herbal medicine
Weleda, the firm founded by Rudolf Steiner and Ita Wegman originally for producing and selling their anthroposophic remedies, celebrates its 100th anniversary. It is a truly auspicious occasion for which I feel compelled to offer a birthday present.
I hope they like it!
On the Weleda UK website, we find an article entitled ‘ An introduction to Homeopathy‘ which contains the following statements:
- Homeopathy works by stimulating the body’s own natural healing capacity. The remedy triggers the body’s own healing forces and so a remedy is prescribed on a very individual basis.
- If you do experience complex, persistent or worrying symptoms then please seek the advice of a doctor who specialises in homeopathy.
- Today there are four homeopathic hospitals offering treatment under the National Health Service – in London, Glasgow, Liverpool and Bristol.
- It’s still the only alternative medicine incorporated into the NHS.
- Homeopathy can be used to treat the same wide range of illness as conventional medicine, and may even prove successful when all other forms of treatment have failed.
- Over-the-counter homeopathic medicines are made using natural plant, mineral and, occasionally, animal substances
- … active elements are in infinitesimally small quantities.
As I understand a bit about the subject – not as much as my friend Dana Ullman, of course, but evidently more than the Weleda team – I thought I might offer them, as a birthday present, a free correction of these 7 passages. Here we go:
- Homeopathy is claimed to work by stimulating the body’s own natural healing capacity. In fact, it does not work. Yet, believers argue that the remedy triggers the body’s own healing forces and so a remedy is prescribed on a very individual basis.
- If you do experience complex, persistent or worrying symptoms then please seek the advice of a doctor who specializes in something other than homeopathy.
- Today there are no homeopathic hospitals offering treatment under the National Health Service – the ones in London, Glasgow, Liverpool, and Bristol all closed or changed their names.
- It’s no longer incorporated into the NHS.
- Homeopathy cannot be used to treat the same wide range of illnesses as conventional medicine and is not successful when all other forms of treatment have failed.
- Over-the-counter homeopathic medicines are made using any imaginable substance and even non-material stuff like vacuum or X-rays.
- … active elements are absent.
HAPPY BIRTHDAY, WELEDA!
This retrospective electronic medical record data analysis compared the characteristics and outcomes of drug-induced liver injury (DILI) caused by paracetamol and non-paracetamol medications, particularly herbal and dietary supplements. Adults admitted with DILI to the Gastroenterology and Liver Centre at the Royal Prince Alfred Hospital, Sydney (a quaternary referral liver transplantation centre), 2009-2020 were included. The 90-day transplant-free survival and the drugs implicated as causal agents in DILI were extracted from the records.
A total of 115 patients with paracetamol-related DILI and 69 with non-paracetamol DILI were admitted to our centre. The most frequently implicated non-paracetamol medications were:
- antibiotics (19, 28%),
- herbal and dietary supplements (15, 22%),
- anti-tuberculosis medications (6, 9%),
- anti-cancer medications (5, 7%).
The number of non-paracetamol DILI admissions was similar across the study period, but the proportion linked with herbal and dietary supplements increased from 2 of 11 (15%) during 2009-11 to 10 of 19 (47%) during 2018-20 (linear trend: P = 0.011). Despite higher median baseline model for end-stage liver disease (MELD) scores, 90-day transplant-free survival for patients with paracetamol-related DILI was higher than for patients with non-paracetamol DILI (86%; 95% CI, 79-93% v 71%; 95% CI, 60-82%) and herbal and dietary supplement-related cases (59%; 95% CI, 34-85%). MELD score was an independent predictor of poorer 90-day transplant-free survival in both paracetamol-related (per point increase: adjusted hazard ratio [aHR], 1.19; 95% CI, 1.09-3.74) and non-paracetamol DILI (aHR, 1.24; 95% CI, 1.14-1.36).
The authors concluded that, in our single centre study, the proportion of cases of people hospitalised with DILI linked with herbal and dietary supplements has increased since 2009. Ninety-day transplant-free survival for patients with non-paracetamol DILI, especially those with supplement-related DILI, is poorer than for those with paracetamol-related DILI.
A co-author of the paper, specialist transplant hepatologist Dr Ken Liu, was quoted in the Guardian saying he felt compelled to conduct the study because he was noticing more patients with liver injuries from drugs not typically associated with liver harm. “I was starting to see injury in patients admitted with liver injury after using bodybuilding supplements for males or weight loss supplements in females,” he said. “I just decided I better do a study on it to see if my hunch that more of these substances were causing these injuries was true.”
Liu and his colleagues said there needed to be more rigorous regulatory oversight for supplements and other alternative and natural therapies. They also noticed almost half the patients with supplement-induced severe liver injury had non-European ethnic backgrounds. Liu said more culturally appropriate community education about the risks of supplements was needed.
Dr Ken Harvey, public health physician and president of Friends of Science in Medicine, said it was important to note that Liu’s study only examined the most severe cases of supplement-induced liver harm and that the actual rate of harm was likely much higher. “The study only examines severe cases admitted to a specialised liver unit; they cannot be extrapolated to the overall incidence of complementary medicine associated liver injury in Australia,” Harvey said.
The Royal Australian College of General Practitioners, Choice, Friends of Science in Medicine and others have called for an educational statement on the pack and promotional material of medicines making traditional claims, for example saying “This product is based on traditional beliefs and not modern scientific evidence”.
“This was opposed by industry and the TGA,” Harvey said. “But is still needed.”
Pelargonium sidoides, a traditional medicinal plant native to South Africa, is one of the ornamental geraniums that is thought to be effective in treating URTIs. The plant seems to contain a large variety of phytochemicals, including amino acids, phenolic acids, α-hydroxy-acids, vitamins, polyphenols, flavonoids, coumarins, coumarins glucosides, coumarin sulphates and nucleotides. It is mostly used to treat the symptoms of acute bronchitis, common cold and acute rhinosinusitis.
The present study aimed to assess the effectiveness of the liquid herbal drug preparation from the root extracts of Pelargonium sidoides in improving symptoms of uncomplicated upper respiratory tract infections (URTIs). One hundred sixty-four patients with URTI were randomized and given either verum containing the root extracts of Pelargonium sidoides (n = 82) or a matching placebo (n = 82) in a single-blind manner for 7 days. The median total scores of all symptoms (TSS) showed a significant decreasing trend in the group treated with the root extracts derived from Pelargonium sidoides compared to the placebo group from day 0 to day 7 (TSS significantly decreased by 0.85 points in the root extract group compared to a decrease of 0.62 points, p = 0.018). “Cough frequency” showed a significant improvement from day 0 to day 3 (p = 0.023). There was also detected a significant recovery in “sneezing” on day 3 via Brunner-Langer model, and it was detected that the extract administration given in the first 24 h onset of the symptoms had provided a significant improvement in day 0 to day 3 (difference of TSS 0.18 point, p = 0.011).
The authors concluded that Pelargonium sidoides extracts are effective in relieving the symptom burden in the duration of the disease. It may be regarded as an alternative option for the management of URTIs.
These findings are less surprising than they may seem. Already in 2008, we published the following systematic review:
Objective: To critically assess the efficacy of Pelargonium sidoides for treating acute bronchitis.
Data sources: Systematic literature searches were performed in 5 electronic databases: (Medline (1950 – July 2007), Amed (1985 – July 2007), Embase (1974 – July 2007), CINAHL (1982 – July 2007), and The Cochrane Library (Issue 3, 2007) without language restrictions. Reference lists of retrieved articles were searched, and manufacturers contacted for published and unpublished materials.
Review methods: Study selection was done according to predefined criteria. All randomized clinical trials (RCTs) testing P. sidoides extracts (mono preparations) against placebo or standard treatment in patients with acute bronchitis and assessing clinically relevant outcomes were included. Two reviewers independently selected studies, extracted and validated relevant data. Methodological quality was evaluated using the Jadad score. Meta-analysis was performed using a fixed-effect model for continuous data, reported as weighted mean difference with 95% confidence intervals.
