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Tuesday, April 14, 2009

Bio-identical hormones - facts & thoughts

Everyone seems to be talking about bioidentical hormones (BHRT) these days. If you are female, and at menopausal age, you would certainly either know someone, or heard about someone using them.

Facts
  1. Bioidentical hormones are NOT natural - they are synthetically made from plant source to be identical to the hormones naturally occurring in your body.
  2. Bioidentical hormones can be given orally, transdermally, sublingually and will be absorbed into the body. There might not have been any large scale clinical trials, but there are enough clinical evidence that it works.
  3. Female who uses bioidentical hormones get relief of their symptoms. There might not have been any large scale clinical trials, but there are enough clinical evidence that it works.
  4. The prescribing and supply of BHRT is legal, and it is governed by the TGA. The most controversial DHEA is a Scheduled 4 item - which means a Doctor may prescribed the item and a pharmacist may supplied it. It not a registered drug on the TGA list because there is no commercial product available. The fact it is not registered doesn't mean it is not approved for use.
  5. The practice of compounding is governed by the Pharmacy Board of the individual state.
  6. There is no hard safety data comparison to an off the shelf product. Bio-identical hormones is potentially as dangerous as an off the shelf product.
  7. The products made by different pharmacies are not standardised. The quality control of each compounding pharmacy varies. There are pharmacies who do the right thing, and there are pharmacies who don't.
  8. A manufactured pharmaceutical would always be more precise than a compounded product. By law, a compounded product must be within 10% of the stated labelled amount. Many manufactured products would only have 90% of the stated amount just before their expiry date - this is very definition of the expiry date.
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Thoughts

Being a compounding pharmacist who is interested in anti-aging, you would be surprised that I don't necessarily promote the use of it without caution. Unlike some advocates, I certainly don't believe everyone at that age should be using it.

It is important to consider what is the intended treatment outcome. If it is for the relief of symptoms associates with menopause, then the lowest possible dose should be used. As for anti-aging, there are still a lack of safety profile and proof of efficacy in the area. A big caution should apply to people who would like to take that path (I would address this at a later blog).

Despite the lack of research in the area, bio-identical hormones should be as safe as other synthetic hormones available on the market. Synthetic hormones are mostly enhanced and behave differently to the hormones found in your body. BHRT, if used appropriately, should not post more risk than synthetic hormones.

However, it doesn't mean bio-identical hormones are safer. It is very important to have the same precautions if an off the shelf hormone is prescribed. I believe that the potential in reduction of risks with BHRT is the patient are often more closely monitored by their physician. Doctors who prescribe BHRT often review their patient more regularly, and using their patient's levels and symptoms as a guide to titrate the dose. Unlike ready made HRT, the dose made by the compounding pharmacist is infinitely adjustable to suit the needs of the patient. BHRT is used incorrectly, it would be as dangerous as off the shelf HRT.

As stated earlier, for the treatment of menopause, it is important to use the lowest dose to relieve symptoms to reduce the potential risks of treatment. I believe it is an important aspect of monitoring of the therapy. Not so much to "treat the levels", but to give clues to the efficacy of the compounded product, treatment failure, and monitor of overdosage. In reviewing many position statements from various societies - I am astounded that they do not promote or recommend hormone level testing. To me, it is just like diagnosing a broken leg without a X-ray.

BHRT is an alternative to conventional HRT. There are risks and benefits. The risks are often overstated by the Againsts, and the Fors often over emphasized the benefits and sometimes even making false claims.

Here are some good links re bio-identical hormones. I have include some balanced presentations as well as the against presentations. It is unfortunately that some well respected society and university don't get their facts right. Should you have any more questions, you can always drop me a line.

sparoz (BPharm)

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