948-ASW_EN.html). This special legal framework has no objective justification, as the EASAC – as official advisor to the EU institutions – clearly stated in its statement of 20.09.2017 (https://easac.eu/publications/details/homeopathic-products-and-practices/).

In the interest of a science-based, honest and patient-oriented health policy, also on behalf of the German Consumer Association e.V. and its regional associations, we ask you to support a revision of the Medicines Directive in the sense described, in order to clear the way for appropriate national regulations under Community law.

You can inform yourself about the scientific status of homeopathy on the (multilingual) website of our association: www.network-homeopathy.info .

Yours sincerely

For the  Information Network Homeopathy

Dr. Natalie Grams – Dr. Ing. Norbert Aust – Dr. Christian Lübbers

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IF YOU FEEL LIKE SUPPORTING THIS INITIALIVE, PLEASE WRITE TO YOUR MEP.

John Dormandy was a consultant vascular surgeon, researcher, and medical educator best known for innovative work on the diagnosis and management of peripheral arterial disease. He had a leading role in developing, and garnering international support for, uniform guidelines that had a major impact on vascular care among specialists.

The Trans-Atlantic Inter-Society Consensus on Management of Peripheral Arterial Disease (TASC) was published in 2000.1 Dormandy, a former president of clinical medicine at the Royal Society of Medicine, was the genial force behind it, steering cooperation between medical and surgical society experts in Europe and North America.

“TASC became the standard for describing the severity of the problem that patients had and then defining what options there were to try and treat them,” says Alison Halliday, professor of vascular surgery at Oxford University who worked with Dormandy at St George’s Hospital, London. “It was the first time anybody had tried to get this general view on the complex picture of lower limb artery disease,” she says.

After stumbling across this totally unexpected obituary in the BMJ, I was deeply saddened. John was a close friend and mentor; I admired and loved him. He has influenced my life more than anyone else.

Our paths first crossed in 1979 when I applied for a post in his lab at St George’s Hospital, London. Even though I had never really envisaged a career in research, I wanted this job badly. At the time, I had been working as a SHO in a psychiatric hospital and was most unhappy. All I wished at that stage was to get out of psychiatry.

John offered me the position (mainly because of my MD thesis in blood clotting, I think) which was to run his haemorheology (the study of the flow properties of blood) lab. At the time, St Georges consisted of a research tract, a library, a squash court and a mega-building site for the main hospital.

John’s supervision was more than relaxed. As he was a busy surgeon then operating at a different site, I saw him only about once per fortnight, usually for less than 5 minutes. John gave me plenty of time to read (and to play squash!). As he was one of the world leader in haemorheology research, the lab was always full with foreign visitors who wanted to learn our methodologies. We all learnt from each other and had a great time!

After about two years, I had become a budding scientist. John’s mentoring had been minimal but nevertheless most effective. After I left to go back to Germany and finish my clinical training, we stayed in contact. In Munich, I managed to build up my own lab and continued to do haemorheology research. We thus met regularly, published papers and a book together, organised conferences, etc. It was during this time that my former boss became my friend.

Later, he also visited us in Vienna several times, and when I told him that I wanted to come back to England to do research in alternative medicine, he was puzzled but remained supportive (even wrote one of the two references that got me the Exeter job). I think he initially felt this might be a waste of a talent, but he soon changed his mind when he saw what I was up to.

John was one of the most original thinkers I have ever met. His intellect was as sharp as a razor and as fast as lightening. His research activities (>220 Medline listed papers) focussed on haemorheology, vascular surgery and multi-national mega-trials. And, of course, he had a wicket sense of humour. When he had become the clinical director of St George’s, he had to implement a strict no-smoking policy throughout the hospital. Being an enthusiastic cigar smoker, this presented somewhat of a problem for him. The solution was simple: at the entrance of his office John put a sign ‘You are now leaving the premises of St George’s Hospital’.

