Is Bioidentical Hormone Therapy Safe
BHRT has been approved by the FDA for the use of treating hormone imbalances. This means the therapy follows the strict regulations and safety guidelines put forth by the FDA.
Its important to note that very few additional clinical studies have been conducted to show the effectiveness and safety of BHRT beyond those performed by the FDA. Here at Balance Hormone Center, weve seen the effects firsthand and believe BHRT to be safe when performed by a qualified physician.
Adverse Event Data For Cbht
At the request of the committee, FDA shared FAERS cases on cBHT.15 Reported events included incidences of overdosing , hormone withdrawal symptoms experienced by children after second-hand exposure to bioidentical estrogens and androgens, and compounding errors. One example of an adverse drug effect caused by medical error relates to an allergic reaction to propylene glycol in a product, which had erroneously been labeled as propylene glycol free. The quality of sterile drugs used in injected or implanted formulations were also identified as the source of localized infections occurring in patients. Pellet extrusions were also identified as a source of localized infections. One side effect reported by
15 These adverse event reports were identified in the FAERS database by the study sponsorFDA. FDA identified adverse events reports that relate to the use of a cBHT by reading through report descriptions of all entries marked as compounded. It is important to note that there may be other FAERS cases related to the use of a cBHT, but if the necessary indication box for compounded medications was not checked during the data entry process, then those cases would not be represented in the full data set.
Suggested Citation:The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use
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 .
Custom Compounding Is Misleading
To buy bioidentical hormones, you can’t just go to any chemist. First, you see a health practitioner. They will often conduct a saliva test, or order a blood test to check your hormone levels. You then take their prescription for biodentical hormones to a compounding pharmacist, who makes up the hormones especially for you.
This customised compounding makes women think that bioidentical hormones are better suited to their specific hormonal imbalances, but this is untrue. In fact, saliva tests are not considered a reliable method for establishing hormone levels. Blood tests are also not necessarily reliable, as women’s hormones during perimenopause and menopause can change from day to day, or even hour to hour, says Dr Newman.
“Women respond in different ways to this hormonal chaos,” she says. “For some women it makes no difference to how they feel, whereas other women may suffer severe symptoms, despite having similar blood results.”
The cost of bioidentical hormones is also considerably higher than conventional HRT.
Summary Of Research Findings
In its review of the evidence, the committee determined there is a dearth of high-quality research with a primary or secondary endpoint focused on the safety, effectiveness, and performance of cBHT preparations. Many of the studies had severe methodological limitations, the most common being the lack of standardized measures and minimal details on participant-specific dosing regimens, formulations, and dosage forms of the treatment, and where relevant, control arms of the study. The variability of cBHT formulations and research methodologies not only affects the quality of the evidence used to support research conclusions, but it also minimizes the ability to compare results among studies or apply meta-analytic methods to draw conclusions from a larger number of patients . The committee recognizes that for the large patient population using cBHT, it is difficult, if not impossible, for clinicians to provide evidence-based guidance on the safety and effectiveness of each unique formulation. That being said, safety and effectiveness data are still required for understanding the risks-to-benefit ratio for all medications, which is fundamental to the practice of medicine in this country.
13 Although this study is a large observational study, the participant-specific dosing regimens prevent the committee from creating a table that could accurately capture the published data.
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Bhrt Stabilizes Mood Swings When Consistent
Most women, and many men, know that taking BHRT stabilizes their mood swings. But, most dont realize that the dramatic rise and drop of various types of therapies can cause mood swings to become worse, with only brief interludes of peace and stability. Consistency is better for the patient.
Take a look at this chart:
As you can see, when a person takes a pill, uses a patch, or an injection, they will get a sudden spike in the hormones they need. And, for a little while, they feel good. But, to avoid an overdose, the levels of hormones have to fall below an optimal level as the dose wears off. Then, the therapy repeats.
Regular hormone therapies like pills and injections rely on providing almost too much of the hormone, so the levels of adequacy stick around for the most prolonged period and doses repeat often.
This is where bioidentical pellet therapy steps in. As you can see on the graph and from this study, BHRT using pellet therapy ramps up a little bit slower and then provides a consistent and measurable dose of hormones over an extended time. People can be at their optimal level for the most extended duration without feeling the spikes or drops. And, research shows that consistency is the key.
Why Bhrt Is Different
BHRT is used around the world primarily to help with age-related hormone changes and associated symptoms.
More and more people are turning to this popular option over non-bioidentical hormones, which include:
- Conjugated Equine Estrogen
- Medroxy Progestin Acetate
BHRT has been used successfully for decades, and its popularity continues to surge.
Bioidentical hormones are derived initially from a molecule called diosgenin found in either soy or yam. The resulting hormone is then manufactured into FDA-approved prescriptions or prepared by compounding pharmacies to patient-specific doses.
