Recently, I received this comment from a reader:
Edzard-‘I see you do not understand much of trial design’ is true BUT I wager that you are in the same boat when it comes to a design of a trial for LBP treatment: not only you but many other therapists. There are too many variables in the treatment relationship that would allow genuine , valid criticism of any design. If I have to pick one book of the several listed elsewhere I choose Gregory Grieve’s ‘Common Vertebral Joint Problems’. Get it, read it, think about it and with sufficient luck you may come to realize that your warranted prejudices against many unconventional ‘medical’ treatments should not be of the same strength when it comes to judging the physical therapy of some spinal problems as described in the book.
And a chiro added:
EE: I see that you do not understand much of trial design
Perhaps it’s Ernst who doesnt understand how to research back pain.
“The identification of patient subgroups that respond best to specific interventions has been set as a key priority in LBP research for the past 2 decades.2,7 In parallel, surveys of clinicians managing LBP show that there are strong views against generic treatment and an expectation that treatment should be individualized to the patient.6,22.”
Journal of Orthopaedic & Sports Physical Therapy
Published Online:January 31, 2017Volume47Issue2Pages44-48
Do I need to explain why the Grieve book (yes, I have it and yes, I read it) is not a substitute for evidence that an intervention or technique is effective? No, I didn’t think so. This needs to come from a decent clinical trial.
And how would one design a trial of LBP (low back pain) that would be a meaningful first step and account for the “many variables in the treatment relationship”?
How about proceeding as follows (the steps are not necessarily in that order):
- Study the previously published literature.
- Talk to other experts.
- Recruit a research team that covers all the expertise you need (and don’t have yourself).
- Formulate your research question. Mine would be IS THERAPY XY MORE EFFECTIVE THAN USUAL CARE FOR CHRONIC LBP? I know LBP is but a vague symptom. This does, however, not necessarily matter (see below).
- Define primary and secondary outcome measures, e.g. pain, QoL, function, as well as the validated methods with which they will be quantified.
- Clarify the method you employ for monitoring adverse effects.
- Do a small pilot study.
- Involve a statistician.
- Calculate the required sample size of your study.
- Consider going multi-center with your trial if you are short of patients.
- Define chronic LBP as closely as you can. If there is evidence that a certain type of patient responds better to the therapy xy than others, that might be considered in the definition of the type of LBP.
- List all inclusion and exclusion criteria.
- Make sure you include randomization in the design.
- Randomization should be to groups A and B. Group A receives treatment xy, while group B receives usual care.
- Write down what A and B should and should not entail.
- Make sure you include blinding of the outcome assessors and data evaluators.
- Define how frequently the treatments should be administered and for how long.
- Make sure all therapists employed in the study are of a high standard and define the criteria of this standard.
- Train all therapists of both groups such that they provide treatments that are as uniform as possible.
- Work out a reasonable statistical plan for evaluating the results.
- Write all this down in a protocol.
Such a trial design does not need patient or therapist blinding nor does it require a placebo. The information it would provide is, of course, limited in several ways. Yet it would be a rigorous test of the research question.
If the results of the study are positive, one might consider thinking of an adequate sham treatment to match therapy xy and of other ways of firming up the evidence.
As LBP is not a disease but a symptom, the study does not aim to include patients that all are equal in all aspects of their condition. If some patients turn out to respond better than others, one can later check whether they have identifiable characteristics. Subsequently, one would need to do a trial to test whether the assumption is true.
Therapy xy is complex and needs to be tailored to the characteristics of each patient? That is not necessarily an unsolvable problem. Within limits, it is possible to allow each therapist the freedom to chose the approach he/she thinks is optimal. If the freedom needed is considerable, this might change the research question to something like ‘IS THAT TYPE OF THERAPIST MORE EFFECTIVE THAN THOSE EMPLOYING USUAL CARE FOR CHRONIC LBP?’
My trial would obviously not answer all the open questions. Yet it would be a reasonable start for evaluating a therapy that has not yet been submitted to clinical trials. Subsequent trials could build on its results.
