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

prevention

I was alerted to the updated and strengthened guidance to ensure safer practice by chiropractors who treat children under the age of 12 years that has recently been published by the Chiropractic Board of Australia after considering the recommendations made by the Safer Care Victoria independent review. The Board also considered community needs and expectations, and specifically the strong support for consumer choice voiced in the public consultation of the independent review.

The Board examined how common themes in the independent review’s recommendations align with its existing regulatory guidance, and used these insights to inform a risk-based approach to updating its Statement on paediatric care. This includes updated advice reinforcing the need to ensure that parents or guardians fully understand their rights and the evidence before treatment is provided to children. ‘Public safety is our priority, and especially so when we consider the care of children’, Board Chair Dr Wayne Minter said.

According to the statement, the Board expects chiropractors to various things, including the following [the numbers in the following passage were added by me and refer to my brief comments below]:

  • inform the patient and their parent/guardian about the quality of the acceptable evidence and explain the basis for the proposed treatment [1]
  • provide the patient and their parent/guardian with information about the risks and benefits of the proposed treatment and the risks of receiving no treatment [2]
  • appropriately document consent, including considering the need for written consent for high-risk procedures [3]
  • refer patients when they have conditions or symptoms outside a chiropractor’s area of competence, for example ‘red flags’ such as the presence of possible serious pathology that requires urgent medical referral to the care of other registered health practitioners [4]

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  1. I know what is meant by the ‘quality of the evidence’ but am not sure what to make of the ‘quality of the acceptable evidence]. Acceptable by whom? In any case, who checks whether this information is being provided?
  2. Imagine the scenatio following this guidance: Chiro informs that there is a serious risk and no proven benefit – which parent would then procede with the treatment? In any case, the informed consent is incomplete because it also requires information as to which conventional treatment is effective for the condition at had [information that chiros are not competent to provide].
  3. Who checks whether this is done properly?
  4. Arguably, all pediatric conditions or symptoms are outside a chiropractor’s area of competence!

In view of these points, I fear that the updated guidance is a transparent attempt of window dressing, yet unfit for purpose. Most certainly, it does not ensure safer practice by chiropractors who treat children under the age of 12 years.

That proponents of anthroposophic medicine have strange attitudes towards established and effective immunizations is hardly a secret. The authors of this review defined anthroposophic communities as people following some/certain views more or less loosely connected to the philosophies of anthroposophy. Their systematic review firstly collated evidence documenting outbreaks linked to anthroposophic communities.

A total of 18 measles outbreaks occurred between 1997 and 2011 in European countries. Eight out of 18 measles outbreaks started at Waldorf schools throughout Germany, Switzerland, Austria, Netherlands, and the UK. Although data from community reporting was limited, the measles cases at Waldorf schools were predominantly higher than in mainstream private or state schools across the five countries. Offering measles vaccination catch-ups by public health authorities (which is an effective way to manage a measles outbreak) was described in several articles but was largely refused by both parents and Waldorf schools. The most effective outbreak control strategy was the immediate closure of the Waldorf school and strict rules regarding entry to the school upon reopening.

Secondly, the review summarized the literature on vaccination coverage in anthroposophic communities. Six articles described vaccine coverage in anthroposophic communities, and one article described the personal belief exception (PBE) rate at Waldorf school in the USA. The papers focussed predominantly on diphtheria, pertussis, tetanus and poliomyelitis (DPTP), and mumps, measles and rubella (MMR) vaccines. Two studies studying the vaccination coverage at Waldorf pre-schools/schools, demonstrated overall low immunization coverage at those schools. One article focusing on PBE rates demonstrated a proportionally high rate at Waldorf schools in California. Three studies from the Netherlands measure vaccination coverage in general and focussed specifically on whether there were special groups that showed specifically low coverage. In these studies, anthroposophic communities were identified as showing low coverage. However, one study suggested that anthroposophic communities are not as significant in terms of low coverage as low-income groups. One paper described rates of vaccination refusal in Switzerland. It showed that complementary alternative medicine users, including people who draw on anthroposophic medicine, are more likely to refuse vaccination. However, the paper also shows that this group was more likely to vaccinate against tick-borne diseases and encephalitis than the general population.

Thirdly, the review discussed the literature that summarized theories and factors influencing vaccine decision-making in anthroposophic communities. Eight articles examining factors and theories influencing vaccine decision-making in anthroposophic communities were included. Five articles focused on parents of children attending Waldorf schools or who considered themselves part of an anthroposophic community. Three articles focused on the perspectives of anthroposophic healthcare providers, although two of those articles mixed and compared views with other alternative/complementary providers or allopathic health providers. Of the eight articles, two were quantitative and did not provide an in-depth discussion. The qualitative findings from six articles were summarized in-depth and revealed four themes.

The authors concluded that this systematic review showed that there have been several measles outbreaks linked to anthroposophic communities in Europe. Although studies on vaccination coverage in anthroposophic communities are limited, it appears that coverage is lower than in the general population. Monitoring outbreak numbers and vaccination coverage could be important. Popular beliefs about the anthroposophic communities’ vaccination beliefs are challenged in this review. As the evidence shows the communities are not categorically against vaccines. Moreover, there are a myriad of factors that influence vaccine decision-making of parents belonging to an anthroposophic community. The importance of experiencing childhood illnesses and concerns over long-term side effects were mentioned. Moreover, parents want to be able to individually select vaccines for their children. They consider themselves actively engaged in vaccine decision-making and well-informed. Stigma regarding vaccine choices was mentioned repeatedly mostly by people outside of the anthroposophic community but also by people within the community. This review calls for a better understanding of vaccine choices and beliefs for vaccines beyond MMR, in particular HPV vaccines. The review also highlights a potentially important research gap, which constitutes understanding not only a belief system but the role that stigma may play in making decisions about vaccines.

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If you ask where this strange anti-vaccination stance of anthroposophic medicine comes from, you don’t need to look far:

“In the future, we will eliminate the soul with medicine.

Under the pretext of a ‘healthy point of view’, there will be a vaccine by which the human body will be treated as soon as possible directly at birth,
(1) so that the human being cannot develop the thought of the existence of soul and Spirit.

To materialistic doctors, will be entrusted with the task of removing the soul of humanity.

As today, people are vaccinated against this disease or disease, so in the future, children will
(2) be vaccinated with a substance that can be produced precisely in such a way that people, thanks to this vaccination, will be immune to being subjected to the “madness” of spiritual life.

He would be extremely smart, but he would not develop a conscience, and that is the
(3) true goal of some materialistic circles.

With such a vaccine, you can easily make the etheric body loose in the physical body.
Once the etheric body is detached, the relationship between the universe and the etheric body would become extremely unstable, and man would become
(4) an automaton, for the physical body of man must be polished on this Earth by spiritual will.

So, the vaccine becomes a kind of arymanique [Ahrimanic] force; man can no longer get rid of a given materialistic feeling.
(5) He becomes materialistic of constitution and can no longer rise to the spiritual “.

Rudolf Steiner 

How often have we seen it stated on this blog and elsewhere by enthusiasts of so-called alternative medicine (SCAM) that COVID vaccinations were useless or even harmful? Here is some rather compelling evidence that should make them think again.

This population based cohort study investigated the effectiveness of primary covid-19 vaccination (first two doses and first booster dose within the recommended schedule) against post-covid-19 condition (PCC).

All adults (≥18 years) participated from the Swedish Covid-19 Investigation for Future Insights (a Population Epidemiology Approach using Register Linkage (SCIFI-PEARL) project, a register based cohort study in Sweden) with covid-19 first registered between 27 December 2020 and 9 February 2022 (n=589 722) in the two largest regions of Sweden. Individuals were followed from a first infection until death, emigration, vaccination, reinfection, a PCC diagnosis (ICD-10 diagnosis code U09.9), or end of follow-up (30 November 2022), whichever came first. Individuals who had received at least one dose of a covid-19 vaccine before infection were considered vaccinated.

The primary outcome was a clinical diagnosis of PCC. Vaccine effectiveness against PCC was estimated using Cox regressions adjusted for age, sex, comorbidities (diabetes and cardiovascular, respiratory, and psychiatric disease), number of healthcare contacts during 2019, socioeconomic factors, and dominant virus variant at time of infection.

Of 299 692 vaccinated individuals with covid-19, 1201 (0.4%) had a diagnosis of PCC during follow-up, compared with 4118 (1.4%) of 290 030 unvaccinated individuals. Covid-19 vaccination with any number of doses before infection was associated with a reduced risk of PCC (adjusted hazard ratio 0.42, 95% confidence interval 0.38 to 0.46), with a vaccine effectiveness of 58%. Of the vaccinated individuals, 21 111 received one dose only, 205 650 received two doses, and 72 931 received three or more doses. Vaccine effectiveness against PCC for one dose, two doses, and three or more doses was 21%, 59%, and 73%, respectively.

The authors concluded that the results of this study suggest a strong association between covid-19 vaccination before infection and reduced risk of receiving a diagnosis of PCC. The findings highlight the importance of primary vaccination against covid-19 to reduce the population burden of PCC.

This study should make the anti-vaxers re-consider their views. Sadly, I have little hope that they will. If they don’t, they provide rational thinkers with yet further evidence that they are cultists who are beyond learning from compelling data.

The British doctor and outspoken anti-vaxer Aseem Malhotra has featured several times on this blog, e.g.:

Now, there has been a potentially important new development in his story. The Good Law Project recently announced the following:

During the pandemic, we depended on doctors telling us how we could protect ourselves and our loved ones. We trusted their advice would be based on the most reliable and up-to-date research.

But when the British cardiologist Dr Aseem Malhotra went on television, or posted to his hundreds of thousands of followers on social media, he repeatedly claimed the vaccine was ineffective and posed a greater threat than Covid, causing “horrific unprecedented harms including sudden cardiac death” – suggestions refuted by medical experts and branded false by factcheckers.

The General Medical Council is responsible for regulating doctors in the UK and investigating those whose conduct falls short of the required standards. Despite the clear risk to public health of vaccine misinformation, it has so far refused to launch an investigation into Malhotra’s public pronouncements, originally saying that they “don’t consider that the comments or posts made by the doctor call his fitness to practice into question…” and subsequently upholding that decision after a number of doctors challenged it.

Good Law Project is supporting a doctor who is taking the regulator to the High Court over their failure to investigate whether Malhotra has breached standards. The judicial review has now been given permission to proceed by the High Court, which held that it raises an “issue of general public importance” as to how the GMC exercises its functions.

According to the claimant, Dr Matt Kneale, medical professionals “should not be using their professional status to promote harmful misinformation”.

“When doctors repeatedly say things that are incorrect, misleading and put people’s health at risk – for example by encouraging them to refuse a vaccine – the GMC must hold them to account,” Kneale said.

For the Good Law Project Executive Director, Jo Maugham, the regulator’s failure to investigate doctors spreading misinformation forms part of a wider pattern.

“What we have learned from both the pandemic inquiry and the calamitous economic consequences of Brexit,” Maugham explained, “is quite how serious are the consequences of deciding, as Michael Gove did, that we have ‘had enough of experts’.”

The council may prefer to avoid becoming embroiled in a controversy over free speech, he continued, but “its primary obligation is to protect the public – and it’s really hard to see how its stance delivers on that objective.”

Dr Malhotra is far from the only proponent of vaccine misinformation in the UK.  Open Democracy revealed that anti-lockdown MPs, including Tufton Street’s Steve Baker, took large donations from a secretive group called The Recovery Alliance, which has been linked with a fake grassroots organisation that campaigned against the vaccine.

We’re working to stop misinformation from going unchallenged, and to make sure that regulators like the General Medical Council hold dangerous doctors who make unfounded claims accountable.

By helping to fund this case, you’ll be fighting for trust in the medical profession and to make sure public safety is doctors’ first priority. Any support you can give will help us make positive change.

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The ‘Good Law Project’?

Who are they?

Good Law Project is a not for profit campaign organisation that uses the law for a better world. We know that the law, in the right hands, can be a fair and decent force for good. It is a practical tool for positive change and can make amazing things happen. We are proud to be primarily funded by members of the public, which keeps us fiercely independent. We want to inspire hope in difficult times by showing that you can make a difference, with the backing of good law. Our mission is to use the law to hold power to account, protect the environment, and ensure no one is left behind. You can learn more about our organisation and achievements in 2022-23 in our annual report.

You might even decide to support this splendid organization!

I hope you do.

It has just been reported that the Düsseldorf Regional Court has dismissed several lawsuits against vaccine manufacturers for alleged coronavirus vaccine damage as unfounded.

Three women and one man had filed a lawsuit against manufacturers of mRNA vaccines. They claimed to have suffered significant impairment and damage to their health as a result of the coronavirus vaccines. They claimed to have suffered from states of exhaustion, concentration disorders, damage to the immune system, respiratory and lung problems, autoimmune reactions and symptoms of myocarditis. The plaintiffs demanded compensation for pain and suffering of up to 250,000 euros and damages.

The court rejected the claims. The requirements for a claim under the German Medicinal Products Act were not met, the court stated. The plaintiffs had not sufficiently proven a “negative risk-benefit balance” of the vaccine. On the contrary, the European Medicines Agency (EMA) had determined a positive balance for the vaccine during the authorisation process.

Furthermore, the plaintiffs had not provided sufficient evidence that the manufacturer had provided incorrect information regarding the vaccine, the court continued. On the contrary, it follows from the official authorisation by the EMA that the manufacturer’s statements “are not objectionable in terms of content”. The judgements are not yet legally binding.

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I have little doubt that antivazers will now claim that the court is in the pocket of the pharmaceutical industry. To give you a flavour of their mindset, here are examples of recent tweets (Xs) that I picked up on the subject (my translations):

  • You stupid arseholes and stupid rabble-rousers, and who is liable for the coronavirus vaccination damage and for the German arms factories in Ukraine?
  • More and more vaccines, no long-term studies…not with me!
    I make decisions about my body and you can see from the coronavirus vaccine damage that I have done everything right. Even if our government wants us to believe that there are none and pays the lawyers for Biontech.
  • Corona vaccination damage, disinformation, corona vaccination no protection, disinformation, that’s how it works with the anti-democrats.
  • The Corona vaccine damage is also still being covered up. This political cesspit also stinks and needs to be emptied as quickly as possible.
  • When the force-financed government TV reports on “vaccine damage”, more and more of the people’s traitors must be getting sick to their stomachs.
  • For the “fact checkers”, facts are opinions – often even contradicting government statistics, e.g. in the case of coronavirus vaccinations – that are considered correct by the establishment. Necessary open discussions are not wanted by them.

There is growing evidence that substituting animal-based with plant-based foods is associated with a lower risk of cardiovascular diseases (CVD), type 2 diabetes (T2D), and all-cause mortality. The aim of this review was to summarize and evaluate the evidence for the substitution of any animal-based foods with plant-based foods on cardiometabolic health and all-cause mortality in a systematic review and meta-analysis.

The researchers systematically searched MEDLINE, Embase, and Web of Science to March 2023 for prospective studies investigating the substitution of animal-based with plant-based foods on CVD, T2D, and all-cause mortality. They calculated summary hazard ratios (SHRs) and 95% confidence intervals (95% CI) using random-effects meta-analyses. We assessed the certainty of evidence (CoE) using the GRADE approach.

In total, 37 publications based on 24 cohorts were included. The results are impressive:

  • There was moderate CoE for a lower risk of CVD when substituting processed meat with nuts [SHR (95% CI): 0.73 (0.59, 0.91), n = 8 cohorts], legumes [0.77 (0.68, 0.87), n = 8], and whole grains [0.64 (0.54, 0.75), n = 7], as well as eggs with nuts [0.83 (0.78, 0.89), n = 8] and butter with olive oil [0.96 (0.95, 0.98), n = 3].
  • There was moderate CoE for an inverse association with T2D incidence when substituting red meat with whole grains/cereals [0.90 (0.84, 0.96), n = 6] and red meat or processed meat with nuts [0.92 (0.90, 0.94), n = 6 or 0.78 (0.69, 0.88), n = 6], as well as for replacing poultry with whole grains [0.87 (0.83, 0.90), n = 2] and eggs with nuts or whole grains [0.82 (0.79, 0.86), n = 2 or 0.79 (0.76, 0.83), n = 2].
  • Replacing red meat for nuts [0.93 (0.91, 0.95), n = 9] and whole grains [0.96 (0.95, 0.98), n = 3], processed meat with nuts [0.79 (0.71, 0.88), n = 9] and legumes [0.91 (0.85, 0.98), n = 9], dairy with nuts [0.94 (0.91, 0.97), n = 3], and eggs with nuts [0.85 (0.82, 0.89), n = 8] and legumes [0.90 (0.89, 0.91), n = 7] was associated with a reduced risk of all-cause mortality.

The authors concluded that their findings indicate that a shift from animal-based (e.g., red and processed meat, eggs, dairy, poultry, butter) to plant-based (e.g., nuts, legumes, whole grains, olive oil) foods is beneficially associated with cardiometabolic health and all-cause mortality.

I am not a vegetarian or vegan but have been interested in vegetarian diets for some time.

The mechanisms by which a vegetarian diet bring about the health benefits are still not entirely clear and require more research. Likewise, we need more evidence on the question wether it is necessary to avoid all animal-based foods to generate the benefits. My reading of the evidence is that a reduction of such foods might suffice. Yet, the optimal balance is unclear as yet.

According to Healthcare.gov, a primary care provider in the US is “a physician (MD or DO), nurse practitioner, clinical nurse specialist or physician assistant, as allowed under state law, who provides, coordinates or helps a patient access a range of healthcare services.” A growing movement exists to expand who can act as a primary care privider (PCP). Chiropractors have been a part of this expansion, but is that wise? This is the question recently asked by Katie Suleta of THE AMERICAN COUNCIL ON SCIENCE AND HEALTH In it, she explains that:

  • chiropractors would like to act as PCPs,
  • chiropractors are not trained in pharmacology,
  • chiropractors receive some training in supplements,
  • chiropractors wish to avoid pumping the body full of “synthetic” hormones and substances.

Subsequently, she adresses the chiropractic profession’s stance on vaccines.

First, look at similar professional organizations to establish a reasonable expectation. The American Medical Association has firmly taken a stance on vaccines and provides resources for physicians to help communicate with patients. There is no question about where they stand on the topic, whether it be vaccines in general or COVID-19 vaccines specifically. Ditto the American Osteopathic Association and American Association of Colleges of Osteopathic Medicine. There is a contingent of vaccine-hesitant MDs and DOs. There is also an anti-vax contingent of MDs and DOs. The vaccine hesitant can be considered misguided and cautious, while anti-vaxxers often have more misinformation and an underlying political agenda. The two groups pose a threat but are, thankfully, the minority. They’re also clearly acting against the recommendations of their professional organizations.

