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

EBM

The ‘Schwaebische Tageblatt’ is not on my regular reading list. But this article of yesterday (16/10/2018) did catch my attention. For those who read German, I will copy it below, and for those who don’t I will provide a brief summary and comment thereafter:

Die grün-schwarze Landesregierung lässt 2019 den ersten Lehrstuhl für Naturheilkunde und Integrative Medizin in Baden-Württemberg einrichten. Lehrstuhl für Naturheilkunde und Integrative Medizin

Ihren Schwerpunkt soll die Professur im Bereich Onkologie haben. Strömungen wie Homöopathie oder Anthroposophie sollen nicht gelehrt, aber innerhalb der Lehre beleuchtet werden, sagte Ingo Autenrieth, Dekan der Medizinischen Fakultät in Tübingen am Dienstag der Deutschen Presse-Agentur. «Ideologien und alles, was nichts mit Wissenschaft zu tun hat, sortieren wir aus.»

Die Professur soll sich demnach mit Themen wie Ernährung, Probiotika und Akupunktur beschäftigten. Geplant ist laut Wissenschaftsministerium, die Lehre in Tübingen anzusiedeln; die Erforschung der komplementären Therapien soll vorwiegend am Centrum für Tumorerkrankungen des Robert-Bosch-Krankenhauses in Stuttgart stattfinden. Die Robert-Bosch-Stiftung finanziert die Professur in den ersten fünf Jahren mit insgesamt 1,84 Millionen Euro, danach soll das Land die Mittel dafür bereitstellen.

«Naturheilkunde und komplementäre Behandlungsmethoden werden von vielen Menschen ganz selbstverständlich genutzt, beispielsweise zur Ergänzung konventioneller Therapieangebote», begründete Wissenschaftsministerin Theresia Bauer (Grüne) das Engagement. Sogenannte sanfte oder natürliche Methoden könnten schwere Krankheiten wie etwa Krebs alleine nicht heilen, heißt es in einer Mitteilung des Ministeriums. Wissenschaftliche Ergebnisse zeigten aber, dass sie häufig zu Therapieerfolgen beitragen könnten, da sie den Patienten helfen, schulmedizinische Therapien gut zu überstehen – etwa die schweren Nebenwirkungen von Chemotherapien mindern.

Im Gegensatz zur Schulmedizin gebe es bisher aber kaum kontrollierte klinische Studien zur Wirksamkeit solcher Therapien, ergänzte Ingo Autenrieth. Ihre Erforschung am neuen Lehrstuhl solle Patienten Sicherheit bringen und ermöglichen, dass die gesetzlichen Krankenkassen die Kosten dafür übernehmen.

Hersteller alternativer Arzneimittel loben den Schritt der Politik. «Baden-Württemberg nimmt damit eine Vorreiterrolle in Deutschland und in Europa ein», heißt es beim Unternehmen Wala Heilmittel GmbH in Bad Boll. Die Landesregierung trage mit der Entscheidung dem Wunsch vieler Patienten und Ärzte nach umfassenden Behandlungskonzepten Rechnung.

Auch hoffen die Unternehmen, dass Licht in die oft kritische Debatte um Homöopathie gebracht wird. «Wir sehen mit Erstaunen und Befremden, dass eine bewährte Therapierichtung wie die Homöopathie, die Teil der Vielfalt des therapeutischen Angebots in Deutschland ist, diskreditiert werden soll», sagte ein Sprecher des Herstellers Weleda AG mit Sitz in Schwäbisch Gmünd der Deutschen Presse-Agentur. Deshalb begrüße man den Lehrstuhl: «Es ist gut, dass Forschung und Lehre ausgebaut werden, da eine Mehrheit der Bevölkerung Komplementärmedizin wünscht und nachfragt. Es braucht Ärzte, die in diesen Bereichen auch universitär ausgebildet werden.»

