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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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Views on the USPSTF recommendation statement

Quick links to Concurring view | Dissenting views 

Concurring View

Menopausal Hormone Therapy for Primary Prevention of Chronic Disease

JAMA Editorial December 12, 2017

In this issue of JAMA, the US Preventive Services Task Force (USPSTF) presents a Recommendation Statement1and an accompanying Evidence Report2 that consider the risks and benefits of menopausal hormone therapy for primary prevention of chronic conditions and arrive at a grade D recommendation.1 The recommendations are based only on evidence from randomized trials and do not pertain to women considering hormone therapy for vasomotor symptoms, given the USPSTF mandate to consider specific preventive care services for patients without related signs and symptoms of illness...

...However, it does seem appropriate for relatively healthy, younger menopausal women with sufficiently severe vasomotor or other climacteric symptoms to draw some comfort from long-term WHI data. These women can consider hormone therapy for symptom relief. Physicians also have more evidence to impart to their patients during discussions about therapies for menopausal symptoms. Symptom relief is distinct from long-term prevention of chronic disease.

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Does Use of Hormonal Contraception Affect Risk for Breast Cancer?

NEJM Journal Watch Women's Health for December 07, 2017

Andrew M. Kaunitz, MD

Reviewing Mørch LS et al. N Engl J Med 2017 Dec 7.

Danish national observational analysis suggests modest excess risk, but methodologic concerns cloud credibility.

Many women and clinicians are concerned that hormonal contraception might raise risk for breast cancer. In a prospective cohort study, investigators used Danish national data to assess the association between use of hormonal contraception and risk for invasive breast cancer in women aged 15 to 49. Some 1.8 million women were followed for a mean of 10.9 years (1995–2012); 11,517 breast cancers were diagnosed. Findings were adjusted for duration of hormonal contraceptive use, age, calendar year, education, parity, polycystic ovary syndrome, endometriosis, and family history of breast or ovarian cancer.

Most hormonal contraceptives were oral formulations, followed by the progestin-releasing intrauterine device (IUD). Relative risk for breast cancer in current or recent users of any hormonal contraceptives compared with never-users was 1.20 (95% confidence interval, 1.14–1.26), an absolute risk of 13 additional cases of breast cancer per 100,000 person-years. Current or recent use of the progestin-releasing IUD was associated with an RR of 1.21 (95% CI, 1.11–1.33). Breast cancer diagnoses were uncommon among users of contraceptive implants or injections.

Comment

Given that >80% of invasive breast cancers are diagnosed in women older than 49 (for U.S. data, see American Cancer Society), I was surprised that these authors limited their analysis to women between 15 and 49 (despite using a database that tracks all Danish women aged 15 to 79). Clinical breast examinations, screening mammograms, and lactation history all contribute to the diagnosis of breast cancer; thus, I was also surprised that the authors did not adjust their findings for these potential confounders. Epidemiologists caution that, in cohort studies, RRs of less than 2 or 3 should not be interpreted as suggesting causation (Obstet Gynecol 2012; 120:920). It's therefore baffling that neither the investigators nor an editorialist mentioned what constitutes a fundamental limitation of this report. Lastly, an NIH-funded case-control study conducted by CDC investigators — considered by many to be among the definitive studies on this topic — found no suggestion of excess risk for breast cancer with use of oral contraceptives (N Engl J Med 2002; 346:2025). The findings of this Danish study will not alter the way in which I counsel patients about the benefits and risks of hormonal birth control: While we cannot rule out the possibility of a small increase in risk for breast cancer, the best available data suggest that use of hormonal contraceptives does not have an impact on this risk.

Reference 

Lina S. Mørch, Ph.D., Charlotte W. Skovlund, M.Sc., Philip C. Hannaford, M.D., Lisa Iversen, Ph.D., Shona Fielding, Ph.D., and Øjvind Lidegaard, D.M.Sci. Contemporary Hormonal Contraception and the Risk of Breast Cancer. N Engl J Med 2017; 377:2228-2239 December 7, 2017 DOI: 10.1056/NEJMoa1700732

Hunter DJ.Oral contraceptives and the small increased risk of breast cancer. N Engl J Med 2017 Dec 7; 377:2276. (http://dx.doi.org/10.1056/NEJMe1709636)

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Heavy Menstrual Bleeding Clinical Care Standard launched

7 December 2017

Women to benefit from first national treatment standard for heavy periods 

Heavy Menstrual Bleeding Clinical Care Standard

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”.

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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.

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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

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Oestrogen patch shortage information

20 April 2017

Fairfax through The Sydney Morning Herald and The Age, has published a story about the current shortage of oestrogen patches, a hormone replacement treatment used to manage menopausal symptoms.

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. 

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