Hormone replacement therapy

Dr Gwen Lewis explains current prescribing guidance for using HRT to treat menopause symptoms.

HRT can be prescribed in the form of patches, tablets or gels
HRT can be prescribed in the form of patches, tablets or gels

In the UK, the average age of the menopause is 51 years.

At this stage in a woman's life, hormonal fluctuations, resulting from falling ovarian reserve and loss of hypothalamic control, can lead to a number of symptoms, including vasomotor symptoms of hot flushes and night sweats, low mood, tiredness, poor cognition, exacerbation of cycle-related symptoms, aches and pains, vaginal dryness and irritation, bladder symptoms and lack of libido.

It is thought that 85-90% of women experience some or all of these symptoms, but not all seek treatment.

There is also decreased insulin sensitivity due to falling estrogen levels, which tends to cause central weight gain and increased risk of metabolic syndrome, type 2 diabetes and CHD.

Prescribing HRT
  • HRT is now licensed for the treatment of symptoms of the menopause, in particular vasomotor symptoms.
  • HRT should not be used for cardiovascular protection and it may only be prescribed for the prevention of osteoporosis in women who are unable to take other medication licensed for this purpose.
  • It is suggested that HRT should be used in the lowest dose for the shortest possible duration.
  • If women have undergone a hysterectomy, they only require estrogen preparations as HRT.
  • Women who have an intact uterus and whose periods have stopped within 12 months of starting HRT need to be prescribed sequential HRT, which will provoke monthly bleeds.
  • If the woman's periods have ceased for more than 12 months, continuous combined HRT may be prescribed, which does not cause monthly bleeds.
  • If the main symptom of the menopause is a local vaginal problem, with dryness or irritation being the predominant symptom, a topical preparation of estrogen may be used to alleviate these symptoms.
  • It is thought that 85-90% of women experience some symptoms of the menopause, but not all will seek treatment.
  • The British Menopause Society recommended in 2011 that all women should be invited to attend for a consultation around the time of their 50th birthday, to discuss their general health and lifestyle around and beyond the menopause.

Discussing HRT

HRT is now licensed only for treatment of symptoms of the menopause, in particular vasomotor symptoms, and it is suggested that it should be used for the shortest possible duration.

Many women are frightened to use HRT after the publication of trial results, such as the Million Women Study.1 This is certainly my experience in general practice. I am asked to discuss HRT with women far less frequently than I was 10 years ago.

The British Menopause Society recommended in 2011 that all women should be invited to attend for a consultation around the time of their 50th birthday, to discuss their general health and lifestyle around and beyond the menopause.

It is suggested that women should take regular exercise and have a well-balanced diet, including a phyto-estrogen rich diet of, for example, soy and pulses. They should also stop smoking and reduce their alcohol intake.

What are the risks?

Data on breast cancer risk with HRT are controversial. If there is an increased risk, it is small, at less than 1:1,000 per year, while its benefits may outweigh the risks.

The progesterone component of HRT is relevant; the risk of breast cancer is increased with certain progestogens, while in two studies from France2 and Finland,3 it was found that dydrogesterone in HRT did not appear to increase the risk at all.

A recent study of 13 years' follow-up data from the landmark Women's Health Initiative found that women taking conjugated equine estrogen plus medroxyprogesterone acetate were 80% more likely to develop coronary artery disease than those taking placebo.4

How to use HRT now

With all of these concerns, the regulatory view in the UK in 2013 is that if HRT is to be prescribed, the minimum effective dose should be used for the shortest duration and annual review should be undertaken.

In particular, HRT should not be used for cardiovascular protection and it may only be prescribed for prevention of osteoporosis in women who are unable to take other medication that is licensed for this purpose.

If women have undergone a hysterectomy, they only require estrogen preparations as HRT. This may be in the form of tablets, which are taken daily, or patches, which are available in the more common twice-weekly regimen or a weekly regimen, or in the form of gel, which is applied daily.

