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Has anybody heard of Bio-identical hormones?

J

james_s_carroll

Member
May 29, 2011
23
0
#1
Has anybody heard of Bio-identical hormones?
I was told they are a standard medical treatment in the USA and limited availability in Europe/Ireland. Looking at these since I have never gone down the steroid route etc.

Any advice or thoughts welcome!


Jc
 
AllTheWay

AllTheWay

TID Lady Member
Mar 17, 2011
4,240
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#2
bio identical hormones are a great way to go if you can find a doctor who knows stuff about it. it is used a lot by good endocrinologists who work with menopausal women or women with hormone troubles. they use your own hormones to compound the exact same hormone so your body utilizes it better. plus often one can use smaller doses. it is a great way to go if you can find someone who does it! i recommend friends and clients of mine all the time to go and find a doctor who specializes in bio identical hormones.
 
PillarofBalance

PillarofBalance

Strength Pimp
Feb 27, 2011
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#3
Wow, I hadn't heard of this... I think I see my next research project!!!!
 
Ms.Wetback

Ms.Wetback

VIP Lady Member
Sep 27, 2010
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#4
Hubby uses it for his thyroid meds. Made a HUGE difference once he got off of synthroid.
 
PillarofBalance

PillarofBalance

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Feb 27, 2011
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#5
From Mayo Clinic
Are bioidentical hormones safer and more effective than traditional hormone therapy for menopause symptoms?

Answer
from Mary Gallenberg, M.D.

No, they aren't. According to the Food and Drug Administration (FDA) and several medical specialty groups, bioidentical hormones may be riskier than standard hormone therapy, and there's no evidence they're any more effective.

Bioidentical hormones have become popular in recent years, partly because of celebrity endorsements and partly in reaction to reports of increased health risks with standard hormone therapy. The term "bioidentical" means the hormones in the product are chemically identical to those your body produces. In fact, they are — but so are the hormones used in many FDA-approved hormone replacement products.

Marketers of bioidentical hormones say their products have these advantages over standard hormone therapy:

They're derived from plant chemicals, not synthesized in a laboratory. Some FDA-approved products (Estrace, Climara patch and Vivelle-Dot patch, and Prometrium natural progesterone) are also derived from plants.
They're produced in doses and forms that differ from those in FDA-approved products. Some bioidentical hormone products are available without a prescription, but most require a prescription. Also, for many nonstandard combinations, you need to go through a compounding pharmacy. Compounding pharmacies specialize in making medications customized for individual needs, such as inability to swallow solids or allergy to a binding agent in a tablet. However, products from compounding pharmacies have not been subject to the same rigorous quality assurance standards that standard commercially available hormonal preparations have to meet.
They're custom made for you, based on a test of your saliva to assess your unique hormonal needs. Unfortunately, however, the hormone levels in your saliva don't reflect the levels in your blood or correspond to menopause symptoms.
Some women may benefit from nonstandard doses and forms of hormones in bioidentical hormone preparations, but there is almost no scientific support for an advantage of these compounds over common commercially produced preparations.

From American College of Obstetricians and Gynocologists

ACOG NEWS RELEASE
For Release: February 3, 2009
Contact: ACOG Office of Communications
(202) 484-3321
[email protected]

ACOG Reiterates Stance on So-Called "Bioidentical" Hormones


Washington, DC -- In response to recent media attention being given to so-called bioidentical hormones, The American College of Obstetricians and Gynecologists (ACOG) reiterates its position that there is no scientific evidence supporting the safety or efficacy of compounded bioidentical hormones.

In November 2005, ACOG issued a committee opinion regarding "Compounded Bioidentical Hormones" that stated its concerns about bioidenticals. More recently, the US Food and Drug Administration (FDA) issued warning letters in 2008 to several pharmacies in the US that make compounded bioidentical hormones. Some of these pharmacies claimed that compounded hormones were superior to FDA-approved hormone therapies and that they also prevented or treated serious diseases, such as Alzheimer's disease, stroke, and various cancers. The FDA stated that the pharmacies' claims of safety and effectiveness were false, misleading, and a violation of federal law. Women are encouraged to learn more by reading the FDA's consumer article "Bioidenticals: Sorting Myths from Facts" at For Consumers.

Despite celebrity testimonials touting scientifically unfounded benefits of compounded bioidentical hormones, the bottom line is that most have not undergone rigorous clinical testing for safety or efficacy, nor are they approved by the FDA. ACOG also stresses that salivary testing of a woman's hormone levels is not useful because they vary within each woman depending on her diet, time of day, the specific hormone being tested, and other variables. Although monitoring salivary hormone levels is promoted by some as a means of 'tailoring' a hormone treatment to an individual, hormone therapy does not require customized dosing.

