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

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On this blog, we constantly discuss the shortcomings of clinical trials of (and other research into) alternative medicine. Yet, there can be no question that research into conventional medicine is often unreliable as well.

What might be the main reasons for this lamentable fact?

A recent BMJ article discussed 5 prominent reasons:

Firstly, much research fails to address questions that matter. For example, new drugs are tested against placebo rather than against usual treatments. Or the question may already have been answered, but the researchers haven’t undertaken a systematic review that would have told them the research was not needed. Or the research may use outcomes, perhaps surrogate measures, that are not useful.

Secondly, the methods of the studies may be inadequate. Many studies are too small, and more than half fail to deal adequately with bias. Studies are not replicated, and when people have tried to replicate studies they find that most do not have reproducible results.

Thirdly, research is not efficiently regulated and managed. Quality assurance systems fail to pick up the flaws in the research proposals. Or the bureaucracy involved in having research funded and approved may encourage researchers to conduct studies that are too small or too short term.

Fourthly, the research that is completed is not made fully accessible. Half of studies are never published at all, and there is a bias in what is published, meaning that treatments may seem to be more effective and safer than they actually are. Then not all outcome measures are reported, again with a bias towards those are positive.

Fifthly, published reports of research are often biased and unusable. In trials about a third of interventions are inadequately described meaning they cannot be implemented. Half of study outcomes are not reported.

END OF QUOTE

Apparently, these 5 issues are the reason why 85% of biomedical research is being wasted.

That is in CONVENTIONAL medicine, of course.

What about alternative medicine?

There is no question in my mind that the percentage figure must be even higher here. But do the same reasons apply? Let’s go through them again:

  1. Much research fails to address questions that matter. That is certainly true for alternative medicine – just think of the plethora of utterly useless surveys that are being published.
  2. The methods of the studies may be inadequate. Also true, as we have seen hundreds of time on this blog. Some of the most prevalent flaws include in my experience small sample sizes, lack of adequate controls (e.g. A+B vs B design) and misleading conclusions.
  3. Research is not efficiently regulated and managed. True, but probably not a specific feature of alternative medicine research.
  4. Research that is completed is not made fully accessible. most likely true but, due to lack of information and transparency, impossible to judge.
  5. Published reports of research are often biased and unusable. This is unquestionably a prominent feature of alternative medicine research.

All of this seems to indicate that the problems are very similar – similar but much more profound in the realm of alternative medicine, I’d say based on many years of experience (yes, what follows is opinion and not evidence because the latter is hardly available).

The thing is that, like almost any other job, research needs knowledge, skills, training, experience, integrity and impartiality to do it properly. It simply cannot be done well without such qualities. In alternative medicine, we do not have many individuals who have all or even most of these qualities. Instead, we have people who often are evangelic believers in alternative medicine, want to further their field by doing some research and therefore acquire a thin veneer of scientific expertise.

In my 25 years of experience in this area, I have not often seen researchers who knew that research is for testing hypotheses and not for trying to prove one’s hunches to be correct. In my own team, those who were the most enthusiastic about a particular therapy (and were thus seen as experts in its clinical application), were often the lousiest researchers who had the most difficulties coping with the scientific approach.

For me, this continues to be THE problem in alternative medicine research. The investigators – and some of them are now sufficiently skilled to bluff us to believe they are serious scientists – essentially start on the wrong foot. Because they never were properly trained and educated, they fail to appreciate how research proceeds. They hardly know how to properly establish a hypothesis, and – most crucially – they don’t know that, once that is done, you ought to conduct investigation after investigation to show that your hypothesis is incorrect. Only once all reasonable attempts to disprove it have failed, can your hypothesis be considered correct. These multiple attempts of disproving go entirely against the grain of an enthusiast who has plenty of emotional baggage and therefore cannot bring him/herself to honestly attempt to disprove his/her beloved hypothesis.

The plainly visible result of this situation is the fact that we have dozens of alternative medicine researchers who never publish a negative finding related to their pet therapy (some of them were admitted to what I call my HALL OF FAME on this blog, in case you want to verify this statement). And the lamentable consequence of all this is the fast-growing mountain of dangerously misleading (but often seemingly robust) articles about alternative treatments polluting Medline and other databases.

