death
At present, we see a wave of promotion of Traditional Chinese Medicine (TCM) as a treatment of corona-virus infections. In this context, we should perhaps bear in mind that much of the Chinese data seem to be less than reliable. Moreover, I find it important to alert people to a stern warning recently published by two Australian experts. Here is the crucial passage from their paper:
We wish to highlight significant concerns regarding the association between traditional herbal medicines and severe, non-infective interstitial pneumonitis and other aggressive pulmonary syndromes, such as diffuse alveolar haemorrhage and ARDS which have emerged from Chinese and Japanese studies particularly during the period 2017−2019. Initially the association between traditional herbal therapies and pneumonitis was based on isolated case reports. These included hypersensitivity pneumonitis associated with the use of traditional Chinese or Japanese medicines such as Sai-rei-to, Oren-gedoku-to, Seisin-renshi-in and Otsu-ji-to (9 references in supplemental file). Larger cohorts and greater numbers now support this crucial relationship. In a Japanese cohort of 73 patients, pneumonitis development occurred within 3 months of commencing traditional medicine in the majority of patients [3], while a large report from the Japanese Ministry of Health, Labor and Welfare, described more than 1000 cases of lung injury secondary to traditional medications, the overwhelming majority of which (852 reports) were described as ‘interstitial lung disease [4].
Currently the constituent of traditional herbal medicines which is considered most likely to underlie causation of lung disease is Scutellariae Radix also known as Skullcap or ou-gon, which has been implicated through immunological evidence of hypersensitivity as well as circumstantial evidence, being present in all of those medicines outlined above [3]. Notably, skullcap is a constituent of QPD as used and described in the paper by Ren et al. relating to COVID-19 [1]. Scutellariae Radix-induced ARDS and COVID-19 disease share the same characteristic chest CT changes such as ground-glass opacities and airspace consolidation, therefore distinguishing between lung injury due to SARS-CoV-2 and that secondary to TCM may be very challenging. The potential for iatrogenic lung injury with TCM needs to be acknowledged [5]…
Morbidity and mortality from COVID-19 are almost entirely related to lung pathology [6]. Factors which impose a burden on lung function such as chronic lung disease and smoking are associated with increased risk for a poor outcome. Severe COVID-19 may be associated with a hypersensitivity pneumonitis component responsive to corticosteroid therapy [7]. Against this background the use of agents with little or no evidence of clinical efficacy and which have been significantly implicated in causing interstitial pneumonitis that could complicate SARS-CoV-2 infection, should be considered with extreme caution.
In conclusion, the benefits of TCM in the treatment of COVID-19 remain unproven and may be potentially deleterious. We recognise that there is currently insufficient evidence to prove the role of TCM in the causation of interstitial pneumonitis, however the circumstantial data is powerful and it would seem prudent to avoid these therapies in patients with known or suspected SARS-CoV-2 infection, until the evidence supports their use.
Declaration of Competing Interest: There are no conflicts to declare.
Frank Odds passed away on 7 July at the age of 75. He was well-known to regular readers of this blog. Having started to submit his views in 2014, he has contributed well over 1 500 insightful and helpful comments.
Prof Odds was a world leading expert in medical mycology, recognized internationally for his studies of fungal pathogens. He was recognized as an authority by academics, clinicians and those in the pharmaceutical industry. The European Confederation of Mycology wrote:
He wrote the defining text on Candida and was a major authority on fungal pathogenesis and antifungal drugs (having led Janssen’s antifungal drug discovery programme for 10 years). In no small measure he helped establish the reputation of the Aberdeen Fungal Group as a pre-eminent presence in medical mycology and was an integral part of the foundations upon which the current University of Exeter MRC-CMM was formed. He was a concert level pianist and he played the piano for the singsong at the BSMM annual meeting that was an integral part of the traditions of this society. During his career he acted as President of the BSMM, as well as of ISHAM and the ECMM.
Prof Odds has published about 300 original research and review articles on the pathogenesis, diagnosis, epidemiology and treatment of fungal infections. He acted as co-editor of the standard textbook ‘Clinical Mycology’ and was listed in the ISI Most Highly Cited Scientists (Microbiology) database in 2007 and he made many seminal contributions to his field.
