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Menopause: New Insight Into Hot Flashes and Night Sweats

Published on July 26, 2016

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Menopause is defined as the time after a woman’s final menstrual period, and is confirmed after one year with no periods. For many women, this is a natural, gradual process, that begins with perimenopause: the four to eight years before the final period. The time through perimenopause, the final menstrual period, and a few years after the final period is known as the menopausal transition. Many women go through this transition naturally as they age, but other women go through induced menopause, caused by surgical removal of the ovaries or cancer treatments.

Symptoms Related to Menopause

The average age of menopause in North America is 51 years, with most women going through menopause between the age of 40 and 58. During the menopausal transition, hormonal changes may result in symptoms that range from mildly bothersome to downright unbearable. Vasomotor symptoms, or hot flashes and night sweats, are one of the main menopause-related symptoms that women seek medical treatment for, and are experienced by about 80% of women during the menopausal transition. Some women also experience vaginal dryness and/or pain with sexual intercourse during menopause.

During perimenopause, many women will start to experience hot flashes and night sweats. Other symptoms of perimenopause include vaginal dryness, irregular periods, sleep problems, mood changes, weight gain, thinning hair, and dry skin (sounds awesome, right?). However, the North American Menopause Society correctly points out that the menopausal transition often coincides with a number of midlife stressors such as relationship issues/divorce, caring for aging parents, career issues, and struggles with adolescents (is anyone else’s hair going grey from teenage daughter stress?). These stressors may also contribute to symptoms a woman experiences at this time.

Hot flashes and night sweats (vasomotor symptoms or VMS) can be troublesome to many women. As with other issues in women’s health, lack of research led to the long held false assumption that these symptoms are generally experienced for only a few years right around the final menstrual period. However, new research has shown that in some women, these symptoms last for a decade or longer. In addition, the pattern of these symptoms, or when they occur relative to the final menstrual period, is not the same in all women.

New Insights into Frequency and Timing of Hot Flashes and Night Sweats

A recent, large study of ethnically diverse women going through natural menopause across the U.S. has provided some new insights into how women experience vasomotor symptoms during menopause and who is at risk for longer lasting or more severe symptoms. This study followed women from 12 years before the final menstrual period to 15 years after. The median duration of vasomotor symptoms was 7.4 years and the median persistence of symptoms after the final period was 4.5 years. In this study, frequent vasomotor symptoms lasting more than seven years occurred in more than 50% of women. Starting to have vasomotor symptoms at a younger age was predictive of having a longer duration of symptoms, and surprisingly, of having a longer persistence of symptoms after the final period.

This study also found that vasomotor symptoms during the menopausal transition fall into four distinct patterns. In about 27% of women, called the early onset, low frequency group, there is a low probability of vasomotor symptoms across the whole menopausal transition, with a slight increase around the time of the final menstrual period. In 26% of women, there was a high frequency of vasomotor symptoms throughout the entire menopausal transition. In the 18% of women who had an early onset, there was a higher frequency of symptoms, which decreased right after the last period. And 29% of women had a late onset of higher frequency symptoms, with a sharp increase just after the final period.

The study also examined whether certain health or lifestyle measures were associated with particular patterns of vasomotor symptoms and some associations were found. Relative to the women in the low frequency group, women with early onset, higher frequency symptoms were older at the final menstrual period, were in poorer health, and were more likely to suffer from depression and anxiety. Women with late onset, higher frequency symptoms were more likely to be African American/black, more likely to be smokers, and less likely to be obese. And women in the high frequency group were more likely to have less education, be in poorer health, have an increased consumption of alcohol, have depression and anxiety, and be African American/black.

These “co-variables” were all independently associated, meaning, for example, that someone with poor physical health, or depression and anxiety, was more likely in this study to be in the early onset, high frequency group, or in the group with high frequency across the whole transition. The other variables did not need to be present in addition, to create the association.

Hormones Levels During the Menopausal Transition

It has generally been thought that declining estrogen levels during the menopausal transition are responsible for vasomotor and other menopausal symptoms. However, not surprisingly, this view is too simplistic. This same study measured the concentrations of one of the major estrogens in the human body, estradiol, throughout the study, and found that estradiol concentrations have four different patterns during this time as well. However, these patterns did not correlate perfectly with the different groupings of vasomotor symptoms.

