15th OCTOBER ‘2021
Hormonal therapy (HT) has been the mainstay of the treatment of menopausal symptoms for a long time. It has rejuvenating abilities, in addition to long-term advantages for the prevention of cardiac disease and bone problems. Many potential risks were described from HT use in the past. The new data from 2010 onwards, along with subsequent studies have either significantly reduced or removed the risk initially described. In general, it is important to weigh up indications, proposed benefits, and potential risk factors for each patient individually before prescribing HT. There is no maximum age at which a woman should stop HT.
If hormone therapy is needed to control menopausal symptoms, then the most appropriate type, dose, route of administration, and duration based on goals of treatment and individual health risk should be determined. Potential benefits and harms should be periodically evaluated. For women who are less than 60 years old or less than 10 years past menopause, potential benefits are more.
Starting hormone therapy in women greater than 60 years or greater than 10-20 years past menopause is not recommended. In these women potential harms (e. g. Coronary artery disease, stroke, venous thromboembolism, dementia) are likely to exceed potential benefits. Health risks change over time.
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It exists in a variety of forms such as pills, gel, creams, lotions, sprays, and skin patches. The oral route is convenient but has an effect on fat metabolism and the coagulation system. Skin patches, gel, creams, and sprays avoid the potentially adverse effect on the liver and coagulation system. Vaginal estrogen comes in form of vaginal tablets, suppositories, creams, and estrogen rings. Progesterone can be administered in the uterine cavity with a device. It delivered much less progestogen in circulation thus reducing side effects. This not only provides contraception and control of troublesome bleeding but also provides endometrial protection during the perimenopausal period.
Types of Hormones
Estrogens are usually given for 3-6 months for hot flashes. Therapy is started with a minimal dose and gradually increased every 2-4 weeks to the effective level. While stopping estrogen is gradually reduced as with sudden withdrawal symptoms may recur. For women who have had a hysterectomy, estrogen alone is used. For women who have a uterus, progesterone is added because unopposed estrogen action increases the risk of endometrial cancer.
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Estrogen and progesterone
If therapy is to be continued for longer than 2-3 months, Progesterone should be added because of its protective action against endometrial cancer, osteoporosis, and hyperestrogenism. It may be given cyclically over a 28-day cycle (cyclical HT) of which 16-18 days estrogens alone first then estrogens and progesterone combined for 10- 12 days. It causes a normal menstrual cycle. Suitable for women during perimenopause or early postmenopausal period. estrogens and progesterone may be given Continuously (Continuous combined -HT) to post-menopausal women. This regimen does not cause menstrual bleeding.
Androstenedione and Testosterone are used in women who failed to respond to HT. Androgens are normally produced by ovaries and adrenal glands. The level falls to half after menopause. Androgens are thought to play a role in maintaining bone density and normal sexual and cognitive function in females. Their use is avoided because of side effects and possible complications.
Absolute Contraindications to Use Hormonal Therapy
In the following conditions, hormones should be avoided.
- Undiagnosed vaginal bleeding
- Breast cancer or endometrial cancer
- Active liver disease
- Uncontrolled hypertension
- Recent thromboembolism (VTE)
- Known thrombophilia (eg factor v Leiden)
- Otosclerosis (decreased hearing)
- History of cardiovascular disease, stroke, TIA, or diabetes.
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Relative Contraindications to Use Hormonal Therapy
Conditions in which hormones can be used with caution
- Large uterine fibroids
- Past history of benign breast disease
- Chronic stable liver disease
- Migraine with aura
- Increased Triglycerides > 400 mg/dl
- Active gallbladder disease
- Family history or past history of thromboembolism.
Side Effects of Hormonal Therapy
Side Effects of Estrogen
Side effects with HT are few and minor. Before prescribing HT it is ensured that there are no contraindications to HT and no serious side effects experienced in the past when on contraceptive pills such as venous thrombosis or migraine with aura. Most side effects can be managed with a change in dose, type, and route of administration of HT. Side effects observed due to estrogen are:
- Breast tenderness or swelling: Usually subsides within 4-6 months of use
- Leg cramps
- Dyspepsia and bloating
- Fluid retention
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Side Effects of Progesterone
- Fluid retention
- Breast tenderness
- Mood swings
Risks and Benefits of Hormonal Therapy
At present due to reanalysis of the data, newer studies, and a better understanding of the communication of risk, many women are using HT for Menopausal symptoms. Breast cancer attracts the most concern from patients and the media. Certain HT promotes the growth of pre-existing malignant cells rather than initiating tumors.
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Breast Cancer (with Estrogen-Progestin)
The risk of breast cancer is related to the duration of taking estrogen. Risk is less with short-term use (less than 5 years) and risk increases with 5 or more years of use. Combined estrogen and progestin regimen appears to increase risk more than only estrogen-only therapy. There is no increased risk found once the treatment stopped. Breast carcinoma risk is more for women who delay their first birth, obesity, and have a family history of carcinoma.
Endometrial Cancer (with Estrogen alone)
The risk of endometrial cancer tripled with estrogen-only therapy in short-term users (1-5years). Risk increases with prolonged use for 10 or more years. Risk remains elevated for 5 or more years even after stopping the treatment. No increased risk has been found with continuous-combined HT. The use of a progestogen that opposes the effects of estrogen on the endometrium eliminates the risk.
Cardiovascular Disease and Stroke
Estrogen decreases LDL and increases HDL cholesterol but it also has other unfavorable effects on the cardiovascular system, that as increasing triglycerides and promoting coagulation via its effects on coagulation factors. Risk likely higher with combined HT. Stroke incidence increases in older women. Timing of initiation of HT influence the association between therapy and heart disease. Estrogen may slow the early stages of atherosclerosis but have adverse effects on advanced atherosclerotic lesions. Women who have less arterial damage and start HT early after menopause have cardiovascular benefits with the use of hormone therapy.
The risk of venous thromboembolism is twice in HT users. The risk of VTE is more likely in the first year of use. It increases with increasing age, obesity and thrombophilia, previous history, and family history of thromboembolism. There is a 5% risk of recurrence. The influence of HT on the clotting system is similar to that of oral contraceptives. There is decreased risk of blood clots and stroke ( due to its avoidance of effect on the liver) with transdermal HT and low-dose estrogen pills.
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The risk of gallstones increases by 2-3 fold in HT users taking oral estrogen. The transdermal route does not seem to increase the risk. Risk increases with age and obesity.
Hormonal Therapy can be used if indicated in stable liver diseases but should not be used in presence of active liver disease. With stable liver disease, parenteral and dermal estrogen is prescribed to avoid hepatic metabolism with monitoring of liver functions.
Migraine may increase in severity and frequency in HT users. Conjugated estrogen is most commonly associated with an increase in frequency. A trail of hormones can be done if indicated. Modification in the dose of estrogen or its preparation may improve symptoms.
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Estrogen reduces or delays the risk of getting Alzheimer’s disease if started early after menopause. Reversal of cognitive function does not occur if the disease already is there. Currently, there is insufficient evidence to recommend the use of hormone therapy to prevent Alzheimer’s disease.
HT reduces the risks of colon and rectal cancer by 20 % when estrogen-progesterone combined therapy is used. This benefit was not observed after 7 years of using estrogen-only therapy.
Estrogen inhibits bone resorption thus slowing age-related bone loss. Estrogen therapy with or without progesterone rapidly increases bone mineral density and decreases the risk of spine and hip bone fractures. Hormone Therapy is not recommended as a first-line treatment or for preventing osteoporosis as there are other medications available that have fewer side effects. When osteoporosis is the only concern then hormones are prescribed only if :
- If there is a significant risk of osteoporosis
- If they do not want to take first-line drugs
- Age less than 60 or less than 10 years past menopause.