Raging (Bioidentical) Hormones

An examination of the popular trend in women's health, bioidentical hormone therapy.

by Brian Dunning

Filed under Health

Skeptoid #70
October 16, 2007
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Today we're going to take a close look at one of the newer trends in popular medicine: so-called bioidentical hormone therapy, espoused by celebrities like Suzanne Somers and Oprah Winfrey, and by all the usual pharmacological conspiracy theorists who reveal "What your doctor doesn't want you to find out."

Most women know all about hormone replacement therapy, but many guys, especially those without wives who have gone through it, have no clue what it is, so here's the 30,000-foot view. When women go through menopause, their hormone levels can go crazy, often dropping to low levels and fluctuating for several years or sometimes longer. This can produce uncomfortable symptoms such as hot flashes and vaginal dryness. For a long time, hormone replacement therapy has been the standard treatment. Doctors would prescribe HRT, hormone replacement therapy, using synthetic hormones made under close FDA supervision and taken orally in pill form, which is usually successful in treating these symptoms.

But things changed in 2001, when the National Institutes for Health sponsored the Women's Health Initiative, a gigantic clinical trial set up to double-check this standard practice. And guess what they found? Conventional HRT could, in some cases, pose risks that outweighed the benefits. Women taking the most popular HRT, a combination of estrogen and progestin called Prempro, were at greater risk for heart disease, breast cancer, stroke, blood clots, and dementia. Women taking estrogen alone, called Premarin, were at slightly larger risk of stroke.

Now there's your headlines. And when headlines appear, the alternative therapy machine mobilizes. And it did, big time, inventing what it calls bioidentical hormone therapy. The term bioidentical means that these hormones are almost chemically identical to, but do not exactly replicate, those manufactured naturally by the human body. Strictly speaking, bioidentical hormones are and have been available in FDA-approved form already. Estrace, the Climara and Vivelle-dot patches, and Prometrium are all FDA-approved bioidentical hormones that your doctor can prescribe. So if you want to give bioidenticals a try, you can go to your family doctor and ask for them, you don't have to look in the back of some magazine.

But the alternative medicine industry is not FDA approved and has no route to your wallet through your doctor, so they had to come up with something that they can sell over the counter. They chose skin creams and paid celebrity endorsers, most notably Suzanne Somers, the esteemed medical and scientific genius. These are prepared by what's called compounding pharmacies, and contain different forms of estrogen and/or progesterone with different potencies. These are not subject to FDA approval. An FDA study in 2003 found inconsistencies in dose and quality among these products. Since their production and distribution is not regulated or monitored, there is no reason to assume them to be free of impurities or to contain any given dosage.

Nevertheless, a major selling point of alternative bioidenticals is that the dosage is claimed to be customized to each individual patient, usually through a saliva test. Doctors, however, dispute the usefulness of such a test, on the grounds that even with a blood test, which is more accurate than a saliva test, hormone levels vary substantially throughout the day just by normal physiological activity. The second selling point is that bioidenticals are "all natural" and are thus somehow safer and more effective than synthetic versions. Not only is this completely unsupported by evidence, it is a logical absurdity, since the term "bioidentical" means that it is intended to be the very same molecule.

Of the risks uncovered by the 2001 trial, none were found to have been caused by the particular molecular structure of the synthetic hormones. Thus the proper conclusion is that whatever risk is caused by the hormone therapy will be exactly the same whether the hormone is synthetic or bioidentical to the synthetic, assuming the same dosage and purity.

But now let's return to the 2001 trial, past the point where the reporters got their sensational headlines then left the room, and where Oprah stopped reading. First of all, the part of the trial that was stopped due to increased risks dealt only with women with a uterus who were taking Prempro, which was only one of the five major groups in the study. There is no clinical evidence of risks exceeding benefits for women on other programs. The Prempro study was stopped because the study's monitoring board set the level of acceptable risk at an unusually low threshold. Many doctors caution their patients not to panic and abruptly end all treatment, but rather to gradually reduce the dosage to a safer level or switch to a different program. But even this may not be necessary for many patients, since the risks found in the study were correlated to the patient's age, number of years since menopause, and number of years that they had been taking the hormone, so even the worst results do not necessarily apply to many women. These qualifications to the alarmist headlines may not play so well on Oprah and may not spur as many celebrity-endorsed self-medication books, but they are typical of what's found when cooler heads prevail and you allow yourself to listen to the actual science.

