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

death

The risks of chiropractic spinal manipulations (CSMs) feature regularly on my blog, not least because most chiropractors are in denial of this important issue and insist that chiropractic spinal manipulations are safe!!!. I therefore thought it might be a good idea to try and summarize the arguments they often put forward in promoting their dangerously fallacious and quasi-religious belief that CSMs are safe:

  1. There is not evidence to suggest that CSMs do harm. Such a statement is based on wishful thinking and ignorance motivated by the need of making a living. The evidence shows a different picture.
  2. There are hundreds of clinical trials that demonstrate the safety of CSMs. This argument is utterly unconvincing for at least two reasons: firstly clinical trials are far too small for identifying rare (but serious) complications; secondly, we know that clinical trials of CSM very often fail to report adverse events.
  3. Case reports of adverse effects are mere anecdotes and thus not reliable evidence. As there is no post-marketing surveillance system of adverse events after CSMs, case reports are, in fact, the most important and informative source of information we currently have on this subject.
  4. Case reports of harm by CSMs are invariably incomplete and of poor quality. Case reports are usually published by doctors who often have to rely on incomplete information. It would be up to chiropractors to publish case reports with the full details; yet chiropractors hardly ever do this.
  5. Case reports cannot establish cause and effect. True, but they do provide important signals which then should be investigated further. It would be up to chiropractors to do this; sadly, this is not what is happening.
  6. Adverse effects such as arterial dissections or strokes occur spontaneaously. True, but many have an identifiable cause, and it is our duty to find it.
  7. The forces applied during CSM are small and cannot cause an injury. This might be true under ideal conditions, but in clinical practice the conditions are often not ideal.
  8. If an arterial dissection occurs nevertheless, it is because there was a pre-existing injury. This argument is largely based on wishful thinking. Even if it were true, it would be foolish to aggravate a pre-existing injury by CSMs.
  9. Injuries happen only if the contra-indications of CSMs are ignored. This obviously begs the question: what are the contra-indications and how well established are they? The answer is that they are largely based on guess-work and not on systematic research. Thus chiropractors are able to claim that, once an adverse effects has occurred, the incident was due to a disregard of contra-indication and not due to the inherent risks of CSM.
  10. Only poorly trained chiropractors cause harm. This is evidently untrue, yet the argument provides yet another welcome escape route for those defending CSMs: if something went wrong, it must have been due to the practitioner and not the intervention!
  11. Chiropractors are an easy target. In my fairly extensive experience in this field, the opposite is true. Chiropractors tend to have multiple excuses and escape routes. As a consequence, they are difficult to pin down.
  12. Other causes, e.g. car accidents, are much more common causes of vascular injuries. Even if this were true, it does certainly not mean that CSM can be ruled out as the cause of serious harm.
  13. Patients who experience harm had pre-existing issues. Again, this notion is mostly based on wishful thinking and not based on sound evidence. Yet, it clearly is another popular escape route for chiropractors. And again, it is irresponsible to administer CSM if there is the possibility that pre-existing issues are present.
  14. The alleged harms of CSMs are merely an obsession for people who don’t really understand chiropractic. That is an old trick of someone trying to defend the indefensible. Chiropractors like to pompously claim that opponents are ignorant and only chiropractors understand the subject area. They use arrogance in an attempt to intimidate or scilence experts who disagree with them.
  15. Chiropractors do so much more than just CSN. True. They have ‘borrowed’ many modalities from physiotherapy and, by pointing that out, they aim at distracting from the dangers of CSMs. Yet, it is also true that practically every patient who consults a chiropractor will receive a CSM.
  16. Doctors are just jealous of the success of chiropractors. This fallacy is used when chiropractors run out of proper arguments. Rather than addressing the problem, they try to distract from it by claiming the opponent has ulterior motives.
  17. Medical treatments cause much more harm than CSM. Chiropractors are keen to mislead us into believing that NSAIDs, for instance, are much more dangerous than CSMs. The notion is largely based on one lousy article and thus not convincing. Even if it were true, it would obviously be no reason to ignore the risks of CSNs.

I am sure my list is far from complete. If you can think of further (pseudo-) arguments, please use the comments section below to let us know.

The WHO has just released guidelines for non-surgical management of chronic primary low back pain (CPLBP). The guideline considers 37 types of interventions across five intervention classes. With the guidelines, WHO recommends non-surgical interventions to help people experiencing CPLBP. These interventions include:

  • education programs that support knowledge and self-care strategies;
  • exercise programs;
  • some physical therapies, such as spinal manipulative therapy (SMT) and massage;
  • psychological therapies, such as cognitive behavioural therapy; and
  • medicines, such as non-steroidal anti-inflammatory medicines.

