Hormone replacement therapy (HRT)

This section provides information on the risks and benefits of hormone replacement therapy (HRT).

In the UK, HRT products are licensed for helping relieve the unpleasant symptoms that can accompany the menopause, including hot flushes, vaginal dryness and night sweats.  Some HRT products may also be used for the longer-term prevention of osteoporosis (which can cause bone fractures) in post-menopausal women who are unable to take any other osteoporosis prevention treatments or for whom other treatments have been unsuccessful.

HRT achieves this by providing low doses of oestrogen, with or without added progestogen, to replace those that your body no longer produces after the menopause. 

HRT products are available as tablets, implants, patches, vaginal rings, gels and as a nasal spray.  There are two main types of HRT – oestrogen-only HRT and combined HRT that contains both oestrogen and progestogen. In combined HRT products, the oestrogen and progestogen may be taken in the same tablet or patch or separately and the progestogen may be taken every day or for 10-14 days of each monthly treatment cycle.

Download the UK Public Assessment Reports, which discuss the latest evidence for the risks and benefits of HRT as at September 2007:
› Hormone-replacement therapy: safety update - UK Public Assessment Report
› Tibolone (Livial): benefit-risk evaluation - UK Public Assessment Report

Side effects
Common side effects of HRT include nausea, breast tenderness, weight gain and fluid retention.  This section contains information about the less common, longer-term side effects associated with HRT use, including:

A summary of the known risks and benefits of HRT was provided for users in July 2002:

› Risks and benefits of HRT - message to health professionals from Deputy Chief Medical Officer, Department of Health and Committee on Safety of Medicines press release - 11 July 2002

Further information may also be found in the following issues of the MHRA's safety bulletins
› Drug Safety Update - September 2007PDF file (opens in new window) (152Kb)
› Current Problems in Pharmacovigilance - April 2002PDF file (opens in new window) (185Kb)
› Current Problems in Pharmacovigilance - October 2002PDF file (opens in new window) (198Kb)
› Current Problems in Pharmacovigilance - September 2003PDF file (opens in new window) (260Kb)
› Current Problems in Pharmacovigilance - October 2004PDF file (opens in new window) (74Kb)

As a result of increasing knowledge about the risks of its long-term use, HRT is no longer recommended as the first choice for preventing osteoporosis. For further information please see the document below:
 
› Use of HRT in the prevention of osteoporosis: important new information

For further information on the side effects of HRT refer to the patient information leaflet (PIL) that should accompany every pack of medicine.  PILs are also available on the electronic Medicines Compendium website.

Studies
Many of the risks associated with longer-term HRT use were identified in the Women’s Health Initiative (WHI) trial,  the Women’s Health Initiative Memory Study, or WHIMS,  and the UK Million Women Study. Further information on the UK Million Women Study is available in the following documents:

› HRT and breast cancer - results of the UK Million Women study - 8 August 2003
› Latest data on HRT from the UK Million Women study - 29 April 2005


Page last modified: 03 March 2008