research methodology
Don’t get me wrong, I have nothing against systematic reviews. Quite to the contrary, I am sure they are an important source of information for patients, doctors, scientists, policy makers and others – after all, I have published more than 300 of such papers!
Having said that, I do dislike a certain type of systematic review, namely systematic reviews by Chinese authors evaluating TCM therapies and arriving at misleading conclusions. Such papers are currently swamping the marked.
At first glance, they look fine. On closer scrutiny, however, most turn out to be stereotypically useless, boring and promotional. The type of article I mean starts by stating its objective which usually is to evaluate the evidence for a traditional Chinese therapy as a treatment of a condition which few people in their right mind would treat with any form of TCM. It continues with details about the methodologies employed and then, in the results section, informs the reader that x studies were included in the review which mostly reported encouraging results but were wide open to bias. And then comes the crucial bit: THE CONCLUSIONS.
They are as predictable as they are misleading. let me give you two examples only published in the last few days.
The first review drew the following conclusions: This systematic review suggests that Chinese Herbal Medicine as an adjunctive therapy can improve cognitive impairment and enhance immediate response and quality of life in Senile Vascular Dementia patients. However, because of limitations of methodological quality in the included studies, further research of rigorous design is needed.
The second review concluded that the evidence that external application of traditional Chinese medicine is an effective treatment for venous ulcers is encouraging, but not conclusive due to the low methodological quality of the RCTs. Therefore, more high-quality RCTs with larger sample sizes are required.
Why does that sort of thing frustrate me so much? Because it is utterly meaningless and potentially harmful:
- I don’t know what treatments the authors are talking about.
- Even if I managed to dig deeper, I cannot get the information because practically all the primary studies are published in obscure journals in Chinese language.
- Even if I did read Chinese, I do not feel motivated to assess the primary studies because we know they are all of very poor quality – too flimsy to bother.
- Even if they were formally of good quality, I would have my doubts about their reliability; remember: 100% of these trials report positive findings!
- Most crucially, I am frustrated because conclusions of this nature are deeply misleading and potentially harmful. They give the impression that there might be ‘something in it’, and that it (whatever ‘it’ might be) could be well worth trying. This may give false hope to patients and can send the rest of us on a wild goose chase.
So, to ease the task of future authors of such papers, I decided give them a text for a proper EVIDENCE-BASED conclusion which they can adapt to fit every review. This will save them time and, more importantly perhaps, it will save everyone who might be tempted to read such futile articles the effort to study them in detail. Here is my suggestion for a conclusion soundly based on the evidence, not matter what TCM subject the review is about:
OUR SYSTEMATIC REVIEW HAS SHOWN THAT THERAPY ‘X’ AS A TREATMENT OF CONDITION ‘Y’ IS CURRENTLY NOT SUPPORTED BY SOUND EVIDENCE.
Today the GUARDIAN published an article promoting acupuncture on the NHS. The article is offensively misleading, I think, and therefore deserves a comment. I write these comments with a heavy heart, I should add, because the GUARDIAN is by far my favourite UK daily. In the following, I will cite key passages from the article in question and add my comments in bold.
Every woman needing pain relief while giving birth at University College London hospital (UCLH) is offered acupuncture, with around half of the hospital’s midwives specially trained to give the treatment. UCLH is far from typical in this respect, though: acupuncture is not standard throughout the UK and many health practitioners claim patients are often denied access to it through the NHS because of entrenched scepticism from sections of the medical establishment.
Entrenched scepticism? I would say that it could be perhaps be related to the evidence. The conclusions of the current Cochrane review on acupuncture for labour pain are cautious and do not seem strong enough to issue a general recommendation for general use in childbirth: “acupuncture and acupressure may have a role with reducing pain, increasing satisfaction with pain management and reduced use of pharmacological management. However, there is a need for further research.”
“There are conditions for which acupuncture works and others where it doesn’t. It is not a cure-all, and should be open to scrutiny. But the focus of my work is for acupuncture to become a standard part of midwifery training, and at the same time change perceptions among clinicians about its appropriate use for a whole range of other conditions.”
Open to scrutiny indeed! And if we scrutinise the evidence critically – rather than engaging in uncritical and arguably irresponsible promotion – we find that the evidence is not nearly as convincing as acupuncture fans try to make us believe.
The UK lags behind many other European countries in its support for acupuncture. Just 2,500 medical professionals here are qualified to practice it, compared with 45,000 in Germany. The National Institute for Clinical Excellence (Nice) recommends WMA specifically for the treatment of only two conditions – lower back pain (which costs the NHS £1bn a year) and headaches.
Yes, the UK also lags behind Germany in the use of leeches and other quackery. The ‘ad populum’ fallacy is certainly popular in alternative medicine – but surely, it is still a fallacy!
A growing body of healthcare practitioners believe it should be offered routinely for a variety of conditions, including pain in labour, cancer, musculoskeletal conditions and even irritable bowel syndrome (IBS).
Here we go, belief as a substitute for evidence and fallacies as a replacement of logical arguments. I had thought the GUARDIAN was better than this!
At a time of NHS cuts the use of needles at 8p per unit look attractive. In St Albans, where a group of nurse-led clinics have been using acupuncture since 2008 for patients with knee osteoarthritis, economics have been put under scrutiny. WMA was offered to 114 patients rather than a knee replacement costing £5,000, and 79% accepted. Two years later a third of them had not required a knee transplant, representing an annual saving of £100,000, as estimated by researchers to the St Albans local commissioning group.
This looks a bit like a ‘back of an envelope’ analysis. I would like to see this published in a reputable journal and see it scrutinised by a competent health economist.
So why is acupuncture not being used more widely? The difficulty of proving its efficacy is clearly one of the biggest stumbling blocks. An analysis of 29 studies of almost 18,000 patients found acupuncture effective in treating chronic pain compared with sham acupuncture.
This passage refers to an analysis by Vickers et al. It was severely and repeatedly criticised for being too optimistic and, more importantly, it is not nearly as positive as implied here. Its conclusions are in fact quite cautious: “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.”
But even treatment proponents question whether a randomised controlled trial – the gold standard of medical research – works, given that faking treatment is nearly impossible.
What do you mean ‘even treatment proponents’? It is only proponents who question these sham needles! The reason: they frequently do not generate the results acupuncture fans had hoped for.
MY CONCLUSIONS
The article is clearly not the GUARDIAN’s finest hour. It lacks even a tinge of critical assessment. This is regrettable, I think, particularly as the truth about acupuncture is not that difficult to transmit to the public:
- Much of the research is of woefully poor quality.
- Its effectiveness is not proven beyond doubt for a single condition.
- Serious adverse effects have been reported.
- Because it requires substantial amounts of therapist time, it also is not cheap.
An Indian chain of homeopathic clinics, Dr Batra’s, has just opened its first branch in London. The new website is impressive. It claims homeopathy is effective for the following conditions:
Hair loss? Are they serious? Have they not seen pictures of Samuel Hahnemann?
I decided to look into the psoriasis claim a little closer. This is what they state regarding the homeopathic treatment of psoriasis:
Research-based evidences speak clear and loud of the success of homeopathy in treating psoriasis.
A study published in the Journal of the European Academy of Dermatology and Venereology, a conventional medical Journal, showed that psoriasis patients experienced significant improvement in their quality of life and reduction in their psoriasis symptoms with homeopathy. And this was without any kind of side-effects whatsoever. Of the 82 patients involved in the study that went on for 2 years, many had suffered psoriasis for as long as 15 years and had previously unsuccessfully tried conventional treatments.
At Dr. Batra’s we have successfully treated more than 25,000 cases of psoriasis with homeopathy over the last 35 years. Our safe and scientific solutions have brought smiles to many suffering patients of psoriasis. In fact, a study conducted by A.C. Nielson showed that as compared to general practitioners, specialists and local homeopaths, a higher than average improvement is seen at Dr. Batra’s in treatment of skin ailments.
To the reader who does not look deeper, this may sound fairly convincing. Sadly, it is not. The first study cited above was an uncontrolled trial. Here is its abstract:
Design Prospective multicentre observational study. Objective To evaluate details and effects of homeopathic treatment in patients with psoriasis in usual medical care. Methods Primary care patients were evaluated over 2 years using standardized questionnaires, recording diagnoses and complaints severity, health-related quality of life (QoL), medical history, consultations, all treatments, and use of other health services. Results Forty-five physicians treated 82 adults, 51.2% women, aged 41.6 +/- 12.2 (mean +/- SD) years. Patients had psoriasis for 14.7 +/- 11.9 years; 96.3% had been treated before. Initial case taking took 127 +/- 47 min. The 7.4 +/- 7.4 subsequent consultations (duration: 19.4 +/- 10.5 min) cumulated to 169.0 +/- 138.8 min. Patients received 6.0 +/- 4.9 homeopathic prescriptions. Diagnoses and complaints severity improved markedly with large effect sizes (Cohen’s d= 1.02-2.09). In addition, QoL improved (SF-36 physical component score d = 0.26, mental component score d = 0.49), while conventional treatment and health service use were considerably reduced. Conclusions Under classical homeopathic treatment, patients with psoriasis improved in symptoms and QoL.
