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

critical thinking

Dr. Dietmar Payrhuber is not famous – no, by no means. I had never heard of him until a watched this TV discussion about homeopathy (it’s in German, and well-worth watching, if you understand the language). I found the discussion totally mesmerising: Payrhuber is allowed to come out with case after case alleging he cured cancer of various types with homeopathy. Prof Frass is also there to defend the indefensible, but hardly intervenes, other than repeatedly and pompously stating that he is a professor with 200 publications who runs a homeopathy clinic at the university hospital of Vienna and therefore he is a cut above.

There are also three very bright and eloquent sceptical disputants who do their best to oppose Payrhuber’s moronic monstrosities. One of them even alerts us (and the broadcaster!) to the fact that some cancer patients might watch this and conclude that homeopathy cues cancer. Yes, TV can be dangerous!

After watching Payrhuber, I felt the urge to learn more about this man. On TV, he mentioned repeatedly his publications, so I first of all conducted a Medline search; it turns out that Medline lists not a single article in his name. However, I did find his (self-published) book: ‘HOMOEOPATHIE UND KREBS’ (HOMEOPATHY AND CANCER). It greatly impressed me – but not in a positive sense.

The preface (in English) is by Jan Scholten (who IS quite famous in the realm of homeopathy); here is a short quote from it:

[Payrhuber’s book] … is an important book for several reasons. The first reason is that it shows that homeopathy is a real healing art. Often homeopathy is seen as good for superficial, light and self-healing diseases such as colds, eczema’s, bronchitis and the like. Together with this view goes the opinion that it is not a real medicine, because it cannot treat „real diseases“. But this shows the opposite: cancer can be healed, cured with homeopathy. It shows that homeopathy can have very profound effect and can really cure deeply. Of course cancer was cured already in the past with homeopathy by famous homeopaths such as Grimmer and Resch. But Dietmar shows that it can be done in a consistent way. Homeopathy cannot be set aside as superficial anymore…

But it gets worse! Payrhuber himself is equally clear that homeopathy can cure cancer; here is a quote that I translated from his German text into English:

The book shows options to treat cancer; this is not an exclusive option of homeopathy. However, it offers an alternative for therapy-resistant and slow-responding cases treated conventionally… The question whether homeopathy is an alternative or a complementary therapy is superfluous. As the cases presented here demonstrate, homeopathy is part of medicine, a method which is more scientific than conventional medicine, because it has clear principles and laws. In certain cases or in certain phases of cancer, homeopathy is quite simply indicated! Homeopathy is holistic and puts the whole patient rather than a local symptom in the centre.

We must not keep homeopathy from cancer patients, because it offers in many cases a cure which cannot be achieved by other means.

(For those who can read German, here is the original: Das Buch zeigt Möglichkeiten auf, Krebs zu behandeln, es stellt keinen Alleinanspruch der Homöopathie dar. Es bietet allerdings alternative Möglichkeiten für therapieresistente und therapieträge Behandlungsverläufe bei konventioneller Therapie an…. 

Es erübrigt sich die Frage, ob Homöopathie eine alternative oder komplementäre Medizin ist. Wie die vorliegenden Fälle zeigen, ist sie ein Teil der Medizin, eine Methode, die „eher wissenschaftlicher ist als die Schulmedizin, weil die Homöopathie deutliche Prinzipien und Gesetze hat“. Die Homöopathie ist in bestimmten Fällen oder in bestimmten Phasen der Behandlung schlicht und einfach indiziert! Sie ist ganzheitlich, setzt den Menschen ins Zentrum und nicht das Lokalsymptom…

Die Homöopathie darf dem Patienten nicht vorenthalten werden, da sie in vielen Fällen Heilungsmöglichkeiten bietet, die auf andere Weise nicht erreicht werden können…)

END OF QUOTE

As I said, Payrhuber is not famous – he is infamous!

This sad story left me with three questions:

  1. Can someone please stop Payrhuber before he does more damage to cancer patients?
  2. And can someone please tell the medical faculty of the university of Vienna (my former employer) that running a homeopathy clinic for cancer patients is not ethical?
  3. Can someone please teach journalists that, in healthcare, giving a voice to dangerous nonsense can do serious harm?

Homeopathy has always enjoyed a special status in Germany, its country of origin. Germans use homeopathy more often than the citizens of most other countries, they spend more money on it, and they even have elevated it to some kind of medical speciality. In 2003, the German medical profession re-considered the requirements for carrying the title of ‘Doctor of Homeopathy’. It was decided that only physicians who already were specialists in one medical field were allowed to be certified with this title after a post-graduate education and training programme of 6 months, or 100 hours of case studies under supervision plus 160 hours of course work. Many German physicians seem to find this rigorously regulated programme attractive, opted for it, and earn good money with it; the number of ‘doctors of homeopathy’ has risen from 2212 to 6712 between 1993 and 2009.

Personally, I find much of this surprising, even laughable, and have repeatedly stated that even the most rigorously regulated education in nonsense can only result in nonsense. 

Luckily, I am not alone. A multidisciplinary group of experts (Muensteraner Kreis) has just filed an official application with the current 121st General Assembly of the German medical profession to completely abolish the title ‘Doctor of Homeopathy’. Our application itself is a lengthy document outlining in some detail the nature of our arguments. Here, I will merely translate its conclusion:

Even though present in science-business, homeopathy is not scientifically founded. Its basis – potentisation and the simile principle – contradicts scientific facts; homeopathy therefore must be categorised as esoteric. The international scientific community does not interpret the clinical studies of homeopathy as a sufficient proof for its efficacy. Giving an esoteric approach to medicine the veneer of credibility by officially establishing the title ‘Doctor of Homeopathy’ contradicts the physicians’ claim of a scientifically-based medicine and weakens the status of the science-based medicine through blurring the boundaries between science and belief. Problems within science-based medicine must be solved internally and cannot be unburdened onto an unscientific approach to medicine. We consider the abolishment of the ‘Doctor of Homeopathy’ to be urgently indicated.

END OF MY TRANSLATION

I think it would be more than a little over-optimistic to assume that the Assembly will swiftly adopt our suggestion. Perhaps this is also not the intention of our application. In Germany (I learnt my homeopathy in this country), homeopathy is still very much protected by powerful lobby groups and financial interests, as well as loaded with heavy emotional baggage. Yet I do hope that our application will start a discussion which, eventually, will bring a rational resolution to the embarrassing anachronism of the ‘Doctor of Homeopathy’ (Arzt fuer Homoeopathie).

The German medical profession might even have the opportunity to be internationally at the forefront of reason and progress.

Clinical trials are a most useful tool, but they can easily be abused. It is not difficult to misuse them in such a way that even the most useless treatment appears to be effective. Sadly, this sort of thing happens all too often in the realm of alternative medicine. Take for instance this recently published trial of homeopathy.

The objective of this study was to investigate the usefulness of classical homeopathy for the prevention of recurrent urinary tract infections (UTI) in patients with spinal cord injury (SCI). Patients were admitted to this trial, if they had chronic SCI and had previously suffered from at least three UTI/year. They were treated either with a standardized prophylaxis alone, or with a standardized prophylaxis in combination with homeopathy. The number of UTIs, general and specific quality of life (QoL), and satisfaction with homeopathic treatment were assessed prospectively over the period of one year. Ten patients were in the control group and 25 patients received adjunctive homeopathic treatment. The median number of self-reported UTI in the homeopathy group decreased significantly, whereas it remained unchanged in the control group. The domain incontinence impact of the KHQ improved significantly, whereas the general QoL did not change. The satisfaction with homeopathic care was high.

The authors concluded that adjunctive homeopathic treatment lead to a significant decrease of UTI in SCI patients. Therefore, classical homeopathy could be considered in SCI patients with recurrent UTI.

Where to begin?

