MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

critical thinking

There has been a flurry of legal actions against manufacturers of homeopathic products (mostly) in the US. Many of these cases seem to settle out of court which means that we hardly hear about them. Of those that go to court, most are being won by the plaintiffs, but unfortunately some are also lost.

The recent case of Allen v. Hyland’s, Inc. is such an incidence. The US lawyer Robert G Knaier has analysed this case in detail and recently published a paper about it. The article is fascinating and well worth reading in full.

Here I take the liberty to show you a (shorted) section of Knaier’s paper where he asks what went wrong:

… How did a jury decide that Hyland’s did not misrepresent the efficacy of its products? Surely, the court’s instruction that Hyland’s would be liable only if the plaintiffs proved homeopathy “cannot work” contributed to the result. So long as defense experts were able to propose ways that homeopathy might work, the jury was left with the difficult decision—for laypersons, in any event—of rejecting that testimony.

But should the jury ever have been put in the position of having to make that choice? Should the defense experts ever have been allowed to testify? Had the court in Allen granted the plaintiffs’ motions to exclude those experts, the case likely would have ended with a settlement. Without the ability to put on evidence supporting its products, Hyland’s may very well have recognized that it had no realistic chance of prevailing at trial. But the court denied those motions.

In this respect, the court erred. There can be little doubt that expert testimony in support of the efficacy of homeopathy fails tests of admissibility. Consider the Federal Rules of Evidence and the factors that courts should evaluate under Daubert and its progeny. Is testimony that homeopathy is effective “the product of reliable principles and methods”?

In other words, does it have a “reliable foundation”? Is “the reasoning or methodology underlying [it] . . . scientifically valid”?  As explained above, homeopathy’s core principles—provings, like cures like, and the law of minimum dose—are based on little more than Samuel Hahnemann’s late eighteenth-century speculations. They were not developed through, nor have they been validated by, controlled scientific studies… the principles and efficacy of homeopathy have been “tested” and “subjected to peer review and publication” — but they have consistently failed those tests and the scrutiny of that review process… Indeed, the FDA has stated that it simply is “not aware of scientific evidence to support homeopathy as effective.”

Thus, homeopathy’s “rate of error” is known, and far from gaining “general acceptance” in the scientific and medical community, it has gained near-universal condemnation. The defense of homeopathy, in some respects, presents a classic example of “unjustifiably extrapolat[ing] from an accepted premise to an unfounded conclusion.”  Advocates extrapolate from the efficacy of vaccines that similia similibus currentur has a sound scientific basis, and from the concept of hormesis that providing ultralow doses is well-founded methodology. But as one contemporary skeptic has explained, unlike homeopathic remedies, vaccines actually “contain measurable numbers of antigen molecules,” and “act by well-understood scientific mechanisms”; and hormesis, even in the limited circumstances in which it appears to operate, “describes a response to a low dose, not to no dose.”  As Martin Gardner noted many decades ago, the defense of homeopathy thus begins with plausible-sounding principles, and then “exaggerate[s] them to the point of absurdity.”  In other words, it impermissibly extrapolates to “unfounded conclusion[s].”

Finally, the defense of homeopathy glaringly fails to “account for obvious alternative explanations.” Do people who take homeopathic remedies sometimes feel better? Of course they do. But studies of homeopathy have overwhelmingly concluded that the reason for this is not that homeopathy is actually efficacious, but rather because it is “the ideal placebo.” It is cheap. It has no side effects (unless, as discussed below, it is adulterated). And practitioners spend substantial time with their “patients,” thus encouraging psychosomatic effects.

In the end, advocates of homeopathy may have little to stand on other than that many people—including some “experts” who would gladly be paid to testify—inexplicably seem to believe that it works. But this will not do. That homeopathy has many believers does not validate it as a scientifically sound “field of expertise,” or color it, against nearly 200 years of evidence to the contrary, as one “known to reach reliable results for the type of opinion the expert would give.”  As our Supreme Court perhaps most saliently observed, “general acceptance” of a principle cannot “help show that an expert’s testimony is reliable where the discipline itself lacks reliability.” As the Court explained, general acceptance of “principles of astrology or necromancy,” for example, would not transform those subjects into appropriately reliable subjects of expert testimony.  The Court could easily have added homeopathy to that list.

Thus, in allowing the jury to receive testimony about the principles of homeopathy—not as a matter of historic curiosity, but as a matter of scientific validity—the Allen court arguably abdicated its gatekeeping responsibility to screen out unreliable expert testimony. By permitting “experts” to testify in favor of a field the bases of which defy basic principles of biology, chemistry, and physics — indeed, in some respects “basic logical principles” — the “integrity and fairness of the trial process” was compromised.

END OF QUOTE

I fully agree with Knaier. Allowing the ‘flat earth society’ to present to a court their views about the shape of our planet, while instructing the jury that they must accept them as ‘evidence’ (unless the plaintiff can prove it to be untrue) cannot be the right way forward. In fact, it is a method of preventing progress. Following this logic, I cannot imagine the proponents of any absurdity – however ridiculous – to not be victorious in court.

Knaier’s ultimate conclusion is, I think correct: “Trial courts have robust power and clear responsibility to preclude litigants from introducing irrelevant and unreliable evidence in support of purportedly scientific claims… To the extent that courts continue abdicating their evidentiary gatekeeping role in this way, they may contribute to a waste of time and resources, financial harm to consumers, and risks to public health. But to the extent that litigants and courts strengthen their spines in this regard, take seriously the dangers of unfounded expert testimony, and make genuine efforts to seek and grant its exclusion, they might contribute to the health and well-being of both the courts and those who turn to them for help.”

