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Hormone Therapy: For Whom? How Long?
June 1, 2006 -- When is menopausal hormone therapy appropriate? An expert panel of doctors tries to cut through the confusion.
Endocrinologist Bruce Ettinger, MD, and colleagues boldly go where none has gone before. Their mission: to determine, specifically, what is an "acceptable" use of hormone therapy, and what is "unacceptable."
"We felt that guidance we were getting from major medical societies was too vague -- it leaves too much unsaid, and there is not enough information to help people make decisions," Ettinger tells WebMD. "Even though our panel never gets to perfect agreement, we can say, "This is mainstream activity, and this is not."
Ettinger, a Kaiser Permanente researcher and a clinical professor of medicine at the University of California, San Francisco, and colleagues report their finding in the current issue of the journal Menopause.
Looking for Menopausal Hormone Therapy Consensus
Doctors agree that hormone therapy can help women whose lives are disrupted by menopausal symptoms. Doctors agree the treatment -- estrogen plus progestin for women with a uterus, and estrogen alone for women who have had a hysterectomy -- carries risks. Doctors agree that for some women, the risks of hormone therapy outweigh the benefits.
And that's where the agreement ends. Doctors disagree over which women need hormone therapy, and why they might need it. They disagree over when it's best to start hormone therapy. And they disagree over when to stop hormone therapy.
Some doctors are very quick to recommend hormone therapy as soon as a woman enters menopause. Others try everything else first -- and then offer only short-term hormone therapy as a treatment of last resort for devastating menopausal symptoms.
Some doctors see hormone therapy as a way to maintain a woman's bone and sexual function as natural estrogen levels wane. Others see hormone therapy -- especially long-term hormone therapy -- as an unwarranted risk for heart diseaseheart disease, strokestroke, and cancercancer.
So far, official advice has been cautious. The word from the National Institutes of Health and the American College of Gynecology is brief: Use hormone therapy only when necessary, in as small a dose as possible, for the shortest time possible.
Finding the Bottom Line
But what, exactly does this mean for specific groups of women? To try to get consensus, Ettinger worked with a panel of eight other experts. The panel started by concluding that the only menopausal women who need hormone therapy are those whose lives are disrupted by severe hot flasheshot flashes.
The panel then found that, in specific circumstances, hormone therapy was acceptable, unacceptable, or uncertain. Uncertain means that most panelists had "midlevel enthusiasm for hormone therapy in a particular setting."
For women with a uterus, the panel found that:
- Oral, standard-dose hormone therapy is appropriate only for women with normal risk of heart diseaseheart disease and normal risk of blood clots. It is uncertain for women at elevated risk of heart disease but normal risk of blood clots.
- Oral, low-dose hormone therapy is appropriate only for women with normal risk of heart disease and normal risk of blood clots. It is uncertain for women with either elevated risk of blood clots or elevated risk of heart disease, but not both.
- Transdermal hormone therapy is appropriate for women with normal or elevated risk of heart disease and normal risk of blood clots. It is uncertain for women with elevated risk of blood clots and both normal or elevated risk of heart disease. It is also uncertain for women with normal risk of blood clots who have had a strokestroke or transient ischemic attack (TIA)transient ischemic attack (TIA).
- For all other combinations of heart disease/blood clot risk or stroke/TIA history, hormone therapy is inappropriate.
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VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
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