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

Ayurvedic medicine

During the coronavirus disease 2019 pandemic, Ayurvedic herbal supplements and homeopathic remedies were promoted as immune boosters (IBs) and disease-preventive agents. This happened in most parts of the world but nowhere more intensely than in India.

The present study examined the clinical outcomes among patients with chronic liver disease who presented with complications of portal hypertension or liver dysfunction temporally associated with the use of IBs in the absence of other competing causes. This Indian single-center retrospective observational cohort study included patients with chronic liver disease admitted for the evaluation and management of jaundice, ascites, or hepatic encephalopathy temporally associated with the consumption of IBs and followed up for 180 days. Chemical analysis was performed on the retrieved IBs.

From April 2020 to May 2021, 1022 patients with cirrhosis were screened, and 178 (19.8%) were found to have consumed complementary and alternative medicines. Nineteen patients with cirrhosis (10.7%), jaundice, ascites, hepatic encephalopathy, or their combination related to IBs use were included. The patients were predominantly male (89.5%). At admission, 14 (73.75%) patients had jaundice, 9 (47.4%) had ascites, 2 (10.5%) presented with acute kidney injury, and 1 (5.3%) had overt encephalopathy. Eight patients (42.1%) died at the end of the follow-up period. Hepatic necrosis and portal-based neutrophilic inflammation were the predominant features of liver biopsies.

Ten samples of IBs, including locally made ashwagandha powder, giloy juice, Indian gooseberry extracts, pure giloy tablets, multiherbal immune-boosting powder, other multiherbal tablets, and the homeopathic remedy, Arsenicum album 30C, were retrieved from our study patients. Samples were analyzed for potential hepatotoxic prescription drugs, known hepatotoxic adulterants, pesticides, and insecticides, which were not present in any of the samples. Detectable levels of arsenic (40%), lead (60%), and mercury (60%) were found in the samples analyzed. A host of other plant-derived compounds, industrial solvents, chemicals, and anticoagulants was identified using GC–MS/MS. These include glycosides, terpenoids, phytosteroids, and sterols, such as sitosterol, lupeol, trilinolein, hydroxy menthol, methoxyphenol, butyl alcohol, and coumaran derivatives.

The authors concluded that Ayurvedic and Homeopathic supplements sold as IBs potentially cause the worsening of preexisting liver disease. Responsible dissemination of scientifically validated, evidence-based medical health information from regulatory bodies and media may help ameliorate this modifiable liver health burden.

The authors comment that Ayurvedic herbal supplements and homeopathic remedies sold as IBs, potentially induce idiosyncratic liver injury in patients with preexisting liver disease. Using such untested advertised products can lead to the worsening of CLD in the form of liver failure or portal hypertension events, which are associated with a high risk of mortality compared to those with severe AH-related liver decompensation in the absence of timely liver transplantation. Severe mixed portal inflammation and varying levels of hepatic necrosis are common findings on liver histopathology in IB-related liver injury. Health regulatory authorities and print and visual media must ensure the dissemination of responsible and factual scientific evidence-based information on herbal and homeopathic “immune boosters” and health supplements to the public, specifically to the at-risk patient population.

It has been reported that King Charles refused to pay Prince Andrew’s £ 32,000-a-year bill for his personal healing guru. The Duke of York has allegedly submitted the claim to the Privy Purse as a royal expense having sought the help of a yoga teacher.

However, the claim has reportedly been denied by the King, who is said to have told Andrew the bill will need to be covered using his own money. It comes after sources claimed Andrew has been using the Indian yogi for a number of years for chanting, massages, and holistic therapy in the privacy of his mansion. The healer has reportedly enjoyed month-long stays at a time at the £30 million Royal Lodge in Windsor.

Previously, the Queen seems to have passed the claims. But now Charles is in control. A source said: “While the Queen was always happy to indulge her son over the years, Charles is far less inclined to fund such indulgences, particularly in an era of a cost-of-living crisis. “Families are struggling and would rightly baulk at the idea of tens of thousands paid to an Indian guru to provide holistic treatment to a non-working royal living in his grace and favour mansion. This time the King saw the bill for the healer submitted by Andrew to the Privy Purse and thought his brother was having a laugh.”

