Hormone replacement therapy

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1. By: S. Arunkumar , IInd Pharm D, JKKN College of Pharmacy, Kumarpalayam . Hormone Replacement Therapy:

2. What is the Hormone? A Hormone is a class of signaling molecules produced by glands in multicellular organisms that are transported by the circulatory system to target distant organs to regulate physiology and behavior .

3. Hormone Replacement Therapy : Definition : Hormone replacement therapy (HRT), also known as menopausal hormone therapy (MHT) or postmenopausal hormone therapy (PHT, PMHT), is a form of   hormone therapy mostly used to treat  symptoms associated with female   menospause . Types: Based on the different combinations and delivery of the hormones, they are classified as Estrogen-only HRT : Women who have had a hysterectomy where their uterus, or womb, and ovaries have been removed do not need progesterone.

4. (ii) Cyclical, or sequential HRT:   Women who are still menstruating but have perimenopausal -like symptoms can use this. Cycles may be monthly, with an estrogen plus progestogen dose at the end of the menstrual cycle for 14 days, or a daily dose of estrogen and progestogen for 14 days every 13 weeks. Continuous HRT : This is used during postmenopause . The patient takes a continuous combination of estrogen and progestogen . Long-cycle HRT : This causes withdrawal bleeds every 3 months. Its safety has been  described as "questionable .“

5. Local estrogen : This includes vaginal tablets, creams, or rings. It can help with urogenital problems, including dry vagina and irritations. Most of the dosage form of HRT : ( i ) Creams or gels (ii) Vaginal rings (iii) Tablets (iv) Skin patches . Benefits of HRT: ( i ) Hormone replacement therapy is used to help balance estrogen and progesterone in women around the time of menopause. (ii) It can also reduce the risk of Oestoporosis . (iii) Hormone replacement treatments are also used in male hormonal therapy and treatment for individuals who undergo a sex change.

6. (iv) Past studies have suggested a link with Cancer, but this is still being investigated. (v) It may help keep skin young, but it cannot reverse or delay the overall effects of aging. (vi) Decreased incidence of colon cancer (vii) Possible decreased incidence of Alzheimer’s disease (viii) Possible improvement of glucose levels Recent studies of HRT: ( i ) A Report published in  The BMJ  in 2012 Concluded that HRT may or may not increase the risk of breast cancer . “Recent studies have suggested that it may: (ii) Improve muscle function (iii) Reduce the risk of Heart Failure and Heart attack.

7. (iv) Lower Mortality  in younger, postmenopausal women (v) Be “ Quite Effective” in preventing skin aging. (vi) Decreased risk of colorectal cancer by 37%. (vii) Decreased age related tooth loss. (viii) Decreased age related macular degeneration. (ix) Delay of onset and progression of Alzheimer’s disease when started early. Indication: ( i ) Premature ovarian failure. (ii) Gonadal dysgenesis . (iii) Surgical or radiation menopause. (iv) For the treatment of menopausal symptoms where the risk : benefit ratio (v) For women with early menopause until the age of natural menopause (around 51 years) (vi) W oman who had her uterus removed (Hysterectomy) Contraindication: For Women : ( i ) History of prior heart attack or stroke and/or increased risk for vascular disease. (ii) Unexplained vaginal bleeding

8. benefit ratio is favorable, in fully informed women. (v) For women with early menopause until the age of natural menopause (around 51 years). (vi) Active or past breast cancer gall bladder disease (vii) Fibrocystic breast disease (viii) Active liver disease (ix) Endometrial cancer. Effects of menopause: ( i ) Vaginal dryness (ii) Bone thinning, (iii) Urinary problems

9. (iv) Thinning hair (v) Sleep problems (vi) Hot flashes and night sweats (vii) Moodiness (viii) Lower fertility (ix) Irregular Periods (x) Concentration and memory difficulties. (xi) Smaller breasts and an accumulation of fat in the abdomen. Contraindication: ( i ) Hypertension Or High Blood Pressure. (ii) Severe Migraines. (iii) Thrombosis or blood clots

10. (iv) Stroke (v) Heart Disease (vi) Endometrial, ovarian or breast cancer. Non – Pharmacological Symptoms : A woman who is experiencing perimenopause can use alternative ways to relieve symptoms. ( i ) Reducing consumption of caffeine, alcohol, and spicy food (ii) Not smoking (iii) Exercising regularly (iv) Wearing loose clothing (v) Sleeping in a well ventilated, cool room (vi) Adding a fan to the bedroom or cooling gel pad or pillows

11. What is the major cause to administrated the Hormone Replacement therapy? Since estrogen deficiency is a major cause of the long-term complications of the menopause, estrogen replacement is the rational treatment to address the cause of the problems after menopause .But as there are limitations of estrogen therapy as HRT, some other drugs are also used besides estrogen

12. Estrogens: Oral: - Conjugated equine estrogen (CEE): 0.625 mg ( Estrone Sulphate + equilin sulphate +17 d dihydro equilin ) Example: ( i ) Estradiol valerate (1, 2, 4 mg). (ii) Estrial succinate (1, 2 mg). Transdermal : - Estradiol Patches: 25 micro gm, 50 micro gm / 24 hour twice weekly. Gel : 75 micro gm / 24 hours daily . Sub cutaneous implant ( estradiol ): - 25 / 50 / 100 mg. - 6 monthly. Vaginal: cream: Estrogens D

13. Progestins : Oral route –. Norgestrol : 150 mg /day. Micronised progesterone: 200 mg /day. Dydrogesterone : 20 mg / day . Medroxy progesterone acetate: 10mg/day. Norethisterone acetate : 0.7 – 2.5 mg/ day. Hormone releasing intra uterine system –. Levonorgestrel : 20 mcg / day . Progestasert : 65mcg / day. Vaginal: Natural progesterone gel / pessary . Transdermal :- sequential / continuous patch

14. Tibolone :- MOA: Synthetic steroid, tissue specific HRT.2 hydroxy metabolites are estrogenic D 4 isomer binds to progesterone & androgen receptors Addition of progesterone not required . Example: Tibella - PO Adults - 2.5mg oral. Androgen:- Oral Tablets Example: Anadrol 50 (Pro) – PO Adult – 50mg – BD. • Implants - Pellets of 100 mg testosterone.

15. Regimens : Estrogen alone: in post hysterectomy cases E + P :- Cyclic sequential: E on day 1-25; P on day 14 –25 (for climacteric patients with intact uterus ) Continuous sequential: E daily; P for 12 days at 16 days interval (for post menopausal patients with intact uterus) . Continuous combined: E + P taken daily Progesterone alone: Cyclic / continuous Estrogen + Progesterone + Androgen

16. Reference: https://www.slideshare.net/rajud521/harmone-replacement-therapy . https://www.slideshare.net/obgymgmcri/hrt-60841680 . PEER GROUP DISCUSSION ON HORMONAL REPLACEMENT THERAPY PRESENTED BY MS. SANTOSH KUMARI – Slideshare . https://www.slideshare.net/arshadchemist1/hormones-43307402 . https://slideplayer.com/slide/13515640/ . https://en.wikipedia.org/wiki/Hormone_replacement_therapy . https://my.clevelandclinic.org/health/articles/16979-estrogen--hormones Used database Drugs.com, Micromedix . 9. Textbook of Pharmacotherapy: A Pathophysiologic Approach, 9 edition Joseph T. Dipiro , Robert L. Talbert. 10. Textbook of Pharmacological approach of Therapeutics, Goodman & Gilman's - 12 th edition.