It is clear that, due to the lack of a control group, no causal inference can be made between the treatment and the outcome. To claim that otherwise is in my view bogus.
I should mention that there is not a single controlled clinical trial of homeopathy for psoriasis that would support the claim that it is effective.
The second study is not listed in Medline. In fact, the only publication of an author by the name of ‘A C Nielson’ is entitled ‘Are men more intuitive when it comes to eating and physical activity?’. Until I see the evidence, I very much doubt that the study cited above produced strong evidence that homeopathy is an effective cure for psoriasis.
Dr Batra’s chain of clinics boasts to provide the best quality and the highest standards of services that percolate down to all levels in an organisation. Everyone in the institute and those associated with it strive for excellence in whatever they do. Measuring the degree of customer satisfaction was the fundamental concept on which this homeopathic institute’s commitment to become a patient-driven institution was built.
Nice words! SHAME THAT THEY HAVE DECIDED TO DILUTE THEIR TRUTH HOMEOPATHICALLY!
This study created a media storm when it was first published. Several articles in the lay press seemed to advertise it as though a true breakthrough had been made in the treatment of hypertension. I would not be surprised, if many patients consequently threw their anti-hypertensives over board and queued up at their local acupuncturist.
Good for business, no doubt – but would this be a wise decision?
The aim of this clinical trial was to examine effectiveness of electroacupuncture (EA) for reducing systolic blood pressure (SBP) and diastolic blood pressures (DBP) in hypertensive patients. Sixty-five hypertensive patients not receiving medication were assigned randomly to one of two acupuncture intervention. Patients were assessed with 24-hour ambulatory blood pressure monitoring. They were treated by 4 acupuncturists with 30-minutes of EA at PC 5-6+ST 36-37 or LI 6-7+GB 37-39 (control group) once weekly for 8 weeks. Primary outcomes measuring effectiveness of EA were peak and average SBP and DBP. Secondary outcomes examined underlying mechanisms of acupuncture with plasma norepinephrine, renin, and aldosterone before and after 8 weeks of treatment. Outcomes were obtained by blinded evaluators.
After 8 weeks, 33 patients treated with EA at PC 5-6+ST 36-37 had decreased peak and average SBP and DBP, compared with 32 patients treated with EA at LI 6-7+GB 37-39 control acupoints. Changes in blood pressures significantly differed between the two patient groups. In 14 patients, a long-lasting blood pressure–lowering acupuncture effect was observed for an additional 4 weeks of EA at PC 5-6+ST 36-37. After treatment, the plasma concentration of norepinephrine, which was initially elevated, was decreased by 41%; likewise, renin was decreased by 67% and aldosterone by 22%.
The authors concluded that EA at select acupoints reduces blood pressure. Sympathetic and renin-aldosterone systems were likely related to the long-lasting EA actions.
These results are baffling, to say the least; and they contradict a recent meta-analysis which did not find that acupuncture without antihypertensive medications significantly improves blood pressure in those hypertensive patients.
So, who is right and who is wrong here?
Or shall we just look for alternative explanations of the effects observed in the new study?
There could be dozens of reasons for these findings that are unrelated to the alleged effects of acupuncture. For instance, they could be due to life-style changes suggested to the experimental but not the control group, or they might be caused by some other undisclosed bias or confounding. At the very minimum, we should insist on an independent replication of this trial.
It would be silly, I think, to trust these results and now recommend acupuncture to the millions of hypertensive patients worldwide, particularly as dozens of safe, cheap and very effective treatments for hypertension do already exist.
Wet cupping is a therapy traditionally used in several cultures. It involves superficial injuries to the skin and subsequently the application of a vacuum cup over the injured site. This procedure would draw a small amount of blood into the cup, and this visible effect was taken as a sign that the humors or life forces or whatever are being restored.
The treatment is obviously painful and carries the risk of infection. But does it work? There are not many clinical trials of this form of alternative medicine, and I was therefore thrilled to find a new paper with a randomised clinical trial.
The aim of this clinical trial was to evaluate the effectiveness and safety of wet cupping therapy as the sole treatment for persistent nonspecific low back pain (PNSLBP). The investigators recruited 80 with PNSLBP lasting at least 3 months and randomly allocated them to an intervention group (n=40) or to a control group (n=40). The experimental group had 6 wet cupping sessions within 2 weeks, each of which were done at two bladder meridian (BL) acupuncture points. The control group had no such treatments. Acetaminophen was allowed as a rescue treatment in both groups. The Numeric Rating Scale (NRS), McGill Present Pain Intensity (PPI), and Oswestry Disability Questionnaire (ODQ) were used as outcome measures. Numbers of acetaminophen tablets taken were compared at 4 weeks from baseline. Adverse events were recorded.
At the end of the intervention, statistically significant differences in all three outcome measures favouring the wet cupping group compared with the control group were seen. These improvements continued for another two weeks after the end of the intervention. Acetaminophen was used less in the wet cupping group, but this difference was not statistically significant. No adverse events were reported.
The authors concluded that wet cupping is potentially effective in reducing pain and improving disability associated with PNSLBP at least for 2 weeks after the end of the wet cupping period. Placebo-controlled trials are needed.
Every now and then – well, actually in alternative medicine this is not so rare an event – I come across a study that ‘smells to high heaven’. This one certainly does; to be precise, it has the stench of TOO GOOD TO BE TRUE.
Apart from the numerous weaknesses of the study design, there is the fact that the results are do simply not seem plausible. Low back pain has a natural history that is well-studied. We therefore know that the majority of cases do get better fairly quickly regardless of whether we treat them or not. In this study, the control group did not improve at all, as shown on the impressive graph below (the grey line depicts the symptoms in the control group and the black one those of the cupping group).
To me, the improvement of the experimental group looks much like one might expect from the natural history of back pain. If this were true, the effect of wet cupping would by close to zero and the conclusion drawn by the authors of this trial would be false-positive.
But why was there no improvement in the control group?
I do not know the answer to this question. All I know is that it is this unexplained phenomenon which has created the impression of effectiveness of wet cupping.
This seems to be the question that occupies the minds of several homeopaths.
Amazed?
So was I!
Let me explain.
In 1997, Linde et al published their now famous meta-analysis of clinical trials of homeopathy which concluded that “The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.”
This paper had several limitations which Linde was only too happy to admit. The authors therefore conducted a re-analysis which, even though published in an excellent journal, is rarely cited by homeopaths. Linde et al stated in their re-analysis of 2000: “there was clear evidence that studies with better methodological quality tended to yield less positive results.” It was this phenomenon that prompted me and my colleague Max Pittler to publish a ‘letter to the editor’ which now – 15 years later – seems the stone of homeopathic contention.
A blog-post by a believer in homeopathy even asks the interesting question: Did Professor Ernst Sell His Soul to Big Pharma? It continues as follows:
Edzard Ernst is an anti-homeopath who spent his career attacking traditional medicine. In 1993 he became Professor of Complementary Medicine at the University of Exeter. He is often described as the first professor of complementary medicine, but the title he assumed should have fooled no-one. His aim was to discredit medical therapies, notably homeopathy, and he then published some 700 papers in ‘scientific’ journals to do so.
Now, Professor Robert Hahn, in his blog, has made an assessment of the quality of his work… In the interests of the honesty and integrity in science, it is an important assessment. It shows, in his view, how science has been taken over by ideology (or as I would suggest, more accurately, the financial interests of Big Corporations, in this case, Big Pharma). The blog indicates that in order to demonstrate that homeopathy is ineffective, over 95% of scientific research into homeopathy has to be discarded or removed!
So for those people who, like myself, cannot read the original German, here is an English translation of the blog…
“I have never seen a science writer so blatantly biased as Edzard Ernst: his work should not be considered of any worth at all, and discarded” finds Sweden’s Professor Robert Hahn, a leading medical scientist, physician, and Professor of Anaesthesia and Intensive Care at the University of Linköping, Sweden.
Hahn determined therefore to analyze for himself the ‘research’ which supposedly demonstrated homeopathy to be ineffective, and reached the shocking conclusion that:
“only by discarding 98% of homeopathy trials and carrying out a statistical meta-analysis on the remaining 2% negative studies, can one ‘prove’ that homeopathy is ineffective”.
In other words, all supposedly negative homeopathic meta-analyses which opponents of homeopathy have relied on, are scientifically bogus…
Who can you trust? We can begin by disregarding Edzard Ernst. I have read several other studies that he has published, and they are all untrustworthy. His work should be discarded…
In the case of homeopathy, one should stick with what the evidence reveals. And the evidence is that only by removing 95-98% of all studies is the effectiveness of homeopathy not demonstrable…
So, now you are wondering, I am sure: HOW MUCH DID HE GET FOR SELLING HIS SOUL TO BIG PHARMA?
No? You are wondering 1) who this brilliant Swedish scientist, Prof Hahn, is and 2) what article of mine he is criticising? Alright, I will try to enlighten you.
PROFESSOR HAHN
Here I can rely on a comment posted on my blog some time ago by someone who can read Swedish (thank you Bjorn). He commented about Hahn as follows:
A renowned director of medical research with well over 300 publications on anesthesia and intensive care and 16 graduated PhD students under his mentorship, who has been leading a life on the side, blogging and writing about spiritualism, and alternative medicine and now ventures on a public crusade for resurrecting the failing realm of homeopathy!?! Unbelievable!
I was unaware of this person before, even if I have lived and worked in Sweden for decades.
I have spent the evening looking up his net-track and at his blog at roberthahn.nu (in Swedish).
I will try to summarise some first impressions:
Hahn is evidently deeply religious and there is the usual, unmistakably narcissistic aura over his writings and sayings. He is religiously confident that there is more to this world than what can be measured and sensed. In effect, he seems to believe that homeopathy (as well as alternative medical methods in general) must work because there are people who say they have experienced it and denying the possibility is akin to heresy (not his wording but the essence of his writing).
He has, along with his wife, authored at least three books on spiritual matters with titles such as (my translations) “Clear replies from the spiritual world” and “Connections of souls”.
He has a serious issue with skeptics and goes on at length about how they are dishonest bluffers[sic] who willfully cherry-pick and misinterpret evidence to fit their preconceived beliefs.
He feels that desperate patients should generally be allowed the chance that alternative methods may offer.
He believes firmly in former-life memories, including his own, which he claims he has found verification for in an ancient Italian parchment.
His main arguments for homeopathy are Claus Linde’s meta analyses and the sheer number of homeopathic research that he firmly believes shows it being superior to placebo, a fact that (in his opinion) shows it has a biological effect. Shang’s work from 2005 he dismisses as seriously flawed.
He also points to individual research like this as credible proof of the biologic effect of remedies.
He somewhat surprisingly denies recommending homeopathy despite being convinced of its effect and maintains that he wants better, more problem oriented and disease specific studies to clarify its applicability. (my interpretation)
If it weren’t for his track record of genuine, acknowledged medical research and him being a renowned authority in a genuine, scientific medical field, this man would be an ordinary, religiously devout quack.
What strikes me as perhaps telling of a consequence of his “exoscientific” activity, is that Hahn, who holds the position of research director at a large city trauma and emergency hospital is an “adjungerad professor”, which is (usually) a part time, time limited, externally financed professorial position, while any Swedish medical doctor with his very extensive formal merits would very likely hold a full professorship at an academic institution.
END OF QUOTE
MY 2000 PAPER THAT SEEMS TO IRRITATE HAHN
This was a short ‘letter to the editor’ by Ernst and Pittler published in the J Clin Epidemiol commenting on the above-mentioned re-analysis by Linde et al which was published in the same journal. As its text is not available on-line, I re-type parts of it here:
In an interesting re-analysis of their meta-analysis of clinical trials of homeopathy, Linde et al conclude that there is no linear relationship between quality scores and study outcome. We have simply re-plotted their data and arrive at a different conclusion. There is an almost perfect correlation between the odds ratio and the Jadad score between the range of 1-4… [some technical explanations follow which I omit]…Linde et al can be seen as the ultimate epidemiological proof that homeopathy is, in fact, a placebo.
And that is, as far as I can see, the whole mysterious story. I cannot even draw a conclusion – all I can do is to ask a question:
DOES ANYONE UNDERSTAND WHAT THEY ARE GOING ON ABOUT?
On a blog about alternative medicine, the issue of ‘pseudoscience’ can never be far. Several posts have already focussed specifically on this topic. Recently, I came across an excellent article on homeopathy (which is well worth reading in full). It concluded by listing the techniques commonly used in pseudoscience.
I think this is important and relevant to much of the discussions about alternative medicine. Therefore I take the liberty to cite it here in full. According to the authors of this article, , the techniques are as follows:
- Ignore settled issues in science: We know a great deal about the behavior of water (and evolution, and other contentious topics), but there are many efforts to introduce new science without ever addressing the existing body of knowledge. As such, many of the basic tenets of topics such as homeopathy appear to be ungrounded in reality as we understand it.
- Misapplication of real science: Quantum mechanics is an undeniably successful description of parts of the natural world, but the limitations of its applicability are widely recognized by the scientific community, if not the general public. Pseudoscientists such as homeopaths appear to cynically target this sort of ignorance by applying scientific principles to inappropriate topics.
- Rejection of scientific standards: Over the centuries, science has established standards of evidence and experiment to ensure that data remains consistent and reproducible. But these strengths are presented as weaknesses that make science impervious to new ideas, a stance that is often accompanied by…
- Claims of suppression: Pseudoscience is rejected because it does not conform to the standards held by the scientific community. That community is depicted as a dangerous hegemony that rejects new ideas in order to perpetuate a stifling orthodoxy. This happens in spite of many examples of radical ideas that have rapidly gained not only acceptance, but major prizes, when they were properly supported by scientific evidence.
- A conclusion/evidence gap: Many areas of pseudoscience do not set out to examine a phenomenon but rather have the stated goal of supporting a preordained conclusion. As such, they often engage in excessive logical leaps when the actual data is insufficient to support the desired conclusion.
- Focusing on the fringes: All areas of science have anomalous data and anecdotal findings that are inconsistent with the existing understanding. But those anomalies should not obscure the fact that the vast majority of current data does support the predominant theories. In the hands of a pseudoscientist, these unconnected edge cases are presented as a coherent body of knowledge that supports the replacement of existing understandings.
Perhaps the clearest theme running through many areas of pseudoscience, however, is the attempt to make a whole that is far, far greater than the sum of its parts. Enlarging a collection of terminally-flawed trivia does not somehow strengthen its scientific significance. This is especially true when many of the components of the argument don’t form a coherent whole. For example, quantum entanglement, structured water, and silica are essentially unrelated explanations, and any support for one of them makes no difference to the others. Yet, somehow, presenting them all at once is supposed to make the case for water’s memory harder to dismiss.
END OF QUOTE
No, this post is not about the pop duo ‘EURYTHMICS’, it is about ‘EURYTHMY’ which pre-dates the pop duo by a few decades.
Eurythmy is a movement therapy of anthroposophic medicine which, according to its proponents, has positive effects on a person’s physical body, spirit, and soul. It is involves expressive movements developed by Rudolf Steiner in conjunction with Marie von Sivers in the early 20th century. It is used as a performance art, in education, especially in Steiner schools, and – as part of anthroposophic medicine – for therapeutic purposes. Here is what one pro-eurymthy website tells us about it:
Eurythmy is one of Rudolf Steiner’s proudest achievements. To better understand what Steiner says about eurythmy, you should read his self-titled “A Lecture on Eurythmy” Not always one to boast, Steiner says:
EURYTHMY has grown up out of the soil of the Anthroposophical Movement, and the history of its origin makes it almost appear to be a gift of the forces of destiny.
Steiner, Rudolf. A Lecture on Eurythmy, 1923
Clearly, Steiner felt that eurythmy was something very special, and of great importance. As such, eurythmy is a tool of Anthroposophy used to reveal and bring about a certain “spiritual impulse” in our age:
Read
OnlineFor it is the task of the Anthroposophical Movement to reveal to our present age that spiritual impulse which is suited to it.I speak in all humility when I say that within the Anthroposophical Movement there is a firm conviction that a spiritual impulse of this kind must now, at the present time, enter once more into human evolution. And this spiritual impulse must perforce, among its other means of expression, embody itself in a new form of art. It will increasingly be realised that this particular form of art has been given to the world in Eurythmy.
Steiner, Rudolf. A Lecture on Eurythmy
The question is, of course, whether as a therapy eurythmy works. A recent publication might give an answer.
The aim of this systematic review was to update and summarize the relevant literature on the effectiveness of eurythmy in a therapeutic context since 2008. It is thus an up-date of a previously published review. This paper found 8 citations which met the inclusion criterion: 4 publications referring to a prospective cohort study without control group (the AMOS study), and 4 articles referring to 2 explorative pre-post studies without control group, 1 prospective, non-randomized comparative study, and 1 descriptive study with a control group. The methodological quality of studies ranged in from poor to good, and in sample size from 5 to 898 patients. In most studies, EYT was used as an add-on, not as a mono-therapy. The studies described positive treatment effects with clinically relevant effect sizes in most cases.
For the up-date, different databases like PubMed, MEDPILOT, Research Gate, The Cochrane Library, DIMDI, Arthe and also the journal databases Der Merkurstab and the European Journal of Integrative Medicine were searched for prospective and retrospective clinical trials in German or English language. There were no limitations for indication, considered outcome or age of participants. Studies were evaluated with regard to their description of the assembly process and treatment, adequate reporting of follow-ups, and equality of comparison groups in controlled trials.
Eleven studies met the inclusion criteria. These included two single-arm, non-controlled pilot studies, two publications on the same non-randomized controlled trial and one case study; six further studies referred to a prospective cohort study, the Anthroposophic Medicine Outcome Study. Most of these studies described positives treatment effects with varying effect sizes. The studies were heterogynous according to the indications, age groups, study design and measured outcome. The methodological quality of the studies varied considerably.
The authors who all come from the Institute of Integrative Medicine, anthroposophical University of Witten/Herdecke in Germany draw the following conclusions: Eurythmy seems to be a beneficial add-on in a therapeutic context that can improve the health conditions of affected persons. More methodologically sound studies are needed to substantiate this positive impression.
I am puzzled! How on earth could they reach this conclusion? There is not a single trial that would allow to establish cause and effect!!! The way I read the evidence from the therapeutic trials included in this and the previous reviews, the only possible conclusion is that EURYTHMY IS A WEIRD THERAPY FOR WHICH THERE IS NOT GOOD EVIDENCE WHATSOEVER.
Anthroposophic medicine is based on Rudolf Steiner’s mystical ideas. It is popular in Germany and is slowly also spreading to other countries. Anthroposophic drugs are prepared according to ancient notions of alchemy and are fly in the face of modern pharmacology. Anthroposophic doctors treat all sorts of diseases, and their treatments include anthroposophic medications, and a range of other modalities.
A recent paper reported a secondary analysis from an observational study of 529 children with respiratory or ear infections (RTI/OM) <18 years from Europe and the USA. Their caregivers had chosen to consult physicians offering either anthroposophic (A-) or conventional (C-) treatment for RTI/OM.
During the 28-day follow-up antibiotics were prescribed to 5.5% of A-patients and 25.6% of C-patients (P < 0.001); the unadjusted odds ratio for non-prescription in A- versus C-patients was 6.58 (95%-CI 3.45-12.56); after adjustment for demographics and morbidity it was 6.33 (3.17-12.64). Antibiotic prescription rates in recent observational studies with similar patients in similar settings, ranged from 31.0% to 84.1%. Compared to C-patients, A-patients also had much lower use of analgesics, somewhat quicker symptom resolution, and higher caregiver satisfaction. Adverse drug reactions were infrequent (2.3% in both groups) and not serious.
What can we conclude from these data?
Not a lot, I fear!
The authors of the study are a little more optimistic than I; they conclude that this analysis from a prospective observational study under routine primary care conditions showed a very low use of antibiotics and analgesics/antipyretics in children treated for RTI/OM by physicians offering AM therapy, compared to current practice in conventional therapy settings (antibiotics prescribed to 5% versus 26% of A- and C-patients, respectively, during days 0–28; antipyretics prescribed to 3% versus 26%). The AM treatment entailed no safety problem and was not associated with delayed short-term recovery. These differences could not explained by differences in demographics or baseline morbidity. The low antibiotic use is consistent with findings from other studies of paediatric RTI/OM in AM settings.
They are clearly careful to avoid causal inferences; but are they implying them? I would like to know what you think.