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Poor Andrew!

How is he going to cope without his guru?

Will he be able to recover from the mysterious condition that prevents him to sweat?

Will his ego take another blow?

How will he be able to afford even the most basic holistic wellness?

How can Charles – who knows only too well about its benefits – be so cruel to his own brother?

Should I start a collection so that Andrew can pay for his most basic needs?

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Yes, these are the nagging questions and deep concerns that keep me awake at night!

 

 

PS

I have just been asked if, by any chance, the yoga teacher is a 16-year-old female. I have to admit that I cannot answer this question.

 

Gut microbiota can influence health through the microbiota–gut–brain axis. Meditation can positively impact the regulation of an individual’s physical and mental health. However, few studies have investigated fecal microbiota following long-term (several years) deep meditation. Therefore, this study tested the hypothesis that long-term meditation may regulate gut microbiota homeostasis and, in turn, affect physical and mental health.

To examine the intestinal flora, 16S rRNA gene sequencing was performed on fecal samples of 56 Tibetan Buddhist monks and neighboring residents. Based on the sequencing data, linear discriminant analysis effect size (LEfSe) was employed to identify differential intestinal microbial communities between the two groups. Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt) analysis was used to predict the function of fecal microbiota. In addition, we evaluated biochemical indices in the plasma.

The α-diversity indices of the meditation and control groups differed significantly. At the genus level, Prevotella and Bacteroides were significantly enriched in the meditation group. According to the LEfSe analysis, two beneficial bacterial genera (Megamonas and Faecalibacterium) were significantly enriched in the meditation group. The functional predictive analysis further showed that several pathways—including glycan biosynthesis, metabolism, and lipopolysaccharide biosynthesis—were significantly enriched in the meditation group. Moreover, plasma levels of clinical risk factors were significantly decreased in the meditation group, including total cholesterol and apolipoprotein B.

The Chinese authors concluded that the intestinal microbiota composition was significantly altered in Buddhist monks practicing long-term meditation compared with that in locally recruited control subjects. Bacteria enriched in the meditation group at the genus level had a positive effect on human physical and mental health. This altered intestinal microbiota composition could reduce the risk of anxiety and depression and improve immune function in the body. The biochemical marker profile indicates that meditation may reduce the risk of cardiovascular diseases in psychosomatic medicine. These results suggest that long-term deep meditation may have a beneficial effect on gut microbiota, enabling the body to maintain an optimal state of health. This study provides new clues regarding the role of long-term deep meditation in regulating human intestinal flora, which may play a positive role in psychosomatic conditions and well-being.

This study is being mentioned on the BBC new-bulletins today – so I thought I have a look at it and check how solid it is. The most obvious question to ask is whether the researchers compared comparable samples.

The investigators collected a total of 128 samples. Subsequently, samples whose subjects had taken antibiotics and yogurt or samples of poor quality were excluded, resulting in 56 eligible samples. To achieve mind training, Tibetan Buddhist monks performed meditation practices of Samatha and Vipassana for at least 2 hours a day for 3–30 years (mean (SD) 18.94 (7.56) years). Samatha is the Buddhist practice of calm abiding, which steadies and concentrates the mind by resting the individual’s attention on a single object or mantra. Vipassana is an insightful meditation practice that enables one to enquire into the true nature of all phenomena. Hardly any information about the controls was provided.

This means that dozens of factors other than meditation could very easily be responsible for the observed differences; nutrition and lifestyle factors are obvious prime candidates. The fact that the authors fail to even discuss these possibilities and more than once imply a causal link between meditation and the observed outcomes is more than a little irritating, in my view. In fact, it amounts to very poor science.

I am dismayed that a respected journal published such an obviously flawed study without a critical comment and that the UK media lapped it up so naively.