I am sure that I have forgotten lots of details. If they come up in discussion, I can try to incorporate them into the study design.
A few months ago, I started contributing to a German blog. This has been fun but only moderately successful in terms of readership. This week, I posted something about a homeopath and his strange attitude towards COVID vaccinations. This post was so far read by around 20 000 people!
As it was so unusually successful (and because there is a big conference today on the subject), I decided to translate it for my non-German readers.
Here we go:
A lot of downright silly stuff is currently being written about vaccine side effects at the moment, not least on Twitter where I recently found the following comment from a medical colleague:
I’ve been a doctor for 25 years now. I have never experienced such an amount of vaccine side effects. I can’t imagine that other colleagues feel differently.
This kind of remark naturally makes you think. So let’s think a little bit about these two sentences. In particular, I would like to ask and briefly answer the following questions:
- How reliable is this physician’s impression?
- What does the reliable evidence say?
- Is it conceivable that this doctor is mistaken?
- What might be the causes of his error?
- Who is the author?
- Why is the tweet questionable?
1. How reliable is this doctor’s impression?
A whole 25 years of professional experience! So we are dealing with a thoroughly experienced doctor. His statement about the current unusually large amount of vaccination side effects should therefore be correct. Nevertheless, one should perhaps bear in mind that the incidence of side effects cannot be determined by rough estimations, but must be precisely quantified. In addition, we also need data on the severity and duration of symptoms. For example, is it only mild pain at the injection site or venous thrombosis? Are the symptoms only temporary, long-lasting, or even permanent? In general, it must be said that the experience of a physician, while not completely insignificant, does not constitute evidence. Oscar Wilde once said, “experience is the name we give to our mistakes.”
2. What does the reliable evidence tell us?
Even if the good doctor had 100 years of professional experience and even if he could accurately characterize the side effects, his experience would be trivial compared to the hard data we have on this subject. Nearly 2 billion vaccinations have now been performed worldwide, and we are therefore in the fortunate position of having reliable statistics to guide us. And they show that side effects such as pain at the injection site, fatigue, and headaches are quite common, while serious problems are very rare. A recent summary comes to the following conclusion (my translation):
The current data suggests that the currently approved mRNA-based COVID-19 vaccines are safe and effective for the vast majority of the population. Furthermore, broad-based vaccine uptake is critical for achieving herd immunity; an essential factor in decreasing future surges of COVID-19 infections. Ensuring sufficient COVID-19 vaccination adoption by the public will involve attending to the rising vaccine hesitancy among a pandemic-weary population. Evidence-based approaches at the federal, state, city, and organizational levels are necessary to improve vaccination efforts and to decrease hesitancy. Educating the general public about the safety of the current and forthcoming vaccines is of vital consequence to public health and ongoing and future large-scale vaccination initiatives.
3. Is it conceivable that this doctor is mistaken?
In answering this question, I agree with Oscar Wilde. The evidence very clearly contradicts the physician’s impression. So the doctor seems to be mistaken — at least about the incidence of side effects that are not completely normal and thus to be expected. Even if indeed ‘other colleagues feel no differently’, such a cumulative experience would still mislead us. The plural of ‘anecdote’ is ‘anecdotes’ and not ‘evidence’.
4. What might be the causes of his error?
I wonder whether our doctor perhaps did not see or did not want to see the following circumstance: It is inevitable that a physician, at a time when soon 50% of all Germans were vaccinated, also sees a lot of patients complaining about side effects. He has never seen anything like that in his 25-year career! That’s because we haven’t been hit by a pandemic in the last 25 years. For a similar reason, the colleague will treat far fewer frostbites in midsummer than during a severe winter. The only surprising thing would be not to see more patients reporting vaccine side effects during the biggest vaccination campaign ever.
