Good News about HRT

In response to the advice of the Irish Medicines Board regarding the prescribing of HRT the Irish Menopause Society at its annual conference held in conjunction with the British Menopause Society on December 6 released a statement endorsing the position of the British Menopause Society and the Women’s Health Concern.

It is the opinion of experts at the joint meeting in Dublin that:

There is no new data that should make clinicians change their practice of prescribing HRT for the two established indications, namely relief of menopausal symptoms, and prevention and treatment of post menopausal osteoporosis. Yet again, the regulatory authorities have confused, rather than clarified, issues for HRT, and have done disservice to both medical practitioners and their patients.

Women considering starting on HRT should expect to derive overall benefit, providing it is started for the right reasons. Those who are on HRT, and are happy to continue it, should feel confident to do so. The problem is that their doctors may not now share this confidence, thanks to inappropriate messages being given to them.

The Chairman of the Committee on Safety of Medicines today issued further advice on the use of hormone replacement therapy (HRT). The new advice comes from a review of recent studies of HRT, although it is not stated who carried out this review. It is correctly stated that the risk-benefit ratio if HRT is favourable for treatment of menopausal symptoms. It is then recommended that the minimum effective dose should be used for the shortest duration, although whether this is days, weeks or years is not stated. Of the main conclusions, a new one is that the risk- benefit of HRT if unfavourable for the prevention of osteoporosis as first-line use. The advice is that HRT should not be considered first-line therapy for the long-term prevention of osteoporosis in women who are over 50 years of age and at an increased risk of fractures. The review appears to be based mainly on the findings of the Women’s Health Initiative (WHI), and the Million Women Study (MWS).

It is extremely surprising that such advice should be issued, when there has been no long-term prospective study of the risk-benefit ratio for HRT give to women at increased risk for osteoporotic fractures. The findings of WHI were derived from a study of healthy women who were not selected because of increased osteoporosis risk. It was deemed by the study authors that the risk-benefit ration was not in favour of HRT, using their own selected outcomes. WHI showed that HRT caused a substantial reduction in osteoporotic fractures. This effect would, of course, be considerably greater in a population at increased risk, and would clearly alter the risk-benefit ratio, shown in WHI, in favour of HRT. HRT is as effective as any other currently available agent for the prevention and treatment of osteoporosis, and has considerable advantage, in terms of cost, over alternatives with similar efficacy. The efficacy of alternatives preventing fractures in younger postmenopausal women is not established, nor is there long-term safety over 10 to 20 years.

The message also continues to perpetrate the myth that all convention oestrogen-only and combined (oestrogen plus progestogen) HRT products are the same. This is true only for symptom relief and osteoporosis prevention. In terms of cardio-vascular effects, the effects are dependant on both dose and type of preparation, a fact previously overlooked by the CSM. It is therefore distinctly possible that HRT could be designed to avoid any cardio-vascular harm, or indeed actually confer benefit. In terms of breast cancer, the type of HRT may be crucial. The oestrogen-only arm of WHI has not reported any increased incidents of breast cancer. The findings of MWS are in conflict with WHI on this issue, and it is surprising that reliance should be placed on a study (MWS) whose findings have been so extensively criticised. The long-term safety of HRT may therefore be determined by the HRT regimen used, and when it is first initiated. In terms of total mortality and life expectancy, there is currently no convincing evidence that women on HRT do not live as long as those not taking it; indeed, there is observational evidence to the contrary.

Dr Paul Fogarty, Dr Chantelle McNamara, Dr Cathy Casey, Ms Netta Williams, Dr Barbara O’Beirne (Irish Menopause Society)

Miss Joan Pitkin, Dr Margaret Rees, Dr John Stevenson, Dr Margaret Upsdell (British Menopause Society & Women’s Health Concern)

National Institutes of Health Press Release