Quackery is rife in India. On this blog, I have occasionally reported on this situation, e.g.:

Now the Chief Justice of India (CJI) NV Ramana has pointed out that legislation needs to be brought in to save people “from falling prey to fraudulent practices in the name of treatment”. Speaking at the inaugural National Academy of Medical Sciences on ‘Law and Medicine’, the CJI said: “Quackery is the biggest disease affecting India” and that hospitals are “being run like companies, where profit-making is more important than service to society”. The CJI added, “another side of lack of accessible healthcare is giving space to quacks. Quackery begins where awareness ends. Where there is room for myths, there is room for quackery”. He continued, “Owing to the financial and time constraints, a huge majority of the Indian population approaches these untrained and uncertified doctors. Lack of awareness and knowledge, misplaced belief, and sheer inaccessibility have massive ramifications on the health of the country, particularly the rural and underprivileged Indian … The need of the hour is to bring in legislation to save people from falling prey to fraudulent practices in the name of treatment … Private hospitals are being opened at an exponential rate. This is not necessarily a bad thing, but there is a glaring need for balance. We are seeing hospitals being run like companies, where profit-making is more important than service to society.”

I am sure the CJI is correct; India does have a quackery problem. If nothing else, the fact that one website lists a total of 746 Alternative Medicine Colleges in India, leaves little doubt about it.

Camilla spent ten days at the end of October in a sophisticated meditation and fitness center in southern India. Life has recently been hectic for the Queen Consort: at 75, she has been in a non-stop succession of various ceremonies for the funeral of Elizabeth II, always one step behind her husband, not to mention her new status as sovereign… Enough to block her chakras in no time.

She came to the resort with her bodyguards and a handful of friends and was able to take advantage of the tailor-made treatments concocted for her by the master of the house, Dr Issac Mathai, who created this high-end holistic centre on a dozen hectares of scented gardens near Bangalore. The program includes massages, herbal steam baths, yoga, naturopathy, homeopathy, meditation, and Ayurvedic treatments to “cleanse, de-stress, soothe and revitalize the mind, body and soul”, as the establishment’s website states.

Guests are required to follow an individualized, meat-free diet, with organic food from the resort’s vegetable gardens, based on lots of salads or soups – Camilla is said to be a fan of sweet corn soup with spinach. Cigarettes and mobile phones are not allowed, although it is assumed that Camilla must have some privileges due to her status… and the basic rate for the suites, which starts at $950 a night – the price of the rooms varies between $260 and $760, the rate including a consultation with the doctors.

Charles and Camilla have been fans of the Soukya Centre in India for a decade. The place corresponds in every way to their deep-rooted convictions about health. Like her husband, Camilla is a follower of organic food, she also practices yoga and treats her face with creams made from nettle and bee venom. For his part, Charles has long been an advocate of alternative medicine, homeopathy, acupuncture, aromatherapy, and also hypnosis… He even set up a foundation to support complementary medicine by lobbying the British health service to include it in complementary therapies for certain patients, which caused an uproar among the pundits of traditional medicine.

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If you suspected I was (yet again) sarcastic about the royal couple, you are mistaken. The text above is only my (slightly shortened) translation of an article published in the French magazine LE POINT (even the title is theirs). I found the article amusing and interesting; so, I looked up the Indian health center. Here are some of the things I found:

The 1st impression is that they are not shy about promotion calling themselves THE WORLD’S BEST AYURVEDA TREATMENT CENTER. The doctor in charge was once a ‘Consultant Physician’ at the Hale Clinic in London, where he treated a number of high-profile people. As his professional background, he offers this:

M.D. (Homeopathy); Hahnemann Post-Graduate Institute of Homeopathy, London M.R.C.H, London; Chinese Pulse Diagnosis and Acupuncture, WHO Institute of Traditional Chinese Medicine, Nanjing, China; Trained (Mind-Body Medicine Programme) at Harvard Medical School, USA

The approach of the center is described as follows:

The fundamental principle underlying Holistic Treatment is that the natural defense and immune system of an individual when strengthened, has the potential to heal and prevent diseases. In the age of super-specialisation where human beings are often viewed as a conglomeration of organs, it is crucial to understand ourselves as multi-dimensional beings with a body, mind and spirit. These interconnected dimensions need to be in perfect harmony to ensure real well-being.

And about homeopathy, they claim this:

Homeopathy originated in 1796 in Germany, and was discovered by Dr. Samuel Hahnemann, a German scientist. Homeopathy is popular today as a non-intrusive, holistic system of medicine. Instead of different medicines for different parts of the body, one single constitutional remedy is prescribed. As a system of medicine, Homeopathy is highly scientific, safe, logical and an extremely effective method of healing. For over 200 years people have used Homeopathy to maintain their good health, and also to treat and cure a wide range of illnesses like allergies, metabolic disorders, atopic dermatitis, Rheumatoid arthritis, Auto-immune disorders.

At this stage, I felt I had seen enough. Yes, you are right, we did not learn a lot from this little exploration. No, hold on! We did learn that homeopathy is highly scientific, safe, logical, and extremely effective!

 

The question, however, is should we believe it?

Turmeric is a commonly used herbal product implicated in causing liver injury. The aim of this case series was to describe the clinical, histologic, and human leukocyte antigen (HLA) associations of turmeric-associated liver injury enrolled in the U.S. Drug Induced Liver Injury Network (DILIN).

All adjudicated cases enrolled in DILIN between 2004-2022 in which turmeric was an implicated product were reviewed. Causality was assessed using a 5-point expert opinion score. Available products were analyzed for the presence of turmeric using ultra-high-performance liquid chromatography. Genetic analyses included HLA sequencing.

Ten cases of turmeric-associated liver injury were found, all enrolled since 2011 and six since 2017. Of the 10 cases, 8 were women, 9 were White and the median age was 56 years (range, 35-71). Liver injury was hepatocellular in 9 patients and mixed in one. Liver biopsies in 4 patients showed acute hepatitis or mixed cholestatic-hepatitic injury with eosinophils. Five patients were hospitalized, and one patient died of acute liver failure. Chemical analysis confirmed the presence of turmeric in all 7 products tested; 3 also contained piperine (black pepper). HLA typing demonstrated that 7 patients carried HLA-B*35:01, 2 of whom were homozygous, yielding an allele frequency of 0.450 compared to population controls of 0.056-0.069.

The authors concluded that liver injury due to turmeric appears to be increasing in the United States, perhaps reflecting usage patterns or increased combination with black pepper. Turmeric causes potentially severe liver injury that is typically hepatocellular, with a latency of 1 to 4 months and strong linkage to HLA-B*35:01.

Turmeric or curcumin is said to cause multiple effects, such as inhibiting inflammation, oxidative stress, tumor cell proliferation, cell death, and infection. Yet, sound clinical trials to test whether these effects might translate into health benefits are rare. In addition, the bioavailability of oral turmeric supplements is known to be low.

Turmeric has been used in food for millennia and is thus generally considered to be safe. Known adverse effects include gastrointestinal problems such as nausea and diarrhea and allergic reactions. Clearly, the new case series casts considerable doubt on the safety of turmeric. Yet, one ought to point out that the number of cases is low (but, on the other hand under-reporting can be assumed to be high). Furthermore, we should take into account that the quality of commercially available products is often low. One must therefore ask whether the liver injuries were truly caused by turmeric itself or by contaminants.

My conclusion is that turmeric is unquestionably an interesting plant with considerable potential as a medicine. At present, there is much hype surrounding it. Yet, hype is almost always contra-productive. If we want to know the true value of turmeric, we need to solve the bioavailability problem and do much more research into its safety and efficacy for defined conditions.

