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

experience

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Having yesterday been to a ‘Skeptics in the Pub’ event on MEDITATION in Cambridge (my home town since last year) I had to think about the subject quite a bit. As I have hardly covered this topic on my blog, I am today trying to briefly summarise my view on it.

The first thing that strikes me when looking at the evidence on meditation is that it is highly confusing. There seem to be:

  • a lack of clear definitions,
  • hundreds of studies, most of which are of poor or even very poor quality,
  • lots of people with ’emotional baggage’,
  • plenty of strange links to cults and religions,
  • dozens of different meditation methods and regimen,
  • unbelievable claims by enthusiasts,
  • lots of weirdly enthusiastic followers.

What was confirmed yesterday is the fact that, once we look at the reliable medical evidence, we are bound to find that the health claims of various meditation techniques are hugely exaggerated. There is almost no strong evidence to suggest that meditation does affect any condition. The small effects that do emerge from some meta-analyses could easily be due to residual bias and confounding; it is not possible to rigorously control for placebo effects in clinical trials of meditation.

Another thing that came out clearly yesterday is the fact that meditation might not be as risk-free as it is usually presented. Several cases of psychoses after meditation are on record; some of these are both severe and log-lasting. How often do they happen? Nobody knows! Like with most alternative therapies, there is no reporting system in place that could possibly give us anything like a reliable answer.

For me, however, the biggest danger with (certain forms of) meditation is not the risk of psychosis. It is the risk of getting sucked into a cult that then takes over the victim and more or less destroys his or her personality. I have seen this several times, and it is a truly frightening phenomenon.

In our now 10-year-old book THE DESKTOP GUIDE TO COMPLEMENTARY AND ALTERNATIVE MEDICINE, we included a chapter on meditation. It concluded that “meditation appears to be safe for most people and those with sufficient motivation to practise regularly will probably find a relaxing experience. Evidence for effectiveness in any indication is week.” Even today, this is not far off the mark, I think. If I had to re-write it now, I would perhaps mention the potential for harm and also add that, as a therapy, the risk/benefit balance of meditation fails to be convincingly positive. 

PS

I highly recommend ‘Skeptics in the Pub’ events to anyone who likes stimulating talks and critical thinking.

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.

Doctor Jens Wurster is no stranger to this blog; previously I discussed his claim that he has treated more than 1000 cancer patients homeopathically and we could even cure or considerably ameliorate the quality of life for several years in some, advanced and metastasizing cases. So far, his claims were based not on evidence published in peer-reviewed journals (I cannot find a single Medline-listed paper by this man); but now Wurster has published an article in a German Journal (Wurster J. Zusatznutzen der Homöopathie … Deutsche Zeitschrift für Onkologie 2018; 50: 85–91; not Medline-listed, I am afraid). The paper is in German, but it has an English abstract; here it is:

____________________________________________________________________________

All over the world, oncology patients receive homeopathic treatment concomitant to conventional treatments, such as chemotherapy and radiation treatment, in order to reduce the side effects of these therapies. It has been shown that cancer patients, who are receiving homeopathic treatment in addition to conventional therapies, have a higher quality of life and a longer survival rate. Studies in cancer cell research have shown the direct effects of highly potentized homeopathic medicines on tumor cell lines. Tumor inhibiting properties of homeopathic medicines have been proven in vivo as well as in vitro. Research projects into complementary medicine (CAMbrella) and research into personalized immunotherapies as well as additive homeopathy open the door to the future of integrative oncology.

_____________________________________________________________________________

In the article, Wurster states that he has 20 years of experience in treating cancer with homeopathy as an add-on to conventional care, and that he can confirm homeopathy’s effectiveness. He claims that ‘very many’ patients have thus benefitted by experiencing less side-effects of conventional treatments. And he offers two case-reports to illustrate this.

[Nach 20 Jahren klinischer Erfahrung in der Clinica St. Croce im Tessin mit der Behandlung onkologischer Patienten mithilfe der Homöopathie können wir deutlich den Zusatznutzen der Homöopathie in der Onkologie bestätigen [1]. So gelang es unserem Ärzteteam in den zurückliegenden Jahren bei sehr vielen Patienten, durch gezielten Einsatz homöopathischer Mittel die Nebenwirkungen von Chemotherapien oder Bestrahlungen erfolgreich zu reduzieren [1]. Wie dabei Schulmedizin und Homöopathie in der Praxis zusammenwirken, zeigt folgendes Beispiel. ([1] Wurster J. Die homöopathische Behandlung und Heilung von Krebs und metastasierten Tumoren. Norderstedt: Books on Demand; 2015)]

The two case-reports lack detail and are less than convincing, in my view. Both patients have had conventional therapies and Wurster claims that his homeopathic remedies reduced their side-effects. There is no way of verifying this claim, and the improvements might have occurred also without homeopathy.

In the discussion section of his paper, Wurster then elaborates that oncologists throughout Europe are now realising the potential of homeopathy. In support he mentions paediatric oncologists in Klagenfurt who managed to spare pain-killers by giving homeopathics. Similarly, at the Inselspital in Bern, they are offering homeopathic consultations to complement conventional treatments.

[Inzwischen haben auch einige Onkologen erkannt, wie eine gezielt eingesetzte homöopathische Behandlung die Nebenwirkungen von Chemotherapien oder Bestrahlungen reduzieren kann. Wir arbeiten inzwischen mit einigen Onkologen aus ganz Europa zusammen, die den Zusatznutzen der Homöopathie in der Onkologie erlebt haben. In der Kinderonkologie in Klagenfurt beispielsweise konnten mithilfe der Homöopathie Schmerzmittel bei den Kindern eingespart werden. Auch am Inselspital Bern werden zusätzliche homöopathische Konsile in der Kinderonkologie angeboten, um die konventionelle Behandlung begleiten zu können [8].]

At this point, Wurster inserts his reference number 8. As several of his references are either books or websites, this reference to an article in a top journal seems interesting. Here is its abstract:

___________________________________________________________________________________

BACKGROUND:

Though complementary and alternative medicine (CAM) are frequently used by children and adolescents with cancer, there is little information on how and why they use it. This study examined prevalence and methods of CAM, the therapists who applied it, reasons for and against using CAM and its perceived effectiveness. Parent-perceived communication was also evaluated. Parents were asked if medical staff provided information on CAM to patients, if parents reported use of CAM to physicians, and what attitude they thought physicians had toward CAM.

STUDY DESIGN:

All childhood cancer patients treated at the University Children‘s Hospital Bern between 2002-2011 were retrospectively surveyed about their use of CAM.

RESULTS:

Data was collected from 133 patients (response rate: 52%). Of those, 53% had used CAM (mostly classical homeopathy) and 25% of patients received information about CAM from medical staff. Those diagnosed more recently were more likely to be informed about CAM options. The most frequent reason for choosing CAM was that parents thought it would improve the patient’s general condition. The most frequent reason for not using CAM was lack of information. Of those who used CAM, 87% perceived positive effects.

CONCLUSIONS:

Since many pediatric oncology patients use CAM, patients’ needs should be addressed by open communication between families, treating oncologists and CAM therapists, which will allow parents to make informed and safe choices about using CAM.

_______________________________________________________________________________________

Any hope that this paper might back up the statements made by Wurster is thus disappointed.

Altogether, this Wurster-paper contains no reliable evidence. The only clinical trial it seems to rely on is the one by Prof Frass which we have discussed previously here and here. The Frass-study is odd in several ways and, before we can take its results seriously, we need to see an independent replication of its findings. In this context, it is noteworthy that my own 2006 systematic review concluded that there is insufficient evidence to support clinical efficacy of homeopathic therapy in cancer care. In view of all this, I feel that the new Wurster-paper provides no reliable evidence and no reason to change my now somewhat dated conclusion of 2006. Moreover, I would insist that those who claim otherwise are unethical and behave irresponsible.

And finally, I need to reiterate what I stated in my previous post: the Wurster-paper indicates that something is amiss with medical publishing. How can it be that, in 2018, the ‘Deutsche Zeitschrift für Onkologie’ (or any other medical journal for that matter) can be so bar of critical thinking to publish such dangerously misleading nonsense? The editors of this journal (Univ.-Prof. Dr. med. Arndt Büssing, Witten/Herdecke; Dr. med. Peter Holzhauer, Bad Trissl und München) and its editorial board members (L. Auerbach, Wien; C. Bahne Bahnson, Kiel; J. Büntzel, Nordhausen; B. Freimüller-Kreutzer, Heidelberg; H.R. Maurer, Berlin; A. Mayr, Starnberg; R. Moss, New York; T. Ostermann, Witten/Herdecke; K. Prasad, Denver; G. Pulverer, Köln; H. Renner, Nürnberg; C.P. Siegers, Lübeck; W. Schmidt, Greifswald; G. Uhlenbruck, Köln; B. Wolf, München; K.S. Zänker, Witten/Herdecke) should ask themselves whether they are taking their moral obligations seriously enough, or whether their behaviour is not a violation of their most fundamental ethical duties.

In our book ‘MORE HARM THAN GOOD‘ we allude to such problems as follows: …Spurious results are frequently paraded by CAM advocates in support of implausible treatments… the more poorly conceived and executed a research project is, the more likely it is to produce false-positive results. These results then may lead to repetitive cycles of unproductive work to explain what was found—often to simply disprove the erroneous results. This is an unfortunate feature of various fields of scientific research, but it has particularly serious implications in medical research. Moreover, researchers who practice and behave as advocates of CAM may unintentionally or deliberately distort or exaggerate weak findings. Invalid CAM research claims tend not to be put to rest; instead they are repeatedly recycled…

And:

The CAM practitioner who promotes untruths has either failed to enlighten themselves as to the facts—this being a central requirement of professional ethics— or has chosen to deliberately deceive patients. Either of these reasons for promulgating falsehoods amounts to a serious breach in terms of virtue ethics. According to almost all forms of ethical theory, the truth-violating nature of CAM renders it immoral in both theory and practice.

The damage that can result from such violations of medical ethics is not merely a matter for the ‘ivory towers of academia’, it can virtually be a matter of life and death.

Why  do most alternative practitioners  show such dogged determination not to change their view of the efficacy of their therapy, even if  good evidence shows that it is a placebo? This is the question that I have been pondering for some time. I have seen many doctors change their mind about this or that treatment in the light of new evidence. In fact, I have not seen one who has not done so at some stage. Yet I have never seen an alternative therapist change his/her mind about his/her alternative therapy. Why is that?

You might say that the answers are obvious:

  • because they have heavily invested in their therapy, both emotionally and financially;
  • because their therapy has ‘stood the test of time’;
  • because they believe what they were taught;
  • because they are deluded, not very bright, etc.;
  • because they need to earn a living.

All of these reasons may apply. But do they really tell the whole story? While contemplating about this question, I thought of something that had previously not been entirely clear to me: they simply KNOW that the evidence MUST be wrong.

Let me try to explain.

Consider an acupuncturist (I could have chosen almost any other type of alternative practitioner) who has many years of experience. He has grown to be a well-respected expert in the world of acupuncture. He sits on various committees and has advised important institutions. He knows the literature and has treated thousands of patients.

This experience has taught him one thing for sure: his patients do benefit from his treatment. He has seen it happening too many times; it cannot be a coincidence. Acupuncture works, no question about it.

And this is also what the studies tell him. Even the most sceptical scientist cannot deny the fact that patients do get better after acupuncture. So, what is the problem?

The problem is that sceptics say that this is due to a placebo effect, and many studies seem to confirm this to be true. Yet, our acupuncturist completely dismisses the placebo explanation.

Why?

  • Because he has heavily invested in their therapy? Perhaps.
  • Because acupuncture has ‘stood the test of time’? Perhaps.
  • Because he believes what he has been taught? Perhaps.
  • Because he is deluded, not very bright, etc.? Perhaps.
  • Because he needs to earn a living? Perhaps.

But there is something else.

He has only ever treated his patients with acupuncture. He has therefore no experience of real medicine, or other therapeutic options. He has no perspective. Therefore, he does not know that patients often get better, even if they receive an ineffective treatment, even if they receive no treatment, and even if they receive a harmful treatment. Every improvement he notes in his patients, he relates to his acupuncture. Our acupuncturist never had the opportunity to learn to doubt cause and effect in his clinical routine. He never had to question the benefits of acupuncture. He never had to select from a pool of therapies the optimal one, because he only ever used acupuncture.

