The Alternative that Isn’t: Bioidentical Hormones

from-flickr-user-auntie-p1

The interest in bioidentical hormone therapy (BHT) has seemingly exploded of late, due in part to celebrity books and daytime television discussion. Suzanne Somers, author of multiple books on BHT, recently made her case for BHT on Oprah. According to Somers, BHT is a veritable “juice of life“; appropriate for women from their twenties right up to menopause and beyond. This article will look at the safety and effectiveness of BHT, and the responsibility of pharmacists and the pharmacy profession in its provision.

Bioidentical and natural is good, synthetic and conventional is bad right?

The term “bioidentical” refers to hormones that are not produced in the body, are but biochemically similar to hormones the body produces. Bioidentical hormones include estrone, estradiol, estriol, progesterone, dehydroepiandrosterone (DHEA), and cortisol. The FDA and Health Canada have approved several prescription products that contain bioidentical hormones.[1] [2]

But this isn’t what celebrities like Somers are promoting. In the popular media, bioidentical hormone therapy refers to products that are custom manufactured in a pharmacy. Bioidentical is often used synonymously with the term “natural”, inferring that bioidentical, compounded hormones are natural, effective, and therefore good, while pharmaceutical-company manufactured hormones (bioidentical or not) are unnatural, ineffective and dangerous.

“Natural” is a meaningless term with respect to BHT. All bioidentical hormones are manufactured using wild yams or soy as the starting ingredient, and all undergo chemical conversion in a laboratory to be synthesized to the final ingredient. [1] [3] There are no bioidentical hormones that do not undergo some sort of laboratory manipulation. Consequently there are no truly “natural” bioidentical hormones.

For the remainder of this article, we will refer to BHT to mean pharmacy-compounded hormones, and focus on estrogen and progesterone replacement approaches.

“Compounded”: What do you mean?

At one time, almost all prescriptions were custom manufactured, or compounded. The pharmacist combined raw chemicals into dosage forms like capsules, tablets, liquids and creams. Compounding allows complete customization of a prescription – from a new strength of a capsule, to a liquid form of a tablet, to creams with combinations of ingredients that can be completely individualized. Hormones are usually compounded into creams or gels, but also into troches (lozenges), and sometimes capsules.

These days, commercial manufacturers supply most drug products, and the need for in-pharmacy compounding has dwindled. At the same time, regulatory oversight, by agencies like Health Canada and the FDA, ensure product uniformity, purity, potency, efficacy, and safety standards for consumers. Most importantly, these regulators require manufacturers to demonstrate that a drug studied in clinical trials is equivalent to the one available in the pharmacy. This allows us to accept that the results of research studies are relevant to patients that will receive the drug. We cannot automatically assume this when a product is compounded in a pharmacy, due to the lack of quality control standards, and batch-to-batch variation from different techniques, recipes, and practices.

Any pharmacy is capable of providing compounded prescriptions, but some specialize, calling themselves “compounding pharmacies” and aggressively promote the service. Professional Compounding Centers of America, provides training, formulations (recipes), and raw ingredients to compounding pharmacies. Other companies exist to supply pharmacies with articles, brochures and handouts to promote BHT and other types of compounded prescriptions. To pharmacies and pharmacists, compounding is a business opportunity, and an ideal way for independent pharmacies to compete against large chain stores, which typically do not offer extensive compounding services.

So what’s the problem with regular hormone therapy?

Hormone replacement therapy (HRT) was routinely used in women for decades. Not only was it effective at reducing menopausal symptoms like hot flashes and sleeplessness, it was believed to reduce the risk of osteoporosis, and possibly even heart disease. There was data to suggest some risks existed, but the balance of risks and benefit was believed to favour the use of HRT.

The Women’s Health Initiative (WHI) study was designed to provide conclusive answers about the risks and benefits of HRT. One part of the WHI was a huge study of over 16,000 post-menopausal women (with an intact uterus). It compared women taking conjugated estrogens (Premarin) plus medroxyprogesterone (Provera), packaged as Prempro, to women taking a placebo. The trial was stopped early when it was observed that the HRT group had more breast cancer cases compared to the group taking the placebo. Overall, the risk and benefit was as follows: If 10,000 post-menopausal women take HRT for one year, compared to a similar group taking a placebo, there will be 8 more cases of breast cancer, 7 more heart attacks, 8 more strokes, and 18 more blood clots. However, there will be 5 less osteoporosis fracture, and 6 fewer cases of colorectal cancer. Overall there will be no difference in death rates. (A superb summary of the WHI is available here (PDF)).

BHT advocates cite the results of the WHI as proof of the harmfulness of HRT. However, the results of the trial actually tell otherwise. Some illnesses increased, some decreased. While overall the benefits do outweigh the risks for many women, especially if taken for long periods, the WHI results continue to be studied, and we’re now seeing physicians using HRT in an evidence-based way. For example, there is a renewed interest in using HRT right around the time of menopause. No other therapy has been shown to be as effective for menopausal symptoms, and the overall risks when used for short periods (i.e., less than five years), are low. In fact, the risks of breast cancer from HRT, while increased, are similar to that of other lifestyle risks, including alcohol consumption, obesity, and physical inactivity. ( See this statement from the Society of Obstetricians and Gynecologists of Canada.)

One unfortunate consequence from the WHI was the sense of betrayal women taking HRT felt from health professionals, regulators, and pharmaceutical companies. Those struggling with menopausal symptoms went looking for alternatives. Enter BHT, celebrity endorsements, and compounding pharmacies.

What are the purported benefits of BHT?

A quick search of the internet reveals all kinds of claims for BHT. If you believe what you hear on Oprah, BHT offers a “fountain of youth” for women, with none of the side effects but all of the benefits of conventional HRT. Advocates boldly state that BHT can prevent or cure heart disease, Alzheimer’s disease, and even breast cancer. [4]

BHT advocates argue that the WHI results were due to the choice of hormones studied, Premarin and Provera, (called PremPro in the US and PremPlus in Canada). Premarin is a mix of bioidentical and other estrogens derived from pregnant horses (PRegnant MARes urINe, hence the name). Provera is medroxyprogesterone, a version of progesterone that is commonly used because bioidentical progesterone is poorly absorbed. BHT advocates describe Premarin and Provera as “unnatural” and the reason for the problems with HRT. For example, Montreal Pharmacy’s website is typical, describing Premarin as “natural for horses but not for women”, and describes BHT estrogens as “anti-carcinogenic.”

Few physician advocates of BHT have any research or significant expertise in hormone replacement, women’s health, or endocrinology. ABC News noted that most of the sixteen physicians quoted in Suzanne Somer’s book,”Ageless – The Naked Truth about Bioidentical Hormones,” have not published a single paper on hormone replacement therapy. Additionally, three of these “cutting edge” physicians have had disciplinary action taken against them.

There are a significant number of supportive articles on BHT in pharmacy compounding journals, with a few appearing in more mainstream medical journals.[5] [6] [7] [8] A close analysis reveals that the evidentiary base relied upon is weak.  A consistent theme is the cherry-picking of supportive studies, and the extrapolation of weak data into broad elaborations of the safety and effectiveness of BHT.

What does the science say?

There are no large well-controlled clinical trials that have evaluated BHT to the extent that HRT has been evaluated. Consequently, there is no conclusive evidence to demonstrate that BHT is either safer, has fewer side effects, or is more effective than HRT. [1] [9] [10]

BHT often contains combination of estrogens such as triest (estriol, estrone, and estradiol) and biest (estradiol and estriol).  Both are arbitrary combinations of estrogens based on bad science. [10] [11] [12] There is no clinical evidence to show these combinations are appropriate. [11] While BHT proponents argue that estriol decreases the risk of breast cancer, there is no conclusive evidence to support this claim. [9] In fact, estriol has been shown to stimulate breast cancer growth to a greater extent than other estrogens. [9] Products containing estriol have not been approved in Canada or the United States, and given this data, its unlikely they would ever be approved. In fact, the FDA forbids compounding pharmacies from preparing products with estriol. [4]

A significant concern with BHT is the effectiveness of pharmacy-compounded progesterone. In women who have not had a hysterectomy, some version of progesterone must be given with estrogen to reduce the risk of endometrial cancer. Published reports have identified cases of endometrial cancer in women using BHT, possibly due to poor absorption from pharmacy-compounded progesterone products. [13] If this is the case, BHT carries significantly greater risks that HRT. Until there is evidence to show otherwise, compounded progesterone should be considered an unreliable source of progesterone. [14]

Overall, BHT has not been shown to prevent or cure any diseases. Statements of effectiveness for any medical condition, other than menopausal symptoms, are not supported by convincing evidence.

