Compounded Hormone Basics

Hormone replacement therapy (HRT) is commonly used to treat menopausal symptoms such as hot flashes, vaginal dryness, mood swings, sleep disorders, decreased libido, and to decrease the risk of fractures secondary to osteoporosis. The terms “natural” or “Compounded Hormone Replacement Therapy” hormone mean that no matter what the precursor ingredient used in synthesis; the resulting molecular structure is identical to a hormone that human beings make in their bodies.

Until recently, HRT was thought to reduce the risk of heart disease and bone fractures caused by osteoporosis, in addition to treating common menopausal symptoms.  In the early 1990s, a group of investigators conducted a study known as the Women Health Initiative (WHI), to identify the benefits and risks of HRT specifically estrogen with or without progesterone. They found that while replacement did in fact decrease the incidence of colon cancer and fractures in those without a diagnosis of osteoporosis and improve menopausal symptoms, there was an increased incidence of thromboembolic disease, breast cancer, coronary artery diseases, and strokes.  The study was prematurely terminated and the investigators concluded that the risks of HRT outweigh its benefits.  Soon after that, the Heart Estrogen/progestin Replacement Study (HERS) confirmed the WHI’s findings and concluded that HRT had no protection against coronary artery disease. Both studies used synthetic hormones (Premarin® and PremPro®) whose molecular structure was not identical to those found in the human body.

The WHI study raised several safety concerns regarding the use of synthetic hormones in HRT.  As a result, a trend promoting the use of hormones that are structurally identical to those actually found in the body has begun.  These hormones are known as “Compounded” hormones, and they are thought by many to have fewer side effects than the synthetic hormones which contain side chains and are not identical to those hormones found in the body.  Compounded Hormone Replacement Therapy (CHRT) goals include relief from the traditional menopausal symptoms, protection from conditions that natural hormones usually protect against, and establishment of hormonal balance.  The hormones are primarily derived from the yam and soybean plants before being altered in the lab to create the compounded hormones.  The term “Compounded Hormones” is not recognized by FDA, and there is no data on the efficacy or safety of compounded hormones.

Hormones commonly used in CHRT include estrogens (estrone, estradiol and estriol), progesterone, and androgens. The estrogens are thought to relieve menopausal symptoms, such as vaginal thinning and dryness, depressed mood, poor energy levels, and sleep problems.  The normal balance of estrogens in the female body is 10% estrone, 10% estradiol, and 80% estriol, but the actual levels fluctuate.  Estrone (E1) is the main estrogen produced in the body after menopause.  Estradiol (E2) is the most potent of the estrogens and is the primary estrogen produced before the onset of menopause.  Estriol (E3) is believed to protect against breast cancer and is produced in higher concentrations during pregnancy.  It also alleviates several vaginal and urinary symptoms of menopause.  Premarin® (Wyeth) is a synthetic estrogen product that is extracted from the urine of pregnant mares, and sometimes referred to as conjugated equine estrogens.  Premarin® contains estrone and at least 10 other estrogens (some sources claim as much as 100 estrogens) not found in the human body.  Estrone comprises 75% of Premarin®, much more than the amount naturally found in the body.  Estrogen is given unopposed by progesterone usually only in cases of hysterectomy; otherwise, estrogen is given with progesterone.  Commonly prescribed compounded formulations include Bi-Est, which is commonly used and comprised of estriol (80%) and estradiol (20%), and Tri-Est, containing all three naturally occurring estrogens in concentrations naturally found in the body.

Compounded hormones are compounded at ProCompounding Pharmacy in Johnson City, TN.  Women usually hear about the option by word-of-mouth and after consulting with their physician and obtaining a prescription, they come into the pharmacy to consult with a pharmacist by appointment.  The pharmacist speaks with the patient about their current symptoms, current HRT method, and past medical history.  While there are saliva and blood tests to determine hormonal levels, developing the proper individualized compound for each patient is guided by symptoms. When starting a new hormone regimen it usually takes 1-3 months to establish the correct dosage and combination of hormones.

Although the use of compounded hormones is increasing in popularity, and the idea of replacing the body’s hormones with identical hormones seems logical, there have not been large-scale studies done on their safety, efficacy, or long-term effects.  Therefore, caution must be exercised in prescribing and using compounded hormones in hormone replacement therapy.

Functions of Progesterone:
Natural Progesterone is synthesized from yams and soybeans.
*Counteracts estrogen’s tendency to induce excess growth in the endometrial lining of the uterus.
*Builds new bone tissue leading to increased bone mass and density.
*Assists in raising HDL – cholesterol levels (if combined with estrogen therapy)
*Synthetic progesterone has an overall negative effect on HDL – cholesterol levels.

Symptoms of Low Progesterone:
*Headaches    *Low sex drive
*Anxiety    *Moodiness
*Swollen breasts    *Depression
*Fuzzy thinking    *Irritability
*Food cravings    *PMS symptoms
*Water retention    *Insomnia
*Cramps    *Emotional swings
*Painful breasts    *Weight gain
*Painful joints    *Inability to concentrate

Functions of Estrogens:
*Promotion and growth of specific cells in the body.
*Responsible for development of most secondary sexual characteristics of the female.
*Slows bone loss…estrogens do not assist in the formation of new bones.
*Improves vasomotor symptoms (hot flashes, night sweats, etc.)

Components of Human Estrogen:
*Estrone (10-20% of circulating estrogens) = E1:
Implicated in hormone-mediated cancers.
*Estradiol (10-20% of circulating estrogens) = E2
*Estriol (60-80% of circulating estrogens) = E3
Thought to be anti-carcinogenic; most protective estrogen ever tested against breast cancer.
Natural estrogens are synthesized from soybeans.

Symptoms of Low Estrogen:
*Hot Flashes    *Night Sweats
*Shortness of breath    *Heart palpitations
*Sleep disorders    *Dry hair/Hair loss
*Vaginal dryness    *Mood swings
*Anxiety    *Headaches
*Short-term memory loss    *Depression
*Dry skin    *Painful intercourse
*Frequent urinary tract & yeast infections

Functions of Testosterone:
Natural testosterone (when replacing inadequate testosterone levels) can:
*Improve mental alertness and mood.
*Make bones stronger (increase calcium retention)
*Revive a lagging sex life.
*Improve hot flashes that have not responded to estrogen alone.
*Improve breast tenderness.

Functions of DHEA:
*Often referred to as the “mother” hormone because it’s more prolific than any other hormone produced by the adrenal glands.
*Restoring DHEA to youthful levels may help safely boost estrogen and testosterone levels.
*Some DHEA is metabolized into testosterone and estrogens (amount is patient-specific), but unmetabolized DHEA may have independent effects including prevention of heart disease, cancer, and weight loss.

What are Compounded Hormones?

Compounded hormones have the exact chemical structure as hormones that are made by the human body. The key to natural or compounded versus synthetic is the molecular structure of the hormone.  In order for a replacement hormone to fully replicate the function of hormones that are naturally produced and present in the human body, the chemical structure must match the original.

Are Your Hormones Out of Balance?

Hormones affect many areas of your health, including your mood, your sleep habits, sexual function and overall well-being. If you hormones become unbalanced, whether due to menopause or other factors, you may feel like a stranger in your own skin. However, compounded (natural) hormone replacement therapy (CHRT) is a way to restore balance and help you feel like yourself again.

Hormone Therapy Designed Specifically For Your Body

Natural Hormone Therapy can be used to treat a variety of conditions that women of all ages may experience, including:
-Pre-Menstrual Syndrome (PMS)
-Irregular Menstrual Cycle
-Post-Partum Depression
-Weight Gain
-Fibrocystic Breasts
-Sleep Disturbances
-Hot Flashes
-Night Sweats
-Decreased Libido
-Painful Sexual Intercourse
-Vaginal Dryness