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J. Kyle Mathews, MD, DVM  
Male, 56
Plano, TX

Specialties: Urogynecolog, Pelvic Reconstructive Medicine

Interests: Women's Health, Bladder Diseases
Plano Urogynecology Associates
Obstetrics and Gynecology
972-781-1444
Plano, TX
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Hormone Replacement Therapy and the Truth About Bioidenticals

Sep 12, 2012 - 13 comments
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hormone

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hormone replacement

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Hormone replacement therapy

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bioidentical

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J. Kyle Mathews

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Dr. Mathews



While the debate rages on about Bioidentical hormones an interesting review of the subject by the Cleveland Clinic Journal of Medicine has gain shown "Bioidentical Hormones" to be more of a marketing scheme than science.  Dr, Sandra Fryhofer discusses the findings.  

Dr. Sandra Fryhofer speaks on  Medicine Matters; the topic, hormone replacement therapy and the truth about bioidenticals. A new review in theCleveland Clinic Journal of Medicine clears up common misconceptions and sets the record straight.[1] Here's why it matters.

In 2002, the Women's Health Initiative dramatically changed medicine's views on the safety of hormone replacement therapy (HRT).[2] After that, discussions on HRT expanded from the doctor's office to self-help books, talk shows, and celebrities with product endorsements.

We now have a different lingo for talking about hormones. The new buzz term is "bioidentical," but what does that really mean?

The term indicates that the molecular structure of the drug is identical to the endogenous hormones estrogen, progesterone, and testosterone. Three estrogens circulate in the human body:

17-beta estradiol, the most biologically active;
estrone, a derivative of estradiol and the second most dominant estrogen; and
estriol, a very short-acting estrogen and the least biologically active.
The first misconception is that US Food and Drug Administration (FDA)-regulated drugs are not bioidentical. This is wrong. A long list of FDA-approved hormone products contain 17-beta estradiol and, therefore, are bioidentical. Examples include oral esterase, estradiol transdermal patches (Climara®, Vivelle®) and the vaginal ring (Estring®). Prometrium® is an oral FDA-approved bioidentical progesterone product.

The next misconception is that progesterone-containing skin creams protect the endometrium. This is false; these creams are not strong enough. In addition, some creams contain an inactive progesterone precursor that the human body can't metabolize.

Many topical forms of progesterone -- gels, lotions, creams -- are made at compounding pharmacies. Some can be purchased over the counter at health food stores. Such progesterone creams are not strong enough to raise blood levels sufficiently to protect the endometrium from estrogen stimulation. Transdermal progesterones therefore do not protect against endometrial cancer in patients taking estrogen.

Another misconception is that compounded therapy is safer. That just isn't so. Compounded therapy may be marketed as being safer, but these claims are false and misleading. Because these products are not FDA-approved, there are no guarantee as to their purity, potency, and efficacy. There is also no proof that compounded products are more effective or that they have fewer side effects. They also often aren't covered by insurance and therefore may cost more.

The final misconception regards saliva hormone testing. It's a gimmick. Although the concept of making a hormone combination just for you sounds appealing, the FDA says that saliva hormone testing has no scientific basis, and it's not reliable.

These are just some key points from this study. For more details, read the entire review.[1] For Medicine Matters, I'm Dr. Sandra Fryhofer.  http://www.medscape.com/viewarticle/769969?src=mp

http://www.drjkm.com/hormone-replacement-therapy-truth-bioidenticals/.

J. Kyle Mathews, MD

Plano OBGyn Associates

Plano Urogynecology Associates

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by tmac912, Sep 14, 2012
I  take (by mouth) 1 MG Estradiol   and I cut a  2.5 MG Medroxprogesterone Acet tablet in half .   Are these bioidentical?   I've taken HRT for many years.    Is a patch a better/safer choice?

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by Gwhonic, Sep 19, 2012
The original study did not include those taking bio identical vs. Premarin. Premarin is only 5% identical to human estradiol. European studies show no harm to the cardiovascular system.






