Why Are These Restrictions Happening Now
The FDA has always had the authority to regulate the substances used in making compounded drugs however, until now, the agency has chosen to leave oversight to the states. Now, all of a sudden, the FDA has decided to regulate substances used in compounding. By doing this, the FDA is, in effect, regulating the practices of medicine and pharmacy rather than regulating the drugs being prescribed and sold. In my opinion, this is a huge overreach of power, and it waves a big red flag for me during this time of increasing government control over our bodies and our lives.
Further, the committees calling for the education of health care providers and pharmacists who currently prescribe, compound, and dispense cBHT is nothing more than a thinly veiled threat against these practitioners, who will be forced to practice medicine the way Big Government and Big Pharma dictate or risk losing their licenses and practices.
And, according to a newly proposed rule on September 5, 2020, it appears that the FDA is on a mission to ban other compounded natural therapies as well, including homeopathic remedies and natural substances, such as curcumin, that have been proven safe and effective for decades!
Birth Control Pills Vs Bioidentical Hormones
Lastly, it’s worth touching upon birth control pills and how they fit into the conversation.
You may be wondering whether or not birth control pills are bioidentical given that they are frequently prescribed by doctors without a second thought.
The answer is NO.
And here is where things get interesting.
Doctors have no problem prescribing birth control pills to YOUNG women which are filled with Frankenstein hormones that “look” like estrogen and progesterone.
And, by the way, these birth control pills contain doses that are so high that they completely shut down your body’s ability to produce its own estrogen and progesterone as a side effect.
But then these same doctors absolutely REFUSE to prescribe bioidentical progesterone to women who are in menopause and have depleted levels of both estrogen and progesterone.
They won’t even prescribe LOW DOSE bioidentical estrogen or progesterone for these women citing the “dangers” of such therapy.
Do you see the problem here?
These doctors are perfectly fine prescribing high doses of fake hormones to women which are associated with all sorts of risks, including an increased risk of breast cancer .
But won’t do the same for women who actually need it.
When it comes to birth control methods, the use of bioidentical hormones doesn’t really come up.
You can use bioidentical progesterone to help with some hormone imbalances, but you wouldn’t want to use it to prevent conception.
How Are These Hormones Different From The Ones In Standard Hrt
Bioidentical hormones are as more ‘natural’ the big selling point to bioidentical hormones is that they are supposed to be the more natural option to HRT, because they are chemically identical to the hormones produced by your body. However, what many people dont realise, is that:
Standard HRT does contain hormones that are identical to our own hormones, and most importantly they are regulated for safety. Dr Heather Currie, chair of The Menopause Society
Many of the standard HRT medications actually do already use hormones that are bioidentical.
Doctors don’t see a medical difference many doctors believe that, in fact, the effects of HRT and BHRT are very similar they carry the same health risks and have similar side effects. The main difference is that HRT is heavily regulated, whereas not all of BHRT is. This is a potential safety issue because the risks associated with unregulated medications are not known, and the levels of the hormones in each product are not controlled.
You doctor can explain bioidentical hormones to you in person if you are interested in bioidentical hormones as a plant-based alternative to HRT, talk to your doctor in the very first instance. They will be able to advise you in your specific situation, and advise you on whether or not the treatment is safe.
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What Are The Signs Of Hormonal Imbalance
Because hormones are so widely used throughout your body, many different signs can point to an imbalance. Both men and women may experience the following signs: weight gain, fatigue, muscle weakness, sweating, frequent urination, decreased sex drive, depression, thinning of hair, irritability, and more.
These signs are common with people who are experiencing hormone imbalance. However, they are also nonspecific and can point to many different things. Just because you have one of these symptoms, doesnt necessarily mean you have a hormonal imbalance.
Many Conventional Mhts Contain Hormones Identical To Those Produced In The Body
When using MHT, you can be assured the safety and effectiveness of the products has been widely tested and you can avoid the uncertainty and potential dangers of compounded BHTs. In most cases, MHT is also cheaper. If you wish to use products containing pharmaceutical-grade body-identical hormones, the following approved and regulated products are available in Australia and New Zealand:
- oestradiol as tablets, transdermal patches or gel and as a vaginal treatment
- progesterone as capsules in Australia and NZ .
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Testing For Hormonal Imbalance
Diagnosing hormonal issues can, at times, be difficult. If you suspect that you are experiencing symptoms common with hormonal imbalances, start tracking your symptoms and maintaining a list of medications.
Make an appointment with your doctor for a physical exam. Be prepared to answer questions similar to:
- Are you more stressed than usual?
- How often are you experiencing symptoms?
- Have you lost or gained weight recently?
- Does anything help to relieve your symptoms?
Depending on your answers to some of these questions, your doctor may set up some different tests: blood tests, pelvic exams, ultrasound, thyroid scan, MRI, x-ray, sperm count test, biopsy, etc.
If you do have a hormonal imbalance, one of these tests should tell your doctor whats going on. Following your testing, you can discuss a treatment option.
Understanding Bioidentical Hormone Replacement Therapy
It has been said that everything gets better with age. While that may be true for fine wine or cured meats, the adage is less accurate when applied to human body.
For many people, middle age is when the body begins to show the wear and tear of the years gone bysigns of aging commonly related to hormonal imbalances. As you age, production of your natural hormones may be impaired. The body may produce too little of one hormone and too much of another. When hormone levels are below normaland keep in mind that normal is different for every personuncomfortable symptoms appear and unhealthy conditions or diseases may develop. Your quality of life diminishes and you wonder if you can ever reclaim that vibrant, energized person you were just a few short years, or perhaps even, just months, ago.
Bio-identical hormone therapy can help you feel better.
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Are Compounded Bioidentical Hormones Bad
There are risks to taking the compounded hormones. But in some cases, they might be the better choice. They might be needed to get the right source , dose or mix of hormones for a patient. Also, a patient might have a bad reaction to the pre-made form. Your doctor will know which type is better for you.
Bioidentical Or Natural Hormones
Bioidentical hormones are hormone preparations made from plant sources that are promoted as being similar or identical to human hormones.
Practitioners claim these hormones are a “natural” and safer alternative to standard HRT medicines.
However, bioidentical preparations are not recommended because:
- they are not regulated and it’s not clear how safe they are there’s no good evidence to suggest they’re safer than standard HRT
- it’s not known how effective they are in reducing menopausal symptoms
- the balance of hormones used in bioidentical preparations is usually based on the hormone levels in your saliva, but there’s no evidence that these levels are related to your symptoms
Bioidentical hormones are not the same as body identical hormones. A body identical hormone, or micronised progesterone, can be prescribed to treat menopausal symptoms.
Many standard HRT hormones are made from natural sources, but unlike bioidentical hormones, they’re closely regulated and have been well researched to ensure they’re as effective and safe as possible.
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What You Can Do To Protect Your Health Freedom
Frankly, I trust Mother Natures millions of years of wisdom much more than I trust 50 years of biochemical wizardry from Big Pharma. If you feel the same way and want to be able to preserve your freedom of choice when it comes to your body and your health and stop the FDA from banning bioidentical hormones and other safe, natural therapies , one of the best things you can do is write to your senator, representative, and the FDA. Here is a letter created by the Alliance for Natural Health USA that you can use. Another thing you can do is join Millions Against Medical Mandates, an organization fighting for your rights to medical freedom and bodily autonomy. The Childrens Health Defense is another wonderful organization founded and run by Robert F. Kennedy Jr.
Have you tried bioidentical hormones? What was your experience? Do you think the FDA is wrong in banning bioidentical hormones? Leave your comments below.
Whats The Difference Between Natural And Bioidentical Hormones
All hormones are natural. But what most women mean when they say they want natural hormones is that they are interested in using bioidentical hormones. The distinction is that bioidentical hormones are identical in their molecular shape, makeup, and structure to hormones made in the human body. This is what makes bioidentical hormones the perfect keys to unlock the bodys receptor sites. In other words, its the shape of the molecule not the source.
Today, most women know that, while natural, the hormone Premarin, which is marketed as Prempro when combined with the synthetic progestin Provera, is not bioidentical. My colleague, the late Dr. Joel Hargrove, used to say, Premarin is a natural hormone if your native food is hay! Thats because its made from conjugated mare urine. Provera does not occur naturally in nature. It is used as a substitute for bioidentical progesterone. Pharmaceutical companies do this because they cannot patent a naturally occurring hormone!
If you are in doubt as to whether a particular product offered to you by prescription is bioidentical, check the label. If it lists esterified estrogens, progestins, or progestogens, the product is not bioidentical. You can also research the products you may be considering, as many have their own websites.
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Which Bioidentical Hormones Should You Take
The molecules naturally produced in the human female body for which we most often seek replacement include:
- Estrone , estradiol , and estriol
- Progesterone
- Testosterone
- DHEA, an adrenal precursor to testosterone.
These truly natural hormones are available by prescription. Estradiol is available as Estrace pills, Estrace vaginal cream, or transdermals as the Vivelle Dot, and Climera. (Pharmaceutical companies have been able to patent the delivery system on these hormones, though the hormone itself is still bioidentical. Estriol is available only through formulary pharmacies. Most women do fine with just estradiol plus or minus some progesterone. And sometimes a bit of testosterone, which is available by prescription as AndroGel.
Bioidentical Hormones: Potential Benefits And Risks
04 November, 2021
Bioidentical hormones are man-made compounds. Some are derived from plants, although experts claim these are similar to those produced by the human body. Theyre used to treat patients whose hormone production is below the normal range.
Theyre also said to provide several benefits and are more effective as a natural solution. However, studies dont support these supposed advantages.
In this article, well review all the implications related to bioidentical hormone treatment, explaining what they are, how they work, their benefits, risks, and possible side effects.
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Hormonal Imbalance And Age
For adults, men and women may start to experience hormonal imbalance around the same time: 45-55 years old. This is the time when most women are going through menopause and middle-age has set in. For children, they also may experience hormonal imbalance during puberty.
