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New guidelines for the evaluation and treatment of perimenopausal depression

New "Guidelines for the Evaluation and Treatment of Perimenopausal Depression: Summary and Recommendations have been co-published in Journal of Women's Health and Menopause: The Journal of The North American Menopause Society. The Guidelines are published online here in Journal of Women's Health, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers, and are available to download free until October 5, 2018.

The North American Menopause Society (NAMS) expert panel was convened by NAMS and the Women and Mood Disorders Task Force of the National Network of Depression Centers (NNDC) to conduct a systematic review of the existing literature, and develop clinical guidelines for the evaluation and treatment of depression during the perimenopause.

Panel co-chairs Pauline M. Maki, PhD, University of Illinois at Chicago and Susan G. Kornstein, MD (Editor-in-Chief of Journal of Women's Health), Virginia Commonwealth University Institute for Women's Health, Richmond, VA, developed the recommendations with panel members on behalf of the Board of Trustees for NAMS and the Women and Mood Disorders Task Force of the NNDC. The panel focused on five key areas: epidemiology of depressive symptoms and depressive disorders; the clinical presentation of depression; the therapeutic effects of antidepressant medications; the effects of hormone therapy; and the efficacy of other therapies, such as psychotherapy, exercise, and natural health products.

"There has been a need for expert consensus, as well as clear clinical guidance regarding how to evaluate and treat depression in women during the perimenopause," states Dr. Kornstein. "These new clinical recommendations address this gap, and offer much-needed information and guidance to healthcare practitioners so that they can provide optimal care and treatment for midlife women."

The guidelines address 5 areas: epidemiology; clinical presentation; therapeutic effects of antidepressants; effects of hormone therapy; and efficacy of other therapies.

Among the recommendations:

  • When selecting antidepressants during perimenopause, a woman’s prior history of antidepressant use should be considered.
  • Cooccurring sleep disturbances and night sweats should be considered as part of treatment for menopause-related depression.
  • While estrogen-based therapies may help improve clinical response to antidepressants, their use in older women should be considered with caution.

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Estrogen may protect against depression after heart attack

Estrogen may protect against heart failure-related depression by preventing the production of inflammation-causing chemicals in the brain. The study is published ahead of print in the American Journal of Physiology - Heart and Circulatory Physiology.

Research suggests that people with heart failure--including those who survive heart attacks--are two to three times more likely to suffer from depression than the general population. The reason for heart failure-related depression is thought to be increased inflammation in the brain. Previous studies have also found that post-menopausal women with heart disease have a greater risk of depression than younger women and men of all ages.

Researchers from the University of Ottawa Heart Institute and Brain and Mind Institute in Canada studied a rat model of heart failure after heart attack. Adult female rats without ovaries--mimicking menopause--were compared to adult males and adult females with ovaries. Half of the "menopausal" rats received estrogen supplements while the other half did not. Sex-matched rats without heart failure served as controls. The animals were given several standardized tests to assess depression-like behavior, learning, memory and the ability to experience pleasure. The researchers also took blood samples to measure inflammation levels in the brain (neuroinflammation).

The male rats, but not the female rats, with heart failure showed signs of depression and brain inflammation compared to their controls. In contrast, the menopausal females displayed higher rates of depression-like behavior than all of the males studied. However, the group receiving estrogen showed no depression--their levels were on par with the control females with ovaries--and no increase in inflammation in brain areas involved in mood and pleasure.

"Our findings demonstrate that sex and estrogens influence neuroinflammation and depression-like behavior in rats with [heart failure] post [heart attack]," the researchers wrote. "Understanding the mechanisms contributing to these sex-specific and estrogen-dependent responses may contribute to new therapies that may be sex-specific."

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Vaginal Laser Therapy

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”

Our most fundamental obligation to the American public is providing patients with access to safe and effective medical products to meet their health care needs as well as protecting them from harmful products and deceptive medical claims. A large part of our work focuses on efforts to bring forth innovative, new products. But we’re equally dedicated to monitoring the landscape to ensure products are delivering on their intended benefits and to ensure that if new health risks arise, we take appropriate action.