Here are just some of the most obvious flaws of and concerns with this study:

  1. There is no plausible rationale to even plan such a study.
  2. The sample size was far too small for allowing generalizable conclusions.
  3. There was no adequate randomisation and patients were able to chose the homeopathy option.
  4. The study seems to lack objective outcome measures.
  5. The study design did not allow to control for non-specific effects; therefore, it seems likely that the observed outcomes are unrelated to the homeopathic treatments but are caused by placebo and other non-specific effects.
  6. Even if the study had been rigorous, we would need independent replications before we draw such definitive conclusions.
  7. Two of the authors are homeopaths, and it is in their clinics that the study took place.
  8. Some of the authors have previously published a very similar paper – except that this ‘case series’ included no control group at all.
  9. The latter paper seems to have been published more than once.
  10. Of this paper, one of the authors claimed that ” the usefulness of classical homeopathy as an adjunctive measure for UTI prophylaxis in patients with NLUTD due to SCI has been demonstrated in a case series”. He seems to be unaware of the fact that a case series cannot possible lend itself to demonstrate this.
  11. I do wonder: did they just add a control group to their case series thus pretending it became a controlled clinical trial?

What strikes me most with such pseudo-research is its abundance and the naivety – or should I call it ignorance? – of the enthusiasts who conduct it. Most of them, I am fairly sure do not mean to do harm; but by Jove they do!

 

Do chiropractors even know the difference between promotion and research?

Probably a rhetorical question.

Personally, I have seen them doing so much pseudo-research that I doubt they recognise the real thing, even if they fell over it.

Here is a recent example that stands for many, many more such ‘research’ projects (some of which have been discussed on this blog).

But first a few sentences on the background of this new ‘study’.

The UD chiropractic profession is currently on the ‘opioid over-use bandwagon’ hoping that this move might promote their trade. Most chiropractors have always been against using (any type of) pharmaceutical treatment and advise their patients accordingly. D D Palmer, the founder of chiropractic, was adamant that drugs are to be avoided; he stated for instance that Drugs are delusive; they do not adjust anything. And “as the Founder intended, chiropractic has existed as a drug-free healthcare profession for better than 120 years.” To this day, chiropractors are educated and trained to argue against non-drug treatments and regularly claim that chiropractic is a drug-free alternative to traditional medicine.

Considering this background, this new piece of (pseudo) research is baffling, in my view.

The objective of this investigation was to evaluate the association between utilization of chiropractic services and the use of prescription opioid medications. The authors used a retrospective cohort design to analyse health insurance claims data. The data source was the all payer claims database administered by the State of New Hampshire. The authors chose New Hampshire because health claims data were readily available for research, and in 2015, New Hampshire had the second-highest age-adjusted rate of drug overdose deaths in the United States.

The study population comprised New Hampshire residents aged 18-99 years, enrolled in a health plan, and with at least two clinical office visits within 90 days for a primary diagnosis of low-back pain. The authors excluded subjects with a diagnosis of cancer. They measured likelihood of opioid prescription fill among recipients of services delivered by chiropractors compared with a control group of patients not consulting a chiropractor. They also compared the cohorts with regard to rates of prescription fills for opioids and associated charges.

The adjusted likelihood of filling a prescription for an opioid analgesic was 55% lower among chiropractic compared to non-chiropractic patients. Average charges per person for opioid prescriptions were also significantly lower among the former group.

The authors concluded that among New Hampshire adults with office visits for noncancer low-back pain, the likelihood of filling a prescription for an opioid analgesic was significantly lower for recipients of services delivered by doctors of chiropractic compared with nonrecipients. The underlying cause of this correlation remains unknown, indicating the need for further investigation.

The underlying cause remains unknown???

Really?

Let me speculate, or even better, let me extrapolate by drawing an analogy:

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

The adjusted likelihood of being a vegetarian was 55% lower among the experimental group compared to controls. The average money spent per person in Hamburger restaurants were also significantly lower among the Hamburger group.

The authors concluded that among New Hampshire adults visiting Hamburger restaurants, the likelihood of vegetarianism was significantly lower for consumers frequenting Hamburger restaurants compared with those who failed to frequent such places. The underlying cause of this correlation remains unknown, indicating the need for further investigation.

Daaaahhhhhhh!

 

The question whether spinal manipulative therapy (SMT) has any specific therapeutic effects is still open. This fact must irritate ardent chiropractors, and they therefore try everything to dispel our doubts. One way would be to demonstrate a dose-effect relationship between SMT and the clinical outcome. But, for several reasons, this is not an easy task.

