The information on HT can be overwhelming and at times can even appear contradictory. As more data appears from clinical trials, staying up to date is a daunting task. Sorting through the information is imperative in making the decision to use HT (as any other treatment should be).

The Red Hot Mamas are committed to providing you with medically sound, up to date information regarding HT. Feel free to use this article to guide you through the decision-making process and check back to our website often for updates.

Tying HT treatment to your personal, specific needs can be a frustrating experience. By educating yourself and weighing the risks and benefits, you will further be able to make the right decisions with your healthcare provider. Hormone therapy (HT) may not be right for everyone, but it definitely can relieve many menopausal symptoms.

0.1. What is HT?

Production of the hormones estrogen and progesterone decrease significantly when a woman reaches menopause. For this reason, a common method of managing the symptoms of menopause and preventing long term diseases is through hormone therapy (HT).

Professionals formerly referred to HT as “hormone replacement therapy” (HRT). Recently, it was decided that HRT was not an accurate name since it is not crucial to “replace” the lost hormones. Many women whose hormone production has declined find relief from their menopause symptoms by using a range of methods.

HT is a program of estrogen and progesterone which are prescribed to relieve perimenopausal and menopausal symptoms. Doctors often prescribe hormones to women who experience symptoms – hot flashes, night sweats, sleeplessness and so on, that’s associated with menopause. HT also protects against osteoporosis and relieves urogenital atrophy (thinning, drying of the vagina and urethra). You and your doctor can discuss whether hormone therapy is right for you.

0.2. Do I need HT?

First, determine whether or not you’re a candidate for HT. If the symptoms of menopause are so severe they interfere with your daily life, you may want to consider this type of therapy. If the hot flashes, night sweats, mood changes, sleep disturbances, vaginal dryness or urogenital problems hinder your ability to function on a daily basis, HT may be something to contemplate. The symptoms of menopause are different for everyone. Menopausal symptoms can disappear for some women without treatment. Others struggle to manage their symptoms and can benefit greatly from short-term HT use. The U.S. Food and Drug Administration (FDA) states, “hormone therapy is the most effective FDA approved medicine for relief of hot flashes, night sweats or vaginal dryness. Hormones may reduce your chances of getting thin, weak bones (osteoporosis) which break easily.”¹ HT is not for everyone but can be very helpful for many women.

Your health history should be closely examined when considering the treatment. If you are at a high risk for breast cancer or other cancers, blood clots, stroke or cardiovascular disease, you may want to think about alternatives. Finding the right doses and combination of hormones is very personalized and different for everyone. The U.S. Food and Drug Administration (FDA) recommends using hormones at the lowest dose that helps and for the shortest time that you need them¹. Your healthcare professional is a valuable resource in the HT decision-making process. They will assist in evaluating your health risks and help you choose the right strategy for managing your symptoms.

Your decision to take hormone therapy is a personal one. Having the knowledge about these questions may help you in your decision-making process:

1. What are the risks and benefits of hormone therapy?
2. Are your symptoms so severe that they interfere with your family life, work and happiness?
3. you have risk factors for heart disease, osteoporosis, breast and/or colon cancer?
4. Do you have any medical condition that may make hormone therapy inadvisable?
5. Are you aware and willing to make lifestyle modifications in diet, exercise and cease smoking?
6. Have you explored the alternatives to hormone therapy?

HT typically involves some combination of estrogen, progestogen (only for women who still have a uterus) and for some, an androgen. The role these hormones play in women are different and the combination of them balances the way our endocrine system functions (including controlling symptoms of menopause). Types of prescription hormone therapies used in conventional medicine for menopause include:

• estrogen therapy ( ET)
• estrogen plus progestogen ( EPT)
• androgen therapy
• hormonal contraceptives

0.3. Estrogen Therapy (ET)

Many types of FDA-approved estrogens are available (along with many different ways to administer the doses with a wide range of strengths). Estrogen is approved by the FDA for the treatment of moderate to severe hot flashes, vaginal atrophy and the prevention of osteoporosis (if used long term). The North American Menopause Society (NAMS) recognizes the long-term benefits of ET but recommends that other “therapeutic options” also be considered for bone health due to the possible increased risk for heart disease and breast cancer. NAMS claims, “…estrogen use for osteoporosis is reserved only for those specific women in whom benefits outweigh the risks. Women using ET for osteoporosis should revisit the decision annually or earlier, if there is a change in their risk status.”²

Estrogen therapy has received a significant amount of attention over the past few years.