Laut Koalitionsvertrag will Baden-Württemberg künftig eine Vorreiterrolle in der Erforschung der Komplementärmedizin einnehmen. Bisher gab es im Südwesten mit dem Akademischen Zentrum für Komplementäre und Integrative Medizin (AZKIM) zwar einen Verbund der Unikliniken Tübingen, Freiburg, Ulm und Heidelberg, aber keinen eigenen Lehrstuhl. Bundesweit existieren nach Angaben der Hufelandgesellschaft, dem Dachverband der Ärztegesellschaften für Naturheilkunde und Komplementärmedizin, Lehrstühle für Naturheilkunde noch an den Universitäten Duisburg-Essen, Rostock und Witten/Herdecke sowie drei Stiftungsprofessuren an der Berliner Charité.

END OF QUOTE

And here is my English summary:

The black/green government of Baden-Wuerttemberg has decided to create a ‘chair of naturopathy and integrated medicine’ at the university of Tuebingen in 2019. The chair will focus in the area of oncology. Treatments such as homeopathy and anthroposophical medicine will not be taught but merely mentioned in lectures. Ideologies and everything that is not science will be omitted.

The chair will thus deal with nutrition, acupuncture and probiotics. The teaching activities will be in the medical faculty at Tuebingen, while the research will be located at the Robert-Bosch Hospital in Stuttgart. The funds for the first 5 years – 1.84 million Euro – will come from the Robert-Bosch Foundation; thereafter they will be provided by the government of the county.

So-called gentle or natural therapies cannot cure serious diseases on their own, but as adjuvant treatments they can be helful, for instance, in alleviating the adverse effects of chemotherapy. There are only few studies on this, and the new chair will increase patient safety and facilitate the reimbursement of these treatments by health insurances.

Local anthroposophy manufacturers like Wala welcomed the move stating it would be in accordance with the wishes of many patients and doctors. They also hope that the move will bring light in the current critical debate about homeopathy. A spokesperson of Weleda added that they ‘note with surprise that time-tested therapies like homeopathy are being discredited. Therefore, it is laudable that research and education in this realm will be extended. The majority of the public want complementary medicine and need doctors who are also university-trained.’

Baden-Wurttemberg aims for a leading role in researching complementary medicine. Thus far, chairs of complementary medicine existed only at the universities of Duisburg-Essen, Rostock und Witten/Herdecke as well as three professorships at the Charité in Berlin.

END OF MY SUMMARY

As I have occupied a chair of complementary medicine for 19 years, I am tempted to add a few points here.

  • In principle, a new chair can be a good thing.
  • The name of the chair is odd, to say the least.
  • As the dean of the Tuebingen medical school pointed out, it has to be based on science. But how do they define science?
  • Where exactly does the sponsor, the Robert-Bosch Stiftung, stand on alternative medicine. Do they have a track-record of being impractical and scientific?
  • In order to prevent this becoming a unrealistic prospect, it is essential that the new chair needs to fall into the hands of a scientist with a proven track record of critical thinking.
  • Rigorous scientist with a proven track record of critical thinking are very rare in the realm of alternative medicine.
  • The ridiculous comments by Wala and Weleda, both local firms with considerable local influence, sound ominous and let me suspect that proponents of alternative medicine aim to exert their influence on the new chair.
  • The above-voiced notion that the new chair is to facilitate the reimbursement of alternative treatments by the health insurances seems even more ominous. Proper research has to be objective and could, depending on its findings, have the opposite effect. To direct it in this way seems to determine its results before the research has started.
  • I miss a firm commitment to medical ethics, to the principles of EBM, and to protecting the independence of the new chair.

Thus, I do harbour significant anxieties about this new chair. It is in danger of becoming a chair of promoting pseudoscience. I hope the dean of the Tuebingen medical school might read these lines.

I herewith offer him all the help I can muster in keeping pseudoscience out of this initiative, in defining the remit of the chair and, crucially, in finding the right individual for doing the job.

Samuel Hahnemann invented homeopathy about 200 years ago. His placebos were better than (or not as bad as) the ‘heroic’ medicine of his time which frequently was more dangerous than the disease it aimed to cure. Thus, homeopathy took Germany by storm. When, about 100 years ago, medicine finally became scientific and was able to offer more and more effective treatments, the popularity of homeopathy began to wane. Yet, before its natural demise, during the Third Reich, it received a significant boost from Nazi-greats such as Hess and Himmler. After this nightmare was over, German homeopathy went into another slow decline. But when the New Age movement and the current boom in alternative medicine reached Germany, homeopathy seemed to thrive once again.

