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

herbal medicine

As regulars on this blog know, I am very sceptical about the plethora of nonsensical surveys published in the realm of so-called alternative medicine (SCAM) and thus rarely refer to them here. Today, however, I will make an exception. This international online-survey assessed the demographical data, clinical practice, and sources of information used by SCAM practitioners in Austria, Germany, United States of America, Australia, and New Zealand.

In total, 404 respondents completed the survey, of which 254 (62.9%) treated cancer patients. Most practitioners were acupuncturists and herbalists (57.1%), had (16.8 ± 9.9) years of clinical experience and see a median of 2 (1, 4) cancer patients per week. Breast cancer (61.8%) is the most common cancer type seen in SCAM clinics. Adjunctive SCAM treatments are frequently concurrent with the patient’s cancer specific treatment (39.9%), which is also reflected by the main goal of a SCAM treatment to alleviate side effects (52.4%). However, only 28.0% of the respondents are in contact with the treating oncologist. According to the respondents, pain is most effectively treated using acupuncture, while herbal medicine is best for cancer-related fatigue. SCAM practitioners mostly use certified courses (33.1%) or online databases (28.3%) but often believe that experts are more reliable to inform their practice (37.0%) than research publications (32.7%).

The authors concluded that acupuncturists and herbalists commonly treat cancer patients. Most practitioners use SCAM as an adjunct to biomedicine as supportive care and use it largely in accordance with current oncological guidelines.

You would think that the combined expertise of these institutions are capable of producing a decent survey:

  • Palliative Care Unit, Division of Oncology, Department of Internal Medicine, Medical University of Graz, 8036 Graz, Austria
  • Northern College of Acupuncture, York YO1 6LJ, United Kingdom
  • School of Health and Society, Faculty of Education, Health and Wellbeing, University of Wolverhampton, Wolverhampton WV1 1LY, United Kingdom
  • National Institute of Complementary Medicine Health Research Institute, Western Sydney University, Penrith NSW 2751, Australia
  • Translational Health Research Institute, Western Sydney University, Penrith NSW 2751, Australia
  • Medical Research Institute of New Zealand, Wellington 6021, New Zealand
  • Translational Oncology, University Hospital of Augsburg, 86156 Augsburg, Germany

Well, you would have been mistaken! This surely is one of the worst investigations I have seen for a while. Here are just three reasons why:

  • The researchers designed an anonymous self-completion questionnaire collecting data about the participating practitioners’ demographics and clinical practice of integrative oncology. Someone should tell them that one ought to validate questionnairs before using them and that validated questionnairs exist. Unvalidated questionnairs cannot tell us much of value.
  • The researchers  invited SCAM practitioners in Austria, Germany, USA, Australia, and New Zealand to participate in this study. Invitations were distributed through social media and emails between October 2022 and December 2022 by professional organizations. Someone should tell them that research needs to be reproducible and surveys need to cover a representative population – both criteria that are not met here.
  • The survey participants had to hold a valid license to perform acupuncture, herbal medicine, or both. That excludes all other SCAM practitioners.

Despite these serious flaws, the survey shows two findings that might be worth mentioning:

  • only 28.0% of the SCAM practitioners were in contact with the treating oncologist;
  • SCAM practitioners believe that “experts” are more reliable to inform their practice than research publications.

For me, these two points alone would be sufficient reason to run a mile!

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.

Need to find a last-minute Christmas present?

What about the ‘libido-boosting soft drink G Spot? That surely would make a wonderful holiday season (provided the drink does not get highjacked by your mother-in-law). Here is more info, in case you are interested:

Launched in May 2023, the line of plant-based sparkling drinks include “life-enhancing adaptogens and nootropics that invigorate and boost performance and cognitive functions”.

“I’ve had a serious soft drink habit for the past 20 years, and I don’t drink enough water,” Gillian Anderson (OBE), the firm’s founder and brain behind the drinks, said. “I know sugar and caffeine are not good for me, but I haven’t found an alternative that has the same effect. And although I love the idea of flavoured water, I really don’t like the taste of what’s out there. So, I thought, if what I’m looking for doesn’t exist, why don’t I make it?”

