Holly Thacker, MD

In October 2013, the Women’s Health Initiative (WHI) investigators published a comprehensive overview of findings from their two hormone therapy (HT) trials, including extended follow-up representing 13 years of cumulative data.¹ When I analyzed this latest WHI report, I initially focused almost exclusively on the data presented in figures and tables within the article itself, as well as on supplemental data presented on the Internet.² Only then did I read the discussion comments by its authors. I would recommend this approach to anyone who has not yet reviewed this publication.

Overall, the WHI investigators maintain a negative stance toward the preventive and therapeutic benefits of menopausal HT. In my opinion, they also under-emphasize the importance of time since menopause in patient selection. These are the same WHI investigators who initially published un-adjudicated data³ and who delayed reporting age-stratified data.⁴ They also erroneously concluded that HT might increase the risk of ovarian cancer, even though their own data showed otherwise.^5,6

The tables and figures contain the most important data point from this extended WHI follow-up: a reduction in all-cause mortality among women who initiated HT within 10 years of menopause, whether they used estrogen-alone (hysterectomized women) or estrogen-progestin therapy (women with an intact uterus), compared with women in the placebo group.¹

Related Article: When should a menopausal woman discontinue hormone therapy? Andrew M. Kaunitz, MD (Cases in Menopause, February 2014)

DO THE RISKS OF HT REALLY OUTWEIGH THE BENEFITS?
The dramatic benefits of estrogen-alone HT, in particular, recently were highlighted by Sarrel and colleagues in an analysis that suggests that as many as 90,000 deaths may have occurred after publication of the initial WHI findings, when estrogen therapy was widely withheld.⁷ The study by Sarrel and colleagues also was highlighted in a recent issue of this journal.⁸

However, based on a “global index,” which has not been validated, the WHI investigators concluded that the risks of estrogen-progestin therapy outweigh the benefits regardless of age. Yet, the global index does not include all key concerns, omitting several quality-of-life concerns, including sleep disturbance, work productivity, and sexual function, as well as type 2 diabetes mellitus, osteoarthritis, and nonosteoporotic musculoskeletal problems. Nor does the global index provide individual weights.

Although the WHI data show reductions in the incidence of some serious chronic diseases, such as osteoporotic fracture and cardiovascular disease (in women within 10 years of menopause), Manson and colleagues make the blanket statement that HT should not be used for disease prevention, although they admit that it may be a “reasonable option for the management of moderate to severe menopausal symptoms among generally healthy women during early menopause.”¹

Related Article: Update on Osteoporosis Steven R. Goldstein, MD (December 2013)

For some time, Wulf H. Utian, MD, PhD, a founder of both the International Menopause Society and the North American Menopause Society, has been calling for an independent commission to reevaluate all of the major WHI reports “to determine whether the data justified the conclusions drawn.”⁹ I support his call and suggest that this latest WHI publication be included in that reevaluation. The fact that total mortality is reduced among women using HT—according to the WHI’s own data—is not only impressive, it argues for, not against, the use of HT for chronic disease reduction.

KEEP YOUR EYE ON THE DATA
I have no doubt that medical history books will note the destructive effects of misinterpretation of WHI data. Until then, it is up to all practitioners and educators to counsel our patients and our trainees about menopause and menopausal HT and to look beyond the textual conclusions of WHI reports to assess the data themselves.

Other important research, such as the Study of Women’s Health Across the Nation (SWAN), shows that untreated menopausal women fall off the work productivity ladder.¹⁰ This is important because economic stability is a critical component of health and wellness. I have heard many women remark that someone will have to “pry” their hormones out of their “cold, dead hands”—meaning that they intend to take HT even if it shortens their lifespan—which is ironic, given that HT is likely to extend their lifespan!

Coronary heart disease (CHD) is the major killer of American women, and the long-term WHI data actually suggest that HT can prevent it, provided it is initiated within 10 years of menopause. In a two-part article, Hodis and Mack shrewdly compare the risks associated with HT with those associated with other commonly used medications in women’s health.^11,12 They note that evidence-based data from randomized, clinical trials are very reassuring, as HT-associated risks are rare (less than 1 event per 1,000 women treated)—and even rarer when HT is initiated within 10 years of menopause. HT reduces CHD and total mortality, whereas aspirin and statins (as primary preventives) do not.^11,12

Related Article: Update: Menopause Andrew M. Kaunitz, MD (May 2010)

THE BOTTOM LINE
We need to look at the totality of the data on menopausal HT, evaluate our patients individually, treat those who are truly hormonally deficient and suffering, and counsel them that many of the harms linked to HT have been exaggerated.

