Hot Flashes

For women going through the menopausal transition, there’s no better discovery than a safe, natural, nonhormonal treatment for hot flashes that really works.

So a study just presented at the annual scientific meeting of the American College of Obstetricians and Gynecologists caught our eye. It focused on an over-the-counter botanical extract derived from pollen. Could such a simple remedy really improve symptoms and quality of life?

To learn more, we spoke with the study’s author, James A. Simon, MD, an ob-gyn in private practice in Washington, DC, and professor at The George Washington University School of Medicine and former president of the North American Menopause Society.

Relizen, the brand name in the US of the botanical extract, was developed after an accidental discovery—a Swedish beekeeper noticed that when bees feasted on the pollen of a particular flower, they seemed more energetic. So he wondered if giving that pollen to men and women would make them more energetic, too.

“It didn’t work,” said Dr. Simon. “But menopausal women who took it said that their hot flashes were better.” So the extract was developed using just the cytoplasm (material inside the cell) of the pollen—according to the manufacturer, that removes the pollen allergens. It’s actually been available in Europe under different names for about 15 years, and it is backed up by peer-reviewed research. In a 2005 double-blind placebo-controlled study of 64 menopausal women, 65% of those who took it had fewer hot flashes—compared with 38% of those who took a placebo. It’s been used by more than a million women in Europe.

In the new study, 324 women going through the menopausal transition took Relizen daily for three months. To get into the study, the women had to be having hot flashes—and be bothered by them.

Results: 86% had fewer hot flashes, and for 91%, their hot flashes were less severe. What the new study adds is an emphasis on self-assessed quality of life—fatigue, irritability, sleep quality. These all got better, says Dr. Simon, who has no financial stake in the company that makes Relizen. “Their sense of well-being improved,” he said. The mechanism—how this extract works—isn’t well understood. Side effects, such as stomach upset, were rare and tended to go away after a week or two.

AN ADDITIONAL BENEFIT FOR BREAST CANCER SURVIVORS

Because research has confirmed that it doesn’t affect hormones, Relizen may have a particular role to play for women who have survived breast cancer who have been told that hormonal treatments aren’t safe for them. Currently, the only nonhormonal FDA-approved prescription for relief of menopausal symptoms such as hot flashes is the antidepressant paroxetine (Brisdelle, which has the same active ingredient as the antidepressant Paxil). But this antidepressant not only has side effects such as headaches, nausea, weight changes, reduced sex drive and interference with the ability to have an orgasm—it may also interfere with the action of Tamoxifen, the drug that is often prescribed after breast cancer treatment to prevent recurrence. Relizen, according to a recent study in Menopause, doesn’t affect the action of Tamoxifen.

SHOULD YOU TRY IT?

If you want relief from hot flashes and night sweats, Relizen is one of many options, said Dr. Simon. Hormone therapy, such as estrogen, is certainly the most effective for symptomatic relief, but many women want to avoid taking systemic hormones based on safety concerns. (We’ll revisit this controversial issue in an upcoming article.)

Plant-based supplements that have estrogenic effects can help, and Dr. Simon occasionally recommends Remifemin, an over-the-counter product that contains the estrogenic herb black cohosh. “I double the dose on the package insert to achieve the best results,” he said. Purified soy phytoestrogens also work for some patients, he notes. If you decide to pursue either option, he recommends that you work with a health-care professional, as there are safety questions for some women in taking estrogenic compounds, especially women with or at high risk of developing breast cancer.

Among nondrug approaches, he’s seen success with hypnosis. Even acupuncture, which hasn’t been shown in studies to be effective for hot flashes, appears to work for some people, said Dr. Simon.

What he likes about Relizen is that it’s so safe—for any woman, including those with a history of hormone-sensitive breast cancer—that it’s fine to try on your own. “A patient can acquire it by herself and see if it’s beneficial—before seeing her practitioner,” said Dr. Simon. “If it doesn’t work after two or three months, she can see her health-care professional for other options.” (Note: Relizen is currently available through the manufacturer’s website.)

