risk/benefit
Guest post by Tobias Katz
What do we know?
ICU admission
Taken from the BMJ (Ref 1): ICNARC latest report 31/12/21 showed that the proportion of patients admitted to critical care in December 2021 with confirmed covid-19 who were unvaccinated was 61%.
Prevention of infection
The government’s week 45 Covid surveillance report (Ref 3) is clear that vaccination prevention of infection (positive PCR, for Delta) effectiveness is estimated at 65% for Oxford-AstraZeneca and 80% for Pfizer.
Prevention of transmission
The Lancet’s (Ref 4) paper, suggests once infected, initial viral load is similar for vaccinated and unvaccinated individuals, suggesting likely equal chance of transmitting on the virus.
Protection of the individual
Ref 3, is clear cut that vaccination protects individuals from hospitalisation and severe infection (for Delta).
(Omicron) “Among those who had received 2 doses of AstraZeneca, there was no effect against Omicron from 20 weeks after the second dose. Among those who had received 2 doses of Pfizer or Moderna effectiveness dropped from around 65-70% down to around 10% by 20 weeks after the 2nd dose. 2 to 4 weeks after a booster dose vaccine effectiveness ranged from around 65 to 75%, dropping to 55 to 70% at 5 to 9 weeks and 40-50% from 10+ weeks after the booster.” (Ref 2)
Effectiveness here is measured by admission to hospital and shows the necessity for booster jabs when fighting Omicron.
Who are Dr James and Dr Malhotra?
Steven James, consultant anaesthetist, has recently been in the news for confronting Sajid Javid RE mandatory vaccinations for hospital and nursing staff. “The science isn’t strong enough” to support the policy he stated and “I’ve got antibodies”, suggesting that he’s as protected as he would be if he had a vaccine.
Aseem Malhotra, who goes by the name of ‘lifestylemedicinedoctor’ on Instagram is an extremely controversial cardiology consultant who seems to be Djokovic’s biggest fan and whose tweets are passionately quoted and forwarded by anti-vaxxers.
With tweets such as “Mark my words, with everything we know and don’t know about the current vaccine Novak Djokovic will ultimately be proven to be on the right side of history #BadPharma #truth #transparency #InformedConsent”:
Mark my words, with everything we know and don’t know about the current vaccine Novak Djokovic will ultimately be proven to be on the right side of history #BadPharma #truth #transparency #InformedConsent
— Dr Aseem Malhotra (@DrAseemMalhotra) January 9, 2022
And a retweet: “Dr Jordan Peterson Oh well. It’s just fertility. Women’s Periods May Be Late After Coronavirus Vaccination, Study Suggests”; he stirs the cooking pot of anti-establishment rhetoric and only deepens an already fractured relationship between doctors and their patients caused by the pandemic.
Oh well. It's just fertility. Women’s Periods May Be Late After Coronavirus Vaccination, Study Suggests https://t.co/ndQC9QgwMH
— Dr Jordan B Peterson (@jordanbpeterson) January 8, 2022
You’d think a mature, well-researched doctor would be able to tell the difference between the menstrual cycle and becoming fertile. You’d also hope he would not be short-sighted enough to support one of the most anti-science/anti-conventional medicine public figures in the world (see here)… Alas, no.
I feel as though both of these figures need to be reminded of their ethical duty of candour as doctors and reminded that their public actions have consequences. I may not completely disagree with Dr James (RE mandatory vaccinations) but the way in which he conducted himself during this nationally broadcasted video left many shaking with rage as it undermines many of his health professional colleagues. Me, included.
When a doctor appears on national news, opposing [mandatory] vaccination and offering incorrect explanations of why this is so, it should be obvious to them that their opinion will inevitably act as anti-vaccine propaganda, whether meant for this or not.
Malhotra’s ideas (cutting back on statins, healthy diet etc.) are often worth consideration/evaluation and as a new-age medical ‘influencer’ with 130k+ followers on Twitter, with ample publications behind him, he deserves to be listened to. Not necessarily agreed with, but listened to. But he also has a duty as a doctor to guard against complacency. Similar to James’ public actions, Malhotra’s tweets that are so one-sided give a biased, inaccurate and frankly dangerous view on the efficacy and safety profile of COVID vaccinations that have been safely and effectively used in millions of people to prevent hospitalisations. Is he doing it for the views? The hits? The likes? The retweets? To have people recognise him for his Pioppi diet?
What should we do?
Candour
Doctors, including James and Malhotra have an ethical responsibility not to spread imperfect information to a wide-receiving audience where their actions can be misconstrued and misrepresented so easily. Doing so may bolster anti-vaccine views, cause less ‘on-the-fence’ people to get the jabs and essentially lead to more preventable deaths.
More and more we are seeing social media take over and often act as the public’s primary source of news. More doctors than ever are now in the [social] media limelight. Some, such as Dr Alex George (mental health advocate) are promoting health responsibly. Others, seek to undermine it. In an era when Joe Rogan has more daily views than Fox News’ Tucker Carlson, to ignore and not rebut [health] social media giants like Malhotra would just worsen the situation. Malhotra and James need to be challenged by the scientific community, as the BBC so brilliantly did here.
Complacency
If doctors want to become socialite Instagram influencers, they must do this without complacency. I think this means being responsible when offering controversial and potentially public health implicating opinions where evidence isn’t clear cut.
Final thoughts
Using all the possible information above, as the vaccines are not 100% without risk, transmission is not completely cut post-vaccine and as we have a decent-ish way of monitoring infection (lateral flows and PCRs), I feel as though mandating vaccines for all NHS staff is currently unjust. I see Steve’s point. But I’d be extremely careful in how I’d make this point. And certainly not on live Sky News when the nation is watching, where it will inevitably be seized upon by the anti-vax community.
Saying this, the data is pretty clear that there is evidence that the vaccines offer protection against infection, reducing viral load quicker once infected and against hospitalisation and so if you’re a rational doctor who thinks that at least one time your lateral flow test may give a false negative, it makes complete sense to get your vaccine to protect your patients…
References
- https://www.bmj.com/content/376/bmj.o5?fbclid=IwAR2MgoD_vYo0FsaVsQdLxfeYCukuRu2RegcJa-HclA13byhH71g-AnNhnP8
- https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1045329/Vaccine_surveillance_report_week_1_2022.pdf
- https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1032859/Vaccine_surveillance_report_-_week_45.pdf
- https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00690-3/fulltext
On this blog and elsewhere, I have heard many strange arguments against COVID-19 vaccinations. I get the impression that most proponents of so-called alternative medicine (SCAM) hold or sympathize with such notions. Here is a list of those arguments that have come up most frequently together with my (very short) comments:
COVID is not dangerous
It’s just a flu and nothing to be really afraid of, they say. Therefore, no good reason exists for getting vaccinated. This, I think, is easily countered by pointing out that to date about 5.5 million people have died of COVID-19. In addition, I fear that the issues of ‘long-COVID’ is omitted in such discussions
It’s only the oldies who die
As an oldie myself, I find this argument quite distasteful. More importantly, it is simply not correct.
Vaccines don’t work
True they do not protect us 100% from the infection. But they very dramatically reduce the likelihood of severe illness or death from COVID-19.
Vaccines are unsafe
We have now administered almost 10 billion vaccinations worldwide. Thus we know a lot about the risks. In absolute terms, there is a vast amount of cases, and it would be very odd otherwise; just think of the rate of nocebo effects that must be expected. However, the risks are mostly minor, and serious ones are very rare. Some anti-vaxxers predicted that, by last September, the vaccinated population would be dead. This did not happen, did it? The fact is that the benefits of these vaccinations hugely outweigh the risks.
Vaccines are a vicious tracking system
Some claim that ‘they‘ use vaccines to be able to trace the vaccinated people. Who are ‘they‘, and why would anyone want to trace me when my credit card, mobile phone, etc. already could do that?
Vaccines are used for population control
‘They‘ want to reduce the world population through deadly vaccines to ~5 billion, some anti-vaxxers say. Again, who are ‘they‘ and would ‘they‘ want to do that? Presumably ‘they‘ need us to pay taxes and buy their goods and services.