What about saliva tests?

So how do you know that your BHT is giving the desired effect? Some prescribers may order saliva tests to monitor a patient’s response to BHT. However, saliva tests are unreliable and considered by experts to be pseudoscience.[1] [10] [11] [12] [14] There is no persuasive scientific evidence that saliva tests are useful to monitor response to BHT or HRT. [12] The single best way to monitor hormone replacement is simply to see if menopause symptoms (e.g., hot flushes) are alleviated. [11] [14] BHT advocates argue that compounding and saliva allows patients to “balance” their hormones. But the science shows this is implausible. Estrogen and progesterone levels vary day-to-day and hour-to-hour. There are no published studies to demonstrate that single or multiple saliva tests reflect hormone need, or can be used to adjust doses accurately.

What about Big Pharma? Isn’t this just Wyeth reacting?

Wyeth, the manufacturer of Premarin, suffered a huge decrease in sales due to the WHI results. And Wyeth did petition the FDA in 2005, requesting the regulation of BHT compounding by pharmacies. The FDA studied the issue and subsequently took action against compounding pharmacies. While this action has been opposed by several pharmacist and pharmacy compounding organizations, many large medical and public organizations, with no vested interest in HRT or in Wyeth, have spoken out against BHT and strongly support the FDA’s action:

The American Medical Association – representing 135,000 physicians

The Endocrine Society -14,000 members in 100 countries – [position paper]

The American College of Obstetricians and Gynecologists – 52,000 members

The American Association of Clinical Endocrinologists

The North American Menopause Society

Public Citizen an outspoken critic of both FDA and no friend of the pharmaceutical industry, is one of the strongest critics of BHT, labeling it “DO NOT USE” on their worstpills.org website. They went on to say the following:

“Compounding pharmacies have their own financially driven interest in selling untested BHRT drugs. The pharmacies do, in fact, make unsubstantiated claims about the safety and effectiveness of their BHRT products. The overhead is probably quite low for producing, promoting and selling drugs that are not FDA-approved and are made from bulk drug substances (powdered drug) of unknown quality from sometimes questionable sources.”

They continue,

“Proponents of BHRT, those benefiting economically from their sale, maintain that the right of women and their doctors to choose must be protected. This is a perversion of consumerism often put forward by producers of shoddy products. There is a more fundamental right that is being violated by compounding pharmacies: the right to a marketplace free of potentially dangerous untested products promoted for unsubstantiated uses.” [Source]

So what’s the bottom line?

BHT is the alternative that isn’t. It isn’t safer, it isn’t more effective, and it isn’t based on sound or convincing science. Celebrity advocates and anecdotal evidence are easy to find, but the scientific data to support the broad claims of BHT advocates is absent. Without reassurance about risk or benefit, BHT is not an appropriate or safe option for the overwhelming majority of women.

I’m a patient. What should I know?

BHT therapy means more unknowns than HRT. These risks could have serious long-term health consequences. Despite what you may read on the internet or what you are told by your physician or pharmacist, you must assume the risks of BHT are at least equivalent to that of HRT.

Remember that some Health Canada/FDA-approved types of HRT contain bioidentical hormones. By taking commercially-manufactured HRT, (bioidentical or not) you and your physician will have better information about expected benefits and risks of treatment. You can then make an informed decision based on actual scientific data. With HRT, you will have access to products that follow highly rigorous and regulated manufacturing standards. Compounded products, on the other hand, mean a decision based on less scientific evidence and risks that equal or possibly exceed that of HRT. Essentially you’re in a clinical trial of one person: you. Regardless of your decision, any HRT, bioidentical or not, should be prescribed at the lowest possible dose and for the shortest duration possible.

In exceptional situations where commercially-manufactured products are intolerable, or for some reason, inappropriate for managing your menopausal symptoms, compounded BHT may be an acceptable option. If this is the case, choose your pharmacy carefully. Ask about the pharmacist’s experience with compounding BHT. Preparing BHT involves the measurement of very, very small amounts of raw materials, approaching the error limits of most pharmacy scales. Consequently unless the pharmacy consistently prepares large volumes of BHT creams, you are more likely to receive a product that varies from batch to batch. Remember that pharmacies are not required to disclose warnings with BHT. However the FDA has made it clear that these risks are real, and should be considered equivalent to that of HRT. Review the data on the WHI study.

The term “Hormone Consultant” is a undefined title that provides no assurance that someone is a qualified health professional, or is capable of providing evidence-based and science-based information on hormone replacement. [14]

Pharmacists or physicians that recommend saliva tests as part of your evaluation are not providing advice that is supported by science.

Most insurance plans refuse to pay for BHT. You may be required to pay cash for your prescription. The costs can be expensive.

Advice for pharmacists?

It is inappropriate to assume that a lack of data with BHT is evidence of safety. Claims cannot be made that BHT is superior with respect to efficacy or safety until these claims have been demonstrated in randomized controlled trials. Further, claims of reduced breast cancer risk, improved cardiovascular protection, improved adherence to therapy, and fewer adverse effects have not been substantiated and are misleading.

Following the release of the WHI, the FDA required all HRT manufacturers to include the same information about risk and benefit of HRT, unless evidence could be provided to demonstrate a different risk profile. Given the size of the WHI it is reasonable to conclude that this data will not emerge for BHT. There is no comparable evidence to demonstrate either improved efficacy or reduced risk with BHT compared with HRT. Consequently it is appropriate to provide the same risk/benefit information to patients taking BHT.

It is the responsibility of pharmacists to offer evidence-based information to patients who are seeking health information. It is also the pharmacist’s responsibility to protect patients from unnecessary risk. It has been argued that the line of professional ethics is crossed when a practitioner promotes his or her own therapy as a “product” which is not considered the standard of care. [15] Menopausal women are vulnerable to anecdote and misinformation as they seek treatment for what can be very debilitating symptoms.  [15] This puts an additional onus on pharmacists to provide ethical, science-based care.

Conclusion

All forms of hormone replacement must be held to the same standard and level of evidence. Given the limitations of data on BHT, and the potential risks, it is doubtful that BHT will ever be considered an accepted, appropriate therapy, or the standard of care, until important questions of safety and efficacy are addressed. Consequently, the onus is on pharmacists and pharmacies that profit from BHT, and the colleges that regulate them, to ensure that patients receive accurate, evidence-based information about this controversial therapy.

Fears and mistrust of HRT are largely unfounded, and propagated in part by advocates for BHT who may not be providing evidence-based information on the facts of HRT and the additional risks of compounded therapies.

The proliferation of compounding pharmacies specializing in BHT has become a largely unmonitored supply chain of untested products, responding to, but also driving demand for, products that are not the standard of care. It is time for the pharmacy profession to reflect on its obligations to patient care and reevaluate the provision of bioidentical hormones.

For More Information

Sasketchewan’s Academic Detailing Program, RxFiles, prepared a summary of clinical data following the WHI events of 2002. While somewhat dated, it provides a good overview of alternatives from a Canadian perspective. Sasketchewan’s drug information service published a good overview of the BHT issues in 2003.

British Columbia”s Therapeutics Initiative prepared a nice summary of the WHI following the publication of the key clinical data.

Dr. Harriet Hall examined BHT in Skeptic magazine in 2007 and in the Science-Based Medicine blog in 2008.

FDA’s Q&A on compounding provides their perspective on the practice.

Pharmwatch’s take on Bioidentical Hormone Therapy.

References

[1]. Pinkerton JV. Bioidentical Hormones. What you (and your patient) need to know. OBG Management 2009;21(1):43-52.

[2] Health Canada. Drug Product Database (Database on the Internet). Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php . Accessed March 10, 2009.

[3] Harvard Women’s Health Watch. “What are Bioidentical Hormones” 2006;13(12):1-3.

[4] Food and Drug Administration. “Bio-Identicals: Sorting Myths from Facts” Available at http://www.fda.gov/consumer/updates/bioidenticals040808.html. Accessed March 10, 2009.