Unopposed estrogen in women who have had a hysterectomy does not have the same possible increased risk of breast cancer, nor increased risk of cardiovascular or venous thromboembolic disease.

Women who have an intact uterus and whose periods have stopped within 12 months of starting HRT need to be prescribed sequential HRT, which will provoke monthly bleeds.

If periods have ceased for more than 12 months, continuous combined HRT may be prescribed, which does not cause monthly bleeds.

It is worth advising women when they start HRT that they may experience some irregular bleeding in the first one to three months, but they should seek advice if bleeding continues for more than three cycles.

Again, HRT may be in the form of daily tablets or patches. Another method of delivery of the protective progesterone is in the form of the levonorgestrel IUS.

If the levonorgestrel IUS is used, the woman need only be prescribed estrogen, which can be in the form of tablets, patches or gel.

It should be noted that if the levonorgestrel IUS is used for this purpose, its licence is for four years (five years for contraception). Progesterone supplied in this way locally to the uterus tends to cause fewer side-effects than systemic progesterone. A new low-dose IUS is in production.

Another potential serious side-effect of HRT is increased risk of venous thromboembolism. The use of transdermal patches possibly reduces the risk of blood clots, as does the type of progesterone used.

Dryness and irritation

If the main symptom of the menopause is a local vaginal problem, with dryness or irritation being the predominant symptom, a topical preparation of estrogen may be used to alleviate symptoms.

It is suggested that topical estrogen should be used once daily at night for 10-14 days and then on a onceor twice-weekly basis. Topical vaginal estrogen is also available as cream or a vaginal ring.

Testosterone implants, which were previously used as a treatment for low libido, are no longer available. Tibolone, which is a treatment used for menopausal symptoms in women in whom it is more than 12 months since their last period, is weakly androgenic and may be used in this circumstance.

An oral selective estrogen-receptor modulator indicated for dyspareunia is expected to be available soon.

Early menopause

Women who experience an early menopause are at increased risk of osteoporosis and cardiovascular disease. It is recommended that women whose periods cease very early (under 50 years of age) should be actively offered HRT. They should be advised to take it until they reach the natural age for cessation of periods and this duration of use of HRT should cause no increased risk of breast cancer.

There are several useful websites for women who experience premature menopause, for example, the Daisy Network (www.daisynetwork.org.uk).

Other treatments

Other medical treatments may be helpful for menopausal symptoms. These include clonidine, which may benefit vasomotor symptoms, as may SSRIs and venlafaxine.

Many women are not keen to take HRT at any cost, but are interested in natural treatments for menopausal symptoms. Some natural treatments available OTC are red clover isoflavones 40 or 80mg daily, black cohosh and pills derived from fermented soya extract. However, NICE/CKS does not recommend these treatments.5

Conclusion

Treatment of the menopause remains difficult and many women continue to be concerned about the use of HRT. As GPs, we should be happy to prescribe HRT with confidence for a short duration for those women experiencing vasomotor symptoms, and this is often all that is required.

In particular, we should be more proactive in searching for women who have a premature menopause and in offering them HRT.

  • Dr Lewis is a GP in Windsor, Berkshire

References

1. Beral V. Million Women Study collaborators. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet 2003; 362(9382): 419-27.

2. Fournier A, Berrino F, Clavel-Chapelon F. Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study. Breast Cancer Res Treat 2008; 107: 103-11.

3. Lyytinen H, Pukkala E, Ylikorkala O. Breast cancer risk in postmenopausal women using estradiol-progestogen therapy. Obs Gyn 2009; 113: 65-73.

4. Mason JE, Chlebowski RT, Stefanick ML et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA 2013; 310(13): 1353-68.

5. NICE. Clinical Knowledge Summaries. Menopause. 2013. cks.nice.org.uk/menopause#!scenariorecommendation:45

Resource

Panay N, Hamoda H, Anja R et al. The 2013 British Menopause Society and Women's Health Concern recommendations on hormone replacement therapy. Menopause Int 2013; 19(2): 59-68.

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