Lynn’s Pharmacy opinions on: Bio-identical Hormone Replacement TherapyPosted: October 27, 2011
Lynn’s Pharmacy opinions on:
Bio-identical Hormone Replacement Therapy
Hormone replacement therapy (HRT) has been commonly used in traditional medicine for the past fifty years to treat menopausal symptoms such as hot flashes, vaginal dryness, mood swings, sleep disorders, decreased libido, and an increased risk of fractures due to osteoporosis. Hormones used in HRT include estrogen and progestin (a synthetic progesterone). Some women, usually those who have had their uterus removed, received estrogen-only therapy. Common examples of HRT therapy include Premarin®,Prempro® Climara®, Estraderm®, Provera®, and Activella®.
Until recently, HRT was taught to physicians, pharmacist and patients that to reduce the risk of heart disease and bone fractures caused by osteoporosis, in addition to treating common menopausal symptoms, hormones were necessary and prudent. In the early 1990s, a group of investigators conducted a study known as the Women’s Health Initiative (WHI), to identify the benefits and risks of HRT, specifically estrogen with or without progesterone. They found that HRT did, in fact, decrease the incidence of colon cancer and fractures in those without a diagnosis of osteoporosis and improved menopausal symptoms; however, there was an increased incidence of thromboembolic disease, breast cancer, coronary artery disease, and strokes. The study was terminated at year 7 instead of continuing for the scheduled 10 years because they had data that proved they were “killing” women in the study. Soon after that, the Heart Estrogen/progestin Replacement Study (HERS) confirmed the WHI’s findings and concluded that HRT had no protection against Cardiovascular accident ( ie. Stroke). Both studies used SYNTHETIC and patentable estrogen and progestin hormones.
The WHI study raised several safety concerns regarding the use of synthetic hormones in HRT. As a result, the use of hormones that are structurally identical to those found in the body has seen a steady increase. Also, since the end of the WHI study, Premarin® and Prempro® (equine ePremarin® sales revenues dropped dramatically. Wyeth, the manufacturer of Premarin®and Prempro® has filed “a friend of the court” law briefs with FDA attempting to ban as dangerous and unproven therapy some of the natural estrogen products even though Wyeth manufactures and promote the same form of estrogen in Europe. The FDA has taken a strong stand against compounded hormonal drugs and allowing their compounding and sale. Keep in mind, that the FDA perceives one of it’s roles is to protect and promote “Big Drug Manufacturing” as well as protect the American consumer.
These hormones that are structurally identical to those found in the body are known as bio-identical hormones. The FDA and Mainstream Medicine do not recognize bio-identical hormones as being “real” or valid drugs and therefore are at best– fraudulent, or hoaxes and at worst dangerous.””Bio-identical” is a marketing term that has no accepted medical meaning.”Misinformation is rampant” about bio-identicals, said Dr. JoAnn Manson, preventive medicine chief at Harvard-affiliated Brigham and Women’s Hospital in Boston. “It really is buyer beware.”” Its implied benefit is not unique to alternative remedies.”
Many believe that bio-identical hormones do not act the same way that the synthetic drugs do. Synthetic hormones contain side chains that alter their chemical relation to hormones found in the body, their metabolism, effects on body cells and other organs such as thyroid, para-thyroid, and other chemical control systems . The goal of Bio-identical Hormone Replacement Therapy (BHRT) includes relief from symptoms due to decreasing hormone production, protection from conditions that natural hormones usually protect against, and the establishment of hormonal balance. The hormones ratios are probably more important than actual blood levels. The term bio-identical is not recognized by the FDA; however, estradiol, progesterone, and testosterone are FDA approved. Moreover, BHRT has been used for over 40 years in Europe and has been extensively studied.
Hormones commonly used in BHRT include the estrogens:-estrone -(E1), estradiol (E2 ) and estriol ( E3), progesterone, and testosterone. These are all hormones that exist in all human bodies in the same chemical form. Estrogens are used 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 among women and even in same person from day to day and week to week.. Estrone is the main estrogen produced in the body after menopause, and is not commonly used in BHRT. Estradiol is the most potent of the estrogens and is the primary estrogen produced before the onset of menopause. Estriol protects against breast cancer and is produced in higher concentrations during pregnancy. Estriol also alleviates several vaginal and urinary symptoms of menopause.
We usually like to balance the estrogen hormones estradiol and estriol ( commonly called Bi-est) in an 20-80 ratio to mimic the body’s natural ratio. We think that balancing the powerful estradiol with the “protective estriol” yields the most rational, safe and effective therapy. We know that the body converts E1 to E2, E3 and back and forth.
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 many as 112 “estrogens” not found in the human body. Estrone comprises 50% of Premarin® which is more than the amount naturally found in the body. Estrogen is given with progesterone unless the patient has had a hysterectomy. We know that giving patients that have not had a hysterectomy synthetic estrogen will cause cervical cancer as “sure as the sun in coming up in the morning” if progesterone is not given along with the estrogen. Estrogen can be given unopposed by progesterone in hysterectomy patients although this is not recommended with BHRT therapy since there are progesterone receptors throughout the body.