Prof Odds led the antifungal drug discovery programme as Director of Bacteriology and Mycology at the Janssen Research Foundation (Johnson & Johnson) in Belgium for 10 years. He played a major role in the development of anti-fungal medicines azole and triazole. Eighteen patents bear Prof. Odds’ name as co-inventor and he served as a consultant and/or experimental contractor for more than 20 pharmaceutical companies.
Born on 29th August 1945 in Devon and educated in the South West of England. He undertook undergraduate and PhD degrees at the University of Leeds and became a visiting Fellow at the Center for Disease Control, in Atlanta USA (1970–72) before returning to the UK to undertake a postdoctoral fellowship at the University of Leeds (1972–75). He became a lecturer and then senior lecturer in Medical Microbiology at the University of Leicester (1975–89). In 1992 he accepted the post of Director of Bacteriology & Mycology at the Janssen Research Foundation, Beerse, Belgium (1992–99), and in 1999 he became Professor of Medical Mycology in the Aberdeen Fungal Group of the University of Aberdeen. He retired in 2009.
Prof Odds served as President of the International Society for Human and Animal Mycology, President of the European Confederation of Medical Mycology, Honorary Secretary and President of the British Society for Medical Mycology, and Chair of the Medical Mycology Division F of the American Society for Microbiology. He was co-chair and chair of the Wellcome Trust Immunology and Infectious Disease grant panel and on numerous editorial boards of international journals including acting as Chief Editor of Current Topics in Medical Mycology.
Prof Odd’s honours included Fellowship of the Royal Society of Edinburgh, Fellowship of the American Academy of Microbiology, and Honorary Membership of the British and International Medical Mycology societies. He received many prestigious prizes including an ISHAM award and medal, the Maxwell L. Littman Award from the New York Medical Mycology Society, and a Pfizer Award in Biology. He was also awarded an MRCPath and FRCPath in recognition of his clinical expertise.
On 9 July, Frank’s wife sent me an email:
The sad news has arrived: Frank died on Tuesday night, peacefully at home as he had wished.
During the final few days, his health deteriorated rapidly, but he was extremely well cared for by the NHS District Nurses, who could not have been kinder or more solicitous…
I feel honoured by the indefatigable attention he devoted to my blog (particularly since I had never met him in person) and am sure that we all will all miss his critical and constructive comments.
This analysis was aimed at assessing the associations of acupuncture use with mortality, readmission and reoperation rates in hip fracture patients using a longitudinal population-based database. A retrospective matched cohort study was conducted using data for the years 1996-2012 from Taiwan’s National Health Insurance Research Database. Hip fracture patients were divided into:
- an acupuncture group consisting of 292 subjects who received at least 6 acupuncture treatments within 183 days of hip fracture,
- and a propensity score matched “no acupuncture” group of 876 subjects who did not receive any acupuncture treatment and who functioned as controls.
The two groups were compared using survival analysis and competing risk analysis.
Compared to non-treated subjects, subjects treated with acupuncture had
- a lower risk of overall death (hazard ratio (HR): 0.41, 95% confidence interval (CI): 0.24-0.73, p = 0.002),
- a lower risk of readmission due to medical complications (subdistribution HR (sHR): 0.64, 95% CI: 0.44-0.93, p = 0.019)
- and a lower risk of reoperation due to surgical complications (sHR: 0.62, 95% CI: 0.40-0.96, p = 0.034).
The authors concluded that postoperative acupuncture in hip fracture patients is associated with significantly lower mortality, readmission and reoperation rates compared with those of matched controls.
That’s a clear and neat finding; the question is, what does it mean?
Here are a few possibilities for consideration:
- As a result of having at least 6 acupuncture sessions, patients had lower rates of mortality, readmission and reoperation.
- As a result of having lower rates of mortality, readmission and reoperation, patients used acupuncture.
- As a result of some other factor, patients had both lower rates of mortality, readmission and reoperation and at least 6 sessions of acupuncture.
Which of the three possibilities is the most likely?
- Some enthusiasts might think that acupuncture makes you live longer. But does anyone truly believe it reduces the likelihood of needing a reoperation? Seriously? Well, I don’t see even a hint of a mechanism by which acupuncture might achieve this. Therefore, I would categorise this possibility as highly unlikely.
- It stands to reason that patients who are alive and well use more acupuncture than those who are dead or in need of surgery. So, this possibility is not entirely inconceivable.
- It seems very likely that people who are more health conscious might use acupuncture and live longer, need less readmissions or surgery. No doubt, this possibility is by far the best explanation of the findings of this retrospective matched cohort study.
If that is so, does this paper tell us anything useful at all?
Not really (that’s why it was published in an acupuncture journal which few people would read)
On second thought, perhaps it does tell us something valuable: retrospective matched cohort studies are hopeless when it comes to establishing cause and effect!
New German Medicine?
German New Medicine?
What on earth is that?
German New Medicine (GNM) is the creation of Ryke Geerd Hamer (1935-2017), a German doctor. The name is reminiscent of the ‘Neue Deutsche Heilkunde’ created by the Nazis during the Third Reich. Hamer received his medical licence in 1963 but was later struck off because of malpractice. He then continued his practice as a ‘Heilpraktiker’. According to proponents, GNM Therapy is a spoken therapy based on the findings and research of the Germanic New Medicine of Dr.Hamer. On the understanding that every disease is triggered by an isolating and shocking event, GNM Therapy assists in finding the DHS (shocking moment) in our lives that preceded the dis-ease and in turn allowing our bodies to complete its natural healing cycle back to full health. Hamer believed to have discovered the ‘5 laws of nature’:
- The Iron Rule of Cancer
- The two-phased development of disease
- Ontogenetic system of tumours and cancer equivalent diseases
- Ontogenetic system of microbes
- Natures biological meaning of a disease
Hamer also postulated that:
- All diseases are caused by psychological conflicts.
- Conventional medicine is a conspiracy of Jews to decimate the non-Jewish population.
- Microbes do not cause diseases.
- AIDS is just an allergy.
- Cancer is the result of a mental shock.
None of Hamer’s ‘discoveries’ and assumptions are plausible or based on facts, and none of his therapeutic approaches have been shown to be effective.
These days, I do not easily get surprised by what I read about so-called alternative medicine (SCAM), but this article entitled ‘Homoeopathy And New German Medicine: Two German Siblings‘ baffled me greatly. Here are a few short excerpts:
… German New Medicine (GNM) like Homoeopathy is one of the gentle healing methods. As siblings, they have some common features as well as their own unique features. So, let’s explore a unique relationship between these two siblings.
1) Holistic aspect:
Both therapeutic methods are believed in holistic concept of body. The disease condition in Homoeopathy and conflict in GNM are very similar in expression as they are reflecting on mental as well as physical level also. In Homoeopathy, Mind, Body and Soul are one of the important trios to understand the Homoeopathic philosophy. While in GNM, Psyche, Brain, Body are important aspect in learning the GNM. Let’s see these trio in their founder’s language,
• Homoeopathy:
Dr. Hahnemann in his oragnon of medicine, 6th edition mentioned about a unity of materialistic body and vital force. Last lines of aphorism 15 are as follows, “…although in thought our mind separates these two unities into distinct conceptions for the sake of easy comprehension.
• German New Medicine:
Dr. Ryke Geerd Hamer, founder of GNM said that, “The differentiation between psyche, brain and the body is purely academic. In reality, they are one.”
2) Disease origin concept:
• Homoeopathy:
In Homoeopathy, disease originates from the dynamic disturbances and followed by functional and pathological changes.
• German New Medicine:
In GNM, morbid condition starts from conflict in the psyche level and later it reflects on body. The common feature is the disturbance is at the all levels of man.
3) Cause of disease:
• Homoeopathy:
In Homoeopathy, among the web of causations, psyche (mind) is also considers as a cause of disease.
• German New Medicine:
So, in GNM, psyche is playing important role in cause of disease. When Conflict starts, its dynamic effect perceived first at mind level.
4) Individuality:
• Homoeopathy:
In Homoeopathy, diathesis is a predisposition for disease condition. i.e. According to the diathesis every individual suffers with their own individual morbid dispositions. Rheumatic diathesis, gouty diathesis, etc. are the examples of diathesis.
