Bioidentical hormones for menopause: what’s the latest?
It’s been some time since I covered the topic of bioidentical hormones. And with the lastest review of the Women’s Health Initiative data and yet another push in favour of hormone replacement therapy (HRT), I thought that an update was in order, particularly because the naysayers continue to emphasize that HRT is the end all to be all and that there are not evidence-based alternatives.
Think again.
For those of you who need a refresher in bioidenticals, they are hormones that are molecularly similar to those produced naturally by the body. HRT is manufactured and consequently, has been shown to alter how cell receptor bind to these hormones and function. Bioidentical hormones are often compounded in specialized pharmacies, i.e., they are individualized as directed by a health professional to the exact dosage and regimen required, based on a woman’s personal symptoms, hormone levels, and preference. Yet, claims that they are safer and equally effective alternatives have been challenged, namely due to the lack of scientifically sound data.
At last, that challenge is beginning to change, as more and more women turn away from HRT. In a recent study published in the open access journal BMC Women’s Health, researchers observed 296 menopausal women receiving compounded bioidenticals from six community pharmacies over a period of 7 years.The majority of women in the study were an average of 52 years old, in good health, and of moderate to average rate; most had not used HRT before. Although various compounded forms of bioidenticals were used in the study, the majority were topical, followed by oral, vaginal and under the tongue (sublingual). Moreover, all women were started at low doses of either progesterone as a single therapy or in combination with estrogen and then adjusted accordingly.
Overall and within three to six months after starting therapy, women reported significant improvements in their mood, including at least a 25% reduction in mood swings, irritability and anxiety. They also reported improvements in night sweats and hot flashes. Moreover, women who started on progesterone only therapy had much greater reductions in their mood symptoms compared to women who started on combination therapy.
Bioidentical hormone therapy also proved to be safe, with no woman experiencing a heart attack or developing breast cancer, although importantly, longer follow up times are needed before safety can be firmly established.
So, what are the drawbacks here? First, this was an observational study and undoubtedly, by relying on women to self report symptoms, there’s always room for bias. Still, this is the first well designed trial looking at compounded bioidentical hormones as opposed to manufactured formulations. And, while significant improvements were seen in mood symptoms, the verdict is still out with regards to vasomotor symptoms, i.e. night sweats and hot flashes.
Like any therapy, hormone or alternative, speak to a health practitioner first. Make choices based on information, not simply advice. Right now? Compounded bioidentical hormones appear to offer an advantage over HRT but more study is needed. Clearly, they may not offer the same benefits in terms of flashes but again, more research is needed.
I like the fact that scientists are starting to pay attention. You?
Read MoreBioidentical Hormones versus HRT: Guest post from Compounding Pharmacist Peter Koshland
I’ve written a number of posts lately about bioidentical and synthetic hormones. Hence, I am very happy to feature a guest post by compounding pharmacist and blogger Peter Kushland, on the distinction between the two.
Please welcome Peter. And stop by his blog – The Compounder’s Forum; it’s terrific!
As a compounding pharmacist, I am often asked what is the difference between bioidentical hormone replacement (BHRT) and conventional hormone replacement (HRT). BHRT, as described in my earlier post, is an approach to hormone replacement that has three key attributes:
- All hormones used are chemically identical to human hormones
- The dosage is individualized to a patent’s specific hormonal needs
- The goal is to achieve a balance of activities of the hormones to improve quality of life
(See my post entitled ” Key Principles of Bioidentical Hormone Replacement Therapy (BHRT)” for a more detailed description)
Conventional HRT is best exemplified by the commercial drug Prempro. Prempro is a combination drug that has both estrogens and a progestin. The estrogens are derived from the urine from pregnant mares and the progestin is medroxyprogesterone, a synthetic hormone not found in nature. Prempro comes in approx. 4 different dosages and is taken orally once daily. It can be found at any pharmacy.
So let’s go down the list and talk about the differences between conventional hormone replacement (HRT) and bioidentical hormone replacement (BHRT):
- Hormones are identical to human hormones – HRT=no; BHRT=yes
- Dosage customized for individual patient – HRT=no; BHRT=yes
- Hormone balance goal of therapy – HRT=no; BHRT=yes
- Primary goal is improved quality of life – HRT=possibly; BHRT=yes
- Primary goal is to prevent disease – HRT=yes; BHRT=no
– there are some who claim that BHRT can prevent all types of diseases from osteoporosis to certain types of cancer, and although there is some scientific evidence supporting these statements, there is not enough good, solid research out there to back-up any definitive claim that BHRT prevents disease.
