Nocturnal Hot Flashes and Alzheimer’s Risk

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In a recent article in the American Journal of Obstetrics & Gynecology, Rebecca C. Thurston, PhD, and Pauline Maki, PhD, leading scientists in the area of menopause’s impact on brain function, presented data from their assessment of 248 late perimenopausal and postmenopausal women who reported hot flashes, also known as vasomotor symptoms (VMS).

Hot flashes are known to be associated with changes in brain white matter, carotid atherosclerosis, brain function, and memory. Dr. Thurston and colleagues objectively measured VMS over 24 hours, using skin conductance monitoring. Plasma concentrations of Alzheimer’s disease biomarkers, including the amyloid beta 42–to–amyloid beta 40 ratio, were assessed. The mean age of study participants was 59 years, and they experienced a mean of five objective VMS daily.

A key finding was that VMS, particularly those occurring during sleep, were associated with a significantly lower amyloid beta 42–to–beta 40 ratio. This finding suggests that nighttime VMS may be a marker of risk for Alzheimer’s disease.

Previous research has found that menopausal hormone therapy is associated with favorable changes in Alzheimer’s disease biomarkers. Likewise, large observational studies have shown a lower incidence of Alzheimer’s disease among women who initiate hormone therapy in their late perimenopausal or early postmenopausal years and continue such therapy long term.

The findings of this important study by Thurston and colleagues provide further evidence to support the tantalizing possibility that agents that reduce nighttime hot flashes (including hormone therapy) may lower the subsequent incidence of Alzheimer’s disease in high-risk women.
 

Dr. Kaunitz is a tenured professor and associate chair in the department of obstetrics and gynecology at the University of Florida College of Medicine–Jacksonville, and medical director and director of menopause and gynecologic ultrasound services at the University of Florida Southside Women’s Health, Jacksonville. He disclosed ties to Sumitomo Pharma America, Mithra, Viatris, Bayer, Merck, Mylan (Viatris), and UpToDate.

A version of this article appeared on Medscape.com.

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In a recent article in the American Journal of Obstetrics & Gynecology, Rebecca C. Thurston, PhD, and Pauline Maki, PhD, leading scientists in the area of menopause’s impact on brain function, presented data from their assessment of 248 late perimenopausal and postmenopausal women who reported hot flashes, also known as vasomotor symptoms (VMS).

Hot flashes are known to be associated with changes in brain white matter, carotid atherosclerosis, brain function, and memory. Dr. Thurston and colleagues objectively measured VMS over 24 hours, using skin conductance monitoring. Plasma concentrations of Alzheimer’s disease biomarkers, including the amyloid beta 42–to–amyloid beta 40 ratio, were assessed. The mean age of study participants was 59 years, and they experienced a mean of five objective VMS daily.

A key finding was that VMS, particularly those occurring during sleep, were associated with a significantly lower amyloid beta 42–to–beta 40 ratio. This finding suggests that nighttime VMS may be a marker of risk for Alzheimer’s disease.

Previous research has found that menopausal hormone therapy is associated with favorable changes in Alzheimer’s disease biomarkers. Likewise, large observational studies have shown a lower incidence of Alzheimer’s disease among women who initiate hormone therapy in their late perimenopausal or early postmenopausal years and continue such therapy long term.

The findings of this important study by Thurston and colleagues provide further evidence to support the tantalizing possibility that agents that reduce nighttime hot flashes (including hormone therapy) may lower the subsequent incidence of Alzheimer’s disease in high-risk women.
 

Dr. Kaunitz is a tenured professor and associate chair in the department of obstetrics and gynecology at the University of Florida College of Medicine–Jacksonville, and medical director and director of menopause and gynecologic ultrasound services at the University of Florida Southside Women’s Health, Jacksonville. He disclosed ties to Sumitomo Pharma America, Mithra, Viatris, Bayer, Merck, Mylan (Viatris), and UpToDate.

A version of this article appeared on Medscape.com.

In a recent article in the American Journal of Obstetrics & Gynecology, Rebecca C. Thurston, PhD, and Pauline Maki, PhD, leading scientists in the area of menopause’s impact on brain function, presented data from their assessment of 248 late perimenopausal and postmenopausal women who reported hot flashes, also known as vasomotor symptoms (VMS).

Hot flashes are known to be associated with changes in brain white matter, carotid atherosclerosis, brain function, and memory. Dr. Thurston and colleagues objectively measured VMS over 24 hours, using skin conductance monitoring. Plasma concentrations of Alzheimer’s disease biomarkers, including the amyloid beta 42–to–amyloid beta 40 ratio, were assessed. The mean age of study participants was 59 years, and they experienced a mean of five objective VMS daily.

A key finding was that VMS, particularly those occurring during sleep, were associated with a significantly lower amyloid beta 42–to–beta 40 ratio. This finding suggests that nighttime VMS may be a marker of risk for Alzheimer’s disease.

Previous research has found that menopausal hormone therapy is associated with favorable changes in Alzheimer’s disease biomarkers. Likewise, large observational studies have shown a lower incidence of Alzheimer’s disease among women who initiate hormone therapy in their late perimenopausal or early postmenopausal years and continue such therapy long term.

The findings of this important study by Thurston and colleagues provide further evidence to support the tantalizing possibility that agents that reduce nighttime hot flashes (including hormone therapy) may lower the subsequent incidence of Alzheimer’s disease in high-risk women.
 

Dr. Kaunitz is a tenured professor and associate chair in the department of obstetrics and gynecology at the University of Florida College of Medicine–Jacksonville, and medical director and director of menopause and gynecologic ultrasound services at the University of Florida Southside Women’s Health, Jacksonville. He disclosed ties to Sumitomo Pharma America, Mithra, Viatris, Bayer, Merck, Mylan (Viatris), and UpToDate.

A version of this article appeared on Medscape.com.

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The safety of vaginal estrogen in breast cancer survivors

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Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

Dr. Andrew M. Kaunitz

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.

Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that in selected well-counseled breast cancer survivors, off-label use of vaginal estrogen may safely improve their sexual function and quality of life.

Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

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Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

Dr. Andrew M. Kaunitz

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.

Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that in selected well-counseled breast cancer survivors, off-label use of vaginal estrogen may safely improve their sexual function and quality of life.

Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

Dr. Andrew M. Kaunitz

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.

Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that in selected well-counseled breast cancer survivors, off-label use of vaginal estrogen may safely improve their sexual function and quality of life.

Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

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Defending access to reproductive health care

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The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,1 establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey2 rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization3 overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.4 It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.5,6

How do we best prepare for these challenges?

  • We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
  • To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
  • When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
  • We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
  • Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.7 This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.8 Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

References
  1. Roe v Wade, 410 U.S. 113 (1973).
  2. Planned Parenthood v Casey, 505 U.S. 833 (1992).
  3. Dobbs v Jackson Women’s Health Organization, 19-1392. https://www.supremecourt.gov/search .aspx?filename=/docket/docketfiles/html /public/19-1392.html. Accessed May 18, 2022.
  4. Gerstein J, Ward A. Supreme Court has voted to overturn abortion rights, draft opinion shows. Politico. May 5, 2022. Updated May 3, 2022.
  5. Gold RB. Lessons from before Roe: will past be prologue? Guttmacher Institute. March 1, 2003. https://www.guttmacher.org/gpr/2003/03 /lessons-roe-will-past-be-prologue. Accessed May 18, 2022.
  6. Edelin KC. Broken Justice: A True Story of Race, Sex and Revenge in a Boston Courtroom. Pond View Press; 2007.
  7. The American College of Obstetricians and Gynecologists. Get involved in your state. ACOG web site. https://www.acog.org/advocacy /get-involved/get-involved-in-your-state. Accessed May 18, 2022.
  8. Institute of Medicine (US) Committee on Improving Birth Outcomes. Bale JR, Stoll BJ, Lucas AO, eds. Reducing maternal mortality and morbidity. In: Improving Birth Outcomes: Meeting the Challenge in the Developing World. Washington, DC: National Academies Press (US); 2003. 
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Author and Disclosure Information

The authors are Editorial Board members of OBG Management and Ob.Gyn. News.

