MD, PhD, FMedSci, FSB, FRCP, FRCPEd

false positive

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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:


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For 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.

While my last post was about the risk following some naturopaths’ advice, this one is about the effectiveness of naturopathic treatments. This is a complex subject, not least because naturopaths use a wide range of therapies (as the name implies, they pride themselves of employing all therapeutic means supplied by nature). Some of these interventions are clearly supported by good evidence; for instance, nobody would doubt the effectiveness of a healthy diet or the benefits of regular exercise. But what about all the other treatments naturopaths use? The best approach to find an answer might be to assess not each single therapy but to evaluate the entire package of the naturopathic approach, and not a single study but all such trials.

This is precisely what US researchers have recently done. The purpose of this interesting, new systematic review was to compile and consolidate research that has investigated the whole practice of naturopathic medicine as it is practiced in community settings in order to better assess the quantity and quality of the research, and clinical effect, if any.

In order to get included into the review, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no meta-analysis was undertaken.

Fifteen studies met the authors’ inclusion criteria. They covered a wide range of chronic diseases. Most studies had low to medium risks of bias including acknowledged limitations of pragmatic trials. Effect sizes for the primary medical outcomes varied and were statistically significant in 10 out of 13 studies. A quality of life metric was included in all of the RCTs with medium effect size and statistical significance in some subscales.

The authors concluded that previous reports about the lack of evidence or benefit of naturopathic medicine (NM) are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM across a range of health conditions.

This sounds like good news for naturopathy! However, there are several important caveats:

  • the authors seem to have only looked at US studies (naturopathy is a European tradition!),
  • the searches were done three years ago, and more recent data were thus omitted,
  • the authors included all sorts of investigations, even uncontrolled studies; only 6 were RCTs,
  • rigorous trials were very scarce; and for each condition, they were even more so,
  • the authors mention the PRISMA guidelines for systematic reviews implying that they followed them but, in fact, they did not.

My biggest concern, however, is something else. It relates to the interventions tested in these studies. The authors claim that their results table provides full details on this issue but this is unfortunately not true. All we have by way of an explanation is the authors’ remark that the interventions tested in the studies of their review included diet counseling and nutritional recommendations, specific home exercises and physical activity recommendations, deep breathing techniques or other stress reduction strategies, dietary supplements including vitamins, hydrotherapy, soft-tissue manual techniques, electrical muscle stimulation, and botanical medicines.

Survey data from two US states tell us that the most commonly prescribed naturopathic therapeutics are botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). They also inform us that the mean length of a consultation with an US naturopath is about 40 minutes.

I think, this puts things into perspective. If I advise a patient with diabetes or hypertension or coronary heat disease to follow an appropriate diet, exercise and to adhere to some stress reduction program, if in addition I show empathy and compassion during a 40 minute consultation and make sure that my advise is taken seriously and subsequently adhered to, the outcome is likely to be positive. Naturopaths may elect to call this package of intervention ‘naturopathy’, however, I would call it good conventional medicine.

The problem, I think is clear: good therapeutic advice is effective but it is not naturopathy, and it cannot be used to justify the use of doubtful interventions like homeopathy or all sorts of dodgy supplements. Testing whole treatment packages of this nature can therefore lead to highly misleading results, particularly if the researchers draw unwarranted conclusions about specific schools of health care.

Of all alternative treatments, aromatherapy (i.e. the application of essential oils to the body, usually by gentle massage or simply inhalation) seems to be the most popular. This is perhaps understandable because it certainly is an agreeable form of ‘pampering’ for someone in need of come TLC. But is aromatherapy more than that? Is it truly a ‘THERAPY’?

A recent systematic review was aimed at evaluating the existing data on aromatherapy interventions as a means of improving the quality of sleep. Electronic literature searches were performed to identify relevant studies published between 2000 and August 2013. Randomized controlled and quasi-experimental trials that included aromatherapy for the improvement of sleep quality were considered for inclusion. Of the 245 publications identified, 13 studies met the inclusion criteria, and 12 studies could be used for a meta-analysis.

The meta-analysis of the 12 studies revealed that the use of aromatherapy was effective in improving sleep quality. Subgroup analysis showed that inhalation aromatherapy was more effective than aromatherapy applied via massage.

The authors concluded that readily available aromatherapy treatments appear to be effective and promote sleep. Thus, it is essential to develop specific guidelines for the efficient use of aromatherapy.

Perfect! Let’s all rush out and get some essential oils for inhalation to improve our sleep (remarkably, the results imply that aroma therapists are redundant!).

Not so fast! As I see it, there are several important caveats we might want to consider before spending our money this way:

  1. Why did this review focus on such a small time-frame? (Systematic reviews should include all the available evidence of a pre-defined quality.)
  2. The quality of the included studies was often very poor, and therefore the overall conclusion cannot be definitive.
  3. The effect size of armoatherapy is small. In 2000, we published a similar review and concluded that aromatherapy has a mild, transient anxiolytic effect. Based on a critical assessment of the six studies relating to relaxation, the effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. The hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.
  4. It seems uncertain which essential oil is best suited for this indication.
  5. Aromatherapy is not always entirely free of risks. Another of our reviews showed that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.
  6. There are several effective ways for improving sleep when needed; we need to know how aromatherapy compares to established treatments for that indication.

All in all, I think stronger evidence is required that aromatherapy is more that pampering.

ENOUGH SAID?

When I come across a study with the aim to “examine the effectiveness of acupuncture to relieve symptoms commonly observed in patients in a hospice program” my hopes are high. When I then see that its authors are from the ‘New England School of Acupuncture’, the ‘All Care Hospice and the ‘Tufts University School of Medicine, Boston, my hopes for a good piece of science are even higher. So, let’s see what this new paper has to offer.

A total of 26 patients participated in this acupuncture ‘trial’, receiving a course of weekly treatments that ranged from 1 to 14 weeks. The average number of treatments was five. The Edmonton Symptom Assessment Scale (ESAS) was used to assess the severity of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and dyspnoea. A two-tailed, paired t test was applied to the data to compare symptom scores pre- versus post-acupuncture treatment. Patients enrolled in All Care Hospice’s home care program were given the option to receive acupuncture to supplement usual care offered by the hospice team. Treatment was provided by licensed acupuncturists in the patient’s place of residence.

The results indicated that 7 out of 9 symptoms were significantly improved with acupuncture, the exceptions being drowsiness and appetite. Although the ESAS scale demonstrated a reduction in symptom severity post-treatment for both drowsiness and appetite, this reduction was not found to be significant.

At tis stage, I have lost most of my hopes for good science. This is not a ‘trial’ but a glorified case-series. There is no way that the stated aim can be pursued with this type of methodology. There is no reason whatsoever to assume that the observed outcome can be attributed to acupuncture; the additional attention given to these patients is but one of several factors that are quite sufficient to explain their symptomatic improvements.

This is yet another disappointment then from the plethora of ‘research’ into alternative medicine that, on closer inspection, turns out to be little more than thinly disguised promotion of quackery. These days, I can bear such disappointments quite well – after all, I had many years to get used to them. What I find more difficult to endure is the anger that overcomes me when I read the authors’ conclusion: Acupuncture was found to be effective for the reduction and relief of symptoms that commonly affect patient QOL. Acupuncture effectively reduced symptoms of pain, tiredness, nausea, depression, anxiety, and shortness of breath, and enhanced feelings of well-being. More research is required to assess the long-term benefits and symptom reduction of acupuncture in a palliative care setting.

This is not disappointing; in my view, this is scientific misconduct by

  • the authors,
  • the institutions employing the authors,
  • the ethics committee that has passed the ‘research’,
  • the sponsors of the ‘research’,
  • the peer-reviewers of the paper,
  • the journal and its editors responsible for publishing this paper.