• German New Medicine:
In GNM, every individual suffers from the disease condition after the receiving conflict. It is different and depending upon the type of conflict they are receiving. E.g. lung cancer- death fright conflict, cervical cancer –female sexual conflict…
Conclusion:
Some similarities and with some own characteristics, these two healing methods are developing at a good length in medical science. The main aim of these both methods is – “to serve the suffering humanity in gentle way”…
_____________________
Could it be that the author forgot the most striking similarities between GNM and homeopathy? How about these points:
- There is nothing truly gentle about either methods.
- Both are based on bizarre fantasies, far removed from reality.
- Both pretend to be a panacea.
- Both lack proof of efficacy.
- Both have the potential to kill patients (mostly through neglect).
- Both mislead consumers.
- Both are deeply anti-scientific.
- Both dissuade patients from using evidence-based healthcare.
- Both are in conflict with medical ethics.
- Both have cult-like features.
- Both are far from being recognised by proper healthcare.
- Both have been repeatedly in conflict with the law.
- Both were invented by deludes fanatics.
On his website, Phillip Hughes – D. Hom (Med), M.A.R.H, describes himself as follows:
In the early 1990’s my life was turned upside-down by a prolapsed disk in my back, putting me in traction in a hospital for 6 weeks! The doctor’s prognosis was poor, leaving me with little hope of full mobility, and no choice but to seek treatment elsewhere.
I decided on Homeopathy, and after treatment I experienced real change in my condition within a month, and was completely well within 3 months. I was so inspired by this I decided to study Homeopathy myself – and in 1994 I enrolled at the Hahnemann College of Homeopathy in London, qualifying in 1998.
After qualifying I set up my first clinic in Waterloo, Liverpool. I also became a senior lecturer at the Hahnemann College of Homeopathy, and founder of the Liverpool branch of the Hahnemann College.
I then moved my clinic to College Road Crosby, when I took up the role of secretary of Homeopathic Medical Association (since resigned). It was during this time that my wife Rosa found a lump in her breast, motivating us again to seek safer and alternative treatments, this time using Thermography. We now run Thermography and Homeopathic clinics side by side.
I had never heard of Mr Hughes until yesterday, when it was reported that he had treated a Sean Walsh, a young musician, for Hodgkin lymphoma that had initially been controlled with chemotherapy, but had later returned. Here is an excerpt from the sad story:
Sean was having scans at a clinic – Medical Thermal Imaging – run by a couple called Philip and Rosa Hughes. Philip Hughes, a homeopath, had previously told Sean’s parents he’d successfully treated Rosa for breast cancer. Dawn [Sean’s girlfriend] went along to Sean’s first appointment. “Phil was just talking all about how damaging chemotherapy is, you know, on the human body… saying, ‘I’ve had lots of people come to my clinic, but by the time I get them, they’re shot with all this chemotherapy, so I can’t help them … And then he was talking all about how you can change your diet, which can reverse cancer. He’d said that Rosa had developed breast cancer. She’d had a lump in her breast, and she decided not to do hospital treatment, and she was going to, you know, reverse the cancer herself. So obviously Sean’s listening to this thinking, ‘Well, if one person’s done it, and then I’m hearing other little stories off them, I can do this’. Sean’s scans did carry a disclaimer, stating that thermography does not see or diagnose cancer and recommending further clinical investigation. But the scan results seemed reassuring – and Sean was convinced his cancer had gone. ‘Medical Thermal Imaging’ describe their scans as “100% safe and radiation-free”.
To find out more about the service the Hughes were offering, a BBC reporter went to the clinic where Sean had his scans, posing as a patient who’d found a lump. They were seen by Rosa Hughes, who had provided scans for Sean. Rosa told our reporter that when she went to the breast clinic to have her lump investigated, she should have an ultrasound rather than a mammogram. This is a transcript of what she said: “Not a mammogram, because you’re going to get radiated, and it’s going to squash… and the amount of women that have had their tumours, the tumour burst, that spreads cancer.”
[The BBC] asked cancer specialist Prof Andrew Wardley, of Manchester’s Christie Hospital, to review the medical claims Rosa Hughes made to our reporter. “That’s preposterous. You don’t burst tumours, they are solid. You do squash the breast down to do a mammogram, it is unpleasant but it’s a short-term thing. You do not spread cancer by doing a mammogram, that’s a complete fallacy.” Rosa and Philip Hughes say they “utterly reject” the allegation that they gave Mr Walsh inappropriate advice. They added they had “consistently made clear” that thermography can only be used alongside other tests, such as MRIs or mammograms.
At first Sean believed he had cured his own cancer. But tragically Sean was wrong. Gradually his health declined, until he was rushed to hospital in Liverpool where medical staff found he had multiple tumours in his stomach and chest. He did eventually receive chemotherapy but it was too late.
Sean died in January 2019.
On Philip Hughes’ website, he advertises his services with the help of several testimonials from happy customers. Here is one of them:
In November 2000, I had an aggressive Sarcoma Tumour removed along with my left lung. Shortly after surgery I was referred to Weston Park Hospital, Sheffield for ‘follow up’ treatments where I was offered both chemotherapy and radiotherapy. At around the same time, I first visited Waterloo Homeopathic Clinic on a friends recommendation. After this initial introduction to Homeopathy I began ti educate myself about my condition and possible treatments. Consequently I considered chemotherapy to be a crude option and decided to refuse it. However, the frightening thought of this aggressive tumour returning encourages me to go ahead with a six week course of radiotherapy as a precaution alongside Homeopathic treatment. Accordingly this holistic approach resulted in my immune system being boosted by Homeopathy and my body prepared for this medical treatment. Leading up to the radiotherapy and during the six weeks of treatments, I took a rang of Homeopathic remedies. Radium Brom, in my opinion, was undoubtedly the input that enabled me to go through an intense course of treatment daily and continue my healthy recovery. I didn’t miss a days work and finished a half marathon only three weeks after completing the radiotherapy. I have since remained in good health and all checks been clear.
I have said it often, but it seems I have to say it again: the homeopathic remedy might be harmless, but the homeopath isn’t!
PS
The BBC documentary provides many more details about Sean and another of Mr Hughes’ patients. It also shows some rare footage from the inside of the Gerson clinic in Mexico where Sean went for a while. Very sad but well worth watching!!!
I have discovered ‘Google Scholar’!
Yes, of course, I knew about it, but I never used it much. In particular, I did not know it has a huge page just on me. So I had a good look at it (who would be able to resist?) and found many things of interest – for instance, the fact that (as of yesterday) my papers have been cited a total of 86 759 times, and that 4 of them have been cited more that a thousand times.
Here they are:
| Interactions between herbal medicines and prescribed drugs AA Izzo, E Ernst
Drugs 61 (15), 2163-2175
|
1517* | 2001 |
| Fibrinogen as a cardiovascular risk factor: a meta-analysis and review of the literature
E Ernst, KL Resch
Annals of internal medicine 118 (12), 956-963
|
1491 | 1993 |
| Influence of context effects on health outcomes: a systematic review
Z Di Blasi, E Harkness, E Ernst, A Georgiou, J Kleijnen
The Lancet 357 (9258), 757-762
|
1458 | 2001 |
| The prevalence of complementary/alternative medicine in cancer: a systematic review
E Ernst
Cancer: Interdisciplinary International Journal of the American Cancer …
|
1124 | 1998 |
Two things are perhaps noteworthy here, I feel:
- Only 2 of the 4 papers are on research in so-called alternative medicine (SCAM).
- In the 4th paper, they forgot to add Barrie Cassileth who was its co-author.
Scanning my own articles, the real revelation was how much I owe to others, how many co-workers I have had, how many of them I had completely forgotten about, and how many have already gone forever.
So, allow me to take this opportunity to honour those who have passed away (in the order they appear on the page).
- ARPAD MATRAI was a brilliant scientist, Olympic swimmer for Hungary, and close friend. He came to London in 1980 to work in my lab. After I had left, I attracted him to Munich where we had several hugely productive years together – until he died of leukaemia in 1988.
- JOHN DORMANDY see here.
- VERONIKA FIALKA was my senior registrar in Vienna and became a good friend. After I had left Vienna, she took over my position as head of the department. We then somehow lost contact and, one day, I received the sad news of her early death.
- NASSIM KANJI was my PhD student at Exeter. She did very well, and we published several papers on autogenic training together.
- PETER FISHER see here.
- GEORGE LEWITH see here.
- CHRIS SILAGY was a brilliant GP and researcher. We did not have much contact except for one paper we had together.
- JOHN GARROW see here.
- ANDREW HERXHEIMER see here.
- WALLACE SAMPSON was a famous and brilliant US sceptic. We had various contacts and shared one paper.
- P T FLUTE was head of haematology at St George’s Hospital, London while I worked there. I remember him as kind and supportive.
I owe more gratitude to these (and all my other) co-authors than I will ever be able to express.
When tested rigorously, the evidence for so-called alternatives medicine (SCAM) is usually weak or even negative. This fact has prompted many SCAM enthusiasts to become utterly disenchanted with rigorous tests such as the randomised clinical trial (RCT). They seem to think that, if the RCT fails to generate the findings we want, let’s use different methodologies instead. In other words, they are in favour of observational studies which often yield positive results.
This line of thinking is prevalent in all forms of SCAM, but probably nowhere more so that in the realm of homeopathy. Homeopaths see that rigorous RCTs tend not to confirm their belief and, to avoid cognitive dissonance, they focus on observational studies which are much more likely to confirm their belief.
In this context, it is worth mentioning a recent article where well-known homeopathy enthusiasts have addressed the issue of observational studies. Here is their abstract:
Background: Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades.
Method: We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide.
Results: Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe “real-world” care settings and can assist with the design and inform the results of randomised controlled trails.
Conclusions: We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.
In their paper, the authors state this:
It is important to realize three areas where observational research can be valuable. For one, as already mentioned, it can be valuable as a preparatory type of research for designing good randomized studies. Second, it can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Additionally, it can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. This might also lead to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions.
My comments to this are as follows:
- Observational research can be valuable as a preparatory type of research for designing good randomized studies. This purpose is better fulfilled by pilot studies (which are often abused in SCAM).
- Observational research can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Such situations rarely arise in the realm of SCAM.
- Observational research can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. I fail to see that this is true.
- Observational research leads to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions. The main aim of research into the effectiveness of SCAM should be, in my view, to determine whether the treatment per se works or not. Observational studies are likely to obscure the truth on this issue.
Don’t get me wrong, I am not saying that observational studies are useless; quite to the contrary, they can provide very important information. But what I am trying to express is this:
- We should not allow double standards in medical research. The standards and issues of observational research as they exist in conventional medicine must also apply to SCAM.
- Observational studies cannot easily determine cause and effect between the therapy and the outcome.
- Observational studies cannot be a substitute for RCTs.
- Depending on their exact design, observational studies measure the outcome caused by a whole range of factors, including the therapy per se, the placebo-effect, the natural history of the disease, the regression towards the mean.
- Observational studies are particularly useful in effectiveness research, AFTER the efficacy of a therapy has been established by RCTs.
- If RCT fail to show that a therapy is effective and observational studies seem to indicate that they work, the therapy in question is probably a placebo.
- SCAM-enthusiasts’ preference for observational studies is transparently due to motivated reasoning.
The objective of this study was to identify adverse drug reactions (ADR) associated with the use of so-called alternative medicine (SCAM) in Malaysia and to define factors which are associated with the more serious reactions. For this purpose, all ADR associated with the use of SCAM products (including health supplements) submitted to the Malaysian Centre for ADR Monitoring, National Pharmaceutical Regulatory Agency over a 15-year period were reviewed and analysed. Multivariate logistic regression analysis was performed to identify predictors of serious ADR.
From a total of 74 997 reports in the database, 930 (1.2%) involved SCAM products. From a total of 930 reports, 242 (26%) were serious ADR with 36 deaths. Six people died as a result of taking the SCAM, while another 30 cases were possibly associated with the SCAM products. Among the 36 mortality cases, adulterants were detected in 30% of cases. Examples of adulterants were dexamethasone, avanafil, nortadalafil and banned drugs such as phenylbutazone and sibutramine
About a third of the reports involved used SCAM products for health maintenance. Most (78.1%) of the ADR reports implicated unregistered products with 16.7% confirmed to contain adulterants which were mainly dexamethasone. Of the 930 reports, the ADR involved skin and appendages disorders (18.4%) followed by liver and biliary system disorders (13.7%). The odds of someone experiencing serious ADR increased if the SCAM products were used for chronic illnesses (odds ratio [OR] 1.99, confidence interval [CI] 1.46-2.71), having concurrent diseases (OR 1.51, CI 1.04-2.19) and taking concurrent drugs (OR 1.44, CI 1.03-2.02).
The authors concluded that the prevalence of serious ADR associated with SCAM products is high. Factors identified with serious ADR included ethnicity, SCAM users with pre-existing diseases, use of SCAM for chronic illnesses and concomitant use of SCAM products with other drugs. The findings could be useful for planning strategies to institute measures to ensure safe use of SCAM products.
The authors also point out that underreporting of ADRs remains a major ongoing issue in pharmacovigilance. Many SCAM consumers may not be vigilant or may be unaware of ADR they experience due to misconceptions on the
safety of SCAM products. Most doctors rarely ask their patients about the use of SCAM.
To this, I would add that SCAM providers do their utmost to give the impression that their products are natural and therefore safe. Furthermore the press is far too often perpetuating the myth, and the regulators tend to turn a blind eye.
I expect that some readers of this post will now point out that the rate of SCAM-related ADRs is very small compared to that of conventional drugs. They would be correct, of course. But they would also miss the point that the value of a treatment is not determined by its risk alone. It is determined by the risk/benefit balance. Where there is no effectiveness, this balance is negative, even if the risk is tiny.
So, now let me challenge the defenders of SCAM to name a few SCAMs that are demonstrably associated with a positive risk/benefit balance.
During the last few months, I have done little else on this blog than trying to expose misinformation about COVID-19 in the realm of so-called alternative medicine (SCAM). However, the usefulness and accuracy of most viewed YouTube videos on COVID-19 have so far not been investigated. Canadian researchers have just published a very nice paper that fills this gap.
They performed a YouTube search on 21 March 2020 using keywords ‘coronavirus’ and ‘COVID-19’, and the top 75 viewed videos from each search were analysed. Videos that were duplicates, non-English, non-audio and non-visual, exceeding 1 hour in duration, live and unrelated to COVID-19 were excluded. Two reviewers coded the source, content and characteristics of included videos. The primary outcome was usability and reliability of videos, analysed using the novel COVID-19 Specific Score (CSS), modified DISCERN (mDISCERN) and modified JAMA (mJAMA) scores.
Of 150 videos screened, 69 (46%) were included, totalling 257 804 146 views. Nineteen (27.5%) videos contained non-factual information, totalling 62 042 609 views. Government and professional videos contained only factual information and had higher CSS than consumer videos (mean difference (MD) 2.21, 95% CI 0.10 to 4.32, p=0.037); mDISCERN scores than consumer videos (MD 2.46, 95% CI 0.50 to 4.42, p=0.008), internet news videos (MD 2.20, 95% CI 0.19 to 4.21, p=0.027) and entertainment news videos (MD 2.57, 95% CI 0.66 to 4.49, p=0.004); and mJAMA scores than entertainment news videos (MD 1.21, 95% CI 0.07 to 2.36, p=0.033) and consumer videos (MD 1.27, 95% CI 0.10 to 2.44, p=0.028). However, they only accounted for 11% of videos and 10% of views.
The authors concluded that over one-quarter of the most viewed YouTube videos on COVID-19 contained misleading information, reaching millions of viewers worldwide. As the current COVID-19 pandemic worsens, public health agencies must better use YouTube to deliver timely and accurate information and to minimise the spread of misinformation. This may play a significant role in successfully managing the COVID-19 pandemic.
I think this is an important contribution to our knowledge about the misinformation that currently bombards the public. It explains not only the proliferation of conspiracy theories related to the pandemic, but also the plethora of useless SCAM options that are being touted endangering the public.
The authors point out that the videos included statements consisting of conspiracy theories, non-factual information, inappropriate recommendations inconsistent with current official government and health agency guidelines and discriminating statements. This is particularly alarming, when considering the immense viewership of these videos. Evidently, while the power of social media lies in the sheer volume and diversity of information being generated and spread, it has significant potential for harm. The proliferation and spread of misinformation can exacerbate racism and fear and result in unconstructive and dangerous behaviour, such as toilet paper hoarding and mask stealing behaviours seen so far in the COVID-19 pandemic. Consequently, this misinformation impedes the delivery of accurate pandemic-related information, thus hindering efforts by public health officials and healthcare professionals to fight the pandemic.
Good work!
I suggest to critically evaluate the statements of some UK and US politicians next.
Dr. Dhanunjaya Lakkireddy, a cardiologist at the Kansas City Heart Rhythm Institute in the US, has started a trial of prayer for corona-virus infection. The study will involve 1000 patients with COVID-19 infections severe enough to require intensive care. The four-month study will investigate “the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 patients,” according to a description provided to the National Institutes of Health.
Inclusion Criteria:
- Male or female greater than 18 years of age
- Confirmed positive for COVID-19
- Patient admitted to Intensive Care Unit
Exclusion Criteria:
- Patients admitted to ICU for diagnosis that is not COVID-19 positive
(Not giving informed consent is not listed as an exclusion criterion!)
Half of the patients, randomly chosen, will receive a “universal” prayer offered in five denominational forms, via:
- Buddhism,
- Christianity,
- Hinduism,
- Islam,
- Judaism.
The other 500 patients in the control group will not be prayed for by the prayer group. All the patients will receive the standard care prescribed by their medical providers. “We all believe in science, and we also believe in faith,” Lakkireddy claims. “If there is a supernatural power, which a lot of us believe, would that power of prayer and divine intervention change the outcomes in a concerted fashion? That was our question.”
The outcome measures in the trial are
- the time patients remain on ventilators,
- the number of patients who suffer from organ failure,
- the time patients have to stay in intensive care,
- the mortality rate.
On this blog, we have seen many other ‘corona-quacks’ come forward with their weird ideas. I ask myself why we give them not the opportunity to test their concepts as well? Why do we not spend our resources testing:
- homeopathy,
- chiropractic,
- ultraviolet blood irradiation,
- dietary supplements of all kinds,
- essential oils,
- TCM,
- cow dung and urine,
- dozens of herbal remedies,
- colloidal silver?
In my recent book, I included a short review of the literature on prayer as a medical intervention. This is what I wrote:
- Prayer can be defined as the solemn request or thanksgiving to God or other object of worship.
- Intercessory prayer is practised by people of all faiths and involves a person or group setting aside time for petitioning god on behalf of another person who is in need. Intercessory prayer is organised, regular, and committed. Those who practise it usually do not ask for payments because they hold a committed belief.
- The mechanisms by which prayer might work therapeutically are unknown, and hypotheses about its mode of action will depend to a large extent on the religious beliefs in question. People who believe in the possibility that prayers might improve their health assume that god could intervene on their behalf by blessing them with healing energy.
- These assumptions lack scientific plausibility.
- Numerous clinical trials have been conducted. Most of them fail to adequately control for bias, and their findings are not uniform.
- A systematic review of all these studies is available. It included 10 trials with a total of 7646 patients. The authors concluded that the findings are equivocal and, although some of the results of individual studies suggest a positive effect of intercessory prayer, the majority do not and the evidence does not support a recommendation either in favour or against the use of intercessory prayer. We are not convinced that further trials of this intervention should be undertaken and would prefer to see any resources available for such a trial used to investigate other questions in health care.[1]
[1] https://www.ncbi.nlm.nih.gov/pubmed/19370557
Lakkireddy says he has no idea what he will find. “But it’s not like we’re putting anyone at risk,” he says. “A miracle could happen. There’s always hope, right?”
Personally, I have a pretty good idea what he will find. I also find Lakkireddy not all that honest and think his assumptions are deeply mistaken:
- Lakkireddy cites an extensive list of references; however, the Cochrane review (usually the most reliable and independent source of evidence) that arrived to the conclusions I quoted above, he somehow ‘forgot’ to mention.
- As the review-authors tried to indicate, further trials of prayer are a waste of resources.
- There are many much more promising interventions to be tested, and by conducting this study, he is diverting research funds that are badly needed elsewhere.
- The study seems to have several ethical problems, e.g. informed consent.
- Contrary to Lakkireddy’s belief, he will harm in more than one way; apart from wasting resources, his study undermines rational thought and public trust in clinical research.
PERSONALLY, I FIND THIS PROJECT DESPICABLE!
