Pitfalls of the WHIs: Women's Health Initiative

George Mastorakos, Evangelos Gr Sakkas, Antonios M Xydakis, George Creatsas
Annals of the New York Academy of Sciences 2006, 1092: 331-40
Recently, the use of hormone replacement therapy (HRT) at menopause has become a matter of debate. Its utility has been questioned after the publication of the results of the Women's Health Initiative (WHI) studies. This trial was divided in two arms of which the first examined the use of combined HRT (continuous estrogens plus progestins) and the second the use of estrogens alone in menopausal women. The first arm was terminated prematurely at 5.2 years because the number of cases of coronary heart disease (CHD), strokes, venous thromboembolic disease, and breast cancer were more in women receiving HRT than in women receiving placebo, if the nominal confidence intervals (CIs) were taken into account. However, in the same study the authors made clear that the adjusted CIs should be taken into account instead of the nominal ones. These latter ones caused the ending of the trial. Moreover, WHI was criticized for its conclusions as far as cardiovascular disease is concerned because of serious defects regarding design of the trial. If the adjusted CIs were taken into account then the increase in adverse events was significant only for deep vein thrombosis. The second arm demonstrated that the use of estrogens was not correlated to an increase of neither breast cancer incidence nor cardiovascular disease. A closer look at the results of the WHI trial reveals that the use of HRT for 5 years should not be considered deleterious for the appearance of breast cancer, cardiovascular diseases, strokes, and pulmonary embolisms. We suggest that HRT should be given early in menopause. The regimen should be individualized for each patient. More intense follow-up should be offered to women with a positive family history of breast cancer, diagnosed coronary disease, and to women with a predisposition to deep venous thrombosis.

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