The most common compounded estrogen is Bi-Est. It is comprised of estriol (80%) and estradiol (20%). Tri-Est, which contains all three naturally occurring estrogens, is sometimes used because it is compounded in concentrations (80%-10%-10% ) naturally found in the body.
Progesterone is another bio-identical hormone used in HRT; however, the term is often applied to synthetic progesterones as well. Synthetic progestins can have serious side effects—these are the chemicals (synthetic hormones ) that the (WHI) data was very strongly connecting with killing women, while bio-identical progesterones have not been shown to have negative side effects. In general, studies suggest bio-identical progesterone improves hot flashes, depression, and anxiety related to menopause. Progesterone also balances estrogen dominance. However, FDA studies have not been conducted on bio-identical progesterone to claim efficacy or safety. Regarding BHRT, the American College of Obstetricians and Gynecologists recommends that progesterone be given with estrogen, so that estrogen in the body is not unopposed. Progesterone is sometimes given alone in perimenopause (the period of time before menopause) because progesterone levels begin to drop before those of estrogen. This leads to estrogen dominance which can cause some of the symptoms seen during perimenopause.
Androgens, which include testosterone and DHEA, are also used in BHRT. They play a role in skin, muscle tone, bone integrity, mood, decision making abilities and libido in both men and women. Testosterone and/or DHEA are sometimes given as a component of BHRT in women due to decreasing levels of testosterone and DHEA that is experienced with increased age. Testosterone is also given to men experiencing andropause also known as male menopause. It is only recommended for men whose testosterone levels are low. The goal for testosterone replacement therapy in men is to replace lost testosterone. This prevents the onset of muscle loss, prevents pot belly, type two diabetes, cardiovascular problems and improves mood, prevents loss of decision making ability, skin tone and sexual problems of erectile dysfunction, and libido.
Bio-identical hormones are compounded at Lynn’s Pharmacy for each patient per prescription from his or her physician. Patients usually hear about this option from their physician or from other patients receiving this treatment option. Patients may contact our pharmacy for information regarding bio-identical hormones. The pharmacist may schedule an appointment and discuss the patient’s current symptoms, current HRT method (if any), and past medical history. We use a computer based quiz analyzing the patient’s symptoms. There are known symptoms of too much —or lack of estrogen, progesterone and testosterone. We use this as a guide to make suggestions as to treatment suggested –for the patient to take to her doctor. We feel that this is a good starting point, it is simple, inexpensive and establishes ratios and needs. As hormones are added….the thyroid, pituitary and many other hormones may change to some degree. Only once have I ever seen the first attempt be correct. Usually, this is a several month process with the patient being the key to inform the medical partners how she feels and what symptoms she is still having or perhaps what new symptoms are occurring.
The patient, physician, and pharmacist must interact to tune the “treatment” to optimum effectiveness. Keep in mind that for everyone’s benefit — patient, physician, and pharmacist — all have a role in the triangle of therapy.
A Note On The Triad Relationship: Compounding is achieved through an essential triad relationship — patient, physician and pharmacist. The physician first prescribes the medication, then the pharmacist compounds the necessary ingredients, and dispenses the compounded medicine to the patient with consultation. As a result , the patient receives the
customized -personalized care from both professionals that he or she deserves.
Other patients simply arrive with a prescription given to them by their physician. They may have been on BHRT therapy for a while and do not need the pharmacist involved in helping guide the therapy –similarly to traditional prescription medications such as blood pressure or heart medications.
There are saliva and blood tests available to help the physician determine hormonal levels, which can be used in along with the patient’s symptoms to develop an individualized BHRT regimen for each patient. My reading and studies indicate that the saliva test are the most accurate hormone indicators—I have changed my mind about blood test. We can also help educate you about BHRT, and want to make it clear that there is not any federal or FDA data on the safety, efficacy or long-term effects of bio-identical hormones nor does the FDA endorse or condone BHRT.
Most patients are started on Bi-est, progesterone and /or testosterone which is applied topically in a cream or gel. Initially multiple hormones may be dispensed to the patient separately so that each hormone can be adjusted as necessary until the patient’s dose is stabilized. The ultimate goal of therapy is to maximize benefits and minimize side effects to the patient. Once this goal is achieved and the final dosage is reached, sometimes all the hormones can be put into one container or syringe to allow for easier administration.
The preferred route of administration is topical, but other dosage forms available are: oral capsules, troches, and sublingual drops. Topical creams release the hormones evenly in low dosing– gradually for about 12 hours. Capsules, troches, and drops release very quickly with a high dose and taper off in blood levels with each pass through the liver. Creams are more natural and I think safer and easier to regulate.
The use of bio-identical hormones continues to increase in popularity. The idea of replacing the body’s hormones with identical hormones seems logical although larger studies need to be done to prove their safety, efficacy, and long-term effects. Larger studies have not been done because bio-identical hormones are compounded primarily by local pharmacies. Since these drugs are natural, they can not be patented: thus large manufactures or nor anyone else can afford to spend the hundreds of millions of dollars to complete the FDA required studies. Hundreds of other smaller studies have been done in USA and Europe, all with positive results as to safety and effectiveness.
For better health,
up dated 2/20/2015