Medical ethics comprise a set of rules and principles which are essential for all aspects of medicine, including of course research. The main issues are:
- Respect for autonomy – patients must have the right to refuse or choose their treatments.
- Beneficence – researchers and clinicians must act in the best interest of the patient.
- Non-maleficence – the expected benefits of interventions must outweigh their risks.
- Justice – the distribution of health resources must be fair.
- Respect for persons – patients must be treated with dignity.
- Truthfulness and honesty – informed consent is an essential element in research and clinical practice.
While all of this has long been fairly standard in conventional health care, it is often neglected in alternative medicine. It is therefore timely to ask, how much of research in the realm of alternative medicine abides by the rules of medical ethics?
After more than two decades of involvement in this sector, I have serious and growing concerns. The subject is, of course complex, but the way I see it, in alternative medicine there are two main areas where medical ethics are violated with some regularity.
- Nonsensical research projects
- Lack of informed consent
NONSENSICAL RESEARCH PROJECTS
At best, nonsensical research is a waste of precious resources, at worst it violates the beneficence principle. In alternative medicine, nonsensical research seems to happen ad nauseam. Regular readers of this blog will have seen plenty of examples of such abuse – for instance, if researchers conduct a clinical trial of chiropractic spinal manipulation for improving the singing voices of choir singers, or homeopaths test whether their remedies enhance female fertility. Often, nonsensical research happens when naïve enthusiasts decide to dabble a bit in science in order to promote their trade – but without realising that research would require a minimum of education.
But there are other occasions when it seems that the investigators know only too well what they are doing. Take for instance the plethora of ‘pragmatic’ trials which are currently so much ‘en vogue’ in alternative medicine. They can be designed in such a way that their results must produce what the researchers intended to show; the ‘A+B versus B’ study design is a prominent and obvious example of this type of abuse which I have repeatedly written about on this blog.
I use the term ‘abuse’ intentionally, because that is precisely what it is, in my view. Nonsensical research abuses the willingness of patients to participate by misleading them that it is a worthwhile sacrifice. In reality it is an unethical attempt to generate findings that can mislead us all. Moreover, it gives science a bad name and can lead to patients’ unwillingness to take part in research that does need doing. The damage done by nonsensical research projects is therefore immeasurable.
INFORMED CONSENT
Informed consent is essential in research for protecting the interests of the volunteering patients. When a clinical trial is first conceived, the researchers need to work out all the details, write a protocol and submit it to their ethics committee. Their submission has to give evidence that all the participating patients have given informed consent in writing before they are enrolled into the study. That means, they have to be told the essential details about what might happen to them during the trial.
In a placebo-controlled trial of homeopathy, for instance, they might be told that they will receive either a homeopathic remedy or a placebo during the study period. They might also be informed that there is some encouraging evidence that the former works, and that the trial is designed to define to what extend this is so. Generating this knowledge, they might further be told, will help future patients and will be an important contribution to improving health care. Based on such phraseology, the ethics committee is likely to allow the study to go ahead, and patients are likely to agree to take part.
But, of course, this information is less than truthful. An honest and full information for patients would need to include the following points:
- you will receive either a homeopathic remedy or a placebo,
- the former contains no active molecules and the totality of the most reliable evidence does not show that it works for your condition,
- this means that you will receive either a homeopathic or a conventional placebo,
- neither of these can possibly help your condition,
- the study can therefore not advance our knowledge in any way,
- during the trial your condition will remain untreated which is likely to increase your suffering unnecessarily.
If any research team would truthfully disclose this information, no ethics committee would pass their protocol. If by some weird mistake they did, no patients would volunteer to participate in the study.
I have chosen here the example of homeopathy (because most readers will understand it quite easily), but I could have used almost any other alternative treatment. The issues are identical or very similar: informed consent is usually misinformed consent. If it were fully and truthfully informed, it would neither pass the hurdle of the essential ethics approval nor would it lend itself to recruiting sufficiently large numbers of patients.
CONCLUSION
There are, I think, very serious concerns about the ethical standards in alternative medicine research. I have been banging on about these issues since many years (for instance here and here and here and here). Predictably, this did not find much resonance in the realm of alternative medicine. Regrettably, very few ethicists have so far taken this subject seriously; they seem to feel that these problems are trivial compared to the important issues medical ethics face in conventional health care. I remain unconvinced that this is true and believe it is high time to systematically address the ethics of alternative medicine.