In the 1990s evidence-based medicine (EBM) grew into one of the central concepts of medicine. In Germany, however, EBM had a relatively hard time to get established. This might be one of the reasons why homeopathy continued to prosper, despite the arrival of ever clearer evidence that highly diluted homeopathic remedies are pure placebos. While, in the UK, we had an increasingly lively debate about the uselessness of homeopathy, Germany remained the promised land of homeopathy. Sales figures of homeopathics continued to increase steadily and reached a level of about half a billion Euros per annum.

The golden age of German homeopathy had dawned:

  • The media, often sponsored by homeopathic interest groups, kept on promoting homeopathy largely unopposed.
  • The mighty Carstens Stiftung worked tirelessly to promote it.
  • Homeopathy became established in many medical schools.
  • Homeopathy was available and often advertised in almost all pharmacies.
  • The public was convinced that homeopathy worked.
  • The Heilpraktiker adopted homeopathy fully.
  • The medical and other conventional healthcare professions embraced it to a large degree.
  • The adult education institutes (Volkshochschulen) offered courses.
  • Politicians were squarely on the side of homeopathy,
  • Health insurances, paid for it.

Of course, there were also some (and always had been) opposing voiced and organisations, such as the GWUP (the German sceptic organisation), for example. But somehow, they remained relatively low-key. When, every now and then, courageous journalists dared to think of a critical take on homeopathy, they had to search far and wide to find a German-speaking expert who was willing or able to tell them the truth: that homeopathy is neither biologically plausible nor evidence-based and therefore an expensive, potentially harmful waste of money that makes a mockery of EBM. During this period, journalists (far too) often asked me for some critical comments. I hardly ever published my research in German, but they nevertheless would find me via my Medline-listed papers. I often felt like a very lone voice in a German desert.

For the German homeopathic industry, I evidently was more than just a lone voice. Unbeknown to me, they clubbed together and financed a PR-man/journalist (at the tune of Euro 30 000/year) to write as many defamatory articles about me as he could muster. First, I was bewildered by his activity, then I tried to communicate with him (only to get mis-quoted), and eventually I ignored his writings. Yet, a German investigative journalist found Fritzsche’s one-sided activities offensive and started investigating. His research and subsequent article disclosed the fact that he was being paid by the homeopathic industry. Once I learn about this scandal, I wrote to some of the financiers directly and asked for an explanation. As a result, they discontinued their sponsorship. Shortly afterwards, Fritzsche committed suicide.

At heart, I have always been an optimist and strongly believe that in medicine the truth, in this case the evidence, will always prevail, no matter what obstacles others might put in its way. Recent developments seem to suggest that I might be right.

In the last few years, several individuals in Germany have, from entirely different angles, taken a fresh look at the evidence on homeopathy and found it to be desperately wanting. Independent of each other, they published articles and books about their research and insights. Here are 5 examples:

Die Homöopathie-Lüge: So gefährlich ist die Lehre von den weißen KügelchenChristian Weymayr, Nicole Heißmann, 2012

In Sachen Homöopathie: Eine Beweisaufnahme, Norbert Aust, 2013

Homöopathie neu gedacht: Was Patienten wirklich hilft, Natalie Grams, 2015

Der Glaube an die Globuli: Die Verheißungen der HomöopathieNorbert Schmacke, Bernd Hontschik, 2015

Der wahrscheinlich teuerste Zucker der Welt: Was Sie über Homöopathie und Alternativmedizin wissen sollten, Oliver Grunau, 2017

Inevitably, these individuals came into contact with each other and subsequently founded several working-groups to discuss their concerns and coordinate their activities. Thus the INH and the Muensteraner Kreis were born. So, now we have at least three overlapping groups of enthusiastic, multidisciplinary experts who voluntarily work towards informing the German public that paying for homeopathy out of public funds is unethical, nonsensical and not in the interest of progress:

  • the GWUP,
  • the INH
  • and the Muensteraner Kreis.

