On Twitter, the hype had begun even before its text was available. Priti Gandhi, for instance, tweeted:
Yet another feather in India’s cap!! 1st evidence-based, CoPP-WHO GMP certified medicine for Covid-19 released today. Congratulations to @yogrishiramdev ji, @Ach_Balkrishna ji & the team of scientists at Patanjali Research Institute. Your efforts have been successful!! #Ayurveda
So, what is it all about? This study included 100 patients and was designed to evaluate the impact of traditional Indian Ayurvedic treatment on asymptomatic patients with COVID-19 infection. It is a placebo-controlled randomized double-blind pilot clinical trial that was conducted at the Department of Medicine in the National Institute of Medical Sciences and Research, Jaipur, India.
- 1 g of Giloy Ghanvati (Tinospora cordifolia)
- 2 g of Swasari Ras (traditional herbo-mineral formulation)
- 0.5 g of Ashwagandha (Withania somnifera)
- 0.5 g of Tulsi Ghanvati (Ocimum sanctum)
The treatment was given orally to the patients in the treatment group twice per day for 7 days. Medicines were given in the form of tablets and each tablet weighed 500 mg. While Swasari Ras was administered in powdered form, 30 min before breakfasts and dinners, rest were scheduled for 30 min post-meals. Patients in the treatment group also received 4 drops of Anu taila (traditional nasal drop) in each nostril every day 1 h before breakfast. Patients in the placebo group received identical-looking tablets and drops, post-randomization, and double-blinded assortments. The RT-qPCR test was used for the detection of viral load in the nasopharyngeal and oropharyngeal swab samples of study participants during the study. Chemiluminescent immunometric assay was used to quantify serum levels of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and high sensitivity C-reactive protein (hs-CRP) on day 1 and day 7 of the study. Patient testing negative for SARS-CoV-2 in the RT-PCR analysis was the primary outcome of this study.
By day three, 71.1 % and 50.0 % of patients recovered in the treatment and placebo groups, respectively. The treatment group witnessed 100 % recovery by day 7, while it was 60.0 % in the placebo group. Average fold changes in serum levels of hs-CRP, IL-6, and TNF-α in the treatment group were respectively, 12.4, 2.5 and 20 times lesser than those in the placebo group at day 7. There was a 40 % absolute reduction in the risk of delayed recovery from infection in the treatment group.
The authors concluded that Ayurvedic treatment can expedite virological clearance, help in faster recovery and concomitantly reduce the risk of viral dissemination. Reduced inflammation markers suggested less severity of SARS-CoV-2 infection in the treatment group. Moreover, there was no adverse effect observed to be associated with this treatment.
I have the following concerns or questions about this trial:
- Why do the authors call it a pilot study? A pilot study is merely for testing the feasibility of a trial design and is not meant to yield definitive efficacy results.
- The authors state that the patients were asymptomatic yet in the discussion they claim they were asymptomatic or mildly symptomatic.
- Some of the effect sizes reported here are extraordinary and seem almost too good to be true.
- The claim of no adverse effect is implausible; even placebos would cause perceived adverse effects in a percentage of patients.
- If the study is solid and withstands the scrutiny of the raw data, it is of huge relevance for public health. So, why did the authors publish it in PHYTOMEDICINE, a relatively minor and little-known journal?
An article in The Economic Times’ reported this:
Patanjali Ayurved released what it called the first “evidence-based” medicine for Covid-19 on Friday. It claimed it has been “recognised by the WHO (World Health Organization) as an ayurvedic medicine for corona”.
Patanjali promoter, yoga guru Baba Ramdev, released a scientific research paper in this regard at the launch, presided over by Union health minister Harsh Vardhan and transport minister Nitin Gadkari.
The Ayurveda products maker said it has received a certification from the Ayush ministry. “Coronil has received the Certificate of Pharmaceutical Product (CoPP) from the Ayush section of Central Drugs Standard Control Organisation (CDSCO) as per the WHO certification scheme,” it said in a statement.
Under the CoPP, Coronil can be exported to 158 countries, the company said, adding that based on the presented data, the ministry has recognised Coronil as medicine for “supporting measure in Covid-19”.
Am I the only one who fears that something is not entirely kosher about the study? (This is an honest question, and I would be pleased to receive answers from my readers)
I am pleased to report that our ‘resident homeopathic doctor’ from Germany, Dr. Heinrich Huemmer, posted a review of my new book on Amazon. As his comments are in German, I translated them which was not easy because they are confusing and confused. Now that it’s done, I cannot resist the temptation to show them to you (the references were inserted by me, and refer to my comments below):
First of all, the author, who as a scientist  once had a thoroughly positive attitude towards homeopathy [and in a meta-analysis even attested to it significantly positive results in a certain clinical picture ], explains the principles and procedures in homeopathy in a clear and objective manner.
In explaining the principle of potentization, however, Ernst’s one-dimensional and completely unscientific matter-bound, quasi-medieval understanding of science shines through for the first time. With the assertion, “both the dilution and the similarity rule contradict the laws of nature” he clearly reveals his unscientific thinking, whereby he could have easily relativized this by an inserted differentiation “presently, known laws of nature”.  And not even the following sentence “…we understand very well that it can function only if the known laws of nature would be invalid” is agreed by critically thinking natural scientists.  Also the assertion: “The totality of this evidence does not show that homeopathic remedies would be no more than placebo”, is countered by a well-known – belonging to the skeptic movement – expert of the homeopathic study situation with the remark: “Furthermore, you should read my statements and those of the INH more carefully again: Our statement is that there is no robust/reliable/convincing evidence for efficacy beyond placebo. ALSO NOT “NONE” but “none conclusive”, which yes makes a difference in absolute numbers. Just like “no beer” is different than “not a good beer”. ”  Since patients usually turn to homeopathy only when so-called scientific medicine negates their illnesses and accordingly has nothing to offer them , Ernst’s reference to the fact that patients could “endanger their health” is to be seen as a cheap attempt at discrediting.  The reference that this assessment comes from the Australian National Health and Medical Research Council is not without a particularly piquant note, since this NHMRC may have to be held responsible for a particularly infamous attempt at scientific fraud to the disadvantage of homeopathy.  Also, the alleged “fact” that “[positive] experiences […] are the result of a long, empathetic, sympathetic encounter with a homoeopath…” can be disproved by immediate – also diagnostically verified – cures, which occurred immediately without a long admission or which failed to appear even after several intensive anamneses under most sympathetic admission against all expectations….. Finally Ernst’s argument “the benefit-cost-argument of homeopathy is not positive” is an absolute air number, because the saving of 1 €/patient and year (in case of abolition of the homeopathy-reimbursement) would not even allow a free new glasses-nose-pad…. 
