Saturday, September 23, 2023

How Safe Are Bioidentical Hormones

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What Are Progesterone And Estrogen

Are Bioidentical Hormones Safe? | Holtorf Medical Group

The female hormone progesterone has many benefits to the body, including easing anxiety, promoting memory, and helping to prevent the overgrowth of certain types of cells. The prevention of the overgrowth of cells can also help prevent some breast and uterine cancers, as well as endometrial problems. Progesterone also may improve the quality of sleep.

Estrogen has an effect on many functions of the body, including cognitive health, bone health, and the cardiovascular system. There are three main types of estrogen: estradiol, estrone, and estriol . Estrogen enables the ovaries, vagina, breasts, and uterus to function optimally. The levels of estrogen in the womans body fluctuate as they complete their cycles.

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. 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 patients knowledge 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 .

Additional Resources On Bioidentical Hormones

For information about compounded hormones or to locate a pharmacy that provides individualized prescriptions, visit the Alliance for Pharmacy Compounding.

American Hormones, Inc., founded by Erika T. Schwartz, M.D., renowned expert in the field of natural hormones, offers concierge medical services, including high-quality pharmaceutical-grade hormones shipped nationwide and internationally. The website has extensive information on bioidentical hormones.

There are also many books that you can consult. My books, The Wisdom of Menopause and Womens Bodies, Womens Wisdom provide in-depth information. I also recommend reading The 30-Day Natural Hormone Plan, by Erika Schwartz, M.D. New Menopausal Years, The Wise Woman Way: Alternative Approaches for Women 3090, by Susun S. Weed and TCM: A Womans Guide to a Trouble-Free Menopause, by Nan Lu, O.M.D., L.Ac., with Ellen Schaplowsky.

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No Reported Adverse Events From Bio

Over-the-counter pain pills such as aspirin, naproxen and ibuprofen are considered fairly safe. After all, you dont need a prescription to buy them, yet they cause an estimated 16,500 deaths in the US annually, mostly from gastric bleeding according to Micheal Wolfe in the New England Journal Compare this to no reported adverse events from bio-identical hormones last year, according to an FDA Press Conference on Bioidentical Hormones Jan 2008.

Not An Elixir Of Youth

Bioidentical Hormones Risks and Side Effects

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.

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The Difference Between Synthetic And Natural

While we are on the topic of bioidentical hormones, we should also spend some time talking about the difference between synthetic hormones and natural hormones.

Most people automatically make the assumption that any hormone which is “natural” is automatically better than one that is “synthetic”.

But what you may fail to realize is that you can have a bioidentical hormone that is synthetic and a non-bioidentical hormone that is natural.

In other words, the term natural or synthetic shouldn’t really play a role in which hormone you are using.

Instead, whether or not it is bioidentical should always take precedence over the source of that hormone and whether or not it is “natural” or “synthetic”.

The term natural and synthetic only refers to the SOURCE of that hormone.

“Synthetic” hormones, also referred to as artificial hormones, are created in a laboratory.

These are manufactured and designed using chemical processes that result in a target compound.

This target compound can either be bioidentical or not. The term synthetic doesn’t automatically mean that the hormone created is one way or the other.

Take Synthroid or Estrace , as an example. Both of these compounds are synthetic in that they were manufactured in a laboratory, but they are still bioidentical because they exact copies of the hormones that your body produces naturally.

Other synthetic hormones that are bioidentical include Humulin , and Cortisone .

Take, for instance, the prescription medication Premarin.

How To Get Started On Hrt

Speak to a GP if you’re interested in starting HRT.

You can usually begin HRT as soon as you start experiencing menopausal symptoms and will not usually need to have any tests first.

A GP can explain the different types of HRT available and help you choose one that’s suitable for you.

You’ll usually start with a low dose, which may be increased at a later stage. It may take a few weeks to feel the effects of treatment and there may be some side effects at first.

A GP will usually recommend trying treatment for 3 months to see if it helps. If it does not, they may suggest changing your dose, or changing the type of HRT you’re taking.

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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 .

Risks Of Using Bioidentical Hormones

Bioidentical Hormone Pellet Therapy is Safe and Effective

According to studies, bioidentical hormones havent only been shown to not have any advantages, but they also lack oversight from the respective health

However, there isnt any research that specifically states that theyre potentially more dangerous. They arent either safe or unsafe. Experts simply urge caution when using them.

Researchers believe that this type of replacement treatment carries the same risks as other forms of hormone therapy. Such potential side effects include the following:

  • Headaches

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Bioidentical Hormone Therapy Benefits

Bioidentical hormone therapy can majorly impact how you feel and function daily. Most of the women and men notice a significant improvement in mood and energy but also an increase in lean muscle mass while reducing fat. With proper diet and exercise, its easier to lose weight and keep it off.

With bioidentical hormone therapy, the benefits can be felt as soon as a few days to a few weeks. Peak absorption happens within 4-5 weeks. Hormones are often reassessed within a number of weeks to ensure the proper dosage is being administered. The optimal level generally is reached within 3-4 months.

Oprah And Bioidentical Hormones: Faq

Oprah Is Talking About Bioidentical Hormones for Menopause Experts Weigh In

Bioidentical hormones are one form of therapy for menopausal symptoms. Winfrey, who turns 55 this month, writes in February’s edition of O, The Oprah Magazine that she felt “out of kilter” and had “issues” for two years that she suspected were hormonal. Upon a friend’s recommendation, Winfrey went to a doctor who specializes in hormones.

Winfrey writes that the hormone specialist told her that her “hormonal tank was empty” and gave her a prescription for bioidentical estrogen.

“After one day on bioidentical estrogen, I felt the veil lift,” Winfrey writes. “After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper. I was literally singing and had a skip in my step.”

Winfrey isn’t recommending bioidentical hormones for every menopausal woman. Instead, she urges women to “take charge of your health” and says it’s time to “start the conversation” about menopause and bioidentical hormones.

Oprah writes that bioidentical hormone therapy is controversial and confusing to many people.

What’s the controversy about? Are bioidentical hormones better or safer than other hormone therapy? WebMD has answers from experts.

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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 .

Adverse Event Data For Cbht

Bioidentical Hormone Pellet Therapy is Safe and Effective ...

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

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How To Stop Taking Bioidentical Hormones

Most doctors recommend that you limit your hormone replacement therapy to a maximum of five years. Stopping hormone replacement therapy suddenly can cause a dramatic return of menopausal symptoms overnight. Gradually weaning yourself off bioidentical hormones, with the help of your doctor, is the safest way to stop hormone replacement therapy.

Whether youre starting or stopping hormone treatment, your doctor will closely monitor your hormone levels with regular check-ups to make sure your levels are in a healthy range for your physiology. You may need regular blood, urine, and saliva tests to determine your current hormone levels.

Your doctor will explain when and how to stop taking bioidentical hormones. Do not try to stop on your own. Safely weaning off bioidentical hormones can take as long as three months. Be patient with yourself, get plenty of rest, and maintain a healthy diet to nourish your body. Make a note of your changing symptoms as you stop treatment, and see your doctor regularly through this transition.

Increased Vs Lowered Risks

The WHI has found that women in the study who took estrogen and progesterone in combination had an increased risk of coronary heart disease, stroke, deep vein thrombosis and breast cancer, but women who took estrogen alone actually had reduced risks of coronary heart disease and breast cancer. All of the women who took hormones had reduced risk of colorectal cancer, fractures, diabetes and all-cause mortality.

Those increases in heart disease and breast cancer risk sound scary, but in absolute numbers, the risks are pretty small, Manson says.

An analysis of the WHI data Manson and her colleagues published in 2017 found that women in the study who used hormone therapy for five to seven years did not have an increased risk of all-cause, cardiovascular or cancer mortality during the 18-year follow-up. And for women in their 50s, there was actually a trend toward a reduced risk of mortality, Manson says.

But perhaps the most important thing to understand, Manson says, is that the WHI was not designed to look at hormones used to address menopause symptoms. Instead, it was examining whether they could reduce chronic conditions such as stroke, heart disease and cognitive decline. It is like the difference between asking whether aspirin is safe to take for a headache vs. whether it is safe and effective to take it on a daily basis in hopes of preventing heart attacks.

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Time For A Change In Direction Before Prescribing

Requiring package labeling would be a good starting point, they said.

“We think any dispensation of hormone therapy should be accompanied by package labeling,” said Dr. Stuenkel. In the JAMA Internal Medicine paper, they referred to that as ”the easiest shortcoming to remedy.”

Additionally, the authors indicated that in 2003, the FDA stipulated that ”in the absence of evidence to the contrary, all approved menopausal hormone therapy products should be considered to have the same risks as those evaluated in the WHI and include the same boxes warnings .”3

That means, of course, that even low-dose vaginal estrogen therapies, with little if any systemic absorption, ought to include the same warnings about heart attack, stroke, blood clots, breast cancer, endometrial cancer, and dementia.

The physicians are proposing that cBHT products should be labeled as not having FDA approval and that the risks of using these products are unknown .

Why Bioidentical Hormones Could Be Banned In The Near Future

Bioidentical Hormones: Are they Safe?

If you are reading this blog, you are most likely interested in natural hormones and other therapies as a way of maintaining your health. Perhaps you have used some or all of the bioidentical hormones I mention above. And maybe you even prefer these proven therapies over prescription drugs and over-the-counter medications to treat illnesses.

If so, here is something you need to know: On July 9, 2020, the FDA made an announcementseemingly out of the bluestating that bioidentical hormones are a public health concern and that a ban is likely. This statement could not be more false. All estrogensbioidentical includedthat bind to the alpha estrogen receptor can act as growth promoters in estrogen-sensitive tissue, including breast and uterine tissue. This is why some women prefer herbal approaches instead. However, bioidentical hormones have long been found to be safer and more effective than their pharmaceutical counterparts. In fact, a review of the studies found that compounded bioidentical hormone therapy is associated with lower risks of breast cancer and cardiovascular disease and is more effective than synthetic or animal-derived hormones. And there are many women who have comfortably stayed on low doses of bioidentical hormones for years with great results.

Finally, the committee recommends increased oversight of traditional pharmacies by the federal government and the State Boards of Pharmacy to ensure quality standards for every cBHT preparation dispensed.

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Safety And Efficacy Issues

Because of a lack of FDA oversight, most compounded preparations have not undergone any rigorous clinical testing for either safety or efficacy, the purity, potency, and quality of compounded preparations are a concern. Over a 6-month period, the FDA performed repeat analytic testing of 29 Internet-ordered samplesincluding estradiol and progesteronefrom 12 compounding pharmacies 8. Although none of the preparations failed identity testing, 10 of the 29 preparations failed one or more standard quality tests performed, including potency testing. In contrast, the analytical testing failure rate for drug therapies approved by the FDA is less than 2%.

Because of variable bioavailability and bioactivity, underdosage and overdosage are both possible. Certain progestin preparations, such as that found in the Mexican wild yam, are not bioavailable to humans and, therefore, patients can believe that they are receiving endometrial protection against hyperplasia when they are not 9. Similarly, underdosing of estrogen can lead a woman to believe that she is protected against osteoporosis when, in fact, bone resorption is progressing. Estriol is substantially less bioactive than estradiol, and large quantities must be used to achieve any biological effect. The potential for overdosage also exists, which can lead to increased risks of endometrial hyperplasia, endometrial cancer, and venous thromboembolism.

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