Hormone Replacement – Part 4

In Part 1, Part 2 and Part 3 of this series, I’ve said just about everything I know, or you would care to know, I expect, about HRT. But before we leave this topic, I need to say…

A Few Words About Bioidentical Hormones

One concerning impact of the Women’s Health Initiative has been the wholesale marketing of so-called “natural” hormone products to women as the safer alternative to Prempro. These “bioidentical hormones” are manufactured replicas of the same molecules our bodies use. They can be found in the FDA-approved HRT products such as Climara, Vivelle and Prometrium, to name a few.

Many women have the misguided belief that when these same compounds are made in a smaller local compounding pharmacy, they are somehow safer and better than Prempro or the FDA-approved products. There is absolutely no data to support this claim. So, until someone does a placebo-controlled, randomized clinical trial to prove otherwise, estrogen is estrogen, whether it comes from plants, mares urine or the moon.

Don’t get me wrong – I am more than happy to prescribe “natural” hormone replacement. Estrogen is estrogen, after all.

But I will not act as if somehow this stuff is risk-free and safer than it’s synthetic counterpart, or hand it out like candy to every woman who comes into my practice looking for the fountain of youth. I treat it the same way I treat Prempro. That means you can have it if you need it, and as long as you understand the potential risks as we know them today, and the benefits as they have been proven to date. The rest is all hype as far as I am concerned.

And speaking of hype…

The bio-identical hormone crowd have found a new guru in Suzanne Somers, whose books tout the age-defying wonders of bio-identical hormones. Suzanne takes these hormones herself, and sells them as the risk-free answer to the problems of aging, from hot flashes to wrinkles to weight gain to Alzheimers.

Look, I love Suzanne, but she is out of control with this hormone thing and someone has got to rein her in. Here’s a quote from the cover of her latest book “Ageless”:

“The second half of life can be wonderful. I know it because I am living it. This new approach to health gives you back your lean body, shining hair, and thick skin, provided you are eating correctly and exercising in moderation. This new medicine allows your brain to work perfectly and offers the greatest defense against cancer, heart attack, and Alzheimer’s disease. Don’t you want that?”

Somers’ books are the new Feminine Forever, except that they tout bio-identical hormones instead of Premarin. And, just as Femine Forever was a marketing tool of Wyeth, Suzanne is being used as the marketing tool of the anti-aging industry. Her own use of the hormones, as well as her sincerity (and I do believe she is sincere) only make her message that much more appealing.

But we can’t hold Wyeth’s feet to the fire, and then turn around and give Suzanne and her friends a free ride. Unfortunately, this group appears to be operating under the radar of both the FDA and the media, both of whom appear to be ignoring the problem. The media, in fact, is part of the problem, letting Suzy hype her message on every talk show known to man, with nary an opposing viewpoint.

Fortunately, Somer’s book has not influenced mainstream medical practice. But it has convinced a fair number of women to go to their doctors and ask for natural hormones to fulfill some vague notion they have of health, youth and beauty. Perhaps they want look and feel like Suzanne. (This reminds me of the movie Shampoo where the little old lady sits in Warren Beatty’s chair holding up a photo of Princess Diana, saying “I want to look like her.”)

More than a few patients have arrived to their appointment toting Suzie’s book. It can take a lot to get them to be specific about what it is they feel they need hormones to treat, and to understand that natural estrogen is indeed estrogen, with all its risks and benefits. And that we are all going to get old (and look old) someday, estrogen or no estrogen.

But then again, I don’t look like Suzanne, so why should they believe me?
____________________________________

Addendum: Good news – the media seem to be getting the message. Head over to Kevin, MD for the links.

Patient information on bioidentical hormone here.

An excellent review article on bioidentical hormones. (Abstract only – full text for a fee for non-members)

Read the National Women’s Health Network Fact Sheet on Natural Hormones.

Category: Second Opinions

20 Responses to Hormone Replacement – Part 4

  1. You state: “There is no data to support this claim”.

    I understood that part of the problem is that bio-identicals can’t be patent. With no patent potential,there’s no big bag of money to be made, so no placebo-controlled, randomized clinical trials will be done.

    Further, are you suggesting that by being in the hands of the highly trained staff of a compounding pharmacy is less safe than taking doctor prescribed, over the counter, one size fits non one, hormone replacement?

    I don’t mean to sound cynical. I’m trying to apply common sense. As a medical doctor, are you not tied into the BIG PHARMA just by the nature of your profession?

  2. Sue Richards:

    The claim that there is no data to support is that which assumes that compounded hrt does not have the same risks as the FDA approved regimens.

    I have no problem prescribing compounded bioidentical hormones – a lot of my patients use them, and I find it is sometimes the best way to get the right dose/formulation for a particular patient.

    But I tell my patients that until proven otherwise, they should assume that these hormones carry the same risks as the FDA approved stuff.

    For most of my patients, though, the FDA approved products come in enough variety of dosing that we can get it right using them, and the plus is that their insurance will cover these, so it is often cheaper.

    Hope that clears thing up for you.

  3. One thing I never understood is why anyone would assume that bio-identical hormones are safe. It is well-know that a woman’s exposure to her OWN estrogens via early menarch, late menopause, and nullipariy is a risk factor for breast and endometrial cancer.

    If hormones from your own ovaries/adrenals have associated risks, how can you assume that idential, exogenous hormones would be safe?

  4. I don’t understand what the problem is,especialoly since she has FDA approval.These are regulatory bodies that make sure on behalf of the public,that the substance is safe.I’m sure the samke goes for over the counter natural products. The argument for natural does make sense.
    Makes sense

  5. But then again, I don’t look like Suzanne, so why should they believe me?
    Maybe you should ask her for the name of her plastic surgeon? Seriously, do people truly believe she looks great because of estrogen and not because of face lifts as well as a bit of Botox and Restylane?

  6. Mr Barry:
    Unfortunately, bioidentical hormones when compounded by a pharmacist are not regulated by the fda, and no one is monitoring the claims that these folks are making on their web sites, books or advertisements.

  7. I’ve been looking through your series on HRT and BHRT because I am doing my own research on the subject and I can’t find your name Dr.BTAM. Interesting blog–I like your recipes. Devi

  8. I participated in the WHI study for eight years. I am also a social science researcer and am familiar with research design.I had some problems with the overall validity of the study, which I think was fairy well structured, becase it relied so heavily on self-reported data from the participants. I ultimately was amazed by the bruhaha that resulted from its findings. I do think that statistical significace (which they didn’t get for breast cancer) is important, even in this large sample size. I tend to be much more impressed by smaller, more rigorously contolled studies that are later meta-analyzed. I therefore think that your aproach to treatment is wise.

  9. Thank you so much for your clear, kind writing. As a non-practicing attorney I feel relatively competent to research the medical/health issues I face but nothing has prepared me for the surprises of this stage of life. Not the least is the difficulty finding a dr that treats you as a person, not a procedure (my soon-to-be-ex GYN). Though my Internist is good, he's a he and I didn't feel he was as responsive to my questions about menopause as I'd hoped.

    I saw the Oprah Menopause show at the gym one day (in general not a fan and detest lemming-like behavior in the age of celebrity cults). Thank you for exposing the imbalance. (and really when will someone muzzle Oz? He's in bed with the wrong sponsors and not at all transparent about it.)

    Anyway, thank you, thank you, thank you. I have added your blog to my feed and will be returning often.

    Jacqueline

  10. JD –

    Both progestins and progesterone are effective in counteracting routine estrogen replacement dose stimulatory effect on the endometrium. Progestins in my experience work better than progesterone in treating dysfunctional bleeding or treating hypeplasia (personal experience, not controlled trial data) Progesterone tends to have more sedating effects, making it my first choice for HRT menopausal use since insomnia is a symptom of menopause, and also since I also find less complaints about side effects such as mood with progesterone than progestins. That said, I have a number of patients on HRT who feel best on progestins, and some patients who cannot tolerate any progestin or progesterone in terms of mood. I have no problem prescribing progestins for women if that’s what they want to use. I have yet to see any compelling data that progesterone is better than progestins in terms of breast cancer risks.

    Thanks for reading.

    • Thank-you for this informative and balanced opinion on a subject that is so complicated and confusing.
      Given that the blog was written in 2006, can I ask if you have either modified or changed any opinions since then.ie. Do you an update for us?

      What would you say to an anti-aging practitioner in 2011 who touts lifelong hormone replacement as absolutely essential for maintaining post menopausal health?
      Given your experience with hormone replacement, if a patient’s main problems are anxiety/panic attacks and insomnia would you choose HRT as the treatment of choice?
      Can oestrogen supplementation exacerbate anxiety in some women?

      • AB – Lots of new conversation, not much new real news. Use the category widget over there on the right and scroll down to hormone replacement to read what I’ve written since 2006 on the topic.

        Re panic attacks, if these are palpitations and anxiety occurring out of the blue in isolation form a true anxiety disorder in an otherwise healthy woman and other causes have been ruled out such as thyroid disease, arrythmias, etc, then HRT is something that may be tried and I have seen be quite effective. But if the symptoms are packaged along with an underlying anxiety disorder, or if there are other things causing the anxiety, then HRT may be only a part of the solution, or may not be effective at all. Exercise is an important part of any approach.

        Menopause occurs at a time of life that is fraught with reasons to feel anxious or depressed, and it is tempting to turn to menopause as the easy reason and HRT as the cure all, but it is actually much more complicated than we all appreciate.
        If this is you, talk to your doctor.

        Thanks for reading.

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