This RCT was aimed at identifying the dose-response relationship between visits for SMT and chronic cervicogenic headache (CGH) outcomes; to evaluate the efficacy of SMT by comparison with a light massage control.

The study included 256 adults with chronic CGH. The primary outcome was days with CGH in the prior 4 weeks evaluated at the 12- and 24-week primary endpoints. Secondary outcomes included CGH days at remaining endpoints, pain intensity, disability, perceived improvement, medication use, and patient satisfaction. Participants were randomized to 4 different dose levels of chiropractic SMT: 0, 6, 12, or 18 sessions. They were treated 3 times per week for 6 weeks and received a focused light-massage control at sessions when SMT was not assigned. Linear dose effects and comparisons to the no-manipulation control group were evaluated at 6, 12, 24, 39, and 52 weeks.

A linear dose-response was observed for all follow-ups, a reduction of approximately 1 CGH day/4 weeks per additional 6 SMT visits (p<.05); a maximal effective dose could not be determined. CGH days/4 weeks were reduced from about 16 to 8 for the highest and most effective dose of 18 SMT visits. Mean differences in CGH days/4 weeks between 18 SMT visits and control were -3.3 (p=.004) and -2.9 (p=.017) at the primary endpoints, and similar in magnitude at the remaining endpoints (p<.05). Differences between other SMT doses and control were smaller in magnitude (p > .05). CGH intensity showed no important improvement nor differed by dose. Other secondary outcomes were generally supportive of the primary.

The authors concluded that there was a linear dose-response relationship between SMT visits and days with CGH. For the highest and most effective dose of 18 SMT visits, CGH days were reduced by half, and about 3 more days per month than for the light-massage control.

This trial would make sense, if the effectiveness of SMT for CGH had been a well-documented fact, and if the study had rigorously controlled for placebo-effects.

But guess what?

Neither of these conditions were met.

A recent review concluded that there are few published randomized controlled trials analyzing the effectiveness of spinal manipulation and/or mobilization for TTH, CeH, and M in the last decade. In addition, the methodological quality of these papers is typically low. Clearly, there is a need for high-quality randomized controlled trials assessing the effectiveness of these interventions in these headache disorders. And this is by no means the only article making such statements; similar reviews arrive at similar conclusions. In turn, this means that the effects observed after SMT are not necessarily specific effects due to SMT but could easily be due to placebo or other non-specific effects. In order to avoid confusion, one would need a credible placebo – one that closely mimics SMT – and make sure that patients were ‘blinded’. But ‘light massage’ clearly does not mimic SMT, and patients obviously were aware of which interventions they received.

So, an alternative – and I think at least as plausible – conclusion of the data provided by this new RCT is this:

Chiropractic SMT is associated with a powerful placebo response which, of course, obeys a dose-effect relationship. Thus these findings are in keeping with the notion that SMT is a placebo.

And why would the researchers – who stress that they have no conflicts of interest – mislead us by making this alternative interpretation of their findings not abundantly clear?

I fear, the reason might be simple: they also seem to mislead us about their conflicts of interest: they are mostly chiropractors with a long track record of publishing promotional papers masquerading as research. What, I ask myself, could be a stronger conflict of interest?

(Pity that a high-impact journal like SPINE did not spot these [not so little] flaws)

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.

The ‘European Scientific Cooperative on Anthroposophic Medicinal Products‘ claim that there is a need for a regulatory framework for anthroposophic medicinal products (AMPs) in Europe. The existing regulatory requirements for conventional medicinal products are not appropriate for AMPs. Special registration procedures exist in some countries for homeopathic products and in the European Union for herbal products. However, these procedures only apply to a proportion of AMPs and the particular properties of AMPs are only in part accounted for. Suitable registration procedures especially for AMPs exist only in Germany and Switzerland.

The European Commission has acknowledged the existence of therapy systems, whose products have no adequate regulation, and it has proposed that the suitability of a separate legal framework for products of certain traditions such as Anthroposophic Medicine should be assessed. This statement should be seen in the context of developments in international trade, whereby representatives of therapy systems such as Traditional Chinese Medicine and Ayurveda wish to market their products in Europe.

It seems obvious that the safety of AMPs must be demonstrated, if regulators are to comply with the wishes of the AMP-industry. In other words, they require evidence. As luck has it, a recent paper provides just what they need.

The main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions.

The researchers conducted a prospective pharmacovigilance study with the patients of physicians in outpatient care in Germany. Diagnoses and prescriptions were extracted from the electronic medical records. A total of 38 German physicians trained in AM were asked to link all AMP prescriptions to the respective indications (diagnoses), and to document all serious ADRs as well as all ADRs of intensity III–IV. In addition, a subgroup of 7 ‘prescriber physicians’ agreed to also document all non-serious ADRs of any intensity. The study was conducted under routine care conditions with ADRs identified at ordinary follow-up consultations, without any additional scheduled follow-up visits. Physicians were remunerated with 15 Euro for each ADR report but not for their regular participation; patients received no remuneration. Patients were eligible for this analysis, if they had one or more AMP prescription in the years 2001–2010, followed by one or more physician visit.

A total of 44,662 patients with 311,731 AMP prescriptions, comprising 1722 different AMPs, were included. One hundred ADRs to AMPs occurred, caused by 83 different AMPs. ADR intensity was mild, moderate, and severe in 50% (n = 50/100), 43%, and 7% of cases, respectively; one ADR was serious. ADRs of any intensity occurred in 0.071% (n = 67/94,734) of AMP prescriptions and in 0.502% (n = 65/12,956) of patients prescribed AMPs. The highest ADR frequency was 0.290% of prescriptions for one specific AMP. Among all patients, serious ADRs occurred in 0.0003% (n = 1/311,731) of prescriptions and 0.0022% (n = 1/44,662) of patients.

The authors concluded that in this analysis from a large sample, ADRs to AMP therapy in outpatient care were rare; ADRs of high intensity as well as serious ADRs were very rare.

Most AMPs are highly diluted, and therefore, one would not expect frequent or serious ADRs. Yet, I still find these incidence figures mysterious. The reason is simple: even the ARDs of pure placebos (such as most AMPs) are known to be much more frequent. In other words, the nocebo-effects of drugs are much more common than these results seem to reflect.

This, I think, leads to one of two possible conclusions:

  1. AMPs are somehow miraculously exempt from the known facts of ADRs.
  2. There is something fundamentally wrong with this study.

I let you decide which is the case.

Oh, I almost forgot. At the end of this paper there is a not unimportant note:

The EvaMed study was funded by the Software AG-Stiftung. This analysis and publication was commissioned by the European Scientific Cooperative on Anthroposophic Medicinal Products (http://www.escamp.org) with financial support from foundations (Christophorus-Stiftung, Damus-Donata-Stiftung, Ekhagastiftelsen, Mahle-Stiftung, Software AG-Stiftung) and manufacturers (Wala, Weleda). The sponsors had no influence on the planning or conduct of the EvaMed study; the collection, preparation, analysis or interpretation of data for this paper; nor on the preparation, review or approval of the manuscript.

“MDs do not make false claims HAHAHA.”

This is from a comment I recently received on this blog.

It made me think.

Yes, of course, MDs do not always reveal the full truth to their patients; sometimes they might even tell lies (in this post, I shall use the term ‘lies’ for any kind of untruth).

So, what about these lies?

The first thing to say about them is obvious: THEY CAN NEVER JUSTIFY THE LIES OF OTHERS.

  • the lies of the Tories cannot justify the lies of Labour party members,
  • the lies of a plaintiff in court  cannot justify any lies of the defendant,
  • the lies of MDs cannot justify the lies of alternative practitioners.

The second thing to say about the lies of MDs is that, in my experience, most are told in the desire to protect patients. In some cases, this may be ill-advised or ethically questionable, but the motivation is nevertheless laudable.

