MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

risk/benefit

Guest post by Christian Lehmann

It’s the end of February. We see the first death, in the Oise department, near Paris, of a French citizen who has not recently travelled abroad. For doctors concerned about what is happening in China, this is the red alert. In spite of of the little notices posted by the health minister, Agnes Buzyn, at airports, the coronavirus has made it onto French soil. Nobody knows at that point how it will spread. Almost nobody, apart from those responsible for it, yet knows that France has completely run down its stocks of masks. Doctors themselves do know that the health service has only held out, for as long as it has, on the backs of its care personnel. Some are assessing the scale of what is to come.

The announcement by Didier Raoult about the spectacular effectiveness of a synthetic antimalarial, chloroquine, has brought enormous relief, followed immediately for many of us health professionals by growing doubts about an accumulation of errors: Raoult denies any toxicity, urges people to “fall upon” a medication requiring sensitive handling. When we locate the Chinese article on which Didier Raoult is basing his crisis communication, we are stupefied. No need for specialised knowledge in statistical methodology to understand that there is something seriously wrong. No numerical data. Nobody knows what dosage has been given, to what type of patient, nor how many have been treated. The article has not been “peer reviewed”, that is to say reviewed by professional equals; decoded, it has the effect of a simple announcement. So of course at this chaotic time we tell ourselves that, given a revelation of such importance, the Chinese wanted to act as quickly as possible, to inform the whole world. And Didier Raoult, who routinely advises, as he explains with delicious modesty, the Chinese, « the world’s best virologists », has probably been entitled to the first fruits of this revelation.

On Youtube, on 28 February, he posts a weird interview, “Why would the Chinese be mistaken?”, in which he repeatedly takes up his interviewer with obvious irritation. “No, that’s not the question that you should be asking me. You should be asking me….” An informal group of doctors and tweeters pass around the link. We are rubbing our eyes in disbelief. What Didier Raoult is passing off as an interview is nothing more then an audience accorded to one of his media aides. We advise him, sarcastically, to make a professional cut of the video before broadcasting it. An hour later the video disappears and returns in a more professional form which could create the illusion of a genuine interview. And rapidly, in the Press which is beginning to turn its microphones towards the Professor from Marseille, he modifies his stance, without ever acknowledging the radical changes.

Chloroquine, spectacular and miraculous only yesterday, disappears as if by magic, replaced from one day to the next by hydroxychloroquine (Plaquenil), a different medicine, less common. Though its chemical structure is close to that of the antimalarial medication, hydroxychloroquine is used primarily in rheumatic conditions such as rheumatoid polyarthritis, or immune conditions such as lupus. So at least it isn’t lying around in large quantities in medicine cabinets. And its cardiac toxicity, very real, is slightly lower then that of chloroquine. Didier Raoult puts forward HCQ as an immense discovery, continuing in his usual manner to ridicule his detractors. “The doctors who criticise me are neither in my field nor up to my weight”. He flays the inaction of embittered petty health officials, only fit to follow the diktats of the authorities, who, bogged down in their catastrophic crisis management, dare not intervene. And his posturing as a refractory Gaul, a loudmouth taking on the system, gains sympathy, from those to whom he gives hope, from those who understand that the State does not tell them everything, and from those looking for a hero to fit in with their stereotypes: the man on his own against the establishment, the White Knight taking on Big Pharma, the Hippocratic colossus besieged by hordes of soulless ants.

No one among those who hold out their microphones to him, not one asks him the question which we are all asking, GPs, cardiologists, pharmaceutical specialists, emergency specialists, resuscitation specialists – by what sleight of hand has Didier Raoult exchanged his miracle medicine, in 48 hours, openly and publicly? And how is it that no one has noticed the sleight-of-hand? Has this man who makes such a big deal of his image on social networks suddenly become aware of the risk of being confronted about chloroquine with a justifiable public outcry and with deaths by self-medication?

While the World Health Organisation is sounding alarm bells, in the context of overall mistrust with regard to scientific opinion, of confrontation with regard to government, of growing awareness ( belated and sometimes disproportionate) of the influence of Big Pharma, and as the initial fear gives way to real panic for some with the registration of each new case, Didier Raoult piles up Facebook likes, fans, sites to his glory. And for us, fearful, begins the long registration of flagrant mistruths delivered as revealed truths, which this professor will never have the honestly to set right.

For Didier Raoult, a minimum of intellectual integrity would demand that he admits having changed horses in midstream. That he admits that the concern of his despised detractors was well founded, with respect to chloroquine to which many have access without knowing its dangers ( Nivaquine is very often used in suicides). And, because Didier Raoult withdraws nothing, he continues to stash away all the profits of his media coverage. Every supporter of the Wise Man of Marseille piles in with testimony. Their brother, sister, uncle, the father-in-law of their hairdresser has been taking the Professor’s medicine ( Which one? ) for eight years in Africa and has never had a problem, so that’s the real proof that his detractors are just jealous, or, even worse, backed by “the lobbies”.

And untiringly we repeat the fundamental truths:

  • Yes chloroquine has existed for years
  • Yes it is widely used
  • But for a different treatment, the prevention of malaria
  • And in dosages 5 to 10 times smaller
  • And in large dosages it causes cardiac arrest
  • And it has never been effective in fighting a virus
  • Not this virus nor any other
  • And the same is true for hydroxychloroquine
  • In fact it’s rather the opposite

In fact what is being patiently stated by the upholders of the scientific method is very counter-intuitive, almost inaudible, because they are telling worried and disorientated people, who have put their trust and their hope in one man, that in his assertions………nothing makes sense.

