October 2002

Position Statement on the Women's Health Initiative Study Findings
By Michelle P. Warren, M.D.

I am professor of Medicine and Obstetrics and Gynecology at Columbia College of Physicians and Surgeons and founded the Center for Menopause, Hormonal Disorders and Women's Health in 1997. My interest stems from our interest in the effects of estrogen deficiency in women, and a long term research and clinical interest in the effects of replacement. Our center is now seeing approximately 2500 patients a year, and is growing rapidly.

I became interested in the devastating effects of estrogen deficiency in premenopausal women by studying amenorrheic women. These studies were started over 20 years ago, have been funded by the NIH and are on-going. We also see large numbers of women with premature menopause, some of whom have not initiated hormone replacement because of fear of breast cancer and ongoing negative announcements on hormone replacement. There is also an increasing number of women who have ovarian failure due to chemotherapy for nonreproductive cancers and seek guidance for the treatment for their symptoms. The severe problems that these women experience, in particular the osteoporosis, have been well-documented. Presently, drugs on the market other than estrogen, are not approved for premenopausal women under age 50, or women with amenorrhea.

The Women's Health Initiative study has given us an important glimpse of the benefits and risks of treatment of women to prevent chronic disease after menopause, but because of the enrollment of large numbers of women who were well past menopause, and an average age at enrollment of 63 years, there is no data for these issues of replacement, particularly focusing on women 10 to 30 years younger. The age of patients in the WHI do not reflect normal clinical practice where replacement is used mainly for symptoms including hot flashes. Other symptoms such as joint pains, non-hot flash-induced palpitations, and mood changes respond to treatment, yet the pathophysiology and effectiveness of HRT or ERT for these symptoms remains unclear, and even the pathophysiology of hot flashes is poorly understood. Treatment of these symptoms is important for quality of life, normal function of women both socially and in the work place, and deserves attention and further study. At the present time, the presentation of the findings of WHI to the public by the press which included emotional quotes and further liability conscious statements by medical organizations, has led large numbers of women, including very young women, to discontinue hormone replacement. Some of these women have turned to the use of oral contraceptives with the misperception that these may be safer, despite their large doses and lack of randomized, double-blind studies on their use in this context. Some women have turned to other preparations, or alternatives with further misconceptions that they may be "safer". So, at the present time the treatment of menopausal women is turning to unknown risks rather than known risks.

WHI has given us interesting observations on the biology of HRT and its effect in women, most of which were well past menopause. There are unanswered questions which remain, particularly on quality of life issues, the age at which risk overtakes benefits with respect to chronic disease prevention, and the disconnect between the biology of HRT on the heart, in particular the positive effects of lipids and coronary endothelial relaxation, and the increase in cardiac risk despite these effects. In that context, little attention has been paid to the very accurate predictor of risk and benefit by the Nurses' Health Study with the exception of the cardiac risk which showed harm rather than benefit. One important issue is that the Nurses' Health Study examined women who were at menopause and initiated treatment paralleling normal clinical practice. The effects of HRT may differ at this age. Also, these women showed clusters of healthier behaviors and profiles than the women in WHI who were heavier, with one third having hypertension, and one half former or present smokers. If clusters of healthy behaviors would lead to safer use of HRT, this needs to be studied. Oral contraceptive use showed an increased risk for women over 35 and smokers. These guidelines are used by clinicians when instituting therapy.

At the present time, although the use of double-blind randomized studies remains a gold standard, we cannot make all clinical decisions by these studies as they appear to apply specifically to the population studied in the trial. By default, clinicians have historically looked to observational studies. Important questions remain which need to be urgently studied especially since there is no effective treatment for menopausal symptoms at the present time. Specifically, at what age the use of hormone replacement leads to a small increased risk of heart disease and breast cancer? Does this small risk justify withholding a modality important for the quality of life of many women? Does data on older women apply to younger women? What is the pathophysiology of the mood changes, hot flashes, palpitations, and joint pain that women experience at menopause? How does estrogen work to treat these symptoms? There is also no treatment for dementia, and the neuroprotective effects of estrogen remain an important issue for estrogen-deficient women since the provocative data suggest that estrogen treatment may delay the onset of dementia.

In summary, I believe that hormone replacement is an important therapeutic modality for the symptoms of menopause which cannot be replaced at the present time by other therapies, that their role in the protection of women from the effects of aging are still pertinent to the younger women under 55 and certainly with early menopause, and that therapy needs to be individualized with more research on minimizing risk. We need to examine lower doses, other preparations and alternatives. The trivialization of these issues will lead to use of inadequately studied preparations and treatment not well grounded in science. In addition, this will have a devastating effect on women with early hysterectomies and oophrectomy and early menopause or estrogen deficiency.

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