With so many theories and conflicting opinions on the subject of hormone replacement and the aging process, no wonder people have questions. The following are frequent questions at our clinical practice:


What are bio-identical hormones?

Hormones that are “bioidentical” are derived from plants and are synthesized to be an exact molecular match – identical in structure and function – to those produced naturally by the human body. Because bioidentical hormones have the identical molecular structure, they also have 100% relative binding affinity (RBA) for hormone receptor sites throughout the body, which means that they are a perfect fit with the specific cells of the body.


I’ve heard that my symptoms could be caused by declining hormone production. Why would this happen to me?

Starting at about 30, almost all women experience a natural falling off of progesterone production and an increase in estrogen production. In men, the decline begins in the late 30s or early 40s. Testosterone and other hormones important to the healthy functioning of the body decrease with age. Lifestyle factors, including what you eat, how much you exercise, whether you are overweight or obese, how you manage stress, and how much you sleep can contribute to the extent of hormone decline.


Why am I gaining weight around the middle and on my hips?

Weight gain of this type, commonly associated with middle age, is a prominent symptom of a hormone imbalance known as estrogen dominance. Women who are estrogen dominant have a higher than normal ratio of estrogen to progesterone. Men with estrogen dominance have less progesterone and testosterone than they need to balance the harmful effects of too much estrogen. Either may also have an unhealthy balance of the three kinds of human estrogen: estrone, estradiol, and estriol. After rebalancing their hormones, most of our patients in clinical practice begin shedding the pounds around their middle – some surprisingly quickly.


What is a compounding pharmacy?

Compounding pharmacists are board-certified by the International Academy of Compounding Pharmacists (IACP) and supervised by the state boards of pharmacy in which they are licensed. They use substances that are approved by the FDA to blend or compound individualized medicines prescribed by physicians. Dr. Randolph started his medical career as a Compounding Pharmacist and is a member of the IACP. The main difference between a compounded prescription and a traditional prescription you would order from a drugstore pharmacy is the individualization of the prescribed dose: Traditional prescription drugs provide ‘one-size-fits-all’ mass-produced dosages.


How are compounding pharmacies regulated?

Legitimate compounding pharmacies are regulated by the states in which they operate and headed by a pharmacist who is board-certified by the International Academy of Compounding Pharmacists (IACP). These pharmacies are as heavily regulated as the traditional corner drugstore.


What is bioidentical hormone replacement therapy (BHRT), and how does it differ from hormone replacement therapy (HRT)?

BHRT is the acronym for bioidentical hormone replacement therapy, a protocol that uses plant-based bioidentical hormones to treat women and men for hormone depletion or imbalance – usually as a result of the aging process, extreme stress or exposure to environmental toxins. BHRT is safe and effective, but it is less well known than its alternative protocol, HRT, hormone replacement therapy that uses synthetic hormones. Synthetic hormones are drugs produced by pharmaceutical companies. Unlike bioidenticals, their chemical structure has been altered in the lab to produce new molecules that can be patented – bioidenticals derived from natural substances cannot be patented. Synthetic hormones have a lower-than-optimal RBA (relative binding affinity), so fit improperly in the cells of the body and cause dangerous side effects. In recent years, medical research has linked the use of HRT to increased risks for cancer, cardiovascular disease, strokes and blood clots, osteoporosis and Alzheimer’s disease.


Why doesn’t my doctor know about bioidentical hormones?

American medical schools teach synthetic hormone therapy. Not coincidentally, they also receive major funding from the pharmaceutical companies that profit from these patented drugs. Doctors who offer bioidentical hormone replacement therapy (BHRT) generally learn about this option through independent observations and research – as was the case with Dr. Randolph.


Why are bioidentical hormones safe and synthetic hormones dangerous?

Bioidentical hormones have exactly the same molecular structure as the hormones produced within the human body. Consequently, they also have a 100 percent relative binding affinity (RBA) for the hormone receptor sites within the body. In other words, they fit perfectly. Because the body recognizes, accepts, and uses bioidentical hormones just as it would naturally occurring human hormones, bioidentical hormone replacement is both safe and effective.

Unfortunately, synthetic hormones, such as the commonly prescribed Premarin, Prempro, Premphase and Premelle (e.g. the Premarin family of products), have a very different molecular structure from the hormones produced within the human body. Premarin is actually a drug made up of conjugated estrogens obtained from the urine of pregnant mares. As the late John Lee, M.D. used to say: “Premarin is only ‘natural’ if your ‘natural’ food is hay!” It is important to note that minor chemical changes in the molecular structure of a hormone can cause striking alterations in biologic activity. Because synthetic hormone molecules fit very poorly within the body’s hormone receptor locks, their RBA is less than 100 percent. The ramifications of this poor fit can include sometimes lethal side effects and health risks.

Many medical studies have substantiated the dangers of synthetic hormone replacement. In July of 2002, the National Institutes of Health (NIH) halted in progress the first large randomized study of its kind to examine the effects of a widely used type of synthetic hormone replacement therapy called Prempro, which combines the altered molecular structures for both estrogen and progesterone. (Note: Synthetic progesterone is referred to as progestin.) The study, which was one of five major studies that comprised the large clinical trial called the Women’s Health Initiative (WHI), was discontinued when the risks among HRT users proved to be greater than the benefits: synthetic hormones were found to increase a woman’s risks for breast cancer as well as heart disease, blood clots and stroke. Later findings also linked synthetic hormone replacement to an increased risk for Alzheimer’s disease. The findings were published in the Journal of the American Medical Association (JAMA).

In addition to WHI’s momentous findings, in 2007 The New England Journal of Medicine published powerful evidence linking the significant drop in breast cancer rates to the sharp drop in synthetic hormone use by menopausal women. Unfortunately for those women who participated in WHI, a 2008 study published in The Journal of the American Medical Association (JAMA) reported that, three years after they stopped taking their drugs, women who had used the synthetic estrogen plus progestin combo drug Prempro during the WHI trials evidenced a 27 percent higher risk of developing breast cancer than those in the trial who took the placebo. Post WHI- discussion centers primarily on the fact that the average age of those in the study was 63 years old; naysayers point to lower cardiovascular risks among younger women in the study and take exception to the overall findings. But even prior to the WHI, a review of existing trials with HRT users (Hemminki and McPherson 1997; HERS 1998) showed no benefit in terms of protection against heart disease and the increased risks for stroke and blood clots that surfaced within the first one to two years of the WHI cannot be underplayed. Nor can the overall finding that the most popularly prescribed form of HRT (Prempro) was shown to be increasing risks for the very diseases it claimed to be protecting us against. The final recommendation from the principal investigators of the WHI was that Prempro should be discontinued. Yet it remains on the market under the provision that it be prescribed for short duration symptom relief only, and at the lowest possible dose. There is little information as to what extent this recommendation is being followed, nor is there evidence that lower dose HRT is any safer or more effective.

Please note that we focus on the dangers of the Premarin family of products because: a) these were the specific synthetic hormone drugs used in the WHI study, and b) they are the synthetic hormones that have been most popularly prescribed. Although other synthetic hormone products do not have the largest market share, they share the same health risks. Brand names include: Femhrt, Activella, Ortho-prefest, Combipatch, Cenestin, Menest, Orth-est, Ogen and Estratab.


How do I get started treating my symptoms of hormone imbalance?

Once you know that you are suffering from symptoms of hormone imbalance, you can get started with our over-the-counter bioidentical hormone cream (in much lower strength than the prescription variety), and make an appointment to see one of our practitioners. Through our clinical practice, we offer individually prescribed bioidentical hormone replacement therapy and treatment protocols designed specifically for your unique situation. During your visit, our practitioners can also recommend specific herbal supplements and vitamins. Or you can order one of our saliva or blood spot kits and have a tele-consultation by phone with one of our experienced providers (MD’s/ARNP’s). You can further support hormone balance with a hormone-healthy diet, regular exercise to stimulate hormone production, sufficient sleep, stress management, and strategies to avoid environmental chemicals that interfere with hormone health.


Where can I go online for information about BHRT and natural hormone remedies?

Are you ready? You may be amazed to see how long the list is – and this is just for starters: Look for more leads when you visit the following sites.


Physician Associations

The American College for Advancement in Medicine
The American Academy of Anti-Aging Medicine (A4M) is a non-profit organization comprised of 24,000+ physicians, health practitioners, scientists, government officials, and members of the general public. The A4M is dedicated to the advancement of technology to detect, prevent, and treat aging related disease and to promote research into methods to optimize the human aging process.

The American Holistic Health Association
AHHA is a leading national resource for people who seek solutions for reaching a higher level of wellness. The site includes a searchable database of over 200 AHHA Practitioners Members who work in partnership with their patients and encourage a holistic approach to wellness.

The Bioidentical Hormone Initiative
A non-profit organization started by a group of conventionally-trained, practicing physicians who have been treating patients successfully with bioidentical hormones for many years. Its mission is to education and share information about BHRT.

John R. Lee, M.D Official Website
The late Dr. Lee was Dr. Randolph’s mentor and an international authority, author and pioneer in the use of natural progesterone cream and natural hormone balance. The Dr. Lee website offers a wide range of information about natural hormones and hormone balance for women and men, resources for finding out more, as well as a variety of books, audio and video tapes and other useful products.

Natural Hormone Education Research Library
A library of articles about hormone balancing by Dr. John Lee and his co-author Virginia Hopkins, including many from the John R. Lee M.D. Medical Letter. The Virginia Hopkins Health Watch newsletter is also available at this site.


Compounding Pharmacy Organizations

Professional Compounding Centers of America (PCCA)
PCCA is an independent pharmacist’s complete resource for bulk pharmaceuticals, equipment, devices, flavors, ACPE-accredited training courses and programs, as well as technical and marketing consultation used for compounding customized dosage forms.

The International Academy of Compounding Pharmacists (IACP)
An international non-profit association that seeks to protect and promote the art and skill of pharmaceutical compounding. IACP’s membership consists of more than 1,300 pharmacists who are committed to protecting compounding, the birthright of the profession of pharmacy.


Other Resources

The Center For The Improvement of Human Functioning International
A non-profit medical, research and educational organization that serves the individual needs of people who are learning how to improve their health and, performance and regain their vigor.

The Institute of Natural Hormone Balance and Health
Dedicated to providing men and women with updated information on hormone balance and its impact on health, this site is an educational resource for health care providers and those seeking to improve their physical and mental health.

Women in Balance
One of the best places on the Web to learn about how to achieve optimal health through natural hormone balance, Women in Balance is a force for education and advocacy. The group unites women, doctors, health care professionals and national organizations in a quest for access to natural solutions for hormone balance and helps find funding for research on bioidentical hormones and other solutions for hormone balance. Be sure to watch the video.

ZRT Laboratory
Established in 1998, ZRT is a CLIA Certified hormone-testing laboratory. It is independently owned and operated by David T. Zava Ph.D. a biochemist and breast cancer researcher. ZRT Laboratory plays a leading role in educating the public and health care professionals about the importance of hormone balance for optimal physical and mental well being.