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Update on vaginal laser therapy

9 November 2018

MJA article Buttini Maher 5 Nov 2018

Earlier this week, Professor Chris Maher a urogynaecologist from the University of Queensland and Dr Melissa Buttini, a gynaecologist at the Wesley Hospital in Brisbane raised some serious questions about vaginal laser treatment of genitourinary syndrome of the menopause (GSM).

The Therapeutics Goods Administration (TGA) approved CO2 laser therapy for a number of body soft tissues, however was not listed specifically for treatment of GSM. There is no Medicare Benefits Schedule item number for CO2 laser therapy and so the extent of its use cannot be measured. We do know however that advertisements for CO2 laser therapy treatment for symptoms of GSM are extensive.

In July this year, the Food and Drug Administration (FDA) in the US issued a warning about the use of CO2 laser therapy for ‘vaginal rejuvenation’ and stated “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.”

AMS President Clinical Associate Professor Amanda Vincent was interviewed for the Australian Doctor in response to the MJA article and noted “There are safety concerns and significant costs involved - the recommendation is for 3 treatments in a 12-month period with each treatment costing $500-$1000.”

Maher and Buttini question the abstract and conclusion of the first randomised control trial undertaken by Cruz et al reported in January this year. While Cruz et al suggest that vaginal laser therapy has a place in the treatment of GSM, further investigation of the methods and results paint a different story. Patients in the vaginal oestrogen intervention reported better outcomes compared with patients in the laser/sham cream arm who reported a significant worsening of pain.

In MJA InSight, Maher warns “What really causes some anxiety for me is we have been through all this within the past 10 years with transvaginal meshes, we’re still going through it.” Clearly further evidence is required from rigorous clinical trials before we can recommend vaginal laser as a therapy for GSM. In the interim, vaginal/topical oestrogen is the gold standard treatment for GSM as it is safe and efficacious. The only group of women who can’t use that are those with breast cancer or breast cancer survivors.

The AMS looks forward to hearing the results of a double-blinded, randomised, placebo-controlled trial of the efficacy of the MonaLisa Touch procedure for the treatment of postmenopausal vulvovaginal symptoms currently being undertaken by Professor Jason Abbott at the Royal Hospital for Women in Randwick.

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Obesity and vitamin D deficiency may indicate greater risk for breast cancer

Vitamin D is already well known for its benefits in building healthy bones. A new study supports the idea that it also may reduce cancer risk as well as breast cancer mortality, especially in women with a lower body mass index. 

Breast cancer remains the most common cancer in women worldwide and is the leading cause of death from cancer in women. Reproductive risk factors such as early onset of puberty, late menopause, later age at first pregnancy, never having been pregnant, obesity, and a family history have all been shown to be associated with breast cancer development. The role of vitamin D concentration in the development of breast cancer, however, continues to be debated.

This study involving more than 600 Brazilian women suggests that vitamin D may reduce cancer risk by inhibiting cell proliferation. Study results appear in the article "Low pretreatment serum concentration of vitamin D at breast cancer diagnosis in postmenopausal women."

Researchers involved in the study concluded that postmenopausal women had an increased risk of vitamin D deficiency at the time of their breast cancer diagnoses, associated with higher rates of obesity, than women of the same age group without cancer. Similar studies also have previously demonstrated a relationship between vitamin D and breast cancer mortality. Women in the highest quartile of vitamin D concentrations, in fact, had a 50% lower death rate from breast cancer than those in the lower quartile, suggesting that vitamin D levels should be restored to a normal range in all women with breast cancer.

"Although published literature is inconsistent about the benefits of vitamin D levels and breast cancer, this study and others suggest that higher levels of vitamin D in the body are associated with lowered breast cancer risk," says Dr. JoAnn Pinkerton, executive director of NAMS. "Vitamin D may play a role in controlling breast cancer cells or stopping them from growing. Vitamin D comes from direct sunlight exposure, vitamin D3 supplements, or foods rich in vitamin D."

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Risk of early menopause and exercise

The amount of physical activity that women undertake is not linked to their risk of early menopause, according to the largest study ever to investigate this question.

Until now, there have been conflicting findings about the relation between physical activity and menopause, with some studies suggesting that women who are very physically active may be at lower risk of a menopause before the age of 45, while others have found evidence of the opposite effect.

However, the study that is published in Human Reproduction [1], one of the world's leading reproductive medicine journals, has analysed data from 107,275 women, who were followed prospectively from the time they joined the Nurses' Health Study II in 1989 until 2011, and found no association between physical activity at any age and early natural menopause.

