Bioidentical Hormones
Holistic healthcare is a hallmark of Natural Clinic MD. With an emphasis on functional medicine, Dr. Patel works to ensure all his hormone patients receive the individually tailored estrogen, progesterone, and testosterone medications that address their particular medical symptoms and lifestyle preferences. But not all hormone replacement therapy (HRT) is created equal. There are major differences—especially in terms of reported health risks—between traditional and bioidentical hormone replacement therapy (BHRT). Unlike synthetic hormones which are mass produced in fixed doses by huge pharmaceutical companies, bioidentical hormones are derived from all-natural ingredients and are formulated at a compounding pharmacy to meet each patient’s unique biological needs.
Whether a woman requires estrogen replacement therapy or a man needs testosterone replacement therapy, Dr. Patel is committed to improving the physical and emotional wellbeing of every patient who visits Natural Clinic MD.
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Bioidenticals—Health the Natural Way
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What are bioidentical hormones?Bioidentical hormones are compounds with the same molecular and chemical structure as hormones naturally produced in the male or female human body. The most common bioidentical hormones are estrogen, progesterone, and testosterone. If obtained from a compounding pharmacy, prescription bioidenticals are individually formulated to meet each patient’s unique biological needs.
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Do synthetic hormones produced by pharmaceutical companies also exactly mimic the body’s natural hormones?No. Synthetic (non-bioidentical) hormones from pharmaceutical companies have significantly different chemical and molecular structures than hormones produced in the body. Two well known examples are Prempro and Premarin, synthetic estrogen drugs that more closely match the chemical and molecular structures found in horses than in humans. (The primary ingredient in these drugs comes the urine of pregnant mares.)
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What are the two main types of bioidentical hormones?The first kind of bioidentical hormones are individually formulated for each patient’s biological needs by a compounding pharmacy based on a prescription from a physician. The second kind of bioidenticals are produced by pharmaceutical companies in a variety of doses and available with a prescription from retail pharmacies.
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Where do the ingredients in bioidentical hormones come from?Unlike the ingredients in synthetic medications, those in bioidentical hormones are derived from all-natural sources. The most common ingredient sources are soy plants and wild yams, which are used to formulate bioidentical estrogen medications.
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Are bioidentical hormone medications derived directly from soy and yams without any laboratory processing?No. The harvested soy and yam must first be synthesized in a laboratory into all-natural ingredients. These are then compounded into bioidentical hormone medications that can be readily absorbed and utilized by the human body.
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Do bioidentical medications effectively treat hormone deficiencies in men and women?Yes. Although individual results vary, research indicates that many patients who use bioidenticals enjoy significant symptom relief and improved overall wellbeing. Many of these individuals previously tried synthetic hormones but stopped because they were not effective or caused unwanted side effects.
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How are bioidentical hormones delivered into the human body?In most cases, male and female patients can choose from a variety of hormone delivery methods. These include creams, injections, gels, transdermal (skin) patches, dissolving lozenges, and more. In cases where multiple treatment methods provide safe, effective symptom relief, patients can choose which works best for them.
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Do bioidentical hormones come in set doses?It depends. Bioidentical drugs from pharmaceutical companies are manufactured in set doses (just like all other commercial drugs). Bioidenticals from compounding pharmacies are individually formulated with no set doses. Each patient medication is unique.
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Is blood work needed before Dr. Patel writes a prescription for bioidentical hormones?Yes. Dr. Patel must first know your current blood levels before he can prescribe the proper medication and dose. Too little of a needed hormone is unlikely to alleviate your distressing symptoms, while too much of any hormone is potentially dangerous.
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Where do I get my bioidentical hormone prescription filled?It depends. If prescribed a commercially manufactured bioidentical medication, you will fill your prescription at a regular pharmacy. If prescribed a bioidentical medication specifically formulated for you, you will fill your prescription at a compounding pharmacy.
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Will my health insurance pay for lab tests related to bioidentical hormone replacement therapy?Typically health insurance will cover a significant portion of lab test fees ordered by Dr. Patel. (Insurance companies generally regard lab fees differently than physician or medication fees.) Please contact your insurance provider for more details.
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Will my health insurance pay for the bioidentical medications themselves?That depends whether they are pharmaceutical bioidenticals or specially compounded bioidenticals. Your insurance’s prescription plan might pay for the commercial medications. They will not pay for compounded medications.
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Bioidentical vs. Synthetic Hormones
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What are the basic types of hormone replacement therapy (HRT)?There are two main kinds of HRT used by men and women to treat a variety of health problems: Protocols that use synthetic drugs produced by pharmaceutical companies and protocols that use bioidentical medications formulated by special compounding pharmacies.
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What are the differences between bioidentical and synthetic hormone medications?While both types of hormones are synthesized in laboratories, that is where the resemblance ends. Synthetic hormones are derived from a mixture of natural and non-natural ingredients and are mass produced in set dosages. These hormones do not closely match those found in the human body. By contrast, bioidentical hormones are derived from all-natural ingredients and are most often formulated at a compounding pharmacy to meet each patient’s unique biological needs. Bioidentical hormones match those naturally produced in the human body on chemical and molecular levels.
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Can the body recognize and utilize both synthetic and bioidentical hormones?Yes. Both synthetics and bioidenticals can provide symptom relief to men and women suffering from specific medical problems. There is considerable variation among patients as to which medication type is most beneficial in their particular case.
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Which are safer—bioidentical hormones or synthetic hormones?It is difficult to be certain because there have been no research studies comparing the two types of HRT for long-term safety. While FDA approval of synthetic drugs might suggest they are safer, the results from the Women’s Health Initiative study (discussed elsewhere on this website) suggest that bioidentical medications might be at least as safe as the alternative.
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Do bioidentical hormones provide effective symptom relief for most men and women?Yes. Although individual results vary, many men and women in the United States and across the world have been successfully and safely treated with bioidentical HRT for numerous health problems that significantly impact physical and emotional wellbeing.
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Why do many patients choose to use bioidentical hormones rather than synthetic alternatives?Research indicates that many patients prefer bioidentical HRT for several key reasons. These include:
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Can both bioidentical and synthetic medications cause unwanted side effects?Yes, especially when you first start taking them. Your body needs time to adjust to the higher levels of hormones now in the bloodstream.
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Do women generally report fewer side effects with bioidentical hormones than with traditional hormones?Yes, women tend to experience fewer side effects when using bioidenticals. For example, a recent research study found that 56% of women taking synthetic hormones gained weight as a result, while for women taking bioidentical hormones the number was only 37%. Similar differences were seen with other common side effects such as bloating and mood swings.
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Do certain types of HRT increase a woman’s chances of developing heart disease or a blood clot?Yes. Large research studies indicate that CEE—the synthetic estrogen used in many traditional hormone medications—increases the risk of heart disease or a blood clot for certain patients. This drug-related risk increases as a woman ages.
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Can significant health problems develop soon after a woman starts using synthetic oral estrogen drugs?Yes. Regardless at what age a woman starts taking such hormones, her risk for a drug-related blood clot is highest within the first two years of use.
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What type of HRT is associated with the greatest risk of vascular (circulatory) complications for menopausal women?Research suggests that estrogen-based oral medications such as Premarin and Prempro, both produced by a large pharmaceutical company, pose the greatest vascular risk. Bioidentical medications applied to the skin (patches, creams and gels) appear to be a safer alternative to these synthetic drugs.
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Pharmaceutical Bioidenticals
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Do pharmaceutical companies manufacture their own bioidentical hormones?Yes. Because of the popularity of bioidentical hormones as an effective alternative to traditional hormone therapy—particularly after the Women’s Health Initiative study was published in 2002— pharmaceutical companies now manufacture their own versions of these medications.
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What types of bioidentical hormones are produced by pharmaceutical companies?They manufacture over a dozen different bioidentical estrogen drugs in a variety of doses and forms. They also produce a smaller number of bioidentical progesterone drugs.
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What about combination estrogen-progesterone bioidentical medications?In the spring of 2019 the first bioidentical estrogen-progesterone drug manufactured by a pharmaceutical company appeared. Called Bijuva, it is an oral medication used to treat menopause-related hot flashes and flushes in women with a uterus.
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Are all these pharmaceutical bioidenticals individually formulated for each patient as with compounded medications?No. Like all drugs from pharmaceutical companies, these hormone medications are mass produced according to a particular chemical formula. They are not individualized for each patient (as happens at a compounding pharmacy).
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Are these bioidentical hormone medications approved by the FDA?Yes. Because they are mass produced at fixed dosages, these drug company products are regulated and approved by the federal government.
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Does that mean they are safer than bioidentical hormone formulations from compounding pharmacies?Not necessarily. It is difficult to generalize because there have been no large research studies comparing drug company bioidenticals and compounded bioidenticals for safety and effectiveness.
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Are there generic versions of these pharmaceutical hormones?In some cases. It depends on the particular bioidentical estrogen or progesterone medication.
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Compounded Bioidenticals
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How many compounding pharmacies are there in the United States?There are currently about 7,500 pharmacies where the pharmacists spend most or all of their time providing compounding services. This represents about 13% of the 56,000 community-based pharmacies across the country.
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How many prescriptions are filled each year at compounding pharmacies?Approximately 30 million compounded prescriptions are filled annually in the U.S. alone. This number continues to grow as more physicians become comfortable prescribing bioidentical medications for their male and female patients who want more natural and individualized medical treatment.
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Are compounding pharmacists fully trained and licensed?Yes. In addition to their standard pharmacy eduction—an extensive science-based curriculum that includes basic compounding practices—compounding pharmacists have advanced training in preparing individually formulated medications with bioidentical ingredients. This specialization means they have worked with many patients suffering from hormonal symptoms similar to yours.
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What special patient services do compounding pharmacies provide?Compounding pharmacists can formulate medications on a patient-by-patient basis, an option not available with commercially manufactured drugs. Specialized patient services include:
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Do big commercial pharmacies (such as Walgreens) offer compounding services as well?Yes, but on a smaller scale than provided at compounding pharmacies. The range of individualized formulations and patient choices is greater at specialized compounding pharmacies. (Some medication compounding also takes place in hospitals and other medical facilities.)
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What are the most commonly prescribed medications formulated at compounding pharmacies?Bioidentical hormones, including estrogen, progesterone, and testosterone—either separately or in combination with each other. Of these, estrogen formulations—compounded in a wide variety of forms and strengths—are the most commonly filled prescriptions.
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What different forms of medication are available from compounding pharmacies?Typical medication absorption options include creams, gels, capsules, injections, skin patches, suppositories, and dissolving tablets. The choices available in a particular case can vary depending on the hormones prescribed, patient symptoms, and other factors.
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Can compounding pharmacies formulate my medications so I can take the lowest dose possible and still achieve desired results?Yes. Many patients are concerned about taking excess amounts of hormones to treat their symptoms. Based on your prescription from Dr. Patel, a compounding pharmacy can ensure you get precisely the amount of medicine needed—but not more than that.
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Do many menopausal women use compounded bioidentical hormones?Yes. The North American Menopause Society estimates that roughly 1.5 million menopausal women in the U.S. use these medications to treat their distressing symptoms. Many of these women previously tried pharmaceutical hormone drugs and experienced insufficient symptom relief and/or bad side effects.
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What percentage of all menopausal women receiving hormone replacement therapy use compounded bioidenticals?A recent national survey found that 35% of menopausal women use compounded rather than commercial hormone medications for symptom relief. This percentage continues to rise for a variety of issues related to medication effectiveness, safety, side effects, and personal preference.
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Are compounding pharmacies in Florida regulated by an oversight agency?Yes. Compounding pharmacies are regulated by the Florida Board of Pharmacy. In addition, the federal government has the authority to impose new regulations on these pharmacies as needed.
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Are medications from compounding pharmacies regulated by the FDA?No. That is because compounded medications are individually formulated for each patient rather than mass produced as with pharmaceutical drugs. However, the ingredients themselves (such as estrogen) that are used in compounded medications are regulated by the FDA.
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Is there a national organization that inspects and accredits individual compounding pharmacies?Yes. The Accreditation Council for Health Care (ACHC) assesses the quality and safety standards of compounding pharmacies that choose to participate in its accreditation program. For more information about the ACHC or to locate an accredited compounding pharmacy near you, click here.