[5] Schwartz ET, Holtorf K. Hormones in wellness and disease prevention: Common practices, current state of the evidence, and questions for the future. Prim Care Clin Office Pract 2008;35:669-705.

[6] Hortorf K. The bioidentical hormone debate. Are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med 2009;121(1):1-13.

[7] Paoletti J. Correcting misconceptions about compounding bioidentical hormones: A review of the literature. Int J Pharmaceutical Compounding 2007;11(4):269-72.

[8] Wepfer S. The science behind bioidentical hormone replacement. Int J Pharmaceutical Compounding 2001;5(6):462-4.

[9] Boothby LA, Doering LA. Bioidentical hormone therapy. a panacea that lacks supportive evidence. Curr Opin Obstet Gynecol 2008;20:400-7.

[10] Sikes CK. Bioidentical hormones for menopausal therapy. Women’s Health 2008;4(2):163-71.

[11] Cirigliano M. Bioidentical hormone therapy: A review of the evidence. J Women’s Health 2007;16(5):600-31.

[12] Boothby LA, Doering PL, Kipersztok S. Bioidentical hormone therapy: a review. Menopause 2004;11(3):356-67.

[13] Eden JA, Hacker NF, Fortune M. Three cases of endometrial cancer associated with”bioidentical” hormone therapy. Med J Aust 2007;187(4):244-5.

[14] MacLennan AH, Sturdee DW. The ‘bioidentical/bioequivalent’ hormone scam. Climacteric 2006;9:1-3.

[15] Rosenthal MS. Ethical problems with bioidentical hormone therapy. Int J Impot Res 2008;20:45-52.

66 thoughts on “The Alternative that Isn’t: Bioidentical Hormones

  1. thecompounder says:

    Thanks for posting a comment on my blog and thanks for taking the time to post such a thorough and well-referenced blog post.

    There are many things I disagree with you about in this posting and I hope to be able to make my case on each specific item as I have more time to write, but I just want to challenge you on a couple of key points.

    With regard to the WHI, just because all-cause mortality did not increase with the CEE/MPA arm doesn’t mean that the treatment arm is safe. The authors of the trial stopped it for a reason. They concluded that “overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women.” JAMA. 2002;288:321-333. Now proponents of conventional HRT are recommending using lower doses for only 1-2 years. Where is the scientific evidence to back that up? And since when did women suffering from menopausal symptoms only have them for 2 years?

    Second, I assume you are a pharmacist who dispenses medications. So, next time you are putting your initial on a prescription that is going to a patient, ask yourself, where is the clinical evidence to support that drug’s use. Have you ever dispensed atenolol for hypertension, orlistat for obesity, or donepezil for Alzheimer’s disease? I would estimate that about one-third do one-half of the drugs behind a typical pharmacy counter do not have solid clinical evidence to support its use. I’m not saying that all these drugs should never be used. The existing clinical evidence needs to be weighed against the patient’s specific circumstance and integrated with our knowledge of physiology and pharmacology to make the best choice for the patient. Why else did we go to pharmacy school to learn that stuff?

    Anyway, I appreciate your willingness to put your thoughts out there into the blogosphere so we could have this debate. I look forward to more postings.

    Peter Koshland, Pharm.D

    • Drew Silverman, Pharm.D. says:

      Dear Dr. Koshland,

      I don’t know what pharmacy school you went to but our knowledge of physiology and pharmacology is only as good as the studies that support what we think we know is true. Most of the pharmacology you learned in school is based upon animal data, and theory. Therefor your own response is conflicted. The human studies are how we find out if what we thought was true really is. It’s called evidence based medicine. Bioequivalent HRT is clearly lacking any of that. Perhaps in the future you will part of the solution to protecting patients. “FIRST DO NO HARM”

      In Answer to Rebecca’s comments regarding lack of data for BHTs there is a boatload of money being made by the practitioners using them. They could certainly fund a study to answer the question, but why would they do that. If they are wrong they just blew up a multimillion, potentially multi-billion dollar industry. What makes you think any of these people are more ethical than the pharmaceutical industry?? I am also curious why you haven’t started taking the BHT yet. The power of suggestion is a very persuasive therapy. This is why studies need to be done.

  2. Hi. Thanks for the comments and feedback.

    The current positioning of HRT as reasonable option for short durations is one that does have published clinical evidence to support it. Here is some further information to support that statement.

    Most women use HRT for less than 5 years. The risk of breast cancer returns to normal after discontinuation. In the WHI, women who had not used HRT prior to enrolment showed no increase in the risk of breast cancer over the duration of the study. Consequently, the evidence suggests that short-term HRT use (i.e., <5yrs) carries little incremental risk.

    Many modifiable and unmodifiable breast cancer risks are similar to that of HRT. For example, failing to exercise regularly is as risky as HRT, with respect to breast cancer. Consequently the incremental risk of hormone replacement (bioidentical or not) needs to be put into this context.

    These statements are based on the following clinical practice guidelines:

    Menopause and Osteoporosis Update. Journal of Obstetrics and Gynaecology Canada. 31(1): January 2009

    as well as

    Estrogen and Progestin use in postmenopausal women: July 2008 Position Statement of the North American Menopause Society (PDF).

    Regardless of one’s perspective on the evidence supporting short-term use of HRT, I am unaware of any data with compounded BHT that demonstrate the risks are any different. As I noted, the use of compounded products introduces several more risk factors that must be considered without persuasive evidence of additional clinical benefit.

    With respect to the level of evidence supporting other prescription drugs, that’s an ad hominem tu quoque argument. The focus of this article was BHT. Perhaps I’ll get to the cholinesterase inhibitors in a future article….thanks for the suggestion!

  3. Rebecca, R.Ph. says:

    I joined your blog today and this was the first article that came up. As a female who has underwent treatment for stage 3 breast cancer, I can tell you first hand that the effects of all the chemicals and radiation and surgeries have taken their toll on my body. At age 39 the chemotherapy put me into a post-menapausal state (sort of) which left me feeling fatigued, mental cloudiness, hot flashes (unbearable at times), sleep disturbances, I could go on and on.
    I am almost 3 years out since my diagnosis and I do credit my oncologist for saving my life. However, he now only wants to give me antidepressents and anti-inflamatory drugs to help with the serious fatigue that I experience. I am so sick of taking pills!
    A few months ago I attended a symposium on nutrition and it’s effects on our bodies. This led me down the path to discover how important hormones are for our bodies and how powerful their effects are.
    I just finished blood test and saliva testing for hormone levels and the saliva test were very similar to the blood test results that my oncologist ordered. I have been reading and investigating these issues (BHT and other hormone replacements) for a couple of months and talking to others who have used BHT.
    If you look at the articles that are against saliva testing they are all funded by pharmaceutical companies (100%) compared to independent studies that found saliva testing to be useful and accurate (92%). I now know my cortisol and progesterone levels are seriously low and my estrogen levels are very high. This is consistent with estrogen dominance – which I now believe to be a large factor to my getting breast cancer in the first place.
    I am looking forward to Peter K. disputing each point that you make with scientific evidence, but I will tell you first hand that when given the choice of Prometrium or a compounded progesterone, I will choose the compounded progesterone that is specific to my needs. One point to make is that a good compounding pharmacist will have samples tested by an independent lab for potency and accuracy.
    I know many women (and their husbands) who would NOT be happy and healthy if it were not for them taking BHT. Tell me why there are no scientific studies on the BHT??? Because the pharmaceutical companies can NOT make any money on these products.

    • Thanks for your comments. I suppose it’s easy and convenient to blame “Big Pharma” for suppressing bioidentical hormones. But rather than trot out conspiracy theories, let’s keep the discussion focused on the science. If you have substantive evidence that refutes the science, please post it here for further discussion. I am particularly interested in seeing the results of your systematic review of the funding sources of articles that examine saliva testing. Please feel free to post your search strategy, citations, and funding sources here.

      • Amber says:

        You noted that there is no science on this “bio-identical” matter yet, so maybe that is why “no substantive evidence exists”. Where is you advocacy of finding answers to severe problems faced by menopausal women. You are stoked with reasons why it does not work. Wonder why such passion to debunk this?

        Here is some form of evidence for you…women (including myself) feel incredibly better, are once again able to compete well in the professional workplace, be a better spouse, mother, daughter, friend — living life again.
        I find that your comments and tone lack objectivity of a scientist. Furthermore, you as a man, lack the personal basis to tell women who have been helped that they are being dupped. Your position is lacking in substantive evidence as well.

      • Thanks for your comments. I do no dispute that you feel better on hormones. Hormone replacement is much more effective than any other treatment for the relief of menopausal symptoms. The point of the article is the relative risk and benefit of pharmacy-compounded products, compared with conventional hormone therapy. I am unclear about your statement that the article is lacking in substantive evidence – the article is referenced, and the citations are at the bottom of the article. If you have data to dispute any statements, please feel free to post it.

  4. Karen Capps says:

    Unless you are a woman and have actually tried some of these HRTs,then I would suggest that you think again about the benefits of bio-identical hormones. Prescriptions are not a one-size fits all for individuals. I personally have tried many products that contain estradiol, i.e. vagifem, evamist, estragel and found that I still had symptoms of hot flashes, trouble sleeping, and aching/tenderness in my abdomen. Once I tried biest cream – bio-identical hormones of 1.25 mg twice daily, my symptoms immediately improved and I am sleeping all night with increased sexual desire. Please do not generalize the benefits of natural hormones. I don’t care if the FDA approves them or not, why do they need to if they are natural.

  5. For health professionals interested in the WHI, I refer you to the following:

    http://journals.lww.com/journalppo/Fulltext/2009/04000/Hormone_Replacement_Therapy__Real_Concerns_and.1.aspx

    Here is the abstract:

    From 2002 to 2008, reports from the Women’s Health Initiative (WHI) claimed that hormone replacement therapy (HRT) significantly increased the risks of breast cancer development, cardiac events, Alzheimer disease, and stroke. These claims alarmed the public and health professionals alike, causing an almost immediate and sharp decline in the numbers of women receiving HRT. However, the actual data in the published WHI articles reveal that the findings reported in press releases and interviews of the principal investigators were often distorted, oversimplified, or wrong. This review highlights the history of research on HRT, including a timeline of studies that have or have not found a link between HRT and breast cancer; discusses how to distinguish important, robust findings from those that are trivial; closely examines the WHI findings on HRT and breast cancer, most of which are weak or statistically insignificant; reviews the current thinking about possible links of HRT with cardiovascular disease and cognitive functioning; and reports research on the benefits of HRT, notably relief of menopausal symptoms, that affect a woman’s quality of life. On these complicated matters, physicians and the public must be cautious about accepting findings by press release in determining whether to prescribe or take HRT.

  6. Great blog!

    I know a doctor (he actually does have MD, but practices woo) who’s managed to make heaps of money by diagnosing just about every woman entering his posh clinic with ‘hormone imblalance’ and prescribing this garbage. This is a really great and informative post, and I’m adding you to my blogroll.

  7. Here’s another study you might be interested in: Bleeding profiles and effects on the endometrium for women using a novel combination of transdermal oestradiol and natural progesterone cream as part of a continuous combined hormone replacement regime. (BJOG, 2005).

    The authors found that progesterone cream did not produce the effects on the uterine lining that naturally produced progesterone does. This study found the same thing, with the added bonus that the authors tested salivary progesterone levels, and found them to be “so variable as to be considered completely unreliable”.

    So in at least one sense, that of endometrial composition, natural progesterone cream is NOT bioidentical and does not produce the same effects as naturally produced progesterone. Given that endometrial transformation and support is the primary function of progesterone in situ, it’s reasonable to question whether natural progesterone cream has any of the other purported effects.

  8. Jane R says:

    Congratulations on such a lucid and comprehensive report on these BHT “alternatives”. I have now been going through the menopause for SEVEN years and having recently been scared by multiple articles on, it now would appear, the ever increasing risk of HRT, I reluctantly stopped taking it. Three separate physicians have verified that I am one of those poor unfortunates suffering “severe syptoms” and I definitely fall into your category of “Menopausal women vulnerable to anecdote and misinformation as they seek treatment for what can be very debilitating symptoms”. So I thank you for your information on BHT. However, I am struggling to maintain a semblance of my true self – sleep, work, socialising is all a nightmare. Surely with all the advances we have made in modern medicine, there has to be an alternative to HRT?? To what degree do the risks associated with HRT increase with duration (7 yrs in my case)? I am in my third month without HRT – NONE of the known homeopathic options have worked for me and I’m just not sure how long I can continue in this way. If there was a specific “stop” point, it might be easier to bear, but my physician says he has one patient of 63 who is still suffering!!! (I am 52!) So if ANYONE out there knows anything to enlighten me – please let me know :o) !

  9. Nicolas (BscPharmacy) says:

    Jane, thanks for sharing your story. As a regular reader of this blog and registered pharmacist, I wish to answer some of your concerns. However, understand that any information found on forums or websites is not a substitute to good communication between you and your GP or specialist.

    For starters, menopause can vary greatly with regards to symptoms, severity and duration. For example, some women may experience hot flashes for months to a few years after start of menopause (around 51 years or age), while others will suffer less from hot flashes but more vaginal-bladder problems, mood (ie: irritable, sleep troubles, depression), or sexual problems due to complications of low estrogen. Average duration is 6 months to 2 years, while some studies show a proportion or women can experience some extent of symptoms for as long as 10 years.

    Scott did partly adress your concern of HRT risk in this post. However, your physician or community pharmacist can explain that the risk is low and is dependant on which HRT combination you were taking (also, for how long).

    Jane quote -
    “Surely with all the advances we have made in modern
    medicine, there has to be an alternative to HRT??”

    As for other treatments, there are various options available. however, they are best determined by what type of symptoms you are experiencing (ie: hot flashed, bladder-vaginal or mood problems?) and by reviewing benefit vs. risk of each treatment by you and your physician. If you think you may need a referal to a specialist, feel free to ask. They are often times more up to date with recent research than your GP.

    Questions to ask your GP or specialist:
    -Are my symptoms (ie: sleep,work, socializing) related to menopause or might be related to something else?
    -Of all the medications I’ve tried, are there others that you think I could try?
    -Would you recommend certain lifestyle changes that may be worthwile?

    If I may suggest further reading, try a reputable health advocate society like Mayo Clinic(1), or the Society of Ob-Gyn of Canada supported website (2) or the UK’s NHS (3).

    1)http://www.mayoclinic.com/health/hormone-therapy/WO00046
    2)http://www.menopauseandu.ca/index_e.aspx
    3)http://www.nhs.uk/Conditions/Menopause/Pages/Treatment.aspx

  10. Jane R says:

    Hi Nicolas! Many thanks for the time taken – it is much appreciated. I am generally very unhappy with my physician, but the system is such in the UK that it is very hard to switch. I will follow your advice and try to get a referral. My main problem is just being hot and flustered virtually all the time – the sweat just pours off me – which can be very embarrassing in some social situations, and which prevents me sleeping through the night. The flashes can be so bad that they are akin to panic attacks. My brain often feels like cotton wool and I have trouble focusing on matters or concentrating. I am suffering from depression – for which I am now receiving treatment – exacerbated I feel due to my constant state of “fluster” and the weight I gained as soon as I went on HRT (around 15 lbs – which has failed to come back off again!). Finding the motivation to exercise to lose the weight is extremely hard, especially when the sweat’s already pouring off me without lifting a finger! I’m also extremely depressed because it has lasted so long, I have now been suffering in this way for seven years and it all just seems so endless …

  11. Jerome Burne says:

    Respect for your very detailed attack on bioidenticals but as a medical journalist whose done some research into them I’d like to make a few points in reply. The first is that, like many such attacks, it glosses over just how striking is the chemical difference between the HRT versions of oestrogen and progesterone and the bioidentical ones. Can’t reproduce it here but there are some very accessible diagrams on the web.

    What they show is that that if you compare the structure of bioidentical estradiol with testosterone (the hormones responsible for differentiating males and females) they are remarkably similar, far more similar than the structures of estradiol and premarin (a major HRT oestrogen). With hormones small differences can have large effects,

    Even more striking is the difference between progestin and progesterone; it is also worth noting that while progesterone is present in large quantities during pregnancy that progestin is contraindicated during pregnancy as it can induce miscarriages.

    A second point is that it is frequently repeated that there are no proper trials comparing HRT and bioidenticals however it is not that simple and the French experience in this respect is interesting. They are much more keen than the US and the UK on using both progestins and progesterone (the version they use is a micronized progesterone that has actually been licensed in the USA for some time (don’t have the details to hand) and and has recently become available in the UK where it is known as Utrogestan.)

    A considerable amount of research into progesterone has been done by Dr Michael Schumacher of the Kremlin-Bicêtre hospital in Paris who cites a range of studies – much of it animal- showing that progesterone has beneficial effects on the breast tissue, on blood vessel function and in strengthening bone. Many of the benefits of progesterone, he says comes from the fact that while oestrogen stimulates cells, progesterone calms them down ( Michael Schumacher, Rachida Guennoun, Abdel Ghoumari et al “Novel perspectives for progesterone in HRT, with special reference to the nervous system” Endocr Rev. 2007 Jun;28(4):387-439)

    Drawing on this work Schumacher believes that progesterone might lower the risk for dementia since oestrogen and progesterone combined have been shown to have a neuroprotective effect, unlike progestins which can reduce this protective effect.

    He also suggests that progesterone may protect against breast cancer and this is supported by a trial that is almost unknown in US and UK comparing the effects of progesterone and oestrogen. It’s a big ongoing French study of 54,548 menopausal women comparing what happens to those who take progesterone in their HRT with those who get progestin. The latest report has found that after eight years while those on progestins have a raised risk of breast cancer, those on progesterone don’t. (Fournier et al “Unequal risks for breast cancer associated with different hormone replacement therapies: results from the (E.sib.3) cohort study” Breast Cancer Res Treat 2008: 107(1): 103-11) It’s not a controlled double blind etc but it’s far from negligible.

    And for trial evidence that isn’t all. In the USA Dr Schumacher’s claim that progesterone can protect blood vessels and cut down the risk of strokes has just been supported in two small trials at Texas University. Researchers gave a progesterone cream or a placebo to 30 post-menopausal women for eight weeks. Not only did the cream improve their symptoms but there was no rise in various markers in the blood that make strokes more likely, such as inflammation and a tendency to form clots. Kenna Stephenson, Pierre Neuenschwander et al Transdermal progesterone: Effects on Menopausal Symptoms and on Thrombotic, Anticoagulant and inflammatory factors in post menopausal women International Journal of Pharmaceutical Compounding Vol 12 No 4 July/August 2008 (not on Pubmed but is on Embase, Emnursing, Compendex, Geobase, Scopus)

    The second trial found a similar beneficial result from giving a cocktail of individualised bio-identical hormones to 75 patients and compared the results regular HRT. The women were tested after a year. The results were reported at the American Heart Association Scientific Sessions 2008, New Orleans, Nov. 8-12, 2008 by Kenna Stephenson, MD, department of family medicine, University of Texas Health Science Center, Tyler.

    Now evidence like this doesn’t completely prove the case for BI and everyone agrees there needs to be more research. So will the big trials that doctors are demanding now be run? The depressing truth is that it’s unlikely without strong consumer pressure. Calls for such research are not new.

    Thirty years ago an editorial in the Journal of the American Medical Association asked how long clinicians will to wait for proper clinical trials on the benefits of estriol, the weakest of the oestrogens. “Enough evidence has been accumulated,” it said “that we may say that it is safer than Estrone and Estradiol.” The trials have still not been done. (Follingstad A. Estriol the forgotten hormone? JAMA, 1978;239:29-30.)

    What I’m still surprised about in these debates (firefights?) over the benefits of pharmaceutical vs (I use my terms carefully here) non patentable treatments is the assumption of scientific superiority on the pharmaceutical side. You must know that a cavalier attitude to evidence has been a hallmark of drug company marketing, frequently with fatal results. In light of the repeated assertions that there is no proper clinical trial evidence for bioidenticals it is worth remembering that until the WHI study there was none for HRT either – lots of observational stuff but no long term trial and the pills were prescribed in their millions.

    But the fiddling was far more specific. Recently a particularly striking example fudging figures on HRT came to light as a result of investigations by Senator Grassley into “ghostwriting”. A report in the New York Times showed how Wyeth Pharmaceuticals and a medical writing firm produced ghostwritten journal articles–all signed by prominent gynecologists—that were designed to deceive doctors about the safety of Prempro. (THE NEW YORK TIMES December 12, 2008
    “Drug Maker Said to Pay Ghostwriters for Journal Articles”)

    One of these was published in The American Journal of Obstetrics and Gynecology in May 2003 – a year after the WHI study had found the increased the risk of breast cancer – saying that there was “no definitive evidence” that progestins cause breast cancer, adding that hormone users had a better chance of surviving cancer.

    Finally although the anti bioidentical camp keep on playing down the HRT risks there is growing evidence that a falling incidence of breast cancer among postmenopausal women in the United Kingdom may be linked to lesser use of hormone replacement therapy (HRT). (See BMJ 2009;338:b791)

    Jerome Burne

  12. Taryn says:

    Scott, you need to correct one of your opening sentences. BHRT is not “biochemically similar to hormones the body produces”, it’s chemically IDENTICAL. So we women who are using BHRT are supplementing EXACTLY what the body can no longer produce at sufficient levels.

    Also, it’s misleading to equate BHRT and “compounded” hormones. I’m using FDA-approved estradiol (EstroGel) purchase from my local CVS pharmacy. I do use a progesterone cream from a compounding pharmacy, but I had the option of using the FDA-approved progesterone pills, Prometrium. Therefore, not all BHRT is “compounded”, and not all BHRT is under the control/guidance of compounding pharmacists. My gynecologist guides my BHRT.

    But your worst error by far is your statement that “BHT is not an appropriate or safe option”. Are you paid by Wyeth? You cannot say that BHRT is safe unless you have evidence. You have no such evidence. All you can say then is that BHRT has not been proven to be safe.

    It’s clear that you think BHRT is risky, or you are being paid to claim that it is. You do realize, don’t you, that all women have estradiol, estriol, and progesterone in their bodies all of their lives, and the pre-menopausal levels are FAR higher than the levels achieved through BHRT. If BHRT is risky then simply being a woman is risky, and we should expect to see far more problems in young women than in menopausal women due to the higher hormone levels. But in fact the exact opposite is true. For example, a woman’s risk of breast cancer is several times higher post-menopause than pre-menopause. Likewise heart disease.

    In my particular case, in the 2 years prior to my menopause, my estradiol serum levels measured in the 350-529 pg/mL range. One year into my BHRT my estradiol serum level measured 70 pg/mL. Do you really think that 70 is more risky than 350-529? Come on now.

    I would like to add that I also did saliva tests, and I found that they correlated extremely well with the serum tests. Wherever I was with respect to the reference range on the serum test, I was in the same spot on the saliva test. Have you done any of your own research on this topic ? Ever done serum and saliva tests to measure your own hormones ? I suggest you try it.

    Because you’re a man, you will never know how horrible menopausal symptoms can be, though you might have a slight clue if you are afflicted with prostate cancer and use hormone-altering drugs. Just two months after my estradiol measured a sky-high 529 pg/mL, my ovaries apparently conked out and I entered an excruciating period of my life during which I suffered unrelenting multiple-times-per-hour adrenaline rushes (increased BP and increased heart rate) followed by hot flashes so disturbing I thought I might pass out. 24×7. Let me repeat, multiple times per hour. Imagine trying to work, trying to attend meetings, trying to walk down the street, trying to shop, trying to deal with loved ones, trying to SLEEP, when you feel like absolute sh*t and every 10 minutes or so you feel like you’re going to burst. I cannot describe in words how awful it feels to wake up in the middle of the night with my heart beating so fast it’s as if I had just finished running up a dozen flights of stairs. I endured this misery for only 9 days before I begged my gynecologist to prescribe estradiol gel, which she and I had already discussed at a prior visit knowing that I was fast approaching menopause. I had already been using progesterone cream for several years with great success. Within 48 hours of beginning my estardiol treatment, using only 1/2 of the standard dose, I had nearly total remission of all of my symptoms. I have continued success more than a year later.

    Now imagine yourself in my position, and imagine reading an article by some MAN who appears to want to convince people that BHRT should be outlawed, and who appears to think that women are too stupid to be able to make the decision for themselves. This is going to sound awful but understand my point, I hope you develop erectile dysfunction and the FDA decides to yank all Viagra-like drugs so you are left to suffer with a limp penis and no way to achieve sexual gratification, because that’s the only thing I can think of that might be as important to you as my quality of life, my health, and my feeling of well-being is to me.

