bogus claims
I was alerted to an interview published in an anthroposophical journal with Prof. Dr. med. Harald Matthes. He is the clinical director of the ‘Gemeinschaftskrankenhauses Havelhöhe‘, a hospital of anthroposophic medicine in Berlin where apparently some COVID-19 patients are presently being treated. Anthroposophic medicine is a medical cult created by the mystic, Rudolf Steiner, about 100 years ago that lacks a basis in science, facts or common sense. Here is the two passages from that interview that I find most interesting (my translation/explanation is below):
Es gibt bisher kein spezifisches Covid-19 Medikament aus der konventionellen Medizin. Remdesivir führt in Studien zu keinem signifikant verbesserten Überleben, sondern lediglich zu einer milden Symptomreduktion. Die anfänglich große Studie vor allem an Universitätskliniken mit Hydrochloroquin und Azithromycin erbrachte sogar eine Steigerung der Todesrate. Daher haben anthroposophische Therapiekonzepte mit Steigerung der Selbstheilungskräfte eine große Bedeutung erfahren. Wichtige anthroposophische Arzneimittel waren dabei das Eisen als Meteoreisen oder als Ferrum metallicum praep., der Phosphor, das Stibium sowie das Cardiodoron® und Pneumodoron®, aber auch Bryonia (Zaunrübe) und Tartarus stibiatus (Brechweinstein). Die Erfolge waren sehr gut, da in Havelhöhe bisher kein Covid-19 Patient verstorben ist, bei einer sonstigen Sterblichkeit von ca. 30% aller Covid-19-Intensivpatienten…
100 Jahre Bazillentheorie und die Dominanz eines pathogenetischen Medizinkonzeptes haben zu der von Rudolf Steiner bereits 1909 vorausgesagten Tyrannei im Sozialen geführt. Der Mensch hat ein Mikrobiom und Virom, das unverzichtbar für seine Immunität ist und von der Quantität mächtiger als der Mensch selbst (Mikrobiom 1014 Bakterien mit ca. 1200 Spezies z.B. im Darm bei nur 1012 Körperzellen).
Matthes explains that, so far, no medication has been demonstrated to be effective against COVID-19 infections. Then he continues: “This is the reason why anthroposophic therapies which increase the self-healing powers have gained great importance”, and names the treatments used in his hospital:
- Meteoric Iron (a highly diluted anthroposophic remedy based on iron from meteors),
- Ferrum metallicum praep. (a homeopathic/anthroposophic remedy based on iron),
- Phosphor (a homeopathic remedy based on phosphor),
- Stibium (a homeopathic remedy based on antimony),
- Cardiodoron (a herbal mixture used in anthroposophical medicine),
- Pneumodoron (a herbal mixture used in anthroposophical medicine containing).
Matthes also affirms (my translation):
“The success has so far been very good, since no COVID-19-patient has died in Havelhöhe – with a normal mortality of about 30% of COID_19 patients in intensive care…
100 years of germ theory and the dominance of a pathogenetic concept of medicine have led to the tyranny in the social sphere predicted by Rudolf Steiner as early as 1909. Humans have a microbiome and virom that is indispensable for their immunity and more powerful in quantity than humans themselves (microbiome 1014 bacteria with about 1200 species e.g. in the intestine with only 1012 somatic cells)…”
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The first 4 remedies listed above are highly diluted and contain no active molecules. The last two are less diluted and might therefore contain a few active molecules but in sub-therapeutic doses. Crucially, none of the remedies have been shown to be effective for any condition.
The germ theory of disease which Matthes mentions is, of course, a bit more than a ‘theory’; it is the accepted scientific explanation for many diseases, including COVID-19.
I have cold sweats when I think of anthroposophical doctors who seem to take it less than seriously, while treating desperately ill COVID-19 patients. If I were allowed to ask just three questions to Matthes, I think, it would be these:
- How did you obtain fully informed consent from your patients, including the fact that your remedies are unproven and implausible?
- If you think your results are so good, are you monitoring them closely to publish them urgently, so that other centres might learn from them?
- Do you feel it is ethical to promote unprovn treatments during a health crisis via a publicly available interview before your results have been formally assessed and published?
Acupuncture-moxibustion therapy (AMT) is a so-called alternative medicine (SCAM) that has been used for centuries in treatment of numerous diseases. Some enthusiasts even seem to advocate it for chemotherapy-induced leukopenia (CIL) The purpose of this review was to evaluate the efficacy and safety of acupuncture-moxibustion therapy in treating CIL.
Relevant studies were searched in 9 databases up to September 19, 2020. Two reviewers independently screened the studies for eligibility, extracted data, and assessed the methodological quality of selected studies. Meta-analysis of the pooled mean difference (MD) and risk ratio (RR) with their respective 95% confidence intervals (CI) were calculated.
Seventeen studies (1206 patients) were included, and the overall quality of the included studies was moderate. In comparison with medical therapy, AMT has a better clinical efficacy for CIL (RR, 1.24; 95% CI, 1.17-1.32; P < 0.00001) and presents advantages in increasing leukocyte count (MD, 1.10; 95% CI, 0.67-1.53; P < 0.00001). Also, the statistical results show that AMT performs better in improving the CIL patients’ Karnofsky performance score (MD, 5.92; 95% CI, 3.03-8.81; P < 0.00001).
The authors concluded that this systematic review and meta-analysis provides updated evidence that AMT is a safe and effective alternative for the patients who suffered from CIL.
A CIL is a serious complication. If I ever were afflicted by it, I would swiftly send any acupuncturist approaching my sickbed packing.
