Menopause Discussion > Alternative Therapies

Progesterone cream undergoing trials

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honeybun:
Seems that Dr Studd was involved in this. The results....whenever they are available should be very interesting.
I found this article.
I think it's quite old but makes interesting reading as we have had many questions about this over the years and this is the place to discuss it.

It comes from an old Guardian article


" Women want them. Doctors have mocked them.
American women rub it on their faces and arms and swear that it reaches places other moisturisers don't.

Now a multi-million dollar cream, sold as a cosmetic in the US, is being tested as one half of a potential dream ticket 'natural' HRT that could hit the market just as the baby-boomer generation hits the menopause.

Natural progesterone cream holds a uniquely contentious position in the UK. It's banned as an over-the-counter product because it's a hormone.

Doctors deride it as a clinical joke, saying it isn't even absorbed through the skin. But thousands of women are rattling at regulators' doors demanding access to a product they believe could add quality to their postmenopausal years. So what is the story with 'natural' progesterone cream?

The history of the cream starts in the States in the late 70s when researchers first realised that using oestrogen on its own as a therapy for osteoporosis raised the risk of cancer.

The pharmaceutical industry responded by adding progestogen, a synthetic form of progesterone developed for the contraceptive Pill, to oestrogen replacement therapy, making what we currently know as HRT.

But progestogens can have unpleasant side-effects in some women including headaches, mood swings, bloating and bleeding symptoms which have helped to make HRT a minority experience. Less than 10% of women continue taking HRT beyond one year, despite studies showing long-term beneficial effects on heart and bones.

The 'natural' version of the hormone, previously only available as an injection, isn't natural in the way that vitamin C in oranges is natural. It is chemically synthesised, from a plant, usually soya or wild yam just as progestogen is.


What allows people to coin the word 'natural' is that it is chemically identical to a woman's own progesterone and therefore, at least theoretically, less likely to cause side effects.

First made up by a US biochemist and sold in health food shops, the cream was taken up by a West Coast physician, John Lee, who has recommended it to thousands of women over the last two decades.

His claims for the hormone never subjected to scientific scrutiny are massive, far out-shining the claims for oestrogen. Progesterone cream, he claims, not only maintains bone mass as oestrogen does, it also actually builds bone, repairing any damage caused by osteoporosis.

Lee's own records of a 100 women patients show an average 15% and up to 50% increase in bone density.

Not surprisingly, such claims have been dismissed by the medical establishment as both unproven and unlikely. The first-ever clinical study on progesterone cream carried out by Kings College Hospital gynaecologist, Professor Malcolm Whitehead, two years ago, found that it wasn't absorbed properly through the skin.

'Even if it could be absorbed, there would still be insurmountable problems, in my view,' says Whitehead. Unlike oestrogen, progesterone acts as a building block for a whole range of other hormones which means its plasma half-life is about 20 minutes. That means huge quantities would be required in order for it to have any effect, he says.

For such an unpromising product, natural progesterone is still the subject of intense clinical interest not least because women users have been so vocal.


Trials of the cream are about to about to start at Chelsea and Westminster hospital in combination with another 'natural' hormone, oestradiol, also extracted from wild yam or soya and chemically identical to the body's oestrogen, unlike the oestrogens most widely used in current HRTs.

It is also available as a cream. Up to seven double-blind randomised trials are being mounted to test the ability of these two hormone creams to work together as well as their impact in preventing menopausal symptoms and their effect on bones. Unusually the studies are being financed by funds raised on the stock market by Higher Nature, an alternative health company.

Gynaecologist John Studd who is supervising the trial, emphasises that the lack of data on natural progesterone means that anything could happen in the trials. 'We've no idea whether it will have any effect at all or whether it will cause bleeding when used in combination with oestrogen.'

But, says Studd, it is undoubtedly true that if a combination of natural oestrogen cream and natural progesterone cream used every day could provide the protection and the health benefits of HRT without the side effects, it would be a brilliant success.

There are encouraging omens. For a start, research already carried out by the Chelsea and Westminster team suggests that absorption is not, in fact, a problem though it may take slightly longer, than previously believed for blood levels of the hormone to rise.

'My personal experience now suggests that there is absorption of progesterone from progesterone creams, though until we have published the evidence, obviously there will be scepticism within the medical community and rightly so,' says Adam Carey, senior registrar working on the trials.

Adam Carey adds that in the second half of their menstrual cycle, women produce around 25mgs of progesterone every day which has a range of important though poorly understood benefits for women.

'Back in the 30s, scientists found that feeding mashed-up sheep's ovaries to menopausal women improved their symptoms - and it's taken us all this time since then to explain what happens. It could be the same story with progesterone.' "


Interesting stuff.


Honeybun
X

Dana:
This is quite an old article, because because Prof Studd has already addressed the results on his site..... http://www.studd.co.uk/bioidentical_hormones.php


--- Quote ---The problem with bioidentical hormones comes with the progestogen components. The much heralded expensive progesterone cream available on the internet with exaggerated claims of increase in bone density and improvement of depression, hot flushes, sweats, etc is in fact virtually ineffective as it is hardly absorbed. My team have spent more than £100,000 studying this preparation over the last few years and it has no effect whatsoever on bone density, no effect upon mood and no effect upon the symptoms of flushes, sweats and headaches which are the common symptoms of the menopause. It might have a tranquilising and sedating effect if it is absorbed. These results have been published in Menopause International (Benster et al).
--- End quote ---

Dana:
Prof Studd - "These results have been published in Menopause International (Benster et al)". Maybe you should look it up if you want more information.

The fact is that he is not in the middle of some new study, so to post an old article that implies he is, is misleading. There seems no point in getting women all excited about a potentially new study, when there isn't one - well not by Prof Studd anyway. Maybe someone else is though. Personally speaking I would love there to be a progesterone cream that actually did all the things that Utrogestan or progestins do, but sadly at the moment that doesn't appear to be the case.

I'm simply posting the facts. People can draw their own conclusions about the findings.

Hurdity:
As Dana has said this is a very old article - from 1999 so I too am puzzled by the thread title?  I am sure there should be further trials - and maybe there are going on somewhere?

There also seems to be some misunderstanding about views on progesterone cream and progesterone itself. As Dana said "Personally speaking I would love there to be a progesterone cream that actually did all the things that Utrogestan or progestins do, but sadly at the moment that doesn't appear to be the case."

I quite agree! As I have said many times on other posts, those of us who are opposed to the promotion of commercial progesterone creams are of course not opposed to progesterone per se - of course we're not - we take it!!! It is the continuing pushing by companies of a very weak formulation of this (commercially - and especially in America but which has filtered over here to some extent) as the answer to all women's menopausal problems! In addition the attempted ongoing use of it for endometrial protection - including to British women on this forum, when it is quite clearly not appropriate for this purpose!!

Like Dana, many women would welcome a transdermal formulation of progesterone in sufficient strength to be used as part of HRT. This can be obtained (I gather) in higher strengths through what is known in America/Australia as BHRT (bio-identical HRT) from compounding phramacies - at great expense - and also probably in UK. However there is no standard for this so it is not possible to determine how much to use and how much will get into your system - and in any case we should be able to obtain all such meds on NHS.

As to your comment Prajna about proof of absence etc - I'm not sure what you are getting at? In medicine a potential drug is identified first for its efficacy and then trialled for this, and above all for it safety - short and long term. Until such evidence shows that the drug is safe and effective for the purpose for which it has been developed then it cannot be licensed for use. Of course absence of evidence does not mean that there never will be evidence nor that does absence of evidence prove that something doesn't work - but science and especially medicine has to operate on the precautionary principle, and as such absence of evidence (about safety and efficacy) means - the substance/drug cannot be used.

The latest article Prajna is an American one produced by supporters of progesterone cream and it is no surprise that right by the article is an advert selling it (the dreaded cream!). The reason there are/were a lot of articles like this in America is because HRT was for a long time Premarin (from horse urine) and synthetic progestogens such as MPA or norethisterone. In UK we have had what they term "natural hormones" for a long time on NHS - as estradiol and progesterone - so the issue doesn't arise in this country as long as women do some homework about HRT types available.

Progesterone seems to have many functions in the body, some of which are not yet properly understood - men have progesterone at low doses, as do women in post-menopause - although not in the quantities need for producing babies once this function is no longer needed. Whether its use pharmaceutically has any health benefits is still unclear - although the areas studied by Prof Studd do not appear to have shown benefits. However, there does seem to be a lot still to be discovered about the role of all hormones and no wonder as we are very complex organisms. Science is a dynamic process and theories are revised constantly in the light of new evidence.

One day theories and therefore practice may be revised, but until such time, the claims made for the OTC cream appear to be largely unsubstantiated.

Hurdity x

ancient runner:
Am I being thick here? What's the difference between "natural oestrogen" and "natural progesterone" and HRT? Genuinely puzzled.

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