5. Who is the author?
At this point, we should ask, who is actually the author and author of the above tweet? Perhaps the answer to this question will provide insight into his motivation for spreading nonsense? Dr. Thomas Quak (no, I did not invent the name) is a practicing homeopath in Fürstenfeldbruck, Germany. Like many homeopaths, this Quak probably has a somewhat disturbed relationship to vaccination. In his case, this goes as far as recommending several vaccine-critical machinations on his website and even offering ‘critical vaccination advice’ as a special service.
Now we can immediately put the Quak tweet in a better perspective. Dr. Quak is a vaccination opponent or critic and wants to warn the public: for heaven’s sake, don’t get vaccinated folks; side effects are more common than ever!!!! Therefore, he also conceals the fact that the side-effects are completely normal, short-term vaccination reactions, which are ultimately of no significance.
6. Why is the tweet concerning?
Perhaps you feel that the Quak and his Quack tweet are irrelevant? What harm can a single tweet do, and who cares about a homeopath from Fürstenfeldbruck? As good as none and nobody! However, the importance does not lie in a single homeopath unsettling the population; it consists in the fact that such things currently happen every day thousandfold.
In their narrow-mindedness, vaccination opponents of all shades want to make us believe that they are concerned about our well-being because they know more than we and all the experts (who are of course bought by the pharmaceutical industry). But if you scratch just a little at the surface of their superficiality, it turns out that the exact opposite is true. They are ill-informed and only interested in spreading their hare-brained, misanthropic ideology.
And why do homeopaths do this? There are certainly several reasons. Although Hahnemann himself was impressed by the success of vaccination, which was invented in his time and hailed as a breakthrough, most of his successors soon sided with vaccination critics. Many do so by warning (like our Quak) of side effects, thinking that they are thus protecting their patients. However, they ignore two very important points:
- Even if the dangers of vaccinations were much greater than they actually are (no one is claiming that they are completely harmless), the benefits would still far outweigh the potential harms.
- If the Quaks (and all the quacks) of this world succeeded in dissuading a sizable percentage of the population from vaccinating and thus save them from the ‘oh-so-dangerous side effects’, they would still be doing a real disservice to public health. With regard to COVID-19, this would mean that the pandemic would remain with us in the long term and cost many more lives.
Whatever the motives of the homeopathic anti-vax brigade, it is certain that their attitude is a threat to our health. This has repeatedly made me state:
The homeopathic pills may be harmless, but unfortunately, the homeopaths are not!
- COVID-19 vaccine availability: what are the side effects? | British Journal of General Practice (bjgp.org) ︎
- Review the safety of Covid-19 mRNA vaccines: a review – PubMed (nih.gov) ︎
- Vaccination Information (doktor-quak.de) ︎
In Germany, homeopathy had a free ride for a very long time. In recent years, however, several doctors, pharmacists, scientists, etc. have started opposing the fact that the public has to pay for ineffective treatments such as homeopathics. As a consequence, homeopaths have begun to fight back. The weapons they chose are often not the most subtle. Now they seem to have reached a new low; the Board of the German Central Association of Homeopathic Physicians (DZVhÄ) has sent an open letter to the Board of the German Society of Internal Medicine (DGIM) and to the participating colleagues of the 127th Congress of the DGIM from April 17 – 20, 2021 in an attempt to stop an invited lecture of a critic of homeopathy.
Here is my translation of the letter:
Dear colleagues on the board of the DGIM,
We were very surprised to read that an ENT colleague will speak on homeopathy at the 127th Congress of Internal Medicine. Dr. Lübbers is known up and down the country as a media-active campaigner against homeopathy. His “awakening experience” he had, according to his own account, when he had to fish homeopathic pills out of the ear of a child with otitis, since then he is engaged – no: not for better education, in the mentioned case of the parents or other users – against the method homeopathy (which was certainly not “guilty” of the improper application!).
It has surely not escaped you that in all media again and again only a small handful of self-proclaimed “experts” – all from the clique of the skeptic movement! – are heard on the subject of homeopathy. A single (!) fighter against homeopathy is a physician who completed her training in homeopathy and practices for a time as a homeopath. All the others come from non-medical and other occupational groups. In contrast, there are several thousand medical colleagues throughout Germany who stand on the ground of evidence-based medicine, have learned conventional medicine, implement it in their practices, and have completed a recognized continuing education program in homeopathy.
In the German Central Association of Homeopathic Physicians – the oldest medical professional association in Germany – 146 qualified internists are currently registered as members, in addition to numerous other medical specialists, all of whom are actively practicing medicine.
Question: Why does the German Society for Internal Medicine invite an ENT specialist, of all people, who lectures on homeopathy without any expertise of his own? Why not at least a specialist colleague in internal medicine? Or even a colleague who could report on the subject from her own scientific or practical experience? For example, on the topic of “hyperaldosteronism,” would you also invite a urologist or orthodontist? And if so, why?
Dear Board of Directors of the DGIM: As an honorary board member of the German Central Association of Homeopathic Physicians e.V.. (DZVhÄ) – and a specialist in internal medicine – I am quite sure that we could immediately name several colleagues with sufficient expertise as homeopathically trained and experienced internists, if you are really interested in a solid and correct discourse on the subject of homeopathy. Under the above-mentioned circumstances, there is, of course, rather the suspicion that it should not be about, but rather exclusively against homeopathy.
If it is planned for a later congress, e.g. in 2022, to deal again with the topic of homeopathy in a truly professionally well-founded and possibly even more balanced form: please contact us at any time! As medical colleagues, we are very interested in a fair and unprejudiced professional discourse.
Dr. med. Ulf Riker, Internist – Homeopathy – Naturopathy
2nd chairman DZVhÄ / 1st chairman LV Bayern
What are Riker and the DZVhÄ trying to say with this ill-advised, convoluted, and poorly written letter?
Let me try to put his points a little clearer:
- They are upset that the congress of internists invited a non-homeopath to give a lecture about homeopathy.
- The person in question, Dr. Lübbers, is an ENT specialist and, like all other German critics of homeopathy (apart from one, Dr. Grams), does not understand homeopathy.
- There are thousands of physicians who do understand it and are fully trained in homeopathy.
- They would therefore do a much better job in providing a lecture.
- So, would the German internists please invite homeopaths for their future meetings?
And what is Riker trying to achieve?
- It seems quite clear that he aims to prevent criticism of homeopathy.
- He wishes to replace it with pro-homeopathy propaganda.
- Essentially he wants to stifle free speech, it seems to me.
To reach these aims, he does not hesitate to embarrass himself by sending and making publicly available a very stupid letter. He also behaves in a most unprofessional fashion and does not mind putting a few untruths on paper.
Having said that, I will admit that they are in good company. Hahnemann was by all accounts a most intolerant and cantankerous chap himself. And during the last 200 years, his followers have given ample evidence that critical thinking has remained an alien concept for them. Consequently, such behavior seems not that unusual for German defenders of homeopathy. In recent times they have:
- Made the results of the largest investigation into homeopathy disappear because its results were devastatingly negative.
- Went to Liberia to cure Ebola with homeopathy.
- Published lots of untruths and exaggerations.
- Hired a journalist to systematically defame me and other critics.
- Likened critics to Roland Freisler, the infamous judge of the Nazi era.
- Threatened critics with legal action.
- Started a media campaign to promote homeopathy.
- Published libelous statements about me.
Quite a track record, wouldn’t you agree?
But, I think, attempting to suppress free speech beats it all and must be a new low in the history of homeopathy.
The General Chiropractic Council’s (GCC) Registrant Survey 2020 was conducted in September and October 2020. Its aim was to gain valuable insights into the chiropractic profession to improve the GCC’s understanding of chiropractic professionals’ work and settings, qualifications, job satisfaction, responsibilities, clinical practice, future plans, the impact of the COVID-19 pandemic on practice, and optimism and pessimism about the future of the profession.