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by J. Kyle Mathews, MD, DVMBlank, Sep 19, 2012
The Estradiol is considered "bioidentical". Studies have suggested that transdermal hormone delivery may carry less risk.  In addition it is now recommended to take hormone replacement for the shortest time possible and not to extend beyond 5 years if possible.  For more information see this link. http://www.drjkm.com/services-2/menopause-2/




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by stella5349, Sep 29, 2012
I think it's important to explore all options of treament for hormone imbalance. Some patients respond very well to external treatment as cream as well as some do using oral medication. Stomach acid and PH balance play a role in every patient's option for treatment when it comes to achieving the best outcome.

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by stella5349, Sep 29, 2012
Perplexing, the FDA has endorsed saliva tests to be of value regarding many conditions and documented specifically with hormone changes.

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm126061.htm


Rapid oral saliva testing FDA approval in HIV test (which affects hormonal changes) are said to have 99% accurracy:

http://www.medicalnewstoday.com/releases/6843.php

Lots of documents on this condition are available.

-----------------------------------------------------------------------------------------------------------------------------------------------------

Hormone Saliva FDA post in 2011-

http://www.fda.gov/forconsumers/consumerupdates/ucm049311.htm

Quoted from this article:

"A woman's hormone levels change throughout the day, and from day to day. FDA-approved tests can tell a woman's hormone level in a specific body fluid, ...................such as saliva, .....................blood, or urine, at that particular point in time.

"These tests are useful to tell if a woman is menopausal or not," says Uhl, "but they have not been shown to be useful for adjusting hormone therapy dosages."


Concluding that the FDA considers saliva tests (EVEN specifically noted above for menopause and female hormonal changes) as a desperate hype for a fool / a "gimmick" is medically frustrating for a professional to conclude and obsurd to be said openly.

The concern of the FDA is NOT the accurracy of the saliva testing for many illnesses and hormone problems, but the growing popularity in recent years with comsumers relying on Compound Pharmacy distribution for individually measured prescriptions reliability.

We had a similiar discussion in August 2010 regarding bio identical hormones:

http://www.medhelp.org/user_journals/show/223919/Bioidentical-Hormones--Sorting-Myths-and-Facts

You said then to a poster: "It is difficult to know what you are actually on and what dose.  In patients that present to my practice on these compounded medications, I usually try to obtain some idea about the concentration of each drug involved in the compounding. If a patient feels their current regiment is beneficial and I do not see a significant risk in what they are on, I suggest they continue."

(The poster noted using a perscribed bio identical progesterone and testosterone CREAM and felt significant improvement)

Based off this personal blog written recently, which has a large amount of exact wording from the Myth/Fact segment of the FDA article link I've posted (http://www.fda.gov/forconsumers/consumerupdates/ucm049311.htm) where do you stand on a patient of yours using external hormonal cream?

While I agree, as an unskilled, uneducated but extremely passionate foolish bio identical patient and blogger for woman's health and wellness (for what that's worth) - The  "advertised" defination of "Bio-Identical" is controversial and abused commerically. We all should still have faith in the growing amount of evidence science IS behind discovering more on saliva test reliability and other alternatives like compound medicine then just rely on the over rated medicine as "proven" has for decades.

Like when a woman went to her doctor after getting hit by a mad truck and getting told "Just take your medicine now." and "This will only hurt for just a little while, my dear,." ..................... there's has to be more (and is) than what's been done.









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by mep33, Jan 27, 2013
I have being taking Premarin 1.25 for almost 15 years, I had a complete hysterectomy at that time, should my doctor start decreasing or stop this medication, I feel the same as always.  I see the doctor every year and he has not mention it. Anyone have an opinion?

