INSIDE

Health Matter

By Virginia Lester,
RN, MSN, ARNP

Women’s Health Initiative, Part I
The Women’s Health Initiative (WHI) was a set of carefully designed, randomized clinical trials in healthy postmenopausal women ages 50 to 79 and was scheduled to be completed in 2005. This was the largest study of its kind (160,000 women in clinical centers throughout the U.S.). The goal of the study was to determine whether estrogen alone or combined with progestin would reduce the risk of cardiovascular events. The WHI was not designed to study the effects of hormone therapy on menopausal symptoms.

In retrospect, perhaps the most startling thing about the hormone replacement therapy (HRT) study was how wrong most experts had been beforehand about the benefits of HRT in postmenopausal women. Now, almost four years after the early halt of the estrogen-plus progestin arm as compared to the placebo arm, the final outcomes balance sheet shows many risks and few benefits. The second trial, unopposed estrogen only versus placebo for approximately 11,000 women who had had a hysterectomy, ran a little longer and compiled better results, with the risks of treatment nearly equal to the benefits. The bottom line for both forms of HRT is that they are recommended only for select clinical situations and age groups. But more importantly, both studies have demonstrated no benefit from HRT in women aged 50 to 79 for heart disease prevention and harm from HRT based on the rates of strokes, venous clotting and dementia in women aged 65 or older.

Data from the WHI trials have led to changes in the recommendations for estrogen therapy. Unopposed estrogen or estrogen and progestin in combination do not appear to protect against cardiovascular disease and may increase the risk of breast cancer. HRT, once believed to prevent osteoporosis, has been replaced with other drugs that can protect against osteoporosis. As a result, the primary indication for HRT (unopposed or combined with progestin) at present is for control of menopausal symptoms.

HRT remains the gold standard for relief of menopausal symptoms (especially hot flashes, sleep and sexual dysfunction), and therefore is a reasonable option for most postmenopausal women, between the ages of 45 to 55 years and who are otherwise healthy and do not have risk factors for heart, vascular diseases or breast cancer. This is especially true if HRT is limited to the shortest duration possible, optimally less than five years and the lowest dose that will control symptoms. Women should be advised to not stop HRT suddenly, but to wean down slowly to avoid having withdrawal symptoms.

Complementary and alternative medicine use is surging among women entering menopause, hoping to have relief and avoiding HRT. Research about the potential benefits of soy on menopausal symptoms has been difficult to interpret due to the differences in product formulations and study parameters. A recent critical review of the beneficial attributes of soy products is mixed. Generally, the studies demonstrate that dietary soy reduces hot flashes by an average of 40-45 percent; however, some studies have found no substantial difference from the overall reduction to placebo. It should be noted that none of the non-HRT alternatives have been approved by the FDA to treat hot flashes. When reviewing information regarding a product, remember to always question if the information is the product of well designed, randomized controlled trials.

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