The decision of whether or not to take hormone therapy for menopausal symptoms is highly individualized, based on a woman's health, risk factors, and personal wishes. There are a number of FDA-approved hormone therapy products available in a variety of formulations. ACOG advises women to talk with their doctor about both the benefits and risks of HT.

# # #

From NY Times in 2006

IT’S almost impossible to turn on the television and not glimpse Suzanne Somers smiling back at you. In the last week, she has appeared on the “Today” show, “The View” and “Entertainment Tonight.” She has chatted with Martha Stewart and bonded with Bill O’Reilly. She is not discussing the war in Iraq, nor offering opinions on the Mark Foley scandal. Her latest book, “Ageless: The Naked Truth About Bioidentical Hormones,” hit stores on Oct. 10, and Ms. Somers is simply doing what celebrities do these days: selling.

She happens to be good at it. The actress made the ThighMaster a household product and, of the 13 books she has written, 7 have been best sellers.

If history — and a good marketing plan — has anything to do with it, “Ageless” may just be her eighth. It is a paean to bioidentical hormone replacement therapy, a controversial treatment for menopausal women that she dubs “the juice of youth.”

“I had bone loss 10 years ago — I restored it with bioidenticals,” Ms. Somers, who turns 60 on Monday, said in a telephone interview from Houston, where she was speaking before a group of 1,100 pharmacists. They also recharged her libido, she said, reduced her depression, and rejuvenated her hair, skin and body. (In February 2001, National Enquirer photographed her leaving a plastic surgery clinic, and she subsequently admitted to having had liposuction on her upper back and hips.)

The book, though, has raised the hormone levels of at least seven medical doctors. The doctors — three of whom are quoted in the book — generally support the concept of bioidentical hormone therapies but say that too little research has been done to assure that they are safe.

Further, they said, they are outraged that Ms. Somers endorses a treatment plan created by T. S. Wiley, a former actress with no formal medical training. Although Ms. Wiley described herself in an interview as “a molecular biologist” and has published two books on women’s health, Ms. Wiley only holds a bachelor’s degree in anthropology from Webster University, in St. Louis.

In a letter to Crown, Ms. Somers’s publisher, the doctors wrote, “Wiley dispenses gratuitous advice on significant medical issues including the use of bioidentical hormone therapies, areas that are legally and ethically the domain of licensed medical practitioners.”

They continued, “The so-called ‘protocols’ endorsed and promulgated throughout the book may expose women to serious health dangers.”

“This is not a territorial fight,” said Dr. Erika Schwartz, a Manhattan internist and the author of “The Hormone Solution,” who led the letter-writing campaign and is quoted in the book. “It’s about safety for women. Suzanne Somers endorses this non-physician, non-medical person who has created this whole protocol. With this book, she has gone too far.”

Most women who receive hormone replacement therapy are prescribed drugs like Premarin or Prempro, which come from the urine of pregnant mares. Bioidenticals, which are also prescribed, are derived from soy, wild yam and other plant extracts. Advocates say their molecular structure is similar to that of the hormones they are replacing and can serve the same purpose.

But hormone replacement therapy, in general, is controversial. The National Institutes of Health reported in 2002 that it posed more health risks than benefits for women in a clinical trial, yet that conclusion hardly appears to be the last word. Little research has been done on the bioidentical alternatives, and it is not even known how or if they work, nor whether they carry the same risks as the drugs, like for breast cancer.

“We just don’t have the information, and I think it would be irresponsible to promise that for women without the information,” said Dr. Isaac Schiff, the chief of obstetrics and gynecology at Massachusetts General Hospital in Boston. “No one has proven that the bioidentical is any safer or any more harmful than Premarin.”

Ms. Somers insists she merely empowers women to ask about the bioidenticals as an alternative to traditional therapies, but the doctors who have written to Crown said she crossed the line by advocating Ms. Wiley’s protocol, which repudiates a single hormonal dose through a monthly cycle and instead recommends raising it “based upon ancient cycles of nature.”

Dr. Diana Schwarzbein, an endocrinologist in Southern California who has been treating women with bioidenticals for 15 years, said, “I applaud Suzanne Somers and her efforts to raise awareness of bioidentical H.R.T. to the general public.” But she signed the letter to Crown.

“I do believe that they are less harmful than drugs, but the public needs to be given correct information so that they can decide for themselves if they are willing to take the risk,” Dr. Schwarzbein continued. She said she most objects to Ms. Somers’s description of Ms. Wiley as an expert researcher, rather than as the lay person she is who has made a business out of promoting bioidenticals.

The criticism seems to roll right off Ms. Wiley, a mother of five who lives in Santa Barbara. “Schwarzbein is smarting because I replaced her as Suzanne’s guru,” she said.