    Pick another group of people to control, leave us suffering women alone. Please.

  13. I’m puzzled by some of these reactions, especially the ones that state that because the author is a man, he has no place to write this article.

    I’m disabled by chronic fatigue syndrome, along with some other health problems, and I have read my share of half-assed articles (which this is not) about my illnesses or about the treatments I use. When I object to them, they are on the basis of the science, not whether the authors have CFS themselves.

    I recognize this is an emotional issue, and one I’ll likely encounter myself, as my mother had many hormonal problems before and during menopause. As I’ve written on my blog this week, you can go just about anywhere to find support, emotional and otherwise, for just about any treatment. In those places, the motto of the critical thinker, that “anecdotes do not equal data,” does not apply. And it shouldn’t always. Without a doubt, there will be people who have found marvelous relief from a treatment that medical science is not ready to endorse. I am one of those. But if all I want is people to say “yes, me too, this really helps for me,” I know where to go. However, on this blog, anecdotes, as perfectly true and valid as they may be, do not equal data.

  14. Excellent – impressively thorough – post. It is a difficult, and highly emotionally-charged area. I would also like to highlight the unhelpfulness of comments about a dreaded man posting about women’s health. By that logic I have nothing to offer any of my patients, as I have not been mentally ill. It is a nonsense. The science is the science, and as a previous commenters noted, anecdotes (reinforced as they are by the clustering effect of Internet forums/support groups) do not constitute a useful argument against it.

  15. Lance Chambers says:

    I have read conflicting views about bioidentical hormones in showing efficay and safety. However, I still believe that bioidentical hormones are better than synthetics because these hormones can be customized to address women’s exact needs so women should be given the opportunity to choose but they should talk to their health provider about the possible risk because only a health provider can recommend all the necessary tests to ensure that patients get the right dosage fit for their circumstance.

  16. Beryl Spiers says:

    I don’t know hwo wrote this article, but whoever it is, is not a post menopausal woman with a prior hystorectomy that has panic attacks, suicidal thoughts,cant sleep,migraine headaches,loss of appetite, bloating, and has mananaged to control the symtoms with Estrodiol Patches and would be happy to go on bioidentical hormones to balance the estogen with progesterone to eliminate some of the risks. Unfortunately neither the government or private insurance providers will cover the cost.

    No wonder in the last centuary, many women were admitted to mental hospitals when they reached menopause. Now we are living longer and it’s about time we address the the problem of aging women.

    Have you visited a long term care facility recently. There you will find women with alzheimers, osteoporsis, stroke, heart disease, and breast cancer.
    All of which could be prevented or reduced with the appropriate treatment of hormone replacement.

    I am a 67 year old woman, The only medication I take is my estradiol patch. I am a competitive dancer and I just received 2 first places, 3 second places, 3 third places and a bronze medal in a dance competition.

    I am currently very healthy and I wish to remain in this condition. Unfortunately, most health care providers are more concerned about treating illness than preventing it.

    I request that you consider promoting legitimate research into the effects of bio-identical HRT for peri-menopausal and post menopausal women.

    It could potentially reduce health care costs and provide the opportunity for many women to remain as productive members of society.

    • Scott is not saying hormone therapy is useless or ineffective, he’s specifically discussing the bold and unsubstantiated claims associated with celebrity-promoted products. There are evidence-based therapies out there.

  17. suzan says:

    So to cut to the chase – how does an NHS GP prescribe the best BHT to a menopausal patient in the UK?

  18. I suggest oestrogel and utrogestan.Why does the NHS insist on 5 years maximum of hormone use
    Do they honestly believe menopause symptoms have a strict time limit?
    I have a private specialist who prescribes me bio identical hormones. Given that female hypogonadism causes depression, arthritis, raised risk of CVD, vaginal atrophy, osteoporosis, reduced sexual libido, hot flushes, sweats and raised cholesterol I’m amazed that research into preventing the climacteric hasn’t been done.
    I’m staying on hormones for life. I might get cancer but nobody can give me information on just how much my risk reduces if I don’t use them.
    However I can vouch for the effects of the symptoms mentioned above – I felt suicidal and received no help from the NHS where a vitamin pill call Menopace was suggested as a cure all.
    We hear of the profits from the makers of bio hormones but nothing about the appalling over priced quack remedies. If I see a remedy with Meno in the blurb I know that the price and exagerated claims will be high – also I have no idea of the potential side effects due to the “naturalness” of the product despite the fact that remedies ie black cohosh have never been found circulating in the bloodstream of a human unlike oestrogen et al
    Louise

  19. Jenny Morris says:

    Louise,
    Please could you advise how you located a private specialist? I looked on the NPIS site but there don’t appear to be any located near me (west yorkshire).
    I’m in a bit of a dilemma since I was advised not to go on “normal” HRT due to stroke in the family but most days suffer really badly with menopausal symptoms that make me feel completely over the hill at 53. This makes me want to try BHRT on the basis that it is bioidentical therefore maybe safer (also both my parents who suffered strokes were heavy smokers and were couch potatoes so maybe I’m far less at risk than the doctor thinks anyway!)
    I’ve been looking online for products where I can bypass a doctor but am very confused re what would be the best product.
    Jenny

  20. Jenny
    My specialist is in London – she has featured in national press which is how I located her. The furthest one north I located is in Newark Nottingham.
    If you google Inhouse Pharmacy you can purchase oestrogel which I’m using and Utrogestan. Pro Gest is available from Vitasun also online.You will need 1/2 tea spoon to every two metered pumps of oestrogel. Inhouse also stocks testosterone patches but I can’t vouch for those as I’m using a compounded testosterone gel from Germany which my London specialist gets in for her patients.
    I use the products I have suggested to you and I’m very happy with them.
    For vascular health a daily glass of tomato juice is considered beneficial. Both my husband and I drink it daily as it is supposed to strengthen the veins and arteries.
    Let me know if I can be of further help. I think doctors seize on any excuse to deny us of hormones despite the damage caused by lack of oestrogen
    Louise

  21. Jenny Morris says:

    Thanks for the info Louise, also for getting back to me so quickly. Interesting too about the tomato juice!
    Quick question about cost – how much does your specialist charge for time and products. I’m on a limited budget so may have to bypass the specialist and go straight for the online products…..
    Jenny

  22. My specialist’s initial costs are high so you might need to bypass this option Jenny. However on Amazon is an excellent book called Hormonal Solutions by Thierry Hertoghe which will give you check lists to balance yourself hormonally.
    The initial cost including hormones, consultation and blood tests was £700.
    However the price of Inhouse Pharmacy’s hormones is very reasonable.
    I just paid £21 for three bottles of oestrogel from the pharmacist in the UK and Inhouse compares favourably and you don’t need a prescription.
    So all you need to do is monitor your blood pressure (mine fell) and get a scan of your endometrial lining.
    Feel free to contact me (greenserpent) on my yahoo group or here for further assistance.
    Beth Rosensheim has an excellent site titled Preventing Menopause – she is very helpful and a member of my pro actively preventing menopause symptoms forum
    Louise

  23. Hi. Given this blog post is to detail the risks and consequences of bioidentical hormones, I’ll request that discussion about obtaining BHT take place elsewhere. Thanks.

    • I contributed my observations about the uses of bio identical hormones. I have yet to note a response from you. Maybe I am cynical but I see from your posts that your prevailing view is hormones bad = menopause good.
      If these hormones are as dangerous as claimed I’m surprised that medical insurance companies do not makes usage of hormones grounds for exclusion for cancer treatments. I will also comment that if the medical profession believes that the use of hormones is high risk then why is there no research into turning off the dreaded menopause switch. Women don’t welcome menopause. It is time that this outdated cultural concept was an option rather then a dreaded reality – until then we use hormones.
      Sorry old thing but if you post about the “risks and consequences of hormones” you are going to attract debate and it is inevitable that would be users in the Uk are going to search for information about availability of these invaluable products in Britain.
      Louise

      • Jenny Morris says:

        Thank you again for the further info (also I agree with you that there will be many users searching for reliable info and that I’m glad I found this)

  24. Scott
    Can you provide reliable statistics which demonstrate that non users of female hormones do not get breast cancer?
    Are you aware that suicide and marital break ups hit an all time high during menopause.
    Did you know that osteoporosis is a killer?
    In Britain the ration of men and women receiving incapacity benefits aged 40 is split 50/50
    By the age of 50 women outnumber men in claiming these benefits by 20% – statistics obtained from Government department DWP.
    Many drugs which are potentially very dangerous are prescribed in a cavalier fashion according to many pharmacists I have spoken to.
    Can you comment on this?
    Would you like to do a blog attacking the unpleasant bisphosphonates which are implicated in jaw bone decay or statins which have many unwanted effects.
    Louise

    • Hi Louise: The suggested topics are all good ones, but they have been covered elsewhere, so I’m not sure what I can add.

      I’m well aware of the benefits and risks of hormone replacement, and that’s why I wrote the post in the first place. As I pointed out in the post, there are ways to use hormones in evidence-based ways (though the evidence keeps evolving). Decisions about use are individual ones, where women need to understand the short term benefits and the long-term risks. This evaluation will be based on individual symptoms, but also an understanding of population-level studies of health effects. I have no personal opinion on hormone replacement, bioidentical or otherwise, as the post should makes clear. I do hope that the post and the discussion does help women ask the right questions of their health-care provider, and not automatically buy into the hype about bioidenticals, where claims of superior safety and efficacy have not, as yet, been demonstrated.

      • Hi Scott
        You only mention the short term benefits of hormone therapy. Why aren’t you focusing on the long term benefits? It is women who are denied hormones who develop a dowagers hump, fractures and shuffle along with a zimmer frame due to lack of oestrogen.
        Also you make no mention of men using bio hormones. Quite a few men use testosterone during mid life. What are your views on this and the lack of data?

      • Hi Louise: I think the most definitive summary of long-term benefit was outlined in the WHI study, as I pointed out above: fewer fractures and colorectal cancer, but more breast cancer, heart attacks and strokes. Your personal underlying risk will shape how you interpret this data. I also point out that short-term use does not seem to raise long-term risks dramatically (see the SOGC link above).

        Testosterone in men is a completely different topic and one worthy of examination at some point. Until then I’ll point to Consumer Reports’ take as a starting point for those seeking science-based information.

    • Louise, that suicide and marital break-ups supposedly coincide with menopause is not an indication that these events are related, let alone evidence as to the efficacy of bioidentical hormones.

      • Kim
        Maybe suicide and marital break ups are just purely coincidentally timed to hit record levels with the onset of menopause. If you know of any other theories I would be interested to hear of them.
        Bio Identical hormones can greatly improve the mood and thus can benefit a relationship. It is human for people to gain pleasure from mixing with cheerful company rather then living with a miserable, angry lethargic indifferent partner.
        If anyone believes that menopause doesn’t have the potential to destroy a relationship then they are displaying a very closed mind.

      • To your first point, yes maybe it is a coincidence. We have no evidence otherwise. Do you have some to present? I’d love to read it.

        Second, there is a difference between evidence-based therapies and the celebrity-peddled “remedies” Scott is referring to. given the levels of evidence, he’s justified in recommending caution.

        Third, I didn’t say anything of the kind about menopause.

  25. Gary says:

    Scott
    If you feel that your blog can’t take on the alternative view then it seems that it is an ego blog rather than a source for discussion and debate.

    • Hi Gary:
      The post explores the data regarding bioidentical hormones. Commenter are asked to focus on the science, and not contribute anecdotes. I’m pleased there’s a robust discussion, and I haven’t deleted any comments, despite the fact they’re straying away from a discussion of the scientific evidence. I would like to steer it back towards the evolving evidence regarding the benefits and risks of hormone replacement. I encourage commenters to bring forward differing opinions, though I ask that they be backed up by scientific evidence. As I pointed out in the post, there is a way to use hormones in evidence-based ways, and there may be roles for compounded products. It’s an evolving area, as the risk-benefit ratio seems to keep shifting as new evidence emerges. However, I’ve yet to see persuasive evidence demonstrating that bioidentical hormones are associated with less risk or better long-term outcomes that other types of hormones. If there is new evidence, I encourage someone to bring it forward. I have absolutely no problem with people seeking out practitioners who use hormone replacement in evidence-based ways: This is a market based largely on hype. I hope this post, and the discussion, helps women ask the right questions. But I encourage commenters to focus on the science.

    • This is an article interpreting a study. And did you notice this part?

      “…although their methods and conclusions have been criticised by other scientists, and they offered no insight into how common this set of genetic variants are, nor how an individual can be tested for them.”

  26. Gary says:

    Science is based both on factual and also observational data. The science in this topic seem to take time to come up with the facts around the danger. Some facts from previous “experiments” .i.e. the million women’s study came out with facts but were then used to drive one point of view when the old chiche of lies, damned lies and statisics was used.
    However observational data can be used from day one, if people find that they get on with Bioidentical hormones and the symtoms that they had are gone then that is another form of testing a theory or product.
    There is of course a risk in relying on observational data but if you want to work in real time with real people it is probably more relevant.

    Gary

    • Observational data is the first step, then research moves on to more objective approaches with appropriate controls to eliminate investigator and participant bias. If there is no further scientific support for observational data, it’s reasonable to conclude that the observational correlations did not constitute a causal effect.

  27. “I don’t know hwo wrote this article, but whoever it is, is not a post menopausal woman with a prior hystorectomy that has panic attacks, suicidal thoughts,cant sleep,migraine headaches,loss of appetite, bloating, and has mananaged to control the symtoms with Estrodiol Patches and would be happy to go on bioidentical hormones to balance the estogen with progesterone to eliminate some of the risks.”

    You are absolutely right. The author is a scientist attempting to provide solid, unbiased science-based information to people who are suffering from those problems. I find it amazing that people are rejecting solid science here just because it may not line up exactly with their own personal experiences. And from some of these comments you’d think the title of this article was “Menopause is AWESOME and everyone should suffer from it.”

    When you go to a doctor for your menopausal problems, do you make sure it is a female doctor who is undergoing all the exact symptoms that you are? Would you insist on an oncologist who is also going through chemotherapy? A neurologist who has MS? A blind ophthalmologist? Or is it the physician’s skill, experience, and outcomes that are important?

    The lack of a medical scientist’s personal experience with a subject has absolutely nothing to do with the quality of his or her information and/or care. And your own personal experience has nothing to do with science. Your anecdotes are useful for your personal physician to decide upon a course of treatment. They are of no use whatsoever when discussing peer-reviewed studies.

    Yes, people with chronic illness and other health problems want empathy and understanding. Believe me, I get that. Luckily there are many, many places on the web for patients to commiserate. There aren’t as many places to find solid, science-based information about complicated and important issues. This is one of them.

    • Empathy and understanding do not solve health issues. Commiseration will not change the current situation.Science should apply itself to finding a safe solution rather then simply attempting to scare women who do not desire menopause.
      Can science demonstrate any health benefits associated with menopause?
      The majority of breast cancer cases are post menopause regardless of hormone use status.
      Here is the results of a recent French study involving bio identical hormones
      http://www.virginiahopkinstestkits.com/bioidenticalbreastcancer.html

      • Where is your evidence that science is not applying itself to provide treatments for women with menopausal symptoms? Research takes time and money. Perhaps it’s simply not fast enough for you. Who’s scaring women? I think you’re falsely attributing natural limitations in scientific research to malice.

  28. I find it fascinating that someone can read such a thoroughly referenced article and criticize it as not being backed up by evidence. Scott, I always appreciate the amount of time you spend researching your posts. That time and effort is obvious to anyone who isn’t reacting viscerally to your conclusions.

    For what it’s worth, I think your conclusion is a good one. I don’t hear you calling for a ban on BHT. You’re advocating a cautious, evidence based approach, which is appropriate for any medical treatment that’s supported primarily by patient anecdote and celebrity testimonial. If there’s any profit motive conspiracy afoot, I’d suggest it’s one possible reason why BHT proponents don’t want to submit their products to that kind of scrutiny.

  29. Emma B says:

    FWIW, I wanted to add a counterpoint here: my personal experience with bioidentical HRT was awful, and I never want anything to do with it again.

    Five years ago, I developed hypothalamic amenorrhea when I went off birth control to become pregnant. My ovaries were non-functional, so from the standpoint of estrogen/progesterone production, I was effectively menopausal, and I had many of the menopause symptoms like hot flashes and night sweats. As part of the diagnostic process, my reproductive endocrinologist put me on estrogel (which is considered bioidentical HRT) for six weeks. During that six weeks, I gained 15 lbs, had my blood pressure shoot up, experienced awful migraines, and various other miseries. I was thrilled to get off it and go back to my “menopausal” state.

    I’ve got endometriosis, and one of the standard treatments for it is to induce temporary menopause with Lupron. My RE’s tried to reassure me that low-dose HRT can substantially alleviate the side effects of Lupron, but as far as I’m concerned, that cure’s worse than the disease.

    • Emma
      Clearly you have a complicated hormone history before you commenced using estrogel. I have used estrogel for 18 months and my blood pressure fell.
      If you are happy to have untreated menopausal symptoms that is your decision – however with your complicated medical history it might not be a simple case of hormone supplementation causing your symptoms.

  30. Emma B says:

    You do realize, don’t you, that all women have estradiol, estriol, and progesterone in their bodies all of their lives, and the pre-menopausal levels are FAR higher than the levels achieved through BHRT.

    progestin is contraindicated during pregnancy as it can induce miscarriages.

    I also wanted to pluck these two comments out, as they illustrate some basic misunderstandings of female reproductive biology and endocrinology.

    Menopausal women have low levels of estradiol and progesterone precisely because they are no longer ovulating, given that their ovaries are no longer responsive to FSH. However, women who are not ovulating for any other reason also have similarly low levels of estradiol and progesterone, and this includes women who experience lactational amenorrhea after childbirth. Prior to the advent of reliable birth control in the 20th century, women had many fewer ovulatory cycles, and spent a much larger portion of their lives with menopausally-low levels of reproductive hormones.

    The reason that progestins are contraindicated in pregnancy isn’t because the progestins themselves cause miscarriage — it’s because STOPPING the progestins can cause one. Low progesterone levels, or a sudden fall in progesterone levels, cause endometrial breakdown, which is menstruation if you’re not pregnant, or an early miscarriage if you are. The placenta doesn’t independently produce enough progesterone to sustain a pregnancy until late in the the first trimester, and until then, pregnancies are vulnerable to progesterone withdrawal. Women who have experienced multiple early pregnancy losses, and women who have become pregnant through IVF, are usually supplemented with daily injections of medroxyprogesterone through the whole first trimester.

    I find it difficult to place much faith in the claims of BHRT advocates vis-a-vis menopause when they don’t seem to fully understand how the hormones in question work in non-menopausal contexts.

  31. Female hypogonadism is a poorly researched subject. However one fact stands out – with improved life expectancy many women outlive their reproductive systems which originally would have failed at the end of a woman’s life rather then mid life.This is not hype but cold fact.
    I’m not interested in Suzanne Somers et al but I am not going to suffer due to hysterical furore with dubious data over the use of hormones in women although Scott appears to give a cautious thumbs up to men using testosterone.
    It is not scientific to think that replacement of sex hormones is safe in one gender only. That flies in the face of logic.
    One major study found that the use of Prempro increased the incidence of breast cancer from 46/1000 non users to 47/1000 users. Mathematically this has no significance yet caused media hysteria and many terrified women abandoned treatment.
    I repeat if hormone supplementation is so lethal why haven’t the insurance companies used this as an exclusion factor?
    Science isn’t perfect as the data is interpreted by imperfect humans and subject to flaws and prejudice. I’m amazed that treatments for menopause always attract odium despite sex hormones having been used in the Middle Kingdom thousands of years ago.
    My conclusion is that we have a visceral response from those who view menopause as essentially benign, natural and to be tolerated at all costs.
    Personally I wouldn’t only see a female doctor – often men show greater sympathy over this issue but neither will I have my quality of life ruled by fear and hysteria.

  32. Scott
    My apologies – I missed the link you had placed re testosterone therapy. Just because The World Health Organisation doesn’t recognise falling testosterone levels as a disease doesn’t prove the case for not supplementing with testosterone. The key in the use of hormones is balance and more is not always a good idea. The answer is balance. Too much or too little of any hormone can cause health problems for the user.
    Some of the erectile dysfunction drugs mentioned in the article can be quite lethal – especially in those men with heart disease.
    If a man or woman doesn’t need hormone supplementation then they will not receive any positive benefits from it.
    However one interesting point is the use of hormonal birth control which rarely attracts the vitriol reserved for those who supplement with hormones for health issues rather then social convenience.

    • Actually, there is plenty of vitriol against birth control pill hormones. For example. That is not to say the vitriol is justified (much of that link reads as a naturalistic fallacy), I just present it as an example.

  33. Kim
    Maybe you feel that science has reached a limit in dealing with hypogonadism – I disagree.I’m not attributing this to malice but cultural apathy. Menopause is viewed as natural and maybe scientists find the subject uninteresting.
    There is already a documented case of a woman who had a successful ovarian transplant which reversed her menopause.IVF has progressed rapidly – clearly plenty of research in that field.
    The hormone Inhibin B is implicated in menopause. As the levels drop FSH rises and the ovaries begin to release eggs in an erractic fashion.Clearly there is still much to learn about menopause.
    Considering the health implications associated with menopause I am surprised that research hasn’t bothered to prevent it.
    In the Uk fractures, arthritis, auto immune diseases and other health issues associated with the onset of menopause cost the country a great deal of hard cash.
    If this could be prevented it would be beneficial economically – not to mention saving women from the indignities of incontinence pants, zimmer frames and possibly care homes.

    • Ok I don’t know where you are getting any of these assumed statements (“Maybe you feel that science has reached a limit in dealing with hypogonadism – I disagree.” et al.), but I have not said anything of the kind.

    • A decent Anti Aging Doctor would not simply give a patient testosterone without taking a detailed medical history and possibly adding other supplements and hormones to the prescription.
      No single hormone is considered a fix. Hormones work in concert with one another. I suggest you refer to the work of Thierry Hertoghe.

  34. Menowatcher says:

    Hi Scott,
    I would like to thank you for taking the time to do the research for this blog. I feel that it represents a balanced and safe view of where we are ‘at’ these days. Make no mistake, the suffering of severely symptomatic menopausal women knows no bounds and these women represent a body of individuals who are severely susceptible to being duped. I am perturbed by the irrational attack on your work by those wishing to peddle the same old anaecdotal scaremongering tactics and conspiracy theories that have been instrumental in blocking much of the progress, that is so very badly needed in this area. You merely urged caution in the use of these medications but were jumped upon for being an anti-woman, hormone hater. Sadly the response is invariably the same and very plausible to a heavily symptomatic woman.

    Little do they realise that unquestioning support of certain alternative practices/practitioners is a risk to everyone’s well being and safety and is fraught with danger, because it is so financially lucrative. I think that we all agree that menopause can be a difficult problem but treating it, within the bounds of efficacy and safety, is everything. A worrying fact is that because BHRT is poorly regulated any negative consequences tend to slip through the net so worrying events out in the field may slip by unoticed until we have an epidemic of problems on our hands. There appears to be no shortage of diciples out there willing to stake their lives on the safety of these compounds. All very disconcerting.
    In a sense, treatment for menopause goes in circles for the reasons you see illustrated on this blog. We must treat according to scientific safety principles and yet there are those zealots who wish to throw caution to the wind because they believe that anti- aging medicine is the answer to fears of their own aging and mortality. You will never argue against the power of that, but it is useful to know what you are dealing with.
    I would ask you to keep us up to date with further developments in this area, as I believe that knowledge is power when it comes to dealing with menopausal issues.

  35. This is crazy – are you assuming that all women suffering hypogonadism are incapable of making a rational decision due to symptoms and fear of aging?
    I have read Endocrinology journals and made a decision based on the pros and cons of hormone use. I consider this post to be patronising and ill thought out. At least Scott holds views which are not coloured by his perception of heavily symptomatic women.
    I doubt that bio hormones are perfect but until science switches off the menopause switch these are the tools that we have to work with. It is hormone supplentation or live with a poor quality life – the choice has to be made by the individual.However choosing hormones and expecting to use them without interference does not indicate unquestioning zealots but women who SEE NO OTHER OPTION OFFERED BY MODERN SCIENCE.
    I’m not suffering from any menopausal symptoms and intend to deny myself that dubious pleasure.

Comments are closed.