Tag Archives: Traditional Herbal Registration

Agnus Castus: Agnus Castus Support – when things are too good to be true…

A friend sent me a link to this product (Agnus Castus Support) after listening to a lecture by Dr Marilyn Glenville recently.

This Agnus Castus supplement contains the most important and highest quality organic herbs which have enjoyed widespread popularity among women for centuries.

60 vegetarian capsules.

Ingredient list:

1 capsule per day provides the following amounts

Agnus castus 206mg
Black cohosh 147mg
Skull cap 88mg
Milk thistle 59mg

 

From the ingredient list I was unable to establish if the 206mg of AC was whole herb or extract – you need around 20mg standardised extract, which is equivalent to  (approximately) 200mg whole herb for it to be effective – therefore I emailed Dr Glenville.

Dear Dr Glenville,

A friend of mine sent me a link to your Agnus Castus product as she knows I am passionate about recommending this herb for PMT and blog about it regularly. However, since the EU legislation, getting the right dosage of Agnus Castus has become very difficult as THR (which most companies have applied for) restricts the amount to 4mg (standardised extract 10:1). I am therefore interested to know how the amount of AC used in your product compares to the standardised extract. From my understanding 20mg is equivalent to approx 200mg whole herb. 20mg has been found in research trials to be the lowest dose that is effective. A lot of women visit my blog looking for advice about where to get AC from and so far I have only found one supplier still producing 20mg tablets. It would be great if I recommend another supplier.

I look forward to your reply,

Two days later I received a reply that seems to suggest this product does contain the right dosage of Agnus Castus.

 

Thank you for your email.

I have always found that combinations of herbs are extremely helpful because of the synergistic effect between the herbs.  NHP’s Agnus Castus Support is not my product but it contains whole herbs and not extracts so the mgs on the label are those for the whole herb. And the herbs are organic where possible.

In the clinic, I always prefer capsules rather than tablets as tablets will have binders added to the ingredients and even with capsules for herbs or vitamins and minerals I want those that do not contain excipients such as anti-caking agents and lubricants like magnesium stearate.

I hope this is helpful.

Kind regards

Marilyn

However, the email also said that the product is not one of Dr Glenville’s, but is made and sold by this company NHP. I went over to the NHP site and found the product, but I couldn’t confirm if the ingredients quoted on Dr Glenville’s site were what was in the tablets.  Luckily they had a Live chat box – so I asked the question there.

NHP: Hello, thank you for visiting. Can I help you in any way?

Me: can you tell me the mg of each herb in this supplement please

NHP: Hi there

Me: Hi, can you tell me the mg for each herb in this supplement

NHP: if you click on the ingredients list under the image it will tell you

Me: I can’t see an ingredients list. it doesn’t have one.other products do, but not this one

are you still there NHP?

NHP: my apologies, bear with me and I will find them for you

Me: thank you

Based on my previous experience, I couldn’t help but be suspicious. Neither Boots or Holland & Barrett informed either their sales staff or customers that the dosage of Agnus Castus had been reduced from 20mg to 4mg. However, NHP came back with the same list of ingredients as on Dr Glenville’s site (and I had already confirmed the Agnus Castus component was whole herb and therefore at the right dosage).  It was looking good, but I still wanted to confirm beyond doubt the ingredients as stated were the ones on the bottle, so I asked this question.

Me: One final question. The ingredient list you quoted did you get that from the actual bottle? I am concerned you are quoting the pre 2011 ones and the mg have been reduced as a result of legislation.

NHP: The ingredients I gave you are correct. i have passed this onto our in house nutritionist and have asked her to come back to you tomorrow. The office is now closed, I will ask the nutritionist to email you tomorrow with regards to your query

Me: Then it sounds like a really promising product. I have around 6000 hits a month on my blog for women looking for a product with the correct dosage. It would be great if I could recommend this product as so far I have only found one supplier who still sells the higher dosage.

NHP: no problem, lets speak tomorrow

Me: Great, I look forward to it. I will be posting our conversation on my blog so other women can see what your product contains.

So far my suspicions had appeared unfounded. I was getting excited. Here at last was another product, which contained levels of herbs that actually worked. However, I wondered how they were able to do this since the EU legislation. Unfortunately the person on the other end was not able to give this information and admitted they didn’t know they THR from their PL.

Me: the reason I ask is since EU legislation in 2011 I was under the impression that Agnus Castus was restricted to no more than 4mg (52mg whole herb) under THR. Does this product have a product license instead?

