Hormone Replacement Therapy (HRT) Information for women

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This leaflet will provide you with a summary of what is known about the benefits and risks of Hormone Replacement Therapy (HRT) and how this might affect you.

What is HRT? When you reach the menopause your levels of the hormones oestrogen and progestogen naturally fall. This causes your menstrual cycle to become irregular and your periods to eventually stop. This may also cause some of the unpleasant symptoms of the menopause such as hot flushes and vaginal dryness. HRT provides low doses of these hormones to replace those that your body no longer produces. There are two main types of HRT: • Oestrogen-only replacement therapy • Combined HRT that contains both oestrogen and progestogen Oestrogen-only replacement products are available as: • Tablets • Patches • Vaginal rings • Gels

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In combined HRT products the oestrogen and progestogen may be taken in the same tablet or patch or they may be taken separately. The progestogen may be taken every day (continuous combined HRT) or for 12-14 days of each monthly treatment cycle (sequential combined HRT) depending on the method used.

The benefits of HRT HRT is effective in relieving the symptoms of the menopause. These symptoms may include: • Hot flushes • Night sweats • Difficulty sleeping • Vaginal dryness and discomfort • Depression • Mood swings • Tiredness • Poor concentration In most cases, using HRT for a short period of time (up to two - three years) is long enough to relieve these symptoms, although they may recur for a short time after stopping HRT. In the past, HRT was used to prevent osteoporosis and heart disease, but it is not used for this now.

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The risks of HRT As with all medicines, the use of HRT is associated with some side effects. While many women have no side effects, nausea, breast tenderness and fluid retention are quite common. Long-term use of HRT may increase the risk of getting some potentially more serious but much rarer conditions (see below). It is important to remember that all these conditions can occur without using HRT and that a woman’s risk of getting any of these conditions depends on her own health, her lifestyle and her family medical history. To help put these risks into perspective, the extra number of cases of each of these conditions associated with HRT is typically smaller than the health risks associated with smoking or being very overweight. For some of these risks, studies have allowed us to estimate the number of extra cases that will occur in a five-year or ten-year period due to HRT.

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Summary of possible risks associated with HRT The following table provides data on the possible risks associated with HRT. Risk

Age range (years)

Background incidence per 1000 women in Europe not using HRT

Over five years

Additional cases per 1000 women using oestrogen only HRT (estimated)

Over For ten five years years use 20 2 30 3 4 4 6 6 4 1 6 1 2 2

For ten years use 6 9 32 48 1 2

Additional cases per 1000 women using combined (oestrogenprogestogen) HRT (estimated) For five years use 6 9 NS NS 1 1 7 10

Breast cancer 50–59 60–69 Endometrial 50–59 cancer 60–69 Ovarian 50–59 cancer 60–69 Venous 50–59 thrombo 60–69

10 15 2 3 2 3 5 8

Stroke

4 9 9-14

1 3 NS

1 3 NS

18-31

NS

NS

29-44

NS

15

embolism

50–59 60–69 50-59

Coronary heart disease Coronary 60-69 heart disease Coronary 70-79 heart disease

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For ten years use 24 36 NS NS 1 2

Where background incidence or additional cases have not been included in the table, this indicates a lack of available data. NS = not significant. The information in the above table is taken from: • MHRA/CHM Drug Safety Update 2007; 1 (2): 2–6 (available at www.mhra.gov.uk/mhra/ drugsafetyupdate); and • Menopausal Hormone Use and Ovarian Cancer Risk: individual participant meta-analysis of 52 epidemiological studies by the Collaborative Group on Epidemiological Studies of Ovarian Cancer (The Lancet, Volume 385, No. 9980, p1835–1842, 9 May 2015 available at http:// www.thelancet.com/journals/lancet/article/ PIIS0140-6736(14)61687-1/abstract).

Breast cancer Using HRT slightly increases the chance of breast cancer within one to two years of starting treatment. The risk from HRT increases the longer you use it but is thought to return to normal within five years of stopping. For example, for women aged 50-59 who do not use HRT, about ten in every 1000 will be diagnosed with breast cancer over a five year period. For women in this age group who start HRT and take it for five years, it is estimated that an additional two cases will occur in women taking oestrogen only HRT and an additional six cases in women using combined HRT. These numbers increase the longer you use HRT. 6

You should take advantage of the breast screening checks offered under your local breast screening programme. You should also make an appointment to see your doctor if you notice any changes to your breasts, including skin changes, nipple changes or lumps.

Ovarian cancer Long term use of combined HRT or oestrogen only HRT is associated with a small increased risk of ovarian cancer. This increased risk disappears within a few years of stopping. A new detailed review looking at the results of 52 previous studies has found a statistically higher risk in current HRT users compared with non-users, even in those with less than five years of use. The reason for this is not fully known. For every 1,000 women using HRT for five years, there will be one additional ovarian cancer diagnosis. This means that if the outcome of the cancer diagnosis is typical, there will be one additional ovarian cancer death for every 1,700 users. Your risk of developing ovarian cancer decreases over time once you have stopped taking HRT. However you still have a significant risk for the first few years after you have stopped taking HRT. You should make an appointment to see your doctor if you experience abdominal swelling and discomfort, weight loss and/or abnormal vaginal bleeding, possibly associated with an abdominal lump. 7

Stroke Recent research suggests that combined or oestrogen only HRT slightly increases the risk of having a stroke. Taking average women in their 50s who do not use HRT, four in a thousand are expected to have a stroke in any five-year period. For women of the same age who use HRT for five years, the expected number of strokes will be five in a thousand. The risk of stroke increases as a woman gets older. For women in their 60s who do not use HRT, nine in a thousand will be expected to have strokes in any five-year period. This compares with 12 in a thousand women of the same age that use HRT for five years. The risk of stroke with tibolone is slightly higher than with combined HRT.

Blood Clots - Venous Thromboembolism (VTE) The risk of harmful blood clots in the veins is increased by taking HRT, especially in the first year. Taking average women in their 50s who do not use HRT, five in a thousand could develop blood clots over five years. In women of the same age who use oestrogen only HRT for five years, an additional two cases will occur. For those using combined HRT, an additional seven cases will occur. 8

The risk of VTE increases with age therefore eight in a thousand women in their 60s who do not use HRT could develop clots over five years. This compares with ten in a thousand women who use oestrogen only HRT for five years and 18 in a thousand women who use combined HRT for five years.

Cancer of the lining of the womb Taking oestrogen-only HRT for a long time increases the risk of cancer in the womb lining (endometrium). For women who have not had their womb removed by hysterectomy, their doctor will normally prescribe a progestogen as well as an oestrogen to reduce this risk. You should make an appointment to see your doctor if you notice any abnormal vaginal bleeding which continues some months after starting HRT. This may include heavy bleeding, irregular bleeding or bleeding regularly after sex.

Heart disease There is an increased risk of heart disease if combined HRT is started more than 10 years after the menopause. There is no evidence that the risk is increased in women who commence combined HRT around the time of the menopause. HRT should not be used to protect against heart disease.

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Gall bladder disease Gall bladder disease increases from 2.7 per cent in women not using HRT, to 4.7 per cent in HRT users.

Summary The benefits of short-term HRT (up to two or three years) for the relief of menopausal symptoms generally outweigh the risks involved. Women who start HRT before the usual age of natural menopause (50 to 51 years) don’t have any extra risks compared to other women of the same age who aren’t using HRT: the risks only start to build up after the age of 50. This means HRT can be used for as long as needed until age 51: there is no need to stop after 2 or 3 years. Discuss your own situation with your doctor at least every year.

Sources of patient information Clinical Knowledge Summaries Guidance Offers advice for clinicians and patients on the management of the menopause, including the use of HRT http://cks.nice.org.uk/menopause

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The Daisy Network The Daisy Network provides support and information for premature menopause. www.daisynetwork.org.uk

Menopause Matters Menopause Matters is an independent clinician-led website whose aim is to provide easily accessible, up-to-date, accurate information about the menopause. www.menopausematters.co.uk

Women’s Health Concern Women’s Health Concern is a charitable organisation which aims to help educate and support women with their healthcare by providing unbiased, accurate information. www.womens-health-concern.org

The Office on Women’s Health (American Site) The Office on Women’s Health provides information on HRT and the menopause. www.womenshealth.gov/menopause

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Last reviewed: October 2015 Leaflet reference: MIS11-028-GD