The guidelines also outline 14 interventions that are not recommended for most people in most contexts. These interventions should not be routinely offered, as WHO evaluation of the available evidence indicate that potential harms likely outweigh the benefits. WHO advises against interventions such as:

  • lumbar braces, belts and/or supports;
  • some physical therapies, such as traction;
  • and some medicines, such as opioid pain killers, which can be associated with overdose and dependence.

As you probably guessed, I am particularly intrigued by the WHO’s positive recommendation for SMT. Here is what the guideline tells us about this specific topic:

Considering all adults, the guideline development group (GDG) judged overall net benefits [of spinal manipulation] across outcomes to range from trivial to moderate while, for older people the benefit was judged to be largely uncertain given the few trials and uncertainty of evidence in this group. Overall, harms were judged to be trivial to small for all adults and uncertain for older people due to lack of evidence.

The GDG commented that while rare, serious adverse events might occur with SMT, particularly in older people (e.g. fragility fracture in people with bone loss), and highlighted that appropriate training and clinical vigilance concerning potential harms are important. The GDG also acknowledged that rare serious adverse events were unlikely to be detected in trials. Some GDG members considered that the balance of benefits to harms favoured SMT due to small to moderate benefits while others felt the balance did not favour SMT, mainly due to the very low certainty evidence for some of the observed benefits.

The GDG judged the overall certainty of evidence to be very low for all adults, and very low for older people, consistent with the systematic review team’s assessment. The GDG judged that there was likely to be important uncertainty or variability among people with CPLBP with respect to their values and preferences, with GDG members noting that some people might prefer manual
therapies such as SMT, due to its “hands-on” nature, while others might not prefer such an approach.

Based on their experience and the evidence presented from the included trials which offered an average of eight treatment sessions, the GDG judged that SMT was likely to be associated with moderate costs, while acknowledging that such costs and the equity impacts from out-of-pocket costs would vary by setting.

The GDG noted that the cost-effectiveness of SMT might not be favourable when patients do not experience symptom improvements early in the treatment course. The GDG judged that in most settings, delivery of SMT would be feasible, although its acceptability was likely to vary across
health workers and people with CPLBP.

The GDG reached a consensus conditional recommendation in favour of SMT on the basis of small to moderate benefits for critical outcomes, predominantly pain and function, and the likelihood of rare adverse events.

The GDG concluded by consensus that the likely short-term benefits outweighed potential harms, and that delivery was feasible in most settings. The conditional nature of the recommendation was informed by variability in acceptability, possible moderate costs, and concerns that equity might be negatively impacted in a user-pays model of financing.

___________________________

This clearly is not a glowing endorsement or recommendation of SMT. Yet, in my view, it is still too positive. In particular, the assessment of harm is woefully deficient. Looking into the finer details, we find how the GDG assessed harms:

WHO commissioned quantitative systematic evidence syntheses of randomized controlled
trials (RCTs) to evaluate the benefits and harms (as reported in included trials) of each of the
prioritized interventions compared with no care (including trials where the effect of an
intervention could be isolated), placebo or usual care for each of the critical outcomes (refer to Table 2 for the PICO criteria for selecting evidence). Research designs other than RCTs
were not considered.

That explains a lot!

It is not possible to establish the harms of SMT (or any other therapy) on the basis of just a few RCTs, particularly because the RCTs in question often fail to report adverse events. I can be sure of this phenomenon because we investigated it via a systematic review:

Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.

Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.

Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors.

Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

The GDG did not cite our review (or any other of our articles on the subject) but, as it was published in a very well-known journal, they must have been aware of it. I am afraid that this wilfull ignorance caused the WHO guideline to underestimate the level of harm of SMT. As there is no post-marketing surveillance system for SMT, a realistic assessment of the harm is far from easy and needs to include a carefully weighted summary of all the published reports (such as this one).

The GDG seems to have been aware of (some of) these problems, yet they ignored them and simply assumed (based on wishful thinking?) that the harms were small or trivial.

Why?

Even the most cursory look at the composition of the GDG, begs the question: could it be that the GDG was highjacked by chiropractors and other experts biased towards SMT?

The more I think of it, the more I feel that this might actually be the case. One committee even listed an expert, Scott Haldeman, as a ‘neurologist’ without disclosing that he foremost is a chiropractor who, for most of his professional life, has promoted SMT in one form or another.

Altogether, the WHO guideline is, in my view, a shameful example of pro-chiropractic bias and an unethical disservice to evidence-based medicine.

 

He came to my attention via the sad story recently featured here about patients allegedly being harmed or killed in a Swiss hospital for so-called alternative medicine (SCAM). What I then learned about the doctor in charge of this place fascinated me:

Rau states about himself (my translation):

Early on, Dr Rau focused on natural therapies, in particular homeopathy and dietary changes. The healing success of his patients proved him right, so he studied alternative healing methods with leading practitioners. These included orthomolecular medicine, Chinese and Ayurvedic medicine and European holistic medicine. With his wealth of knowledge and over 30 years of experience, Dr Rau formed his own holistic theory of healing: Swiss Biological Medicine – Dr Rau’s Biological Medicine. It is based on the principles of detoxification, nutrition, digestion and sustainable strengthening of the immune system.

Career & studies:

  • Medical studies at the University of Bern
  • Final medical examinations in Switzerland and the USA
  • Subsequent work in rheumatology, internal and general medicine
  • Member of the Swiss Medical Association FMH since 1981
  • 1981 to 1992 conventional physician & medical director of a Swiss spa centre for rheumatology and rehabilitation medicine
  • 1983 to 1992 Doctor at a drug rehabilitation centre
  • 1992 to 2019 Establishment of the Paracelsus Clinic Lustmühle as medical director and partner
  • until 2020 Head of the academic network and training organisation “Paracelsus Academy”

Rau also states this:

  • 2019 mit dem Honorarprofessoren-Titel von der Europäischen Universität in Wien ausgezeichnet (2019, he was awarded the title of homorary professor at the European University in Vienna)

This puzzles me because there is no such institution as the ‘Europäische Universität in Wien’. There is a Central European University but this can hadly be it?!

Now, I am intrigued and see what the ‘honorary professor’ might have published. Sadly, there seems to be nothing on Medline except 2 interviews. In one interview, Rau explains (amongst other things) ‘live blood analysis’, a method that we have repeatedly discussed before (for instance, here and here):

Darkfield microscopy shows a lot. We take 1 drop of blood and look at it under a very large-scale magnification. The blood is life under the glass. Once it’s on the glass, there isn’t oxygen or light or heat. This is a giant stress for the blood. So we see how, over a time, the blood reacts to this stress, and how the blood cells tolerate the stress. You can see the changes. So we take a drop of blood that represents the organism and put it under stress and look at how the cells react to the stress, and then we can see the tolerance and the resistiveness of these cells. Do they have a good cell-membrane face? Do they have good energetic behavior? Do they clot together? Is there a chance for degenerative diseases? Is there a cancerous tendency in this blood? We see tendencies. And that’s what we are interested in, tendencies.

Question: If you saw a cancerous tendency, what would that look like?

Rau: Cancerous tendency is a change in the cells. They get rigid, so to say. They don’t react very well.

Question: And how long does blood live outside the body?

Rau: It can live for several days. But after 1 hour, the blood is already seriously changed. For example, a leukemia patient came to my clinic for another disease. But when we did darkfield, I found the leukemia. We saw that his white blood cells were atypical. Look at this slide—the fact that there are so many white blood cells together is absolutely unusual, and the fact that there are atypical white blood cells. This shows me that the patient has myeloid leukemia. The patient had been diagnosed as having rheumatoid lung pain, but it was absolutely not true. The real cause of his pain was an infiltration of the spinal bone by these lymphocytes.

This is, of course, complete nonsense. As I explained in my blog post, live blood analysis (LBA) is not plausible and there is no evidence to support the claims made for it. It also is by no means new; using his lately developed microscope, Antony van Leeuwenhoek observed in 1686 that living blood cells changed shape during circulation. Ever since, doctors, scientists and others have studied blood samples in this and many other ways.

New, however, is what today’s SCAM practitioners claim to be able to do with LBA. Proponents believe that the method provides information about the state of the immune system, possible vitamin deficiencies, amount of toxicity, pH and mineral imbalance, areas of concern and weaknesses, fungus and yeast infections, as well as just about everything else you can imagine.

LBA is likely to produce false-positive and false-negative diagnoses. A false-positive diagnosis is a condition which the patient does not truly have. This means she will receive treatments that are not necessary, potentially harmful and financially wasteful. A false-negative diagnosis would mean that the patient is told she is healthy, while in fact she is not. This can cost valuable time to start an effective therapy and, in extreme cases, it would hasten the death of that patient. The conclusion is thus clear: LBA is an ineffective, potentially dangerous diagnostic method for exploiting gullible consumers. My advice is to avoid practitioners who employ this technique.

And what does that say about ‘honorary professor’ Rau?

I think I let you answer that question yourself.

 

The NZZ recently published a long and horrific report about a natural health clinic and its doctors. Here is a  version translated and shortened by me; perhaps it makes a few people think twice before they waste their money and risk their health:

It is a narrow mountain road that they are racing down on this spring evening. Over the green Appenzell hills, towards Herisau hospital. Kathrin Pfister* is fighting for her life in the car. At the wheel is Thomas Rau, internationally renowned practitioner of so-called alternative medicine (SCAM) and director of his own luxury clinic, the Biomed Centre Sonnenberg. Three days later, Kathrin Pfister is dead. The most likely finding according to the experts: Pfister was injected with a drug that was not authorised in Switzerland at the time, the side effects of which killed her.

Pfister is not the only woman to have lost her life following treatment at the Sonnenberg. Other experts accuse Rau of serious breaches of duty that led to the death of a patient. Rau and another doctor are thus being investigated for involuntary manslaughter.

The events remained hidden from the public for over two years. It’s not just about one doctor, not just about one clinic. The events are politically explosive for Appenzell Ausserrhoden. The canton is the centre of alternative medicine in Switzerland. SCAM doctors are an important economic factor in Ausserrhoden. Wealthy people from all over the world fly here for therapies that most conventional doctors just shake their heads at. Treatments lasting several weeks with a hotel stay cost five-figure sums.

The 73-year-old Dr Rau is the star among Swiss alternative medicine practitioners.He describes himself as the “Mozart of medicine”. The Biomed Centre Sonnenberg is “Mozart’s” last big project. The clinic has a hotel and gluten-free vegan restaurant from the Tibits chain. Even the feather pillows are replaced with bamboo ones. All for the “detox” that Rau praises.

Kathrin Pfister’s case began in mid-April 2021, just four months after the Sonnenberg centre opened. She is actually healthy and comes to the clinic anyway; because of some digestive problems and headaches. The hospital records show that Pfister received infusions. Initially only those containing vitamin C and homeopathic remedies. Then one with artesunate, a preparation against malaria. And finally, on a Friday, Pfister was injected with a solution of alpha-lipoic acid into his bloodstream. The infusion is used in Germany for long-term diabetics with nerve damage. It was not authorised as a medicinal product in Switzerland at the time. According to the forensic experts, it was this substance that was “ultimately causally linked to the death”.

A few hours later, Pfister had severe abdominal cramps. Then pain throughout the body. The number of platelets in her blood drops dramatically. Anxiety sets in at the clinic. The intensive care doctors in Herisau and later at the cantonal hospital in St. Gallen can do nothing more. Pfister had a massive blood clotting disorder. Her liver and kidneys were no longer functioning.

Mary Anne Hawrylak meets Thomas Rau by chance at the clinic that weekend. She too is a patient, recently flown in from the USA. Hawrylak had massive side effects after infusions that Friday. “When I told him about it, he turned white as a sheet, like a ghost,” says Hawrylak. “Doctor Rau told me in horror that I had received the same infusions as ‘Kathrin’ and that he had to test my blood.” The tests showed that her blood platelet count had also dropped, says Hawrylak.

The forensic experts point to a central fact: Alpha lipoic acid can cause blood clotting disorders.  They come to the conclusion that this is “most likely a lethal side effect of a drug”. The use of drugs that are not authorised in Switzerland is legal if they are authorised in a country with a comparable procedure. However, there is no real reason to inject this medication into the bloodstream of healthy people. It was authorised in Germany for diabetes patients with nerve damage. So, Pfister did not have this authorisation.

Experts refer to such applications as “off-label use”.  Off-label treatments should only be carried out “on the basis of valid guidelines, generally recognised recommendations or scientific literature”. The guidelines also require that patients are given comprehensive information about off-label use. This counselling session should be documented in writing. None of this can be found in the clinic’s files. No written consent, no documented risk-benefit assessment, no reference to the risk of blood clotting disorders. The forensic experts state: “The scant documentation from the Sonnenberg Biomed Centre does not contain any corresponding information document.” The question arises as to “whether the medical treatment at the Sonnenberg Biomed Centre was carried out with the necessary medical care”.

Patient Hawrylak also says: “I was not told exactly what was in the infusions. I was never told that the medication was not authorised in Switzerland or that its use was off-label. I spoke to Dr Rau about what had happened to ‘Kathrin’ because I was worried about myself,” says Hawrylak. “He said to me: ‘I don’t think it was the infusions. I think it was the Covid vaccinations.” He only justified this with his “intuition”.

The Pfister case triggered an investigation by the public prosecutor’s office. But what hardly anyone knew at the time was that it was not the first questionable death at the clinic – not even the first in a month. Ruth Schmid*, a 77-year-old Swiss woman, had died just three weeks earlier. In this case, the forensic pathologists accused Rau: He had made mistakes that not even a medical student should have made, thus causing Schmid’s death.

Schmid was also in the clinic for a kind of cure. When she was about to leave, she began to tremble violently and had extreme stomach pains. She screamed “like an animal”, her partner said during the interrogation. Ultrasound examinations were carried out at the clinic and Rau gave Schmid painkillers, including morphine. According to the partner’s statement to the public prosecutor’s office, he asked Rau whether Schmid needed to be taken to hospital. Rau said no. Schmid stayed in the hotel room overnight. The next day – according to Rau, she had been feeling better since the previous evening – she travelled home. According to Rau’s confiscated notes, “she was to report closely” and return in four days. At home, Ruth Schmid fell into a coma-like state overnight. Admitted to Zurich University Hospital in an emergency, Schmid died there of cardiovascular failure due to septic shock.

The Zurich forensic pathologists performed an autopsy on Schmid’s body. Their findings: Schmid had suffered from intestinal paralysis. As a result, bacteria entered her body and poisoned her blood, leading to a heart attack. “From a forensic medical point of view, it is incomprehensible why the attending physician, Dr Thomas Rau, did not carry out appropriate diagnostics.” The irritation of the forensic experts is evident in almost every line. There had been several warning signs of intestinal paralysis. The forensic experts wrote: “This knowledge is taught in medical school and is considered basic knowledge in human medicine.” Rau’s behaviour was “a breach of the doctor’s duty of care”. With timely treatment, the prognosis for intestinal paralysis is excellent. The sad conclusion: Ruth Schmid did not have to die.

During questioning by the public prosecutor’s office, Rau denied any guilt. Schmid had left in “good condition”. There was no causality between what happened in the clinic and the death. The findings and conclusions of the Zurich forensic pathologists were wrong. Schmid did not have intestinal paralysis or septicaemia. He had been able to rule out intestinal paralysis because intestinal noises had been audible in the morning. The dose of morphine had been very small, so that it had had no effect. There were no indications of a serious condition. Rau testified that he had acted professionally, as would be expected of an internal medicine doctor.

In the Kathrin Pfister case, the doctors treating her also deny any culpability and question the forensic medical report. The doctor’s lawyer writes that the criminal investigation will show that there was no breach of the doctor’s duty to provide information. Alpha-lipoic acid was not responsible for the death. The expert opinion is not convincing in terms of method or content: “When analysed in depth, it contains no justification that the use of alpha-lipoic acid was in any way causal for the patient’s death.”

During the hearing on the Pfister case, Rau said that restricting the use of alpha-lipoic acid to diabetics was “a joke” and far too narrowly defined. He claimed that Pfister had polyneuropathy, a complex nerve disease. However, there is no mention of this in the files of Rau’s clinic.

The criminal investigation is ongoing in both cases. But did more happen on the Sonnenberg? A former hospital employee, who independently reported to the police, told the public prosecutor about other hair-raising incidents. During the interrogation, she testified that she had seen a young woman being carried out of the clinic extremely weak after an infusion. Days later, she had overheard parts of a telephone conversation between Rau and the patient’s angry husband which made it clear that the woman had died. The former employee also recounted a conversation with Rau’s wife, who is a trained nurse. She said that she had driven a patient to a hospital in Zurich in a private car with Rau because Rau was determined to take her to a particular specialist. The patient was so unwell that she was afraid the woman would die on the way. If this is true, Rau would have travelled past several hospitals with a seriously ill patient.

Hawrylak has one last memory of Appenzell etched in his memory. The departure. She was just leaving the clinic when Rau wished her good luck: “I could only say to him: I wish you good luck too, Doctor Rau. I think you’re really going to need it.”

*Names were altered.

As promised, here is my translation of the article published yesterday in ‘Le Figaro’ arguing in favour of integrating so-called alternative medicine (SCAM) into the French healthcare system [the numbers in square brackets were inserted by me and refer to my comments listed at the bottom].

So-called unconventional healthcare practices (osteopathy, naturopathy, acupuncture, homeopathy and hypnosis, according to the Ministry of Health) are a cause for concern for the health authorities and Miviludes, which in June 2023 set up a committee to support the supervision of unconventional healthcare practices, with the task of informing consumers, patients and professionals about their benefits and risks, both in the community and in hospitals. At the time, various reports, surveys and press articles highlighted the risks associated with NHPs, without pointing to their potential benefits [1] in many indications, provided they are properly supervised. There was panic about the “booming” use of these practices, the “explosion” of aberrations, and the “boost effect” of the pandemic [2].

But what are the real figures? Apart from osteopathy, we lack reliable data in France to confirm a sharp increase in the use of these practices [3]. In Switzerland, where it has been decided to integrate them into university hospitals and to regulate the status of practitioners who are not health professionals, the use of NHPs has increased very slightly [4]. With regard to health-related sectarian aberrations, referrals to Miviludes have been stable since 2017 (around 1,000 per year), but it should be pointed out that they are a poor indicator of the “risk” associated with NHPs (unlike reports). The obvious contrast between the figures and the press reports raises questions [5]. Are we witnessing a drift in communication about the risks of ‘alternative’ therapies? [6] Is this distortion of reality [7] necessary in order to justify altering the informed information and freedom of therapeutic choice of patients, which are ethical and democratic imperatives [8]?

It is the inappropriate use of certain NHPs that constitutes a risk, more than the NHPs themselves! [9] Patients who hope to cure their cancer with acupuncture alone and refuse anti-cancer treatments are clearly using it in a dangerous alternative way [10]. However, acupuncture used to relieve nausea caused by chemotherapy, as a complement to the latter, is recommended by the French Association for Supportive Care [11]. The press is full of the dangers of alternative uses, but they are rare: less than 5% of patients treated for cancer according to a European study [12]. This is still too many. Supervision would reduce this risk even further [13].

Talking about risky use is therefore more relevant than listing “illusory therapies”, vaguely defined as “not scientifically validated” and which are by their very nature “risky” [14]. What’s more, it suggests that conventional treatments are always validated and risk-free [15]. But this is not true! In France, iatrogenic drug use is estimated to cause over 200,000 hospital admissions and 10,000 deaths a year [16]. Yes, some self-medication with phytotherapy or aromatherapy does carry risks… just like any self-medication with conventional medicines [17]. Yes, acupuncture can cause deep organ damage, but these accidents occur in fewer than 5 out of every 100,000 patients [18]. Yes, cervical manipulations by osteopaths can cause serious or even fatal injuries, but these exceptional situations are caused by practitioners who do not comply with the decree governing their practice.[19] Yes, patients can be swindled by charlatans, but there are also therapeutic and financial abuses in conventional medicine, such as those reported in dental and ophthalmology centres. [20]

Are patients really that naive? No. 56% are aware that “natural” remedies can have harmful side-effects, and 70% know that there is a risk of sectarian aberrations or of patients being taken in by a sect [21]. In view of the strong demand from patients, we believe that guaranteeing safe access to certain NHPs is an integral part of their supervision, based on regulation of the training and status of practitioners who are not health professionals, transparent communication, appropriate research, the development of hospital services and outpatient networks of so-called “integrative” medicine combining conventional practices and NHPs, structured care pathways with qualified professionals, precise indications and a safe context for treatment.[22] This pragmatic approach to reducing risky drug use [17] has demonstrated its effectiveness in addictionology [23]. It should inspire decision-makers in the use of NHPs”.

  1. Reports about things going wrong usually do not include benefits. For instance, for a report about rail strikes it would be silly to include a paragraph on the benefits of rail transport. Moreover, it is possible that the benefits were not well documented or even non-existent.
  2. No, there was no panic but some well-deserved criticism and concern.
  3. Would it not be the task of practitioners to provide reliable data of their growth or decline?
  4. The situation in Switzerland is often depicted by enthusiasts as speaking in favour of SCAM; however, the reality is very different.
  5. Even if reports were exaggerated, the fact is that the SCAM community does as good as nothing to prevent abuse.
  6. For decades, these therapies were depicted as gentle and harmless (medicines douces!). As they can cause harm, it is high time that there is a shift in reporting and consumers are informed responsibly.
  7. What seems a ‘distortion of reality’ to enthusiasts might merely be a shift to responsible reporting akin to that in conventional medicine where emerging risks are taken seriously.
  8. Are you saying that informing consumers about risks is not an ethical imperative? I’d argue it is an imperative that outweighs all others.
  9. What if both the inappropriate and the appropriate use involve risks?
  10.  Sadly, there are practitioners who advocate this type of usage.
  11. The recommendation might be outdated; current evidence is far less certain that this treatment might be effective (“the certainty of evidence was generally low or very low“)
  12. The dangers depend on a range of factors, not least the nature of the therapy; in case of spinal manipulation, for instance, about 50% of all patients suffer adverse effects which can be severe, even fatal.
  13. Do you have any evidence showing that supervision would reduce this risk, or is this statement based on wishful thinking?
  14. As my previous comments demonstrate, this statement is erroneous.
  15. No, it does not.
  16. Even if this figure is correct, we need to look at the risk/benefit balance. How many lives were saved by conventional medicine?
  17. Again: please look at the risk/benefit balance.
  18. How can you be confident about these figures in the absence of any post-marketing surveillance system? The answer is, you cannot!
  19. No, they occur even with well-trained practitioners who comply with all the rules and regulations that exist – spoiler: there hardly are any rules and regulations!
  20. Correct! But this is a fallacious argument that has nothing to do with SCAM. Please read up about the ‘tu quoque’ and the strawman’ fallacies.
  21. If true, that is good news. Yet, it is impossible to deny that thousands of websites try to convince the consumer that SCAM is gentle and safe.
  22. Strong demand is not a substitute for reliable evidence. In any case, you stated above that demand is not increasing, didn’t you?
  23. Effectiveness in addictionology? Do you have any evidence for this or is that statement also based on wishful thinking?

My conclusion after analysing this article in detail is that it is poorly argued, based on misunderstandings, errors, and wishful thinking. It cannot possibly convince rational thinkers that SCAM should be integrated into conventional healthcare.

PS

The list of signatories can be found in the original paper.

It has been reported that a man has been charged after the death of a woman attending a slapping therapy workshop run by Hongchi Xiao. Danielle Carr-Gomm died aged 71 at Cleeve House in Seend, Wiltshire, on 20 October 2016. Hongchi Xiao (60), an alternative healer who advocates a technique known as “slapping therapy”, living in Cloudbreak in California, has now been charged with manslaughter by gross negligence, after being extradited back to the UK.

Xiao promotes paida lajin therapy, also called slapping therapy, in which patients are slapped or slap themselves repeatedly, ostensibly to release toxins from the body. Patients often end up with bruises or bleeding. The technique has its roots in Chinese medicine, but critics say it has no scientific basis. Xiao, who is originally from China and runs the California-based Pailala Institute, has led paida lajin workshops around the world.

Carr-Gomm’s son Matthew said after his mother’s death that she had sought “alternative methods of treating and dealing with her diabetes” because she struggled to inject insulin due to a fear of needles. “I know she was desperate to try and cure herself of this disease,” he said. “She always maintained a healthy lifestyle and was adamant that nothing would stop her from living a full life.”

A warrant for Mr Xiao’s arrest was originally issued in October 2019. He has now been arrested after returning to the United Kingdom from Australia on an extradition warrant and was taken to Gablecross custody in Swindon where he was charged with manslaughter by gross negligence. Police said Xiao, 60, is due to appear in court in Salisbury, southwest England, on Friday.

The Pailala Institute claims to be  a non-profit organization incorporated in California. It is managed by a team of non-paying volunteers to promote and support the self-healing practice of Paida Lajin, led by Mr. HongChi Xiao. Their mission is to “transform our world into a healthier place, by enabling every one of us to awaken our self-healing power, we were born with, to heal ourselves, reducing medical cost and its related potential side effects.”

The institute also claims that “based on Traditional Chinese Medicine, the practice of PaidaLajin helps you to relieve from chronic pain, hypertension or diabetes, without equipment or medication. It can quickly improve your circulation and let your body heal itself. PaidaLajin has facilitated the healing of over 210 different illnesses worldwide. Join millions of practitioners in China, Taiwan, Hong Kong, Bulgaria, Germany, Indonesia, India, South Africa, Australia, etc. Just Google and following their witnesses.”

It goes almost without saying that the evidence for slapping therapy’s effectiveness is non-existent.

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.

Omega-3 fatty acids (fish oil) supplementation reduces the occurrence of cardiovascular disease (CVD) and CVD-related mortality in patients at high-risk of CVD and in patients with elevated plasma triglyceride level. Yet, some studies have found an increased risk of atrial fibrillation (AF). AF is the most common sustained cardiac arrhythmia worldwide. It is associated with high morbidity and mortality rates and significant public health burden. Previous studies of the effect of omega-3 fatty acids on AF occurrence have reported contradictory results.

This review evaluated the effect of omega-3 fatty acids on the risk of AF. The results suggest that omega-3 fatty acids supplementation is associated with increased AF risk, particularly in trials that used high doses. Therefore, several factors should be considered before prescribing omega-3 fatty acids, including their dose, type, and formulation (fish, dietary fish oil supplements, and purified fatty acids), as well as patient-related factors and atrial mechanical milieu. Because the benefits of omega-3 fatty acids are dose-dependent, the associated AF risk should be balanced against the benefit for CVD. Patients who take omega-3 fatty acids, particularly at high doses, should be informed of the risk of AF and followed up for the possible development of this common and potentially hazardous arrhythmia.