One of the biggest danger of SCAM, in my view, is the fact that SCAM-practitioners all too often advise their patients to forego effective conventional medicine. This probably applies to most medicines, but is best-researched for immunisations. A recent article puts it clearly:

… negative attitudes towards vaccines reflect a broader and deeper set of beliefs about health and wellbeing… this alternative worldview is influenced by ontological confusions (e.g. regarding purity, natural energy), and knowledge based on personal lived experience and trusted peers, rather than the positivist epistemological framework. [This] view is supported by recent social-psychological research, including strong correlations of vaccine scepticism with adherence to complementary and alternative medicine, magical health beliefs, and conspiracy ideation. For certain well-educated and well-resourced individuals, opposition to vaccines represents an expression of personal intuition and agency, in achieving a positive and life-affirming approach to health and wellbeing. These core beliefs are not amenable to change – and especially resistant to communications from orthodox, authoritative sources.

The authors concluded suggesting that a better long-term strategy is to combine with other disciplines in order to address the root causes of vaccine scepticism. Vaccine scepticism is unlikely to thrive in a cultural context that trusts and values the scientific consensus.

If I understand them correctly, the authors believe it is necessary to change the societal attitude to science.

I am sure they are correct.

We live in a time when anyone’s opinion is deemed as valuable as the next person’s. Pseudo-experts who have their knowledge from a couple of google searches are being considered as trustworthy as the true experts who have the background, knowledge and experience to issue responsible advice. Science is viewed by many as just another way of knowing, or even as the new cult or religion that must be viewed with suspicion.

It is clear that these are deplorable developments. But how to stop them?

This is where it gets complex.

One is tempted to lay the blame at the door of our politicians. Why do we tolerate the fact that so many of them have not the slightest inkling about science?

But hold on, WE elected them!

Why?

Because large sections of the public are ignorant too.

So, one must start much earlier. We need better science education, and that has to begin in the first year of schooling! We need evening classes in critical thinking. We need adult science courses for politicians.

But this is not going to happen, because our politicians fail to see the importance of such measures (and, of course, they might feel that an uneducated public is easier to govern than an educated one).

How to break this vicious circle?

It is clear from these simple (and simplistic) reflections that a multifactorial approach is required. And it is clear that it ought to be a strategy that prevents standards in the most general terms from slipping ever lower. But how?

I wish I knew!!!

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.

An article has just been published announcing the reform of the German Heilpraktiker, the profession of alternative practitioners that has been discussed repeatedly on this blog and criticised recently by the ‘Muensteraner Kreis’. As the new article is in German, I will try to summarise the essence of it here:

The health ministers of all German counties have decided yesterday that they will start reforming the profession of the Heilpraktiker that has attracted much criticism in recent months. The current laws are no longer fit for purpose. There is neither a mandatory agreement for the education of the Heilpraktiker, nor a uniform regulation of the profession.

The senator for health from Hamburg stated: “We feel that the Heilpraktiker should not be allowed to do certain thing, but be permitted to do plenty of activities that remain legal.” At present, the Heilpraktiker is allowed to treat fractures, malignancies, give injections, and even manufacture certain medicines. “We believe there is a need for regulation to protect patients.”

Now a working group will be formed to investigate and produce a report within a year. Remarkably, the German health secretary avoided commenting. In a statement, it was said that patients must be empowered to make decisions on the basis of quality-assured information.

The full German text is below.

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Nach mehreren deutschlandweit Aufsehen erregenden Todesfällen beispielsweise von Krebspatienten, die kurz nach der Therapie durch einen Heilpraktiker in Brüggen-Bracht starben, will die Politik sich nun diesen Berufszweig vornehmen. Die Gesundheitsminister aller Bundesländer haben am Donnerstag beschlossen, eine Reform anzugehen. „Das unzureichend regulierte Heilpraktikerwesen mit seiner umfassenden Heilkundebefugnis steht unverändert in der Kritik“, heißt es in einer Erklärung. Das Heilpraktikergesetz könne dem heutigen Anspruch an den Gesundheitsschutz der Patienten nicht mehr gerecht werden. Für Heilpraktiker gebe es weder verbindliche Regeln zur Ausbildung noch eine einheitliche Berufsordnung. Andere Gesundheitsberufe müssten hingegen strenge Qualifikationskriterien erfüllen.