Results: Six RCTs met the inclusion criteria, of which 4 were suitable for statistical pooling. Methodological quality of most trials was good. One study compared an extract of P. sidoides, EPs 7630, against conventional non-antibiotic treatment (acetylcysteine); the other five studies tested EPs 7630 against placebo. All RCTs reported findings suggesting the effectiveness of P. sidoides in treating acute bronchitis. Meta-analysis of the four placebo-controlled RCTs suggested that EPs 7630 significantly reduced bronchitis symptom scores in patients with acute bronchitis by day 7. No serious adverse events were reported.
Conclusion: There is encouraging evidence from currently available data that P. sidoides is effective compared to placebo for patients with acute bronchitis.
Meanwhile, P.sidoides has been associated with liver damage, a fact that might dampen our enthusiasm for this remedy. Nevertheless, it seems to me that this plant merits further study.
Tinospora cordifolia, a plant used in Ayurvedic medicine, is a widely grown glabrous, deciduous climbing shrub which has been described in traditional medicine texts to have a long list of health benefits. It contains diverse phytochemicals, including alkaloids, phytosterols, glycosides.
Preparations utilize the stem and root of the plant which is consumed in the form of capsules, powder, or juice or in an unprocessed form. Its benefits are said to include anti-inflammatory, anti-pyretic properties, anti-viral and anti-cancer, and immune-boosting properties. The latter alleged activity made it popular during the pandemic. Indian researchers recently reported 6 patients who presented with liver injuries after taking Tinospora cordifolia.
Case 1
A previously healthy 40- year-old male without comorbidities, presented with jaundice of 15 days duration. On persistent probing, he gave a history of consumption of TC plant twigs (10 to 12 pieces) boiled with cinnamon and cloves in half a glass of water, once in two days for 3 months prior to presentation. USG of the abdomen was unremarkable. He underwent a percutaneous liver biopsy which showed features of the hepatocellular pattern of liver injury – with lymphoplasmacytic cell infiltrate, interface hepatitis, and foci of necrosis – suggesting the diagnosis of DILI with autoimmune features. He was managed with standard medical treatment (SMT) which included multivitamins and ondansetron for associated nausea. He was followed up for 5 months till the complete resolution of symptoms and normalization of liver function.
Case 2
A 54- year -old female, with type 2 diabetes mellitus, presented with jaundice for 1 week. A 7-month history of unsupervised consumption of TC plant (1 twig per day), which was boiled and extract consumed – was obtained. Evaluation for cause revealed a positive ANA (1:100), negative ASMA, negative viral markers, and normal IgG. USG features showing a liver with coarse echotexture, spleen of 13.4 cm, and minimal free fluid in the abdomen. A percutaneous liver biopsy showed a mixed pattern of liver injury (hepatocellular and cholestatic) with features of lymphocytic, neutrophilic and eosinophilic infiltrate, prominent interface hepatitis, intracytoplasmic and canalicular cholestasis, and altered architecture. She was managed with SMT. In view of chronicity, she was started on oral prednisolone in a dose of 40 mg which was tapered over a period of 10 weeks following which there was the resolution of her symptoms, improvement in LFTs and she was advised regular follow up.
Case 3
A 38- year-male with Beta-thalassemia minor presented with jaundice of 1-week duration. He gave a history of consumption of 3-4 TC plant twigs – boiled and extract consumed 15 ml/day for 6 months prior to presentation. Work up for the etiology showed a positive ANA (1:100). USG showed hepatomegaly (16 cm) with diffuse fatty infiltration and splenomegaly (17.3 cm). A percutaneous liver biopsy suggested the diagnosis of drug-induced hepatitis with a hepatocellular pattern of liver injury along with moderate lymphocytic infiltrate admixed with plenty of eosinophils and few plasma cells, mild interface hepatitis. He was managed with SMT and followed up until complete resolution of symptoms and LFTs.