These are exceptional times and they need exceptional measures. Therefore, I am yet again deviating from my policy of focussing exclusively on SCAM and welcome my French colleague Dr Lehmann posting a series of articles on the hydroxychloroquine story.

Guest post by Christian Lehmann

 

THE ELEPHANT IN THE ROOM

This pandemic diary was begun just before lock down, already four weeks ago, and yet I have scarcely touched on the elephant in the room. Our personal elephant is called Didier Raoult. White-haired with age, venerable in appearance, he has been number one in the press, constantly in capitals in online news headlines, waking hopes, feeding passions. And arousing the interest of a plethora of epidemiologists of renown, from Valerie Boyer to Donald Trump, by way of Alain Soral and Alexandre Benalla.

Everything begins on 25 February 2020, when the microbiology professor from Marseille posts his famous video “Coronavirus, game over”, since more modestly re-baptised “Coronavirus, towards a way out of the crisis?”.

Standing in front of a student audience out of camera, Didier Raoult reveals “a last-minute scoop, a very important piece of news”: the Chinese, whom he regularly advises, rather than seeking a vaccine or new products have been “repositioning”, trying old molecules, “known, old, without toxicity,” among them chloroquine, which has shown itself to be effective in a daily dose of 500 mg per day “with a spectacular improvement and it is recommended for all clinically positive cases of coronavirus. This is excellent news, it is probably the easiest respiratory infection of all to treat” Here, the whole roomful laughs, with pleasure, with relief, and I remember sharing these sentiments, briefly, but completely. Because this was 26th of February, because like others I felt confusedly that the reassurances with which Agnes Buzyn ( then the French Health Minister) was inundating us were built on sand, and that the virus would only laugh at little notices in airports.

I knew Didier Raoult only by name, as a columnist in Point, I had read some of his articles and I had felt simultaneously soothed by his smooth eloquence, attracted by some of his iconoclastic stances, but also sometimes rather irritated by his Mandarin-style fake cool posturing. At the end of February, I immediately reposted the video in the medical forums, on the walls of worried friends, explaining that, if the suggestions of Didier Raoult were confirmed, we would have escaped with a scare which would soon be dispelled by this “magic bullet”, this “game changer”.

Then between two consultations in my GP’s office, later that afternoon, I watched that video “Game Over” again. How could such an important piece of news have reached me by means of a Youtube video? Where were the overseas publications, the much vaunted Chinese study, the releases from AgenceFrancePresse, Reuters, the first articles from the New York Times and the Guardian, proclaiming from the rooftops that the pandemic we had so much feared was in fact only a technical hitch, easily controllable by a widely available drug. It was at that second viewing that I balked. As a GP who had worked in cardiac resuscitation some years ago, I was brought up short by hearing Didier Raoult talking up a medicine “well known, and devoid of any toxicity”. If chloroquine or Nivaquine, to give it its commercial name, is celebrated for the prevention of malaria, it is also a medicine known for its frightening toxicity as soon as the dose is exceeded, with the risk of irreversible visual damage and extremely serious problems with cardiac rhythm which can prove fatal. To say that chloroquine is without toxicity problems is in fact an error, all the more so because the dose suggested by “the Chinese”, without an iota of proof at this stage, is five times larger than the customary dose, 500 mg instead of 100 mg.

Deeply uneasy, I’m in discussion with doctor friends on Twitter when the video makes its appearance there. We know nothing at this point about Didier Raoult’s past, or about his Marseille Institute. Neither the enmity felt towards him by the Parisian intelligentsia represented by Agnes Buzyn and her husband, nor the fact that his institute has just lost its INSERM and CNRS accreditations, nor the stance adopted by him a month earlier explaining that coronavirus would never escape from China and that it was ridiculous to get worked up about it because “the world has gone mad, something or other happens and three Chinese die and that brings about a world-scale alert”.

Some of us, practitioners and first responders, knew well the toxicity of chloroquine, that it was to be handled with care, and that was about all we said on Twitter. It was already too much. The next day in a 20 minute interview Didier Raoult brushed away his detractors. “Malicious gossip, I don’t give a damn about it. When a medication has been shown to work on 100 people while all the world is busy having a nervous breakdown, and there’s some idiots who say there’s no certainty that it works, I’m not interested! It would honestly be medical misconduct not to use chloroquine to treat Chinese coronavirus”. And he drives the point home. “People who have lived in Africa like me took chloroquine every day. Everybody who went to hot countries took it throughout their time there, and for two months after they came home. Billions of people have taken this medication. And it costs nothing: ten centimes per pill. It is a medication which is extremely reliable and it’s the cheapest imaginable. So this is super amazing news. Everybody who learns about these benefits should fall upon it.” This is no longer a mistake, this is grave medical misconduct. Nobody who knows about therapeutics would use such words so lightly.

Cardiologists, resuscitation specialists, emergency doctors, GPs, public-health specialists, we are all alarmed. Our first warnings are vehement and rational, reaffirming the toxicity of chloroquine in cardiology, and the majority of us insisting on the senseless and significant risk which Didier Raoult is running. Because it is familiar, prescribed for long stays in Africa in packages of 100 tablets, chloroquine is lying around in many medicine cabinets. To declare as a fact that we should “fall upon it” in this agonising pandemic context is to encourage unrestrained self medication, and to endanger life. Incoherent, dangerous, this announcement disturbs us deeply. Incredulous, not for a moment do we imagine just what Didier Raoult will unleash, nor that the nightmare had already begun.

