Menopause & HRT/HT

Indications for HRT/HT

Contraindications to HRT/HT

Assessment, precautions & advice

General principles for prescribing HRT/HT

HRT/HT regimens

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Menopause may be spontaneous, or surgically induced after bilateral oophorectomy, pelvic radiation or chemotherapy.

Menopausal symptoms - hot flushes, night sweats, mood swings, dry vagina, dyspareunia, urinary frequency & incontinence, loss of energy, insomnia, depression.

The perimenopause or climacteric – an ill-defined period prior to true menopause (12 months without periods) when symptoms may occur, bleeding may be irregular.

Indications for Hormone Replacement Therapy (HRT) also called Hormone Therapy (HT)

• Treatment of vasomotor symptoms
• Prevention of bone loss in women with premature menopause (<40 years) or osteoporosis in 50-60 year old women
• Symptomatic urogenital atrophy

The indications are being reviewed continuously & have been the cause of much controversy with two randomized trials in the 2000s showing low incidence risks exceeding low incidence benefits. HRT may be requested by the patient.

Contraindications to HRT/ HT

• Active of history of thromboembolism
• Thrombophilia
• History of CHD, stroke or TIA
• Current, past, suspected breast, endometrial, or other estrogen dependant ca (women with one first degree relative may want to consider non-hormonal therapy)
• Undiagnosed genital tract bleeding
• Untreated hypertension
• Liver disease
• Porphyria

Assessment, precautions, & advice

1. Counsel about menopause, options, to stop smoking, balanced diet, exercise
2. Full medical & gynaecological history to exclude contraindications.
3. Physical examination, including breast and gynaecological
4. Blood pressure & at least annual rechecking. Pap smear if not in last 3 years
5. Mammogram & annual repeats. Fasting lipogram, HbA1c, TFT
6. Breast cancer risk is +/- 10% for all women without HRT, increased to about 11% if HRT is used. Risk with estrogen alone may be less than opposed
7. Monthly withdrawal bleeds will occur with opposed HRT (oestrogen plus progestogen), which should diminish over time
8. Nausea and breast discomfort may be troublesome early on
9. Unopposed HRT (oestrogen alone) must never be given when a uterus is present (risk of endometrial hyperplasia then cancer)
10. When starting HRT, review the patient after 6 months, then annually
11. On review, ask about problems (irregular bleeding, breast discomfort etc.)
12. Blood pressure check at least annually
13. Mammogram and breast examination annually
14. Record ALL important discussions at initiation & follow up visits

General principles for prescribing HRT/HT

HRT is best started within 2-3 years of the menopause. With previous hysterectomy, unopposed oestrogen-only therapy is sufficient (breast ca risk may be smaller). With an intact uterus, sequentially opposed oestrogen therapy will result in cyclical bleeding. The lowest dose that reduces symptoms should be used. Continuously opposed oestrogen (best started 1 year after the menopause to avoid irregular spotting) often results in amenorrhoea.

HRT/HT REGIMENS

Oral opposed oestrogen (with progestogens) (EPT)

Sequentially opposed

• Estradiol valerate 2 mg with cyproterone acetate 1 mg & placebo in a 28-day pack (Climen)
• Conjugated oestrogen 0.625 mg or 1.25 mg with medrogestone 5 mg & placebo in a 28-day pack (Prempak-N)
• Estradiol 1 mg & 2 mg with norethisterone acetate 1 mg in a 28-day pack (Trisequens)

Continuously opposed

• Estradiol 2 mg with norethisterone acetate 1 mg (Kliogest) – taken continuously, no withdrawal bleeds, not to be used in the first 2 years after menopause
• Estradiol 1mg with drosperinone 2mg (Angeliq)
• Conjugated oestrogen 0.625mg with medroxyprogesterone acetate 2.5mg – 5mg (Premelle 2.5 or 5) 

Oral unopposed oestrogen (ONLY if no uterus present)

• Conjugated oestrogen (Premarin) 0.3, 0.625 or 1.25mg daily
• Estradiol (Estrofem)1-2 mg daily
• Start with lower doses and increase if necessary according to symptoms
• Newer lower dose preparations are emerging

Parenteral unopposed oestrogen

• Oestradiol Implants 20 mg have been withdrawn. Patches (applied to dry clean area & transdermal gels (both applied away from the breast) may not available in the state. They are good options if patient obese, hypertensive or DM
• Transdermal systems - estradiol 3.9mg or 7.8mg, change weekly, can use continuously or for 3w then interrupt for 1w (Climara)
• Transdermal patch – estradiol 25mcg, 37,5mcg, 50mcg, 75mcg or 100mcg/day, change every 3-4days (Estradot)

Vaginal oestrogen – only after a clear diagnosis of atrophy

• Conjugated oestrogen (Premarin) vaginal cream, apply 1-4 g daily – only used after full assessment of any vaginal bleeding
• Vaginal cream - Conjugated oestrogen, apply 1-2g daily, max 4g, on a cyclical basis (Premarin)
• Vaginal ring - Estradiol 2mg  - max 2 years (Estring)
• Vaginal tablets – Estradiol 25mcg, 1 tab/d for 2w, then 1 twice weekly – safety not established >1 year (Vagifem)

For vasomotor symptoms: Herbal remedies, phyto-estrogens(e.g. black cohosh) have so far not been found effective, also acupuncture. Tibolone & clonidine do have some benefit as have SSRIs. Newer agents & existing selective estrogen receptor modulators (SERMS) remain under consideration.

The South African Menopause Society (SAMS) website contains many details. The MenoPro app by the north American society (NAMS) is free from the app store.