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Hum. Reprod. Advance Access published online on March 23, 2006
Human Reproduction, doi:10.1093/humrep/del043
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© The Author 2006. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org
Received October 7, 2005
Revised December 4, 2005
Accepted December 13, 2005

Opinion

HRT, osteoporosis and regulatory authorities Quis custodiet ipsos custodes?

John C.Stevenson 1 * and on behalf of the International Consensus Group on HRT and Regulatory Issues

1 National Heart & Lung Division, Faculty of Medicine, Imperial College London, Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK

* To whom correspondence should be addressed.
John C.Stevenson, E-mail: j.stevenson{at}imperial.ac.uk


  Abstract

HRT has been widely used for the relief of menopausal symptoms and the prevention and treatment of post-menopausal osteoporosis. However, following the publication of the Women’s Health Initiative (WHI) and the Million Women Study (MWS), regulatory authorities issued an urgent safety restriction on HRT use in preventing post-menopausal osteoporosis, recommending that it now be considered a second-line treatment. Are such recommendations justified? Treatments for osteoporosis, in women with increased future risk for fractures but who have not yet developed the disease, should prevent all types of osteoporotic fractures. Of the available therapies, none other than HRT has been clearly demonstrated to prevent hip fractures in such women. Thus, HRT should be recommended as first-line treatment for osteoporosis prevention. Potential risks of HRT, such as increased development of breast cancer and increased thromboembolism, have long been known. The WHI showed risks in less than 0.3% of women studied, and the MWS appears to have overestimated the risk of breast cancer. Thus, no new safety issues have been identified, and the regulatory authorities may have misinterpreted the data from these recent studies. When given for the correct indications, HRT is of major benefit to many women.


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