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by kej54, Feb 11, 2013
I am not comfortable, any longer, taking Premarin after reading the many articles regarding what Premarin actually is; how the horses are neglected, misused, abused, die very young, very little contact with humans and all they are good for is producing large amounts of urine so we can have our Rx Premarin. I am now researching and looking for a replacement. My Dr. wants me to continue on the Premarin; I had a hysterectomy in 1998 and I've been on Premarin since then and I see where you shouldn't take it more than 5 yrs. I no longer trust many doctors as I wonder if they really have my best interest at heart or is it about their making more $$$ the more Rx's they write out and the Incentives from the Pharm Companies. I'm going to Whole Foods to ask some questions about what women are taking in lieu of Premarin. I hope this helps but I may be just as needy for help as you are mep33

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by rwilson30, May 23, 2013
Listen i couldn't find any other way to contact you so this isn't about your blog. However, I have a very serious problem. The problem is exactly the same type as zach94 that you didn't answer. Maybe you should invest some time into this devistating problem see my posts about a full muscle partial that leaves you impotent. The problem is you go to a general practioner, in turn they send you to a urologist that says theres nothing wrong down there so they send you to a general surgeon and sends you back to urology. All over a muscle rupture that i can point to it and say that is where it is and these two ends need to be sewn back together. I understand muscles normally repair themselves, but when they don't there needs to be someone that knows what the heck is going on. I have something wrong with a muscle 2 inches below my belly button. I tore it in half. How do you know? you might ask...... I know because i did it to myself on accident and it is devistating.

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by msteri47, Jul 09, 2013
I had a hysterectomy when I was 27.  At that time Dr. O put in progynon pellets.  I could always tell when the pellets were used up which was usually 2-3 years.  I went in every year for a checkup and pap smear.  Dr. O died and after trying to find another doc that would do this and trying all the other methods of HRT, I finally found Dr. Finch and have had this particular brand of pellets for 38 years.  They work for me with NO side effects. The doc that was recommended to replace Dr. Finch said he did not do the pellet implant and that I was too old for hormones (65).  I am trying to find a doc that will get the Progynon Pellets and put them in.  I can show whoever how to do it, since I watched 13 times.
I found that the Progynon Pellets are available overseas on drugs.com and am to the point of going there.  Can you do this?

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by R78, Sep 27, 2013
I have a close personal friend who is 74 years old, she was put on Premarin when she was 9 years old, for Acne, she was on Premarin for the next 13 years to control Acne, as she was working as a Fashion Model part time to pay for her education(triple masters).  She married at 22 and stayed on Premarin as a "Birth Control" medication and, except for one year when she had a son, until she had a Hysterectomy at the age of 36.(27 years of Premarin use)  After her Hysterectomy, she was taking Premarin to prevent symptoms of Menopause.  The lady remained on Premarin until a few months ago, when she saw a new doctor, her Premarin was cut off "Cold Turkey".

After stopping Premarin she experienced VERY SEVERE Menopause symptoms.  Including very severe Hot Flashes that prevented her from sleeping, along with all of the other typical symptoms of Menopause, however these symptoms were extreme and completely prevented her from functioning.  These symptoms were so severe she barely avoided having several accidents while driving.

The various medications that were given to her to ameliorate her symptoms caused her to be unable to function due to severe side effects.

At this point she has changed doctors again, and is now back on Premarin and her symptoms have cleared up, and she is back to her normal active life style.  Her position is she will take what ever increase in the potential for a Stroke, rather than be reduced to a person who is unable to function.  She lives alone, and absolutely refuses to entertain the possibility of stopping her Premarin again.  She has looked up the various risk factors listed in the literature, and when she totals up the cumulative effects over a 75 year period, her % increase for Stroke calculates out to approximately 2.3%.

Is there ANY data covering the use of Premarin for such a long period of time?  Could the 65 years of Premarin use result in more severe risk factors in discontinuing it's use than continued use?

Thanks

Concerned

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by poppykiote, Sep 10, 2014
I turned to the creams because of adverse affects taking the pills.  Since I have liver disease too (thanks to a blood transfusion in 1971), the creams seemed like a better route.  So, now I am wondering what to do if this is true.

