Hormone replacement therapy

Treatment algorithm Table of recommended products Transdermal patches vs tablets Formulary HRT drugs Read codes Oestrogen implants HRT and the menopause tutorial PAL HRT Menopause self help guide Thrombosis risk Breast cancer risk HRT risks and benefits (technical)

Diagnosing the menopause Indications for HRT Possible benefits Which regime? Contra-indications Alternative therapies for controlling menopausal symptoms Menopause and contraception Recommended products Non-equine alternatives Risks of HRT HRT risks and benefits (Regional Drug and Therapeutics update 11/01) HRT - optimising treatment  (Regional Drug and Therapeutics update 11/01) Further information 2005 update Where are we now with hormone replacement therapy? Klim McPherson http://bmj.com/cgi/content/full/328/7436/357?etoc Benefits and harms associated with hormone replacement therapy: clinical decision analysis Cosetta Minelli, Keith R Abrams, Alex J Sutton, Nicola J Cooper http://bmj.com/cgi/content/abstract/328/7436/371?etoc Commentary: Time to review all the evidence for hormone replacement therapy Fay Crawford and Peter Langhorne http://bmj.com/cgi/content/full/330/7487/345?etoc Menopause Matters

Diagnosing the menopause

• The menopause is often a diagnosis made retrospectively
• Contraception is still needed during the peri-menopausal years
• There is little place for the routine measuring of FSH, LH or oestradiol as women may suffer with vasomotor symptoms but have normal FSH, LH and oestradiol levels.
• If FSH, LH and oestradiol levels are measured then blood should be taken within the first 5-7 days of the menstrual cycle.
• FSH may be of some use in women: - Under 45 years with atypical symptoms - To help diagnose the menopause in those women taking COC or HRT - Who have had a hysterectomy with conservation of the ovaries.
• Oestradiol levels may be useful:
  • To assess the level of oestradiol absorption in patients using non-oral therapy in respect to adequate bone preservation or poor vasomotor symptom control. 
  • In the management of patients with oestradiol implants (preventing tachyphylaxis).

Menopause and contraception

• Menopausal women over the age of 50 should use a contraceptive method for one year following their last menstrual period.
• Women under 50 should use a contraceptive method for 2 years following their last menstrual period as break through ovulation can occur.

Women using the combined oral contraceptive PILL (COC)

• May develop vasomotor symptoms in the pill free interval
• May have a rise in FSH during the pill free interval in 30% of menopausal women
• Diagnosis of the menopause may be possible by checking the FSH on day 7 of the pill free interval.
  • if the FSH is 30 U/L or more it should be repeated in 3 months - if the FSH is again raised above 30 U/L it is likely that the woman is menopausal 
  • contraception should be continued for the next 2 years (the COC should only be used in women under 50 years old).
• Alternatively, a 50 year old woman could change to using a different contraceptive method such as a POP. If no bleeding occurs in the first two months an FSH level can be measured. If the FSH level is 30 U/L or more the above procedure is followed.

Contraception in women using HRT

• A number of women start HRT before the cessation of menstruation 
• HRT is not a contraceptive 
• The menopause is suggested if an FSH level taken within 7 days of the start of a withdrawal bleed is >30 U/L on two separate occasions, 1 – 3 months apart. 
• In women under 50, contraception should be continued for two years. 
• In women over 50, contraception should be continued for one year.

Indications for HRT

• To treat menopause vasomotor symptoms.
• To treat menopause urogenital symptoms.
• To prevent and treat osteoporosis.

Possible benefits

• To prevent the development of coronary heart disease and secondary prevention of CHD.
• To reduce cerebrovascular accidents.
• To delay the onset and retard the progression of Alzheimer's disease.
• To prevent mood swings and depression at the time of the menopause.
• To decrease the incidence of large bowel cancer.

Which regime?

1. Women who have had a hysterectomy can use unopposed oestrogen orally, by patch, gel or implant.
2. Women who have a uterus or who have undergone endometrial ablation need continuous oestrogen with cyclical or continuous progesterone, i.e. for 10-14 days every 28 days, for 14 days every 3 months or continuously.

Contra-indications

• Active breast cancer/undiagnosed breast lump
• Active thrombo-embolic disease (not phlebitis)
• Undiagnosed vaginal bleeding
• Uncontrolled hypertension

Extra caution is required if prescribing for women with the above conditions.

Alternative therapies for controlling menopausal symptoms

• Tibolone may decrease vasomotor symptoms.
• Clonidine may reduce vasomotor symptoms in 30% of women.
• Norethisterone 5-15 mg and Megestrol 40 mg may reduce vasomotor symptoms in 60% of women and may offer bone protection.
• Transdermal natural Primrose Oil (no scientific data).
• Chinese angelica (unproven).

Alternative Therapies for the Prevention of Osteoporosis

• Tibolone
• Raloxi feve (selective oestrogen receptor modulator)

Menopause and contraception

• Menopausal women over the age of 50 should use a contraceptive method for one year following their last menstrual period. *
• Women under 50 should use a contraceptive method for two years following their last menstrual period as breakthrough ovulation can occur.

Women using the Combined Oral Contraceptive Pill

• May develop vasomotor symptoms in the pill-free interval.
• May have to rise in FSH during the pill-free interval.
• Diagnosis of the menopause is possible by checking the FSH on day 7 of the pill-free interval. If the FSH is 30 U/L or more it should be repeated in 3 months. If the FSH again is raised above 30 U/L, then it is likely that the woman is menopausal. Contraception should however by continued for the next two years.

Contraception in Women Using HRT

A number of women are commenced on HRT before the cessation of menstruation. The menopause is suggested if an FSH level taken within 7 days of the start of the withdrawal bleed is more than 30 U/L on two separate occasions.

• In women under 50, contraception should be continued for the next two years.
• In women over the age of 50, contraception should be continued for one year.

Recommended products

Non-equine alternatives

Risks of HRT

• Breast cancer
• HRT risks and benefits (Regional Drug and Therapeutics update 11/01)
• HRT - breast cancer risk 2005

Oestrogen implants

• Check the Oestradiol levels 6-monthly to make sure that the implant is needed.
• The Oestradiol level should be between 300 and 600 units

Further information

• HRT patient advice leaflet
• HRT and breast cancer patient advice leaflet
• HRT - breast cancer risk 2005
• The Womens Nutritional Advisory Service offers a free menopause information package: tel 01273 487 366
• The Menopause Helpline gives free advice on 0181 444 5202
• Menopause Matters

 Based on guidelines of the Newcastle and North Tyneside Health District Drug and Therapeutics Committee.

Clare Bromly 1999

• Brad Cheek: last updated Dec 2006
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