- I am not sure where Homeopathy Heinrich Huemmer (HHH) got the claim from that I, as a scientist, once had a thoroughly positive attitude towards homeopathy. This is not even remotely true! As a very young clinician (40 years ago), I once was quite impressed by homeopathy, never as a scientist (for full details, see my memoir). What HHH seems to display here is his very own misunderstanding about science and scientists: if they are for real (i.e. not pseudoscientists like many of those who research homeopathy), scientists try not to let their personal attitudes get in the way of good science.
- I presume that HHH refers here to this meta-analysis: Homeopathy for postoperative ileus? A meta-analysis. I fear that HHH has yet to learn how to read a scientific paper. Our conclusions were: There is evidence that homeopathic treatment can reduce the duration of ileus after abdominal or gynecologic surgery. However, several caveats preclude a definitive judgment. These results should form the basis of a randomized controlled trial to resolve the issue.
- This made me laugh! Does HHH think that only the handful of homeopathic loons who claim that homeopathy has a scientific basis in the unknown laws of nature are truly scientific? And all the rest are unscientific?
- I doubt that anyone can understand this passage, perhaps not even HHH. My conclusion that “the totality of this evidence does not show that homeopathic remedies are more than placebo” merely expresses what even most homeopaths would admit and is unquestionably correct.
- This statement is untrue in more than one way. Firstly, responsible clinicians never tell a patient that they have nothing more to offer, simply because this is never the case – there is always something a good clinician can do for his/her patient, even if it is just in terms of palliation or moral support. Secondly, we know that German patients opt to use homeopathy for all sorts of reasons, including as first-line therapy and not as a last resort.
- In the book, I refer (and reference the source) to the phenomenon that many homeopaths discourage their patients from vaccination. Unfortunately, this is no ‘cheap attempt’, it is the sad reality. HHH does not even try to dispute it.
- HHH does not like the NHMRC report. Fair enough! But he omits to mention that, in the book, I list a total of 4 further official verdicts. Does HHH assume they are all fraudulent? Is there perhaps a worldwide conspiracy against homeopathy?
- We all know that HHH is enormously proud of his only publication to which he refers here (on this blog, he must have mentioned it a dozen times). However, in the book, I refer to an RCT for making my point. Which is more convincing, a case report or an RCT?
- Here HHH simply demonstrates that he has not understood the concept of cost-effectiveness.
So, what we have here is a near-perfect depiction of a homeopath’s way of thinking. But there is worse in HHH’s comment< I fear.
My book (of 224 pages) scrutinizes – as even its title states – not one but 40 types of so-called alternative medicine (SCAM); 20 of the most effective and 20 of the most dangerous SCAMs. In addition, it covers (in ~ 50 pages) many general topics (like ‘WHAT IS EVIDENCE? or WHY IS SCAM SO POPULAR?). It includes over 200 references to published papers. Yet, HHH reviews and judges the book by commenting exclusively on the meager 5 pages dedicated to homeopathy!
If that does not exemplify the limitations of the homeopathic mind, please tell me what does.
THANK YOU, HHH, FOR MAKING THIS SO CLEAR TO US!
There are skeptics who keep claiming that there is no research in so-called alternative medicine (SCAM). And there are plenty of SCAM enthusiasts who claim that there is an abundance of good research in SCAM.
Who is right and who is wrong?
I submit that both camps are incorrect.
To demonstrate the volume of SCAM research I looked into Medline to find the number of papers published in 2020 for the SCAMs listed below:
- acupuncture 2 752
- anthroposophic medicine 29
- aromatherapy 173
- Ayurvedic medicine 183
- chiropractic 426
- dietary supplement 5 739
- essential oil 2 439
- herbal medicine 5 081
- homeopathy 154
- iridology 0
- Kampo medicine 132
- massage 824
- meditation 780
- mind-body therapies 968
- music therapy 539
- naturopathy 68
- osteopathic manipulation 71
- Pilates 97
- qigong 97
- reiki 133
- tai chi 397
- Traditional Chinese Medicine 15 277
- yoga 698
I think the list proves anyone wrong who claims there is no (or very little) research into SCAM.
As to the enthusiasts who claim that there is plenty of good evidence, I am afraid, I disagree with them too. The above-quoted numbers are perhaps impressive to some SCAM proponents, but they are not large. To make my point more clearly, let me show you the 2020 volumes for a few topics in conventional medicine:
- psychiatry 668,492
- biologicals 300,679
- chemotherapy 109,869
- radiotherapy 17,964
- rehabilitation 21,751
- rehabilitation medicine 21,751
- surgery 256,958
I think we can agree that these figures make the SCAM numbers look pitifully small.
But the more important point is, I think, not the quantity but the quality of the SCAM research. As this whole blog is about the often dismal rigor of SCAM research, I do surely not need to produce further evidence to convince you that it is poor, often even very poor.
So, both camps tend to be incorrect when they speak about SCAM research. The truth is that there is quite a lot, but sadly reliable studies are like gold dust.
But actually, when I started writing this post and doing all these Medline searches to produce the above-listed volumes of SCAM research, I was thinking of a different subject entirely. I wanted to see which areas of SCAM were research-active and which are not. This is why I chose terms for my list that do not overlap with others (yet we need to realize that the figures are not precise due to misclassification and other factors). And in this respect, the list is interesting too, I find.
It identifies the SCAMs that are remarkably research-inactive:
- anthroposophic medicine
Perhaps more interesting are the areas that show a relatively high research activity:
- dietary supplements
- essential oils
- herbal medicine
- mind-body therapies
This, in turn, suggests two things:
- It is not true that only commercial interests drive research activity.
- The Chinese (TCM and acupuncture) are pushing the ferociously hard to conquer SCAM research.
The last point is worrying, in my view, because we know from several independent studies that Chinese studies are often the flimsiest and least reliable of all the SCAM literature. As I have suggested recently, the unreliability of SCAM research might one day be its undoing: This self-destructive course of SCAM might be applauded by some skeptics. However, if you believe (as I do) that there are a few good things to be found in SCAM, this development can only be regrettable. I fear that the growing dominance of Chinese research will help to speed up this process.
Yes, I have just published a new book! Its title is ‘Alternativmedizin – was hilft, was schadet: Die 20 besten, die 20 bedenklichsten Methoden’ (Alternative medicine – treatments that help and treatments that harm: The 20 best and the 20 most worrying methods). Yes, it is in German, and somehow I doubt that there will be an English version of it. Therefore I take the liberty of translating a short section for those who do not read German.
But first, let me tell you about the book’s concept.
Some people who read this blog seem to have the impression that I am dead against so-called alternative medicine (SCAM) – my friend Dana Ullman, for instance, is convinced of it. This, however, is not quite correct (Dana rarely is). The truth is that I am
- FOR evidence-based medicine,
- FOR a level playing field in all areas of healthcare,
- FOR critically evaluating all options.
This also means, of course, that I am against misleading consumers about the value of SCAM. And therefore I am FOR any SCAM that demonstrably does more good than harm.
This attitude should have been clear from all my books. However, it seems to be difficult to understand for those who are on the more fanatical end of the SCAM spectrum. And because it is not that obvious, I decided to write a book that analyses (understandably yet analytically [including ~300 references of the original science]) the evidence for 20 SCAMs that are supported by reasonably sound evidence together with 20 for which this is not the case. My hope is that, with this approach, I might reach more consumers who are in favour of SCAM.
There is a risk, of course. Chances are that, instead of reaching more people from the pro-camp, I will merely offend both the sceptics as well as the enthusiasts.
We shall see.
Anyway, here is the promised bit that I translated for you. It is the postscript of the book, and I hope it gives you a flavour of what it is all about. Here we go:
In the first chapter of the book, I promised that I would neither uncritically hype alternative medicine nor unfairly condemn it. I have taken great pains to keep this promise.
Have I succeeded?
I fear there will be many who answer this question in the negative. And I can’t even blame my critics! Who likes to be criticized for something in which he deeply believes? Who likes to hear that his prejudices against everything called alternative medicine are wrong and counter-productive? Who doesn’t mind an ugly fact that destroys his beautiful theory? Both the dogmatic naysayers and the naive believers will be dissatisfied with my book (or at least parts of).
That’s a shame, but ultimately it is irrelevant. My point was not to take the word of one camp or another in the endless trench warfare that is alternative medicine. My main concern was to present the evidence as up-to-date, understandable, and objective as possible, and to serve those who are seriously interested in facts.
The book is thus not for dogged trench warriors; rather, it is aimed at ordinary consumers with an interest in their health. After all, the vast majority of the population is not among the unteachables of one camp or the other. Most people don’t want ideology, they want effective medicine. And most of them are baffled by the unmanageable variety of alternative medicine on offer, the grandiose promises of healing, and the vehement emotions that it all triggers.
In the area of alternative medicine, there is undoubtedly a lot of nonsense, charlatanry, and danger. But there are also some things that demonstrably do more good than harm. In order to separate the wheat from the chaff, consumers don’t need creeds. What they need above all is reliable evidence!
You can read about this evidence in my book. How you then deal with it is solely your decision. I do not want to tell anyone what to do with my presentation of the facts. But I know that the abundance of misinformation in the field of alternative medicine causes great damage and that the consumer and reader of my book, deserve better than to be led up the garden path.
If this book helps readers to make wise treatment decisions, my efforts will have been worthwhile. And if they get half as much pleasure from reading it as I did from writing it, my goal has been achieved.
(If by any chance you do read German and are in the position to publish a book review, please let me know and I will see that you get a free review copy of my book)
Yesterday, someone posted a disparaging comment about Indian research into homeopathy; he claimed that it was unreliable. I agreed, but later I thought ‘HOW ARROGANT OF ME!’. So, I decided to do a little research – actually, it turned out to be a little more than just ‘a little’.
I searched Medline for ‘homeopathy, study, India’. This resulted in 101 hits. Of these 101 articles, 31 contained data published by Indian authors providing evidence at least vaguely related to the effectiveness of homeopathy. I decided to include these in my analysis. Below I quote first the title of each paper followed by (in brackets) the sentence from the 31 abstracts that best describes the direction of the results.
- Multimorbidity After Surgical Menopause Treated with Individualized Classical Homeopathy: A Case Report (She was treated with individualized classical homeopathy and followed up for 31 months. She was relieved of the vasomotor symptoms and psychological disturbances of climacteric syndrome, her weight reduced, the ultrasound scan showed absence of lipomatosis/gall bladder disease/hepatic steatosis. Blood tests showed reduction of thyroid stimulating hormone and a balance in the lipid status. Individualized classical homeopathy may have a role in the climacteric syndrome and comorbidities after surgical menopause.)
- Therapeutic evaluation of homeopathic treatment for canine oral papillomatosis (The current study proves that the combination of homeopathy drugs aids in fastening the regression of canine oral papilloma and proved to be safe and cost-effective.)
- Deep vein thrombosis cured by homeopathy: A case report (The present case report intends to record yet another case of DVT in an old patient totally cured exclusively by the non-invasive method of treatment with micro doses of potentized homeopathic drugs selected on the basis of the totality of symptoms and individualization of the case.)
- Diabetic retinopathy screening uptake after health education with or without retinal imaging within the facility in two AYUSH hospitals in Hyderabad, India: A nonrandomized pilot study (AYUSH hospitals could provide a feasible and acceptable location for providing DR screening services.)
- Individualised Homeopathic Therapy in ANCA Negative Rapidly Progressive Necrotising Crescentic Glomerulonephritis with Severe Renal Insufficiency – A Case Report (A 60-year-old Indian woman was treated with classical homeopathy for ANCA-negative RPGN, and after one year of treatment, serum creatinine and other parameters indicating renal injury dropped steadily despite the withdrawal of immunosuppressive drugs; renal dialysis, which was conducted twice a week initially, was made rarer and stopped after one year. Classical homeopathy may be considered a potential therapeutic modality in severe pathologies.)
- Improvements in long standing cardiac pathologies by individualized homeopathic remedies: A case series (… individualized homeopathic therapy was instituted along with the conventional medicines and the results were encouraging. The changes in the laboratory diagnostic parameters (single-photon emission computed tomography, electrocardiograph, echocardiography and ejection fraction as the case may be) are demonstrated over time. The key result seen in all three cases was the preservation of general well-being while the haemodynamic states also improved.)
- Could Homeopathy Become An Alternative Therapy In Dengue Fever? An example Of 10 Case Studies (We present a retrospective case series of 10 Indian patients who were diagnosed with dengue fever and treated exclusively with homeopathic remedies at Bangalore, India. This case series demonstrates with evidence of laboratory reports that even when the platelets dropped considerably there was good result without resorting to any other means.)
- Homeopathic Treatment of Vitiligo: A Report of Fourteen Cases (In 14 patients with vitiligo treated with individualized homeopathy, the best results were achieved in the patients who were treated in the early stages of the disease. We believe that homeopathy may be effective in the early stages of vitiligo, but large controlled clinical studies are needed in this area.)
- An Exploratory Study of Autonomic Function Investigations in Hemophiliacs on Homoeopathy Medications Using Impedance Plethysmography (Homoeopathic medicines used as an adjunct was associated with decrease in parasympathetic modulations.)
- Embryonic Zebrafish Model – A Well-Established Method for Rapidly Assessing the Toxicity of Homeopathic Drugs: – Toxicity Evaluation of Homeopathic Drugs Using Zebrafish Embryo Model (Our findings clearly demonstrate that no toxic effects were observed for these three homeopathic drugs at the potencies and exposure times used in this study. The embryonic zebrafish model is recommended as a well-established method for rapidly assessing the toxicity of homeopathic drugs.)
- Treatment of hemorrhoids with individualized homeopathy: An open observational pilot study (Under classical homeopathic treatment, hemorrhoids patients improved considerably in symptoms severity and anoscopic scores. However, being observational trial, our study cannot provide efficacy data. Controlled studies are required.)
- Patients’ preference for integrating homeopathy (PPIH) within the standard therapy settings in West Bengal, India: The part 1 (PPIH-1) study (A favorable attitude toward integrating homeopathy into conventional healthcare settings was obtained among the patients attending the homeopathic hospitals in West Bengal, India.)
- Patients’ Preference for Integrating Homoeopathy Services within the Secondary Health Care Settings in India: The Part 3 (PPIH-3) Study (A total of 82.40% (95% confidence interval = 79.23, 85.19) of the participants were in favor of integrating homoeopathy services.)
- Obstetrics and gynecology outpatient scenario of an Indian homeopathic hospital: A prospective, research-targeted study (The most frequently treated conditions were leucorrhea (20.5%), irregular menses (13.3%), dysmenorrhea (10%), menorrhagia (7.5%), and hypomenorrhea (6.3%). Strongly positive outcomes (+3/+2) were mostly recorded in oligomenorrhea (41.7%), leucorrhea (34.1%), polycystic ovary (33.3%), dysmenorrhea (28%), and irregular menses (22.2%). Individualized prescriptions predominated (95.6%).)
- Relative Apoptosis-inducing Potential of Homeopa-thic Condurango 6C and 30C in H460 Lung Cancer Cells In vitro: -Apoptosis-induction by homeopathic Condurango in H460 cells (Condurango 30C had greater apoptotic effect than Condurango 6C as claimed in the homeopathic doctrine.)
- Beliefs, attitudes and self-use of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy medicines among senior pharmacy students: An exploratory insight from Andhra Pradesh, India (Pharmacy students held favorable attitude and beliefs about AYUSH use.)
- Integrative nanomedicine: treating cancer with nanoscale natural products (Taken together, the nanoparticulate research data and the Banerji Protocols for homeopathic remedies in cancer suggest a way forward for generating advances in cancer treatment with natural product-derived nanomedicines.)
- Evidence of an Epigenetic Modification in Cell-cycle Arrest Caused by the Use of Ultra-highly-diluted Gonolobus Condurango Extract (Condurango 30C appeared to trigger key epigenetic events of gene modulation in effectively combating cancer cells, which the placebo was unable to do.)
- Calcarea carbonica induces apoptosis in cancer cells in p53-dependent manner via an immuno-modulatory circuit (Our results indicated a “two-step” mechanism of the induction of apoptosis in tumor cells by calcarea carbonica)
- Post-cancer Treatment with Condurango 30C Shows Amelioration of Benzo[a]pyrene-induced Lung Cancer in Rats Through the Molecular Pathway of Caspa- se-3-mediated Apoptosis Induction: -Anti-lung cancer potential of Condurango 30C in rats (The overall result validated a positive effect of Condurango 30C in ameliorating lung cancer through caspase-3-mediated apoptosis induction and EGFR down-regulation.)
- The potentized homeopathic drug, Lycopodium clavatum (5C and 15C) has anti-cancer effect on hela cells in vitro (Thus, the highly-diluted, dynamized homeopathic remedies LC-5C and LC-15C demonstrated their capabilities to induce apoptosis in cancer cells, signifying their possible use as supportive medicines in cancer therapy.)
- Ameliorating effect of mother tincture of Syzygium jambolanum on carbohydrate and lipid metabolic disorders in streptozotocin-induced diabetic rat: Homeopathic remedy (The result of the present study indicated that the homeopathic drug S jambolanum (mother tincture) has a protective effect on diabetic induced carbohydrate and lipid metabolic disorders in STZ-induced diabetic animal.)
- SEM studies on blood cells of Plasmodium berghei infected Balb/c mice treated with artesunate and homeopathic medicine China (The combination of artesunate and China was found to be very effective and did not cause any alteration on the surface of blood cells as observed in SEM.)
