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…

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66 thoughts on “Agnus Castus: Last rant, promise”

  1. What a saga! I understand the misery of the severe period pain you describe. I used to be off sick every month with ‘gastro’ because I’d get vomiting and diarrhea along with the acute abdominal pain. My solution was to have a baby – that obviously didn’t work for you. I’m glad you’ve found a new supply of the 20mg tabs.

  2. Hi Juliet,
    Just wanted to check the dosage. I’ve purchased via Nature’s Best who are using Lamberts old stock. The dosage is 100 mg extract (equivalent 1000 mg – 10:1).
    It says take 1 tablet a day. Is this the equivalent of 20 mg?

    I’ve only just discovered Agnus via your web site, and I want to make sure I take the right dose.
    Over the last 18 months I’ve suffered a variety of symptoms – the worst being the severe hot flashes in my body causing severe rashes, and itchy/hot scalp which causes my hair to break off. My hair is really thin now, and the itching keeps me awake at nights. I have tried everything. Bio-identical progesterone, estrogen, diet, acupuncture etc. But my problem seems to be the imbalance of hormones, and so supplementing it doesn’t help. It’s a nightmare. I can’t remember when I last felt like myself!
    Best wishes

  3. Hi Juliet, thanks for a very useful post/rant! I do this for a job and, believe me, you really do want these things regulated, mostly because it makes sure the tablets contain what they say on the label and the constituents (eg lactose) aren’t full of toxic impurities. Not happy about paying the same for less drug though! I had a look at the data and agree that 20mg of dry extract is the recommended dose, maybe higher for severe symptoms. Just want to point out that a lower dose eg 2x4mg might still work for some people with milder symptoms – could start with low dose for at least 3 cycles and work up depending on effects. Also please be careful what you buy online, stick with EU sources if possible.

  4. Hi C, thanks for stopping by – can you explain in more detail your job. Do you produce the herbal remedies or provide the licenses? I don’t disagree that herbal medicines should be regulated, they are powerful drugs and she be accorded the same respect as ‘chemical concoctions. Part of the issue is that people don’t realise the power of herbal medicines because the pharmaceutical industry dominates medicines in the UK and there is much misinformation out there, downplaying the power herbal drugs.

    Although buying outside the EU does mean you have less protection in terms of the constituents of the product, in the case of agnus castus there is little choice. The cost of taking 5 tablets a day is ridiculous. And yes, it is possible a lower dosage may work for some women, but the clinical evidence does not support this.

    The answer is for UK companies who produce Agnus Castus to apply for Marketing Authorisation, but of all the companies I spoke to, none of them was considering this option because of cost and lack of return.

    The medicines industry is corrupt and not altruistic. A lot of new drugs developed provide no additional benefits to patients and infact may put them at risk of unknown long term side effects. While patents attract huge profits this situation will not change anytime soon. And in the meantime the herbal licensing legislation has made many remedies (e.g. St John’s Wort) ineffective – this of course benefits the drug companies as people will turn away from safe, efficacious herbal remedies, believing them not to work and take ‘new’ patented drugs, which may have many more side effects and lack long term data on use.

  5. Hi again Juliet, sorry to ask another question. I have been taking your recommended dose for 6 weeks, I skipped a period 3 weeks after starting it, but just had my period (3 weeks late) and it has been worse than ever – pain not responding to tablets and heavier than normal (and normal is pretty heavy). Can I expect this to improve? Is it likely that for some women, it will be worse before getting better or should I stop it now. I’m scared of having another nightmare one, my periods have been lifelong bad, but they usually respond to strong pain relief (lots of it mind you). Thanks in advance, Jo

  6. Hi Jo, unfortunately I don’t have the medical expertise to advise you. I can only give you my experiences of Agnus Castus, and for me my symptoms improved from the start and certainly didn’t worsen. I do know that some medical professionals and herbalist categorise PMT into types – and it maybe that the ‘type’ of PMT you have doesn’t respond to Agnus Castus in the same way the ‘type’ I have does. I do think you should see a registered herbalist or a doctor to discuss how you continue. I don’t want anyone to suffer more as a result of my blog posts on Agnus Castus and it does sound to me that you are not getting the relief from Agnus Castus that I did. Research your symptoms and look for advice that is helpful for those particular symptoms. For me it was period pain and IBS that were the predominant symptoms, rather than the emotional ones, although I was prone to crying on the day before my period, which doesn’t happen now. Do let me know how you get on.

      1. Hi Mandy, As far as my research goes I have found no evidence that AC causes weight gain. I guess you need to look at your lifestyle overall and see what else has changed which may account for it. Your other option is to stop taking AC for a couple of months and see if your weight reduces again. One explanation might be if AC is making you feel better, you might be eating more – but you really need to do some investigating of your own to establish what has caused this change in weight. As far as I am aware Kira tablets are only 4mg and that level you are unlikely to get any effect at all let alone side effect, unless you are taking at least 4 tablets. Do let me know how you get on.

  7. Hi, can I clarify something? You said that H&B sell 4mg extract A-C tabs, but on their website they only have 400mg berry capsules. If the extract is 10:1 as it is on the Prime Health site, surely 20mg standardised extract is equivlaent to a 200mg whole berry capsule? Am I missing something?