It is this lack of experience that never led him to think critically about acupuncture. He is in a similar situation as physicians were 200 years ago; they only (mainly) had blood-letting, and because some patients improved with it, they had no reason to doubt it. He only ever saw his successes (not that all his patients improved, but those who did not, did not return). He simply KNOWS that acupuncture works, because his own, very limited experience never forced him to consider anything else. And because he KNOWS, the evidence that does not agree with his knowledge MUST be wrong.

I am of course exaggerating and simplifying in order to make a point. And please don’t get me wrong.

I am not saying that doctors cannot be stubborn. And I am not saying that all alternative practitioners have such limited experience and are unable to change their mind in the light of new evidence. However, I am trying to say that many alternative practitioners have a limited perspective and therefore find it impossible to be critical about their own practice.

If I am right, there would be an easy (and entirely alternative) cure to remedy this situation. We should sent our acupuncturist to a homeopath (or any other alternative practitioner whose practice he assumes to be entirely bogus) and ask him to watch what kind of therapeutic success the homeopath is generating. The acupuncturist would soon see that it is very similar to his own. He would then have the choice to agree that highly diluted homeopathic remedies are effective in curing illness, or that the homeopath relies on the same phenomenon as his own practice: placebo.

Sadly, this is not going to happen, is it?

 

Traditional vaginal practices usually relate to personal hygiene, genital health or sexuality. Hygiene practices involve external washing and intravaginal cleansing or douching and ingestion of substances. Health practices include intravaginal cleansing, traditional cutting, insertion of herbal preparations, and application of substances to soothe irritated vaginal tissue.

One such traditional practice is ‘vaginal steaming’.

Recently vaginal steaming has become a fad promoted by SCAM-promoters (such as the vagina-obsessed Gwyneth Paltrow) with the claim that it leads to a range of health benefits. According to one website, for instance, vaginal steaming, Yoni Eggs, yoni or v-steam, as it is casually known, acts as an internal cleanser of the membranes of the vaginal tissues and uterus. This is considered especially important for stagnant fertility conditions and/or incomplete emptying of menses each cycle. This women’s treatment gently but effectively cleanses, tones and revitalizes a woman’s center, providing a myriad benefits from reduced menstrual cramps to increased fertility and more. Support your natural feminine cycle, help your body to heal, relax, and detoxify both physically and emotionally with a yoni steam.

The method is recommended for a wide range of conditions and is said to achieve all of the following and much, much more:

  • Significant reduction of pain, bloating and exhaustion associated with menstruation.
  • Significant reduction of PMS.
  • Decrease of menstrual flow as well as reduction of dark purple or brown blood at the onset or end of menses.
  • Regulation of irregular or absent menstrual cycles.
  • Increased fertility.
  • Faster healing and toning of the reproductive system following childbirth.
  • Assisting in healing uterine fibroids, ovarian cysts, uterine weakness, uterine prolapse & endometriosis.
  • Breaking down of reproductive adhesion/scar tissue. Assisting with the repair of a vaginal tear, episiotomy, or C-section scar.
  • Assisting with the healing of haemorrhoids.
  • Treating chronic vaginal/yeast infections and maintaining healthy vaginal odour.
  • Relief of menopausal symptoms such as vaginal dryness or pain during sex.
  • Detoxification of the womb/removal of toxins from the body. Release of stored emotions.
  • Reconnection with our female bodies and tapping into the sexual energy that is our creative potential.

Frequently, entrepreneurs recommend adding herbal or other ingredients. Herbs often used include:

  • mugwort
  • wormwood
  • chamomile
  • calendula
  • basil
  • oregano
None of these claims are supported by anything we would recognise as evidence, and it would be easy to make fun at the quacks who make them (and the women who fall for them) – unless, of course, there was real and significant harm involved. I fear, the potential for harm is undeniable:
  • vaginal steaming arms your bank account;
  • it disrupts the normal pH balance of the vagina;
  • in turn, this increases the risk of fungal and bacterial infections;
  • vaginal steaming can cause burns;
  • with added herbs, it can cause allergies.

New Zealand psychologists analysed online accounts of vaginal steaming to determine the sociocultural assumptions and logics within such discourse, including ideas about women, women’s bodies and women’s engagement with such ‘modificatory’ practices. Ninety items were carefully selected from the main types of website discussing vaginal steaming: news/magazines; health/lifestyle; spa/service providers; and personal blogs. Within an overarching theme of ‘the self-improving woman’ the researchers identified four themes: (1) the naturally deteriorating, dirty female body; (2) contemporary life as harmful; (3) physical optimisation and the enhancement of health; and (4) vaginal steaming for life optimisation. The authors concluded that online accounts of vaginal steaming appear both to fit within historico-contemporary constructions of women’s bodies as deficient and disgusting, and contemporary neoliberal and healthist discourse around the constantly improving subject.

