Views Of The Menopause Societies/regulators
The conventional regulatory view is that compounding can only be justified when a medicine has to be created because the strength, concentration, or dosage form that is required for a specific patient is not commercially available.
The 2015 NICE NG23 menopause diagnosis and management guideline 1.4.15 stated Explain to women that the efficacy and safety of unregulated compounded bioidentical hormones are unknown.
The 2016 Revised Global Consensus Statement of the key stakeholder societies1 , initiated by the International Menopause Society, advised that custom-compounded hormone therapy is not recommended because of lack of:
- rigorous safety and efficacy testing
- batch standardisation
- purity measures.
A BMS statement published online in 2017 stated Trustees and Members of the MAC of the BMS are concerned about the safety of unregulated bioidentical hormonal therapy which is being prescribed by clinicians who do not usually have any recognised menopause training and provided from compounding pharmacies.
History And Facts About Bioidentical Hormone Replacement Therapy
The North American Menopause Society reports that about 1.4 million women now use BHRT treatments, which is around 40 percent of all prescriptions for hormone therapy in women who are menopausal or postmenopausal.
To date, no large, long-term study has been done to determine the adverse effects of bioidentical hormones, so safety concerns remain a serious issue. The Womens Health Initiative, one large, long-term study that tested the effects of FDA-approved hormone replacement drugs, determined that side effects are possible in some patients and that these drugs have not been proven to prevent any diseases. That being said, millions of women have reported improvements from using hormone replacement drugs.
As described above, one concern with the use of BHRT is using a custom-mixed solution that has not been FDA-tested. According to the FDA, other concerns can include disguising/leaving untreated symptoms that are really caused by another illness or potential side effects like raising the risk for blood clots, stroke, gallbladder disease, vision changes, skin changes, mood swings, and possibly heart disease or breast cancer. As of now, the FDA has also never approved any drug containing estriol, so keep in mind that benefits associated with products containing this hormone remain especially unknown.
Claim : Compounded Bht Has A Lower Breast Cancer Risk Than Fda
Observational studies and the WHI HT trial have established an association between HT and an increased risk of breast cancer.3,37 Advocates for CBHT have claimed that estriol, given its decreased estrogenic activity, is not only safer but also associated with a decreased breast cancer risk. Some sources found on Internet sites go so far as to claim that it protects against cancer, yet no controlled trials substantiate this claim. Moreover, concerns have been raised about the continued use of estriol in high doses and its potential risk for stimulating breast parenchyma.38 It is unknown whether the increased risk of breast cancer in the E+P arm of the WHI vs the estrogen-only arm was the result of the addition of a progestin, the specific combination and dosage of E+P that was used in the trial, or the specific type of progestin that was used.27
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When Do Results Become Evident
Each individual will experience the results of bioidentical HRT differently, which also means their time frames for symptom relief differ as well. Some symptoms may be impacted immediately, while others may improve steadily over a period of three to six months. You can expect to reach normal levels of hormones within six months of starting your regimen. Again, this time frame varies from person to person, but let us know if youre not getting any relief from symptoms at all.
Is Bioidentical Hormone Replacement Therapy Approved By The Fda
This therapy is a not a new approach to hormone replacement it has been used since the 1930s. Bioidentical hormones are legal to prescribe and use in the US, although the FDA has not given its specific approval. The lack of FDA approval is because there are no official placebo-controlled studies to prove whether bioidentical hormones are safer than standard hormone replacement therapy.
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Discussion Point #: Fda
FDA approval indicates that an agent has undergone extensive testing, scrutiny, and standardization. First, the manufacturer must submit safety and efficacy data. Then, the product is standardized for purity and potency with a minimization of batch-to-batch variation. The FDA then conducts analyses after marketing, during which reporting of adverse events continues. Approval can be revoked for safety concerns. The FDA-approved bioidentical hormones have met the requirements above. The North American Menopause Society provides an excellent summary of different types of FDA-approved HTs.
Custom-compounded hormones are regulated by states boards of pharmacy and there are specific guidelines for appropriate use, but they are not subject to the same federal laws. There seems a lack of systematic tracking and reporting of side effects. Most patients who opt for compounded hormones believe they are safe, thus spawning an inherent bias against reporting side effects. This underreporting is misinterpreted by many women to mean that there are no side effects. Women must exercise caution when interpreting safety information.