– Be very skeptical of anyone who claims that BHRT is going to prevent any type of disease. With that said, there is lots of good evidence to support that BHRT is safe.
– furthermore, there is lots of good evidence that conventional HRT actually causes disease!
- close monitoring is regular part of treatment – HRT=no; BHRT=yes
- only available from a compounding pharmacist – HRT=no; BHRT=yes and no
– Here’s another area where people get confused. BHRT does not necessarily have to be made by a compounding pharmacist. Now, I don’t want to put myself out of a job and there are lots of reasons why a compounded product is superior to an off-the-shelf medication, but there are a handful of mass produced prescription drugs that are bioidentical.
There are various estradiol containing patches and an oral form of progesterone called Prometrium available. Dosages and routes of administration (topical vs. oral) are limited, but these products are biologically identical to human hormones and therefore meet at least the first criteria of BHRT.
- The estrogen “estriol” is available – HRT=no; BHRT=yes
– I will discuss the specific hormones that are bioidentical in future posts
- Hormones can be given topically – HRT=sometimes (estradiol patches); BHRT=yes (any hormone)
- Drug manufactured with FDA oversight – HRT=yes; BHRT=no
– Here’s one of the areas that critics of BHRT pounce on. Compounded bioidentical hormones are not regulated by the FDA. This is true. Compounding pharmacies are regulated by the state agencies that regulate retail pharmacies and for that reason the quality and potency of compounded medications can vary greatly. With that said, a compounding pharmacy that is using the top of the line equipment and has the proper quality assurance procedures in place will consistently exceed any standards the FDA might have for a mass produced medication.
It is important, however, to make sure you choose a compounding pharmacy that is using this equipment and has good quality assurance. I will discuss specific questions to ask when evaluating a compounding pharmacy in future posts.
- Drugs covered by most insurance plans – HRT=usually; BHRT=sometimes
– in my experience practicing in Californa, about 25-30% if insurance plans will pay for compounded medications
- Clinical evidence to support its use – HRT=no; BHRT=yes
– This is where the critics get it wrong. Many nay-sayers say that there is little scientific evidence to support the use of bioidentical hormones, when this couldn’t be further from the truth. for example, the hormone progesterone has been available for almost 80 years now and there are reams of clinical trials that have looked at its efficacy and safety in a number of ways. Also, estradiol, progesterone, and testosterone are available as mass produced pharmaceuticals and have passed the current FDA safety and efficacy standards.
Furthermore, there are good clinical trials that have studied HRT and they all show that it is dangerous, so the scientific evidence clearly does not support its use.
Read MoreWednesday “Bubble:” Bioidentical “hormones”
Quotation marks are used to signal the reader that something is important. Sometimes their use works counter to their intention. In this highly sarcastic editorial in Menopause Management, the esteemed Dr. Wolf H. Utian, president of the North American Menopause Society (NAMS), demonstrates what happens when quotation marks and information, go wrong.
The first indication that something was awry was a press release I received from NAMS confirming the Organization’s support of the FDA position on bioidenticals and reiterating their dangers. This release, like many others, was a direct response to informercial actress Suzanne Somers (who looks to be age 30) and her two-day miracles of plastic surgery bioidenticals sound-off on the Oprah Winfrey show last month.
No wonder the wagons have started to circle.
And yet, Dr. Utian’s assertion that supporters of bioidentical hormones be thrown into one categorical cult set out to acquire/garner the publicity around so-called “natural” therapies” does a huge disservice to the very women he proports to be protecting.
Warning that this new “cultlike” phenomenon of compounding bioidentical hormones will end in the courtroom and that folks should not anticipate supporting evidence from real experts, Dr. Utian states that the majority of the most significant national medical associations and societies are now coming out with statements of reservation about the bioidentical cult.
To healthcare practitioners everywhere, he warns that the responsibility to counsel women about risks and benefits of all pharmacotherapies is yours. You sign the prescription, you carry the liability. It’s time to tell women, “Buyers beware!”
I think it’s time to tell women to do their research, consult with an accredited practitioner, and follow your heart and head. I believe it’s time to take back our bodies and stop treating menopause like a disease for which “one size fits all.” And I think it’s time to tell government that we know the reach and influence of Big Pharma and that it time to question the rationale behind applying Western methodology to every type of integrative therapy in order measure its effectiveness.