 

DD Palmer, the founder of chiropractic, famously claimed that 95% of all diseases are caused by subluxations of the spine and the rest by subluxations of other joints. He said and stated this theory in different forms not once but dozens of times, and it thus quickly became the mantra of chiropractic. When it was noted that subluxation, as imagined by Palmer and his son BJ, did not exist, chiropractors found themselves with a considerable amount of egg on their faces.

Ever since, they have tried to cover up the blemish, some by repeatedly re-defining subluxation, others by claiming that they do not believe in Palmer’s theory anyway. The issue was and is fiercely fought over even threatened to break up the profession. At present, we are being told incessantly that large chunks of the profession are reformed, have come to terms with their profession’s foundation in a fictional concept, and have now abandoned subluxation altogether.

Critics, in turn, are quick to point out that, if that is so, chiropractors lack a ‘raison d’être’. The best chiropractors of this persuasion could do, they say, is to re-train as physiotherapists who also use spinal manipulation but without the nonsensical chiropractic ‘philosophy’.

While this debate is ongoing and shows no sign of subsiding, it is relevant, of course, to ask what proportions of the chiropractic profession belongs to which persuasion. This paper evaluated the issue of the professional identity within the profession of chiropractic based on the literature from 2000 to 2019. Initially 562 articles were sourced, of which 24 met the criteria for review.

The review confirmed three previously stated professional identity subgroups:

  • a vitalistic approach pro subluxation,
  • a approach contra subluxation,
  • a centrist or mixed view.

Whilst these three main chiropractic identity sub-types exist, the terminology used to describe them differs. Research aimed at categorising the chiropractic profession identity into exclusive sub-types found that at least 20% of chiropractors have an exclusive vertebral subluxation focus. However, deeper exploration of the literature shows that vertebral subluxation is an important practice consideration for up to 70% of chiropractors.

The review also found that practising chiropractors consider themselves to be primary care or primary contact practitioners with a broad scope of practice across a number of patient groups not limited to musculoskeletal management.

So, if I understand these findings correctly, they confirm that chiropractors like to see themselves as physicians who are able to treat most conditions that present themselves in primary care. At the same time, their majority considers that vertebral subluxation is an important practice consideration. This clearly suggests they are likely to treat most conditions by adjusting spinal subluxations. In turn, this implies that DD Palmer’s dictum, ‘95% of all conditions are caused by subluxations of the spine’, is still adhered to by about 70% of all chiropractors.

If this is so, the best advice I can give to the general public is this: if you have a health problem, the last person you should consult is a chiropractor.

Wouldn’t it be wonderful, if we had a treatment that reduces the risk of getting infected with the corona-virus? Well, this paper claims that there is one. Here is its abstract:

Since December 2019, an outbreak of corona virus disease 2019 (COVID-19) occurred in Wuhan, and rapidly spread to almost all parts of China. This was followed by prevention programs recommending Chinese medicine (CM) for the prevention. In order to provide evidence for CM recommendations, we reviewed ancient classics and human studies.

Methods

Historical records on prevention and treatment of infections in CM classics, clinical evidence of CM on the prevention of severe acute respiratory syndrome (SARS) and H1N1 influenza, and CM prevention programs issued by health authorities in China since the COVID-19 outbreak were retrieved from different databases and websites till 12 February, 2020. Research evidence included data from clinical trials, cohort or other population studies using CM for preventing contagious respiratory virus diseases.

Results

The use of CM to prevent epidemics of infectious diseases was traced back to ancient Chinese practice cited in Huangdi’s Internal Classic (Huang Di Nei Jing) where preventive effects were recorded. There were 3 studies using CM for prevention of SARS and 4 studies for H1N1 influenza. None of the participants who took CM contracted SARS in the 3 studies. The infection rate of H1N1 influenza in the CM group was significantly lower than the non-CM group (relative risk 0.36, 95% confidence interval 0.24–0.52; n=4). For prevention of COVID-19, 23 provinces in China issued CM programs. The main principles of CM use were to tonify qi to protect from external pathogens, disperse wind and discharge heat, and resolve dampness. The most frequently used herbs included Radix astragali (Huangqi), Radix glycyrrhizae (Gancao), Radix saposhnikoviae (Fangfeng), Rhizoma Atractylodis Macrocephalae (Baizhu), Lonicerae Japonicae Flos (Jinyinhua), and Fructus forsythia (Lianqiao).

Conclusions

Based on historical records and human evidence of SARS and H1N1 influenza prevention, Chinese herbal formula could be an alternative approach for prevention of COVID-19 in high-risk population. Prospective, rigorous population studies are warranted to confirm the potential preventive effect of CM.

So, what should we make of this conclusion?

To provide an evidence-based answer, I tried to look up the original studies cited in the article. The links provided by the authors seem to be all dead except one which leads to a paper published in the infamous JCAM. Here is its abstract:

Objectives: To investigate the efficacy of an herbal formula in the prevention of severe acute respiratory syndrome (SARS) transmission among health care workers. The secondary objectives are to investigate quality of life (QOL) and symptomology changes among supplement users, and to evaluate the safety of this formula.

Design: Controlled clinical trial.

Settings: Hong Kong during epidemic of SARS.

Subjects: Two cohorts of health care workers from 11 hospitals in Hong Kong, 1 using an herbal supplement for a 2-week period (n = 1063) and a control cohort comprising all other health care workers who did not receive the supplement (n = 36,111) were compared prospectively.