Here is what it boils down to. If you are a menopausal woman suffering from symptoms, check with your doctor to find out if you are a candidate for hormone replacement therapy, and to learn whether you are at risk for any of the stated conditions. Suzanne Somers is not your doctor. If you want to go with what you've heard about a dosage customized for your body's hormone levels, get a blood test from your doctor instead of the far less useful saliva test, and ask to understand whether this is a useful indicator of your hormone levels. If you pass your doctor's tests and are comfortable with any risks, and you decide to try hormone replacement therapy, and if you feel that a bioidentical compound is right for you, have your doctor prescribe an FDA approved bioidentical product, rather than buying a celebrity-endorsed unapproved product of unknown purity and origin. And no matter what you do, be aware that your natural hormone levels will fluctuate naturally during this period, so check back with your doctor at recommended intervals.

Tip Skeptoid $2/mo $5/mo $10/mo One time

Brian Dunning

© 2007 Skeptoid Media, Inc. Copyright information

References & Further Reading

Boothby, L. A., Doering, P. L., Kipersztok, S. "Bioidentical hormone therapy: a review." Menopause. 1 May 2004, Volume 11, Issue 3: 356-367.

Food and Drug Administration. "Report: Limited FDA Survey of Compounded Drug Products." Drugs: Guidance, Compliance & Regulatory Information. US Department of Health and Human Services, 13 Feb. 2003. Web. 13 Oct. 2007. <http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm155725.htm>

Goldberg, N., Greenwood, A. Dr. Nieca Goldberg's Complete Guide to Women's Health. New York: Ballantine Books, 2008. 80-91.

Landau, C., Cyr, M. G., Moulton A.W. The Complete Book of Menopause: Every Woman's Guide to Good Health. New York: G. P. Putnam's Sons, 1994.

MacLennan, A., Sturdee, D. "The 'bioidentical/bioequivalent' hormone scam." Climacteric. 1 Feb. 2006, Volume 9, Issue 1: 1-3.

National Heart Lung and Blood Institute. "Postmenopausal Hormone Therapy." Health Information for the Public. United States Department of Health and Human Services, 30 Oct. 2002. Web. 16 Oct. 2007. <http://www.nhlbi.nih.gov/health/women/>

Reference this article:
Dunning, B. "Raging (Bioidentical) Hormones." Skeptoid Podcast. Skeptoid Media, Inc., 16 Oct 2007. Web. 22 Dec 2014. <http://skeptoid.com/episodes/4070>

Discuss!

10 most recent comments | Show all 20 comments

I took I am 44 yrs. old, had blood work done, spent a lot of money went on Willey's bio identical protocal for 7 months. The first couple of months felt good. Then I blew up like a I was pregnant, hormone doc. bacially said I didn't exercise enough and I would be back to take them again. Wrong if you have 100.00 a month to flush down the toilet be careful ladies these doctors don't have the magic cure oh just a few more months you will feel great just give a little bit longer. Yeah, right and a larger wardrobe for the new you.

shelley hart, Phelan , CA
September 29, 2009 6:10pm

I have always been a very healthy person with no prior menstrual or pms issus. At 51 years out of the blue I began having hot flashes, night sweats and irritability. After 6 months of losing sleep, and taking showers in the middle of the night to cool off I researched and then began taking bio-identical hormones. I recommend having a blood test done, not saliva testing. I feel completely back to normal. The key is finding the right physician and also taking the time to educate yourself. I am a supporter of bio-identical hormones.

Linda, Brookfield, WI
August 4, 2010 6:48am

Hmmm... a bio identical hormone isnt a bio identical hormone?

Its easy to verify. Just go to the companies trial data base and look at how effective the product is and its long term safety data.

The trials should show results for many thousand folk having undergone the double blind placebo contolled trials, a quality control system and full safety submissions to the FDA as a MEDICINE.

Same here in Oz, but its the TGA and ultimately, the PBS if effective enough to ameliorate disease/discomfort.

Can only find a google site and some nice papers? Enjoy taking something with no long term risk assessment, quality assessment and veracity assessment. Maybe even $100 for a jar of 30.

