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…

Advertisements