Interventions: Taking an herbal supplement for a 2-week period.

Outcome measures: SARS attack rates and changes in quality of life and influenza-like symptoms were also examined at three timepoints among herbal supplement users.

Results: None of the health care workers who used the supplement subsequently contracted SARS compared to 0.4% of the health care workers who did not use the supplement (p = 0.014). Improvements in influenza-like symptoms and quality of life measurements were also observed among herbal supplement users. Less than 2% reported minor adverse events.

Conclusion: The results of this pilot study suggest that there is a good potential of using Traditional Chinese Medicine (TCM) supplements to prevent the spread of SARS.

How can I be polite and still say what I think about this article? Perhaps by stating this: THIS STUDY WAS INCAPABLE OF INVESTIGATING THE ‘EFFICACY’ OF ANYTHING AND ITS RESULTS ARE NOT CONVINCING.

So, are the Chinese authors correct when concluding that Chinese herbal formula could be an alternative approach for prevention of COVID-19 in high-risk population?

No, I don’t think so! And I even feel that it is irresponsible in the current situation to misguide consumers, patients, scientists and decision-makers into believing that TCM offers an answer to the pandemic.

 

Here is an open letter published yesterday, initiated by SENSE ABOUT SCIENCE and signed by many UK scientists and other experts. If you agree with it, you can still add your name to the signatories (see below):

 

 

Dear Mr Johnson

We urge you to start publishing the government’s evolving plans for coronavirus testing, and the evidence they are based on.

Testing is key to understanding the risks and to how people can get back to work and normal life. It is what major decisions will be based on, but there are also limits to what it can tell us.

People are frustrated and confused about the scientific and logistical challenges of testing and what the government is doing about it. The internet and media are awash with rumours and the public are valiantly trying to work their way through fragments of information. People in senior positions in healthcare, in government departments, in research and in the related industries are struggling to see whether their input is needed and how to give it.

Why is testing delayed? Is there a shortage of tests? Is there a shortage of chemicals? Do they only work 30% of the time? Will there be tests to see whether someone’s had the virus? Can people test themselves or does it have to be done by a clinic? These are just a handful of the many questions being asked. Scientists and government representatives are trying to answer them but it’s a losing battle with volume and reach.

The UK government’s response to this epidemic started by levelling with people in a clear way about the emerging evidence and transparency on the government’s evolving thinking about that evidence. Of course, continuing to tell people what is happening has become complex and challenging. But that won’t be brought under control by limiting communication to behavioural instructions or by your efforts to clamp down on misinformation. The government cannot clamp down on misinformation without substituting information in its place. Would the government please maintain its commitment to evidence transparency and put its evolving plans and evidence on testing on an open site where the public, experts and government agencies can follow them and to which those who are trying to address confusion can direct people.

Yours faithfully

Tracey Brown OBE, director, Sense about Science

Carl Heneghan, director, Centre for Evidence Based Medicine

Justine Roberts, CEO, Mumsnet

Emma Friedmann, campaign director, FACSaware

Professor Sarah Harper, The Oxford Institute of Population Ageing, University of Oxford

Mairead MacKenzie, Independent Cancer Patient Voices

Rose Woodward, Founder, Patient & Advocate, Kidney Cancer Support Network

Dr Bu’Hussain Hayee PhD FRCP AGAF, Clinical Lead for Gastroenterology

I.Chisholm-Bunting, School of Nursing and Allied Health

Rachael Jolley, editor in chief, Index on censorship

Caroline Fiennes, director, Giving Evidence

Dr Ritchie Head, director, Ceratium

Tommy Parker, KiActiv

Professor Annette Dolphin FRS, FMedSci, President of British Neuroscience Association

Dr James May, Vice Chair, Healthwatch and GP

Peter Johnson, Patient representative with respiratory conditions

A. P. Dawid, FRS Emeritus Professor of Statistics, University of Cambridge

Stafford Lightman FMedSci FRS, Professor of Medicine, University of Bristol

Dr Christie Peacock CBE PhD FRAgS FRSB Hon DSc, Founder and Chairman, Sidai Africa (Kenya) Ltd

Caroline Richmond, Medical journalist

Professor Stephan Lewandowsky FAcSS, Chair in Cognitive Psychology, University of Bristol

Hugh Pennington CBE, Emeritus Professor of Bacteriology, University of Aberdeen

Prof. Wendy Bickmore FRS, FRSE, FMedSci, Director: MRC Human Genetics Unit, University of Edinburgh

Benjamin Schuster-Böckler, PhD, Research Group Leader, Ludwig Institute for Cancer Research

Dr Max Pemberton, Daily Mail columnist and NHS Doctor

Diana Kornbrot, Emeritus Professor of Mathematical Psychology, University of Hertfordshire

Professor Patrick Eyers, Chair in Cell Signalling, University of Liverpool

Lelia Duley, Emeritus Professor, University of Nottingham

Edzard Ernst, Emeritus Professor University of Exeter

Ianis Matsoukas, Biomedical Sciences, University of Bolton

Dr Lorna Gibson, Radiology Registrar, New Royal Infirmary of Edinburgh

Sylvia Schröder, Senior Research Fellow, UCL

Dr Emma Dennett, St George’s University of London.