Case 4
A 62- year-old female with type 2 diabetes mellitus, presented with complaints of malaise, reduced appetite and yellowish discoloration of urine, eyes, and skin with abdominal distension for 15 days. She confirmed consumption of commercially available syrup containing TC plant – 15 ml/day, every alternate day for a month, prior to the onset of her symptoms. Investigations revealed a positive ANA (1:320) and ASMA. Imaging showed hepatomegaly and ascites. A trans-jugular liver biopsy suggested a diagnosis of autoimmune hepatitis suggested by lymphoplasmacytic infiltrate with eosinophils and neutrophils, as well as interface hepatitis. There was also cirrhosis suggested by marked lobular disarray, pseudo-glandular transformation, and bridging hepatic fibrosis. She was treated with standard medical therapy including a low salt diet and diuretics for ascites and started on oral prednisolone 40 mg per day. She initially showed clinical improvement and improving trends of LFTs. However, on tapering of steroids, she came back with increasing ascites and oliguria and succumbed to hepato-renal syndrome around 120 days from the first presentation.
Case 5
A 56- year-old female with hypothyroidism presented with yellowish discoloration of urine and eyes. A short, 3-week history of consumption of TC plant boiled extract of 1 twig, 2 to 3 days/week was obtained. Standard investigations for etiology were negative except for a high serum IgG of 2570 mg/dl. The auto-immune markers were negative. USG showed mild ascites, nodular liver, and spleen of 12.3 cm. A trans-jugular liver biopsy showed lymphoplasmacytic infiltrate admixed with plasma cells and eosinophils, moderate interface hepatitis, fibrosis, and altered architecture suggestive of auto-immune cirrhosis. SMT and tapering doses of prednisolone starting with 40 mg orally over 6 weeks led to the resolution of symptoms with the improvement of LFT. She was continued on a maintenance dose of steroids and advised to close follow-up.
Case 6
A 56- year-old female, with hypothyroidism presented with jaundice of 20 days duration. History of TC plant formulation in the form of commercially available tablets – 1 pill a day, for 3 months prior to presentation was obtained. Routine evaluation for the cause of liver injury showed a weakly positive ASMA and a high serum IgG (2045 mg/dl). ANA was negative. USG showed diffuse heterogeneous echotexture of liver and normal-sized spleen. A percutaneous liver biopsy showed chronic hepatitis with lymphoplasmacytic infiltrate, interface hepatitis with significant bridging fibrosis suggesting the possibility of autoimmune hepatitis. She was managed with SMT, leading to complete symptomatic and biochemical resolution. There was no relapse of hepatitis after stopping TC and a follow-up of 2 months.
The authors believe that the liver injury seen in these patients was caused by autoimmune-like hepatitis due to consumption of TC, or the unmasking of latent chronic auto-immune liver disease. Most drug-induced autoimmune liver injuries are an acute idiosyncratic reaction which was also supported by the fact that one patient taking the drug for only 3 weeks on alternate days.
On FACEBOOK I recently found this advertisement posted by ‘LifeCell Health’
Guys, weight loss starts at our gut. The reishi mushroom targets this key area of the body and promotes weight loss in a unique way, by changing our gut bacteria to digest food in a manner that improves weight loss and can even prevent weight gain. By combining 3 of the most researched mycological species on the planet, LifeCell Myco+ delivers a blend of weight loss mushrooms like no other: Improve gut health, speed up weight loss, enhance immune function, natural energy and more with our blend of Reishi, Turkey Tail, and Shiitake mushrooms. Each mushroom has been the subject of several in-vivo studies proving their efficacy when it comes to weight loss.
Why Mushrooms Work.
Reishi: Prevents weight gain by altering bacteria inside the digestive system
Shiitake: Helps the body develop less fat by nourishing good gut bacteria.
Turkey Tail: Reduces inflammation and helps prevent weight gain.