Several national organisations of sceptics give annual awards to people and institutions who do outstanding work and those who do the opposite. Later this week, I will travel to Vienna, for instance, to give away one of this year’s ‘GOLDENES BRETT’, a negative prize for the most outrageous BS of 2017. Such things are good fun but also important tools in fighting nonsense. I probably will report about it when I am back.

Earlier this year, the UK sceptics awarded Gwyneth Paltrow with the well-earned RUSTY RAZOR. The ‘Bent Spoon’ is a similar type of prize. It has just been awarded by the Australian Skeptics to the proponent of the most preposterous piece of pseudoscientific or paranormal piffle of the year. Past winners have included Pete ’Paleo’ Evans, the CSIRO’s head Larry Marshall, the ABC, the Pharmacy Guild of Australia, the University of Wollongong, and a psychic dentist.

This year’s nominations are listed here. The winner of the 2017 Bent Spoon is the National Institute of Complementary Medicine at the University of Western Sydney. “When they were nominated last year they said they’d have a closer look at their site,” said Eran Segev, president of Australian Skeptics Inc. “But they’re still promoting unproven treatments and now also involved in a project to establish a clinic for Traditional Chinese Medicine on the campus of the University of Western Sydney. The 2017 winner’s involvement is described as ‘clinical trials’, but the University acknowledges that the TCM clinic may be opened to the public – a highly dubious pseudomedicine given the imprimatur of university ‘research’. “

On this blog, we have discussed several of the NICM’s papers. An interesting article about the NICM can also be found here. To give you an additional flavour of their research, here are the conclusions of just 5 of their recent articles:

CONCLUSION: In our study of acupuncture for menopausal hot flashes, higher expectancy after the first treatment did not predict better treatment outcomes. Future research may focus on other determinants of outcomes in acupuncture such as therapist attention. The relationship between smoking and hot flashes is poorly understood and needs further exploration.

Conclusion: There is a clear need to understand breast cancer survivors’ needs for physical and psychological support as they aim to regain control over their life through their experience of illness. More studies are needed to measure and evaluate these outcomes and to help identify breast cancer survivors’ healthcare seeking behaviours, during and after the acute treatment stage that addresses their physical, emotional, and spiritual needs. These results aim to inform future research design and evaluate and develop support services that are patient-centred and focus on whole health outcomes, shared decision-making, and quality of life.

CONCLUSION: These results are important for healthcare providers as they work with patients to identify life experiences, including ‘loss/potential loss’ and ‘the need for preservation’, that have personal significance. Some patients may realize that ‘enough is enough’; something needs to change. These intrinsic motivating factors may also be the impetus for eventual recovery for some individuals.

CONCLUSIONS: 16 weeks of Bikram yoga significantly improved perceived stress, general self-efficacy and HRQoL in sedentary, stressed adults. Future research should consider ways to optimise adherence, and should investigate effects of Bikram yoga intervention in other populations at risk for stress-related illness.

CONCLUSIONS: These findings suggest that long-term acupuncture treatment has targeted regulatory effects on multiple brain regions in rats with Alzheimer’s disease.

The ‘Bent Spoon’ was awarded mostly, I think, because of the persistently misleading claims made on the websites of the NICM. Go and have a look – I am sure you will agree: they are highly deserving winners.

In my opinion, these awards deserve our support. They are an effective means of fighting charlatans and promoting progress. They should be publicised much more widely.

 

This is too wonderful (I found it on Twitter where it was posted by ‘Doctors Leonard and Michael Valentine’, chiropractors at Valentine Chiropractic in Fountain Valley, CA.) – I have to show it to you.

This could almost pass without a comment. But for what it’s worth, here are my 7 points:

  1. platitude,
  2. platitude,
  3. no, they do not easily move out of alignment, and if they do, you are severely ill and need urgent treatment but not chiropractic,
  4. subluxations as dreamt up by chiropractors are a myth; they simply do not exist,
  5. it is vital that we don’t disclose this BS, if not chiros need to find new jobs,
  6. chiros pretend to find subluxations because this is their livelihood,
  7. pathetic platitude.

 

This randomized controlled trial was aimed to investigate the effect of aromatherapy massage on anxiety, depression, and physiologic parameters in older patients with acute coronary syndrome. It was conducted on 90 older women with acute coronary syndrome. The participants were randomly assigned into the intervention and control groups. The intervention group received reflexology with lavender essential oil plus routine care and the control group only received routine care. Physiologic parameters, the levels of anxiety and depression in the hospital were evaluated using a checklist and the Hospital’s Anxiety and Depression Scale, respectively, before and immediately after the intervention.

Significant differences in the levels of anxiety and depression were reported between the groups after the intervention. The analysis of physiological parameters revealed a statistically significant reduction in systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate. However, no significant difference was observed in the respiratory rate.

The authors concluded that aromatherapy massage can be considered by clinical nurses an efficient therapy for alleviating psychological and physiological responses among older women suffering from acute coronary syndrome.

WRONG!

This trial does not show remotely what the authors think. It demonstrates that A+B is always more than B. We have discussed this phenomenon so often that I hesitate to mention it again. Any study with the ‘A+B versus B’ design can only produce a positive result. The danger that this result is false-positive is so high that it is best to forget about such investigations altogether.

Ethics committees should not accept such protocols.

Researchers should stop running such studies.

Reviewers should not pass them for publication.

Editors should not publish such trials.

THEY MISLEAD ALL OF US AND GIVE CLINICAL RESEARCH A BAD NAME.

It was the very first sentence of the Boiron US website on Oscillococcinum (we have discussed this amazing product before) that caught my attention: “Homeopathy is a therapeutic method that uses diluted substances to relieve symptoms.” I think this is demonstrably wrong.

