MD, PhD, FMedSci, FSB, FRCP, FRCPEd

evidence

Is spinal manipulative therapy (SMT) dangerous? This question has kept us on this blog busy for quite some time now. To me, there is little doubt that SMT can cause adverse effects some of which are serious. But many chiropractors seem totally unconvinced. Perhaps this new overview of reviews might help to clarify the issue. Its aim was to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT.

The authors searched five electronic databases from inception to December 8, 2015 and included reviews on any type of studies, patients, and SMT technique. The primary outcome was SAEs. The quality of the included reviews was assessed using a measurement tool to assess systematic reviews (AMSTAR). Since there were insufficient data for calculating incidence rates of SAEs, they used an alternative approach; the conclusions regarding safety of SMT were extracted for each review, and the communicated opinion were judged by two reviewers independently as safe, harmful, or neutral/unclear. Risk ratios (RRs) of a review communicating that SMT is safe and meeting the requirements for each AMSTAR item, were calculated.

A total of 283 eligible reviews were identified, but only 118 provided data for synthesis. The most frequently described adverse events (AEs) were stroke, headache, and vertebral artery dissection. Fifty-four reviews (46%) expressed that SMT is safe, 15 (13%) expressed that SMT is harmful, and 49 reviews (42%) were neutral or unclear. Thirteen reviews reported incidence estimates for SAEs, roughly ranging from 1 in 20,000 to 1 in 250,000,000 manipulations. Low methodological quality was present, with a median of 4 of 11 AMSTAR items met (interquartile range, 3 to 6). Reviews meeting the requirements for each of the AMSTAR items (i.e. good internal validity) had a higher chance of expressing that SMT is safe.

The authors concluded that it is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.

This article is valuable, if only for the wealth of information one can extract from it. There are, however, numerous problems. One is that the overview included mostly reviews of the effectiveness of SMT for various conditions. We know that studies of SMT often do not even mention AEs. If such studies are then pooled in a review, they inevitably generate an impression of safety. But this would, of course, be a false-positive result!

The authors of the overview are aware of this problem and address it in the following paragraph: “When only considering the subset of reviews, where the objective was to investigate AEs (37 reviews), then 8 reviews (22%) expressed that SMT is safe, 13 reviews (35%) expressed that SMT is harmful and 16 reviews (43%) were neutral or unclear regarding the safety of SMT. Hence, there is a tendency that a bigger proportion of these reviews are expressing that SMT is harmful compared to the full sample of reviews…”

To my surprise, I found several of my own reviews in the ‘neutral or unclear’ category. Here are the verbatim conclusions of three of them:

  1. It is concluded that serious cerebrovascular complications of spinal manipulation continue to be reported.
  2. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome.
  3. These data indicate that mild and transient adverse events seem to be frequent. Serious adverse events are probably rare but their incidence can only be estimated at present.

I find it puzzling how this could be classified as neutral or unclear. The solution of the puzzle might lie in the methodology used: “we appraised the communicated opinions of each review concerning the safety of SMT based on their conclusions regarding the AEs and SAEs. This was done by two reviewers independently (SMN, LK), who judged the communicated opinions as either ‘safe’, ‘neutral/unclear’ or ‘harmful’, based on the qualitative impression the reviewers had when reading the conclusions. The reviewers had no opinion about the safety/harmfulness of SMT before commencing the judgements. Cohen’s weighted Kappa was calculated for the agreement between the reviewers, with a value of 0.40–0.59 indicating ‘fair agreement’, 0.60–0.74 indicating ‘good agreement’ and ≥0.75 indicating ‘excellent agreement’. Disagreements were resolved by a third reviewer (MH).”

In other words, the categorisation was done on the basis of subjective judgements of two researchers. It seems obvious that, if their attitude was favourable towards SMT, their judgements would be influenced. The three examples from my own work cited above indicates to me that their verdicts were indeed far from objective.

So what is the main message here? In my view, it can be summarized in the following quote from the overview: “a bigger proportion of these reviews are expressing that SMT is harmful …”

Yes, yes, yes – I know that, if you are a chiropractor (or other practitioner using mostly SMT), you are unlikely to agree with this!

Perhaps you can agree with this statement then:

As long as there is reasonable doubt about the safety of SMT, and as long as we cannot be sure that SMT generates more good than harm, we should be very cautious using it for routine healthcare and do rigorous research to determine the truth (it’s called the precautionary principle and applies to all types of healthcare).

THE TELEGRAPH reported that “homeopathic medicines will escape an NHS prescribing ban even though the Chief Medical Officer Dame Sally Davies has dismissed the treatments as ‘rubbish’ and a waste of taxpayers money.”

But why?

This sounds insane!

Sorry, I do not know the answer either, but below I offer 10 possible options – so bear with me, please.

