Hormone Therapy (HT) Many symptoms of menopause can interfere with daily routines and alter quality of life. Considering that one of the primary goals of medicine is to help people feel well enough to perform their daily activities, many women are looking for information about menopause treatment options.  Hormone therapy is the gold standard for many women to treat menopause problems such as hot flashes, night sweats and vaginal dryness.  Over the last decade more and more research has been done on menopause. As a result, much has been written about HT over the past few years.  The purpose of this review is to provide an overview of some of the lastest information about Hormone Therapy.   Please read the entire article, or click on any of the topics below for specific information: Who Should Use Hormone Therapy? What Are the Different Types of Hormone Therapy? Learn About Bio-Identical Hormone Therapy Learn About Androgens Learn About Progesterone Learn About Hormone Patches Absorption: Oral Versus The Patch What is the Women's Health Initiative? What is the Controversy? Risks and Contraindications of HT Top Ten Steps to a Healthy Menopause

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Who Should Use Hormone Therapy?

The decision to seek treatment is generally based on the severity of short term symptoms.  Each women's experience is different, particularly between women who have natural menopause (have retained their uterus and ovaries) and those who have surgical menopause (removal of ovaries, possibly at the time of a hysterectomy).  Experts agree that younger women with menopausal symptoms should still consider using prescription hormone therapy that most effectively treats moderate to severe symptoms of menopause.  To date, HT is the most effective treatment for the relief of hot flashes and sleep disturbances associated with menopause, which can affect both physical and mental health.  It's also effective in treating genitourinary symptoms such as vaginal dryness, which can affect sexual pleasure. 

Hormone treatment should always be with the lowest effective dose for the shortest time needed.  The lowest dose needed and length of therapy will vary from woman to woman.  For most women, relieving menopausal symptoms by taking hormone therapy for short periods of time is safe and effective.  HT may favorably improve many quality of life symptoms, such as:  

1. Hot flashes.   Hormone therapy is FDA approved for the treatment of moderate to severe hot flashes.  These symptoms can have a tremendous negative impact on quality of life and are often accompanied by perspiration, embarrassment and anxiety. 
2. Sleep Disturbance.   Sleep disturbances can be due to night sweats during menopause.  Many studies have shown that HT improves quality of sleep.
3. Mood disturbances.  Irritability, depression and difficulty concentrating are reported by many menopausal women.  While numerous reasons exist for these disturbances (such as life stressors), some of these changes may be due to hormonal changes.   HT may be used in conjunction with other therapies for significant mood disturbances during menopause. 
4. Vaginal atrophy.  Vaginal atrophy is a thinning and drying of the tissues in and around the vagina and can result in itching, burning and discomfort during intercourse.  Estrogen therapy is FDA approved for the treatment of vaginal atrophy.
5. Skin changes.  Many effects associated with aging can have a negative impact on quality of life.  Lack of estrogen during menopause can cause some of these changes.  Changes such as wrinkles, lines and dryness can be positively impacted by the use of estrogen therapy. 

"I've read that hormones are bad. Can taking hormones mean that I'm at risk for having a heart attack?
The media tends to report stories that attract your attention. Often the facts are incomplete and sometimes don't paint the entire picture. Actually, cholesterol and lipid changes that occur during menopause and the natural loss of estrogen can place a women at greater risk for heart disease. Many experts believe the main issue is beginning estrogen therapy early in menopause (while you are still young enough to maintain a healthy cholesterol profile) if you going to use hormone therapy at all.

The unfavorable news reports were based on the WHI. The women studied were, on average, 12 years beyond the menopause. Study participants that received combination hormone therapy experienced a higher rate of heart disease than those who did not take the hormones. However, the study also showed that younger women in the study who were within five years of their final menstrual period had NO increased risk for heart attacks. Therefore, it is imperative to speak to your health care provider about your risks and benefits.

If you choose HT for relief of menopausal symptoms, The American College of Ob/Gyn (ACOG) recommends the following:

1. Take HT for the shortest possible time that works for you, in the smallest effective dose;
2. Have regular consultations with your physician - at least once a year - to review your reasons for taking HT and to see if you can successfully discontinue HT use; and
3. Get regular breast cancer screenings, including annual physician breast exams and periodic mammogram's (which ACOG recommends every one to two years during your forties, and annually thereafter).