  • Homeopathy is a therapeutic method that uses mostly the complete absence of an ingredient, and not ‘diluted substances’; specifically, Oscillococcinum is a  C 200 potency ( 1: 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000) which means the likelihood of any substance being present is zero.
  • Homeopathy is, according to Hahnemann, not ‘to relieve symptoms’ but to tackle the root cause of the condition. Hahnemann meant it to be a causal and not a symptomatic treatment (the truth is that it neither relieves symptoms or the root cause of anything).

And then the website continued to puzzle me by stating this: “The active ingredients in homeopathic medicines include diluted plants, animals or minerals that relieve the same symptoms they cause at full strength (i.e., a micro dose of coffee bean helps to relieve nervousness).” This is wrong too, I think:

  • there is no active ingredient in homeopathic medicines,
  • many of the mother tinctures used in homeopathy cause no symptoms whatsoever,
  • a zero dose is not a micro dose,
  • homeopathic coffee does not relieve nervousness better than a placebo.

Now my interest was aroused and I decided to read on. This is what I found under the heading of ‘Frequently Asked Questions’:

START OF QUOTE

Are there clinical studies on Oscillococcinum?

Yes. Two studies, published in peer-reviewed journals, show that Oscillococcinum helps to reduce the severity and shorten the duration of flu-like symptoms.1-2 The most recent study showed that 63 percent of the patients who took Oscillo at the onset of flu-like symptoms showed “clear improvement” or “complete resolution” of their symptoms after 48 hours, vs. 48% with a placebo.2

1Papp R, Schuback G, Beck E, et al. Oscillococcinum in patients with influenza-like syndromes: a placebo-controlled, double-blind evaluation. Br Homeopath J. 1998;87:69-76. 2Ferley JP, Zmirou D, D’Adhemar D, Balducci F. A controlled evaluation of a homeopathic preparation in the treatment of influenza-like syndromes. Br J Clin Pharmacol. 1989;27:329-335.

END OF QUOTE

Now, this is strange!

Why would they cite just two studies when there are several more? Surely they don’t want to be seen to be cherry picking!?!? The current Cochrane review by Mathie RT, Frye J, Fisher P., for instance, included 6 trials!

And what did this review show?

The authors concluded that “There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum® in the prevention or treatment of influenza and influenza-like illness. Our findings do not rule out the possibility that Oscillococcinum® could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum®.”

Even though the authors of this Cochrane review are amongst the most ardent homeopathy-promoters on the planet (if not they would not have included this odd 2nd sentence in the above quote), this conclusion does not seem to please Boiron (Christian Boiron seems to have not much time for critical thinking; in a recent, short interview he opined that “Il y a un Ku Klux Klan contre l’homéopathie” THERE IS A KU KLUX KLAN AGAINST HOMEOPATHY).

After studying all this, I ask myself whether Boiron is telling the truth.

What do you think?

 

 

 

George Vithoulkas * (GV) is one of today’s most influential lay-homeopaths, a real ‘super guru’. He has many bizarre ideas; one of the most peculiar one was recently outlined in his article entitled ‘An innovative proposal for scientific alternative medical journals’. Here are a few excerpts from it:

…the only evidence that homeopathy can present to the scientific world at this moment are these thousands of cured cases. It is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.

… the international “scientific” community, which has neither direct perception nor personal experience of the beneficial effects of homeopathy, is forced to repeat the same old mantra: “Where is the evidence? Show us the evidence!” … the successes of homeopathy have remained hidden in the offices of hardworking homeopaths – and thus go largely ignored by the world’s medical authorities, governments, and the whole international scientific community…

… simple questions that are usually asked by the “gnorant”, for example, “Can homeopathy cure cancer, multiple sclerosis, ulcerative colitis, etc.?” are invalid and cannot elicit a direct answer because the reality is that many such cases can be ameliorated significantly, and a number can be cured…

A journal could invite a selected number of good prescribers from all over the world as a start to this project and let them contribute to their honest experience and results, as well as their failures. The possibilities and limitations would soon be revealed…

I admit that an argument against accepting cases is that it is possible that false or unreliable information could be provided. This risk could be minimized by preselecting a well-known group of good prescribers, who could be asked to submit their cases, at least in the first phase of such a radical change in the policy of the journals…

This way, instead of rejecting important homeopathic case studies, in the name of a dry intellectualism and conservatism, homeopathy journals (including alternative and complementary journals) could become lively and interesting: initiating debates and discussions on real issues of therapeutics in medicine…

Our own “Evidence Based Medicine” lies in the multitude of chronic cases treated with homeopathy that we can present to the world and on the better quality of life that such cures offer.

END OF QUOTES

So, GV wants homeopathy to thrive by means of publishing lots of case reports of patients who benefitted from homeopathy. And he believes that this suggestion is ‘innovative’? It is not! Case reports were all the rage 150 years ago before medicine started to become a little more scientific. And today, there are several journals specialising in the publication of case-reports, hundreds of journals that like accepting them, as well as dozens of websites that do little else but publishing case reports of homeopathy.

But case reports essentially are anecdotes. Medicine finally managed to progress from its dark ages when we realised how unreliable case reports truly are. To state it yet again (especially for GV who seems to be a bit slow on the uptake): THE PLURAL OF ANECDOTE IS ANECDOTES, NOT EVIDENCE!