I saw John last in February this year. My wife and I had invited him for dinner, and when I phoned him to confirm the booking he said: ‘We only need a table for three; Klari (his wife) won’t join us, she died just before Christmas.’ I know how he must have suffered but, in typical Dormandy style, he tried to dissimulate and make light of his bereavement. During dinner he told me about the book he had just published: ‘Not a bestseller, in fact, it’s probably the most boring book you can find’. He then explained the concept of his next book, a history of medicine seen through the medical histories of famous people, and asked, ‘What’s your next one?’, ‘It’s called ‘Don’t believe what you think’, ‘Marvellous title!’, he exclaimed.

We parted that evening saying ‘see you soon’.

I will miss my friend vey badly.

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!

One of the favourite arguments of proponents of so-called alternative medicine (SCAM) is that conventional medicine is amongst the world’s biggest killers. The argument is used cleverly to discredit conventional medicine and promote SCAM. It has been shown to be wrong many times, but it nevertheless is much-loved by SCAM enthusiasts and thus refuses to disappear. Perhaps this new and important review might help instilling some realism into this endless discussion? Here is its abstract:

Objective To systematically quantify the prevalence, severity, and nature of preventable patient harm across a range of medical settings globally.

Design Systematic review and meta-analysis.

Data sources Medline, PubMed, PsycINFO, Cinahl and Embase, WHOLIS, Google Scholar, and SIGLE from January 2000 to January 2019. The reference lists of eligible studies and other relevant systematic reviews were also searched.

Review methods Observational studies reporting preventable patient harm in medical care. The core outcomes were the prevalence, severity, and types of preventable patient harm reported as percentages and their 95% confidence intervals. Data extraction and critical appraisal were undertaken by two reviewers working independently. Random effects meta-analysis was employed followed by univariable and multivariable meta regression. Heterogeneity was quantified by using the I2 statistic, and publication bias was evaluated.

Results Of the 7313 records identified, 70 studies involving 337 025 patients were included in the meta-analysis. The pooled prevalence for preventable patient harm was 6% (95% confidence interval 5% to 7%). A pooled proportion of 12% (9% to 15%) of preventable patient harm was severe or led to death. Incidents related to drugs (25%, 95% confidence interval 16% to 34%) and other treatments (24%, 21% to 30%) accounted for the largest proportion of preventable patient harm. Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery; regression coefficient b=0.07, 95% confidence interval 0.04 to 0.10).

Conclusions Around one in 20 patients are exposed to preventable harm in medical care. Although a focus on preventable patient harm has been encouraged by the international patient safety policy agenda, there are limited quality improvement practices specifically targeting incidents of preventable patient harm rather than overall patient harm (preventable and non-preventable). Developing and implementing evidence-based mitigation strategies specifically targeting preventable patient harm could lead to major service quality improvements in medical care which could also be more cost effective.

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One in 20 patients is undoubtedly an unacceptably high proportion, but it is nowhere close to some of the extraordinarily alarming claims by SCAM enthusiasts. And, as I try regularly to remind people, the harm must be viewed in relation to the benefit. For the vast majority of conventional treatments, the benefits outweigh the risks. But, if there is no benefit at all – as with some form of SCAM – a risk/benefit balance can never be positive. Moreover, many experts work hard and do their very best to improve the risk/benefit balance of conventional healthcare by educating clinicians, maximising the benefits, minimising the risks, and filling the gaps in our current knowledge. Do equivalent activities exist in SCAM? The answer is VERY FEW?

This press-release caught my attention:

Following the publication in Australia earlier this year of a video showing a chiropractor treating a baby, the Health Minster for the state of Victoria called for the prohibition of chiropractic spinal manipulation for children under the age of 12 years. As a result, an independent panel has been appointed by Safer Care Victoria to examine the evidence and provide recommendations for the chiropractic care of children.