That sounded interesting, I thought, and I investigated a bit further. On the website of the firm, I found this text:
By combining 3 of the most researched mycological species on the planet, LifeCell Myco+ delivers an organic wellness formula unlike any other. Improve gut health, speed up weight loss, enhance immune function, natural energy and more with our blend of Reishi, Turkey Tail, and Shiitake mushrooms.
Keeping a healthy balance of beneficial bacteria in your gut is critical for maintaining a strong immune system. Your gut bacteria interact with immune cells and directly impact your immune response. Turkey tail mushrooms contain prebiotics, which help nourish these helpful bacteria. An 8-week study in 24 healthy people found that consuming 3,600 mg of PSP extracted from turkey tail mushrooms per day led to beneficial changes in gut bacteria and suppressed the growth of the possibly problematic E. coli and Shigella bacteria.
Next, I conducted a few Medline searches but was unable to find any trial data suggesting that any of the three mushrooms or their combination might reduce body weight. So, I wrote to the company:
Dear Madam/Sir
I am intrigued by your product MYCO +. Would you be kind enough to send me the studies showing that it can reduce body weight?
Many thanks
Edzard Ernst
What followed was a bizarre correspondence with several layers of administrators in the firm. They all said that I should discuss this with the next higher person. So, I asked myself up the hierarchy of LiveCell. The last email I received was this one:
Good morning Edzark,
Thank you for your email and I hope you are enjoying your day.
It is great to hear that you are interested in our LifeCell Myco. I have forwarded your request for additional information and once received I will be sure to forward the information to you.
What do I conclude from this experience?
Apart from being unable to get my name right, the people responsible at ‘LifeCell Health’ seem also not able to send me the evidence I asked for. This, I fear, means that there is no such evidence which means the claims are unsubstantiated. Scientifically, this might amount to misconduct; legally, it could be fraudulent.
But I am, of course, no lawyer and therefore leave it to others to address the legal issues.
PS
If anyone happens to know of some evidence, please let me know and I will correct my post accordingly.
Chinese researchers evaluated the effect of Chinese medicine (CM) on survival time and quality of life (QoL) in patients with small-cell lung cancer (SCLC). They conducted an exploratory and prospective clinical observation. Patients diagnosed with SCLC receiving CM treatment as an add-on to conventional cancer therapies were included and followed up every 3 months. The primary outcome was overall survival (OS), and the secondary outcomes were progression-free survival (PFS) and QoL.
A total of 136 patients including 65 limited-stage SCLC (LS-SCLC) patients and 71 extensive-stage SCLC (ES-SCLC) patients were analyzed. The median OS of ES-SCLC patients was 17.27 months, and the median OS of LS-SCLC was 40.07 months. The survival time was 16.27 months for SCLC patients with brain metastasis, 9.83 months for liver metastasis, 13.43 months for bone metastasis, and 18.13 months for lung metastasis. Advanced age, pleural fluid, liver, and brain metastasis were risk factors, while longer CM treatment duration was a protective factor. QoL assessment indicated that after 6 months of CM treatment, scores increased in function domains and decreased in symptom domains.
The authors concluded that CM treatment might help prolong OS of SCLC patients. Moreover, CM treatment brought the trend of symptom amelioration and QoL improvement. These results provide preliminary evidence for applying CM in SCLC multi-disciplinary treatment.
Sorry, but these results provide NO evidence for applying CM in SCLC multi-disciplinary treatment! Even if the findings were a bit better than those reported for SCLC in the literature – and I am not sure they are – it is simply not possible to say with any degree of certainty what effect the CM had. For that, we would obviously need a proper control group.
The study was supported by the National Natural Science Foundation of China (No. 81673797), and Beijing Municipal Natural Science Foundation (No. 7182142). In my view, this paper is an example for showing how the relentless promotion of dubious Traditional Chinese Medicine by Chinese officials might cost lives.
I feel that it is time to do something about it.
But what precisely?
Any ideas anyone?