„Wir sehen es als kritisch an, dass einige Tätigkeiten zwar den Heilpraktikern untersagt sind, aber es noch eine Fülle von Tätigkeiten gibt, die zugelassen sind“, sagte die Hamburger Senatorin für Gesundheit, Cornelia Prüfer-Storcks, auf einer Pressekonferenz – sie hatte die Initiative maßgeblich  vorangetrieben.  So dürfen Heilpraktiker Knochenbrüche therapieren, schwere und bösartige Erkrankungen behandeln und Injektionen geben. Selbst die Herstellung von Arzneimitteln für bestimmte Patienten sei Heilpraktikern erlaubt. „Ohne die Prüfmechanismen, die wir normalerweise haben, wenn wir Arzneimittel zulassen und produzieren“, kritisierte Prüfer-Storcks. „Wir glauben, dass es hier Regelungsbedarf gibt aus Sicht des Patientenschutzes.“

„Die Ministerinnen und Minister, Senatorinnen und Senatoren für Gesundheit sehen eine zwingende Reformbedürftigkeit des Heilpraktikerwesens“, heißt es in dem kurzen, MedWatch vorliegenden Beschluss. „Der Bund wird gebeten, eine Bund-Länder-Arbeitsgruppe einzurichten, die eine grundlegende Reform des Heilpraktikerwesens prüft.“ Das Ergebnis der Prüfung solle bis zur Gesundheitsministerkonferenz in einem Jahr vorgelegt werden.

Bundesgesundheitsminister Jens Spahn erklärte auf der Pressekonferenz das Patientenwohl zwar zum entscheidenden Maßstab für die Gesundheitspolitik. „Deshalb finde ich es richtig, dass die Gesundheitsministerkonferenz bei der Patientenorientierung ihren Schwerpunkt setzt“, sagte er. Auf mögliche Reformen des Heilpraktikerberufes ging der Minister bei der Pressekonferenz jedoch nicht ein. Inwiefern sein Haus die von den Landesministern geforderte Reform des Heilpraktikerwesens mit unterstützen wird, bleibt offen. Auf Nachfrage, ob das Ministerium eine Bund-Länder-Arbeitsgruppe unterstützen würde, versteckte sich eine Sprecherin bereits im Mai hinter der Mini-Reform von Gröhe. Mit Blick auf die kurze Zeit seit Inkrafttreten dieser Änderungen sei es angemessen, zunächst zu prüfen, ob und inwieweit diese zum Schutz des Patientenwohles beiträgt, erklärte sie – „ehe weitere gesetzliche Maßnahmen in Betracht gezogen werden sollten“.

In einem Grundsatzbeschluss sprach sich die Gesundheitsministerkonferenz außerdem für „Patientenorientierung als Element einer zukunftsweisenden Gesundheitspolitik“ aus. „Das heißt, dass der Patient natürlich das Heft in der Hand haben muss, dass er versteht, was mit ihm gemacht wird, warum es mit ihm gemacht wird, mit welchen Chancen die Behandlung verbunden ist“, sagte NRW-Gesundheitsminister Karl Laumann. Auch in der Ausbildung des Gesundheitspersonals sollten diese Aspekte einen großen Stellenwert bekommen, betonte Laumann – und erwähnte zwar Ärzte als Berufsgruppe explizit, nicht aber Heilpraktiker. Der frühere Bundespatientenbeauftragte forderte außerdem mehr Transparenz ein. In Teilen des Gesundheitssystems gebe es wegen mangelnder Transparenz „eine gewisse Misstrauenskultur“, sagte er.

Die Minister wollen laut dem Beschluss die Patientensouveränität und der Orientierung im Gesundheitswesen verbessern, die Gesundheitskompetenz und gesundheitliche Eigenverantwortung beispielsweise durch die Einrichtung eines nationalen Gesundheitsportals deutlich stärken und Kommunikation und Wissenstransfer zwischen Patienten und allen Beteiligten im Gesundheitswesen fördern. „Patienten sollen so in die Lage versetzt werden, ihre Interessen besser zu vertreten und ihre Entscheidungen auf der Basis qualitätsgesicherter Informationen zu treffen“, heißt es.

Kommunikationskompetenz und wertschätzende Beziehungsgestaltung sei im Gesundheitswesen von wesentlicher Bedeutung für die Partizipation, Qualität, Sicherheit und den Erfolg der gesundheitlichen Prävention und der medizinischen Behandlung, betonen die Minister. Allgemeinverständliche „Patientenbriefe“ sollen als erster Schritt die Informiertheit von Patienten nach Krankenhausbehandlungen erhöhen. Außerdem soll das Bundesgesundheitsminister eine Pflicht schaffen, dass niedergelassene Ärzte ihren Patienten neutrale und evidenzbasierte schriftliche Informationen zu Zusatzangeboten – sogenannten „Individuellen Gesundheitsleistungen“ – zur Verfügung stellen müssen.

Bei Behandlungsfehlern sollen nach Ansicht der Landesminister auf Bundesebene weitere Erleichterungen umgesetzt werden: Die Beweislast und das Beweismaß soll zu Gunsten von Patienten überarbeitet werden. Außerdem sollten Krankenkassen gesetzlich verpflichtet werden, Patienten beim Nachweis eines Behandlungsfehlers besser zu unterstützen.

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I have been banging on about the German Heilpraktiker, its infamous history and its utter inadequacy since many years. This is what I published in 1996, for instance:

Complementary medicine is increasing in popularity. In most countries its practice is in the hands of non-medically trained practitioners, professions which are often not properly regulated. When discussing solutions to this problem the German “Heilpraktiker” is often mentioned. The history and present situation of this profession are briefly outlined. The reasons why the “Heilpraktiker concept” is not an optimal solution are discussed. It is concluded that the best way forward consists of regulation and filling the considerable gaps in knowledge relating to complementary medicine.

It goes without saying that, after so many tears of warning about the risks involved in allowing poorly trained practitioners, who are all too often unable to see the limits of their competency (and after many unnecessary fatalities), I am delighted that progress seems finally to be on the horizon.

This is a somewhat unusual post.

I do not normally dwell on personal anecdotes or experiences – but this one might be relevant, and it is absolutely true.

About 7 or 8 years ago (we had just published our book Trick or Treatment), I was invited to a meeting of health insurers. Not just any old meeting, but a top-notch conference where many of the world’s most influential executives of large insurance companies were gathered. It took place in one of the most luxurious hotels of Istanbul. The most prominent speaker was the brother of France’s president Sarkozy (who flew in by helicopter and came with two body-guards). He began his lecture by stating “You of course all know me because I have a famous sister in law.”

I did not have such a witty opening phrase for my talk. My task was to review the evidence for and against the major alternative therapies (at the time, I did such lectures regularly). My audience of about 300 people listened politely to what I had to say and, during, question time, they made some relevant comments. Altogether, it was a good and well-received lecture.

But the interesting bit came later.

Over coffee, I was surrounded by people who came to me and said something like this: “We know the evidence, of course, and we know how flimsy it is, particularly for homeopathy. But we still pay for it, because the competition does it too. We cannot be seen to offer less than they do. This is purely a commercial decision about being seen to be competitive.”

Such honesty came as a surprise to me. I had expected that they were well-informed about the evidence; after all, they were in charge of huge companies selling health insurances. Not knowing about the evidence would have been negligent. But I had not expected they would volunteer their motives quite so openly. I got the impression that they were trying to justify their nonsensical actions without seeming irrational. In a way, they seemed to say: ‘Such treatments might not work for the patient, but they do work for us’.

I remember suggesting to some of these executives that they could even be more competitive, progressive and ethical by telling their customers that they took better care of their money that the competition by NOT paying for ineffective treatments. Such remarks  resulted in blank faces or vague smiles. I felt my audience had not really understood the opportunity. Being honest, transparent and evidence-based was evidently not understood as a viable marketing tool.

As I said, this was almost a decade ago

… lots has happened since.

I wonder whether the message might be more attractive today.

An announcement by the UK Society of Homeopaths caught my attention. Here it is in its full and unabbreviated beauty:

START OF ANNOUNCEMENT

Homeopaths are being urged to contribute to an inquiry exploring ways to tackle a looming public health crisis threatened by ‘superbugs’ – bacteria resistant to antibiotics and other antimicrobial drugs.

The Commons Select Committee on Health and Social Care is inviting evidence for its investigation into the progress made by the government so far in responding to the challenge.

The two angles it is exploring are:

  • What results have been delivered by the current UK strategy on antimicrobial resistance (AMR), launched in 2013?
  • Key actions and priorities for the government’s next AMR strategy, due to be published at the end of 2018.

The Society of Homeopaths is putting together a submission and is asking members to submit their own evidence to the inquiry of using homeopathic alternatives to antimicrobials.

According to the inquiry background papers, antimicrobial resistance – in which bacteria have evolved into ‘superbugs’,  resistant to drugs devised to kill them – is a “significant and increasing threat” to public health in the UK and globally. EU data indicates that it is responsible for 700,000 deaths a year worldwide and at least 50,000 in the US and Europe.

The death toll could reach 10m people a year by 2050 if the rise in resistance is not headed off, it is estimated.

Society Chief Executive Mark Taylor said: “Our members know a great deal about the alternatives to antibiotics through their own practice and knowledge. This is a timely inquiry from the Health and Social Care Committee to assess the success of the existing strategy and an opportunity to make the case again for fresh thinking on this pressing public health challenge.”

END OF ANNOUNCEMENT

Yes, of course!

We have a crisis of antibiotic resistance.

Who is going to offer the solution?

THE HOMEOPATHS!!!

How?

They are going to treat us all with homeopathic remedies when the superbugs strike.

And the result?

No more crisis.

How come?

Because they have turned it into a catastrophe!!!

When NHS England announced several months ago that they plan to stop the reimbursement of homeopathy, UK homeopaths were understandably upset and decided to launch a legal challenge to this decision. Yesterday, the result of this challenge has been published in a NHS press-release:

START OF QUOTE

NHS chief Simon Stevens has today welcomed the High Court’s decisive rejection of a legal challenge by the British Homeopathic Association to overturn plans to no longer routinely fund homeopathy on the NHS.

As part of action to clamp down on waste, over the last two years NHS England has taken action to curb prescriptions for medicines that can be bought over the counter or are of low value.

At the end of last year NHS England published guidance to curb prescriptions for 18 ineffective, unsafe or low clinical priority treatments, such as coproxamol, some dietary supplements, herbal treatments and homeopathy, saving up to £141 million a year. Earlier this year NHS England published a further list of 35 minor, short-term conditions for which over the counter medicines should not routinely be prescribed, saving around a further £100 million a year.

Savings form a key building block of the NHS’s 10 point efficiency plan contained in the Next Steps on the NHS Five Year Forward View, published in March 2017.

NHS chief, Simon Stevens said: “There is no robust evidence to support homeopathy which is at best a placebo and a misuse of scarce NHS funds.

“So we strongly welcome the High Court’s clear cut decision to kick out this costly and spurious legal challenge.”

Guidance on items which should not be routinely prescribed in primary care is available on the NHS England website.

END OF QUOTE

The reaction of UK homeopaths was as swift and deluded as it was predictable. The British Homeopathy Association, for instance, commented thus:

… The charity’s main claims against NHS England were that the consultation misrepresented homeopathy and therefore was unfair; and a report used in the consultation to inform the public was so complicated it would deter rather than encourage people to respond. Although the judge found there were sufficient grounds for a judicial review, after four days of lengthy legal arguments he dismissed the claims. Margaret Wyllie, BHA Chair, said the case highlighted how health bosses were unfairly manipulating the consultation process and making decisions about healthcare services without genuine patient engagement. “That NHS England attracted fewer than 3,000 responses from patients to a national consultation that ran for three months highlights its failure to genuinely engage with the public on important decisions about healthcare provision. Although 18 medicines were under review the only negative statement in NHS England’s press release promoting its public consultation was about homeopathy. The statement was so prejudicial it was widely reported in the media that the decision to deny patients homeopathic medicines had already been taken. How the judge failed to recognise that this was a deliberate attempt by NHS England to unfairly influence the public is astonishing,” said Mrs Wyllie.

In The Telegraph, Wyllie is quoted saying: It appears NHS England can fail to engage with patients properly on removing services and get away with it. That is not good enough, for it is important to remember that the real losers in this case are the patients who are now being refused a treatment on which they have come to depend.”

One can only marvel at the lack of insight and self-criticism. I should to add that the BHA is a charity; with this court case, they have wasted significant amounts of public money for their own, hopelessly misguided interests. To me, this indicates that they no longer deserve a charitable status.

Personally, I had very little doubt that the court would decide as it did. The evidence was simply overwhelming and indisputable. In the written judgement, the judge stated that “I am satisfied that NHSE was rigorous in the discharge of the duty to have “due regard” to relevant matters, and that it was entitled, on the evidence before it, to conclude that the Guidance would not have an adverse impact on the statutory equality objectives, but rather, as the Analysis found, “would [enable] patients to have access to the most effective medications to achieve the best outcomes”.

 

In all this, the open questions, in my view, were whether

  1. Prince Charles, the prime defender of quackery in the UK, would intervene,
  2. and whether his intervention might change anything.

So, did he try to intervene?

I do not know. It could be that, after all the hoo-ha about his spider memos, he now is a little more cautions about meddling in health politics. It could also be that, as he is getting ready to become king, he wants to keep a low profile about his more bizarre ideas. Lastly, it could be that his opinion does not weigh as heavily as I had feared.

In any case, The High Court ruling is most welcome and unquestionably just, progressive, and long-overdue. I applaud all who have worked hard to bring it about, and am sure that (most of) my readers agree.

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.

Nipah virus (NiV) infection is a zoonosis that causes severe disease in both animals and humans. The natural host of the virus are fruit bats of the Pteropodidae Family, Pteropus genus. Human-to-human transmission has also been documented, including in a hospital setting in India. Clinical presentations range from asymptomatic infection to acute respiratory syndrome and fatal encephalitis. There is no vaccine for either humans or animals. The primary treatment for human cases is intensive supportive care. In Kerala, India, several people have died of the deadly NiV.  The infection has a mortality rate of around 70%.

It was predictable that such events would bring homeopaths to the fore. This article explains:

The Indian Homeopathic Medical Association’s Kerala unit has claimed to have the medicines to treat Nipah virus. B Unnikrishnan, an association official, said homeopathy has the appropriate medicines for all types of fever and hence they should be allowed to treat the infected patients. The association has requested the state Health Minister KK Shailaja to allow their professionals to examine the records of all those patients who have been tested positive for Nipah… So far, 16 people have died and two are recovering. Some 2,000 people who came in contact with the infected patients are also being monitored.

Knowing that an international delegation of homeopaths travelled to Liberia to treat Ebola (with the official support of their respective professional organisations), this news cannot surprise anyone.

Homeopaths dilute their remedies and delude themselves.

Sadly, the victims of their dilutions/delusions are: 

  • their patients,
  • public health,
  • progress,
  • and rationality.

I have said it often, and I say it again: I do like well-conducted systematic reviews; and Cochrane reviews are usually the best, i. e. most transparent, most thorough and least biased. Thus, I was pleased to see a new Cochrane review of acupuncture aimed at assessing the benefits and harms of acupuncture in patients with hip OA.

The authors included randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, another active treatment, or no specific treatment; and RCTs that evaluated acupuncture as an addition to another treatment. Major outcomes were pain and function at the short term (i.e. < 3 months after randomization) and adverse events.

Six RCTs with 413 participants were included. Four RCTs included only people with OA of the hip, and two included a mix of people with OA of the hip and knee. All RCTs included primarily older participants, with a mean age range from 61 to 67 years, and a mean duration of hip OA pain from two to eight years. Approximately two-thirds of participants were women. Two RCTs compared acupuncture versus sham acupuncture; the other four RCTs were not blinded. All results were evaluated at short-term (i.e. four to nine weeks after randomization).In the two RCTs that compared acupuncture to sham acupuncture, the sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture-specific effects, due to placement of non-penetrating needles at the correct acupuncture points in one RCT, and the use of penetrating needles not inserted at the correct points in the other RCT. For these two sham-controlled RCTs, the risk of bias was low for all outcomes.

