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

herbal medicine

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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:

  1. is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world.
  2. That the hefty combination of purity and potency makes it unrivalled in its ability to reduce inflammation.
  3. That the product neutralises anxiety.
  4. 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.

  1. 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.
  2. I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha reduces inflammatory conditions in humans.
  3. 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.
  4. 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:

  1. 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.
  2. The LYMA people are irresponsible and mislead the public with untenable claims.

I am looking forward to their response.

“I don’t take chemicals,

I prefer natural herbal remedies!”

How often have we heard such statements? They are usually pronounced with an air of smug superiority and condescending pity towards those poor consumers who swallow paracetamol, ibuprofen, or other chemicals when having a headache or other health problem.

But the air of superiority seems misplaced because these ‘herbivores’ actually consume many more chemicals than the ‘chemivores’. What those who swear by ‘non-chemical’ medicines ignore is the fact that herbal remedies are packed with many different chemicals.

Below I have listed the main active chemical compound of some very well-known herbal remedies:

  • Calendula (Calendula officinalis L.): flavonoids, triterpene alcohols, triterpene saponins, carotenoids, polysaccharides, essential oil
  • Chamomile (Matricaria recutita L.): essential oil, sesquiterpenes, dicycloethern
  • Echinacea (Echinacea purpurea): polysaccharides, caffeic acid derivatives, alkamides, polyacetylenes, essential oil.
  • Eucalyptus (Eucalyptus globulus Labill.): cineole, euglobales, macrocarpales
  • Garlic (Allium sativum L.): alliin [(+)- S-allyl-L-cystein sulfoxide],  allicin (allyl 2- thiosulphate propane)
  • Hops (Humulus lupulus L.): phloroglucinol derivates, essential oil
  • Lavender (Lavandula angustifolia Mill.): linalyl acetate and linalool, tannins
  • Liquorice (Glycyrrhiza glabra L.): triterpenoid, flavonoids, isoflavones, polysaccharides
  • Peppermint (Mentha x piperita L.): menthol, menthone, menthyl acetate, tannins, flavonoids
  • Valerian (Valeriana officinalis L.): essential oil, sesquiterpene acids, iridoids, lignans, caffeic acid derivatives, alkaloids

Whenever I explain this to a ‘herbivore’ (here defined as a person who prefers herbal to conventional medicine), she is initially taken aback but, as soon as she has recovered from the shock, she regains their superior attitude and says: “Ah yes, but these are natural chemicals; they cannot do any harm, you know.”

“No, I don’t know!” I then reply, “There are two errors in what you just said: firstly, many chemicals that plants produce are highly poisonous – in fact, some of the most potent toxins we know come from plants – and secondly there is no difference between a chemical XY produced by a plant and the same chemical produced in a factory.”

At this stage, we usually change the subject or part our ways.

Post-traumatic stress disorder (PTSD), previously known as battle fatigue syndrome or shell shock, is a condition that can be triggered by the experience of some frightening event. PTSD can be debilitating leading to the production of feelings of helplessness, intense fear, and horror. Numerous treatments of PTSD exist but few have been shown to be truly effective. A team of Canadian researchers explored the effects of cannabis on PTSD symptoms, quality of life (QOL), and return to work (RTW). Their systematic review also investigated harms such as adverse effects and dropouts due to adverse effects, inefficacy, and all-cause dropout rates.

Their electronic searches located one RCT and 10 observational studies (n = 4672). Risk of bias (RoB) was assessed with the Cochrane risk of bias tool and ROBINS-I. Evidence from the included studies was mainly based on studies with no comparators. Results from unpooled, high RoB studies suggested that cannabis was associated with a reduction in overall PTSD symptoms and improved QOL. Dry mouth, headaches, and psychoactive effects such as agitation and euphoria were the most commonly reported adverse effects. In most studies, cannabis was well tolerated. A small proportion of patients experienced a worsening of PTSD symptoms.

The authors concluded that the evidence in the current study primarily stems from low quality and high RoB observational studies. Further RCTs investigating cannabis effects on PTSD treatment should be conducted with larger sample sizes and explore a broader range of patient-important outcomes.

