Hormone Replacement: Part 3

In part one and part two of this four part series, I reviewed the history and findings of the WHI, the impact of those findings on the medical establishment, and the newer data that have gotten us all muddled up again in our thinking about estrogen.

In the face of all that uncertainty, I have to practice medicine. To that end, I have created my own set of guidelines for prescribing HRT that I would like to share with you now. Feel free to comment, question, criticize or amend these guidelines, or god forbid, to use them yourself.

Please do not ask me if I am “pro-HRT” or “believe in HRT”. Health care is neither politics nor religion, despite that picture up there. It is, however, an uncertain science. Therefore, one must be wary of anyone expressing extremes of opinion about HRT, either for or against its use, and of anyone claiming to have the final word on HRT.

  1. I am willing to prescribe HRT for any of its approved indications (vasomotor symptoms, vaginal dryness, osteoporosis), provided you understand the risks as well as the benefits and know about alternative treatments for these conditions.
  2. I will give you the best data I can find that defines your personal risks and benefits from using HRT. Unfortunately, that data is imperfect, and may change in your lifetime. This will be frustrating for both of us.
  3. I am willing to prescribe HRT for reasons of well-being, mental or physical, provided you are willing to accept the risks and can describe the benefit for me as best as you can.
  4. If you are at increased risk for or have had breast cancer, I am willing to prescribe HRT provided you accept the risks and we have exhausted the non-HRT solutions to your problem, assuming, of course, that it is a problem that HRT can address. (I can count on less than one half of one hand the number of my patients with breast cancer who would fit this rule, but for them, I have it. )
  5. I will not prescribe estrogen without progesterone if you have an intact uterus. If you use anything less than standard progesterone regimens, you must undergo frequent monitoring of the endometrium.
  6. I am unwilling to prescribe estrogen if you are at increased risk for blood clot or stroke. I will do everything I can to find you an alternative that will address your symptoms or condition.
  7. I am not willing to prescribe HRT for cosmetic reasons alone.
  8. I am happy to prescribe bioidentical hormones, but you must assume they have the same risks as Prempro until there is data to prove otherwise.
  9. I consider vaginal estrogen to be safe in almost every woman. (I’ll let you know if I think you are the exception to this rule, and why.) If you feel otherwise, I completely understand.
  10. I will support your decision to use or not use HRT, and will work with you to find the optimal way to manage your menopause, whether it be through lifestyle changes, diet, exercise, hormones and/or medications. It is, after all, your body and your menopause.

Up next: A few words about bioidentical hormones.

Image: I mutilated The Ten Commandments Pressbook Cover. (I just ordered it from Ebay, and can’t wait to get it and see what other images are inside. It is one of my favorite movies of all time.)

Category: Second Opinions

19 Responses to Hormone Replacement: Part 3

  1. I like that clarity here, and the sense that you’re really interested in communicating and helping women make decisions that feel right for them.

  2. This series has been awesome. One question…what do you do with your smokers? I’m running into some difficulty when assessing risks in heavy smokers.

  3. Thank you for taking the time to do this. Would you exclude women with a history of blood clots in Q.#9 as you did in Q.#6? What about those with a clotting disorder, e.g., FVL, who have never had a clotting incident?

  4. Dr Whoo?:

    Funny, I haven’t run into this situation. I have so few smokers in my practice, although many, many ex-smokers. Naybe it is a NY thing…

    Heavy smokers fall into the category of women at increased risk for cardiac disease and thromboembolic disease, whether they take estrogen or not.

    I would spend a lot of time making sure they know their risks, and do all I can to get them to use a non-estrogen treatment for their menopausal symptoms. Progesterone alone can sometimes be enough, and should not increase clot risks per se, though long term use and heart disease remains a question.

    I would enroll her internist in the decision-making process, or even have her consult a cardiologist first to get a handle on her other risk factors and get their input. Don’t handle this one alone…

    If we are talking about a newly menopausal heavy smoker who has tried and failed a non-hormonal method such as SSRI’s, I would start with progesterone first. It would have to be a pretty desperate woman for me to add estrogen, and her lipids are hopefully normal, and then I would use transdermal estrogen and probably monitor her estradiol levels as well. (It goes without saying that I would try also to get her to quit, and offer pharmacologic support for that.) Hopefully she will only need it for a year or so.

    I do a fair amount of hypercoagulability screening in women with family histories to make sure they do not carry Factor V leyden, ATIII deficiency, etc. Maybe the heavy smoker would fall into a category of a woman I would screen as well, to be sure she doesn’t have an additional risk factor that has as yet been identified.

    Hope this helps.

  5. Great series. Nevertheless, what I found completely missing in your guidelines is any kind of exception for Premature Ovarian Failure. This omission makes one wonder if you apply the same guidelines to a 20- or 30- something woman instead of full-replacement-until-50 that for example this NIH doctor who studies POF suggests.
    I realize that there are no studies on the matter; nor does USPSTF feels the need to even mention us (even if to say “we don’t know”). Still, WHI included no women younger than 50; and nobody claimed that HRT increases, for example, breast cancer risk of a woman with POF above that of a woman of the same age who still has her periods. At the same time the risk of osteoporosis in women with POF is pretty high. And if there is a suggestion of a reduced risk of heart desease in 50-something woman, what would mean more of a reduction for a 20- or 30- or maybe even 40-something woman who by the way is at increased risk of heart desease compared to women who have their periods.

