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

I have to admit, I only read the DAILY MAIL, if I have to (and certainly not today). This is probably why I missed this article announcing the 1st traditional Chinese medicine to be licensed in the UK.

The plant Sigesbeckia, which has an unpleasant smell, is renowned for its ability to treat aches and pains – including those caused by arthritis.  It is the active ingredient in Phynova Joint and Muscle Relief Tablets, which have just been licensed by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency.

The directive also made it more difficult for medicines to get a licence as it demanded they had to have been in use for 30 years, of which at least 15 years had to be in the EU. Some Western herbal medicines have managed to gain licences in a process costing thousands of pounds to verify their ingredients. But the Phynova tablets are the first traditional Chinese medicine to be approved.

Robert Miller, chief executive of Oxford-based Phynova, said he was ‘extremely proud’, adding: ‘This has come from years of working with our Chinese colleagues. ‘Britain can now benefit from having access to high quality, regulated Chinese medicines.’ He also said that the company is planning to apply for a licence for a second traditional Chinese medicine, a cold and flu remedy.

Dr Chris Etheridge, a medical herbalist and adviser to Potter’s Herbals, celebrated the ‘good news’, adding that Sigesbeckia, which is not commonly used in the West, ‘offers an alternative to those who prefer not to take non-steroidal anti-inflammatory drugs for muscle and joint pain’.

But Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, warned that the new product demonstrates the difficulties the EU rules created for supplying herbal products safely to the public.  He said it is ‘almost impossible to satisfy the licensing conditions’.  He added that some people have therefore turned to the internet to buy unlicensed products, but this means they have ‘no idea whether they are safe or effective’.

How exciting!

Exciting enough to do a quick search for the evidence. Are there any clinical trials to show or suggest that this herbal remedy does anything other than filling the bank account of the manufacturer? Sadly, the answer seems to be NO! At least, I could not find a single such study (if anyone knows more, I’d be pleased to stand corrected).

Frustrated I looked at the website of the manufacturer. Here I found this:

Exclusively containing Sigesbeckia extract, Phynova Joint and Muscle Relief Tablets is a traditional herbal medicinal product used for the relief of backache, rheumatic, joint and muscle pain as well as minor sports injuries. Sigesbeckia has been used for thousands of years around the world to relieve painful joints and muscles.

Benefits

– Relief from joint & muscle pain
– Gentle on the stomach
– No known side effects
– No known drug indications or contraindications
– Can be taken with or without food

And this:

What can Sigesbeckia be used to treat?

Traditionally used for arthritic pain, rheumatic pain, back pain and sciatica. Today, Sigesbeckia can be used for;

Backache

Back pain can occur through a sprain or strain, spasms, nerve compression, herniated discs and other problems in your lower, middle and upper back.

Poor posture, lifting and stretching, sudden movements placing strain on your lower back and sports injuries, are amongst the main culprits for causing back pain.

Minor sports injuries

Minor sports injuries can be caused by an accident such as a fall or blow, not warming up properly before exercise, pushing yourself too hard and not using the appropriate equipment or perhaps poor technique.

Rheumatic and muscular pain

Common causes of rheumatic and muscle pain can be due to; tension and stress, lack of minerals, certain medication, dehydration, sprains and strains, sleep deficiency, too much physical activity and sometimes other underlying health conditions and diseases.

General aches and pains in muscles and joints

Overexertion due to a new exercise routine or from a sprain or strain can cause general aches and pains in muscles and joints. But so too can modern day busy life. The impact on our bodies can trigger aches and pains in your muscles and joints and lower your resistance to illness and disease.

The Benefit of Sigesbeckia extract

One of the benefits of Sigesbeckia extract, as used in approved licensed products, is that it has no known side effects or interactions with other medications according to the Summary of Product Characteristics (SmPC). Always check that the product you purchase is an approved Traditional Herbal Medicine Product in the UK.

In summary: Look after your joints and muscles with Sigesbeckia

Our bodies are all different, and our approach and tolerances will vary. Used for over a thousand years and known for its anti-inflammatory and mobility benefits alongside being used for joint and muscle pain; Sigesbeckia is a herbal medicine that works best when used over time.

Looking for a traditional remedy for joint and muscle relief? Why not try Sigesbeckia?

But again no sign of a clinical trial to back up this plethora of therapeutic claims. How can this be? The answer lies in the directive mentioned in the Mail article. To obtain a licence that enables the manufacturer to make therapeutic claims, a herbal remedy merely needs to demonstrate that it has been in use for 30 years, of which at least 15 years had to be in the EU.

I think I understand the intention of the directive. But I would nevertheless have thought that, 4 years after obtaining a license, the manufacturer could have conducted a study to test whether the product works. In my view this should be a moral and ethical, if not legal obligation. The ‘test of time’ is woefully insufficient and unreliable and no basis for generating progress or securing the best interests of patients.

Considering the total lack of efficacy and safety data, do you agree that the above comment by Michael McIntyre are ironic to the extreme? And do you agree that manufacturers who manage to obtain such a license should be obliged to deliver a proof of efficacy within a reasonable period of time?

6 Responses to The 1st Chinese herbal medicine with a UK license

  • What worries me is that the herbal committee at the EU essentially has no criteria for setting up comparison. In such a situation the use of the terminology licence, creates an expectation that there has been a process for verification. Of course, all of this is just so much blather now we are inevitably leaving the EU but – guess what, as we speak the EMA of which I have several colleagues are stepping up procedures for bilateral authentication, ie they say yes we say yes.

    time to act.

  • Is this Michael McIntyre the so called “comedian” Sounds like a joke but I have never heard him utter anything funny.

  • I note in Mr. McIntyre’s bio that he has a degree in Modern History. Clearly he has not only read but studied the history of other SCAMs and can see just how profitable they can be. Education pays off.

  • Not sure McIntyre has understood why the EU-licensing of traditional herbal remedies are problematic… As “graham”/Graham Balmforth (if the picture ia anything to go on) pointed out there is no criteria of efficacy. Personally I see this as an information problem – if you are willing to try or use a traditional herbal drug you need to understand that that is exactly what it is: no investigation of efficacy beyond “people bought it and didn’t complain or end up in hospital”! Here the other problem of misrepresentation also comes into effect – is there really an extract of Siegesbeckia used in TCM? Because what EU-licensing demand is that quality control regarding reproducible dosage ensures that there is consistancy in usage (unlike the heavily ecologically-affected traditional herbal teas).

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