MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

Yesterday, a press-release reached me announcing that a Chinese herbal medicine, ‘Phynova Joint and Muscle Relief Tablets’, containing the active ingredient Sigesbeckia, is now on sale in the UK for the first time in Boots The Chemist: 

Sigesbeckia is the first traditional Chinese treatment granted a traditional herbal registration (THR) under the traditional herbal medicines product directive in the UK, by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA).  Oxford based Phynova which manufactures the product was granted the UK licence last year. 

Containing 500mg of the active ingredient, Phynova Joint and Muscle Relief Tablets are specially formulated for the relief of backache, arthritis, minor sports injuries, rheumatic or muscular pains and general aches and pains in muscles or joints.  Two tablets are taken each day, one in the morning and one in the evening. They have no known side effects and are non-addictive. .. 

The product, which retails at £19.99 for one month’s supply of 60 tablets, is available in 950 UK Boots outlets and online via Click and Collect from all stores.  It will be sold both Over the Counter (OTC) by pharmacist staff and off the shelf as part of Boots’ pain relief fixture… 

END OF QUOTE

What on earth is a ‘joint and muscle relief’? Personally I do not want to be relieved of my joints and muscles!!!

Yes, I know, they probably mean ‘joint and muscle pain relief’ but were not allowed to say so because this is a medical indication.

And what about the claim of ‘no side-effects’; is it possible that a pharmacological treatment has positive effects without any risks at all? This is not what they told me during my pharmacology course, if I remember correctly. And anyway, even placebos have side-effects!

I admit, I was puzzled.

The covering letter of the press-release provided more amazement: it informed me that “Phynova joint and muscle relief contains the active ingredient Sigesbeckia which has been through clinical trials and has been used for pain relief in China for hundreds of years…” It was the remark about clinical trials (PLURAL!!!) that caught my interest most.

So, I looked up ‘Sigesbeckia’ on Medline and found as good as nothing. This is mainly because the plant is spelled correctly ‘Siegesbeckia’ in honour of the famous botanist Siegesbeck.

Looking up ‘Siegesbeckia’, I found many pre-clinical studies but no clinical trials.

Next I searched for a comment from the MHRA and discovered that their account makes it very clear that a licence has been granted to this product “exclusively upon long standing use… and not upon data from clinical trials.”

So, who is right?

Are there clinical trials of this product or not? And, if there are any, where are they?

Perhaps someone from Phynova can enlighten us?

 

26 Responses to The first traditional Chinese treatment granted a traditional herbal registration in the UK

  • Wouldn’t the Advertising Standards Authority have a thing or two to say about the wording of their marketing material?

  • As part of the application for a THR, the manufacturer has to provide:

    [a] review of safety with an expert report including clinical and non-clinical safety areas carried out by either:
    * a registered doctor
    * a registered pharmacist
    * a scientifically qualified competent individual (eg toxicologist)
    * herbal practitioner who is a member of a professional body and working towards statutory regulation of herbal medicine profession

    We don’t know what the manufacturer provided or what expert they relied on, but the last category is curious: there may well be herbalists who are ‘working towards statutory regulation’, but the last time this was looked at, the then Deputy Chief Medical Officer, Prof David Walker, concluded:

    Having taken into account the evidence available and the views of representatives of the sector, I consider that, despite strong calls by many for statutory regulation, there is not yet a credible scientific evidence base to demonstrate risk from both products and practitioners which would support this step. There is also very limited evidence of effectiveness of herbal medicines in improving health outcomes. This makes it difficult to establish the boundaries of good practice which would be required for both educational qualification and for the implementation of statutory regulation.

    The herbals sector must recognise that its overall approach (including the rationale for use of products and methods of treatment, education and training, and interaction with the NHS) needs to be more science and evidence based if in order to be established as a profession on the same basis as other groups that are statutorily regulated. (My emphasis)

    Unless the last category of expert covers herbalists who like to dream of statutory regulation, it’s difficult to understand how any herbalist could meet that requirement.

  • “Phynova Joint and Muscle Relief Tablets are specially formulated for the relief of backache, arthritis, minor sports injuries, rheumatic or muscular pains and general aches and pains in muscles or joints.” I’m not au fait with regulation of medical claims, but this statement very clearly states a medical indication — “relief of … general aches and pains in muscles or joints”. Is it only the product name that is obliged not to make a medical claim?

