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Remember in middle school (we called it junior high in those days) when the boys and the girls were shepherded into separate rooms for those awkward films? It might have been presented by the gym teacher or the guidance counselor; maybe your school was large enough to have a health teacher who presided as we were introduced to the signs and effects of puberty—and the dangers of acting on urges.

My conversations with women lately have reminded me that while we take great pains to introduce our younger selves to their biology, we don’t quite follow through. In the sex ed I’m familiar with, the story stops with the fertile years. We don’t introduce the full cycle we can all expect to experience if we only live long enough.

Yes, breasts bud and menstrual cycles begin. We have children, or we don’t; we may have illnesses or surgeries. At some point, the cocktail of hormones shifts, and the parts of our bodies once prepared for reproduction begin to change once more. Our periods become unpredictable and eventually stop (a year without defines menopause). Our tissues become dryer, more fragile, less elastic. Without care and attention—and often in spite of them—our vulvovaginal tissues atrophy, which means they actually shrink.

And where do we learn this? Not in a gym or a cafeteria with a hundred of our same-sex classmates! For too many of us, we learn it only through our own experience, at a point in life when there aren’t many people we’re talking to about sex. We’re tempted to think this is an odd thing that’s happening only to us. We’re a little embarrassed, maybe a little ashamed.

There’s so much more common about our experience than most women think! If only there were a middle school for midlife, so we could all get together and learn about this next phase of physical transitions. As we thought (or it was hoped we were thinking) back in the original sex ed, knowing what’s ahead is the first step in making good decisions and taking charge of our own sexual health.

I haven’t yet figured out where to offer my midlife sex ed classes, or how to get busy women to attend! So I’ll keep having conversations with women one on one in my practice and through the MiddlesexMD website. I hope you’ll be having conversations, too, because even without the awkward films, we’re all in this together.

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Itchy beyond words. Crotch of underwear rubs painfully against labia. Sensation of being on the receiving end of a vulvar wedgie. Feels like tiny razor blade nicks in my vagina during intercourse without lube or adequate foreplay. Also difficulty with penetration.

Doesn’t that sound awful? If that were you, I wouldn’t be surprised that you’re not thinking about sex. Just as awful, about half of us think that vaginal dryness is something we just have to live with—and about the same number of us are hesitant to raise the topic with our doctors.

The truth is that vaginal dryness does not need to end the intimacy you have with your partner—or the afterglow you experience yourself after sex.

First, a word about what’s happening: Yes, it’s likely hormones. As estrogen levels decline, the vaginal lining changes. It becomes more delicate and less stretchy. There’s less lubrication and less circulation. Vaginal dryness is a typical first sign of vaginal atrophy, when vulvo-vaginal tissues shorten and tighten. It’s common; you’re not alone, and you’re not deficient.

If you’re just beginning to notice some discomfort, you can take the easy step of adding lubricant to your foreplay. Lubricants come in three types: water-based, silicone, and hybrid. My patients with dryness issues typically like the silicone and hybrid best, because they last the longest without reapplication, and because they seem just a little bit slipperier to some. Lubricants are made specifically for safe use on and in your vagina; if you want to experiment with a few, you can try our Personal Selection Kit (and read more about it here).

Next, you can add a vaginal moisturizer. While lubricants provide temporary comfort, reducing friction during sex, moisturizers work to “feed” and strengthen vaginal tissues around the clock. Moisturizing here is just like moisturizing your neck or your face: You have to be faithful! I recommend application at least twice a week. Moisturizers need to be placed directly in your vagina, which can be done with an applicator or a clean syringe you reserve for that purpose.

For some women, these two products—and the right amount of foreplay—are enough to make a difference. If they don’t do it for you, please talk to your health care provider, even if you think it will be awkward: Your sex life is important! There are localized estrogen products and a relatively new oral medication (called Osphena) that may be helpful for you, but you’ll need a consultation with your physician and a prescription.

This isn’t the end; it’s only a transition, which we as women have a lot of practice with. Take heart and take charge!