- Induction of apoptosis of tumor cells by some potentiated homeopathic drugs: implications on mechanism of action (These data indicate that apoptosis is one of the mechanisms of tumor reduction of homeopathic drugs.)
- TDZ-induced high frequency shoot regeneration in Cassia sophera Linn. via cotyledonary node explants (Regenerated plantlets were successfully acclimatized and hardened off inside the culture room and then transferred to green house with 100 % survival rate.)
- Modulation of Signal Proteins: A Plausible Mechanism to Explain How a Potentized Drug Secale Cor 30C Diluted beyond Avogadro’s Limit Combats Skin Papilloma in Mice (We tested the hypothesis if suitable modulations of signal proteins could be one of the possible pathways of action of a highly diluted homeopathic drug, Secale cornutum 30C (diluted 10(60) times; Sec cor 30). It could successfully combat DMBA + croton oil-induced skin papilloma in mice as evidenced by histological, cytogenetical, immunofluorescence, ELISA and immunoblot findings.)
- Can homeopathy bring additional benefits to thalassemic patients on hydroxyurea therapy? Encouraging results of a preliminary study (The homeopathic remedies being inexpensive and without any known side-effects seem to have great potentials in bringing additional benefits to thalassemic patients; particularly in the developing world where blood transfusions suffer from inadequate screening and fall short of the stringent safety standards followed in the developed countries.)
- Effect of homeopathic medicines on transplanted tumors in mice (These findings support that homeopathic preparations of Ruta and Hydrastis have significant antitumour activity. The mechanism of action of these medicines is not known at present.)
- Inhibition of chemically induced carcinogenesis by drugs used in homeopathic medicine (These studies demonstrate that homeopathic drugs, at ultra low doses, may be able to decrease tumor induction by carcinogen administration.)
- Can homeopathic treatment slow prostate cancer growth? (The findings indicate that selected homeopathic remedies for the present study have no direct cellular anticancer effects but appear to significantly slow the progression of cancer and reduce cancer incidence and mortality in Copenhagen rats injected with MAT-LyLu prostate cancer cells.)
- Ameliorating effect of microdoses of a potentized homeopathic drug, Arsenicum Album, on arsenic-induced toxicity in mice (The results lend further support to our earlier views that microdoses of potentized Arsenicum Album are capable of combating arsenic intoxication in mice, and thus are strong candidates for possible use in human subjects in arsenic contaminated areas under medical supervision.)
So, 31 of 31 yield positive results and conclusions – 100%!
When I suggested that Indian research into homeopathy is suspect, I was merely speculating on the basis of reading such papers for many years. I had not seen a systematic analysis to justify my harsh judgment; in fact, I don’t think that such a review is currently available (which would make this post the first of its kind). I had no idea how true my seemingly disrespectful remark would turn out to be. There is not one paper from India that does not suggest positive findings for homeopathy. I find this truly remarkable!
You can, of course, interpret my findings in two very different ways:
- Either you assume that homeopathy is hugely effective and works always and for everything under every experimental condition.
- Or you conclude that Indian research into homeopathy is suspect and far from trustworthy.
If you believe the first option to be true, I fear that you must be as deluded as homeopathic remedies are diluted.
Unintended consequences are outcomes of a purposeful action that are not intended or foreseen. They exist almost everywhere and often have effects that are the opposite of what was intended.
Just look at our current misery, the pandemic, for instance. Practically all epidemiologists advocated stricter and earlier preventative measures than the ‘anti-lockdown’ brigade in politics and elsewhere wanted and implemented. Had we listened to the epidemiologists, we would almost certainly have had fewer lockdowns and less economic downturn. The unintended consequences of the political decisions to be slow and less than strict with lockdowns are what we can currently observe in many countries:
- repeated, longer, and less and less effective lockdowns,
- huge economic damage,
- more deaths,
- more long-term illness;
- financial hardship for many,
- more psychological problems and frustration.
But I am not here to moan about politicians not listening enough to scientists. I want to vent my anger and concern about much of the research that is currently being published in the realm of so-called alternative medicine (SCAM).
What is happening here – slightly simplified and exaggerated to make my point – is (as often discussed previously) roughly this:
- more and more enthusiasts of SCAM feel that they should conduct and publish some research;
- they are largely ignorant of or willfully ignore the accepted standards of science;
- they have little interest in cause and effect or critical thinking;
- they aim to promote and not to test SCAM;
- several SCAM journals have realized that there is good money to be earned from publishing utter rubbish;
- more and more papers are being published that are flawed to the point of being meaningless;
- the few relevant SCAM papers with sound science get drowned out and become all but invisible;
- outsiders glancing at the literature get the impression that SCAM is swamped with rubbish and thus an area that is best avoided;
- consequently, SCAM research is fast losing all credibility and is becoming the laughing stock of proper scientists;
- eventually, the notion that ‘ALL SCAM IS RUBBISH’ must filter through into public life;
- in the end, the pseudo-researchers of SCAM will have provided the nail in SCAM’s coffin.
The INTENDED consequence was to promote SCAM.
The UNINTENDED consequence will be to destroy SCAM.
This self-destructive course of SCAM might be applauded by some skeptics. However, if you believe (as I do) that there are a few good things to be found in SCAM, this development can only be regrettable.
What can be done to avert such a negative outcome?
I wish I knew!
But four productive steps might be the following:
- make sure researchers are adequately trained and supervised to do sound science;
- motivate funding agencies to stop supporting pseudo-science;
- ensure that journal editors and reviewers realize they have the responsibility to avoid publishing nonsense
- motivate Medline to de-list a few of the worst SCAM journals.