    In what way are the tablets “specially formulated” for the indications described? Does this imply that, formulated differently, Siegesbeckia might be effective against lassa fever or multiple sclerosis?! The sheer chutzpah of Phynova beggars belief: the fact that Boots has undertaken to sell this product further damages their ethical reputation.

    In previous comments I have often asked those supporting Big Snakeoil if they have the same ‘freedom of choice’ attitude to non-medical areas of consumer protectionism. How would they react if no action were taken against the suppliers of duff TVs, washing machines, mobile phones, etc.? I have never yet had a response. Today’s post is possibly the clearest example yet of why Edzard Ernst runs this blog. Surely even supporters of alternative medicine will understand the parallels between these Siegesbeckia tablets and, for example, dodgy mains chargers?

    • Frank Odds said:

      “Phynova Joint and Muscle Relief Tablets are specially formulated for the relief of backache, arthritis, minor sports injuries, rheumatic or muscular pains and general aches and pains in muscles or joints.” I’m not au fait with regulation of medical claims, but this statement very clearly states a medical indication — “relief of … general aches and pains in muscles or joints”. Is it only the product name that is obliged not to make a medical claim?

      The words they are permitted to use – and the only words they are permitted to use – are those identified in the Public Assessment Report that Edzard linked to:

      A traditional herbal medicinal product used for the relief of backache, minor sports injuries, rheumatic or muscular pains and general aches and pains in the muscle and joints, based on traditional use only

      The ‘based on traditional use only’ bit is the get-out clause for herbalists that is supposed to tell the public that there’s not a jot of good evidence that it actually works.

  • Clicking on the “read more on the herb here” link on Phynova’s website (https://www.phynovajointrelief.com/about/) I was quite shocked to see Rhino Horn listed in the sidebar under “latest herbs and remedies” http://www.chineseherbshealing.com/siegesbeckia.

    Even though it has nothing to do with the Siegesbeckia product consumers are directed to this site where they “advertise” (in a very clever way) rhino horn! Surely this will not fly with the UK consumer?

    • Oh, good grief! There really needs to be some public protest about this company!

      Frank van der Kooy says they ‘advertise’ rhino horn in a very clever way. Here’s a sample. They say “According to Evidence based medicine (EBM), rhinoceros horn or Xi Jiao has no medicinal value at all. This conclusion is almost completely opposite to what traditional medicine professed about this herb. That’s to say, it has been scientifically proven ineffective no matter it is used as an aphrodisiac or a drug for fever and convulsions…As a Chinese herb with an extremely cold property, it was once considered as one of the few lifesaving drugs people suffering from severe fever could rely on…To save endangered rhinos and alleviate the shortage, buffalo horns have been used as its substitute since the 1990s.”

      FFS! For a start, the definition of a ‘herb’ is based in a plant. Rhino horn by any definition is animal material. So not only can Phynova not spell Siegesbeckia correctly: they also think rhino horn is a herb! The entry goes on at great length: like Frank vdK says, it is a subtly worded paean of praise to the medicinal value of rhino horn, based entirely on the fallacious ‘argument from popularity’. If you read the verbiage carefully the article says rhino horn has zero medicinal value. At least the majority of the comments plead for the webpage to be taken down, but some of the pro-rhino horn remarks from TCM practitioners beggar belief.

      Evidently, ‘traditional’ Chinese medicine means exactly what it says. A monolith of ancient ‘wisdom’ unmoved by any advances in knowledge.

      • Frank

        “FFS! For a start, the definition of a ‘herb’ is based in a plant.”

        Actually, in most (if not all) traditional medicine systems, “herb” includes animal & mineral, in addition to plant. Just FYI.

        • sorry, but this is nonsense. the term herb/herbal is regulated and well-defined; it excludes non-plant based materials.

        • No need to be sorry. Common mistake. This is from wikipedia:

          “The term herbology is misleading in the sense that, while plant elements are by far the most commonly used substances, animal, human, and mineral products are also utilized. In the Neijing they are referred to as 毒藥 [duyao] which means toxin, poison or medicine. Unschuld points out that this is similar etymology to the Greek pharmakon and so he uses the term ‘pharmaceutic’.[2] Thus, the term “medicinal” (instead of herb) is usually preferred as a translation for 药 (pinyin: yào).[3]”

          Using translation “herb” in traditional medicine is the common practice. It might be a bad translation, but what can you do. If you want to be accurate, know that trad med folk use herb to mean animal, plant, mineral.

          • nobody denies that trad meds use other things than herbs; but herbal medicine is based on herbs.

          • And nobody in the trad med realm denies that “herb” can mean animal, plant, or mineral – when talking about traditional medicine.

          • the regulators in Europe and the US do, however.

          • From EU Directive 2001/83/EC:

            29. Traditional herbal medicinal product:

            A herbal medicinal product that fulfils the conditions laid down in Article 16a(1).

            30. Herbal medicinal product:

            Any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations.

            31. Herbal substances:

            All mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author).

            32. Herbal preparations:

            Preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates.

          • yes, and other parts of the world have similar definitions.

          • Alan and Edzard – thanks for the clarification. I’ll fix the comment:
            _________________________

            Frank

            “FFS! For a start, the definition of a ‘herb’ is based in a plant.”

            Actually, in most (if not all) traditional medicine systems, “herb” includes animal & mineral, in addition to plant. Regardless of current regulator/EU directive definitions, and Unschuld’s preferred translation of “pharmaceutic”, most simply go with “herb”. Just FYI.

          • jm said:

            Alan and Edzard – thanks for the clarification. I’ll fix the comment:
            _________________________

            Frank

            “FFS! For a start, the definition of a ‘herb’ is based in a plant.”

            Actually, in most (if not all) traditional medicine systems, “herb” includes animal & mineral, in addition to plant. Regardless of current regulator/EU directive definitions, and Unschuld’s preferred translation of “pharmaceutic”, most simply go with “herb”. Just FYI.

            Irrelevant.

          • Alan

            Yeah, it’s pretty irrelevant. There’s no real reason you need to know how the term is used – and I doubt anyone expects you to. Sorry it seemed to upset you so…it’s really not that big of a deal.

            But Frank commented earlier (on a different thread): “Using words that have existing, fully understood definitions in a way that they mean something quite different is dishonest and obfuscatory.”

            I take that to mean that Frank is interested in using the terms correctly. And the term “herb” used in the context of Chinese herbalism is fully understood to mean to animal, plant, and mineral. It’s so common, it made it to Wikipedia.

            And no, I don’t think Frank is being dishonest or obfuscatory. I think he probably doesn’t know how commonly accepted that particular use of the term is, in that context. So it might be relevant to him.

          • I freely confess my ignorance of the use of the word ‘herb’ in TCM as an approximate translation of a term for anything with a (purported) pharmacological effect. I was previously aware only of its English language meaning and the terminology of the EU directive on traditional medical products.

            This new knowledge does nothing to enhance my appreciation of TCM. I shall mentally add ‘herb’ to ‘energy’, ‘vibrations’ and other terms that are commandeered by camists and used by them with different meanings from what is commonly understood. As jm points out, I find this practice dishonest and obfuscatory.

            The exchanges on this topic on this thread have something in common with discussions on other threads (most notably on the highly overbloated recent one about acupuncture). A running theme from supporters of therapy ‘X’ [herbs, acupuncture, reiki: add your own favourite] is that one should refrain from comments on X unless one has extensively read the literature from supporters of ‘X’. This is a version of what PZ Myers (Pharyngula blog) calls the ‘courtier’s reply’. In essence: how dare someone claim the emperor is wearing no clothes when by their own admission they have not even read the books on the exquisite and exotic leathers of the emperor’s boots and the the luminescence of the emperor’s feathered hat?

            Life is of finite duration. When I come across an extraordinary claim I am willing to search for evidence supporting that claim. When I find credible evidence lacking, I feel no obligation to spend further time reading the fine detail of the claim’s proponent(s). In the context of the present thread, I am fully aware that many plant materials are the sources of medically beneficial effects. The science of pharmacognosy is dedicated to discovery of such plant materials, and — over very many years — has eliminated the majority of ‘traditional’ medicine materials as having no reproducible medical effects. Therefore, I consider practitioners of traditional medicine are largely perpetuating unsupportable myths. In common with other camists they feel no need to change their beliefs in the light of new information. How they misuse the English language is therefore not my concern.

          • jm said:

            Yeah, it’s pretty irrelevant.

            Glad you agree…

            There’s no real reason you need to know how the term is used – and I doubt anyone expects you to.

            The etymology might be interesting, but how others elsewhere happen to use the term is irrelevant: this post is about a herbal product licensed by the MHRA in the UK and what that entails, not a treatise on TCM..

            Sorry it seemed to upset you so…it’s really not that big of a deal.

            It didn’t upset me – what on earth gave you that idea? I love correcting errors and educating others.

            But Frank commented earlier (on a different thread): “Using words that have existing, fully understood definitions in a way that they mean something quite different is dishonest and obfuscatory.”

            In this case, it’s the legal definition that matters, nothing else.

          • “It didn’t upset me – what on earth gave you that idea?”

            You seem too emotionally distraught to see why it’s not that big of a deal. After you calm down a bit, you might see that I wasn’t contesting a legal definition – just letting Frank know why rhino horn would be called an ‘herb’.

  • Sorry for this rant but I get extremely Xoff when I see endangered species on the menu of TCM practitioners. The problem for me is that when you sell a product, as described in this blog post, as a TCM product this basically imply that you support and advertise the underlying theory of TCM – which is as we all know based on pseudoscience. My previous employer, Prof Alan Bensoussan (a registered TCM and acupuncture practitioner) is an expert at convincing the public that the the theory behind TCM is scientifically proven and yet when it comes to rhino horn, or any other endangered species, he will oppose the use of these species in TCM. Problem is can he do this? On the one hand you convince the public of TCM (and he theory behind it) but as soon as it comes to endangered species (and thus politically unacceptable practices) then suddenly the theory behind TCM breaks down and then there is no scientific evidence that it works! But only for endangered species – the rest, according to him, still obviously works. Sorry, but Rhino horn is part and parcel of TCM.

    If there is one thing that I’ve learned in my 3 years working with him is that what they say and what they do is two completely different things. They will never acknowledge the fact that very few plants might contain an active ingredient which can be useful (eg artemisinin) and that the theory of TCM (diagnostics plus treatment) is based on pseudoscience. They have to stick with their story – and thus I hold people like Alan Bensoussan and this UK company, Phynova, indirectly responsible for the rhino poaching crises.

    In May 2016 two of the last three Rhinos in our city was killed (authorities have since de-horned the last one – for what it is worth). http://www.news24.com/SouthAfrica/News/two-white-rhinos-killed-dehorned-in-rietvlei-nature-reserve-20160527

    Last year a total of 1175 rhinos were killed in South Africa (https://www.savetherhino.org/rhino_info/poaching_statistics)
    almost three a day – let alone the number of people killed by poachers!

    Thanks Alan and Phynova!!

  • From a brief glance at the studies in PubMed, members of the genus have traditionally been used in China as topical analgesics. No matter how how you slice it, the product is clearly being marketed for pain. If my experience in this type of marketing is correct, by avoiding the lengthy task of publishing the results of oral dosing studies or applying for regulatory status of the product under more stringent requirements, purveyors of traditional herbal products stand to profit without nearly as much expense. As for the clinical trials, assuming any were conducted, they will more than likely be limited to China, where they may or may not have been published. In fact, the product may have been a packaged deal made in China, with Phynova not the first to sniff it out.

    http://www.ncbi.nlm.nih.gov/pubmed/21798328

  • It’s worth pointing out what EU Directive 2001/83/EC says in Article 16a:

    3. However, in cases where the competent authorities judge that a traditional herbal medicinal product fulfils the criteria for authorisation in accordance with Article 6 or registration pursuant to Article 14, the provisions of this chapter shall not apply.

    Article 14 concerns homeopathic products and Article 6 concerns full marketing Authorisation (the full authorisation pharmaceutical products have to comply with).

    The competent authority in the UK is the MHRA. What this paragraph means is that if the MHRA decides that a herbal product fulfils the requirements of a ‘proper’ medicine or a homeopathic product, they cannot issue a Traditional Herbal Registration. This is done to prevent manufacturers from circumventing the requirements for providing clinical trial evidence but it also prevents herbal products for which there is (in the judgement of the MHRA) some good clinical trial evidence already.

  • I’m sitting opposite a Phynova advert for this product right now, in a train. It states “exclusively based on long-standing use…” and makes no mention of trials. Which is good news I suppose – albeit the only good news about this whole sorry business.

Leave a Reply

Your email address will not be published. Required fields are marked *

Gravityscan Badge

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories