bias
The COVID-19 pandemic has been notable for the widespread dissemination of misinformation regarding the virus and appropriate treatment. The objective of this study was to quantify the prevalence of non–evidence-based treatment for COVID-19 in the US and the association between such treatment and endorsement of misinformation as well as lack of trust in physicians and scientists.
This single-wave, population-based, nonprobability internet survey study was conducted between December 22, 2022, and January 16, 2023, in US residents 18 years or older who reported prior COVID-19 infection.
Self-reported use of ivermectin or hydroxychloroquine, endorsing false statements related to COVID-19 vaccination, self-reported trust in various institutions, conspiratorial thinking measured by the American Conspiracy Thinking Scale, and news sources.
A total of 13 438 individuals (mean [SD] age, 42.7 [16.1] years; 9150 [68.1%] female and 4288 [31.9%] male) who reported prior COVID-19 infection were included in this study. In this cohort, 799 (5.9%) reported prior use of hydroxychloroquine (527 [3.9%]) or ivermectin (440 [3.3%]). In regression models including sociodemographic features as well as political affiliation, those who endorsed at least 1 item of COVID-19 vaccine misinformation were more likely to receive non–evidence-based medication (adjusted odds ratio [OR], 2.86; 95% CI, 2.28-3.58). Those reporting trust in physicians and hospitals (adjusted OR, 0.74; 95% CI, 0.56-0.98) and in scientists (adjusted OR, 0.63; 95% CI, 0.51-0.79) were less likely to receive non–evidence-based medication. Respondents reporting trust in social media (adjusted OR, 2.39; 95% CI, 2.00-2.87) and in Donald Trump (adjusted OR, 2.97; 95% CI, 2.34-3.78) were more likely to have taken non–evidence-based medication. Individuals with greater scores on the American Conspiracy Thinking Scale were more likely to have received non–evidence-based medications (unadjusted OR, 1.09; 95% CI, 1.06-1.11; adjusted OR, 1.10; 95% CI, 1.07-1.13).
The authors concluded that, in this survey study of US adults, endorsement of misinformation about the COVID-19 pandemic, lack of trust in physicians or scientists, conspiracy-mindedness, and the nature of news sources were associated with receiving non–evidence-based treatment for COVID-19. These results suggest that the potential harms of misinformation may extend to the use of ineffective and potentially toxic treatments in addition to avoidance of health-promoting behaviors.
This study made me wonder to what extend a lack of trust in physicians or scientists, and conspiracy-mindedness are also linked to the use of so-called alternative medicine (SCAM) for treatning COVID infections. As I have often discussed, such associations have been reported regularly, e.g.:
- Homeopathy as an Adjuvant to Standard Care in Moderate and Severe Cases of COVID-19
- Arrests in Germany of healthcare professionals who issued fake COVID certificates
- Classical homeopathy worsens the prognosis of patients infected with COVID-19.
- “No jabby-jabby for me! Praise GOD!” But now this antivaxer has died of COVID-related pneumonia
- Homeopathy for COVID: opinions expressed on Twitter
- Efficacy of Persian barley water on clinical outcomes of hospitalized moderate-severity COVID-19 patients
- Effectiveness of Homeopathic Arsenicum album 30C in the Prevention of COVID-19
- Homoeopathy in the Prophylaxis and Symptomatic Management of COVID-19
- Is aromatherapy the answer to long-COVID? I fear not!
- Anthroposophical hospital defies COVID-19 regulations
- An Ayurvedic medication is effective for patients suffering from mild to moderate COVID-19 – true or false?
- Homeopathy for COVID-19: A randomized, double-blind, placebo-controlled trial shows that it does not work
- Micronutrient supplements for patients with COVID-19 infection
- A new trial of homeopathy for preventing COVID-19 infections
- Homeopathy and other SCAMs for long-COVID: WHERE IS THE EVIDENCE?
- Upper Bavaria is struggling with COVID-19, not least due to so-called alternative medicine
- And again: is vitamin C the solution for COVID-19 infections?
- Parents’ Willingness to Vaccinate with a COVID-19 Vaccine: strongly influenced by homeopathy
- A new study of homeopathy for the prevention of COVID-19 infections
- Homeopathic Treatment for COVID-19: a case of scientific misconduct and/or irresponsible behavior?
- The ‘AYUSH COVID-19 Helpline’: have they gone bonkers?