In the above article, GV claims that ‘it is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.’ That is most puzzling because, only a few years ago, he did publish this:

Alternative therapies in general, and homeopathy in particular, lack clear scientific evaluation of efficacy. Controlled clinical trials are urgently needed, especially for conditions that are not helped by conventional methods. The objective of this work was to assess the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome (PMS). It was a randomised controlled double-blind clinical trial. Two months baseline assessment with post-intervention follow-up for 3 months was conducted at Hadassah Hospital outpatient gynaecology clinic in Jerusalem in Israel 1992-1994. The subjects were 20 women, aged 20-48, suffering from PMS. Homeopathic intervention was chosen individually for each patient, according to a model of symptom clusters. Recruited volunteers with PMS were treated randomly with one oral dose of a homeopathic medication or placebo. The main outcome measure was scores of a daily menstrual distress questionnaire (MDQ) before and after treatment. Psychological tests for suggestibility were used to examine the possible effects of suggestion. Mean MDQ scores fell from 0.44 to 0.13 (P<0.05) with active treatment, and from 0.38 to 0.34 with placebo (NS). (Between group P=0.057). Improvement >30% was observed in 90% of patients receiving active treatment and 37.5% receiving placebo (P=0.048). Homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo. The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy. Further research is in progress.

I find this intriguing, particularly because the ‘further research’ mentioned prominently in the conclusions never did surface! Perhaps its results turned out to be unfavourable to homeopathy? Perhaps this is why GV dislikes RCTs these days? Perhaps this is why he prefers case reports such as this one which he recently published:

START OF QUOTE

An 81-year-old female patient was admitted in July 2015 to the Cardiovascular Surgery Department of a hospital in Bucharest for an aortic valve replacement surgery.

The patient had a history of mild hypertension, insulin-dependent type 2 diabetes, coronary artery disease, congestive heart failure NYHA 2, severe aortic stenosis, moderate mitral regurgitation, mild pulmonary hypertension, bilateral carotid atheromatosis with a 50% stenosis of the left internal carotid artery, complete right mastectomy for breast cancer (at that moment in remission).

After a preoperative evaluation and preparation, the surgery was completed with the replacement of the aortic valve with a bioprosthesis (Medtronic Hancock II Ultra no. 23) and myocardial revascularization by using a double aortic-coronary bypass.

The post-operatory evolution was a good one in terms of the heart disease. However, the patient did not regain consciousness after the anaesthesia, maintaining a deep comatose state (GCS 7 points – E1V2M4).

A brain CT was performed the third day postoperatively, showing no recent ischemic or haemorrhagic cerebral lesions, moderate diffuse cerebral atrophy and carotid atheromatosis.

After the surgery, the patient was admitted to the Intensive Care Unit and was treated by using a multidisciplinary approach. The patient was treated with inotropic, antiarrhythmic, and diuretic drugs, insulin and antidiabetic drugs were used in order to keep the blood sugar levels under control. The patient was kept hydrated and the electrolytes balanced by using an i.v. line, prophylaxis for deep vein thrombosis, and pulmonary thromboembolism was performed by using low molecular weight heparin. Prophylaxis for bedsores was also performed by using a pressure relieve air mattress.

The patient went into acute respiratory distress, needing mechanical ventilation in order to maintain oxygenation.

Despite these complex and correctly performed therapeutic efforts, the patient did not regain consciousness and was still in a deep coma in the fourteenth day post-operatory (GCS 7 points – E1V2M4), without having a confirmed medical explanation.

At that point, the patient’s family requested a consult from a homeopathic specialist.

The homeopathic examination, which was performed in the fourteenth day postoperatively, revealed the following: old, comatose, tranquil patient, with pale and cold skin, with the need to uncover herself (the few movements that she made with her hands were to remove her blanket and clothes, as if she wanted more air – “thirst for air”), abdominal distension, and bloating.

The thorough evaluation of the patient and the analysis of her symptoms led us to the remedy most appropriate for this critical situation – Carbo Vegetabilis.

Homeopathic treatment was initiated the same day, by using Carbo Vegetabilis 200CH 7 granules twice a day, administered diluted in 20ml of water by using a nasogastric tube.

The patient’s evolution was spectacular. The next day after the initiation of the treatment (fifteenth day postoperatively) the patient was in a superficial coma (GCS 11 points – E2V4M5), and the following day she regained consciousness. Carbo Vegetabilis was administered in the same dose for a total of five days (including the nineteenth day postoperatively).

After these five days, the case was reassessed from a homeopathically point of view and the second evaluation revealed the following: severely dyspnoeic patient (even talking caused exhaustion) with pale skin, severe fatigue aggravated by the slightest movements, a weakness sensation located in the chest area, extreme lack of energy, the wish “to be left alone”.

Considering the state of general exhaustion the patient was in at that moment and her lack of energy, the homeopathic treatment was changed to a new remedy: Stanum metallicum 30CH 7 granules administered sublingually twice a day for a week.

After the administration of the second remedy, the patient’s general condition improved dramatically: she started eating, she was able to get up in a sitting position with only little help, her fatigue diminished significantly.

The patient was then transferred to a recovery clinic in Cluj-Napoca in order to continue the cardiovascular recovery treatment. During her three-week admission in the clinic, she followed an individualized cardiovascular recovery program, which led to her ability to walk short distances with minimal support and has was released from the hospital in September 2015.

The following weeks after release, the patient recovered almost entirely, both physically and mentally. She was able to retake her place in her family and in society in general.

END OF QUOTE

One has to be a homeopath (one who is ignorant of the ‘post hoc propter hoc fallacy’) to believe in a causal link between the intake of the homeopathic remedy and the recovery of this patient. Thankfully, comatose patients do re-gain consciousness all the time! Even without homeopathy! But GV seems to not know that. In the discussion of this paper, he even states this: “ even after a well-conducted therapy, this condition leads to the death of the patient.” Is it ethical to publish such falsehoods, I wonder?