If not how are you able to sell it? Is it old stock? I and many women are desperate to get supplements at the right dosage and forgive my questions but I have yet to find a UK supplier who is able to do this as they have all opted for THR not PL>

NHP: all of our products have been approved by the HMRA

we did have to withdrawer our Black Cohosh Support for a while but we have now reformulated it. We have not been asked to withdraw our Agnus Castus

Me: I am sure they are. I am not questioning your integrity, rather than am keen to know if I can recommend your supplement on my blog. I need to be sure the agnus castus component is correct. Does this product have THR or PL?

NHP: no problem, maybe if you contact me directly I can give you some more info (email address removed on NHP’s request)

I am not familiar with THR or PL, I can ask somebody to come back to you if you email me directly with your enquiry.

Fair enough. I wouldn’t expect sales staff to know the ins and outs of EU legislative policy, but then they said this …

NHP: I would rather you did not post our conversation on your blog, please wait to hear back from the nutritionist

Me: Now I am wondering why not, if the ingredients you stated are the ones listed on the product. I am not trying to catch you out, rather i am trying to share information with women on where they can get this product from at the dosage recommended in research trials

NHP: we regard any conversations we have on Chat Box as confidential due to the highly personal issues people discuss with us on here.

Me: I won’t use your name then, or show your email. That should cover confidentiality. Me, I am not concerned, I have blogged about my ongoing battles to get Agnus castus and other herbs properly recognised ever since 2011.

SILENCE

Me: Thanks for the chat. I look forward to hearing from the nutritionist tomorrow. Can also ask that you reinstate the ingredient list under the product so it is clear how much of each herb the product contains. If it is less than quoted this does need to be made clear as research trials have shown for agnus castus that below 200mg whole herb it is not effective and I don’t want women buying something that doesn’t work.

SILENCE

Me: Have you gone?

Make of it what you will. However, I would be cautious about buying this product until the ingredients can be confirmed. I am also wondering why they did not want me to share this information on my blog, surely as a profit making company they would want to shout about this product. I am also interested to learn why they have not listed the ingredients under this product, as they do for their other products.

 

So let’s see what tomorrow brings… ever hopeful…

If anyone has tried or plans to try this product, I would love to know whether it helped with symptoms.

 

 

 

Agnus Castus: Holland & Barrett an ethical company?

I had a disturbing insight into the tactics of the big herbal suppliers when a homeopath called Maeve, who used to work at Holland & Barrett, commented on my blog recently (see the comments under ‘About’ for the full conversation). In our correspondence I asked her if the sales staff were informed about the massive reduction in dosage of Agnus Castus tablets forced onto the herbal industry by 2011 legislation – see this post and this one for more on the impact of these changes.

Maeve replied:

“I can honestly say that they [Holland & Barrett] never sent through a training update or any info on the new doses, there was never any explanation, this has most likely left staff floundering, forcing them to tell customers that they are equivalent to the same levels as the whole herb.”

This is shocking. If the change in dosage was minimal then you might forgive H&B for not informing the sales staff, but the dosage was reduced from the equivalent standardised extract of 20mg to 4mg (1/5 of the original dose). If your GP prescribed you a drug at a dosage five times lower than you had used before (and your health was damaged as result), this would constitute gross negligence. But it appears Holland & Barrett, Healthspan, Boots and so on can do this to a herbal remedy with no explanation to the customer nor a legal imperative to provide one.

Taking Agnus Castus at the correct dosage is vital for my continued well-being. Prior to taking it I was prescribed morphine for period pains and routinely missed 2 to 3 days a month of work. I was depressed and desperate and even contemplated a total hysterectomy at the age of 35 (which, without taking a hormone replacement, would have brought on early menopause and the risks to bone density as well as an assault on my sexuality and identity). Thankfully, I have reached 43 with my ovaries and womb intact and take nothing stronger than ibuprofen for period pain.

As it is Agnus Castus is not on the list of prescribable drugs for PMT despite being recommended by Dr Nick Panay, Consultant Obstetrician and trustee for NAPS (see this post for more on guidelines to GP’s). This means many women are being prescribed antidepressants with their long list of side effects (e.g. loss of libido), when trials for Agnus Castus reveal it is at least as effective if not more so (with none of the side effects). On top of this inability to prescribe the herb, Agnus Castus is rendered ineffective by draconian and frankly bizarre licensing decisions by the European Medicines Agency – see this document for the responses to consultation prior to licensing.  Even if women do their research and buy Agnus Castus on the UK high street, they will believe it be a con when they find their symptoms do not improve (RCT’s reveal that 20mg is the optimal dose – see this study). Because of the prohibitive costs of obtaining a product licence for Agnus Castus (£100,000 approx), retailers have opted for the cheaper Traditional Herbal Registration option (£10,000 approx), restricting dosage to no more than 4mg per tablet with the corresponding advice to take 1-2 tablets a day with a warning not to exceed the stated dose. I am not one to buy into conspiracy theories, but you only have to read this post on ‘Sarafem’ (Prozac in disguise) to realise big pharmaceutical companies will do anything to ensure their drugs are sold as widely as possible, including eliminating the competition.

As Maeve comments:

“This erosion of choice will have a serious impact for the next generation. The goal of all this is to create a complementary health free world, free of herbalists and homeopaths and all natural practitioners to be ruled and dominated by the Pharmaceutical drug lords. Sounds like fantasy- it is happening now. In the next 10-20 years, we’ll either need to learn the old ways and grow our own herbs or forget they existed entirely.”

With recent news about doctors in the US receiving ‘perks’ from drug companies in ‘return’ for prescribing a particular drug, the world Maeve predicts doesn’t seem that far-fetched. She is right, it is happening now. We are already forgetting remedies our grandparents routinely used and believe everything can be solved by a pill, from acne and addiction to schizophrenia and weight loss.

Take statins and cure dying!

Of course it is not just Big Pharma that is corrupt, it is capitalism itself. Profits for the few at the expense of the majority is bound to result in the blurring of ethics, or, as this satirised advert makes plain, absence of ethics altogether. Holland & Barrett are no worse than the majority of high street chains that ‘claim’ to put their customers first and as Maeve points out not everyone at H&B is corrupt (just the ones at the top it seems).

“I joined H&B hoping they were an ethical company. I left a year later deeply disillusioned and disappointed. I know there to be a lot of good people in H&B but there is a constant tug of war going on and unfortunately, the sales force is stronger than the integrity force. H&B are not investors in people. Having said that. It is still possible to find good products in an H&B along with lovely, knowledgeable staff if you know what you’re looking for.”

In my quest to make women aware of the incredible benefits of Agnus Castus I have been confronted with the selfish, self-interested nature of capitalism. Curing a distressing condition is only worthwhile if it makes a lot of money for a niche few. The dystopian future of Atwood’s trilogy (Oryx & Crake, The Year of the Flood, and MaddAddam) where pharmaceutical corporations manufacture diseases in order to sell drugs to cure them, seems less like speculative fiction and more an inevitable reality.

So what can us little people do? (I am only 5ft 2 so this is a literal statement for me 🙂  We can keep sharing knowledge of herbs and vitamins, passing this information onto the next generation so it is not lost and we are not beholden to big Pharma to ‘solve’ all our health problems (when nature has already provided us with solutions). We can seek out like minded others and support campaigns such as this one or write to our MEP’s  – see this post for template – but don’t expect a reply. We can do our own research on the web; I find this blog gives a refreshing perspective on modern medicine, although I don’t always agree with every view it espouses, it has certainly made me question in whose interests am I being ‘sold’ a particular cure. I also find medical journalist Jerome Burne’s blog an insightful and at times shocking read. We can also, where our climate is favourable, grow our own herbs and learn how to harness their properties. There are many books and internet guides out there to help you achieve this.

“Herb users are going to have to learn the old and safe ways of using safe, medicinal herbs if they don’t want to be a captive consumer audience 🙂 ” Maeve

I, for one, will keep blogging about it and plan to grow my very own Agnus Castus bush. Join me. Please. Let’s start a backyard revolution!

Agnus Castus: News about dosage and where to get 20mg tablets

agnus castus flowerFirst off, the good news. I spoke to Peter from Prime Health Direct this week as a number of women had ordered the 20mg tablets (including me) but not received the order. He apologised for the delay and then explained they had sold out (I think this blog might have something to do with that), but he assured me the new stock was almost ready (bar the packaging) and he would be fulfilling the back orders next week. HURRAY!!

Secondly, I finally received a reply from Holland Barrett, explaining their new dosage and why despite a reduction in amount of herb per tablet the price remained the same (posted in full below). Make of it what you will – however, the assertion that they never sold it a higher dosage is clearly nonsense as illustrated by this comment I received today.

“Thank you for this info. I was taking old stock high strength Agnus Castus capsules (1 per day) from Holland and Barrett about a year ago and felt my PMS improve, but then I couldn’t buy them anymore. I struggled to take 4 capsules a day with their new stock and felt rubbish only taking 2, and now I know why!” EM

Dear Juliet,
Thank you for your enquiry relating to your concerns over the new THR licensed H&B Agnus Castus product. I am sorry for the length of time it has taken to obtain answers to your questions and am grateful for your patience.