Arouse, specifically, has been designed to “awaken your senses” with Passionfruit, White Peach and Habanero, blended expertly with functional ingredients, including: Butterfly Pea (Clitoria ternatea), a plant species used in traditional medicine as an aphrodisiac; I-Arginine and I-Citrulline, amino acids which increase blood flow to sexual organs to improve libido; and Vitamin B6, a nutrient that regulates sexual hormones.

“At G Spot, we believe wellness is due a fresh take. One that’s less intense and anxiety inducing. One that truly makes you feel good, without guilt or inhibition. Our newest drink, Arouse, embodies our commitment to this philosophy. Arouse isn’t just a flavour; it’s an experience!” says CEO Rebekah Hall.

Named after their intended effects, the rest of the line comes in the form of Lift, combining berry, apply and peppercorn flavors with the wellbeing benefits of bacopa, theanine, cordyceps, and lion’s mane (boosting energy levels, stamina, and brain power while also combating stress); Protect, blending meadowsweet, ginger, lemon, turmeric, peppercorn and chaga (offering additional immune system-boosting benefits)’ and Soothe, which combines apples, sage, and cornflower with magnesium, maca, reishi, and ashwagandha (which works to relax the body as it benefits from the brand-wide libido boost).

All G Spot drinks available online in 6- and 12-pack bundles (250ml per can), as well as in Harvey Nichols (in-store and online) in the UK.

Prices range from £3.50 to £29.99 ($4.28 to $36.54).

The drinks are advertised to invigorate and boost performance and cognitive functions.

Any evidence for these medicinal claims?

Sadly not – at least I could not find any.

A case for the Advertising Standards Agency (ASA)?

Possibly!

 

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.

In May this year, I reported that my ex-friend Michael Dixon had been appointed as HEAD OF THE ROYAL MEDICAL HOUSEHOLD. The story was picked up by Gabriel Pogrund, one of the top investigative journalists of THE SUNDAY TIMES, who published a long article about Dixon yesterday which I encourage you to read in full.

In it he revealed many things about Dixon including, for instance, that some of the academic titles he often carries might not be what they seem. On ‘X’. Pogrund commented that “He [Dixon] faces Qs after three unis could not confirm his academic roles”. The article prompted many other newspapers to report on the matter.

The Guardian, for instance, contacted The Good Thinking Society, which promotes scientific scepticism. Michael Marshall, project director at the society, said: “It [promoting homeopathy] isn’t appropriate. I think the role of the monarchy, if it has one in current society, isn’t to be advocating for their own personal projects and their own personal beliefs or using the power and influence they have to further causes that run directly counter to the evidence that we have. “It’s absolutely unequivocal that homeopathic remedies do not work and just because you happen to be in a position of extreme power and privilege, that doesn’t change that.” Marshall said the appointment was also worrying because it suggested the king might still be supporting complementary medicine behind the scenes. He added: “Before Charles became king, he was the patron of homeopathic organisations, he was an outspoken advocate in favour of homeopathy and pushing back the bounds of science towards pseudoscience. And the argument was that he would stop doing that once he became king. This appears to be a sign that he isn’t going to do that, that he isn’t going to stop. What’s worrying is, as we’ve seen from the black spider memos, Charles is someone who also wields his power and influence quietly behind the scenes as well as publicly, so if this is the kind of step he’s willing to make in public, it raises questions about whether he’s willing to make even more steps in private.”

The Guardian also asked me three questions and I provided my answers in writing:

Q: Do you think it’s appropriate that the king has appointed Dr Michael Dixon to such a prestigious role? If not, why?
A; Surely, the King can appoint who he wants. In the realm of health care, he often seemed to favour people wo promote dubious therapies [Charles, The Alternative King: An… by Ernst, Edzard (amazon.co.uk)
Q: Do you think the king’s public position on homeopathy is problematic? and if so, why?
A: Anyone who promotes homeopathy is undermining evidence based medicine and rational thinking. The former weakens the NHS, the latter will cause harm to society.
Q: Do you think homeopathy has a place in medicine and if not, why? What has your research shown on its efficacy?
A: We and others have shown that homeopathy is not an effective therapy, which has today become the accepted consensus. To me, this means its only legitimate place is in the history books of medicine.

