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

critical thinking

I have already posted challenges to homeopaths. For instance, in a previous post, I asked the ‘homeopaths of the world’ to answer a few questions satisfactorily. In return, I promised to no longer doubt their memory of water theory. If they cannot do this, I contended, they should to admit that all their ‘sciency’ theories about the mode of action of highly diluted homeopathic remedies are really quite silly – more silly even than Hahnemann’s idea of a ‘spirit-like’ effect.

And then there is the challenge to correctly identify their own remedies. In return, they would even earn the neat sum of Euro 50 000.

So far, none of these challenges have been met. But one must not give up hope!!!

Meanwhile, I have decided to issue another one. Let me explain:

One argument that the ‘defenders of the homeopathic realm’ love and almost invariably use, when someone states that it is time to move on and ban homeopathy to the history books, is this one:

IF WE BANNED HOMEOPATHY FROM OUR CLINICAL ROUTINE, WE WOULD ALSO HAVE TO BAN MANY OF THE TREATMENTS USED IN CONVENTIONAL MEDICINE WHICH ARE EQUALLY POORLY SUPPORTED BY SOUND EVIDENCE FOR EFFICACY.

This looks like a good argument!

I am sure that politicians, journalists, consumers and even many healthcare professionals find it convincing.

We know that lots of conventional treatments are less well supported than many of us would hope or think.

But less well-supported than homeopathy?

Let’s see: Homeopathy has been around for ~200 years. Controlled clinical trials of homeopathy have been conducted since 1835. Today, we have about 500 controlled clinical trials of homeopathy. The totality of these data fails to convincingly demonstrate that homeopathy is more than a placebo.

Are there many other therapies that fulfil these criteria? Personally, I am not aware of such a therapy, and if I did know one, I am fairly certain that I would advocate its elimination from our clinical routine.

But I am, of course, not an expert in all fields of healthcare.

Perhaps such treatments do exist!

I want to find out, and – as always – the burden of proof is with those who use this argument.

Which brings me to my challenge.

I HEREWITH CHALLENGE HOMEOPATHS AND THEIR FOLLOWERS TO NAME THERAPIES THAT ARE AS USELESS AS HOMEOPATHY!

To be clear, they ought to fulfil the following criteria:

  1. The treatment must be about 200 years old (plenty of time for a thorough evaluation).
  2. It should have been extensively tested in about 500 controlled clinical trials.
  3. The totality of this evidence should be negative.
  4. The treatment should be part of the clinical routine and have ardent proponents who insist it should be paid for by public funds.

I hope lots of homeopaths can name lots of such therapies.

Failing this, they should think twice before they use the above argument again.

 

The wishes of a patient do not over-rule medical knowledge!” (Patientenwunsch steht nicht über medizinischem Wissen)

This was one brave conclusion drawn in a discussion about homeopathy during a recent German radio programme. Specifically, the discussion was about the pros and cons of a leading paediatric hospital of the Ludwig Maximilian Universitaet (LMU) Munich offering homeopathy to its patients (they also run a course in homeopathy which we discussed previously).

The wishes of a patient does not over-rule medical knowledge!

This sentence made me think.

Is it correct?

An interesting question with ethical dimensions!

The short answer is NO, I believe..

Patients can always refuse to have a given therapy, if they so wish. Or they might opt for one evidence-based therapy instead of another. And in certain circumstances such wishes may well be completely against the current best medical knowledge.

But this is probably where the dominance of the patient’s wishes over medical knowledge ends — at least, if we only consider wishes paid for by the public purse (otherwise, anyone can, of course, buy almost any rubbish).

And that was not what the above-mentioned discussion was about. It focussed on the arguments by the LMU to justify their offer of homeopathy to sick children. Essentially, they seem to say:

  • We believe in evidence-based medicine (EBM) and are fully dedicated to its principles.
  • We know that homeopathy is not evidence-based.
  • Yet, many of the parents want us to use homeopathy in the treatment of their kids.
  • And the wish of a patient over-rules the medical evidence.

This is, of course, a flawed argument. One cannot subscribe to EBM and, at the same time, administer overt nonsensical, disproven treatments. A patient’s wish does not render a nonsensical treatment evidence-based. If one would follow the LMU logic, one would have to use any idiotic therapy … and could still pride oneself to follow EBM practice. In England, we call this ‘having the cake and eat it’; once you eat the cake, it’s gone and you cannot have it any longer.

What follows is simple: the decision makers at the LMU have been found out with (homeopathically potentised) egg on their faces (for some reason they had this homeopathy enclave for years, it is well-established and, I suspect, even better protected by some people of influence). They quickly tried to find a way out of their dilemma. Unfortunately, they did not think hard enough; the solution to bank on patient choice turns out to be a non-solution.

I therefore suggest they get in line with the role of a University hospital, with today’s medical thinking and medical ethics. This would mean re-considering their homeopathy course as well as their inclusion of homeopathy in publicly-funded routine care.

One of the aims in running this blog has always been to stimulate critical thinking (not just in my readers but also in myself).

Critical thinking means making decisions and judgements based on (often confusing) evidence. According to the ‘National Council for Excellence in Critical Thinking’ it is the intellectually disciplined process of actively and skilfully conceptualizing, applying, analysing, synthesizing, and/or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action.

Carl Sagan explained it best: “It seems to me what is called for is an exquisite balance between two conflicting needs: the most skeptical scrutiny of all hypotheses that are served up to us and at the same time a great openness to new ideas. Obviously those two modes of thought are in some tension. But if you are able to exercise only one of these modes, whichever one it is, you’re in deep trouble. If you are only skeptical, then no new ideas make it through to you. You never learn anything new. You become a crotchety old person convinced that nonsense is ruling the world. (There is, of course, much data to support you.) But every now and then, maybe once in a hundred cases, a new idea turns out to be on the mark, valid and wonderful. If you are too much in the habit of being skeptical about everything, you are going to miss or resent it, and either way you will be standing in the way of understanding and progress. On the other hand, if you are open to the point of gullibility and have not an ounce of skeptical sense in you, then you cannot distinguish the useful as from the worthless ones.”