Don’t drink the Kool-Aid
So, dear readers. Dismiss Suzanne Somers and her promise of youth forever. Don’t drink the Kool-Aid. But do your homework, talk to real practitioners not cutting edgers trying to cash in on the latest craze, and assuage your symptoms responsibly.
I wrote about bioidentical hormones last June. I am reposting it now rather than sending you back in time. The more things “change,” the more they stay the “same.”
Be safe. Be well.
Bioidenti what? [originally posted, June 13, 2008]
Bioidentical hormones (also known in many circles as “compounded biodentical hormones”) are compounds that have exactly the same chemical and molecular structure as hormones produced in the human body. The term is most often used in the context of estrogen and progesterone (and androgens), although any hormone can be made this way. Notably, there are a few of these agents that are actually FDA-regulated and available from retail and not compounding pharmacies (meaning that dosage and purity are theoretically on par with synthetic types).
There’s been a lot of hullaballoo over these products from many of the major associations that are involved in women’s health (e.g. The Endocrine Society, North American Menopause Society) primarily because: 1) they are not regulated by the FDA or have any oversight whatsoever and 2) potency is inconsistent. In fact, the FDA sent warning letters to nine pharmacies in January due to what the agency felt were unsupported claims about safety and effectiveness.
FDA does not just randomly go after pharmacists who practice traditional compounding and who don’t make false claims about their products. Traditional compounding, in fact, involves the preparation of a drug for a specific patient based on a doctor’s request.
Consequently, FDA action might have been driven, in party, by Wyeth Pharmaceuticals, who filed a Citizens Petition that claimed: 1 that compounding pharmacies were not actually compounding but “manufacturing” mimics of approved agents; 2) that they used a form of estrogen known as “estradiol” not commonly found in “traditional” hormone therapies; 3) that they were engaging in illegal promotional practices. (BTW, Wyeth manufactures several estrogen products, including Premarin, Prempro, and Premphase.) You can read the rest of the petition here.
It’s important to recognize that not all compounded products are bad. In fact, compounding pharmacies continue to provide options to patients with contraindications to commercially-produced therapies. An article in a large monograph sponsored by the North American Menopause Society explains that pharmacies were compounding micronized progesterone years before an agent (Prometrium) was approved in the US. It also goes on to highlight several advantages that compounded hormones might offer over conventional products, including greater dosing flexibility, lower doses for women who are especially sensitive and the avoidance of potential allergens.
Organizations such as the International Academy of Compounding Pharmacists (IACP) have become quite outspoken about what they consider to be the FDA’s interference in physician decisions to prescribe estriol to their patients. Congress has even introduced a bipartisan-sponsored bill (Resolution 342) to reverse the FDA’s decision on estriol. There’s a website that further explains these efforts.
In the meantime, if you decide you want to try bioidentical hormones, speak to your health practitioner. S/he can devise a regimen that best meets your needs (and not the needs of the masses) and may be able to recommend a credible compounding pharmacy. The IACP might also be able to assist with your search.
Read MoreNewsflash: International Menopause Society has issued updated guidelines on HRT
Got news?
I sure do!
The International Menopause Society has issued updated recommendations on the use of hormone replacement therapy (HRT, a term that they use to refer to estrogen, progesterone, combined therapies, androgens and tibolone). They note that the current guidelines are similar to those issued in 2007 but “include additional clinical data where needed.” And while they claim that there are “no reasons to place mandatory limitations on how long HRT is used (which by the way, runs counter to current recommendations of several major national and international medical associations), they do emphasize that HRT “should not be recommended without a clear indication for use, i.e. significant symptoms or physical effects of estrogen deficiency.”
The following are some highlights of the updated report:
- HRT should be used at the lowest effective dose to effectively reduce symptoms and maintain life quality
- Women who enter early menopause either spontaneously or due to hysterectomy or other condition before age 45 and particularly before age 40 may be at increased risk for heart disease, osteoporosis, mental disorders or dementia. Notably, the evidence of reduction of this risk via HRT is limited but is nevertheless recommended to preserve bone and reduce symptoms, at least until they enter the average age for menopause (i.e. ~52)
- Progestogen should be added to estrogen in all women with an intact uterus to prevent endometrial malignancies and cancer (except for in the case of low-dose estrogen)
- HRT is recommended to preserve bone health although it should not be started after age 60 and loses its effectiveness once therapy is stopped.