Within hours, the story became an international isse. For example a short article in DER SPIEGEL informed Germany as follows (my translation):

He works with Christian healers and prescribes goat weed for impotence: Dr Michael Dixon looks after the health of the British royal family. Scientists are appalled.

King Charles has appointed a homeopathy advocate as head of the royal medical household and has been heavily criticised by scientists. They call the decision worrying and inappropriate, as reported by the Guardian, among others. Dr Michael Dixon, who promotes faith healing and herbalism in his work as a general practitioner, has quietly held the senior position for a year, writes the Sunday Times. Although 71-year-old Dixon is head of the royal medical household, this is the first time that this role has not been combined with that of a doctor to the monarch. His duties include taking overall responsibility for the health of the King and the entire royal family – and also representing them in discussions with the government. He once invited a Christian healer into his practice to treat chronically ill patients. He also experimented with prescribing devil’s claw for shoulder pain and goat’s weed for impotence, reports the Sunday Times.

Will all this have consequences? Will the King reflect and reconsider his affiliations with those who promote quackery? Will Dixon change?

Personally, I will not hold my breath.

“Acute Fulminant Hepatic Failure in 23-Year-Old Female Taking Homeopathic Remedy” is not a title we see often on a scientific paper. Naturally, it attrackted my interest. In the paper, a US team presented a case of a 23-year-old otherwise healthy woman with body mass index 32.3 and a history of polycystic ovarian syndrome who presented with acute liver failure (ALF) ultimately requiring orthotopic liver transplantation. The patient was originally from India where she reported taking homeopathic medications for various indications for several years without known toxicity. She had no history of alcohol, tobacco, or other drug use. At the time of her presentation, she was living and working in the US and reported she was unable to refill her homeopathic product with the primary ingredient of eggshells from India. She was off of all medications and supplements with the exception of Berberis vulgaris for approximately 1 month before obtaining a similarly named homeopathic product with the primary ingredient of eggshells from Amazon. She reported originally taking 4 pills/d for 10 days, and then increased to 10 pills/d for 10 days as she was unsure of the appropriate dose.

She subsequently developed orange discoloration of her urine and nausea, reportedly without any preceding muscle-related effects or symptoms, and she discontinued all of her medications/supplements. Approximately 2 weeks later, she presented to the emergency department for nausea and malaise, where a blood test revealed abnormal liver enzymes. Mononucleosis screen and hepatitis panel were negative. She had no evidence of hepatic encephalopathy at that time. Ultrasound of the abdomen was notable for hypoechoic liver parenchyma only.

She was discharged home with gastroenterology telehealth follow-up. She was seen 1 week later and reported worsening nausea, vomiting, anorexia, jaundice, and fatigue. She presented to a local emergency department where she received intravenous vitamin K and underwent further laboratory evaluation. She was transferred to another hospital for higher level of care and admitted with acute liver injury. There she received intravenous N-acetylcysteine per institutional protocol, ursodiol, albumin, vitamin K, and fresh frozen plasma transfusions given for coagulopathy. Magnetic resonance cholangiopancreatography was performed and demonstrated no evidence of biliary obstruction or chronic liver disease (no ascites, contour nodularity, mass, or lymphadenopathy), though liver size noted to be small (11.5 cm in span). At 21 to 28 days after the onset of symptoms, her lab results were still highly abnormal and her mental status deteriorated. She was intubated for airway protection given severe encephalopathy, “cooling protocols” were initiated, and she was transferred again to a higher level of care at a center for emergent liver transplant evaluation. She was evaluated and listed as status 1A for acute liver failure. Her clinical status continued to decline and her labs continued to worsen.