Critical thinking is not something one is born with; but I strongly believe that most people can be taught this skill. This study suggests that I may be right. The researchers measured the relationship between student’s religion, gender, and propensity for fantasy thinking with the change in belief for paranormal and pseudoscientific subjects following a science and critical thinking course. Student pre-course endorsement of religious, paranormal, and pseudo-scientific beliefs ranged from 21 to 53%, with religion having the highest endorsement rate. Pre-course belief in paranormal and pseudo-scientific subjects was correlated with high scores in some fantasy thinking scales and showed a gender and a religion effect with females having an 11.1% higher belief across all paranormal and pseudo-science subcategories. Students’ religion, and frequency of religious service attendance, was also important with agnostic or atheist students having lower beliefs in paranormal and pseudo-science subjects compared to religious students. Students with either low religious service attendance or very high attendance had lower paranormal and pseudoscientific beliefs.

Following the critical thinking course, overall beliefs in paranormal and pseudo-scientific subcategories lowered 6.8–28.9%, except for superstition, which did not significantly change. Change in belief had both a gender and religion effect with greater reductions among religious students and females.

The link between religion and alternative medicine is relatively well-established. A 2014 study, for instance, showed an association between alternative medicine use and religiosity. The finding that females have an 11.1% higher belief in the paranormal and pseudo-science is new to me, but it would tie in with the well-documented fact that women use alternative medicine more frequently than men.

The most important finding, however, is clearly that critical thinking can be taught.

That must be good news! As discussed previously, critical thinkers experience fewer bad things in life than those of us who do not have acquired that skill. This cannot come as a surprise – being able to tell useful concepts from worthless ones should achieve exactly that.

Is homeopathy effective for specific conditions? The FACULTY OF HOMEOPATHY (FoH, the professional organisation of UK doctor homeopaths) say YES. In support of this bold statement, they cite a total of 35 systematic reviews of homeopathy with a focus on specific clinical areas. “Nine of these 35 reviews presented conclusions that were positive for homeopathy”, they claim. Here they are:

Allergies and upper respiratory tract infections 8,9
Childhood diarrhoea 10
Post-operative ileus 11
Rheumatic diseases 12
Seasonal allergic rhinitis (hay fever) 13–15
Vertigo 16

And here are the references (I took the liberty of adding my comments in blod):

8. Bornhöft G, Wolf U, Ammon K, et al. Effectiveness, safety and cost-effectiveness of homeopathy in general practice – summarized health technology assessment. Forschende Komplementärmedizin, 2006; 13 Suppl 2: 19–29.

This is the infamous ‘Swiss report‘ which, nowadays, only homeopaths take seriously.

9. Bellavite P, Ortolani R, Pontarollo F, et al. Immunology and homeopathy. 4. Clinical studies – Part 1. Evidence-based Complementary and Alternative Medicine: eCAM, 2006; 3: 293–301.

This is not a systematic review as it lacks any critical assessment of the primary data and includes observational studies and even case series.

10. Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials. Pediatric Infectious Disease Journal, 2003; 22: 229–234.

This is a meta-analysis by Jennifer Jacobs (who recently featured on this blog) of 3 studies by Jennifer Jacobs; hardly convincing I’d say.

11. Barnes J, Resch K-L, Ernst E. Homeopathy for postoperative ileus? A meta-analysis. Journal of Clinical Gastroenterology, 1997; 25: 628–633.

This is my own paper! It concluded that “several caveats preclude a definitive judgment.”

12. Jonas WB, Linde K, Ramirez G. Homeopathy and rheumatic disease. Rheumatic Disease Clinics of North America, 2000; 26: 117–123.

This is not a systematic review; here is the (unabridged) abstract:

Despite a growing interest in uncovering the basic mechanisms of arthritis, medical treatment remains symptomatic. Current medical treatments do not consistently halt the long-term progression of these diseases, and surgery may still be needed to restore mechanical function in large joints. Patients with rheumatic syndromes often seek alternative therapies, with homeopathy being one of the most frequent. Homeopathy is one of the most frequently used complementary therapies worldwide.

Proper systematic reviews fail to show that homeopathy is an effective treatment for rheumatic conditions (see for instance here and here).

13. Wiesenauer M, Lüdtke R. A meta-analysis of the homeopathic treatment of pollinosis with Galphimia glauca. Forschende Komplementärmedizin und Klassische Naturheilkunde, 1996; 3: 230–236.

This is a meta-analysis by Wiesenauer of trials conducted by Wiesenauer.

My own, more recent analysis of these data arrived at a considerably less favourable conclusion: “… three of the four currently available placebo-controlled RCTs of homeopathic Galphimia glauca (GG) suggest this therapy is an effective symptomatic treatment for hay fever. There are, however, important caveats. Most essentially, independent replication would be required before GG can be considered for the routine treatment of hay fever. (Focus on Alternative and Complementary Therapies September 2011 16(3))

14. Taylor MA, Reilly D, Llewellyn-Jones RH, et al. Randomised controlled trials of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. British Medical Journal, 2000; 321: 471–476.

This is a meta-analysis by David Reilly of 4 RCTs which were all conducted by David Reilly. This attracted heavy criticism; see here and here, for instance.

15. Bellavite P, Ortolani R, Pontarollo F, et al. Immunology and homeopathy. 4. Clinical studies – Part 2. Evidence-based Complementary and Alternative Medicine: eCAM, 2006; 3: 397–409.

This is not a systematic review as it lacks any critical assessment of the primary data and includes observational studies and even case series.

16. Schneider B, Klein P, Weiser M. Treatment of vertigo with a homeopathic complex remedy compared with usual treatments: a meta-analysis of clinical trials. Arzneimittelforschung, 2005; 55: 23–29.

