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…
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 honor 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 license 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?
Top image: Sigesbeckia serrata, Wikipedia. Originally on edzardernst.com
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