There has not been enough research
If those who make this argument would bother to go on Medline and look for COVID-related research, they might see how ill-informed this argument is. Since 2021, more than 200 000 papers on the subject have emerged.
I trust my immune system
This is just daft. I am triple-vaccinated and also hope that I can trust my immune system – this is why I got vaccinated in the first place. Vaccinations rely on the immune system to work.
It’s all about making money
Yes, the pharma industry aims to make money; this is a sad reality. But does that really mean that their products are useless? I don’t see the logic here.
People should have the choice
I am all for it! But if someone’s poor choice endangers my life, I do object. For instance, I expect other people not to smoke in public places, stop at red traffic lights and drive on the correct side of the street.
Most COVID patients in hospitals have been vaccinated
If a large percentage of the population has been vaccinated and the vaccine conveys not 100% protection, it would be most surprising, if it were otherwise.
I have a friend who…
All sorts of anecdotes are in circulation. The thing to remember here is that the plural of anecdote is anecdotes and not evidence.
SCAM works just as well
Of course, that argument had to be expected from SCAM proponents. The best response here is this: SHOW ME THE EVIDENCE! In response SCAM fans have so far only been able to produce ‘studies’ that are unconvincing or outright laughable.
In conclusion, the arguments put forward by anti-vaxxers or vaccination-hesitant people are rubbish. It is time they inform themselves better and consider information that originates from outside their bubble. It is time they realize that their attitude is endangering others.
Bloodletting therapy (BLT) has been widely used for centuries until it was discovered that it is not merely useless for almost all diseases but also potentially harmful. Yet in so-called alternative medicine (SCAM) BLT is still sometimes employed, for instance, to relieve acute gouty arthritis (AGA). This systematic review aimed to evaluate the feasibility and safety of BLT in treating AGA.
Seven databases were searched from the date of establishment to July 31, 2020, irrespective of the publication source and language. BLT included fire needle, syringe, three-edged needle, and bloodletting followed by cupping. The included articles were evaluated for bias risk by using the Cochrane risk of bias assessment tool.
Twelve studies involving 894 participants were included in the final analysis. A meta-analysis suggested that BLT was highly effective in relieving pain (MD = -1.13, 95% CI [-1.60, -0.66], P < 0.00001), with marked alterations in the total effective (RR = 1.09, 95% [1.05, 1.14], P < 0.0001) and curative rates (RR = 1.37, 95%CI [1.17, 1.59], P < 0.0001). In addition, BLT could dramatically reduce serum C-reactive protein (CRP) level (MD = -3.64, 95%CI [-6.72, -0.55], P = 0.02). Both BLT and Western medicine (WM) produced comparable decreases in uric acid (MD = -18.72, 95%CI [-38.24, 0.81], P = 0.06) and erythrocyte sedimentation rate (ESR) levels (MD = -3.01, 95%CI [-6.89, 0.86], P = 0.13). Lastly, we demonstrated that BLT was safer than WM in treating AGA (RR = 0.36, 95%CI [0.13, 0.97], P = 0.04).
The authors concluded that BLT is effective in alleviating pain and decreasing CRP level in AGA patients with a lower risk of evoking adverse reactions.
This conclusion is optimistic, to say the least. There are several reasons for this statement:
- All the primary studies came from China (and we have often discussed that such trials need to be taken with a pinch of salt).
- All the studies had major methodological flaws.
- There was considerable heterogeneity between the studies.
- The treatments employed were very different from study to study.
- Half of all studies failed to mention adverse effects and thus violate medical ethics.
The Corona Committee (Corona Ausschuss) was founded in Berlin in July 2020 by the lawyers Viviane Fischer, Antonia Fischer, Dr. Reiner Füllmich, and Dr. Justus Hoffmann. Its aim is to provide a “factual analysis” of the coronavirus events and the consequences of the measures taken against them. In live sessions lasting several hours, the committee hears experts from all COVID-affected fields.