Think I'll drink some of that plant sterol milk...NO way!

PS how do you know that the company selling the stuff is actually making the same stuff discussed in a paper or two bandied around in blurbs?

You don't.

Henk van der Gaast, Sydney
October 7, 2010 10:00pm

I have been on bio- identical for 20 years , I look 20 years younger than my 76 years. (so I am told) . The best test for hormones is: 24o urine test. Take the minimum dose.3mgm Docs know little about hormones unless they are women and and ad menopausal symptoms . FDA researchers go straight to Pharma jobs without a waiting period, Hum! Most of research is paid for by Pharma
The first symptom of superfluous estrogens is tender breasts. An excess of Progesterone is loss of hair. The study which revealed Ca in women was probably due to excessive dosage.

Bee, new Orleans
February 4, 2011 3:05pm

Bee, if you are being honest, I am 52 and I would like to check your claims out and possibly date you..

What was wrong with normal hormones.. If they are identical, they are identical. No matter what the source organism or process.

Henk v, sin city NSW, Oz
August 10, 2011 10:33pm

Rita,Congratulations with your success being cacner free for a year! Many women with a history of breast cacner think that they are not candidates for hormone therapy and that they have to suffer. True, you may not be a candidate for estradiol, but we can look at adrenals, thyroid, insulin, DHEA and testosterone. You may benefit from treatment of adrenal fatigue or low thyroid function. There are also studies out that suggest that testosterone therapy may balance estradiol and be protective against breast cacner. Testosterone therapy would also help energy, libido, lean muscle mass and overall sense of well-being if your tests show that you are low. I would recommend having your hormones tested and consulting with a knowledgeable physician who can help balance your hormones and show you the most optimal diet, nutrition and lifestyle choices for you.Alicia Stanton, MDChief Medical Officer BodyLogicMD

Narmin, aOPskcNbjguxXiQoH
August 27, 2012 12:50pm

Thanks for the unwelcome medical advice from a googlespert.

Rita hopefully is OK, happy and seeing a medical professional and expert.

Twitverse is so helpful at times. Sore knees?

Magnanamous Dinoflagellate, sin city, Oz
July 2, 2013 11:29pm

This a pretty broad brush. Not that long ago diabetics used bovine insulin and then a combo of porcine and bovine and then porcine and some eventually cadaver insulin. The progression was needed due to the rejection of foreign animal insulin. The discovery of recombinant DNA in bacteria making "identical" human insulin by the vat full changed that.

Michaelb, Poway, USA
July 9, 2013 10:03am

AND THE ANSWER IS: find a doctor you trust and talk to him/her about your problem at length. Don't be afraid to say no to something you don't understand or think is wrong.

Read all of the information from the pharmacy for your prescription. Always strive to know absolutely everything about anything you put in your mouth.

And avoid Premarin if you possibly can: to collect the pregnant mare urine (the source of the hormone) mares stand in a stall 11 months of the year and are deprived of adequate water in order to concentrate the urine. Animal abuse is unacceptable even if you are willing to take horse hormones

I went insane at menopause and used a hormone patch to return the world of the living. Then I got breast cancer and the discussion I had with the chemo doctor boiled down to two medical points of view: 1] plant hormones are not the same as animal hormones, and 2] hormones are hormones regardless of source. (I decided to forego hormones altogether.) I love my chemo doctor dearly and have great confidence in all the doctors who treated me in the course of killing the cancer without killing me along with it.

The mastectomy surgeon wanted me to go on a selective serotonin reuptake inhibitor (an antidepressant similar to Zoloft) for the hot flashes. She seemed surprised that I said no (take a slam/bang antidepressant developed to treat unipolar depression for a vascular dilation problem? I don't think so: I have hot flashes, I am not suicidally depressed!) I got the impression that this was the first time a patient ever said no to her. She got over it.

Each person is unique: there is no cure-all. If a treatment doesn't work for you go back to your doctor. If your doctor won't list

Swampwitch, Gainesville Fl
July 11, 2013 9:35am

Swampwitch.. thanks for the anecdote

Your personal history and your interpretation doesnt really help anyone.

It reveals a lot about you.

Midrash Delinquent, Gerringong NSW Oz
July 13, 2013 12:14am

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