It’s sad but true: not everyone likes THE ALTERNATIVE MEDICINE HALL OF FAME. Take this recent comment, for instance:
It is pathetic to see that Edzard only engages in the systematic harassment of his former colleagues or people who in most cases ignore him. Perhaps because he knows that his battle against homeopathy was totally lost in Germany, Switzerland and Brazil, as could be seen in the imminent failure of the “Questao Da Ciencia Institute”… Edzard acts as a real bully against Dr. Jacobs by including her in a “hall of fame” to humiliate her before the hoolingans who applaud her, who are always the four guardian trolls who never contribute or benefit to the discussion…
But then there are others who do appreciate it and recognize that it serves an important purpose: to alert the public to the fact that there is something deeply wrong with much of the published research in so-called alternative medicine (SCAM). Incidentally, this was also the theme of my last post on acupuncture and is the topic of many of my recent articles. Thus the aim of my HALL OF FAME is not to humiliate anyone; it is merely one of many of my attempts to protect the public from misleading information that has the potential to do much harm.
And therefore, I am not likely to close the HALL OF FAME any time soon.
Someone who has been waiting for ages to get admitted is the prolific psychologist Professor Harald Walach. He has in the past changed employment frequently. After building up a research group in SCAM at the University Hospital in Freiburg he held a research professorship with the University of Northampton, UK from 2005-2009 where he directed the MSc Program of Transpersonal Psychology and Consciousness Studies. From 2010 to 2016, he worked at the European University Viadrina in Frankfurt (Oder), where he headed a postgraduate Master program training doctors in SCAM and cultural sciences. Currently, Walach is affiliated with three institutions:
- Department of Pediatric Gastroenterology, Medical University Poznan, Poznan, Poland.
- Department of Psychology, University Witten-Herdecke, Witten, Germany.
- Change Health Science Institute, Berlin, Germany
In 2012, Walach was elected pseudoscientist of the year, a fact that should almost automatically unlock the HALL’s door for him. But let’s not be hasty; let’s have a look at his publications. My Medline search for ‘Walach H, clinical trial’ generated 40 hits of which 19 related to clinical studies of so-called alternative medicine (SCAM). Here are their conclusions:
- Both physiotherapy and PPT improve subacute low back pain significantly. PPT is likely more effective and should be studied further.
- One treatment session of enhanced MMT physiotherapy or RegentK can lead to nearly full function and thus recovery of a ruptured ACL after 1 year.
- MBSR did not produce cardiac autonomic benefits or changes in daily activity in FM. Furthermore, the lack of an association between patient-experienced clinical improvement and objective physiological measures suggests that subjective changes in the wellbeing of FM patients over time are not related to alterations in the cardiorespiratory autonomic function or activity levels.
- Mindfulness therapy may prevent disability pension and it may have a potential to significantly reduce societal costs and increase the effectiveness of care. Accumulated weeks of unemployment and sickness benefit are possible risk factors for BDS.
- Mindfulness therapy is a feasible and acceptable treatment. The study showed that mindfulness therapy was comparable to enhanced treatment as usual in improving quality of life and symptoms.
- In conclusion, primary outcome analyses did not support the efficacy of MBSR in fibromyalgia, although patients in the MBSR arm appeared to benefit most.
- Homeopathic remedies produce different symptoms than placebo.
- We, therefore, conclude that homeopathic remedies produce more symptoms typical for a remedy than non-typical symptoms. The results furthermore suggest a somewhat non-classical pattern because symptoms of one remedy appear to be mimicked in the other trial arm. This might be indicative of entanglement in homeopathic systems.
- In patients with CFS, distant healing appears to have no statistically significant effect on mental and physical health but the expectation of improvement did improve outcome.
- Treatments with QUANTEC may be accompanied by beneficial health effects.
- The results showed that both remedies ‘produced’ significantly more symptoms than placebo. With regard to the specificity, the Calendula officinalis group displayed more remedy-specific symptoms than placebo. However, in the Ferrum muriaticum group more Calendula symptoms than placebo were also recorded.
- Homeopathic proving symptoms appear to be specific to the medicine and do not seem to be due to a local process.
- We conclude that in an unselected sample of headache patients some may indeed be susceptible to the low intensity type of electromagnetic radiation exemplified by sferics pulses.
- We conclude that Bach-flower remedies are an effective placebo for test anxiety and do not have a specific effect.
- Approximately 30% of patients in homeopathic treatment will benefit after 1 y of treatment. There is no indication of a specific, or of a delayed effect of homeopathy.
- There is no indication that belladonna 30CH produces symptoms different from placebo or from no intervention. Symptoms of a homeopathic pathogenetic trial (HPT) are most likely chance fluctuations.
- Chronically ill patients who want to be treated by distant healing and know that they are treated improve in quality of life.
- Mind machines do not have a specific effect on general well-being and physiological relaxation, although they may produce unusual psychological experiences; people with psychiatric illnesses should not use such devices.
- Group evaluation showed no clearcut differences. The claim that homoeopathic potencies can produce symptoms other than placebo in healthy subjects should be put to further scrutiny.
So, as we see, Prof Walach has published many clinical trials on numerous SCAMs . Their majority arrived at positive conclusions. His TI is therefore sky-high. But he has also published studies that were dramatically negative, even some of homeopathy!
The main criterion for admission to THE ALTERNATIVE MEDICINE HALL OF FAME is to have published SCAM research that hardly ever concludes negatively. Does Walach fulfill it? Should he be allowed to join this illustrious group of people?
- Andreas Michalsen ( various SCAMs, Germany)
- Jennifer Jacobs (homeopath, US)
- Jenise Pellow (homeopath, South Africa)
- Adrian White (acupuncturist, UK)
- Michael Frass (homeopath, Austria)
- Jens Behnke (research officer, Germany)
- John Weeks (editor of JCAM, US)
- Deepak Chopra (entrepreneur, US)
- Cheryl Hawk (US chiropractor)
- David Peters (osteopathy, homeopathy, UK)
- Nicola Robinson (TCM, UK)
- Peter Fisher (homeopathy, UK)
- Simon Mills (herbal medicine, UK)
- Gustav Dobos (various SCAMs, Germany)
- Claudia Witt (homeopathy, Germany/Switzerland)
- George Lewith (acupuncture, UK)
- John Licciardone (osteopathy, US)
I have to admit, the decision was not easy in this case. However, after considering all the evidence, I have decided in favour of admission.
WELCOME PROF WALACH!
