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.
iPrevent: an evidence-based tool to assess and manage breast cancer risk
A 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.
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.
Heavy Menstrual Bleeding Clinical Care Standard launched
7 December 2017:
Women to benefit from first national treatment standard for heavy periods
The first nationally agreed standard of care for women experiencing heavy menstrual bleeding says women should be offered less invasive treatments before considering a hysterectomy – a major operation best done only when other treatments are not suitable.
Heavy menstrual bleeding affects an estimated 1 in 4 women of reproductive age. Despite being common, it is also under-recognised, and can significantly reduce a woman’s social, emotional and physical quality of life. It causes considerable disruption to women’s lives lasting several days each month, with some women experiencing associated pain. Sometimes the cause of the bleeding, such as fibroids, can be identified, but for about 50% of women it cannot.
Figures strongly suggest many Australian women are having hysterectomies for heavy menstrual bleeding rather than less invasive treatments. These include a hormone-releasing intra-uterine device (IUD), or a surgical technique called endometrial ablation, which reduces the bleeding by removing the lining of the uterus.
The new Heavy Menstrual Bleeding Clinical Care Standard, from the Australian Commission on Safety and Quality in Health Care, says most women with heavy menstrual bleeding can be effectively cared for by their GP. Referral to a specialist may be warranted in some situations – such as if the woman has uterine fibroids or polyps, or in less common situations where cancer is suspected, if symptoms do not resolve with initial treatments, or if the woman would prefer surgery.
The new clinical care standard offers guidance to clinicians about appropriate care, such as by clarifying on which days during a woman’s cycle an ultrasound scan will be most useful. It also informs patients about the care they can expect to receive.
Commission Senior Medical Advisor Professor Anne Duggan, said Australia had high rates of hysterectomy relative to the UK and New Zealand – and there was also strong variation within Australia, with stark differences between regional and metropolitan areas.
“This clinical care standard was developed after the Commission’s Australian Atlas of Healthcare Variation found the rate of hospital admissions for hysterectomy and endometrial ablation combined in 2012–13 was 5.2 times as high in the local area with the highest rate compared to the area with the lowest rate,” Professor Duggan said.
“The Commission’s second Atlas, released in June this year, found the gap was even wider – 6.6 times as high between different local areas – for hysterectomy admissions alone in 2014–15. Admissions for endometrial ablation were nearly 21 times as high between different local areas.
“Hysterectomy used to be one of the few options for women with heavy menstrual bleeding, but there are now several less invasive treatment options. These differences in admission rates for hysterectomy suggest that the full range of options is not being used across the country – and may indicate women are not being informed about all the options.”
University project officer and mother-of-one Hayley Harrison, 38, from Perth, has experienced heavy menstrual bleeding all her life and says a period lasting eight days is “a good month”, while 10 days is more usual. She estimates she has had 10–20 pelvic ultrasounds and spends $40 on sanitary products for every period.
“I presented to doctors because of the pain associated with heavy menstrual bleeding,” she said. “None of them really asked how heavy my period was. I didn’t know that changing a tampon every hour for at least three to four days was abnormal.
“It wasn’t until I went to see a different doctor – she asked these questions that I’d never been asked by a doctor before. She said ‘You really do have very, very heavy periods – this is really not normal’.”
Clinical Associate Professor Deborah Bateson, Medical Director of Family Planning NSW, said family planning doctors “often see women who have been putting up with heavy menstrual bleeding for years”.
Oestrogen patch update - supply returned
30 November 2017:
Novartis has advised that the company has both received and released stock for supply locally of the following lines;
- ESTALIS CONT 50+140MCG
- ESTALIS SEQ 50MCG/50+ 140MCG
- ESTALIS SEQ 50MCG/50+ 250MCG
As a result the only remaining HRT line now still unavailable is ESTALIS CONT 50+250MCG
This line is confirmed for arrival into Sydney early next week - 4 December 2017.
Novartis is in the process of re-stocking wholesalers for all products and the products should be in pharmacies sometime next week.
Prasterone (Intrarosa) for Dyspareunia
From the Medical Letter
The FDA has approved the steroid prasterone (Intrarosa – Endoceutics) for intravaginal treatment of postmenopausal women with moderate-to-severe dyspareunia due to vulvovaginal atrophy (VVA) (Table 1). Also called dehydroepiandrosterone (DHEA), prasterone is produced in the adrenal glands, gonads, and brain and converted intracellularly into active metabolites of estrogens and androgens. DHEA has been available over the counter for years as an oral dietary supplement claimed to benefit sexual, cardiovascular, and neuropsychiatric dysfunction.1- 3
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Bioidentical Hormones - risks revisited
The October issue of Endocrine news (1) carries an article that once again tackles the complexity of bioidentical hormones.
The freelance US writer highlights the confusion surrounding "bioidentical hormones" and more specifically the compounded formulations that are promoted as "natural".
The 2015 study by Santoro and Pinkerton (2) estimated that 1 million to 2.5 million U.S. women aged 40 years or older are using compounded hormone therapy. This may mean that custom-compounded products represent a quarter to a third of the market for hormone therapy products. Custom-compounded products lack protections of purity, controlled manufacturing processes, and evidence from clinical trials that products from less-regulated compounding pharmacies do not.
