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Controversy in Hormone Therapy

Jan 12, 2012

Written by Barbara Bushman, Ph.D., FACSM

Research and media attention on hormone therapy (HT) within the past decade has resulted in many questions. The reported number of prescriptions for HT declined following the release of certain clinical research study results. The decision to utilize HT is one that must include consideration of the risks and benefits for the individual woman.

Although a blanket recommendation might be desired, it would not be appropriate. Rather, this article will provide the typical indications for HT use as well as the background related to HT use with regard to heart disease. For the purposes of this article, HT refers to both estrogen therapy as well as combined estrogen-progestogen therapy (as would be prescribed for women with an intact uterus in order to avoid increased risk of endometrial cancer from unopposed estrogen therapy). HT is not recommended for women with a history of hormone-sensitive cancers, liver disease, blood-clotting disorders, or confirmed cardiovascular disease.

The primary indication for use of HT is for treatment of menopause-related vasomotor symptoms (i.e., hot flashes, night sweats). HT is very effective for women experiencing troublesome vasomotor symptoms. Treatment of vaginal symptoms (e.g., vaginal dryness) is another indication for HT prescriptions with regulatory agency approval in place for many systemic products as well as local vaginal estrogen therapy products. Bone health may also benefit from extended HT use, although regulatory agency approval is not in place for all products (for a list of government-approved post-menopausal osteoporosis drugs see http://www.menopause.org/edumaterials/otcharts.pdf). HT is currently not recommended as a primary method for protection of heart health for women of any age. This is an area of research focus and at the center of media attention.

Reductions in coronary heart disease for HT users compared with non-users have been noted in observational studies (i.e. those studies that simply “observe” or track women who are already using HT over a given period of time). This benefit was not noted with recent randomized controlled trials (RCT). RCT are typically considered to be a more rigorous type of research since women are randomly assigned to either HT or a placebo (non-active pill), thus removing potential bias of self-selection.

The issue of “safety” regarding HT use came to the attention of the media and thus the American consumer when a number of the RCT associated with the Women’s Health Initiative (WHI) were prematurely stopped due to risks exceeding benefits based on specific criteria. Why did the RCT result in such different results compared with the observational studies? Selection of the subjects as well as timing of HT likely played a role. Subjects in the RCT were older and had started on HT at a later point following menopause (10+ years compared to less than two to six years). For women in the WHI who initiated HT closer to menopause, the risk of coronary heart disease was reduced compared to those who initiated HT later. Some researchers now suggest that early initiation of HT (within six years of menopause or by age 60) continued for six years or more following menopause is associated with heart disease risk reduction. There are a number of clinical trials currently underway that should help clarify the influence of the timing of HT initiation and age of the woman.

Until more details become available, the individual woman should consult with her physician to determine if HT is the best decision when considering personal health history. In general, HT use is recommended at the lowest dose for the shortest duration to reach treatment goals. Hormone therapy is still considered a viable short-term option for management of moderate to severe vasomotor symptoms for recently menopausal women in good health.5 However, at this time, HT is not considered appropriate for the single purpose of preventing cardiovascular disease.

Although not the focus of this article, exercise is one intervention without side effects that is beneficial for bone, cardiovascular health, and, for some women, menopausal symptoms. ACSM is committed to encouraging and providing guidance for women with regard to exercise (please see ACSM’s Action Plan for Menopause published by Human Kinetics, 2005, at www.humankinetics.com).

References
1. Hersh AL, Stefanick ML, Stafford RS. National use of postmenopausal hormone therapy: annual trends and response to recent evidence. JAMA. 2004;291:47-53.

2. North American Menopause Society. Treatment of menopause-associated vasomotor symptoms: position statement of The North American Menopause Society. Menopause. 2004;11:11-33.

3. Hodis HN, Mack WJ. Randomized controlled trials and the effects of postmenopausal hormone therapy on cardiovascular disease: facts, hypotheses, and clinical perspective. In: Lobo RA, editor. Treatment of the postmenopausal women: basic and clinical aspects, 3rd edition. Oxford UK: Elsevier;2007, p. 529-564.

4. Hodis HN, Mack WJ. Postmenopausal hormone therapy and cardiovascular disease in perspective. Clinical Obstetrics and Gynecology. 2008;51:564-580.

5. Gass MLS, Bassuk SS, Manson JE. Reassessing benefits and risks of hormone therapy. American Journal of Lifestyle Medicine. 2009;3:29-43.

View the full fall 2009 issue of the ACSM Fit Society® Page online.

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