In an interview, Dr. Fuellmich said: “The decision to set up a Corona Inquiry Committee came about in the first telephone conversation Viviane Fischer and I ever had. After I had spoken out in the USA via various videos since April 2020 about the fact that the principle ‘audiatur et altera pars’ (hear the other side as well) had been blatantly violated here on the part of the government, I had come back to Germany from the USA because I felt that this was now my place and that I had to stand up here to ensure that our democracy and our constitutional state did not go completely to the dogs. I wanted to organize a symposium on the legal issues surrounding Corona, but I didn’t know any critical lawyers in Germany. I called my old friend Dr. Wolfgang Wodarg, whom I knew from the Justice Working Group at Transparency International, and he then referred me to Viviane Fischer.”
The ‘Speerspitze‘, an “anonymous collective of contrarians, Corona deniers, Nazi witches and conspiracy heretics” considers the work of the Corona Committee to be “one of the most important pillars of the fight against the madness to which we have been subjected for the last year and a half and [has] great respect for all the activists, actors, and interviewees of the Committee who publicly denounce with their name and face what is happening.” Numerous further websites have joined in the promotion of the Corona Committee.
However, if you look at the information that the Corona Committee is disseminating, and if you are able to think critically, you are likely to come to very different conclusions:
– There is the expert who warns that the unvaccinated could soon be picked up and put into concentration camps. There is the threat of a “manhunt”, and loving parents might then have to hide their children under the boards of the floor at home to prevent them from being sprayed to death.
– There is the man who claims that Israel’s government is currently carrying out a holocaust on its own population (“You can see that by how many people are dying from the vaccinations”). A guest declares that there are “something like living octopuses” in the vaccine against Corona.
Anyone who takes a look at the many tediously long videos will quickly realize that every Corona denier, vaccination opponent, conspiracy theorist, mask opponent, and lateral thinker, no matter how paranoid, have their say here and spreads their pipe dreams under the guise of evidence-based information with the nodding approval of the lawyers present. Opposition is never raised and there is no trace of ‘audiatur et altera pars’; everyone agrees: worldwide, all governments are hell-bound at smashing everything there is to govern.
For those who are still not fed up, the website of the Corona Committee offers written answers to 31 very specific questions. Here is just one.
QUESTION: IS THE COVID-19 DISEASE SEVERE AND WIDESPREAD?
ANSWER: No, most people have no or only mild flu symptoms. Children and adolescents are extremely rarely affected. Post-mortem examinations by a Hamburg forensic pathologist on over 100 elderly people who died with a positive corona test revealed at least one other serious cause of death in all cases. Other published figures are mostly based on non-transparent attributions and assumptions without excluding other causes. Often, no attention was even paid to other pathogens or previous medication.
Factual analyses?
Afraid not!
For a long time, I have been wondering where the penetratingly vociferous opposition to COVID vaccinations in Germany might come from. After studying the dangerous nonsense that the Corona Committee has been spreading for many months, I wonder a little less.
(texts in German were translated by me)
This review investigated whether mind-body therapies are effective for relieving cancer-related pain in adults, since at least one-third of adults with cancer are affected by moderate or severe pain.
The authors searched for all randomized or quasi-randomized controlled trials that included adults (≥18 years) with cancer-related pain who were treated with:
- mindfulness,
- hypnosis,
- yoga,
- guided imagery,
- progressive muscle relaxation.
The primary outcome was pain intensity.
A total of 40 primary studies involving 3569 participants were found. The meta-analysis included 24 studies (2404 participants) and showed a significant effect of -0.39 (95% CI -0.62 to -0.16) with considerable heterogeneity (I2 = 86.3%, p < 0.001). After excluding four “outlier” studies in sensitivity analyses, the effect size remained significant but became weaker. There was a high risk of bias in all studies, for example, performance bias due to lack of participant blinding. Patients in multiple settings were included but many studies were of low quality.
The authors concluded that mind-body therapies may be effective in improving cancer pain, but the quality of the evidence is low. There is a need for further high-quality clinical trials.
These conclusions are broadly correct. I can confirm this because I recently summarized the evidence in a book and arrived at very similar conclusions. If I had to criticize the review, it would be for not including all mind-body therapies for which there is evidence from clinical trials. In my book, I was able to include the following additional treatments:
- Autogenic training
- Music therapy
- Qigong
- Tai chi
The effects of these treatments are about the same regardless of which one we use. This might lead us to suspect that they work not via specific but via non-specific effects, e.g. placebo.
Compelling evidence has long shown that diagnostic imaging for low back pain does not improve care in the absence of suspicion of serious pathology. However, the effect of imaging use on clinical outcomes has not been investigated in patients presenting to chiropractors. The aim of this study was to determine if diagnostic imaging affects clinical outcomes in patients with low back pain presenting for chiropractic care.
A matched observational study using prospective longitudinal observational data with a one-year follow-up was performed in primary care chiropractic clinics in Denmark. Data were collected from November 2016 to December 2019. Participants included low back pain patients presenting for chiropractic care, who were either referred or not referred for diagnostic imaging at their initial visit. Patients were excluded if they were younger than 18 years, had a diagnosis of underlying pathology, or had previously had imaging relevant to their current clinical presentation. Coarsened exact matching was used to match participants referred for diagnostic imaging with participants not referred for diagnostic imaging on baseline variables including participant demographics, pain characteristics, and clinical history. Mixed linear and logistic regression models were used to assess the effect of imaging on back pain intensity and disability at two weeks, three months, and one year, and on global perceived effect and satisfaction with care at two weeks.
A total of 2162 patients were included, and 24.1% of them were referred for imaging. Near perfect balance between matched groups was achieved for baseline variables except for age and leg pain. Participants referred for imaging had slightly higher back pain intensity at two weeks (0.4, 95%CI: 0.1, 0.8) and one year (0.4, 95%CI: 0.0, 0.7), and disability at two weeks (5.7, 95%CI: 1.4, 10.0), but these differences are unlikely to be clinically meaningful. No difference between groups was found for the other outcome measures. Similar results were found when a sensitivity analysis, adjusted for age and leg pain intensity, was performed.
The authors concluded that diagnostic imaging did not result in better clinical outcomes in patients with low back pain presenting for chiropractic care. These results support that current guideline recommendations against routine imaging apply equally to chiropractic practice.
This study confirms what most experts suspected all along and what many chiropractors vehemently denied for years. One could still argue that the outcomes do not differ much and therefore imaging does not cause any harm. This argument would, however, be wrong. The harm it causes does not affect the immediate clinical outcomes. Needless imaging is costly and increases the cancer risk.
Neck pain affects a vast number of people and leads to reduced quality of life and high costs. Clinically, it is a difficult condition to manage, and the effect sizes of the currently available treatments are moderate at best. Activity and manual therapy are first-line treatment options in several guidelines. But how effective are they really?
This study investigated the combination of home stretching exercises and spinal manipulative therapy in a multicentre randomized controlled clinical trial, carried out in a multidiscipline range of primary care clinics.
The treatment modalities utilized were spinal manipulative therapy combined with home stretching exercises compared to home stretching exercises alone. Both groups received 4 treatments for 2 weeks. The primary outcome was pain, where the subjective pain experience was investigated by assessing pain intensity (NRS – 11) and the quality of pain (McGill Pain Questionnaire). Neck disability and health status were secondary outcomes, measured using the Neck Disability Indexthe EQ-5D, respectively.
One hundred thirty-one adult subjects were randomized to one of the two treatment groups. All subjects had experienced persistent or recurrent neck pain the previous 6 months and were blinded to the other group intervention. The clinicians provided treatment for subjects in both groups and could not be blinded. The researchers collecting data were blinded to treatment allocation, as was the statistician performing data analyses. An intention-to-treat analysis was used.
Sixty-six subjects were randomized to the intervention group, and 65 to the control group. For NRS – 11, a B-coefficient of – 0,01 was seen, indication a 0,01 improvement for the intervention group in relation to the control group at each time point with a p-value of 0,305. There were no statistically significant differences between groups for any of the outcome measures.
Four intense adverse events were reported in the study, three in the intervention group, and one in the control group. More adverse incidents were reported in the intervention group, with a mean pain intensity (NRS-11) of 2,75 compared to 1,22 in the control group. There were no statistically significant differences between the two groups.
