Hormone pellet safety data ‘not very reassuring at all’ for women

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Changed
Tue, 06/22/2021 - 11:22

 

Women who receive pellet hormonal therapy may be significantly more likely to have side effects such as mood swings, anxiety, breast tenderness, hair pattern change, acne, and weight gain, compared with women who receive hormonal treatments that have been approved by the Food and Drug Administration, a study indicates.

Dr. Robert P. Kauffman is a professor of obstetrics and gynecology at Texas Tech University School of Medicine in Amarillo
Dr. Robert P. Kauffman

In addition, abnormal uterine bleeding may be significantly more common in women who receive pellets than it is in women who receive Food and Drug Administration–approved options, according to the retrospective study, which was published online in Menopause.

Women receiving pellets also were more likely to undergo hysterectomy while on hormonal therapy, and they had higher supraphysiological levels of estradiol and total testosterone during treatment, compared with women on conventional therapy, the study of 539 women shows.

The findings, which had been presented at the North American Menopause Society annual meeting, were highlighted during a lecture at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

The data are “not very reassuring at all,” said Robert P. Kauffman, MD, a professor of obstetrics and gynecology at Texas Tech University, Amarillo, who was not involved in the study.

Dr. Kauffman commented on the research during a review of concerns surrounding non–FDA-approved hormone replacement therapies at the ACOG meeting. Concerns include variations in compounded products, a lack of randomized, controlled trial data supporting their use, and ethical dilemmas that may exist if clinicians have financial incentives to provide compounded bioidentical hormone therapy over FDA-approved treatments.

No peer-reviewed studies show that compounded hormone creams or pellets are safer, more efficacious, or less likely to cause adverse effects, compared with FDA-approved products, Dr. Kauffman said.
 

Data from Pennsylvania

For the retrospective study, Xuezhi (Daniel) Jiang, MD, PhD, and colleagues identified postmenopausal patients in the Reading Hospital Electronic Medical Record System, including 10,801 on FDA-approved hormonal therapy and 1,061 on pellet hormonal therapy. Their analysis focused on data from the medical records of 384 women on pellet hormonal therapy and 155 women on FDA-approved hormonal therapy. Dr. Jiang is affiliated with the department of obstetrics and gynecology at Reading (Pa.) Hospital and Sidney Kimmel Medical College, Philadelphia.

Dr. Xuezhi Jiang is affiliated with the dept of ob/gyn of Reading Hospital in Reading, Penn. and Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia
Dr. Xuezhi Jiang

The researchers examined data from 2005 to 2017 for patients in the pellet therapy group, and from 1985 to 2017 for patients in the conventional therapy group.

Patients in the conventional therapy group received 24 brands of FDA-approved hormone products; 4.5% received testosterone or methyltestosterone in addition to estrogen. Patients in the pellet therapy group had pellets prescribed by clinicians at two private practices in the hospital system that use this treatment approach. Patients in the pellet group received compounded estradiol and testosterone pellets made at a pharmacy in Tennessee.* Almost all of the patients in the pellet group received testosterone and estradiol pellets.

Low libido was listed as a reason why women started treatment for 83.5% of the pellet group versus 4.5% of the conventional therapy group.

In all, 57.6% of patients on pellet therapy had side effects, versus 14.8% on FDA-approved therapy, the researchers found. Patients on pellet hormonal therapy reported higher incidence of mood swings (7% vs. 1.9%), anxiety (18.5% vs. 5.8%), breast tenderness (10.1% vs. 2.6%), hair pattern change (13.5% vs. 2.6%), acne (8.6% vs. 1.3%), and weight gain (34.4% vs 4.5%), relative to patients on FDA-approved options.

Among those with an intact uterus when starting therapy (246 of those on pellets and 133 of those on FDA-approved treatments), abnormal uterine bleeding occurred in 55.3% on pellets, compared with 15.2% on FDA-approved treatments (adjusted odds ratio, 7.9). Hysterectomy secondary to abnormal uterine bleeding occurred in 20.3% of the patients on pellets versus 6.3% on FDA-approved treatments (aOR, 3.2).

In many cases, records show that patients chose to have a hysterectomy so they could continue pellet therapy without worrying about abnormal uterine bleeding, Dr. Jiang said in an interview.

Dr. Kauffman has seen patients on pellet therapy, usually implanted by family physicians, develop postmenopausal bleeding because of high levels of estrogen. “Our experience has been too that, if you have pellets, you are more likely to get a hysterectomy for bleeding issues. And I think these are the safety issues that need to be looked at on a broader scope,” he said in an interview.