Let’s now turn to the American Chiropractic Association (ACA). Unlike the American Medical Association or American Osteopathic Association, they seem to take no stance on vaccines. None. Zip. Zilch. As of this writing, if you go to the ACA website and search for “vaccines,” zero results are returned. Venturing over to the ACA-CDID, there is a category under their “News and Articles” section for ‘Vaccines.’ This seems promising! However, when you click on it, it returns one article on influenza vaccines from Fox News from 2017. It’s not an original article. It’s not a perspective piece. No recommendations are to be found—nothing even on the COVID-19 vaccines. Basically, there is effectively nothing on ACA-CDID’s website either. We’re oh for two.

The last one we’ll try is DABCI University. No, it’s not a professional organization, but it does train DCs. The words ‘university’ and ‘internist’ are involved, so they must talk about vaccines…right? Wrong again. While there is a lot of content available only to paying members and students, the sections of their website that are publicly available are noticeably short on vaccine information. There is a section dedicated to articles, currently including five whole articles, and not a single one talked about vaccines. One report addresses the pharmacokinetics of coffee enemas, but none talks about one of the most fundamental tools PCPs have to help prevent illness.

Why It’s Important

Chiropractic was defined by DD. Palmer, its founder, as “a science of healing without drugs.” It relies on spinal manipulation. In traditional chiropractic, there is no room for medications at all. A rift has developed within the profession, and some chiropractors, those seeking that internal medicine certification, “try to avoid pumping the body with synthetic hormones and other prescriptions.”

During the COVID-19 pandemic, several prominent chiropractors publicly pushed anti-vaccine views. To highlight just a few prominent examples: Vax Con ’21Mile Hi Chiro, and Ben Tapper. Vax Con ’21 was organized and orchestrated by the Chiropractic Society of Wisconsin. It featured Judy Mikovits, of Plandemic fame, as a speaker and touted her book with a forward written by Robert F. Kennedy Jr. It offered continuing education units (CEUs) to DCs to attend this anti-vaccine conference that peddled misinformation about COVID-19 vaccines and other prevention measures. Healthcare providers are often required to complete a certain number of continuing education units to maintain licensure, ensuring that they stay current and sharp as healthcare evolves or, in this case, devolves.

This conference was not unique in this either. Mile Hi Chiro was just held in Denver in September of this year, had several questionable speakers (including RFK and Ben Tapper of Disinformation Dozen fame), and offered continuing education. If professional conferences offer continuing education units for attendees and push vaccine misinformation, that should concern everyone. Especially if the profession in question wants to act as PCPs.

Despite training in a system that believes “the body has an innate intelligence, and the power to heal itself if it is functioning properly, and that chiropractic care can help it do that,” without medications, but frequently with supplements, roughly 58% of Oregon’s chiropractors were vaccinated against COVID-19. That said, their training and inclination, along with the silence of their professional organizations and the chiropractic conferences featuring anti-vaccine sentiment, make them a profession that, at the very least, doesn’t consider vaccinations or medications viable health alternatives. We’re now talking about an entire profession that wants to be PCPs.

Irrespective of your belief about the efficacy of COVID-19 vaccination, the germ theory of disease remains unchallenged. Anyone unwilling to work to treat and prevent infectious diseases within their community with the most effective means at our disposal should not be allowed to dispense medical advice. Chiropractors lack the basic training that a PCP should have. I’ve said it before and I’ll say it again: I want healthcare accessible for everyone. But, if you’re looking for a PCP, consider going to an MD, DO, NP, or PA – they come fully equipped for your primary care needs.

Regular readers of this blog will be aware that I have discussed the thorny issue of chiros and vaccinations many times before, e.g.:

I agree with Katie Suleta that the issue is important and thank her for raising it. I also agree with her conclusion that, if you’re looking for a PCP, consider going to an MD, DO, NP, or PA – they come fully equipped for your primary care needs.

Do not consult chiropractors. 

Traditionally, strokes were considered a condition primarily affecting older adults. But in recent years, doctors have noticed a disturbing trend: the rise of stroke cases among younger adults, a demographic that was once considered low-risk. New data reveals an increase in the number of young adults facing an unexpected battle with strokes. Experts point to poor lifestyle choices as the main risk factor. Smoking, unhealthy diets, lack of exercise, and increased stress have played a role because they lead to problems like high cholesterol, high blood pressure and obesity.

But one risk factor most people don’t consider has to do with chiropractic adjustments. US doctors say forceful and rapid neck rotations during these procedures can potentially cause damage to the vertebral arteries supplying blood to the brain stem. “We see five, if it’s a bad year, up to eight or 10 a year per hospital, and some of them can be quite devastating because the brain stem and the cerebellum are in an enclosed compartment and that only so much room,” said Dr. Melissa McDonald, with McKay Dee Hospital.

Stroke symptoms in young adults are similar to those seen in older adults: weakness or numbness in the face, arm, or leg; sudden change in speech, difficulty walking or keeping your balance; and sudden severe headaches and change in vision. Any of these symptoms require immediate medical attention, but doctors say younger adults tend to wait longer than older adults to go to the ER.

Dr. McDonald says younger adults face an increased risk of complications from brain swelling following a stroke due to the relatively larger size of their brains within the skull compared to older individuals.

Readers of this blog can hardly be surprised by this news. I have often enough reported on the fact that chiropractic adjustments can cause a stroke, e.g.:

And what is the solution?

I’m glad you asked; it is simple! In the words of one neurologists:

DON’T LET THE BUGGARS TOUCH YOUR NECK!

Much of the discussions on this blog are directly or indirectly related to the subject of research integrity. Research integrity refers to the ethical and professional standards that researchers must adhere to while conducting research. It involves conducting research in a way that allows others to have confidence and trust in the methods and findings of the research. Research integrity includes honesty, rigour, transparency, open communication, care and respect for all participants, and accountability. According to the ‘Concordat To Support Research Integrity‘, the core elements of research integrity are:

  1. Honesty in all aspects of research, including in the presentation of research goals, intentions and findings; in reporting on research methods and procedures; in gathering data; in using and acknowledging the work of other researchers; and in conveying valid interpretations and making justifiable claims based on research findings.
  2. Rigour, in line with prevailing disciplinary norms and standards, and in performing research and using appropriate methods; in adhering to an agreed protocol where appropriate; in drawing interpretations and conclusions from the research; and in communicating the results.
  3. Transparency and open communication in declaring potential competing interests in the reporting of research data collection methods; in the analysis and interpretation of data; in making research findings widely available, which includes publishing or otherwise sharing negative or null results to recognise their value as part of the research process; and in presenting the work to other researchers and to the public.
  4. Care and respect for all participants in research, and for the subjects, users and beneficiaries of research, including humans, animals, the environment and cultural objects. Those engaged with research must also show care and respect for the integrity of the research record.
  5. Accountability of funders, employers and researchers to collectively create a research environment in which individuals and organisations are empowered and enabled to own the research process. Those engaged with research must also ensure that individuals and organisations are held to account when behaviour falls short of the standards set by this concordat.

These points apply to all types and aspects of research and to all individuals involved in it. Obviously, they apply also to research of so-called alternative medicine (SCAM). I will therefore briefly discuss each point in respect of SCAM research.

Ad 1

Honesty in research is an important ethical prerequisite. In SCAM, we regularly see that the honesty seems to be in short supply. There are many ways in which lack of honesty shows itself. For me, the most impressive one is when SCAM researchers disclose – as they often do –  that their aim is to demostrate that their assumptions/theories/hypotheses are correct. In such cases, they abuse the tools of science which are not for confirming hypotheses but for testing, i.e. trying to falsifying them. This blog offers plenty of examples for this phenomenon (e.g. here or here)

Ad 2

The lack of rigor in much of SCAM research is legend and has become a constant theme on this blog. How often have we seen useless and unnecessary observational studies or pilot studies on subjects where controlled trials already exist? How often have we lamented over misinterpretation of a study’s findings? How often have we reported research that was ill-conceived from the outset, unable to answer any meaningful research question? My all time favourite examples of drawing a wrong conclusions are from the area of homeopathy, e.g. here and here.

Ad 3

Much of SCAM research is being conducted by SCAM enthusiasts who have no qualitification or experience in research or science. Inevitably, this must lead to bias. Just think of the fact that some countries, e.g. China, or some SCAM journals, or some SCAM researchers (e.g. THE ALTERNATIVE MEDICINE HALL OF FAME) publish as good as no negative findings

Ad 4

Lack of respect for research subjects has many guises. For instance, if clinical trials are being conducted of treatments that are utterly implausible. This, in my view, constitutes an abuse of the willingness of volunteers to make a contribution to research. Another example is the incessant flow of untrustworthy research by SCAM enthusiasts which eventually can only erode the public’s trust in research and is bound to render the essential cooperation of researchers and volunteers more and more problematic.

Ad 5

When I think of accountability, I think yet again of the men and women in my ALTERNATIVE MEDICINE HALL OF FAME. As any of its members ever been held accountable for misleading the public through their pseudo-research? Sadly, the answer, as far as I know, is NO.

This study investigated whether Tongxinluo,a traditional Chinese medicine compound that has shown promise in in vitro, animal, and small human studies for myocardial infarction, could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). The randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021.

Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months. A loading dose of 2.08 g was given after randomization, followed by the maintenance dose of 1.04 g, 3 times a day, in addition to STEMI guideline-directed treatments. The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year.

Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group. Individual components of 30-day MACCEs, including cardiac death, were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs and cardiac death. There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis. More adverse drug reactions occurred in the Tongxinluo group than the placebo group, mainly driven by gastrointestinal symptoms.

The authors concluded that in patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. Further research is needed to determine the mechanism of action of Tongxinluo in STEMI.

Tongxinluo is mixture of various active ingredients, including

  • ginseng,
  • leech,
  • scorpion,
  • Paeonia lactiflora,
  • cicada slough,
  • woodlouse bug,
  • centipede,
  • sandalwood.

With chaotic mixtures of this type, it is impossible to name all the potentially active ingredients, list their actions, or identify the ones that are truly relevant. According to the thinking of TCM proponents, this would also be the wrong way to go about it – such mixtures work as a whole, they would insist.

Tongxinluo is by no means a mixture that has not been studied before.

A previous systematic review of 12 studies found that Tongxinluo capsule is superior to conventional treatment in improving clinical overall response rate and hemorheological indexes and is relatively safe. Due to the deficiencies of the existing studies, more high-quality studies with rigorous design are required for further verification.

A 2022 meta-analysis indicated that the mixture had beneficial effects on the prevention of cardiovascular adverse events, especially in TVR or ISR after coronary revascularization and may possibly lower the incidence of first or recurrent MI and HF within 12 months in patients with CHD, while insufficient sample size implied that these results lacked certain stability. And the effects of TXLC on cardiovascular mortality, cerebrovascular events, and unscheduled readmission for CVDs could not be confirmed due to insufficient cases. Clinical trials with large-sample sizes and extended follow-up time are of interest in the future researches.

A further meta-analysis suggested beneficial effects on reducing the adverse cardiovascular events without compromising safety for CHD patients after PCI on the 6-month course.

Finally, a systematic review of 10 studies found that the remedy is an effective and safe therapy for CHD patients after percutaneous coronary interventions.

So, should we believe the new study with its remarkable findings? On the one hand, the trial seems rigorous and is reported in much detail. On the other hand, the study (as all previous trials of this mixture) originates from China. We know how important TCM is for that country as an export item, and we know how notoriously unreliable Chinese research sadly has become. In view of this, I would like to see an independent replication of this study by an established research group outside China before I recommend Tongxinluo to anyone.

Let’s not forget:

if it sound too good to be true, it probably is!

 

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