The authors concluded that there is no additional treatment effect from adding spinal manipulative therapy to neck stretching exercises over 2 weeks for patients with persistent or recurrent neck pain.
This is a rigorous and well-reported study. It suggests that adjuvant manipulations are not just ineffective for neck pain, but also cause some adverse effects. This seems to confirm many previously discussed investigations concluding that chiropractors do not generate more good than harm for patients suffering from neck pain.
Long-COVID syndrome is a condition that will affect a large proportion of those who survived a COVID-19 infection. According to a recent meta-analysis, it is associated predominantly with poor quality of life, persistent symptoms including fatigue, dyspnea, anosmia, sleep disturbances, and mental health problems.
At present, we are still struggling to understand the exact causes and mechanisms of this condition. Therefore, its optimal treatment is as yet uncertain. Governments around the world have therefore made sizable research funds available to make progress in this area, and research in this area is frantically active.
Regardless of the evidence, practitioners and entrepreneurs of so-called alternative medicine (SCAM) are gearing up to jump on this bandwagon by declaring that their offerings are a solution to this growing problem. Indeed, many of them have already done so. Here are just three sites that I found today which are promoting homeopathy for long COVID:
- Post Covid Syndrome – Homeopathy for Support & Symptom Management
- HOMEOPATHY FOR POST- COVID-19 SYNDROME
- Homeopathic medicines for Post Covid
One hardly needs to mention that homeopathy is not supported by sound evidence in the management of long-Covid (or any other condition for that matter). Neither does one need to stress that homeopaths are just one example, and virtually all other SCAM providers are promoting their services in the absence of evidence.
A recent review of the literature stated this:
Patients with long COVID commonly refer to taking ‘the stack’ or ‘the supplement stack’, which includes high-dose vitamin C and D, niacin (nicotinic acid), quercetin, zinc, selenium, and sometimes also magnesium. Further research is needed to confirm or refute the impact of supplements in long COVID. Examples of noteworthy interactions with supplements include: niacin causing an increased risk of bleeding events when combined with selective serotonin reuptake inhibitors or non-steroidal anti-inflammatory drugs, increased risk of rhabdomyolysis together with statins, and quercetin causing inhibition and induction of various human cytochrome P450 enzymes.
Why then are SCAM providers promoting SCAM for long-COVID?
This is a daft question if there ever was one.
It seems obvious they do it because:
- they are believers who don’t care about evidence,
- they are in it for the money,
- or both.
Some time ago, this homeopath already indicated, that SCAM providers should see COVID as an opportunity: For homeopathy, shunned during its 200 years of existence by conventional medicine, this outbreak is a key opportunity to show potentially the contribution it can make in treating COVID-19 patients. We should perhaps not hold our breath to see the emergence of convincing evidence, but we should be prepared to warn the public of getting exploited by charlatans who disregard both ethics and evidence.
The Austrian Health Insurance Fund is the largest social health insurance in Austria. Currently, about 82 percent of the people living in our country are insured with the ÖGK – that is 7.2 million insured persons. The ÖGK was created on 01.01.2020 through the merger of the nine former regional health insurance funds.
I was alerted to the following announcement by the Austrian Health Insurance Fund (my translation):
The Austrian Health Insurance Fund (ÖGK) ensures comprehensive medical care. However, medical services that do not treat an illness or contribute to preventive health care have to be paid for by the insured persons themselves
In the following cases, you have to pay for the services yourself, even if you use a panel doctor (Vertrauensarzt):
- Sports or driving licence examinations
- Exemptions from gym classes
- Vaccinations (if they are not medical treatment)
- Second medical opinions
- Requests for nursing leave
- Employment examinations on commencement of employment
- Treatments for which there is no scientific medical evidence of effectiveness (e.g. homeopathy)
- Purely cosmetic treatments
- Examinations for the clarification of claims for disability, occupational incapacity, incapacity to work.
The term HOMEOPATHY was not highlighted in the original. As it is, however, of particular interest to the discussions on this blog, I took the liberty of doing so.
The writing for homeopathy had been on the wall for some time in Austria- to be exact, since 1819!