The role of the panel is to (a) examine and assess the available evidence, including information from consumers, providers, and other stakeholders, for the use of spinal manipulation by chiropractors on children less than 12 years of age and (b) provide recommendations regarding this practice to the Victorian Minister for Health.
Members of the public and key stakeholders, including the WFC’s member for Australia, the Australia Chiropractors Association (AusCA), were invited to submit observations. The AusCA’s submission can be read here

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This submission turns out to be lengthy and full of irrelevant platitudes, repetitions and nonsense. In fact, it is hard to find in it any definitive statements at all. Here are two sections (both in bold print) which I found noteworthy:

1. There is no need to restrict parental or patient choice for chiropractic care for children under 12 years of age as there is no evidence of harm. There is however, expressed outcome of benefit by parents70 who actively choose chiropractic care for their children … 

No evidence of harm? Really! This is an outright lie. Firstly, one has to stress that there is no monitoring system and that therefore we simply do not learn about adverse effects. Secondly, there is no reason to assume that the adverse effects that have been reported in adults are not also relevant for children. Thirdly, adverse effects in children have been reported; see for instance here. Fourthly, we need to be aware of the fact that any ineffective therapy causes harm by preventing effective therapies from being applied. And fifthly, we need to remember that some chiropractors harm children by advising their parents against vaccination.

2. Three recent systematic reviews have focused on the effectiveness of manual therapy for paediatric conditions. For example, Lanaro et al. assessed osteopathic manipulative treatment for use on preterm infants. This systematic review looked at five clinical trials and found a reduction of length of stay and costs in a large population of preterm infants with no adverse events (96).

Carnes et al.’s 2018 systematic review focused on unsettled, distressed and excessively crying infants following any type of manual therapy. Of the seven clinical trials included, five involved chiropractic manipulative therapy; however, meta-analyses of outcomes were not possible due to the heterogeneity of the clinical trials. The review also analysed an additional 12 observational studies: seven case series, three cohort studies, one service evaluation survey, and one qualitative study. Overall, the systematic review concluded that small benefits were found. Additionally, the reporting of adverse events was low. Interestingly, when a relative risk analysis was done, those who had manual therapy were found to have an 88% reduced risk of having an adverse event compared to those who did not have manual therapy (97).

A third systematic review by Parnell Prevost et al. in 2019 evaluated the effectiveness of any paediatric condition following manual therapy of any type and summarizes the findings of studies of children 18 years of age or younger, as well as all adverse event information. While mostly inconclusive data were found due to lack of high-quality studies, of the 32 clinical trials and 18 observational studies included, favourable outcomes were found for all age groups, including improvements in suboptimal breastfeeding and musculoskeletal conditions. Adverse events were mentioned in only 24 of the included studies with no serious adverse events reported in them (98).

(96) Lanaro D, Ruffini N, Manzotti A, Lista G. Osteopathic manipulative treatment showed reduction of length of stay and costs in preterm infants: A systematic review and meta-analysis. Medicine (Baltimore). 2017; 96(12):e6408 10.1097/MD.0000000000006408.

(97) Carnes D, Plunkett A, Ellwood J, Miles C. Manual therapy for unsettled, distressed and excessively crying infants: a systematic review and meta-analyses. BMJ Open 2018;8:e019040. doi:10.1136/bmjopen-2017-019040.

(98) Parnell Prevost et al. 2019.

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And here are my comments:

(96) Lanaro et al is about osteopathy, not chiropractic (4 of the 5 primary trials were by the same research group).

(97) The review by Carnes et al has been discussed previously on this blog. This is what I wrote about it at the time:

The authors concluded that some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

For several reasons, I find this review, although technically sound, quite odd.

Why review uncontrolled data when RCTs are available?

How can a qualitative study be rated as high quality for assessing the effectiveness of a therapy?

How can the authors categorically conclude that there were benefits when there were only 4 RCTs of high quality?

Why do they not explain the implications of none of the RCTs being placebo-controlled?

How can anyone pool the results of all types of manual therapies which, as most of us know, are highly diverse?

How can the authors conclude about the safety of manual therapies when most trials failed to report on this issue?

Why do they not point out that this is unethical?