Bioidentical hormones are different from these synthetic hormone therapies because the hormones are identical to endogenous hormones in our body.
Unlike most synthetic hormones, bioidentical hormones are molecularly identical to endogenous hormones and have the same:
- Biological action, effect, and response
- Receptor binding affinity
- Metabolic pathways
Because bioidentical hormones have the same structure as those made in the body, they have the potential to be extremely safe and effective.
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Regulatory Exemptions For Dietary Supplements
Under the Dietary Supplement Health and Education Act of 1994, compounded hormones applied to the skin are considered to be supplements; the argument being that the hormones came from natural sources and should be considered in a category similar to herbs. Thus, the potential for such agents to cause harm was considered minimal. The Dietary Supplement Health and Education Act exempted remedies that fell into the category of supplements from regulation by the FDA, which requires that, unless a drug is generally recognized as safe, its safety and efficacy must be demonstrated before it can be marketed. Dietary supplements are not required to prove safety or efficacy; hence, there is no major barrier to marketing them. However, the FDA can remove these supplements from the market and subject them to further testing if there is sufficient suspicion that they are not safe.
A Safer More Natural Approach
Unlike traditional hormone replacement options, bio-identical hormone replacement therapy is tailored to each patient on an individual basis. A clinician will test your hormone levels, determine the issues that are most pressing to you and write a prescription for BHRT that addresses those concerns. A compounding pharmacy then fills the order. Bio-identical hormones are a safer option for many patients because they mimic the bodys natural hormone production. As a result, you wont need as many treatments.;Synthetic hormone therapy;works on the premise that you need as little as possible for as short a duration as possible. By contrast, bio-identical HRT can be taken for the rest of your life if you need the relief.
There are still controversies associated with BHRT, primarily because individual treatments and compounded hormones are not approved or regulated by the FDA. The reason for this is because each person receives a unique dosage, making it impossible for one regulating agency to monitor and approve each course of treatment.
Pharmaceutical companies may also play a role since bio-identical hormones cannot be patented, and patented treatments drive the prescription medication industry. Synthetic hormones, which can increase the risk of certain cancers and heart disease, are regulated by the FDA. As a patient, you can choose a method that works for you. For thousands of women, bio-identical hormone replacement therapy is the answer.
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Is Hormone Therapy Safe
Bioidentical hormones are all-natural, plant-based products made from yams and a small amount of soy. Unlike creams, gels or injections, the pellets provide bioidentical hormones at consistent levels over a longer period of time.
The hormones being delivered have the same molecular structure to the hormones your body produces and arent synthetic derivatives, which dramatically lowers the risk of unwanted side-effects**.
How Long Can You Take Hormone Replacement Safely
Hormone replacement therapy is oftentimes an effective solution for men and women struggling with symptoms of hormone imbalance related to aging or certain conditions and diseases. Hormone therapy is one of the most effective treatment options for hormone imbalance when administered under the care and guidance of a highly-trained medical practitioner.
The safety and efficacy of hormone replacement therapy is largely dependent on the medical team you choose to partner with for your treatment plan. There is no one-size-fits-all planthe length of time that you can safely supplement hormones varies by patient and the condition being treated. Discover how to make the best choice for your health.
What Is Hormone Replacement Therapy ?
Hormone replacement therapy is supplementation of exogenous hormones to treat hormonal imbalance. Therapy is available in a variety of forms and delivery methods. Perimenopause and menopausal symptoms in women are among the most commonly diagnosed conditions of hormone imbalance that are frequently treated with estrogen and progesterone therapyexamples of hormone replacement therapy. Andropause, or low testosterone in men, is another frequently diagnosed condition of hormone imbalance that is treated with testosterone therapy, another example of HRT. However, thyroid disorders and adrenal fatigue, among other conditions may also be treated with hormone replacement therapy.
What is Bioidentical Hormone Replacement Therapy ?
What Are The Side Effects Of Bioidentical Hormones
When the FDA approves a drug, the drug company must report on any side effects they are told about, including prominently noting it in the paperwork when picked up at the pharmacy. Pharmacies that compound hormones do not have to report drug side effects to the FDA, or provide such paperwork. This contributes to the myth that compounded hormones are safer, when in fact doctors dont know all of the possible side effects of these hormones.
Side effects can occur when a dose is first given. The body is not used to the new level of hormones. The dose may need to be changed. Some side effects can be linked to a certain hormone in the mixture. Many side effects get better as the body adjusts to the new level of hormones. Some common side effects include:
- Weight gain
What Does The Research Say About Effectiveness
To answer this question, we looked at multiple studies into the effectiveness of bioidentical hormones, both alone and compared to synthetics. Heres what we found:
- This study concluded that bioidentical progesterone does not have a negative effect on blood lipids or vasculature in the same way as synthetic progesterone sometimes does. Ergo, the author believed there was sufficient evidence to support using bioidenticals over synthetics.
- This study from the Mayo Clinic identified a significant benefit to women going through menopause through compounded BHRT because they provide practitioners the option to prescribe HT for women who cannot tolerate FDA-approved products.
- This study supported that women given BHRT for symptoms of menopause did, in fact, experience a reduction of symptoms within six months of initial treatment
- This study indicated a potential connection between endogenous estradiol and a reduction in breast cancer cells. Because BHRT more closely matches endogenous hormones, this could potentially open up the floor to future breast cancer treatments. Researchers continue to investigate the protective effects of endogenous estradiol.
It is important to note that hormone treatments of any kind are not without risk. Though current research does support the use of BHRT, especially in special situations where non-commercial doses or formulations are required, you should always speak with your pharmacist or physician before initiating treatment.
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Compounded Bioidentical Hormone Therapy
Bryce Harvey, PharmD Candidate 2021Creighton University School of Pharmacy & Health ProfessionsOmaha, NebraskaAssociate Professor of Pharmacy PracticeCreighton University School of Pharmacy & Health ProfessionsOmaha, Nebraska
US Pharm. 2020;45:27-29.
ABSTRACT: Since synthetic hormones were first combined in the 1940s, hormone replacement therapy has been widely used by women experiencing undesirable menopausal symptoms. Subsequent research led to discoveries of several negative effects associated with the use of hormone therapy, sparking discussions on the risks versus benefits of hormonal treatment. Because of the risks associated with commercial preparations, compounded hormone therapy has become more prominent, as it has been touted as a biologically equivalent alternative to synthetic hormones. However, because of minimal to no FDA oversight in the compounding realm generally, CHT may not be as safe as has been advertised. In 2018, based on favorable trial results, Bijuva became the first FDA-approved bioidentical combination 17-beta estradiol-progesterone formulation.
Let Us Help You Share The Benefits Of Bhrt With Patients
Patients appreciate the opportunity to discuss health goals and challenges in detail, especially regarding highly personal topics like aging and reproductive health.
They are looking for well-informed, open-minded practitioners who will teach them about the safety of bioidentical hormones to be more empowered about meeting both immediate and long-term health goals.
BHRT providers offer a valuable service, and this type of therapy should be readily available. Whether youre looking to open your clinic or learn to prescribe BHRT accurately, we can guide you.
If you want to move forward on this fascinating journey drop me a line!
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Not An Elixir Of Youth
Hormone therapy is not a magic bullet or an elixir of youth, and it shouldnt be used willy-nilly, Manson says.
But women who are suffering with menopause symptoms should not be denied hormone therapy, she says, unless they are at increased risk of cardiovascular disease, breast cancer or other estrogen-sensitive cancers.
The pendulum has swung widely from the perception that hormone therapy is good for all women to the perception that its all bad for all women, to now a more appropriate place in between where hormone therapy is perceived to be good for some but not all women, Manson says. Were recommending that hormone therapy be used for the duration that its needed to address symptoms at the lowest effective dose and with ongoing reassessment of the balance of risks and benefits.
The time to start therapy is as soon as the symptoms start. Intervening earlier, rather than later, actually seems to carry less risk, Santoro says.
Once symptoms start, they are unlikely to get better soon. On average, the menopause transition lasts about four years, Santoro says. Some women have symptoms that persist even longer, however. Although there are exceptions, most women wont go through menopause before 45, Santoro says.
If youre 45 or older and starting to have hot flashes, night sweats or mood or sleep changes, it could be your hormones and it might be time to start some active management, she says.
Concerns Over The Safety Of Hrt A History
HRT was first available in the 1940s but became more widely used in the 1960s, creating a revolution in the management of the menopause. HRT was prescribed commonly to menopausal women for the relief of their symptoms such as hot flushes, night sweats, sleep disturbances, psychological and genito-urinary problems urinary frequency and vaginal dryness and for the prevention of osteoporosis.
In the 1990s two of the largest studies of HRT users were undertaken, one clinical randomised trial in the USA and one observational questionnaire study in the UK . The published results of these two studies during 2002 and 2003 raised concerns regarding the safety of HRT. These safety concerns revolved around two main issues: 1) that the extended use of HRT may increase the risk of breast cancer and 2) that the use of HRT may increase the risk of heart disease.
The results of the studies received wide publicity, creating panic amongst some users and new guidance for doctors on prescribing.
After the results were published, the UK regulatory authorities issued an urgent safety restriction about HRT, recommending that doctors should prescribe the lowest effective dose for symptom relief, should use it only as a second line treatment for the prevention of osteoporosis, and advised against its use in asymptomatic postmenopausal women.
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