- Adjunctive homeopathic treatment of hospitalized COVID-19 patients. A case study of homeopathic delusion
- US Chiropractor in court for making false claims related to COVID-19
- Chinese Herbal Medicine for COVID-19? The evidence remains unconvincing
- Vitamin C and/or zinc for managing COVID patients?
- An RCT on the efficacy of ayurvedic treatment on asymptomatic COVID-19 patients
- Herbal solutions to the COVID-19 pandemic?
The authors point out that the endorsement of misinformation related to COVID-19 has been shown to decrease the intention to vaccinate against COVID-19, to decrease the belief that it is required for herd immunity, and to correlate with forgoing various COVID-19 prevention behaviors. Such false information is largely spread online and often originates as disinformation intentionally spread by political actors and media sources, as well as illicit actors who profit from touting supposed cures for COVID-19. A substantial minority of the public endorses false information related to COVID-19, although certain subgroups are more likely to do so, including those who are more religious, who distrust scientists, and who hold stronger political affiliations. Cultivating and maintaining trust is a crucial factor in encouraging the public to engage in prosocial health behaviors. The extent to which addressing conspiratorial thinking could represent a strategy to address obstacles to public health merits further investigation.
When the media does not adhere to reporting guidelines regarding so-called alternative medicine (SCAM), this may deceive or mislead consumers about the safety and efficacy of these practices. A team of researchers analyzed whether Serbian online media adheres to reporting guidelines and described dominant psychological appeals used to promote TM/CAM.
They conducted a content analysis of 182 articles from six news and six magazine websites, published July–December 2021. Biologically based treatments – predominantly herbal products – were the most common (205/289 practices). SCAM practices were claimed to:
- improve general health (71/386 claims),
- alleviate respiratory problems,
- boost the immunity,
- and detox the body.
The tone was overwhelmingly positive, with most of the positive articles (145/176) neglecting to disclose the potential harms of SCAM. Few articles provided a recommendation to speak with a healthcare provider (24/176). Articles tended to appeal to SCAM’s long tradition of use (115/176), naturalness (80/176), and convenience (72/176). They used vague pseudoscientific jargon (105/176) and failed to cite sources for the claims that SCAM use is supported by science (39/176).
The authors concluded that given that SCAM use may lead to harmful outcomes (such as adverse events, avoidance of official treatment or interaction with it), Serbian online media reports on SCAM are inadequate to assist consumers’ decision-making. Our findings highlight issues that need to be addressed towards ensuring more critical health reporting, and, ultimately, better informed SCAM consumption choices.
A long time agao, in 2000, we did a similar survey. We compared what UK newspapers published about SCAM and conventional medicine to what German papers did. We found that the proportion of articles about SCAM seems to be considerably larger in the UK (15% v 5%), and, in contrast to articles on medical matters in general, reporting on SCAM in the UK was overwhelmingly positive. I wonder whether, 23 years later, the situation has changed.
The Skeptic reported that a cardiologist and one of the UK’s most influential critics of the COVID-19 vaccine, Dr Aseem Malhotra, has been named the 2023 recipient of the “Rusty Razor” award, the prize given by The Skeptic to the year’s worst promoters of pseudoscience.
Dr Malhotra has made a name for himself over the last decade as a cardiologist who advocates strongly against the broad use of statins. He has described the drugs as a multi-billion dollar “con” by the pharmaceutical industry, saying that his critics have “received millions in research funding from the pharmaceutical industry”. He has described the link between heart disease and saturated fat as a “myth”, drawing criticism from the British Heart Foundation.
In 2017, his book The Pioppi Diet put forward a diet that he claimed could prevent 20 million deaths per year from cardiovascular disease. The book was named by the British Dietetic Association as one of the celebrity diets to most avoid – with the BDA highlighting his apparently Mediterranean diet excluded pasta and bread, but included coconuts.
Throughout the COVID-19 pandemic, Dr Malhotra has been a prolific and powerful voice spreading narratives that run contrary to the best available evidence. In 2021, his book The 21-Day Immunity Plan included a diet claimed to improve the immune system and help fight off infections – claims that drew criticism from medical professionals.
In 2022, Dr Malhotra released a paper claiming that COVID-19 mRNA vaccines posed a serious risk to cardiovascular health and that the vaccines were “at best a reckless gamble”. The paper was published in the Journal of Insulin Resistance – where Dr Malhotra sits on the editorial board.
Dr Malhotra and his campaign against the COVID-19 vaccine was subsequently praised in Parliament by Andrew Bridgen MP as part of the reasoning behind his ongoing anti-vaccine crusade. In January of this year, Dr Malhotra used a BBC interview about statins to claim that deaths from coronary artery disease were actually complications from the vaccine, prompting a slew of complaints, and an apology from the broadcaster.
The Skeptic Editor Michael Marshall said: “In our opinion, Dr Malhotra has been an incredibly prolific promoter of pseudoscience throughout the pandemic, including spreading the false notion that vaccines are responsible for thousands of excess deaths.
“Dr Malhotra’s media career has given him a very large platform, from which he spreads misinformation that undermines confidence in a health intervention that has saved the lives of countless people across the world. In doing so, he stokes the flames of conspiracy, paranoia and mistrust of medical consensus.
“For anyone with so large a platform to do this would be concerning enough, but Dr Malhotra shares these pseudoscientific messages as a registered medical professional whose opinions have influenced at least one current member of parliament.
“All of this, we feel, makes Dr Aseem Malhotra a highly deserving winner of the 2023 Rusty Razor award”
The ‘Rusty Razor’ award was announced as part of The Skeptic’s annual Ockham Awards at a ceremony that took place during Saturday’s QED conference on science and skepticism, in Manchester. Also recognised during the event was the Knowledge Fight podcast, who won the 2023 award for Skeptical Activism.
I agree, Malhortra is a deserverd winner. The prize raises, in my view, an important question:
WHAT ON EARTH IS THE GENERAL MEDICIN COUNCIL (GMC) DOING ABOUT THIS GUY?
Malhotra’s activities have been compared to the case of Andrew Wakefield who falsely claimed that the MMR vaccine was linked to autism. While Wakefield was ultimately struck off by the GMC in 2010, the regulator has so far rebuffed repeated pleas to investigate Dr Malhotra.
The BMJ recently reported that Dr. Matt Kneale, who had previously complained to the GMC about the conduct of Aseem Malhotra, was told that the GMC would not be investigating Malhotra because his statements were not sufficiently “egregious” to merit action and he had a right to “freedom of speech.” Kneale’s appeal against this decision in 2023 was also turned down.
Kneale has now filed a claim with the High Court, arguing that the GMC should consider not only whether a doctor’s behaviour could harm individual patients but also whether their actions undermined public trust in medicine. He said that this was particularly important when examining statements relating to vaccines, where doctors with a high profile on social media could potentially cause great harm.
This case report aims to describe the effects of craniosacral therapy and acupuncture in a patient with chronic migraine.
A 33-year-old man with chronic migraine was treated with 20 sessions of craniosacral therapy and acupuncture for 8 weeks. The number of migraine and headache days were monitored every month. The pain intensity of headache was measured on the visual analog scale (VAS). Korean Headache Impact Test-6 (HIT-6) and Migraine Specific Quality of Life (MSQoL) were also used.
The number of headache days per month reduced from 28 to 7 after 8 weeks of treatment and to 3 after 3 months of treatment. The pain intensity of headache based on VAS reduced from 7.5 to 3 after 8 weeks and further to < 1 after 3 months of treatment. Furthermore, the patient’s HIT-6 and MSQoL scores improved during the treatment period, which was maintained or further improved at the 3 month follow-up. No side effects were observed during or after the treatment.
The authors concluded that this case indicates that craniosacral therapy and acupuncture could be effective treatments for chronic
migraine. Further studies are required to validate the efficacy of craniosacral therapy for chronic migraine.
So, was the treatment period 8 weeks long or was it 3 months?
No, I am not discussing this article merely for making a fairly petty point. The reason I mention it is diffteren. I think it is time to discuss the relevance of case reports.
What is the purpose of a case report in medicine/healthcare. Here is the abstract of an article entitled “The Importance of Writing and Publishing Case Reports During Medical Training“:
Case reports are valuable resources of unusual information that may lead to new research and advances in clinical practice. Many journals and medical databases recognize the time-honored importance of case reports as a valuable source of new ideas and information in clinical medicine. There are published editorials available on the continued importance of open-access case reports in our modern information-flowing world. Writing case reports is an academic duty with an artistic element.
An article in the BMJ is, I think, more informative:
It is common practice in medicine that when we come across an interesting case with an unusual presentation or a surprise twist, we must tell the rest of the medical world. This is how we continue our lifelong learning and aid faster diagnosis and treatment for patients.
It usually falls to the junior to write up the case, so here are a few simple tips to get you started.
First steps
Begin by sitting down with your medical team to discuss the interesting aspects of the case and the learning points to highlight. Ideally, a registrar or middle grade will mentor you and give you guidance. Another junior doctor or medical student may also be keen to be involved. Allocate jobs to split the workload, set a deadline and work timeframe, and discuss the order in which the authors will be listed. All listed authors should contribute substantially, with the person doing most of the work put first and the guarantor (usually the most senior team member) at the end.
Getting consent
Gain permission and written consent to write up the case from the patient or parents, if your patient is a child, and keep a copy because you will need it later for submission to journals.
Information gathering
Gather all the information from the medical notes and the hospital’s electronic systems, including copies of blood results and imaging, as medical notes often disappear when the patient is discharged and are notoriously difficult to find again. Remember to anonymise the data according to your local hospital policy.
Writing up
Write up the case emphasising the interesting points of the presentation, investigations leading to diagnosis, and management of the disease/pathology. Get input on the case from all members of the team, highlighting their involvement. Also include the prognosis of the patient, if known, as the reader will want to know the outcome.
Coming up with a title
Discuss a title with your supervisor and other members of the team, as this provides the focus for your article. The title should be concise and interesting but should also enable people to find it in medical literature search engines. Also think about how you will present your case study—for example, a poster presentation or scientific paper—and consider potential journals or conferences, as you may need to write in a particular style or format.
Background research
Research the disease/pathology that is the focus of your article and write a background paragraph or two, highlighting the relevance of your case report in relation to this. If you are struggling, seek the opinion of a specialist who may know of relevant articles or texts. Another good resource is your hospital library, where staff are often more than happy to help with literature searches.
How your case is different
Move on to explore how the case presented differently to the admitting team. Alternatively, if your report is focused on management, explore the difficulties the team came across and alternative options for treatment.
Conclusion
Finish by explaining why your case report adds to the medical literature and highlight any learning points.
Writing an abstract
The abstract should be no longer than 100-200 words and should highlight all your key points concisely. This can be harder than writing the full article and needs special care as it will be used to judge whether your case is accepted for presentation or publication.
What next
Discuss with your supervisor or team about options for presenting or publishing your case report. At the very least, you should present your article locally within a departmental or team meeting or at a hospital grand round. Well done!
Both papers agree that case reports can be important. They may provide valuable resources of unusual information that may lead to new research and advances in clinical practice and should offer an interesting case with an unusual presentation or a surprise twist.
I agree!
But perhaps it is more constructive to consider what a case report cannot do.
It cannot provide evidence about the effectiveness of a therapy. To publish something like:
- I had a patient with the common condition xy;
- I treated her with therapy yz;
- this was followed by patient feeling better;
is totally bonkers – even more so if the outcome was subjective and the therapy consisted of more than one intervention, as in the article above. We have no means of telling whether it was treatment A, or treatment B, or a placebo effect, or the regression towards the mean, or the natural history of the condition that caused the outcome. The authors might just as well just have reported:
WE RECENTLY TREATED A PATIENT WHO GOT BETTER
full stop.
Sadly – and this is the reason why I spend some time on this subject – this sort of thing happens very often in the realm of SCAM.
Case reports are particularly valuable if they enable and stimulate others to do more research on a defined and under-researched issue (e.g. an adverse effect of a therapy). Case reports like the one above do not do this. They are a waste of space and tend to be abused as some sort of indication that the treatments in question might be valuable.
This systematic review and meta-analysis was aimed at analyzing the effectiveness of craniosacral therapy in improving pain and disability among patients with headache disorders.
PubMed, Physiotherapy Evidence Database, Scopus, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases were searched in March 2023. Two independent reviewers searched the databases and extracted data from randomized clinical trials comparing craniosacral therapy with control or sham interventions. The same reviewers assessed the methodological quality and the risk of bias using the PEDro scale and the Cochrane Collaboration tool, respectively. Grading of recommendations, assessment, development, and evaluations was used to rate the certainty of the evidence. Meta-analyses were conducted using random effects models using RevMan 5.4 software.
The searches retrieved 735 papers, and 4 studies were finally included. The craniosacral therapy provided statistically significant but clinically unimportant change on pain intensity (Mean difference = –1.10; 95% CI: –1.85, –0.35; I2: 44%), and no change on disability or headache effect (Standardized Mean Difference = –0.34; 95% CI –0.70, 0.01; I2: 26%). The certainty of the evidence was downgraded to very low.
The authors concluded that very low certainty of evidence suggests that craniosacral therapy produces clinically unimportant effects on pain intensity, whereas no significant effects were observed in disability or headache effect.
I find it strange that researchers seem so frequently unable to formulate their conclusions clearly. Is it political correctness? Or are they somehow favorably inclined (i.e. biased) towards the treatment that they pretend to critically evaluate?
Let’s look at the facts related to this review:
- Craniosacral therapy (CST) is utterly implausible.
- Only 4 RCTs were found.
- They were of poor quality.
- They were published mostly by people who want to promote CST.
- Therefore the overall statistically significant effect is most likely a false-positive result.
- This means that the conclusion should be much more straight forward.
I suggest something along the following lines:
A critical evaluation of the existing RCTs failed to find convincing evidence that CST is an effective treatment for headache disorders.
Exercise is often cited as a major factor contributing to improved cognitive functioning. As a result, the relationship between exercise and cognition has received much attention in scholarly literature. Systematic reviews and meta-analyses present varying and sometimes conflicting results about the extent to which exercise can influence cognition. The aim of this umbrella review was to summarize the effects of physical exercise on cognitive functions (global cognition, executive function, memory, attention, or processing speed) in healthy adults ≥ 55 years of age.
This review of systematic reviews with meta-analyses invested the effect of exercise on cognition. Databases (CINAHL, Cochrane Library, MEDLINE, PsycInfo, Scopus, and Web of Science) were searched from inception until June 2023 for reviews of randomized or non-randomised controlled trials. Full-text articles meeting the inclusion criteria were reviewed and methodological quality assessed. Overlap within included reviews was assessed using the corrected covered area method (CCA). A random effects model was used to calculate overall pooled effect size with sub-analyses for specific cognitive domains, exercise type and timing of exercise.
A total of 20 met the inclusion criteria. They were based on 332 original primary studies. Overall quality of the reviews was considered moderate with most meeting 8 or more of the 16 AMSTAR 2 categories. Overall pooled effects indicated that exercise in general has a small positive effect on cognition (d = 0.22; SE = 0.04; p < 0.01). Mind–body exercise had the greatest effect with a pooled effect size of (d = 0.48; SE = 0.06; p < 0.001). Exercise had a moderate positive effect on global cognition (d = 0.43; SE = 0,11; p < 0,001) and a small positive effect on executive function, memory, attention, and processing speed. Chronic exercise was more effective than acute exercise. Variation across studies due to heterogeneity was considered very high.
The authors concluded that mind–body exercise has moderate positive effects on the cognitive function of people aged 55 or older. To promote healthy aging, mind–body exercise should be used over a prolonged period to complement other types of exercise. Results of this review should be used to inform the development of guidelines to promote healthy aging.
It seems to me that the umbrella review hides the crucial fact that many of the primary studies had major flaws, e.g. in terms of:
- lack of randomisation,
- lack of blinding.
Eleven studies investigated the effects of aerobic exercise on cognition. Only three studies investigated the effects of mind body exercise on cognition, two analysed the effects of resistance exercise, and five investigated the effects of mixed exercise interventions. I am therefore mystified how the authors managed to arrive at such a hyped conclusion in favour of the effectiveness of mind body exercises. Even an optimistic interpretation of the data would allow merely a weak indication that a positive effect might exist. To state that mind body exercises should be promoted for ‘healthy aging’ borders on the irresponsible, in my view. Surely even the most naive researcher must see that, for such a far-reaching recommendation, we would need much more solid evidence.
I strongly suspect that a proper review of the primary studies of mind body exercise with a critical evaluation of the quality of the primary studies would lead to dramatically different conclusion.
It has been reported that two London councils have written to parents to warn that children who are not vaccinated against measles may need to self-isolate for 21 days if a classmate is infected with the disease. It comes after modelling by the UK Health Security Agency (UKHSA) warned that up to 160,000 cases could occur in the capital alone as a result of low vaccination rates. Just three-quarters of London children have received the two required doses of the MMR jab, which protects against measles. This is 10 per cent lower than the national average.
Barnet Council wrote to parents on July 20 warning that any unvaccinated child identified as a close contact of a measles case could be asked to self-isolate for up to 21 days. “Measles is of serious concern in London due to low childhood vaccination rates. Currently we are seeing an increase in measles cases circulating in neighbouring London boroughs, so now is a good time to check that your child’s MMR vaccination – which not only protects your child against measles but also mumps and rubella – is up to date,” the letter reads. “Children who are vaccinated do not need to be excluded from school or childcare,” the letter added.
Neighbouring Haringey Council also warned that children without both MMR doses may be asked to quarantine for 21 days. Just over two-thirds (67.9 per cent) of children in the area had received both doses by the age of five. The councils stated that they had sent the letters based on guidance by the UKHSA, but the agency said that headteachers should consider “excluding” unvaccinated pupils who become infected with measles rather than instructing them to self-isolate.
Data published by the UKHSA showed that 128 cases of measles were recorded between January 1 and June 30 this year, compared to 54 cases in the whole of 2022. Two-thirds of the cases were detected in London. The agency have said that there is a high risk of cases linked to overseas travel leading to outbreaks in specific population groups such as young people and under-vaccinated communities.
Dr Vanessa Saliba, a consultant epidemiologist at UKHSA, said: “When there are measles cases or outbreaks in nurseries or schools, the UKHSA health protection team will assess the situation, together with the school and other local partners, and provide advice for staff and pupils. “Those who are not up to date with their MMR vaccinations will be asked to catch up urgently to help stop the outbreak and minimise disruption in schools.”
____________________________
Measles is a significant concern with approximately 10 million people infected annually causing over 100,000 deaths worldwide. In the US before use of the measles vaccine, there were estimated to be 3 to 4 million people infected with measles annually, causing 400 to 500 deaths. Complications of measles include otitis media, diarrhea, pneumonia, and acute encephalitis. Measles is a leading cause of blindness in the developing world, especially in those who are vitamin A deficient. Malnourished children with measles are also at higher risk of developing noma (or cancrum oris), a rapidly progressive gangrenous infection of the mouth and face. Most deaths due to measles are caused by pneumonia, diarrhea, or neurological complications in young children, severely malnourished or immunocompromised individuals, and pregnant women. A rare sequela of measles is subacute sclerosing panencephalitis.
Back in 2003, we investigated what advice UK homeopaths, chiropractors and general practitioners give on measles, mumps and rubella vaccination programme (MMR) vaccination via the Internet. Online referral directories listing e-mail addresses of UK homeopaths, chiropractors and general practitioners and private websites were visited. All addresses thus located received a letter of a (fictitious) patient asking for advice about the MMR vaccination. After sending a follow-up letter explaining the nature and aim of this project and offering the option of withdrawal, 26% of all respondents withdrew their answers. Homeopaths yielded a final response rate (53%, n = 77) compared to chiropractors (32%, n = 16). GPs unanimously refused to give advice over the Internet. No homeopath and only one chiropractor advised in favour of the MMR vaccination. Two homeopaths and three chiropractors indirectly advised in favour of MMR. More chiropractors than homeopaths displayed a positive attitude towards the MMR vaccination. We concluded that some complementary and alternative medicine providers have a negative attitude towards immunisation and means of changing this should be considered.
The problem is by no means confined to the UK. German researchers, for instance, showed that belief in homeopathy and other parental attitudes indicating lack of knowledge about the importance of vaccinations significantly influenced an early immunisation. Moreover, being a German homeopath has been independently associated with lower own vaccination behavior. Data from France paint a similar picture.
Some homeopaths, of course, claim that ‘homeopathic vaccinations’ are effective and preferable. My advice is: DON’T BELIEVE THESE CHARLATANS! A recent study demonstrated that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.
Homeopathic remedies are highly diluted formulations without proven clinical benefits, traditionally believed not to cause adverse events. Nonetheless, published literature reveals severe local and non–liver-related systemic side effects. Here is the first series on homeopathy-related severe drug-induced liver injury (DILI) from a single center.
A retrospective review of records from January 2019 to February 2022 identified 9 patients with liver injury attributed to homeopathic formulations. Competing causes were comprehensively excluded. Chemical analysis was performed on retrieved formulations using triple quadrupole gas chromatography-mass spectrometry and inductively coupled plasma atomic emission spectroscopy.
Males predominated with a median age of 54 years. The most typical clinical presentation was acute hepatitis, followed by acute or chronic liver failure. All patients developed jaundice, and ascites were notable in one-third of the patients. Five patients had underlying chronic liver disease. COVID-19 prevention was the most common indication for homeopathic use. Probable DILI was seen in 77.8%, and hepatocellular injury predominated (66.7%). Four (44.4%) patients died (3 with chronic liver disease) at a median follow-up of 194 days. Liver histopathology showed necrosis, portal and lobular neutrophilic inflammation, and eosinophilic infiltration with cholestasis. A total of 29 remedies were consumed between 9 patients, and 15 formulations were analyzed. Toxicology revealed industrial solvents, corticosteroids, antibiotics, sedatives, synthetic opioids, heavy metals, and toxic phyto-compounds, even in ‘supposed’ ultra-dilute formulations.
The authors concluded that homeopathic remedies potentially result in severe liver injury, leading to death in those with underlying liver disease. The use of mother tinctures, insufficient dilution, poor manufacturing practices, adulteration and contamination, and the presence of direct hepatotoxic herbals were the reasons for toxicity. Physicians, the public, and patients must realize that Homeopathic drugs are not ‘gentle placebos.’
The authors also cite our own work on this subject:
A detailed systematic review of homeopathic remedies-induced adverse events from published case reports and case series by Posadzski and colleagues showed that severe side effects, some leading to fatality, are possible with classic and unspecified homeopathic formulations. The total number of patients included was 1159, of which 1142 suffered adverse events directly related to homeopathy. The direct adverse events had acute pancreatitis, severe allergic reactions, arsenical keratosis, bullous pemphigoid, neurocognitive disorders, sudden cardiac arrest and coma, severe dyselectrolytemia, interstitial nephritis, kidney injury, thallium poisoning, syncopal attacks, and focal neurological deficits as well as movement disorders. Fatal events involved advanced renal failure requiring dialysis, toxic polyneuropathy, and quadriparesis. The duration of adverse events ranged from a few hours to 7 months, and 4 patients died. The authors state that in most cases, the mechanism of action for side effects of homeopathy involved allergic reactions or the presence of toxic substances—the use of strong mother tinctures, drug contaminants, adulterants, or poor manufacturing (incorrect dilutions).
When we published our paper back in 2012, it led to a seies of angry responses from defenders of homeopathy who claimed that one cannot ‘have the cake and eat it’; either homeopathic remedies are placebos and thus harmless, or they have effects and thus also side-effects, they claimed. As the new publication by Indian researchers yet again shows, they were mistaken. In fact, homeopathy is dangerous in more than one way:
- the homeopathic remedies can do harm if not diluted or wrongly manufactured;
- the homeopaths can do harm through their often wrong advice in health matters;
- homeopathy erodes rational thinking (as, for instance, the resopnses to our 2012 paper demonstrated).
Many community pharmacies in Switzerland provide so-called alternative medicine (SCAM) approaches in addition to providing biomedical services, and a few pharmacies specialise in SCAM. A common perception is that SCAM providers are sceptical towards, or opposed to, vaccination.
The key objectives of this study were to examine the potential roles of biomedically oriented and SCAM-specialised pharmacists regarding vaccine counselling and to better understand the association between vaccine hesitancy and SCAM. The researchers thus conducted semistructured, qualitative interviews. Transcripts were coded and analysed using thematic analysis. Interview questions were related to:
- type of pharmaceutical care practised,
- views on SCAM and biomedicine,
- perspectives on vaccination,
- descriptions of vaccination consultations in community pharmacies,
- and views on vaccination rates.
Qualitative interviews in three language regions of Switzerland (German, French and Italian). A total of 18 pharmacists (N=11 biomedically oriented, N=7 SCAM specialised) were invited.
Pharmacist participants expressed generally positive attitudes towards vaccination. Biomedically oriented pharmacists mainly advised customers to follow official vaccination recommendations but rarely counselled vaccine-hesitant customers. SCAM-specialised pharmacists were not as enthusiastic advocates of the Swiss vaccination recommendations as the biomedically oriented pharmacists. Rather, they considered that each customer should receive individualised, nuanced vaccination advice so that customers can reach their own decisions. SCAM-specialised pharmacists described how mothers in particular preferred getting a second opinion when they felt insufficiently advised by biomedically oriented paediatricians.
The authors concluded that vaccination counselling in community pharmacies represents an additional option to customers who have unmet vaccination consultation needs and who seek reassurance from healthcare professionals (HCPs) other than physicians. By providing individualised vaccination counselling to vaccine-hesitant customers, SCAM-specialised pharmacists are likely meeting specific needs of vaccine-hesitant customers. As such, research and implementation efforts should more systematically involve pharmacists as important actors in vaccination provision. SCAM-specialised pharmacists particularly should not be neglected as they are important HCPs who counsel vaccine-hesitant customers.
I must say that I find these conclusions odd, perhaps even wrong. Here are my reasons:
- Pharmacists are well-trained healthcare professionals.
- As such, they have ethical obligations towards their customers.
- These obligations include behaving in a way that is optimal for the health of their customers and follows the rules of evidence-based practice.
- This includes explaining to vaccine-hesitant customers why the recommended vaccinations make sense and advising them to follow the official vaccination guidelines.
- SCAM-specialised pharmacist should ask themselves whether offering SCAM is in line with their ethical obligation to provide optimal care and advice to their customers.
I fear that this paper suggests that SCAM-specialised pharmacists might be a danger to the health of their customers. If that is confirmed, they should consider re-training, in my view.
This randomised, double blind controlled trial compared the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.
The interventions were:
- curcumin alone (C),
- omeprazole alone (O),
- curcumin plus omeprazole (C+O).
Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.
Main outcome measure was unctional dyspepsia symptoms on days 28 and 56, assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.
A total of 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (−4.83, –5.46 and −6.22), non-pain (−2.22, –2.32 and −2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (−7.19, –8.07 and −8.85), non-pain (−4.09, –4.12 and −3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.
The authors concluded that curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.
This study, which was funded by the Thai Traditional and Alternative Medicine Fund, has been picked up by the press and is being lauded as a solid proof of efficacy. Its authors too are not half proud of their splendid trial:
This multicentre randomised controlled trial provides highly reliable evidence for the treatment of functional dyspepsia. PPIs, widely used and approved for over-the-counter use, were compared with curcumin, a popular herbal remedy. The study design, including double blind randomisation, minimised biases. Participants met strict criteria, underwent endoscopy and were tested for H pylori infection. Furthermore, we implemented measures to minimise biases by ensuring that the individuals administering the drugs, participants receiving the drugs and individuals conducting the assessment remained blinded to the type of medications administered to the participants. The trial was carried out in hospitals, and certified individuals used standardised questionnaires for assessments. Statistical methods were appropriate and followed accepted principles.
Two follow-up appointments were scheduled, and blood tests showed no abnormal symptoms or liver function abnormalities. However, participants with high body mass index indicated a trend towards liver function impairment in the curcumin group, suggesting the need for larger studies. Some participants did not provide follow-up information, which is a study weakness. However, the number of participants who provided this information was sufficient for statistical analysis and the majority of the participants attended the follow-up visit. Therefore, it can be deduced from the results that even if the number of participants followed after drug administration increased, the study findings would not be significantly different. Another limitation of this study was the absence of long term follow-up data for all patients after treatment. This is a question that will require further investigation.
The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects. The study was unbiased, partially funded by government organisations and the first well designed trial comparing curcumin with PPI for functional dyspepsia, with confirmation through endoscopy and ruling out H pylori infection. Limitations of this study included the small number of patients who were lost to follow-up and the lack of long term follow-up data.
However, I am far less impressed.
Why?
Curcumin is bright yellow and has a very distinct taste/smell. Even though curumin was given in capsules, patients can easily tell what they are taking. I therefore doubt that they were adequately blinded. In fact, the authors seem to agree when they state the following:
We observed that despite improvements in pain and non-pain scores, there was no significant improvement in the SODA satisfaction scores in the O and C+O groups (table 3). A possible explanation for this observation could be related to the taste and/or smell of curcumin, which might have caused reduced pleasantness for the participants while ingesting it. This potential discomfort could offset the improvements in pain and non-pain symptoms, leading to the non-significant change in satisfaction score. Further studies may be needed to explore this hypothesis as well as to improve the palatability of curcumin.
Sadly, the success of blinding (which under such circumstances should always be tested) was not reported and probably not even quantified. If many patients were de-blinded, it seems inevitable that their expectation influenced the results. In other words, the much-lauded effect of curcumin might just be due to placebo and curcumin might be entirely useless. Or, to put it bluntly, the trial was not nearly as good as many made it out to be.
PS
Sad to see that the reviewers of a reputable journal failed to pick up on this significant flaw.