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A couple of weeks ago, I talked about an article I’d seen about how sexual intimacy is linked to marital happiness. The research, by Adena M. Galinsky and Linda J. Waite, found that continued healthy sex-lives help couples dealing with physical illness, especially chronic health problems.

Couples who had sex frequently (and sex was defined broadly—it didn’t need to include vaginal intercourse) were more likely to say they had a good relationship.

This is, of course, a chicken and egg: More sex doesn’t automatically make a relationship good. It’s more likely—and perfectly reasonable—that an unsatisfying relationship will include less sex. And the women I meet through my practice as well as the rest of life show me that this is often a time when our relationships get some re-evaluation.

Sometimes it’s the empty nest, and the change in schedules and priorities that comes with it. Sometimes it’s retirement, for one or both partners, which means a lot more together time. Sometimes it’s the stress of caring for aging parents along with everything else. Whatever the prompt, when some of us look at our relationships, we say, “Is this really what I want?”

So it was interesting to me to read the details of the Galinsky Waite study, to see how they measured the quality of relationships. These are the questions they asked:

  • How close do you feel your relationship with your partner is?
  • How often can you open up with your partner if you want to talk about worries?
  • How often can you rely on your partner for help with a problem?
  • How often does your partner make too many demands?
  • How often does your partner criticize you?
  • How happy is your relationship with your partner?
  • Do you like to spend your free time together, separately, or some of both?
  • How emotionally satisfying is your relationship?
  • How often does your partner get on your nerves?

If you’re feeling some vague discontent, those questions might help you with a conversation with your partner—or with a couples therapist if you decide some outside perspective and coaching would be helpful. If you’re feeling angry, or resentful, or isolated in your relationship, it’s no surprise that you’re not feeling sexy.

And you deserve to.

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I referred a few weeks ago to the controversy surrounding recommendations for the frequency of mammograms. A conversation over the weekend reminds me that there’s a similar fog surrounding the change in guidelines for Pap guidelines, introduced about two years ago and now working its way through health insurance policies.

We used to all take for granted that our annual Pap screen was the centerpiece of our annual physical exam. In fact, many women calling my office for appointments referred to the appointment that way: “my annual Pap test.” And the prevalence of annual Pap screenings did have an effect, lowering the cervical cancer rate in the U.S. by more than 50 percent over the past 30 years, according to the American Congress of Obstetricians and Gynecologists (ACOG).

Current guidelines call for Pap screening every three to five years, depending on your age and other health conditions—and there’s a lot of agreement about that from the American Cancer Society, ACOG, the American Society for Clinical Pathology, and, likely, your insurance company.

But! This doesn’t mean that there’s no need for an annual “well-woman” visit, including a pelvic exam. Exactly what happens at each annual visit should vary according to your age and your health history. What’s common, though, in addition to updating overall health statistics, is a thorough inspection of the vulva and vagina, including palpation of the area, including the lower abdomen, rectal, and bladder regions. We’re looking for any early indication of abnormality, but if your general health is such that you wouldn’t treat a condition if discovered, no further evaluation is necessary. A clinical breast exam is also part of the annual exam.

In addition to the “clinical” part of the exam, though, there are benefits that you can especially appreciate as you navigate perimenopause and menopause. First, your body is changing, so having an annual “date” to check in on your body helps you be aware of what’s happening. When you share your observations with your provider—which I hope you do—they’ll be part of your medical record, which gives you both a view of trends over time. With our busy lives (jobs, parents, kids, grandkids, volunteer projects), without a checkpoint, we can find we’re simply adapting to changes without even being conscious of them.

And the second benefit is that, with regular communication, your health care provider can be a genuine partner in keeping you healthy—physically, emotionally, and sexually. Seeing him or her at least once a year is part of that; the other part is setting the expectation that your appointment includes answering your questions—about everything from your tennis elbow to your vaginal dryness.

If you don’t find that expectation being met, get bossy. An annual exam—and, just as important, the conversation that goes along with it—is part of managing your own health. Having a health care provider with the time, expertise, and patience to answer your questions is not too much to ask. And when you’re comfortable with and confident about your health care provider, you won’t be a stranger.

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Shhh No More!

We had a focus group a couple of weeks ago, a gathering of women to check in on what’s on women’s minds. One of the questions we asked was to whom women talked about sex—beyond their partners—and about any sexual health questions they might have. The answers were just as varied as I thought they might be. One woman said she’d talk to a stranger on an airplane—someone to whom she could say, “See you never!” Another woman has a group of long-term friends who she says frequently talk about any part of life—including sex.

I remember sex as a subject of great interest and fascination when I was very young—whispers, conjectures, a lot of mis-information and tall tales. By high school, we knew more, the better informed among us bringing along the uninformed. In college, we received a great deal more detail as data from actual, rather than fictional, experimentation became more commonplace.

It may be marriage that closes our mouths. We may be willing to share exploits or guess at sex before we choose our mates, but once we do, the walls of privacy go up, and silence rules our sexual lives. Or maybe we’re susceptible to the cultural messages that suggest that older women plus sex equals nonstarter. Maybe we’re embarrassed, as we approach and pass into menopause, that we’ve got “symptoms”; we don’t want to become Great Aunt Tessie, who shared her upper-GI details at every family gathering.

I buy the privacy reason, the loyalty to one’s partner. But I reject the cultural messages and the embarrassment. We should allow nothing to get in the way of our opportunities to continue to learn and explore, and to find reliable sources of information and aid when things aren’t working. Because, let’s face it, most of us weren’t trained in sexual techniques—or even anatomy. We need information as we grow and change sexually, and most particularly during menopause, when our bodies, while still miraculous and powerful, are less predictable and consistent.

So, please. Talk. As a reserved Midwesterner, I’m not sure I recommend raising the topic with your fellow passengers on airplanes—but far be it from me to discourage you. Talk to your partner about how your experience is changing. Talk to your friends to compare notes—and recommendations for health care practitioners or websites or books you find helpful. Talk to your health care provider, and be sure s/he is listening. Join us on Facebook or Twitter. Use our Ask Dr. Barb button, front and center on our website; you’ll get a private, personal answer and may inspire a future blog post Q&A.

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Navigating Breast Health

Breasts play a role in our sexual response, as I’ve described before. Our nipples are bundles of nerve endings that respond to touch. Some women (though not most) can reach orgasm through nipple stimulation alone. Others of us rely on breast and nipple fondling to put them “over the top” in experiencing orgasm during oral sex or vaginal intercourse.

So while breast cancer isn’t central to my focus on women’s sexuality, it’s obviously connected—as the heel bone is to the ankle bone, the ankle bone to the shin bone. And because in my practice, I advise women on many aspects of their health, I pay attention to the discussion about mammograms and breast cancer diagnosis.

It’s complicated, and it’s controversial right now. An article in the New York Times last month previewed a study published in JAA Internal Medicine. Dr. H. Gilbert Welch, of the Dartmouth Institute, concludes that three to fourteen 50-year-old women in 1,000 (that range tells you something of the current controversy about data) will be overdiagnosed and overtreated as a result of mammograms. Zero to three women in that same 1,000 will avoid a breast-cancer death. Dr. Welch encourages more study, but also concludes that mammograms are over-used and ineffective.

That article prompted an almost immediate response from Dr. Elaine Schattner. Dr. Schattner takes issue with the notion that women are overly harmed by false positives. Mammogram technology is “more accurate and involves less radiation than ever before,” she says. Instead of doing more study, she suggests we focus on making high-quality screening facilities available to all women, get really good at accurately reading the images, and let women themselves decide how to manage the balance between risk and reward.

In my own practice, I use the guidance from the American Congress of Obstetricians and Gynecologists, which calls for annual mammograms for best early detection. I balance that with my own knowledge of each woman’s history and risk factors, but it’s still complicated. I might have a patient whose mammogram comes back entirely negative—which is positive!—but still receive a recommendation for further imaging because of family history. The family history might be for cancer detected in a woman in her 80s or 90s.

Cost factors in, too, both individually and collectively. As more of my patients have high-deductible health insurance, the decision about whether to have an MRI is more consequential. And, of course, tests that aren’t necessary or productive are part of what’s driving the cost of health care up for all of us.

And yet! Given where we are with treatment, early detection remains one of our best assets in combating breast cancer. I’m reminded of an earlier paper that concluded that of the study subjects—women from 40 to 49 with stage I, II, or III invasive breast cancer—77 percent who died hadn’t had regular screenings.

As a physician, I’m frustrated by the difficulty we have in sending consistent messages to women. I don’t want women to be afraid of breast cancer, but neither do I want them to be casual or skeptical about screening methods—like mammograms—that are relatively low risk and low cost.

What about you? Are you confused by what you read about mammograms? Do you know what’s recommended for you? Do you follow those recommendations? Are you confident your health care provider is taking you—individually—into account? Have you had to navigate insurance guidance as well as medical guidance?

The worst thing we can do is to throw up our hands and give in to the ambiguity. The best thing we can do is to encourage each other, speak up, demand common sense paths to follow, and work to make screening readily available.

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It’s going on eight years since I transformed my medical practice. I studied and became certified by the North American Menopause Society as a menopause care provider, and while welcoming patients into my practice, used their questionnaire — a thorough document that makes it easy for new patients to give me a comprehensive view of their symptoms and health histories.

On that eight-page-long form there are just a few questions for women to answer about their current and past sexual experiences:

  • Do you have concerns about your sex life?
  • Do you have a loss of interest in sexual activities (libido, desire)?
  • Do you have a loss of arousal (tingling in the genitals or breasts;
    vaginal moisture, warmth)?
  • Do you have a loss of response (weaker or absent orgasm)?
  • Do you have any pain with intercourse (vaginal penetration)? If yes, how long ago did the pain start? Please describe the pain: Pain with penetration? Pain inside? Feels dry?

I continue to be amazed by the responses from my patients. Sixty percent of my patients have experienced a loss of interest in sexual activities, 45 percent have a loss of arousal, and 45 percent a loss of sexual response.

And when I talk to them, they are

  • Perplexed—because they don’t understand what’s changed.
  • Disappointed—because they expected there to be more.
  • Frustrated—because they don’t know what to do about it.

And when you carry those numbers from my practice to the rest of the country–well, more than 44 million women are aged 40 to 65 in the US alone. Some 6,000 of us reach menopause every day. And at least half of us experience sexual problems with menopause. Probably more.

That’s a lot of disappointed women. And a lot of disappointed men, too.

But you know what it means? Those symptoms you think are setting you apart, making you the odd woman out? They’re not unusual. You’d be more unusual if you sailed through perimenopause and menopause without symptoms.

So speak up! Talk to your health care provider about what you’re experiencing. Read sites like ours to learn more about your options for compensating for changes that aren’t making you happy. Talk to your friends and sisters about your experiences.

We don’t give up reading when our eyesight weakens—we snag some cheaters from the drugstore. We don’t have to just accept the changes if we don’t want to. We’re smart, resourceful, and can do what it takes to live the lives we want to live.

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We’ve been following the development of Flibanserin, also called “pink Viagra,” since 2010, when its developer shelved it after hitting a bump in the road to FDA approval. Several years later, we were talking about alternatives, Librido and Lybridos, which were moving forward with clinical trials (and have not yet been approved).

We’ve just learned that the manufacturer that now owns Flibanserin has filed an appeal of the FDA denial, saying that other drugs have been approved with less data and more extreme side effects. And that’s reignited discussion about whether pharmaceutical products targeting women’s sexual disorders are evaluated on a level—or relevant—playing field.

Flibanserin, Librido, and Lybridos (and a small handful of others) are all drugs designed to play a part in awakening libido for women. They counter hypoactive sexual desire disorder (HSDD), in physicians’ terminology (the rest of us call it “not tonight—or tomorrow night, either” syndrome). There are, for context, a couple of dozen FDA-approved drugs for the comparable problem among men, including Viagra.

I don’t have the insider information I’d need to assert a double standard, although people I know and respect—like my colleague Sheryl Kingsberg—suggest there is one. Women’s health psychologist at University Hospitals MacDonald Women’s Hospital, Sheryl said, “There’s a double standard of approving drugs with a high risk for men versus a minimal risk for women.” The side effects for Flibanserin, for example, were reported as dizziness and nausea; Sheryl compares those to side effects of penile pain, penile hematoma, and penile fracture—all from a drug that was approved.

That does sound like some extra protectiveness of women. Given my focus on sexual health for women, I run into a lot of cultural expectations and hesitations; we Americans are still just a bit prudish when it comes to, especially, older women having sex. That’s in spite of what I see in my practice every day: Women themselves want to live whole lives, which means being physically active, emotionally engaged, and sexually active within their relationships.

I recognize that sexuality for women is complex, and there won’t be a “magic bullet.” For women, arousal and desire is a mix of emotional intimacy, biological responses, and psychological responses; a drug won’t address all of the components. But because I’m often working with patients to untangle interlocking causes of problems with sex, I’m eager for as many tools as possible, including pharmaceuticals.

As a physician, I also see the need to evaluate trade-offs and risks. I’ve talked before about the pros and cons of hormone therapy. For some women, living longer doesn’t really count if they’re not able to be active—including being actively sexual. “Pink Viagra” drugs may well require the same kind of close collaboration between women and their doctors to evaluate risks and benefits. Again, Sheryl: “Give women a chance to decide for themselves, within reason. There is no drug out there that has no risk.” In the case of Flibanserin, only 8 percent of testers said the side effects were bad enough to make them want to drop the drug.

These decisions by the FDA are also important because pharmaceutical research is done by businesses, businesses that can decide that one problem or another is too expensive or too complicated to take on. Sheryl sees this, too, saying, “My worry is that research in this area will dry up and will leave many women without a pharmacological option.”

One way to make your voice heard about the importance of continued research is by signing the International Society for the Study of Women’s Sexual Health (ISSWSH) WISH petition. Our sexual health is integral to our overall health, and we need more investigation and even-handed, common-sense consideration of therapies for women.

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Few things affect quality of life like lack of sleep. Nothing kills the jazz or even dulls the everyday ho-hum routine like that head-in-a-fog, feet-in-the-mud feeling of too little sleep.

And sex? Romance? That delicate dance we do to stay connected with our life partner? Fuggedaboudit. We’re having enough trouble keeping our heads up and off the desk at work. All we want is a good night’s sleep, and that’s the very thing that’s as elusive as a four-leaf clover in an alfalfa field.

If you haven’t discovered already, insomnia is the dark shadow of the menopausal years. (And insomnia can begin years before other menopausal symptoms and can last long after other symptoms subside.) In fact, almost half of women age 40-64 report having sleep problems, according to a 2007 National Sleep Foundation survey. Compared to premenopausal women, those in peri-and post-menopause report sleeping less, sleeping badly, and are twice as likely to use prescription sleep aids.

Yuck. That’s a lot of cranky, sleep-deprived women.

As you might expect, menopausal insomnia can be caused by a lot of things—hormonal changes, for one.  “With impending menopause, most women experience a reduction in progesterone and estrogen,” says David Slamowitz, MD, medical director of the SleepWell Center in Denver, in this article for More magazine. “These hormones help regulate sleep, so declining levels can cause sleeping difficulties.”

Better sleep may be another reason to consider hormone therapy.

But these years are often associated with change in our careers, health, children, parents, and partners. Change is stressful, and stress is the archenemy of sleep. If you’re anxious about your health (or your parents’ or your partner’s), if your children are adjusting to adult life, if you’re having difficulty covering the demands of your job, it’s hard (or impossible) to drop these worries at the bedroom door.

Other causes of sleeplessness can be the physical insults of getting older—arthritis, frequent nighttime urination, sleep apnea, restless leg syndrome. Not to mention the misery of hot flashes and night sweats, which can awaken us several times a night. The only mercy here is that if we can make it to blessedly sound REM sleep, hot flashes tend to lose their power to wake us up.

So, what is a foggy-brained, sleep-deprived, menopausal woman to do?

Well, first, if you snore, feel depressed, or find insomnia to be seriously affecting your ability to function, talk to your doctor. You may need to tease out how other factors may be influencing your sleep. Review the medications you’re taking, which can also interfere with sleep (and sex). Ask him or her to check your thyroid for an endocrine disorder that can disturb sleep.

But you have some control over your sleep (or lack thereof) as well. You can be proactive about getting a good night’s sleep. Plus, good sleep hygiene often ends up being good for your overall health as well. (You knew we were going there.)

Here’s a regimen that may have you sleeping, if not like a baby, perhaps almost like a normal human being.

  • Exercise. Vigorously in the morning with maybe a bit of gentle yoga in the evening. Here’s a nice yoga stretching routine that I use frequently.
  • Get outside when you exercise. Natural light helps establish a good sleep-wake cycle, and we tend to become more housebound as we age.
  • Don’t nap. Yeah, this can be tough when you haven’t slept at night, but we’re moving toward establishing a rhythm here.
  • No stimulants. Obviously, a double latte at 8 p.m. will keep you jittery into the wee hours, but avoid caffeine in any form, including chocolate. Ditto for nicotine and alcohol. Contrary to common (mis)perception, alcohol will relax you at first and wake you up later when your body begins to metabolize it.
  • Don’t eat heavily before bedtime.
  • Establish a soothing bedtime routine that sends “now we’re getting ready to sleep” signals to your brain. And do it at the same time every evening. (That rhythm thing again.) Drink an herbal tea. Read a book. Do your yoga. Don’t watch TV or do computer work if it winds you up. Don’t engage in stressful conversation in the evening.
  • Make the bedroom pleasant and sleep-inducing. It should be dark and cool but not cold. The bed should be comfortable and you should use it only for sleep—and sex. Oh yeah, remember that?

With any luck, you’ll gradually move beyond this tough transition and slowly reestablish more normal sleep patterns as your hormones settle down. But as with many issues during menopause, we may need to adjust to a new normal as well. Some women say they’ve been able to make their peace with and adapt to different sleep patterns.

And whether we’re talking about sex or sleep, adaptation is what it’s all about right now.

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Recently, I was browsing through an online discussion board about the pros and cons of hormone replacement therapy. I ran across this comment from a participant: “I’m going to try bioidentical hormones like Suzanne Somers. I’ve heard they’re safer.”

Whoa! I thought. Let’s do some objective homework first, and weigh the risks before you jump in.

Celebrity endorsements notwithstanding, bioidentical hormone replacement therapy (bHRT) is neither the miracle cure nor fountain of youth touted by Ms. Somers. Nor is it some kind of snake oil concocted by salacious quacks or unscrupulous doctors and pharmacists.

The truth is, of course, much more nuanced.

As a physician, I’d always opt for more treatment choices when it comes to helping women with the unpleasantries of menopause. I want more drugs in the arsenal, more ways to treat hot flashes, sleeplessness, and loss of libido. However, the entire topic of bioidentical hormones is so laden with emotion and misinformation that it takes a very fine point to tease fact from hyperbole.

We laid the groundwork on bioidenticals before, but the issue continues to befuddle and mislead, so let’s circle back and fill in some gaps.

Any hormone therapy, whether bioidentical or synthetic, is only intended to ease menopausal symptoms. Hormones were never meant to keep your memory sharp or your hair shiny or your skin taut. Hormones are not a fountain of youth. The latest medical guidelines state that hormones should be taken at the lowest possible dose for the shortest period of time needed to ease symptoms. This is because hormones, whether bioidentical or synthetic, are drugs and they interact with other systems in the body, sometimes in ways that are not well understood.

Point #1. Menopause isn’t a disease; it’s a natural transition. Hormone therapy is intended neither to keep your hormones “in harmony” nor to keep menopause at bay indefinitely. Hormone therapy is intended to ease the symptoms of the menopausal transition when they are interfering with your life.