This is a meta-analysis of 2 (!) RCTs and 2 observational studies of ‘Vertigoheel’, a preparation which is not a homeopathic but a homotoxicologic remedy (it does not follow the ‘like cures like’ assumption of homeopathy) . Moreover, this product contains pharmacologically active substances (and nobody doubts that active substances can have effects).

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So, positive evidence from 9 systematic reviews in 6 specific clinical areas?

I let you answer this question.

The ‘Pharmaceutical Journal’ just published a ‘pro/contra’ piece discussing whether UK community pharmacists should be selling homeopathic remedies to the public. Here are the essential parts of both arguments:

PRO

… I do not believe there is good scientific evidence to validate homeopathic remedies as medicines, but it is important to provide patients with choice in an informed environment — pharmacists and pharmacy teams are able to provide this expertise.

It is better for the public to buy these products from a reputable source where the community pharmacist — the expert on medicines — can provide professional advice, which is not available from unregulated online suppliers or other non-healthcare outlets…

So, I’m not here to argue the science: I argue that some people can benefit from homeopathy.

We ought to explore homeopathy’s placebo effect. Placebos are often dismissed as fakes, but they seem to act on the same brain pathways that are targeted by ‘real’ treatments. I wonder whether, through the placebo effect, homeopathy has a role to play in mental health treatment and pain relief. Whether for anxiety, mild-to-moderate depression, sleeplessness or stress, taking a little white tablet may benefit the patient, have fewer side effects than conventional medication, cause no harm, and is better than an excess of alcohol or illegal drugs.

Of course, homeopathy should not replace conventional medicines, and people should continue to be vaccinated, should use their inhalers and take their insulin. Homeopathy should not be funded on the NHS, but we do not live in a nanny state.

The clinical efficacy of many other products sold in the pharmacy is also questionable, but we still provide them. One example is guaifenesin for chesty coughs, which, at over-the-counter strength, provides a suboptimal dose. Many people are sceptical of the benefits of vitamin and mineral supplements. Bach flower remedies claim to tackle stress. We drink herbal tea for its ‘health’ benefits or buy fortified cereals because they are ‘better for you’, but these benefits are not clinically proven.

If the public finds comfort in a complementary therapy — whether it is acupuncture, reflexology, vitamins or homeopathy — I am happy to offer that choice, as long as the chosen therapies do no harm, and people continue to take their prescribed medicines.

If the patient wants my professional advice, I will explain that homeopathic medicines are not clinically proven but they may help certain conditions. I will probably recommend a different product, but at least I am there to do so.

You will not find a pharmacist in a health shop or on the internet, but in the community pharmacy you will find a highly qualified medicines expert, who will advise and inform, and who truly cares about the public’s health.

 

CONTRA

… given pharmacy’s heavy promotion of homeopathy, I feared that the profession was in danger of losing science as its bedrock.

… in 2009, a London-based pharmacy was supplying homeopathic ‘swine flu formula’. This was a dangerous practice but government agencies failed to regulate it effectively or to close it down.

In 2010, the then professional standards director at Boots, Paul Bennett (now chief executive, Royal Pharmaceutical Society), appeared before the Science and Technology Committee in its discussion of homeopathy’s availability on the NHS. Bennett stood by the sale of homeopathic remedies in Boots’ stores: “It is about consumer choice for us,” he said. I disagree with this argument.

Like the sale of cigarettes in US pharmacies, homeopathy threatens to fatally damage the reputation of community pharmacy. Pharmacies that sell homeopathic remedies give them unjustified credibility. Informed patient choice should be king; if pharmacists, pharmacy staff and shelf-barkers fail to clearly inform customers that homeopathic remedies are no more effective than placebo, we have acted unethically.

Yet Boots, perhaps alarmed by the number of subsequent protests against homeopathy outside its stores, got the message. Its website now reflects a more scientific approach: the homeopathic remedies it supplies state that they are “without approved therapeutic indications”. Boots also seems to have modified its range and offering of homeopathic remedies. So there is hope for community pharmacy.

Homeopathic remedies are still sold in pharmacies only because they make a profit. Sales in pharmacy are nonsense because, as most homeopathic practitioners claim, it is not possible to sell homeopathic remedies in isolation of a homeopathic consultation. The consultation determines the remedy. Off-the-shelf homeopathy is a relatively recent phenomenon.

The remedies are no more effective compared with placebo, anyway. Systematic reviews from the Cochrane Library — the gold standard of medical science — have considered homeopathy in the treatment of dementia, asthma and attention deficit hyperactivity disorder, all of which have confirmed the placebo effect. Irritatingly, supporters of homeopathy will always, in any debate, quote a bunkum study that shows some possible efficacy. Some might argue that placebo, or suggestion, is effective therapy, so why not use it? We must question the ethics of this approach.

Pharmacists act immorally when they sell the products without making clients aware that homeopathy does not work.

… I find that most pharmacists, when asked, appreciate that homeopathy has no scientific basis and provides merely a placebo effect. I sincerely hope that with this insight, pharmacy will finally clear its shelves of this expensive hocus pocus for good.

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I find both pieces quite weak and poorly argued. In fact, the ‘pro’ – arguments are quite laughable and could easily be used for teaching students the meaning and use of logical fallacies. In my view, all that needs to be pointed out here is this:

  1. Homeopathy is based on implausible assumptions.
  2. Despite 200 years of research and around 500 clinical trials, there is still no proof that highly diluted homeopathic remedies have effects beyond placebo.
  3. Therefore, selling them to the naïve public, while pretending they are real medicines, is dishonest, arguably fraudulent and certainly not the behaviour one would expect of a healthcare professional.
  4. Pharmacists who nevertheless sell these remedies as medicines are in breach of their very own regulations.

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Strangely enough, when trying to find the relevant passage from the code of ethics for UK pharmacists, I struggled. The General Pharmaceutical Council’s ‘Standards fro Pharmacy Professionals‘ merely states this:

People receive safe and effective care when pharmacy professionals reflect on the application of their knowledge and skills and keep them up-to-date, including using evidence in their decision making. A pharmacy professional’s knowledge and skills must develop over the course of their career to reflect the changing nature of healthcare, the population they provide care to and the roles they carry out. There are a number of ways to meet this standard and below are examples of the attitudes and behaviours expected.