  8. Hi Bryony, All I know for sure is that no UK company has applied for Marketing Authorisation and therefore they are restricted in dosage to the equivalent of 4mg. To be honest I find the whole very confusing myself. If you search on the Community monograph for Agnus Castus (there is a link in one of my posts on AG), you can read the dosage restrictions, which relate to THR or WEU (Well established Use requires Market Authorisation).

  9. Why can prime health direct still sell the correct dosage? is this a safe website and why can’t others sell this dose?

  10. Hi Laura, something to do with the channel islands and not being covered by EU directives, I think – but not entirely sure. Just happy I still get 20mg tablets at a reasonable price.

  11. Well mine arrived today really fast delivery so def recommend them, keeping everything crossed they work. Just out of interest do you take them for the whole month or have a break? Is that just if your ttc which I’m not.

  12. Sorry stupid Internet abbreviations ttc = trying to conceive which I’m not. I’m going to take them everyday and hope they work so happy I stumbled over your blog it could change my life immensely!

  13. I too am really confused about the difference between the standardised extract and the whole herb. Bio-Health, for instance, a reputable UK company, are selling 400mg of whole herb (well, fruit in this case), as are many other companies. http://www.bio-health.co.uk/periagna This formulation has a THR (Traditional Herbal Registration), so clearly this doesn’t just apply to the standardised extract. Do you have any idea about this? And could you perhaps make your posts reflect the fact that it’s only the standardised extract which is limited, since it seems that the whole fruit form isn’t in this country?

    Generally I go for companies I know and trust, but when taking ginger for poor circulation I found that the pure herb wasn’t enough, I had to take an extract instead (and I could really do with a cheaper source of that). And this one is so much cheaper, as well. But I’m rather wary of buying from companies in Guernsey I know nothing about! Well, almost nothing: a quick Google has revealed that they’ve fallen foul of the ASA for making inappropriate medical claims, which is far from being a good sign. http://www.asa.org.uk/Rulings/Adjudications/2009/1/Prime-Health-Direct-Ltd/TF_ADJ_45587.aspx Right now I’m thinking of buying their ginger to see if it works as well as the Solgar, since the effect of ginger on my body temperature is pretty speedy. Actually, that’s flagged up something odd. The Solgar says that 300mg ginger root extract gives ginger phenols (which include gingerol and others) 15mg (5%). The PHD ginger says that 100mg extract gives 20mg gingerol. Unless their extraction process is four times as efficient, something shady is going on here.

    I tried agnus castus ten or fifteen years ago, and it didn’t do a thing for me. I’m not quite sure what I was trying it for: menstrual migraine, perhaps, since I’ve had that since the age of fifteen. Since then I’ve developed PMDD and other cyclical problems. I do appallingly on progestogen-only contraception (they won’t try me on the combined pill due to migraineurs having an increased stroke risk), and I’ve heard that of the people who do really badly on agnus castus – and they do exist, please discuss them – tend to be the ones who do badly on progestogen-only contraception. But then a lot of people don’t realise that progestogen is entirely different from progesterone, so who knows. Do you know anything more about this? It sounds like a surprising number of women take hormone-affecting herbs while on hormonal contraception, plus it also sounds as if agnus castus can cause a bad reaction in women who have ADHD.

  14. Hello, me again. I’ve been hunting through the internet, looking for a reliable firm selling agnus castus at an effective dose. I’ve found nothing that meets both criteria if we look at the 20mg extract, since I’m afraid I remain suspicious of Prime Health Direct. The only public information about them is that the ASA took action against them for making untruthful medical claims, and they never even bothered to respond! I’ve never seen so little information about a brand before. There’s another brand, Nature’s Answer, selling what I assume is the extract, 40mg, but again, it didn’t look particularly reliable.

    Then I had a chat with Bio-Health, who have a fairly good reputation as a herbal supplement manufacturer in the UK. Their agnus castus (400mg whole fruit, marketed under the name Periagna) has a THR (Traditional Herbal Registration) licence, unlike practically everything else out there. I was still trying to work out this extract vs. whole fruit business, so they put me through to the managing director. He said that while the research has been on the extract, labelled as “well-established use”, they’re simply not granting any licences for that, which is why you can’t find anyone selling 20mg extract in the UK. However, 400mg dried fruit is meant to be equally effective, labelled under “traditional use”, and they do have the THR for that. He pointed me to this article in the European Medicines Agency, “Community herbal monograph on Vitex agnus-castus L., fructus”.

    http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Community_herbal_monograph/2011/01/WC500101541.pdf

    According to him, the 20mg extract is equivalent to the 400mg whole fruit or certain amounts of the tincture. It sounds worth a shot. I think I’ll go for the Bio-Health one first, since they are a reputable company and I haven’t found anywhere else with the THR yet, and see how that goes for, hmm, six months. I monitor my cycles fairly closely, including FAM charting (well, just the temperatures by now, but they tell me plenty – short luteal phase, migraine occurring when my temperature and therefore progesterone plummets around CD3) and tracking my four main symptoms, so it should give me a good idea of whether it’s helping. Then I might switch to the extract you recommend, just to compare them, unless I get such amazing results from the Bio-Health that it doesn’t seem necessary.