But this is not an evidence-based attitude!!!, I hear some TCM-fans mutter. What more do you want that a systematic review showing it works?
I beg to differ. Why? Because the ‘evidence’ is hardly what critical thinkers can accept as evidence. Have a look at the list of the primary studies included in this review:
- Lin Z. T., Wang Q., Yu Y. N., Lu J. S. Clinical observation of post-chemotherapy-leukopenia treated with ShenMai injectionon ST36. World Journal of Integrated Traditional and Western Medicine. 2010;5(10):873–876. [Google Scholar]
- Wang H. Clinical Observation of Acupoint Moxibustion on Leukopenia Caused by Chemotherapy. Beijing, China: Beijing University of Chinese Medicine; 2011. [Google Scholar]
- Fan J. Y. Coupling of Yin and Yang between Ginger Moxibustion Improve the Clinical Effect of the Treatment of Chemotherapy Adverse Reaction. Henan, China: Henan University of Chinese Medicine; 2013. [Google Scholar]
- Lu D. R., Lu D. X., Wei M., et al. Acupoint injection with addie injection for patients of nausea and vomiting with cisplatin induced by chemotherapy. Journal of Clinical Acupuncture and Moxibustion. 2013;29(10):33–38. [Google Scholar]
- Yang J. E. The Clinical Observation on Treatment of Leukopenia after Chemotherapy with Needle Warming Moxibustion. Hubei, China: Hubei University of Chinese Medicine; 2013. [Google Scholar]
- Fu Y. H., Chi C. Y., Zhang C. Y. Clinical effect of acupuncture and moxibustion on leukopenia after chemotherapy of malignant tumor. Guide of China Medicine. 2014;12(12) [Google Scholar]
- Wang J. N., Zhang W. X., Gu Q. H., Jiao J. P., Liu L., Wei P. K. Protection of herb-partitioned moxibustion on bone marrow suppression of gastric cancer patients in chemotherapy period. Chinese Archives of Traditional Chinese Medicine. 2014;32(12):110–113. [Google Scholar]
- Zhang J. The Clinical Research on Myelosuppression and Quality of Life after Chemotherapy Treated by Grain-Sized Moxibustion. Nanjing, China: Nanjing University of Chinese Medicine; 2014. [Google Scholar]
- Tian H., Lin H., Zhang L., Fan Z. N., Zhang Z. L. Effective research on treating leukopenia following chemotherapy by moxibustion. Clinical Journal of Chinese Medicine. 2015;7(10):35–38. [Google Scholar]
- Hu G. W., Wang J. D., Zhao C. Y. Effect of acupuncture on the first WBC reduction after chemotherapy for breast cancer. Beijing Journal of Traditional Chinese Medicine. 2016;35(8):777–779. [Google Scholar]
- Zhu D. L., Lu H. Y., Lu Y. Y., Wu L. J. Clinical observation of Qi-blood-supplementing needling for leukopenia after chemotherapy for breast cancer. Shanghai Journal of Acupuncture and Moxibustion. 2016;35(8):964–966. [Google Scholar]
- Chen L, Xu G. Y. Observation on the prevention and treatment of chemotherapy-induced leukopenia by moxibustion therapy. Zhejiang Journal of Traditional Chinese Medicine. 2016;51(8):p. 600. [Google Scholar]
- Mo T., Tian H., Yue S. B., Fan Z. N., Zhang Z. L. Clinical observation of acupoint moxibustion on leukocytopenia caused by tumor chemotherapy. World Chinese Medicine. 2016;11(10):2120–2122. [Google Scholar]
- Nie C. M. Nursing observation of acupoint moxibustion in the treatment of leucopenia after chemotherapy. Today Nurse. 2017;4:93–95. [Google Scholar]
- Wang D. Y. Clinical Research on Post-chemotherapy-leukopenia with Spleen-Kidney Yang Deficiency in Colorectal Cancer Treated with Point-Injection. Yunnan, China: Yunnan University of Chinese Medicine; 2017. [Google Scholar]
- Gong Y. Q, Zhang M. Q, Zhang B. C. Prevention and treatment of leucocytopenia after chemotherapy in patients with malignant tumor with ginger partitioned moxibustion. Chinese Medicine Modern Distance Education of China. 2018;16(21):135–137. [Google Scholar]
- Li Z. C., Lian M. J., Miao F. G. Clinical observation of fuzheng moxibustion combined with wenyang shengbai decoction in the treatment of 80 cases of leukopenia after chemotherapy. Hunan Journal of Traditional Chinese Medicine. 2019;35(3):64–66. [Google Scholar]
Notice anything peculiar?
- The studies are all from China where data fabrication was reported to be rife.
- They are mostly unavailable for checking (why the published adds links that go nowhere is beyond me).
- Many do not look at all like randomised clinical trials (which, according to the authors, was an inclusion criterion).
- Many do not look as though their primary endpoint was the leukocyte count (which, according to the authors, was another inclusion criterion).
Intriguingly, the authors conclude that AMT is not just effective but also ‘safe’. How do they know? According to their own data extraction table, most studies failed to mention adverse effects. And how exactly is acupuncture supposed to increase my leukocyte count? Here is what the authors offer as a mode of action:
I think it is high time that we stop tolerating that the medical literature gets polluted with such nonsense (helped, of course, by journals that are beyond the pale) – someone might actually believe it, in which case it would surely hasten the death of vulnerable patients.
Some consumers believe that research is by definition reliable, and patients are even more prone to this error. When they read or hear that ‘RESEARCH HAS SHOWN…’ or that ‘A RECENT STUDY HAS DEMONSTRATED…’, they usually trust the statements that follow. But is this trust in research and researchers justified? During 25 years that I have been involved in so-called alternative medicine (SCAM), I have encountered numerous instances which make me doubt. In this post, I will briefly discuss some the many ways in which consumers can be mislead by apparently sound evidence (for an explanation as to what is and what isn’t evidence, see here).
ABSENCE OF EVIDENCE
I have just finished reading a book by a German Heilpraktiker that is entirely dedicated to SCAM. In it, the author makes hundreds of statements and presents them as evidence-based facts. To many lay people or consumers, this will look convincing, I am sure. Yet, it has one fatal defect: the author fails to offer any real evidence that would back up his statements. The only references provided were those of other books which are equally evidence-free. This popular technique of making unsupported claims allows the author to make assertions without any checks and balances. A lay person is usually unable or unwilling to differentiate such fabulations from evidence, and this technique is thus easy and poular for misleading us about SCAM.
FAKE-EVIDENCE
On this blog, we have encountered this phenomenon ad nauseam: a commentator makes a claim and supports it with some seemingly sound evidence, often from well-respected sources. The few of us who bother to read the referenced articles quickly discover that they do not say what the commentator claimed. This method relies on the reader beeing easily bowled over by some pretend-evidence. As many consumers cannot be bothered to look beyond the smokescreen supplied by such pretenders, the method usually works surprisingly well.
An example: Vidatox is a homeopathic cancer ‘cure’ from Cuba. The Vidatox website clains that it is effective for many cancers. Considering how sensational this claim is, one would expect to find plenty of published articles on Vidatox. However, a Medline search resulted in one paper on the subject. Its authors drew the following conclusion: Our results suggest that the concentration of Vidatox used in the present study has not anti-neoplastic effects and care must be taken in hiring Vidatox in patients with HCC.
The question one often has to ask is this: where is the line between misleading research and fraud?
SURVEYS
There is no area in healthcare that produces more surveys than SCAM. About 500 surveys are published every year! This ‘survey-mania’ has a purpose: it promotes a positive message about SCAM which hypothesis-testing research rarely does.
For a typical SCAM survey, a team of enthusiastic researchers might put together a few questions and design a questionnaire to find out what percentage of a group of individuals have tried SCAM in the past. Subsequently, the investigators might get one or two hundred responses. They then calculate simple descriptive statistics and demonstrate that xy % use SCAM. This finding eventually gets published in one of the many third-rate SCAM journals. The implication then is that, if SCAM is so popular, it must be good, and if it’s good, the public purse should pay for it. Few consumers would realise that this conclusion is little more that a fallacious appeal to popularity.
AVOIDING THE QUESTION
Another popular way of SCAM researchers to mislead the public is to avoid the research questions that matter. For instance, few experts would deny that one of the most urgent issues in chiropractic relates to the risk of spinal manipulations. One would therefore expect that a sizable proportion of the currently published chiropractic research is dedicated to it. Yet, the opposite is the case. Medline currently lists more than 3 000 papers on ‘chiropractic’, but only 17 on ‘chiropractic, harm’.
PILOT-STUDIES
A pilot study is a small scale preliminary study conducted in order to evaluate feasibility, time, cost, adverse events, and improve upon the study design prior to performance of a full-scale research project. Yet, the elementary preconditions are not fulfilled by the plethora of SCAM pilot studies that are currently being published. True pilot studies of SCAM are, in fact, very rare. The reason for the abundance of pseudo-pilots is obvious: they can easily be interpreted as showing encouragingly positive results for whatever SCAM is being tested. Subsequently, SCAM proponents can mislead the public by claiming that there are plenty of positive studies and therefore their SCAM is supported by sound evidence.
‘SAFE‘ STUDY-DESIGNS
As regularly mentioned on this blog, there are several ways to design a study such that the risk of producing a negative result is minimal. The most popular one in SCAM research is the ‘A+B versus B’ design. In this study, for instance, cancer patients who were suffering from fatigue were randomised to receive usual care or usual care plus regular acupuncture. The researchers then monitored the patients’ experience of fatigue and found that the acupuncture group did better than the control group. The effect was statistically significant, and an editorial in the journal where it was published called this evidence “compelling”. Due to a cleverly over-stated press-release, news spread fast, and the study was celebrated worldwide as a major breakthrough in cancer-care.
Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual alone, and the former is therefore more than likely to produce a better result. This will be true, even if acupuncture is a pure placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.
A more obvious method for generating false positive results is to omit blinding. The purpose of blinding the patient, the therapist and the evaluator of the group allocation in clinical trials is to make sure that expectation is not a contributor to the result. Expectation might not move mountains, but it can certainly influence the result of a clinical trial. Patients who hope for a cure regularly do get better, even if the therapy they receive is useless, and therapists as well as evaluators of the outcomes tend to view the results through rose-tinted spectacles, if they have preconceived ideas about the experimental treatment.
Failure to randomise is another source of bias which can mislead us. If we allow patients or trialists to select or chose which patients receive the experimental and which get the control-treatment, it is likely that the two groups differ in a number of variables. Some of these variables might, in turn, impact on the outcome. If, for instance, doctors allocate their patients to the experimental and control groups, they might select those who will respond to the former and those who don’t to the latter. This may not happen with intent but through intuition or instinct: responsible health care professionals want those patients who, in their experience, have the best chances to benefit from a given treatment to receive that treatment. Only randomisation can, when done properly, make sure we are comparing comparable groups of patients. Non-randomisation can easily generate false-positive findings.