The fact that this sort of thing happens virtually every day in the realm of alternative medicine does not render this case less scandalous, it merely makes it more upsetting.

For ‘my’ journal FACT, I review all the new articles that have emerged on the subject of alternative medicine on a monthly basis. Here are a few impressions and concerns that this activity have generated:

  • The number of papers on alternative medicine has increased beyond belief: between the year 2000 and 2010, there was a slow, linear increase from 335 to 610 Medline-listed articles; thereafter, the numbers exploded to 1189 (2011), 1674 (2012) and 2236 (2013).
  • This fast growing and highly lucrative ‘market’ has been cornered mainly by one journal: ‘EVIDENCE BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE’ (EBCAM), a journal that I mentioned several times before (see here, for instance). In 2010, EBCAM published 76 papers, while these figures increased to 546, 880 and 1327 during the following three years.
  • Undeniably, this is big business, as authors have to pay tidy sums each time they get published in EBCAM.
  • The peer-review system of EBCAM is farcical: potential authors who send their submissions to EBCAM are invited to suggest their preferred reviewers who subsequently are almost invariably appointed to do the job. It goes without saying that such a system is prone to all sorts of serious failures; in fact, this is not peer-review at all, in my opinion, it is an unethical sham.
  • As a result, most (I estimate around 80%) of the articles that currently get published on alternative medicine are useless rubbish. They tend to be either pre-clinical investigations which never get followed up and are thus meaningless, or surveys of no relevance whatsoever, or pilot studies that never are succeeded by more definitive trials, or non-systematic reviews that are wide open to bias and can only mislead the reader.
  • Nowadays, very few articles on alternative medicine are good enough to get published in mainstream journals of high standing.

The consequences of these fairly recent developments are serious:

  • Conventional scientists and clinicians must get the impression that there is little research activity in alternative medicine (while, in fact, there is lots) and that the little research that does emerge is of poor quality.
  • Consequently alternative medicine will be deemed by those who are not directly involved in it as trivial, and the alternative medicine journals will be ignored or even become their laughing stock.
  • At the same time, the field of alternative medicine and its proponents (the only ones who might actually be reading the plethora of rubbish published in alternative medicine journals) will get more and more convinced that their field is supported by an ever- abundance of peer-reviewed, robust science.
  • Gradually, they will become less and less aware of the standards and requirements that need to be met for evidence to be called reliable (provided they ever had such knowledge in the first place).
  • They might thus get increasingly frustrated by the lack of acceptance of their ‘advances’ by proper scientists – an attitude which, from their perspective, must seem unfair, biased and hostile.
  • In the end, conventional and alternative medicine, rather than learning from each other, will move further and further apart.
  • Substantial amounts of money will continue to be wasted for research into alternative medicine that, whenever assessed critically, turns out to be too poor to advance healthcare in any meaningful way.
  • The ones who medicine should be all about, namely the patients who need our help and rely on the progress of research, are not well served by these developments.

In essence this suggests, I think, that alternative medicine is ill-advised and short-sighted to settle for standards that are so clearly below those generally deemed acceptable in medicine. Similarly, conventional medicine does a serious disfavour to progress and to us all, if it ignores or tolerates this process.

I am not at all sure how to reverse this trend. In the long-term, it would require a change of attitude that obviously is far from easy to bring about. In the short-term, it might help, I think, to de-list journals from Medline that are in such obvious conflict with publication ethics.

A new RCT of Reiki healing has been published by US authors from the following institutions: Union Institute & University, Psychology Program, Brattleboro, VT, Coyote Institute, Augusta and Bangor, ME, Eastern Maine Medical Center and Acadia Hospital, Bangor, ME, University of New England College of Osteopathic Medicine, Biddeford, ME, Coyote Institute, Orono, ME. The purpose of this study was to determine if 30 minutes of healing touch could reduce burnout in community mental health clinicians.