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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Claim : Custom Cbht Contains Safer Ingredients Than Fda
The production of US Pharmacopeia ingredients begins with the extraction of diosgenin from plants such as soy and yams.32 A chemical conversion is then required to produce progesterone, which is the precursor to the estrogens and the androgens that are used to formulate the final compounded product.32 This derivation and production process is similar to that of many commercially available, FDA-approved BHT products for which safety and efficacy data are available.
Top Five Reasons Doctors May Prescribe Compounded Hormones For Women
For women like Laurie, relief from the sometimes debilitating effects of menopause often can be found in bio-identical hormone replacement therapy available by prescription as either commercially available manufactured products or as compounded medication prepared by a pharmacist. The aim of either therapeutic approach chosen by the prescriber is to improve the overall health and well-being of the patient, whose hormones are out of balance.
Three years ago, I started menopause and I had horrible hot flashes/sweats and the insomnia ruined my quality of life.
Laurie T., Bolivar, Ohio
Compounded hormones provide patients with an individualized experience that stems from the customization of not only the strength of the hormones, but also in the delivery system options. Plus, physicians and pharmacists have the ability to combine hormones into a single dosage form through compounding.
Here are the top five reasons doctors may prescribe compounded hormones for women.
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Do You Combine Other Treatments With Bioidentical Hrt
Yes! Patients often use our mineral and vitamin infusions to increase the benefits of Bioidentical HRT. We have a variety of nutrient injections available, including B12, glutathione, amino acids, and lipotropic compounds. We provide nutrient injection kits that you can use at home so that you do not need to come into the office to receive them. Injections allow the nutrients to be fully absorbed rather than ending up as waste. We do require a consultation before starting at-home injections.
How To Talk To Your Doctor
I receive letters almost daily from women who have taken the initiative to offer their health care providers information on bioidentical hormones. If you want to use bioidentical hormones as replacement therapy, here are the salient points to know and share with your doctor about bioidentical hormones:
- They have been prescribed by doctors for many years.
- They are readily available through formulary pharmacies.
- They are easily titrated to suit a womans individual needs.
- They are readily absorbed and utilized.
- They are safe and effective.
Many formulary pharmacists work in partnership with physicians to provide individualized hormone-replacement solutions. You may want to call a local formulary pharmacy to consult with a knowledgeable pharmacist to develop your customized plan.
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Mistaken Fears About Hrt/mht
There have been reports in the media about the risks of HRT in relation to cancer, further illness and disease.
However, over the past few years, re-evaluation of the data from the Women’s Health Initiative, and recent comprehensive reviews of evidence on HRT, have found HRT is both an effective and a safe treatment for the relief of menopause symptoms, and prevention of osteoporosis, for healthy women.
Women who may be at risk if they take HRT whether traditional or bioidentical include those who:
- have previously been diagnosed with breast cancer
- have previously been diagnosed with cardiovascular disease
- had a venous thrombosis, or deep vein thrombosis .
As bioidentical hormones have not undergone rigid long-term clinical trials, it is not clear whether long-term use may cause health issues. A Cochrane review stated that “no data are yet available about the safety of BHT with regard to long-term outcomes such as heart attack, stroke and breast cancer”.
Navigating The World Of Hrt
The types of HRT can be very confusing for women, with terms like traditional body-identical, ‘nature-identical, bio-identical and compounded HRT being bandied about, with some claiming superior effectiveness and lower side-effects than others. Let us help you navigate the world of HRT.
In the USA, the original the only licensed form of HRT available on a prescription was made from horse urine. It came under the name Premarin . It was available as a tablet either on its own or with another ovarian hormone added in. These products have names like Prempak-C, Premique, Premique Cycle 10, etc. and they were very popular in Ireland too. Horse Oestrogen or Equine Oestrogen as it is called, is really effective at controlling menopause symptoms but can be quite strong and some women experience unwanted side effects while using it. Furthermore, many women didnt like the idea of using a hormone that involved animal cruelty.
There are many other forms of HRT available around the world that do not involve horses!
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Can Bioidentical Hrt Be Obtained Through A General Physician
Usually, the answer to this question is no. General physicians do not have the time to invest in becoming experts at bioidentical HRT. They are trained to provide traditional HRT and only in instances where the benefits outweigh the risks. Our specialists have undergone extensive training to fully understand bioidentical hormones and how to use them to treat a variety of symptoms. We are the best source for this treatment due to our specialized knowledge of bioidentical medicine.
