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Date of release: 08 June, 2015

Breaking News: Menopause - NICE guideline (short version draft)

The UK National Institute for Health and Care Excellence (NICE) has issued a draft guideline on the diagnosis and management of menopause for consultation (closes 13 July 2015). The guideline concentrates on the clinical management of menopause-related symptoms and considers both pharmaceutical and non-pharmaceutical treatments. The IMS is proud to have two of its members serving as pivotal persons in the NICE committee – Mary Ann Lumsden and Nick Panay. I reviewed the short version of the guideline, but the full, detailed paper is available for the public as well. The document can be downloaded by clicking here.

Comment

NICE is known for being 'tough' with clinical recommendations, taking into special consideration all cost-effective and safety issues, stressing the principle of having a rigorous evidence-based approach. Based on the concept that patients should have the opportunity to make informed decisions about their care and treatment, in partnership with their health-care professionals, the document is phrased in a very simple language and provides very clear guidance for women. This draft paper addresses the diagnosis and management of menopause (covering women in the perimenopause and postmenopause) and the particular needs of women with premature ovarian insufficiency and women with breast cancer. The guideline concentrates on the clinical management of menopause-related symptoms, considers both pharmaceutical and non-pharmaceutical treatments, includes a health economic analysis, and reviews the benefits and adverse effects of HRT used for up to 5 years. The definitions used in the document are a little different from the common scientific ones, as it is meant to be read by the consumers: the term ‘offer’ (and similar words such as ‘refer’ or ‘advise’) is used when the contributors are confident that, for the vast majority of patients, an intervention will do more good than harm, and be cost-effective. The term ‘consider’ is used when the contributors are confident that an intervention will do more good than harm for most patients, and be cost-effective, but other options may be similarly cost-effective.

There is nothing new in the guideline when compared to other similar products from medical societies, such as the IMS or the Endocrine Society, but the short, simple, easy-to-read and straightforward messages produced by a national health organization which is very influential world-wide make this document quite unique in my eyes. It should be remembered that this is just a draft, and I anticipate a fierce debate on its final version. Below are the main items that I consider the most important.

Vasomotor symptoms: Offer HRT for vasomotor symptoms after discussing the short-term (up to 5 years) and longer-term benefits and risks. Offer a choice of oral or transdermal preparations. Do not routinely offer selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) as first-line treatment for vasomotor symptoms alone.

Mood: Consider HRT to alleviate low mood in menopausal women. Ensure that menopausal women and health-care professionals involved in their care understand that there is no clear evidence for SSRIs or SNRIs to ease low mood in menopausal women who have not been diagnosed with depression.

Sexuality: Consider testosterone supplementation for menopausal women with low sexual desire if HRT alone is not effective.

Urogenital atrophy: Offer low-dose vaginal estrogen to women with urogenital atrophy (including those on systemic HRT) and continue treatment for as long as needed to relieve symptoms. Advise women with vaginal dryness that moisturizers and lubricants can be used alone or in addition to vaginal estrogen.

Compounded hormones: Explain to women that the efficacy and safety of unregulated compounded bioidentical hormones are unknown. Explain to women who wish to try complementary therapies that the quality, purity and constituents of products may be unknown.

Follow-up: At 3 months to assess efficacy and tolerability of a new therapy. Annually thereafter unless there are clinical indications for an earlier review (such as treatment ineffectiveness, side-effects or adverse events). Refer women to a health-care professional with expertise in menopause if treatments do not improve their menopausal symptoms or they have ongoing troublesome side-effects.

Cardiovascular disease: HRT does not increase cardiovascular disease risk when started in women aged under 60 years. Be aware that cardiovascular risk factors (for example hypertension) do not automatically preclude a woman from taking HRT but should be taken into account. HRT with estrogen alone is associated with no, or reduced, risk of coronary heart disease. HRT with estrogen and progestogen is associated with little or no increase in the risk of coronary heart disease. Explain to women that taking oral (but not transdermal) estrogen is associated with a small increase in the risk of stroke. Also explain that the baseline risk of stroke in women aged under 60 years is very low. The risk of venous thromboembolism associated with HRT is greater for oral than transdermal preparations. The risk associated with transdermal HRT given at standard therapeutic doses is no greater than baseline risk.

Breast cancer: Ensure that menopausal women and health-care professionals involved in their care understand that HRT does not affect the risk of dying from breast cancer. HRT with estrogen alone is associated with little or no increase in the risk of breast cancer. HRT with estrogen and progestogen can be associated with an increase in the risk of breast cancer. Any increase in risk of breast cancer is related to treatment duration and reduces after stopping HRT.

Osteoporosis: Explain to women that their risk of fragility fracture is decreased while taking HRT and that this benefit is maintained during treatment but decreases once treatment stops. Benefit may continue for longer in women who take HRT for longer.

Dementia: Explain to menopausal women that the likelihood of HRT affecting their risk of dementia is unknown. 

When HRT is contraindicated: For women with menopausal symptoms and contraindications to HRT: provide information on non-hormonal and non-pharmaceutical treatments (for example, cognitive behavioral therapy, hypnosis, acupuncture and relaxation techniques) for the relief of menopausal symptoms.

Premature menopause: A special section in the guideline addresses premature menopause. I picked the following sentences: offer sex steroid replacement with a choice of HRT or a combined oral contraceptive to women with premature ovarian insufficiency, unless contraindicated (for example, in women with hormone-sensitive cancer). Explain to women with premature ovarian insufficiency the importance of starting hormonal treatment either with HRT or a combined oral contraceptive and continuing treatment until at least the age of natural menopause (unless contraindicated).

Amos Pines
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel