Bio-identical Hormone Replacement Therapy                                       

                                                        Believing in the Wisdom of the Human Body

                                                                                    Overview

What is a natural or bio-identical hormone?

Bio-identical hormones are exact duplicates of those that are natural to, or occurring in the human body.  ANatural@ or Abio-identical@ have to do with the chemical structure of a hormone and not it=s source.  We do NOT define natural as coming from a plant (ex. phytoestrogens) or animal (ex. Premarin7).   Synthetic hormones are not found in humans, and are not identical in structure or function to the bio-identical hormones they are intended to replace.

Examples of bio-identical hormones include:

  • estriol, estradiol, and estrone
  • progesterone
  • testosterone
  • DHEA

Is there a difference between bio-identical and synthetic hormones?

YES!! Bio-identical hormones cause the same response as your own hormones.  Synthetic hormones cause some of the same actions, but because they have been chemically altered may have different and/or unintended effects.  Our body recognizes a bio-identical hormone as a Afriend@, someone it has seen before and knows what to do with.

Why should I consider bio-identical hormone replacement therapy anyway?

Even before menopause, certain symptoms may be signs that hormonal adjustments are needed (breast tenderness and fibrocystic breast disease, migraines and headaches, bloating, mood swings, anxiety, and hot flashes, for example).Use of bio-identical hormones in the proper doses will not only control menopausal and peri-menopausal symptoms, but will greatly improve quality of life both short-term and long-term.  Protection against heart disease, reduced risk of breast cancer, improved cholesterol and lipid profiles, and osteoporosis prevention are all valid reasons for monitoring hormone levels and using individualized bio-identical hormone replacement therapy (HRT). 

Are there side effects associated with use of bio-identical hormones?  Can these hormones increase the risk of breast cancer, stroke or heart disease?

Because bio-identical hormones are just like the ones produced by your body, there are relatively few side effects.  Women in general tolerate bio-identical HRT better than synthetic hormone therapy.  The risks identified are primarily associated with excess estrogen levels, whether the excess occurs naturally or as a result of hormone replacement therapy, even bio-identical hormones.  The body=s natural mechanism for moderating estrogen includes progesterone, and studies have demonstrated its effectiveness in decreasing the risks of breast cancer and cardiovascular disease.  We are confident that it is Asafer@ to restore hormone balance with bio-identical hormones than to leave the body with a state of deficiency or excess.  Bio-identical hormones must be dosed properly for each individual in order to avoid adverse effects.

Should bio-identical hormone replacement therapy (HRT) be individualized?

YES!! HRT is not a Aone size fits all@ situation.  A woman=s need for hormones is as individual and unique as she is.   The few selected strengths of hormones manufactured by pharmaceutical companies do not meet the needs of every woman.  Bio-identical hormones can be compounded on prescription to meet your exact needs.  Ask our pharmacists for more information!

Should I quit or change my hormone replacement therapy?

Always consult your healthcare provider before stopping any medication, including hormones.  Discuss your situation and the options available to you with both your physician and pharmacist.  You do have choices regarding HRT and we encourage you to learn as much as possible about the pros and cons of the different options before making your decision.  Our pharmacists are knowledgeable and experienced with bio-identical hormones, and are available to answer more detailed questions.

So, how do I get started on bio-identical HRT?

Review the information in this handout.  Talk with your physician.  Often one cannot determine the types and amounts of necessary hormones by symptoms alone.  We now have the ability to tailor bio-identical HRT more precisely by measuring active hormone levels in saliva rather than in blood.  Our pharmacists can speak with you about your symptoms and what hormone levels might be checked.  Saliva test results can be interpreted for you taking into consideration your symptoms, history and needs.  A recommendation for possible therapy, which might include both prescription and OTC products, can be developed for you and your provider to consider.


Estrogen

There are 3 types of estrogen natural to the human body:

                Estriol (E3)

  •  about 80% of circulating estrogen prior to menopause

  • weakest estrogen, not stimulating to breast and uterine tissues

  • produced in high amounts during pregnancy

  • excellent for vaginal dryness

  • available through compounding pharmacies

                Estradiol (E2)

  • about 10% of circulating estrogen prior to menopause   

  • most potent human estrogen; stimulating effect on breast and uterus

  • deficiency of excess is often related to symptoms

  • precursor to estrone and estriol

  • available through compounding pharmacies, and commercially as tablets, patches, and vaginal products

                  Estrone (E1)

  • about 10% of circulating estrogen prior to menopause 

  • most abundant estrogen after menopause due to formation in fatty tissues   

  • can be metabolized from estradiol    

  • available through compounding pharmacies

 

Replacing estrogen in the same percentages as produced naturally is recommended.  These 3 human estrogens are often compounded together as:

Triestrogen: 80% estriol, 10% estradiol, 10% estrone

Biestrogen: 80% estriol, 20% estradiol

 

Conjugated Estrogens

 

Estriol

 

Tri-Est or

Bi-Est

 

Estrace

(Estradiol)

 

Estradiol

Transdermal

 

Estropipate

(Ogen)

 

Esterified

Estrogens

 

0.625 mg

 

 

5.0 mg

 

2.5 mg

 

1.0 mg

 

.05 mg/24hrs

 

.075 mg

 

0.625mg

 

 

Benefits:   When prescribed for menopause, estrogen can assist with hot flashes, night sweats, vaginal dryness, sleeplessness, mood and mental clarity.  Cardiovascular benefits include increasing HDL and decreasing LDL cholesterol.  Estrogen is important for preventing bone loss.

 

Side Effects:  Are usually not noticeable if the lowest possible dose and the right type of estrogen is used, and especially if the estrogen is balanced correctly by bio-identical progesterone.  Side effects may include headaches, breast tenderness, nausea, water retention, and anxiety or irritability.  An increased risk of breast cancer may be decreased by balancing with progesterone.

 


Ten Reasons Why Your Hormones Are Imbalanced

Estrogen dominance (too much estrogen in relation to progesterone) can be created by both an excess of estrogen and a deficiency of progesterone. 

Too much estrogen may be caused by:

1.  Foods that have hormones added to them, such as commercial meat, milk, eggs, and dairy products

2.  Herbs that have an estrogenic effect in the body, such as licorice, black cohosh

3.   Birth control pills that contain estrogen

4.   Environmental toxins that mimic the actions of estrogen (known as xenoestrogens); the largest source of xenoestrogens is pesticides

5.   Exposure to radiation, which increases estrogen levels in the blood

6.   Chronic constipation which interferes with the body=s ability to eliminate estrogen properly; estrogen then builds up in the colon and can be reabsorbed by the body

7.    Estrogen supplements as part of a hormone replacement therapy for menopausal symptoms

Too little progesterone may be caused by:

1. Birth controll pills or HRT with synthetic progestins, which decrease the body's natural production of progesterone

2. Chronic stress

3. Lack of insufficient ovulation (which is a natural consequence of going into menopause)


Progesterone: Nature's Anti-Estrogen

Progesterone controls and balances the effects of estrogen in the body.  It is produced during the last half of the menstrual cycle, after ovulations, and is essential for a pregnancy to occur and be carried to term.  Progesterone can be deficient during several stages of a woman=s life, including during PMS, peri-menopause and beyond  menopause.  We are noticing that progesterone production tends to decline long before periods actually stop, during the peri-menopausal years, as the ovary ages.  It is this drop in progesterone that often causes the first menopausal symptoms, even while still menstruating.  This lack of progesterone to balance estrogen in the body is known as Aestrogen dominance.@  Estrogen dominance can be defined as having normal or high levels of estrogen in the absence of sufficient progesterone to balance estrogen effectsProgesterone - estrogen balance is essential in eliminating menopausal symptoms, and in preventing breast cancer.

 

Much confusion exists between the hormones progesterone and the synthetic progestins.  Unfortunately, the two terms have often been mistakenly used interchangeably, even in the scientific literature.  There are vast difference between these hormones, as noted in the comparison chart on the next page.  The recent Women=s Health Initiative study with Prempro7 that was halted in July 2002, as well as previous studies reported on in the Journal of the American Medical Association and the Lancet, have reported an increased risk of breast cancer when estrogen is combined with a synthetic progestin.  Bio-identical progesterone is completely different, and plays many important roles in breast cancer prevention.  Progestins tend to cause many of the same menopausal symptoms women seek to relieve; progesterone is well-tolerated and can often be used alone to control menopausal symptoms.  Side effects can occur with excessive doses, but are usually not problematic with normal physiologic doses.

 

Do you need progesterone if you have had a hysterectomy?  Yes.  Progesterone would not be necessary if the intent of using it was merely to slough off endometrial tissue.   However, a May 2000 study by Mayo Clinic researchers determined that there were impressive improvements in quality of life issues such as hot flashes, menstrual problems, sexual functioning, anxiety and depression with bio-identical progesterone.  A recent study by Leonetti and Anasti noted an 83% improvement in hot flashes in postmenopausal women as compared to placebo.  These are important issues for women with and without a uterus.

 

Progesterone is not as well-absorbed orally as topically.  More than 90% of an oral dose can be lost to metabolism, depending on the type of oral dosage form.  Topical dosing via cream or gels provides more efficient absorption, and lower doses can be used because of bypassing liver and intestinal metabolism of the hormone.

 

 

                 Bio-identical Progesterone

 

                     Synthetic Progestins

 

compounded prescription creams,gels, injections, suppositories, etc.

 

medroxyprogesterone acetate

     Ex. Provera7, Cycrin

 

over the counter topical cream

 

norethindrone acetate Ex. FemHRT7

 

Crinone7 vaginal gel

 

norgestrel (birth control pills)

 

Prometrium7 (in allergenic peanut oil)

     

 

 

 



Comparing Progesterone and Progestins

 

 

         Condition/Effect

 

           Progesterone

 

              Progestins

 

Increases sodium & water in cells

 

                       

 

                       X

 

Causes loss of minerals and electrolyes from cells

 

 

 

                               X

 

Causes depression

 

 

 

                               X

 

Causes facial hair & scalp hair loss

 

 

 

                               X

 

Elevates blood sugar

 

 

 

                               X

 

Causes acne and skin rashes

 

 

 

                               X

 

Increases risk of birth defects

 

 

 

                               X

 

Increases risk of blood clots

 

 

 

                               X

 

Protects against endometrial cancer

 

                               X

 

                               X

 

Protects against breast cancer

 

                               X

 

                               X

 

Normalizes sex drive

 

                               X

 

 

 

Regrowth of scalp hair

 

                               X

 

 

 

Improves lipid levels

 

                               X

 

 

 

Improves in vitro fertilization

 

                               X

 

 

 

Assists in new bone formation

 

                               X

 

                            some

 

Decreases risk of coronary artery spasm

 

                               X

 

 

 

Increases action of thyroid hormone

 

                               X

 

 

 

Prevents implantation of fertilized egg

 

                               

 

                               X

 

Essential for successful pregnancy

 

                               X

 

 

 

Essential for normal nerve function

 

                               X

 

 

 

Restores normal sleep patterns

 

                               X

 

 

 

Building block for other hormones

 

                               X

 

 

 

Relives hot flashes

 

                               X

 

                           slightly

                                                                                         

Adapted from What Your Doctor May Not Have Told You About Peri-Menopause, John R. Lee MD

Medroxyprogesterone acetate package insert

 


 

Effects of Estrogen and Progesterone

How Hormonal Balance Works

 

                      Progesterone Effects

 

Maintains secretory endometrium

 

Protects against breast fibrocysts

 

Helps use fat for energy

 

Natural diuretic

 

Natural anti-depressant

 

Facilitates thyroid hormone action

 

Normalizes blood clotting

 

Restores libido

 

Normalizes blood sugar levels

 

Normalizes zinc and copper levels

 

Restores proper cell oxygen levels

 

Prevents endometrial cancer

 

Helps prevent breast cancer

 

Decreases risk of ovarian cancer

 

Stimulates osteoblast bone building

 

Precursor of cortisol (stress support)

 

 

 

 

Estrogen Effects

 

Creates proliferative endometrium

 

Breast stimulation

 

Increased body fat

 

Salt and fluid retention

 

Depression and headaches

 

Interferes with thyroid hormone

 

Increased blood clotting

 

Decreases libido

 

Impairs blood sugar control

 

Loss of zinc and retention of copper

 

Reduced oxygen levels in all cells

 

Increased risk of endometrial cancer

 

Increased risk of breast cancer

 

Increased risk of ovarian cancer

 

Slightly restrains osteoclast function

 

Increased risk of gallbladder disease

 


 

Symptoms Related to Estrogen and Progesterone

How Hormonal Balance Works

 

Estrogen Deficiency

 

Hot flashes

Night Sweats

Vaginal Dryness

Anxiety

Short term memory loss

Sleep disturbances

Frequent urinary tract infections

 

 

 

 

 

 

 

 

 

 

Estrogen Excess/Dominance

 

Headaches

Water Retention

Nervous/irritable/anxious

Moods swings (PMS)

Breast tenderness

Fibrocystic breast disease

Uterine fibroids

Weight gain (hips)

Hypothyroid symptoms

Bleeding Irregularities

 

Progesterone Deficiency

(Estrogen Dominance)

 

Headaches

Water Retention

Nervous/irritable/anxious

Mood swings (PMS)

Breast tenderness

Fibrocystic breast disease

Uterine fibroids

Weight gain (hips)

Hypothyroid symptoms

 

 

 

 

Progesterone Excess

(from too much replacement)

 

Lethargy or sleepiness

Water retention

Gastrointestinal bloating

Breast swelling

Mild depression

Foggy thinking

Exacerbates estrogen deficiency

 


Testosterone

Believe it or not . . . women make and need testosterone too!  Testosterone levels may decline during menopause, and usually drop by about 50% after a total hysterectomy (removal of ovaries and uterus).  It is important to check your testosterone level before supplementation is started to avoid side effects.  Topical is a more efficient route for dosing than oral.  The synthetic methytestosterone (in Estratest7, for example) is not usually recommended due to the extra stress it places on the liver and increased possibility of side effects.  Adverse effects of excessive testosterone include oily skin, acne, hair growth, scalp hair loss, and irritability.


 

Testosterone Effects

Enhances libido

Enhances bone formation

Improves energy level

Improves mental alertness

Improves sense of well-being

Maintains muscle tone and  skin

 

 

 

Deficiency Symptoms

Low libido

Bone loss

Fatigue                      

Memory lapses

Depressed feelings

Vaginal dryness

 

DHEA (dehydroepiandrosterone)

Other hormones are metabolized from DHEA.  Because of this precursor role, it is often referred to as the Amother hormone.@   It is a hormone produced by the adrenal glands.  It assists with menopausal symptoms, bone strength, stress, and some consider it to have anti-aging effects.  The effects and deficiency symptoms can be similar to those for testosterone.  Side effects, including heart palpitations, have been reported primarily due to us of higher than necessary dosage strengths that are available over the counter.  Usually an oral dose of 5 - 10mg is a good starting point for a woman, and 10-20mg for a man.  Baseline levels should always be assessed before assuming supplementation is needed.


Dosage Forms

Compounding of bio-identical HRT allows complete flexibility of dose and dosage form.   Prescriptions can be tailor-made to each individual=s unique needs.  Dye-free, preservative-free, and lactose-free preparations are among some of the many options available to you.

 

Oral Dosage Forms

<     Immediate Release Capsules

<     Sustained Release or Delayed Action Capsules

<     Oil Filled Capsules

<     Enteric Coated Capsules

<     Suspensions

 

Topical Dosage Forms

<                    Creams or Gels

<                    Ointments

 

Rectal Dosage Forms

<     Suppositories

<     Enemas

 

Vaginal Dosage Forms

<     Suppositories

<     Creams

<     Gels

<     Capsules

 

Sublingual Dosage Forms

<     Troches / Lozenges

<     Tablet Triturates

<     Drops

 

Injectable Dosage Forms

<     Oil Solutions

 

Nasal Dosage Forms

 

Ophthalmic Dosage Forms

 


 

Hormone Saliva Tests

Frequently Asked Questions

 

What is a hormone saliva test?

The saliva test measures the active level of hormone in the body.  This level is very closely related to the menopausal symptoms that a person may be experiencing.  Both men and women can be tested.  This is different and more specific than a blood test.  This test can be used to establish baseline levels and to monitor hormone replacement therapy (HRT).

 

How much does a saliva test cost?

The cost depends on the number of hormones tested.  Our basic panel of 5 hormones is $150.  This measures estradiol, progesterone, testosterone, DHEA and a morning cortisol level.  Individual hormones cost $40 each. The decision to test for specific hormones depends on a person=s symptoms, history, and hormones in use.  This cost is separate from that of HRT that may be needed.

 

How is the test done?

The saliva is collected in a test tube first thing in the morning, within half an hour of arising.  You must not brush your teeth, eat or drink anything but water prior to the test.  It is not one Abig spit@.  As saliva is produced, you just spit it into the tube instead of swallowing.  It may take 15 minutes or up to 2 hours to collect.

 


How is the saliva stored after collecting?

The saliva is kept at room temperature.  The specimen will stay stable for several days.

 

Is the test done at any special time of the month?

If a woman still has periods, the test is usually done on cycle day 19, 20 or 21 (day 1 is the first day of your period).  Otherwise, any day may be fine, but it will depend on what hormones are being taken and the reason for testing.  A pharmacist will guide you on the specifics.

 

Do I have to stop my hormones to take the test?

You may continue to take your hormones but the timing of the test in relation to when a dose of a hormone is taken is important.  The pharmacist can answer more specific questions.

 

Can my usual lab do a saliva test?

At this time only certain labs are equipped to process this test.  We prefer to use ZRT Laboratory because of their accuracy and reliability.

 

How do I ship the saliva to the lab?

The price of shipping is included when the kit is purchased.  The collected saliva and requisition form are packaged in a UPS envelope and dropped off at any location that accepts UPS.

 

                                                      How long before my results are back?

Results are typically back in about 2-3 weeks.  We will contact you by mail or by phone when the results are in.  You will get the original copy of the results, and we can fax a copy to your healthcare provider and assist with interpretation.

 

Is the test covered by insurance?

A saliva test does not require a prescription; it is an over the counter test kit.  Some insurance companies cover hormone saliva testing when ordered by a physician.

 

Can you explain the insurance process?

 

1.     A prescription from a physician usually helps.  The doctor will need to provide diagnosis (ICD-9) code for billing purposes.

 

2.     The insurance company will need these CPT codes to classify the laboratory tests: