alternative medicine
In the last few years, several individuals in Germany have, from entirely different angles, taken a fresh look at the evidence on homeopathy and found it to be desperately wanting. Independent of each other, they published articles and books about their research and insights. Here are 5 examples:
Die Homöopathie-Lüge: So gefährlich ist die Lehre von den weißen Kügelchen, Christian Weymayr, Nicole Heißmann, 2012
In Sachen Homöopathie: Eine Beweisaufnahme, Norbert Aust, 2013
Homöopathie neu gedacht: Was Patienten wirklich hilft, Natalie Grams, 2015
Der Glaube an die Globuli: Die Verheißungen der Homöopathie, Norbert Schmacke, Bernd Hontschik, 2015
Der wahrscheinlich teuerste Zucker der Welt: Was Sie über Homöopathie und Alternativmedizin wissen sollten, Oliver Grunau, 2017
Inevitably, these individuals came into contact with each other and subsequently founded several working-groups to discuss their concerns and coordinate their activities. Thus the INH and the Muensteraner Kreis were born. So, now we have at least three overlapping groups of enthusiastic, multidisciplinary experts who voluntarily work towards informing the German public that paying for homeopathy out of public funds is unethical, nonsensical and not in the interest of progress:
- the GWUP,
- the INH
- and the Muensteraner Kreis.
No wonder then, that the German homeopathic industry and other interested parties got worried. When they realised that (presumably due to the work of these altruistic enthusiasts) the sales figures of homeopathics in Germany had, for the first time since many years, started declining, they panicked.
Their reaction was, as far as I can see, similar to their previous response to criticism: they started a media campaign in an attempt to sway public opinion. And just like before, they have taken to employing PR-people who currently spend their time defaming all individuals voicing criticism of homeopathy in Germany. Their prime targets are those experts who are most exposed to activities of responsibly informing the public about homeopathy via lectures, publications social media, etc. All of us currently receive floods of attack, insults and libellous defamations. As before (innovation does not seem to be a hallmark of homeopathy), these attacks relate to claims that:
- we are incompetent,
- we do not care about the welfare of patients,
- we are habitual liars,
- we are on the payroll of the pharmaceutical industry,
- we aim at limiting patient choice,
- we do what we do because we crave the limelight.
So, what is going to happen?
I cannot read tea leaves but am nevertheless sure of a few things:
- The German homeopathy lobby will not easily give up; after all, they have half a billion Euros per year to lose.
- They will not argue on the basis of science or evidence, because they know that neither are in their favour.
- They will fight dirty and try to defame everyone who stands in their way.
- They will use their political influence and their considerable financial power.
AND YET THEY WILL LOSE!
Not because we are so well organised or have great resources – in fact, as far as I can see, we have none – but because, in medicine, the evidence is invincible and will eventually prevail. Progress might be delayed, but it cannot be halted by those who cling to an obsolete dogma.
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The above text is from a blog post I published 17 moths ago. It seems that my prediction was not wrong. Today, I saw two tweets which suggest that, in Germany, homeopathy is continuing to disappear from the realm of conventional medicine:
- Soeben erreicht mich die Nachricht, dass der Vorstand der Bayerischen Landesärztekammer in der Sitzung am 5.12. einstimmig beschlossen hat, die Zusatzweiterbildung Homöopathie aus der ärztlichen Weiterbildungsordnung zu entfernen. EINSTIMMIG!!!
- 11 von 17 Ärztekammern haben die Homöopathie gekickt. Bleiben noch 6. Die nächste Entscheidung steht in Berlin an.
I’ll translate them for you:
- I have just received the news that the Board of the Bavarian Medical Association has unanimously decided in the meeting on 5.12. to remove the additional training in homeopathy from the medical training regulations. UNANIMOUSLY!!!
- 11 of 17 medical associations have kicked homeopathy. That leaves 6. The next decision is due in Berlin.
This means that in most German counties (there is hope that, sooner or later, the other 6 will follow suit), doctors will no longer be able to train in homeopathy and use the title ‘homeopath’.
Yes, it took a while – about 200 years – but it seems that the German medical profession is finally realising that homeopathy is treatment with placebos.
This systematic review and meta-analysis was aimed at investigating the effect and safety of acupuncture for the treatment of chronic spinal pain.
The authors included 22 randomized controlled trials (RCTs) involving patients with chronic spinal pain treated by acupuncture versus sham acupuncture, no treatment, or another treatment were included. Chronic spinal pain was defined as:
- chronic neck pain,
- chronic low back pain,
- or sciatica for more than 3 months.
Fourteen studies had a high risk of bias, 5 studies had a low risk of bias, and 5 studies had an unclear risk of bias. Pooled analysis revealed that:
- acupuncture can reduce chronic spinal pain compared to sham acupuncture (weighted mean difference [WMD] -12.05, 95% confidence interval [CI] -15.86 to -8.24),
- acupuncture can reduce chronic spinal pain compared to mediation control (WMD -18.27, 95% CI -28.18 to -8.37),
- acupuncture can reduce chronic spinal pain compared to usual care control (WMD -9.57, 95% CI -13.48 to -9.44),
- acupuncture can reduce chronic spinal pain compared to no treatment control (WMD -17.10, 95% CI -24.83 to -9.37).
In terms of functional disability, acupuncture can improve physical function at
- immediate-term follow-up (standardized mean difference [SMD] -1.74, 95% CI -2.04 to -1.44),
- short-term follow-up (SMD -0.89, 95% CI -1.15 to -0.62),
- long-term follow-up (SMD -1.25, 95% CI -1.48 to -1.03).
Trials assessed as having a high risk of bias (WMD −13.45, 95% CI −17.23 to −9.66, I 2 96.2%, moderate-quality evidence, including 14 studies and 1379 patients) found greater effects of acupuncture treatment than trials assessed as having a low risk of bias (WMD −11.99, 95% CI −13.94 to −10.03, I 2 44.6%, high-quality evidence, including 4 studies and 432 patients), but smaller effects than trials assessed as having an unclear risk of bias (WMD −14.51, 95% CI −17.25 to −11.78, I 2 0%, high-quality evidence, including 3 studies and 190 patients).
Only 6 trials provided information on adverse events. No trial reported data on serious adverse events during acupuncture treatment. The most frequent adverse events were temporarily worsened pain and needle pain at the acupuncture site, which can decrease quickly after a short period of rest.
The authors concluded that compared to no treatment, sham acupuncture, or conventional therapy such as medication, massage, and physical exercise, acupuncture has a significantly superior effect on the reduction in chronic spinal pain and function improvement. Acupuncture might be an effective treatment for patients with chronic spinal pain and it is a safe therapy.
I think this is a thorough review which produced interesting findings. I agree with most of what the authors report, except with their conclusions which I find too optimistic. In view of the facts that
- only 5 RCTs had a low risk of bias,
- collectively, the rigorous trials reported smaller effect sizes,
- the majority of trials failed to mention adverse effects which, in my view, casts considerable doubt on their quality and ethical standard,
I would have phrased the conclusion differently: compared to no treatment, sham acupuncture, or conventional therapies, acupuncture seems to have a significantly superior effect on pain and function. Due to the lack rigour of most studies, these effects are less certain than one would have wished. Many trials fail to report adverse effects which reflects poorly on their quality and ethics and prevents conclusions about the safety of acupuncture. In essence, this means that the effectiveness and safety of acupuncture as a treatment of chronic spinal pain remains uncertain.
Bloodletting has been used for centuries in many cultures. Its principle, it was assumed, consisted in re-balancing the body’s four humours. Bloodletting had a detrimental effect on most diseases and must have killed millions. It is a good historical example of the harm that ensues, if healthcare adheres to dogma. Today, we know that bloodletting is useful only in rare conditions such as polycythaemia vera or haemochromatosis (and some 30 years ago, a variation of bloodletting, isovolaemic haemodilution, was being discussed as a treatment for circulatory diseases such as intermittent claudication or stroke).
Yet, in so-called alternative medicine (SCAM), there are some practitioners who seem to find it hard to concede that ancient treatments might be not as good as they think. Thus, bloodletting has survived in this realm as a therapy for a wide range of conditions. This study assessed the efficacy of bloodletting therapy (acupoint pricking and cupping) in patients with chronic idiopathic urticaria (CIU) in a randomized, control, parallel-group trial.
A total of 174 patients with CIU were randomized into three groups:
- group A was treated with bloodletting therapy and ebastine (an anti-histamine),
- group B was treated with placebo treatment (acupoint pseudopricking and cupping) and ebastine,
- group C was treated with ebastine only.