Ellie Wood, School of GeoSciences, University of Edinburgh

Sophie Faulkner, clinical doctoral research fellow / occupational therapist

Dr Maya Hanspal, research assistant, UK Discovery Lab

Dr John Baird, University of Aberdeen

Martin Stamp, managing director, Ionic Information

Saša Jankovic, Journalist

Kate Ravilious, Freelance Science Writer

Charise Johnson, policy advisor

Dr Sophie Millar, University of Nottingham

Bissera Ivanvoa, Research Assistant in Linguistics, The University of Leeds

Baroness Jolly, House of Lords

Dr. Simon Keeling MSc, PhD, RMet, FRMetS, The weather centre

Laurie van Someren, Aleph One Ltd

Prof Chris Kirk, former Hon. Sec. Royal Society of Biology.

Sergio Della Sala, Professor of Human Cognitive Neuroscience, University of Edinburgh

Dr. Wilber Sabiiti,Senior Research fellow in Medicine, University of St Andrews

Prof. Bob Brecher, Director, Centre for Applied Philosophy, Politics and Ethics, University of Brighton

Dr Sabina Michnowicz, UCL Hazard Centre

David Orme, Research Assistant, Cortex Lab

Rebecca Dewey PhD, Research Fellow in Neuroimaging

Dr Ricky Nathvani, Imperial College London.

Rita F. de Oliveira, Senior lecturer Sport and Exercise Science, London South Bank University

Prof Christopher C French, Head of the Anomalistic Psychology Research Unit, Goldsmiths, University of London

Kirstie Tew, Lead Scientist, KiActiv®

Dr Ben Martynoga, Freelance writer

Nigel Johnson, Patient representative with respiratory conditions

Dr Mimi Tanimoto – Science Communications Consultant

Till Bruckner, TranspariMED

Lesley-Anne Pearson, The University of Dundee

Sue O’Connell, retired consultant microbiologist, Health Protection Agency

Hao Ni, Associate Professor, Department of Mathematics, UCL, The Turing Fellow, the Alan Turing Institute

Dr Simon Underdown, FSA, FRSB, Director – Centre for Environment and Society

Matthew A Jay, PhD Student in Legal Epidemiology, University College London

Michael Butcher, Chairman, dataLearning Ltd

Professor Tom Crick, Swansea University

Dr J K Aronson, Consultant Physician and Clinical Pharmacologist, Centre for Evidence Based Medicine

Dr Thomas O’Mahoney, Anglia Ruskin University

Professor Ianis G. Matsoukas PhD (Biomedical Sciences), University of Bolton

Emeritus Professor Nigel Brown, Blackah-Brown Consulting

Danae Dodge, Ask for Evidence Ambassador

Ieuan Hughes, Department of Paediatrics, University of Cambridge, Addenbrooke’s Hospital

Mandy Payne, Freelance Medical Editor

Lyssa Gold, University of St Andrews

Please email hello@senseaboutscience.org with your name and description if you wish to add yourself to the letter.

Many hundreds of plants worldwide have a place in folk medicine as treatments for microbial infections and antimicrobial activity of extracts in vitro may be readily assessed in microbiology laboratories. Many so tested are reported to show inhibitory effects against a range of organisms. For less than responsible entrepreneurs, this is often enough reason to promote them as therapeutic options.

But laboratory testing can at best be only a very crude, though relatively inexpensive and rapid screen, while in vivo testing is very costly and time consuming. On this background, we conducted a review in 2003 to examine the range of plants or herbs that have been tested for antiviral properties in laboratories, animals and humans. Here is its abstract:

Background and aims: Many antiviral compounds presently in clinical use have a narrow spectrum of activity, limited therapeutic usefulness and variable toxicity. There is also an emerging problem of resistant viral strains. This study was undertaken to examine the published literature on herbs and plants with antiviral activity, their laboratory evaluation in vitro and in vivo, and evidence of human clinical efficacy.

Methods: Independent literature searches were performed on MEDLINE, EMBASE, CISCOM, AMED and Cochrane Library for information on plants and herbs with antiviral activity. There was no restriction on the language of publication. Data from clinical trials of single herb preparations used to treat uncomplicated viral infections were extracted in a standardized, predefined manner.

Results: Many hundreds of herbal preparations with antiviral activity were identified and the results of one search presented as an example. Yet extracts from only 11 species met the inclusion criteria of this review and have been tested in clinical trials. They have been used in a total of 33 randomised, and a further eight non-randomised, clinical trials. Fourteen of these trials described the use of Phyllanthus spp. for treatment of hepatitis B, seven reporting positive and seven reporting negative results. The other 10 herbal medicines had each been tested in between one and nine clinical trials. Only four of these 26 trials reported no benefit from the herbal product.

Conclusions: Though most of the clinical trials located reported some benefits from use of antiviral herbal medicines, negative trials may not be published at all. There remains a need for larger, stringently designed, randomised clinical trials to provide conclusive evidence of their efficacy.

One of the herbal remedies that seemed to show some promise specifically for upper respiratory infections was Andrographis paniculata. This evidence prompted us in 2004 to conduct a systematic review focused on this herb specifically. Here is its abstract:

Acute respiratory infections represent a significant cause of over-prescription of antibiotics and are one of the major reasons for absence from work. The leaves of Andrographis paniculata (Burm. f.) Wall ex Nees (Acanthaceae) are used as a medicinal herb in the treatment of infectious diseases. Systematic literature searches were conducted in six computerised databases and the reference lists of all papers located were checked for further relevant publications. Information was also requested from manufacturers, the spontaneous reporting schemes of the World Health Organisation and national drug safety bodies. No language restrictions were imposed. Seven double-blind, controlled trials (n = 896) met the inclusion criteria for evaluation of efficacy. All trials scored at least three, out of a maximum of five, for methodological quality on the Jadad scale. Collectively, the data suggest that A. paniculata is superior to placebo in alleviating the subjective symptoms of uncomplicated upper respiratory tract infection. There is also preliminary evidence of a preventative effect. Adverse events reported following administration of A. paniculata were generally mild and infrequent. There were few spontaneous reports of adverse events. A. paniculata may be a safe and efficacious treatment for the relief of symptoms of uncomplicated upper respiratory tract infection; more research is warranted.