The combined analysis of two sham-controlled RCTs gave moderate quality evidence of little or no effect in reduction in pain for acupuncture relative to sham acupuncture. Due to the small sample sizes in the studies, the confidence interval includes both the possibility of moderate benefit and the possibility of no effect of acupuncture (120 participants; Standardized Mean Difference (SMD) -0.13, (95% Confidence Interval (CI) -0.49 to 0.22); 2.1 points greater improvement with acupuncture compared to sham acupuncture on 100 point scale (i.e., absolute percent change -2.1% (95% CI -7.9% to 3.6%)); relative percent change -4.1% (95% CI -15.6% to 7.0%)). Estimates of effect were similar for function (120 participants; SMD -0.15, (95% CI -0.51 to 0.21)). No pooled estimate, representative of the two sham-controlled RCTs, could be calculated or reported for the quality of life outcome.

The four other RCTs were unblinded comparative effectiveness RCTs, which compared (additional) acupuncture to four different active control treatments. There was low quality evidence that addition of acupuncture to the routine primary care that RCT participants were receiving from their physicians was associated with statistically significant and clinically relevant benefits, compared to the routine primary physician care alone, in pain (1 RCT; 137 participants; mean percent difference -22.9% (95% CI -29.2% to -16.6%); relative percent difference -46.5% (95% CI -59.3% to -33.7%)) and function (mean percent difference -19.0% (95% CI -24.41 to -13.59); relative percent difference -38.6% (95% CI -49.6% to -27.6%)). There was no statistically significant difference for mental quality of life and acupuncture showed a small, significant benefit for physical quality of life.

The effects of acupuncture compared with either advice plus exercise or NSAIDs are uncertain. The authors are also uncertain whether acupuncture plus patient education improves pain, function, and quality of life, when compared to patient education alone.

In general, the overall quality of the evidence for the four comparative effectiveness RCTs was low to very low, mainly due to the potential for biased reporting of patient-assessed outcomes due to lack of blinding and sparse data.

Information on safety was reported in 4 RCTs. Two RCTs reported minor side effects of acupuncture, which were primarily minor bruising, bleeding, or pain at needle insertion sites.

The authors concluded that acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants’ greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor.

This is an excellent review of data that (because of contradictions, methodological limitations, heterogeneity etc.) are not easy to evaluate fairly. The review shows that previous verdicts about acupuncture for osteoarthritis might have been too optimistic. Acupuncture has no or only very small specific therapeutic effects. As we have much better therapeutic options for this condition, it means that acupuncture can no longer be recommended as an effective therapy.

That surely must be big news in the little world of acupuncture!

I have been personally involved in several similar reviews:

In 1997, I concluded that the most rigorous studies suggest that acupuncture is not superior to sham-needling in reducing pain of osteoarthritis: both alleviate symptoms to roughly the same degree.

In 2006, the balance of evidence seemed to have shifted and more positive data had emerged; consequently our review concluded that sham-controlled RCTs suggest specific effects of acupuncture for pain control in patients with peripheral joint OA. Considering its favourable safety profile acupuncture seems an option worthy of consideration particularly for knee OA. Further studies are required particularly for manual or electro-acupuncture in hip OA.

Now, it seems that my initial conclusion of 1996 was more realistic. To me this is a fascinating highlight on the fact that in EBM, we change our minds based on the current best evidence. By contrast, in alternative medicine, as we have often lamented on this blog, minds do not easily change and all too often dogma seems to reign.

The new Cochrane review is important in several ways. Firstly, it affirms an appropriately high standard for such reviews. Secondly, it originates from a research team that has, in the past, been outspokenly pro-acupuncture; it is therefore unlikely that the largely negative findings were due to an anti-acupuncture bias. Thirdly – and most importantly – osteoarthritis has been THE condition for which even critical reviewers had to admit that there was at least some good, positive evidence.

It seems therefore, that yet again a beautiful theory has been slain by an ugly fact.

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