A NAMS-conducted survey of 3,700 US women aged 40 to 84 years found that about a third of those who use hormone therapy (HT) at menopause are using compounded hormones. There is a common and mistaken belief that compounded hormones are safer and offer more benefits than FDA-approved therapies. Concerns over health risks have prompted many women who want to take hormones to seek out practitioners who prescribe compounded hormones, which are marketed as natural or bioidentical and therefore perceived as safer than FDA-approved hormones. The so-called bioidentical hormones are plant-derived and chemically similar to those produced by the body. These hormones include commercially available products approved by FDA along with compounded preparations that are not regulated by FDA. The phrase bioidentical hormone therapy has been recognized by FDA as a marketing term and not one based on scientific evidence. Compounded hormones are custom made by a compounding pharmacist from a healthcare provider’s prescription and specifications, unlike FDA-approved drugs that are manufactured and sold in standardized dosages. Compounded drugs lack an FDA finding of safety, efficacy, and manufacturing quality. Prescribing patterns about compounded hormones are difficult to obtain because prescriptions of compounded hormones aren’t tracked the way those for FDA-approved drugs are. Adverse effects of hormone therapy were not common among the survey respondents, but the women who used compounded HT reported higher rates of vaginal bleeding and acne than women who used FDA-approved hormones, and four women who used compounded hormones reported that they had endometrial cancer (cancer of the uterine lining), whereas none who used FDA-approved hormones reported a case.
The survey was supported by a grant from TherapeuticsMD, and the survey results were published online in Menopause.
As many as 75% of perimenopausal women in North America experience hot flashes, and for a quarter of these women, hot flashes are so disturbing that they seek help.
There is no question that hormone therapy is the most effective treatment for bothersome hot flashes, but in many cases, hormone therapy is not appropriate, and some women simply choose not to try it. In fact, from 50% to 80% of perimenopausal women try nonhormonal therapies for hot flashes, but without any real guidance on what works (and what doesn’t), woman experiment with different products, often delaying their chance at finding effective treatment, wasting capital, or they suffer in silence.
A number of nonhormonal products and techniques are promoted for hot flashes, but they are often untested and unproven. To learn what really works, a NAMS panel of experts looked at the evidence and made recommendations in the Position Statement, “Nonhormonal Management of Menopause-Associated Vasomotor Symptoms.”
The NAMS panel found solid evidence that a few therapies do work, including two behavioral approaches (a combination behavioral approach and clinical hypnosis) and certain nonhormonal prescription medications. Other lifestyle and behavioral approaches, treatments, and a supplement under study (S-equol) look beneficial, but the evidence is not as strong.
Evidence for other lifestyle approaches, herbs, and supplements is insufficient, inconclusive, or just plain negative. The panel found no evidence that exercise, yoga, paced respiration, and acupuncture work on hot flashes, although they may offer other health benefits. They are not recommended as hot flash therapy. Over-the-counter and herbal therapies (such as black cohosh, dong quai, evening primrose, flaxseed, maca, omega-3s, pollen extract, and vitamins), relaxation, calibration of neural oscillations (a brain-training technique), and chiropractic intervention also were not found to work, and risk-free approaches such as stay-cool techniques and avoiding hot flash “triggers” have no studies testing their effectiveness, so these are not recommended therapies either.
The NAMS panel prepared this Position Statement to educate healthcare providers and menopausal women. With this careful, critical look at all the available studies, NAMS has highlighted the need for further research. In the meanwhile, women are better informed on how to handle hot flashes without hormones.
The Position Statement has been published online in the NAMS journal, Menopause.
For some women, miserable hot flashes may resemble Energizer Bunnies. They keep going and going and going well past age 60. But when these women want to keep using hormones, many Medicare plans, insurance companies, and healthcare providers say no because supposed safety concerns put hormones on a standard list of medications that older people shouldn’t have, called the “Beers list.” NAMS thinks there shouldn’t be a hard and fast rule against hormones after age 65. Yes, there may be safety concerns, and the Society does recommend that a woman use the lowest dose of hormones for the time appropriate to meet her needs. But NAMS has also stated that, under some circumstances, hormone therapy can be OK for women over age 65. They can be appropriate when the benefits for hot flashes outweigh the risks or when a woman has a high risk of bone fractures and can’t take other bone drugs or can’t withstand their side effects. In fact, that Beers list wasn’t meant to be a hard and fast rule, and it has changed. In 2012, it added a new category of medications that should be used “with caution.” And that’s just how to use them—knowing what the risks are and having your doctor monitor you closely for any problems. NAMS calls it “judicious use.” You can read the official statement from NAMS about continuing hormones after age 65 here.
NAMS has just released a new MenoNote on sleep. Here’s a sneak peek:
You have had enough sleep when you can function in an alert state during waking hours. Most adults need between 7 and 9 hours of sleep each night. During the menopause transition, you may find that you have more trouble falling asleep, staying asleep, or waking up feeling refreshed. These interventions may improve your sleep:
A new year is upon us. It is a great time to think about where we are and where we want to be. What are your personal priorities for 2015? If you're still trying to come up with a resolution or a new direction, here are a few options to consider:
At midlife, we generally have lot to reflect upon looking backwards and a lot to envision looking forward. The move from 2014 to 2015 provides yet another opportunity to be intentional about out life choices. Be sure to give yourself credit for all the good things you accomplished in 2014. Happy New Year!
It is really your choice. If your hot flashes are not bothering you that much, you may want to just wait them out. Hot flashes generally become milder and less frequent as time goes on, and for most women they totally disappear. However, there are some women who have a long experience with hot flashes for several years, maybe longer, and then an occasional hot flash forever. The challenge is that no one can predict how long your hot flashes will persist. Hormone therapy provides very effective treatment for hot flashes, but it is not always a permanent cure. About forty percent of women have a return of their hot flashes when they stop treatment—somewhat like a second menopause when the estrogen level drops again.
There are a number of low-risk coping strategies and lifestyle changes that may be helpful to you for managing hot flashes, but if hot flashes remain very disruptive then prescription therapy can be considered. Prescription hormone therapy (HT) approved by the US Food and Drug Administration (FDA) and by Health Canada include systemic estrogen therapy (ET) and estrogen-progestogen therapy (EPT; for women with a uterus). Some of these treatments have been around for 70 years. A newer FDA-approved hormone product, for women with a uterus, combines estrogen with bazedoxifene instead of a progestogen. Bazedoxifene is an estrogen agonist/antagonist, which means that it works like estrogen in some tissues while inhibiting estrogen activity in others. In this case, it helps to protect the uterus from cancer. There are reasons why some women should not use HT and the list includes such things as a history of estrogen-related cancers such as breast cancer, a history of liver disease, blood clots in the legs or lungs, cardiovascular disease, and stroke. A review of your health history with your healthcare provider is an important first step.
For women who prefer not to take hormones or cannot take them for other health reasons, nonhormonal drugs approved to treat depression, called selective serotonin-reuptake inhibitors (SSRIs), have been found to be effective in treating hot flashes in women who don’t have depression. The only SSRI the FDA has approved thus far for treating hot flashes is paroxetine 7.5 mg. It was shown to improve hot flashes and offers women a new choice. Discuss with your healthcare provider all of these options to see which ones are appropriate for you.
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JoAnn V. Pinkerton, MD, NCMP