Tag Archives: agnus castus 20mg standardised extract

Agnus Castus: HELP! Where can I get it from?

I have a lot of women send me links to Agnus Castus products and ask if they are at the right dosage. It is very difficult for me to judge because they doesn’t seem to be a standard way of reporting this. Some labels talk about extracts and others talk about accubins, others whole herb.

My advice is always the same however.

1) Contact the company and ask them how their Agnus Castus compares to the 20mg standardised extract used in clinical trials. If they don’t bother to reply, then don’t bother to buy.

2) Be wary of wild claims about potency. You only need 20mg standardised extract (200mg approx whole fruit). PURECLINICA, for example, claims the most potent dose on the internet,  however I have emailed them three times asking them to explain their dosage simply and clearly in relation to the standardised extract. They have never replied.

3) Avoid products that have Traditional Herbal Registration THR logo as they will be restricted to 4mg per tablet. Boots and Holland & Barrett have, but be wary of any high street product. On the internet HealthSpan are also only selling 4mg tablets.

So where can you buy Agnus Castus from at a dose that will be effective? Unfortunately the choice is limited. Prime Health Agnus Castus

Prime Health Direct sell 20mg tablets for £11.95 (180 tablets). I have taken these for a number of years and found them to be effective. They are competitively priced, but often they run out of stock, so can be unreliable.

ACsupportNatural Health Practice sell a food supplement of the whole herb (in capsule) 200mg called Agnus Castus Support. I have been taking these for just over 2 months and found them to be equally effective. They cost £19.97 (60 capsules). They are more expensive than Prime Health Direct, but they do contain black cohosh, skull cap and milk thistle. I also like the packaging and how you can actually smell the herb in the capsule – but in terms of effect I haven’t noticed a major difference between them and Prime Health Direct, although my last two cycles have been longer, 28 days rather than 24 – (but then I have also had some major changes in my life recently, which may also be the reason).

A. Vogel Tincture: I haven’t tried this, but others report success. The dosage does seems to be lower –A vogel

20 drops of A.Vogel Agnus castus tincture contains 54.2mg of dried fruit, or 542mg of extract (which is the fruit once it’s been macerated in a water/alcohol mix and extracted). So if you take a daily dose of 40 drops you get 108mg of dried fruit or 1,084mg of extract.

– but it is certainly an alternative to tablets/ capsules. The product has a lot of positive reviews.

All three companies I have linked to above spent time answering my questions and were more than happy to talk about their product and what the dosage actually means.

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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: Tincture – another option?

I recently received an email from Alison Cullen a Nutritional Therapist who works for A.Vogel. She recommends the tincture as an effective way to achieve relief from PMT. I have often thought about trying tincture, but find the dosage (drops) unfathomable when compared to the standardised extract used in trials.

Alison has helpfully provided an explanation, which actually makes sense:

20 drops of A.Vogel Agnus castus tincture contains 54.2mg of dried fruit, or 542mg of extract (which is the fruit once it’s been macerated in a water/alcohol mix and extracted). So if you take a daily dose of 40 drops you get 108mg of dried fruit or 1,084mg of extract.

We make our own tinctures, so we can answer any queries as to the process, should they arise.

On the packaging of the licensed product (which hasn’t come out yet – licence came through last week), the SPC of which I attach, the strength is given as 895mg of extract in 33 drops, which is just a ratio of the figure for 20 or 40 drops. The MHRA make us put it this way because they require the strength to be equivalent to the amount in 1ml, and for our Agnus castus tincture this is 33 drops.

Now from my research, based on trials, 20mg or 200mg dried fruit is the dose that has found to be most effective, however, I also accept that the tincture may work differently from tablets (possibly absorbed more easily?) The reviews from the A.Vogel site do seem to endorse Alison’s claim that this dosage is effective, even though it is around 40% lower than the recommended.

More importantly, for the practitioners who use this product, myself included, and the women who take them, this is the dose that we find to work! I started using the A.Vogel range because of the tincture format, which is very easily absorbed, and now work with the company partly because I like their products so much and appreciate their methods and principles, but mostly because they work. The range was made by a practitioner, Alfred Vogel, so it is pretty practical.

I have always been uncomfortable with the fact that I can only recommend one supplier. So with the dosage explained the tincture is a viable alternative and may suit some women better. However, price-wise, the tincture is £9.15 for around one month of herb, whereas Prime Health tablets are £11.75 for six months.

I am not endorsing either product and I receive no perks or payment from either company, but I do want women who visit this blog to have options. So now we have at least two choices of where to buy and I am still planning on growing my own (once a house move is sorted).

Anyone else found a supply of Agnus Castus in the UK that works for them?

Do share and do please keep telling other women, doctors, consultants and anyone that will listen about Agnus Castus. As Alison points out the new restrictions imposed by legislation are already making some herbs unavailable and with it the knowledge of them.

I was reading about the difficulty of finding a suitable Agnus castus product on your blog, and your position is very much reflected by women who are contacting us currently, searching for a product they can take with some degree of confidence.

The problem has occurred previously with Black Cohosh, no worthwhile dose of which now exists on the market, sad to say.

The news for Agnus castus is slightly better, because it is part of the A.Vogel range and we have managed to avoid losing it (as we did Black Cohosh) and even get a licence, without having to compromise on the dose. We have the same dose on our (very newly) licensed product as we had previous to the licence, which is a relief, as it is a dose that I have found to work very well in my clinic.

How can it be progress when future generations of women will have no knowledge that the answer to their health lies in their hands and the natural world around them. That is why I am also urging Dr Nick Panay, Consultant Gynaecologist, to get a trial up and running on AC so that it can become a prescribable treatment for PMT. See this post and if you feel so compelled drop Dr Nick an email or letter in support of his attempts to obtain funding for a trial.

If we can get one herb on the recommended list for GP’s then it could open the floodgates for others. When I visit my doctor I want to be recommended the best treatment for me (be that a herb or a lab produced drug), rather than the best drug (in terms of profit) for the Pharmaceutical industry.

Help me. I can’t do this alone 🙂

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 and the Healthspan review they won’t publish

I had an email from a lady who was looking for Agnus Castus 20mg tablets. I explained to her that you can no longer get them due to the EU legislation restricting dosage to 4mg under Traditional Herbal Registration (THR). She replied she could see 20mg tablets on the Healthspan website, which surprised me as the reason I stopped ordering from them is because they chose to apply for the THR, rather than the costlier Product License, which would have enabled them to continue to sell the 20mg tablets. I briefly thought they’d had a change of heart and were no longer deceiving their customers (all the clinical evidence makes it very clear the effective dosage is 20mg). I asked her to send me the link to the page, which she duly did and yes it was an advert for 20mg tablets, but my joy was short-lived as it soon became clear the page was an old one and that there was link to take you to the current Agnus Castus product at a much reduced dosage.

What Healthspan used to sell

healthspan

What they sell now

healthspan2

However, the whole thing got me riled up again because Healthspan along with Boots, Holland and Barrett etc reduced the dosage to a fifth of what it used to be without informing their customers. Did they really think customers wouldn’t notice? And if they did what does that say about their belief in the product and its ‘claimed’ benefits? Who cares as long as the schmucks buy it, perhaps? 

Saddened that women ordering from Healthspan would think AC was ineffective and end up turning to more drastic treatments e.g. antidepressants, I decided to post a review. There were already a couple of reviews on there, which remarked on the fact the tablets were no longer effective, so I hoped my review would add a little context as to why the dosage had changed.

As I suspected, the review remains blocked (forever as far as I can tell) – so here it is below:

Overall Rating:1

Product Quality:1

Value for Money:1

Ordering/Service:0

HealthSpan have reduced the active ingredient from 20mg to 4mg in line with legislation. Under Traditional Herbal Registration 4mg is the maximum dosage, despite clinical evidence that 20mg needs to be taken to gain relief. They are unfortunately bound by the THR, but they could have applied for a product license, which would have allowed them to sell 20mg tablets. However the cost of a product license is ten times higher than the THR, and profits on herbal medicines are nowhere near that of patented drugs (whose manufacturers do apply and pay for product licenses). HealthSpan could possibly have been trailblazers and gathered other herbal manufactures together to get the trial data needed for a product license (sharing the cost and putting the customer first), but they haven’t. If you buy these tablets, you will need to take five a day, if you want them to work. A small ray of hope: Dr Nick Panay, Consultant Gynaecologist, Queen Charlotte’s & Chelsea and Chelsea & Westminster Hospitals, has promised to look into running a trial so that Agnus Castus can be prescribed by GP’s – that would be incredible and give weight to the guidelines he produced for GP’s recommending Agnus Castus.

However, although they blocked my review they did send me an email:

Dear Mrs O’Callaghan

Thank you for your recent enquiry regarding our products.

Firstly, we must inform you that we are not medically trained at Healthspan. Please check compatibility with your GP or Pharmacist if you are taking any prescription medication.

We can confirm the new THR products are manufactured according to evidence of traditional use from over 30 years including 15 years in Europe. The dosage, nutritional information and recommended daily intakes are all based on this accumulation of evidence.

The dose from the previous product was based on a combination of clinical trials and recommendations from our panel of experts. However now this extract has to be licensed by law we are required to adhere to the MHRA recommendations.

We have also noted your comments in your feedback and have forwarded these onto our Product Development Team.

We hope this information is of help to you and if you have any further questions please contact us.

Kind regards

Nicola Butler

Product Information Specialist

Healthspan Ltd

What I find ridiculous about their response is the fact they freely admit that when they sold 20mg tablets they did so because of sound clinical data:

The dose from the previous product was based on a combination of clinical trials and recommendations from our panel of experts

And that the 4mg dose they now sell is ONLY backed up by traditional use i.e. anecdotal evidence.

Forgive me if I sound a little peeved, but clinical data is the gold standard, so what Healthspan are admitting to is taking a backward step and selling Agnus Castus based on a poorer evidence base than they used to. On top of that they are going to charge the same amount for one 1/5 of the dose.

If they have taken that approach to Agnus Castus then you have to question whether any of the herbs they sell are actually going to be effective?

What I would love is for others to post reviews for Agnus Castus on Healthspan, questioning the effectiveness of the dosage (and why Healthspan did not flag up this massive reduction). If they won’t publish them, then come here and post it in the comments section. Maybe if they think their profits will be hurt, they may actually do something about making Agnus Castus available at the dosage they used to sell it at. Yes it will cost them, and yes the price may have to rise, but I don’t believe it will be as expensive as taking 5 TABLETS a day, which is the current option.

HEALTHSPAN are treating us like fools – are we going to let them?

Agnus Castus: Why this little blog actually matters

Another woman has taken the time to come onto this blog and endorse Agnus Castus. It reminds me that I might only be one individual and this blog occupies a teeny space in the vast blogosphere, but it does make a difference.

Hi Juliet,

I bought Agnus Castus 400mg from Holland and Barrett. I took five capsules a day at quite an expense. However i must say the first month the only difference I noticed I had no sweats at night and no breast tenderness. This was amazing. By month 2 my period came a week early I had no sweats, breast tenderness, mood swings and flow was a lot lighter. Most importantly for me I had no pain at all and period ended on day 5 rather than a week. AMAZING! It seems to definitely shorten the 28 day cycle by a week. But who cares. Unfortunately I ran out and forgot to restock. I did pay the price. Pain was horrendous. I will not make that mistake again. My advice to any women give this herb time to work its magic as it has for me. Thank You Juliet, I have told all the women I know including my doctor about you and this little miracle.

Rosemarie

Agnus Castus: Thank you Dr Nick Panay

NAPS guidelines for GP's
NAPS guidelines for GP’s

I wrote again to Dr Nick Panay last week, Consultant Gynaecologist, Queen Charlotte’s & Chelsea and Chelsea & Westminster Hospitals. I was following up on his promise to raise the issue of why Agnus Castus was not prescribable by GP’s, at the next NAPS (National Association Premenstrual Syndrome) trustees meeting. Dr Panay has developed guidelines for GP’s on how to treat PMS, and one of his recommendations is for women to try 20mg – 40mg of Agnus Castus, if diet and exercises changes do not improve the symptoms (see above). The problem is since changes to the status of herbal remedies from food supplements to medicines, the dose of Agnus Castus can be no more than 4mg per tablet, with the recommended dose of 8mg – to understand why, see this previous blog post and this one and this one and this one.

Dear Juliet

We discussed this at our last trustees meeting.

We are in full agreement with you that Agnus Castus should be prescribable.

However, this would require registration studies and to our knowledge no company would be able/prepared to conduct these at present.

In the meantime NAPS will continue to support the recognition of this product as an effective evidence based therapy for PMS.

I have copied this email to our CEO for information.

Best wishes

Nick Panay

I was really pleased to hear Dr Panay once again endorse Agnus Castus as an effective therapy for PMS. I know this, of course. My life has been transformed by taking one 20mg tablet a day. But I felt NAPS could do more. Below is my rather impertinent reply and Dr Panay’s gracious response:

Dear Dr Panay,

Thank you for your response, although it saddens me that the NHS can’t find a way to fund the research needed, considering the savings it is likely to make if AC was offered by GP’s. I know I placed a lot of cost on the NHS with repeated GP visits, various hormonal treatments, consultant referral, scans, more treatments – I have not visited my GP for PMT symptoms in over 5 years since taking AC. Based on my blog I am not unique in this.

What I struggle to understand is why the RCT studies already conducted in Germany and China are not sufficient evidence for AC to be prescribable in the UK as it is in Germany. I know the China study was rejected by the EMA as it did not contain European participants – although the reason for this exclusion escapes me.

Could you tell me what registration studies? I assume RCT’s – but how many, on what sample size.

I also struggle to understand why a commercial company must fund them when there is new NHS research fund: Increasing research and innovation in health and social care, just being set up that academic researchers could access. Surely this would be something NAPS could consider applying to – I would certainly get involved in any way I can.

I feel strongly that NAPS could take a lead in this and with your authority engage hospital departments to trial AC as part of an RCT.

Possibly I am being naive, but your guidelines should be more than guidelines, they should be the standard by which GP’s assess and manage women coping with PMT. It would have saved me a lot of pain, side effects, time off work and NHS money if my GP had followed them (and been able to prescribe Agnus Castus).

I hope you will consider how to move this simple (if not fraught with complexity) issue forward. Agnus Castus works for many women and they should be able to get access to it. I understand that pharmaceutical companies need to make money, but health and the solutions to health concerns should not rest solely in the hands of commercial interests.

Yours faithfully,

Juliet O’Callaghan

We share your frustration Juliet.

What is required is a European study with around 100 patients, minimum of 3 months to assess symptoms and one year to assess risks and benefits; this would be the gold standard. We will see what we can do about raising funds for such a project … the funds do not necessarily need to come from the pharmaceutical industry but grant money is not easy to come by.

In the meantime, we are working with the International Society for Premenstrual Disorders and the RCOG to make our guidelines the benchmark by which all health physicians manage PMS.

We look forward to your ongoing support.

Best wishes

Nick

What a brilliant response! Dr Panay is looking into how to raise funds for registration studies. If Agnus Castus were prescribable it could pave the way for other herbal remedies, which, since the change in legislation, have been ‘downgraded’ with the dosage in most cases below effective levels.

Thank you Dr Nick Panay. If you can make this happen, then I know many, many women will benefit.

Please add a message of support and encouragement to Dr Nick Panay in the comments below. It can only help.

Antipsychotics: firmly on the wall of shame for quackery and woo.

This is so worrying and mirrors my experience with treatment for PMT. Not once did any doctor suggest I try Agnus Castus, but they were willing to give me anti-depressants.