- Despite the controversy as to whether or not HRT is heart protective, the IMS says that it has the potential to boost or improve one’s risk profile because of how it affects the vascular system, metabolism of blood sugar, blood pressure and cholesterol levels. However, this recommendation is also framed within the recommendation that women adopt major primary prevention measures, such as stopping smoking, regular exercise, weight control, blood pressure reduction, and control of diabetes and blood pressure.
So, what about the risks of HRT that I’ve long written about on this blog? The convened panel disputes the conclusion of the Women’s Health Initiative (due to average older age of participants and when they started HRT) as well as data that have come down the pike since 2002. In fact, they say that the link with breast cancer is controversial and that HRT doesn’t initiate cancer (but rather, promotes an existing tumour). They also concur that data are still lacking with regards to type of HRT, doses, and administration type and incidence of breast cancer. And, with regards to endometrial cancer or stroke? They write that women with a uterus should be certain to add a progesterone component to their hormones to counteract any undue stimulation of their endometrium, and that stroke risk is related to increasing age and obesity, noting that risks may be avoided by using an estrogen patch or stopping use of hormones after the age of 60.
In general, the conclusion of the panel is than “most menopausal women have little to fear from the adverse effects of HRT” and that the benefits of hormone therapy outweigh the risks. Still, they do suggest that the decision to take HRT should be discussed with a physician and reviewed annually.
Not surprisingly, alternative therapies are completely
discounted in the IMS guidelines and they do not support the use of any bioidentical hormones whatsoever. Moreover, they make a point to place blame on the media without providing clear examples of their claims for “superficial and uncritical evaluations” of HRT, as if all media were one and the same.
I am not quite sure what to make of these recommendations. On one hand, they claim to have reviewed all the data since WHI but this panel convened four years ago. And while they are sure to promote HRT within a cautious framework, menopause continues to be positioned as a disease requiring treatment.Indeed, one of the report authors, Dr. Roger Lobos (Columbia University, New York), says that “the bottom line is that most doctors nowadays should feel comfortable about prescribing HRT to most women going through the menopause [but] like most medicines, you need to look at individual circumstances before deciding to taken it.”
Notably, media are once again positioned as the big bad wolf that misconstrue findings and attack pharmaceutical companies for their profit motivations.
Has anything really changed except the date of the report? Well, the good news is that the IMS acknowledges that there are risks associated with HRT, at least for some women. And yet, the report still appears lack objectivity.
Do yourself a favour. Speak to your practitioner. HRT will shut down your symptoms. Period. But you must ask yourself, at what cost? Do your research. Ask the hard questions. And then ask them again.
You may be sweating. But the issue is greater than the sum of all sweats.
Read MoreA doc and a diva walk up to the rooftop
Taking the mystery out of menopause, one rooftop conversation at a time. Drifters optional.
Yup ladies, the Nation’s own ‘Red Hot Mama’s”, THE source for everything menopause, has teamed up with Novagyne Pharmaceuticals to promote VIVELLE-Dot®, a hormone replacement topical patch. Perched up on the roof, the doc and diva discuss the changes of menopause, hot flashes and more. The conversation is lively and takes the “pause” out of menopause, so much so that makes you wonder what the heck you’re doing up on a roof with these two ladies.
Better yet, why are they up on a roof?!
Let’s talk about Vivelle for just a minute.
VIVELLE-Dot is a patch that is applied to the skin. It delivers a constant dose of a form of a natural (as opposed to synthetic) estrogen called estradiol, which enters the body through a very small skin patch. VIVELLE-Dot is applied twice weekly.
Granted, transdermal, or ‘through-the-skin’ delivery of medications is generally associated with fewer side effects than oral medications since the drug bypasses the liver and directly enters the blood stream. Still, although estradiol is a bioidentical hormone, with the same molecular structure as estrogen found naturally in the body, potentially seriously risks associated with taking estrogen, endogenous or not, include:
- a 2- to 12-fold risk of developing endometrial cancer, depending on length of time taken and dose
- breast cancer
- dementia
- a 2- to 4-fold increased risk for gallbladder disease
- increased risk of heart attack, stroke and blood clots
Note that using bioidentical hormones is not the same as using bioidentical hormone replacement that is customized to your needs. This is an important distinction to keep in mind the next time that you see the phrase.
Here’s my question: still hanging on the roof with the doc and the diva? Or do you want to drift away?
Menopause isn’t something to “fix,” it’s something to address with safe, effective strategies that don’t turn women into long-term guinea pigs. Do you want to be a Red Hot Mama? Or do you want give the Mama’s a run for their money?
This ain’t your mama’s menopause, it’s yours.’
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