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The rise and fall of HRT

Mr Narendra Pisal and

Dr Michael Sindos review the latest evidence that is forcing doctors to re-evaluate HRT

ignificant shifts in opinion about hormone replacement therapy (HRT) in recent medical literature are forcing us to re-evaluate the way we prescribe this drug so beloved by many peri- and post-menopausal women. The current spate of key papers suggest HRT should be prescribed on an individual basis only after careful consideration of indication, risks and benefits.

A major recent study involving 16,608 women by the Women's Health Initiative (WHI) in the US concluded risks for the study group on combined HRT outweighed any potential benefits. Publication of latest findings from the WHI study on the New England Journal of Medicine website in April this year suggested HRT did not even enhance health-related quality of life in a meaningful way.

Risks and benefits of HRT

Heart disease Unlike earlier observational studies suggesting the possibility of some protection against heart disease, the WHI study showed a small but significant increased risk for events such as non-fatal myocardial infarctions. The risk for heart disease was 29 per cent higher for the group taking combined HRT than for the group on placebo. While this percentage seems large, the annual increased risk for an individual woman is relatively small.

On average during a year of the WHI study, there were 37 heart disease events per 10,000 women in the HRT group compared with 30 in the placebo group. This amounts to an average of just seven more cases per 10,000 women per year in the HRT group. This risk appeared in the first year of HRT use.

Breast cancer The risk for invasive breast cancer was 26 per cent higher in the group on HRT. There were 38 cases of breast cancer per 10,000 women per year on HRT compared with 30 on placebo ­ amounting to, on average, eight additional cases per 10,000 women per year in the HRT group. The increase in breast cancer was apparent after four years of HRT use, and the risk appears to be cumulative.

Stroke There was a 41 per cent increased risk of stroke for the group on HRT. On average, per year there were 29 cases of stroke per 10,000 women on HRT compared with 21 on placebo (eight more cases per 10,000 women).

Thromboembolism Patients on HRT had twice the rate of thrombosis as those taking placebo. On average, per year there were 34 cases of thrombosis per 10,000 women on HRT compared with 16 on placebo (18 more cases per 10,000 women).

Colon cancer The risk of colon cancer was reduced by 37 per cent in the HRT group. On average, per year there were 10 cases of colorectal cancer per 10,000 women on HRT compared with 16 on placebo (six fewer cases per 10,000 women). The benefit appeared after three years of HRT use and became more significant over time.

Osteoporotic fractures In the HRT group, there was a 24 per cent reduction in the incidence of total fractures and a 34 per cent reduction in hip fractures. On average, per year there were 10 cases of hip fracture per 10,000 women on HRT compared with 15 on placebo (five fewer cases per 10,000 women).

Relief of vasomotor symptoms HRT is very effective in relieving vasomotor symptoms ­ with the present evidence this appears to be the only valid indication for prescribing it.

Quality of life HRT makes no meaningful difference to the health-related quality of life of women, according to a recent NEJM article. HRT resulted in no significant effects on general health, vitality, mental health, depressive symptoms or sexual satisfaction, but it was associated with some benefit in terms of sleep disturbance, physical functioning and bodily pain.

To prescribe or not to prescribe?

HRT is no longer recommended to prevent heart disease in healthy women (primary prevention) or to protect women with pre-existing heart disease (secondary prevention). Not only does it not work, but it may actually increase risk of a myocardial infarction or stroke.

Lifestyle changes can help prevent heart disease ­ particularly regular exercise, smoking cessation and weight control. For certain women at high risk of heart disease, other medications (statins and antihypertensive medications) have been shown effective.

If HRT is prescribed solely to prevent osteoporosis, consider other options such as bisphosphonates and selective oestrogen receptor modulators (SERMs), which do not increase risk of breast cancer or heart disease. For these women, lifestyle recommendations should include a diet high in calcium (1200-1500mg per day for post-menopausal women) and regular weight-bearing exercise such as jogging or walking. To date, HRT is the most effective treatment for relieving vasomotor symptoms such as hot flushes and sleep disturbances. It is also effective in treating genitourinary symptoms such as vaginal dryness.

If HRT is prescribed for relief of menopausal symptoms:

 · It should be prescribed for the

shortest possible time in the smallest effective dose.

 · The reasons for prescribing HRT should be reviewed annually and, if it is reasonable, HRT should be discontinued.

 · Regular self-examination of breast and mammography should be recommended.

If a woman is on HRT for more than five years, it is time to consider whether treatment should be discontinued. Some lifestyle modifications may help reduce returning menopausal symptoms.

These include smoking cessation, avoiding or reducing foods or substances that may trigger flushes (spicy foods, caffeine and alcohol), lowering stress levels, exercising regularly and wearing loose clothing. Medications such as selective serotonin reuptake inhibitors (SSRIs) for sleep disturbances and clonidine for hot flushes may be useful.

For symptoms such as vaginal dryness, alternative oestrogen delivery methods may be effective: vaginal creams, tablets or rings. Although systemic absorption of oestrogen appears to be minimal, long-term safety data of local administration of HRT are not available.

What about women already on it?

For this group, the following factors should be considered:

 · Indication for HRT use.

 · Benefits already present.

 · Individual's risk factors, such as family history of breast cancer or heart disease.

Many women may wish to continue taking HRT. They need to make an informed decision after a thorough discussion of the risks and benefits and other treatment options.

The role for HRT now appears to have shrunk to a well-selected group of peri- or post-menopausal women with moderate to severe vasomotor symptoms. HRT use should generally be limited to a maximum of five years. For protection against osteoporosis alone, SERMs or bisphosphonates should be used instead

of HRT.

clinical

HRT risks and benefits shown in WHI studies

 · Heart disease 7 more cases per 10,000 women per year

 · Breast cancer 8 more cases per 10,000 women per year

 · Stroke 8 more cases per 10,000 women per year

 · Thromboembolism 18 more cases per 10,000 women per year

 · Colon cancer 6 fewer cases per 10,000 women per year

 · Osteoporotic fractures 5 fewer cases per 10,000 women per year

 · Vasomotor symptom relief Very effective and only valid reason for

prescribing

 · Quality of life No significant effects on general health,

vitality, mental health, depressive symptoms and sexual satisfaction, but some benefits for sleep disturbance, physical functioning and bodily pain

The rise and fall of HRT

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