Dr. Kaunitz reports that his institution receives financial support from Merck and Bayer for ongoing clinical trials. Dr. Simon reports receiving grant/research support from: AbbVie Inc, Bayer Healthcare LLC, Dare´ Bioscience, Ipsen, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Sebela Pharmaceuticals Inc, Viveve Medical; being consultant/advisory board member for: Bayer HealthCare Pharmaceuticals Inc, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services LLC, Covance Inc, Dare´ Bioscience, DEKA M.E.L.A S.r.l., Femasys Inc, KaNDy/NeRRe Therapeutics Ltd, Khyria, Madorra Pty Ltd, Mitsubishi Tanabe Pharma Development America Inc, QUE Oncology Pty, Limited, Scynexis Inc, Sebela Pharmaceuticals Inc, Sprout Pharmaceuticals Inc, Vella Bioscience Inc; and having served on the speakers’ bureaus of: Mayne Pharma Inc, Myovant Sciences Inc, Pfizer Inc, Pharmavite LLC, Scynexis Inc, TherapeuticsMD; and being a stockholder (direct purchase) in: Sermonix Pharmaceuticals. The other authors report no financial relationships relevant to this article. 

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The authors are Editorial Board members of OBG Management and Ob.Gyn. News.

Dr. Kaunitz reports that his institution receives financial support from Merck and Bayer for ongoing clinical trials. Dr. Simon reports receiving grant/research support from: AbbVie Inc, Bayer Healthcare LLC, Dare´ Bioscience, Ipsen, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Sebela Pharmaceuticals Inc, Viveve Medical; being consultant/advisory board member for: Bayer HealthCare Pharmaceuticals Inc, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services LLC, Covance Inc, Dare´ Bioscience, DEKA M.E.L.A S.r.l., Femasys Inc, KaNDy/NeRRe Therapeutics Ltd, Khyria, Madorra Pty Ltd, Mitsubishi Tanabe Pharma Development America Inc, QUE Oncology Pty, Limited, Scynexis Inc, Sebela Pharmaceuticals Inc, Sprout Pharmaceuticals Inc, Vella Bioscience Inc; and having served on the speakers’ bureaus of: Mayne Pharma Inc, Myovant Sciences Inc, Pfizer Inc, Pharmavite LLC, Scynexis Inc, TherapeuticsMD; and being a stockholder (direct purchase) in: Sermonix Pharmaceuticals. The other authors report no financial relationships relevant to this article. 

Author and Disclosure Information

The authors are Editorial Board members of OBG Management and Ob.Gyn. News.

Dr. Kaunitz reports that his institution receives financial support from Merck and Bayer for ongoing clinical trials. Dr. Simon reports receiving grant/research support from: AbbVie Inc, Bayer Healthcare LLC, Dare´ Bioscience, Ipsen, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Sebela Pharmaceuticals Inc, Viveve Medical; being consultant/advisory board member for: Bayer HealthCare Pharmaceuticals Inc, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services LLC, Covance Inc, Dare´ Bioscience, DEKA M.E.L.A S.r.l., Femasys Inc, KaNDy/NeRRe Therapeutics Ltd, Khyria, Madorra Pty Ltd, Mitsubishi Tanabe Pharma Development America Inc, QUE Oncology Pty, Limited, Scynexis Inc, Sebela Pharmaceuticals Inc, Sprout Pharmaceuticals Inc, Vella Bioscience Inc; and having served on the speakers’ bureaus of: Mayne Pharma Inc, Myovant Sciences Inc, Pfizer Inc, Pharmavite LLC, Scynexis Inc, TherapeuticsMD; and being a stockholder (direct purchase) in: Sermonix Pharmaceuticals. The other authors report no financial relationships relevant to this article. 

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The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,1 establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey2 rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization3 overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.4 It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.5,6

How do we best prepare for these challenges?

  • We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
  • To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
  • When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
  • We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
  • Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.7 This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.8 Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

 

 

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,1 establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey2 rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization3 overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.4 It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.5,6

How do we best prepare for these challenges?

  • We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
  • To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
  • When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
  • We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
  • Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.7 This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.8 Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

References
  1. Roe v Wade, 410 U.S. 113 (1973).
  2. Planned Parenthood v Casey, 505 U.S. 833 (1992).
  3. Dobbs v Jackson Women’s Health Organization, 19-1392. https://www.supremecourt.gov/search .aspx?filename=/docket/docketfiles/html /public/19-1392.html. Accessed May 18, 2022.
  4. Gerstein J, Ward A. Supreme Court has voted to overturn abortion rights, draft opinion shows. Politico. May 5, 2022. Updated May 3, 2022.
  5. Gold RB. Lessons from before Roe: will past be prologue? Guttmacher Institute. March 1, 2003. https://www.guttmacher.org/gpr/2003/03 /lessons-roe-will-past-be-prologue. Accessed May 18, 2022.
  6. Edelin KC. Broken Justice: A True Story of Race, Sex and Revenge in a Boston Courtroom. Pond View Press; 2007.
  7. The American College of Obstetricians and Gynecologists. Get involved in your state. ACOG web site. https://www.acog.org/advocacy /get-involved/get-involved-in-your-state. Accessed May 18, 2022.
  8. Institute of Medicine (US) Committee on Improving Birth Outcomes. Bale JR, Stoll BJ, Lucas AO, eds. Reducing maternal mortality and morbidity. In: Improving Birth Outcomes: Meeting the Challenge in the Developing World. Washington, DC: National Academies Press (US); 2003. 
References
  1. Roe v Wade, 410 U.S. 113 (1973).
  2. Planned Parenthood v Casey, 505 U.S. 833 (1992).
  3. Dobbs v Jackson Women’s Health Organization, 19-1392. https://www.supremecourt.gov/search .aspx?filename=/docket/docketfiles/html /public/19-1392.html. Accessed May 18, 2022.
  4. Gerstein J, Ward A. Supreme Court has voted to overturn abortion rights, draft opinion shows. Politico. May 5, 2022. Updated May 3, 2022.
  5. Gold RB. Lessons from before Roe: will past be prologue? Guttmacher Institute. March 1, 2003. https://www.guttmacher.org/gpr/2003/03 /lessons-roe-will-past-be-prologue. Accessed May 18, 2022.
  6. Edelin KC. Broken Justice: A True Story of Race, Sex and Revenge in a Boston Courtroom. Pond View Press; 2007.
  7. The American College of Obstetricians and Gynecologists. Get involved in your state. ACOG web site. https://www.acog.org/advocacy /get-involved/get-involved-in-your-state. Accessed May 18, 2022.
  8. Institute of Medicine (US) Committee on Improving Birth Outcomes. Bale JR, Stoll BJ, Lucas AO, eds. Reducing maternal mortality and morbidity. In: Improving Birth Outcomes: Meeting the Challenge in the Developing World. Washington, DC: National Academies Press (US); 2003. 
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Contraception for women taking enzyme-inducing antiepileptics

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Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

A version of this article first appeared on Medscape.com.

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Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

A version of this article first appeared on Medscape.com.

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

A version of this article first appeared on Medscape.com.

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Addressing women’s concerns about the J&J vaccine

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Thu, 08/26/2021 - 15:48

A rare form of venous thromboembolism (VTE) has developed in premenopausal women who have received the Johnson & Johnson (J&J) SARS-CoV-2 vaccine.

Johnson & Johnson

This week we learned that of the more than 6.8 million individuals in the United States who received the single-dose J&J vaccine, six women aged 18-48 years have been diagnosed with cerebral venous sinus thrombosis, and all had thrombocytopenia. In each case, symptoms were first noted 1-2 weeks after vaccination. The Food and Drug Administration and Centers for Disease Control and Prevention have recommended a pause in the administration of this vaccine.

Women’s health clinicians are already hearing from concerned patients, who understandably have questions about what this news means for them.

If they have already received the J&J vaccine within the past 3 weeks, I advise them that, although risks for any vaccine-related problems are extremely low, they should be mindful of new-onset leg or abdominal pain, or an unusual or severe headache. Such patients should contact their physician as soon as possible, and if they cannot be seen quickly, it would be appropriate to visit a hospital ED. When seeking medical care, patients should specify details of their vaccination history. Depending on the individual issues present, women with suggestive symptoms should receive blood work, Doppler venous studies (if there is a suspicion of lower-extremity deep vein thrombosis), and appropriate imaging (if there is concern for cerebral venous sinus thrombosis or pulmonary embolism).