Professor Andreas Michalsen is the clinical director of the department of naturopathy in a Berlin hospital. He seems most keen to represent the scientific side of so-called alternative medicine in Germany. He has published several (fairly uncritical) books on SCAM and numerous papers in the medical literature. I had a look at those papers and hope you agree that Michalsen should join the other extraordinary experts in THE ALTERNATIVE MEDICINE HALL OF FAME:
- Jennifer Jacobs (homeopath, US)
- Jenise Pellow (homeopath, South Africa)
- Adrian White (acupuncturist, UK)
- Michael Frass (homeopath, Austria)
- Jens Behnke (research officer, Germany)
- John Weeks (editor of JCAM, US)
- Deepak Chopra (entrepreneur, Us)
- Cheryl Hawk (US chiropractor)
- David Peters (osteopathy, homeopathy, UK)
- Nicola Robinson (TCM, UK)
- Peter Fisher (homeopathy, UK)
- Simon Mills (herbal medicine, UK)
- Gustav Dobos (various, Germany)
- Claudia Witt (homeopathy, Germany and Switzerland)
- George Lewith (acupuncture, UK)
- John Licciardone (osteopathy, US)
My Medline search on 10/1/2021 for ‘Michalsen A, clinical trial’, generated 69 hits. Below I list the key conclusions of the 47 SCAM studies that were published in English by Andreas Michalsen et al:
- In this explorative pilot trial, an increase of HRV (more parasympathetic dominance and overall higher HRV) after ten weeks of yoga in school in comparison to regular school sports was demonstrated, showing an improved self-regulation of the autonomic nervous system. (pilot)
- Results showed a contrast between the high agreement of the consented final diagnosis and disagreement on certain diagnostic details.
- A single session of leech therapy is more effective over the short term in lowering the intensity of pain over the short term and in improving physical function and quality of life over the intermediate term.
- Short term fasting during chemotherapy is well tolerated and appears to improve QOL and fatigue during chemotherapy. Larger studies should prove the effect of STF as an adjunct to chemotherapy. (pilot)
- Administering verum (a complex homeopathic drug) resulted in a statistically significantly greater improvement of the Cough Assessment Score than the placebo. The tolerability was good and not inferior to that of the placebo.
- Ayurvedic treatment is beneficial in reducing knee OA symptoms.
- We did not find any clinically relevant differences between groups in this controlled clinical pilot trial of 8 wk of intermittent fasting in healthy volunteers.
- We found positive effects for both groups, which however were more pronounced in the Ayurvedic group. The conversational and counseling techniques in the Ayurvedic group offered more opportunities for problem description by patients as well as patient-centered practice and resource-oriented recommendations by the physician.
- Results of this study suggest that prolonged fasting is feasible and might have beneficial clinical effects. (pilot)
- This clinical trial indicates comparable efficacy of the herbal combination and antibiotic, although non-inferiority was not proved. However, the results and lessons learned are important for the planning of future trials.
- Thus, cycles of a 5-day fasting-mimiking diet are safe, feasible, and effective in reducing markers/risk factors for aging and age-related diseases.
- Ayurvedic external treatment is effective for pain-relief in chronic low back pain in the short term.
- Focused meditation and self-care exercise lead to comparable, symptomatic improvements in patients with chronic low back pain.
- This randomized trial found no effects of yoga on health-related quality of life in patients with colorectal cancer. Given the high attrition rate and low intervention adherence, no definite conclusions can be drawn from this trial.
- The Alexander Technique was not superior to local heat application in treating chronic non-specific neck pain.
- In conclusion, meditation may support chronic pain patients in pain reduction and pain coping.
- The herbal preparation of myrrh, chamomile extract and coffee charcoal is well tolerated and shows a good safety profile. We found first evidence for a potential efficacy non-inferior to the gold standard therapy mesalazine, which merits further study of its clinical usefulness in maintenance therapy of patients with ulcerative colitis.
- Yoga was more effective in relieving chronic nonspecific neck pain than a home-based exercise program. Yoga reduced neck pain intensity and disability and improved health-related quality of life. Moreover, yoga seems to influence the functional status of neck muscles, as indicated by improvement of physiological measures of neck pain.
- In this preliminary trial, yoga appears to be an effective treatment in chronic neck pain with possible additional effects on psychological well-being and QOL. (pilot)
- These results suggest that Gua Sha may be an effective treatment for patients with chronic neck and low back pain.
- The data indicate that during needle insertion high dose acupuncture stimulation leads to a higher increase of sympathetic nerve activity than low dose stimulation independent of personality. After needle insertion subjects who tend to augment incoming stimuli might show a lack of psychological relaxation when receiving high dose stimulation.
- In patients with METS, phlebotomy, with consecutive reduction of body iron stores, lowered BP and resulted in improvements in markers of cardiovascular risk and glycemic control.
- The present study gives preliminary evidence that healing clay jojoba oil facial masks can be effective treatment for lesioned skin and mild acne vulgaris.
- In a laboratory setting, an electroacupuncture procedure was as effective as a single dose of an orally administered opiate in reducing experimentally induced ischaemic pain.
- In the presence of modern treatments, complementary prescription of comprehensive lifestyle modification has no impact on coronary artery calcium progression but sustainable benefit for blood pressure, heart rate and the need of anti-ischemic medication is demonstrated.
- A single course of leech therapy was effective in relieving pain in the short-term and improved disability in intermediate-term. Leeches might be considered as an additional option in the therapeutic approach to lateral epicondylitis.
- Gua sha has beneficial short-term effects on pain and functional status in patients with chronic neck pain.
- Alterations in short-chain fatty acids were found in terms of significant changes to increased acetate levels in the fasting group.
- In this first study on the efficacy of cantharidin blisters, a clinically relevant pain-relieving short-term effect on lumbar spinal stenosis was observed.
- We conclude that cupping therapy may be effective in relieving the pain and other symptoms related to CTS.
- A single course of leech therapy is effective in relieving pain, improving disability and QoL for at least 2 months.
- The high effect sizes indicate that repeated rhythmic embrocation with Solum Oil may improve mood, pain perception (sensory PPS), and the ability to cope with pain (affective PPS) in patients with chronic low back pain.
- The data indicate, that verum acupuncture and sham acupuncture might have a beneficial influence on the autonomic nervous system in migraineurs with a reduction of the LF power of HRV related to the clinical effect. This might be due to a reduction of sympathetic nerve activity. VA and SA induce different effects on the high-frequency component of HRV, which seem, however, not to be relevant for the clinical outcome in migraine.
- Gua Sha increases microcirculation local to a treated area, and that increase in circulation may play a role in local and distal decrease in myalgia. Decrease in myalgia at sites distal to a treated area is not due to distal increase in microcirculation. There is an unidentified pain-relieving biomechanism associated with Gua Sha.
- These results are consistent with possible short-term benefits of a comprehensive lifestyle modification program on some aspects of quality-of-life and emotional well-being, but no effects were discernable 12 months after completion of therapy.
- In the presence of modern treatments, comprehensive lifestyle modification provides no additional benefits on progression of atherosclerosis but improves autonomic function, angina, and QOL with concomitant reduced need of medication. These responses are more pronounced in GNB3*825T allele carriers.
- Neither Mediterranean diet nor fasting treatments affect the microbiologically assessed intestinal flora and sIgA levels in patients with RA and FM.
- Women suffering from mental distress participating in a 3-month Iyengar yoga class show significant improvements on measures of stress and psychological outcomes.
- Adoption of a Mediterranean diet by patients with medically treated CAD has no effect on markers of inflammation and metabolic risk factors.
- A comprehensive lifestyle modification and stress management program did not improve psychological outcomes in medically stable CAD patients. The program did appear to confer psychological benefits for women but not men. Further trials should investigate gender-related differences in coronary patient responses to behavioral interventions.
- Mind-body therapy may improve quality of life in patients with UC in remission, while no effects of therapy on clinical or physiological parameters were found, which may at least in part be related to selective patient recruitment.
- Leech therapy helps relieve symptoms in patients with osteoarthritis of the knee.
- A home-based hydrotherapeutic thermal treatment program improves quality of life, heart-failure-related symptoms and heart rate response to exercise in patients with mild chronic heart failure. The results of this investigation suggest a beneficial adaptive response to repeated brief cold stimuli in addition to enhanced peripheral perfusion due to thermal hydrotherapy in patients with chronic heart failure.
- This open pilot study demonstrates that along with a decrease in sleep arousals a 1-week fasting period promotes the quality of sleep and daytime performance in non-obese subjects.
- Periarticular application of 4 leeches led to rapid relief of pain with sustained improvement after 4 weeks in the absence of major complications.
- Short-term fasting in inpatients with pain and stress syndromes is safe and well tolerated, concomitant mineral supplements have no additive benefit.
- The results suggest that the cardiovascular response during whole-body infrared-A irradiation is accompanied by significant changes in autonomic cardiac regulation: A significant decrease of low-frequency power corresponding to depressed vagal activity results in an increase of Iow/high-frequency ratio. During serial hyperthermias the acute response is diminished suggesting an adaption of the autonomic response to hyperthermia.
This list is impressive in several ways: very few SCAM researchers managed to publish 47 Medline-listed clinical studies, and nobody I know has ever conducted clinical trials of so many different SCAMs in so many different medical conditions. They include:
- Alexander technique
- Ayrurvedic medicine
- Blood letting
- Gua cha
- Herbal medicine
- Mind/body therapies
- Life style modification
While this is astounding, another fact is even more baffling: with just 2 or 3 exceptions, all these studies yield postive results. Whatever Michalsen touches turns to gold! And if it doesn’t, he spins the findings such that the conclusions are at least partly positive; see for instance No 14, 33, 36, 40 or 41 in the above list.
WELCOME TO THE ALTERNATIVE MEDICINE HALL OF FAME PROFESSOR MICHALSEN!
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.
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?
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’.
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.
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.
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.
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.
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.
I have to thank one of our regular commentators for inspiring me to write this post. He recently contributed this insight about homeopathic provings:
If you didn’t experience anything from a proving you didn’t perform it properly.
It is an argument that, in different forms and shapes, I have heard very often. Essentially it holds that, if an investigation or a test fails to produce the desired result, the methodology must have been faulty. Donald Trump is, I fear, about to use it in the upcoming US election: if he is voted out, he will claim that there was too much fraud going on. Therefore, he cannot accept the result as valid. Thus it is his democratic duty to remain in post, he is likely to claim.
In medicine, the argument has been popular since millennia. In our book TRICK OR TREATMENT?, we recount the story of blood letting. Based on the doctrine of the 4 humours, it was believed for centuries to be a panacea. If someone died after losing litres of blood to the believers in the doctrine, the assumption was not that he had been bled to death, but that he had sadly not received enough of the ‘cure all’. Eventually, some bright chap had the novel idea of running a rigorous test of blood-letting, and it turned out that the patients who had received the treatment had a worse chance of survival than those who had escaped it. Aaaahhh !!!, shouted the blood-letters, this shows that the concept of the scientific test is flawed.
Checking the methodological rigour of clinical studies (or homeopathic provings) can be a tricky and tedious business. It requires proper learning and experience – qualities that SCAM fanatics rarely possess. Amongst other things, one needs to know about:
- trial design,
- sources of bias,
- and the many tricks people use to hide flaws in published studies.
This is not easy and it takes time – lots of time – to acquire the necessary skills. Having discussed such issues with enthusiasts of so-called alternative medicine (SCAM) for decades, I realise that it would be unrealistic to expect of them to spend all this time learning all these complicated things (they have to make a living, you know!). I therefore propose an entirely new and much simpler method of differentiating between valid and invalid research of SCAM. It rests on merely 2 golden rules:
- Any research methodology is valid, if it produces the desired result.
- Any research methodology is invalid, if it fails to produce the desired result.
In analogy to these two rules, one can easily extrapolate further. For instance, one can state that:
- any person who generates or promotes the desired result is honest;
- any person who contradicts the desired result is corrupt (bought by ‘Big Pharma’).
I am sure my readers all see the beauty of this revolutionary, new system: it’s easy to learn, practical to apply, it avoids controversy and it takes full account of the previously much-neglected needs of the SCAM fraternity.