Bio-identical Hormones NAPS

Bio-identical hormones: why all the hype?

Nick Panay BSc MRCOG MFSRH, Chairman NAPS

Consultant Gynaecologist, Specialist in Reproductive Medicine, Queen Charlotte’s and Chelsea & Chelsea and Westminster Hospitals.

Honorary Senior Lecturer, Imperial College London.

Director, International Centre for Hormone Health, 92 Harley Street, London

What are bioidentical hormones?

Bioidentical hormones are precise duplicates of estradiol, progesterone and testosterone as synthesised by the human ovary. They are manufactured from plant sources in the laboratory and are available from pharma companies as oral tablets, transdermal patches, implants and gels. Other possible delivery routes include nasal and wafer forms. Fundamental differences exist between conjugated equine (mare’s urine) estrogens and natural estradiol and between synthetic and natural progesterone. These differences might have been partly responsible for the adverse outcomes in HRT trials such as the USA Women’s Health Initiative.1-2

Why the controversy?

Compounding pharmacies have hijacked the term to market their unregulated products which have been promoted in a number of countries by high profile celebrities. Some practitioners promoting these compounded preparations claim to be able to calculate the precise level of each deficiency from salivary hormone levels and then replace the precise amount using estrogen, progesterone and testosterone delivered by lozenges or creams. This practice is not supported by evidence for efficacy nor safety. In reality, imbalances of estrogen / progesterone can lead to problems such as endometrial overgrowth. It is time the regulatory authorities looked at this issue seriously and introduced a statute to bring these hormones under the same regulation as other medicinal products.

Key Messages

  • In order to avoid confusion, it is proposed that regulated products should be referred to as “body” identical rather than “bio” identical.
  • Some studies suggest that beneficial effects can be achieved by the use of body-identical hormones in comparison to non body-identical HRT.
  • Further data from larger studies on cardiovascular and breast endpoints are required to confirm these effects.
  • In the interim, the logical approach is to continue to use individualised HRT regimens according to the evidence
  • Regulated bioidentical products must not be confused with unregulated products from compounding pharmacists.

1) Panay N, Fenton A. Bioidentical hormones: what is all the hype about? Climacteric 2010 Feb; 13(1):1-3.
2) Panay N. Body-identical hormone replacement. Climacteric 2012 Apr; 15 Suppl 1:1-2.
3) Panay N, Hamoda H, Arya R, Savvas M. British Menopause Society and Women’s Health Concern. The 2013 British Menopause Society & Women’s Health Concern recommendations on hormone replacement therapy. Menopause Int 2013 June; 19(2): 59-68

  • base and British Menopause Society guidelines (www.thebms.org.uk), taking into account each woman’s individual risk profile.3Key References