Dr Elizabeth Bertone-Johnson, Professor of Epidemiology at the University of Massachusetts, USA, who directed the research, said: "Our study provides considerable information in helping us understand the relationship between activity and timing of menopause; this is because of its size, its focus on early menopause specifically, and because of its prospective design, which limited the likelihood of bias and allowed us to look at physical activity at different time periods.

"Several previous well-designed studies have found suggestions that more physical activity is associated with older age at menopause, but even in those studies the size of the effect was very small. Our results, in conjunction with other studies, provides substantial evidence that physical activity is not importantly associated with early menopause."

Female US registered nurses aged 25-42 were enrolled in the Nurses' Health Study II in 1989 and they completed questionnaires about lifestyles and medical conditions every two years thereafter. They were asked about the time they spent in recreational physical activities such as walking, running, cycling, racquet sports, swimming laps, aerobic activities, yoga, weight training and high intensity activities such as lawn mowing. The researchers also collected information on factors such as race, ethnicity, age, education, height, the age when the women had their first periods, whether or not they had been pregnant and how often, use of oral contraceptives and hormone therapy, whether or not they smoked, weight and body mass index (BMI), diet and use of dietary supplements.

In order to assess the frequency, duration and intensity of the activities, the researchers multiplied the hours per week of each activity by its metabolic equivalent (MET) score to create total MET hours per week. One MET equals one kilogram calorie per kilogram per hour (kcal/kg/h), which is the amount of energy expended by sitting quietly for an hour.

During the 20 years of follow-up, 2786 women experienced natural menopause before the age of 45. The researchers found no significant difference in the risk of early menopause between, for instance, women reporting less than three MET hours a week of physical activity and women reporting 42 or more hours a week (the equivalent to four or more hours of running or eight or more hours of brisk walking per week). The amount of physical activity that the women reported in their teenage years was also unrelated to the risk of early menopause.

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Chemotherapy may lead to early menopause in young women with lung cancer

A study suggests chemotherapy may cause acute amenorrhea leading to early menopause in women with lung cancer. The study is the first to comment on amenorrhea rates in women younger than 50, concluding that women with lung cancer who desire future fertility should be educated about risks and options before starting treatment. 

According to the Mayo Clinic, although the rate of lung cancer diagnoses in men has decreased by 32% since 1975, it has risen 94% percent in women and now has surpassed breast cancer as the leading cause of cancer death in US women. Although lung cancer is more common in older adults, women are diagnosed at a younger age compared with men, and approximately 5,000 premenopausal US women are diagnosed with lung cancer annually. Extensive research of women receiving treatment for breast cancer has found that between 40% and 80% have premature menopause. However, early menopause rates after lung cancer treatments are understudied.

Unique to the premenopausal survivor population is the concern that systemic chemotherapy may cause acute amenorrhea and menopause, leading not only to hot flashes, vaginal dryness, and bone loss but also the possibility of loss of fertility. Premenopausal women with lung cancer may want children and should consult their healthcare providers about options for embryo and oocyte cryopreservation, the gold standard for fertility preservation.

The study included 182 premenopausal women (average age at diagnosis, 43 years). The Mayo Clinic Epidemiology and Genetics of Lung Cancer Research Program surveyed women between 1999 and 2016 at diagnosis and annually thereafter about their menstrual status. Types of lung cancer treatments were recorded, and frequencies of self-reported menopause at each survey were calculated.

The results of the study appear in the article "Amenorrhea after lung cancer treatment." Although the study is small, for the 85 women who received chemotherapy, 64% self-reported that they were menopausal within a year of diagnosis. Only 15% of the 94 patients who did not receive systemic therapy within a year of diagnosis experienced self-reported menopause. Three patients received targeted therapy alone, two of whom remained premenopausal at the final survey completed a median of 3 years after diagnosis. The results suggest that chemotherapy for patients with lung cancer increases the risk of the early loss of menses in survivors.

"Although more definitive research is needed, premenopausal women who need chemotherapy for lung cancer appear to have a similar risk of amenorrhea, early menopause, and loss of fertility as premenopausal women receiving chemotherapy for breast cancer and lymphoma," according to Dr. JoAnn Pinkerton, executive director of NAMS. "I agree that premenopausal patients with lung cancer need to be educated about the risk for chemotherapy-related amenorrhea, menopause issues (hot flashes, vaginal dryness, and bone loss), and the potential loss of fertility before chemotherapy is initiated."

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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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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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