Some agnus castus product used in research studies have used a 20mg strength agnus castus formulation. The new THR licensed H&B Agnus Castus product will provide a 3.9mg strength agnus catsus extract. This is a highly concentrated extract which in fact equates to 24.4 – 31.2mg of agnus castus fruit and so will be in line with the amount of agnus castus used in research studies and the level based on traditional use.

In regards to issues of a comparison to a product that we used to sell that contained a 20mg strength extract I am unsure which product are referring to. Holland and Barrett have never sold a 20mg strength agnus catus extract and the current Good and Natural products contain agnus castus in a standard strength whole herb form and not an extract. Any price comparison is therefore dubious coupled with the fact the new THR licensed H&B Agnus Castus product has not been released for sale yet and will not be so until July this year. If making a price comparison between the current Good and Natural product (which provides agnus castus in a standard strength, whole herb form and not in an extract form) and the new THR licensed H&B Agnus Castus product, the new product will indeed be more expensive. This is due to increased manufacturing costs and quality testing for the new THR licensed products and also due to the cost associated with gaining a THR license for a herb.

Finally, the new product will have the following information stated on the packaging in regards to the indication for the product as follows:-

…to help relieve symptoms associated with premenstrual syndrome such as irritability, mood swings, breast tenderness, bloating and menstrual cramps. This is based on traditional use only.

The dose used is consistent with traditional use and would be therefore be expected to provide good benefits for many customers. This effect would be comparable to the Good and Natural product which contains agnus castus in different form to the new H&B product, i.e. in a standard strength, whole herb form rather than in an extract and so there would not be expected to a significant change in the management of symptoms. This is a key difference which must be accounted for when comparing the two products.

Please do not hesitate to contact me again if you have any further questions.

Kind regards,

Alexander Thompson, BSc (Hons)

Nutritionist
Customer Services Team
NBTY Europe
The home of Holland & Barrett, GNC, Nature’s Way and De Tuinen.

Agnus Castus and PMS: Don’t buy it from Boots or Holland & Barrett if you actually want it to work

agnus castus flowerDear Juliet,

I ended up on your blog  while looking for information about agnus castus and PMS.

A few months ago a counsellor asked me whether the episodes of anger or low self worth were happening at any particular time. For the first time in more than 10 years of counselling, therapy, CBT etc I realised that there might be a connection between me feeling like not me and PMS. I started looking into it and a set of completely new ideas opened in front of me. First, is the idea that the emotional pain I carry with me could actually be triggered from something different than my mind. Second is the idea that there are remedies.

It is so great to receive an email like that, however, the writer of the email is finding it difficult to get the correct dosage of Agnus Castus and more importantly ascertain what the correct dosage is, as each supplier seems to calculate the active ingredients completely differently.

For example:

Nature’s Best sell 100mg tablets, equivalent to 100omg of fruit, ratio 10:1 (this old stock*).

Prime Health, advertise (although you can’t actually purchase it) 20mg standardised extract tablets, equivalent to 24omg dried fruit, ration 12:1. This is the dosage described in the clinical data, and the only one I understand.

Herbs sell Agnus Castus Tincture 1ml equivalent to 500mg, ratio 1:2 (again this is advertised as old stock.*)  This is the response I received to information on dosage. “Our dose equivalence is 1ml (ie 10 drops) to 500mg of dried herb.  So to get close to your current tablet equivalence you would take 0.4ml or 0.5ml (4 or 5 drops) three times a day.” (remember this is old stock, so you would have to take 5 times that, once new stock carries the THR logo.)

*The reason these companies are pointing out they are selling old stock is because the new regulations of herbal medicines has restricted the amount of active ingredient per tablet/ ml. What that means is the recommended dosage is no longer based on data from clinical trials, but rather is based on the restrictions of selling herbal remedies under the Traditional Herbal Registration license (THR).

In short, up until 2011 herbal medicines were unlicensed (meaning dosage was not restricted). Since 2011 all suppliers of herbal remedies must apply for a license. In the case of Agnus Castus there are two sorts of licenses. The Traditional Herbal Registration (THR), which restricts dosage to 4mg per tablet, or the Marketing Authorization (MA), which would allow dosage of 20mg (based on Well Established Use). The information on dosage allowed under each type of license can be found in the EMA Community Monograph, which is the document to which member states should refer to when deciding on whether to an issue a license or not.