For treating the symptoms of menopause, there are many treament options to consider. The tables below show the various forms and common brand names of hormone therapy. Examples include pills, gels, patches, lotions and vaginal rings.

What Are the Different Types of Hormone Therapy?
Hormone Therapy for Women Without a Uterus and who are Experiencing Menopausal Symptoms

Women who have had a hysterectomy (removal of the uterus) do not need a progestogen, and can take estrogen alone. The following are the most commonly used FDA-approved treatments for women without a uterus.

Hormone Therapy for Women With a Uterus and are Experiencing Menopausal Symptoms

In addition to estrogen, women who still have a uterus should use another hormone (a progestogen in combination with estrogen) because estrogen therapy alone causes the lining of the uterus to grow.  The progestogen protects the uterus from the risk of endometrial cancer. The following are the most commonly used FDA-approved treatments that contain an estrogen and progestogen for women with a uterus.

Learn More About Progesterone
There are many progestin products available, including micronized progesterone (Prometrium). Norethindrone (Aygestin), medroxyprogesterone (Provera), and megesterol (Megace) are all chemical derivatives of progesterone that act like progesterone in the body.  Micronized progesterone (Prometrium) is bio-identical to the progesterone produced by the ovary before menopause and has been shown to be well tolerated when used as part of an HT regimen. A recent study revealed 80% of study subjects reported excellent satisfaction with micronized progesterone. Over 65% thought the micronized progesterone containing HT was better than other HT regimens they had taken. Specifically, study participants reported significant improvements in anxiety, depression, fluid retention and hot flash symptoms when taking micronized progesterone compared to medroxyprogesterone.

Topical progesterone creams and gels:
Touted as a way to relieve hot flashes, osteoporosis, among a myriad of other health claims, topical progesterone creams and gels are available as over-the-counter products or custom-compounded by prescription.

The primary reason physicians prescribe progesterone during menopause is to protect the lining of the uterus in women who have not had a hysterectomy and are taking estrogen therapy.

Topical progesterone creams and gels may not sufficiently protect the uterine lining when taken with estrogen as part of a hormone regimen and could lead to an abnormally thickened lining called endometrial hyperplasia. Endometrial hyperplasia can be associated with abnormal, heavy vaginal bleeding and pre-cancerous changes within the uterus. Therefore, MenopauseRx.com does not recommend their use as part of a hormone regimen. Talk to your healthcare provider about FDA-approved options that may be right for you.
Click here to learn more about progesterone

Learn more about Bio-Identical Hormone Therapy BIO-IDENTICAL HORMONE THERAPY. Is it natural? Is it better? In your search for relief from the symptoms of menopause, you may have heard about natural or bio-identical hormone therapy. And you may be wondering whether these therapies are safe and effective. Here are some things to think about when considering this option in hormone therapy. What is bio-identical? When something is "bio-identical," it is structurally identical to the naturally occurring substance in your body. Most bio-identical estrogens and progesterone come from soy (estrogen) or yams (progesterone). Once the hormones are extracted from the plant source, they are processed to be used by a woman's body, and are available by prescription in pills, patches or a gel, as well as compounded formulations. An important distinction is that this is not the same as herbal compounds, such as black cohosh, dong quai or other herbal remedies that are sometimes used by women during the menopause that are usually marketed as "natural" remedies. Is bio-identical better? While there is not one "best" hormone therapy option for all women, the reality is that women are much more responsive to the types of hormones normally found in the body. These include bio-identical hormones such as estradiol (the primary estrogen produced by the ovary) and micronized progesterone. Women respond to these bio-identical prescription products because they are so similar to what the body made naturally prior to midlife changes.

Results From Our Recent Survey When asked about whether 'bio-identical' and 'natural' mean the same thing, nearly 40% of women said 'no' and a little over 50% weren't sure. Almost 35% feel that compounded hormone products are safer than prescription options, and almost 60% weren't sure. Nearly 70% weren't sure whether compounded hormone products are FDA-approved; yet more than 70% prefer an FDA-approved option and would be interested in an FDA-approved option.

Bio-identical options
If you're interested in bio-identical hormone therapy, there are several options available to you. These options allow you and your healthcare professional to tailor your therapy to your specific symptoms and medical history. They also allow you to choose a delivery method that fits your needs and preferences.

Estradiol is available by prescription in many FDA-approved estrogen products, including transdermal gels, lotions, patches and tablets. Micronized progesterone is available in capsules, creams and gels. Many of these products have been on the market for a number of years, and they commonly offer hormone formulations in varying dosages for symptom relief.

Bio-identical hormone therapy is available through:

• FDA-approved prescription products, such as gels, lotions, patches and pills
• Non-FDA-approved compounded products prepared in select pharmacies

The importance of choosing FDA-approved options
Today, some pharmacies offer to custom-compound bio-identical hormone therapies for a woman's individual menopause symptoms. Commonly referred to as 'Triest' or 'Biest', the active ingredient in these products is estradiol, the same active ingredient in FDA-approved prescription products and therefore carry the same risks and side-effects as other hormone therapy products. 'Triest' also contains estrone and estriol, while 'Biest' also contains estriol. Estrone and estriol are less potent estrogens normally produced by the ovary prior to menopause.

Often, a saliva test is given to determine hormone levels, and formulations are customized based on the results. Caution is advised if you are considering this method of therapy for the following reasons*:

Saliva tests are unreliable. The concentration of hormones in saliva can vary widely depending upon diet, the time of day the test was performed, and the laboratory testing procedures.

Safety and effectiveness cannot be assured. While these compounded formulations may use FDA-approved ingredients like estradiol, the customized formulations are not approved and there are no guidelines for their use. In addition, there are concerns regarding the purity, potency and quality of compounded products. In 2001, the FDA found that 9 out of 10 compounded products failed potency tests, and 34% failed one or more standard quality test.

* The American College of Ob/Gyn (ACOG) states that 'there is no evidence that hormonal levels in saliva are biologically meaningful' ACOG Committee Opinion Number 322, November 2005

Commercially available estradiol and progesterone products have withstood the rigors of FDA monitoring. When prescribed by your healthcare professional, these medications are usually covered by insurance companies. Conversely, insurance coverage for compounded products is quite variable and often subject to higher co-pays.

So, is natural naturally better?
Research indicates that FDA-approved and prescribed bio-identical hormones are an effective way to alleviate the symptoms of menopause. Talk to your healthcare professional about this treatment option.

Although estrogens are the primary female sex hormone, androgens are important for the female body. Overall, there are four primary androgens produced by women, including testosterone, androstenedione, DHEA, and DHEA-sulfate. These androgens are typically produced by the ovary and adrenal glands. Menopause may be associated with a 50% decrease in androgen production. Androgens affect the body by maintaining muscle mass, stimulating sexual desire, stimulating bone growth, and controlling oil gland activity in the skin. Androgens can also lead to a more efficient use of estrogen. By improving the amount of estrogen that can be available for use by the body, androgens can improve symptom relief from HT. Research has shown that lower testosterone levels in some menopausal women may lower sex drive and lead to bone loss. By supplementing testosterone, many women notice improvement in their libido and theoretically improved bone density. Physicians often recommend a combination of estrogen and testosterone in women experiencing diminished libido after menopause.  

Learn About Hormone Patches
Today's Hormone Patches
The technology of hormone patches has evolved since the first was introduced in 1986.  There is a patch technology (known as DOT Matrix^T) available that has overcome the long-standing criticisms of the old technologies: large, bulky, irritating to the skin, and problems staying on the skin.  For today's active menopausal woman there are patches that are very ultra thin and discreet in appearance that stay on whether swimming, exercising, or showering. Because of these patch advancements, patch use is becoming more common.

DOT Matrix^T is a trademark of Noven Pharmaceuticals, Inc.

How Hormone Patches Compare to Pill

To select the treatment that's right for you, you should know about the differences between the two most common forms of therapy and the impact of these differences. 

Absorption: Oral Versus The Patch
Patches relieve menopausal symptoms with less hormone compared to pills.  Patches use less hormone because estrogen taken via a patch is absorbed through the skin directly into the blood stream to be delivered to the body.  The skin efficiently delivers the hormone it absorbs since the hormone does not have to first go through the GI tract and liver.  Pills require "extra" hormone because estrogen taken via a pill must be absorbed by the GI tract and liver first (called the "first pass liver effect") where it is metabolized before entering the blood stream.  As the estrogen is metabolized by the liver it is converted into a less active form of estrogen before reaching the blood stream to be delivered to target organs.  This difference can lead to lower dosages of estrogen for the same relief of symptoms among patch users. 

Another major difference between the patch and the pill that also results from the way the hormone is delivered to the body is the consistency of estrogen delivered.  The patch releases estrogen evenly over time, maintaining a steady level of estrogen throughout the day.  This results in around-the-clock symptom relief, even when changing to a new patch.  The pill provides a sudden increase in estrogen and then a drop-off in estrogen everyday it's taken; as a result, some women get erratic symptom relief.  If you take oral hormone therapy and still don't feel well, ask your doctor about changing over to a patch. 

The following table compares transdermal patch and pill therapy:

Risks and Contraindications of HT

As with any medication, there are side effects and risks associated with HT. Years ago, many doctors thought that HT would help a woman reduce her risk of heart disease and stroke. Although HT will have favorable effects on cholesterol, it does not reduce the risk of heart attack or stroke. In fact, it is associated with a slight increase in heart attack, stroke, and blood clots within the first year of use. The WHI reported 7 more cases of heart disease events (like heart attacks), 8 more cases of stroke, and 18 more cases of blood clots per 10,000 women per year in users of combination estrogen and progestin compared to non-users.

Other known risks of HT include a slight, but significant, increase in breast cancer, and an increase in gallbladder disease. The WHI trial reported 8 more cases of breast cancer per 10,000 women taking HT. When women on HT develop breast cancer, the tumors tend to be smaller at the time of discovery and more localized, which tends to a more favorable prognosis. The Nurses’ Health Study found estrogen increases the risk of gallbladder disease by 1.5 to 2 times.

Contraindications of HT use include:

1. Known or suspected cancer of the breast
2. Known or suspected estrogen dependent cancer
3. Undiagnosed genital bleeding
4. Active blood clots or predisposition to blood clotting disorders
5. Active liver disease
6. Known or suspected pregnancy

Estrogens provide valuable therapy for many women, but carry serious risks, and therefore postmenopausal women who use or are considering using estrogen or estrogen with progestin treatments should discuss with their physicians whether the benefits outweigh the risks. For hot flashes and symptoms of vulvar and vaginal atrophy, these products are the most effective approved therapies. Estrogens and progestins should be used at the lowest effective doses for the shortest duration to reach treatment goals.

The FDA will continue to engage the National Institutes of Health (which sponsored the WHI) as well as manufacturers in pursuing research on questions involving the safety and effectiveness of these products.

As with all medical decisions, you and your doctor need to weigh the risks and benefits in light of your own situation.

The American College of Ob/Gyn has issued a list of questions and answers regarding HT and the WHI study. A number of questions and answers from this guide have been listed below.  Experts from The American College of Obstetricians and Gynecologists (ACOG) have carefully reviewed the published study results. Here ACOG addresses the most frequently asked questions about the published results of the WHI study and what they may mean for women facing decisions about HT.

How do I apply these conflicting accounts of risk - whether "small" or "significant" -- to my own situation? If a study was halted, isn't HT unsafe, period?

Knowing how to apply the risks uncovered by the WHI is complex for both patients and physicians. That's because there's a difference between the size of the risks found for the group of women using HT, which were large enough to warrant stopping the study, and the size of the risks for each individual woman using HT, which -- though real and often increasing over time -- were still quite small. A look at the breast cancer risk illustrates this difference, and some of the problems.

Risks for the Group on HT: The NIH stopped the study for public health reasons, both in fairness to the group of women on HT and because they were looking at the increased risks for an entire population of women using HT over time. While the rate of increased breast cancer risk described in Question 1 may not sound huge (8 additional cases of breast cancer per 10,000 women, on average per year, in the HT group), in a drug taken by millions of women over many years, this can result in a large number of women with breast cancer.

Risks for the Individual Woman on HT: Since the percentage of women in the WHI study who actually had adverse effects from HT use was small, the size of the risk for each individual woman on HT was also small. For example, with breast cancer, while the increased risk for the group on HT was 26%, an individual woman's increased risk for breast cancer with HT use was less than one tenth of one percent a year, according to study authors. There's one important caveat however. This small increase in individual risk appeared to be cumulative over time. The longer a woman stayed on HT, the more her risk for breast cancer increased, at a higher rate than would normally occur with advancing age.

What does this mean for a woman trying to make a decision about HT?
The bottom line is that while HT is still an acceptable option for the treatment of menopausal symptoms in certain cases, the decision for a woman considering whether to use HT and for how long has become much more complex.

