The Latest Word on Hormone Therapy

Hormone Therapy

If you’re entering the age of menopause, you’re old enough to remember your mother’s hormone therapy. At the time, doctors and scientists believed that replacing the estrogen being lost in women’s aging bodies would not only stem the aggravating symptoms, but prevent all kinds of other age-related issues including heart attacks. Flash forward to 1998 and 2002 when two large studies, the Heart and Estrogen/Progestin Replacement Study and the Women’s Health Initiative, actually showed the opposite: women in the study who were taking hormones had an increased risk for cardiac disease and were also at higher risk for blood clots, stroke and breast cancer.

Women around the world responded by going cold-turkey on hormones, with full support of their doctors.  But did this mean no medical options could stem menopausal symptoms? Experts began to take a closer look at these studies to find a different approach to hormone therapy.

Risa Kagan, M.D., a gynecologist with Sutter East Bay Medical Foundation, certified menopause practitioner and former member of the Board of Trustees of The North American Menopause Society, was among physicians who noticed that the participants were much older than the average symptomatic woman, and were taking hormones in relatively high doses. They also were using hormones as a preventive drug, rather than to address symptoms.

“These studies never said that symptomatic women should never use hormones. The findings said that hormone therapy shouldn’t be considered only for preventive health benefits, long into the future,” she says.

In other words, hormone therapy for younger women, taken only during early menopause to reduce symptoms, was worth investigating. And that hypothesis was supported by a recent, though smaller, study called the Kronos Early Estrogen Prevention Study, released in 2012. Estrogen and cyclic monthly progesterone given to healthy women ages 42 to 59 proved both safe and helpful in improving symptoms of menopause, as well as mood, bone density and several markers of cardiovascular risk.

Expanding Options

Even so, scientific studies have shown that hormone therapy does carry risks for women with certain health histories or conditions and so may not prove the best option for everyone. Women with a history of breast cancer, blood clots, heart disease or liver disease, in particular, should look into non-hormone medications. Luckily, alternative medical treatments have expanded over the last decade to address certain health concerns.

Though not as effective as hormone therapy, some drugs typically used for other health issues, such as depression, anxiety and epilepsy, reduce hot flashes in many women without the same risks of hormone therapy. One of these drugs, a selective serotonin reuptake inhibitor called Brisdelle®, is the first non-hormonal therapy approved by the Food and Drug Administration specifically for hot flashes.

Sleep medications will not reduce hot flashes, but may help you sleep through them.

Alternative options also exist for women with specific health needs or concerns such as:

• Women who have a uterus but cannot take progestin — DUAVEE® is a newer drug that combines estrogen with bazedoxifene to protect the uterus. It is a selective estrogen receptor modulator, which means it works like estrogen in some tissues and opposes estrogen in others. This makes it viable for certain women who might be at higher risk of endometrial or breast cancer, experience side effects from progestin or have abnormal bleeding.
• Women who desire contraception and a regular menstrual cycle — A low-dose, estrogen-progestin birth control pill may work well for perimenopausal women who are non-smokers. These medications can restore regular, lighter periods, offer relief from hot flashes, and also provide contraception.
• Women who prefer not to take a pill — The methods to take hormone therapy have grown to include patches, gels and sprays in addition to pills. This allows doctors to tailor the medication to each patient’s medical history and lifestyle. “The transdermal patch is great for some women because it allows the body to absorb the hormones without going through the liver. So if you have certain risk factors, this provides a safer option. The patch also provides a more consistent dose of hormones, so it’s better for women who are sensitive to hormone fluctuations,” Dr. Kagan says.

Is Bio-identical Better?

Amid the larger debate about the risks and benefits of hormone therapy has lingered the question of whether bio-identical hormones are safer, more effective or more natural than traditional hormone treatments. Bio-identical refers to hormones created in a lab to directly mimic the natural hormones found in a woman’s ovaries. Traditionally, hormone therapies have been derived instead using conjugated equine (horse-derived) hormones.

“There’s no evidence to show these hormones are more effective or safer,” Dr. Kagan says. “In fact, most bio-identical hormones are compounded products that are not FDA tested and have been proven to have inconsistent levels of hormones, which puts women at great risk. I tell my patients, if you want to try a bio-identical hormone therapy, use one of the FDA tested and approved products currently on the market.”

Targeted Therapies

Although most hormone therapy treats multiple symptoms systemically (throughout the entire body), some more targeted medications are emerging. Most promising among these are creams, a tablet and a ring applied locally to treat vaginal dryness, a common side effect of dropping estrogen.

“These are really outstanding methods to treat vaginal dryness without the systemic risk of other hormone therapies. The medications are localized, low dose and very safe,” Dr. Kagan says.

For women whose vaginal changes make sex extremely painful, a new oral, non-estrogen pill called Osphena may help. Osphena, a selective estrogen receptor modulator (see Duavee, above), mimics estrogen on vaginal tissues to thicken and strengthen them, reducing pain during intercourse.

Hormone therapies also can prevent another common effect of low estrogen, bone loss. For women who have a high risk of bone fracture or osteoporosis, hormone therapy can help protect bones at the time most vulnerable for bone thinning, the early years of menopause. However, Dr. Kagan stresses that, unlike the early days of hormone therapy, these medications are rarely appropriate as a preventive tool because there are safer, better ways for most women to stem the dangers of aging – starting with diet and exercise.

What Now?

If menopausal symptoms have begun to interfere with your life, see your doctor for a thorough consultation. Your doctor will conduct a physical exam, discuss your symptoms and review your health history. Then he or she will make a recommendation on the type and dose of hormones – or non-hormonal medication – appropriate for your situation. Women who no longer have a uterus can typically take estrogen alone, without increased risk, while those with a uterus must take progesterone along with estrogen to protect from uterine cancer or the new drug DUAVEE®, described above.

In general, starting hormone therapy within 10 years of your last period is now considered safe for most women, though the earlier the better. After that time frame, your doctor will recommend alternative, non-hormonal treatment.

And remember, once on a therapy, allow at least 12 weeks to determine its effectiveness, and contact your doctor immediately if you have any health changes or concerns. Even if the therapy works, your doctor will want to see you regularly – probably annually – to reevaluate. Typically, about half of women are able to decrease or go off hormones completely after three to five years without returning symptoms. The other half remain symptomatic and may choose to continue therapy, Dr. Kagan says. 

“The process requires shared decision-making between the patient and the doctor where we look at her health history and quality of life and make a treatment decision together,” she says.

With this new, evidence-based and thoughtful approach to hormone therapy, women entering menopause can rest assured that they have more options than ever to help them manage symptoms while maintaining great long-term health.

Need more information? Visit the website of The North American Menopause Society, which contains numerous articles, data and tips about menopause. NAMS also has a helpful app designed to help you and your doctor make personalized decisions on menopause treatment.