For the sake of ‘journalistic balance’, let’s give Gwyneth the last word about the benefits of vaginal steaming. She knows best because she has done it and was quoted uttering these profound and scientific views: “The first time I tried v-steaming, I was like, ‘This is insane’. My friend Ben brought me and I was like, ‘You are out of your f**king mind. What is this? But then by the end of it I was like, ‘This is so great.’ Then I start to do research, and it’s been in Korean medicine for thousands of years and there are real healing properties. If I find benefit to it and it’s getting a lot of page views, it’s a win-win.”

And who would or could argue with that?

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.

My friend Gustav Born FRS died on 16 April 2018.

Gustav was born into a Jewish family that emigrated from 1930s Goettingen (Germany) to the UK. His father Max, a friend of Einstein, was a physicist who received a Nobel Prize for his work in quantum mechanics. Gustav  served in the British forces as a doctor during WW2. After the war, he became a pharmacologist in London and Cambridge who had many achievements to his name. For instance, he discovered the mechanisms through which the body stops bleeding and initiates blood clotting. He also invented the platelet aggregometer that is still used universally to quantify platelet activity and which he never patented so that not he but mankind would benefit from it. Gustav was indefatigable and continued his research for many years after his retirement. His work was crowned with uncounted scientific awards.

There have been numerous, much more detailed obituaries honouring Gustav e. g.:

https://www.theguardian.com/science/2018/apr/26/gustav-born-obituary

https://www.thetimes.co.uk/article/gustav-born-obituary-gt5k9r8jc

Mine is merely a personal tribute. I met Gustav in the early 1990s while working in Vienna. We became close friends, and he took me under his wings, encouraged me to come to the UK, wrote a glowing reference when I applied for the Exeter post, and gave me moral support whenever I needed it.

After I had moved to the UK, we regularly met, and he even came to my 50th birthday party insisting to make a speech. About 15 years ago, he once attended one of my public lectures on alternative medicine; afterwards his comment was: “you know, your work is going to save lives.” Since my retirement, he kept phoning me at home (apparently Gustav had an irresistible attraction to the telephone) and urged me, usually speaking in German, to arrange a meeting. We always concluded that this must be soon; sadly, however, this did not happen.

Gustav was a great story-teller. One of his preferred anecdotes related to homeopathy. He recounted (interrupting himself giggling) that, when Einstein and his father once were talking, someone mentioned homeopathy and asked them what they thought of it. Einstein reflected for a little while and then said: “If one were to lock up 10 very clever people in a room and told them they were only allowed out once they had come up with the most stupid idea conceivable, they would soon come up with homeopathy.”

It is therefore not surprising that, when I invited Gustav to contribute a chapter to my book ‘HEALING, HYPE OR HARM?‘, he agreed to write an essay entitled ‘HOMEOPATHY IN CONTEXT’. Here is a short extract from it: What can be done to counteract the persistence of homeopathy? Its unwarranted claims must be continuously exposed. The diversion of public money from the proper purposed of the NHS must be stopped.

I shall miss Gustav for his clear thinking, his wry humour, his unfailing support and fatherly friendship.

Today, enthusiasts of homeopathy celebrate the start of the HOMEOPATHY AWARENESS WEEK. Let’s join them by re-addressing one of their favourite themes: their personal experience with homeopathy.

Most homeopathy-fans argue that the negative scientific evidence must be wrong because they have had positive experiences. Whenever I give a lecture, for instance, there will be at least one person in the audience who presents such an experience (and I too could contribute a few such stories from my own past). Such ‘case reports’ can, of course, be interesting, illuminating or leading to further research, but they can never be conclusive.

This concept is often profoundly confusing for patients and consumers. They tend to feel that I am doubting their words, but nothing could be further from the truth. Their experience is certainly true – what might be false is their interpretation of it. I think, I better explain this in more detail using a concrete, published example.