Sources: Study titled “Nonhormonal Treatment of Perimenopausal and Menopausal Climacteric Symptoms” by James A. Simon, MD, CCD, NCMP, clinical professor of obstetrics and gynecology, The George Washington University School of Medicine, and René Druckman, MD, presented at the American College of Obstetricians and Gynecologists Annual Scientific and Clinical Meeting 2016. Dr. Simon is a Washington, DC–based physician who provides patient-focused care for women across the reproductive life cycle, from adolescence to childbirth, and through the menopausal transition.

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fda approved addyi todayDear Patient, Supporters and Friends,

Today the FDA made #HERstory for women with the approval of a first-ever medical treatment option for women’s most common sexual dysfunction, known as Hypoactive Sexual Desire Disorder, or HSDD. You can think of this disorder (HSDD) as: distressing low desire that can affect a woman, her partner or both and that lasts and lasts and lasts for more than 6 months regardless of circumstances, mood, vacation, health, etc. After enjoying normal sexual function, and then totally losing one’s interest in or desire for sex for longer than 6 months gives you some idea of the scope and impact of HSDD.

I know all of you have been closely monitoring the national conversation over the “little pink pill” or the “female Viagra” during the last year as the drumbeat has built among organizations such as ours – and among hundreds of thousands of people across the country – for treatment options for a condition that the FDA itself has recognized as a key unmet medical need. We at James A. Simon, MD, PC have been actively involved in the development of Flibanserin, or its new trade name ADDYI, for many years and have conducted several of the clinical trials used for FDA approval right here in the Washington, DC, office. For those of you who participated in those clinical studies, we want to personally thank you. Whether you received the active treatment in those trials or the matching placebo, soon you will be able to take “the real thing.”

James A. Simon, MD, PC is proud to be a part of such a thrilling moment in women’s sexual health and for the 16 million American women currently living without a single FDA-approved medical treatment option for HSDD.

With the FDA’s action today, The Agency not only approved a first-ever medical treatment option for HSDD, it also demonstrated that there IS a viable regulatory pathway forward toward approval of additional therapies for this and other female sexual health indications. Further, Flibanserin’s (ADDYI’s) approval today, opens the pipeline for other future options yet to come for women’s sexual health. In that vein, we are currently conducting additional studies on other medications for female sexual dysfunction right here at James A. Simon, MD, PC, and we are always looking for qualified study subjects/volunteers.

Women with HSDD deserve the safety and peace of mind that comes with access to FDA-approved medical treatment options, and today we write a new chapter in the fight for equity in sexual health.

Sincerely,
The entire James A. Simon, MD, PC family

 

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Vulvovaginal Atrophy

vulvovaginalVulvovaginal atrophy (VVA) is a common condition associated with the decreased estrogenization of the vaginal tissues. It occurs most often after menopause, but it can also develop during breast-feeding or at any other time your body’s estrogen production declines.

The inevitable estrogen deficiency that accompanies reproductive aging and menopause results in universal changes in the vaginal ecosystem associated with a variety of vulvovaginal and urogenital complaints. At some point in their lives, the majority of women will experience these symptoms, collectively termed the genitourinary syndrome of menopause (GSM), a term which has recently replaced vulvovaginal atrophy (VVA) in the accepted nomenclature. VVA or GSM symptoms usually develop gradually and become most bothersome as women transition to the mid-to-late 50’s. These symptoms typically follow the vasomotor symptoms of menopause, such as hot flashes and night sweats. Unlike VMS, which usually subside after several years, the symptoms of GSM (see below) persist and increase in both frequency and intensity as women age.

With estrogen deficiency, the epithelium (aka the surface cells) of the vagina and vulva thins and loses its rugal folds. Those folds are really important. Think of the difference between a pair of pants with elastic, or a skirt with pleats vs one without. Imagine how you would feel trying to put them on if you’ve gained 20 pounds. Which pants would you like to squeeze into? With menopause and increasing VVA or GSM, the elasticity provided by those rugal folds diminishes, and susceptibility to injury, even with minor trauma, can ensue. Estrogen deficiency also leads to diminished vaginal glycogen and decreased acidity of the vaginal secretions (increased pH), thereby reducing the vagina’s natural defense against local pathogens (i.e. yeast and coliforms [the most common bacteria of fecal material]). The close proximity of the lower urinary tract to fecal contamination is associated with an increased risk for acute and recurrent urethritis and cystitis (bladder infections).

When a woman doesn’t have intercourse or other vaginal sexual activity on a regular basis following menopause, her vagina may also become shorter and narrower. Continuing to have regular vaginal sexual activity through menopause helps keep the vaginal tissues thick and moist and maintains the vagina’s length and width. This can help keep sexual activity pleasurable. This has euphemistically been referred to as “use it or lose it”.

If you do experience vulvovaginal symptoms (dryness, irritation, burning, itchiness, pain) do not automatically assume that reduced estrogen levels are the reason for these symptoms. Because vaginal discomfort can arise from many different sources, persistent symptoms should be brought to the attention of your healthcare provider for evaluation.

 

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Non-Hormonal Prescription Option for Hot Flashes

Hot-Flashes1Hot flashes and its nocturnal cousin, night sweats, the highly descriptive street names for the vasomotor symptoms (VMS) experienced by as many as 80% of menopausal women, are the most common of all menopausal symptoms.

No consensus exists on the pathophysiology of menopausal VMS, although many hypotheses have been proposed. Hot flashes (HFs) are hypothesized to result from a dysregulation of the hypothalamic temperature-regulating mechanisms, triggered by a decline in estrogen levels.

Alterations in neurotransmitters such as serotonin and norepinephrine (NE) are thus likely to play a crucial role in menopausal VMS. Core body temperature (CBT) is regulated between an upper threshold for sweating and a lower threshold for shivering. Between these thresholds is a “thermoneutral” zone, within which major thermoregulatory responses (sweating and shivering) do not occur. Fine thermoregulatory adjustments within the thermoneutral zone are affected by variations in peripheral blood flow. According to this theory, heat dissipation responses of HFs (sweating and peripheral vasodilation) would be triggered if CBT were elevated such that the upper threshold was crossed.

Hormone therapy (HT) has been known to be efficacious for most women with VMS due to menopause. Current clinical guidelines for HT recommend using the lowest dose for the shortest duration to relieve symptoms and reach treatment goals. Dose, route of administration, and duration of use should be tailored to the needs of each woman, and periodic reassessment of symptoms is required to evaluate whether a change of treatment is necessary. However, VMS recur in approximately half of women after discontinuation of HT. Certain health risks may preclude the use of HT in some patients, and some menopausal women with VMS who would otherwise be suitable candidates for HT prefer not to initiate or continue such treatments for a variety of reasons, including concerns about potential side effects.

When hormone therapy is not suitable or if there is an unwillingness to take HT, or if a woman simply prefers a non-hormonal therapy, the prescription medication, BRISDELLE, offers women and practitioners an FDA-approved, non-hormonal pharmacologic treatment option for moderate to severe VMS due to menopause. BRISDELLE® (paroxetine) 7.5 mg is a low-dose selective serotonin reuptake inhibitor (SSRI) shown to be efficacious in treating moderate to severe VMS associated with menopause. This dose is lower than those used in treating psychiatric disorders. BRISDELLE is not indicated for depression or any other psychiatric condition. BRISDELLE’s efficacy, safety and tolerability were demonstrated in rigorous clinical trials specifically designed to treat moderate to severe hot flashes due to menopause

The median age of natural menopause is 51.3 years. Women of this age are no longer old and could expect to live an additional active 20 – 30 – 40 years with good health habits and proper medical care. There is no need to debilitate yourself by neglecting any condition for which there are suitable therapies available.

Talk to your doctor or health care professional about your options!

 

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The “Pink Pill”-Who Is It For?

Pink PillsThe “pink pill”, flibanserin, was developed for premenopausal women. Although preliminary data on flibanserin use among postmenopausal women are available, the drug was studied primarily in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD), the indication sought at this time.

In the premenopausal population, problems such as pain with intercourse or hyperestrogenism aren’t typically present, simplifying the identification of HSDD. In clinical trials of the drug, HSDD was secondary, generalized, and acquired—that is, it followed a period of normal sexual function. And it didn’t come and go but was present regardless of location and circumstance.

Study participants had had a normal sex drive before their desire “turned off,” an occurrence they found distressing.