As far as the case report goes, the homeopathic remedy might even have delayed the process – perhaps the patient would have re-gained consciousness quicker and more completely without it! My hypothesis (homeopathy cased harm) is exactly as strong and silly as the one (homeopathy cased benefit) of GV. Anecdotes will never be able to answer the question as to who is correct.

One has to be a homeopath (and a daft one at that) to believe that this sort of evidence will lead to the acceptance of homeopathy by the scientific community. No journal will take GV seriously. No editor can be that stupid!

Oooops! Hold on, I might be wrong here.

Dr Peter Fisher, editor of the journal ‘Homeopathy’ just published an editorial ( Fisher P, Homeopathy and intellectual honesty, Homeopathy (2017), see also my previous post) stating that, in future, ‘we will increase publication of well-documented case-reports’.

Did I just claim that no editor can be that stupid?

 

 

 

  • I should declare a conflict of interest: when he got his ‘Right Livelihood Award’, GV sent me (and other prominent homeopathy-researchers) some of the prize money (I think it was around £ 1000) to support my research in homeopathy. I used it for exactly that purpose.

 

The German Heilpraktiker (a phenomenon vaguely equivalent to the ‘naturopath’ in English speaking countries) has become a fairly regular feature on this blog – see, for instance here, here, and here. The nationally influential German Medical Journal, a weekly publication of the German Medical Association, recently published an article about the education of this profession.

In it, we are told that the German Ministry of Health has drafted a 9-page document to unify the examination of the Heilpraktiker throughout Germany. The German Medical Association, however, are critical about the planned reform. The draft document suggest that, in future, all Heilpraktiker should pass an exam consisting of 60 multiple choice questions, in addition to an oral examination in which 4 candidates are being interviewed simultaneously for one hour. The draft also stipulates that Heilpraktiker may only practice such that they present no danger for public health and only use methods they muster.

The German Medical Association feel that these reforms do not go far enough. They claim that the authors of the draft have ‘totally misunderstood the complexity of the medical context, particularly the amount of necessary knowledge necessary for risk-minimisation in clinical practice’. They furthermore feel that the document is ‘an effort that is in every respect insufficient for protecting the public or individuals from the practice of the Heilpraktiker’. They also state that it is unclear how the document might provide a means to test Heilpraktiker in respect of risk-minimisation. The Medical Association demands that ‘the practice of certain therapies by Heilpraktiker must be forbidden. Finally, they say that ‘the practice of invasive methods and the treatment of caner by Heilpraktiker must be urgently prohibited’.

The German Heilpraktiker has been a subject of much public debate recently, not least after the ‘Muenster Group’ suggested a comprehensive reform. (I reported about this at the time.)

For those who can read German, the original article from the German Medical Journal is copied below:

Das Bundesministerium für Gesundheit (BMG) will gemeinsam mit den Ländern die Heilpraktikerüberprüfung bundesweit vereinheitlichen und Patienten besser schützen. Dafür haben Bund und Länder einen neunseitigen Entwurf erarbeitet. Die Bundes­ärzte­kammer (BÄK) zeigt sich angesichts der Pläne besorgt und übt deutliche Kritik.

Der Entwurf sieht vor, dass zur Überprüfung der Kenntnisse von Heilpraktikern künftig eine Prüfung verpflichtend sein soll. Diese soll aus 60 Multiple-Choice-Fragen bestehen, von denen der Anwärter innerhalb von zwei Stunden 45 korrekt ankreuzen muss. Darüber hinaus ist ein mündlicher Prüfungsteil von einer Stunde vorgesehen – bei vier Prüflingen gleichzeitig.

Zusätzlich stellt der Entwurf klar, dass Heilpraktiker nur in dem Umfang Heilkunde ausüben dürfen, in dem von ihrer Tätigkeit keine Gefahr für die Gesundheit der Bevölkerung oder für Patientinnen und Patienten ausgeht. Sie müssten zudem „eventuelle Arztvorbehalte beachten und sich auf die Tätigkeiten beschränken, die sie sicher beherrschen“, heißt es in der Präambel des Bund-Länder-Entwurfes, der dem Deutschen Ärzteblatt vorliegt.

Der Bundes­ärzte­kammer geht der Text nicht weit genug. Die Autoren der Leitlinie für die Prüfung haben laut BÄK „die Komplexität des medizinischen Kontextes“ völlig verkannt, „insbesondere das Ausmaß des notwendigen medizinischen Wissens, das für eine gefahrenminimierte Ausübung der Heilkunde notwendig ist“, so die Kammer weiter. Die jetzt vorgelegten Leitlinien für die Überprüfung stelle „eine in jeder Hinsicht unzureichende Maßnahme zum Schutz der Bevölkerung oder gar einzelner Patienten vor möglichen Gesundheitsgefahren durch die Tätigkeit von Heilpraktikern dar.

Es sei nicht nachvollziehbar, „wie auf der Grundlage dieser Leitlinien eine Überprüfung von Heilpaktikeranwärtern unter dem Aspekt einer funktionierenden Gefahrenabwehr erfolgen soll“, so die Kammer weiter. Sie fordert, dass Heilpraktikern bestimmte Tätigkeiten verboten werden. „Konkret sieht die Bundes­ärzte­kammer insbesondere den Ausschluss aller invasiven Maßnahmen sowie der Behandlung von Krebserkrankungen als zwingend notwendig an“, heißt es in der Stellungnahme.

Der Bund-Länder-Entwurf ist Ergebnis einer Debatte darüber, was Heilpraktiker dürfen oder künftig nicht (mehr) dürfen sollten und wie die Regeln für den Gesundheitsberuf aussehen. Eine Expertengruppe, der „Münsteraner Kreis“, hatte unlängst Vorschläge für eine umfassende Reform erarbeitet. Das Thema war zuletzt in der Öffentlichkeit und auch der Ärzteschaft heftig diskutiert worden.