Withania somnifera, commonly known as Ashwagandha, is a plant belonging to the family of Solanaceae. It is widely used in Ayurvedic medicine. The plant is promoted as an immunomodulator, anti-inflammatory, anti-stress, anti-Parkinson, anti-Alzheimer, cardioprotective, neural and physical health enhancer, neuro-defensive, anti-diabetic, aphrodisiac, memory-boosting, and ant-cancer remedy. It contains diverse phytoconstituents including alkaloids, steroids, flavonoids, phenolics, nitrogen-containing compounds, and trace elements.
But how much of the hype is supported by evidence? Unsurprisingly, there is a shortage of good clinical trials. Yet, during the last few years, a surprising number of reviews of the accumulating evidence have emerged:
- One review suggested that pre-clinical, as well as clinical studies, suggest the effectiveness of Withania somnifera (L.) against neurodegenerative disease.
- A further review suggested a potential role of W. somnifera in managing diabetes.
- A systematic review of 5 clinical trials found that W. somnifera extract improved performance on cognitive tasks, executive function, attention, and reaction time. It also appears to be well tolerated, with good adherence and minimal side effects.
- Another systematic review included 4 clinical trials and reported significant improvements in serum hormonal profile, oxidative biomarkers, and antioxidant vitamins in seminal plasma. No adverse effects were reported in infertile men taking W. somnifera treatment.
- Another review concluded that the root of the Ayurvedic drug W. somnifera (Aswagandha) appears to be a promising safe and effective traditional medicine for management of schizophrenia, chronic stress, insomnia, anxiety, memory/cognitive enhancement, obsessive-compulsive disorder, rheumatoid arthritis, type-2 diabetes and male infertility, and bears fertility promotion activity in females adaptogenic, growth promoter activity in children and as adjuvant for reduction of fatigue and improvement in quality of life among cancer patients undergoing chemotherapy.
- A systematic review of 13 RCTs found that Ashwagandha supplementation was more efficacious than placebo for improving variables related to physical performance in healthy men and women.
- Another systematic review concluded that Ashwagandha supplementation might improve the VO2max in athletes and non-athletes.
Impressed?
This certainly looks as though that this plant is worthy of further study. But I can never help feeling a bit skeptical when I hear of such a multitude of benefits without evidence for adverse effects (other than minor upset stomach, nausea, and drowsiness).
Boris Johnson has recently bent over backward in order to please the Indian PM, Narendra Mondi. Some even say that a trade agreement between the two countries was achieved at the cost of letting the Delta variant into the UK. Now it seems that political considerations are at the heart of the decision to lend official support to Indian traditional medicine in the UK. The ‘2030 Roadmap for India-UK future relations‘ is a policy document of the UK government. In it, we find that the UK government intends to:
- Explore cooperation on research into Ayurveda and promote yoga in the UK.
- Increase opportunities for generic medicine supply from India to the UK by seeking access for Indian pharma products to the NHS and recognition of Indian generic and Ayurvedic medicines that meet UK regulatory standards.
This clearly begs the question, are these plans good or bad for UK public health?
Ayurveda is a system of healthcare developed in India around the mid-first millennium BCE. Ayurvedic medicine involves a range of techniques, including meditation, physical exercises, nutrition, relaxation, massage, and medication. Ayurvedic medicine thrives for balance and claims that the suppression of natural urges leads to illness. Emphasis is placed on moderation. Ayurvedic medicines are extremely varied. They usually are mixtures of multiple ingredients and can consist of plants, animal products, and minerals. They often also contain toxic substances, such as heavy metals which are deliberately added in the ancient belief that they can have positive health effects. The truth, however, is that they can cause serious adverse effects.
Relatively few studies of Ayurvedic remedies exist and most are methodologically weak. A Cochrane review, for instance, concluded that” although there were significant glucose-lowering effects with the use of some herbal mixtures, due to methodological deficiencies and small sample sizes we are unable to draw any definite conclusions regarding their efficacy. Though no significant adverse events were reported, there is insufficient evidence at present to recommend the use of these interventions in routine clinical practice and further studies are needed.”