The survey involved a census of chiropractors registered with the GCC. It was administered online, with an invitation email was sent to every GCC registrant, followed by three reminders for those that had not responded to the survey. An open-access online survey was also available for registrants to complete if they did not respond to the mailings. This was promoted using the GCC website and social media channels. In total, 3,384 GCC registrants were eligible to take part in the survey. A fairly miserable response rate of 28.6% was achieved.
Here are 6 results that I found noteworthy:
- Registrants who worked in clinical practice were asked if performance was monitored at any of the clinical practices they worked at. Just over half (55%) said that it was and a third (33%) said it was not. A further 6% said they did not know and 6% preferred not to say. Of those who had their performance monitored, only 37% said that audits of clinical care were conducted.
- Registrants working in clinical practice were asked if any of their workplaces used a patient safety incident reporting system. Just under six in ten (58%) said at least one of them did, whilst 23% said none of their workplaces did. A further 12% did not know and 7% preferred not to say.
- Of the 13% who said they had a membership of a Specialist Faculty, a third (33%) said it was in paediatric chiropractic, 25% in sports chiropractic, and 16% in animal chiropractic. A further 13% said it was in pain and the same proportion (13%) in orthopaedics.
- Registrants who did not work in chiropractic research were asked if they intended to work in that setting in the next three years. Seven in ten (70%) said they did not intend to work in chiropractic research in the next three years, whilst 25% did not know or were undecided. Only 5% said they did intend to work in chiropractic research.
- Registrants were also asked how easy it is to keep up to date with recommendations and advances in clinical practice. Overall, two-thirds (67%) felt it was easy and 30% felt it was not.
- Registrants were asked in the survey whether they felt optimistic or pessimistic about the future of the profession over the next three years. Overall, half (50%) said they were optimistic and 23% were pessimistic. A further 27% said they were neither optimistic nor pessimistic.
Perhaps even more noteworthy are those survey questions and subject areas that might have provided interesting information but were not included in the survey. Here are some questions that spring into my mind:
- Do you believe in the concept of subluxation?
- Do you treat conditions other than spinal problems?
- How frequently do you use spinal manipulations?
- How often do you see adverse effects of spinal manipulation?
- Do you obtain informed consent from all patients?
- How often do you refer patients to medical doctors?
- Do you advise in favour of vaccinations?
- Do you follow the rules of evidence-based medicine?
- Do you offer advice about prescribed medications?
- Which supplements do you recommend?
- Do you recommend maintenance treatment?
I wonder why they were not included.
The new NICE draft guideline on acupuncture for chronic pain has been published several months ago, and we discussed it here. Now the final document entitled ‘Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain‘ has been published on 7/4/2021. Like the draft, it includes quite a bit about acupuncture. Let me just quote three essential sections:
Recommendations: Acupuncture for chronic primary pain
Consider a single course of acupuncture or dry needling, within a traditional Chinese or Western acupuncture system, for people aged 16 years and over to manage chronic primary pain, but only if the course:
- is delivered in a community setting and
- is delivered by a band 7 (equivalent or lower) healthcare professional with appropriate training and
- is made up of no more than 5 hours of healthcare professional time (the number and length of sessions can be adapted within these boundaries) or
- is delivered by another healthcare professional with appropriate training and/or in another setting for equivalent or lower cost.
Many studies (27 in total) showed that acupuncture reduced pain and improved quality of life in the short term (up to 3 months) compared with usual care or sham acupuncture. There was not enough evidence to determine longer-term benefits. The committee acknowledged the difficulty in blinding for sham procedures, but agreed that the benefit compared with a sham procedure indicated a specific treatment effect of acupuncture. There was a wide variation among the studies in the type and intensity of the intervention used, and the studies were from many different countries. The committee agreed that the type of acupuncture or dry needling should depend on the individual needs of the person with pain.
Two economic evaluations (1 in the UK) showed that acupuncture offered a good balance of benefits and costs for people with chronic neck pain. However, both studies had limitations; a notable limitation being that the costs of acupuncture seemed low. Threshold analysis based on these studies indicated the maximum number of hours of a band 6 and 7 healthcare professional’s time that would make the intervention cost effective.
