HRT - Initial Consultation

It is very important to explore a woman's fears and understanding of the menopause and her expectations concerning hormone replacement therapy (HRT).

Recent publicity highlighted the risks and benefits of HRT when the results of a Women's Health Initiative (WHI) study in the USA and the Million Women Study in the UK were published.^1,2,3 Therefore, a thorough discussion, supported by written information, is essential for the woman to make informed decisions before starting HRT.

There are separate articles that cover the Menopause and its Management, Hormone Replacement Therapy in general, HRT - Follow-up Assessments, Combined Hormone Contraception and HRT (Risks vs Benefits) and Topical HRT.

The following outlines assessment and discussion points in an initial consultation about HRT.

History

• Confirm menopause - diagnosis is usually clinical.⁴
• Discuss symptoms being experienced - are they likely to respond to HRT? How much are they affecting the woman's life?
• Bleeding: is the woman still having periods? If not, when did the last period occur? The majority of women notice irregularities to their cycle around the menopause: the cycle may lengthen to many months or shorten to 2-3 weeks; a slight increase in the amount of menstrual blood loss is common. Postmenopausal bleeding is vaginal bleeding occurring after 12 months of amenorrhoea and needs urgent investigation. Enquire about postcoital bleeding. Any abnormal bleeding pattern should be investigated before starting HRT.
• Age: premature menopause is menopause <45 years. Refer any woman who is under 40 years to investigate the cause.⁴
• Uterus intact: cyclical progestogen must be added for those women who have not had a hysterectomy to prevent endometrial cancer.
• Explore risk factors for osteoporosis, breast cancer and coronary heart disease (CHD).

Examination

• Blood pressure
• Height and weight
• Other examination as indicated by the history (routine vaginal/bimanual examination is not required)⁴

Health promotion

Take the opportunity for health promotion, and offer lifestyle advice:⁵

• Smoking and alcohol⁶
• Diet and exercise⁷
• Check cervical smear is up-to-date
• Discuss breast self-examination and breast cancer screening

Consider potential contra-indications to HRT⁴

• Pregnancy and breast-feeding
• Undiagnosed abnormal vaginal bleeding
• Venous thromboembolic disease
• Active or recent angina or myocardial infarction
• Suspected, current or past breast cancer
• Endometrial cancer or other oestrogen-dependent cancer
• Active liver disease with abnormal liver function tests

A recent post-hoc analysis of the WHI study has shown that, although treatment with oestrogen plus progestogen in postmenopausal women did not increase the incidence of lung cancer, it did increase the number of deaths from lung cancer, in particular deaths from non-small-cell lung cancer. The analysis concluded that these findings should be incorporated into risk-benefit discussions with women considering combined hormone therapy, especially those with a high risk of lung cancer.⁸

Women who would like HRT but have a contra-indication to it (e.g. current or past breast or endometrial cancer) should be referred for specialist advice.

Investigations

• Follicle-stimulating hormone (FSH): routine FSH measurement isn't recommended if a woman is >45 and has typical symptoms.⁴ FSH may be normal during the perimenopause. However, measure FSH if premature menopause is suspected.⁴
• Thrombophilia screen if indicated in history or family history.
• Further investigation of bone density, cardiovascular risk factors and abnormal bleeding pattern as indicated by the history and examination.

Explain indications for HRT

• Short-term - for relief of vasomotor symptoms for up to 2-3 years. Some women may need HRT for longer.⁴ Note that symptoms may recur for short periods after stopping HRT.⁴
• Long-term - for prevention and treatment of cardiovascular disease and osteoporosis (where there is premature menopause) until 50 years.⁹

Discuss potential benefits

HRT can help:⁴

• Vasomotor symptoms (including sleep or mood disturbance caused by these symptoms)
• Urogenital symptoms
• Prevent osteoporosis (though HRT should not be used as a first-line treatment except in women who have premature menopause because the risks outweigh the benefits)
• Reduce the risk of colorectal cancer (but HRT should not be used just for this purpose)

Discuss potential side-effects

• Oestrogen: breast tenderness, leg cramps, bloating, nausea, headaches.
• Progestogen: premenstrual syndrome-like symptoms, breast tenderness, backache, depression, pelvic pain.
• Bleeding: monthly sequential preparations should produce regular, predictable and acceptable bleeds starting towards the end, or soon after, the progestogen phase. Breakthrough bleeding is common in the first 3-6 months of continuous combined and long-cycle HRT regimens.

Discuss risks

• Advise the woman that there is a small increased risk of:⁴
  • Breast cancer (risk is lower with oestrogen-only HRT)
  • Endometrial cancer (addition of cyclical progestogen effectively eliminates risk)
  • Ovarian cancer
  • Venous thromboembolism (VTE) - risk higher with combined HRT
  • CHD for women who have started combined therapy more than 10 years after menopause
  • Stroke
• Explain that some of the risks (e.g. breast cancer, ovarian cancer) increase with longer duration of HRT.⁴
• Please refer to the separate article covering combined hormone contraception and HRT benefits and risks for a full discussion of risks.
• Record in the patient's records that you have discussed the risks.

Discuss contraception

• HRT does not suppress ovulation.
• In those with an intact uterus, contraception should be used:⁴
  • For 1 year after the last menstrual period in woman >50.
  • For 2 years after the last menstrual period in woman <50.

Discuss alternatives to HRT

There is a separate article 'HRT - Alternatives' that discusses these in detail.

Use the lowest effective dose of HRT.

Systemic or local; cyclical or continuous?

• Women with an intact uterus
  • Vasomotor symptoms
    • Perimenopausal: systemic cyclical combined HRT (a 3-monthly regimen can be used for women with infrequent periods or who cannot tolerate progestogens).
    • Postmenopausal: systemic continuous combined HRT or tibolone.
  • Urogenital symptoms
    • Perimenopausal: low-dose vaginal oestrogen or systemic cyclical combined HRT.
    • Postmenopausal: low-dose vaginal oestrogen or systemic continuous combined HRT.
• Women who have had a hysterectomy
  • Vasomotor symptoms: systemic oestrogen-only HRT.
  • Urogenital symptoms: low-dose vaginal oestrogen or systemic oestrogen-only HRT.

Which delivery route?⁴

• This depends partly on patient preference.
• Transdermal patches may be preferred to oral administration in some situations:
  • If there is poor control of symptoms with oral treatment.
  • If there are side-effects such as nausea.
  • There may be a lower risk of VTE with patches.
  • If the woman is taking a liver enzyme-inducing drug.
  • If the woman has a bowel disorder which may affect oral absorption.
  • Steadier hormone levels with patches may be beneficial if there is a history of migraine.
  • Most HRT tablets contain lactose, so patches are preferred if there is lactose sensitivity.
• Low-dose vaginal oestrogen (tablet, cream, pessary, or vaginal ring) may be preferred if symptoms are primarily urogenital.
• Estradiol implants are sometimes used after hysterectomy if symptoms cannot be controlled using other delivery routes.
• Levonorgestrel-releasing intrauterine system (Mirena®) plus oestrogen component may be used if:
  • Progestogen side-effects are experienced with other progestogen preparations and delivery routes.
  • Contraception is still needed.
  • There is persistent heavy bleeding on cyclical combined HRT and normal investigations.

Tibolone

• Tibolone is a selective oestrogen receptor modulator (SERM) which has oestrogenic, progestogenic and androgenic properties.
• It can be used in women with an intact uterus who have had no bleeding for more than 1 year, without the need for cyclical progesterone.
• Randomised controlled trials suggest it may be helpful in improving sexual function and vasomotor symptoms.^10,11 It may also reduce the risk of spinal fractures.⁴
• There may be a small increased risk of stroke, endometrial and breast cancer (including breast cancer recurrence) with tibolone.
• Tibolone probably has a similar risk profile to combined HRT in younger women. However, in women over the age of 60 years, the increased stroke risk means that the risks outweigh the benefits.⁴

1. Rossouw JE, Anderson GL, Prentice RL, et al; Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. [abstract]
2. Beral V; Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet. 2003 Aug 9;362(9382):419-27. [abstract]
3. Anderson GL, Limacher M, Assaf AR, et al; Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004 Apr 14;291(14):1701-12. [abstract]
4. Menopause, Clinical Knowledge Summaries (January 2008)
5. Greendale GA, Gold EB; Lifestyle factors: are they related to vasomotor symptoms and do they modify the effectiveness or side effects of hormone therapy? Am J Med. 2005 Dec 19;118(12 Suppl 2):148-54. [abstract]
6. Sievert LL, Obermeyer CM, Price K; Determinants of hot flashes and night sweats. Ann Hum Biol. 2006 Jan-Feb;33(1):4-16. [abstract]
7. Simkin-Silverman LR, Wing RR, Boraz MA, et al; Lifestyle intervention can prevent weight gain during menopause: results from a 5-year randomized clinical trial. Ann Behav Med. 2003 Dec;26(3):212-20. [abstract]
8. Chlebowski RT, Schwartz AG, Wakelee H, et al; Oestrogen plus progestin and lung cancer in postmenopausal women (Women's Health Initiative trial): a post-hoc analysis of a randomised controlled trial. Lancet. 2009 Sep 18. [abstract]
9. Jones GL, Ledger W, Mitchell C; Suspected premature menopause. BMJ. 2008 Apr 12;336(7648):833.
10. Nathorst-Boos J, Hammar M; Effect on sexual life--a comparison between tibolone and a continuous estradiol-norethisterone acetate regimen. Maturitas. 1997 Jan;26(1):15-20. [abstract]
11. Al-Azzawi F, Wahab M, Habiba M, et al; Continuous combined hormone replacement therapy compared with tibolone. Obstet Gynecol. 1999 Feb;93(2):258-64. [abstract]

• The Medicines and Healthcare Products Regulatory Agency (MHRA); UK Public Assessment Report. Hormone-replacement therapy: safety update. (As at September 2007).
• The British Menopause Society