The authors utilized a crossover design to explore the efficacy of Reiki versus sham Reiki, a pseudo treatment performed by volunteers who had no experience with Reiki and pretended to be healers vis-à-vis the patients. This sham control intervention was designed to mimic true Reiki.

Subjects were randomized to whether they started with Reiki or sham. The Maslach Burnout Inventory-Human Services Survey (MBI-HSS) and the Measure Your Medical Outcome Profile Version 2 (MYMOP-2) were used as outcome measures. Multilevel modeling was used to represent the relations among variables.

The results showed that real Reiki was significantly better than sham Reiki in reducing burnout among community mental health clinicians. Reiki was significant in reducing depersonalization, but only among single people. Reiki reduced the primary symptom on the MYMOP also only among single people.

The authors concluded that the effects of Reiki were differentiated from sham Reiki. Reiki could be helpful in community mental health settings for the mental health of the practitioners.

My team has published on Reiki (see here and here, for instance), and on this blog I have repeatedly been expressed my doubts that Reiki is more than an elaborate placebo (see here and here, for instance). Do these new results mean that I need to eat my words and henceforth praise the wonders of Reiki? No, I don’t think so!

Having conducted studies on ‘energy healing’ myself, I know only too well of the many pitfalls and possibilities of generating false-positive findings with such research. This new study has many flaws, but we need not look far to find the reason for the surprising and implausible finding. Here is my explanation why this study suggests one placebo to be superior to another placebo.

The researchers had to recruit 16 Reiki healers and several non-Reiki volunteers to perform the interventions on the small group of patients. It goes without saying that the Reiki healers were highly motivated to demonstrate the value of their therapy. This means they (unintentionally?) used verbal and non-verbal communication to maximise the placebo effect of their treatment. The sham healers, of course, lacked such motivation. In my view, this seemingly trivial difference alone is capable of producing the false-positive result above.

There are, of course, ways of minimising the danger of such confounding. In our own study of ‘energy healing’ with sham healers as controls, for instance, we instructed both the healers and the sham healers to abstain from all communication with their patients, we filmed each session to make sure, and we asked each patient to guess which treatment they had received. None of these safeguards were incorporated in the present study – I wonder why!

The press officers of journals like to send out press-releases of articles which are deemed to be particularly good and important. Sadly, it is not often that articles on alternative medicine fulfil these criteria. I was therefore excited to receive this press-release which seemed encouraging, to say the least:

Medical evidence supports the potential for acupuncture to be significantly more effective in the treatment of dermatologic conditions such as dermatitis, pruritus, and urticaria than alternative treatment options, “placebo acupuncture,” or no treatment, according to a review of the medical literature published in The Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers

The abstract was equally promising:

Objectives: Acupuncture is a form of Traditional Chinese Medicine that has been used to treat a broad range of medical conditions, including dermatologic disorders. This systematic review aims to synthesize the evidence on the use of acupuncture as a primary treatment modality for dermatologic conditions.

Methods: A systematic search of MEDLINE, EMBASE, and the Cochrane Central Register was performed. Studies were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language. Studies involving moxibustion, electroacupuncture, or blood-letting were excluded.

Results: Twenty-four studies met inclusion criteria. Among these, 16 were randomized controlled trials, 6 were prospective observational studies, and 2 were case reports. Acupuncture was used to treat atopic dermatitis, urticaria, pruritus, acne, chloasma, neurodermatitis, dermatitis herpetiformis, hyperhidrosis, human papillomavirus wart, breast inflammation, and facial elasticity. In 17 of 24 studies, acupuncture showed statistically significant improvements in outcome measurements compared with placebo acupuncture, alternative treatment options, and no intervention.

Conclusions: Acupuncture improves outcome measures in the treatment of dermatitis, chloasma, pruritus, urticaria, hyperhidrosis, and facial elasticity. Future studies should ideally be double-blinded and standardize the control intervention.

One has to read the actual full text article to understand that the evidence presented here is dodgy to the extreme. In fact, one has to go into the tedious details of the methods section to find the reasons why:  All searches were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language.

There are many more weaknesses of this review, but the inclusion of uncontrolled studies and even anecdotes is, in my view, a virtual death sentence to its credibility. It means that no general conclusions about the effectiveness of acupuncture, such as the authors have decided to make, are possible.

Such overt exaggerations are sadly no rarities in the realm of alternative medicine.  I think, this begs a number of serious questions:

  1. Does this cross the line between flawed research and scientific misconduct?
  2. Why did the reviewers not pick up these flaws?
  3. Why did the editor pass this article for publication?
  4. How can the publisher tolerate such dubious behaviour?
  5. Should this journal (which I have commented on before here and which is one with the highest impact factor of all the alt med journals) be de-listed from Medline?

I don’t think that we will get answers from the people responsible for this disgrace, but I would like to learn my readers’ opinions.

Chiropractors are back pain specialists, they say. They do not pretend to treat non-spinal conditions, they claim.

If such notions were true, why are so many of them still misleading the public? Why do many chiropractors pretend to be primary care physicians who can take care of most illnesses regardless of any connection with the spine? Why do they continue to happily promote bogus treatments? Why do chiropractors, for instance, claim they can treat gastrointestinal diseases?

This recent narrative review of the literature, for example, was aimed at summarising studies describing the management of disorders of the gastrointestinal (GI) tract using ‘chiropractic therapy’ broadly defined here as spinal manipulation therapy, mobilizations, soft tissue therapy, modalities and stretches.

Twenty-one articles were found through searching the published literature to meet the authors’ inclusion criteria. The retrieved articles included case reports to clinical trials to review articles. The majority of articles chronicling patient experiences under chiropractic care reported that they experienced mild to moderate improvements in GI symptoms. No adverse effects were reported.

From this, the authors concluded that chiropractic care can be considered as an adjunctive therapy for patients with various GI conditions providing there are no co-morbidities.

I think, we would need to look for a long time to find an article with conclusions that are more ridiculous, false and unethical than these.

The old adage applies: rubbish in, rubbish out. If we include unreliable reports such as anecdotes, our finding will be unreliable as well. If we do not make this mistake and conduct a proper systematic review, we will arrive at very different conclusions. My own systematic review, for instance, of controlled clinical trials drew the following conclusion: There is no supportive evidence that chiropractic is an effective treatment for gastrointestinal disorders.

That probably says it all. I only want to add a short question: SHOULD THIS LATEST CHIROPRACTIC ATTEMPT TO MISLEAD THE PUBLIC BE CONSIDERED ‘SCIENTIFIC MISCONDUCT’ OR ‘FRAUD’?

The last time I had contact with Dr Fisher was when he fired me from the editorial board of his journal ‘Homeopathy’. He did that by sending me the following letter:

Dear Professor Ernst,

This is to inform you that you have been removed from the Editorial Board of Homeopathy.  The reason for this is the statement you published on your blog on Holocaust Memorial Day 2013 in which you smeared homeopathy and other forms of complementary medicine with a ‘guilt by association’ argument, associating them with the Nazis.

I should declare a personal interest….[Fisher goes on to tell a story which is personal and which I therefore omit]…  I mention this only because it highlights the absurdity of guilt by association arguments.

Sincerely

Peter Fisher Editor-in-Chief, Homeopathy

I did not expect to have any more dealings with him after this rather unpleasant encounter. But, as it turns out, I recently did have a further encounter.

When the BMJ invited me to write a debate article about the question whether homeopathy should continue to be available on the NHS, I accepted (with some reservations, I hasten to add). At the time, I did not know who would do the ‘other side’ of this debate. It turned out to be Peter Fisher, and our two articles have just been published.

As one would expect from a good journal, the articles were both peer reviewed. One of the peer-reviewers of my piece was most scathing of it essentially claiming that it was entirely worthless. Feeling that this was a bit harsh and very impolite, I was keen to see who this reviewer had been; it was none other than Andrew Vickers. This is remarkable because Vickers had not only published several homeopathic papers with Fisher, but also had been in the employment of the ‘Royal London Homeopathic Hospital’ under Fisher. To the best of my knowledge, his conflicts of interested had not been disclosed. I did point that out to the BMJ, but they seemed to think nothing of it.

Anyway, I was pleased to eventually (the whole procedure took many months) see the articles published, but at the same time somewhat irritated by Fisher’s piece. It contained plenty of misleading information that the peer-reviewers obviously had failed to correct. Here is a small sample from Fishers piece:

… recent overviews have had more favourable conclusions, including a health technology assessment commissioned by the Swiss federal government that concluded that homeopathy is “probably” effective for upper respiratory tract infections and allergies.

Readers interested in the clinical evidence can access the CORE-HOM database of clinical research in homeopathy free of charge (www.carstens-stiftung.de/core-hom). It includes 1117 clinical trials of homeopathy, of which about 300 are randomised controlled trials.

In the podcast that accompanies the articles Fisher insists that, on this database, there are well over 300 RCT, and I had to admit that this was new to me. Keen to learn more, I registered with the database and had a look. What I found startled me. True, the database does claim that almost 500 RCTs are available, but just a very superficial scrutiny of these studies reveals that

  • some are not truly randomised,
  • some are not even clinical trials,
  • the list includes dual publications, re-analyses of already published studies as well as aborted trials,
  • many have never been peer-reviewed,
  • many are not double-blind,
  • many are not placebo controlled,
  • the majority are of poor methodological quality.

As to the other thing mentioned in the above excerpt from Fisher’s article, the famous ‘health technology assessment commissioned by the Swiss federal government’, I can refer my readers to a blog post by J W Nienhuys which probably says it all, if not, there is plenty more criticism of this report available on the Internet.

My conclusion from all this?

THE QUEEN’S HOMEOPATH USES ARGUMENTS THAT SEEM JUST AS BOGUS AS HOMEOPATHY ITSELF.

A paper entitled ‘Real world research: a complementary method to establish the effectiveness of acupuncture’ caught my attention recently. I find it quite remarkable and think it might stimulate some discussion on this blog.  Here is its abstract:

Acupuncture has been widely used in the management of a variety of diseases for thousands of years, and many relevant randomized controlled trials have been published. In recent years, many randomized controlled trials have provided controversial or less-than-convincing evidence that supports the efficacy of acupuncture. The clinical effectiveness of acupuncture in Western countries remains controversial.

Acupuncture is a complex intervention involving needling components, specific non-needling components, and generic components. Common problems that have contributed to the equivocal findings in acupuncture randomized controlled trials were imperfections regarding acupuncture treatment and inappropriate placebo/sham controls. In addition, some inherent limitations were also present in the design and implementation of current acupuncture randomized controlled trials such as weak external validity. The current designs of randomized controlled trials of acupuncture need to be further developed. In contrast to examining efficacy and adverse reaction in a “sterilized” environment in a narrowly defined population, real world research assesses the effectiveness and safety of an intervention in a much wider population in real world practice. For this reason, real world research might be a feasible and meaningful method for acupuncture assessment. Randomized controlled trials are important in verifying the efficacy of acupuncture treatment, but the authors believe that real world research, if designed and conducted appropriately, can complement randomized controlled trials to establish the effectiveness of acupuncture. Furthermore, the integrative model that can incorporate randomized controlled trial and real world research which can complement each other and potentially provide more objective and persuasive evidence.

