The Pharmaceutical Journal
Vol 270 No 7252 p783
7 June 2003

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Further trial results cast doubts over benefits of hormone therapy

Further results from the Women's Health Initiative (WHI) study support earlier conclusions that the risks of hormone replacement therapy (HRT) outweigh the benefits. Two analyses examined dementia and cognitive function and a third looked at risk of stroke.

In the first, the Women's Health Initiative Memory Study, 4,532 post-menopausal women free of dementia and aged over 65 years were given either HRT (as 0.625mg conjugated oestrogen plus 2.5mg medroxyprogesterone) or placebo. A total of 61 patients developed probable dementia, 40 in the HRT group and 21 in the placebo group. Evidence of increased risk began to appear after one year and persisted for five years of follow-up.

Although the rate of women developing probable dementia in the HRT group was twice that in the placebo group, the researchers say that the absolute risk is small. "The increased risk would result in an additional 23 cases of dementia per 10,000 women per year." (JAMA 2003;289:2651).

A second part of WHIMS found that HRT did not improve global cognitive function compared with placebo. Patients were assessed using a mental state examination. Patients in the HRT group had smaller, although not clinically important, increases in score than did patients in the placebo group (ibid, p2663).

Finally, further analysis of the main WHI study, involving 16,000 women, has confirmed that HRT increases risk of stroke.

Overall, 1.8 per cent of the HRT group and 1.3 per cent of the placebo group had strokes. For all types of stroke, this represented a 31 per cent increased risk of stroke in the HRT group. Looking at subtypes of stroke, this risk was significant for ischaemic stroke (hazard ratio, 1.44) but not for haemorrhagic stroke (hazard ratio, 0.82). The increase in risk did not appear until after the first year of treatment (ibid, p2673).