Despite the fact that estrogen replacement therapy has been demonstrat
ed to be of great value to postmenopausal women, many patients are sti
ll reluctant to use it. This is primarily because of fears that sex ho
rmone therapy increases the risk of developing uterine and breast canc
er. Because retrospective epidemiolog ical studies have failed to clar
ify the issue for breast cancer, ambitious prospective trials have bee
n initiated to determine the role of hormones in the development of br
east cancer and cardiovascular disease. The main studies have been the
Women's Health Initiative, the Postmenopausal Estrogen/Progestin Inte
rvention (PEPI) Trial, the Heart and Estrogen-Progestin Replacement St
udy (HERS), the Women's International Study of long Duration Oestrogen
after Menopause (WISDOM) and the Million Women Study. Only the PEPI T
rial has been completed. It showed a substantial benefit for women usi
ng hormone replacement therapy, but was insufficiently powerful to det
ermine whether such therapy affected the incidence of breast cancer. D
espite the immense costs involved and the considerable time that must
elapse before results are published, it is imperative that these major
prospective studies are completed, analysed and published. Only then
can physicians advise their patients in an appropriate manner.