Another recent review included 54,799 participants from 17 cohorts. A total of 7,720 incident cases of AF were ascertained after a median 13.3 years of follow-up. In multivariable analysis, EPA levels were not associated with incident AF, HR per interquintile range (ie, the difference between the 90th and 10th percentiles) was 1.00 (95% CI: 0.95-1.05). HRs for higher levels of DPA, DHA, and EPA+DHA, were 0.89 (95% CI: 0.83-0.95), 0.90 (95% CI: 0.85-0.96), and 0.93 (95% CI: 0.87-0.99), respectively.

The authors concluded that in vivo levels of omega-3 fatty acids including EPA, DPA, DHA, and EPA+DHA were not associated with increased risk of incident AF. Our data suggest the safety of habitual dietary intakes of omega-3 fatty acids with respect to AF risk. Coupled with the known benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption can be maintained.

Faced with contradictory results based on non-RCT evidence, we clearly need an RCT. Luckily such a trial has recently been published. It was an ancillary study of a 2 × 2 factorial randomized clinical trial involving 25 119 women and men aged 50 years or older without prior cardiovascular disease, cancer, or AF. Participants were recruited directly by mail between November 2011 and March 2014 from all 50 US states and were followed up until December 31, 2017.

Participants were randomized to receive EPA-DHA (460 mg/d of EPA and 380 mg/d of DHA) and vitamin D3 (2000 IU/d) (n = 6272 analyzed); EPA-DHA and placebo (n = 6270 analyzed); vitamin D3 and placebo (n = 6281 analyzed); or 2 placebos (n = 6296 analyzed). The primary outcome was incident AF confirmed by medical record review.

Among the 25 119 participants who were randomized and included in the analysis (mean age, 66.7 years; 50.8% women), 24 127 (96.1%) completed the trial. Over a median 5.3 years of treatment and follow-up, the primary end point of incident AF occurred in 900 participants (3.6% of study population). For the EPA-DHA vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.24; P = .19). For the vitamin D3 vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.25; P = .19). There was no evidence for interaction between the 2 study agents (P = .39).

The authors concluded that among adults aged 50 years or older, treatment with EPA-DHA or vitamin D3, compared with placebo, resulted in no significant difference in the risk of incident AF over a median follow-up of more than 5 years. The findings do not support the use of either agent for the primary prevention of incident AF.

So, does the regular supplementation with omega-3 fatty acids increase the risk of atrial fibrillation? The evidence is not entirely clear but, on balance, I conclude that the risk is low or even non-existent.

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!

Suzanne Somers, born Suzanne Marie Mahoney on October 16, 1946 in San Bruno, California, was an American actress, author and businesswoman.  Somers has published several best-selling self-help books, such as I’m Too Young for This! and The Natural Hormone Solution to Enjoy Menopause. In 2001, it was reported that she had breast cancer and was opting for so-called alternative medicine (SCAM) to treat it, In particular, she used Iscador, a preparation of mistletoe that we have discissed many times before on this blog, e.g.:

In an interview with Larry King in 2001, Somers revealed that she had been receiving treatment for a year. She also explained that she refused to go through with chemotherapy and instead used SCAM. “I decided to find alternative things to do,” she continued. “Because I have done so much work in my books about hormones, and that hormonal balance is why people gain or lose weight, and, it was my belief that a balanced environment of hormones prevents disease. And the first thing they said to me, we are taking of off all hormones. I said no, I’m going to continue taking my hormones, which is the first thing against the common course…”

Recently, it was reported that Somers has died of cancer aged 76. Earlier this year, Somers said they had “used the best alternative and conventional treatments to combat it [her cancer].” But now, a source close to the star shares that many around her didn’t like it. Somers’ friends tried to convince her to ditch SCAM in favor of chemotherapy. “She was advised by several people to consider the more conventional approach, but she did not listen,” a source close to Somers told the Daily Mail. The source continued, “She has always rejected chemo, so it wasn’t even an option. Her friends and loved ones urged her to reconsider so many times during her cancer battles and at the end.” A statement read. “Her family was gathered to celebrate her 77th birthday on October 16th. Instead, they will celebrate her extraordinary life, and want to thank her millions of fans and followers who loved her dearly.”

Perhaps this sad case is an apt occasion for rephrasing the warning that I posted only a few days ago:

be very cautious about using SCAMs for cancer and seek professional advice, preferably NOT from a SCAM provider.

 

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