The NHS spends around £4 million a year on homeopathic remedies, the article claimed. Sandra Gidley, chairwoman of the Royal Pharmaceutical Society, said: “We are surprised that homeopathy, which has no scientific evidence of effectiveness, is not on the list for review. We are in agreement with NHS England that products with low or no clinical evidence of effectiveness should be reviewed with urgency.”

The NHS Clinical Commissioners, the body which was asked to review which medications should no longer be prescribed for NHS England, said it had included drugs with ‘little or no clinical value’, yet could not offer an explanation  why homeopathic medicines had escaped the cut. Julie Wood, Chief Executive, NHS Clinical Commissioners said: “Clinical commissioners have always had to make difficult choices about prioritising how they spend their budget on services, but the finance and demand challenges we face at the moment are unprecedented. Clinical Commissioning Groups have been looking at their medicines spend, and many are already implementing policies to reduce spending on those prescribeable items that have little or no clinical value for patients, and are therefore not an effective use of the NHS pound.”

Under the new rules, NHS doctors will be banned from routinely prescribing items that are cheaply available in chemists. The list includes heartburn pills, paracetamol, hayfever tablets, sun cream, muscle rubs, Omega 3 fish oils, medicine for coughs and colds and travel vaccinations. Coeliacs will also be forced to buy their own gluten-free food.

So, why are homeopathic remedies excluded from this new cost-saving exercise?

I am puzzled!

Is it because:

  1. The NHS has recently found out that homeopathy is effective after all?
  2. The officials have forgotten to put homeopathics on the list?
  3. In times of Brexit, the government cannot be bothered about reason, science and all that?
  4. The NHS does not need the money?
  5. Homeopathic globuli look so pretty?
  6. Our Health Secretary is in love with homeopathy?
  7. Experts are no longer needed for decision-making?
  8. EBM has suddenly gone out of fashion?
  9. Placebos are now all the rage?
  10. Some influential person called Charles is against it?

Sorry, no prizes for the winner of this quiz!

 

It was a BBC journalist who alerted me to this website (and later did an interview to be broadcast today, I think). Castle Treatments seem to have been going already for 12 years; they specialise in treating drug and alcohol dependency. And they are very proud of what they have achieved:

“We are the U.K.’s leading experts in advanced treatments to help clients to stop drinking, stop cocaine use and stop drug use. Over the last 12 years we have helped over 9,000 private clients stop using: alcohol, cocaine, crack, nicotine, heroin, opiates, cannabis, spice, legal highs and other medications…

All other treatment methods to help people stop drinking or stop using drugs have a high margin for error and so achieve very low success rates as they use ‘slow and out-dated methods’ such as talking therapies (hypnosis, counselling, rehab, 12 steps, CBT etc) or daily medications (pharma meds, sprays, opiates, subutex etc) which don’t work for most people or most of the time.

This is because none of these methods can remove the ’cause’ of the problem which is the ‘frequency of the substance’ itself. The phase signal of the substance maintains the craving or desire for that substance, once neutralised the craving/desire has either gone or is greatly diminished therefore making it much easier to stop drinking or using drugs as per the client feedback.
When compared to any other method there is no doubt our treatments produce the best results. Over the last 12 years we have helped over 9,000 clients the stop drinking, stop cocaine use or stop using drugs with excellent results as each client receives exactly the same treatment program tailored to their substance(s) which means our success rates are consistently high, making our advanced treatment the logical and natural choice when you want help.

Our technicians took basic principles in physics and applied them to new areas to help with addiction and dependency issues. Our treatment method uses specific phase signals (frequency) to help:

  • neutralise any substance and reduce physical dependency
  • improve and restore physical & mental health

When the substance is neutralised, the physical urge or craving has ‘gone or is greatly diminished’ therefore making it much easier to stop drinking or using drugs. The body can also absorb beneficial input frequencies so physically and mentally our clients feel much better and so find it much easier to ‘stop and regain control’…

The body (muscle, tissue, bones, cells etc) radiate imbalances including disease, physical, emotional and psychological conditions which have their own unique frequencies that respond to various ‘beneficial input frequencies’ (Hz) or ‘electroceuticals’ which can help to improve physical and mental health hence why our clients feel so much better during/after treatment…”

END OF QUOTE

Sounds interesting?

Not really!

To me this sounds like nonsense on stilts.

Bioresonance is, as far as I can see, complete baloney. It originates from Germany and uses an instrument that is not dissimilar to the e-meter of scientology (its inventor had links to this cult). This instrument is supposed to pick up unhealthy frequencies from the body, inverses them and thus treats the root cause of the problem.

There are two seemingly rigorous positive studies of bioresonance. One suggested that it is effective for treating GI symptoms. This trial was, however, tiny. The other study suggested that it works for smoking cessation. Both of these articles appeared in a CAM journal and have not been independently replicated. A further trial published in a conventional journal reported negative results. In 2004, I published an article in which I used the example of bioresonance therapy to demonstrate how pseudo-scientific language can be used to cloud important issues. I concluded that it is an attempt to present nonsense as science. Because this misleads patients and can thus endanger their health, we should find ways of minimizing this problem (I remember being amazed that a CAM journal published this critique). More worthwhile stuff on bioresonance and related topics can be found here, here and here.