In general, women with a consistently lower concentrations of estradiol were more likely to have frequent symptoms across the menopausal transition. However, the study also found that fluctuations in estradiol around the time of the final menstrual period may be associated with vasomotor symptoms at this time. A greater rise in follicle-stimulating hormone (FSH) was also associated with a greater likelihood of vasomotor symptoms. The conclusion of the study was that estradiol alone was not solely responsible for vasomotor symptoms; that other hormones varying during this time may also play a role. For example, some adrenal steroid hormones increase transiently during menopause. DHEAS, a steroid hormone that generally declines with age, increases transiently in some women during menopause.

Are Cardiac Risks Related to Vasomotor Symptoms?

After menopause, a women’s risk of certain serious conditions increases, including cardiovascular disease and osteoporosis. Some preliminary results suggest that the pattern of vasomotor symptoms may be correlated to an increased risk for cardiovascular disease. In one study, carotid intima media thickness (IMT) was measured, which can detect the presence of atherosclerotic disease before cardiovascular symptoms appear. Women with early onset vasomotor symptoms had higher IMT compared to women with low frequency of vasomotor symptoms. This could indicate a higher risk of cardiac events for women who fall into this group. In another study, late vasomotor symptoms were found to be associated with an increased risk of major cardiovascular events, stroke, and death from all causes, and this association was not accounted for by other risk factors. However, because of the size of the study, these results are considered preliminary. More research may allow doctors to predict, based on a woman’s pattern of vasomotor symptoms, her risk of cardiac and other serious events, and may allow doctors to direct lifestyle and other early interventions to those most at risk.

Altogether, this research on vasomotor symptoms during the menopausal transition is helpful because it can help women understand what to expect. It may also help guide treatment decisions for women who are seeking treatment for symptoms; for example, if they start having frequent symptoms early, this may be a sign that these symptoms will persist. In addition, if risks for serious health problems are associated with distinct patterns of vasomotor symptoms, again, this information could help guide early interventions, and help women be alert for early warning signs of a problem.

Advisory Panel Votes No, But FDA Approves Antidepressant for Hot Flashes Anyway

by Robin Karr

Published on July 2, 2013

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OK, here we go again. Antidepressants are being touted as a treatment for menopausal hot flashes . This is nothing new because antidepressants have been prescribed for treatment of hot flashes for quite some time. A 2003 study reported in JAMA (Journal of the American Medical Association) showed a slight improvement in hot flashes for women using paroxetine (the active ingredient in antidepressants and the new hot flash treatment – Brisdelle) versus placebo. Other studies, show similar results and antidepressants for hot flashes have been prescribed off-label for about a decade. What’s new is that an antidepressant has now been ‘officially approved and recommended’ by the FDA.

So much about this FDA approval just didn’t set right with me. Perhaps, I am just tired of so many procedures, surgeries and drugs being recommended and approved for women, when in reality, most are not remotely helpful and can actually be quite harmful in the long run. So, I did some research and I uncovered a number of things that are very interesting, concerning and even somewhat alarming about Brisdelle and paroxetine.

What is Brisdelle?

Brisdelle is a selective serotonin reuptake inhibitor (SSRI) that contains the active ingredient paroxetine. Paroxetine is the SSRI used in common antidepressants such as Paxil, Aropax,Pexeva, Seroxat, Sereupin.

Side Effects of Paroxetine

The most common side effects associated with Brisdelle and other SSRIs include headache, fatigue and nausea or vomiting. As a paroxetine-based SSRI, Brisdelle may have side effects such as reduced sex drive and an elevated risk of osteoporotic fractures – both already risk factors for many menopausal women. Although the dosage of paroxetine in Brisdelle, approved for hot flashes, is lower than that typically prescribed for depression, the medication will still carry a black-box warning regarding paroxetine’s link to suicide (a known side-effect of paroxetine-based antidepressants is an increased risk of suicide). The black-box warning is the most serious warning that can be placed on the label of any prescription drug. Additional warnings will include an increased risk of bleeding and a risk of developing the rare, but increasingly more common adverse event ‘Serotonin Syndrome’. Serotonin Syndrome is a condition where there’s too much serotonin – leading to excessive nerve cell activity and causing a deadly collection of symptoms including confusion, changes in blood pressure, irregular heartbeat, seizures and unconsciousness.

Brisdelle Background

Noven Pharmaceuticals makes Brisdelle and funded the studies on the use of Brisdelle to treat hot flashes. Dr. James A. Simon, Clinical Professor of Obstetrics and Gynecology at the George Washington University School of Medicine in Washington DC, led the study. Dr. Simon openly reports having a financial relationship with Noven. The fact that Noven supported the study and provided the drug for the study, along with the fact that the lead doctor overseeing the study has financial ties with Noven, is troubling in my opinion, but standard fair in pharmaceutical research.

The FDA Approval of Brisdelle

The media is correctly reporting that the FDA approved Brisdelle. What seems to be missing from the headlines and discussion is the fact that the FDA’s advisory panel on reproductive health drugs voted against approval by a very large margin. Indeed, the advisory panel voted 10 to 4 against Noven’s request for Paroxetine Mesylate, formulated as low-dose Mesylate salt of Paroxetine (7.5 mg/day), saying the drug’s minimal benefit didn’t outweigh its risks.

Panel members who voted against the drug pointed to the fact that women who experienced an average of 10 hot flashes per day experienced as few as 4 after 12 weeks of being on Brisdelle while women on the placebo went from having 10 a day to around 5. “I voted against recommending approval when I looked at the magnitude of the treatment effect relative to the magnitude of the placebo effect where there is no risk involved,” said Daniel L. Gillen, PhD, from the University of California, Irvine.

The FDA did not say why it ignored the advisory panel’s recommendation and approved the drug. Technically, it doesn’t have to follow the recommendation of its panel, but it is highly unusual that it didn’t in this case, since the vote was overwhelmingly negative. Where is the outrage? Where is the investigative reporting to determine why the FDA overrode its own advisory panel?

Why Approve Brisdelle?

What are we to make of this new drug that has been approved by the FDA for the treatment of menopausal hot flashes? In my opinion, I don’t believe the FDA really needed to bother approving it because doctors routinely prescribe antidepressants off-label for women – for everything from heavy periods to insomnia and sometimes for no reason at all. Perhaps that is why they approved Brisdelle in the first place, it’s already being prescribed widely to women in this age group. A recent report suggests that 25% of women aged 44-59 are using antidepressants and overall there has been a 400% increase in antidepressant use from 2005-2008. Since women are already using antidepressants and there are currently no effective treatments for menopausal hot flashes, why not capitalize on this? According to the New York Times:

Women “are begging for alternatives,” Dr. Andrew London, an obstetrician and gynecologist in the Baltimore area, told the committee, which met in Silver Spring, Md. If there were no approved drugs, he added, “They will get help on their own without us.”

Brisdelle looks like just one more way to entice women to spend money on antidepressants and it could very well be dangerous.

The Dangers of Prescription Medications

According to Melody Petersen, author of “Our Daily Meds”, approximately 100,000 Americans die every year from their prescription drugs that they took just as the doctor directed. “This isn’t when a doctor or a pharmacist made a mistake or the patient accidentally took too much. This is when everything went right” she said.

My Take on Brisdelle and other Antidepressants for Hot Flashes

I am personally very leery of using paroxetine (no matter how small the dosage) to combat hot flashes. Simply stated, paroxetine is one of the most potent and selective of the SSRI-type drugs and the dangerous side-effects associated with it are well documented. With all of the evidence against Brisdelle or paroxetine and very little for it, I certainly don’t trust that it is a safe and effective treatment for menopausal hot flashes. Even if it has some small potential to help, I am not sure it would be worth the risks. I am very suspect of the FDA’s approval on this one. I don’t think I’ll be taking paroxetine anytime soon for any reason – least of all for relief of hot flashes.

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