Dr. Alan M. Altman is an Assistant Professor
of Obstetrics, Gynecology and Reproductive Medicine at Harvard Medical
School. He is a board-certified gynecologist in private practice and specializes
in menopause. Dr. Altman is on the professional staff at Brigham and Women's
Hospital and Beth Israel Hospital in Boston. A distinguished and sought-after
speaker, Dr. Altman presents frequently throughout the country on topics
such as perimenopause, menopause, sexuality, state-of-the-art developments
in hormone therapy and treatments for menopausal patients.
New Transdermal Options in Managing Menopause Allow for Better Individualization
Menopausal women have an increasing number of treatment options available to
them, including transdermal estrogen therapies with different delivery systems.
These options are welcome because they allow women more choices in tailoring
hormone therapy to their individual needs and preferences. Individualizing care
is the key to effective treatment.
The Transdermal Trend
Over the past decade, transdermal estrogen delivery products have become increasingly
popular because they allow estrogen to be absorbed directly through the skin
into the bloodstream without first passing through the liver. This helps minimize
the side effects associated with estrogen pills, such as the risk of cardiovascular
complications. When taken orally, estrogen must be first filtered through the
liver where it is modified before entering the bloodstream, increasing the risk
of blood clots and elevated levels of a cardiovascular risk factor called C-reactive
protein. By avoiding this initial processing by the liver, transdermal therapies
decrease the risk of cardiovascular side effects and, with their direct absorption
into the bloodstream, effectively manage menopausal symptoms with a lower dose
of estrogen than oral therapies.
Transdermal delivery systems also provide more consistent management of vasomotor
symptoms, such as hot flashes and night sweats that result from fluctuating
levels of estrogen. Whereas the delivery of oral estrogen peaks and then declines,
transdermal delivery systems allow a continuous absorption of estrogen through
the skin at a steady level without fluctuations. This consistent delivery of
estrogen provides the stable hormone levels needed to better manage menopause
symptoms throughout the day.
The patch, which became available about a decade ago, was the first FDA-approved
transdermal estrogen delivery system. More recently, newer options such as lotions
and gels have allowed healthcare providers to further individualize therapy
for their patients, specifically tailoring therapy to a woman's symptoms, medical
history and delivery preference.
The newest hormone therapy (HT) option approved by the FDA, a transdermal gel
called EstroGel (estradiol gel), demonstrates how we have moved beyond oral
hormone therapy to provide a delivery system that can work particularly well
for women. Applied once daily to one arm from shoulder to wrist, the gel is
absorbed directly into the bloodstream. EstroGel does not need to be massaged
or rubbed-in and dries in as little as two to five minutes. The transdermal
delivery of EstroGel provides a consistent and continuous supply of estradiol,
an estrogen that is bio-identical to the estrogen produced by the ovaries prior
to menopause. The new gel allows estrogen to be absorbed through the skin, minimizes
skin irritation often associated with the patch and avoids the adhesion problems
that sometimes cause the patch to come off. Once applied, the gel also is a
visually discrete therapy, which may be important to physically active women.
The only FDA-approved estrogen therapy available as a gel, EstroGel has been
a prescribed therapy for more than 25 years in Europe. As with any estrogen
preparation, it should be used with a progestogen in women with an intact uterus.
In a clinical study, researchers found that postmenopausal women, who had been
experiencing moderate-to-severe hot flashes at least seven times a day or 60
times a week, had significantly fewer hot flashes after receiving EstroGel,
when compared to those receiving a placebo; women using the gel also had an
overall reduction in the severity of hot flashes. Since vasomotor complaints
are the primary reason women begin estrogen therapy, this new option may appeal
to women who experience side effects when taking oral estrogen, have skin irritation
when using the patch, or are looking for new options for estrogen delivery.
The Value of Hormone Therapy
As women age, timely and appropriate estrogen replacement is needed because
estrogen not only impacts the reproductive system and the genitalia, but also
the brain, bone, heart, blood vessels, skin, and the ability to see and hear.
Without estrogen, it appears that many women may be at higher risk for certain
diseases. On average, women in the United States now live 30 to 40 years beyond
the time when the ovaries stop producing estrogen. Once estrogen production
ends, most women experience the vasomotor symptoms of menopause, such as hot
flashes, night sweats, palpitations, headaches, mood swings, and anxiety reactions.
By replacing the essential estrogen hormone, hormone therapy (HT) helps women
avoid these disruptive, disorienting and sometimes debilitating symptoms. As
with any medication, women should discuss the side effects of estrogen with
her healthcare provider.
How Should Hormone Therapy be Prescribed?
Individualized therapy is the key to effective HT treatment. Therapy that
is customized to the needs of the individual woman will help minimize side effects
and maximize the effectiveness of treatment. Women should select a healthcare
provider who specializes in menopause treatment, can devote time to discuss
her particular symptoms, and tailor treatment to manage those symptoms. Healthcare
providers and patients should plan an appropriate therapy based on medical and
family history, lifestyle, dietary and exercise habits, body shape and symptoms.
Additionally, the patient must communicate her treatment expectations to the
healthcare provider: Is she seeking short-term benefits (relief of vasomotor
systems such as hot flashes) or a long-term benefit (maintenance of health and
vitality as she ages)? HT should be assessed annually; patient and healthcare
provider should discuss how well the current treatment is working, how the patient's
body may have changed over the year, and whether newly available options should
be considered as treatment. While estrogen is the most commonly prescribed hormone
for menopausal women, there may be a need to add androgen to the treatment for
women whose symptoms have not responded to estrogen therapy. Women who have
had a hysterectomy may take estrogen alone, but, because estrogen causes cells
to multiply and may increase the risk of uterine cancer, women with an intact
uterus may need progesterone as well.
Who Should Receive Hormone Therapy?
HT is the most effective FDA-approved treatment for the relief of moderate
to severe menopausal symptoms. It is an effective, safe and reliable treatment
option, especially if customized to a patient's needs. Many studies have shown
that HT options using appropriate estrogen, progesterone and other hormone combinations
can safely and effectively help manage menopausal symptoms. These treatments
are also used to effectively treat vaginal dryness and as a way to prevent osteoporosis.
While initial reaction to the Women's Health Initiative (WHI) study in 2002
caused many women to stop HT, healthcare providers and patients have come to
realize that WHI did not provide any evidence to dispute the fact that HT is
the best way to treat a typical woman in her forties or fifties seeking relief
for moderate to severe menopausal symptoms. Lost in the media coverage of the
study were the essential facts that WHI studied women whose average age was
64 and who, on average, were 12 years beyond menopause before starting hormone
therapy. Thus, the study told us little about the needs of women who begin individualized
hormone therapy immediately after menopause.
Women are "Naturally" Responsive to Bioidentical Treatments
In the confusion that followed the release of the initial Women's Health Initiative
(WHI) study results, many women turned to alternative, so-called "natural" treatment
options such as black cohosh, dong quai and evening primrose oil. It is important
for women to understand that, although these products may be natural to the
plant world, they are not natural to a woman's body, and they have not been
approved by the FDA as safe and effective treatments.
The therapeutic reality is that a woman's body is much more responsive to estradiol
and the micronized progesterone, which are bio-identical to the estrogen and
progesterone produced by the ovaries. Women respond to these prescription products
because they are so similar to what a woman's body makes naturally prior to
the midlife changes in her body. Estradiol is available through a prescription
in many FDA-approved estrogen products, including EstroGel, and micronized progesterone
is available in a capsule, Prometrium.
As a further caveat, some of the over-the-counter herbal products have been
reported to be associated with serious side effects. One reason for this is
that the use of OTC herbal products is often potluck therapy. With no systematic
government oversight in place, what is on the product label may not be in the
jar, and what is in the jar may not be on the label. Additionally, these products
have not undergone the appropriate clinical trial for safety and efficacy required
by FDA-approved medications. In the few studies that have been completed, many
have been shown not to work beyond an initial placebo effect.
Caution is also advised for women considering natural hormones compounded by
a pharmacy. These new remedies of natural progesterone and natural estrogen
are being touted as bio-identical, customized formulations based on each woman's
hormone levels. Again, these are not FDA-approved preparations, and there are
no guidelines for their use.
In a separate category of treatment, some antidepressants have been found to
relieve hot flashes and mood swings in some women. However, these medications
may have side effects in some patients, including drowsiness, dry mouth, nausea
and loss of both sexual desire and sexual response.
HT options using appropriate estrogen, progesterone and other hormone combinations
can safely and effectively help manage menopausal symptoms. Transdermal hormone
therapies provide some distinctive advantages over oral estrogen. When patient
and healthcare provider discuss how to individualize care, they should determine
which treatment approach best suits the patient's health needs and lifestyle
preferences. Therapy that is customized to the needs of the individual woman
will maximize the effectiveness of treatment.
For more information about menopause, click here.
Created: 11/23/2004  - Donnica Moore, M.D.