An original economic model was developed for this guideline, which compared acupuncture with no acupuncture. The model used data from studies with usual care comparisons, not comparisons with sham acupuncture, because the committee agreed that a usual care comparison in an economic model better reflects the real world benefit of the intervention. The model showed that acupuncture was likely to be cost effective. The committee considered the results to be robust, and agreed that the studies used in the model were representative of the whole evidence review. Acupuncture remained cost effective when the assumed benefits and costs were varied (sensitivity analysis).
Overall, the committee agreed that there was a large evidence base showing acupuncture to be clinically effective in the short term (3 months); the original economic modelling also showed it is likely to be cost effective. However, they were uncertain whether the beneficial effects would be sustained long term and were aware of the high resource impact of implementation. Taking these factors into account, the committee made a recommendation to consider acupuncture or dry needling for chronic primary pain, caveated by the factors likely to make the intervention cost effective. These were: only if delivered in the community, and with a maximum of 5 treatment hours (based on the average resource use in the trials in the model and on the threshold analysis), and from a band 7 (equivalent cost or lower) healthcare professional (based on the threshold analysis). It was agreed there may be different ways of delivering the service that enable acupuncture to be delivered for the same costs, which would equally be appropriate. The committee agreed that discontinuing before this total amount of course time would be an option if the person finds that the first few sessions are not effective.
Acupuncture versus sham acupuncture
Very low quality evidence from 13 studies with 1230 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months.
Low quality evidence from 4 studies with 376 participants showed no clinically important difference between acupuncture and sham acupuncture at >3 months. Moderate quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at >3 months. Low quality evidence from 1 study with 61 participants showed no clinically important difference between acupuncture
and sham acupuncture at >3 months.
______________END OF QUOTES____________
I will leave this here without a comment for the moment and look forward to reading what you think about this.
After yesterday’s post entitled ‘What does a holistic doctor do that a traditional doctor doesn’t?‘, I thought it would only be fair to turn the question around and ask: What does a proper doctor do that a holistic healer doesn’t? The answers will upset a lot of practitioners of alternative medicine (SCAM), but so be it.
So, what does a proper doctor do that a holistic healer doesn’t?
I suggest several answers and hope that the readers of this blog will contribute to further points. Many of them center around safeguarding the public:
- Proper doctors avoid confusing or misleading the public with titles they do not have.
- They do have rigorous education and training.
- They avoid making false therapeutic claims.
- They adhere to the ethical standards of their profession.
- They resist the temptation to advertise their services to the consumer.
- They do their best to identify the cause of their patient’s symptoms.
- They treat the causes of disease whenever possible.
- They avoid pretending that they always have all the answers.
- They abide by the rules of evidence-based medicine.
- They are aware that almost any effective treatment comes with adverse effects.
- They try to keep abreast with the rapid advances in medicine.
- They know that a patient is more than a diagnostic label.
- They try to treat patients holistically.
At this stage, I can hear some readers shout in anger:
- Ahh, but that is rubbish!
- I know doctors who are not at all like that!
- You are idealizing your profession!
- This is little more than wishful thinking!
Yes, I know that many patients are disappointed and have had a bad experience with conventional medicine. That is one of the reasons many try SCAM. I know that many doctors occasionally fail to live up to the ideal that I depicted above. And I fear that some do so more often than just occasionally.
This is regrettable and occasionally it is unacceptable. Medicine is populated not by perfect people; it is run by humans like you and me. Humans are fallible. Doctors have bad days just like you and me. If that happens regularly, we need to address the problems that may the cause of the deficit. If necessary, the case has to go before a disciplinary hearing. There are thousands of experts who are dedicated to improving healthcare in the hope of generating progress.
The point I was trying to make is that there is such a thing as an ideal physician. It relies on:
- rigorous training,
- ethical codes,
- post-graduate education,
- swift disciplinary procedures,
- advances brought about through colossal research efforts,
- etc., etc.
