NAMS 2013 Annual Meeting

To varying degrees, vulvovaginal atrophy affects an estimated 20%-40% of menopausal women, but the name of the condition fails to appropriately characterize the range of associated signs and symptoms that women may experience.

Representatives from the North American Menopause Society (NAMS) and the International Society for the Study of Women’s Sexual Health, Inc. (ISSWSH) propose a new term: genitourinary syndrome of menopause, or GSM.

Earlier this year, the two organizations convened a 2-day consensus conference to consider what an appropriate term would encompass. The goal of that conference, according to Dr. Margery Gass of the Cleveland Clinic Center for Specialized Women’s Health and the executive director of NAMS, was to identify a term that was descriptive, comprehensive, and suitable for professionals, consumers, and the media.

Participants reviewed the symptoms and signs of genitourinary aging and the available relevant data, and decided on a number of components that should be covered by the new nomenclature, including the affected anatomy, descriptive factors, problems caused by the condition, and context with respect to life phase, she said in an interview.

Dr. Gass and Dr. David J. Portman, director of the Columbus Center for Women’s Health Research and an adjunct instructor at Ohio State University, Columbus, cochaired the consensus conference. They presented the conclusions from the conference at the annual meeting of the North American Menopause Society in October.

"Several concerns have forced the issue of a name change for this condition," Dr. Gass said, noting that persistent societal resistance to openly discussing women’s sexuality and sexual health is not the least among them.

The word "vagina," for example, still can’t be uttered in many media outlets, she explained. Additionally, the term "atrophy" has unpleasant connotations that aren’t necessarily reflective of the experience of women affected by the condition, she noted.

"In fact, atrophy in and of itself is a natural part of aging – something many women experience – and is not necessarily a problem; some women with atrophy experience no symptoms, while others experience significant symptoms.

"We feel that the name we’re putting forward (genitourinary syndrome of menopause) very accurately describes the parts of the body that are involved – namely the genital system and the lower urinary tract," she said.

The use of the word "syndrome" further allows for a diagnosis based on the range of symptoms women may experience, and doesn’t limit the condition to specific symptoms.

"This is not a disease or a deficiency, so we think ‘genitourinary syndrome of menopause’ is a neutral term that would be acceptable, Dr. Gass said.

A change in the nomenclature could potentially open the door to more productive, health-promoting dialogue. During his presentation at the NAMS meeting, Dr. Portman explained how a term that is more acceptable to patients and the media could have the power to start the conversation, change attitudes, and promote understanding and acceptance of more open communication. He used male sexual dysfunction as an example.

In 1992, a National Institutes of Health consensus development panel determined that the term "erectile dysfunction" was preferable to the term "impotence." Indeed, along with the subsequent approval of Viagra and other drugs related to male sexual health, the term "erectile dysfunction" is now widely used in advertising, promoted by politicians and celebrities, and openly discussed in the community, he said.

In contrast, open discussion about women’s sexuality and sexual health remains constrained. In fact, in a survey of more than 1,000 women – including 330 women aged 60-65 years – 75% "completely agreed" that society constrains the sexual expression of "women my age more so than men my age." Nearly as many completely agreed that society is more accepting of discussion around men’s physical sexual problems than women’s physical sexual problems. More than half completely agreed that "society would prefer to believe that women my age do not have sex."

The use of more "socially acceptable" terminology (the word "penis," like "vagina," is still not used openly, Dr. Gass noted) helped make male sexual health a mainstream topic; it is hoped that transitioning from "vulvovaginal atrophy" to "genitourinary syndrome of menopause," would have a similar effect with respect to women’s sexual health, Dr. Portman said.

GSM would be defined as "a collection of symptoms and signs associated with decreased estrogen levels that can involve the labia majora/minora, vestibule/introitus, clitoris, vagina, urethra, and bladder," conference attendees agreed.

It is a syndrome for which treatment is indicated if symptoms are bothersome; treatment should be individualized based on the severity of symptoms and the woman’s preference after discussion of treatment options and risks and benefits.

In addition to working toward agreement on appropriate nomenclature, the consensus conference participants are developing an assessment tool, currently in draft form, to aid clinicians in evaluating women for the syndrome.

"We feel we’ve identified a number of signs and findings that would help clinicians – particularly those who don’t treat a lot of patients with this condition. The tool – which involves a grid-based design outlining mild, moderate, and severe symptom categories – may prove valuable for providers who want to chart severity or just scan the grid to assist in making a diagnosis," Dr. Gass said. The tool also could prove useful in the research setting, he added.

ISSWSH and NAMS will be publishing the proceedings of the workshop in upcoming issues of their respective journals – the Journal of Sexual Medicine and the journal Menopause.

The groups also plan to put forward the proposed new name at a December meeting of the American College of Obstetricians and Gynecologists. At that meeting, ACOG will review all terminology related to obstetrics and gynecology and update terminology as appropriate.

"We hope to address the ACOG urogynecology and menopause working group to see if the new name is acceptable to that group as well. Personally I think it’s important to have an accurate term that is as neutral as possible," Dr. Gass said.

Dr. Gass reported having no disclosures. Dr. Portman has been a speaker, consultant, or advisory board member for, and/or received grant or research support from Bayer, Noven Pharmaceuticals, Palatin Technologies, and other companies.

To varying degrees, vulvovaginal atrophy affects an estimated 20%-40% of menopausal women, but the name of the condition fails to appropriately characterize the range of associated signs and symptoms that women may experience.

Representatives from the North American Menopause Society (NAMS) and the International Society for the Study of Women’s Sexual Health, Inc. (ISSWSH) propose a new term: genitourinary syndrome of menopause, or GSM.

Earlier this year, the two organizations convened a 2-day consensus conference to consider what an appropriate term would encompass. The goal of that conference, according to Dr. Margery Gass of the Cleveland Clinic Center for Specialized Women’s Health and the executive director of NAMS, was to identify a term that was descriptive, comprehensive, and suitable for professionals, consumers, and the media.

Participants reviewed the symptoms and signs of genitourinary aging and the available relevant data, and decided on a number of components that should be covered by the new nomenclature, including the affected anatomy, descriptive factors, problems caused by the condition, and context with respect to life phase, she said in an interview.

Dr. Gass and Dr. David J. Portman, director of the Columbus Center for Women’s Health Research and an adjunct instructor at Ohio State University, Columbus, cochaired the consensus conference. They presented the conclusions from the conference at the annual meeting of the North American Menopause Society in October.

"Several concerns have forced the issue of a name change for this condition," Dr. Gass said, noting that persistent societal resistance to openly discussing women’s sexuality and sexual health is not the least among them.

The word "vagina," for example, still can’t be uttered in many media outlets, she explained. Additionally, the term "atrophy" has unpleasant connotations that aren’t necessarily reflective of the experience of women affected by the condition, she noted.

"In fact, atrophy in and of itself is a natural part of aging – something many women experience – and is not necessarily a problem; some women with atrophy experience no symptoms, while others experience significant symptoms.

"We feel that the name we’re putting forward (genitourinary syndrome of menopause) very accurately describes the parts of the body that are involved – namely the genital system and the lower urinary tract," she said.

The use of the word "syndrome" further allows for a diagnosis based on the range of symptoms women may experience, and doesn’t limit the condition to specific symptoms.

"This is not a disease or a deficiency, so we think ‘genitourinary syndrome of menopause’ is a neutral term that would be acceptable, Dr. Gass said.

A change in the nomenclature could potentially open the door to more productive, health-promoting dialogue. During his presentation at the NAMS meeting, Dr. Portman explained how a term that is more acceptable to patients and the media could have the power to start the conversation, change attitudes, and promote understanding and acceptance of more open communication. He used male sexual dysfunction as an example.

In 1992, a National Institutes of Health consensus development panel determined that the term "erectile dysfunction" was preferable to the term "impotence." Indeed, along with the subsequent approval of Viagra and other drugs related to male sexual health, the term "erectile dysfunction" is now widely used in advertising, promoted by politicians and celebrities, and openly discussed in the community, he said.

In contrast, open discussion about women’s sexuality and sexual health remains constrained. In fact, in a survey of more than 1,000 women – including 330 women aged 60-65 years – 75% "completely agreed" that society constrains the sexual expression of "women my age more so than men my age." Nearly as many completely agreed that society is more accepting of discussion around men’s physical sexual problems than women’s physical sexual problems. More than half completely agreed that "society would prefer to believe that women my age do not have sex."

The use of more "socially acceptable" terminology (the word "penis," like "vagina," is still not used openly, Dr. Gass noted) helped make male sexual health a mainstream topic; it is hoped that transitioning from "vulvovaginal atrophy" to "genitourinary syndrome of menopause," would have a similar effect with respect to women’s sexual health, Dr. Portman said.

GSM would be defined as "a collection of symptoms and signs associated with decreased estrogen levels that can involve the labia majora/minora, vestibule/introitus, clitoris, vagina, urethra, and bladder," conference attendees agreed.

It is a syndrome for which treatment is indicated if symptoms are bothersome; treatment should be individualized based on the severity of symptoms and the woman’s preference after discussion of treatment options and risks and benefits.

In addition to working toward agreement on appropriate nomenclature, the consensus conference participants are developing an assessment tool, currently in draft form, to aid clinicians in evaluating women for the syndrome.

"We feel we’ve identified a number of signs and findings that would help clinicians – particularly those who don’t treat a lot of patients with this condition. The tool – which involves a grid-based design outlining mild, moderate, and severe symptom categories – may prove valuable for providers who want to chart severity or just scan the grid to assist in making a diagnosis," Dr. Gass said. The tool also could prove useful in the research setting, he added.

ISSWSH and NAMS will be publishing the proceedings of the workshop in upcoming issues of their respective journals – the Journal of Sexual Medicine and the journal Menopause.

The groups also plan to put forward the proposed new name at a December meeting of the American College of Obstetricians and Gynecologists. At that meeting, ACOG will review all terminology related to obstetrics and gynecology and update terminology as appropriate.

"We hope to address the ACOG urogynecology and menopause working group to see if the new name is acceptable to that group as well. Personally I think it’s important to have an accurate term that is as neutral as possible," Dr. Gass said.

Dr. Gass reported having no disclosures. Dr. Portman has been a speaker, consultant, or advisory board member for, and/or received grant or research support from Bayer, Noven Pharmaceuticals, Palatin Technologies, and other companies.

To varying degrees, vulvovaginal atrophy affects an estimated 20%-40% of menopausal women, but the name of the condition fails to appropriately characterize the range of associated signs and symptoms that women may experience.

Representatives from the North American Menopause Society (NAMS) and the International Society for the Study of Women’s Sexual Health, Inc. (ISSWSH) propose a new term: genitourinary syndrome of menopause, or GSM.

Earlier this year, the two organizations convened a 2-day consensus conference to consider what an appropriate term would encompass. The goal of that conference, according to Dr. Margery Gass of the Cleveland Clinic Center for Specialized Women’s Health and the executive director of NAMS, was to identify a term that was descriptive, comprehensive, and suitable for professionals, consumers, and the media.

Participants reviewed the symptoms and signs of genitourinary aging and the available relevant data, and decided on a number of components that should be covered by the new nomenclature, including the affected anatomy, descriptive factors, problems caused by the condition, and context with respect to life phase, she said in an interview.

Dr. Gass and Dr. David J. Portman, director of the Columbus Center for Women’s Health Research and an adjunct instructor at Ohio State University, Columbus, cochaired the consensus conference. They presented the conclusions from the conference at the annual meeting of the North American Menopause Society in October.

"Several concerns have forced the issue of a name change for this condition," Dr. Gass said, noting that persistent societal resistance to openly discussing women’s sexuality and sexual health is not the least among them.

The word "vagina," for example, still can’t be uttered in many media outlets, she explained. Additionally, the term "atrophy" has unpleasant connotations that aren’t necessarily reflective of the experience of women affected by the condition, she noted.

"In fact, atrophy in and of itself is a natural part of aging – something many women experience – and is not necessarily a problem; some women with atrophy experience no symptoms, while others experience significant symptoms.

"We feel that the name we’re putting forward (genitourinary syndrome of menopause) very accurately describes the parts of the body that are involved – namely the genital system and the lower urinary tract," she said.

The use of the word "syndrome" further allows for a diagnosis based on the range of symptoms women may experience, and doesn’t limit the condition to specific symptoms.

"This is not a disease or a deficiency, so we think ‘genitourinary syndrome of menopause’ is a neutral term that would be acceptable, Dr. Gass said.

A change in the nomenclature could potentially open the door to more productive, health-promoting dialogue. During his presentation at the NAMS meeting, Dr. Portman explained how a term that is more acceptable to patients and the media could have the power to start the conversation, change attitudes, and promote understanding and acceptance of more open communication. He used male sexual dysfunction as an example.

In 1992, a National Institutes of Health consensus development panel determined that the term "erectile dysfunction" was preferable to the term "impotence." Indeed, along with the subsequent approval of Viagra and other drugs related to male sexual health, the term "erectile dysfunction" is now widely used in advertising, promoted by politicians and celebrities, and openly discussed in the community, he said.

In contrast, open discussion about women’s sexuality and sexual health remains constrained. In fact, in a survey of more than 1,000 women – including 330 women aged 60-65 years – 75% "completely agreed" that society constrains the sexual expression of "women my age more so than men my age." Nearly as many completely agreed that society is more accepting of discussion around men’s physical sexual problems than women’s physical sexual problems. More than half completely agreed that "society would prefer to believe that women my age do not have sex."

The use of more "socially acceptable" terminology (the word "penis," like "vagina," is still not used openly, Dr. Gass noted) helped make male sexual health a mainstream topic; it is hoped that transitioning from "vulvovaginal atrophy" to "genitourinary syndrome of menopause," would have a similar effect with respect to women’s sexual health, Dr. Portman said.

GSM would be defined as "a collection of symptoms and signs associated with decreased estrogen levels that can involve the labia majora/minora, vestibule/introitus, clitoris, vagina, urethra, and bladder," conference attendees agreed.

It is a syndrome for which treatment is indicated if symptoms are bothersome; treatment should be individualized based on the severity of symptoms and the woman’s preference after discussion of treatment options and risks and benefits.

In addition to working toward agreement on appropriate nomenclature, the consensus conference participants are developing an assessment tool, currently in draft form, to aid clinicians in evaluating women for the syndrome.

"We feel we’ve identified a number of signs and findings that would help clinicians – particularly those who don’t treat a lot of patients with this condition. The tool – which involves a grid-based design outlining mild, moderate, and severe symptom categories – may prove valuable for providers who want to chart severity or just scan the grid to assist in making a diagnosis," Dr. Gass said. The tool also could prove useful in the research setting, he added.

ISSWSH and NAMS will be publishing the proceedings of the workshop in upcoming issues of their respective journals – the Journal of Sexual Medicine and the journal Menopause.

The groups also plan to put forward the proposed new name at a December meeting of the American College of Obstetricians and Gynecologists. At that meeting, ACOG will review all terminology related to obstetrics and gynecology and update terminology as appropriate.

"We hope to address the ACOG urogynecology and menopause working group to see if the new name is acceptable to that group as well. Personally I think it’s important to have an accurate term that is as neutral as possible," Dr. Gass said.

Dr. Gass reported having no disclosures. Dr. Portman has been a speaker, consultant, or advisory board member for, and/or received grant or research support from Bayer, Noven Pharmaceuticals, Palatin Technologies, and other companies.

With seemingly ageless celebrities touting the benefits of bioidentical, compounded hormones, and the cloud of the Women’s Health Initiative still obscuring the view, both physicians and patients want to know the truth about natural hormone replacement.

But as in so many areas of life, the truth can be many things to many people, Dr. Jan L. Shifren shared at the annual meeting of the North American Menopause Society (NAMS).

"For a woman with bothersome menopausal symptoms and concerns about potential hormone therapy [HT] risks, ‘bioHT’ may mean a formulation of hormones with all of the benefits and no risks, as it’s ‘natural’ and contains no package insert with a black box warning," said Dr. Shifren, director of the menopause program at Massachusetts General Hospital, Boston. "For a bioHT practitioner, it may mean a way of helping menopausal women disenfranchised with the medical establishment, while providing a steady source of income. For a clinician or pharmacist practicing within the current standard of care, an FDA inspector, or a lawyer for a women with endometrial cancer associated with its use, bioHT may mean something quite different!"

Bioidentical hormones are typically plant-based compounds with a molecular structure identical to that of the corresponding human hormone. Dosing is individual and based on a woman’s salivary hormone levels. Prescriptions are pharmacist compounded, typically in a topical preparation, but sometimes in an oral tablet or injected pellet.

All of this may sound reasonable at first glance, Dr. Shifren said. But science and money just keep getting in the way of the celebrity endorsements.

"Hormone therapy should be guided by symptoms. There are no data to support the use of blood or saliva measurements to improve treatment efficacy," Dr. Shifren said. Serum hormone levels constantly fluctuate – not only within the menstrual cycle, but also within a single day, "so it’s impossible to ‘match’ any individual woman’s ‘ideal’ hormone levels."

Additionally, Dr. Shifren said, salivary levels don’t even correspond to serum levels.

Safety is one of the biggest problems with such compounds. Because their manufacture is in the hands of a single individual, there’s no quality oversight. Women can’t count on getting the correct prescribed dose of hormone – and sometimes not even close to it.

A recent study commissioned by MORE magazine examined the exact hormone content in 12 bioHT prescriptions, which were filled by 12 pharmacies. Two pharmacies were retail stores and 10 were online companies.

Flora Research Labs analyzed the medications with mass spectrometry. The values varied widely: 96%-260% of the prescribed estrogen dose and 60%-80% of the prescribed progesterone dose.

"None of these would have met FDA standards," Dr. Shifren said. "The purity, bioavailability, and dose-to-dose consistency of any given prescription is an unknown."

Concern about the safety of conventional HT frequently drives women to seek out what they consider a more natural alternative. Although much more data have emerged, the original furor over the Women’s Health Initiative still casts HT in a negative light for many, Dr. Shifren said.

For women in good health, who start combination estrogen/progesterone HT early in menopause, at the lowest effective dose, the increased risks of cardiovascular disease and cancer are negligible. A 2010 British study of 15,710 cases and almost 60,000 controls found that low-dose transdermal HT had no effect on stroke risk. High-dose patch estrogen increased the risk by 89%, and both low- and high-dose oral estrogen increased the risk by 69%; however, each of those increases translated to an absolute increase of only about 1 stroke per year (BMJ 2010;340:c2519 [doi: 10.1136/bmj.c2519]).

A 2008 French study of almost 81,000 women found no significant associations between breast cancer and route of HT administration. However, the study did conclude that the combination of estrogen and progesterone was probably the safest, with a risk ratio of 1.0. Estrogen plus dydrogesterone resulted in a nonsignificant risk increase (relative risk, 1.16). Estrogen in combination with other progestogens carried a significant 69% risk increase (Breast Cancer Res. Treat. 2008;107:103-11).

Finally, Dr. Shifren said, it’s just about impossible to take profit out of the picture. Compounding HT sales are reaching more than $2 billion per year now.

"Many practitioners who prescribe compounded hormones also sell them, or benefit financially from relationships with compounders. This poses a potential conflict of interest and violates standards of professional ethical conduct," she said.

Dr. Shifren provides research consulting for New England Research Institutes.

[email protected]

With seemingly ageless celebrities touting the benefits of bioidentical, compounded hormones, and the cloud of the Women’s Health Initiative still obscuring the view, both physicians and patients want to know the truth about natural hormone replacement.

But as in so many areas of life, the truth can be many things to many people, Dr. Jan L. Shifren shared at the annual meeting of the North American Menopause Society (NAMS).

"For a woman with bothersome menopausal symptoms and concerns about potential hormone therapy [HT] risks, ‘bioHT’ may mean a formulation of hormones with all of the benefits and no risks, as it’s ‘natural’ and contains no package insert with a black box warning," said Dr. Shifren, director of the menopause program at Massachusetts General Hospital, Boston. "For a bioHT practitioner, it may mean a way of helping menopausal women disenfranchised with the medical establishment, while providing a steady source of income. For a clinician or pharmacist practicing within the current standard of care, an FDA inspector, or a lawyer for a women with endometrial cancer associated with its use, bioHT may mean something quite different!"

Bioidentical hormones are typically plant-based compounds with a molecular structure identical to that of the corresponding human hormone. Dosing is individual and based on a woman’s salivary hormone levels. Prescriptions are pharmacist compounded, typically in a topical preparation, but sometimes in an oral tablet or injected pellet.

All of this may sound reasonable at first glance, Dr. Shifren said. But science and money just keep getting in the way of the celebrity endorsements.

"Hormone therapy should be guided by symptoms. There are no data to support the use of blood or saliva measurements to improve treatment efficacy," Dr. Shifren said. Serum hormone levels constantly fluctuate – not only within the menstrual cycle, but also within a single day, "so it’s impossible to ‘match’ any individual woman’s ‘ideal’ hormone levels."

Additionally, Dr. Shifren said, salivary levels don’t even correspond to serum levels.

Safety is one of the biggest problems with such compounds. Because their manufacture is in the hands of a single individual, there’s no quality oversight. Women can’t count on getting the correct prescribed dose of hormone – and sometimes not even close to it.

A recent study commissioned by MORE magazine examined the exact hormone content in 12 bioHT prescriptions, which were filled by 12 pharmacies. Two pharmacies were retail stores and 10 were online companies.

Flora Research Labs analyzed the medications with mass spectrometry. The values varied widely: 96%-260% of the prescribed estrogen dose and 60%-80% of the prescribed progesterone dose.

"None of these would have met FDA standards," Dr. Shifren said. "The purity, bioavailability, and dose-to-dose consistency of any given prescription is an unknown."

Concern about the safety of conventional HT frequently drives women to seek out what they consider a more natural alternative. Although much more data have emerged, the original furor over the Women’s Health Initiative still casts HT in a negative light for many, Dr. Shifren said.

For women in good health, who start combination estrogen/progesterone HT early in menopause, at the lowest effective dose, the increased risks of cardiovascular disease and cancer are negligible. A 2010 British study of 15,710 cases and almost 60,000 controls found that low-dose transdermal HT had no effect on stroke risk. High-dose patch estrogen increased the risk by 89%, and both low- and high-dose oral estrogen increased the risk by 69%; however, each of those increases translated to an absolute increase of only about 1 stroke per year (BMJ 2010;340:c2519 [doi: 10.1136/bmj.c2519]).

A 2008 French study of almost 81,000 women found no significant associations between breast cancer and route of HT administration. However, the study did conclude that the combination of estrogen and progesterone was probably the safest, with a risk ratio of 1.0. Estrogen plus dydrogesterone resulted in a nonsignificant risk increase (relative risk, 1.16). Estrogen in combination with other progestogens carried a significant 69% risk increase (Breast Cancer Res. Treat. 2008;107:103-11).

Finally, Dr. Shifren said, it’s just about impossible to take profit out of the picture. Compounding HT sales are reaching more than $2 billion per year now.

"Many practitioners who prescribe compounded hormones also sell them, or benefit financially from relationships with compounders. This poses a potential conflict of interest and violates standards of professional ethical conduct," she said.

Dr. Shifren provides research consulting for New England Research Institutes.

[email protected]

With seemingly ageless celebrities touting the benefits of bioidentical, compounded hormones, and the cloud of the Women’s Health Initiative still obscuring the view, both physicians and patients want to know the truth about natural hormone replacement.

But as in so many areas of life, the truth can be many things to many people, Dr. Jan L. Shifren shared at the annual meeting of the North American Menopause Society (NAMS).

"For a woman with bothersome menopausal symptoms and concerns about potential hormone therapy [HT] risks, ‘bioHT’ may mean a formulation of hormones with all of the benefits and no risks, as it’s ‘natural’ and contains no package insert with a black box warning," said Dr. Shifren, director of the menopause program at Massachusetts General Hospital, Boston. "For a bioHT practitioner, it may mean a way of helping menopausal women disenfranchised with the medical establishment, while providing a steady source of income. For a clinician or pharmacist practicing within the current standard of care, an FDA inspector, or a lawyer for a women with endometrial cancer associated with its use, bioHT may mean something quite different!"

Bioidentical hormones are typically plant-based compounds with a molecular structure identical to that of the corresponding human hormone. Dosing is individual and based on a woman’s salivary hormone levels. Prescriptions are pharmacist compounded, typically in a topical preparation, but sometimes in an oral tablet or injected pellet.

All of this may sound reasonable at first glance, Dr. Shifren said. But science and money just keep getting in the way of the celebrity endorsements.

"Hormone therapy should be guided by symptoms. There are no data to support the use of blood or saliva measurements to improve treatment efficacy," Dr. Shifren said. Serum hormone levels constantly fluctuate – not only within the menstrual cycle, but also within a single day, "so it’s impossible to ‘match’ any individual woman’s ‘ideal’ hormone levels."

Additionally, Dr. Shifren said, salivary levels don’t even correspond to serum levels.

Safety is one of the biggest problems with such compounds. Because their manufacture is in the hands of a single individual, there’s no quality oversight. Women can’t count on getting the correct prescribed dose of hormone – and sometimes not even close to it.

A recent study commissioned by MORE magazine examined the exact hormone content in 12 bioHT prescriptions, which were filled by 12 pharmacies. Two pharmacies were retail stores and 10 were online companies.

Flora Research Labs analyzed the medications with mass spectrometry. The values varied widely: 96%-260% of the prescribed estrogen dose and 60%-80% of the prescribed progesterone dose.

"None of these would have met FDA standards," Dr. Shifren said. "The purity, bioavailability, and dose-to-dose consistency of any given prescription is an unknown."

Concern about the safety of conventional HT frequently drives women to seek out what they consider a more natural alternative. Although much more data have emerged, the original furor over the Women’s Health Initiative still casts HT in a negative light for many, Dr. Shifren said.

For women in good health, who start combination estrogen/progesterone HT early in menopause, at the lowest effective dose, the increased risks of cardiovascular disease and cancer are negligible. A 2010 British study of 15,710 cases and almost 60,000 controls found that low-dose transdermal HT had no effect on stroke risk. High-dose patch estrogen increased the risk by 89%, and both low- and high-dose oral estrogen increased the risk by 69%; however, each of those increases translated to an absolute increase of only about 1 stroke per year (BMJ 2010;340:c2519 [doi: 10.1136/bmj.c2519]).

A 2008 French study of almost 81,000 women found no significant associations between breast cancer and route of HT administration. However, the study did conclude that the combination of estrogen and progesterone was probably the safest, with a risk ratio of 1.0. Estrogen plus dydrogesterone resulted in a nonsignificant risk increase (relative risk, 1.16). Estrogen in combination with other progestogens carried a significant 69% risk increase (Breast Cancer Res. Treat. 2008;107:103-11).

Finally, Dr. Shifren said, it’s just about impossible to take profit out of the picture. Compounding HT sales are reaching more than $2 billion per year now.

"Many practitioners who prescribe compounded hormones also sell them, or benefit financially from relationships with compounders. This poses a potential conflict of interest and violates standards of professional ethical conduct," she said.

Dr. Shifren provides research consulting for New England Research Institutes.

[email protected]

With seemingly ageless celebrities touting the benefits of bioidentical, compounded hormones, and the cloud of the Women’s Health Initiative still obscuring the view, both physicians and patients want to know the truth about natural hormone replacement.

But as in so many areas of life, the truth can be many things to many people, Dr. Jan L. Shifren shared at the annual meeting of the North American Menopause Society (NAMS).

"For a woman with bothersome menopausal symptoms and concerns about potential hormone therapy [HT] risks, ‘bioHT’ may mean a formulation of hormones with all of the benefits and no risks, as it’s ‘natural’ and contains no package insert with a black box warning," said Dr. Shifren, director of the menopause program at Massachusetts General Hospital, Boston. "For a bioHT practitioner, it may mean a way of helping menopausal women disenfranchised with the medical establishment, while providing a steady source of income. For a clinician or pharmacist practicing within the current standard of care, an FDA inspector, or a lawyer for a women with endometrial cancer associated with its use, bioHT may mean something quite different!"

Bioidentical hormones are typically plant-based compounds with a molecular structure identical to that of the corresponding human hormone. Dosing is individual and based on a woman’s salivary hormone levels. Prescriptions are pharmacist compounded, typically in a topical preparation, but sometimes in an oral tablet or injected pellet.

All of this may sound reasonable at first glance, Dr. Shifren said. But science and money just keep getting in the way of the celebrity endorsements.

"Hormone therapy should be guided by symptoms. There are no data to support the use of blood or saliva measurements to improve treatment efficacy," Dr. Shifren said. Serum hormone levels constantly fluctuate – not only within the menstrual cycle, but also within a single day, "so it’s impossible to ‘match’ any individual woman’s ‘ideal’ hormone levels."

Additionally, Dr. Shifren said, salivary levels don’t even correspond to serum levels.

Safety is one of the biggest problems with such compounds. Because their manufacture is in the hands of a single individual, there’s no quality oversight. Women can’t count on getting the correct prescribed dose of hormone – and sometimes not even close to it.

A recent study commissioned by MORE magazine examined the exact hormone content in 12 bioHT prescriptions, which were filled by 12 pharmacies. Two pharmacies were retail stores and 10 were online companies.

Flora Research Labs analyzed the medications with mass spectrometry. The values varied widely: 96%-260% of the prescribed estrogen dose and 60%-80% of the prescribed progesterone dose.

"None of these would have met FDA standards," Dr. Shifren said. "The purity, bioavailability, and dose-to-dose consistency of any given prescription is an unknown."

Concern about the safety of conventional HT frequently drives women to seek out what they consider a more natural alternative. Although much more data have emerged, the original furor over the Women’s Health Initiative still casts HT in a negative light for many, Dr. Shifren said.

For women in good health, who start combination estrogen/progesterone HT early in menopause, at the lowest effective dose, the increased risks of cardiovascular disease and cancer are negligible. A 2010 British study of 15,710 cases and almost 60,000 controls found that low-dose transdermal HT had no effect on stroke risk. High-dose patch estrogen increased the risk by 89%, and both low- and high-dose oral estrogen increased the risk by 69%; however, each of those increases translated to an absolute increase of only about 1 stroke per year (BMJ 2010;340:c2519 [doi: 10.1136/bmj.c2519]).

A 2008 French study of almost 81,000 women found no significant associations between breast cancer and route of HT administration. However, the study did conclude that the combination of estrogen and progesterone was probably the safest, with a risk ratio of 1.0. Estrogen plus dydrogesterone resulted in a nonsignificant risk increase (relative risk, 1.16). Estrogen in combination with other progestogens carried a significant 69% risk increase (Breast Cancer Res. Treat. 2008;107:103-11).

Finally, Dr. Shifren said, it’s just about impossible to take profit out of the picture. Compounding HT sales are reaching more than $2 billion per year now.

"Many practitioners who prescribe compounded hormones also sell them, or benefit financially from relationships with compounders. This poses a potential conflict of interest and violates standards of professional ethical conduct," she said.

Dr. Shifren provides research consulting for New England Research Institutes.

[email protected]

With seemingly ageless celebrities touting the benefits of bioidentical, compounded hormones, and the cloud of the Women’s Health Initiative still obscuring the view, both physicians and patients want to know the truth about natural hormone replacement.

But as in so many areas of life, the truth can be many things to many people, Dr. Jan L. Shifren shared at the annual meeting of the North American Menopause Society (NAMS).

"For a woman with bothersome menopausal symptoms and concerns about potential hormone therapy [HT] risks, ‘bioHT’ may mean a formulation of hormones with all of the benefits and no risks, as it’s ‘natural’ and contains no package insert with a black box warning," said Dr. Shifren, director of the menopause program at Massachusetts General Hospital, Boston. "For a bioHT practitioner, it may mean a way of helping menopausal women disenfranchised with the medical establishment, while providing a steady source of income. For a clinician or pharmacist practicing within the current standard of care, an FDA inspector, or a lawyer for a women with endometrial cancer associated with its use, bioHT may mean something quite different!"

Bioidentical hormones are typically plant-based compounds with a molecular structure identical to that of the corresponding human hormone. Dosing is individual and based on a woman’s salivary hormone levels. Prescriptions are pharmacist compounded, typically in a topical preparation, but sometimes in an oral tablet or injected pellet.

All of this may sound reasonable at first glance, Dr. Shifren said. But science and money just keep getting in the way of the celebrity endorsements.

"Hormone therapy should be guided by symptoms. There are no data to support the use of blood or saliva measurements to improve treatment efficacy," Dr. Shifren said. Serum hormone levels constantly fluctuate – not only within the menstrual cycle, but also within a single day, "so it’s impossible to ‘match’ any individual woman’s ‘ideal’ hormone levels."

Additionally, Dr. Shifren said, salivary levels don’t even correspond to serum levels.

Safety is one of the biggest problems with such compounds. Because their manufacture is in the hands of a single individual, there’s no quality oversight. Women can’t count on getting the correct prescribed dose of hormone – and sometimes not even close to it.

A recent study commissioned by MORE magazine examined the exact hormone content in 12 bioHT prescriptions, which were filled by 12 pharmacies. Two pharmacies were retail stores and 10 were online companies.

Flora Research Labs analyzed the medications with mass spectrometry. The values varied widely: 96%-260% of the prescribed estrogen dose and 60%-80% of the prescribed progesterone dose.

"None of these would have met FDA standards," Dr. Shifren said. "The purity, bioavailability, and dose-to-dose consistency of any given prescription is an unknown."

Concern about the safety of conventional HT frequently drives women to seek out what they consider a more natural alternative. Although much more data have emerged, the original furor over the Women’s Health Initiative still casts HT in a negative light for many, Dr. Shifren said.

For women in good health, who start combination estrogen/progesterone HT early in menopause, at the lowest effective dose, the increased risks of cardiovascular disease and cancer are negligible. A 2010 British study of 15,710 cases and almost 60,000 controls found that low-dose transdermal HT had no effect on stroke risk. High-dose patch estrogen increased the risk by 89%, and both low- and high-dose oral estrogen increased the risk by 69%; however, each of those increases translated to an absolute increase of only about 1 stroke per year (BMJ 2010;340:c2519 [doi: 10.1136/bmj.c2519]).

A 2008 French study of almost 81,000 women found no significant associations between breast cancer and route of HT administration. However, the study did conclude that the combination of estrogen and progesterone was probably the safest, with a risk ratio of 1.0. Estrogen plus dydrogesterone resulted in a nonsignificant risk increase (relative risk, 1.16). Estrogen in combination with other progestogens carried a significant 69% risk increase (Breast Cancer Res. Treat. 2008;107:103-11).

Finally, Dr. Shifren said, it’s just about impossible to take profit out of the picture. Compounding HT sales are reaching more than $2 billion per year now.

"Many practitioners who prescribe compounded hormones also sell them, or benefit financially from relationships with compounders. This poses a potential conflict of interest and violates standards of professional ethical conduct," she said.

Dr. Shifren provides research consulting for New England Research Institutes.

[email protected]

With seemingly ageless celebrities touting the benefits of bioidentical, compounded hormones, and the cloud of the Women’s Health Initiative still obscuring the view, both physicians and patients want to know the truth about natural hormone replacement.

But as in so many areas of life, the truth can be many things to many people, Dr. Jan L. Shifren shared at the annual meeting of the North American Menopause Society (NAMS).

"For a woman with bothersome menopausal symptoms and concerns about potential hormone therapy [HT] risks, ‘bioHT’ may mean a formulation of hormones with all of the benefits and no risks, as it’s ‘natural’ and contains no package insert with a black box warning," said Dr. Shifren, director of the menopause program at Massachusetts General Hospital, Boston. "For a bioHT practitioner, it may mean a way of helping menopausal women disenfranchised with the medical establishment, while providing a steady source of income. For a clinician or pharmacist practicing within the current standard of care, an FDA inspector, or a lawyer for a women with endometrial cancer associated with its use, bioHT may mean something quite different!"

Bioidentical hormones are typically plant-based compounds with a molecular structure identical to that of the corresponding human hormone. Dosing is individual and based on a woman’s salivary hormone levels. Prescriptions are pharmacist compounded, typically in a topical preparation, but sometimes in an oral tablet or injected pellet.

All of this may sound reasonable at first glance, Dr. Shifren said. But science and money just keep getting in the way of the celebrity endorsements.

"Hormone therapy should be guided by symptoms. There are no data to support the use of blood or saliva measurements to improve treatment efficacy," Dr. Shifren said. Serum hormone levels constantly fluctuate – not only within the menstrual cycle, but also within a single day, "so it’s impossible to ‘match’ any individual woman’s ‘ideal’ hormone levels."

Additionally, Dr. Shifren said, salivary levels don’t even correspond to serum levels.

Safety is one of the biggest problems with such compounds. Because their manufacture is in the hands of a single individual, there’s no quality oversight. Women can’t count on getting the correct prescribed dose of hormone – and sometimes not even close to it.

A recent study commissioned by MORE magazine examined the exact hormone content in 12 bioHT prescriptions, which were filled by 12 pharmacies. Two pharmacies were retail stores and 10 were online companies.

Flora Research Labs analyzed the medications with mass spectrometry. The values varied widely: 96%-260% of the prescribed estrogen dose and 60%-80% of the prescribed progesterone dose.

"None of these would have met FDA standards," Dr. Shifren said. "The purity, bioavailability, and dose-to-dose consistency of any given prescription is an unknown."

Concern about the safety of conventional HT frequently drives women to seek out what they consider a more natural alternative. Although much more data have emerged, the original furor over the Women’s Health Initiative still casts HT in a negative light for many, Dr. Shifren said.

For women in good health, who start combination estrogen/progesterone HT early in menopause, at the lowest effective dose, the increased risks of cardiovascular disease and cancer are negligible. A 2010 British study of 15,710 cases and almost 60,000 controls found that low-dose transdermal HT had no effect on stroke risk. High-dose patch estrogen increased the risk by 89%, and both low- and high-dose oral estrogen increased the risk by 69%; however, each of those increases translated to an absolute increase of only about 1 stroke per year (BMJ 2010;340:c2519 [doi: 10.1136/bmj.c2519]).

A 2008 French study of almost 81,000 women found no significant associations between breast cancer and route of HT administration. However, the study did conclude that the combination of estrogen and progesterone was probably the safest, with a risk ratio of 1.0. Estrogen plus dydrogesterone resulted in a nonsignificant risk increase (relative risk, 1.16). Estrogen in combination with other progestogens carried a significant 69% risk increase (Breast Cancer Res. Treat. 2008;107:103-11).

Finally, Dr. Shifren said, it’s just about impossible to take profit out of the picture. Compounding HT sales are reaching more than $2 billion per year now.

"Many practitioners who prescribe compounded hormones also sell them, or benefit financially from relationships with compounders. This poses a potential conflict of interest and violates standards of professional ethical conduct," she said.

Dr. Shifren provides research consulting for New England Research Institutes.

[email protected]