Dr. Sharon Winer is an obstetrician and gynecologist with a subspecialty in reproductive endocrinology and infertility who practices in Beverly Hills, Calif
Dr. Sharon Winer

Although hysterectomy may stop the bleeding, other safety risks may remain with pellet therapy, noted Sharon Winer, MD, MPH, an obstetrician and gynecologist with a subspecialty in reproductive endocrinology and infertility who practices in Beverly Hills, Calif.

Pellets, which are about the size of a grain of rice, typically are implanted in the hip, lower abdomen, or buttock and release hormones over 3-6 months. The pellets are not retrievable. “The question becomes, what if she has a new breast cancer diagnosis or a diagnosis where estrogen is contraindicated? She has got that estrogen already in her system,” Dr. Winer said.

“The hysterectomy may solve the bleeding problem ... but it doesn’t solve the safety problem overall,” said Dr. Winer, who also is a professor of obstetrics and gynecology and codirector of the reproductive endocrinology and infertility clinic at the University of Southern California, Los Angeles.

 

 



Elevated levels

Average peak serum estradiol was significantly higher in the pellet treatment group than in the conventional therapy group (237.70 pg/mL vs. 93.45 pg/mL), as was average peak serum testosterone (192.84 ng/dL vs. 15.59 ng/dL), the researchers reported. Patients on FDA-approved treatments were less likely to have had their hormone levels measured. How concentrations of hormone levels correlate with side effects is unclear, Dr. Jiang said.

The study was limited by its single-institution, retrospective design, and some patient characteristics differed between the treatment groups, the authors noted.

Still, “clinicians ought to be mindful of fully counseling patients on side effects identified in the current study,” Dr. Jiang and coauthors concluded. Clinicians also need to discuss potential risks of breast cancer, endometrial cancer, and cardiovascular disease with patients.

Many primary care clinicians rely on outdated information from the Women’s Health Initiative, published in 2002 and 2004, in their understanding of postmenopausal hormonal therapy and its risks and benefits, Dr. Jiang said. And some patients consider custom-compounded hormone therapy to be safer and more natural, “which is totally misleading.”

Pellets and other custom-compounded medicine containing testosterone may make patients feel better and more energetic, Dr. Jiang acknowledged. “That’s a reason why patients ... tend to stay on, even though they have side effects. The only issue is the safety.”

Additional questions remain. The researchers recently started to examine rates of breast cancer and abnormal breast pathology and mammogram results. “It’s a long journey,” he said.



Plenty of approved options

Custom-compounded medicines are not FDA approved and are not recommended by medical menopause societies, Dr. Jiang said. Meanwhile, plenty of approved hormone therapies, including bioidentical treatments, have safety data and are available.

A 2020 consensus study report from the National Academies of Sciences, Engineering, and Medicine that examined the use of compounded hormonal therapy and provides guidance for clinicians is a good start in addressing this major issue, he added.

A committee determined “there is insufficient evidence to support the overall clinical utility of [compounded bioidentical hormone therapies] as treatment for menopause and male hypogonadism symptoms.”

If an FDA-approved option is available, “I would always go with an FDA-approved product before I would go with a compounded product,” Dr. Winer said. A 2012 fungal meningitis outbreak linked to a compounding pharmacy highlighted risks associated with poor quality compounded drugs.

“I think at least now it is recognized that compounding is an issue that has got to be dealt with,” Dr. Winer said. “It is just that it is so widespread and it is sometimes under the radar ... that I think it is really hard for the FDA to get a handle on it.”

Dr. Winer has seen patients on compounded treatments who are underdosed and patients who are overdosed. “I’ve also seen patients who do quite well with it, but I’m not happy continuing it because tomorrow there may be inconsistency in potency or quality resulting in a different clinical response,” she said.

Nevertheless, compounded pharmacies are needed, Dr. Winer said. If she wants to give natural progesterone that is FDA approved but happens to be made with peanut oil, she will have a compounding pharmacy make it with canola oil instead if a patient has a peanut allergy, for example. Other patients need dosages that are so low that they are not available as FDA-approved products.


Dr. Jiang and Dr. Kauffman had no relevant financial disclosures. Dr. Winer has done work with AbbVie (related to endometriosis), TherapeuticsMD (related to a menopause bioidentical hormonal pill and vaginal estrogen product), and Biogix (related to an antioxidant supplement for menopause symptoms).

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Women who receive pellet hormonal therapy may be significantly more likely to have side effects such as mood swings, anxiety, breast tenderness, hair pattern change, acne, and weight gain, compared with women who receive hormonal treatments that have been approved by the Food and Drug Administration, a study indicates.

Dr. Robert P. Kauffman is a professor of obstetrics and gynecology at Texas Tech University School of Medicine in Amarillo
Dr. Robert P. Kauffman

In addition, abnormal uterine bleeding may be significantly more common in women who receive pellets than it is in women who receive Food and Drug Administration–approved options, according to the retrospective study, which was published online in Menopause.

Women receiving pellets also were more likely to undergo hysterectomy while on hormonal therapy, and they had higher supraphysiological levels of estradiol and total testosterone during treatment, compared with women on conventional therapy, the study of 539 women shows.

The findings, which had been presented at the North American Menopause Society annual meeting, were highlighted during a lecture at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

The data are “not very reassuring at all,” said Robert P. Kauffman, MD, a professor of obstetrics and gynecology at Texas Tech University, Amarillo, who was not involved in the study.

Dr. Kauffman commented on the research during a review of concerns surrounding non–FDA-approved hormone replacement therapies at the ACOG meeting. Concerns include variations in compounded products, a lack of randomized, controlled trial data supporting their use, and ethical dilemmas that may exist if clinicians have financial incentives to provide compounded bioidentical hormone therapy over FDA-approved treatments.

No peer-reviewed studies show that compounded hormone creams or pellets are safer, more efficacious, or less likely to cause adverse effects, compared with FDA-approved products, Dr. Kauffman said.
 

Data from Pennsylvania

For the retrospective study, Xuezhi (Daniel) Jiang, MD, PhD, and colleagues identified postmenopausal patients in the Reading Hospital Electronic Medical Record System, including 10,801 on FDA-approved hormonal therapy and 1,061 on pellet hormonal therapy. Their analysis focused on data from the medical records of 384 women on pellet hormonal therapy and 155 women on FDA-approved hormonal therapy. Dr. Jiang is affiliated with the department of obstetrics and gynecology at Reading (Pa.) Hospital and Sidney Kimmel Medical College, Philadelphia.

Dr. Xuezhi Jiang is affiliated with the dept of ob/gyn of Reading Hospital in Reading, Penn. and Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia
Dr. Xuezhi Jiang

The researchers examined data from 2005 to 2017 for patients in the pellet therapy group, and from 1985 to 2017 for patients in the conventional therapy group.

Patients in the conventional therapy group received 24 brands of FDA-approved hormone products; 4.5% received testosterone or methyltestosterone in addition to estrogen. Patients in the pellet therapy group had pellets prescribed by clinicians at two private practices in the hospital system that use this treatment approach. Patients in the pellet group received compounded estradiol and testosterone pellets made at a pharmacy in Tennessee.* Almost all of the patients in the pellet group received testosterone and estradiol pellets.

Low libido was listed as a reason why women started treatment for 83.5% of the pellet group versus 4.5% of the conventional therapy group.

In all, 57.6% of patients on pellet therapy had side effects, versus 14.8% on FDA-approved therapy, the researchers found. Patients on pellet hormonal therapy reported higher incidence of mood swings (7% vs. 1.9%), anxiety (18.5% vs. 5.8%), breast tenderness (10.1% vs. 2.6%), hair pattern change (13.5% vs. 2.6%), acne (8.6% vs. 1.3%), and weight gain (34.4% vs 4.5%), relative to patients on FDA-approved options.

Among those with an intact uterus when starting therapy (246 of those on pellets and 133 of those on FDA-approved treatments), abnormal uterine bleeding occurred in 55.3% on pellets, compared with 15.2% on FDA-approved treatments (adjusted odds ratio, 7.9). Hysterectomy secondary to abnormal uterine bleeding occurred in 20.3% of the patients on pellets versus 6.3% on FDA-approved treatments (aOR, 3.2).

In many cases, records show that patients chose to have a hysterectomy so they could continue pellet therapy without worrying about abnormal uterine bleeding, Dr. Jiang said in an interview.

Dr. Kauffman has seen patients on pellet therapy, usually implanted by family physicians, develop postmenopausal bleeding because of high levels of estrogen. “Our experience has been too that, if you have pellets, you are more likely to get a hysterectomy for bleeding issues. And I think these are the safety issues that need to be looked at on a broader scope,” he said in an interview.

Dr. Sharon Winer is an obstetrician and gynecologist with a subspecialty in reproductive endocrinology and infertility who practices in Beverly Hills, Calif
Dr. Sharon Winer

Although hysterectomy may stop the bleeding, other safety risks may remain with pellet therapy, noted Sharon Winer, MD, MPH, an obstetrician and gynecologist with a subspecialty in reproductive endocrinology and infertility who practices in Beverly Hills, Calif.

Pellets, which are about the size of a grain of rice, typically are implanted in the hip, lower abdomen, or buttock and release hormones over 3-6 months. The pellets are not retrievable. “The question becomes, what if she has a new breast cancer diagnosis or a diagnosis where estrogen is contraindicated? She has got that estrogen already in her system,” Dr. Winer said.

“The hysterectomy may solve the bleeding problem ... but it doesn’t solve the safety problem overall,” said Dr. Winer, who also is a professor of obstetrics and gynecology and codirector of the reproductive endocrinology and infertility clinic at the University of Southern California, Los Angeles.

 

 



Elevated levels

Average peak serum estradiol was significantly higher in the pellet treatment group than in the conventional therapy group (237.70 pg/mL vs. 93.45 pg/mL), as was average peak serum testosterone (192.84 ng/dL vs. 15.59 ng/dL), the researchers reported. Patients on FDA-approved treatments were less likely to have had their hormone levels measured. How concentrations of hormone levels correlate with side effects is unclear, Dr. Jiang said.

The study was limited by its single-institution, retrospective design, and some patient characteristics differed between the treatment groups, the authors noted.

Still, “clinicians ought to be mindful of fully counseling patients on side effects identified in the current study,” Dr. Jiang and coauthors concluded. Clinicians also need to discuss potential risks of breast cancer, endometrial cancer, and cardiovascular disease with patients.

Many primary care clinicians rely on outdated information from the Women’s Health Initiative, published in 2002 and 2004, in their understanding of postmenopausal hormonal therapy and its risks and benefits, Dr. Jiang said. And some patients consider custom-compounded hormone therapy to be safer and more natural, “which is totally misleading.”

Pellets and other custom-compounded medicine containing testosterone may make patients feel better and more energetic, Dr. Jiang acknowledged. “That’s a reason why patients ... tend to stay on, even though they have side effects. The only issue is the safety.”

Additional questions remain. The researchers recently started to examine rates of breast cancer and abnormal breast pathology and mammogram results. “It’s a long journey,” he said.



Plenty of approved options

Custom-compounded medicines are not FDA approved and are not recommended by medical menopause societies, Dr. Jiang said. Meanwhile, plenty of approved hormone therapies, including bioidentical treatments, have safety data and are available.

A 2020 consensus study report from the National Academies of Sciences, Engineering, and Medicine that examined the use of compounded hormonal therapy and provides guidance for clinicians is a good start in addressing this major issue, he added.

A committee determined “there is insufficient evidence to support the overall clinical utility of [compounded bioidentical hormone therapies] as treatment for menopause and male hypogonadism symptoms.”

If an FDA-approved option is available, “I would always go with an FDA-approved product before I would go with a compounded product,” Dr. Winer said. A 2012 fungal meningitis outbreak linked to a compounding pharmacy highlighted risks associated with poor quality compounded drugs.

“I think at least now it is recognized that compounding is an issue that has got to be dealt with,” Dr. Winer said. “It is just that it is so widespread and it is sometimes under the radar ... that I think it is really hard for the FDA to get a handle on it.”

Dr. Winer has seen patients on compounded treatments who are underdosed and patients who are overdosed. “I’ve also seen patients who do quite well with it, but I’m not happy continuing it because tomorrow there may be inconsistency in potency or quality resulting in a different clinical response,” she said.

Nevertheless, compounded pharmacies are needed, Dr. Winer said. If she wants to give natural progesterone that is FDA approved but happens to be made with peanut oil, she will have a compounding pharmacy make it with canola oil instead if a patient has a peanut allergy, for example. Other patients need dosages that are so low that they are not available as FDA-approved products.


Dr. Jiang and Dr. Kauffman had no relevant financial disclosures. Dr. Winer has done work with AbbVie (related to endometriosis), TherapeuticsMD (related to a menopause bioidentical hormonal pill and vaginal estrogen product), and Biogix (related to an antioxidant supplement for menopause symptoms).

 

Women who receive pellet hormonal therapy may be significantly more likely to have side effects such as mood swings, anxiety, breast tenderness, hair pattern change, acne, and weight gain, compared with women who receive hormonal treatments that have been approved by the Food and Drug Administration, a study indicates.

Dr. Robert P. Kauffman is a professor of obstetrics and gynecology at Texas Tech University School of Medicine in Amarillo
Dr. Robert P. Kauffman

In addition, abnormal uterine bleeding may be significantly more common in women who receive pellets than it is in women who receive Food and Drug Administration–approved options, according to the retrospective study, which was published online in Menopause.

Women receiving pellets also were more likely to undergo hysterectomy while on hormonal therapy, and they had higher supraphysiological levels of estradiol and total testosterone during treatment, compared with women on conventional therapy, the study of 539 women shows.

The findings, which had been presented at the North American Menopause Society annual meeting, were highlighted during a lecture at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

The data are “not very reassuring at all,” said Robert P. Kauffman, MD, a professor of obstetrics and gynecology at Texas Tech University, Amarillo, who was not involved in the study.

Dr. Kauffman commented on the research during a review of concerns surrounding non–FDA-approved hormone replacement therapies at the ACOG meeting. Concerns include variations in compounded products, a lack of randomized, controlled trial data supporting their use, and ethical dilemmas that may exist if clinicians have financial incentives to provide compounded bioidentical hormone therapy over FDA-approved treatments.

No peer-reviewed studies show that compounded hormone creams or pellets are safer, more efficacious, or less likely to cause adverse effects, compared with FDA-approved products, Dr. Kauffman said.
 

Data from Pennsylvania

For the retrospective study, Xuezhi (Daniel) Jiang, MD, PhD, and colleagues identified postmenopausal patients in the Reading Hospital Electronic Medical Record System, including 10,801 on FDA-approved hormonal therapy and 1,061 on pellet hormonal therapy. Their analysis focused on data from the medical records of 384 women on pellet hormonal therapy and 155 women on FDA-approved hormonal therapy. Dr. Jiang is affiliated with the department of obstetrics and gynecology at Reading (Pa.) Hospital and Sidney Kimmel Medical College, Philadelphia.

Dr. Xuezhi Jiang is affiliated with the dept of ob/gyn of Reading Hospital in Reading, Penn. and Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia
Dr. Xuezhi Jiang

The researchers examined data from 2005 to 2017 for patients in the pellet therapy group, and from 1985 to 2017 for patients in the conventional therapy group.

Patients in the conventional therapy group received 24 brands of FDA-approved hormone products; 4.5% received testosterone or methyltestosterone in addition to estrogen. Patients in the pellet therapy group had pellets prescribed by clinicians at two private practices in the hospital system that use this treatment approach. Patients in the pellet group received compounded estradiol and testosterone pellets made at a pharmacy in Tennessee.* Almost all of the patients in the pellet group received testosterone and estradiol pellets.

Low libido was listed as a reason why women started treatment for 83.5% of the pellet group versus 4.5% of the conventional therapy group.

In all, 57.6% of patients on pellet therapy had side effects, versus 14.8% on FDA-approved therapy, the researchers found. Patients on pellet hormonal therapy reported higher incidence of mood swings (7% vs. 1.9%), anxiety (18.5% vs. 5.8%), breast tenderness (10.1% vs. 2.6%), hair pattern change (13.5% vs. 2.6%), acne (8.6% vs. 1.3%), and weight gain (34.4% vs 4.5%), relative to patients on FDA-approved options.

Among those with an intact uterus when starting therapy (246 of those on pellets and 133 of those on FDA-approved treatments), abnormal uterine bleeding occurred in 55.3% on pellets, compared with 15.2% on FDA-approved treatments (adjusted odds ratio, 7.9). Hysterectomy secondary to abnormal uterine bleeding occurred in 20.3% of the patients on pellets versus 6.3% on FDA-approved treatments (aOR, 3.2).

In many cases, records show that patients chose to have a hysterectomy so they could continue pellet therapy without worrying about abnormal uterine bleeding, Dr. Jiang said in an interview.

Dr. Kauffman has seen patients on pellet therapy, usually implanted by family physicians, develop postmenopausal bleeding because of high levels of estrogen. “Our experience has been too that, if you have pellets, you are more likely to get a hysterectomy for bleeding issues. And I think these are the safety issues that need to be looked at on a broader scope,” he said in an interview.

Dr. Sharon Winer is an obstetrician and gynecologist with a subspecialty in reproductive endocrinology and infertility who practices in Beverly Hills, Calif
Dr. Sharon Winer

Although hysterectomy may stop the bleeding, other safety risks may remain with pellet therapy, noted Sharon Winer, MD, MPH, an obstetrician and gynecologist with a subspecialty in reproductive endocrinology and infertility who practices in Beverly Hills, Calif.

Pellets, which are about the size of a grain of rice, typically are implanted in the hip, lower abdomen, or buttock and release hormones over 3-6 months. The pellets are not retrievable. “The question becomes, what if she has a new breast cancer diagnosis or a diagnosis where estrogen is contraindicated? She has got that estrogen already in her system,” Dr. Winer said.

“The hysterectomy may solve the bleeding problem ... but it doesn’t solve the safety problem overall,” said Dr. Winer, who also is a professor of obstetrics and gynecology and codirector of the reproductive endocrinology and infertility clinic at the University of Southern California, Los Angeles.