Various drugs are currently used for the treatment of PTSD including selective serotonin reuptake inhibitors; tricyclic antidepressants (amitriptyline and isocarboxazid); mood stabilizers (Divalproex and lamotrigine); atypical antipsychotics (aripiprazole and quetiapine) but their effectiveness has not been proven. A recent systematic review included 30 RCTs of a range of heterogeneous non-psychological and non-pharmacological interventions. There was emerging evidence for 6 different approaches:

  • acupuncture,
  • neurofeedback,
  • saikokeishikankyoto (a herbal preparation),
  • somatic experiencing,
  • transcranial magnetic stimulation,
  • yoga.

This list makes me wonder: are these treatments, including cannabis, truly promising, or is PTSD one of those conditions for which nearly every treatment works a little because of its placebo effect?

Due to polypharmacy and the rising popularity of so-called alternative medicines (SCAM), oncology patients are particularly at risk of drug-drug interactions (DDI) or herb-drug interactions (HDI). The aims of this study were to assess DDI and HDI in outpatients taking oral anticancer drugs.

All prescribed and non-prescribed medications, including SCAMs, were prospectively collected by hospital pharmacists during a structured interview with the patient. DDI and HDI were analyzed using four interaction software programs: Thériaque®, Drugs.com®, Hédrine, and Memorial Sloan Kettering Cancer Center (MSKCC) database. All detected interactions were characterized by severity, risk, and action mechanism. The need for pharmaceutical intervention to modify drug use was determined on a case-by-case basis.

A total of 294 patients were included, with a mean age of 67 years [55-79]. The median number of chronic drugs per patient was 8 [1-29] and 55% of patients used at least one SCAM. At least 1 interaction was found for 267 patients (90.8%): 263 (89.4%) with DDI, 68 (23.1%) with HDI, and 64 (21.7%) with both DDI and HDI. Only 13% of the DDI were found in Thériaque® and Drugs.com® databases, and 125 (2.5%) were reported with a similar level of risk on both databases. 104 HDI were identified with only 9.5% of the interactions found in both databases. 103 pharmaceutical interventions were performed, involving 61 patients (20.7%).

The authors concluded that potentially clinically relevant drug interactions were frequently identified in this study, showing that several databases and structured screening are required to detect more interactions and optimize medication safety.

These data imply that DDIs are more frequent than HDIs. This does, however, not tell us which are more important. One crucial difference between DDIs and HDIs is that the former are usually known to the oncology team who should thus be able to prevent them or deal with them appropriately; in contrast, HDIs are often not known to the oncology team because many patients fail to disclose the fact that they take herbal remedies. Some forget, some do not think of herbals as medicine, others may be worried about their physician’s reaction.

It follows that firstly, conventional healthcare practitioners should always ask about the usage of herbal remedies, and secondly, they need to be informed about which herbal remedy might interact with which drug. The first can easily be implemented into routine history-taking; the second is more problematic, not least because our knowledge about HDIs is still woefully incomplete. In view of this, it might often be wise to tell patients to stop taking herbal remedies while they are on prescription drugs.

This amazing announcement reached me via Twitter. It seems that the people in the AYUSH ministry are highly delusional. According to Wikipedia, the Ministry of AyurvedaYogaNaturopathyUnaniSiddha, Sowa-Rigpa and Homoeopathy (abbreviated as AYUSH) is purposed with developing education, research and propagation of indigenous alternative medicine systems in India. As per a recent notification published in the Gazette of India on 13 April 2021, the  Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy), will now be known as the Ministry of Ayush.

India is suffering from a very severe health crisis, and the ministry should stop its propaganda for useless solutions.

  • Ayurveda,
  • Homeopathy (considered to be indigenous in India),
  • Yoga,
  • Naturopathy,
  • Unani,
  • Sidda,
  • Sowa-Rigpa (the traditional medicine of Tibet)

have in common that they can offer very little help to patients infected by COVID-19. In view of this fact, the announcement is ununderstandable and irresponsible, in my view.

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