An appropriate organ became available 28 hours after listing. At the time of her surgery, her explanted liver was noted to have massive parenchymal loss with hemorrhage, and pathology confirmed near complete collapse of the organ’s framework with only small foci of steatotic hepatocytes remaining. After her initial operation, her hospital course was complicated by coagulopathy, hypotension, leukocytosis, kidney failure requiring temporary dialysis, and multiple operations for completion of biliary anastomoses and delayed complex abdominal wall closure with mesh given large donor size. She was discharged from the hospital 2 weeks after transplant and her outpatient course continues to go well over 1 year after liver transplantation.

The product in this case has not been previously reported to be toxic. Its primary ingredient is calcium from “toasted eggshells,” which is also not generally known to cause liver failure or disease. However, the authors point out that it is not uncommon for supplements such as this one to contain other potentially toxic agents that are not specifically listed on the bottles’ label. For example, toxic metals including lead, mercury, and arsenic have reportedly been discovered in many (almost 20%) naturopathic medicines manufactured in India, particularly those sold by US websites. As such, the authors hypothesize that this patient’s ALF was likely caused by a contaminant (also consumed in higher quantities than intended) in her homeopathic product with the primary ingredient of eggshells.

The authors of this paper repeatedly state that the product was a homeopathic remedy; however, on other occasions they claim that it was a herbal supplement. In their Figure 1, they name the product as ‘OVA TOSTA’; on Amazon USA, I did indeed find a remedy by that name. Sadly, I was unable to obtain any information about its exact ingredients or composition.

Regardless whether the product was herbal or homeopathic, this case report is a poignant reminder that, in so-called alternative medicine (SCAM) many dangerous remedies are offered for sale. Therefore, it is advisible to be cautious and insist on sound information about the quality, safety, and efficacy before trying any such therapy.

On the occasion of a talk that I recently gave in Italy, I was interviewed by VANITY FAIR ITALY. I gave it in English and it was published in Italian. As I don’t expect many readers to be fluent in Italian and since it was a good interview, in my view, I thought I give you here the English original:

 

1.How can we exactly define «alternative medicine»?

There is much confusion and a plethora of definitions, none of which is fully satisfactory. In fact, the term “alternative medicine” itself is nonsensical: if a therapy works, it belongs to evidence-based medicine; and if it doesn’t work, it cannot possibly be an alternative. I therefore have long been calling it “so-called alternative medicine” (SCAM). The definition I use for SCAM with lay audiences is simple: SCAM is an umbrella term for a diverse range of therapeutic and diagnostic methods that have little in common, other than being excluded from mainstream medicine.

2.Who uses it and why?

Predominantly women! Statistics say about 30-70% of the general population use SCAM. And with patient populations, the percentage can be close to 100%. They use it because they are told over and over again that SCAM is natural and thus safe, as well as effective for all sorts of conditions.

3.Focusing on terminology, is there a difference between «complementary» and «alternative» medicine?

Theoretically, there is a big difference between «complementary» and «alternative» medicine. The former is supposed to be used as an add-on to, while the latter is a replacement of mainstream medicine. In practice, this dividing line is very blurred; most SCAMs are used in both ways, depending on the actual situation and circumstance.

4.Are users different from non-users?

Yes, there has been much research on this and my reading of it is that SCAM users tend to be less intelligent, more religious, more superstitious, less trusting in science, and more prone to conspiracy theories, for instance.

5.Which forms of alternative medicine are the most popular?

There are certain national differences, but in most European countries herbal medicine, acupuncture, chiropractic, osteopathy, homeopathy, aromatherapy, and reflexology are amongst the most popular SCAMs.

6.Does it work?

With such a wide range – someone once counted over 400 modalities and my last book evaluated 202 of them (Alternative Medicine: A Critical Assessment of 202 Modalities (Copernicus Books): Amazon.co.uk: Ernst, Edzard: 9783031107092: Books) – it is impossible to answer with yes or no. In addition we need to consider the conditions that are being treated. Acupuncture, for example, is touted as a panacea, but might just work for pain. If you take all this into account, I estimate that less than 3% of the therapeutic claims that are being made for SCAM are supported by sound evidence.

