The Pharmaceutical Journal
Vol 269 No 7222 p633
2 November 2002

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MRC stops HRT safety trial early

A trial looking at the long-term effects of hormone replacement therapy (HRT) has been stopped early, the Medical Research Council announced last week.

The Women's International Study of Long Duration Oestrogen after Menopause (WISDOM) was designed to assess the balance of risks and benefits of both oestrogen combined with progestogen and oestrogen alone, on conditions such as heart disease, breast cancer, osteoporosis and dementia.

Following the termination of a similar study — the US Women's Health Initiative (WHI) — in July (PJ, 13 July, p43), the MRC set up a committee of advisers to review the findings from WHI and to assess the progress of WISDOM. The committee decided that WISDOM was unlikely to provide substantial evidence to influence clinical practice in the next 10 years and therefore recommended that the trial be halted.

Professor Ray Fitzpatrick, director of the Institute of Health Sciences, University of Oxford, and chairman of the committee of advisers, said: "When the WISDOM trial began recruiting in 1999, there were important questions about the risks and benefits of taking HRT long term that needed to be answered. But since then new findings have provided evidence in relation to those questions."

The WISDOM study, which was funded in part by the MRC and the Department of Health, started in 1999 and was due to end in 2016.