You will have to decide in consultation with your doctor whether the risks uncovered by the WHI are acceptable to you. This means reviewing with your doctor:
(1) why you want to be on HT;
(2) your personal benefits with HT use; and
(3) your increased risks with HT use, taking into account your individual and family history for conditions such as heart disease or breast cancer.

ACOG recognizes that many women are tired of the phrase "talk to your doctor," which has been in constant use since the WHI report was published. But the phrase has never been more important. When it comes to HT, there is no one-size-fits-all answer, and decisions about HT will have to be made on a case-by-case (or woman-by-woman) basis.

I'm at high risk for osteoporosis. Can I continue on HT?
If you are taking HT solely for the prevention of osteoporosis consider stopping it, because there are other medications that can help prevent osteoporosis and fractures that appear to carry lower risks for conditions such as breast cancer or heart disease. If you are also taking HT for treatment of menopausal symptoms, it may be appropriate.

Other preventive drug therapies include the family of drugs known as bisphosphonates, which can reduce the breakdown of bone. Other options are the selective estrogen receptor modulators, or SERMS, which are a new class of synthetic estrogens that act like estrogen in certain parts of the body (such as the bones) while leaving other parts of the body unaffected.

Some women with heartburn or ulcer problems may be unable to take bisphosponates, and each of the medications discussed here will have its own side effects. Although these medications appear to have a better ratio of benefits to risks for you compared to HT, studies are continuing on the effects of these drugs, some of which have been in use for only a few years. Talk to your doctor about whether these medications would be appropriate for you. Weigh any benefits of continued HT use against your personal risks for cardiovascular disease and breast cancer.

For all women, lifestyle recommendations for healthy bones include a diet high in calcium (postmenopausal women should be taking 1,200 to 1,500 mg of calcium per day), a multi-vitamin containing Vitamin D, and regular weight-bearing exercise such as jogging or walking.

Where does this leave me if I want to take HT for menopausal symptoms such as hot flashes or sleep problems?
HT is highly effective in treating certain menopausal symptoms and may still be appropriate for you, depending on your circumstances. However, the small but real increased risks uncovered by the WHI study mean that this is now a more complicated decision.

You will have to evaluate, with your physician, the pros and cons of HT use in your individual circumstance. This includes weighing any benefits of continued HT use against your individual risks for conditions such as breast cancer, to decide whether taking HT is an acceptable or an unacceptable risk for you.

To date, HT is the most effective treatment for the relief of vasomotor symptoms such as hot flashes and sleep disturbances, which can affect both physical and mental health. It's also effective in treating genitourinary symptoms such as urinary incontinence, or vaginal dryness, which can affect sexual pleasure.

The effects of these menopausal symptoms on the quality of a woman's life can be considerable, and the severity and duration of symptoms can vary widely from woman to woman. Some women experience few or very short-lived symptoms, while others experience severe symptoms over many years. Yet too often, women are made to feel guilty about how they respond to menopausal symptoms, which are often trivialized by such comments that women should simply be able to "put up with it." In fact, each woman will have her own physiological reaction to menopause, and each will have to make the decision that is right for her.

Some women may choose to manage their symptoms without any use of HT, either through lifestyle changes alone or with other therapies. Other women, particularly those with severe menopausal symptoms, may conclude that the benefits of short-term HT use are worth the small increased risks.

If you choose HT for relief of menopausal symptoms, ACOG recommends the following:

(1) Take HT for the shortest possible time that works for you, in the smallest effective dose;
(2) Have regular consultations with your physician - at least once a year - to review your reasons for taking HT and to see if you can successfully discontinue HT use; and
(3) Like all women, get regular breast cancer screenings, including annual physician breast exams and periodic mammograms (which ACOG recommends every one to two years during your forties, and annually thereafter).

If I've been on HT for more than 5 years for relief of menopausal symptoms, should I go off of it?
Try to discontinue HT use if you have been on it for this period of time, since the increased risk of breast cancer and other conditions rises over time. If you do experience a return of symptoms, ask your doctor about alternative therapies.

What if you discontinue HT after several years of use, but your menopausal symptoms come back and other therapies do not work for you?
You can consider returning to HT so long as you understand the risks involved. There are some women who will do better on HT than on other therapies, and HT may be a reasonable option for them if they have weighed the pros and cons with their physician. If you do resume HT, do so at the lowest possible effective dose for you for the shortest possible time and, as discussed above, review with your physician at least annually whether you can successfully discontinue HT.