  • I might not tell the truth when I say (this really should be ‘said’, because I have not treated patients for many years) THIS WILL NOT HURT AT ALL. In the end, it hurt quite a bit but we all understand why I lied.
  • I might claim that this treatment is sure to work (knowing full well that such a prediction is impossible), but we all know that I said so in order to maximise my patient’s compliance and expectation in order to generate the best possible outcome.
  • I might dismiss a patient’s fear that his condition is incurable (while strongly suspecting that it is), but I would do this to improve his anxiety and well-being.

Yet, these are not the type of lies my commentator referred to. In fact, he provided a few examples of the lies MDs tell, in his opinion. He claimed that:

  • They tell them that diabetes is not curable. False claim
  • They compare egg intake with smoking on their affect to your health. False claim
  • They say arthroscopic surgery of the knee is beneficial. False claim
  • They state that surgery, chemo, and radiation is the only treatment for cancer. False claim
  • They say that family association is the cause of most inflammatory conditions. False claim

I don’t want to go into the ‘rights or wrongs’ of these claims (mostly wrongs, as far as I can see). Instead, I would argue that any MD who makes a claim that is wrong behaves unethical and should retrain. If he erroneously assumes the claim to be correct, he is not fully informed (which, of course is unethical in itself) and needs to catch up with the current best evidence. If he makes a false claim knowing that it is wrong, he behaves grossly unethical and must justify himself in front of his professional disciplinary committee.

As this blog focusses on alternative medicine, let’s briefly consider the situation in that area. The commentator made his comments in connection to a post about chiropractic, so let’s look at the situation in chiropractic.

  • Do many chiropractors claim to be able to treat a wide array of conditions without good evidence?
  • Do they misadvise patients about conventional treatments, such as vaccinations?
  • Do they claim that their spinal manipulations are safe?
  • Do they tell patients they need regular ‘maintenance treatment’ to stay healthy?
  • Do they claim to be able to diagnose subluxations?
  • Do they pretend that subluxations cause illness and disease?
  • Do they claim to adjust subluxations?

If you answered several of these questions with YES, I probably have made my point.

On reflection, it turns out that clinicians of all types do tell lies. Some are benign/white lies and others are fundamental, malignant lies. Most of us probably agree that the former category is largely negligible. The latter category can, however, be serious. In my experience, it is hugely more prevalent in the realm of alternative medicine. When it occurs in conventional medicine, appropriate measures are in place to prevent reoccurrence. When it occurs in alternative medicine, nobody seems to bat an eyelash.

My conclusion from these random thoughts: the truth is immeasurably valuable, and lies can be serious and often are damaging to patients. Therefore, we should always pursue those who tell serious lies, no matter whether they are MDs or alternative practitioners.

Yesterday, a press-release about our new book has been distributed by our publisher. As I hope than many regular readers of my blog might want to read this book – if you don’t want to buy it, please get it via your library – I decided to re-publish the press-release here:

Governments must legislate to regulate and restrict the sale of complementary and alternative therapies, conclude authors of new book More Harm Than Good.

Heidelberg, 20 February 2018

Commercial organisations selling lethal weapons or addictive substances clearly exploit customers, damage third parties and undermine genuine autonomy. Purveyors of complementary and alternative medicine (CAM) do too, argue authors Edzard Ernst and Kevin Smith.

The only downside to regulating such a controversial industry is that regulation could confer upon it an undeserved stamp of respectability and approval. At best, it can ensure the competent delivery of therapies that are inherently incompetent.

This is just one of the ethical dilemmas at the heart of the book. In all areas of healthcare, consumers are entitled to expect essential elements of medical ethics to be upheld. These include access to competent, appropriately-trained practitioners who base treatment decisions on evidence from robust scientific research. Such requirements are frequently neglected, ignored or wilfully violated in CAM.

“We would argue that a competent healthcare professional should be defined as one who practices or recommends plausible therapies that are supported by robust evidence,” says bioethicist Kevin Smith.

“Regrettably, the reality is that many CAM proponents allow themselves to be deluded as to the efficacy or safety of their chosen therapy, thus putting at risk the health of those who heed their advice or receive their treatment,” he says.

Therapies covered include homeopathy, acupuncture, chiropractic, iridology, Reiki, crystal healing, naturopathy, intercessory prayer, wet cupping, Bach flower therapy, Ukrain and craniosacral therapy. Their inappropriate use can not only raises false hope and inflicts financial hardship on consumers, but can also be dangerous; either through direct harm or because patients fail to receive more effective treatment. For example, advice given by homeopaths to diabetic patients has the potential to kill them; and when anthroposophic doctors advise against vaccination, they can be held responsible for measles outbreaks.

There are even ethical concerns to subjecting such therapies to clinical research. In mainstream medical research, a convincing database from pre-clinical research is accumulated before patients are experimented upon. However, this is mostly not possible with CAM. Pre-scientific forms of medicine have been used since time immemorial, but their persistence alone does not make them credible or effective. Some are based on notions so deeply implausible that accepting them is tantamount to believing in magic.

“Dogma and ideology, not rationality and evidence, are the drivers of CAM practice,” says Professor Edzard Ernst.

Edzard Ernst, Kevin Smith
More Harm than Good?
1st ed. 2018, XXV, 223 p.
Softcover $22.99, €19,99, £15.99 ISBN 978-3-319-69940-0
Also available as an eBook ISBN 978-3-319-69941-7

END OF PRESS RELEASE

As I already stated above, I hope you will read our new book. It offers something that has, I think, not been attempted before: it critically evaluates many aspects of alternative medicine by holding them to the ethical standards of medicine. Previously, we have often been asking WHERE IS THE EVIDENCE FOR THIS OR THAT CLAIM? In our book, we ask different questions: IS THIS OR THAT ASPECT OF ALTERNATIVE MEDICINE ETHICAL? Of course, the evidence question does come into this too, but our approach in this book is much broader.

The conclusions we draw are often surprising, sometimes even provocative.

Well, you will see for yourself (I hope).

The chiropractor Oakley Smith had graduated under D D Palmer in 1899. Smith was a former Iowa medical student who also had investigated Andrew Still’s osteopathy in Kirksville, before going to Palmer in Davenport. Eventually, Smith came to reject the Palmer concept of vertebral subluxation and developed his own concept of “the connective tissue doctrine” or naprapathy. Today, naprapathy is a popular form of manual therapy, particularly in Scandinavia and the US.

But what exactly is naprapathy? This website explains it quite well: Naprapathy is defined as a system of specific examination, diagnostics, manual treatment and rehabilitation of pain and dysfunction in the neuromusculoskeletal system. The therapy is aimed at restoring function through treatment of the connective tissue, muscle- and neural tissues within or surrounding the spine and other joints. Naprapathic treatment consists of combinations of manual techniques for instance spinal manipulation and mobilization, neural mobilization and Naprapathic soft tissue techniques, in additional to the manual techniques Naprapaths uses different types of electrotherapy, such as ultrasound, radial shockwave therapy and TENS. The manual techniques are often combined with advice regarding physical activity and ergonomics as well as medical rehabilitation training in order to decrease pain and disability and increase work ability and quality of life. A Dr. of Naprapathy is specialized in the diagnosis of structural and functional neuromusculoskeletal disorders, treatment and rehabilitation of patients with problems of such origin as well as to differentiate pain of other origin.

DOCTOR OF NAPRAPATHY? I hear you shout.

Yes, in the US, the title exists: The National College of Naprapathic Medicine is chartered by the State of Illinois and recognized by the State Board of Higher Education to grant the degree, Doctor of Naprapathy (D.N.). Graduates of the College are eligible to take the Naprapathic Medicine examination for licensure in the State of Illinois. The D.N. Degree requires:

  • 66 hours – Basic Sciences
  • 64 hours – Naprapathic Sciences
  • 60 hours – Clinical Internship

Things become even stranger when we ask, what does the evidence show?

I found all of three clinical trials on Medline.

A 2016 clinical trial was designed to compare the treatment effect on pain intensity, pain related disability and perceived recovery from a) naprapathic manual therapy (spinal manipulation, spinal mobilization, stretching and massage) to b) naprapathic manual therapy without spinal manipulation and to c) naprapathic manual therapy without stretching for male and female patients seeking care for back and/or neck pain. 

Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of Naprapathögskolan – the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 1057) were randomized to one of three treatment arms a) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage), b) manual therapy excluding spinal manipulation and c) manual therapy excluding stretching. The primary outcomes were minimal clinically important improvement in pain intensity and pain related disability. Treatments were provided by naprapath students in the seventh semester of eight total semesters. Generalized estimating equations and logistic regression were used to examine the association between the treatments and the outcomes.

At 12 weeks follow-up, 64% had a minimal clinically important improvement in pain intensity and 42% in pain related disability. The corresponding chances to be improved at the 52 weeks follow-up were 58% and 40% respectively. No systematic differences in effect when excluding spinal manipulation and stretching respectively from the treatment were found over 1 year follow-up, concerning minimal clinically important improvement in pain intensity (p = 0.41) and pain related disability (p = 0.85) and perceived recovery (p = 0.98). Neither were there disparities in effect when male and female patients were analyzed separately.

The authors concluded that the effect of manual therapy for male and female patients seeking care for neck and/or back pain at an educational clinic is similar regardless if spinal manipulation or if stretching is excluded from the treatment option.

Even though this study is touted as showing that naprapathy works by advocates, in all honesty, it tells us as good as nothing about the effect of naprapathy. The data are completely consistent with the interpretation that all of the outcomes were to the natural history of the conditions, regression towards the mean, placebo, etc. and entirely unrelated to any specific effects of naprapathy.

A 2010 study by the same group was to compare the long-term effects (up to one year) of naprapathic manual therapy and evidence-based advice on staying active regarding non-specific back and/or neck pain. 

Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409), recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group), and advice to stay active and on how to cope with pain, provided by a physician (Control Group). Pain intensity, disability and health status were measured by questionnaires.

89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD) = 21%, 95% CI: 10-30) and disability (RD = 11%, 95% CI: 4-22) at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28). The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p < or = 0.005). There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status) favoring the Index Group.

The authors concluded that combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck pain.

This study is hardly impressive either. The results are consistent with the interpretation that the extra attention and care given to the index group was the cause of the observed outcomes, unrelated to ant specific effects of naprapathy.

The last study was published in 2017 again by the same group. It was designed to compare naprapathic manual therapy with evidence-based care for back or neck pain regarding pain, disability, and perceived recovery. 

Four hundred and nine patients with pain and disability in the back or neck lasting for at least 2 weeks, recruited at 2 large public companies in Sweden in 2005, were included in this randomized controlled trial. The 2 interventions were naprapathy, including spinal manipulation/mobilization, massage, and stretching (Index Group) and support and advice to stay active and how to cope with pain, according to the best scientific evidence available, provided by a physician (Control Group). Pain, disability, and perceived recovery were measured by questionnaires at baseline and after 3, 7, and 12 weeks.

At 7-week and 12-week follow-ups, statistically significant differences between the groups were found in all outcomes favoring the Index Group. At 12-week follow-up, a higher proportion in the naprapathy group had improved regarding pain [risk difference (RD)=27%, 95% confidence interval (CI): 17-37], disability (RD=18%, 95% CI: 7-28), and perceived recovery (RD=44%, 95% CI: 35-53). Separate analysis of neck pain and back pain patients showed similar results.

The authors thought that this trial suggests that combined manual therapy, like naprapathy, might be an alternative to consider for back and neck pain patients.

As the study suffers from the same limitations as the one above (in fact, it might be a different analysis of the same trial), they might be mistaken. I see no good reason to assume that any of the three studies provide good evidence for the effectiveness of naprapathy.

So, what should we conclude from all this?

If you ask me, naprapathy is something between chiropractic (without some of the woo) and physiotherapy (without its expertise). There is no good evidence that it works. Crucially, there is no evidence that it is superior to other therapeutic options.

I was going to finish on a positive note stating that ‘at least the ‘naprapathologists’ (I refuse to even consider the title of  ‘doctor of naprapathy’) do not claim to treat conditions other than musculoskeletal problems’. But then I found this advertisement of a ‘naprapathologist’ on Twitter:

And now, I am going to finish by stating that A LOT OF NAPRAPATHY LOOKS VERY MUCH LIKE QUACKERY TO ME.

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