The issue of hormone therapy to treat menopausal symptoms used to be a simple one. You had hot flashes, sleep disturbances, vaginal changes—you took hormones. Worried about your bones and heart—you took hormones.
All that changed, of course, in the summer of 2002 with the announcement of the results of part of the Women's Health Initiative (WHI), the first-ever, long-term study of the effects of hormone therapy on postmenopausal women. One of the study's main goals was to investigate whether using estrogen (Premarin) or estrogen plus progestin (Prempro) as part of a hormone therapy regimen could prevent coronary heart disease in healthy women between the ages of 50 to 79.
The investigators chose these two hormone products to study, because at the time they were the most-used form of hormone therapy. Researchers abruptly ended the Prempro arm three years early, because initial results showed an increased risk of breast cancer, heart disease, blood clots in the lungs and stroke in women taking hormone therapy.
You know what happened next—millions of women panicked, ditched their hormone therapy and frantically searched for options. A couple of years later, when the estrogen-only (Premarin) arm of the WHI found an increased incidence of stroke in women on the drug with no cardiovascular benefits, it seemed that hormone therapy as a treatment for menopausal symptoms would go the way of the typewriter.
But don't write off estrogen therapy yet. As researchers looked more closely at the WHI results, they found the data wasn't as dire as first presented. Experts note that the WHI study included women who were more than 10 years older (average age 64) than the average hormone therapy user. And, in fact, a 2006 publication based on data from the long-running Nurse's Health Study found that women who started hormone therapy soon after menopause reduced their risk of coronary heart disease 30 percent.
Plus, the risks identified in the WHI and a similar study called the Heart and Estrogen/progestin Replacement Study (HERS) were actually quite small, a message that finally began resonating with women and their doctors. Basically, of 10,000 women taking Prempro, over the course of one year, 23 additional women would develop dementia, eight more would have blood clots in the lung, strokes or breast cancer, and seven more would have heart attacks or other coronary events, than women not taking Prempro.
And don't forget the study's good news: Over the course of a year, those 10,000 women taking Prempro would have five fewer hip fractures and six fewer incidences of colon cancer.
Further analysis of the data, announced in April 2006, revealed more good news: Women taking estrogen only (Premarin) had no increased risk of breast cancer.
Confused? Don't be. Here are the basics you need to know based on extensive evaluation of existing data by the North American Menopause Society:
- The primary reason to use hormone therapy—whether estrogen alone (for women without a uterus) or estrogen plus progesterone (for women with a uterus)— is for treatment of moderate to severe menopause symptoms, primarily hot flashes, sleep disturbances from night sweats and vaginal changes.
- If you use hormone therapy, start at the lowest dose for the shortest amount of time needed to gain relief. However, if you need to, you can use hormone therapy for an extended length of time.
- Talk with one of us about the most appropriate form of hormone therapy for your symptoms. For vaginal dryness, local intravaginal is safest and very effective.
- Hormone therapy can still be used to prevent osteoporosis for women at high risk of the condition (most forms of hormone therapy are approved for this purpose), but you should weigh the pros and cons of hormone treatment against other osteoporosis therapies.
And keep in mind that there are literally dozens of hormone therapy formulations—from low-dose pills to patches, rings and even a clear, odorless gel you rub on your arm. The term “bioidentical hormone therapy” is often used to describe a medication containing estrogen, progesterone, or other hormones that are chemically exact duplicates of hormones produced by women, primarily in the ovaries.
Many of these bioidentical hormones (eg, estradiol, progesterone) are commercially available in several well-tested, FDA-approved, brand-name prescription drugs. A list of government-approved bioidentical hormone therapy products in the United States and Canada is listed on menopause.org.
Concern arises with the bioidentical hormone medications that are “custom-compounded” (custom-mixed) recipes prepared by a pharmacist following an individual prescriber’s order for a specific patient.
These medications do not have FDA approval because individually mixed recipes have not been tested to prove that the active ingredients are absorbed appropriately or provide predictable levels in blood and tissue. Further, there is no scientific evidence about the effects of these compounded medications on the body—both good and bad.