Ms. Wiley, 54, said she came upon bioidenticals about a decade ago after suffering from an ovarian cyst, fibroid tumor and lump on her chest. “I got tired of being scared,” she said, and started to work with a molecular biologist to refine what has since become the Wiley Protocol, which consists of a bioidentical estradiol and progesterone preparation in a topical cream (she holds the patent) that is “dosed to mimic the natural hormones produced by your body when you were 20 years old,” she said.

Dr. Schiff said that that concept does not resemble any science he knows of. “To take a 50- or 60-year-old woman and give her the same hormonal levels as a 20-year-old who’s having regular periods on her own is all wrong,” he said.

According to her Web site, Ms. Wiley charges doctors $1,500 to become certified in her methodology; pharmacies are charged $500 for the right to dispense the product. She said 60 doctors have been trained in the protocol and 12 pharmacies have signed on, though none have paid. On her site, thewileyprotocol.com, she promises that in exchange for the right to use the Wiley Protocol name, she will “drive a revenue stream of customers to you by listing your pharmacy on this Web site” and in a coming book.

Members of the medical profession said they were surprised by her boldness. “I truly don’t understand how she can certify anyone to do anything,” said Dr. C. W. Randolph Jr., a gynecologist in Jacksonville Beach, Fla., who was quoted in “Ageless” and also signed the letter to Crown. “Everyone is entitled to their own opinion, but for a non-physician lay person to have her own hormone protocol for prescription medication is a bit of a question.”

Ms. Wiley shrugged this off. “Does it have to come from a pedigreed source?” Instead, she maintains that the debate is really a “fight over women’s bodies and how much money those women are worth to doctors, who gets to prescribe and sell hormones to these women,” she said. “Suzanne is giving women enough ammunition and information to ask the right questions when they go to the doctors. They’re not happy she’s thinking on their own and they don’t want women to do that, either.”

Ms. Somers said the Wiley Protocol is just one of many options she advocates. She also takes vitamins, does yoga and has sworn off sugar. “I’m not selling anything,” she said. “I don’t have an agenda. I give every doctor equal time. I spent two years interviewing 16 doctors. It was like getting a Ph.D.”

From American Medical Association

Bioidentical hormone replacement: Safety requires oversight
The AMA at its November Interim Meeting adopted policy calling for FDA surveys of compounded hormones' purity and for adverse event reporting.
Editorial. Dec. 11, 2006.

PRINT|RESPOND|REPRINTS| SHARE
Three is company, says the title of the 1970s sitcom. Many doctors might find one of its stars, Suzanne Somers, surprise company in the exam room.

Somers recently released her second book touting bioidentical hormones as a cure for many of the complaints of aging, including the sometimes severe symptoms of menopause. Ageless: The Naked Truth About Bioidentical Hormones quickly made a number of bestsellers' lists. It even reached No. 1 in the New York Times advice category.

Links
See related content
Many of her readers are likely patients worried about the health risks of traditional hormone therapy discovered by Women's Health Initiative. They're eager to bring their symptoms under control and looking for safer alternatives. Chances are they're going to bring Somer's ideas up with their doctors.

Those patient-doctor conversations are a good thing because the medical profession has concerns with the safety and efficacy of these products when created through pharmaceutical compounding.

Last month, the American Medical Association took a stand on the issue at its Interim Meeting.

The Association adopted policy asking the Food and Drug Administration to conduct surveys of compounded bioidenticals for purity and accuracy. It also calls for mandatory adverse event reporting by the hormones' makers, including pharmacies, and a registry of these occurrences.

Bioidentical hormones have the same chemical and molecular structure as hormones produced in the human body. Traditional hormone therapy relies on estrogen or estrogen-progestin products made by pharmaceutical companies and approved by the FDA. Compounded bioidenticals are typically derived from plants and formulated by a pharmacy to meet individual patient needs. They are not FDA regulated.

In the past few years these custom-compounded hormones have come under increasing criticism from the medical community, including the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine, the American Assn. of Clinical Endocrinologists and the Endocrine Society.

Some of their makers, and even some physician proponents, have promoted the products as a safer, natural alternative to traditional hormone therapy. The problem, the medical groups say, is that no scientific evidence exists to support claims that they're less risky than their FDA-approved counterparts. The National Institutes of Health also warns that there are "scant data on the benefits and adverse effects of these compounds."

Given that the compounded products have the same chemical composition as traditional therapy, the risks for heart disease, stroke and breast cancer must be considered the same until it is proven otherwise.

Companies manufacturing traditional hormone therapy must include black-box warnings of the risks. The makers of compounded products don't have the same requirement. This leaves women unaware of potential risks. That is why the AMA and others are calling for standardized patient information in compounded bioidenticals' packaging.

Because the FDA doesn't test these products, the medical groups also worry about their purity, potency and quality. Agency surveys of bioidenticals can help ensure their safety.

Wyeth, a leading maker of FDA-approved hormone therapy, shares these concerns. It filed a petition with the agency last fall asking for enforcement actions against compounding pharmacies that violate the rules by stepping into manufacturing, as opposed to making individualized products. It calls for labeling that describes the products' risks. The FDA has not made a decision on the issue.

The International Academy of Compounding Pharmacists responded to the AMA vote by accusing organized medicine of being in cahoots with Wyeth. The pharmacists group denies Wyeth's claims that compounding pharmacies are in the manufacturing business. It notes that there is no evidence that compounded drugs are unsafe, given that the Women's Health Initiative studied only traditional therapy.

The group has enlisted thousands of women taking bioidenticals in its fight against the company's petition. As of April, nearly 30,000 had written the FDA, the academy reported.

But until more study has been conducted and federal quality control has begun, there is no way to know if their faith in the safety and efficacy of these products has been misplaced. Women deserve better.
 
PillarofBalance

PillarofBalance

Strength Pimp
Feb 27, 2011
17,066
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#6
There is a lot of info out there on this stuff and really none of it seems good to me. Ms. W's husband apparently has had some good experience with it, but all the major players seem to say this stuff is very questionable.
 
AllTheWay

AllTheWay

TID Lady Member
Mar 17, 2011
4,240
411
#7
i know many women who had terrible results with the regular stuff and great results with bioidentical hormones. so regardless of what is put out in print and im sure paid for by the companies that have the regular stuff out there, i think there is much to be said about bioidentical hormones. if for no other reason than the doctors that specialize in them pay more attention to their clients maybe.

once again, anyone can prove anything just by changing the variables involved. the question becomes is it falsifiable or unfalsifiableresults? :D
 
PillarofBalance

PillarofBalance

Strength Pimp
Feb 27, 2011
17,066
4,629
#8
i know many women who had terrible results with the regular stuff and great results with bioidentical hormones. so regardless of what is put out in print and im sure paid for by the companies that have the regular stuff out there, i think there is much to be said about bioidentical hormones. if for no other reason than the doctors that specialize in them pay more attention to their clients maybe.

once again, anyone can prove anything just by changing the variables involved. the question becomes is it falsifiable or unfalsifiableresults? :D
I did come across a petition from Wyeth sent to FDA to get them to take enforcement actions against companies/pharmacists compounding BHRT. That one raised red flags for me... Your right about a lot of women having terrible results from the "approved" drugs for HRT. Its a tough situation for women for sure and apparently deserves more study :)
 
marx

marx

MuscleHead
Sep 29, 2010
4,671
625
#9
Big pharma v. independent pharmacists. My money is on the smaller actors integrity...

Just sayin' :)
 
Ms.Wetback

Ms.Wetback

VIP Lady Member
Sep 27, 2010
1,599
118
#10
He took synthroid for years and has eye twitches which we later found out was common with anyone taking over 125mcg.
Switch to bio-identical and it is gone plus he feels WAY better.

Scam or not, we are believers in it.
 
T

THE-DET-OAK

Senior Member
Sep 11, 2010
135
9
#11
supposedly they wont affect your hemo like synthetic hormones, and they are suppose to have less long term side effects. it really just boils down to the raw material the hormones are made out of, as said, its identical to the hormones in our body. they are made out of plants and animals.


"The interest in a more natural approach to hormone therapy has focused attention on bioidentical hormones — hormones that are identical in molecular structure to the hormones women make in their bodies. They’re not found in this form in nature but are made, or synthesized, from a plant chemical extracted from yams and soy. Bioidentical estrogens are 17 beta-estradiol, estrone, and estriol. (Estradiol is the form of estrogen that decreases at menopause.) Bioidentical progesterone is simply progesterone. It’s micronized (finely ground) in the laboratory for better absorption in the body.

Bioidentical hormone therapy is often called “natural hormone therapy” because bioidentical hormones act in the body just like the hormones we produce. But here again, that tricky word natural muddies the waters. Pregnant mares’ urine is natural, but Premarin is not bioidentical, at least not to human estrogen. The same goes for Cenestin, which is made from plants but is not bioidentical.

Technically, the body can’t distinguish bioidentical hormones from the ones your ovaries produce. On a blood test, your total estradiol reflects the bioidentical estradiol you’ve taken as well as the estradiol your body makes. On the other hand, Premarin is metabolized into various forms of estrogen that aren’t measured by standard laboratory tests. Proponents of bioidentical hormones say that one advantage of bioidentical estrogen over Premarin is that estrogen levels can be monitored more precisely and treatment individualized accordingly. Skeptics counter that it hardly matters, because no one knows exactly what hormone levels to aim for, and symptoms, not levels, should be treated and monitored."

http://www.health.harvard.edu/newsweek/What-are-bioidentical-hormones.htm
 
Last edited:
SJA

SJA

MuscleHead
Feb 24, 2011
611
91
#12
I've also seen these advertised for men......isn't testosterone...umm....testosterone?
 
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