It is also possible to mislead people with studies which do not test whether an experimental treatment is superior to another one (often called superiority trials), but which assess whether it is equivalent to a therapy that is generally accepted to be effective. The idea is that, if both treatments produce similarly positive results, both must be effective. Such trials are called non-superiority or equivalence trials, and they offer a wide range of possibilities for misleading us. If, for example, such a trial has not enough patients, it might show no difference where, in fact, there is one. Let’s consider a simple, hypothetical example: someone comes up with the idea to compare antibiotics to acupuncture as treatments of bacterial pneumonia in elderly patients. The researchers recruit 10 patients for each group, and the results reveal that, in one group, 2 patients died, while, in the other, the number was 3. The statistical tests show that the difference of just one patient is not statistically significant, and the authors therefore conclude that acupuncture is just as good for bacterial infections as antibiotics.
Even trickier is the option to under-dose the treatment given to the control group in an equivalence trial. In the above example, the investigators might subsequently recruit hundreds of patients in an attempt to overcome the criticism of their first study; they then decide to administer a sub-therapeutic dose of the antibiotic in the control group. The results would then seemingly confirm the researchers’ initial finding, namely that acupuncture is as good as the antibiotic for pneumonia. Acupuncturists might then claim that their treatment has been proven in a very large randomised clinical trial to be effective for treating this condition. People who do not happen to know the correct dose of the antibiotic could easily be fooled into believing them.
Obviously, the results would be more impressive, if the control group in an equivalence trial received a therapy which is not just ineffective but actually harmful. In such a scenario, even the most useless SCAM would appear to be effective simply because it is less harmful than the comparator.
A variation of this theme is the plethora of controlled clinical trials in SCAM which compare one unproven therapy to another unproven treatment. Perdicatbly, the results would often indicate that there is no difference in the clinical outcome experienced by the patients in the two groups. Enthusiastic SCAM researchers then tend to conclude that this proves both treatments to be equally effective. The more likely conclusion, however, is that both are equally useless.
Another technique for misleading the public is to draw conclusions which are not supported by the data. Imagine you have generated squarely negative data with a trial of homeopathy. As an enthusiast of homeopathy, you are far from happy with your own findings; in addition you might have a sponsor who puts pressure on you. What can you do? The solution is simple: you only need to highlight at least one positive message in the published article. In the case of homeopathy, you could, for instance, make a major issue about the fact that the treatment was remarkably safe and cheap: not a single patient died, most were very pleased with the treatment which was not even very expensive.
OMISSION
A further popular method for misleading the public is the outright omission findings that SCAM researchers do not like. If the aim is that the public believe the myth that all SCAM is free of side-effects, SCAM researchers only need to omit reporting them in clinical trials. On this blog, I have alerted my readers time and time again to this common phenomenon. We even assessed it in a systematic review. Sixty RCTs of chiropractic were included. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT.
Most trails have many outcome measures; for instance, a study of acupuncture for pain-control might quantify pain in half a dozen different ways, it might also measure the length of the treatment until pain has subsided, the amount of medication the patients took in addition to receiving acupuncture, the days off work because of pain, the partner’s impression of the patient’s health status, the quality of life of the patient, the frequency of sleep being disrupted by pain etc. If the researchers then evaluate all the results, they are likely to find that one or two of them have changed in the direction they wanted (especially, if they also include half a dozen different time points at which these variables are quatified). This can well be a chance finding: with the typical statistical tests, one in 20 outcome measures would produce a significant result purely by chance. In order to mislead us, the researchers only need to “forget” about all the negative results and focus their publication on the ones which by chance have come out as they had hoped.
FRAUD
When it come to fraud, there is more to chose from than one would have ever wished for. We and others have, for example, shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. This strange phenomenon indicates that something is amiss with Chinese acupuncture research. This suspicion was even confirmed by a team of Chinese scientists. In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively. The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
A survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
I hasten to add that fraud in SCAM research is certainly not confined to China. On this blog, you will find plenty of evidence for this statement, I am sure.
CONCLUSION
Research is obviously necessary, if we want to answer the many open questions in SCAM. But sadly, not all research is reliable and much of SCAM research is misleading. Therefore, it is always necessary to be on the alert and apply all the skills of critical evaluation we can muster.
Recent comments on this blog prompted me to look into a very strange therapeutic and diagnostic device used by some practitioners of so-called alternative medicine (SCAM):
The OBERON provides the most unique tool for scanning the various organs and systems of the physical body without having to make a medical or surgical intrusion. Developed by Russian scientists since the early 1990’s, the OBERON is the most revolutionary computer programmed invention available in the world today for analyzing and treating all the body’s organs and functions.
This device scans each organ or tissue on a cellular level. It compares the measurements to a database of thousands of referenced conditions and their diagnosis. OBERON uses a special emitter to modulate the carrier frequency for the cell communication and it uses special sensor trigger readers built into headphones to read the cells own signals.
OBERON finds out how stressed an organ is, and if there are any diseases developing, how much the cells are influenced by a specific disease, and which micro organisms and bacteria are in the area at the time of the scan.
BENEFITS OF THE OBERON:
Rebalances the body so that it can start to heal itself!
Makes intrusive and embarrassing examinations a THING OF THE PAST!!!!
Quick examination (in seconds) with immediate results
Replaces dozens of traditional diagnostic methods.
Finds weaknesses in the skeleton, organs, blood, tissue, etc.
