Tag Archives: European Medicines Agency

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.

 

 

 

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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…

View original post 855 more words

Agnus castus saved my marriage!! Seriously!

PMT cartoon shedAt times I have wondered if there is any point keep blogging about Agnus Castus. Whatever I do makes little difference to what is on sale in the UK.

I can sadly envisage a future where women will have completely forgotten that there was once a safe and side-effect free cure for PMT that was effective for over 80% of women in trials (and didn’t involve artificial hormones, mind altering drugs or surgery), but what good can my lone voice really do?

And then I get a comment like the one below and every word I have ever typed about agnus castus and the decimation of the herbal market in Europe suddenly feels like it matters again, and that just maybe I can make a difference, even if it is one woman at a time.

Thank you Vicki for making me feel less like a crazy, ranting bint 🙂

Hi,

My case is one of severe PMS (PMDD). My situation was so bad that I had moved out of my marital home due to me being such a complete bitch for no reason to my hubby… he had enough (fairly!) of me turning on him for no particular reason (over 3 years plus),,, Once separated I went to the doctor as I noticed my flare ups were around the week before my period… investigated further and realised I had PMS if not PMDD… went to the doctor and was prescribed fluoxetine – which did help, yet the Progesterone only pills also prescribed made me worse (Couldn’t take combined pill due to age and family history of DVT). After reading your blog investigated Agnus Castus further… working at a Doctor’s surgery I spoke to Health Practitioners who also read the British Medical Journal report I printed, to ask their advice. I went ahead and ordered Agnus Castus and have now taken it for nearly 2 months… in this time the change has been amazing. I have been ‘pushed’ on many occasions where I would have flared before… however I haven’t. I feel calm and like a new woman… for the first time in years I feel happy… can’t believe that people have just accepted I have a temper and that’s me!!! IT’S NOT AT ALL!! Agnus Castus has given us our marriage back, I am now moving back to our marital home, and we are so happy…. thank you for your blog… you have helped so much I cannot thank you enough!!

Vicki Daniels

Has this blog helped you? Where did you find out about agnus castus?

Agnus Castus: Not a rant, but ACTION!

I’ve had enough of big pharmaceutical companies dictating what I am allowed to take to improve my health and well being. Agnus Castus is a safe and effective treatment for PMT and I want to be able to buy it on the high street. Urged on by this organisation Alliance for Natural Health, I have written the following email to the MEP that represents my constituency – Glenis Willmott. Please do the same. You can find sample letters and how to find your MEP on the Alliance for Natural Health website.

Dear Ms Willmott,

I am greatly concerned about the way in which the European Commission, the European Food Safety Authority and Member State governments have restricted maximum levels of vitamins and minerals in food supplements (on the basis of Article 5 of the Food Supplements Directive,2002/46/EC).

I am writing to you in the hopes you can do something about making it possible for me and many other women to obtain 20mg of Agnus Castus for treatment of PMT. Up until May 2011, getting the efficacious dosage (based on sound clinical data – see Schellenberg 2001, 2012) was easy enough, with Boots and many online stores stocking the product at a reasonable price. However, since the THMPD, the dosage has been restricted to 4mg per tablet based on Traditional Herbal Registration. No UK company has applied for Market Authorisation, so the MRHA informed me recently (unsurprising considering the cost), which would allow them to continue selling 20mg tablets based on Well Established Use. The THMPD has therefore taken away the only treatment that has worked for PMT; my alternative is to take 5 tablets a day at a cost of £20 a week – as it seems despite the reduction in dosage, there has not been a reduction in price, 4mg tablets cost the same as 20mg.

To impress on you the significance of this directive on my life, let me tell you what life was like before I stumbled across Agnus Castus in  newspaper article in 2008:

“For me the biggest issue was painful periods, so painful I stood at the top of the stairs and seriously toyed with the possibility of throwing myself down them either to knock myself out or at least end up in hospital. Unbelievable pain that had my lying in my own vomit on the bathroom floor wishing I would black out. I was prescribed morphine, which left me muddled, sick, and unable to drive to work the next day (as a secondary school teacher, I was missing 2-3 days a month, which was terrible for my students and my career prospects). I was offered anti-depressants: I said I wasn’t depressed. They recommended exercise, cutting out caffeine, eating more healthily. I did all those things. I still spent 3-4 days a month dealing with constant grinding pain that stopped me sleeping, eating, working, living. The consultant suggested the Mirena coil. I said I didn’t need contraception. He said it was like a chemical hysterectomy. I agreed. I just wanted the pain to stop. The pain was so overwhelming, I barely registered the irritable bowel, painful breasts, anxiety and tearfulness.

The evening after the coil was inserted the pain started and didn’t stop. After three days, where I was in so much pain, I considered overdosing on morphine, and absolutely no support from the gynae clinic who had inserted the coil, even when I begged them on the phone to see me, I ended up in A&E, crying, shaking, vomiting and delirious. They gave me a lot more morphine, which made me even sicker. I pleaded with them to remove the coil (possibly hysterically, it is all a blur). They told me Minera coils are expensive and I should give it more time, before giving up. I hadn’t slept for three days. I was exhausted and distressed. My husband insisted they remove it. The pain stopped immediately.