The efficacy of Ayurvedic remedies obviously depends on the exact nature of the ingredients. Generalizations are therefore problematic. Promising findings exist for a relatively small number of ingredients, including Boswellia, Frankincense, Andrographis paniculata.
Yoga has been defined in several different ways in the various Indian philosophical and religious traditions. From the perspective of alternative medicine, it is a practice of gentle stretching exercises, breathing control, meditation, and lifestyles. The aim is to strengthen prana, the vital force as understood in traditional Indian medicine. Thus, it is claimed to be helpful for most conditions affecting mankind. Most people who practice yoga in the West practise ‘Hatha yoga’, which includes postural exercises (asanas), breath control (pranayama), and meditation (dhyana). It is claimed that these techniques bring an individual to a state of perfect health, stillness, and heightened awareness. Other alleged benefits of regular yoga practice include suppleness, muscular strength, feelings of well-being, reduction of sympathetic drive, pain control, and longevity. Yogic breathing exercises are said to reduce muscular spasms, expand available lung capacity and thus alleviate the symptoms of asthma and other respiratory conditions.
There have been numerous clinical trials of various yoga techniques. They tend to suffer from poor study design and incomplete reporting. Their results are therefore not always reliable. Several systematic reviews have summarised the findings of these studies. An overview included 21 systematic reviews relating to a wide range of conditions. Nine systematic reviews arrived at positive conclusions, but many were associated with a high risk of bias. Unanimously positive evidence emerged only for depression and cardiovascular risk reduction (Ernst E, Lee MS: Focus on Alternative and Complementary Therapies Volume 15(4) December 2010 274–27).
Yoga is generally considered to be safe. However, the only large-scale survey specifically addressing the question of adverse effects found that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases.
So, should we be pleased about the UK government’s plan to promote Ayurveda and yoga? In view of the mixed and inconclusive evidence, I feel that a cautious approach would be wise. Research into these subjects could be a good idea, particularly if it were aimed at finding out what the exact risks are. Whole-sale integration does, however, not seem prudent at this stage. In other words, let’s find out what generates more good than harm for which conditions and subsequently consider adopting those elements that fulfill this vital criterium.
In the UK, a new post-Brexit regulatory framework is being proposed for food supplements by the government. The nutraceutical sector is estimated to be worth £275bn globally and £4bn in the UK. A new report claims that “science is starting to point the way to a new sector of nutritional products with increasingly explicable and/or verifiable medicinal benefits, which needs to be reflected in our regulatory framework.” Tory MP George Freeman, one of the authors of the report, was quoted saying:
“We are living through an extraordinary period of technological change – not just in life science but in host of sectors: from AI to robotics to agri-tech, nutraceuticals, nanotechnology, synthetic biology, biofuels, satellites and fusion energy. The UK is indeed a ‘science superpower’. But we have traditionally been woeful at commercialising here in the UK. There are many reasons. But, in recent years, the EU’s increasingly slow, bureaucratic and ‘precautionary’ approach – copied in Whitehall – has made the EU and the UK an increasingly poor place to commercialise new technology.”
If a product like a food or a herbal remedy makes ‘medicinal’ claims, it is currently regulated by the MHRA. If a product only makes general ‘health’ claims, it is regulated by the Department of Health and Social Care in England, by the FSA in Wales and Northern Ireland, and by Food Standards Scotland in Scotland. This ‘patchwork of regulators’ is bound to change as it is deemed to create additional costs and uncertainty for businesses who would like to see the relevant functions brought together in a central regulatory body and a clearer UK landscape.
In response to the task force’s report, PM Boris Johnson stated that bold and ambitious ideas such as these are needed to encourage growth and innovation:
“The Government, through our Better Regulation Committee, is already hard at work on reform of the UK’s regulatory framework. Your bold proposals provide a valuable template for this, illustrating the sheer level of ambitious thinking needed to usher in a new golden age of growth and innovation right across the UK. So we will give your report the detailed consideration it deserves, consult widely across industry and civil society, and publish a response as soon as is practicable.”
Am I the only one who feels more than a little uneasy about all this? I honestly do not see much new science that, according to the report, points to ‘verifiable medicinal benefits’ of food supplements or nutraceuticals. What the report does however point to, I fear, is that the UK government is about to deregulate quackery with a view to making some entrepreneurs wealthy snake oil salesmen at the cost of public health and wealth.
I hope I am mistaken.
Ever since I published a post about the irresponsible and aggressive advertising campaign of LYMA (“the world’s 1st super-supplement”), I am pursued by them with emails informing me about the wonders of this supplement. Here is one I received recently:
Here at LYMA we are firm believers that optimal productivity depends on good quality sleep and your day is only as good as the previous night.
Suffering from bad sleep is debilitating whether it’s ourselves or we’re watching someone we love suffer, the search for good rest is something we’re all united in.
Energy levels, positive mindset and strong cognitive function all come from sleep, which is why we spent so long formulating the LYMA supplement. Our patented KSM-66® Ashwagandha is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world. The hefty combination of purity and potency make it unrivalled in its ability to reduce inflammation, neutralise anxiety and promote deep, restful sleep, night after night.
Thousands of customers have told us that after years of bad sleep, they’re finally getting the rest they need and feeling transformed as a result. In fact, it’s one of the very first benefits most people notice. We’re happy to hear it.
And the knock-on effects of a good night’s sleep in how we feel, how we perform and our overall health are far reaching. Which is why we are so delighted to welcome Michael Grandner, world-renowned sleep expert and Director of the Behavioural Sleep Medicine Clinic, Arizona to the LYMA team.
Michael is one of the most cited sleep experts in the world and has himself published over 175 articles on issues relating to sleep and health. We plan on tapping into every area of his expertise to understand our own sleep habits and how we can all become the best at rest.
To introduce Michael to the LYMA community we’re hosting a seminar dedicated to understanding sleep on Tuesday 22nd June…
I was tempted to discard all this as rather pathetic advertising hype. But then I had second thoughts. This text does after all make several medical claims, and the question is: ARE THEY SUPPORTED BY EVIDENCE?
It claims that KSM-66® Ashwagandha:
- is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world.
- That the hefty combination of purity and potency makes it unrivalled in its ability to reduce inflammation.
- That the product neutralises anxiety.
- That it promotes deep, restful sleep, night after night.
I ran a few searches to find out whether there is any sound evidence for any of these claims.
- There seem to be several supplements that contain,KSM-66® Ashwagandha’. The impression that LYMA is the only one is thus wrong. Zero toxicity must also be wrong; not even water has zero toxicity. In fact, epigastric pain/discomfort and loose stools were reported as most common (>5%); and giddiness, drowsiness, hallucinogenic, vertigo, nasal congestion (rhinitis), cough, cold, decreased appetite, nausea, constipation, dry mouth, hyperactivity, nocturnal cramps, blurring of vision, hyperacidity, skin rash and weight gain have all been associated with the herbal remedy. Moreover, if it is true that Ashwagandha stimulates the immune system, it might cause problems for people with autoimmune diseases.
- I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha reduces inflammatory conditions in humans.
- I found a study concluding that Ashwagandha given as an adjunct offered some potential advantages as a safe and effective adjunctive therapy to SSRIs in GAD. Yet, I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha as a single supplement reduces anxiety in otherwise healthy individuals.
- A 2021 study suggested that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Yet the authors cautioned that additional clinical trials are required to generalize the outcome.
So, what does that tell us?
It could mean that:
- My searches were not sufficiently thorough and that I have missed compelling evidence. If so, I would appreciate, if the LYMA promoters would show me their evidence so that I can assess it.
- The LYMA people are irresponsible and mislead the public with untenable claims.
I am looking forward to their response.