As physicians and scientists at the CDC and FDA dig into this issue, I assume they are asking questions to determine whether the affected women have any factors that might increase their baseline risk for VTE, such as:

  • A body mass index of at least 30 kg/m2
  • Use of combination estrogen-progestin contraceptives (pill, ring, or patch)
  • Known or suspected chronic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, or
  • Known familial or other thrombophilic conditions or chronic
  • Recent prolonged immobility, such as a long airplane or automobile trip, which might increase risk for VTE

cookie_cutter/Thinkstock

Experts say that the risk for a serious adverse event following receipt of the J&J vaccine is outweighed by the benefits of vaccination against COVID disease. However, that may not be enough to allay concerns among some premenopausal women.

Even if the “pause” in the administration of the vaccine is lifted, some women may be asking whether they should receive J&J’s viral vector vaccine or request one of the messenger RNA vaccines. I will be looking to the expert opinions of Anthony S. Fauci, MD, and advice from the CDC and FDA for guidance here. However, it may be reasonable to steer high-risk reproductive-age women away from the J&J vaccine in favor of the Moderna and Pfizer vaccines, if these options are available.

A version of this article first appeared on Medscape.com.
 

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A rare form of venous thromboembolism (VTE) has developed in premenopausal women who have received the Johnson & Johnson (J&J) SARS-CoV-2 vaccine.

Johnson & Johnson

This week we learned that of the more than 6.8 million individuals in the United States who received the single-dose J&J vaccine, six women aged 18-48 years have been diagnosed with cerebral venous sinus thrombosis, and all had thrombocytopenia. In each case, symptoms were first noted 1-2 weeks after vaccination. The Food and Drug Administration and Centers for Disease Control and Prevention have recommended a pause in the administration of this vaccine.

Women’s health clinicians are already hearing from concerned patients, who understandably have questions about what this news means for them.

If they have already received the J&J vaccine within the past 3 weeks, I advise them that, although risks for any vaccine-related problems are extremely low, they should be mindful of new-onset leg or abdominal pain, or an unusual or severe headache. Such patients should contact their physician as soon as possible, and if they cannot be seen quickly, it would be appropriate to visit a hospital ED. When seeking medical care, patients should specify details of their vaccination history. Depending on the individual issues present, women with suggestive symptoms should receive blood work, Doppler venous studies (if there is a suspicion of lower-extremity deep vein thrombosis), and appropriate imaging (if there is concern for cerebral venous sinus thrombosis or pulmonary embolism).

As physicians and scientists at the CDC and FDA dig into this issue, I assume they are asking questions to determine whether the affected women have any factors that might increase their baseline risk for VTE, such as:

  • A body mass index of at least 30 kg/m2
  • Use of combination estrogen-progestin contraceptives (pill, ring, or patch)
  • Known or suspected chronic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, or
  • Known familial or other thrombophilic conditions or chronic
  • Recent prolonged immobility, such as a long airplane or automobile trip, which might increase risk for VTE

cookie_cutter/Thinkstock

Experts say that the risk for a serious adverse event following receipt of the J&J vaccine is outweighed by the benefits of vaccination against COVID disease. However, that may not be enough to allay concerns among some premenopausal women.

Even if the “pause” in the administration of the vaccine is lifted, some women may be asking whether they should receive J&J’s viral vector vaccine or request one of the messenger RNA vaccines. I will be looking to the expert opinions of Anthony S. Fauci, MD, and advice from the CDC and FDA for guidance here. However, it may be reasonable to steer high-risk reproductive-age women away from the J&J vaccine in favor of the Moderna and Pfizer vaccines, if these options are available.

A version of this article first appeared on Medscape.com.
 

A rare form of venous thromboembolism (VTE) has developed in premenopausal women who have received the Johnson & Johnson (J&J) SARS-CoV-2 vaccine.

Johnson & Johnson

This week we learned that of the more than 6.8 million individuals in the United States who received the single-dose J&J vaccine, six women aged 18-48 years have been diagnosed with cerebral venous sinus thrombosis, and all had thrombocytopenia. In each case, symptoms were first noted 1-2 weeks after vaccination. The Food and Drug Administration and Centers for Disease Control and Prevention have recommended a pause in the administration of this vaccine.

Women’s health clinicians are already hearing from concerned patients, who understandably have questions about what this news means for them.

If they have already received the J&J vaccine within the past 3 weeks, I advise them that, although risks for any vaccine-related problems are extremely low, they should be mindful of new-onset leg or abdominal pain, or an unusual or severe headache. Such patients should contact their physician as soon as possible, and if they cannot be seen quickly, it would be appropriate to visit a hospital ED. When seeking medical care, patients should specify details of their vaccination history. Depending on the individual issues present, women with suggestive symptoms should receive blood work, Doppler venous studies (if there is a suspicion of lower-extremity deep vein thrombosis), and appropriate imaging (if there is concern for cerebral venous sinus thrombosis or pulmonary embolism).

As physicians and scientists at the CDC and FDA dig into this issue, I assume they are asking questions to determine whether the affected women have any factors that might increase their baseline risk for VTE, such as:

  • A body mass index of at least 30 kg/m2
  • Use of combination estrogen-progestin contraceptives (pill, ring, or patch)
  • Known or suspected chronic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, or
  • Known familial or other thrombophilic conditions or chronic
  • Recent prolonged immobility, such as a long airplane or automobile trip, which might increase risk for VTE

cookie_cutter/Thinkstock

Experts say that the risk for a serious adverse event following receipt of the J&J vaccine is outweighed by the benefits of vaccination against COVID disease. However, that may not be enough to allay concerns among some premenopausal women.

Even if the “pause” in the administration of the vaccine is lifted, some women may be asking whether they should receive J&J’s viral vector vaccine or request one of the messenger RNA vaccines. I will be looking to the expert opinions of Anthony S. Fauci, MD, and advice from the CDC and FDA for guidance here. However, it may be reasonable to steer high-risk reproductive-age women away from the J&J vaccine in favor of the Moderna and Pfizer vaccines, if these options are available.

A version of this article first appeared on Medscape.com.
 

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How does long-term OC use affect breast, ovarian, and endometrial cancer risk?

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Karlsson T, Johansson T, Hoguland J, et al. Time-dependent effects of oral contraceptive use on breast, ovarian and endometrial cancers. Cancer Research. 2020;canres.2476.2020. doi:10.1158/0008-5472.CAN-20-2476.

EXPERT COMMENTARY

The long-term effects of OC use on gynecologic and breast cancers has been uncertain, with different reports yielding conflicting findings. To assess the time-dependent and long-term associations between OC use and the risk of breast, ovarian, and endometrial cancer in women born between 1939 and 1970, Karlsson and colleagues used data from the UK Biobank (which includes a large cross-sectional cohort of individuals recruited between 2006 and 2010) and national databases.

Details of the study

A total of 256,661 women were included in this study. Of these, 82% (210,443) had used or were currently using OC (ever-users) and 18% (46,218) had never used OC (never-users). There were 17,739; 1,966; and 2,462 cases of breast, ovarian, and endometrial cancer, respectively, identified.

In analyses adjusted for 10 parameters, the ORs for ovarian (OR, 0.72) and endometrial cancer (OR, 0.68) were lower among ever-users of OC compared with never-users (P<.05). However, the OR for breast cancer (OR, 1.02) was similar among ever-users and never-users of OC (P>.05).

Among women followed to age 55, results were similar for the 2 gynecologic cancers but were significantly higher for breast cancer (OR, 1.10; P<.05). With 20 or more years of OC use, greater prevention of ovarian (OR, 0.60) and, particularly, endometrial cancer (OR, 0.36) was observed (P<.05). However, the risk of breast cancer was similar in never-users and long-term users of OC.

Study strengths and limitations

A strength of this study is that, compared with most previous studies, it had a much longer follow-up period.