There are no side effects, unpleasantness or injury after treatment
Bio-resonance META-therapy
A print out of the report on findings can be taken at the end of the session…
The method is based on an analysis of the brain stems electromagnetic waves which contain the complete information of the entire organism. This information is read by a sensor. A frequency transmitter aimed at the projection area of the brain stem stimulates this electromagnetic radiation.
Meta- Therapy repairs the organism using a diversity of modulated electromagnetic waves. This treatment stimulates the body’s own functions so that they solve the problem and it stimulates the immune defense and is a very good supplement or alternative to traditional treatment. The patient can follow on the screen how the organ progressively gets better, and afterwards one can take a new measurement showing the improvement…
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Sounds fantastic?
Yes, indeed – fantastic as in fantasy!
Almost as much relation to reality as OBERON, king of the fairies in medieval literature.
The modern OBERON device is being used by infamous proponents of integrated medicine like Dr Julian Kenyon who already made an appearance on this blog. On his website, Kenyon published a paper in which he provides details about the OBERON. To a lay person, the sciency text might look like science; however, this impression would be false. The ‘study’ Kenyon mentioned is not on Medline. In fact, Dr Kenyon (former associate of the late George Lewith) has merely 4 Medline-listed papers:
- Physiological and psychological explanations for the mechanism of acupuncture as a treatment for chronic pain. Soc Sci Med. 1984;19(12):1367-78. doi: 10.1016/0277-9536(84)90026-1.PMID: 6085191 Review.
- Is electrodermal testing as effective as skin prick tests for diagnosing allergies? A double blind, randomised block design study. BMJ. 2001 Jan 20;322(7279):131-4. doi: 10.1136/bmj.322.7279.131.PMID: 11159567 Free PMC article. Clinical Trial.
- Randomised double-blind trial on the immediate effects of naloxone on classical Chinese acupuncture therapy for chronic pain. Acupunct Electrother Res. 1983;8(1):17-24. doi: 10.3727/036012983816715064.PMID: 6135300 Clinical Trial.
- Food sensitivity, a search for underlying causes. Case study of 12 patients. Kenyon JN.Acupunct Electrother Res. 1986;11(1):1-13. doi: 10.3727/036012986816359238.PMID: 2872775
And what about other researchers? Aren’t there ANY decent studies of the OBERON?
Not as far as I can see (if anyone does know of peer-reviewed research, please let me know).
So, what is the conclusion?
My conclusion is this:
There is no evidence that the OBERON does anything useful other than putting money in the bank accounts of those charlatans who use or manufacture it.
And what does that make Kenyon and all the other SCAM practitioners using the OBERON or similar devices?
I leave it to you to decide.
The Center for Science in the Public Interest*** (CSPI) announced its agreement with Boiron to improve the labeling on the homeopathic products manufactured by Boiron and sold under the Boiron or other private label brands. The agreement covers the labeling for over 50 homeopathic products.
On Boiron’s Oscillococcinum and two similar products, Boiron will substantially increase the prominence of the words “Homeopathic Medicine” on the front of the box and the disclaimer on the back of the box that says the product’s uses have not been evaluated by the Food and Drug Administration (FDA). These changes will make it easier for consumers to identify that the products are homeopathic products, and are not FDA approved over-the-counter medicines.
For all of the other homeopathic products manufactured by Boiron, consumers will receive much more information on the packages. In addition to increasing the prominence of the words “Homeopathic Medicine,” a new disclaimer in large and contrasting font will be added to the back of the package (endorsed by the American Association of Homeopathic Pharmacists) stating: “Claims based on traditional homeopathic practice, not accepted medical evidence, and not FDA evaluated.”…
“The labeling changes that Boiron has agreed to on all the products covered by the agreement will help consumers more clearly identify that these are homeopathic products and are not FDA approved over-the-counter medicines that have been scientifically proven to be safe and effective,” said CSPI litigation director Lisa Mankofsky. “In addition, the vast majority of the covered homeopathic products will bear a disclaimer clarifying that they are based on traditional homeopathic practice, not accepted medical evidence, and not FDA evaluated. We think that consumers will find this labeling change important when choosing a remedy. We encourage other manufacturers to similarly make their labels more transparent and clear for consumers.”
Bravo!
Clearly a step into the right direction!
But it’s a small step only. It is a long way short of what Dylan Evans suggestied in his book ‘Placebo‘, first published in 2004:
Warning: this product is a placebo. It will work only if you believe in homeopathy, and only for certain conditions such as pain and depression. Even then, it is not likely to be as powerful as orthodox drugs. You may get fewer side-effects from this treatment than from a drug, but you will probably also get less benefit.
***The Center for Science in the Public Interest is perhaps the oldest independent, science-based consumer advocacy organization with an impressive record of accomplishments and a clear and ambitious agenda for improving the food system to support healthy eating.
There is some encouraging evidence regarding the positive influence of vitamin D on COVID-19. But is it convincing? Is it causal? As always, it is worth looking at the totality of the reliable evidence.
In this systematic review and meta-analysis, the researchers analyze the association between vitamin D deficiency and COVID-19 severity. They conducted an analysis of the prevalence of vitamin D deficiency and insufficiency in people with the disease. Five online databases—Embase, PubMed, Scopus, Web of Science, ScienceDirect and pre-print Medrevix were searched. The inclusion criteria were observational studies measuring serum vitamin D in adult and elderly subjects with COVID-19. The main outcome was the prevalence of vitamin D deficiency in severe cases of COVID-19.