Clinicians, myself included, have been frustrated by our inability to prescribe an effective treatment for this common problem. The recent recommendation of an FDA Advisory panel to approve flibanserin for the treatment off HSDD in premenopausal women brings us a step closer to having additional options for treatment.
(Excerpted from an editorial by Dr. James Simon published in OBG Management, July 2015)

 

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Women’s Sexual Health- Is There A Remedy For Hypoactive Sexual Desire Disorder (HSDD)?

woman-506120_640Women’s sexual health took a step forward last month when an advisory panel to the US Food and Drug Administration (FDA) recommended approval of the drug, flibanserin, for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. The approval came with some reservations regarding safety (use with certain medications and alcohol). And it’s worthwhile to note that the FDA had on hand its own Drug Safety and Risk Management Committee during deliberations. However, assuming the agency follows the recommendations of the Bone, Reproductive, and Urologic Drugs Advisory Committee, women will soon have available the first agent for sexual dysfunction—aside from a medication for intercourse-associated pain—developed specifically for them.

The wait may be over.

(Excerpted from an editorial by Dr. James Simon published in OBG Management, July 2015) Women’s sexual health

 

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Hypoactive Sexual Desire Disorder (HSDD) is described as having the following characteristics:

  • persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activitypillows-820149_640
  • marked distress or interpersonal difficulty in response to this deficiency
  • lack of another explanation known to affect sexual function.

In other words, a person once had a healthy desire for sex which they have lost, and there is no other explanation for that loss of interest or desire. In addition, the loss of this desire is noted by the person and the change is causing distress, relationship difficulty or both. (Source: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)

In clinical practice, HSDD is easily identified using the Decreased Sexual Desire Screener (DSDS), a simple screening test that asks 4 yes/no questions:

  1. In the past, was your level of sexual desire or interest good and satisfying to you?
  2.  Has there been a decrease in your level of sexual desire or interest?
  3.  Are you bothered by your decreased level of sexual desire or interest?
  4. Would you like your level of sexual desire or interest to increase?

A “yes” response to each of these questions is required. In addition, a fifth question asks whether a number of conditions, drugs, or circumstances might be responsible for the decreased desire or interest:

  • an operation, depression, injuries, or other medical condition
  • medications, drugs, or alcohol you are currently taking
  • pregnancy, recent childbirth, or menopausal symptoms
  • other sexual issues you may be having (pain, decreased arousal or orgasm)
  • your partner’s sexual problems
  • dissatisfaction with your relationship or partner
  • stress or fatigue.

Only when all of these items are excluded as possibilities can a diagnosis of HSDD be made. (Source: OBG Management, July 2015, sidebar)

 

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Over-the-Counter Menopause RemediesThere’s a vast array of drugstore products available that claim to treat menopause symptoms. Many patients want to know if these products truly provide relief. While there are certainly over-the-counter products that work for mild hot flashes, night sweats or other menopause symptoms, few will work on severe or persistent symptoms.

As a general rule, I suggest being wary of “miracle cures” when you go to select a product. Since these herbal and nutritional products are not regulated by the U.S. Food and Drug Administration (FDA), they are seldom tested for efficacy or safety the way pharmaceuticals are. So there’s no way to know for certain that they contain the amount of active ingredients that they claim to have or if the benefit claims on the packaging are valid.

When exploring over-the-counter products, be an extremely savvy shopper. There’s no way to know whether the amount of active ingredients listed is incomplete or incorrect. The packaging could also tout benefits that are exaggerated since there’s no testing required by the FDA on these products.  It’s very hard to know exactly what you’re buying, so if you want to explore over-the-counter products, be an extremely savvy shopper.

Overall, it is important to talk to your healthcare provider before taking any unregulated over-the-counter product. Most importantly, discuss the following:

  • Does this herb or dietary supplement have possible side effects?
  • Will this product interact with any of my other medications or affect an unrelated medical condition?
  • What scientific evidence is there about how effective this remedy might be for my particular menopausal symptoms?
  • What are the risks of over-the-counter menopause treatments?

Remember, there’s no one-size-fits-all approach to treating menopause symptoms. What works for one woman may not for another. Talk to your doctor or ask your pharmacist to help you choose a product for easing mild menopausal symptoms that’s right for you.

 

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