Before you now rush to buy a dietary supplement of A. paniculata, let me stress this in no uncertain terms: the collective evidence is at best suggestive, but it is not compelling. Importantly, there is, to the best of my knowledge, no sound evidence that any herbal remedy is effective in preventing or treating Covid-19 infections.

I truly wished to be able to report more encouraging news, but the truth is the truth, even (I would argue, particularly) in desperate times.

During my almost 30 years of research into so-called alternative medicine (SCAM), I have published many papers which must have been severe disappointments to those who advocate SCAM or earn their living through it. Many SCAM proponents thus reacted with open hostility. Others tried to find flaws in those articles which they found most upsetting with a view of discrediting my work. The 2012 article entitled ‘A Replication of the Study ‘Adverse Effects of Spinal Manipulation: A Systematic Review‘ by the Australian chiropractor, Peter Tuchin, seems to be an example of the latter phenomenon (used recently by Jens Behnke in an attempt to defame me).

Here is the abstract of the Tuchin paper:

Objective: To assess the significance of adverse events after spinal manipulation therapy (SMT) by replicating and critically reviewing a paper commonly cited when reviewing adverse events of SMT as reported by Ernst (J Roy Soc Med 100:330-338, 2007).

Method: Replication of a 2007 Ernst paper to compare the details recorded in this paper to the original source material. Specific items that were assessed included the time lapse between treatment and the adverse event, and the recording of other significant risk factors such as diabetes, hyperhomocysteinemia, use of oral contraceptive pill, any history of hypertension, atherosclerosis and migraine.

Results: The review of the 32 papers discussed by Ernst found numerous errors or inconsistencies from the original case reports and case series. These errors included alteration of the age or sex of the patient, and omission or misrepresentation of the long term response of the patient to the adverse event. Other errors included incorrectly assigning spinal manipulation therapy (SMT) as chiropractic treatment when it had been reported in the original paper as delivered by a non-chiropractic provider (e.g. Physician).The original case reports often omitted to record the time lapse between treatment and the adverse event, and other significant clinical or risk factors. The country of origin of the original paper was also overlooked, which is significant as chiropractic is not legislated in many countries. In 21 of the cases reported by Ernst to be chiropractic treatment, 11 were from countries where chiropractic is not legislated.

Conclusion: The number of errors or omissions in the 2007 Ernst paper, reduce the validity of the study and the reported conclusions. The omissions of potential risk factors and the timeline between the adverse event and SMT could be significant confounding factors. Greater care is also needed to distinguish between chiropractors and other health practitioners when reviewing the application of SMT and related adverse effects.

The author of this ‘replication study’ claims to have identified several errors in my 2007 review of adverse effects of spinal manipulation. Here is the abstract of my article:

Objective: To identify adverse effects of spinal manipulation.

Design: Systematic review of papers published since 2001.

Setting: Six electronic databases.

Main outcome measures: Reports of adverse effects published between January 2001 and June 2006. There were no restrictions according to language of publication or research design of the reports.

Results: The searches identified 32 case reports, four case series, two prospective series, three case-control studies and three surveys. In case reports or case series, more than 200 patients were suspected to have been seriously harmed. The most common serious adverse effects were due to vertebral artery dissections. The two prospective reports suggested that relatively mild adverse effects occur in 30% to 61% of all patients. The case-control studies suggested a causal relationship between spinal manipulation and the adverse effect. The survey data indicated that even serious adverse effects are rarely reported in the medical literature.

Conclusions: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation.

In my view, there are several things that are strange here:

  1. Tuchin published his paper 5 years after mine.
  2. He did not publish it in the same journal as my original, but in an obscure chiro journal that hardly any non-chiropractor would ever read.
  3. Tuchin never contacted me and never alerted me to his publication.
  4. The journal that Tuchin chose was not Medline-listed in 2012; consequently, I never got to know about the Tuchin article in a timely fashion. (Therefore, I did never respond to it.)
  5. A ‘replication study’ is a study that repeats the methodology of a previous study.
  6. Tuchin’s paper is therefore NOT a replication study. Firstly, mine was a review and not a study. Secondly, and crucially, Tuchin never repeated my methodology but used an entirely different one.

But arguably, these points are trivial. They should not distract from the fact that I might have made mistakes. So, let’s look at the substance of Tuchin’s claim, namely that I made errors or omissions in my review.

As to ‘omissions’, one could argue that a review such as mine will always have to omit some details in order to generate a concise summary. The only way to not omit any details is to re-publish all the primary papers in one large volume. Yet, this can hardly be the purpose of a systematic review.

As to the ‘errors’, it seems that the ages and sex of three patients were wrong (I have not checked this against the primary publications but, for the moment, I believe Tuchin). This is, of course, lamentable and – even though I have no idea whether the errors happened at the data extraction phase, during the typing, the revising, or the publishing of the paper – it is entirely my responsibility. I also seem to have mistaken a non-chiropractor for a chiropractor. This too is regrettable but, as the review was about spinal manipulation and not about chiropractic, the error is perhaps not so grave.