Puberty is different for every single person. Many children can have delayed puberty while their peers are developing much faster. In some cases, though, a condition called hypogonadism can signal a hormonal imbalance.
Boys with this condition may experience a voice that doesnt deepen, lack of body hair, lack of development of muscle mass, etc. For girls with this condition, they may experience: menstruation doesnt begin, breast tissue isnt developing, and their growth rate doesnt increase.
Claim : Compounding Provides Improved Delivery And Tolerability Of Ht
Compounded medications require a written prescription from a licensed physician. Prescriptions filled in a compounding pharmacy are prepared, mixed, and assembled according to the specifications of the prescriber. Compounding plays an important role in providing drugs to meet the individualized needs of patients that cannot be met by a commercially available FDA-approved preparation. It may provide a different strength, dose, or delivery system, or it may allow a medication that is otherwise poorly tolerated to be essentially reformulated and delivered in an alternative form ., Compounded hormone preparations are not required to undergo the rigorous safety and efficacy studies required of FDA-approved HT and can demonstrate wide variation in active and inactive ingredients.
The oversight of accredited compounding pharmacies falls to state pharmacy boards, which are to direct the method of preparation and enforce standards for compounding as dictated by the US Pharmacopeia. Thus, most compounded products do not have scientifically rigorous clinical testing for either safety or efficacy., A limited FDA survey in 2001 analyzed 29 product samples from 12 compounding pharmacies. None of the products failed identity testing however, 10 of the 29 failed 1 or more quality test, and 9 of the 10 failing products also failed potency or assay testing. For FDA-approved therapies, the usual comparison failure rate is less than 2%.
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Bioidentical Hormone Replacement Therapy For The Menopause
Bioidentical hormone replacement therapy is used to treat both men and women when their hormone levels drop or become unbalanced. Its most frequently used to ease the symptoms of perimenopause and menopause in women, and this is what we specialise in here at The Menopause Clinic.
Recent research has shown that women are experiencing perimenopause and menopause at much earlier ages than is predicted, and sometimes by the age of 40, a woman can be totally depleted of normal levels of estrogen, have lost almost all their progesterone, and have lost more than half of their testosterone. These fluctuating levels and hormone imbalances can cause serious health issues in some cases, and its for this reason that we really encourage patients not to wait until symptoms are strong before getting their hormone levels assessed.
Delivery Formats Of Bhrt: Why It Matters
We recently wrote about one small study which discussed the reasons why more women today are turning to compounded BHRT for menopause-related symptoms, and finding it effective.
The effectiveness of a given treatment may vary depending on factors such as:
- The patients age and risk profile
- The patients specific symptoms
- The patients preferences and wellness goals
- The combination of hormones offered
- The dosage amount
- The format of the treatment
Tailored prescriptions and individualized treatments are central to BHRT therapy, and this often requires a fine-tuned approach to see results.
Thus, its essential that health practitioners have a solid grasp on the different ways that these formats are used, and understand the benefits and drawbacks of each.
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Impact Of Bioidentical Hormone Replacement Therapy On Your Health
People need to take replacement hormones for different reasons. Sometimes, itâs due to old age or life changes, like menopause. Taking certain hormones your body no longer makes can help improve your health and overall well-being.
Without a proper balance of hormones, your body can go through unpleasant symptoms. Replacing the hormones you no longer produce with doctor-prescribed bioidentical hormone replacement therapy can reduce symptoms and help you achieve a better quality of life.
BHRT can help with the following symptoms:
- Weight gain
- Difficulty sleeping
While hormone therapy can offer its share of benefits, there are also some risks involved. People who undergo not just BHRT â but any hormone therapy â can be at risk to develop blood clots and gallbladder disease. It can also increase your risk of stroke and breast cancer.
As with most hormone therapies, there is an adjustment period when you first start taking a course. Side effects can appear within the first few weeks and subside as your body adjusts to the new hormone level.
Some of these side effects can appear when you begin BHRT:
- Weight gain
What Do Bioidentical Hormones Do For You
Reversing the signs and discomforts of aging is just one benefit of bioidentical hormone therapy. Diseases and conditions, such as thyroid disorders, erectile dysfunction, insomnia, depression, anxiety and muscle weakness may be treated with bioidentical hormone therapy. In some cases, low energy, weight gain and muscle loss are attributed to hormone imbalance and may be addressed with a comprehensive treatment plan that includes bioidentical hormone therapy.
Treatment plans may include therapy using estrogen, progesterone, testosterone or a combination of hormones. For specific conditions, such as thyroid disorders, thyroid-stimulating hormone , triiodothyronine , and thyroxine may be supplemented.
The hormones of the human body are designed to work in perfect harmonyquantity of available hormone is essential to perfect function. As the body ages or is plagued by a disease that alters hormone production, one or two hormones can fall out of sync. Your bodys efforts to function with the imbalance can lead to discomfort, disease, or a diminished quality of life. Bioidentical hormones can do for you, what synthetic treatments cannot. They can ideally replicate and replace the missing hormones in your body, restoring optimal function, not just achieving some obscure standard of normal.
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