 Body of Evidence

Quackery and woo are among the favourite insults directed at anyone who practices most forms of CAM (Complementary and Alternative Medicine) – and especially those who use of homeopathy, herbs or vitamins – by staunch and vocal supporters of evidence based medicine.

 However a feature in the Daily Mail today describes a class of drugs that are  being offered to millions with everyday emotional problems, which seems to fulfil all the requirements for a diagnosis of quackery and woo.

In explaining why they attack CAM, anti-quackery hunters claim that they are protecting consumers. Despite its apparent harmlessness, they say, CAM can be deadly for three reasons. Firstly there is no good evidence – properly conducted randomised trials – that any of it works.

Secondly even if the treatment is relatively harmless, by fooling sick and vulnerable people into using them, practitioners are keeping them away from real and effective…

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Agnus Castus, Prozac and Sarafem: Corporate deception by any other name would be called bare-faced lying

Watching that advert, you would think that Eli Lilly had discovered a brand new drug to treat the more distressing symptoms of PMT.

You would be wrong. SARAFEM is in fact PROZAC (fluoxetine hydrochloride), renamed and repackaged to appeal to a new market of users in the US – women suffering from PMT (also repackaged as Pre-Menstrual Dysmorphic Disorder , which gives it a status as an illness and therefore can be targeted by drug companies).

“To return to the history of PMDD, some feminist professionals, including the APA’s Committee on Women and the National Coalition for Women’s Mental Health, objected to the inclusion of such a syndrome under any label. From their point of view, menstruation is a normal bodily function, and any psychological changes associated with this function should be seen as normal as well. Classifying PMS or PMDD as a mental disorder stigmatizes women, and may have other undesirable social consequences by laying additional foundations for disability claims and the insanity defense.” Click here for source.

 All Eli Lilly did was run a trial on PROZAC with women suffering from PMT. Based on this trial, where they found 60% of women reported a reduction in some symptoms, they were able to gain FDA approval for SARAFEM (Prozac put inside pink and lilac capsules).

The fact that trials on Agnus Castus (with minimal if no side effects) reports an 80% reduction in most symptoms of PMT is neither here nor there. Herbal stockists do not have the marketing budgets available to them that profit hungry Pharma companies do. And of course since 2011, in Europe at least, the dosage of Agnus Castus is restricted to 4mg per tablet, rendering them ineffective if taken as directed on the bottle.

20mg is needed to gain relief, supported by a number of trials, all of which were rejected by the European Medicines Agency – and you have to ask yourself why?  Look up Schellenberg 2001 and 2011 for trials – or see previous blog posts on agnus castus.

But why did Eli Lilly do this? Funnily enough in 2000 the patent on PROZAC was coming to an end. FDA approval of SARAFEM specifically for the treatment of PMDD, meant the patent could be extended until 2007. Eli Lilly also sold the rights to Sarafem for £187 million to NI drug company Galen in 2002, they also made profits in excess of £300 million in the first year of Sarafem’s launch in 2001.

Galen Holdings Plc, Northern Ireland’s largest drugmaker, will pay $295 million for Eli Lilly & Co.’s Sarafem, a treatment for a severe form of premenstrual syndrome…  Although cheap copycat versions of Prozac are available, Sarafem is protected from generics until 2007, King said in an interview. Sarafem is prescribed by gynecologists, who are less likely to use generic Prozac instead, analysts said. “Generic erosion, which is illegal, is thought to be modest, and underlying prescriptions are growing,” Merrill Lynch analyst James Culverwell said in a note to clients. “Sarafem fits well with Galen, as over half of Sarafem prescriptions are made by obstetrician-gynecologists, where Galen has a specialist sales force.” click here for source.

Now all Eli Lilly had to do was to convince women that firstly they were suffering from PMDD and secondly that the only cure was SARAFEM. It didn’t really matter if doctors knew the truth or not because if a patient asked for SARAFEM, doctors (in the US) could not prescribe a cheaper generic fluoxetine tablet because only SARAFEM had been specifically trialled on women with PMT. No other SSRI (the class of antidepressants prozac belongs to) had been tested specifically for PMT and therefore could not be substituted for the expensive patented SARAFEM – which don’t forget it is actually PROZAC which is actually FLUOXETINE HYDROCHLORIDE.

Drug trials (RCT’s) were supposed to be used to test out new drugs, in order to make sure they were safe and did not have dangerous side effects. Instead their use is corrupted, with pharma companies not compelled (by law or conscience) to release the results of trials conducted, meaning they can cherry pick the ones that support their commercial aims. 

The fact that the link between PMT and depression and depression and Serotonin levels is little understood should also be of no surprise. The theory goes that depression is a result of low levels of the neurotransmitter SEROTONIN, which is how messages pass between neurons (in the brain). Of course, it could equally be that feeling depressed results in low levels of SEROTONIN. It could also be the case that SEROTONIN levels in the depressed are no lower than those not reporting depression. In the case of PMT, there is the added fiction (presented as fact) that fluctuating hormone levels impact on the levels of SEROTONIN in the brain in the second part of the cycle.

None of this theory is proven and in fact the role of neurotransmitters in bodily functions, feelings and emotions is turning out to be an extremely complex picture of interrelated dependence, with neurotransmitters having a variety of roles based on where they are in the body and whether they are excitatory or inhibitory.

 “Sarafem® is an FDA-approved prescription treatment that relieves both the mood and physical symptoms of PMDD (Premenstrual Dysphoric Disorder). Many physicians believe that Sarafem helps to correct the imbalance of serotonin that could contribute to PMDD.”  Click here for source.

Note the official information above states that ‘many physicians BELIEVE that Sarafem helps…’  Even Eli Lilly daren’t claim to know there is a link between hormones, serotonin and PMT – and yet they are prepared to give out a drug to many, many women with distressing side effects, such as loss of libido and suicidal thoughts.

So there we have it. And it is not just PMT sufferers that has become a target group for money hungry pharma company boards. We have a proliferation of behaviours now classified as mental illnesses. Childhood tantrums are now called ‘Conduct disorders’. Concentration problems are labelled ‘Attention Deficit Disorder’ and if the child is also very active and doesn’t need much sleep, we can add an ‘H’ for Hyperactivity. Being shy, is called ‘Social Phobia’ and worrying about the state of a world run by capitalist corporations who serve the top 1% is called ‘Generalised Anxiety Disorder’.

And for each of these ‘disorders’ there is a corresponding drug, which messes with a delicate system we actually know very little about. And don’t get me started on halitosis, a completely made up condition to sell mouthwash. And ‘panty liners’!!! WTF! Women have secretions, they are normal, that is what knickers are for!

It is time we women said enough! We been having periods long before big pharma companies decided they were an illness.

PMT is not an illness, but some side effects of menstruation (like irritability and cramps) can make life very difficult for some women. This is no different to how it was for women hundreds of years ago. The difference was those women didn’t have pharmaceutical companies convincing them they were ill and suffering PMDD and needed this particular drug to cure them.

Instead they listened to each other and tried out remedies handed down over the generations until they found something that worked for them.

The answer to our ills doesn’t necessarily reside in a bottle of pills, but in talking to each other and not believing everything we are sold.

For more on psychiatric labels and the drug industry, James Davies has written a book called ‘Cracked: why the psychiatry is doing more harm than good’. Published by Icon 2013. 

Why is psychiatry such big business? Why are so many psychiatric drugs prescribed – 47 million antidepressant prescriptions in the UK alone last year – and why, without solid scientific justification, has the number of mental disorders risen from 106 in 1952 to 374 today? The everyday sufferings and setbacks of life are now ‘medicalised’ into illnesses that require treatment – usually with highly profitable drugs. Psychological therapist James Davies uses his insider knowledge to illustrate for a general readership how psychiatry has put riches and medical status above patients’ well-being. 

 Do you have any further examples of drugs that have been re-branded as a cure for something else? Have you tried Prozac for PMT and did it work for you? What side-effects did you have if any? 

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.