There is no good evidence that bioresonance is effective for drug or alcohol dependency (and even thousands of testimonials do not amount to evidence: THE PLURAL OF ANECDOTE IS ANECDOTES, NOT EVIDENCE!!!). Claiming otherwise is, in my view, highly irresponsible. If I then consider the fees Castle Treatments charge (Alcohol Support: Detox 1: £2,655.00, Detox 2: £3,245.00, Detox 3: £3,835.00) I feel disgusted and angry.

I hope that publishing this post somehow leads to the closure of Castle Treatments and similar clinics.

The love-affair of many nurses with complementary medicine is well-known. We have discussed it many times on this blog – see for instance here, here and here. Yet the reasons for it remain somewhat mysterious, I find. Therefore I was interested to see a new paper on the subject.

The aim of this ‘meta-synthesis‘ was to review, critically, appraise and synthesize the existing qualitative research to develop a new, more substantial interpretation of nurses’ attitudes regarding the, use of complementary therapies by patients. Fifteen articles were included in the review.

Five themes emerged from the data relating to nurses’ attitude towards complementary therapies:

  1. the strengths and weaknesses of conventional medicine;
  2. complementary therapies as a way to enhance nursing practice;
  3. patient empowerment and patient-centeredness;
  4. cultural barriers and enablers to integration;
  5. structural barriers and enablers to integration.

Nurses’ support for complementary therapies, the authors of this article claim, is not an attempt to challenge mainstream medicine but rather an endeavour to improve the quality of care available to patients. There are, however, a number of barriers to nurses’ support including institutional culture and clinical context, as well as time and knowledge limitations.

The authors concluded that some nurses promote complementary therapies as an opportunity to personalise care and practice in a humanistic way. Yet, nurses have very limited education in this field and a lack of professional frameworks to assist them. The nursing profession needs to consider how to address current deficiencies in meeting the growing use of complementary therapies by patients.

In my view, there are two most remarkable misunderstandings here:

  1. While it is undoubtedly laudable that nurses “endeavour to improve the quality of care available to patients”, it has to be said that such an endeavour does not require complementary medicine. Are they implying that with conventional medicine the quality of care cannot be improved?
  2. I fail to understand why the lack of good evidential support for most complementary therapies did not emerge as a prominent theme. Are nurses not concerned about the (lack of) evidence that underpins their actions?

The notorious tendency of pharmacist to behave like shop-keepers when it comes to the sale of bogus remedies has been the subject of this blog many times before. In my view, this is an important subject, and I will therefore continue to report about it.

On the website of the AUSTRALIAN JOURNAL OF PHARMACY (AJP), we find interesting new data on Australian pharmacists’ love affair with bogus alternative medicine. The AJP recently ran a poll asking readers: “Do you stock Complementary Medicines (CMs) in your pharmacy?” The results of this little survey so far show that 54% of all participating pharmacists say they stock CMs, including homeopathic products. About a quarter (28%) of respondents stock CMs but not homeopathic products. And 9% said they “only stock evidence-based CMs”. Three percent completely refuse to stock CMs, while 2% stock them but with clear in-store labels saying that they may not work. One person stated they stock CMs but have recently decided to no longer do so.

The President of the Pharmaceutical Society of Australia (PSA) Joe Demarte commented on these findings: “The latest survey results, showing over 40% of pharmacists are adhering to PSA’s Code of Ethics on complementary medicines, are very encouraging… However it’s disappointing that some pharmacists are still stocking homeopathy products, which are not supported by PSA’s Code of Ethics or our Position Statement on Complementary Medicines… Irrespective of the products stocked in a pharmacy, the important thing is when discussing the use of complementary medicines with consumers, pharmacists must ensure that consumers are provided with the best available information about the current evidence for efficacy, as well as information on any potential side effects, drug interactions and risks of harm… It’s important for pharmacists to provide a fair, honest and balanced view of the current evidence available on all complementary medicines,” Demarte added.