Santoro is quoted as recognising “Maybe 1% of people will have a reaction to all forms of hormone therapy and might do better with compounding” but emphasises the availability of "government-approved bioidentical hormone therapy".
The “Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement” published in The Journal of Clinical Endocrinology & Metabolism in April 2016 (3) is worth a read or review along with Bioidentical Hormones for Menopausal Symptoms and Bioidentical Hormone Preparations - History of Development.
Oestrogen patch shortage information
20 April 2017:
With so many questions being raised about the shortage, Jean Hailes Medical Director Dr Elizabeth Farrell AO and Jean Hailes endocrinologist Dr Sonia Davison, were asked for some further advice.
With Jean Hailes for Women's kind permission, the advice is as follows:
If I use oestrogen patches such as Estradot (oestrogen only) and Estalis (combined oestrogen and progestogen), what does the shortage mean for me?
While these products are unavailable you might need to consider alternative HRT products.
How do I decide what alternative HRT I should use?
There are different options available, including a topical gel or substituting with another patch, but it's best to make an appointment and talk to your health professional to work out what's appropriate for you.
When are supplies expected to return to normal?
According to an official statement on the website of Novartis, a pharmaceutical company that supplies some oestrogen patches: "Novartis is currently undergoing a disruption in supply of Estradot, Estalis Continuous and Estalis Sequi in Australia. We apologise for the inconvenience this has caused and are working to resolve the fluctuations in supply. We anticipate a return to stable supply in Australia by mid-2017."
I'm a health practitioner, where can I find reliable information on HRT products?
The Australasian Menopause Society has an excellent guide to MHT/HRT equivalent-dose products (Aus) and MHT/HRT equivalent-dose products (NZ) and should be consulted for further guidance as to other products that may be used.
Are natural alternatives to estrogen replacement therapy safe?
Although individuals often consume natural products because of their potential health benefits, a review indicates that it is not clear whether the benefits of plant-derived compounds that mimic estrogen outweigh the possible health risks.
Phytoestrogens are compounds from plants that are similar in structure to estrogen and are found in a variety of foods, especially soy. Some women may consume phytoestrogens promoted as natural alternatives to hormone replacement therapy to help ease menopausal symptoms such as hot flushes or to protect against bone loss.
When Ivonne Rietjens, PhD, of Wageningen University in The Netherlands, and her colleagues analyzed the published medical literature, they found that several potential health benefits of phytoestrogens have been reported, including lowered risks of cardiovascular disease, obesity, metabolic syndrome and type 2 diabetes, brain function disorders, and various types of cancer, in addition to reduced menopausal symptoms. Phytoestrogens are considered endocrine disruptors, however, which indicates that they have the potential to cause negative health effects, including infertility and increased risks of cancer in estrogen-sensitive organs such as the breast and uterus.
Sex after menopause - survey
New survey shows women still don't understand why sex hurts after menopause
Women's EMPOWER survey confirms reluctance to discuss sex problems and seek treatment despite major educational efforts
The Women's EMPOWER survey, an internet-based survey of 1,858 US postmenopausal women with symptoms of vulvovaginal atrophy (VVA). VVA, was specifically designed to assess women's awareness of VVA and their behaviors and attitudes associated with the treatment of symptoms. The findings came as little surprise to insiders in the medical industry, because they were consistent with six other past VVA surveys that also confirmed that postmenopausal women generally failed to recognize VVA and its chronic progressive course (including urinary problems) and were reluctant to discuss vaginal or sexual symptoms with their healthcare providers.
In the Women's EMPOWER survey, 81% of women were not aware that VVA is a medical condition. More than two-thirds of respondents were not familiar or only somewhat familiar with most of the prescription VVA products.
"The results of the Women's EMPOWER survey demonstrate and reinforce that, even with multimedia marketing and educational strategies in the years after other major VVA surveys, minimal progress has been made toward increasing women's awareness and understanding of VVA," says Michael Krychman, MD, of the Southern California Center for Sexual Health and Survivorship Medicine and a lead author of the Women's EMPOWER survey. "Women remain naive to the safe and effective treatment options that are currently available and are still, for the most part, underinformed and undertreated."
More Articles ...
- Memory and hormone therapy after menopause
- Young Researchers: Sambrook award - applications close 15th July
- Are women suffering in silence? - UK survey
- Endocrine Society encourages clinicians to avoid prescribing compounded hormones
- FDA Approval of Flibanserin - Treating Hypoactive Sexual Desire Disorder
- HRT - more on risks and benefits
- Hormone replacement therapy may benefit the kidneys
- 'Natural' hormones hurting women - doctor
- Pharmacy Board of Australia has released new FAQs on the compounding of medicines
- Short-term use of hormone replacement therapy (HRT) and ovarian cancer risk
- Women play dangerous waiting game with heart symptoms
- Coping with change revisited
- Soy may help women's hearts if they start early
- Alzheimer's disease and B vitamins
- Acupuncture: the answer to hot flushes
- Weight loss and hot flush reduction
- Sex hormones and heart disease risk in mid-life women
- HRT substitution questioned
- Older mums at birth of last child and exceptional longevity
- Why you need olive oil on your salad