People receive safe and effective care when pharmacy professionals:

  • recognise and work within the limits of their knowledge and skills, and refer to others when needed
  • use their skills and knowledge, including up-to-date evidence, to deliver care and improve the quality of care they provide
  • carry out a range of continuing professional development (CPD) activities relevant to their practice
  • record their development activities to demonstrate that their knowledge and skills are up to date
  • use a variety of methods to regularly monitor and reflect on their practice, skills and knowledge

This, I admit, is not as clear as I had hoped (if my memory serves me right, this used to be much more explicit; in case anyone knows of a more suitable section in the code of ethics, please let me know); but it does preclude selling placebos, while pretending they are effective medicines.

Shiatsu is an alternative therapy that is popular, but has so far attracted almost no research. Therefore, I was excited when I saw a new paper on the subject. Sadly, my excitement waned quickly when I stared reading the abstract.

This single-blind randomized controlled study was aimed to evaluate shiatsu on mood, cognition, and functional independence in patients undergoing physical activity. Alzheimer disease (AD) patients with depression were randomly assigned to the “active group” (Shiatsu + physical activity) or the “control group” (physical activity alone).

Shiatsu was performed by the same therapist once a week for ten months. Global cognitive functioning (Mini Mental State Examination – MMSE), depressive symptoms (Geriatric Depression Scale – GDS), and functional status (Activity of Daily Living – ADL, Instrumental ADL – IADL) were assessed before and after the intervention.

The researchers found a within-group improvement of MMSE, ADL, and GDS in the Shiatsu group. However, the analysis of differences before and after the interventions showed a statistically significant decrease of GDS score only in the Shiatsu group.

The authors concluded that the combination of Shiatsu and physical activity improved depression in AD patients compared to physical activity alone. The pathomechanism might involve neuroendocrine-mediated effects of Shiatsu on neural circuits implicated in mood and affect regulation.

The Journal Complementary Therapies in Medicine also published three ‘Highlights’ of this study:

  • We first evaluated the effect of Shiatsu in depressed patients with Alzheimer’s disease (AD).
  • Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients.
  • Neuroendocrine-mediated effect of Shiatsu may modulate mood and affect neural circuits.

Where to begin?

1 The study is called a ‘pilot’. As such it should not draw conclusions about the effectiveness of Shiatsu.

2 The design of the study was such that there was no accounting for the placebo effect (the often-discussed ‘A+B vs B’ design); therefore, it is impossible to attribute the observed outcome to Shiatsu. The ‘highlight’ – Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients – therefore turns out to be a low-light.

3 As this was a study with a control group, within-group changes are irrelevant and do not even deserve a mention.

4 The last point about the mode of action is pure speculation, and not borne out of the data presented.

5 Accumulating so much nonsense in one research paper is, in my view, unethical.

Research into alternative medicine does not have a good reputation – studies like this one are not inclined to improve it.

Grace Dasilva-Hill has just published an article entitled “Autism/ADHD and Vaccines – are we walking a tightrope whilst blindfolded?“. Who is Grace Dasilva-Hill, you will ask.

She is a professional registered homeopath, based in Charing – East Kent, UK. She has been in practice since 1997. During this time she has developed a busy practice, alongside teaching, running students’ clinics and tutorials. She was a team member of the Ghana Homeopathy Project soon after it started, and later became their treasurer as well. Grace has published in the Journal Homeopathy in Practice, and HPathy. She also is an ‘Energy EFT Master Practitioner Trainer’ and a ‘qualified CEASE therapist’.

And what is the Ghana Homeopathy Project ? It is an organization whose goal is the establishment of homeopathy as a recognised part of the health care system in Africa and Ghana in particular. Their objective is the relief and prevention of disease. They support the development of homeopathic education and wish to make homeopathy available to deprived communities as a valid and affordable form of treatment.

The lengthy article by Grace Dasilva-Hill re-hashes all the bogus arguments about immunisation that you could ever wish for. I will show you only what she calls her ‘conclusions’:

START OF QUOTE

…at the present time we have only just scratched the surface of the issue of autism and ADHD; my aim in this article is to challenge the reader to pause, reflect and ask: do vaccines do more good than harm, or it is actually the other way round? Just who is considered to be responsible for my health and that of my family – my doctor, my country’s government or myself? Do we need to stand up as a profession, and be more pro-active?

The big question seems to be, are we not only failing our patients but also the greater good of the world’s populations, unless we question and do not just ‘accept’ what science and medicine tells us, especially as ‘vested interests’ seem to have such a strong influence on what we are told?
The health journalist Phillip Day has done just that in his book ‘Health Wars’ – he argues how the multinationals have a vested interest in keeping all of us ill, for this is the only way that they can continue making money. His propositions are supported by Goldman Sacks Bank which recently stated that they would not invest in the alternative health industry because it tends to cure people, so there is little profit to be made from it.

I invite you to become an advocate for those who are unable or who are too young to ask questions, or to stand up for themselves, or whose parents don’t have the knowledge or tenacity to challenge.
Children and young adults suffering with autism, ADHD, ASD, deserve our loyalty, support and action.

In the UK, we recently shared the anguish and pain felt by baby Alfie Evans’ parents and family. It is impossible for anyone who is caring to witness such horror, and not to ask any questions. Hopefully we will learn much from this very sad event. There are questions not only about causative factors (ie. the role that vaccinations may have played), but also the issue of parental rights versus the State’s perceived protectionist rights.

What has been happening in the field of healthcare is fast becoming unsustainable. On the other hand Homeopathy has so much to offer, being a sustainable form of medicine not influenced by market forces.

One could argue that one of the reasons why the denialists want to see the demise of homeopathy and other natural modalities, is that more and more people are choosing these modes of healthcare in place of conventional medicine which is reductionist in approach and only has drugs to offer.

I find myself wondering whether there is a need for something radically different to happen. As a profession, do we need to do something collectively? Do we need to stand up more, do we need to speak up more? How do we go about doing this? I know that I am asking more questions than providing answers, and this is because at the moment I don’t have the answers either. But I have a deep and sincere desire to do my best to make a difference that will be both worthwhile and sustainable.
I would like to believe that others in our community would like to do the same for the bigger benefit of sustainable and effective healthcare for all.

Footnote: I have just carried out an impromptu, unrepresentative survey of homeopathic colleagues on a homeopathic professional group. I asked them if they knew of any health care professionals (doctors, nurses, midwives) who did not vaccinate their children. Most of those who replied, surprisingly said that they do know of at least one doctor, or nurse or midwife who did not vaccinate their children, and they added that these professionals keep this quiet. I certainly know of two medical doctors who do not vaccinate their children, and again they do not talk about it. It was shared with me in confidence.

END OF QUOTE

Of course, these words are not really ‘conclusions’, they are just a continuation of a barmy rant.

And yes, such articles exist in abundance. Many homeopaths are active campaigners against vaccination.

The Society of Homeopaths (SoH), the professional UK organisation for lay homeopaths, has recently stated that it is unethical for a homeopath to advise a patient against the use of conventional vaccines…  This could not be clearer! Yet, I suspect that the homeopaths put out such statements mainly to cover their backs and subsequently they do what they feel like – and they rarely feel like supporting vaccinations.

They obviously try to give the impression that lay homeopaths are not antivaxers. I fear, however, this impression is wrong: as we have discussed repeatedly on this blog, many homeopaths do advise their patients against immunisation. And many claim that homeopathic immunisations are an effective alternative. It takes not long to find even VIP-members of the SoH putting parents off from immunising their kids. And thanks to the Ghana Homeopathy and several similar projects, this is happening not just in the UK but also in Africa and elsewhere.

Is that not irresponsible?

In my view, it is!

Is that not illegal?

Apparently not, because such homeopaths usually add a clever disclaimer; Grace Dasilva-Hill for instance states that  Any information obtained here is not to be construed as medical OR legal advice. The decision to vaccinate and how you implement that decision is yours and yours alone. 

Forgive me, if this post is long and a bit tedious, but I think it is important.

The claims continue that I am a dishonest falsifier of scientific data, because the renowned Prof R Hahn said so; this, for instance, is from a Tweet that appeared a few days ago

False claims, Edzard Ernst is the worst. Says independent researcher prof Hahn in his blog. His study: https://www.ncbi.nlm.nih.gov/pubmed/24200828 
His blog (German translation) http://www.homeopathy.at/betruegerische-studien-um-homoeopathie-als-wirkungslos-darzustellen…

The source of this permanent flow of defamations is Hahn’s strange article which I have tried to explain several times before. As the matter continues to excite homeopaths around the world, I have decided to give it another go. The following section (in bold) is directly copied from Hahn’s infamous paper where he evaluated several systematic reviews of homeopathy.

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In 1998, he [Ernst] selected 5 studies using highly diluted remedies from the original 89 and concluded that homeopathy has no effect [5].

In 2000, Ernst and Pittler [6] sought to invalidate the statistically significant superiority of homeopathy over placebo in the 10 studies with the highest Jadad score. The odds ratio, as presented by Linde et al. in 1999 [3], was 2.00 (1.37–2.91). The new argument was that the Jadad score and odds ratio in favor of homeopathy seemed to follow a straight line (in fact, it is asymptotic at both ends). Hence, Ernst and Pittler [6] claimed that the highest Jadad scores should theoretically show zero effect. This reasoning argued that the assumed data are more correct than the real data.

Two years later, Ernst [7] summarized the systematic reviews of homeopathy published in the wake of Linde’s first metaanalysis [2]. To support the view that homeopathy lacks effect, Ernst cited his own publications from 1998 and 2000 [5, 6]. He also presented Linde’s 2 follow-up reports [3, 4] as being further evidence that homeopathy equals placebo. 

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And that’s it! Except for some snide remarks (copied below) in the discussion section of the article, this is all Hahn has to say about my publications on homeopathy; in other words, he selects 3 of my papers (references are copied below) and (without understanding them, as we will see) vaguely discusses them. In my view, that is remarkable in 3 ways:

  • firstly, there I have published about 100 more papers on homeopathy which Hahn ignores (even though he knows about them as we shall see below);
  • secondly, he does not explain why he selected those 3 and not any others;
  • thirdly, he totally misrepresents all the 3 articles that he has selected.

In the following, I will elaborate on the last point in more detail (anyone capable of running a Medline search and reading Hahn’s article can verify the other points). I will do this by repeating what Hahn states about each of the 3 papers (in bold print), and then explain what each article truly was about.

HERE WE GO

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FIRST ARTICLE

In 1998, he [Ernst] selected 5 studies using highly diluted remedies from the original 89 and concluded that homeopathy has no effect [5].

This paper [ref 5] was a re-analysis of the Linde Lancet meta-analysis (unfortunately, this paper is not available electronically, but I can send copies to interested parties). For this purpose, I excluded all the studies that did not

  • use homeopathy following the ‘like cures like’ assumption (arguably those studies are not trials of homeopathy at all),
  • use remedies which were not highly diluted and thus contained active molecules (nobody doubts that remedies with pharmacologically active substances can have effects),
  • that did not get the highest rating for methodological quality by Linde et al (flawed trials are known to produce false-positive results).

My methodology was (I think) reasonable, pre-determined and explained in full detail in the article. It left me with 5 placebo-controlled RCTs. A meta-analysis across these 5 trials showed no difference to placebo.

Hahn misrepresents this paper by firstly not explaining what methodology I applied, and secondly by stating that I ‘selected’ the 5 studies from a pool of 89 trials. Yet, I defined my inclusion criteria which were met by just 5 studies.

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SECOND ARTICLE

In 2000, Ernst and Pittler [6] sought to invalidate the statistically significant superiority of homeopathy over placebo in the 10 studies with the highest Jadad score. The odds ratio, as presented by Linde et al. in 1999 [3], was 2.00 (1.37–2.91). The new argument was that the Jadad score and odds ratio in favor of homeopathy seemed to follow a straight line (in fact, it is asymptotic at both ends). Hence, Ernst and Pittler [6] claimed that the highest Jadad scores should theoretically show zero effect. This reasoning argued that the assumed data are more correct than the real data.

The 1st thing to notice here is that Hahn alleges we had ‘sought to invalidate’. How can he know that? The fact is that we were simply trying to discover something new in the pool of data. The paper he refers to here has been discussed before on this blog. Here is what I stated:

This was a short ‘letter to the editor’ by Ernst and Pittler published in the J Clin Epidemiol commenting on the above-mentioned re-analysis by Linde et al which was published in the same journal. As its text is not available on-line, I re-type parts of it here:

In an interesting re-analysis of their meta-analysis of clinical trials of homeopathy, Linde et al conclude that there is no linear relationship between quality scores and study outcome. We have simply re-plotted their data and arrive at a different conclusion. There is an almost perfect correlation between the odds ratio and the Jadad score between the range of 1-4… [some technical explanations follow which I omit]…Linde et al can be seen as the ultimate epidemiological proof that homeopathy is, in fact, a placebo.

Again Hahn’s interpretation of our paper is incorrect and implies that he has not understood what we actually intended to do here.

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THIRD ARTICLE

Two years later, Ernst [7] summarized the systematic reviews of homeopathy published in the wake of Linde’s first metaanalysis [2]. To support the view that homeopathy lacks effect, Ernst cited his own publications from 1998 and 2000 [5, 6]. He also presented Linde’s 2 follow-up reports [3, 4] as being further evidence that homeopathy equals placebo. 

Again, Hahn assumes my aim in publishing this paper (the only one of the 3 papers that is available as full text on-line): ‘to support the view that homeopathy lacks effect’. He does so despite the fact that the paper very clearly states my aim: ‘This article is an attempt to critically evaluate all such papers published since 1997 with a view to defining the clinical effectiveness of homeopathic medicines.‘ This discloses perhaps better than anything else that Hahn’s article is not evidence, but opinion-based and not objective but polemic.

Hahn then seems to resent that I included my own articles. Does he not know that, in a systematic review, one has to include ALL relevant papers? Hahn also seems to imply that I merely included a few papers in my systematic review. In fact, I included all the 17 that were available at the time. It might also be worth mentioning that numerous subsequent and independent analyses that employed similar methodologies as mine arrived at the same conclusions as my review.

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Despite Hahn’s overtly misleading statements, he offers little real critique of my work. Certainly Hahn does not state that I made any major mistakes in the 3 papers he cites. For his more vitriolic comments, we need to look at the discussion section of his article where he states:

Ideology Plays a Part

Ernst [7] makes conclusions based on assumed data [6] when the true data are at hand [3]. Ernst [7] invalidates a study by Jonas et al. [18] that shows an odds ratio of 2.19 (1.55–3.11) in favor of homeopathy for rheumatic conditions, using the notion that there are not sufficient data for the treatment of any specific condition [6]. However, his review deals with the overall efficacy of homeopathy and not with specific conditions. Ernst [7] still adds this statistically significant result in favor of homeopathy over placebo to his list of arguments of why homeopathy does not work. Such argumentation must be reviewed carefully before being accepted by the reader.

After re-studying all this in detail, I get the impression that Hahn does not understand (or does not want to understand?) the research questions posed, nor the methodologies employed in my 3 articles. He is remarkably selective in choosing just 3 of my papers (his reference No 7 cites many more of my systematic reviews of homeopathy), and he seems to be determined to get the wrong end of the stick in order to defame me. How he can, based on his ‘analysis’ arrive at the conclusion that ” I have never encountered any scientific writer who is so clearly biased (biased) as this Edzard Ernst“, is totally beyond reason.

In one point, however, Hahn seems to be correct: IDEOLOGY PLAYS A PART (NOT IN MY BUT IN HIS EVALUATION).

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REFERENCES AS CITED IN HAHN’S ARTICLE

5 Ernst E: Are highly dilute homeopathic remedies placebos? Perfusion 1998;11:291.

6 Ernst E, Pittler MH: Re-analysis of previous metaanalysis of clinical trials of homeopathy. J Clin Epidemiol 2000;53:1188.

7 Ernst E: A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol 2002;54:577–582.

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For more information about Hahn, please see two comments on my previous post (by Björn Geir who understands Hahn’s native language).

This is also where you can find the only comment by Hahn that I am aware of:
Robert Hahn on Saturday 17 September 2016 at 09:50

Somebody alerted me on this website. Dr. Ernst spends most of his effort to reply to my article in Forsch Komplemetmed 2013; 20: 376-381 by discussing who I might be as a person. I hoped to see more effort being put on scientific reasoning.

1. For the scientific part: my experience in scientific reasoning of quite long and extensive. I am the most widely published Swede in the area of anesthesia and intensive care ever. Those who doubt this can look “Hahn RG” on PubMed.

2. For the religious part that, in my mind, has nothing to do with this topic, is that my wife developed a spiritualistic ability in the mid 1990:s which I have explored in four books published in Swedish between 1997 and 2007. I became convinced that much of this is true, but not all. The books reflect interviews with my wife and what happened in our family during that time. Almost half of all Swedes believe in afterlife and in the existence of a spiritual world. Dr. Ernsts reasoning is typical of skeptics, namely that a person with a known religious belief in not to trust – i.e. a person cannot have two sides, a religious and a scientific. I do not agree with that, but the view has led to that almost no scientist dares to tell his religious beliefs to anyone (which Ernst enforces by his reasoning). Besides, I am not very religious person at all, although the years spent writing these books was quite an interesting period of my life. In particular the last book which involved past-life memories that I had been revived during self-hypnotims. I am interested in exploring many sorts of secrets, not only scientific. But all types of evidence must be judged according to its own rules and laws.

3. Why did I write about homeopathy? The reason is a campaign led by skeptics in some summers ago. Teenagers sat in Swedish television and expressed firmly that “there is not a single publication showing that homeopathy works – nothing!”. I wonder how these young boys could know that, and suspected that had simply been instructed to say so by older skeptics . I looked up the topic on PubMed and soon found some positive papers. Not difficult to find. Had they looked? Surely not. I was a frequent blogger at the time, and wrote three blogs summarizing meta-analyses asking the question whether homeopathy was superior to placebo (disregarding the underlying disease). The response for my readers was impressive and I was eventually urged to write it up in English, which I did. That is the background to my article. I have no other involvement in homeopathy.

4. Me and Dr Ernst. I came across his name when scanning articles about homeopathy, and decided to look a bit deeper into what he had written. The typical scenario was to publish meta-analyses but excluding almost all material, leaving very little (of just a scant part of the literature) to summarize. No wonder there were no significant differences. If there were still significant differences the material was typically considered by him to be still too small or too imprecise or whatever to make any conclusion. This was quite systematic, and I lost trust in Ernst´s writings. This was pure scientific reasoning and has nothing to do with religion or anything else.

// Robert Hahn

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Lastly, if you need more info about Hahn, you might also want to read this.

The HRI is an innovative international charity created to address the need for high quality scientific research in homeopathy… HRI is dedicated to promoting cutting research in homeopathy, using the most rigorous methods available, and communicating the results of such work beyond the usual academic circles… HRI aims to bring academically reliable information to a wide international audience, in an easy to understand form. This audience includes the general public, scientists, healthcare providers, healthcare policy makers, government and the media.

This sounds absolutely brilliant!

I should be a member of the HRI!

For years, I have pursued similar aims!

Hold on, perhaps not?

This article makes me wonder:

START OF QUOTE

… By the end of 2014, 189 randomised controlled trials of homeopathy on 100 different medical conditions had been published in peer-reviewed journals. Of these, 104 papers were placebo-controlled and were eligible for detailed review:
41% were positive (43 trials) – finding that homeopathy was effective
5% were negative (5 trials) – finding that homeopathy was ineffective
54% were inconclusive (56 trials)

How does this compare with evidence for conventional medicine?

An analysis of 1016 systematic reviews of RCTs of conventional medicine had strikingly similar findings2:
44% were positive – the treatments were likely to be beneficial
7% were negative – the treatments were likely to be harmful
49% were inconclusive – the evidence did not support either benefit or harm.

END OF QUOTE

The implication here is that the evidence base for homeopathy is strikingly similar to that of real medicine.

Nice try! But sadly it has nothing to do with ‘reliable information’!!!

In fact, it is grossly (and I suspect deliberately) misleading.

Regular readers of this blog will have spotted the reason, because we discussed (part of) it before. Let me remind you:

_______________________________________________________________________________

A clinical trial is a research tool for testing hypotheses; strictly speaking, it tests the ‘null-hypothesis’: “the experimental treatment generates the same outcomes as the treatment of the control group”. If the trial shows no difference between the outcomes of the two groups, the null-hypothesis is confirmed. In this case, we commonly speak of a negative result. If the experimental treatment was better than the control treatment, the null-hypothesis is rejected, and we commonly speak of a positive result. In other words, clinical trials can only generate positive or negative results, because the null-hypothesis must either be confirmed or rejected – there are no grey tones between the black of a negative and the white of a positive study.

For enthusiasts of alternative medicine, this can create a dilemma, particularly if there are lots of published studies with negative results. In this case, the totality of the available trial evidence is negative which means the treatment in question cannot be characterised as effective. It goes without saying that such an overall conclusion rubs the proponents of that therapy the wrong way. Consequently, they might look for ways to avoid this scenario.

One fairly obvious way of achieving this aim is to simply re-categorise the results. What, if we invented a new category? What, if we called some of the negative studies by a different name? What about INCONCLUSIVE?

That would be brilliant, wouldn’t it. We might end up with a simple statistic where the majority of the evidence is, after all, positive. And this, of course, would give the impression that the ineffective treatment in question is effective!

How exactly do we do this? We continue to call positive studies POSITIVE; we then call studies where the experimental treatment generated worst results than the control treatment (usually a placebo) NEGATIVE; and finally we call those studies where the experimental treatment created outcomes which were not different from placebo INCONCLUSIVE.

In the realm of alternative medicine, this ‘non-conclusive result’ method has recently become incredibly popular . Take homeopathy, for instance. The Faculty of Homeopathy proudly claim the following about clinical trials of homeopathy: Up to the end of 2011, there have been 164 peer-reviewed papers reporting randomised controlled trials (RCTs) in homeopathy. This represents research in 89 different medical conditions. Of those 164 RCT papers, 71 (43%) were positive, 9 (6%) negative and 80 (49%) non-conclusive.

This misleading nonsense was, of course, warmly received by homeopaths. The British Homeopathic Association, like many other organisations and individuals with an axe to grind lapped up the message and promptly repeated it: The body of evidence that exists shows that much more investigation is required – 43% of all the randomised controlled trials carried out have been positive, 6% negative and 49% inconclusive.

Let’s be clear what has happened here: the true percentage figures seem to show that 43% of studies (mostly of poor quality) suggest a positive result for homeopathy, while 57% of them (on average the ones of better quality) were negative. In other words, the majority of this evidence is negative. If we conducted a proper systematic review of this body of evidence, we would, of course, have to account for the quality of each study, and in this case we would have to conclude that homeopathy is not supported by sound evidence of effectiveness.

The little trick of applying the ‘INCONCLUSIVE’ method has thus turned this overall result upside down: black has become white! No wonder that it is so popular with proponents of all sorts of bogus treatments.

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But one trick is not enough for the HRI! For thoroughly misinforming the public they have a second one up their sleeve.

And that is ‘comparing apples with pears’  – RCTs with systematic reviews, in their case.

In contrast to RCTs, systematic reviews can be (and often are) INCONCLUSIVE. As they evaluate the totality of all RCTs on a given subject, it is possible that some RCTs are positive, while others are negative. When, for example, the number of high-quality, positive studies included in a systematic review is similar to the number of high-quality, negative trials, the overall result of that review would be INCONCLUSIVE. And this is one of the reasons why the findings of systematic reviews cannot be compared in this way to those of RCTs.

I suspect that the people at the HRI know all this. They are not daft! In fact, they are quite clever. But unfortunately, they seem to employ their cleverness not for informing but for misleading their ‘wide international audience’.

Personally, I find our good friend Dana Ullman truly priceless. There are several reasons for that; one is that he is often so exemplarily wrong that it helps me to explain fundamental things more clearly. With a bit of luck, this might enable me to better inform people who might be thinking a bit like Dana. In this sense, our good friend Dana has significant educational value.

Recently, he made this comment:

According to present and former editors of THE LANCET and the NEW ENGLAND JOURNAL OF MEDICINE, “evidence based medicine” can no longer be trusted. There is obviously no irony in Ernst and his ilk “banking” on “evidence” that has no firm footing except their personal belief systems: https://medium.com/@drjasonfung/the-corruption-of-evidence-based-medicine-killing-for-profit-41f2812b8704

Ernst is a fundamentalist whose God is reductionistic science, a 20th century model that has little real meaning today…but this won’t stop the new attacks on me personally…

END OF COMMENT

Where to begin?

Let’s start with some definitions.

  • Evidence is the body of facts that leads to a given conclusion. Because the outcomes of treatments such as homeopathy depend on a multitude of factors, the evidence for or against their effectiveness is best based not on experience but on clinical trials and systematic reviews of clinical trials (this is copied from my book).
  • EBM 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 (and this is from another book).

Few people would argue that EBM, as it is applied currently, is without fault. Certainly I would not suggest that; I even used to give lectures about the limitations of EBM, and many experts (who are much wiser than I) have written about the many problems with EBM. It is important to note that such criticism demonstrates the strength of modern medicine and not its weakness, as Dana seems to think: it is a sign of a healthy debate aimed at generating progress. And it is noteworthy that internal criticism of this nature is largely absent in alternative medicine.

The criticism of EBM is often focussed on the unreliability of the what I called above the ‘best research evidence’. Let me therefore repeat what I wrote about it on this blog in 2012:

… The multifactorial nature of any clinical response requires controlling for all the factors that might determine the outcome other than the treatment per se. Ideally, we would need to create a situation or an experiment where two groups of patients are exposed to the full range of factors, and the only difference is that one group does receive the treatment, while the other one does not. And this is precisely the model of a controlled clinical trial.

Such studies are designed to minimise all possible sources of bias and confounding. By definition, they have a control group which means that we can, at the end of the treatment period, compare the effects of the treatment in question with those of another intervention, a placebo or no treatment at all.

Many different variations of the controlled trial exist so that the exact design can be adapted to the requirements of the particular treatment and the specific research question at hand. The over-riding principle is, however, always the same: we want to make sure that we can reliably determine whether or not the treatment was the cause of the clinical outcome.

Causality is the key in all of this; and here lies the crucial difference between clinical experience and scientific evidence. What clinician witness in their routine practice can have a myriad of causes; what scientists observe in a well-designed efficacy trial is, in all likelihood, caused by the treatment. The latter is evidence, while the former is not.

Don’t get me wrong; clinical trials are not perfect. They can have many flaws and have rightly been criticised for a myriad of inherent limitations. But it is important to realise that, despite all their short-comings, they are far superior than any other method for determining the efficacy of medical interventions.

There are lots of reasons why a trial can generate an incorrect, i.e. a false positive or a false negative result. We therefore should avoid relying on the findings of a single study. Independent replications are usually required before we can be reasonably sure.

Unfortunately, the findings of these replications do not always confirm the results of the previous study. Whenever we are faced with conflicting results, it is tempting to cherry-pick those studies which seem to confirm our prior belief – tempting but very wrong. In order to arrive at the most reliable conclusion about the efficacy of any treatment, we need to consider the totality of the reliable evidence. This goal is best achieved by conducting a systematic review.

In a systematic review, we assess the quality and quantity of the available evidence, try to synthesise the findings and arrive at an overall verdict about the efficacy of the treatment in question. Technically speaking, this process minimises selection and random biases. Systematic reviews and meta-analyses [these are systematic reviews that pool the data of individual studies] therefore constitute, according to a consensus of most experts, the best available evidence for or against the efficacy of any treatment.

END OF QUOTE

Other criticism is aimed at the way EBM is currently used (and abused). This criticism is often justified and necessary, and it is again the expression of our efforts to generate progress. EBM is practised by humans; and humans are far from perfect. They can be corrupt, misguided, dishonest, sloppy, negligent, stupid, etc., etc. Sadly, that means that the practice of EBM can have all of these qualities as well. All we can do is to keep on criticising malpractice, educate people, and hope that this might prevent the worst abuses in future.

Dana and many of his fellow SCAMers have a different strategy; they claim that EBM “can no longer be trusted” (interestingly they never tell us what system might be better; eminence-based medicine? experience-based medicine? random-based medicine? Dana-based medicine?).

The claim that EBM can no longer be trusted is clearly not true, counter-productive and unethical; and I suspect they know it.

Why then do they make it?

Because they feel that it entitles them to argue that homeopathy (or any other form of SCAM) cannot be held to EBM-standards. If EBM is unreliable, surely, nobody can ask the ‘Danas of this world’ to provide anything like sound data!!! And that, of course, would be just dandy for business, wouldn’t it?

So, let’s not be deterred  or misled by these deliberately destructive people. Their motives are transparent and their arguments are nonsensical. EBM is not flawless, but with our continued efforts it will improve. Or, to repeat something that I have said many times before: EBM is the worst form of healthcare, except for all other known options.

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