Expert committee gives advice on combined HRT
12 July 2002
The use of long-term combined (containing oestrogen and progestin) hormone replacement therapy (HRT) has been called into question by a large US trial. An expert committee convened by the Australian Government has advised what action Australian doctors and their patients taking combined oral HRT should take.
Findings of the expert committee
The Expert Committee has agreed with the authors of the US trial that combination HRT (that is, HRT containing oestrogen and progestin, also known as progestogen) should not be used in any form for long-term
disease prevention in women who have gone through the menopause. In Australia, long-term combined HRT has been used in the prevention of osteoporosis. The benefits of such treatment do not outweigh the risks involved with taking it.
It may be that women who already have established osteoporosis who are taking combined HRT will be advised by their doctors to continue taking it, but this will depend upon the risks and benefits for that individual.
Short-term use for relief of menopausal symptoms
Use of combination HRT in the short-term, for example, for relief of menopausal symptoms such as hot flushes, remains an appropriate treatment.
The Committee advises that women taking combined HRT should discuss their individual circumstances with their doctor. The risks and the benefits to be gained from taking combined HRT will weigh up differently for different women. For example, in a younger woman going through premature menopause, combined HRT might be expected to have greater benefits and smaller risks than in an older woman.
Future action in Australia
The following are the recommendations of the Committee.
- That a full review be carried out on the use of combined HRT in the long-term treatment and prevention of osteoporosis.
- That all Australian trials currently in progress that are studying combination hormone therapy for chronic diseases be reviewed.
- That all product and consumer information for combination HRT products should be updated.
Why the US trial was stopped
The US Women’s Health Initiative trial into the use of oestrogen plus progestin in more than 16,000 healthy women past their menopause was stopped early because overall health risks of taking the combined HRT were greater than its benefits to women in the trial.
The combined HRT trial was stopped after about 5 years because women treated with the HRT combination had a higher risk of invasive breast cancer than women treated with dummy tablets — they had 1.26 times the risk. Women taking the combination HRT also had 1.29 times the risk of coronary heart disease (primarily heart attack).
Put in perspective, this means that if 10,000 women took combined HRT for 5 years there would be 8 more invasive breast cancers per year (38 cases versus 30 cases) than if the 10,000 women had not taken the combined HRT. There would also be 7 more coronary heart disease events per year (37 versus 30) and 8 more strokes per year (29 versus 21).
On the other side of the coin, the benefits that would be gained among the 10,000 women if they took combined HRT for 5 years would be that there would be 6 fewer colorectal cancers per year and 5 fewer hip fractures per year than if they had not taken the combined HRT. However, these benefits are overridden by the increased risks of invasive breast cancer, coronary heart disease events and stroke, so the risks outweigh the benefits to be gained from taking combined HRT long term.
Advice for Australian women
In Australia, the Jean Hailes Foundation, which provides expert commentary on women’s health issues, has cautioned that Australian women should not panic.
The Foundation has pointed out that the findings indicate that this specific combination of oral HRT can’t be recommended for long-term use, however, the main use of HRT is for short-term relief of menopausal symptoms.
Women on combined HRT
Australian women who have been taking combined oral oestrogen and progestogen for less than 5 years should have an annual review of their therapy with their doctor, says the Jean Hailes Foundation.
Women who have been taking oral combined HRT for coming up to or longer than 5 years should discuss their individual circumstances with their doctor at their next appointment.
Women taking oestrogen who have had a hysterectomy
Women who have had a hysterectomy who take HRT usually take oestrogen alone, without any progestogen (so-called ‘unopposed oestrogen therapy’) and should not worry as the US findings relate to combined HRT. The part of the trial that is studying women who have had a hysterectomy and who are taking oestrogen without progestogen is still continuing.
What about other HRT preparations?
These findings are specifically about oral
combination HRT (tablets), however, the Committee has recommended that combination HRT in any
form should not be used for long-term disease prevention in women after menopause. The Jean Hailes Foundation points out that the findings do not apply to women using HRT alternatives such as raloxifene (Evista) or tibolone (Livial).
Last Reviewed: 12 July 2002