The treatment period lasted 4 weeks. An intention-to-treat analysis was conducted, and the primary outcome was the effective rate of UAS7 score being reduced to 7 or below after treatment phase.
The effective rates at the end of treatment phase were different among the three groups, which were
- 73.7% in group A,
- 45.6% in group B,
- and 42.9% in group C.
Multiple analysis indicated differences between groups A and B (P < 0.0125) and groups A and C (P < 0.0125) and no difference between groups B and C (P > 0.0125). No severe bloodletting therapy-related adverse events were observed.
The authors concluded that one month of bloodletting therapy combined with ebastine is clinically beneficial compared with placebo treatment combined with ebastine and treatment with ebastine only. Thus, bloodletting therapy can be an effective complementary treatment in CIU.
Amazed?
Me too!
How on earth might bloodletting help for CIU? Luckily, the authors have an answer to this question:
The clinical feature of urticaria with wheals and pruritus coming and going quickly is the manifestation of wind-evil that lurks in and circulates with blood. Hence, in the treatment of urticaria, dispersing wind is the one of the principle methods, and treating blood before wind is an important procedure because when blood flows fluently , wind-evil will resolve spontaneously. Bloodletting therapy is a direct and effective way of regulating blood.
You see, it’s all perfectly clear!
In this case, the results must be true. And the argument that patients might have known in which treatment group they had ended up (and were thus not blinded) can be discarded.
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.
Two Dutch scientists tested the hypothesis that spiritual training operates like other self‐enhancement tools and contribute to a contingent self‐worth that depends on one’s spiritual accomplishments.
In three studies, a measure of spiritual superiority showed good internal consistency and discriminant validity. Spiritual superiority was distinctly related to spiritual contingency of self‐worth, illustrating that the self‐enhancement function of spirituality is similar to other contingency domains. It was correlated with self‐esteem and, more strongly, with communal narcissism, corroborating the notion of spiritual narcissism. Spiritual superiority scores were consistently higher among energetically trained participants than mindfulness trainees and were associated with supernatural overconfidence and self‐ascribed spiritual guidance.
Spititual superiority is claimed to be a measure to which degree people feel superior to those “who lack the spiritual wisdom they ascribe to themselves.” The measure’s questionnaires ask people to respond on a scale of 1 to 7 to a series of statements. Example statements include “I am more in touch with my senses than most others,” “I am more aware of what is between heaven and earth than most people,” and “The world would be a better place if others too had the insights that I have now.”
Essentially, the studies suggest that the use of spiritual training techniques such as
- energy healing,
- aura reading,
- mindfulness,
- and meditation
correlate with both narcissism and “spiritual superiority.” By encouraging self-compassion and non-judgmental self-acceptance, spiritual training should presumably make people less concerned with such things. Yet, it seems to have the opposite effect: it enhances the need to feel “more successful, more respected or more loved.”
The authors argue that, “like religiosity, spirituality is a domain that seems like a safe and secure investment for self-worth. One’s spiritual attainments allow lots of room for wishful thinking, thus easily lending themselves to the grip of the self-enhancement motive.” And because spiritual matters are generally “elusive to external objective standards,” that makes them a “suitable domain for illusory beliefs about one’s superiority.”
The causal arrow might work in both directions, the authors argue:
- People use spirituality as a self-esteem booster. It allows them to see themselves as special, and they can achieve progress in the spiritual domain relatively easily, as there are no objectively measurable outcomes.
- Spiritual training attracts people who already feel superior. And the “extensive exploration of one’s personal thoughts and feelings” that spiritual training encourages “may be particularly appealing” to narcissists.
The authors concluded as follows: “The phenomenon of spiritual superiority is widely recognized, both by authors who have written about it and by lay people who have felt the condescension of spiritually ‘enlightened’ others. At the same time, it has not yet been empirically studied before. We developed a measure of spiritual superiority, along with scales for self-proclaimed spiritual guidance, supernatural overconfidence, and spiritual contingency of self-worth. We have demonstrated their reliability and we have presented initial findings on correlations with other variables and differences between types of spiritual training, corroborating the validity of our scales. Our results and our theoretical analysis can stimulate further research into this phenomenon. In the applied domain, this could reveal more insights into the effects of spiritual training, and possibly the conditions and personality characteristics that facilitate genuine spiritual growth. More importantly, our results reveal the sovereignty and tenacity of the self-enhancement motive, showing its operation in a context designed to quiet the ego. This can be understood in terms of dual process models, assuming that self-enhancement is an automatic tendency whereas mindful awareness requires thoughtful processes. Our results thus extend the current body of knowledge on self-enhancement, by including a domain in which self-superiority might be least expected.”
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.
The amount of different so-called alternative medicines (SCAMs) that are being tried or promoted against COVID-19 is legion. Anything really from vitamins to herbal remedies, homeopathics to chiropractic. In fact, it is hard these days to find a SCAM that is not touted for COVID-19.
This study aimed to evaluate if a dietary supplement of quercetin (a polyphenol contained in many fruit and vegetables), vitamin C and bromelain (a proteolytic enzyme contained in pineapple) could be protective against coronavirus infections.
In the verum group, a supplement containing
- 500mg of quercetin,
- 500mg of vitamin C,
- 50mg of bromelain (QCB)
was administered daily in 2 divided doses for 71 healthcare workers working in areas with high risk of COVID-19, whereas 42 were the control group who received no supplements. The maximum period of follow-up was 120 days. Termination of QCB use prematurely or having a coronavirus infection was the end of a volunteer’s study participation. A rapid diagnostic test was used to detect immunoglobulin positivity.
Graphic demonstrated survival without COVID-19 during follow up time between groups
A total of 113 persons were included. No significant difference were detected between groups at baseline. Mean age of QCB group was 39.0 ± 8.8 years and control group was 32.9 ± 8.7. Average follow-up period for the QCB group was 113 days, and for the control group, 118 days. During the follow-up period, 1 healthcare worker in the QCB group and 9 out in 42 in control group contracted COVID-19. One case was asymptomatic, while others were not. Transmission risk hazard ratio of participants who did not receive QCB was 12.04 (95% Confidence interval= 1.26-115.06, P = 0.031). No significant effect of gender, smoking, antihypertensive medication exposure and having chronic disease on rate of transmission. The authors concluded that this study revealed that QCB was protective for healthcare workers.
The sudy is so poorly written and reported that I had trouble making sense of it. In fact, I first thought it was a fake. Then I saw this note:
Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed.
If the results are for real (because of the small sample size, the lack of a placebo-control, dozens of potential confounders, etc., the findings could easily false-positive), they would merit urgent replication in a larger, more rigorous trial.
And meanwhile?
Meanwhile I would be very sceptical about the validity of the results. The paper (it really is just a submission for publication in the Lancet; I am not even sure that it will be officially published and I don’t quite see why it is being made available to the public in this way) is too flimsy for words. Despite these warnings, it is likely that many consumers will fall for the claim that QCB was protective for healthcare workers.
In these pre-Xmas days, many homes will smell of cinnamon. It’s certainly a wonderful spice for creating an atmosphere. But ther are also other uses for ciannamon.
Current treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, this double-blind randomized, placebo-controlled trial was conducted.
The 6-week study was conducted in an outpatient setting; 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points.
In total, 66 participants (40 women and 26 men), 60 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP and placebo groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores, PPBC scores, and USS scores.
The authors concluded that compared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.
Cinnamon (Cinnamomum zeylanicum and Cinnamon cassia)belongs to the Lauraceae family. It contains manganese, iron, dietary fiber, and calcium as well as cinnamaldehyde, cinnamic acid, cinnamate, and numerous other components such as polyphenols and antioxidant, anti-inflammatory, antidiabetic, antimicrobial, anticancer effects. Several reports have dealt with the numerous properties of cinnamon in the forms of bark, essential oils, bark powder, and phenolic compounds, and each of these properties can play a key role in human health.
The new study is interesting and prompts me to ponder:
- Do the pharmacologically active ingredients of cinnamon pass the skin barrier in sufficient amounts to have any effect at all? Or perhaps it was the scent? In which case, this would have been a study of aromatherapy.
- Considering the typical scent of cinnamon, I find it hard to imagine that this study was truly double blind.
- Cinnamon is alleged to have antimicrobial, antiviral, antifungal, antioxidant, antitumor, antihypertensive, antilipemic, antidiabetic, gastroprotective, and immunomodulatory effects. I do wonder which, if any, of these are responsible for the observed clinical results of this trial.
- Cinnamon is known to sometimes lead to allergic reactions. I wonder whether this could be a problem when it is applied in patches.
So, for the time being, I think, I prefere cinnamon, the spice, to cinnamon, the medicine.
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.
