Hormone replacement therapy (HRT) should no longer be the treatment of choice for preventing osteoporosis in women aged over 50, the United Kingdom's regulatory agency on medicines and devices has advised.
In addition, women with severe menopausal symptoms should be prescribed only the “minimal effective dose... for the shortest duration,” recommended the Medicines and Health-care Products Regulatory Agency, last week.
The move follows a Europe-wide review of the risks and benefits of HRT in response to growing concerns about its long term use.
Recently, the German Commission on the Safety of Medicines advised their doctors to prescribe HRT only for particularly severe menopausal symptoms. The head of the commission, Professor Bruno Müller-Oerlinghausen, likened HRT to thalidomide.
Recent research findings have dented confidence in the use of HRT. One arm of the women's health initiative study (JAMA 2002;288: 321-33) showed a small increased risk of breast cancer, cardiovascular disease, blood clots, and stroke among women taking the combined form. A second arm of this study, comparing the effects of oestrogen alone with placebo in women who have had a hysterectomy, is ongoing.
The million women study, published in August (Lancet 2003;362: 419-27) showed that use of HRT among women aged over 50 during the past decade in the United Kingdom has resulted in an extra 20 000 cases of breast cancer, with the combined form accounting for 15 000 of these.
Although welcomed by osteoporosis and breast cancer charities, this latest advice prompted the swift resignation of one of the key players involved in drawing it up on behalf of the agency.
Professor David Purdie, of the independent Edinburgh Osteoporosis Centre and a member of the Committee on Safety of Medicines' Expert Working Group, considered that HRT still had a role in preventing osteoporosis among women in their early 50s, although in October he chaired the organising committee of a consensus conference at the Royal College of Physicians of Edinburgh, which came up with similar conclusions (www.rcpe.ac.uk/esd/consensus/hrt_03.html).
A copy of the advice can be found at www.medicines.mhra.gov.uk