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.
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.
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.
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.
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.