Is it safe?

Again, impossible to say. Some treatments are outright dangerous; for instance, chiropractic neck manipulations can injure an artery and the patient suffers a stroke of which she can even die. Other treatments are assumed to be entirely harmless; for example homeopathy. But even that is untrue: if a cancer patient relies exclusively on homeopathy for a cure, she might easily hasten her death. Sadly, such things happen not even rarely.

Do its benefits outweigh its risks?

That depends very much on the treatment, the disease, and the precise situation. Generally speaking, there are very few SCAMs that fulfill this condition.

You said that these were the research questions that occupied all your life in Exeter. Did you find the answers?

We published more on SCAM than any other research group, and we found mostly disappointing answers. But still, I am proud of having found at least some of the most pressing answers. Even negative answers can make an important contribution to our knowledge.

7.What is the problem with the placebo effect?

All therapies can prompt a placebo effect. Thus an ineffective treatment can easily appear to be effective through generating a placebo effect. This is why we need to rely on properly conducted, if possible placebo-controlled trials, if we want to know what works and what not.

8.Is it true that some alternative medicines can cause significant harm?

see above

9.What about herbal remedies? What do studies show about them?

Many of our modern drugs originate from plants, Therefore, it is not surprising that we find herbal remedies that are effective. But careful! This also means that plants can kill you – think of hemlock, for instance. In addition herbal medicine can interact powerfully with synthetic drugs. So, it is wise to be cautious and get responsible advice.

10.Which alternative therapies are overrated and why?

In my view, almost all SCAMs are over-rated. If you go on the Internet, you find ~5 000 000 websites on SCAM. 99% of them try to sell you something and are unreliable or even dangerous. We need to be aware of the fact that SCAM has grown into a huge business and many entrepreneurs are out to get your money based on bogus claims.

11.On the contrary, which therapies could be seen as an integration in routine care?

The best evidence can be found in the realm of herbal medicine, for instance St John’s Wort. Some mind-body interventions can be helpful; also a few massage techniques might be worth a try. Not a lot, I’m afraid.

12.Would you tell us what happened in 2005 with Prince Charles?

He complained about my actions via his private secretary to my University. A 13 month investigation followed. At the end, I was found not guilty but my funding, my team, my infrastructure had been dismantled. So, in effect, Charles managed to close down what was the only research group that looked critically and systematically into SCAM. A sad story – not so much for me but for progress and science, I think.

3.Why is alternative medicine still a controversial subject?

Mainly because the gap between the claims and the evidence is so very wide – and getting wider all the time.

14.Would you suggest the «right way» to approach it?

I often recommend this: if it sounds too good to be true, it probably is! I might add that, if you want reliable advice, don’t listen to those who profit from giving it.

It has been reported that a cancer patient died of multiple organ failure after he took a herbalist’s remedy that included mistletoe. Retired electrician Haydn Owen Jones had been receiving a third course of treatment for his multiple myeloma when he turned to a herbalist. Alongside two chemotherapy drugs and a steroid, Jones started using a remedy which included mistletoe, yarrow, lily of the valley, cat’s claw, echinacea, and corn silk. Days later he fell ill with a fever, swelling and a rash. He was treated for sepsis but never recovered as his liver function deteriorated. Coroner concluded that it was probable the mix of cancer drugs and the alternative therapy proved deadly to him.

Retired electrician Haydn Owen Jones had been receiving a third course of treatment for bone marrow cancer when he turned to a herbalist

Mistletoe contains Phoratoxin and Viscotoxin – both of which are poisonous when ingested. While a more severe reaction is caused from eating the berries than the leaves, possible symptoms can include nausea, heart problems and fever.

_____________________

As with all tragic cases of this nature, it is difficult or even impossible to establish what caused the death. Was the herbal remedy involved at all? If so, it could be the toxicity of one or more of its ingredients, interactions between them, interactions with prescribed drugs, or contaminations/adulterations of the remedy. If there is a lesson at all to learn from this case, it is, I think, this: be very cautious about using herbal remedies, particularly when combined with other medicines, and seek professional advice, preferably NOT from a herbalist.