    I’m still wondering about my experience with powdered ginger vs. ginger extract. It occurs to me that the difference here is that when I’ve been getting the ginger extract, it also includes powdered ginger, so I end up with a lot more ginger overall per capsules. Whereas with the agnus castus, the extract comes in much smaller quantities than the powdered fruit does, so it seems to be an equivalent rather than something stronger. Probably because ginger is relatively harmless stuff and people can tolerate a far wider variation in dose than would be wise with agnus castus.

    Would you be able to chat to Bio-Health, and anyone else selling the THR if you manage to find it, and let me know what you think?

  15. Hi Eletteria, The restriction in dosage doesn’t just apply to the standardised extract – it just means the active of component of a tablet can only contain 4mg under Traditional Herbal Registration. How the company chooses to advertise the product e.g. 400mg whole fruit makes no odds because the bottom line is it can only contain 4mg active ingredient. So from the link you sent me if it has THR, then each tablet can only contain 4mg, therefore the advice to take two a day means you would only be getting 8mg of active ingredient. However, I really do find all the different dosages really confusing. I based my search on the research evidence which quoted 20mg standardised extract as that was the only thing I was sure of.

    As for Prime Health Direct falling foul of advertising regulations, I am sure they have, but that doesn’t make them underhand. This is the problem with herbal remedies they do lack randomised control trials to back up their claims, but that doesn’t mean the effects are not what they say there are. The reason the dosage for AC is restricted is because the EU felt there were not enough controlled trials to substantiate its claims, but running a trial and getting a product license costs £100,000 as quoted by the MRHA (UK drug regulatory body) only companies with patented medicines can recoup those sorts of costs.

    As for people not responding to AC, yes I am sure that is the case, I have a friend who tried it and didn’t get relief and it could be to do with the biological mechanisms underlying her PMT. As yet these mechanisms/ interactions are not fully understood and as in a lot of medicine the approach is trial and error. I know the UK PMS charity guidelines also recommend Red CLover and i have heard Black Cohosh is also one that can improve symptoms for some people. SO for people for whom AC isn’t effective (at the right dosage) I would recommend they see a trained herbalist and look at a variety of options.

    However for those that AC does work it is a life saver and the PHD ones have certainly kept me symptoms at bay.

  16. Forgot to say if bio-health have THR then as far as I am aware the dosage however they label it can only be equivalent to 4mg standardised extract. I don’t like the fact that PHD is the only company selling 20mg, but because no one has applied for a product license (due to the costs of running research trials), they are the only place I can get them. Do let me know how you get on if you try the bio-health tablets. I am sticking with PHD as I am still pretty much symptom free.

    1. I had to break off the call to Bio-Health as I had someone ringing me, but I’ll get back to them about that. There are six companies selling THR agnus castus, I think (http://www.mhra.gov.uk/Safetyinformation/Medicinesinformation/SPCandPILs/?subsName=AGNUS%20CASTUS%20EXTRACT&pageID=SecondLevel), and the rest are all selling 4mg extracts. There wasn’t anything about “contains 4mg extract equivalent” with the dried fruit, and to be honest, I wouldn’t necessarily assume that the MHRC have restricted the whole fruit in the same way they’ve restricted the extract. They might have, it’d be the logical way to proceed, but they don’t seem particularly knowledgeable about herbal medicines! It might be the case that if you’re selling the extract, you’re limited to 4mg, but if you’re selling the whole fruit, anything goes. Periagna is certainly listed separately from the extracts, for some reason. Actually, I might try ringing them to ask about this. There are some details on http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Herbalmedicines/TheTHRscheme/index.htm

      Certainly people are generally talking about a 1:10 ratio of extract to whole fruit, so that 400mg seems to be the equivalent of 40mg extract. I plan to start on 1 capsule and raise or lower the dose depending on how I feel on it. According to what I’ve read, one of its actions should be to lengthen my luteal phase (9-10 days), which would show up nicely on the charts.

      The obvious question, of course, is exactly what goes on with the extract, how it differs from the whole fruit. Is it just more concentrated? It sounds as if it has certain elements removed, from what I’ve read somewhere, which may or may not affect how it affects people. Do you just take ten times as much of the fruit to get the same effect? Is the extract more bioavailable in some way?

      I wasn’t talking about people not responding to AC, I was talking about the people who report severe side effects, including suicidal ideation in some cases. That’s not something to be taken lightly. The research didn’t find any problems with side effects, even though some of the participants were on the pill, and I’m getting the impression that it’s a fairly small group and there may be other factors. Still, it’s something to bear in mind.

      Out of curiosity, do your tablets smell? It sounds like the proper stuff smells quite strong.

      Here’s the ASA ruling on PHD. It really isn’t making them sound more appealing. http://www.asa.org.uk/Rulings/Adjudications/2009/1/Prime-Health-Direct-Ltd/TF_ADJ_45587.aspx It also sounds as if they should be subject to the 4mg limit, come to that, since they’re subject to the ASA. Healthspan, also in Guernsey, are, for instance. Do you have anything you can link me to on the 4mg limit? I’ve been reading up about the THR scheme, but that seems to be a separate issue.

      I’ve noticed that when you look up AC on various websites, there are loads of products marked as “discontinued”. It’s all very odd. It seems that products are being constantly whisked off the market, in a way I’ve never seen elsewhere. Normally this popular a herb would be quite steady in that respect. I also considered importing it from iHerb, but again, there weren’t any products/manufacturers leaping out at me as reputable, and messing with your hormones is something you don’t want to do lightly, you know?

      Oh, and apart from the 1:10 ratio I generally see kicking around for extracts, there is also a 0.6% figure which is popping up for standardised extracts, which appears to be about something else entirely. Look at http://www.amazon.co.uk/Natures-Aid-199220-Castus-1000mg/dp/B000GY76FC, for instance. (Legally available in the UK.) It says that it’s 100mg AC, equivalent to 1000mg whole fruit, standardised to 600mcg aucubins. Agnusides come up as well. If that’s the same strength, then it’s five times the dose you’re on, and 20-40mg was what the research recommended, I believe, but then the Periagna would come in at 40-80mg if it’s really a 1:10 ratio. This is varying an infuriating amount. Maybe the 1:10 thing is more about 100mg being the equivalent of 1000mg fresh fruit, rather than 400mg dried fruit being the equivalent to 40mg extract?

  17. I am now determinedly googling the key components, aucubin and agnuside. This looks useful:

    http://www.askic.co.jp/gakujyutu/vitex-agnus-castus.pdf

    “c) Extract dosage:
    In empirical medicine there are only few data on the dosage of Agni casti fructus. For Z-94040 the dosage of 20 mg of native extract per tablet, already registered in Switzerland, was chosen and was maintained because of the positive experience in the clinical trial [8]. With a drug/extract ratio (DER) of approximately 6-12:1 the 20 mg native extract corresponds to 120-240 mg of dried drug.”

    Apparently the important bits vary like mad. How useful. Here’s another one:

    http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con185667.pdf

    “Description and Composition of the Herbal Product
    Each film-coated tablet contains 3.9mg of extract (as dry extract) from Agnus Castus
    Fruit (Vitex agnus-castus L.) (equivalent to 23.4mg – 31.2mg of Agnus Castus Fruit).
    Extraction solvent: Ethanol 75% v/v.”

    That would be a 6:1 ratio, which fits with the earlier thing. According to this, I should probably be taking 100-200mg dried fruit to get the equivalent of 20mg extract, so 400mg may well be the equivalent of the 40mg dose sometimes popping up in the research. In which case Bio-Health’s recommendation of taking two of them is pretty high.

    I wish we had access to, oh, I don’t know, THE FLIPPING TABLETS USED IN THE RESEARCH! Preferably at a nice affordable price!

    And then I found this (by now I’m googling this string: “agnus castus” extract dried equivalent):

    http://examine.com/supplements/Vitex+agnus+castus/

    “Several extracts of Vitex Agnus Castus are currently on the market, which include:

    Ze110 (20mg), which is a 60% ethanolic extract
    BNO1095 (4mg), which is a 70:30 ethanolic:water extract (brand name Agnucaston)

    Both of which are equivalent to 150-250mg dry weight of the plant’s fruits and are to be taken once daily. If neither extract is available, then the basic fruit extract can be taken at 150-250mg in their place.”

    Well, this backs up my supposition that 400mg dried fruit is the equivalent of the 20mg, but *hang on a minute*. 20mg of Ze110 is equivalent to 4mg BNO1095? Due, it seems, to a different extraction process?

    This could be why we have research about 20mg and manufacturers then selling 4mg. Did you ever find out why they made that switch? Have you actually tried the 4mg from the THR-listed manufacturers? Is it possible that you’re on 500% the recommend dose, rather than everyone else being on 20% of it? And whom do we talk to to find out about this?

  18. Hi again,

    This is what the monograph for THR applies to:

    Posology
    Adults
    Daily dose:
    a) two times daily 400 mg powdered herbal
    substance
    b) once daily 40 drops
    c) once daily 30-40 drops corresponding to
    approximately 33 mg herbal substance
    d) once daily 4 mg dry extract corresponding
    to 28-52 mg herbal substance
    e) once daily 2-3 mg dry extract
    corresponding to 30-48 mg herbal
    substance

    From that i took it that all the above are equivalents of each other, so 400mg herbal substance equates to 4mg standardised extract. As for why PHD can sell 20mg but others in can’t, I don’t know and it does worry me that they will have to stop. The reason you are seeing so many AC products discontinued is that they used to all be sold at the 20mg (standardised extract equivalent) but now can’t due to the restrictions under THR. As for suicidal ideation, I have never found evidence that this is linked to AC, prozac yes, but not AC – do you have a reference?

    The dosage differences really do stump me, hence why I am keen for AC to be prescribable by GP’s as a second line treatment for PMT as recommended in the NAPS guidelines written by Dr Nick Panay. I have spoken to him about this and he has agreed to look into how this treatment can be made available (he clearly believes in its efficacy).

    I hope you find some answers and come back on here to share more information. It seems you already know more than me on dosage (will look into standardised extract and try to find out more). I will continue to buy mine from PHD as long as they sell them because they work, but I do wish I could get them from other places – it is not good to rely on one source. My ultimate goal is that they are recognised as one thing to try before resorting to more drastic treatments.

  19. I completely flooded you with links there, didn’t I. Go and look at the last one. It explains why 4mg and 20mg may actually be the same dosage if different extraction methods are used.

    http://examine.com/supplements/Vitex+agnus+castus/

    Read the whole thing, but this is the really important bit:

    “Several extracts of Vitex Agnus Castus are currently on the market, which include:

    Ze110 (20mg), which is a 60% ethanolic extract
    BNO1095 (4mg), which is a 70:30 ethanolic:water extract (brand name Agnucaston)

    Both of which are equivalent to 150-250mg dry weight of the plant’s fruits and are to be taken once daily. If neither extract is available, then the basic fruit extract can be taken at 150-250mg in their place.”

  20. you posted again while I was posting. I will check out your links.

    As for why the research says 20mg and manufacturers are selling 4mg that is purely the result of legislation, which has affected the whole herbal market rendering many treatments ineffective (as has happened with AC). I can’t help but think this legislation was less about safety to patients and more about ensuring new medicines, which achieve hefty profits, are given preference. You only have to read about the Sarafem debacle which I blogged about earlier this year, to understand why I am suspicious of laws that purport to protect, but take away my choice instead.

    As for whether I tried the 4mg, yes, by accident, when Boots changed the dosage from 20mg to 4mg without informing the customer. My symptoms returned and I couldn’t understand why until I compared the new package with the old and saw the huge decrease in active ingredient.

    All the research makes clear that 20mg is the optimal dose and before the legislation this was the dosage that was sold. For no reason I can find it was decided that THR would only license a product up to 4mg, unless the manufacturer applied for a product license, which herbal companies just can’t afford to do.

    I am deeply frustrated by the whole thing and even more frustrated that there is no active research in the UK on AC and its effects.

  21. My current theory on What The *$^% Is Going On is this:

    There are two methods of producing AC extracts, one producing an extract five times as concentrated as the other.

    Method A (60% ethanolic extract) is effective at 20mg.
    Method B (70:30 ethanolic:water extract) is effective at 4mg.

    Hypothetically, the problem arises when you use Method A at 4mg. If you start with a 20mg Method A product and then reduce it to 4mg *without changing to Method B extraction*, you now only have 20% of the efficacy. But hey, you’ve saved money, and you’re adhering to the guidelines!

    My guess is that there was a mix-up with the extract equivalencies, which is why 4mg was blithely set as the limit even though nobody appears to be using Method B. Healthspan, for example, say theirs is a 60% ethanolic extract. Maybe there’s been a change in which extraction method is more favoured? Or maybe it’s purely about cost?

    Or it could just be drug companies playing silly buggers, but the really striking point is that they discuss 20mg as the therapeutic dose and recommend 4mg *in the same document*. And according to that source, they are indeed equivalent if you use the different extraction methods. I doubt that the 4mg dose was arrived at by pure coincidence.

    I’ve put a shout-out on Facebook to see if anyone can understand the extract method discrepancies. So far I’ve had this response from a friend:

    “It sounds as if the first uses 60 percent alcohol and the second uses 70 percent alcohol.

    Both extracts probably would include some water-soluble compounds as well as the ethanol-soluble ones. The higher ethanol extract might include more alcohol-soluble compounds and fewer water soluble ones. Some compounds might not survive the higher alcohol content, for better or worse.

    Whether any of this is therapeutically relevant in this particular case, I don’t know. Extracts can concentrate good stuff or bad stuff.”

    If the PHD product was the only one that was any use at all, agnus castus wouldn’t be selling at all. There are oodles of strong reviews for a variety of products. They can’t all be useless. I’m thinking it’s the 20mg/4mg mixup which is the problem, and perhaps the full-herb ones are OK as long as the dosage is high enough, since they miss out on the extract problem?

  22. Oh, and those 4mg tablets *all* say:

    “contains 4mg of extract (as dry extract) from Agnus Castus fruit (Vitex agnus castus L) (7-13:1) equivalent to 28-52mg of Agnus Castus”

    no matter who the manufacturer is. Maybe they’re all using the same tablet?

  23. It does seem the extraction method is the important thing, so a 4mg tablet maybe at the right dosage, but you would have to check the extraction method before buying them. I definitely know that when Boots changed from 20mg to 4mg the strength of the AC was affected as my symptoms returned. I tend to look for 20mg just because it is in the research, but I agree other companies maybe selling the same potency but using a different extraction method. So confusing.

    1. It really is. And who knows how the whole fruit versions compare. So it looks like unless there’s somewhere selling 4mg using the different extraction method that’s equivalent to 20mg, your choices are:

      1) Take five tablets of a 4mg extract, which means that you can get something with a THR registration and thus a reliable brand, but is horribly expensive.

      2) Buy from abroad, e.g. the 20mg PHD version you’re on. There is also a 40mg version by Nature’s Answer being sold in the UK. In both cases it’s companies that aren’t particularly well-known. Riskier, but if the herbs are good quality (and they certainly seem to be working for you), much much cheaper. The Nature’s Answer one is cheaper, incidentally, although at the dose you’re on, you’d be taking it every other day.

      3) Buy the whole fruit, which does give you a decent choice of brands, including one that’s THR registered (Bio-Health), and try to figure out what the equivalent dosage is. I think this comes out in the middle, in terms of cost.