0.3.1. The Women’s Health Initiative (WHI)

The WHI study was sponsored by the National Heart, Lung and Blood Institute (NHLBI) in collaboration with the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the Office of Research on Women’s Health and Wyeth Ayerst Research. It focused on the effects of long-term use in healthy, postmenopausal women (ages 50-79 years) regarding the prevention of heart disease and hip fractures and breast cancer. The women were randomly assigned a daily dose of estrogen (0.625 mg/day of Premarin) or a placebo. The study was not designed to assess the risks and benefits of short-term use.

In February, 2004 the National Institute of Health (NIH) released a letter to all active participants in the Women’s Health Initiative (WHI) study regarding estrogen-alone participants. The letter explains how and why NIH decided to stop the multi-center trial³. The primary reason for moving to the follow-up phase of the study was due to newly found results of an increased risk of stroke. Although the study found estrogen alone does not affect heart disease and breast cancer, the increased risk of stroke (an additional 8 strokes per 10,000 women studied) was enough to stop the trial and move to the follow-up phase.

Although estrogen alone products are approved by the FDA, the Red Hot Mamas recommends postmenopausal women who are considering the use of this therapy to thoroughly discuss the risks and benefits with their physicians to find out if ET is right for you. Currently, the FDA has updated their labeling guidance for non-contraceptive estrogen drug products for the treatment of vasomotor symptoms and vulvar and vaginal atrophy symptoms. The FDA administers recommended prescribing information to the manufactures of estrogen products. They are then given to patients when they purchase the products.

The North American Menopause Society's Menopause Guidebook² provides a complete list of hormone products available in the US and Canada.

0.3.2. Systemic or Local Estrogen Delivery

Estrogen therapy can be administered through two routes, systemic or local using a range of dosage forms. Systemic dosage can be used orally (tablet-form), through the skin (via a patch or gel) or as an injection (not recommended because this form does not provide a consistent level of estrogen in the body). The systemic dosage circulates estrogen through the body.

The local dosage form is different and includes the current vaginal estrogen products (creams, rings, tablets) that affect only a specific, localized area of the body. For example, local dosages commonly called vaginal forms are used to treat moderate to severe vaginal dryness and atrophy. Although some estrogen is absorbed into the bloodstream, this dosage usually will not relieve other symptoms like hot flashes.

Studies to date have not shown any effect on the uterine lining when women use low dosages of localized estrogen but it should still be something to think about when considering this type of treatment. Even small doses of vaginal estrogen so close to the uterine lining could eventually cause a problem. Some experts suggest a person starting this type of local dosage have either an ultrasound to see uterine thickness (it should be 4mm or less) or have an endometrial biopsy to be sure the lining is normal to begin with. Adding progesterone to your dosage can counteract negative affects by protecting against uterine cancer (see Progestogen section below). If you are not on progesterone also, experts suggest repeating the ultrasound or endometrial biopsy every two years or so to ensure thickening of the uterine lining has not occurred.

0.3.3. Side Effects of ET

• uterine bleeding (starting or returning)
• breast tenderness (sometimes enlargement)
• nausea
• bloating
• fluid retention in extremities
• changing in the shape of the cornea of the eye (sometimes leading to contact lens intolerance)
• headache
• dizziness

0.4. Combined Estrogen-Progestogen Therapy(EPT)

Combination therapy refers to taking a combination of hormones as opposed to taking only estrogen. This type therapy consists of combination of estrogen and progesterone (or the synthetic form of progesterone called progestin).

If a woman still has her uterus, she needs to add progestogen to protect against endometrial hyperplasia (the thickening of the lining of the uterus that can sometimes develop into cancer). Progesterone is the naturally occurring hormone produced by the ovaries. When a woman reaches menopause, the ovaries slow down production. Many times we will hear the word progestin which refers to any synthetically produced hormone that acts on the body like progesterone. The term progestogen is the more general term that applies to both natural and synthetic hormones that act like progesterone on the uterus.

Progestogen can be used alone for the treatment of some menopausal symptoms such as hot flashes but are usually used together with estrogen (referred to as estrogen-progestogen therapy or EPT). The combination of hormones is also commonly used in birth control pills.View a complete list of progestogens available in the US and Canada.

While there are many benefits of using EPT for menopausal symptoms, you should be aware of the risks as well. The Women’s Health Initiative (WHI) released a statement in July of 2002 stopping their clinical trials of combined estrogen and progestin therapy in menopausal women⁴. They discontinued the trials due to an increased breast cancer risk (26% increased risk; in actual numbers, there was an increase of 8 patients per 10,000 women taking the medication which equals an increase of <1/10^th of one percent) and “lack of overall benefit” for women on long-term EPT (longer than 3 or 4 years). Other findings included an increase in heart attacks, strokes and blood clots in the lungs and legs. The study did not examine the short-term benefits of using EPT.

Although the Red Hot Mamas backs the FDA's decision, EPT may still be a reasonable option for short-term relief of symptoms. You should consult a physician if considering EPT and weight both the benefits and risks for you as an individual.

As with estrogen-only therapies, the FDA continues to boost warnings and strengthen the labeling of estrogen and estrogen-progestin products. As more information becomes available, the FDA will be modifying other labels for HT products.

0.4.1. Side effects of ET and/or EPT:

• Fluid retention
• Bloating
• Breast tenderness (sometimes enlargement)
• Headaches (some migraines
• Dizziness
• Mood changes
• Nausea
• Skin irritation under patch
• Uterine bleeding (starting or returning)
• Increased frequency of hot flashes when stopped all at once. Gradually tapering the dosage may be beneficial if you need to stop.

Side effects of progestogen include uterine bleeding and some conditions similar to PMS (fluid retention, headache, breast tenderness, mood changes, etc.). The Red Hot Mamas agrees with NAMS’ strategy for determining whether ET or EPT is right for you; a trial of 3 months is advised to see if side effects resolve. Side effects may actually be the result of something else if you stop the HT and they still exist. Taper the HT slowly if you decide to stop treatment. It can take up to 6 months or longer.

The benefits of EPT (besides helping menopausal symptoms) found in the WHI study include a 37% decrease in the risk of colorectal cancer (6 fewer colorectal cancers per 10,000 women. On the positive side, 34% decreased risk of hip fractures (5 fewer hip fractures per 10,000 women per year). ET and EPT are commonly prescribed (and FDA-approved) for the symptoms of moderate to severe hot flashes and night sweats, moderate to severe vaginal dryness, and prevention of osteoporosis associated with menopause. You should not be taking HT for any other reason than as prescribed by the FDA.

You should not be taking HT for any other reason than as prescribed by the FDA without a clear understanding of the risks and benefits. As with any treatment, you must weigh the pros and the cons. There are many factors that influence your decision to use HT. Age, risks, medical history, preferences and cost are a few you should definitely discuss with your physician. You may discover that it will require several attempts to find a regimen that works for you. It is normal for women to try a few before they find the one that is right for them.

0.5. Hormonal Contraceptives

Oral contraceptives (OCs) and other hormonal contraceptives are increasing in popularity recently due to their effectiveness with alleviating menopausal symptoms. They are further being used for noncontraceptive health benefits. Low-dose oral-contraceptives are either estrogen-based, progesterone-based or a combination of the two and can be administered to women in their perimenopausal years (a woman’s late 30s and 40s).

Low-dose estrogen is usually recommended for women without a uterus while low-dose estrogen-progesterone is usually prescribed for women with a uterus. For these women over the age of 35, oral contraceptives not only protects against unwanted pregnancy but also maintains a hormonal balance that decreases abnormal menstrual bleeding, reduces bone loss, suppresses hot flashes, and protects against anemia, breast cancer, endometrial cancer and ovarian cancer.

Perimenopausal women (in the transitional stage leading up to menopause) usually still have menstrual bleeding and are still at risk for pregnancy. Oral contraceptives can protect against pregnancy while providing women with a low-dose of estrogen that may balance their decreasing hormone levels so that menopausal symptoms are less noticeable. Treating symptoms of menopause with “the Pill” is not approved by the FDA. As any risk associated with non-FDA approved uses, take caution and discuss with your physician thoroughly, especially if you are a smoker.

References

¹ U.S. Food and Drug Administration information on menopause and hormones, July 2005

² The North American Menopause Society, Menopause Guidebook

³Letter from the director of the Women’s Health Initiative asking participants in the estrogen-alone study to stop study pills and begin follow-up phase:

⁴ The National Insitutes of Health news release regarding the discontinuation of Women’s Health Initiative’s trials of estrogen plus progestin.Specific study findings are listed

⁵ U.S. Food and Drug Administration Estrogen with Progestin Therapies for Postmenopausal women

Additional resources on hormone therapy are available from
The Mayo Clinic