Bioidentical Hormone Therapy

Learn More About Bioidentical Hormone Therapy

After 40, birthdays aren’t as exciting as before. Increasing age has its downside, more so for women due to a constant decrease in their hormonal levels, tilting the balance scale to a lower level each year. Female hormones i.e. Estrogen and Progesterone are the secrets behind their youth, energy, menstrual cycles, libido, mood, and the list goes on and on…

Even men aren’t spared. Their secret hormone is Testosterone. In both men and women, hormonal imbalance reflects striking changes in their physical, emotional and sexual health. An Optimized and balanced hormonal level is the key to a happy and healthy life.

To keep the balance scale of key hormones neutral, hormone replacement therapy is the solution. Recently, bioidentical hormones have been introduced to serve as man-made substitutes of naturally occurring hormones. Up until a few years back, synthetic hormone replacement therapies were the only option, but with Bioidentical hormonal therapy (BHT), a natural solution to a natural problem has been devised.

bioidentical hormones

What are Hormones?

Before talking about bioidentical hormones, we must know what hormones are? Hormones are special chemical agents secreted by structures in our bodies, called glands. Hormones control almost all the body functions, from the brain to the digestive system and beyond, hence a variety of symptoms in case of imbalance. Widely known premenstrual symptoms like mood swings, breast tenderness, bloating, etc. and the notorious menopausal symptoms such as hot flushes, vaginal dryness, decreased libido, etc. have correctly been blamed upon hormones.

bioidentical hormone therapy

What can we do to maintain the hormonal levels?

Hormone substitutes can be given to prevent a hormonal imbalance. Either synthetic or bio-identical hormones.

What are bioidentical hormones?

As the name suggests, bio-identical hormones are identical copies of endogenous hormones (eg: 17-beta estradiol), so the body cannot distinguish between the two. The Endocrine Society defines bioidentical hormones as“compounds that have exactly the same chemical and molecular structure as hormones that are produced in the human body” (Julia A. Files, 2011). These are derived from plant and soy extracts (Julia A. Files, 2011) which are then modified structurally. A standard definition hasn’t been established yet, but it echoes the words: ‘plant-derived’, ‘natural’, ‘not artificial’ etc. This is in contrast to conventional hormone replacement therapy which is synthetic, thus not similar to endogenous hormones.

risks and benefits chart for bioidentical hormone therapy

Why bioidentical hormone therapy over conventional hormone therapy?

In 2002, the Women’s Health Initiative (WHI), concluded that the risks of conventional HT outweighed the preventive benefits. Two prime risk factors studied were: increase in cardiovascular consequences and a 26% rise in breast cancer risk. This conclusion was reached after a randomized trial was conducted over 10,000 women of ages between 50 to 79 years who were taking conjugated equine estrogens 0.625 mg with medroxyprogesterone acetate, 2.5 mg daily or placebo, orally (Endocrine Society, 2019). This, along with celebrity advocacy and media endorsement led to a 63% decrease in the prescription of conventional estrogen+progesterone. With more women seeking alternatives, bioidentical hormone therapy seemed a safer way to compensate for the decline in hormonal levels. Bioidentical hormone replacement therapy is being supported by claims of better efficacy and safer side effect profile, though none of the claims have yet been proven.

bioidentical hormones

Types and route of Bioidentical Hormones(BHT):

BHT is a combo of estrogen and progesterone (rarely testosterone). Currently, two categories of BHT are available. One is FDA approved, preformed formulation by drug companies, strictly monitored and regulated. The other is Compounded BHT (cBHT). Compounding is defined by the FDA as ‘the combining or altering of ingredients by a pharmacist, in response to a licensed practitioner’s prescription, to produce a drug tailored to an individual patient’s special medical needs.” Compounded BHT, in other words, it is a custom-made BHT, varying from patient to patient, thus neither pre-formulated nor approved by the FDA. A noteworthy point here is that there isn’t sufficient evidence supporting the use of compounded BHT is the presence of FDA approved BHT, as the latter is strictly regulated and scrutinized medically. Having said that, cBHT is attracting more women than FDA approved BHT due to cheaper prices and claims of better tolerability.

Formulations are available in the form of pills, transdermal patches, vaginal creams, vaginal rings micronized oral or vaginal progesterone. Oral bioidentical estradiol is first converted into estrone after passing through the liver. In the liver, it stimulates certain clotting factors, predisposing coagulation. On the contrary, liver is bypassed when Estradiol is given transdermally or vaginally, thus a lower risk of thromboembolism, also supported by a Case-control study (Canonico M, 2007 Feb 20;115(7):840-5.). The subcutaneous route (into subcutaneous abdominal fat) isn’t available in the FDA-approved BHT and is a less common method. The subcutaneous pellet is biodegradable but may have a prolonged stimulatory effect on the endometrium (Lynn Pattimakiel, 2011 December).

Benefits of bioidentical hormone replacement therapy?

Older men and postmenopausal women have lower levels of testosterone and estrogen (17-beta estradiol (E2)) respectively. This replacement therapy serves as a bridge to minimize the symptoms arising secondary to hormone depletion. Therefore, it helps to alleviate postmenopausal symptoms like:

  • reduces hot flushes, muscle pains, and body aches
  • reduces cardiovascular risk
  • improves osteoporosis
  • improves sleep
  • maintains libido and reduces vaginal dryness
  • helps with mood changes

Moreover, the doses can be customized. Since each body has a different level of decline in hormones and a unique response to replenishment, bioidentical hormone replacement therapy can be customized and tailored to meet the exact demands of a particular patient, in which case it’s called compounded BHT.

How soon does hormone replacement therapy show its effects?

HRT usually takes anywhere between a few weeks to three months. But if no improvement is seen even after four to six months of therapy, then a different combination of HRT may be tried.

Downside:

BHT has gained popularity in the name of safety and better tolerability when compared with conventional HT. The latter consists of estrogen (conjugated equine estrogens (CEE)), derived from pregnant mares’ urine (Lynn Pattimakiel, 2011 December), whereas the former has plant derivatives, one way or the other, neither of the two is completely natural as both have to be modified chemically (Lynn Pattimakiel, 2011 December). Lay press, media releases and non-medical entities have erroneously advocated BHT to be safer alternatives though there hasn’t been any trial to support this claim nor any studies have labeled BHT to be better than conventional HT in any regard. Undeniably, BHT has been approved by the FDA because it successfully relieves menopausal symptoms, not because of its hypothetical better side effect

profile. Apart from this, custom made i.e. compounded bioidentical hormones (cBHT) are a bigger threat at present, as these aren’t FDA approved, for one. Which in other words means, no strict regulations, no black box warnings on packaging, no compulsion to report adverse outcomes and last but not the least, no trials to prove its clinical effects. ( Harvard Women’s Health Watch, 2011) Secondly, cBHT is comparatively cheaper. Due to this, patients are more inclined to get their hands on cBHT under the misapprehension of buying a safer alternative. Having said that, due to lack of evidence, both the Endocrine Society and the American College of Obstetricians and Gynecologistshaveadvised against the use of cBHTwhenan FDA approved BHT formulation is available.(Endocrine Society, 2019)This conclusion was drawn after salivary, serum andurine testing.(American College of Obstetricians and Gynecologists., 2012). Therefore, physicians must exercise utter caution when dealing with the prescription and requirementof cBHT.

regulated versus customized compounded

Should tests be performed to check the therapeutic effects of BHT?

There is no standard set value for the level of hormones in postmenopausal women, nor is regular testing required to check if the woman has an optimal level. However, if required, levels can be tested on blood, urine or saliva. Some entities have promoted the idea of saliva testing to measure hormonal levels during compounded bioidentical hormone therapy. Firstly because saliva is easier to collect and test, secondly because it resembles ultrafiltrate of blood. However, results are highly variable, depending upon salivary flow, age of the patient, diet, time of the day, etc. thus unreliable. Moreover, no scientific evidence suggests the relationship between salivary hormone levels and menopausal symptoms, therefore, the FDA has advised against saliva testing. (Julia A. Files, 2011). Even blood tests cannot accurately reflect the hormonal level (Bioidentical Hormone Therapy, n.d.). Having said that, it is advisable to clinically judge the response rather than extensive lab testing.

Adverse effects:
Although hormonal replacement therapy helps with the symptoms of menopause and reduces the risk of osteoporosis,few side effects bag along too.Usually, these side effects improve or fade away with time.Common ones include:

  • weight gain (37.2%)
  • bloating (23%)
  • breast tenderness (19.2%).(Vigesaa KA, Downhour NP, Chui MA, Cappellini L, Musil JD, McCallian DJ., 2004).

Other side effects include:

  • Blurred vision
  • Tiredness,
  • Acne
  • Headaches
  • Indigestion, etc

Hormone replacement therapy, in general,increases the risk of breast cancer when used for prolonged periods. There is noresearch yet to explain the relationship between BHT and breast cancer,therefore, it will be safer to use the lowest doses for the shortest period of time. Moreover, doses should beadjusted according to the patient’schanging hormone needs.(Cleveland Clinic, 2014)

Conclusion:
It is imperative to mention that HRT alone cannot heal all the symptoms. HRT is to be backed up with balance nutrition, proper sleep cycle, and exercise routine.

If you are a victim of hormonal imbalance, gear up for a change by contacting The Health & Vitality Center for a step towards a happy and balanced life.

saliva test kit

References

Harvard Women’s Health Watch. (2011, September). Harvard Health Publishing. Retrieved from Harvard Medical School: https://www.health.harvard.edu/womens-health/bioidentical-hormones-help-or-hype

American College of Obstetricians and Gynecologists. (2012). American College of Obstetricians and Gynecologists. Retrieved from Compounded bioidentical menopausal hormone therapy. Committee Opinion No. 532: https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Compounded-Bioidentical-Menopausal-Hormone-Therapy?IsMobileSet=false

Bioidentical Hormone Therapy. (n.d.). Retrieved from North American Menopause Society: https://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy/what-is-hormone-testing-

Canonico M, O. E.-B. (2007 Feb 20;115(7):840-5.). Hormone therapy and venous thromboembolism among postmenopausal women: impact of the route of estrogen administration and progestogens: the ESTHER study. DOI: 10.1161/CIRCULATIONAHA.106.642280.

Cleveland Clinic. (2014). Retrieved from https://my.clevelandclinic.org/health/articles/15660-bioidentical-hormones

Endocrine Society. (2019, October). Compounded Bioidentical Hormone Therapy. Retrieved from Endocrine.org: https://www.endocrine.org/advocacy/position-statements//compounded-bioidentical-hormone-therapy

Julia A. Files, M. M. ( 2011, July). Bioidentical Hormone Therapy. MayoClinic Proceedings, PMCID: PMC3127562. DOI:10.4065/mcp.2010.0714 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3127562/#

Lynn Pattimakiel, M. N. (2011 December). 78(12):829-836. Cleveland Clinic Journal of Medicine. https://www.mdedge.com/ccjm/article/95466/womens-health/bioidentical-hormone-therapy-clarifying-misconceptions/page/0/2

Vigesaa KA, Downhour NP, Chui MA, Cappellini L, Musil JD, McCallian DJ. (2004). Efficacy and tolerability of compounded bioidentical hormone replacement therapy. Int J Pharm Compd. 2004 Jul-Aug;8(4):313-9. https://www.ncbi.nlm.nih.gov/pubmed/23924704

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