    I find it amazing that virtually every British website listing HRT guidelines specifically mentions women with POF while most US websites ignore us. By not mentioning younger women you are implicitely applying the same guidelines to us as to 50-something women who had already had 35 years of their own hormones.

  6. ANONYMOUS:

    If you read the package insert, clotting history (and I would include Factor V Leyden without a clot event) is a contraindication to vaginal estrogen use. (By vaginal estrogen, I mean the low dose therapies for vaginal atrophy, and not the higher dose Femring which is used for systemic replacement.)

    This is class labeling, and not based on any studies showing an increased risk of clotting with vaginal estrogen that I know of. Most vaginal estrogen studies are of short duration, six months or less.

    Unfortunately, the recent Cochrane review of vaginal estrogen did not address clotting at all, and the AFP recent article on the Cohrane review continues to list thromboembolism as a contraindication. So we are stuck wiht contraindication that is probably not supported, but unfortunately not refuted in any large prospective long term studies. So if you decide to use vaginal estrogen in a woman with a clotting history, it is off-label usage and you are on your own.

    What I do depends on the patient, so I am not going to give a specific answer here. I would say that there are things one can do to minimize the risks of vaginal estrogen use in any patient. These are:

    Use Vagifen or the ring rather than cream, since systemic levels are lower with these two than the cream. (Or, if using the cream, use a smaller dose than 1 gram.)

    Check estradiol levels before and during treatment to reassure everyone, including yourself.

    See if you can get away without the initial two week daily part of the regimen, since that dose raises serum levels for a short time.

    See if using it once a week is enough for the symptoms.

    Make sure that you have the blessing of her cardiologist or hematologist.

    Hope this is helpful

  7. Kitty:

    You are correct, of course, I did not mention the woman with POF. THe WHI results do not apply to her, in the same way that they do not apply to the woman with symptoms, since these two groups of women were excluded from the study.

    My guidelines are broadly written, so they actually can be applied to any menopausal woman, including the one with POF. HRT has risks and benefits at any age -it is the balance between those that shifts depending upon may factors, one of which is the age of the patient. In most women with POF, the balance tips well in favor of use, although for certain women that may not be so. I have a fair number of younger women who are manopausal due to chemotherapy for breast cancer, and I would do all I could to avoid estrogen in that group, at whatever age.

    Thanks for your comments. The reference is a good one.

    Take care.

  8. Thanks, tbtam! I’ve been treating my smokers in much the same way that you suggest….alternate methods first (SSRIs, even Catapres), then progesterone, avoiding estrogens and the associated cardiovascular risks. I’ve even gotten a few people to quit smoking(amazing!) The smoking population where I practice is, unfortunately, flourishing. Thanks again!

  9. Dr Whoo?

    Congrats on getting them to quit. It’s such a great feeling when we can actually effect positive change, isn’t it?

    I don;t mean to imply I don’t have smokers in my practice, they just tend to be younger than the HRT crowd.

    Thanks for reading.

  10. I found your site because I wanted cite-able data re: Title X funding. Then I found your HRT writing. I just asked my Dr. to place me on HRT based on my body and the research I have done. Your writing is such a lovely summary! I wish I’d found it before! However, it affirmed both my intincts towards HRT and my sense that I should remain vigilant and informed. Thanks for your empircal, reasoned approach. And your humor!

  11. Dr Polaneczky
    I have a question for you about HRT.Most women who take HRT know that the transdermal delivery method is the best.But because of our economic time things need to be looked at outside the box. There are women who are now using generic estradiol vaginally. What is your take on this ? They are also using a progesterone . The different’s in cost of a patch,gel and femring is great compared to generic PO estradiol.
    Is there anything that you can see that would happen? I’m sure some would say that they would get a high dose of estrogen but is that really true. Today’s low dosage of HRT is not even enough to totally eliminate vaginal atrophy and Dr’s in France use much higher dosages and have better results.

    • JD-

      Using vaginal estrogen for systemic hormone replacement is not a standard regimen, and other than the Femring, not FDA approved for HRT other than for vag dryness. The risk lies in not knowing which dosages are safe for the endometrium and how best to counteract that with progesterone and at what dose. The pharacokinetics of absorption via the vagina are variable from oral and transdermal,and would need study separately for any given regimen.

      So on the whole, I do not prescribe vaginal estrogen in other than FDA approved regimens for either hrt (Femring) or for vaginal dryness (estring, vagifem, estrace and premarin creams) though with occasional exceptions but even then usually just for dryness.

      Note – I removed names of docs you referenced in your comment so that it would not be perceived as spam, and if it was, well, that took care of that. 🙂

      Thanks for reading.

  12. […] It is, however, just one paper, and must be taken in context with prior research in this area. As a clinician, I have to say that this study does not change anything at the moment in my clinical practice, since I do not prescribe hormones for heart disease prevention. I will continue to offer HRT as one of several treatment options for women suffering from menopausal symptoms, so long as they understand its risks as well as benefits. (See my 10 Rules for Prescribing HRT) […]

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