      I’m quite keen on reputable brands, so I’ve ordered in the Bio-Health one and will try that first. If it doesn’t disagree with me, I should probably give it six months, or however long it takes to get a clear idea of what effect it’s having on me. Then I will give the extract tablets a try. Meanwhile, I might buy the ginger extract from one of those other companies, as it gives me a chance to try them out. I should be able to tell whether it’s decent stuff with the ginger, as my reaction to that is fairly strong. PHD is more expensive for the AC, but half the price for the ginger, and I take a lot of ginger, so it looks like I’m trying PHD first.

      How long did you find that it took to kick in? How noticeable were the effects? Apparently PMS has a very high placebo response rate, but only for about three months, and after that the placebo effect wears off.

      1. I noticed the first month, but like you was dubious about placebo effect, but six years on haven’t looked back 🙂 Do come back and let me know how you get on with the bio-health ones, it would be good to have another option from PHD.

  24. Juliet (and others), thanks so so much for posting about this. I came across the idea of AC in Dr John Lee’s books where he mentions several herbs as well as ‘natural progesterone’.
    My symptoms were far far worse than anything I’ve seen listed here yet (nearly died twice, had massive blood transfusion), I was ready to try anything – tho didn’t want any of the medical interventions offered – from coils to hysterectomy.
    The natural progesterone turned out to be a nightmare and made things far worse. My doctor’s advice was to “slam my body with more of it” to oppose oestrogen. I used it for 2 cycles then dropped it. Natural isn’t actually natural when you look and at the end of the day it is an unregulated medicine. Tho I know many women are helped by it, the experience for me was terrifying.
    So gradually, AC was what was left. I took it for 3 days and bingo! Such an overwhelming result. After 5 years of hell, it was unbelievable at first.
    But dosage? I’m grateful you’ve discussed it extensively here, although there was no mention of Neal’s Yard. I got mine from there through a herbalist. So I’ll go back and ask about dosage and report back if it’s different.
    Thanks so much again. Without posts like these, I’d still be wishing (truly) that I was dead. x

    1. Hi Amanda, thanks so much for sharing your experience, which mirrors many others (including my own). I too went through a lot of failed treatments before stumbling across an article in the paper about AC. So glad it works for you 🙂 I must contact Dr Nick Panay to find out where he has got to in pushing for AC to be prescribable as a second line treatment for PMS. It should be offered to all women, certainly before other more drastic treatments are tried. As for dosage, I would be interested to know how it compares to the 20mg standardised extract quoted in trials. Thanks so much for posting.

  25. I’ve been trying some products from Prime Health Direct. Their ginger does not appear to be good quality. Ginger’s one where I can tell the difference immediately, as it has a marked effect on how cold I feel. A ginger tablet with the dosage they claim should smell strongly of ginger, and theirs doesn’t. I ended up ramping the dose up to six tablets a day, and still wasn’t getting anywhere near the effect I get from one Solgar capsule.

    Similarly, I’ve been on the PHD agnus castus for a couple of months, and I can’t see any difference. I chart my hormones, including symptoms and basal temperature, so I should be able to tell. I still had a short luteal phase, for instance. I’ve noticed that with other agnus castus extracts, people comment that the tablet smells strongly of the herb. The PHD tablet doesn’t smell of anything at all. To be honest, I strongly suspect that this could be one of the many companies which puts far less of the active ingredient into the product than they claim. I’ll keep going for a while longer, then I’ll double the dose, then I’ll try another brand.

    PHD is *not* the only manufacturer of decent amounts of the extract available in the UK – Nature’s Answer sells a 40mg extract here, and it’s far cheaper than PHD. And we still haven’t established what the 400mg dried fruit is equivalent to in terms of extract.

    1. thanks for coming back to share this information. I will have a look at Nature’s Answer. I agree PHD is not the only manufacturer, but having suffered with low dose tablets (after Boots withdrew the 20mg tablet and replaced it with 4mg) I have found the PHD ones to be effective.

  26. I’m talking to Nature’s Answer over email, but it sounds like it may be a whole herb rather than an extract, which is very odd for 40mg. And also annoying, now that I’ve bought it.

    Meanwhile, if you’re buying from abroad anyway, you can get all sorts of doses if you buy from the US. I’ve seen anything up to 300mg extract, and I do mean extract rather than whole herb. I’m not sure any of the extracts were as weak as 20mg, actually. I think the lowest I found in a single-herb product, rather than a combination product, was 80mg.

  27. Blast. Nature’s Answer first told me the product was 40mg whole herb, then said it was an extract equivalent to 40mg of the whole herb, which I think means that it’s probably 4mg extract. That would explain why it’s on sale in the UK. The fact that they can’t even say for sure whether it’s an extract or the whole herb is highly suspect. I might throw it in as an extra, may as well use the stuff up, and after that I will probably be buying higher levels of extract from iHerb, depending on what dose seems to work for me.

    Judging by everything I’ve read, 400mg whole herb is equivalent to 40mg extract. The whole herb doesn’t seem to be governed by the same limit that’s been placed on the extract. So a 400mg whole herb product may well be twice as strong as the 20mg extract you’re getting at the moment. If I end up trying a high dose, I quite fancy trying the Planetary Herbals product, which contains 375mg whole herb and 125mg extract per tablet. Although having seen the size of a 400mg whole herb capsule, I’m suspicious about how anyone could get that much into a tablet, alongside the extract, too.