No wonder then, that the German homeopathic industry and other interested parties got worried. When they realised that (presumably due to the work of these altruistic enthusiasts) the sales figures of homeopathics in Germany had, for the first time since many years, started declining, they panicked.

Their reaction was, as far as I can see, similar to their previous response to criticism: they started a media campaign in an attempt to sway public opinion. And just like before, they have taken to employing PR-people who currently spend their time defaming all individuals voicing criticism of homeopathy in Germany. Their prime targets are those experts who are most exposed to activities of responsibly informing the public about homeopathy via lectures, publications social media, etc. All of us currently receive floods of attack, insults and libellous defamations. As before (innovation does not seem to be a hallmark of homeopathy), these attacks relate to claims that:

  • we are incompetent,
  • we do not care about the welfare of patients,
  • we are habitual liars,
  • we are on the payroll of the pharmaceutical industry,
  • we aim at limiting patient choice,
  • we do what we do because we crave the limelight.

So, what is going to happen?

I cannot read tea leaves but am nevertheless sure of a few things:

  • The German homeopathy lobby will not easily give up; after all, they have half a billion Euros per year to lose.
  • They will not argue on the basis of science or evidence, because they know that neither are in their favour.
  • They will fight dirty and try to defame everyone who stands in their way.
  • They will use their political influence and their considerable financial power.

AND YET THEY WILL LOSE!

Not because we are so well organised or have great resources – in fact, as far as I can see, we have none – but because, in medicine, the evidence is invincible and will eventually prevail. Progress might be delayed, but it cannot be halted by those who cling to an obsolete dogma.

The following announcement was made by the NHS on 7 August 2018:

The Governing Body of Bristol, North Somerset and South Gloucestershire (BNSSG) Clinical Commissioning Group (CCG) today approved changes that mean NHS funded homeopathy will only be available in exceptional circumstances in the area. The changes will mean the CCG’s Individual Funding Request (IFR) Panel would need a clinician to set out why the patient is clinically exceptional before treatment could be provided.

The decision comes after the publication of a report, which took evidence from local people, clinicians, patient groups, providers of homeopathic treatments and national guidelines.

CCG Clinical Chair Dr Jonathan Hayes said, “We are working hard to become an evidence-informed organisation because we need to make the best use of all resources to offer treatment and care to the widest range of people. The decision on homeopathy funding today is a step towards this and brings us in line with national guidelines.”

It is estimated that 41 patients receiving NHS funded homeopathic consultations in the area cost the local NHS £109,476 in the 2017/2018 financial year.

END OF QUOTE

R.I.P. NHS #homeopathy 5 July 1948 - 7 August 2018

The move is the result of 4 years of excellent work by the GOOD THINKING SOCIETY, a charity dedicate to the promotion of rational thinking.

Michael Marshall, its Project Director, said: “We are very pleased to see the Bristol CCGs take this decision to cease funding for homeopathy – every other CCG across the country has made it clear that homeopathic remedies are no better than placebo and such there is simply no place for homeopathy on the NHS.

“With the end to homeopathy funding in Bristol, the region joins NHS bodies across the rest the country in recognising that homeopathy is not a valid use of limited NHS resources. There is now no CCG in England where homeopathic pills or consultations can be routinely funded with NHS money – instead, funding can be directed towards treatments that have been shown to actually work.”

Does that not call for a knighthood for Mr Marshall?

One would have thought so!

Who will tell Prince Charles to get the ball rolling?

And while we are all waiting for the big event, you might as well donate a few £s to this truly splendid charity.

Please be generous!!!

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.

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.

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.

Have you ever wondered whether doctors who practice homeopathy are different from those who don’t.

Silly question, of course they are! But how do they differ?

Having practised homeopathy myself during my very early days as a physician, I have often thought about this issue. My personal (and not very flattering) impressions were noted in my memoir where I describe my experience working in a German homeopathic hospital:

some of my colleagues used homeopathy and other alternative approaches because they could not quite cope with the often exceedingly high demands of conventional medicine. It is almost understandable that, if a physician was having trouble comprehending the multifactorial causes and mechanisms of disease and illness, or for one reason or another could not master the equally complex process of reaching a diagnosis or finding an effective therapy, it might be tempting instead to employ notions such as dowsing, homeopathy or acupuncture, whose theoretical basis, unsullied by the inconvenient absolutes of science, was immeasurably more easy to grasp. 

Some of my colleagues in the homeopathic hospital were clearly not cut out to be “real” doctors. Even a very junior doctor like me could not help noticing this somewhat embarrassing fact… 

But this is anecdote and not evidence!

So, where is the evidence?

It was published last week and made headlines in many UK daily papers.

Our study was aimed at finding out whether English GP practices that prescribe any homeopathic preparations might differ in their prescribing of other drugs. We identified practices that made any homeopathy prescriptions over six months of data. We measured associations with four prescribing and two practice quality indicators using multivariable logistic regression.

Only 8.5% of practices (644) prescribed homeopathy between December 2016 and May 2017. Practices in the worst-scoring quartile for a composite measure of prescribing quality were 2.1 times more likely to prescribe homeopathy than those in the best category. Aggregate savings from the subset of these measures where a cost saving could be calculated were also strongly associated. Of practices spending the most on medicines identified as ‘low value’ by NHS England, 12.8% prescribed homeopathy, compared to 3.9% for lowest spenders. Of practices in the worst category for aggregated price-per-unit cost savings, 12.7% prescribed homeopathy, compared to 3.5% in the best category. Practice quality outcomes framework scores and patient recommendation rates were not associated with prescribing homeopathy.

We concluded that even infrequent homeopathy prescribing is strongly associated with poor performance on a range of prescribing quality measures, but not with overall patient recommendation or quality outcomes framework score. The association is unlikely to be a direct causal relationship, but may reflect underlying practice features, such as the extent of respect for evidence-based practice, or poorer stewardship of the prescribing budget.

Since our study was reported in almost all of the UK newspapers, it comes as no surprise that, in the interest of ‘journalistic balance’, homeopaths were invited to give their ‘expert’ opinions on our work.

Margaret Wyllie, head of the British Homeopathic Association, was quoted commenting: “This is another example of how real patient experience and health outcomes are so often discounted, when in actuality they should be the primary driver for research to improve our NHS services. This study provides no useful evidence about homeopathy, or about prescribing, and gives absolutely no data that can improve the health of people in the UK.”

The Faculty of Homeopathy was equally unhappy about our study and stated: “The study did not include any measures of patient outcomes, so it doesn’t tell us how the use of homeopathy in English general practice correlates with patients doing well or badly, nor with how many drugs they use.”

Cristal Summer from the Society of Homeopathy said that our research was just a rubbish bit of a study.

Peter Fisher, the Queen’s homeopath and the president of the Faculty of Homeopathy, stated: “We don’t know if these measures correlate with what matters to patients – whether they get better and have side-effects.”

A study aimed at determining whether GP practices that prescribe homeopathic preparations differ in their prescribing habits from those that do not prescribe homeopathics can hardly address these questions, Peter. A test of washing machines can hardly tell us much about the punctuality of trains. And an investigation into the risks of bungee jumping will not inform us about the benefits of regular exercise. Call me biased, but to me these comments indicate mainly one thing: HOMEOPATHS SEEM TO HAVE GREAT DIFFICULTIES UNDERSTANDING SCIENTIFIC PAPERS.

I much prefer the witty remarks of Catherine Bennett in yesterday’s Observer: Homeopath-GPs, naturally, have mustered in response and challenge Goldacre’s findings, with a concern for methodology that could easily give the impression that there is some evidential basis for their parallel system, beyond the fact that the Prince of Wales likes it. In fairness to Charles, his upbringing is to blame. But what is the doctors’ excuse?

I have written about the use of homeopathy in France before (as I now live half of my time in France, this is a subject of considerable interest to me). After decades of deafening silence and uncritical acceptance by the French public, it seems that finally some change to the better might be on its way. Recently, a sizable number of prominent doctors protested publicly against the fact that, despite its implausibility and the lack of proof of efficacy, homeopathy continues to be reimbursed in France and scarce funds are being wasted on it. This action seems to have put pressure on officials to respond.

Yesterday (just in time for the ‘HOMEOPATHIC AWARENESS WEEK’) the French minister of health was quoted making a statement on homeopathy. Here is my translation of what Agnès Buzyn was quoted saying:

“There is a continuous evaluation of the medicines we call complementary. A working group* at the head office of my department checks that all these practices are not dangerous. If a therapy continues to be beneficial without being harmful, it continues to be reimbursed… The French are very attached [to homeopathy]; it’s probably a placebo effect. If it can prevent the use of toxic medicine, I think that we all win. I does not hurt.”

Agnès Buzyn

  • I would like to know who they are, how they can be contacted, and whether they would consider recruiting my assistance in evaluating alternative therapies.

So, if I understand her correctly, Agnès Buzyn believes that:

  1. the French people are fond of homeopathy;
  2. homeopathy is a placebo-therapy;
  3. homeopathy does no harm;
  4. homeopathy can even prevent harm from conventional medicine;
  5. on balance, therefore, homeopathy should continue to be reimbursed in France.

My views of this type of reasoning have been expressed repeatedly. Nevertheless, I will briefly state them again:

  1. true but not relevant; healthcare is not a popularity contest; and the current popularity is essentially the result of decades of systematic misinformation of consumers;
  2. correct;
  3. wrong: we have, on this blog, discussed ad nauseam how homeopathy can cause serious harm; for instance, whenever it replaces effective treatments, it can cause serious harm and might even kill patients;
  4. if doctors harm patients by needlessly prescribing harmful treatments, we need to re-train them and stop this abuse; using homeopathy is not the solution to bad medicine;
  5. wrong: the reimbursement of homeopathy is a waste of money and undermines evidence-based medicine.

So, what’s the conclusion?

Politicians are usually not good at understanding science or scientific evidence. They (have to?) think in time spans from one election to the next. And they are, of course, keenly aware that, in order to stay in power, they rely on the vote of the people. Therefore, the popularity of homeopathy (even though it is scientifically irrelevant) is a very real factor for them. This means that, on a political level, homeopathy is sadly much more secure than it should be. In turn, this means we need to:

  • use different arguments when arguing with politicians (for instance, the economic impact of wasting money on placebo-therapies, or the fact that systematically misinforming the public is highly unethical and counter-productive),
  • and make politicians understand science better than they do at present, perhaps even insist that ministers are experts in their respective areas (i. e. a minister of health fully understands the fundamental issues of healthcare).

Does that mean the new developments in the realm of French homeopathy are all doomed to failure?

No, I don’t think so – at least (and at last) we have a vocal group of doctors protesting against wasteful nonsense, and a fairly sound and accurate statement from a French minister of health:

HOMEOPATHY, IT’S PROBABLY A PLACEBO EFFECT!

 

In recent days, journalists across the world had a field day (mis)reporting that doctors practising integrative medicine were doing something positive after all. I think that the paper shows nothing of the kind – but please judge for yourself.

The authors of this article wanted to determine differences in antibiotic prescription rates between conventional General Practice (GP) surgeries and GP surgeries employing general practitioners (GPs) additionally trained in integrative medicine (IM) or complementary and alternative medicine (CAM) (referred to as IM GPs) working within National Health Service (NHS) England.

They conducted a retrospective study on antibiotic prescription rates per STAR-PU (Specific Therapeutic group Age–sex weighting Related Prescribing Unit) using NHS Digital data over 2016. Publicly available data were used on prevalence of relevant comorbidities, demographics of patient populations and deprivation scores. setting Primary Care. Participants were 7283 NHS GP surgeries in England. The association between IM GPs and antibiotic prescribing rates per STAR-PU with the number of antibiotic prescriptions (total, and for respiratory tract infection (RTI) and urinary tract infection (UTI) separately) as outcome. results IM GP surgeries (n=9) were comparable to conventional GP surgeries in terms of list sizes, demographics, deprivation scores and comorbidity prevalence.

Statistically significant fewer total antibiotics  were prescribed at NHS IM GP surgeries compared with conventional NHS GP surgeries. In contrast, the number of antibiotics prescribed for UTI were similar between both practices.

The authors concluded that NHS England GP surgeries employing GPs additionally trained in IM/CAM have lower antibiotic prescribing rates. Accessibility of IM/CAM within NHS England primary care is limited. Main study limitation is the lack of consultation data. Future research should include the differences in consultation behaviour of patients self-selecting to consult an IM GP or conventional surgery, and its effect on antibiotic prescription. Additional treatment strategies for common primary care infections used by IM GPs should be explored to see if they could be used to assist in the fight against antimicrobial resistance.

The study was flimsy to say the least:

  • It was retrospective and is therefore open to no end of confounders.
  • There were only 9 surgeries in the IM group.

Moreover, the results were far from impressive. The differences in antibiotic prescribing between the two groups of GP surgeries were minimal or non-existent. Finally, the study was financed via an unrestricted grant of WALA Heilmittel GmbH, Germany (“approx. 900 different remedies conforming to the anthroposophic understanding of man and nature”) and its senior author has a long track record of publishing papers promotional for anthroposophic medicine.

Such pseudo-research seems to be popular in the realm of CAM, and I have commented before on similarly futile projects. The comparison, I sometimes use is that of a Hamburger restaurant:

Employees by a large Hamburger chain set out to study the association between utilization of Hamburger restaurant services and vegetarianism. The authors used a retrospective cohort design. The study population comprised New Hampshire residents aged 18-99 years, who had entered the premises of a Hamburger restaurant within 90 days for a primary purpose of eating. The authors excluded subjects with a diagnosis of cancer. They measured the likelihood of  vegetarianism among recipients of services delivered by Hamburger restaurants compared with a control group of individuals not using meat-dispensing facilities. They also compared the cohorts with regard to the money spent in Hamburger restaurants. The adjusted likelihood of being a vegetarian was 55% lower among the experimental group compared to controls. The average money spent per person in Hamburger restaurants were also significantly lower among the Hamburger group.

To me, it is obvious that such analyses must produce a seemingly favourable result for CAM. In the present case, there are several reasons for this:

  1. GPs who volunteer to be trained in CAM tend to be in favour of ‘natural’ treatments and oppose synthetic drugs such as antibiotics.
  2. Education in CAM would only re-inforce this notion.
  3. Similarly, patients electing to consult IM GPs tend to be in favour of ‘natural’ treatments and oppose synthetic drugs such as antibiotics.
  4. Such patients might be less severely ill that the rest of the patient population (the data from the present study do in fact imply this to be true).
  5. These phenomena work in concert to generate less antibiotic prescribing in the IM group.

In the final analysis, all this finding amounts to is a self-fulfilling prophecy: grocery shops sell less meat than butchers! You don’t believe me? Perhaps you need to read a previous post then; it concluded that physicians practicing integrative medicine (the 80% who did not respond to the survey were most likely even worse) not only use and promote much quackery, they also tend to endanger public health by their bizarre, irrational and irresponsible attitudes towards vaccination.

What is upsetting with the present paper, in my view, are the facts that:

  • a reputable journal published this junk,
  • the international press has a field-day reporting this study implying that CAM is a good thing.

The fact is that it shows nothing of the kind. Imagine we send GPs on a course where they are taught to treat all their patients with blood-letting. This too would result in less prescription of antibiotics, wouldn’t it? But would it be a good thing? Of course not!

True, we prescribe too much antibiotics. Nobody doubts that. And nobody doubts that it is a big problem. The solution to this problem is not more CAM, but less antibiotics. To realise the solution we do not need to teach GPs CAM but we need to remind them of the principles of evidence-based practice. And the two are clearly not the same; in fact, they are opposites.

 

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