The US Food and Drug Administration created the Tainted Dietary Supplement Database in 2007 to identify dietary supplements adulterated with active pharmaceutical ingredients (APIs). This article compared API adulterations in dietary supplements from the 10-year time period of 2007 through 2016 to the most recent 5-year period of 2017 through 2021. Its findings are alarming:

  • From 2007 through 2021, 1068 unique products were found to be adulterated with APIs.
  • Sexual enhancement and weight-loss dietary supplements are the most common products adulterated with APIs.
  • Phosphodiesterase-5 inhibitors are commonly included in sexual enhancement dietary supplements.
  • A single product can include up to 5 APIs.
  • Sibutramine, a drug removed from the market due to cardiovascular adverse events, is the most included adulterant API in weight loss products.
  • Sibutramine analogues, phenolphthalein (which was removed from the US market because of cancer risk), and fluoxetine were also included.
  • Muscle-building dietary supplements were commonly adulterated before 2016, but since 2017 no additional adulterated products have been identified.

The authors concluded that the lack of disclosure of APIs in dietary supplements, circumventing the normal procedure with clinician oversight of prescription drug use, and the use of APIs that are banned by the Food and Drug Administration or used in combinations that were never studied are important health risks for consumers.

The problem of adulterated supplements is by no means new. A similar review published 4 years ago already warned that “active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.”

These papers relate to the US where supplement use is highly prevalent. The harm done by adulterated products is thus huge. If we focus on Chinese or Ayurvedic supplements, the problem might even be more serious. In 2002, my own review concluded that adulteration of Chinese herbal medicines with synthetic drugs is a potentially serious problem which needs to be addressed by adequate regulatory measures. Twenty years later, we seem to be still waiting for effective regulations that protect the consumer.

Progress in medicine, they say, is made funeral by funeral!

 

Guest post by Derk P. Kooi

Political lobbying is not only restricted to major companies, even quackery lobbies extensively in Dutch politics as well as at a European and global level. The EUROpean Complementary and Alternative Medicine Stakeholder Group (EUROCAM) has been active in Europe for some time. EUROCAM recently attracted attention with a statement on antibiotic resistance during the European Antibiotics Awareness Day.[1] EUROCAM claims that Complementary and Alternative Medicine (CAM) could enhance the immune system and could therefore contribute to the fight against antibiotic resistance. An early study conducted by the anthroposophist Erik Baars was referenced, inter alia. However, this medical claim turns out to be pure nonsense.

EUROCAM regularly publishes so-called ‘position papers’ on the contribution CAM could provide to the European health care system. EUROCAM is currently cautious with its medical claims, and rightly so, as it has seriously overstepped the mark in the past. For example, claims about the efficacy of CAM for infections referred to research by Erik Baars, doctor, anthroposophical healthcare lector at the University of Applied Sciences Leiden and researcher at the Louis Bolk Institute. Baars is an associate of the society due to his misleading statements in his publications on the usefulness of CAM, more specifically of the anthroposophical variant.

Where does this fairly unknown club actually come from, what does it do and how seriously should we take it? Well, EUROCAM is an umbrella organisation for various alternative therapists and their patients. We are talking about Ayurveda, homeopathy, osteopathy, anthroposophy, herbal medicine, traditional (Chinese) medicine, Reiki and acupuncture. The Dutch Registry of Complementary Care Professionals (RBCZ) is also affiliated with EUROCAM. Classical homeopath Annemieke Boelsma is the contact person of the RBCZ at EUROCAM.

It is unclear precisely when EUROCAM was created, the LinkedIn page says 2009. The figurehead of the club is “secretary general” Ton Nicolaï. This homeopathic doctor is also well known to Vereniging tegen de Kwakzalverij, (www.kwakzalverij.nl) the Dutch Society against Quackery. The treasurer of EUROCAM is business administrator Wim Menkveld. Menkveld is on the Advisory Board of the Hortus Botanicus of Leiden. He is also active on the board of the European Patients’ Federation of Homeopathy. EUROCAM thus seems to have originated mainly from Dutch homeopathic circles.

Furthermore, TV producer Miranda Eilert-Ruchtie from Hilversum sits on the EUROCAM board. According to the EUROCAM website, she acts as their “operations manager” and communications advisor. The German Heilprakterin Sonja Maric, an anthropologist and “specialist in Tibetan medicine”, also acts as a communications consultant.