Custom Compounding Is Misleading
To buy bioidentical hormones, you cant 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 womens 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.
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Where Do The Actual Bio
Most bio-identical hormones come from natural plant sterols that are derived from soy and/or wild yams. Plants such as soy and wild yam have pre-cursor molecules known as phyto-hormones that can be easily converted into bio-identical hormones such as estrogen, progesterone, testosterone, etc. These are taken to a laboratory where they are converted chemically, or semi-synthesized to hormones that are identical and indistinguishable from the bodys own.
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!
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Melissa Hernandez Msn Aprn Fnp
San Antonio Bio-identical Hormones Specialist, Melissa Hernandez, APRN, at Hormone Rejuvenation Center uses advanced anti-aging protocols, such as bioidentical hormone replacement therapy to increase vitality and improve the overall quality of life.
Melissa Hernandez, APRN endeavors to listen to patients needs and concerns, while really taking the time to evaluate lifestyle factors, social habits, stress levels, environmental factors, and hormonal balance.
After taking all of a patients history and current health factors into consideration Melissa Hernandez, APRN will develop a customized treatment plan to suit the individual.
At the Greater San Antonio based clinic, patients can feel confident that they will receive comprehensive care in a warm and caring environment, and Melissa Hernandez, APRN will use only the most effective treatment protocols to help patients recover their health and wellness.
How And When Are Bio
Men and women often start experiencing systems of hormone imbalance between the ages of 35-40. If you decide to begin BHRT, your physician will run a series of tests and will work in conjunction with a compounding pharmacy to create your personalized treatment approach. Bio-identical hormones are typically compounded in the following forms: capsules, injections, suppositories, gels or creams.
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Side Effects And Risks Of Bhrt
While the FDA has approved some preparations of bioidentical estradiol and progesterone, it hasnt approved any compounded bioidentical hormones. There are claims that bioidentical hormones are safer and more effective than traditional HRT because theyre identical in structure to those produced in the body. But these claims have not been confirmed by large-scale, reputable studies. The FDA urges caution when using compounded products.
Research has shown that hormone replacement therapy in general may increase the risk for certain conditions and diseases including:
Talk to your doctor about which form may be best for you and your lifestyle. Youll likely need to be monitored regularly once you begin BHRT to evaluate your bodys response. However, the FDA cautions against monitoring hormone levels via blood and saliva tests. These only tell you your hormone levels at a moment in time and can vary widely throughout the day.
The FDA recommends that if you do choose any form of hormone therapy that you use the lowest dose that produces results. The FDA also says you should use it for the shortest length of time possible.
How Bioidentical Hrt Works
Before you begin any type of HRT, you must obtain an accurate measurement of your hormone levels. Therefore, this is the first step in understanding how bioidentical HRT works. At our clinic, youll receive a technologically advanced hormone test through blood, saliva, and/or urine to determine if you have a hormone balance and if we believe that bioidentical HRT will be beneficial for your needs. In some cases, we may recommend other treatments for your symptoms.
Once we determine your specific needs based on your symptoms and measured hormone levels, we will develop a custom treatment plan that includes the exact dosages your body needs. These are not mass-produced hormones that can be used in the same doses for everyone. Compounding pharmacies that produce bioidentical hormones will receive a prescription for creating the bioidentical hormones that youll use during treatment. No other person will have the exact same prescription as you.
After you receive your prescription in the form determined to be best for your lifestyle, youll begin taking your personalized doses. The deficiencies in your hormone levels will gradually disappear as the replacement hormones increase your levels to normal. Since these hormones are exact replications of the ones you already produce, your body wont reject them and there will be fewer side effects. Over time, your bodys hormones will be restored to their optimal levels, thereby alleviating your symptoms.
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Hormones That Are Replicated
Any hormone that is naturally produced by the body can be replicated in a compounding pharmacy using plant derivatives, usually from yams and soy products. The most commonly replaced hormones in BHRT are estrogen, progesterone, testosterone, DHEA, triiodothyronine , thyroxine , and melatonin. The specific hormones you will replace are dependent on a test that measures which ones are deficient. We will measure your hormone levels at your initial appointment through a blood, saliva, and/or urine test.