I was a bad patient. The gynaecological consultant had run out of options. I floated the idea of a hysterectomy. I was told it was a drastic measure, and  I should have tried harder with the coil, because they didn’t like to recommend hysterectomies on woman of my age (37 at the time). It was suggested I try the coil again. I told them I would think about it. I left, depressed and lost. Menopause seemed my only hope, but that was ten years away yet.” Extract from my blog and for the full post and more posts about Agnus Castus and the countless women who have commented see link:  https://julietocallaghan.wordpress.com

As you can see Agnus Castus was life changing, I have not missed a day of work since. I know many other women for whom this herb has been a life and marriage saviour, but unfortunately even if a woman was to find out about the benefits of Agnus Castus and bought it on UK high streets, she would not realise the recommended dosage (4-8mg) would render it ineffective and she would assume it doesn’t work, leaving very few alternatives (all with terrible side effects).

I urge you to act on this subject, which is based on sound scientific principles as judged by leading integrated medicine institutions, the Alliance for Natural Health International and other respected and independent organisations.

Please let me know what action you might be prepared to take to bring to end this strangulation, which benefits large pharma companies and keeps UK citizens chained to dangerous and less effective treatments for PMT and other ailments.

From the activity on my blog, there are many, many women left in pain and confused by the result of this directive.

Very best wishes,

Juliet O’Callaghan

You can use my letter as a template, but do give your personal story of what life was like before Agnus Castus. I feel better for doing something rather than just whinging on this blog.

Agnus Castus: Last rant, promise

It must seem like I am obsessed with this subject. And I guess I am. But then taking Agnus Castus has been life changing.

Business is about profit. This is why monopolies are bad because the only thing that ensures the customer gets value for money is competition. So if a product is the same wherever you buy it from (bottled water for example), then the way the customer wins is companies will compete on price. Although increasingly in this ‘brand’ led world, it is the quality (perceived or actual) of the product that seduces the consumer.  Hence the millions of pounds spent on packaging and advertising. ibuprofenGeneric Ibuprofen is exactly the same drug as Nurofen, but we are visual creatures and we are persuaded by taglines and posh boxes to pay three times as much for the same thing. The fact that products would be so much cheaper if we weren’t paying for the advertising and nurofenpackaging is a blog post for another day.

The point I am getting to is since the introduction of legislation which means herbal medicines cannot be sold without a license, it has created a monopoly over dosage. This is bad for the customer. This is especially bad for me.

kira 20mg
Look at the dosage
kira 4mg image
and now its 4mg, so where did the other 16mg go?

Under Traditional Herbal Registration, Agnus Castus, cannot be sold in a higher dosage than 4mg tablets, with the recommended daily intake of 1-2 tablets.Holland & Barrett, Boots (Schwabe) and Kira have all applied for and received THR to sell their 4mg tablets at the same price they were selling their 20mg tablets (before the EU legislation on licensing). Now that would be OK (if a little underhand) if 8mg a day actually was effective for PMT, but it isn’t. A clinical trial conducted in 2012 (Schellenberg et al) found:

“Each of the treatments was well tolerated. Improvement in the total symptom score (TSS) in the 20mg group was significantly higher than in the placebo and 8 mg treatment group. The higher dose of 30 mg, on the other hand, did not significantly decrease symptom severity compared to the 20mg treatment, providing a rational for the usage of 20mg. Corresponding results were observed with the single PMS symptom scores.” Link to source.

I can also testify from personal experience that at 4mg, 8mg and 12mg my PMT symptoms did not diminish – for me the biggest issue was painful periods, so painful I stood at the top of the stairs and seriously toyed with the possibility of throwing myself down them either to knock myself out or at least end up in hospital. Unbelievable pain that had my lying in my own vomit on the bathroom floor wishing I would black out. I was prescribed morphine, which left me muddled, sick, and unable to drive to work the next day. I was offered anti-depressants: I said I wasn’t depressed. They recommended exercise, cutting out caffeine, eating more healthily. I did all those things. I still spent 3-4 days a month dealing with constant grinding pain that stopped me sleeping, eating, working, living. The consultant suggested the Mirena coil. I said I didn’t need contraception. He said it was like a chemical hysterectomy. I agreed. I just wanted the pain to stop. The pain was so overwhelming, I barely registered the irritable bowel, painful breasts, anxiety and tearfulness.

The evening after the coil was inserted the pain started and didn’t stop. After three days, where I was in so much pain, I considered overdosing on morphine, and absolutely no support from the gynae clinic who had inserted the coil, even when I begged them on the phone to see me, I ended up in A&E, crying, shaking, vomiting and delirious. They gave me a lot more morphine, which made me even sicker. I pleaded with them to remove the coil (possibly hysterically, it is all a blur). They told me Minera coils are expensive and I should give it more time, before giving up. I hadn’t slept for three days. I was exhausted and distressed. My husband insisted they remove it. The pain stopped immediately.

I was a bad patient. The gynaecological consultant had run out of options. I floated the idea of a hysterectomy. I was told it was a drastic measure, and  I should have tried harder with the coil, because they didn’t like to recommend hysterectomies on woman of my age (37 at the time), unless it was proven that my symptoms were definitely related to PMT. It was suggested I try the coil again. I told them I would think about it. I left, depressed and lost. Menopause seemed my only hope, but that was ten years away yet.

Back to square one, I chanced upon an article in a newspaper. I was on holiday in Centre Parcs in Nottingham. In it, the author described pretty much what I was going through and she said she had found a solution.

agnus castus flowerThe solution was a herb called Agnus Castus and since she’d been taking it her life had been transformed. I googled it and was amazed to find the BMJ had published a study, which revealed highly significant results for 20mg a day for over 80% of women with PMT. I read more case studies and personal stories about both its effectiveness and its lack of side effects. I found more clinical trials like the one below, which has been accepted by the HMPC, reluctantly it seems, as evidence of efficacy.

“The proposal is accepted for the extract tested in the
study of Schellenberg et al. (2001):
“Adolescents, Adults
Daily dose:
Once daily 20 mg extract equivalent to 180 mg of the
herbal substance”
As mentioned in the assessment report, until now the
WEU was not favoured by the HMPC, because the extract
has not been on the market in the EU for more than ten
years. The ten year – threshold is reached in February
2011 and therefore the rapporteur proposes to accept
the WEU for this extract.” Link to EMA document on comments received on monograph for Vitex Angus Castus.

I ordered some 20mg tablets from Health Span (now also only selling 4mg tablets). My next period was a breeze, and by that I don’t mean pain free, but controllable with paracetemol and a hot water bottle. I was cautious and maintained it was a fluke (as I did occasionally have a bearable period). The next period arrived. Again it was a breeze and I also realised my IBS had gone, and so had the breast pain. I felt like me again.

Six years later and I have never looked back. My life is simply transformed and I didn’t have to have my womb and ovaries removed and suffer the consequences of a premature menopause, nor put myself under an unnecessary anesthetic.

Fast forward to now and the problem on dosage is this. The HMPC did grant a well established use (WEU) mongraph for 20mg of Agnus Castus. However the WEU monograph insists on rigorous clinical evidence in order to grant a Product license (Marketing Authorisation),but to get this license costs a lot of money. And more importantly a lot more money (10x) than a Traditional Herbal Registration (THR) (which restricts dosage to 4mg per tablet), and only requires evidence that it has been ‘used’ for 30 years.

I wrote to the MRHA – which is the drug regulatory body in the UK whose job it is give licenses to all medicines- to find out why the Marketing authorisation (MA) process was so much more costly than THR. This was their response.

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.

“The traditional registration scheme is a simplified procedure which allows products, based on traditional use only, to be supplied provided  they fulfil the legal requirements of the Traditional Use Directive. It is therefore a less costly procedure as there is less information to be submitted and assessed.”

My second question to MRHA was:  Have any UK suppliers applied for and been granted Market authorisation (can you tell me who they are)

Their response: There are no current product licences for Agnus castus products. Previously, in the UK we did have one product with a product licence but the licence was cancelled by the company some years ago for commercial reasons. We currently have 3 products with traditional registrations containing 4 mg of extract equivalent to approximately 50 mg of the fruit.

The loser in all this is the woman, just like me, with PMT, who either has to take 5 tablets a day at a cost of around £20 a week, or if she isn’t aware that a THR logo guarantees the ineffectiveness of the product and follows the recommended guidelines, will find her PMT is no better and she will believe she has been sold a myth and take her anti-depressants like a good girl.

Side effects of SSRIs (anti-depressants) include the following:

  • Anxiety
  • Sedation
  • Insomnia
  • Decreased libido
  • Gastrointestinal disturbances (including nausea and indigestion)
  • Fatigue
  • Headache
  • Dry mouth
  • Dizziness
  • Tremor
  • Sweating
  • Weight gain

Orgasmic dysfunction (normal libido and arousal with delayed or absent orgasm) is the most problematic side effect of this class of drugs, reported in up to 80% of patients taking SSRIs continuously and for long duration.

or Danazol

Side effects:

  • Amenorrhea
  • Weight gain
  • Acne
  • Fluid retention
  • Hirsutism
  • Hot flashes
  • Vaginal dryness
  • Emotional lability

or subject herself to unnecessary surgery and possible complications.

So I apologise for another Agnus Castus rant, but I do want as many women as possible to know about the effectiveness of agnus castus for PMT/PMS, as long as you take 20mg (standardised extract) a day (equivalent to 200-24omg dried fruit).

Prime Health in Guernsey have restarted selling 2omg tablets. Click here for their website.

Why aren’t doctors allowed to prescribe herbal medicines, it is common practice in Germany and many other countries? Who really controls health policy, the Department of Health or the multi-million pound drug companies? Have you found somewhere else in the UK stocking 2omg tablets? Experiences of Agnus Castus always welcome. Spread the word…