After the publication of our 2003 RCT of homeopathic Arnica which showed that two different potencies have effects that do not differ from those of placebo, I received lots of angry responses from people who told me that they had the opposite experience or observed positive outcomes on their pets. In my subsequent publication in the journal ‘Homeopathy‘ entitled ‘The benefits of Arnica: 16 case reports‘, I have tried my best to explain their experiences in the light of our finding that highly diluted homeopathic Arnica is a placebo:

Sixteen case reports of the apparent benefits of Arnica … raise several relevant points. Firstly, topical Arnica preparations are often wrongly equated with homeopathic Arnica, the subject of our trial. The former are herbal preparations (ie not homeopathically diluted), which have undisputed pharmacological activity. Taken orally they would even be toxic. Thus all Arnica for oral administration must be highly diluted and has therefore no pharmacological effects. The case reports show that many lay people seem to be unclear about the difference between herbal and homeopathic Arnica.

Secondly, if animals seem to respond to homeopathic Arnica, as claimed in several of the case reports, this is not necessarily a proof of its effectiveness. Animals are not immune to placebo effects. Think of Pavlov’s experiments and the fact that conditioning is clearly an element in the placebo response.

Thirdly, the natural history of the condition can mimic clinical improvement caused by therapy. Many of the 16 cases summarized can be explained through a placebo response or the natural history of disease or the combination of both phenomena…

Many of the letters I received were outspoken to say the least. The authors stated that they were ‘appalled’, ‘saddened and angry’ by our research. Others implied that I was paid by the pharmaceutical industry to abolish homeopathy in the UK. One person felt that ‘it is highly irresponsible to dismiss a natural healing remedy with no evidence at all’. I believe the case reports … convey an important message about the power of belief, anecdotes, placebos and expectation.

END OF QUOTE

The thing about case reports and personal experiences is quite simply this: they may seem almost overwhelmingly convincing, but they can NEVER serve as a proof that the treatment in question was effective. The reason for this fact could not be more simple. Any therapeutic response is due to a complex combination of factors: placebo effects, natural history of the condition, regression to the mean, etc.

See it this way: you wake up one morning with an enormous hangover. You try to identify the cause of it. Was it the beer you had in the pub? The wine you drank before you went out? Or the whiskey you consumed before you went to bed? Perhaps you think it was the Cognac you enjoyed at a friend’s house? Only one thing is for sure: it was not the glass of shaken water you drank during the night.

 

Lock 10 bright people into a room and tell them they will not be let out until they come up with the silliest idea in healthcare. It is not unlikely, I think, that they might come up with the concept of visceral osteopathy.

In case you wonder what visceral osteopathy (or visceral manipulation) is, one ‘expert’ explains it neatly: Visceral Osteopathy is an expansion of the general principles of osteopathy which includes a special understanding of the organs, blood vessels and nerves of the body (the viscera). Visceral Osteopathy relieves imbalances and restrictions in the interconnections between the motions of all the organs and structures of the body. Jean-Piere Barral RPT, DO built on the principles of Andrew Taylor Still DO and William Garner Sutherland DO, to create this method of detailed assessment and highly specific manipulation. Those who wish to practice Visceral Osteopathy train intensively through a series of post-graduate studies.  The ability to address the specific visceral causes of somatic dysfunction allows the practitioner to address such conditions as gastroesophageal reflux disease (GERD), irritable bowel (IBS), and even infertility caused by mechanical restriction.

But, as I have pointed out many times before, the fact that a treatment is based on erroneous assumptions does not necessarily mean that it does not work. What we need to decide is evidence. And here we are lucky; a recent paper provides just that.

The purpose of this systematic review was to identify and critically appraise the scientific literature concerning the reliability of diagnosis and the clinical efficacy of techniques used in visceral osteopathy.

Only inter-rater reliability studies including at least two raters or the intra-rater reliability studies including at least two assessments by the same rater were included. For efficacy studies, only randomized-controlled-trials (RCT) or crossover studies on unhealthy subjects (any condition, duration and outcome) were included. Risk of bias was determined using a modified version of the quality appraisal tool for studies of diagnostic reliability (QAREL) in reliability studies. For the efficacy studies, the Cochrane risk of bias tool was used to assess their methodological design. Two authors performed data extraction and analysis.

Extensive searches located 8 reliability studies and 6 efficacy trials that could be included in this review. The analysis of reliability studies showed that the diagnostic techniques used in visceral osteopathy are unreliable. Regarding efficacy studies, the least biased study showed no significant difference for the main outcome. The main risks of bias found in the included studies were due to the absence of blinding of the examiners, an unsuitable statistical method or an absence of primary study outcome.

The authors (who by the way declared no conflicts of interest) concluded that the results of the systematic review lead us to conclude that well-conducted and sound evidence on the reliability and the efficacy of techniques in visceral osteopathy is absent.

It is hard not to appreciate the scientific rigor of this review or to agree with the conclusions drawn by the French authors.

But what consequences should we draw from all this?

The authors of this paper state that more and better research is needed. Somehow, I doubt this. Visceral osteopathy is not plausible and the best evidence available to date does not show it works. In my view, this means that we should declare it an obsolete aberration of medical history.

To this, the proponents of visceral osteopathy will probably say that they have tons of experience and have witnessed wonderful cures etc. This I do not doubt; however, the things they saw were not due to the effects of visceral osteopathy, they were due to chance, placebo, regression towards the mean, the natural history of the diseases treated etc., etc. And sometimes, experience is nothing more that the ability to repeat a mistake over and over again.

  • If it looks like a placebo,
  • if it behaves like a placebo,
  • if it tests like a placebo,

IT MOST LIKELY IS A PLACEBO!!!

And what is wrong with a placebo, if it helps patients?

GIVE ME A BREAK!

WE HAVE ALREADY DISCUSSED THIS AD NAUSEAM. JUST READ SOME OF THE PREVIOUS POSTS ON THIS SUBJECT.

An article in the medical magazine ‘GP’ caught my eye. In it, a GP from Southampton argues that it is counter-productive for the NHS to ban ineffective treatments. Here are a few excerpts (my comments are inserted in brackets and are in bold print):

START OF QUOTES

NHS England’s recent decision requiring GPs stop prescribing a list of 18 medicines will reinforce the fears of many doctors that healthcare rationing is being introduced by the back door (all finite NHS resources need to be and always have been rationed). I would also argue that it is an illogical and ill-informed decision that will not achieve the professed aim of saving NHS resources (perhaps the decision is not purely based on the need to save money but also on a matter of principle and an attempt to make the NHS evidence-based?).

The decision to impose a blanket ban on these items will disproportionately affect those patients who currently receive free prescriptions: the young, the poor and the elderly (where is the evidence for this statement?). The conditions these patients are suffering from will persist (treating them with ineffective medications would also make them persist).

If in future these vulnerable patients want to continue with their medicines, they will be forced to pay for them. While wealthier patients will have the option to pay for their medications, those unable to do so will return to their GP for an alternative medication or procedure that has not been prohibited by NHS England’s recommendations. GPs will then find themselves prescribing other more costly medications. How this is helping NHS England to reduce prescribing costs is difficult to see (really? I don’t find it difficult to see that spending money on effective treatments is a better investment than wasting it on ineffective stuff)…

… ‘evidence-informed practice’… not only includes scientific research, but also evidence from clinical practice acquired over many years and endorsed by numerous clinicians. Yet this type of evidence, from the front line of medicine, is being dismissed as ‘unscientific’ or ‘anecdotal’ (no, it has never been considered to be evidence; remember: the plural of anecdote is anecdotes, not evidence)…

We all want the NHS to operate cost effectively… (as long as the NHS continues to pay for homeopathy?). Of course, treatments that have no good evidence of benefit to patients should be questioned (as long as the NHS continues to pay for homeopathy?)…

NHS England needs to conduct a review of how it evaluates treatments and take far more notice of the experiences of doctors and patients. Then perhaps we will see a more financially efficient health service, healthier patients and an end to the injustice of healthcare rationing (the author forgot to tell her readers that she is a homeopath – in fact, she did not even once use the word ‘homeopathy’ in her diatribe. Because of her extreme views, she has featured on this blog before. [“homeopathy can be helpful for pretty much any condition”] Dr Day also forgot to declare conflicts of interest in her most recent vituperation [easy mistake to make; I know I am being petty).

 

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If I were a fan of homeopathy and a believer in the magical healing power of shaken water, I would be very worried. While homeopaths put forward such embarrassingly daft arguments, the future of homeopathy looks bleak indeed.

 

 

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