Unfortunately, most high street and online stores have applied and been granted a Traditional Herbal Registration (THR), which means they can’t sell any Agnus Castus with a dosage higher than 4mg.

If it has this logo, then the dosage can be no more than 4mg per tablet.
If it has this logo, then the dosage can be no more than 4mg per tablet.

So where you see the THR symbol on herbal remedies, it is a guarantee the dosage will be too low to have an effect. This means products from Boots, Kira and Holland & Barrett are not worth buying (unless you’re can afford and are prepared to take 5 tablets each day.) They are selling 4mg tablets at the same price they used to sell 2omg tablets.

Why has the EMA interfered? I hear you ask.

It seems there is a grave fear in Europe that herbal medicines are dangerous and in particular they interact with prescribed drugs leading to undesirable effects. To protect the (silly) public all herbs must have a license in order to be sold. THR license is based on traditional use for thirty years, and doesn’t require rigorous clinical trials to be granted (even though there are rigorous clinical trials accepted by the EMA for Agnus Castus).  Because of the lower requirements for THR, that means the dosage is set at a level where it is unlikely to have any effect (adverse of therapeutic). Which makes you wonder why Boots would bother selling the products at all (I have emailed Boots this very question and will post their response). They are in fact cheating their customers, by implying the drug will work at the lower dosage, despite overwhelming clinical evidence to the contrary.

So where can you get the correct dosage of Agnus Castus from?

1) Not from any supplier who has a THR license. If it’s got the THR logo, then it is going to be too low to be effective. You will need 5 times the dosage suggested. Products from Boots, Holland & Barrett, Healthspan, Kira all carry the THR logo.

2) Some companies are still selling old stock, this is likely to be at higher dosage. If it doesn’t have the THR logo it is likely to be old stock. Nature’s Best, mentioned above, wrote to me about their dosage, and the problems they are experiencing in restocking:

“The Natures Best Vitex Agnus Castus currently provides 100mg of Vitex Agnus Castus fruit extract at a one a day dose.  This is a 10:1 extract which means the starting material is 1000mg (dried fruit).  Vitex contains the flavonoid casticin and we ensure that that our extract contains not less than 0.4% casticin per tablet which is an excellent marker of potency. At the time of formulating this herb we did review all of the data referring to tincture, traditional use and extracts that were available.  This was launched 14 years ago and we have received excellent feed-back from
customer who have used it.

In April 2011 the status of this herb changed from food supplement to medicine.  We have applied for a medicinal licence but we are struggling to get the potency to match our current product.  Nothing has been finalised yet and once we sell through our stock of food supplements, we will have to wait for our licensed product to become available.   We are close (weeks away) from running out and although this may appear like a hard sell, I am really only telling you so you have the choice.”

3) If the product has a PL code (product license required for all medicines), which means the supplier has obtained Marketing Authorisation. Although I have not as yet found any supplier that has got an MA, I do have an email from one, who is attempting to get this (and will give you their details as soon as I can). I have also emailed the MRHA (UK regulatory body for medicines) to ask them if they have a list of suppliers who have applied for the Market Authorisation. I await their reply.

4) Finding a supplier outside of the EU (possibly US or Canada).

I wish the news was better, but the EU regulations have, in effect, decimated the herbal medicines industry, rendering the herbs ineffective, by restricting dosage to levels too low to be effective (this hasn’t just affected Agnus Castus). For more on the herbal industry’s take on the regulations, click here.

Something is very wrong here. You have to wonder who really benefits from these regulations (the public or the drug companies), because as one herbal company, who emailed me this morning said:

“The pharmacists at the MHRA will have their way with regard to recommended doses, their is nothing that can be done to prevent that. As you cannot patent a herb, it is highly unlikely a company would go to the expense of trials to justify market authorisation. So it is most likely once current stocks are are sold through and the MHRA has attacked the sale of agnus castus food supplements that agnus castus will only be sold at very low doses.”

Link to fees for Market Authorisation and Traditional Herbal Registration.

The main medical treatments offered for PMT are anti-depressants and hormonal treatments (with the well documented side effects), despite the overwhelming evidence that Agnus Castus works (with minimal side effects). Doctors cannot prescribe Agnus Castus in the UK because it is not listed in the BNF (the British National Formulary).

All I want is somewhere I can buy the correct dose of Agnus Castus and continue to be free of the debilitating PMT I suffered for years under the ‘care’ of a gynaecologist. Is that too much to ask?

If anyone else finds old stock of Agnus Castus, post a link here. Or if you find a supplier that has a PL code, please let us know.