    The dosages really do vary enormously. Femaprin is very popular, and I think is the one which is used medically in some European countries. That contains 100mg herb and 225mg extract. It’s extremely popular.

    1. Hi there
      I just wondered if you tried the Bio Health 400mg tablets? If so, did they work? When I found them online I thought they sounded just like the old ones I used to get from Holland & Barrett, only without any fillers or added ingredients! So I ordered them, haven’t started taking them yet, but then discovered they have the THR logo. I’m really hoping they are the equivalent of the old H&B ones, as I found 2 per day of them worked great for me!

      1. With THR logo they can only be 4mg (standardised equivalent) per tablet. You will need to take 5 for them to meet the dose found to be effective in trials. You could however start with 2 and see if it helps – at least if they don’t work you will know the reason. Let me know how you get on.

  28. Thank you for all this very helpful info and work you have put in above!
    I found this page that seem to sell a good concentration product http://www.vitaminbutiken.se/vitex-agnus-castus-munkpeppar-extrakt-kosttillskott.html
    Otherwise I also noticed that lots of people feed Agnus Castus powder to their horses and in that case, one should be able to get hold of the powder pretty cheap.. (like here http://www.justingredients.co.uk/agnus-castus-powder-3704.html) and make the pills one self. This is my blog below where I experimented with making pills some year ago..
    http://matfysik.wordpress.com/2013/05/28/home-made-seaweed-pills/
    I also bought the slippery elm at just ingredients as well as lots of great herbs etc. What ya think? 🙂

    1. Some interesting links. The tablets say they are equivalent to 100mg, so based on my knowledge you would need 2 a day – but I don’t get the 1000mg headline on the bottle. In terms of the powder, I don’t know how it relates to the standardised extract and how much you would need to take – but certainly they are alternatives worth considering thanks for the links.

      1. Thanks for the feedback. So in reality it is 10mg of active ingredient in the pills you think? They do say their pills correspond to 1000 mg dried fruit “Lamberts® Vitex is a standardised extract equivalent to 10OOmg of dried Vitex fruit” and I read before that 200mg dried fruit could be enough.. I’m worried of taking too much.
        I read somewhere on you commentary section someone stating:
        “Each Lindens Agnus Castus tablet provides 50mg x 20:1 extract, equivalent to wholedried herb 1000mg.
        20mg x 10:1 extract is equivalent to 200mg whole dried herb.”
        Mine promises “100mg of a 10:1 extract, equivalent to 10OOmg of dried Vitex fruit” – could it be the active amount is 100mg rather than 10? (This product and brand is quite hyped up in Sweden…could it be because its pretty potent? If I would to email them, can I say “active ingredient” to ask how much of it is the compound we are after??
        Thanks again!

        Btw. on the topic of improving progesterone, which is what Vitex does I came across this info that was pretty interesting. http://www.pcosdietsupport.com/supplements/inositol-and-pcos/

    1. Hi Chris,

      I can ensure you that this is not a sponsored blog. Can you let me know what makes you think it is? Getting hold of agnus castus at that right dosage is quite difficult since 2011 EU regulations on the herbal industry. If I recommend a product it is because I have researched and used it, but I do not receive any money or incentives to do so. I really am just trying to share information about AC with other women. Do take care.

  29. Hello ladies I am a bit lost through all the links on page and have kne simple question as I believe all stated above by yourself Julie, I have secondary amhenorea and desperately trying to concieve and have this week started vitex ac drops using 20 drops twice daily. Is this brand ok? I have seen gynecology/ endocrinoligy/ bloods being checked regularly and no abnormalities in this apart from constantly low lh, and next is gastroenterologist!
    I am aware to stop if I’m fortunate to concieve however feeling annoyed and frustrated I have taken my own health into my own hands recently! I hope to see some results from atarting ac.
    Thanks again

    1. Hi there. Not sure what the dosage actually means in terms of 20 drops. What you need to be taking is the equivalent of 20mg standardised extract. The best way to find this out is to contact the company. A number of women have reported a good result with AC when attempting to conceive, so I wish you luck.

      1. Hello again Julie it has the THR sign and states 1ml (33 drops) contains 895mg of tincture from agnus castus fruits (vitex agnus castus l) (1:10) extraction sil ent: 69.5% v/v
        The other ingredients used for liquid are ethanol and water.

        Can you recommend me a brand that has 20mg please.

        Thanks again

      2. If has THR then the dosage is limited to 4mg per tablet – however in the case of tincture I am not sure how this works. It looks like each 1ml contains around 89mg herb (1:10), so you would need to take at least 2 ml to get to close to 200mg. See my link at top of blog on where to get AC from for further options. Take care and let us know how you get on.