Next, bioidenticals aren’t necessarily “natural” and therefore “safer.” The marketing message that hooks women is that bioidentical hormones are derived from “natural” sources and are therefore safer than hormones from other sources.

Bioidenticals are estrogens that are indeed made from plant sources, but they are processed (synthesized, if you will) to create a hormone that can be absorbed by humans. “All plant-derived hormone preparations, whether they come from a compounding pharmacy or a large commercial pharmacy, require a chemical process to synthesize the final product,” writes Dr. Oz in this article.

With bioidenticals, however, you end up with a molecule that is exactly like (identical to) human hormones, whereas non-bioidentical hormones are similar but not identical.

Any hormone, whether those your body produces or those you ingest, affects your body. Also, the delivery method, whether a patch, pill, or vaginal cream, also affects the way your body absorbs and responds to the hormone.

Point #2: Don’t equate “bio” with something “natural” and therefore risk free. Taking any hormone involves some risk. (Decisions about hormone therapy need to be based on careful consideration for each individual—understanding both the potential risks and benefits for that woman.) Bioidentical hormones are so-called because the molecule is identical to the human hormone and because they are derived from plant sources, even though they must be synthesized to be useful.

“So ‘natural’ doesn’t necessarily equal ‘safe’—and may simply be a euphemism for ‘unregulated,’” according to this article in the Harvard Women’s Health Watch.

You can, we should note, get bioidentical hormones that are FDA approved and regulated. Many familiar brands of hormonal rings, creams, patches, pills, and gels are both commercially manufactured by pharmaceutical companies and bioidentical. These include Estrace, Femring, Vivelle, Vagifem, and Prometrium, and more.

You know what you’re getting with these products. You know that the active ingredient is in the form and dosage that the label says it is. That kind of uniformity and “safety” is the assurance provided by FDA testing and approval.

Point #3: Many major brands of commercially manufactured hormones are both bioidentical and FDA approved.

Next, let’s understand what “custom-compounding” means. Many bioidenticals are touted as natural, safe, and custom-made just for you to bring your hormones back in balance. Custom-compounded drugs are made in small, customized batches by pharmacies that specialize in custom-compounding. They can be prescribed by a clinician.

Custom-compounding is very helpful when a patient needs a special dosage of a medication, or a different delivery method, or is allergic to a filler in a commercial drug. Maybe, for example, you need a lower dose of progesterone than is commercially available, or you need it in a vaginal cream, and the big pharmas only make it for administering orally.

However, neither the process nor the product is FDA-regulated or approved, and in fact, studies have shown that they are much less consistent than commercial products. In a few highly publicized cases, contaminated medications distributed by custom-compounders have been responsible for serious illness, infection, and death. An example is the outbreak of fungal meningitis in the fall of 2012.

The problem with custom-compounded hormones arises with claims of customized products that are safe, natural, and that will restore hormonal balance, among other things.

In actuality, it’s not possible to accurately pinpoint hormonal levels in an individual because they are constantly changing. The hypothalamus, pituitary and ovaries (the HPO axis, as we call it) work in a very integrated and precise way to direct hormone production. Our replacements aren’t able to replicate that concert of events, but we can do a good job of replacing the hormones more consistently, which many women prefer to the ‘ups and downs’ we’re familiar with. The only way to determine an effective dose is through symptom control—the lowest dose that relieves a woman’s symptoms. “Salivary and blood testing of hormone levels used by custom compounders is meaningless for midlife women as their hormone levels vary throughout the day, and from day to day” is the North American Menopause Society position.

“This doesn’t mean that you shouldn’t consider compounded hormones. Just realize that, in a real sense, you’re going to be an experiment of one,” says the Harvard Medical Watch article.

Also realize that custom-compounded drugs usually aren’t covered by insurance, and the regimen of testing and compounding gets expensive very quickly.

Point #4. Custom-compounding of drugs is a time-honored practice of making drugs in small batches or according to specific needs (while the processes and products aren’t subject to federal regulation or oversight). Claims that these products are healthier, safer, or somehow contain properties lacking in commercial products should be viewed with suspicion.

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