The European Transparency Register shows that in 2020 the total budget of the organisation was 40,498 euros; no more recent data is available. In the year 2018, 5,000 euros were reserved as an honorarium for Mr Nicolaï, for the 0.5 FTE that he works for the organisation. Miranda Eilert-Ruchtie works a number of hours a week for EUROCAM, as a freelancer. Sonja Maric does this on a voluntary basis.

EUROCAM is a member of the European Public Health Alliance (EPHA), the European Union Health Policy Platform. The World Health Organisation (WHO) recognises the organisation as a non-state actor, which means that both the EU and the WHO consider EUROCAM to be a serious legal entity. In the past, EUROCAM has intervened in public EU consultations in the fields of aging, pharmaceutical strategy, cancer, and digital data and services.

EUROCAM provides the secretariat of the MEP Interest Group on Integrative Medicine and Health, a group of five European parliamentarians who have set themselves the goal of promoting integrative medicine at the European level. Co-chairs are Finish Sirpa Pietikäinen, a European parliamentarian for the Christian Democrats, and French Michèle Rivasi, a European parliamentarian for the Greens. The other members are Luxembourg’s Tilly Metz, the Italian Eleonara Evi, and the Danish Margrete Auken. It is noteworthy that they are European parliamentarians for the Greens. They are all members of the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). Eleonara Evi was part of the illustrious Five Star Movement until 2020, known for its anti-vaccination stance. The Member of European Parliament (MEP) Interest Group organises annual events with speakers who are the same people who perform at EUROCAM symposia. These include the aforementioned anthroposophist Erik Baars. Baars worked closely with EUROCAM boss Ton Nicolaï in a European research project on CAM alternatives to antibiotics. More about his bad science later.

The texts EUROCAM produces nowadays (on its website) are carefully written, and the medical claims are carefully formulated. The texts are larded with synonyms for “possible”, known in linguistics as hedging. For example “Several CAM methods have shown high potential to reduce cancer pain”.[2] Generic health claims are also often used to suggest medical benefits, for example in the context of COVID-19, ‘In building and maintaining resistance to infectious illness, CAM modalities as a part of Integrative Medicine & Health can play an important role because they mobilise and stimulate people’s self-regulating capacity, thus increasing their resilience, their immune system.’.[3]

Furthermore, claims are put in the mouths of others, which can be read, for example, in quoting patient expectations: ‘While improving quality of life is the major rationale for CAM use, there is a definite undercurrent of expectation, particularly among the younger patients, that some therapies might have an anticancer effect (prolongation of remission periods) and slow/stagnate tumour growth (prolongation of survival periods), boost the immune system, making it easier to overcome the disease.’.[4]

The educated reader will immediately see through these strategies, but the question is whether the lobbied politicians targeted by EUROCAM understand these subtleties. EUROCAM has not always been so cautious, by the way. In an undated (presumably 2013) interview with the Dutch Association for Classical Homeopathy, “secretary general” Ton Nicolaï made a number of remarkable statements. For example, he claimed at the time that research shows “that for a number of herbal medicines there is a reasonable amount of evidence that scientifically confirms their effectiveness in respiratory infection treatments”. [5] Nicolaï bases his assertion on recent research by Erik Baars conducted as part of a European research programme that aimed to find CAM alternatives to antibiotics.

The report of this project, which ended in 2018, can be found on the EUROCAM website.[6] The authors of this report are, not surprisingly, Erik Baars and Ton Nicolaï. The report contains practically no hard science. Sub-studies focus on, for example, the frequency of antibiotic prescribing among alternative-working GPs and on the best practice of CAM believers. A so-called systematic review of systematic reviews offers good starting points to evaluate Mr Nicolaï’s claim: ‘A systematic review of systematic reviews demonstrates that there are specific, evidence-supported, promising CAM treatments for acute, uncomplicated RTIs [uncomplicated respiratory tract infections, ed.] and that they are safe.’

Here, a medical claim is made, which is weakened by the use of the hedge term “promising”. The conclusion can be summarised with “There would be ‘promising’ CAM treatments for respiratory infections, and they would be safe”. However, surprisingly, the project report does not refer to this “systematic review of systematic reviews”, nor to any of the other concrete results of the project!

Due to the lack of references, we cannot but conclude that the claim is based on a 2019 article by Erik Baars. One of the co-authors is Ton Nicolaï.[7] The article was published in the journal Evidence Based Complementary and Alternative Medicine (EBCAM), which has a shady reputation. Even one of the founders of EBCAM states that the peer-review system is a farce, and therefore the majority of the articles published in it are useless nonsense.[8] In this article, besides a large amount of vagueness about the “worldview differences” between CAM and medicine, systematic reviews are discussed about the effectiveness and safety of CAM treatments. From this systematic review of systematic reviews, it is concluded that there are promising CAM treatments for respiratory, urinary tract and skin infections and that there is even evidence that some CAM treatments are effective for respiratory infections, but what is this based on?

The reviews that were looked at were split into Cochrane and non-Cochrane reviews. Among the Cochrane reviews, there is one that would demonstrate the efficacy of CAM. It is a review on the use of immunostimulants for the prevention of respiratory tract infections in children.[9] Of the 35 studies that were analysed, six involve small molecules, such as isoprinosine, levamisole and pidotimod. In other words, regular medicine, if it turns out to work, but describing it as being experimental would be more appropriate. Baars’ article states that the review also contains herbal medicine. This is somewhat exaggerated: only one of the 35 studies deals with herbs. Of the remaining 28 studies, 25 cover bacterial extracts and three thymus extracts. Again: Baars does not make clear what this has to do with the CAM that EUROCAM represents.

In summary, EUROCAM is a small European lobbying organisation with perhaps some influence at both European and WHO level. One keeps coming across the same names. The organisation is currently using woolly, disguising language to mask medical claims and to fend off criticism. In the past, this was different when EUROCAM, by means of Ton Nicolaï among others, made very reprehensible statements about the role of CAM in (respiratory tract) infections. For the time being, this little club does not seem to pose much of a threat, but European politicians should, of course, ignore this hobby club.

 

References

1. ‘Improving patient resilience to reduce the need to rely on anti-infection treatment: the role of Integrative Medicine’. EUROCAM. https://cam-europe.eu/statement-on-amr-2021/ (visited on 28 December 2021) 2. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021) 3. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021) 4. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021)

5. Miranda Ruchtie. In gesprek met Ton Nicolaï, CAM integreren in de Europese gezondheidszorg. [In discussion with Ton Nicolaï, integrating CAM into the European health care system]. Nederlandse Vereniging van Klassiek Homeopaten. [Dutch Association of Classical Homeopaths] https://www.nvkh.nl/nieuwsbrieven-nvkh/interview-met-ton-nicolai (visited on 3 October 2021)

6. Erik Baars, et al. Reducing the need for antibiotics, the contribution of Complementary and Alternative Medicine. EUROCAM, 2018. https://cam-europe.eu/wp-content/uploads/2019/01/CAM-AMR-EUROCAM-Post-Conference-Paper-2018.pdf (visited on 3 October 2021)

7. Erik W. Baars et al. The Contribution of Complementary and Alternative Medicine to Reduce Antibiotic Use: A Narrative Review of Health Concepts, Prevention, and Treatment Strategies. Evid. Based Complement. Alternat. Med., 2019:5365608. DOI: 10.1155/2019/5365608

8. Edzard Ernst. “EBCAM: an alt med journal that puzzles me a great deal”, URL: http://edzardernst.com/2016/05/ebcam-an-alt-med-journal-that-puzzles-me-a-great-deal/ (visited on 8 January 2022)

9. B. E. Del-Rio-Navarro, F. J. Espinosa-Rosales, V. Flenady, and J. J. Sienra-Monge, “Cochrane Review: Immunostimulants for preventing respiratory tract infection in children,” Evidence-Based Child Health: A Cochrane Review Journal, 2012, 7 (2), 629–717.

Ayush-64 is an Ayurvedic formulation, developed by the Central Council for Research in Ayurvedic Sciences (CCRAS), the apex body for research in Ayurveda under the Ministry of Ayush. Originally developed in 1980 for the management of Malaria, this drug has now been repurposed for COVID-19 as its ingredients showed notable antiviral, immune-modulator, and antipyretic properties. Its ingredients are:

Alstonia scholaris R. Br. Aqueous extract of (Saptaparna) Bark-1 part
Picrorhiza Kurroa Royle Aqueous extract of (Kutki) Rhizome-1 part
Swertia chirata Buch-Ham. Aqueous extract of (Chirata) Whole plant-1 part
Caesalphinia crista, Linn. Fine powder of seed (Kuberaksha) Pulp-2 parts

The crucial question, of course, is does AYUSH-64 work?

An open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India with 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone.

The outcome measures were:

  • the proportion of participants who attained clinical recovery on days 7, 15, 23, and 30,
  • the proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point,
  • change in pro-inflammatory markers,
  • metabolic functions,
  • HRCT chest (CO-RADS category),
  • the incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE).

Out of 80 participants, 74 (37 in each group) contributed to the final analysis. A significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. The mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG.

The authors concluded that AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials.

I do object to these conclusions for several reasons:

  1. The study cannot possibly determine the safety of AYUSH-64.
  2. Even for assessing its efficacy, it was too small.
  3. The trial design followed the often-discussed A+B vs B concept and is thus prone to generate false-positive results.

I believe that it is highly irresponsible, during a medical crisis like ours, to conduct studies that can only produce unreliable findings. If there is a real possibility that a therapy might work, we do need to test it, but we should take great care that the test is rigorous enough to generate reliable results. This, I think, is all the more true, if – like in the present case – the study was done with governmental support.

A press release informs us that the World Health Organization (WHO) and the Government of India recently signed an agreement to establish the ‘WHO Global Centre for Traditional Medicine’. This global knowledge centre for traditional medicine, supported by an investment of USD 250 million from the Government of India, aims to harness the potential of traditional medicine from across the world through modern science and technology to improve the health of people and the planet.

“For many millions of people around the world, traditional medicine is the first port of call to treat many diseases,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Ensuring all people have access to safe and effective treatment is an essential part of WHO’s mission, and this new center will help to harness the power of science to strengthen the evidence base for traditional medicine. I’m grateful to the Government of India for its support, and we look forward to making it a success.”

The term traditional medicine describes the total sum of the knowledge, skills and practices indigenous and different cultures have used over time to maintain health and prevent, diagnose and treat physical and mental illness. Its reach encompasses ancient practices such as acupuncture, ayurvedic medicine and herbal mixtures as well as modern medicines.

“It is heartening to learn about the signing of the Host Country Agreement for the establishment of Global Centre for Traditional Medicine (GCTM). The agreement between Ministry of Ayush and World Health Organization (WHO) to establish the WHO-GCTM at Jamnagar, Gujarat, is a commendable initiative,” said Narendra Modi, Prime Minister of India. “Through various initiatives, our government has been tireless in its endeavour to make preventive and curative healthcare, affordable and accessible to all. May the global centre at Jamnagar help in providing the best healthcare solutions to the world.”

The new WHO centre will concentrate on building a solid evidence base for policies and standards on traditional medicine practices and products and help countries integrate it as appropriate into their health systems and regulate its quality and safety for optimal and sustainable impact.

The new centre focuses on four main strategic areas: evidence and learning; data and analytics; sustainability and equity; and innovation and technology to optimize the contribution of traditional medicine to global health and sustainable development.

The onsite launch of the new WHO global centre for traditional medicine in Jamnagar, Gujarat, India will take place on April 21, 2022.

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Of course, one must wait and see who will direct the unit and what work the new centre produces. But I cannot help feeling a little anxious. The press release is full of hot air and platitudes and the track record of the Indian Ministry of Ayush is quite frankly abominable. Here are a few of my previous posts that, I think, justify this statement:

 

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