Be that as it may, these errors are unquestionably not good, and I can only apologise for them. If Tuchin had dealt with them in the usual way – by publishing in a timely fashion a ‘letter to the editor’ of the JRSM – I could have easily corrected them for everyone to see.

But I think there is a more important point to be made here:

Tuchin concludes his paper stating that it is unwise to make conclusions regarding causality from any case study or multiple case studies. The number of errors or omissions in the 2007 Ernst paper significantly limit any reported conclusions. I believe that both sentences are unjustified. The safety of any intervention in routine use has to be examined on the basis of published case studies. This is particularly true for chiropractic where no post-marketing surveillance similar to that for drugs exists.

The conclusions based on such evidence can, of course, never be firm, but they provide valuable signals that can prompt more rigorous investigations in the interest of patient safety. In view of such considerations, my own conclusions in my 2007 paper were, I think, correct and are NOT invalidated by my relatively trivial mistakes: spinal manipulation, particularly when performed on the upper spine, has repeatedly been associated with serious adverse events. Currently the incidence of such events is unknown. Adherence to informed consent, which currently seems less than rigorous, should therefore be mandatory to all therapists using this treatment. Considering that spinal manipulation is used mostly for self-limiting conditions and that its effectiveness is not well established, we should adopt a cautious attitude towards using it in routine health care. 

And my conclusions in the abstract have now, I believe, become established wisdom. They are thus even less in jeopardy through my calamitous lapsus or Tuchin’s ‘replication study’: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation. 

 

 

A team of chiropractic researchers conducted a review of the safety of spinal manipulative therapy (SMT) in children under 10 years. They aimed to:

1) describe adverse events;

2) report the incidence of adverse events;

3) determine whether SMT increases the risk of adverse events compared to other interventions.

They searched MEDLINE, CINAHL, and Index to Chiropractic Literature from January 1, 1990 to August 1, 2019. Eligible studies were case reports/series, cohort studies and randomized controlled trials. Studies of high and acceptable methodological quality were included.

Most adverse events are mild (e.g., increased crying, soreness). One case report describes a severe adverse event (rib fracture in a 21-day-old) and another an indirect harm in a 4-month-old. The incidence of mild adverse events ranges from 0.3% (95% CI: 0.06, 1.82) to 22.22% (95% CI: 6.32, 54.74). Whether SMT increases the risk of adverse events in children is unknown.

The authors concluded that the risk of moderate and severe adverse events is unknown in children treated with SMT. It is unclear whether SMT increases the risk of adverse events in children < 10 years.

Thanks to their ingenious methodology, the authors managed to miss 11 of the 13 studies included in the review by Vohra et al which reported 9 serious adverse events and 20 cases of delayed diagnosis associated with SMT. Another review reported 15 serious adverse events and 775 mild to moderate adverse events following manual therapy. As far as I can see, the authors of the new review make just one reasonable point:

We recommend the implementation of a population-based active surveillance program to measure the incidence of severe and serious adverse events following SMT treatment in this population.

In the absence of such a surveillance system, any incidence figures are not just guess-work but also a depiction of the tip of a much bigger iceberg. So, why do the authors of this review not make this point clearly and powerfully? Why does the review read mostly like an attempt to white-wash a thorny subject? Why do they not provide a breakdown of the adverse events according to profession? The answer to these questions can be found at the very end of the paper:

This study was supported by the College of Chiropractors of British Columbia to Ontario Tech University. The College of Chiropractors of British Columbia was not involved in the design, conduct or interpretation of the research that informed the research. This research was undertaken, in part, thanks to funding from the Canada Research Chairs program to Pierre Côté who holds the Canada Research Chair in Disability Prevention and Rehabilitation at Ontario Tech University, and from the Canadian Chiropractic Research Foundation to Carol Cancelliere who holds a Research Chair in Knowledge Translation in the Faculty of Health Sciences at Ontario Tech University.

This study was supported by the College of Chiropractors of British Columbia to Ontario Tech University. The College of Chiropractors of British Columbia was not involved in the design, conduct or interpretation of the research that informed the research. This research was undertaken, in part, thanks to funding from the Canada Research Chairs program to Pierre Côté who holds the Canada Research Chair in Disability Prevention and Rehabilitation at Ontario Tech University, and funding from the Canadian Chiropractic Research Foundation to Carol Cancelliere who holds a Research Chair in Knowledge Translation in the Faculty of Health Sciences at Ontario Tech University.

I have often felt that chiropractic is similar to a cult. An investigation by cult members into the dealings of a cult is not the most productive of concepts, I guess.

I missed this article by Canadian vascular surgeons when it came out in 2018. It is well-argued, and I think you should read it in full, if you can get access (it’s behind a pay wall). It contains interesting details about the anti-vax attitude of doctors of integrative medicine (something we discussed before), as well as the most dubious things that go on in the ‘Cleveland Clinic’. Here is at least the abstract of the article:

Evidence-based medicine, first described in 1992, offers a clear, systematic, and scientific approach to the practice of medicine. Recently, the non-evidence-based practice of complementary and alternative medicine (CAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of CAM may cause harm to patients through interactions with evidence-based medications or if patients choose to forego evidence-based care. CAM may also put financial strain on patients as most CAM expenditures are paid out-of-pocket. Despite these drawbacks, patients continue to use CAM due to media promotion of CAM therapies, dissatisfaction with conventional healthcare, and a desire for more holistic care. Given the increasing demand for CAM, many medical institutions now offer CAM services. Recently, there has been controversy surrounding the leaders of several CAM centres based at a highly respected academic medical institution, as they publicly expressed anti-vaccination views. These controversies demonstrate the non-evidence-based philosophies that run deep within CAM that are contrary to the evidence-based care that academic medical institutions should provide. Although there are financial incentives for institutions to provide CAM, it is important to recognize that this legitimizes CAM and may cause harm to patients. The poor regulation of CAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy. Governments in Australia and England have successfully improved regulation of CAM and can serve as a model to other countries.

Those who have been following this blog a little know how much I agree with these authors. In fact, in the peer-reviewed literature, I have been publishing similar arguments for almost 20 years, e.g:

Consumer Advocate is an organisation that say this about themselves:

We want to make sure that you understand how we make money and who pays us. So we have taken proactive measures to ensure that any advertiser whom we have a paid relationship with is labeled as a “Partner” across our website. If you choose to click on the links on our site, we may receive compensation. If you don’t click or use the phone numbers listed on our site we will not be compensated.

Also, ranking and the order of products on our site are subject to change and partners may influence their position on our website, including the order in which they appear on a Top 10 list. Regardless of partner or compensation, we take into account many additional factors, which are the result of the 200+ hours of research our editorial team spends on average to provide insights and recommendations around each category displayed on our website.

The analyses and opinions on our site are our own and our editors and staff writers follow guidelines to ensure editorial integrity. Our brand, ConsumersAdvocate.org, stands for accuracy and helpful information. We know that we can only be successful if we take your trust in us seriously.

They recently conducted independent lab tests on the purity of 33 samples of essential ois from well-known names in the essential oil industry to see what was really inside each bottle. Their report raises lots of concerns, in my view. The team that wrote the report kindly sent me a summary and asked me to publish it here which I now do without any alteration, abbreviation or further comment:

Everybody’s talking about essential oils. More importantly, everybody’s using them. The global demand for these fragrant chemical compounds reached an extraordinary 226.9 kilotons in 2018 and further growth is projected by the marketing people who measure such things. The proliferation of essential oil users is tied to growth in the food and beverage, personal care and aromatherapy industries.

It’s not surprising that the scientific study of essential oils has also increased with demand for the products. The best essential oil brands invest in quality testing but don’t necessarily follow scientific protocol or make detailed testing results available to consumers. So the literature is still limited— and the jury is still out on whether these compounds are effective in treating medical conditions.

Essential oils are extracted from plants. In their pure form, they are highly concentrated—and sometimes toxic.  To make them practical to use, essential oils are typically mixed with diluting carrier oils. Methods of extraction include cold-pressing, steam and water distillation, and the use of chemical solvents. Evaluating individual products made with essential oils is challenging because there are thousands of brands on the market. Neither the extraction methods used or the potency of the products—let alone, testing methods—are standardized. Manufacturers’ ambitious marketing claims, which often rely on ambiguous language, further obscure consumers’ ability to judge for themselves which oils are best suited to their purposes. The list of problems some products purport to solve can run the gamut from an itchy scalp to menopause symptoms.

What’s more, few essential oil manufacturers educate consumers on proper dosage or contraindications, which can lead to accidental misuse and illness. Children are particularly sensitive to many oils and yet most manufacturers fail to warn against applying oils to children’s skin. Pregnant women are usually advised not to use essential oils during their first trimesters, though some studies have suggested they can help alleviate pain during childbirth. Some essential oils should never be used during pregnancy. Essential oils can interact or interfere with prescription medicines and nutritional supplements. But unlike prescription drugs, they don’t come with warning labels about these potential interactions.

Genuinely scientific, peer-reviewed studies of essential oils have primarily focused on using aromatherapy as an adjunct to conventional medical treatment. Science has confirmed that when inhaled, essential oil molecules travel quickly to the brain—specifically the limbic region, which controls pulse, respiration, sexual arousal, and other autonomic functions. Emotional responses like fear and motivation originate in the limbic system. The most promising applications of aromatherapy appear to be in diminishing stress and offering pain relief. But actual clinical trials into such topics as reducing nausea in by chemotherapy patients, relieving anxiety during childbirth, alleviating headaches, and improving sleep have been inconclusive.

Other studies have focused on the subject of inflammation, which is known to contribute to a wide range of medical problems. Essential oils derived from the thyme, clove, rose, eucalyptus, fennel, and bergamot have been demonstrated through one study to activate chemicals in the body which suppress inflammation and suppress chemicals that activate it.

Researchers are also exploring the potential of essential oils as antibacterial agents. Parts of the juniper, cumin, coriander and lavender plants may be effective in battling E coli, while cinnamon may prove useful in treating strep throat and pneumonia.

As ancient and traditional as their use may be in certain cultures, the scientific reality is it’s too early to tell how effective essential oils are in treating the wide range of conditions they are theorized (and now, commonly advertised) to treat.

But that’s not to say you shouldn’t use them, according to recommendations from your doctor. When considering the efficacy of essential oils, bear in mind that the act of self-care can be therapeutic in and of itself. We all know that treating ourselves to a hot bath—or an ice cream cone for that matter—can give us a temporary sense of well-being. For the time being, short-term selfsoothing may be all we can count on from essential oils. But there’s something to be said for even temporary relief. An entire industry of over-the-counter medicines has been founded upon it.

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