  30. Hi Juliet, so glad to find you and your blog this evening. I have severely messed up hormones & cycle ‘naturally’ and a few years ago a herbal practitioner advised agnus castus, which set everything straight literally the first day I took it. After about a year on it, I stopped taking it and about 8 months later, everything was out of sync again. I didn’t mind this as I was having periods infrequently and didn’t have to deal with them as often as I would if they were ‘normal’. However, the past few months, things have got bad and I also started realising that my severe mood problems are probably tied in with the hormones.
    So, two days ago I decided I had to go back to the health shop and get agnus castus again. They didn’t have the capsules, which I thought was odd. They said the shop in town might have them (vs the one in my suburban village) and I got A. Vogel drops of it instead. Today, I’ve been searching online only to find that the capsules I used to take, that were so distinctly effective, have been discontinued!?!!?!?!? I can’t believe this.
    Then I found this blog and I’m delighted to see someone so vocal about the herb. It’s incredibly powerful and yet so harmless. I can’t believe doctors don’t routinely recommend it to people like me and all the other women that suffer in various ways with their hormones.
    My questions for you: Have you come across the A. Vogel drops and what do you think of them? Would you recommend tablets/capsules over the drops? I’ve been taking the drops and I feel a lot better but I wonder is it the drops or the hormonal change that happens at the onset of the cycle anyways.. I won’t have a clear picture of the drops’ effectiveness until I’ve been taking it for two months, I wonder if it’s a case of ‘cutting my losses’ and going for the pills you link to in this article or if I should continue with them and see how they go…
    Thanks so much & would really appreciate your perspective.
    Keep up the good fight!
    N

    1. Hi Niamh, I have read some good feedback about the A Vogel drops and I list them as potential place to buy them in my post on where to to get AC on. I have not tried this product personally however. Let me know how you get on.

  31. Hi girls,
    i am using A. Vogel drops from almost 2 months to regulate my menstrual cycle, pain, cysts and for PMS. My PMS is reduced, my cycle started with a few days spotting but in time, may be is early for big results, but i think it works 😉 Sometimes i have trouble to sleep and strange dreams, may be that will go away. I start wonder if the dose is low because 20 drops provide 500mg extract, which is 50mg dried fruit.
    The maximum dose is 2 x 20 drops. I am confused what is important the extract number or the number of dried fruit… well i will continue that way for now, till i get more info 🙂 Thanx for sharing all that info with us, so helpful 🙂
    All the best to all, Eli

  32. Hi do you still buy & recommend buying from prime health? Iam taking 5 tablets a day 4mg dose from natures aid company…they are good & do work but is going to be very expensive as I’m used to 20mg..I’ve been taking this dosage for years now! Thank you Mandy

  33. I was using A Vogel drops for about 10 months for breast pain and peri-menopausal symptoms – it really helped but in the last 6 weeks I started to get skin itching on my arms and body and have had to stop as I can not think of another cause and I read this is a side effect. Anyone know how long it takes to get the AC out of the system- I have stopped for around 5 days now but although the itching is milder it still persists?
    Thanks

  34. Hi Juliet,
    I have been taken the primehealthdirect 20mg agnus cactus tablets for the last three months. I am 39, in good health and not obese (I do have some fat around belly though)

    I have noticed a small reduction in PMS settings, however I do still get quite irritable. I know it says it doesn’t work for everyone but as some studies show women saying their PMS almost disappears I was hoping for more reduction of symptoms.

    It has done nothing for my flow which is just as heavy.

    Should I try two tablets a day instead as it has been 3 months now?

    Many thanks,

    Lucy

    1. Hi Lucy, I can’t offer you medical advice, but I am glad you have had some relief. I am not sure AC will be effective for flow and you may want to see your GP if this is an issue. You could try 2 tablets a day for a month and see if it makes any difference – research suggests 20-40mg is effective. Let me know how things go.

  35. After finding your article on Google, I just wanted to say thank you. I have suffered for years with irritability, depression, fatigue and soreness every month. I’ve been taking 20mg of Angus Castus daily for around 5 months (purchased from Prime Health) and am happy to report that myself and my husband have noticed huge changes for the better. I am actually quite bearable to be around these days 😉 I’m just so glad that I stumbled across this page in a moment of desperation! Take care, Anna

  36. Hi there, I have been taking Nature’s Aid PremEze which says it is 400mg (assume this means standardized dose 40mg) – it works for me (I really notice if I stop taking it and have been taking it for about 6 months I think). The dose recommended is one x 2 per day but this is actually 80mg and according to the research you mention & also Univ Maryland Med Centre study 40mg is probably optimal, more not necessarily better. So I am going to try reducing to 1 a day and save myself ££££ – Will see what happens. I have just bought some from e-bay for £6.50 inc p&p which is much cheaper than Health food shop (£12.50). Thank you so much for this info – your website which I just came across by accident – is v interesting. Shocked at cynical behaviour of Holland Barrett etc re dosages. Also herbalist James Wong tells you how to make Agnus Castus vinegar in his book, but when I tried it, it did not seem to work v well (may be because hard to get a standardized dose this way). Namaste.

  37. PS just read some more of the posts above and am a bit confused now (it is a minefield) about what is in the Natures Aid Premeze! Is it 400mg whole herb I wonder? Could then be only 4mg not 40mg. It does seem to work, however. Think will try the Channel Islands Prime Health product you mention as this looks very good value and sounds like the real deal.

    1. If it is working then I wouldn’t worry too much – it sounds like you are taking 8mg, although in research trials this didn’t appear to be an effective dose overall, I am sure there are individual variations.

  38. Hi Juliet, I have found some Periagna Angus cactus fruit capsules 400mg (60 capsules) from Victoria health. Is this not enough? I am going to buy from the link where you posted the 20mg! Confused 🙂 x

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