The authors noted, however, that among the potential limitations in the study design was the fact that only 6% of participants invited to the UK Biobank volunteered to participate in the study. This may have resulted in participation bias within the cohort, reflecting a healthier cohort that is not representative of the overall population. ●

WHAT THIS EVIDENCE MEANS FOR PRACTICE

These study findings from a large cross-sectional cohort by Karlsson and colleagues suggest that controversy regarding the association of breast cancer with OC use may reflect different study methodologies with respect to timing. The authors note that while the lifetime risk of breast cancer may not differ between OC ever-users and never-users, there appears to be a transient elevated risk associated with OC use. By contrast, OC use, particularly when used long-term, appears to “dramatically” reduce the risk of ovarian and endometrial cancer, according to the study authors.

ANDREW M. KAUNITZ, MD

 

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Author and Disclosure Information

Andrew M. Kaunitz, MD, is Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville; Medical Director and Director of Menopause and Gynecologic Ultrasound Services, UF Women’s Health Specialists at Emerson, Jacksonville. He serves on the OBG Management Board of Editors.

Dr. Kaunitz reports serving on the advisory board of Mithra and that the University of Florida receives research funding from Mithra.

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Andrew M. Kaunitz, MD, is Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville; Medical Director and Director of Menopause and Gynecologic Ultrasound Services, UF Women’s Health Specialists at Emerson, Jacksonville. He serves on the OBG Management Board of Editors.

Dr. Kaunitz reports serving on the advisory board of Mithra and that the University of Florida receives research funding from Mithra.

Author and Disclosure Information

Andrew M. Kaunitz, MD, is Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville; Medical Director and Director of Menopause and Gynecologic Ultrasound Services, UF Women’s Health Specialists at Emerson, Jacksonville. He serves on the OBG Management Board of Editors.

Dr. Kaunitz reports serving on the advisory board of Mithra and that the University of Florida receives research funding from Mithra.

Article PDF
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Karlsson T, Johansson T, Hoguland J, et al. Time-dependent effects of oral contraceptive use on breast, ovarian and endometrial cancers. Cancer Research. 2020;canres.2476.2020. doi:10.1158/0008-5472.CAN-20-2476.

EXPERT COMMENTARY

The long-term effects of OC use on gynecologic and breast cancers has been uncertain, with different reports yielding conflicting findings. To assess the time-dependent and long-term associations between OC use and the risk of breast, ovarian, and endometrial cancer in women born between 1939 and 1970, Karlsson and colleagues used data from the UK Biobank (which includes a large cross-sectional cohort of individuals recruited between 2006 and 2010) and national databases.

Details of the study

A total of 256,661 women were included in this study. Of these, 82% (210,443) had used or were currently using OC (ever-users) and 18% (46,218) had never used OC (never-users). There were 17,739; 1,966; and 2,462 cases of breast, ovarian, and endometrial cancer, respectively, identified.

In analyses adjusted for 10 parameters, the ORs for ovarian (OR, 0.72) and endometrial cancer (OR, 0.68) were lower among ever-users of OC compared with never-users (P<.05). However, the OR for breast cancer (OR, 1.02) was similar among ever-users and never-users of OC (P>.05).

Among women followed to age 55, results were similar for the 2 gynecologic cancers but were significantly higher for breast cancer (OR, 1.10; P<.05). With 20 or more years of OC use, greater prevention of ovarian (OR, 0.60) and, particularly, endometrial cancer (OR, 0.36) was observed (P<.05). However, the risk of breast cancer was similar in never-users and long-term users of OC.

Study strengths and limitations

A strength of this study is that, compared with most previous studies, it had a much longer follow-up period.

The authors noted, however, that among the potential limitations in the study design was the fact that only 6% of participants invited to the UK Biobank volunteered to participate in the study. This may have resulted in participation bias within the cohort, reflecting a healthier cohort that is not representative of the overall population. ●

WHAT THIS EVIDENCE MEANS FOR PRACTICE

These study findings from a large cross-sectional cohort by Karlsson and colleagues suggest that controversy regarding the association of breast cancer with OC use may reflect different study methodologies with respect to timing. The authors note that while the lifetime risk of breast cancer may not differ between OC ever-users and never-users, there appears to be a transient elevated risk associated with OC use. By contrast, OC use, particularly when used long-term, appears to “dramatically” reduce the risk of ovarian and endometrial cancer, according to the study authors.

ANDREW M. KAUNITZ, MD

 

Karlsson T, Johansson T, Hoguland J, et al. Time-dependent effects of oral contraceptive use on breast, ovarian and endometrial cancers. Cancer Research. 2020;canres.2476.2020. doi:10.1158/0008-5472.CAN-20-2476.

EXPERT COMMENTARY

The long-term effects of OC use on gynecologic and breast cancers has been uncertain, with different reports yielding conflicting findings. To assess the time-dependent and long-term associations between OC use and the risk of breast, ovarian, and endometrial cancer in women born between 1939 and 1970, Karlsson and colleagues used data from the UK Biobank (which includes a large cross-sectional cohort of individuals recruited between 2006 and 2010) and national databases.

Details of the study

A total of 256,661 women were included in this study. Of these, 82% (210,443) had used or were currently using OC (ever-users) and 18% (46,218) had never used OC (never-users). There were 17,739; 1,966; and 2,462 cases of breast, ovarian, and endometrial cancer, respectively, identified.

In analyses adjusted for 10 parameters, the ORs for ovarian (OR, 0.72) and endometrial cancer (OR, 0.68) were lower among ever-users of OC compared with never-users (P<.05). However, the OR for breast cancer (OR, 1.02) was similar among ever-users and never-users of OC (P>.05).

Among women followed to age 55, results were similar for the 2 gynecologic cancers but were significantly higher for breast cancer (OR, 1.10; P<.05). With 20 or more years of OC use, greater prevention of ovarian (OR, 0.60) and, particularly, endometrial cancer (OR, 0.36) was observed (P<.05). However, the risk of breast cancer was similar in never-users and long-term users of OC.

Study strengths and limitations

A strength of this study is that, compared with most previous studies, it had a much longer follow-up period.

The authors noted, however, that among the potential limitations in the study design was the fact that only 6% of participants invited to the UK Biobank volunteered to participate in the study. This may have resulted in participation bias within the cohort, reflecting a healthier cohort that is not representative of the overall population. ●

WHAT THIS EVIDENCE MEANS FOR PRACTICE

These study findings from a large cross-sectional cohort by Karlsson and colleagues suggest that controversy regarding the association of breast cancer with OC use may reflect different study methodologies with respect to timing. The authors note that while the lifetime risk of breast cancer may not differ between OC ever-users and never-users, there appears to be a transient elevated risk associated with OC use. By contrast, OC use, particularly when used long-term, appears to “dramatically” reduce the risk of ovarian and endometrial cancer, according to the study authors.

ANDREW M. KAUNITZ, MD

 

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Which hormonal management approach for women with premature ovarian insufficiency is best for bone?

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Carvalho Gazarra LB, Bonacordi CL, Yela DA, et al. Bone mass in women with premature ovarian insufficiency: a comparative study between hormone therapy and combined oral contraceptives. Menopause. 2020;27:1110-1116.

EXPERT COMMENTARY

Premature ovarian insufficiency (POI) refers to a condition in women in whom ovarian function ceases prior to age 40 years. Although hormone therapy (HT) is a mainstay of treatment for women with POI, it is uncertain which approach to HT is most effective in terms of bone mineral density (BMD). Investigators recently published their results of an observational study that aimed to evaluate the use of combined oral contraceptives (COCs) for preserving BMD in women with POI.

Details of the study

At an academic center in Brazil, Carvalho Gazarra and colleagues identified women with POI who had undergone 2 or more BMD assessments performed 2 or more years apart.1 HT regimens (all of which were taken continuously) employed the following: a COC with ethinyl estradiol (EE) 30 µg and levonorgestrel; low-dose estrogen plus progestin therapy (EPT, conjugated equine estrogen [CEE] 0.625 mg with medroxyprogesterone acetate or estradiol 1.0 mg with norethindrone acetate); or high-dose estrogen plus progestin (CEE 1.25 mg or estradiol 2.0 mg combined with the same progestins).

Results. Among 119 evaluable women with POI (mean age, 30.3 years), the use of COC was associated with the most positive BMD trends. For women using COC or high-dose EPT, BMD at the lumbar spine increased. By contrast, BMD of the lumbar spine declined in women who used no treatment or low-dose EPT.1

Other studies’ take on dose, route of administration, and cost considerations

Sequelae of POI include infertility, bothersome hot flashes, vaginal dryness, sexual dysfunction, mood disorders, and an elevated risk of cardiovascular disease, dementia, Parkinson’s disease, and osteoporosis. Importantly, clinicians and patients need to understand that the results from the Women’s Health Initiative studies do not apply to women with POI.2 Physiologic doses of HT (that is, doses higher than those used to treat menopausal symptoms in women with normal/spontaneous menopause) are appropriate for women with POI, at least until they reach the normal age of menopause (51 to 52 years).

A clinical trial conducted in Scotland in women with POI found that high-dose transdermal estrogen (application of one to two 0.1-mg estradiol patches) daily had an impact on BMD that was more positive than that of an oral contraceptive formulated with EE 30 µg.3 Likewise, a trial in the United States found that, among oligo-amenorrheic athletes, a hormone replacement regimen using a 0.1-mg estradiol patch had a more positive impact on BMD than an oral contraceptive formulated with EE 30 µg.4

Although Carvalho Gazarra and colleagues acknowledged awareness of reports suggesting the skeletal health benefits of high-dose estradiol patches, in the Brazilian public health system oral hormone therapy is less expensive and oral contraceptives are available at no charge.1

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
When replacing estrogen and progestin in young women who lack ovarian function, it is appropriate to use considerably higher doses than those used to treat bothersome vasomotor symptoms in women with normal/spontaneous menopause. From the perspective of venous thromboembolism risk, the transdermal route of administration is safer than the oral route,5 and the Scottish and US studies discussed here indicate that transdermal estradiol is an effective approach to maintaining skeletal health in young women without ovarian function. Accordingly, hormonal management with high-dose transdermal estradiol with a progestin (such as progesterone 200–300 mg at bedtime or medroxyprogesterone 5–10 mg daily) represents an appropriate strategy. In situations where transdermal estradiol plus oral progestin treatment is not covered by health insurance or acceptable to the patient, an oral estrogen-progestin contraceptive formulated with EE 30 or 35 µg will provide protection against bone loss.
References
  1. Carvalho Gazarra LB, Bonacordi CL, Yela DA, et al. Bone mass in women with premature ovarian insufficiency: a comparative study between hormone therapy and combined oral contraceptives. Menopause. 2020;27:1110-1116. 
  2. Jiang XD. Bone health and beyond in women with primary ovarian insufficiency: time to narrow the knowledge-action gap in care. Menopause. 2020;27:1101-1103. 
  3. Crofton PM, Evans N, Bath LE, et al. Physiological versus standard sex steroid replacement in young women with premature ovarian failure: effects on bone mass acquisition and turnover. Clin Endocrinol (Oxf). 2010;73:707-714. 
  4. Ackerman KE, Singhal V, Baskaran C, et al. Oestrogen replacement improves bone mineral density in oligo-amenorrhoeic athletes: a randomised clinical trial. Br J Sports Med. 2019;53:229-236. 
  5. Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ. 2019;364:k4810.
Article PDF
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The author reports serving on the advisory boards of Pfizer (contraception) and Mithra, and that the University of Florida has received clinical trial support from Mithra.  
 

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The author reports serving on the advisory boards of Pfizer (contraception) and Mithra, and that the University of Florida has received clinical trial support from Mithra.  
 

Author and Disclosure Information

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The author reports serving on the advisory boards of Pfizer (contraception) and Mithra, and that the University of Florida has received clinical trial support from Mithra.  
 

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Carvalho Gazarra LB, Bonacordi CL, Yela DA, et al. Bone mass in women with premature ovarian insufficiency: a comparative study between hormone therapy and combined oral contraceptives. Menopause. 2020;27:1110-1116.

EXPERT COMMENTARY

Premature ovarian insufficiency (POI) refers to a condition in women in whom ovarian function ceases prior to age 40 years. Although hormone therapy (HT) is a mainstay of treatment for women with POI, it is uncertain which approach to HT is most effective in terms of bone mineral density (BMD). Investigators recently published their results of an observational study that aimed to evaluate the use of combined oral contraceptives (COCs) for preserving BMD in women with POI.

Details of the study

At an academic center in Brazil, Carvalho Gazarra and colleagues identified women with POI who had undergone 2 or more BMD assessments performed 2 or more years apart.1 HT regimens (all of which were taken continuously) employed the following: a COC with ethinyl estradiol (EE) 30 µg and levonorgestrel; low-dose estrogen plus progestin therapy (EPT, conjugated equine estrogen [CEE] 0.625 mg with medroxyprogesterone acetate or estradiol 1.0 mg with norethindrone acetate); or high-dose estrogen plus progestin (CEE 1.25 mg or estradiol 2.0 mg combined with the same progestins).

Results. Among 119 evaluable women with POI (mean age, 30.3 years), the use of COC was associated with the most positive BMD trends. For women using COC or high-dose EPT, BMD at the lumbar spine increased. By contrast, BMD of the lumbar spine declined in women who used no treatment or low-dose EPT.1

Other studies’ take on dose, route of administration, and cost considerations

Sequelae of POI include infertility, bothersome hot flashes, vaginal dryness, sexual dysfunction, mood disorders, and an elevated risk of cardiovascular disease, dementia, Parkinson’s disease, and osteoporosis. Importantly, clinicians and patients need to understand that the results from the Women’s Health Initiative studies do not apply to women with POI.2 Physiologic doses of HT (that is, doses higher than those used to treat menopausal symptoms in women with normal/spontaneous menopause) are appropriate for women with POI, at least until they reach the normal age of menopause (51 to 52 years).

A clinical trial conducted in Scotland in women with POI found that high-dose transdermal estrogen (application of one to two 0.1-mg estradiol patches) daily had an impact on BMD that was more positive than that of an oral contraceptive formulated with EE 30 µg.3 Likewise, a trial in the United States found that, among oligo-amenorrheic athletes, a hormone replacement regimen using a 0.1-mg estradiol patch had a more positive impact on BMD than an oral contraceptive formulated with EE 30 µg.4

Although Carvalho Gazarra and colleagues acknowledged awareness of reports suggesting the skeletal health benefits of high-dose estradiol patches, in the Brazilian public health system oral hormone therapy is less expensive and oral contraceptives are available at no charge.1

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
When replacing estrogen and progestin in young women who lack ovarian function, it is appropriate to use considerably higher doses than those used to treat bothersome vasomotor symptoms in women with normal/spontaneous menopause. From the perspective of venous thromboembolism risk, the transdermal route of administration is safer than the oral route,5 and the Scottish and US studies discussed here indicate that transdermal estradiol is an effective approach to maintaining skeletal health in young women without ovarian function. Accordingly, hormonal management with high-dose transdermal estradiol with a progestin (such as progesterone 200–300 mg at bedtime or medroxyprogesterone 5–10 mg daily) represents an appropriate strategy. In situations where transdermal estradiol plus oral progestin treatment is not covered by health insurance or acceptable to the patient, an oral estrogen-progestin contraceptive formulated with EE 30 or 35 µg will provide protection against bone loss.

Carvalho Gazarra LB, Bonacordi CL, Yela DA, et al. Bone mass in women with premature ovarian insufficiency: a comparative study between hormone therapy and combined oral contraceptives. Menopause. 2020;27:1110-1116.

EXPERT COMMENTARY

Premature ovarian insufficiency (POI) refers to a condition in women in whom ovarian function ceases prior to age 40 years. Although hormone therapy (HT) is a mainstay of treatment for women with POI, it is uncertain which approach to HT is most effective in terms of bone mineral density (BMD). Investigators recently published their results of an observational study that aimed to evaluate the use of combined oral contraceptives (COCs) for preserving BMD in women with POI.

Details of the study

At an academic center in Brazil, Carvalho Gazarra and colleagues identified women with POI who had undergone 2 or more BMD assessments performed 2 or more years apart.1 HT regimens (all of which were taken continuously) employed the following: a COC with ethinyl estradiol (EE) 30 µg and levonorgestrel; low-dose estrogen plus progestin therapy (EPT, conjugated equine estrogen [CEE] 0.625 mg with medroxyprogesterone acetate or estradiol 1.0 mg with norethindrone acetate); or high-dose estrogen plus progestin (CEE 1.25 mg or estradiol 2.0 mg combined with the same progestins).

Results. Among 119 evaluable women with POI (mean age, 30.3 years), the use of COC was associated with the most positive BMD trends. For women using COC or high-dose EPT, BMD at the lumbar spine increased. By contrast, BMD of the lumbar spine declined in women who used no treatment or low-dose EPT.1

Other studies’ take on dose, route of administration, and cost considerations

Sequelae of POI include infertility, bothersome hot flashes, vaginal dryness, sexual dysfunction, mood disorders, and an elevated risk of cardiovascular disease, dementia, Parkinson’s disease, and osteoporosis. Importantly, clinicians and patients need to understand that the results from the Women’s Health Initiative studies do not apply to women with POI.2 Physiologic doses of HT (that is, doses higher than those used to treat menopausal symptoms in women with normal/spontaneous menopause) are appropriate for women with POI, at least until they reach the normal age of menopause (51 to 52 years).

A clinical trial conducted in Scotland in women with POI found that high-dose transdermal estrogen (application of one to two 0.1-mg estradiol patches) daily had an impact on BMD that was more positive than that of an oral contraceptive formulated with EE 30 µg.3 Likewise, a trial in the United States found that, among oligo-amenorrheic athletes, a hormone replacement regimen using a 0.1-mg estradiol patch had a more positive impact on BMD than an oral contraceptive formulated with EE 30 µg.4

Although Carvalho Gazarra and colleagues acknowledged awareness of reports suggesting the skeletal health benefits of high-dose estradiol patches, in the Brazilian public health system oral hormone therapy is less expensive and oral contraceptives are available at no charge.1

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
When replacing estrogen and progestin in young women who lack ovarian function, it is appropriate to use considerably higher doses than those used to treat bothersome vasomotor symptoms in women with normal/spontaneous menopause. From the perspective of venous thromboembolism risk, the transdermal route of administration is safer than the oral route,5 and the Scottish and US studies discussed here indicate that transdermal estradiol is an effective approach to maintaining skeletal health in young women without ovarian function. Accordingly, hormonal management with high-dose transdermal estradiol with a progestin (such as progesterone 200–300 mg at bedtime or medroxyprogesterone 5–10 mg daily) represents an appropriate strategy. In situations where transdermal estradiol plus oral progestin treatment is not covered by health insurance or acceptable to the patient, an oral estrogen-progestin contraceptive formulated with EE 30 or 35 µg will provide protection against bone loss.
References
  1. Carvalho Gazarra LB, Bonacordi CL, Yela DA, et al. Bone mass in women with premature ovarian insufficiency: a comparative study between hormone therapy and combined oral contraceptives. Menopause. 2020;27:1110-1116. 
  2. Jiang XD. Bone health and beyond in women with primary ovarian insufficiency: time to narrow the knowledge-action gap in care. Menopause. 2020;27:1101-1103. 
  3. Crofton PM, Evans N, Bath LE, et al. Physiological versus standard sex steroid replacement in young women with premature ovarian failure: effects on bone mass acquisition and turnover. Clin Endocrinol (Oxf). 2010;73:707-714. 
  4. Ackerman KE, Singhal V, Baskaran C, et al. Oestrogen replacement improves bone mineral density in oligo-amenorrhoeic athletes: a randomised clinical trial. Br J Sports Med. 2019;53:229-236. 
  5. Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ. 2019;364:k4810.
References
  1. Carvalho Gazarra LB, Bonacordi CL, Yela DA, et al. Bone mass in women with premature ovarian insufficiency: a comparative study between hormone therapy and combined oral contraceptives. Menopause. 2020;27:1110-1116. 
  2. Jiang XD. Bone health and beyond in women with primary ovarian insufficiency: time to narrow the knowledge-action gap in care. Menopause. 2020;27:1101-1103. 
  3. Crofton PM, Evans N, Bath LE, et al. Physiological versus standard sex steroid replacement in young women with premature ovarian failure: effects on bone mass acquisition and turnover. Clin Endocrinol (Oxf). 2010;73:707-714. 
  4. Ackerman KE, Singhal V, Baskaran C, et al. Oestrogen replacement improves bone mineral density in oligo-amenorrhoeic athletes: a randomised clinical trial. Br J Sports Med. 2019;53:229-236. 
  5. Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ. 2019;364:k4810.
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How effective is screening mammography for preventing breast cancer mortality?

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Changed
Thu, 12/15/2022 - 17:35

EXPERT COMMENTARY

Although recommending screening mammograms continues to represent the standard of care, studies from the United States and abroad have questioned their value.1-3

In the June issue of JAMA Network Open, Australian investigators assessed the relative impacts of mammography screening and adjuvant therapy on breast cancer mortality, using data from population-based studies from 1982 through 2013.4 In recent decades, screening has increased substantially among Australian women.

Details of the study

Burton and Stevenson identified 76,630 women included in the Victorian Cancer Registry with invasive breast cancer in the state of Victoria, where women aged 50 to 69 are offered biennial screening.4 During the study’s time period, the use of adjuvant tamoxifen and chemotherapy increased substantially.

In the 31-year period assessed in this study, breast cancer mortality declined considerably. During the same period, however, the incidence of advanced breast cancer doubled.

These findings from Australia parallel those from the United States, Holland, and Norway, where the incidence of advanced breast cancer was stable or increased after screening mammography was introduced.1-3

According to Burton and Stevenson, the increased incidence of advanced cancer clarifies that screening mammography is not responsible for declining breast cancer mortality, but all of the decline in mortality can be attributed to increased uptake of adjuvant therapy.

The authors concluded that since screening mammography does not reduce breast cancer mortality, state-sponsored screens should be discontinued.

Study strengths and limitations

Relevant data for this study were obtained from large population-based surveys for premenopausal and postmenopausal women with breast cancer.

The authors noted, however, that this analysis of observational data examining time trends across the study period can show only associations among breast cancer mortality, mammography screening participation, and adjuvant therapy uptake, and that causality can only be inferred.

The study in perspective

Although some will view the findings and recommendations of these Australian authors with skepticism or even hostility, I view their findings as good news—we have improved the treatment of breast cancer so dramatically that the benefits of finding early tumors with screening mammography have become attenuated.

Although it is challenging given the time constraints of office visits, I try to engage in shared decision making with my patients regarding when to start and how often to have screening mammography. ●

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Given our evolving understanding regarding the value of screening mammograms, it is time to stop pressuring patients who are reluctant or unwilling to undergo screening. Likewise, insurance companies and government agencies should stop using screening mammography as a quality metric.

ANDREW M. KAUNITZ, MD

 

References
  1. Bleyer A, Welch GH. Effect of three decades of screening mammography on breast cancer-incidence. N Engl J Med. 2012;367:1998-2005. 
  2. Autier P, Boniol M, Koechlin A, et al. Effectiveness of and overdiagnosis from mammography screening in the Netherlands: population based study. BMJ. 2017;359:j5224. 
  3. Kalager M, Zelen M, Langmark F, et al. Effect of screening mammography on breast-cancer mortality in Norway. N Engl J Med. 2010;363:1203-1210. 
  4. Burton R, Stevenson C. Assessment of breast cancer mortality trends associated with mammographic screening and adjuvant therapy from 1986 to 2013 in the state of Victoria, Australia. JAMA Netw Open. 2020;3:e208249.
Article PDF
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Andrew M. Kaunitz, MD, is Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville; Medical Director and Director of Menopause and Gynecologic Ultrasound Services, UF Women’s Health Specialists at Emerson, Jacksonville. He serves on the OBG Management Board of Editors.

 

The author reports no financial relationships relevant to this article.

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The author reports no financial relationships relevant to this article.

Author and Disclosure Information

Andrew M. Kaunitz, MD, is Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville; Medical Director and Director of Menopause and Gynecologic Ultrasound Services, UF Women’s Health Specialists at Emerson, Jacksonville. He serves on the OBG Management Board of Editors.

 

The author reports no financial relationships relevant to this article.

Article PDF
Article PDF

EXPERT COMMENTARY

Although recommending screening mammograms continues to represent the standard of care, studies from the United States and abroad have questioned their value.1-3

In the June issue of JAMA Network Open, Australian investigators assessed the relative impacts of mammography screening and adjuvant therapy on breast cancer mortality, using data from population-based studies from 1982 through 2013.4 In recent decades, screening has increased substantially among Australian women.

Details of the study

Burton and Stevenson identified 76,630 women included in the Victorian Cancer Registry with invasive breast cancer in the state of Victoria, where women aged 50 to 69 are offered biennial screening.4 During the study’s time period, the use of adjuvant tamoxifen and chemotherapy increased substantially.

In the 31-year period assessed in this study, breast cancer mortality declined considerably. During the same period, however, the incidence of advanced breast cancer doubled.

These findings from Australia parallel those from the United States, Holland, and Norway, where the incidence of advanced breast cancer was stable or increased after screening mammography was introduced.1-3

According to Burton and Stevenson, the increased incidence of advanced cancer clarifies that screening mammography is not responsible for declining breast cancer mortality, but all of the decline in mortality can be attributed to increased uptake of adjuvant therapy.

The authors concluded that since screening mammography does not reduce breast cancer mortality, state-sponsored screens should be discontinued.

Study strengths and limitations

Relevant data for this study were obtained from large population-based surveys for premenopausal and postmenopausal women with breast cancer.

The authors noted, however, that this analysis of observational data examining time trends across the study period can show only associations among breast cancer mortality, mammography screening participation, and adjuvant therapy uptake, and that causality can only be inferred.

The study in perspective

Although some will view the findings and recommendations of these Australian authors with skepticism or even hostility, I view their findings as good news—we have improved the treatment of breast cancer so dramatically that the benefits of finding early tumors with screening mammography have become attenuated.

Although it is challenging given the time constraints of office visits, I try to engage in shared decision making with my patients regarding when to start and how often to have screening mammography. ●

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Given our evolving understanding regarding the value of screening mammograms, it is time to stop pressuring patients who are reluctant or unwilling to undergo screening. Likewise, insurance companies and government agencies should stop using screening mammography as a quality metric.

ANDREW M. KAUNITZ, MD

 

EXPERT COMMENTARY

Although recommending screening mammograms continues to represent the standard of care, studies from the United States and abroad have questioned their value.1-3

In the June issue of JAMA Network Open, Australian investigators assessed the relative impacts of mammography screening and adjuvant therapy on breast cancer mortality, using data from population-based studies from 1982 through 2013.4 In recent decades, screening has increased substantially among Australian women.

Details of the study

Burton and Stevenson identified 76,630 women included in the Victorian Cancer Registry with invasive breast cancer in the state of Victoria, where women aged 50 to 69 are offered biennial screening.4 During the study’s time period, the use of adjuvant tamoxifen and chemotherapy increased substantially.

In the 31-year period assessed in this study, breast cancer mortality declined considerably. During the same period, however, the incidence of advanced breast cancer doubled.

These findings from Australia parallel those from the United States, Holland, and Norway, where the incidence of advanced breast cancer was stable or increased after screening mammography was introduced.1-3

According to Burton and Stevenson, the increased incidence of advanced cancer clarifies that screening mammography is not responsible for declining breast cancer mortality, but all of the decline in mortality can be attributed to increased uptake of adjuvant therapy.

The authors concluded that since screening mammography does not reduce breast cancer mortality, state-sponsored screens should be discontinued.

Study strengths and limitations

Relevant data for this study were obtained from large population-based surveys for premenopausal and postmenopausal women with breast cancer.

The authors noted, however, that this analysis of observational data examining time trends across the study period can show only associations among breast cancer mortality, mammography screening participation, and adjuvant therapy uptake, and that causality can only be inferred.

The study in perspective

Although some will view the findings and recommendations of these Australian authors with skepticism or even hostility, I view their findings as good news—we have improved the treatment of breast cancer so dramatically that the benefits of finding early tumors with screening mammography have become attenuated.

Although it is challenging given the time constraints of office visits, I try to engage in shared decision making with my patients regarding when to start and how often to have screening mammography. ●

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Given our evolving understanding regarding the value of screening mammograms, it is time to stop pressuring patients who are reluctant or unwilling to undergo screening. Likewise, insurance companies and government agencies should stop using screening mammography as a quality metric.

ANDREW M. KAUNITZ, MD

 

References
  1. Bleyer A, Welch GH. Effect of three decades of screening mammography on breast cancer-incidence. N Engl J Med. 2012;367:1998-2005. 
  2. Autier P, Boniol M, Koechlin A, et al. Effectiveness of and overdiagnosis from mammography screening in the Netherlands: population based study. BMJ. 2017;359:j5224. 
  3. Kalager M, Zelen M, Langmark F, et al. Effect of screening mammography on breast-cancer mortality in Norway. N Engl J Med. 2010;363:1203-1210. 
  4. Burton R, Stevenson C. Assessment of breast cancer mortality trends associated with mammographic screening and adjuvant therapy from 1986 to 2013 in the state of Victoria, Australia. JAMA Netw Open. 2020;3:e208249.
References
  1. Bleyer A, Welch GH. Effect of three decades of screening mammography on breast cancer-incidence. N Engl J Med. 2012;367:1998-2005. 
  2. Autier P, Boniol M, Koechlin A, et al. Effectiveness of and overdiagnosis from mammography screening in the Netherlands: population based study. BMJ. 2017;359:j5224. 
  3. Kalager M, Zelen M, Langmark F, et al. Effect of screening mammography on breast-cancer mortality in Norway. N Engl J Med. 2010;363:1203-1210. 
  4. Burton R, Stevenson C. Assessment of breast cancer mortality trends associated with mammographic screening and adjuvant therapy from 1986 to 2013 in the state of Victoria, Australia. JAMA Netw Open. 2020;3:e208249.
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Prioritizing ambulatory gynecology care during COVID-19: The latest guidance

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What exactly constitutes appropriate ambulatory gynecology during this time of social distancing?

On March 30, 2020, the American College of Obstetricians and Gynecologists (ACOG) weighed in, releasing COVID-19 FAQs for Obstetrician-Gynecologists. These recommendations, which include information about obstetric and gynecologic surgery, are available to everyone, including the general public. They are intended to supplement guidance from the Centers for Disease Control and Prevention, as well as previously released ACOG guidance.

The recommendations include examples of patients needing in-person appointments, telehealth visits, or visits that should be deferred.

In-person appointments. Examples of patients for whom in-person appointments are appropriate include those with suspected ectopic pregnancy or profuse vaginal bleeding. With respect to contraceptive services, ACOG suggests that placement of IUDs and implants should continue whenever possible. If placement of the contraceptive device is deferred, use of self-administered hormonal contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring) should be encouraged as a bridge to later initiation of long-acting methods.

Telehealth visits. Video or telephone visits are advised for women desiring counseling and prescribing for contraception or menopausal symptoms.

Deferred. Deferral of office visits until after COVID-19 lockdowns is advised for average-risk women wishing routine well-woman visits. Other situations in which deferral should be considered include the following:

  • For patients with abnormal cervical cancer screening results, ACOG suggests that colposcopy with cervical biopsies could be deferred for 6-12 months for patients with low-grade test results. In contrast, for patients with high-grade results, ACOG recommends that evaluation be performed within 3 months.
  • For women who wish to discontinue their contraceptive, ACOG advises that removal of IUDs and implants be postponed when possible. These women should be counseled regarding extended use of these devices.

ACOG emphasizes that decisions regarding ambulatory gynecology should be individualized and take into consideration such issues as availability of local and regional resources, staffing, personal protective equipment, and the local prevalence of COVID-19.

As a gynecologist focused on ambulatory care, I believe that many clinicians will welcome this guidance from ACOG, which helps us provide optimal care during these challenging times.

Dr. Kaunitz is professor and associate chairman in the department of obstetrics and gynecology at the University of Florida, Jacksonville. He has disclosed receiving royalties from UpToDate, serving on the safety monitoring board for Femasys, and serving as a consultant for AMAG Pharmaceuticals, Merck & Co, Mithra, and Pfizer. His institution has received funding from pharmaceutical companies and nonprofits.

A version of this article originally appeared on Medscape.com.

Publications
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What exactly constitutes appropriate ambulatory gynecology during this time of social distancing?

On March 30, 2020, the American College of Obstetricians and Gynecologists (ACOG) weighed in, releasing COVID-19 FAQs for Obstetrician-Gynecologists. These recommendations, which include information about obstetric and gynecologic surgery, are available to everyone, including the general public. They are intended to supplement guidance from the Centers for Disease Control and Prevention, as well as previously released ACOG guidance.

The recommendations include examples of patients needing in-person appointments, telehealth visits, or visits that should be deferred.

In-person appointments. Examples of patients for whom in-person appointments are appropriate include those with suspected ectopic pregnancy or profuse vaginal bleeding. With respect to contraceptive services, ACOG suggests that placement of IUDs and implants should continue whenever possible. If placement of the contraceptive device is deferred, use of self-administered hormonal contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring) should be encouraged as a bridge to later initiation of long-acting methods.

Telehealth visits. Video or telephone visits are advised for women desiring counseling and prescribing for contraception or menopausal symptoms.

Deferred. Deferral of office visits until after COVID-19 lockdowns is advised for average-risk women wishing routine well-woman visits. Other situations in which deferral should be considered include the following:

  • For patients with abnormal cervical cancer screening results, ACOG suggests that colposcopy with cervical biopsies could be deferred for 6-12 months for patients with low-grade test results. In contrast, for patients with high-grade results, ACOG recommends that evaluation be performed within 3 months.
  • For women who wish to discontinue their contraceptive, ACOG advises that removal of IUDs and implants be postponed when possible. These women should be counseled regarding extended use of these devices.

ACOG emphasizes that decisions regarding ambulatory gynecology should be individualized and take into consideration such issues as availability of local and regional resources, staffing, personal protective equipment, and the local prevalence of COVID-19.

As a gynecologist focused on ambulatory care, I believe that many clinicians will welcome this guidance from ACOG, which helps us provide optimal care during these challenging times.

Dr. Kaunitz is professor and associate chairman in the department of obstetrics and gynecology at the University of Florida, Jacksonville. He has disclosed receiving royalties from UpToDate, serving on the safety monitoring board for Femasys, and serving as a consultant for AMAG Pharmaceuticals, Merck & Co, Mithra, and Pfizer. His institution has received funding from pharmaceutical companies and nonprofits.

A version of this article originally appeared on Medscape.com.

 

What exactly constitutes appropriate ambulatory gynecology during this time of social distancing?

On March 30, 2020, the American College of Obstetricians and Gynecologists (ACOG) weighed in, releasing COVID-19 FAQs for Obstetrician-Gynecologists. These recommendations, which include information about obstetric and gynecologic surgery, are available to everyone, including the general public. They are intended to supplement guidance from the Centers for Disease Control and Prevention, as well as previously released ACOG guidance.

The recommendations include examples of patients needing in-person appointments, telehealth visits, or visits that should be deferred.

In-person appointments. Examples of patients for whom in-person appointments are appropriate include those with suspected ectopic pregnancy or profuse vaginal bleeding. With respect to contraceptive services, ACOG suggests that placement of IUDs and implants should continue whenever possible. If placement of the contraceptive device is deferred, use of self-administered hormonal contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring) should be encouraged as a bridge to later initiation of long-acting methods.

Telehealth visits. Video or telephone visits are advised for women desiring counseling and prescribing for contraception or menopausal symptoms.

Deferred. Deferral of office visits until after COVID-19 lockdowns is advised for average-risk women wishing routine well-woman visits. Other situations in which deferral should be considered include the following:

  • For patients with abnormal cervical cancer screening results, ACOG suggests that colposcopy with cervical biopsies could be deferred for 6-12 months for patients with low-grade test results. In contrast, for patients with high-grade results, ACOG recommends that evaluation be performed within 3 months.
  • For women who wish to discontinue their contraceptive, ACOG advises that removal of IUDs and implants be postponed when possible. These women should be counseled regarding extended use of these devices.

ACOG emphasizes that decisions regarding ambulatory gynecology should be individualized and take into consideration such issues as availability of local and regional resources, staffing, personal protective equipment, and the local prevalence of COVID-19.

As a gynecologist focused on ambulatory care, I believe that many clinicians will welcome this guidance from ACOG, which helps us provide optimal care during these challenging times.

Dr. Kaunitz is professor and associate chairman in the department of obstetrics and gynecology at the University of Florida, Jacksonville. He has disclosed receiving royalties from UpToDate, serving on the safety monitoring board for Femasys, and serving as a consultant for AMAG Pharmaceuticals, Merck & Co, Mithra, and Pfizer. His institution has received funding from pharmaceutical companies and nonprofits.

A version of this article originally appeared on Medscape.com.

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ACOG offers guidance on optimizing patient care in the midst of COVID-19

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The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.1

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

  • suspected ectopic pregnancy
  • profuse vaginal bleeding

Video or telephone visits

  • contraceptive counseling and prescribing
  • management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

  • routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that2:

  • for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
  • for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.
 

References
  1. American College of Obstetricians and Gynecologists website. COVID-19 FAQs for obstetrician-gynecologists, gynecology. https://www.acog.org/clinical-information/physician-faqs/covid19-faqs-for-ob-gyns-gynecology. Accessed April 3, 2020.
  2. ASCCP website. ASCCP interim guidance for timing of diagnostic and treatment procedures for patients with abnormal cervical screening tests. https://www.asccp.org/covid-19. Accessed April 3, 2020.
Author and Disclosure Information

Dr. Kaunitz is University of Florida Term Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville; Medical Director and Director of Menopause and Gynecologic Ultrasound Services, UF Women’s Health Specialists at Emerson, Jacksonville. Dr. Kaunitz serves on the OBG Management Board of Editors.

Dr. Kaunitz reports that he has received grant or research support from Medicines360 and that he is a consultant to Merck and Pfizer.

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Author and Disclosure Information

Dr. Kaunitz is University of Florida Term Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville; Medical Director and Director of Menopause and Gynecologic Ultrasound Services, UF Women’s Health Specialists at Emerson, Jacksonville. Dr. Kaunitz serves on the OBG Management Board of Editors.

Dr. Kaunitz reports that he has received grant or research support from Medicines360 and that he is a consultant to Merck and Pfizer.

Author and Disclosure Information

Dr. Kaunitz is University of Florida Term Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville; Medical Director and Director of Menopause and Gynecologic Ultrasound Services, UF Women’s Health Specialists at Emerson, Jacksonville. Dr. Kaunitz serves on the OBG Management Board of Editors.

Dr. Kaunitz reports that he has received grant or research support from Medicines360 and that he is a consultant to Merck and Pfizer.

The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.1

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

  • suspected ectopic pregnancy
  • profuse vaginal bleeding

Video or telephone visits

  • contraceptive counseling and prescribing
  • management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

  • routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that2:

  • for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
  • for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.
 

The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.1

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

  • suspected ectopic pregnancy
  • profuse vaginal bleeding

Video or telephone visits

  • contraceptive counseling and prescribing
  • management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

  • routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that2:

  • for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
  • for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.
 

References
  1. American College of Obstetricians and Gynecologists website. COVID-19 FAQs for obstetrician-gynecologists, gynecology. https://www.acog.org/clinical-information/physician-faqs/covid19-faqs-for-ob-gyns-gynecology. Accessed April 3, 2020.
  2. ASCCP website. ASCCP interim guidance for timing of diagnostic and treatment procedures for patients with abnormal cervical screening tests. https://www.asccp.org/covid-19. Accessed April 3, 2020.
References
  1. American College of Obstetricians and Gynecologists website. COVID-19 FAQs for obstetrician-gynecologists, gynecology. https://www.acog.org/clinical-information/physician-faqs/covid19-faqs-for-ob-gyns-gynecology. Accessed April 3, 2020.
  2. ASCCP website. ASCCP interim guidance for timing of diagnostic and treatment procedures for patients with abnormal cervical screening tests. https://www.asccp.org/covid-19. Accessed April 3, 2020.
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