My greatest general concern about this review is the overt lack of critical input. A systematic review is not a means of promoting an intervention but of critically assessing its value. This void of critical thinking is palpable throughout the paper. In the discussion section, for instance, the authors state that “previous systematic reviews from 2012 and 2014 concluded there was favourable but inconclusive and weak evidence for manual therapy for infantile colic. They mention two reviews to back up this claim. They conveniently forget my own review of 2009 (the first on this subject). Why? Perhaps because it did not fit their preconceived ideas? Here is my abstract:

Some chiropractors claim that spinal manipulation is an effective treatment for infant colic. This systematic review was aimed at evaluating the evidence for this claim. Four databases were searched and three randomised clinical trials met all the inclusion criteria. The totality of this evidence fails to demonstrate the effectiveness of this treatment. It is concluded that the above claim is not based on convincing data from rigorous clinical trials.

Towards the end of their paper, the authors state that “this was a comprehensive and rigorously conducted review…” I beg to differ; it turned out to be uncritical and biased, in my view. And at the very end of the article, we learn a possible reason for this phenomenon: “CM had financial support from the National Council for Osteopathic Research from crowd-funded donations.”

(98) Parnell et al was easy to find despite the incomplete reference in the submission. This paper has also been discussed previously. Here is my post on it:

This systematic review is an attempt [at] … evaluating the use of manual therapy for clinical conditions in the paediatric population, assessing the methodological quality of the studies found, and synthesizing findings based on health condition.

Of the 3563 articles identified through various literature searches, 165 full articles were screened, and 50 studies (32 RCTs and 18 observational studies) met the inclusion criteria. Only 18 studies were judged to be of high quality. Conditions evaluated were:

      • attention deficit hyperactivity disorder (ADHD),
      • autism,
      • asthma,
      • cerebral palsy,
      • clubfoot,
      • constipation,
      • cranial asymmetry,
      • cuboid syndrome,
      • headache,
      • infantile colic,
      • low back pain,
      • obstructive apnoea,
      • otitis media,
      • paediatric dysfunctional voiding,
      • paediatric nocturnal enuresis,
      • postural asymmetry,
      • preterm infants,
      • pulled elbow,
      • suboptimal infant breastfeeding,
      • scoliosis,
      • suboptimal infant breastfeeding,
      • temporomandibular dysfunction,
      • torticollis,
      • upper cervical dysfunction.

Musculoskeletal conditions, including low back pain and headache, were evaluated in seven studies. Only 20 studies reported adverse events.

The authors concluded that fifty studies investigated the clinical effects of manual therapies for a wide variety of pediatric conditions. Moderate-positive overall assessment was found for 3 conditions: low back pain, pulled elbow, and premature infants. Inconclusive unfavorable outcomes were found for 2 conditions: scoliosis (OMT) and torticollis (MT). All other condition’s overall assessments were either inconclusive favorable or unclear. Adverse events were uncommonly reported. More robust clinical trials in this area of healthcare are needed.

There are many things that I find remarkable about this review:

      • The list of indications for which studies have been published confirms the notion that manual therapists – especially chiropractors – regard their approach as a panacea.
      • A systematic review evaluating the effectiveness of a therapy that includes observational studies without a control group is, in my view, highly suspect.
      • Many of the RCTs included in the review are meaningless; for instance, if a trial compares the effectiveness of two different manual therapies none of which has been shown to work, it cannot generate a meaningful result.
      • Again, we find that the majority of trialists fail to report adverse effects. This is unethical to a degree that I lose faith in such studies altogether.
      • Only three conditions are, according to the authors, based on evidence. This is hardly enough to sustain an entire speciality of paediatric chiropractors.

Allow me to have a closer look at these three conditions.

      1. Low back pain: the verdict ‘moderate positive’ is based on two RCTs and two observational studies. The latter are irrelevant for evaluating the effectiveness of a therapy. One of the two RCTs should have been excluded because the age of the patients exceeded the age range named by the authors as an inclusion criterion. This leaves us with one single ‘medium quality’ RCT that included a mere 35 patients. In my view, it would be foolish to base a positive verdict on such evidence.
      2. Pulled elbow: here the verdict is based on one RCT that compared two different approaches of unknown value. In my view, it would be foolish to base a positive verdict on such evidence.
      3. Preterm: Here we have 4 RCTs; one was a mere pilot study of craniosacral therapy following the infamous A+B vs B design. The other three RCTs were all from the same Italian research group; their findings have never been independently replicated. In my view, it would be foolish to base a positive verdict on such evidence.

So, what can be concluded from this?

I would say that there is no good evidence for chiropractic, osteopathic or other manual treatments for children suffering from any condition.

_________________________________________________________________

The ACA’s submission ends with the following conclusion:

The Australian Chiropractors Association (ACA) intent is to improve the general health of all Australians and the ACA supports the following attributes to achieve this:

      • The highest standards of ethics and conduct in all areas of research, education and practise
      • Chiropractors as the leaders in high quality spinal health and wellbeing
      • A commitment to evidence-based practice – the integration of best available research evidence, clinical expertise and patient values
      • The profound significance and value of patient-centred chiropractic care in healthcare in Australia.
      • Inclusiveness and collaborative relationships within and outside the chiropractic profession…

After reading through the entire, tedious document, I arrived at the conclusion that

THIS SUBMISSION CAN ONLY BE A CALL FOR THE PROHIBITION OF CHIROPRACTIC SPINAL MANIPULATION FOR CHILDREN.

The fact that homeopathy is under siege in France, has been discussed before. Now even the international media have picked up the story. Here are some excerpts from an interesting article in Bloomberg:

… The looming brawl gets to the heart of conflicting visions of the state’s involvement in the country’s health system at a time of eroding quality and services. Jobs are also at stake: France is home to Boiron SA, the leader in a global homeopathy market estimated at more than $30 billion.

Boiron’s pills and tinctures have long coexisted with conventional care in France, prescribed by regular doctors and dispensed in almost every pharmacy. Ending public support for the remedies would discredit homeopathy and “send a shock wave” through the industry worldwide, says Boiron’s chief executive officer, Valerie Poinsot. “We’ve been caught in this storm for the past year,” Poinsot says. “Why the hostility, when we contribute to caring for patients?”

Facing a possible backlash, Boiron, based in Lyon, teamed with rivals Weleda AG of Switzerland and closely held family group Lehning to fund a campaign called MyHomeoMyChoice. The push has garnered just over 1 million signatures in an online petition and placed bright-colored posters framed with the recognizable little white pills at pharmacies across the country. “Homeopathy has treated generations of French patients,” says one slogan. “Why deprive future generations?”

For now, French people can walk into any pharmacy and buy a tube of Arnica granules — recommended for shocks and bruises — or roughly a thousand other similar remedies for 1.6 euros ($1.80) with a prescription, because the state health system shoulders about 30% of its cost. In some cases, private insurers cover the remainder and patients pay nothing. That may all soon change. A science agency is wrapping up a study of the relative benefits of alternative medicine that will inform the government’s position: Keep the funding, trim it or scrap it altogether.

If the government cuts funding, Boiron would instantly feel the pain. Poinsot estimates that sales of reimbursed treatments could plummet by 50% in France, where the company brings in almost half its revenue. The company’s stock price has lost about 13% since May 15, when a French newspaper wrote that the panel reviewing homeopathy funding would probably rule against it…

In France, the controversy first erupted last year when the influential Le Figaro newspaper published a letter from a doctor’s collective called FakeMed lambasting alternative medicines. The authors called for ending support of “irrational and dangerous” therapies with “no scientific foundation.” The ensuing debate prompted Health Minister Agnes Buzyn to place funding under review and ask the country’s High Authority for Health to rule on homeopathy’s scientific merits…

David Beausire, a doctor in palliative care at the hospital in Mont de Marsan, in southwest France, is among those who signed the FakeMed letter. Beausire, who sees many terminally ill patients, said he regularly gets people who consult too late because they first explored alternative medicine paths that include homeopathy. “I am not an extremist,” he says. But homeopathy’s reimbursement by the state health system gives it legitimacy when “there’s no proof that it works.”…

Stung by accusations of quackery, Antoine Demonceaux, a doctor and homeopath in Reims, founded a group called SafeMed last November to relay the message that homeopathy has a role to play alongside standard care. He points to the growing number of cancer centers offering consultations to relieve treatment-related symptoms, such as nausea, with homeopathic medicine. Demonceaux says neither he nor his colleagues would ever use homeopathy as a substitute for treatments intended to, say, shrink tumors. “A general practitioner or a specialist who’d claim to be a homeopath and to cure cancer with homeopathy? Just sack him,” he says. “Let’s get real. We are doctors.”

_________________________________________

On the whole, this is a good report which – as far as I can see – describes the situation quite well and provides interesting details. What, however, with this articles and many like it is this: journalists (and others) are too often too lethargic or naïve to check the veracity of the claims that are being made during these disputes. For instance, it would not have been all that difficult to discover that:

  1. Hahnemann called clinicians who used homeopathy alongside conventional treatments ‘traitors‘! He categorically forbade it and denied that such an approach merits the name ‘HOMEOPATHY’. In other words, let’s get real and let’s not pull wool over the eyes of the public (and let’s be honest, it is not possible to practice homeopathy within the boundaries of medical ethics).
  2. Many homeopaths do advocate homeopathy as a sole treatment for cancer and other serious conditions (see for instance here, here and here).

The obvious risk of such lack of critical thinking is that homeopathy might be kept refundable on the basis of big, fat lies. And clearly, that would not be in the interest of anyone (with the exception of family Boiron, of course).

My friend and colleague Willem Betz has died on 8 June 2019. He was a physician and professor emeritus at the Belgian university Vrije Universiteit Brussel. Willem was a leading sceptic and a founding member of the Belgian sceptic organization SKEPP.

After having worked 20 years as a general practitioner, he made a career change and became a teacher of general practice and a researcher. As a clinician, he received training in several alternative therapies and practiced them of a short while. Soon, he started questioning the validity of these methods and thus became a dedicated sceptic. He served SKEPP as vice-president and as president and became a fellow of the Committee for Scientific Inquiry.

His last paper was published less than a year ago. Here is its abstract:

Conventional treatment of multiple sclerosis (MS) is often disappointing. As a result, some of these patients seek salvation in traditional and complementary medicine (T&CM). The aim of this study is to describe how many patients with MS use T&CM and what their motives and expectations are in doing so. Methods. Ninety-nine patients with diagnosed MS, attending the service of ambulatory revalidation of the National Clinic for Multiple Sclerosis in Melsbroek (Belgium) were included in February 2004 in this retrospective study. All patients had MS resulting in motoric or psychosocial symptoms. The disability was not quantified for this study. Participants were interviewed by means of a structured questionnaire on their current treatment of MS including T&CM. Results. In total 44% of the participants had experiences with T&CM. The most frequently used T&CM were homeopathy and acupuncture. Participants using conventional treatment were more satisfied with the support (p=0.006) and the treatment outcome (0.018) than T&CM users. The use of T&CM was not related to gender, education, living conditions, causal treatment such as disease modifying-therapy (DMT), grade of disability or subtype of the disease. Conclusion. Patients diagnosed with MS seek hope in T&CM such as homeopathy or acupuncture. The results of this study suggest that MS patients need more professional support in their personal search for alternative therapies. Key point. 50% of patients diagnosed with multiple sclerosis search relief in traditional and complementary medicine such as homeopathy or acupuncture. These patients often feel compelled to try every opportunity to heal, often stimulated or urged on by friends or relatives. Multiple sclerosis patients are more satisfied with their conventional treatment than with the traditional and complementary medicine.

Through his personality, enthusiasm, analytical mind, humour and dedication, Willem has inspired an entire generation of sceptics. We will miss you Willem.

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