This is when his majesty, the emperor Franz 2nd, issued the above decree strictly forbidding Hahnemann’s method.
My translation:
Prohibition of Hahnemann’s healing method
His Majesty, by the highest resolution of October 13, 1819, decreed: Doctor Hahnemann’s homeopathic method of treatment is to be generally and strictly prohibited.
Court Chancellery Decree of 21 October 1819, to all State Offices
I have reported about Lyma twice before (see here and here). So, why again? I know, it’s just a supplement, but it is still a special case because
- it is being marketed very aggressively,
- it is the “world’s 1st super supplement”,
- we have on this blog a long debate with one of the experts responsible for Lyma.
On 18 March 2019, Paul Clayton, a clinical pharmacologist employed by the firm, stated the following about Lyma: you will realise that all the actives bar one (the ashwagandha) are food derivates / extracts. I take this to mean that, except for ashwagandha, all the ingredients of Lyma ought to be inherently safe. If we accept this for a moment (even though I am not sure that it is entirely correct), it means that ashwagandha determines the safety of Lyma more than any of the other ingredients. Paul Clayton also assured us that Lyma is totally safe, meaning that no serious concerns about ashwagandha’s safety have been reported.
Sadly, this does not seem to be quite true. There have been several reports of liver injury after the consumption of the herbal remedy. Here is another article that is not Medline-listed: Inagaki K, Mori N, Honda Y, Takaki S, Tsuji K, Chayama K. A case of drug-induced liver injury with prolonged severe intrahepatic cholestasis induced by Ashwagandha. Kanzo 2017; 58: 448-54. (20 year old man developed jaundice a month after increasing the dose of ashwagandha [bilirubin 20.7 mg/dL, ALT 94 U/L, Alk P 343 U/L, INR 1.02], jaundice persisting for more than 2 months, but ultimately resolving).
Perhaps the most concerning paper is this latest article:
Background & aims: Ashwagandha (Withania somnifera) is widely used in Indian Ayurvedic medicine. Several dietary supplements containing ashwagandha are marketed in the US and Europe, but only one case of drug-induced liver injury (DILI) due to ashwagandha has been published. The aim of this case series was to describe the clinical phenotype of suspected ashwagandha-induced liver injury.
Methods: Five cases of liver injury attributed to ashwagandha-containing supplements were identified; three were collected in Iceland during 2017-2018 and two from the Drug-Induced Liver Injury Network (DILIN) in 2016. Other causes for liver injury were excluded. Causality was assessed using the DILIN structured expert opinion causality approach.
Results: Among the five patients, three were males; mean age was 43 years (range 21-62). All patients developed jaundice and symptoms such as nausea, lethargy, pruritus and abdominal discomfort after a latency of 2-12 weeks. Liver injury was cholestatic or mixed (R ratios 1.4-3.3). Pruritus and hyperbilirubinaemia were prolonged (5-20 weeks). No patient developed hepatic failure. Liver tests normalized within 1-5 months in four patients. One patient was lost to follow-up. One biopsy was performed, showing acute cholestatic hepatitis. Chemical analysis confirmed ashwagandha in available supplements; no other toxic compounds were identified. No patient was taking potentially hepatotoxic prescription medications, although four were consuming additional supplements, and in one case, rhodiola was a possible causative agent along with ashwagandha.
Conclusions: These cases illustrate the hepatotoxic potential of ashwagandha. Liver injury is typically cholestatic or mixed with severe jaundice and pruritus, but self-limited with liver tests normalizing in 1-5 months.
In the lengthy exchanges between Paul Clayton and others on my blog – truly worth reading! – Paul assured us all that he is a serious scientist who would not mislead the consumer. At the time, he might not have been aware of the above-mentioned reports (the most recent of the above-mentioned papers was published in April 2020). Today, however, he must know of these concerns. Therefore, we can soon expect some serious measures from him and his employers, the firm that manufactures/sells Lyma.
I wonder what they will do. As far as I can see, it will have to be the voluntary withdrawal of Lyma from the market or, at the very least, the inclusion of a warning in all their materials:
“This product may cause severe liver damage”.
