What Is Bioidentical Hormone Replacement Therapy
Bioidentical hormone replacement therapy is the use of hormones to help resolve symptoms related to hormonal imbalance or decline in hormone production tied to aging. Certain hormone treatments are called bioidentical or sometimes natural because the types of hormones used are chemically identical to those produced by the human body.
Specific hormones that BHRT aims to increase or balance include those tied to reproduction and youth, such as estrogen , progesterone, and sometimes testosterone, dehydroepiandrosterone and adrenal hormones. During the years leading up to menopause, and then through this transition, a womans body produces less of these hormones , which may lead to symptoms like fatigue, hot flashes/night sweats, vaginal dryness and thinning bones. Various hormone therapy products are used to overcome these symptoms, some of which have been approved by the FDA and are available by prescription through health care providers, but many of which have not.
BHRT treatments include creams, lotions, injections, gels, sprats or tablets that have the goal of raising hormone levels back up to a more youthful state. Examples of popular bioidentical hormone replacement therapy products now on the market include Estrace, Premphase, Prempro, Activara and Vivelle-Dot, just to name a few .
Safety Concerns About Compounded Bioidentical Hormones
Risk of endometrial hyperplasia and neoplasia
A major concern is the question of adequate endometrial protection with compounded progestogen regimens. Here, significant failings have been documented, in that compounded progesterone delivery, both by transdermal and troche route, have been reported to be inadequate for endometrial protection when administered in combination with oestrogen, leading to endometrial cancer .
Quality control and contaminants
Pharmaceutical grade hormone therapies are manufactured under strict conditions and are required to undergo rigorous testing of content purity and efficacy. Custom compounded hormones are produced under unregulated conditions without quality standards regarding content, efficacy, or contamination. It is impossible to know what excipients are in the preparations and how those excipients will affect pharmacokinetics . Contamination of compounded therapies may contain impurities which compromise sterility or those which lead to more serious consequences .
The Myth Of Saliva Testing
Another tactic used by compounded products marketers is the notion that through saliva testing, they can provide each individual a perfect match of hormone needs, another claim that the scientific statement seeks to knock down. The custom compounders for menopause everybody is a special snowflake, and you need your special recipe of hormones, and we can do that for you, Santoro says.
The scientific statement makes the point that salivary testing unreliable, Pinkerton says. Patients pay significant costs to receive data that they believe is individualized to them, when in reality, dosing for hormone therapy is done based on symptoms, not based on blood levels or salivary testing,
A patient whose hot flashes are gone is on the correct dose, Santoro agrees: Only in rare cases, if they are outliers on the pharmacokinetic curve, do you need to measure blood levels. Saliva testing adds a level of complexity that doesnt need to be there.
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Compounding Interests: The Risks Of Bioidentical Hormones
According to an Endocrine Society Scientific Statement, patients need to be counseled about the risks of custom-compounded bioidentical hormones. The preferred treatments should have been vetted by the U.S. Food and Drug Administration, not Oprah.
Physicians may need to take time to explain to patients the potential risks of using bioidentical hormone formulations made by compounding pharmacies, say the authors of an Endocrine Society scientific statement.
Many practitioners and patients find the subject confusing because of misleading information from the Internet and endorsements for alternative menopausal replacement hormones from celebrities such as Oprah Winfrey and Suzanne Somers. The compounded formulations are touted as natural and tailored to an individuals needs, but bioidentical hormones is better understood as a marketing term to sell products that are not approved by the Food and Drug Administration , according to Nanette Santoro, MD, chair of the task force that wrote the scientific statement.
Patients need to understand that FDA-approved hormones from pharmaceutical companies offer protections of purity, controlled manufacturing processes, and evidence from clinical trials that products from less-regulated compounding pharmacies do not. In addition, many of the newer FDA-approved formulations can be described as bioidentical because they are the same molecules as hormones found in the body.
Are Bioidentical Hormones Safe
The bioidentical hormones that are approved by the FDA have been tested for safety. They have passed the FDA’s strict standards and are safe for people to use. Like all hormone treatments, there are risks involved. You should weigh the pros and cons of even the FDA-approved bioidentical hormones with your healthcare provider.
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Get The Help You Need
If you are a patient and you are experiencing a hormone imbalance, talk to your medical provider about getting your hormones tested. If you want to avoid needles and labs, ask them about a prescription for an At-Home Testing Kit.
If you are a practitioner looking to provide your patients with an easier way for testing hormones and vitamin levels, talk to our pharmacists about how we can help. We are a BHRT compounding pharmacy with experts that have helped thousands of men and women find relief.
Who Needs Bioidentical Hormones
Due to the controversy still surrounding the safety of bioidentical hormones, most women going through perimenopause may want to consider other treatment options first.
Not all women respond well to traditional treatments, however. In these cases, women may consider bioidentical hormones as potential alternatives.
Also, women who have tried other medications may want to consider changes in their lifestyles before starting bioidentical hormone therapy. Some additional measures to try can include:
The application of a treatment is supposed to restore the natural hormones that younger women have, but that reduce as they age.
When under a doctors care, a woman will be tested for hormone levels, typically by sampling saliva or blood. The doctor will determine what hormones the woman needs and a pharmacist will mix a treatment of supposedly natural ingredients.
During her treatment, a woman will have her hormone levels assessed several times to check for balance.
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What Evidence Is There That Bioidentical Hormones Are Safe
Letâs start by pointing out that not all hormones are safe for every woman. The benefits vs. risks of hormone therapy should always be discussed in detail with oneâs doctor to determine if hormone therapy is appropriate. Reviewing personal and family medical history is of the utmost importance when determining the safety of hormone therapy in any patient. For example, estrogen therapy is not recommended for those with a history of breast cancer.
A 10 year observational safety study done in France showed no increase in the risk of stroke, heart attack, or breast cancer in women who used bioidentical estrogen combined with progesterone . Combined Hormone Replacement Therapy and risk of Breast Cancer in French Cohort Study of 3175 women. Climacteric, 5:332-340). There was another study published which supports the safety and efficacy of bioidentical hormones concluding that, âPhysiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal derived counterpartsâ . The Bioidentical Hormone Debate: Are Bioidentical Hormones Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy? Postgraduate Medicine, 121:1-12). To view click on the link at the bottom of this page.
Prevalence Of Cbht Use
Although there is little historical data on the prevalence of CBHT use, it appears that its popularity rose dramatically among women following the halt of the WHI hormone therapy clinical trials, when many women stopped using conventional HT and sought alternative approaches for managing menopausal symptoms . In the years that followed, there were also a number of high profile endorsements, including from Oprah Winfrey, who declared, After one day on bioidentical estrogen, I felt the veil lift .
Today CBHT remains hotly debated and in the news , and recent data suggests that CBHT use remains high: A recent, national population-weighted survey determined that 35% of U.S. women currently using HT are using CBHT others have similarly estimated that 1 to 2.5 million U.S. women over the age of 40 are currently using CBHT . A survey of U.S. pharmacies estimated 2633 million annual CBHT prescriptions, totaling $1.31.6 billion U.S. dollarsmost of this in out-of-pocket spending . Most of these pharmacies projected growth in compounding around 5% – 25% over the next 2 years . The only national-level, population-based study of the prevalence of CBHT to date comes from Australia, where authors find that 6% of women aged 5069 have used CBHT and 2% are current users .
Storefront promotion of CBHT in Portland, Oregon, 2016.
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Vi Summary And Conclusions
Both clinicians and patients believe that hormones prescribed for the treatment of deficiency syndromes should be as natural as possible. Studies have shown that bioidentical HTs are safe and effective for many endocrinopathies, and they are FDA approved. Theoretically, these substances represent the most physiologic treatment possible and therefore some patients and clinicians prefer them to synthetic compounds. For example, observational data suggest less risk of VTE and stroke with low-dose nonoral estrogen, and there are a number of FDA-approved nonoral E2 preparations that deliver the hormone through various routes . There are fewer FDA-approved preparations of testosterone and thyroid hormone available. There are currently no FDA-approved bioidentical preparations of DHEA. The use of custom-compounded hormones should be limited to those situations in which a patient is either allergic to or does not tolerate any of the FDA-approved preparations of a substance that is necessary for his or her health.
The Endocrine Society, the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine, and the North American Menopause Society have all concluded that there is no scientific evidence to support claims of increased efficacy or safety for custom-compounded bioidentical estrogen or progesterone regimens over FDA-approved HTs .
The Optimal Type Of Hrt
There is now evidence demonstrating that transdermal estrogen in association with natural micronised progesterone represents one of the optimal HRT regimens.6 Transdermal estrogen is the preferred route of administration because, in contrast with oral estrogen, estrogen as a patch or gel is not associated with an increased risk of venous thromboembolism. It can be safely given to women who have a history of migraines, gallbladder disease, diabetes, or who are obese. The optimal progestogen is micronised progesterone which is body identical. This usually has less side effects associated with it compared with the older progestogens.7 In addition, there is no increased risk of breast cancer for the first 5 years of taking estrogen with micronised progesterone.8
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Testing Is Key For Achieving Accurate Diagnosis
At ITC Pharmacy, accurate testing is key for achieving positive outcomes for our patients. Convenient, easy-to-use saliva and neurotransmitter test kits are available which allows for collection at your convenience and in the privacy of your own home. We offer a variety of kits including Labrix saliva, neurotransmitter, and saliva/neurotransmitter combo kits.
Our saliva test kits allow you to test Estrogens, Progesterone, Testosterone, DHEAS, and the adrenal hormone, Cortisol, four times throughout the day. We recommend saliva testing for Bioidentical Hormone Replacement Therapy sex hormones and adrenals however testing of sex hormones are not recommended if you are currently on birth control pills.
Saliva Hormone Testing: Here’s How It Works
Stop by our pharmacy, or call us and we can mail the test kit to your home with complete instructions. You provide a small saliva sample in the four containers provided, then fill out the requisition form, and send both the saliva samples the requisition form in a prepaid FedEx envelope to our testing laboratory. In approximately 10 to 14 business days your test results will arrive at our pharmacy.Once the results are sent to our pharmacy we will call you to discuss your. Most patients choose set up a consultation with our pharmacist who specializes in hormone replacement to discuss your results in detail. Working with you and you healthcare provider, our pharmacist will make recommendations based on your current symptoms, medical history, and saliva lab results.
Hormonal balance is a cornerstone of your overall health. Male or female, you should monitor your hormone levels regularly to help maintain that balance. With InHealth Specialty Pharmacy’s Saliva Hormone Testing, hormone monitoring has never been easier.
To order over the phone, simply stop by our pharmacy or give one of our friendly pharmacists a call today at 365-6050 or 365-6050 and take charge of your hormonal health.
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Saliva Hormone Testing: Hormonal Health Affects Your Quality Of Life
We at InHealth Specialty Pharmacy, a compounding pharmacy located in Fargo, ND, know that hormones play an important role in your overall health at every stage of life, whether you are a man or a woman. Whether it’s your reproductive health, sex drive, emotional balance, or just your overall energy level, hormones regulate the daily quality of life.
Because hormones play such a vital role, they are often among the first functions to be tested when you have a medical complaint. If a hormonal imbalance is indeed the culprit, your healthcare provider and one of our pharmacists can work together with you to determine the best course of action utilizing bio-identical hormone replacement therapy .
Hormone Level Testing And Compounded Bioidentical Hormone Use
Many advocates and compounders of bioidentical hormones recommend the use of salivary hormone level testing as a means of offering individualized therapy. However, individualized testing only is indicated when a narrow therapeutic window exists for a drug or a drug class. This includes drugs with nonlinear pharmacokinetics, that are eliminated by the kidney as the active drug, that are not metabolized during first pass through the liver, and that have clearly defined therapeutic and toxic concentrations based on large-population pharmacokinetic studies of serum concentrations. Steroid hormones, such as estrogen and progesterone do not meet these criteria and, thus, do not require individualized testing.
Although more sensitive testing is becoming available through the use of mass spectrometry, there are few indications for the measurement of hormone levels to ascertain success of therapy when treating a postmenopausal woman with hormones. If treatment is initiated for symptom control, subjective improvement in symptoms is the therapeutic end point, and there is no need to assess hormone levels. Hormone therapy should not be titrated to hormone levels .
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Who Shouldn’t Take Bioidentical Hormones
Using any type of hormone therapy is a decision made between you and your healthcare provider after carefully weighing the risks and benefits. Bioidentical hormones have been controversial, and many are not FDA-approved, but that doesn’t mean your healthcare provider will rule them out as a treatment option.
If you’ve had or are at high risk for the following conditions, hormone therapy may not be safe:
- Memory loss or confusion.
Replacing these lost or low hormones is the goal of bioidentical hormone therapy or conventional hormone therapy. Once hormone levels are increased, most people see their symptoms improve. However, there is not much evidence to support that bioidentical hormones are equal to conventional hormone therapy. Your healthcare provider can discuss your options for hormone replacement with you based on your symptoms and health history.
Push Away From Alternative Therapies
Widely available over the counter, dietary supplements like soy, red clover, and black cohosh are a convenient alternative for women seeking to avoid conventional HT nevertheless, for the most part, these products have not proven themselves efficacious in clinical trials . Eighty-one percent of the CBHT users in this study reported trying dietary supplements at some point to manage symptoms they associated with menopause. Many said that specific herbal or soy supplements had been recommended to them by their health care providers, while others reported receiving recommendations from friends or media sources, or reading the labels to find products to fit their needs. Like others who use dietary supplements , many women in this study described supplements as more natural than pharmaceuticals, and thus perceived them to be safer. Sandra, who tried black cohosh during her search for the right treatment, put it this way, I tried it. I tried it before I on hormone therapy. Didnt like it much. I dont know about the safety of it, but its an herb, so very safe. It didnt work.
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Significance Of This Research
This work is situated within a larger body of work that aims to understand health care decisions within an increasingly patient-centered health care paradigm that encourages shared decision-making between patients and clinicians.1 This is especially relevant in a health care environment where information and treatment optionseach with their own risks, benefits, and side effectsproliferate. In this context, there is increasing recognition by clinicians that patients priorities and preferences matter . A systematic review of patient-reported barriers to and facilitators of shared decision-making identified patientsknowledge and patients perceived power to participate as key themes influencing patients participation in shared decision-making . However, there is also compelling evidence that merely providing patients with more information is not sufficient to support shared decision-making. Rather, atients need to feel supported so they feel capable of acquiring and understanding knowledge about the available options, and so that they value their personal knowledge contribution .
Five Reasons To Add Bhrt To Your Holistic Practice
BHRT is a safe, natural, and effective treatment for a comprehensive range of physical and emotional conditions. Suitable for both women and men, BHRT can treat the symptoms of menopause, age-related bone loss, sleep disruptions, and complex conditions such as PMDD. In addition, bio-identical hormone replacement therapy can improve sexual function, increase lean body mass, address diminished libido, assist with weight management,
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