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by poppykiote, Sep 10, 2014
I've been using the creams for over 12 years.  I also developed interstitial cystitis while using them.  Don't believe it is related.  It began after treatments for hep C .Interferon stressed my body to such a degree that it revived this old problem that I had for a couple of years in my early 30's and I still have it to this day now since the treatment 12 years ago.  So... it seems i'm damned if I do and damned if I don't get help for some health issues. Most doctors don't know what to make of the creams.  I did get a new doctor to continue with them since they do keep away the hot flashes.

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by SKai465, Dec 10, 2014
I hate one-sided articles like this. The Women's Health Initiative study only evaluated Premarin and synthetic progestins. Premarin is made from horse urine and is only natural to a woman's body if she eats hay. There is a huge difference between those hormones and bioidentical hormones. There also appears to be a major push to discourage women from using bio-identical hormones by using fear tactics and disinformation. This I believe is because bid-identical hormones can NOT be patented by a drug company, only the delivery system. 17-beta estradiol is the estrogen hormone and progesterone (not progestin) is USP progesterone. Those substances can not be patented but can be put into different shaped pills, capsules, creams and gels which can be patented. If you buy progesterone cream at the health food store and it says on the label that it contains USP progesterone then it is progesterone. If it says it is yam cream then it doesn't contain progesterone. Over the counter progesterone may be just enough to help a woman who is suffering during the early stages of peri-menopause because our progesterone levels are usually the first to decrease. However, a woman who is taking estrogen therapy usually needs more progesterone than an OTC cream can provide. For me, once the hot flashes and night sweats started, progesterone alone did not help and I needed both estrogen and progesterone.

There are many good doctors with differing opinions about hormone replacement therapy and I think I've been to all of them. I had recently started on hormone replacement when the WHI study concluded and my doctor at the time tried to talk me into getting off of HRT. I was using Vivelle patches and Prometrium and both are FDA approved bio-identical forms of hormone replacement. I continued to take them because I had done plenty of research before starting the therapy and in fact had to tell my doctor what I wanted to take because he didn't know the difference between synthetic and bio-identical. After almost 15 years, I am still on BHRT. I am healthy, happy and my doctors, one of which is a specialist in the field, are pleased and supportive. I now use Estrogel (topical) every day and Prometrium (oral) for 12 days of the month and have a mild "period" when I get off the Prometrium.

What most doctors don't understand is that hormone replacement can't be prescribed like aspirin. We are all different, our hormones can radically change from day to day in most women and the trick is balance. You have to learn to know and trust your body. Even post menopausal women can have naturally occurring estrogen and progesterone that changes daily so it is wrong to assume that you need to supplement the same amount every day.  I use the topical gel because I want to use the smallest amount I can to eliminate symptoms and at the same time, balance the progesterone I'm taking. For me it's become easy: tender breasts = too much estrogen; hot flashes = too little. What really irritates me is the "wisdom" that we all need exactly the same amounts of replacement hormones and that we should take them for the shortest amount of time and a maximum of 5 years. For some women that might work. For me it is a life of non-stop hot flashes, recurring bladder infections, zero libido and a husband that looks at me like some alien has inhabited the body of his previously easy going wife.

And here's the final kicker. To get you off of BHRT (or to keep you from getting on it) your doctor may prescribe anti-depressents to suppress the alien takeover and Lunesta so you can sleep (but only occasionally since it is not indicated for daily use) and the side effects of both those drugs are well documented and can be very dangerous. In fact, I have known women who have been diagnosed as bi-polar or referred to phsycologist when what they needed was hormones. Quality of life should be worth something.

If I sound angry it's because I am. A hundred years ago many women were lucky to live past 40. Now we have the opportunity to live very long, happy, productive lives and I refuse to be discarded because I am no longer of child bearing age (or sedated so I stop asking questions). The FDA is not always our friend. Read, research, work with your doctor or find another one who will listen, but take control of your body and do what you feel is right for you.

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