Delivering on this complementary mission is a key aim of our Medical Device Safety Action Plan. The plan outlines how the FDA will encourage innovation to improve safety, detect safety risks earlier and keep doctors and patients better informed. Our plan would establish a robust medical device patient safety net in the U.S. We are taking steps to streamline and modernize how we implement post-market actions to address device safety issues to make our response to risks more timely and effective.

Advancing the health of women is a priority for the FDA. As part of our action plan, we’re working to improve evidence generation about the safety and effectiveness of health technologies in clinical areas that are unique to women. And as part of these efforts, we also watch for, and take action against, bad actors who unfortunately take advantage of unsuspecting consumers by marketing unapproved, deceptive products that may pose safety risks and violate the trust of American consumers.

That’s what we’re doing today.

We’ve recently become aware of a growing number of manufacturers marketing “vaginal rejuvenation” devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.

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Update on Femoston Conti Shortage

The supplier of Femoston Conti has advised that the recent supply shortage of Femoston Conti has been restored.

Pharmacies across Australia are currently being restocked. No other Femoston product has been affected by the shortage. 

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About vaginal dryness

SWAN data demonstrate lack of communication when it comes to vaginal itching and burning that occurs during the menopause transition, but few women are taking action to correct the problem

It's a common problem that only gets worse during the menopause transition; yet, no one wants to talk about it, and even fewer women are doing anything to correct it. A study identifies those factors that contribute to the taboo problem of vaginal dryness. 

Many women experience vaginal dryness during menopause, which often manifests as burning, itching, or lack of lubrication during sexual activity, and they have a lot of company. Data from the Study of Women Across the Nation (SWAN) tracked more than 2,400 women over a 17-year-period showed that, at baseline, 19.4% of women (aged 42-53 y) reported vaginal dryness. By the time the women in the study were aged 57 to 69 years, 34% of them complained of symptoms.

More surprising, however, is the fact that more than 50% of women don't report vaginal dryness to their healthcare providers, and less than 4% of affected women are actively using any of the many proven therapies that include vaginal estrogen tablets, creams, and rings, according to "Factors associated with developing vaginal dryness symptoms in women transitioning through menopause: a longitudinal study," the Menopause article detailing the study results.

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Hormone therapy may lead to improved cognitive function

Study demonstrates cognitive benefits of transdermal estradiol in combination with an oral progesterone for postmenopausal women

Hormones affect just about everything that goes on in a woman's body, from reproductive function and sexual libido to weight gain and overall mood. A new study shows how, in the right dosage and combination, hormones also may slow cognitive decline in postmenopausal women as they age. 

It comes as no surprise that cognitive function declines as we age. We recognize memory decline in a number of ways, such as not being able to remember a grocery list as easily as we once did. Mild cognitive impairment (MCI) is defined as that intermediate stage between normal aging and dementia. Persons with MCI have an increased risk of progressing to Alzheimer disease or other dementia, with roughly 20% of this population crossing over from MCI to a more severe level each year. To date, no pharmacologic treatment has proven effective in managing MCI.

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Climara 50mcg Patch Shortage

The Therapeutic Goods Administration (TGA) have reported an anticipated shortage of CLIMARA 50 mcg transdermal patches with supply due to return on 31 July 2018.

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iPrevent: an evidence-based tool to assess and manage breast cancer risk

iPreventA new web-based tool is available at https://www.petermac.org/iprevent to help women understand their personal breast cancer risk and then act on it. It is designed to be used collaboratively by women and their doctors. Women can use it at home, print the output, and bring it to a consultation for discussion.

AMS has been given permision to link to the tool from our Self Assessment Tools  Are you at risk of cancer? page on breast cancer.

How Does iPrevent Work?

iPrevent asks women to first enter their family cancer history, lifestyle and reproductive risk factor information. Using that information, it then provides 10 year and residual life-time risk estimates; there are options to view these as pictograms or graphs. It then provides tailored estimates of the absolute risk reductions for relevant breast cancer prevention strategies, personalised lifestyle change suggestions, and tailored advice on breast cancer screening. Women can print out a summary to take to a medical consultation for discussion, and so the doctor can incorporate it into the woman’s medical record.

What is the Evidence Base for iPrevent?

iPrevent uses the well-validated IBIS and BOADICEA algorithms to estimate each woman’s personal risk of breast cancer. An international prospective validation study, conducted using data on over 16,000 women, has confirmed the accuracy of the risk estimates provided. It uses Cancer Australia guidelines to determine which risk management options women are advised about, based on their risk level. An Australian pilot study of women and clinicians has also demonstrated that iPrevent has high usability and acceptability, and suggested that it improves knowledge without increasing anxiety. More detail on iPrevent peer-reviewed publications can be found by clicking the “Information For Clinicians” button on the iPrevent front page.

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Not Time to Abandon Use of Local Vaginal Hormone Therapies

Clinicians caring for menopausal women are familiar with the genitourinary syndrome of menopause (GSM), previously referred to as vulvovaginal atrophy, a progressive condition that impairs sexual function and quality of life. Although GSM affects up to 45% of midlife and older women, most with the condition go undiagnosed and untreated.1

Estrogen represents a key regulator of vaginal physiology. Declines in estrogen associated with menopause play a central role in the pathophysiology of GSM. The occurrence of symptomatic GSM in premenopausal women with hypoestrogenemic states, including lactation and use of GnRH agonists, underscores the central role estrogen plays in maintaining normal vaginal function.

Over-the-counter (OTC) vaginal lubricants used with sexual activity and vaginal moisturizers used on a routine basis several times per week can provide some relief from symptoms of GSM.1

In March 2018, a report published in JAMA Internal Medicine described results of an NIH-funded, short-term (3 mo), double-blind trial that randomized women with symptoms suggestive of GSM to these three groups: 1) Currently marketed 10 µg estradiol tablets plus placebo vaginal gel, 2) Placebo vaginal tablets plus a currently marketed vaginal moisturizer gel, or 3) Placebo tablets plus placebo gel.2 The trial’s primary outcome related to reported severity of participants’ most bothersome symptom (MBS), which was defined at enrollment.

In the 302 women randomized, pain with penetration represented the most common MBS (reported by 69% of participants), followed by dryness (21%). A small reduction in MBS was observed with all treatments. Neither vaginal estradiol tablets nor the commercially marketed moisturizer reduced the MBS more than placebo gel. Likewise, participants reported an improvement in sexual function that was similar in those randomized to estradiol versus placebo gel as well as those randomized to moisturizer versus placebo gel.

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Stem cell therapy may help reverse effects of premature menopause, restore fertility

Young women with premature ovarian insufficiency (POI) may be able to use their own bone marrow stem cells to rejuvenate their ovaries and avoid the effects of premature menopause, new research suggests. The preliminary results from the ongoing ROSE clinical trial were presented at ENDO 2018, the 100th annual meeting of the Endocrine Society, in Chicago, USA.

"In the two participants who have completed the treatment to date, serum estrogen levels have increased as soon as 3 months after the injection of stem cells, and the effect has lasted for at least one year. Their menopausal symptoms have been alleviated, and six months after the injection of the stem cells into the ovaries, they have resumed menses," said senior author Ayman Al-Hendy, M.D., Ph.D., Professor of Gynecology and Director of Translational Research at the University of Illinois at Chicago.

The researchers plan to enroll 33 participants in their clinical trial. For the two patients who have undergone the procedure so far, they collected each woman's own mesenchymal stem cells from her posterior iliac crest bone marrow and used minimally invasive laparoscopy to inject the cells into one ovary, keeping the second, untreated, ovary as a control. The authors followed the patients closely with frequent blood work, imaging of the ovaries, menopausal symptom questionnaires, and safety studies.

Now that both women's estrogen levels have increased significantly and they have begun to menstruate, the research team looks forward to the possibility that they may again become fertile.

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