END OF QUOTE

So, how well should alt med practitioners be educated and trained?

The answer depends, I think, on what precisely they are allowed to do. Medical responsibility must always be matched to medical competence. If a massage therapist merely acts on the instructions of a doctor, she does not need to know the differential diagnosis of a headache, for instance.

If, however, practitioners independently diagnose diseases (and alt med practitioners often do exactly that!), they must have a knowledge-base similar to that of a GP. If they use potentially harmful treatments (and which therapy does not have the potential to do harm?), they must be aware of the evidence for or against these interventions, as well as the evidence for all other therapeutic options for the conditions in question. Again, this would mean having a knowledge close to GP-level. If there is a mismatch between responsibility and competence (as very often is the case), patients are exposed to avoidable risks.

It is clear from these considerations that an exam with 60 multiple-choice questions followed by an hour-long interview is woefully inadequate for testing whether a practitioner has sufficient medical competence to independently care for patients. It is also clear, I think, that practitioners who regularly diagnose and treat patients – usually without any supervision – ought to have an education that covers much of what doctors learn while in medical school. Finally, it is clear that even after an adequate education, practitioners need to gather experience and work under supervision for some time before they can responsibly practice independently.

In any case, uncritically teaching obsolete notions of vitalism, yin and yang, subluxation, detox, potentisation, millennia of experience etc. is certainly not good enough. Education has to be based on sound evidence; if not, it is not education but brain-washing. And the result would be that students do not become responsible healthcare professionals but irresponsible charlatans.

Of course, alt med practitioners will argue that these arguments are merely the expression of medics defending their lucrative patch. But even if this were true (which, in my view, it is not), it would not absolve them from the moral, ethical and legal duty to demonstrate that their educational standards are sufficiently rigorous to avoid harm to their patients.

In a nutshell: an education in nonsense must result in nonsense.

 

I have often cautioned about what I call the ‘survey mania’ in alternative medicine. Yet, once in a while, an informative survey gets published. Take this recent survey, for instance:

It was based on a design-based logistic regression analysis of the European Social Survey (ESS), Round 7. The researchers distinguished 4 modalities: manual therapies, alternative medicinal systems, traditional Asian medical systems and mind-body therapies.

In total, 25.9% of the general population had used at least one of these therapies during the last 12 months which was around one-third of the proportion of those who had visited a general practitioner (76.3%). Typically, only one treatment had been used, and it was used more often as complementary rather than alternative treatment. The usage varied greatly by country (see Table 1 below). Compared to those in good health, the use of CAM was two to fourfold greater among those with health problems. The health profiles of users of different CAM modalities varied. For example, back or neck pain was associated with all types of CAM, whereas depression was associated only with the use of mind-body therapies. Individuals with difficult to diagnose health conditions were more inclined to utilize CAM, and CAM use was more common among women and those with a higher education. Lower income was associated with the use of mind-body therapies, whereas the other three CAM modalities were associated with higher income.

The authors concluded that help-seeking differed according to the health problem, something that should be acknowledged by clinical professionals to ensure safe care. The findings also point towards possible socioeconomic inequalities in health service use.

As I said, this is one of the rare surveys that is worth studying in some detail. This is mainly because it is rigorous and its results are clearly presented. Much of what it reports has been known before (for instance, we showed that the use of CAM in the UK was 26% which ties in perfectly with the 21% figure considering that here only 4 CAMs were included), but it is undoubtedly valuable to see it confirmed based on sound methodology.

Apart of what the abstract tells us, there are some hidden gems from this paper:

  • 8% of CAM users had used CAM exclusively (alternative use), without any visits to biomedical professionals in the last 12 months. This may look like a low figure, but I would argue that it is worryingly high considering that alternative usage of CAM has the potential to hasten patients’ deaths.
  • The most frequently used CAM treatment was massage therapy, used by 11.9% of the population, followed by homeopathy (5.7%), osteopathy (5.2%), herbal treatments (4.6%), acupuncture (3.6%), chiropractic (2.3%), reflexology (1.7%) and spiritual healing (1.3%). Other modalities (Chinese medicine, acupressure and hypnotherapy) were used by around by 1% or less. The figure for homeopathy is MUCH smaller that the ones homeopaths want us to believe.
  • About 9% of healthy survey-participants had used at least one of the CAM modalities during the last 12 months. One can assume that this usage was mostly for disease-prevention. But there is no good evidence for CAM to be effective for this purpose.
  • The highest ORs for the use of Traditional Asian Medical Systems were found in Denmark, Switzerland and Israel, followed by Austria, Norway and Sweden. The highest OR for the use of Alternative Medical Systems was found in Lithuania, while manual therapies were most commonly used in Finland, Austria, Switzerland, Germany and Denmark. Moreover, Denmark, Ireland, Slovenia and Lithuania had the highest ORs for using mind-body therapies. France, Spain and Germany presented a common pattern, with relatively similar use of the different modalities. Poland and Hungary had low ORs for use of the different CAM modalities.

But by far the nicest gem, however, comes from my favourite source of misinformation on matters of health, WDDTY. They review the new survey and state this: The patients are turning to alternatives for a range of chronic conditions because they consider the conventional therapy to be inadequate, the researchers say. Needless to point out that this is not a theme that was addressed by the new survey, and therefore its authors also do not draw this conclusion.

The British press recently reported that a retired bank manager (John Lawler, aged 80) died after visiting a chiropractor in York. This tragic case was published in multiple articles, most recently in THE SUN. Personally, I find this regrettable – not the fact that the press warns consumers of chiropractic, but the tone and content of the articles.

Let me explain this by citing the one in THE SUN of today. Here is the critical bit that concerns me:

Ezvard Ernst, Emeritus Professor of Complementary Medicine at Exeter University, published a study showing at least 26 people had died as a result. He said: “The evidence is not in favour of chiropractic treatments. Nobody knows how many have suffered severe complications or died.” Edvard Ernst, Professor of Complementary Medicine, says many have suffered complications or died from chiropractors treatments… A study from Exeter University shows at least 26 people have died as a result of treatment.

And what is wrong with this?

The answer is lots:

  • My first name is consistently misspelled (a triviality, I agree).
  • I am once named as Emeritus Professor and once as Professor of Complementary Medicine. The latter is wrong (another triviality, perhaps, but some of my more demented critics have regularly accused me of carrying wrong titles)
  • The mention of 26 deaths after chiropractic treatments is problematic and arguably misleading (see below).
  • Our ‘study’ was not a study but a systematic review (another triviality?).

Now you probably think I am being pedantic, but I feel that the article is regrettable not so much by what it says but by what it fails to say. To understand this better, I will below copy my emails to the journalist who asked for help in researching this article.

  • My email of 17/10 answering all 7 of the journalist’s specific questions:
  • 1. Why are you sceptical of chiropractic?
  • I have researched the subject for more than 2 decades, and I know that the evidence is not in favour of chiropractic
  • 2. How many people do you believe have died in Britain as a result of being treated by a chiropractor? If it’s not possible to say, can you estimate?
  • nobody knows how many patients have suffered severe complications or deaths. there is no system to monitor such events that is comparable to the post-marketing surveillance of conventional medicine. we did some research and found that the under-reporting of cases of severe complications was close to 100% in the UK.
  • 3. What is so dangerous about chiropractic? Is there a particular physical treatment than endangers life?
  • manipulations that involve rotation and over-extension of the upper spine can lead to a vertebral artery breaking up. this causes a stroke which sometimes is fatal.
  • 4. Is the industry well regulated?
  • UK chiropractors are regulated by the General Chiropractic Council. it is debatable whether they are fit for purpose (see here:http://edzardernst.com/2015/02/the-uk-general-chiropractic-council-fit-for-purpose/)
  • 5. Should we be suspicious of claims that chiropractic can cure things like IBS and autism?
  • such claims are not based on good evidence and therefore misleading and unethical. sadly, however, they are prevalent.
  • 6. Who trains chiropractors?
  • there are numerous colleges that specialise in that activity.
  • 7. Is it true Prince Charles is to blame for the rise in popularity/prominence of chiropractic?
  • I am not sure. certainly he has been promoting all sorts of unproven treatments for decades.
  • My email of 18/10 answering 3 further specific questions
  • 1. Would you actively discourage anyone from being treated by a chiropractor?
    yes, anyone I feel responsible for
    2. Are older people particularly at risk or could one wrong move affect anyone?
    older people are at higher risk of bone fractures and might also have more brittle arteries prone to dissection
    3. If someone has, say, a bad back or stiff neck what treatment would you recommend instead of chiropractic?
    I realise every case is different, but you are sceptical of all complementary treatments (as I understand it) so what would you suggest instead?
    I would normally consider therapeutic exercises and recommend seeing a good physio.
  • 3. My email of 23/10 replying to his request for specific UK cases
  • the only thing I can offer is this 2001 paper
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1297923/
  • where we discovered 35 cases seen by UK neurologists within the preceding year. the truly amazing finding here was that NONE of them had been reported anywhere before. this means under-reporting was exactly 100%.

END OF QUOTES
I think that makes it quite obvious that much relevant information never made it into the final article. I also know that several other experts provided even more information than I did which never appeared.

The most important issues, I think, are firstly the lack of a monitoring system for adverse events, secondly the level of under-reporting and thirdly the 50% rate of mild to moderate adverse-effects. Without making these issues amply clear, lay readers cannot possibly make any sense of the 26 deaths. More importantly, chiropractors will now be able to respond by claiming: 26 deaths compare very favourably with the millions of fatalities caused by conventional medicine. In the end, the message that will remain in the heads of many consumers is this: CONVENTIONAL MEDICINE IS MUCH MORE DANGEROUS THAN CHIROPRACTIC!!! (The 1st comment making this erroneous point has already been published: Don’t be stupid Andy. You wanna discuss how many deaths occur due to medication side effects and drug interactions? There is a reason chiros have the lowest malpractice rates.)

Don’t get me wrong, I am not accusing the author of the SUN-article. For all I know, he has filed a very thoughtful and complete piece. It might have been shortened by the editor who may also have been the one adding the picture of the US starlet with her silicone boobs. But I am accusing THE SUN of missing a chance to publish something that might have had the chance of being a meaningful contribution to public health.

Perhaps you still think this is all quite trivial. Yet, after having experienced this sort of thing dozens, if not hundreds of times, I disagree.

For some time now, I got the impression that the research literature of alternative medicine is yielding more and more animal experiments. But impressions can of course be misleading, so I did a small statistical analysis. I went on to Medline, searched for all papers on ‘complementary/alternative medicine’, and counted the number of animal studies as well as clinical studies (including observational studies but excluding surveys) amongst the first 100 hits.

The results confirmed the above-named impression. There were:

  • 30 animal studies,
  • 12 clinical trials,
  • the rest was made up of other pre-clinical studies (mostly in-vitro studies), comments and other types of publications.

I find this dominance of animal studies surprising, particularly as I got the impression that many were odd, meaningless and not followed by adequate further research. But again, this is just an impression. Let’s see some data. Here are the first 3 papers listed:

Paper number 1

BACKGROUND:

Essential hypertension is mainly caused by endothelial dysfunction which results from nitric oxide (NO) deficiency. The present study was design to evaluate the protective effect of Bidens pilosa ethylene acetate extract (Bp) on L-NAME induced hypertension and oxidative stress in rats.

METHODS:

Male Wistar rats were used to induce hypertension by the administration of L-NAME (a non-pecific nitric oxide inhibitor) (50 mg/kg/day). The others groups were receiving concomitantly L-NAME plus Bp extract (75 and 150 mg/kg/day) or losartan (25 mg/kg/day). All the treatments were given orally for 4 weeks. At the end of the treatment, the hemodynamic parameters were recorded using the direct cannulation method. The effects of the extract on lipid profile, kidney and liver functions as well as oxidative stress markers were evaluated by colorimetric method. Results were expressed as the mean ± SEM. The difference between the groups was compared using one-way analysis of variance (ANOVA) followed by the Duncan’s post hoc test.

RESULTS:

Animals receiving L-NAME presented high blood pressure, normal heart rate and lipid profile as well as NO depletion, liver and kidney injuries and oxidative stress. The concomitant treatment with L-NAME and Bp or losartan succeeded to prevent the raised of blood pressure and all the other injuries without affecting the heart rate.

CONCLUSION:

These results confirm the antihypertensive effects of Bidens pilosa and highlight its protective properties in L-NAME model of hypertension in rat, probably due to the presence of Quercetin 3,3 ‘-dimethyl ether 7-0-β-D-glucopyranoside.

Paper number 2

BACKGROUND:

Oxidative stress has a pivotal role in the pathogenesis and development of diabetic peripheral neuropathy (DPN), the most common and debilitating complications of diabetes mellitus. There is accumulating evidence that Juglans regia L. (GRL) leaf extract, a rich source of phenolic components, has hypoglycemic and antioxidative properties. This study aimed to determine the protective effects of Juglans regia L. leaf extract against streptozotocin-induced diabetic neuropathy in rat.

METHODS:

The DPN rat model was generated by intraperitoneal injection of a single 55 mg/kg dose of streptozotocin (STZ). A subset of the STZ-induced diabetic rats intragastically administered with GRL leaf extract (200 mg/kg/day) before or after the onset of neuropathy, whereas other diabetic rats received only isotonic saline as the same volume of GRL leaf extract. To evaluate the effects of GRL leaf extract on the diabetic neuropathy various parameters, including histopathology and immunohistochemistry of apoptotic and inflammatory factors were assessed along with nociceptive and biochemical assessments.

RESULTS:

Degeneration of the sciatic nerves which was detected in the STZ-diabetic rats attenuated after GRL leaf extract administration. Greater caspase-3, COX-2, and iNOS expression could be detected in the STZ-diabetic rats, which were significantly attenuated after GRL leaf extract administration. Also, attenuation of lipid peroxidation and nociceptive response along with improved antioxidant status in the sciatic nerve of diabetic rats were detected after GRL leaf extract administration. In other word, GRL leaf extract ameliorated the behavioral and structural indices of diabetic neuropathy even after the onset of neuropathy, in addition to blood sugar reduction.

CONCLUSION:

Our results suggest that GRL leaf extract exert preventive and curative effects against STZ-induced diabetic neuropathy in rats which might be due to its antioxidant, anti-inflammatory, and antiapoptotic properties.

Paper number 3

BACKGROUND:

Many people still experience pain and inflammation regardless of the available drugs for treatments. In addition, the available drugs have many side effects, which necessitated a quest for new drugs from several sources in which medicinal plants are the major one. This study evaluated the analgesic and anti- inflammatory activity of the solvent fractions of Moringa stenopetala in rodent models of pain and inflammation.

METHODS:

Successive soxhlet and maceration were used as methods of extractions using solvents of increasing polarity; chloroform, methanol and water. Swiss albino mice models were used in radiant tail flick latency, acetic acid induced writhing and carrageenan induced paw edema to assess the analgesic and anti-inflammatory activities. The test groups received different doses (100 mg/kg, 200 mg/kg and 400 mg/kg) of the three fractions (chloroform, methanol and aqueous). The positive control groups received morphine (20 mg/kg) or aspirin (100 mg/kg or 150 mg/kg) based on the respective models. The negative control groups received the 10 ml/kg of vehicles (distilled water or 2% Tween 80).

RESULTS:

In all models, the chloroform fraction had protections only at a dose of 400 mg/kg. However, the methanol and aqueous fraction at all doses have shown significant central and peripheral analgesic activities with a comparable result to the standards. The aqueous and methanol fractions significantly reduced carrageenan induced inflammation in a dose dependent manner, in which the highest reduction of inflammation was observed in aqueous fraction at 400 mg/kg.

CONCLUSION:

This study provided evidence on the traditionally claimed uses of the plant in pain and inflammatory diseases, and Moringa stenopetala could be potential source for development of new analgesic and anti-inflammatory drugs.

END OF QUOTE

I may be wrong, but I have my doubts that these papers are useful (and there are many that are far worse than these 3. Take for instance this one that I blogged about previously). Animal studies could clearly be helpful, but they have to fulfil certain conditions.

Medline is currently littered with dubious animal experiments which never seem to be followed up with further research. Without subsequent research verifying whether the effects observed in animals might have any meaning for treating humans, such studies are, I think, in danger of being a waste of animals, money and time. It is my impression – one that would be difficult to back up by hard data – that most of these dubious animal studies are never followed by further research. If true, this would render them meaningless and arguably unethical.

Yet I am not an expert in pre-clinical research and would be most interested to hear your opinion on this matter.

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