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!

 

Mistletoe, an anthroposophical medicine, is often recommended as a so-callled alternative medicine (SCAM) for cancer patients. But what type of cancer, what type of mistletoe preparation, what dosage regimen, what form of application?

The aim of this systematic analysis was to assess the concept of mistletoe treatment in published clinical studies with respect to indication, type of mistletoe preparation, treatment schedule, aim of treatment, and assessment of treatment results. The following databases were systematically searched: Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL, and “Science Citation Index Expanded” (Web of Science). The researchers assessed all studies for study types, methods, endpoints and mistletoe preparations including their ways of application, host trees and dosage schedules.

The searches revealed 3296 hits. Of these, 102 publications with a total of 19.441 patients were included. The researchers included several study types investigating the application of mistletoe in different groups of participants: cancer patients with any type of cancer were included as well as studies conducted with healthy volunteers and pediatric patients. The most common types of cancer were:

  • breast cancer,
  • pancreatic cancer,
  • colorectal cancer,
  • malignant melanoma.

Randomized controlled studies, cohort studies and case reports make up most of the included studies. A huge variety was observed concerning the type and composition of mistletoe extracts (differing pharmaceutical companies and host trees), ways of applications and dosage schedules. Administration varied widely, e. g. between using mistletoe extract as sole treatment and as concomitant therapy to cancer treatment. The researchers found no relationship between the mistletoe preparation used, host tree, dosage, and cancer type.

A variety of different mistletoe preparations was used to treat cancer patients. Due to the heterogeneity of the mistletoe preparations used, no comparability between different studies or within single studies using different types of mistletoe preparations or host trees is possible. Moreover, no relationship between mistletoe preparation and type of cancer can be observed. This results in a severely limited comparability of studies with regard to the different cancer entities and mistletoe therapy in oncology in general. Analyzing the methods sections of all articles, there are no information on how the selection of the respective mistletoe preparation took place. None of the articles provided any argument which type of preparation (homeopathic, anthroposophic, standardized) or which host tree was chosen due to which selection criteria. Considering preparations from different companies, funding may have been the reason of the selection.

Dosage or dosage regimens varied strongly in the studies. Due to the heterogeneity of dosage and dosage regimens within studies and between studies of the endpoints the comparability of the different studies is severely limited. Duration of mistletoe treatment varied strongly in the studies ranging from a single dose given on one day to the application of mistletoe preparations for several years. Moreover, the duration of treatment frequently varied within the studies. Mistletoe preparations were administered by different ways of application. Most frequently, the patients received mistletoe preparations subcutaneously. The second most common way was intravenous administration of mistletoe preparations. According to the respective manufacturers, this type of application is only recommended for Lektinol® and Eurixor®. Other preparations were given as off-label intravenous applications. No dosage recommendations from the respective manufacturers were available. Only in two studies the dose schedules were mentioned: according to the classical phase I 3 + 3 dose escalation schedule or in ratio to the body surface area.

The authors concluded that despite a large number of clinical studies and reports, there is a complete lack of transparently reported, structured procedures considering all fields of mistletoe therapy. This applies to type of mistletoe extract, host tree, preparation, treatment schedules as well as indication with respect of type of cancer and the respective treatment aim. All in all, despite several decades of clinical mistletoe research, no clear concept of usage is discernible and, from an evidence-based point of view, there are serious concerns on the scientific base of this part of anthroposophical treatment.

A long time ago, I worked as a junior doctor in a hospital where we used subcutaneous misteloe injections regularly to treat cancer. I remember being utterly confused: none of my peers was able to explain to me what preparation to use and how to does it. There simply were no rules and the manufacurer’s instructions made little sense. I suspected then that mistletoe therapy was a danerous nonsense. Today, after much research has been published on mistletoe, I do no longer suspect it, I know it.

I would urge every cancer patient to stay well clear of mistletoe and those practitioners who recommend it.

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