The researchers identified 1542 articles and 27 met their inclusion criteria. The results show that
- vitamin D deficiency was not associated with a higher chance of infection by COVID-19,
- severe cases of COVID-19 present 64% more vitamin D deficiency compared with mild cases,
- vitamin D concentration insufficiency increased hospitalization and mortality rates,
- There was a positive association between vitamin D deficiency and the severity of the disease.
The authors concluded that the results of the meta-analysis confirm the high prevalence of vitamin D deficiency in people with COVID-19, especially the elderly. We should add that vitamin D deficiency was not associated with COVID-19 infection. However, we observed a positive association between vitamin D deficiency and the severity of the disease. From this perspective, evaluating blood vitamin D levels could be considered in the clinical practice of health professionals. Moreover, vitamin D supplementation could be considered in patients with vitamin D deficiency and insufficiency, if they have COVID-19. However, there is no support for supplementation among groups with normal blood vitamin D values with the aim of prevention, prophylaxis or reducing the severity of the disease.
These are interesting findings, no doubt. They relate to associations, as the authors repeatedly stress in the text of the paper. They do not, however, signify cause and effect relationships. The principal outcome of this research should be a hypothesis that subsequently needs testing in clinical trials.
So, why on earth did the authors chose that seriously misleading title of their paper? It clearly implies a causal effect; and this can only be verified by conducting clinical trials. One such study has been published (as discussed here) and it concluded that administration of calcifediol may improve the clinical outcome of subjects requiring hospitalization for COVID-19.
My conclusion: it seems well worth conducting more and more rigorous clinical trials.
Out of the blue I received an email infroming me that Wellness consultancy and online health boutique Conscious Spaces is marking the Black Friday sale season with 12% off its hugely popular Qi tech EMF protection devices. Shop Black EMFriday at consciousspaces.com/collections/black-emfriday…
I must be a sucker for such stuff, so I had to have a look.
Most impressive!
The ‘Qi-Max Cell™ 5G / WIFI / EMF Protection For Home & Business’ for instance is for sale at £4,399.00 Sale Price (normally it costs £600 more!!!).
Naturally, I was fascinated and had to know more. Luckily, the email told me all I needed to know:
What are EMFs?
EMFs, or electromagnetic fields, are invisible fields of energy, or radiation waves. There are many different types of electromagnetic fields in the world around us. They come from both natural sources (like sunlight) and man-made sources (like mobile phones). Over the last century, exposure to man-made EMFs has been steadily increasing in line with the growing demand for electricity and the more recent explosion of wireless technology, including smart phones, laptops and tablets.
Where’s the harm?
Exposure to EMFs of the kind emitted by mobile technologies has been found to be harmful to health by a growing number independent, non-industry funded scientists and doctors. With thousands of papers, the extent of scientific research into the health impacts of EMF radiation exposure is too vast to list, but a cohesive body of evidence exists surrounding the damage caused to DNA, cells, organ systems, fertility, brain function, liver and memory.
How do Qi tech devices work?
WaveGuard’s Qi technology provides a sanctuary from EMFs by creating a protective shield of negatively charged electrons. These devices come in a variety of sizes to provide different size torus fields of protection, from the Qi-Me, for personal protection on the go, through to the Qi-Max, providing a protective field with a 50m radius.
The Qi-Me device uses the same technology as the larger Qi-Shield device which has been scientifically proven to provide EMF Protection tested using a double-blind study at the BION Institute. Priced at £399 (£350 during Black Friday), it provides a 1m radius (2m diameter) of EMF protection and is available in Walnut, Maple, Olive and Yew.
The Qi-Shield provides an EMF protection field of 2.5m radius (5m diameter). Perfect for your office, bedroom, vehicle or air travel, it is priced at £899 (£790 during Black Friday) and is available in walnut.
The Qi-Home provides the relief of being protected from harmful and damaging EMFs while at home, with an EMF protection field of 7.5m radius (15m diameter). It is priced at £2750 (£2,420 during Black Friday) it is available in Swiss pine, oak and beech.
The Qi-Max Cell is the largest and most powerful EMF protection device, creating an EMF protection field of 50m radius (100m diameter). Available in Swiss pine, it is priced at £4999 (£4,399 during Black Friday).
Tara Williams, founder of Conscious Spaces, says: ‘The calming effect I felt when I first held a Qi-Shield in a high EMF environment was a revelation. My heart rate is usually up in those sorts of settings, but this had an immediate positive effect. I now carry this or the Qi-Me with me wherever I go and have noticed a real improvement in my EHS (electromagnetic hypersensitivity) symptoms.’
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As I said, I am most impressed by the ‘Qi-Max Cell’ (it creates an EMF protection field of 50m radius (100m diameter) in width and 35m radius (70m diameter) in height, protecting your family, workplace and business against mobile phone radiation, WiFi, electrical frequencies, electro-magnetic frequencies) and, of course by the prospect of saving £600!
But seriously! Would it not be illuminating to get such a device and take it apart to see what technology it actually contains? Or does one of my readers already know?
Misinformation by chiropractors is unfortunately nothing new and has been discussed ad nauseam on this blog. It is tempting to ask whether chiropractors have lost (or more likely never had) the ability to ditinguish real information from misinformation or substantiated from unsubstantiated claims. During the pandemic, the phenomenon of chiropractic misinformation has become even more embarrassingly obvious, as this new article highlights.
Chiropractors made statements on social media claiming that chiropractic treatment can prevent or impact COVID-19. The rationale for these claims is that spinal manipulation can impact the nervous system and thus improve immunity. These beliefs often stem from nineteenth-century chiropractic concepts. The authors of the paper are aware of no clinically relevant scientific evidence to support such statements.
The investigators explored the internet and social media to collect examples of misinformation from Europe, North America, Australia and New Zealand regarding the impact of chiropractic treatment on immune function. They discussed the potential harm resulting from these claims and explore the role of chiropractors, teaching institutions, accrediting agencies, and legislative bodies.
The authors conclude as follows: In this search of public media in Europe, North America, New Zealand, and Australia, we discovered many cases of misinformation. Claims of chiropractic treatment improving immunity conflict with the advice from authorities and the scientific consensus. The science referenced by these claims is missing, flawed or has no clinical relevance. Consequently, their claims about clinical effectiveness are spurious at best and misleading at worst. However, our examples cannot be used to make statements about the magnitude of the problem among practitioners as our samples were not intended to be representative. For that reason, we also did not include an analysis of the arguments provided in the various postings. In view of the seriousness of the topic, it would be relevant to conduct a systematic study on a representative sample of public statements, to better understand these issues. Our search illustrates the possible danger to public health of misinformation posted on social media and the internet. This situation provides an opportunity for growth and maturation for the chiropractic profession. We hope that individual chiropractors will reflect on and improve their communication and practices. Further, we hope that the chiropractic teaching institutions, regulators, and professional organisations will always demonstrate responsible leadership in their respective domains by acting to ensure that all chiropractors understand and uphold their fiduciary duties.
Several previous papers have found similar things, e.g.: Twitter activity about SMT and immunity increased during the COVID-19 crisis. Results from this work have the potential to help policy makers and others understand the impact of SMT misinformation and devise strategies to mitigate its impact.
The pandemic has crystallised the embarrassment about chiropractic false claims. Yet, the phenomenon of chiropractors misleading the public has long been known and arguably is even more important when it relates to matters other than COVID-19. Ten years ago, we published this paper:
Background: Some chiropractors and their associations claim that chiropractic is effective for conditions that lack sound supporting evidence or scientific rationale. This study therefore sought to determine the frequency of World Wide Web claims of chiropractors and their associations to treat, asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence).
Methods: A review of 200 chiropractor websites and 9 chiropractic associations’ World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States was conducted between 1 October 2008 and 26 November 2008. The outcome measure was claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment.
Results: We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain,
Conclusions: The majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.
It makes it clear that the misleading information of chiropractors is a serious problem. And I find it disappointing to see that so little has been done about it, and that progress seems so ellusive.
This, of course, begs the question, where does all this misinformation come from? The authors of the new paper stated that beliefs often stem from nineteenth-century chiropractic concepts. This, I believe, is very true and it gives us an important clue. It suggests that, because it is good for business, chiro schools are still steeped in obsolete notions of pseudo- and anti-science. Thus, year after year, they seem to churn out new generations of naively willing victims of the Dunning Kruger effect.
We have often heard it said on this blog and elsewhere that chiropractors are making great strides towards reforming themselves and becoming an evidence-based profession. In view of the data cited above, this does not ring all that true, I am afraid. Is the picture that emerges not one of a profession deeply embroiled in BS with but a few fighting a lost battle to clean up the act?
- the chiro suggests a manipulation of the neck;
- this often involves forcing a spinal joint beyond its physiological range of motion;
- the treatment will be short but needs repeating several times during the coming weeks;
- the expected benefits are a reduction of pain and improvement of motion;
- the total cost of the treatment series will be xy;
- there are many other treatment options for neck pain;
- most of these have a better risk/benefit profile than neck manipulation;
- having no treatment for neck pain at all is likely to lead to full resolution of the problem over time.
Apart from any doubts that chiropractors would actually comply with these requirements, the question remains: is the listed information sufficient? Does it outline a truly a fully informed consent? I think that essential aspects of informed consent are missing.
- The code does not explicidly require an explanation about the possible harms of spinal manipulation (i.e. 50% of all patients will suffer mild to moderate adverse effects lasting 2-3 days, and occasionally patients will have a stroke of which some have died).
- Moreover, the code mentions EXPECTED benefits, but not benefits supported by evidence. Chiros may well EXPECT their treatment to work, but what does the evidence show? As often discussed on this blog, the evidence is negative or very week, depending how you want to interpret it. The code does not require a chiro to inform his patients about this fact.
So, the way I see it, the code does not expressedly demand the chiro to explain his patient that the treatment he is being asked to consent to is
- not supported by sound evidence for effectiveness,
- nor that the treatment is burdened with significant risks.
And what about the other questions listed above? An Australian chiropractor who will remain anonymous gave me the following answers:
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Yet, Australian chiropractors claim that they abide by the ethical imperative of informed consent. Are they taking the Mickey?
Perhaps not. Perhaps they are merely trying to make sure they do not lose the majority of their clientele. As I already pointed out in my previous post, fully informed consent would make most chiropractic patients turn round and run a mile.
Governments and key institutions have had to implement decisive responses to the danger posed by the coronavirus pandemic. Imposed change will increase the likelihood that alternative explanations take hold. In a proportion of the general population there may be strong scepticism, fear of being misled, and false conspiracy theories.
The objectives of this survey were to estimate the prevalence of conspiracy thinking about the pandemic and test associations with reduced adherence to government guidelines. The survey was conducted in May 2020 as a non-probability online survey with 2501 adults in England, quota sampled to match the population for age, gender, income, and region.
Approximately 50% of this population showed little evidence of conspiracy thinking, 25% showed a degree of endorsement, 15% showed a consistent pattern of endorsement, and 10% had very high levels of endorsement. Higher levels of coronavirus conspiracy thinking were associated with less adherence to all government guidelines and less willingness to take diagnostic or antibody tests or to be vaccinated. Such ideas were also associated with
- paranoia,
- general vaccination conspiracy beliefs,
- climate change conspiracy belief,
- a conspiracy mentality, and distrust in institutions and professions.
Holding coronavirus conspiracy beliefs was also associated with being more likely to share opinions.
The authors concluded that, in England, there is appreciable endorsement of conspiracy beliefs about coronavirus. Such ideas do not appear confined to the fringes. The conspiracy beliefs connect to other forms of mistrust and are associated with less compliance with government guidelines and greater unwillingness to take up future tests and treatment.
The authors also state that the coronavirus conspiracy ideas ascribe malevolent intent to individuals, groups, and organisations based on what are likely to be long-standing prejudices. For instance, almost half of participants endorsed to some degree the idea that ‘Coronavirus is a bioweapon developed by China to destroy the West’ and around one-fifth endorsed to some degree that ‘Jews have created the virus to collapse the economy for financial gain’.
The survey did not include questions about so-called alternative medicine (SCAM). This is a great shame, in my view. We know from previous research that people who adhere to conspiracy theories feel strongly that SCAM is being suppressed via some sinister complot by the establishment. Moreover, we know that SCAM enthusiasts tend to believe in vaccination conspiracy theories. One might therefore expect that proponents of SCAM are also prone to conspiracy beliefs about coronavirus.
When reading some of the comments on this blog, I have little doubt that this is, in fact, the case.
FOUR QUESTIONS TO DC + CRITICAL CHIRO (CC):
1) what does the law say about informed consent for Australian chiros?
2) what info exactly do you have to provide?
3) who monitors it?
4) what published evidence do we have about compliance?
CC then posted this reply:
Here we go again you demand evidence while providing little if any for your own assumptions (poor case studies do not count. The pleural of anecdote does not equal evidence whether it’s from chiro’s or you).
We have been over this many times over many years, I cite research/provide links yet you still find it challenging to take it onboard. It is human nature to feel obligated once making a public statement to defend it no matter how much evidence is sent your way. So not surprising.
“1) what does the law say about informed consent for Australian chiros?”
It is all freely available on the national regulators website (as you know and as I have referenced in the past):
https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx
https://www.chiropracticboard.gov.au/Search.aspx?q=Informed+consent
Some research by chiropractors on this topic (cited many times in the past):
Risk Management for Chiropractors and Osteopaths. Informed consent
A Common Law Requirement (2004):
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2051308/
Quick advanced PubMed with filters set to “Chiropractic” AND “Informed consent”.
https://www.ncbi.nlm.nih.gov/pmc/?term=(Chiropractic)+AND+Informed+consent
Not rocket science
Latest paper that you wrote an ill informed blog on and the comments were not going as you expected (So I expected you to double down like Donald Trump with a new blog within days. Your getting predictable).
https://chiromt.biomedcentral.com/articles/10.1186/s12998-020-00342-5
This paper questions the legal implications of vertebral subluxations with high powered legal input and is a broadside by evidence based chiropractors against vitalistic chiropractors. You respond a snide fantasy informed consent dialogue when you should be supporting the authors:
https://edzardernst.com/2020/11/informed-consent-why-chiropractors-dont-like-it/
“2) what info exactly do you have to provide?”
“4) what published evidence do we have about compliance?”
We have discussed this as well. It is a common law requirement for every profession and is checked upon re-registration by AHPRA every year and by the professional indemnity insurers every year. No informed consent, no registration and no professional indemnity insurance.
Checked AHPRA’s panel decisions and went back 5 YEARS and found ONE decision relating to informed consent:
https://www.ahpra.gov.au/Publications/Panel-decisions.aspx
“3) who monitors it?”
Another of your tired old arguments that we have discussed many times over the years.
In the UK there is the “‘Chiropractic Reporting and Learning System’ (CRLS)” but this is set up by the association representing chiropractors and not the registration board that advocates for patients. Right idea and step in the right direction, wrong organization.
Here years ago there was a trial of an adverse event reporting system in a Melbourne emergency department systematically collected relevant AE information on all professions which was sent to the relevant board for investigation.
It was supported by doctors and chiropractors while physio’s were not involved. A doctor involved told me it was killed off by ER doctors who “snivelled” about the extra paperwork.
There is no AE reporting system for physio’s, chiro’s, osteo’s, GP’s in private practice etc.
Over the years you have harped on and on about this topic as if it is a failing purely of the chiropractic profession when we have supported initiatives for its implementation.
You have also kept up with the research even commenting on an chiropractic researcher on AE’s Charlotte Leboeuf-Yde (who you highly regard) yet ignored until you could take issue with two sentences written in a blog then you wrote this hatchet blog:
https://edzardernst.com/2017/04/we-have-an-ethical-legal-and-moral-duty-to-discourage-chiropractic-neck-manipulations/
So you are asking for evidence yet willfully ignore an author who “I have always thought highly of Charlotte’s work”.
Stop the cynical cherry picked blogs and start supporting the researchers and reformers otherwise you are just someone standing on the sidelines blindly throwing grenades. You do not care who you hit or the damage you do to the chiropractors leading the reform you demand yet consistently fail to support.
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I thought the tone of this response was oddly aggressive and found that CC had failed to understand some of my questions. Yet the link to the chiro’s code of conduct https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx was useful. This is what it says about informed consent: