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Safety concerns about HRT are virtually reversed

5th April 2007

Five years ago, the investigators of the US Women’s Health Initiative (WHI) published their first paper on the effects of hormone replacement therapy (HRT), stating that combined oestrogen/progestogen HRT resulted in increases in coronary heart disease, stroke, blood clots and breast cancer. This led to widespread adverse publicity about HRT, and to regulatory authorities issuing safety restrictions on its use throughout Europe and the USA. The effect of this was to dissuade both women and their doctors from using HRT, with the results that thousands of women have subsequently suffered from menopausal complaints and may have done untold harm to their future health. Many international groups of experts, including the British Menopause Society and Women’s Health Concern, had expressed disquiet about the initial conclusions of the WHI, and further publications from the same study showed in fact that the risks for coronary disease with combined HRT were not significantly increased, and were actually lower with oestrogen-alone HRT, particularly in the younger age group of 50-59 years. The WHI investigators have now published the combined results of their trials of HRT on cardiovascular disease, using oestrogen both with and without additional progestogen. They have confirmed that those women aged below 60 years and less than 10 years past menopause have a lower risk of coronary disease, a lower risk of death from any cause, and no increased risk for stroke. It is only in the older age groups where increased risks are seen, ages at which it is unusual to commence HRT. Furthermore, the WHI gave the same dose of HRT to all women irrespective of their age, yet there are good reasons to think that the dose was too high for the older women, hence causing vascular harm. The WHI investigators signally failed to comment on this important issue. It also emerged last year that the increase in risk of breast cancer was confined to women using combined HRT who had previously taken HRT before entering into the study. Women taking oestrogen-alone HRT actually had a lower risk of breast cancer. It is quite astonishing that the study, which initially warned us of all the dangers of HRT, is now showing us virtually the opposite. But where is the publicity about this? And will the regulatory authorities act with the same speed as they did to warn against HRT to now correct their advice. There were calls from an International Consensus Group last year for them to revisit their recommendations. The British Menopause Society and Women’s Health Concern request that the regulatory authorities, including the European Agency for the Evaluation of Medicinal Products (EMEA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) now do so as a matter of urgency.

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