In the article itself, the authors list seven criteria for what they consider good research into acupuncture:

  1. Acupuncture should be regarded as complex and individualized treatment;
  2. The study aim (whether to assess the efficacy of acupuncture needling or the effectiveness of acupuncture treatment) should be clearly defined and differentiated;
  3. Pattern identification should be clearly specified, and non-needling components should also be considered;
  4. The treatment protocol should have some degree of flexibility to allow for individualization;
  5. The placebo or sham acupuncture should be appropriate: knowing “what to avoid” and “what to mimic” in placebos/shams;
  6. In addition to “hard evidence”, one should consider patient-reported outcomes, economic evaluations, patient preferences and the effect of expectancy;
  7. The use of qualitative research (e.g., interview) to explore some missing areas (e.g., experience of practitioners and patient-practitioner relationship) in acupuncture research.

Furthermore, the authors list the advantages of their RWR-concept:

  1. In RWR, interventions are tailored to the patients’ specific conditions, in contrast to standardized treatment. As a result, conclusions based on RWR consider all aspects of acupuncture that affect the effectiveness.
  2. At an operational level, patients’ choice of the treatment(s) decreases the difficulties in recruiting and retaining patients during the data collection period.
  3. The study sample in RWR is much more representative of the real world situation (similar to the section of the population that receives the treatment). The study, therefore, has higher external validity.
  4. RWR tends to have a larger sample size and longer follow-up period than RCT, and thus is more appropriate for assessing the safety of acupuncture.

The authors make much of their notion that acupuncture is a COMPLEX INTERVENTION; specifically they claim the following: Acupuncture treatment includes three aspects: needling, specific non-needling components drove by acupuncture theory, and generic components not unique to acupuncture treatment. In addition, acupuncture treatment should be performed on the basis of the patient condition and traditional Chinese medicine (TCM) theory.

There is so much BS here that it is hard to decide where to begin refuting. As the assumption of acupuncture or other alternative therapies being COMPLEX INTERVENTIONS (and therefore exempt from rigorous tests) is highly prevalent in this field, let me try to just briefly tackle this one.

The last time I saw a patient and prescribed a drug treatment I did all of the following:

  • I greeted her, asked her to sit down and tried to make her feel relaxed.
  • I first had a quick chat about something trivial.
  • I then asked why she had come to see me.
  • I started to take notes.
  • I inquired about the exact nature and the history of her problem.
  • I then asked her about her general medical history, family history and her life-style.
  • I also asked about any psychological problems that might relate to her symptoms.
  • I then conducted a physical examination.
  • Subsequently we discussed what her diagnosis might be.
  • I told her what my working diagnosis was.
  • I ordered a few tests to either confirm or refute it and explained them to her.
  • We decided that she should come back and see me in a few days when her tests had come back.
  • In order to ease her symptoms in the meanwhile, I gave her a prescription for a drug.
  • We discussed this treatment, how and when she should take it, adverse effects etc.
  • We also discussed other therapeutic options, in case the prescribed treatment was in any way unsatisfactory.
  • I reassured her by telling her that her condition did not seem to be serious and stressed that I was confident to be able to help her.
  • She left my office.

The point I am trying to make is: prescribing an entirely straight forward drug treatment is also a COMPLEX INTERVENTION. In fact, I know of no treatment that is NOT complex.

Does that mean that drugs and all other interventions are exempt from being tested in rigorous RCTs? Should we allow drug companies to adopt the RWR too? Any old placebo would pass that test and could be made to look effective using RWR. In the example above, my compassion, care and reassurance would alleviate my patient’s symptoms, even if the prescription I gave her was complete rubbish.

So why should acupuncture (or any other alternative therapy) not be tested in proper RCTs? I fear, the reason is that RCTs might show that it is not as effective as its proponents had hoped. The conclusion about the RWR is thus embarrassingly simple: proponents of alternative medicine want double standards because single standards would risk to disclose the truth.

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