Do ‘holistic healers’ offer all of these safeguards?
The sad answer is no.
For those who disagree, let’s briefly look at a recent example.
- Mr. Lawler died because of a tear and dislocation of the C4/C5 intervertebral disc caused by a considerable external force.
- The pathologist’s report also showed that the deceased’s ligaments holding the vertebrae of the upper spine in place were ossified.
- This is a common abnormality in elderly patients and limits the range of movement of the neck.
- There was no adequately informed consent by Mr. Lawler.
- Mr. Lawler seemed to have been under the impression that the chiropractor, who used the ‘Dr’ title, was a medical doctor.
- There is no reason to assume that the treatment of Mr. Lawler’s neck would be effective for his pain located in his leg.
- The chiropractor used an ‘activator’ that applies only little and well-controlled force. However, she also employed a ‘drop table’ which applies a larger and not well-controlled force.
As far as I can see, most of the safeguards and standards that apply to conventional medicine were not in place to safeguard Mr. Lawler. And that includes a timely disciplinary hearing of the case. Mr. Lawler died in 2017! The CCG has been dragging its feet ever since, and, as far as I know, the chiropractor was meanwhile allowed to practise. The HEARING BEFORE THE PROFESSIONAL CONDUCT COMMITTEE OF THE GENERAL CHIROPRACTIC COUNCIL has now been scheduled to commence on 19 April 2021.
I know, it’s just an example. But it should make us think.
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)
The fact that the NHS England has stopped reimbursing homeopathy in 2018 is probably quite well known. France followed more recently, and then Germany too reported trouble for homeopaths on various levels. About two years ago, the manufacturer of homeopathic products, Hevert (Germany), threatened legal action against several German critics of homeopathy for expressing the fact that highly diluted homeopathic remedies do not work beyond placebo. Crucially, the medical associations of many regions in Germany have – one after the next – discontinued their training in and recognition of homeopathy.
Now similar difficulties are being felt also by Austrian homeopaths. In 2019, the Vienna medical school closed its course on homeopathy because students had filed a complaint about its unethical content. And recently, it was reported by the Austrian ‘Initiative für Wissenschaftliche Medizin‘ that at a secret webinar run by lobbyists in Vienna things were reported to no longer going well for homeopathy. Faced with such problems, the lobbyist, Dr. Jens Behnke, recommended in the above-mentioned secret webinar an alliance of all so-called alternative medicine (SCAM):
“…..and if we do not form this broad alliance now, in order to make appropriate professional PR and lobbying … then everything will fall apart….”
Now a union of pseudomedicine and politics is being forged with the aim of stopping the decline of quackery and paving the way for pseudomedicine in Austria. A resolution has been tabled in the Austrian parliament with the following demands:
- Institutionalising of the field of “Complementary Medicine” as “Integrative Medicine” in the academic education at all medical schools.
- Appropriate support for and funding of complementary medicine research, especially in the university sector.
- Establishment of a broad range of complementary medicine in the hospital sector, in outpatient but also inpatient healthcare.
- Promotion of active knowledge transfer in the area of integrative and complementary medicine within the Austrian medical profession.
- Securing of complementary diplomas by the Austrian Medical Association.
The motion was introduced by the Freedom Party (FPÖ, the Austrian far-right party) on 21.12.2020, forwarded to the Health Committee for consultation, and is now scheduled for consultation there. The application was introduced by the FPÖ-Nationalratsabgeordnete Mag. Gerhard Kaniak (Chairman of the Health Committee of Parliament, pharmacist), Peter Wurm (entrepreneur), Dr. Dagmar Belakowitsch (physician), and “other deputies”. It is supported by members of the “Initiative Complementary Medicine at Austrian Universities” of the Austrian Society for Homeopathic Medicine. The list of signatories of the motion reads like the “Who’s Who” of pseudo-medicine procedures in Austria – foremost homeopathy, but also anthroposophic medicine, ozone therapy, functional myo-diagnostics (= kinesiology), Ayurvedic medicine, orthomolecular medicine, TCM, etc. It almost goes without saying that it also includes Prof Michael Frass (a prominent member of THE ALTERNATIVE MEDICINE HALL OF FAME), who regular readers of my blog would have met several times before.
Instead of a comment (other than I sincerely wish that reason prevails in Austria and the motion is going to be defeated), I think I will quote the concluding phrases from my memoir (which incidentally also covers my most turbulent time in Vienna):
When science is abused, hijacked, or distorted in order to serve political or ideological belief systems, ethical standards will inevitably slip. The resulting pseudoscience is a deceit perpetrated on the weak and the vulnerable. We owe it to ourselves, and to those who come after us, to stand up for the truth, no matter how much trouble this might bring.
Physicians who include so-called alternative medicine (SCAM) in their practice are thought to have an understanding of health and disease different from that of colleagues practicing conventional medicine. The aim of this study was to identify and compare the thoughts and concepts concerning infectious childhood diseases (measles, mumps, rubella, chickenpox, pertussis, and scarlet fever) of physicians practicing homeopathic, anthroposophic and conventional medicine.
This qualitative study used semistructured interviews. Participating physicians were either general practitioners or pediatricians. Data collection and analysis were guided by a grounded theory approach.
Eighteen physicians were interviewed (6 homeopathic, 6 anthroposophic, and 6 conventional). All physicians agreed that while many classic infectious childhood diseases such as measles, mumps, and rubella are rarely observed today, other diseases, such as chickenpox and scarlet fever, are still commonly diagnosed. All interviewed physicians vaccinated against childhood diseases.
- A core concern for physicians practicing conventional medicine was the risk of complications of the diseases. Therefore, it was considered essential for them to advise their patients to strictly follow the vaccination schedule.
- Homeopathic-oriented physicians viewed acute disease as a biological process necessary to strengthen health, fortify the immune system and increase resistance to chronic disease. They tended to treat infectious childhood diseases with homeopathic remedies and administered available vaccines as part of individual decision-making approaches with parents.
- For anthroposophic-oriented physicians, infectious childhood diseases were considered a crucial factor in the psychosocial growth of children. They tended to treat these diseases with anthroposophic medicine and underlined the importance of the family’s resources. Informing parents about the potential benefits and risks of vaccination was considered important.
All physicians agreed that parent-delivered loving care of a sick child could benefit the parent-child relationship. Additionally, all recognized that existing working conditions hindered parents from providing such care for longer durations of time.
The authors concluded that the interviewed physicians agreed that vaccines are an important aspect of modern pediatrics. They differed in their approach regarding when and what to vaccinate against. The different conceptual understandings of infectious childhood diseases influenced this decision-making. A survey with a larger sample would be needed to verify these observations.
The authors (members of a pro-SCAM research group) stress that the conventional physicians saw many risks in the natural course of classic childhood illnesses and appreciated vaccinations as providing relief for the child and family. By contrast, the physicians trained in homeopathy or anthroposophic medicine expected more prominent unknown risks because of vaccinations, due to suppression of the natural course of the disease. Different concepts of disease lead to differences in the perceptions of risk and the benefit of prevention measures. While prevention in medicine aims to eliminate classic childhood diseases, anthroposophic and homeopathic literature also describes positive aspects of undergoing these diseases for childhood development.
This paper thus provides intriguing insights into the bizarre thinking of doctors who practice homeopathy and anthroposophical medicine. The authors of the paper seem content with explaining and sometimes even justifying these beliefs, creeds, concepts, etc. They make no attempt to discuss the objective truths in these matters or to disclose the errors in the thought processes that underly homeopathy and anthroposophical medicine. They also tell us that ALL the interviewed physicians vaccinated children. They, however, fail to provide us with information on whether these doctors all recommend vaccinations for all patients against all the named infectious diseases. From much of previous research, we have good reasons to fear that their weird convictions often keep them from adhering strictly to the current immunization guidelines.
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)