NSW pharmacist Ian Carr, who is a member of the Friends of Science in Medicine group, commented that many pharmacists may not have much choice when it comes to stocking complementary and alternative medicines. “CMs policy is not being filtered through the professional assessment of the pharmacist… It’s basically a business deal with the franchise, and as a pharmacist taking on a franchise you’ve basically got to sign those rights away about what you get to sell. Some of the chains offer basically everything that is available, no questions asked. As an independent pharmacist I am able to make my own decisions about what to stock… We’ve got a ‘de-facto’ corporatisation happening with marketing groups and franchises, and I’m concerned the government will look at this trend and ask, why are we not deregulating the industry to reflect the apparent reality of pharmacy today? We’re only playing into the hands of people who want deregulation… We should be telling people in no uncertain terms that if something is on the shelf it doesn’t mean it’s been assessed or approved by the TGA… There is no doubt that there has been a long-term relationship between the supplement industry and pharmacy. But it was also a few decades ago that researchers started applying the concept of evidence-based medicine to healthcare generally. That should have been the point where we said, ‘we’re not just going to be a conduit for your products without questioning their basis in evidence’. That’s where we lost the plot. The question now is: where do we draw that line? I’m really trying to say to my fellow pharmacists: Please let us reassess the unquestioning support of the CM industry, or we’ll all be tarred with the same brush. I and many others are concerned about – and fighting for – the reputation of the pharmacy profession.”

A BMC Complementary and Alternative Medicine survey by researchers from Alfred Hospital in Melbourne found that 92% thought pharmacists should provide safety information about CMs, while 93% thought it important for pharmacists to be knowledgeable about CMs. This shows a huge divide between what is happening in Australian pharmacy on the one side and ethical demands or public opinion on the other side. What is more, there is little reason to believe that the situation in other countries is fundamentally different.

And did you notice this little gem in the comments above?  “…over 40% of pharmacists are adhering to PSA’s Code of Ethics…” – the PSA president finds this ‘VERY ENCOURAGING’.

When I saw this, I almost fell off my chair!

Does the president know that this means that 60% of his members are violating their own code of ethics?

Is that truly VERY ENCOURAGING, I ask myself.

My answer is no, this is VERY WORRYING.

 

‘Country News’ just published an article about our heir to the throne. Here is an excerpt:

The Prince of Wales has revealed he uses homeopathic treatments for animals on his organic farm at Highgrove to help reduce reliance on antibiotics, the article stated. He said his methods of farming tried wherever possible to ‘‘go with the grain of nature’’ to avoid dependency on antibiotics, pesticides and other forms of chemical intervention.

The prince made these comments to experts at a summit at the Royal Society in London as part of a global battle against the growing threat of antibiotic resistance. ‘‘In fact, it was one of the reasons I converted my farming operation to an organic, or agro-ecological, system over 30 years ago, and why incidentally we have been successfully using homeopathic — yes, homeopathic — treatments for my cattle and sheep as part of a program to reduce the use of antibiotics,’’ Prince Charles said. Calling for ‘‘urgent and coherent’’ global action, he said antibiotics were being overused. ‘‘It must be incredibly frustrating to witness the fact that, as has been pointed out by many authorities, antibiotics have too often simply acted as a substitute for basic hygiene, or as it would seem, as a way of placating a patient who has a viral infection or who actually needs little more than patience to allow a minor bacterial infection to resolve itself.’’

The prince continued: ‘‘I find it difficult to understand how we can continue to allow most of the antibiotics in farming, many of which are also used in human medicine, to be administered to healthy animals… Could we not devise more effective systems where we reserve antibiotics for treating animals where the use is fully justified by the seriousness of the illness?’’

END OF EXCERPT

Charles seems to have a few reasonable points her. Sadly he then spoils it all by not being able to resist his passion for quackery.

  • Yes, we have over-used antibiotics both in human and in veterinary medicine.
  • Yes, this has now gone so far that it now endangers our health.
  • Yes, it is a scandal that so little has happened in this respect, despite us knowing about the problem for many years.
  • No, homeopathy is not the solution to any of the above!!!

The Prince claims he has been ‘successfully using homeopathy’. This is nonsense, and he should know it. Highly diluted homeopathic remedies are pure placebos, and to use placebos for sick animals cannot be a good idea. For those who need the evidence for these (all too obvious) statements, here it is:

A recent systematic review assessed the efficacy of homeopathy in cattle, pigs and poultry. Only peer-reviewed publications dealing with homeopathic remedies, which could possibly replace or prevent the use of antibiotics in the case of infective diseases or growth promotion in livestock were included. Search results revealed a total number of 52 trials performed within 48 publications fulfilling the predefined criteria. Twenty-eight trials were in favour of homeopathy, with 26 trials showing a significantly higher efficacy in comparison to a control group, whereas 22 showed no medicinal effect. Cure rates for the treatments with antibiotics, homeopathy or placebo varied to a high degree, while the remedy used did not seem to make a big difference. No study had been repeated under comparable conditions. Consequently, the use of homeopathy cannot claim to have sufficient prognostic validity where efficacy is concerned. When striving for high therapeutic success in treatment, the potential of homeopathy in replacing or reducing antibiotics can only be validated if evidence of efficacy is confirmed by randomised controlled trials under modified conditions.

If we want to reduce antibiotics, we need to stop using them for situations where they are not necessary, and we must improve husbandry such that antibiotics are not required for disease prevention. To a large extent this is a question of educating those who are responsible for administering antibiotics. Education has to be rational and evidence-based. Homeopathy is irrational and believe-based.

Yet again, Prince Charles’ views turn out to be a hindrance to progress.

God save the Queen!

The anti-vaccination attitudes of alternative practitioners such as chiropractors, homeopaths and naturopaths are well documented and have been commented upon repeatedly here. But most of these clinicians are non-doctors; they have not been anywhere near a medical school, and one might therefore almost excuse them for their ignorance and uneducated stance towards immunisations. As many real physicians have recently taken to practicing alternative therapies under the banner of ‘integrated medicine’, one may well ask: what do these doctors think about vaccinations?

This study tried to answer the question by evaluating the attitudes and practices regarding vaccination of members of the American Board of Integrative and Holistic Medicine (ABIHM). Prospective participants were 1419 diplomats of the ABIHM. The survey assessed members’ (1) use of and confidence in the vaccination recommendations of the Centers for Disease Control and Prevention (CDC) and of medical-specialty associations, (2) confidence in the manufacturing safety of vaccines and in manufacturer’s surveillance of adverse events, and (3) attitudes toward vaccination mandates. The questionnaire included 33 items, with 5 open-ended questions that provided a space for comments.

The survey was completed by 290 of 1419 diplomats (20%). Its findings showed a diversity of opinions in many vaccination issues. Integrative medicine physicians were less likely to administer vaccinations than physicians in traditional allopathic medicine. Among the 44% who provide vaccinations, 35% used alternative schedules regularly. Integrative medicine physicians showed a greater support of vaccination choice, were less concerned about maintaining herd immunity, and were less supportive of school, day care, and employment mandates. Toxic chemical and viral contaminants were of greater concern to a higher percentage of integrative medicine physicians. Integrative medicine physicians were also more likely to accept a connection between vaccinations and both autism and other chronic diseases. Overall, there was dissatisfaction with the Vaccine Adverse Event Reporting System as well as the vaccination recommendations of the CDC and their primary specialty.

The authors concluded that significant variations in the vaccination attitudes and practices of integrative medicine physicians. This survey provides benchmark data for future surveys of this growing specialty and other practitioners. It is important for public health leaders and the vaccination industry to be aware that integrative medicine physicians have vaccination attitudes and practices that differ from the guidelines of the CDC and the Advisory Council on Immunization Practices.

Now we know!

Physicians practicing integrative medicine (the 80% who did not respond to the survey were most likely even worse) not only use and promote much quackery, they also tend to endanger public health by their bizarre, irrational and irresponsible attitudes towards vaccination.

From bad to worse!

Yes, I am afraid it is Dana Ullman again!

On the last post, he commented: “If you actually think that homeopathic medicines will KILL people, then, we all must assume that you think that conventional medicines create MASS MURDERS.”

In my view, this is a sad comment indeed. It reveals that a homeopath who has, after all, been in the business for decades has really very little idea about what makes an intervention a potentially good or a bad treatment.

Is it its efficacy?

No!

Is it its safety?

No!

IT IS THE RATIO OF THE TWO!!!

For the Ullmans of this world, I provide two very simple examples:

  1. One could prevent a common cold effectively with interferon. Why don’t we do this routinely? Because the benefit would not out-weigh its harm.
  2. We all know that chemotherapy can have terrible adverse effects. Why do we nevertheless use it for cancer? Because the benefits of saving a life out-weigh all the significant harm chemotherapy might do.

The conclusion is simple: to be useful, a therapy must demonstrably generate more good than harm. If there is no effectiveness, the risk/benefit balance can never be positive, even if the risks are relatively small. But risk/benefit balance can still be favourable, even if the therapy causes considerable harm.

This hardly is rocket science, is it? But the Ullmans of this world do refuse to get it, and that is sad, in my view. This ignorance is the basis for the fundamentally misguided advice they issue to their patients day in, day out.

What is more, the Ullmans of this world stubbornly deny that anyone can do significant harm with homeopathic remedies; they evidently think that homeopathy cannot kill patients. Yet they are evidently wrong.

Whenever the simple rules of risk/benefit are ignored, even apparently harmless treatments, like highly diluted homeopathic remedies, can – and sadly will – kill patients.

I suspect that the Ullmans of this world are still in closed-minded denial about this point. Let me therefore quote a few of my own posts where cases of ‘death by homeopathy’ have been mentioned:

I fear that the Ullmans of this world will still not be convinced. Perhaps a look at this website might do the trick? No, probably not – changing one’s mind vis a vis facts requires intelligence. They will carry on claiming that, in comparison, “conventional medicines creates MASS MURDERS”.

And this is where we go full circle and I start again explaining about the balance of risk and benefit…

GIVE ME STRENGTH!!!

Dana Ullman is an indefatigable promotor of bogus claims and an unwitting contributor of hilarity. Therefore he has become a regular feature of this blog (see for instance here, here and here). His latest laughable assertion is that lead and other poisonings can be successfully treated with homeopathy.

Just to make sure: lead poisoning is no joke. The greatest risk is to brain development in babies, where irreversible damage can occur. Higher levels can damage the kidneys and nervous system in both children and adults. Very high lead levels may cause seizures, unconsciousness and death.

In view of this, Ullman’s claim is surprising, to say the least. In order to persuade the unsuspecting public of his notion, Ullman first cites a review of basic research on homeopathy and toxins published in Human and Experimental Toxicology. “Of forty high-quality studies, 27 showed positive results from homeopathic treatment”, Ullman states.

Now, now, now Dana!

Has your mom not taught you that telling porkies is forbidden?

Or did you perhaps miss this line in the article’s abstract? “The quality of evidence in these studies was low with only 43% achieving one half of the maximum possible quality score and only 31% reported in a fashion that permitted re-evaluation of the data. Very few studies were independently replicated using comparable models.”

Hardly ‘high quality studies’, wouldn’t you agree?

But this review was of pre-clinical studies; what about the much more important clinical evidence?

Here Ullman cites one trial where a potentized homeopathic remedy, Arsenicum Album 30C, was administered to  55 people who were entered into a double-blind, placebo-controlled trial. According to Ullman, the homeopathically treated group “experienced higher excretion of arsenic in their urine for the first eleven days, compared to those given a placebo.”

Na, na, na, Dana, this is getting serious!!!

Another porky – and not even a little one.

The authors of this study clearly stated that, at the end of the 11-day RCT, there was no significant difference between the homeopathy and the placebo group: “The differences in the concentration between the two groups (drug versus placebo) were generally a little higher during the first week, but subsequently the differences were not so palpable, particularly at the 11th day.” And for those who are a bit slow on the uptake, they even included a graph that makes it abundantly clear.

The only other clinical study cited by Ullman in support of his surprising claim is a double-blind randomized trial which was conducted with 131 workers who suffered lead poisoning at the Ajax battery plant in Bauru, São Paulo State, Brazil. Subjects were prescribed homeopathic doses of lead (Plumbum metallicum 15C) or placebo which they took orally for 35 days. The results of this RCT show that homeopathy is not better than placebo.

So, we seem to have all of two RCTs on the subject (I did a quick Medline-search and also found no further RCTs), and both are negative.

Anyone who is not given to compulsive porky-telling would, I guess, conclude from this evidence that people suffering from lead poisoning should urgently see conventional experts and avoid homeopaths at all costs – not so Dana Ullman who boldly concludes his article with these words:

“As an adjunct to conventional medical treatment, professional homeopathic care is recommended for people who have been exposed (or think they have been exposed) to toxic substances… Even if you do not have a professional homeopath in your town, many homeopathic practitioners “see” their patients via Skype or do consultations over the telephone. Unlike acupuncturists, who put needles in you, or chiropractors, who adjust your spine, homeopaths are not “hands-on”: they simply need to conduct a detailed interview… If your symptoms are serious or potentially serious, it is important to see a professional homeopath and/or physician. While a homeopath will commonly prescribe a safe homeopathic dose of the toxic substance to which one was exposed, the homeopath may instead decide that a different substance more closely matches the patient’s unique symptoms…”

It takes a lot these days to make me speechless but there, Dana, you almost succeeded!

Prof Walach has featured on this blog before, for instance here, and here. He is a psychologist by training and a vocal and prominent advocate of several bogus treatments, including homeopathy. He also is the editor in chief of the journal ‘Complementary Medicine Research’ and regularly uses this position to sing the praise of homeopathy. There is a degree of mystery about his affiliation: he informed me about 10 months ago that he has left his post at the Europa Universität Viadrina, Frankfurt/Oder (“Dass ich als “ehemaliger Professor” geführt werde liegt daran, dass ich  Ende Januar aufgehört habe. Meine Stelle ist ausgelaufen und ich habe
sie nicht mehr verlängert.”). Yet all, even his recent papers still carry this address.

His latest article is entitled ‘The future of homeopathy’ is no exception. It is remarkable not just because of the mysterious affiliation but also – and mostly – because of its content. Here is my translation of a brief passage from this paper [I added some numbers in square brackets which refer to footnotes below].

START OF MY TRANSLATION

It is entirely undisputed that homeopathy with its therapeutic principles runs against the mainstream of science; and in this, Weymayr [1] is correct. However, to build on this fact a veritable research prohibition, such as the ‘scientability-concept’ suggests, is not just wrong from a science theoretical perspective, but… also discloses a dogmatic and unscientific stance.

If we see things soberly, homeopathy is – from a science theory point of view – an anomaly: empiric data prove that effects appear regularly and more and more frequently [2].  This is being demonstrated with meta-analyses of placebo-controlled clinical trials. And this also shows with our own provings, which conform well with the newly developed standards as well as with the newer provings. Effects are furthermore noted with such frequency in animal and plant-based studies. Contrary to often voiced statements, there are also models which produce replicated effects – for instance the model of children with ADHD which is currently being replicated. Repeatedly high quality pilot studies emerge, such as the one by Gassmann et al., which show that unexpected effects also appear with higher potencies, documented with objective methods. Homeopathy proves itself as useful in large pragmatic trials of which we, however, have far too few. And let’s not forget: homeopathy is pragmatically useful. Even though aggravations do occur occasionally during homeopathic treatments, the claim that homeopathy is dangerous is a careless interpretation of the data. [3]

In what way is homeopathy an anomaly? I have already years ago argued that the signature of the data does not suggest that we are dealing with a classical local effect. This would be an effect which would conform with the usual criterion of causality and would thus be stable, regular and more and more evident with improved experimentation. It is unnecessary to repeat this argument [4] for the purpose of this editorial. But precisely the question of the classic causal effect is the controversy. And exactly this is the issue used by the new wave of critic of homeopathy which is openly aimed at the demise of homeopathy. This situation occurs because also the homeopaths are victims of the misapprehension  that homeopathy is based on a classic causal process. But this assumption is most likely wrong, and homeopaths would be well-advised on the one side to point to the empiric evidence, and on the other side to practice theoretical chastity making clear that, for the time being, we have not a clue how homeopathy functions. This is the typical situation when a scientific anomaly occurs…

My prognosis would be: if we stop to misunderstand homeopathy as a classic causal phenomenon and instead view and research it as a non-classical phenomenon, homeopathy would have a chance and science would get richer by a new category of phenomena. This approach will prompt criticism, because it renders the world more complex rather than simpler. But this cannot be changed. Perhaps a new era of therapeutics might even emerge which does not abolish the molecular paradigm but makes it appear as one of several possibilities. [5]

END OF MY TRANSLATION

For those of you who can read German, here is the original text with references:

Dass die Homöopathie mit ihren therapeutischen Prinzipien dem Hauptstrom der Wissenschaft immer schon zuwiderlief, ist völlig unbestritten, und darin hat Weymayr recht. Aber auf dieser Tatsache ein regelrechtes «Forschungsverbot» aufbauen zu wollen, wie es das Szientabilitätskonzept vorsieht, das ist nicht nur wissenschaftstheoretisch absolut falsch, wie wir in einer Replik gezeigt haben [2], sondern offenbart auch eine dogmatische und unwissenschaftliche Einstellung.

Wenn man die Sache nüchtern sieht, ist die Homöopathie – wissenschaftstheoretisch betrachtet – eine Anomalie [3]: Empirische Daten belegen, dass immer wieder und insgesamt häufiger als zufällig erwartet Effekte auftreten. Das zeigen Meta-Analysen placebokontrollierter klinischer Studien [4,5,6]. Und das zeigt sich sowohl in unseren eigenen Arzneimittel-Prüfungen [7], die im Übrigen den erst neuerdings entwickelten Standards gut entsprechen [8], als auch in neueren Prüfungen [9]. Auch in Tierexperimenten [10,11,12,13] und in Pflanzenstudien [14,15,16] treten Effekte in solcher Häufigkeit auf. Entgegen oft gehörten Äußerungen gibt es durchaus auch Modelle, die replizierte Effekte ergeben – etwa das Modell homöopathischer Behandlung von Kindern mit Aufmerksamkeitsdefizit-/Hyperaktivitätssyndrom [17,18], das gerade repliziert wird [19]. Immer wieder gibt es qualitativ hochwertige Pilotstudien, wie die unlängst publizierte von Gassmann et al. [20], die zeigen, dass unerwartete Effekte auch unter höheren Potenzen und dokumentiert mit objektiven Methoden zu beobachten sind. Homöopathie erweist sich in großen pragmatischen Studien, von denen es allerdings viel zu wenige gibt, als nützlich [21,22,23]. Und nicht zu vergessen: Homöopathie ist pragmatisch hilfreich [24,25,26,27]. Zwar kommt es bei homöopathischer Behandlung gelegentlich zu einer Erstverschlimmerung [28,29], aber die Behauptung, Homöopathie sei gefährlich [30], ist eine fahrlässige Interpretation der Daten [31].

Inwiefern ist die Homöopathie dann eine Anomalie? Ich habe schon vor Jahren argumentiert, dass die Signatur der Daten in der Homöopathie nicht dafür spricht, dass wir es mit einem klassischen, lokalen Effekt zu tun haben [32]. Das wäre ein Effekt, der dem gewöhnlichen Kriterium der Kausalität entspräche und somit stabil, regelmäßig und bei immer besserer Experimentierkunst immer deutlicher hervorträte. Dieses Argument jetzt wieder aufzurollen, ist im Rahmen eines Editorials müßig. Aber genau die Frage nach einem klassisch-kausalen Effekt ist letztlich der Stein des Anstoßes. Und genau diesen Anstoß nimmt nun die neue Welle der Homöopathiekritik, die erklärtermaßen auf die Abschaffung der Homöopathie abzielt, zu ihrem Anlass. Diese Situation ergibt sich, weil auch die Homöopathen dem Selbstmissverständnis aufsitzen, Homöopathie sei ein klassisch-kausaler Prozess. Das ist höchstwahrscheinlich falsch, und die Homöopathie wäre gut beraten, einerseits auf die empirischen Befunde hinzuweisen und auf der anderen Seite theoretische Enthaltsamkeit zu üben und klarzulegen, dass wir vorläufig keinerlei Ahnung haben, wie Homöopathie funktioniert. Das ist die typische Situation, wenn eine wissenschaftliche Anomalie vorliegt…

Meine Prognose wäre: Wenn wir aufhören, die Homöopathie als klassisches Phänomen misszuverstehen, und sie stattdessen als ein mögliches nichtklassisches Phänomen betrachten und beforschen, dann hat die Homöopathie eine Chance und die Wissenschaft wird um eine neue Kategorie von Phänomenen reicher. Dieser Ansatz wird Kritik hervorrufen, denn er macht die Welt eher komplexer als einfacher. Aber das lässt sich nicht ändern. Vielleicht kann sogar eine neue Ära der Therapie beginnen, die das molekulare Paradigma nicht abschafft, aber als eine von mehreren Möglichkeiten erscheinen lässt.


Rather than commenting on this text in full detail, I simply want to provide a few explanations [they refer to the numbers in square brackets inserted by me into my translation] in order to facilitate understanding. I hope, however, that my readers will comment as much as they feel like.

1) Weymayr argued that certain fields lack plausibility to a degree that they do not merit being investigated. Here is an abstract of an article by him:

Evidence-based medicine (EbM) has proved to be very useful in healthcare; thanks to its methodology the reliability of our knowledge of the benefits and harms of interventions can be assessed. This at least applies to interventions which are based on a plausible concept for their mechanism of action and which have already achieved positive effects in experiments and simple studies. However, for interventions whose concepts contradict scientific findings EbM has proved to be unsuitable; it has not been able to prevent that they are still regarded as effective amongst wide parts of the population and medical experts. Particularly homeopathy has managed to even present itself as scientifically justified by using EbM. With the aim of highlighting the speculative character of homeopathy and other procedures and of preventing EbM from getting damaged, the concept of scientability is introduced in this article. This concept only approves of clinical studies if the intervention that is to be tested does not contradict definite scientific findings.

2) A scientific anomaly is “something which cannot be explained by currently accepted scientific theories. Sometimes the new phenomenon leads to new rules or theories, e.g., the discovery of x-rays and radiation.

3) Even a minimal amount of critical thinking leads to the conclusion that the claims made about homeopathy in this paragraph are mostly not true or exaggerated. On this blog, there is plenty of evidence to contradict Walach on all the points he made here.

4) Walach’s argument is detailed in this article:

Among homeopaths the common idea about a working hypothesis for homeopathic effects seems to be that, during the potentization process, ‘information’ or ‘energy’ is being preserved or even enhanced in homeopathic remedies. The organism is said to be able to pick up this information, which in turn will stimulate the organism into a self-healing response. According to this view the decisive element of homeopathic therapy is the remedy which locally contains and conveys this information. I question this view for empirical and theoretical reasons. Empirical research has shown a repetitive pattern, in fundamental and clinical research alike: there are many anomalies in high-dilution research and clinical homeopathic trials which will set any observing researcher thinking. But no single paradigm has proved stable enough in order to produce repeatable results independent of the researcher. I conclude that the database is too weak and contradictory to substantiate a local interpretation of homeopathy, in which the remedy is endowed with causal-informational content irrespective of the circumstances. I propose a non-local interpretation to understand the anomalies along the lines of Jung’s notion of synchronicity and make some predictions following this analysis.

5) In a nutshell, Walach seems to be saying:

  • the empirical evidence for homeopathy is strong;
  • nobody understands the mechanisms by which the effects of homeopathy are brought about;
  • if we all claim that homeopathy is a ‘scientific anomaly’ which operates according to Jung’s notion of synchronicity, the discrepancy between strong evidence and lack of plausible explanation disappears and everyone can be happy.

This is wrong for the following reasons, in my view:

  • the evidence is not strong but negative or extremely weak;
  • we understand very well that the effects of homeopathy are due to non-specific effects;
  • therefore there is no need for a new paradigm;
  • Jung’s notion of synchronicity is pure speculation and not applicable to therapeutics.

In summary, Prof Walach would do well to stop philosophising about homeopathy, read up about critical analysis, fine-tune his BS-detector and familiarise himself with Occam’s razor.

 

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