The pendulum is finally swinging back toward a more balanced assessment of the benefits and risks of HT, indicating that it may be appropriate for primary prevention of cardiovascular disease, osteoporosis, and type 2 diabetes—and thus can potentially expand the lifespan. It’s up to us to communicate this fact to our patients.

TELL US WHAT YOU THINK!
Share your thoughts on this article or on any topic relevant to ObGyns and women’s health practitioners. Tell us which topics you’d like to see covered in future issues, and what challenges you face in daily practice.
We will consider publishing your letter and in a future issue.
Send your letter to: obg@frontlinemedcom.com
Please include the city and state in which you practice.
Stay in touch! Your feedback is important to us!

In October 2013, the Women’s Health Initiative (WHI) investigators published a comprehensive overview of findings from their two hormone therapy (HT) trials, including extended follow-up representing 13 years of cumulative data.¹ When I analyzed this latest WHI report, I initially focused almost exclusively on the data presented in figures and tables within the article itself, as well as on supplemental data presented on the Internet.² Only then did I read the discussion comments by its authors. I would recommend this approach to anyone who has not yet reviewed this publication.

Overall, the WHI investigators maintain a negative stance toward the preventive and therapeutic benefits of menopausal HT. In my opinion, they also under-emphasize the importance of time since menopause in patient selection. These are the same WHI investigators who initially published un-adjudicated data³ and who delayed reporting age-stratified data.⁴ They also erroneously concluded that HT might increase the risk of ovarian cancer, even though their own data showed otherwise.^5,6

The tables and figures contain the most important data point from this extended WHI follow-up: a reduction in all-cause mortality among women who initiated HT within 10 years of menopause, whether they used estrogen-alone (hysterectomized women) or estrogen-progestin therapy (women with an intact uterus), compared with women in the placebo group.¹

Related Article: When should a menopausal woman discontinue hormone therapy? Andrew M. Kaunitz, MD (Cases in Menopause, February 2014)

DO THE RISKS OF HT REALLY OUTWEIGH THE BENEFITS?
The dramatic benefits of estrogen-alone HT, in particular, recently were highlighted by Sarrel and colleagues in an analysis that suggests that as many as 90,000 deaths may have occurred after publication of the initial WHI findings, when estrogen therapy was widely withheld.⁷ The study by Sarrel and colleagues also was highlighted in a recent issue of this journal.⁸

However, based on a “global index,” which has not been validated, the WHI investigators concluded that the risks of estrogen-progestin therapy outweigh the benefits regardless of age. Yet, the global index does not include all key concerns, omitting several quality-of-life concerns, including sleep disturbance, work productivity, and sexual function, as well as type 2 diabetes mellitus, osteoarthritis, and nonosteoporotic musculoskeletal problems. Nor does the global index provide individual weights.

Although the WHI data show reductions in the incidence of some serious chronic diseases, such as osteoporotic fracture and cardiovascular disease (in women within 10 years of menopause), Manson and colleagues make the blanket statement that HT should not be used for disease prevention, although they admit that it may be a “reasonable option for the management of moderate to severe menopausal symptoms among generally healthy women during early menopause.”¹

Related Article: Update on Osteoporosis Steven R. Goldstein, MD (December 2013)

For some time, Wulf H. Utian, MD, PhD, a founder of both the International Menopause Society and the North American Menopause Society, has been calling for an independent commission to reevaluate all of the major WHI reports “to determine whether the data justified the conclusions drawn.”⁹ I support his call and suggest that this latest WHI publication be included in that reevaluation. The fact that total mortality is reduced among women using HT—according to the WHI’s own data—is not only impressive, it argues for, not against, the use of HT for chronic disease reduction.

KEEP YOUR EYE ON THE DATA
I have no doubt that medical history books will note the destructive effects of misinterpretation of WHI data. Until then, it is up to all practitioners and educators to counsel our patients and our trainees about menopause and menopausal HT and to look beyond the textual conclusions of WHI reports to assess the data themselves.

Other important research, such as the Study of Women’s Health Across the Nation (SWAN), shows that untreated menopausal women fall off the work productivity ladder.¹⁰ This is important because economic stability is a critical component of health and wellness. I have heard many women remark that someone will have to “pry” their hormones out of their “cold, dead hands”—meaning that they intend to take HT even if it shortens their lifespan—which is ironic, given that HT is likely to extend their lifespan!

Coronary heart disease (CHD) is the major killer of American women, and the long-term WHI data actually suggest that HT can prevent it, provided it is initiated within 10 years of menopause. In a two-part article, Hodis and Mack shrewdly compare the risks associated with HT with those associated with other commonly used medications in women’s health.^11,12 They note that evidence-based data from randomized, clinical trials are very reassuring, as HT-associated risks are rare (less than 1 event per 1,000 women treated)—and even rarer when HT is initiated within 10 years of menopause. HT reduces CHD and total mortality, whereas aspirin and statins (as primary preventives) do not.^11,12

Related Article: Update: Menopause Andrew M. Kaunitz, MD (May 2010)

THE BOTTOM LINE
We need to look at the totality of the data on menopausal HT, evaluate our patients individually, treat those who are truly hormonally deficient and suffering, and counsel them that many of the harms linked to HT have been exaggerated.

The pendulum is finally swinging back toward a more balanced assessment of the benefits and risks of HT, indicating that it may be appropriate for primary prevention of cardiovascular disease, osteoporosis, and type 2 diabetes—and thus can potentially expand the lifespan. It’s up to us to communicate this fact to our patients.

TELL US WHAT YOU THINK!
Share your thoughts on this article or on any topic relevant to ObGyns and women’s health practitioners. Tell us which topics you’d like to see covered in future issues, and what challenges you face in daily practice.
We will consider publishing your letter and in a future issue.
Send your letter to: obg@frontlinemedcom.com
Please include the city and state in which you practice.
Stay in touch! Your feedback is important to us!

In October 2013, the Women’s Health Initiative (WHI) investigators published a comprehensive overview of findings from their two hormone therapy (HT) trials, including extended follow-up representing 13 years of cumulative data.¹ When I analyzed this latest WHI report, I initially focused almost exclusively on the data presented in figures and tables within the article itself, as well as on supplemental data presented on the Internet.² Only then did I read the discussion comments by its authors. I would recommend this approach to anyone who has not yet reviewed this publication.

Overall, the WHI investigators maintain a negative stance toward the preventive and therapeutic benefits of menopausal HT. In my opinion, they also under-emphasize the importance of time since menopause in patient selection. These are the same WHI investigators who initially published un-adjudicated data³ and who delayed reporting age-stratified data.⁴ They also erroneously concluded that HT might increase the risk of ovarian cancer, even though their own data showed otherwise.^5,6

The tables and figures contain the most important data point from this extended WHI follow-up: a reduction in all-cause mortality among women who initiated HT within 10 years of menopause, whether they used estrogen-alone (hysterectomized women) or estrogen-progestin therapy (women with an intact uterus), compared with women in the placebo group.¹

Related Article: When should a menopausal woman discontinue hormone therapy? Andrew M. Kaunitz, MD (Cases in Menopause, February 2014)

DO THE RISKS OF HT REALLY OUTWEIGH THE BENEFITS?
The dramatic benefits of estrogen-alone HT, in particular, recently were highlighted by Sarrel and colleagues in an analysis that suggests that as many as 90,000 deaths may have occurred after publication of the initial WHI findings, when estrogen therapy was widely withheld.⁷ The study by Sarrel and colleagues also was highlighted in a recent issue of this journal.⁸

However, based on a “global index,” which has not been validated, the WHI investigators concluded that the risks of estrogen-progestin therapy outweigh the benefits regardless of age. Yet, the global index does not include all key concerns, omitting several quality-of-life concerns, including sleep disturbance, work productivity, and sexual function, as well as type 2 diabetes mellitus, osteoarthritis, and nonosteoporotic musculoskeletal problems. Nor does the global index provide individual weights.

Although the WHI data show reductions in the incidence of some serious chronic diseases, such as osteoporotic fracture and cardiovascular disease (in women within 10 years of menopause), Manson and colleagues make the blanket statement that HT should not be used for disease prevention, although they admit that it may be a “reasonable option for the management of moderate to severe menopausal symptoms among generally healthy women during early menopause.”¹

Related Article: Update on Osteoporosis Steven R. Goldstein, MD (December 2013)

For some time, Wulf H. Utian, MD, PhD, a founder of both the International Menopause Society and the North American Menopause Society, has been calling for an independent commission to reevaluate all of the major WHI reports “to determine whether the data justified the conclusions drawn.”⁹ I support his call and suggest that this latest WHI publication be included in that reevaluation. The fact that total mortality is reduced among women using HT—according to the WHI’s own data—is not only impressive, it argues for, not against, the use of HT for chronic disease reduction.

KEEP YOUR EYE ON THE DATA
I have no doubt that medical history books will note the destructive effects of misinterpretation of WHI data. Until then, it is up to all practitioners and educators to counsel our patients and our trainees about menopause and menopausal HT and to look beyond the textual conclusions of WHI reports to assess the data themselves.

Other important research, such as the Study of Women’s Health Across the Nation (SWAN), shows that untreated menopausal women fall off the work productivity ladder.¹⁰ This is important because economic stability is a critical component of health and wellness. I have heard many women remark that someone will have to “pry” their hormones out of their “cold, dead hands”—meaning that they intend to take HT even if it shortens their lifespan—which is ironic, given that HT is likely to extend their lifespan!

Coronary heart disease (CHD) is the major killer of American women, and the long-term WHI data actually suggest that HT can prevent it, provided it is initiated within 10 years of menopause. In a two-part article, Hodis and Mack shrewdly compare the risks associated with HT with those associated with other commonly used medications in women’s health.^11,12 They note that evidence-based data from randomized, clinical trials are very reassuring, as HT-associated risks are rare (less than 1 event per 1,000 women treated)—and even rarer when HT is initiated within 10 years of menopause. HT reduces CHD and total mortality, whereas aspirin and statins (as primary preventives) do not.^11,12

Related Article: Update: Menopause Andrew M. Kaunitz, MD (May 2010)

THE BOTTOM LINE
We need to look at the totality of the data on menopausal HT, evaluate our patients individually, treat those who are truly hormonally deficient and suffering, and counsel them that many of the harms linked to HT have been exaggerated.

The pendulum is finally swinging back toward a more balanced assessment of the benefits and risks of HT, indicating that it may be appropriate for primary prevention of cardiovascular disease, osteoporosis, and type 2 diabetes—and thus can potentially expand the lifespan. It’s up to us to communicate this fact to our patients.

TELL US WHAT YOU THINK!
Share your thoughts on this article or on any topic relevant to ObGyns and women’s health practitioners. Tell us which topics you’d like to see covered in future issues, and what challenges you face in daily practice.
We will consider publishing your letter and in a future issue.
Send your letter to: obg@frontlinemedcom.com
Please include the city and state in which you practice.
Stay in touch! Your feedback is important to us!

To the Editor: I have to say I am disappointed, but not surprised, at Dr. Dore’s article, “How to prevent glucocorticoid-induced osteoporosis” in your August issue.¹ The section “Estrogen is being used more selectively” was shorter and had older and out of date references compared with the section “A role for testosterone?” and it was actually blatantly sexist: the comment in the estrogen section is that “…the consensus…that hormone replacement therapy should be restricted to women with menopausal symptoms or to older women who cannot tolerate other therapies or who express a strong preference for hormone replacement therapy despite being informed about potential adverse events” [my italics],¹ while the comment in the testosterone section is that males who “… are hypogonadal, and have no contraindications to androgen replacement therapy (eg, prostate cancer) be offered testosterone therapy to preserve lean body mass and bone mineral density” [my italics].¹

While I am not arguing that menopausal hormone therapy should be used first-line for the prevention or treatment of glucocorticoid-induced osteoporosis, I would like to note the following:

First, the referenced 2002 Women’s Health Initiative study² was a prevention trial, not a therapeutic menopausal trial, and to reference it as a position statement on the use of hormone therapy is ridiculous and perpetuates misinformation about the role of menopausal hormone therapy.

Next, there has been updated information from the Women’s Health Initiative, as well as updated position statements on the use of hormone therapy—the 2010 position statement on the use of estrogen and progestogen in menopausal women³ as well as the 2008 American Association of Clinical Endocrinologists position statement⁴ noting that the benefits of hormone therapy outweigh the risks for most women under age 60. So Dr. Dore’s reference citation from 2004⁵ is hopelessly outdated.

And lastly, females, unlike males, routinely become hypogonadal at midlife. When faced with a medical condition that requires glucocorticoids that further intensifies the hypogonadal state by suppressing adrenal adrenogens, females may face a “triple whammy” on the bone.

The Women’s Health Initiative actually showed fracture reduction in postmenopausal women who did not even carry the diagnosis of osteoporosis, while the referenced studies in Dr. Dore’s article related to males admittedly “cannot be considered conclusive in view of their small size and the lack of fracture data…”¹

So what is bad (actually potentially good) for the goose is apparently just fine for the gander.

To the Editor: I have to say I am disappointed, but not surprised, at Dr. Dore’s article, “How to prevent glucocorticoid-induced osteoporosis” in your August issue.¹ The section “Estrogen is being used more selectively” was shorter and had older and out of date references compared with the section “A role for testosterone?” and it was actually blatantly sexist: the comment in the estrogen section is that “…the consensus…that hormone replacement therapy should be restricted to women with menopausal symptoms or to older women who cannot tolerate other therapies or who express a strong preference for hormone replacement therapy despite being informed about potential adverse events” [my italics],¹ while the comment in the testosterone section is that males who “… are hypogonadal, and have no contraindications to androgen replacement therapy (eg, prostate cancer) be offered testosterone therapy to preserve lean body mass and bone mineral density” [my italics].¹

While I am not arguing that menopausal hormone therapy should be used first-line for the prevention or treatment of glucocorticoid-induced osteoporosis, I would like to note the following:

First, the referenced 2002 Women’s Health Initiative study² was a prevention trial, not a therapeutic menopausal trial, and to reference it as a position statement on the use of hormone therapy is ridiculous and perpetuates misinformation about the role of menopausal hormone therapy.

Next, there has been updated information from the Women’s Health Initiative, as well as updated position statements on the use of hormone therapy—the 2010 position statement on the use of estrogen and progestogen in menopausal women³ as well as the 2008 American Association of Clinical Endocrinologists position statement⁴ noting that the benefits of hormone therapy outweigh the risks for most women under age 60. So Dr. Dore’s reference citation from 2004⁵ is hopelessly outdated.

And lastly, females, unlike males, routinely become hypogonadal at midlife. When faced with a medical condition that requires glucocorticoids that further intensifies the hypogonadal state by suppressing adrenal adrenogens, females may face a “triple whammy” on the bone.

The Women’s Health Initiative actually showed fracture reduction in postmenopausal women who did not even carry the diagnosis of osteoporosis, while the referenced studies in Dr. Dore’s article related to males admittedly “cannot be considered conclusive in view of their small size and the lack of fracture data…”¹

So what is bad (actually potentially good) for the goose is apparently just fine for the gander.

To the Editor: I have to say I am disappointed, but not surprised, at Dr. Dore’s article, “How to prevent glucocorticoid-induced osteoporosis” in your August issue.¹ The section “Estrogen is being used more selectively” was shorter and had older and out of date references compared with the section “A role for testosterone?” and it was actually blatantly sexist: the comment in the estrogen section is that “…the consensus…that hormone replacement therapy should be restricted to women with menopausal symptoms or to older women who cannot tolerate other therapies or who express a strong preference for hormone replacement therapy despite being informed about potential adverse events” [my italics],¹ while the comment in the testosterone section is that males who “… are hypogonadal, and have no contraindications to androgen replacement therapy (eg, prostate cancer) be offered testosterone therapy to preserve lean body mass and bone mineral density” [my italics].¹

While I am not arguing that menopausal hormone therapy should be used first-line for the prevention or treatment of glucocorticoid-induced osteoporosis, I would like to note the following:

First, the referenced 2002 Women’s Health Initiative study² was a prevention trial, not a therapeutic menopausal trial, and to reference it as a position statement on the use of hormone therapy is ridiculous and perpetuates misinformation about the role of menopausal hormone therapy.

Next, there has been updated information from the Women’s Health Initiative, as well as updated position statements on the use of hormone therapy—the 2010 position statement on the use of estrogen and progestogen in menopausal women³ as well as the 2008 American Association of Clinical Endocrinologists position statement⁴ noting that the benefits of hormone therapy outweigh the risks for most women under age 60. So Dr. Dore’s reference citation from 2004⁵ is hopelessly outdated.

And lastly, females, unlike males, routinely become hypogonadal at midlife. When faced with a medical condition that requires glucocorticoids that further intensifies the hypogonadal state by suppressing adrenal adrenogens, females may face a “triple whammy” on the bone.

The Women’s Health Initiative actually showed fracture reduction in postmenopausal women who did not even carry the diagnosis of osteoporosis, while the referenced studies in Dr. Dore’s article related to males admittedly “cannot be considered conclusive in view of their small size and the lack of fracture data…”¹

So what is bad (actually potentially good) for the goose is apparently just fine for the gander.