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Bioidentical Hormones

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Bio-Identical Hormones: Hormonal Replacement
By: Misty Sightler
PT 146
Mrs. Martin

Bio-Identical Hormones: Hormonal Replacement

The word bioidentical means that the hormones are exactly the same as the hormones that the human body produces. Bioidentical hormones have the same exact molecular structure as the hormones produced naturally within the body. The body does not distinguish between supplemental bioidentical hormones and the hormones produced within the body. As a result, bio-identical hormones are properly utilized, and are then able to be naturally metabolized and excreted from the body. The use of bioidentical HRT has increased during the last several years as women have sought out a more natural approach to restoring hormonal balance. Bioidentical hormones therapy is safe as long as the amounts of hormones used and the levels of hormones in the body are carefully monitored. Bioidentical hormones include estradiol, progesterone, testosterone, cortisol, human growth hormone, thyroxine (T4), and triiodothyronine (T3). I don’t recommend non-bioidentical chemicals such as medroxyprogesterone and norgestimate because they are not produced by the human body and because they have known side effects such as cancer, hypertension, depression, and fluid retention. They are more appropriately referred to hormone disrupting chemicals. Not all women experience hot flashes, night sweats, insomnia, or any of the other classical symptoms of perimenopause. However, sometimes there more subtle changes that occur, these may include decline in memory (“senior moments”), decreased libido or sexual satisfaction, skin changes, hair changes, vaginal dryness, and loss of sense of feminity
There are two main reasons for recommending bioidentical hormone replacement therapy: 1) Relief of symptoms, 2) Reduction of disease risk. We know that properly dosed and monitored bioidentical hormone replacement is a safe and effective therapy for relieving symptoms of perimenopause. We also know that the risk for heart disease, cancer, osteoporosis, and Alzheimer’s disease increases as people get older and their hormones levels decline. Young people with high hormone levels tend to be at very low risk for these health conditions. There are indications that bioidentical hormone replacement may reduce the risk for developing such health problems and allow people to have a better quality of life. Bioidentical hormone replacement therapy can be used for as long as a patient desires. Bioidentical hormone replacement therapy can be stopped at any time. This will return the patient to their previous (usually) hormone deficient state.
Numerous studies have demonstrated an increased risk of breast cancer with the use of non-bioidentical progestins. However, the use of bioidentical progesterone has not been associated with an increased risk of breast cancer. Quite the contrary, research has revealed that bioidentical progesterone decreases the risk of breast cancer. In a study published in the journal Breast Cancer Research and Treatment, 80,000 postmenopausal women using various forms of HRT were followed for more than 8 years. Women who used estrogen in combination with non-bioidentical progestins had a 69% increased risk of breast cancer, compared to women who had never used HRT. However, for women who used bioidentical progesterone in combination with estrogen, the increased risk of breast cancer was completely eliminated with a significant reduction in breast cancer risk compared with non-bioidentical progestin. Although several studies suggest that the oral route of administration of estriol appears relatively safe over the short term (e.g., less than five years), topical application is preferred for long-term use. For example, one study found an increased risk of endometrial atypical hyperplasia and endometrial cancer with oral use of estriol, but not with topically applied estriol over a five-year period. Compared with individuals who did not take estriol, those who took oral estriol for at least five years had a significantly greater risk of uterine cancer. Women using topical estriol for at least five years did not have any increased risk.
Bioidentical hormones are identical to hormones used in some commercial pharmaceutical preparations. Estradiol, for example, is available in pills (including Estrace®, Gynodiol®, and generics), transdermal delivery systems (Climara®, Alora®, Estraderm®, Vivelle®, and generics), vaginal creams (Estrace® and generics), and vaginal rings (Estring®) and Femring®). Progesterone is available in capsules (Prometrium®, Solvay Pharmaceuticals, Marietta, Ga, USA [marketed], manufacturer: Schering Plough) and vaginal gels (Crinone®, Serono Laboratories, Inc., Rockland, Mass, USA and Prochieve, Columbia Laboratories, Livingston, NJ, USA). Ironically, the estrogen in the best-selling hormone preparations Premarin®, PremPro®, and Premphase® (Wyeth, Philadelphia, Pa, USA) is derived from pregnant mare’s urine, an inarguably natural source. Currently, widespread commercial availability of individually tailored bioidentical hormone prescriptions is lacking. As a result, many physicians utilize compounding pharmacies to dispense bioidentical hormone prescriptions for their patients.
Bioidentical hormones are an unusual form of alternative medicine. Unlike dietary supplements, most orally administered hormones require a physician’s prescription. Despite the fact that these hormones are no more natural than (and in many cases are identical to) commercially available drugs, when formulated by a compounding pharmacy these preparations fall outside of the current realm of FDA regulation. No reliable data support the claim that bioidentical hormones are safer than other hormones, and natural, bioidentical, and compounded preparations must be assumed to have the same risks as commercial hormone preparations.
Commercial or compounded estrogen preparations should be effective for treating hot flashes or vaginal dryness, and oral micronized progesterone is acceptable as the progestogen portion of menopausal hormone therapy. Any estrogen, including estriol, should be opposed with an oral progestogen in nonhysterectomized women. Whereas some progesterone creams may provide some endometrial protection in some women, studies to date are not reassuring. Progesterone creams should not be relied upon to protect uterine endometrium from estrogen-induced stimulation. Oral progestogens with known effects are preferred.
Saliva testing for hormones has been promoted to individualize the dosing of bioidentical hormone treatment. It is not clear how best to correlate progesterone levels with endometrial effects, but it is clear that salivary progesterone levels are unreliable. Correlations between serum and salivary levels of reproductive hormones vary by hormone tested, time of day, diet, and type of assay. Also, serum levels may not reflect tissue levels.
Hormone tests are not indicated for menopausal symptoms because there is no correlation between hormone levels and symptoms. Salivary tests may be used to persuade asymptomatic women to use hormones, and may encourage symptomatic women to use higher doses than are necessary to treat symptoms. This would be expected to result in an unfavorable risk–benefit ratio. As Boothby et al. stated in an excellent review, “Although attractive on the surface, individualized NHT [natural hormone therapy] is an ill-conceived attempt to apply pharmacokinetic principles to drugs that do not meet the criteria for individualized dosing.”

References
JAMA. 2002 Jul 17;288(3):321-33. https://www.health.harvard.edu/newsweek/ What-are-bioidentical-hormones.htm.
Climacteric. 2002 Sep;5(3):229-35.
Lancet. 1999 May 29;353(9167):1824-8
Fertil Steril. 2003 Jan;79(1):221-2. Menopause. 2003 Jul;10(4):373-4.
Menopause. 2003 Jul-Aug;10(4):374-7.
College Pharmacy. Available at http://www.collegepharmacy.com/specializations/biest.asp. Accessed Jul 2005.
Premier Pharmacy. Available at http://premier-pharmacy.com/abouthrt3.html. Accessed Jul 2005. (PDF no longer available)
Women’s International Pharmacy. Especially Designed for Women. Youngtown, Ariz, and Madison, Wisc., USA: Women’s International Pharmacy; 8–9 April 2002.
Food and Drug Administration. Available via the internet at http://www.cfsan.fda.gov/~dms/cfsand04.html. Accessed 19 Sep 2006.
Hermann AC, Nafziger AN, Victory J, Kulaway R, Rocci ML, Bertino JS. Over-the-counter progesterone cream produces significant drug exposure compared to a Food and Drug Administration approved oral progesterone. J Clin Pharmacol. 2005;45:614–9. [PubMed]
Stanczyk FZ, Paulson RJ, Roy S. Percutaneous administration of progesterone: blood levels and endometrial protection. Menopause. 2005;12(2):232–7. [PubMed]

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