Criticisms
Upon halting the estrogen-progestin study in women with a uterus in 2002, many women feared using hormone replacement due to the risks of heart disease and breast cancer. Many postmenopausal women stopped their hormone replacement in the mid 2000's with the release of results from the WHI and subsequently the incidence of breast cancer was reduced by thousands of women each year. Despite the reduction in the incidence of breast cancer, experts questioned the applicability of the WHI to the general population.
Women enrolled in the WHI were 63 years old on average, asymptomatic, and on average a decade had passed since the onset of their menopause. Furthermore, the focus of the WHI study was disease prevention. Most women take hormone replacement therapy to treat symptoms of menopause rather than for disease prevention and therefore the risks and benefits of hormone replacement therapy in the general population differ from the women included in the WHI.
Post-study analysis showed that the age of hormone replacement initiation plays a major role in the risk of heart disease and breast cancer. Women who begin hormone replacement therapy 10 years after menopause have much greater risk than women who begin therapy less than 10 years after menopause. In the estrogen-only trial of WHI, women from 50-59 years taking estrogen had fewer heart attacks, deaths, and adverse events than women taking placebo while women from 70-79 years taking estrogen has more heart attacks, death, and adverse events than women taking placebo.
Women in the WHI estrogen-only trial had a mean duration of therapy of 6 years. Women in the estrogen-progestin trial had an even shorter duration of hormone therapy. The risks and benefits of long-term hormone replacement therapy are unknown.
The dietary trial has been criticized by epidemiologists for its lack of validity, both internal (the desired endpoint for fat reduction in diet was not fully achieved) as well as external (a group of post menopausal women is not generalizable to all women). Finally, the mechanism of disease of developing breast cancer may have a significantly longer time course than the duration of the study, and intervention may have been most effective prior to menopause.
Read more about this topic: Women's Health Initiative
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