 

 



Elevated levels

Average peak serum estradiol was significantly higher in the pellet treatment group than in the conventional therapy group (237.70 pg/mL vs. 93.45 pg/mL), as was average peak serum testosterone (192.84 ng/dL vs. 15.59 ng/dL), the researchers reported. Patients on FDA-approved treatments were less likely to have had their hormone levels measured. How concentrations of hormone levels correlate with side effects is unclear, Dr. Jiang said.

The study was limited by its single-institution, retrospective design, and some patient characteristics differed between the treatment groups, the authors noted.

Still, “clinicians ought to be mindful of fully counseling patients on side effects identified in the current study,” Dr. Jiang and coauthors concluded. Clinicians also need to discuss potential risks of breast cancer, endometrial cancer, and cardiovascular disease with patients.

Many primary care clinicians rely on outdated information from the Women’s Health Initiative, published in 2002 and 2004, in their understanding of postmenopausal hormonal therapy and its risks and benefits, Dr. Jiang said. And some patients consider custom-compounded hormone therapy to be safer and more natural, “which is totally misleading.”

Pellets and other custom-compounded medicine containing testosterone may make patients feel better and more energetic, Dr. Jiang acknowledged. “That’s a reason why patients ... tend to stay on, even though they have side effects. The only issue is the safety.”

Additional questions remain. The researchers recently started to examine rates of breast cancer and abnormal breast pathology and mammogram results. “It’s a long journey,” he said.



Plenty of approved options

Custom-compounded medicines are not FDA approved and are not recommended by medical menopause societies, Dr. Jiang said. Meanwhile, plenty of approved hormone therapies, including bioidentical treatments, have safety data and are available.

A 2020 consensus study report from the National Academies of Sciences, Engineering, and Medicine that examined the use of compounded hormonal therapy and provides guidance for clinicians is a good start in addressing this major issue, he added.

A committee determined “there is insufficient evidence to support the overall clinical utility of [compounded bioidentical hormone therapies] as treatment for menopause and male hypogonadism symptoms.”

If an FDA-approved option is available, “I would always go with an FDA-approved product before I would go with a compounded product,” Dr. Winer said. A 2012 fungal meningitis outbreak linked to a compounding pharmacy highlighted risks associated with poor quality compounded drugs.

“I think at least now it is recognized that compounding is an issue that has got to be dealt with,” Dr. Winer said. “It is just that it is so widespread and it is sometimes under the radar ... that I think it is really hard for the FDA to get a handle on it.”

Dr. Winer has seen patients on compounded treatments who are underdosed and patients who are overdosed. “I’ve also seen patients who do quite well with it, but I’m not happy continuing it because tomorrow there may be inconsistency in potency or quality resulting in a different clinical response,” she said.

Nevertheless, compounded pharmacies are needed, Dr. Winer said. If she wants to give natural progesterone that is FDA approved but happens to be made with peanut oil, she will have a compounding pharmacy make it with canola oil instead if a patient has a peanut allergy, for example. Other patients need dosages that are so low that they are not available as FDA-approved products.


Dr. Jiang and Dr. Kauffman had no relevant financial disclosures. Dr. Winer has done work with AbbVie (related to endometriosis), TherapeuticsMD (related to a menopause bioidentical hormonal pill and vaginal estrogen product), and Biogix (related to an antioxidant supplement for menopause symptoms).

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Intersection of trauma and race in pregnancy calls for more study

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Thu, 06/03/2021 - 14:49

 

Black patients experienced more moderate to severe violent trauma during pregnancy than did non-Black patients at a single Baltimore institution, according to a small retrospective cohort study presented in a poster at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“Trauma is the leading nonobstetric cause of death in pregnant women,” and Black communities are at a disproportionately greater risk of trauma, Rebecca H. Jessel, MD, of Icahn School of Medicine at Mount Sinai in New York, and associates wrote in their poster.

The study’s findings raise research questions that need more exploration, according to Neel Shah, MD, assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, and founding director of the Delivery Decisions Initiative at Harvard’s Ariadne Labs.

“This is an interesting study that opens a line of inquiry into how trauma may impact the pregnancies of those who are Black differently,” Dr. Shah, who was not involved in the research, said in an interview. “The observed disparity is consistent with the racial inequities in outcomes we see across obstetric outcomes and requires further research into the causes and solutions.”

The researchers retrospectively reviewed all pregnant patients treated between 2015 and 2018 at the University of Maryland’s R Adams Cowley Shock Trauma Center in Baltimore. In addition to maternal demographics, details about the delivery, and perinatal outcomes, the researchers noted whether the trauma was violent, such as assault, or nonviolent, such as motor vehicle accidents. Moderate to severe trauma was defined as an injury severity score of at least 9.

Among 3,536 women aged 15-49 treated at the shock trauma center, 62 were pregnant, and 71% of these women were Black. Nineteen percent were White patients, 5% were Asian patients, and 5% were of a different race/ethnicity. Black patients were, on average, 27 years old at the time of the trauma. Non-Black patients were, on average, 25 years old. The average gestational age at the time of trauma was 25 weeks, 3 days in Black women and 23 weeks, 4 days in non-Black women.

The most common cause of trauma was a car accident, implicated in 56% of the trauma cases. Assault was the next most common cause of trauma, making up nearly a quarter (23%) of cases. The other injuries came from accidents (16%) or inhalation (5%). The average injury severity score was 4.7, with a mild injury for 76% of patients and a moderate to severe injury in 24%.

The researchers then compared the mechanisms and severity of injuries between Black and non-Black patients. The severity of trauma was similar between the two groups: Seventy-five percent of Black patients and 78% of non-Black patients had mild trauma with injury severity scores below 9. However, assault or another violent form of trauma was more likely to occur to Black patients than to non-Black patients. More than a quarter (27%) of Black patients experienced violent trauma, compared to 11% of non-Black patients.

“It is very notable that among pregnant people who experience trauma, obstetric complications leading to preterm delivery were observed much more often for those who are Black,” Dr. Shah said. “A case series to understand the underlying causes could be very valuable.”

Black patients delivered an average 59 days (8 weeks, 3 days) after the trauma compared to an average 83 days (11 weeks, 6 days) for non-Black patients, but the difference was not statistically significant. However, preterm birth was more likely in non-Black patients (83%) than in Black patients (78%). A similar proportion of deliveries were preterm in Black (57%) and non-Black (56%) patients.

Though the poster did not show the data, the researchers wrote that Black women who experienced moderate to severe trauma after 24 weeks’ gestational age either had a preterm birth or a fetal demise.

Though the study findings warrant deeper investigation, the study has substantial limitations.

“It is challenging to generalize from this study because the sample size is small and it is from a single institution,” Dr. Shah said. “It does not appear to be adequately powered to draw statistically significant conclusions. In particular, the data are not adequate to support the authors’ statement that Black people are more likely to experience the forms of described trauma generally.”

The authors and Dr. Shah reported no disclosures.

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Black patients experienced more moderate to severe violent trauma during pregnancy than did non-Black patients at a single Baltimore institution, according to a small retrospective cohort study presented in a poster at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“Trauma is the leading nonobstetric cause of death in pregnant women,” and Black communities are at a disproportionately greater risk of trauma, Rebecca H. Jessel, MD, of Icahn School of Medicine at Mount Sinai in New York, and associates wrote in their poster.

The study’s findings raise research questions that need more exploration, according to Neel Shah, MD, assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, and founding director of the Delivery Decisions Initiative at Harvard’s Ariadne Labs.

“This is an interesting study that opens a line of inquiry into how trauma may impact the pregnancies of those who are Black differently,” Dr. Shah, who was not involved in the research, said in an interview. “The observed disparity is consistent with the racial inequities in outcomes we see across obstetric outcomes and requires further research into the causes and solutions.”

The researchers retrospectively reviewed all pregnant patients treated between 2015 and 2018 at the University of Maryland’s R Adams Cowley Shock Trauma Center in Baltimore. In addition to maternal demographics, details about the delivery, and perinatal outcomes, the researchers noted whether the trauma was violent, such as assault, or nonviolent, such as motor vehicle accidents. Moderate to severe trauma was defined as an injury severity score of at least 9.

Among 3,536 women aged 15-49 treated at the shock trauma center, 62 were pregnant, and 71% of these women were Black. Nineteen percent were White patients, 5% were Asian patients, and 5% were of a different race/ethnicity. Black patients were, on average, 27 years old at the time of the trauma. Non-Black patients were, on average, 25 years old. The average gestational age at the time of trauma was 25 weeks, 3 days in Black women and 23 weeks, 4 days in non-Black women.

The most common cause of trauma was a car accident, implicated in 56% of the trauma cases. Assault was the next most common cause of trauma, making up nearly a quarter (23%) of cases. The other injuries came from accidents (16%) or inhalation (5%). The average injury severity score was 4.7, with a mild injury for 76% of patients and a moderate to severe injury in 24%.

The researchers then compared the mechanisms and severity of injuries between Black and non-Black patients. The severity of trauma was similar between the two groups: Seventy-five percent of Black patients and 78% of non-Black patients had mild trauma with injury severity scores below 9. However, assault or another violent form of trauma was more likely to occur to Black patients than to non-Black patients. More than a quarter (27%) of Black patients experienced violent trauma, compared to 11% of non-Black patients.

“It is very notable that among pregnant people who experience trauma, obstetric complications leading to preterm delivery were observed much more often for those who are Black,” Dr. Shah said. “A case series to understand the underlying causes could be very valuable.”

Black patients delivered an average 59 days (8 weeks, 3 days) after the trauma compared to an average 83 days (11 weeks, 6 days) for non-Black patients, but the difference was not statistically significant. However, preterm birth was more likely in non-Black patients (83%) than in Black patients (78%). A similar proportion of deliveries were preterm in Black (57%) and non-Black (56%) patients.

Though the poster did not show the data, the researchers wrote that Black women who experienced moderate to severe trauma after 24 weeks’ gestational age either had a preterm birth or a fetal demise.

Though the study findings warrant deeper investigation, the study has substantial limitations.

“It is challenging to generalize from this study because the sample size is small and it is from a single institution,” Dr. Shah said. “It does not appear to be adequately powered to draw statistically significant conclusions. In particular, the data are not adequate to support the authors’ statement that Black people are more likely to experience the forms of described trauma generally.”

The authors and Dr. Shah reported no disclosures.

 

Black patients experienced more moderate to severe violent trauma during pregnancy than did non-Black patients at a single Baltimore institution, according to a small retrospective cohort study presented in a poster at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“Trauma is the leading nonobstetric cause of death in pregnant women,” and Black communities are at a disproportionately greater risk of trauma, Rebecca H. Jessel, MD, of Icahn School of Medicine at Mount Sinai in New York, and associates wrote in their poster.

The study’s findings raise research questions that need more exploration, according to Neel Shah, MD, assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, and founding director of the Delivery Decisions Initiative at Harvard’s Ariadne Labs.

“This is an interesting study that opens a line of inquiry into how trauma may impact the pregnancies of those who are Black differently,” Dr. Shah, who was not involved in the research, said in an interview. “The observed disparity is consistent with the racial inequities in outcomes we see across obstetric outcomes and requires further research into the causes and solutions.”

The researchers retrospectively reviewed all pregnant patients treated between 2015 and 2018 at the University of Maryland’s R Adams Cowley Shock Trauma Center in Baltimore. In addition to maternal demographics, details about the delivery, and perinatal outcomes, the researchers noted whether the trauma was violent, such as assault, or nonviolent, such as motor vehicle accidents. Moderate to severe trauma was defined as an injury severity score of at least 9.

Among 3,536 women aged 15-49 treated at the shock trauma center, 62 were pregnant, and 71% of these women were Black. Nineteen percent were White patients, 5% were Asian patients, and 5% were of a different race/ethnicity. Black patients were, on average, 27 years old at the time of the trauma. Non-Black patients were, on average, 25 years old. The average gestational age at the time of trauma was 25 weeks, 3 days in Black women and 23 weeks, 4 days in non-Black women.

The most common cause of trauma was a car accident, implicated in 56% of the trauma cases. Assault was the next most common cause of trauma, making up nearly a quarter (23%) of cases. The other injuries came from accidents (16%) or inhalation (5%). The average injury severity score was 4.7, with a mild injury for 76% of patients and a moderate to severe injury in 24%.

The researchers then compared the mechanisms and severity of injuries between Black and non-Black patients. The severity of trauma was similar between the two groups: Seventy-five percent of Black patients and 78% of non-Black patients had mild trauma with injury severity scores below 9. However, assault or another violent form of trauma was more likely to occur to Black patients than to non-Black patients. More than a quarter (27%) of Black patients experienced violent trauma, compared to 11% of non-Black patients.

“It is very notable that among pregnant people who experience trauma, obstetric complications leading to preterm delivery were observed much more often for those who are Black,” Dr. Shah said. “A case series to understand the underlying causes could be very valuable.”

Black patients delivered an average 59 days (8 weeks, 3 days) after the trauma compared to an average 83 days (11 weeks, 6 days) for non-Black patients, but the difference was not statistically significant. However, preterm birth was more likely in non-Black patients (83%) than in Black patients (78%). A similar proportion of deliveries were preterm in Black (57%) and non-Black (56%) patients.

Though the poster did not show the data, the researchers wrote that Black women who experienced moderate to severe trauma after 24 weeks’ gestational age either had a preterm birth or a fetal demise.

Though the study findings warrant deeper investigation, the study has substantial limitations.

“It is challenging to generalize from this study because the sample size is small and it is from a single institution,” Dr. Shah said. “It does not appear to be adequately powered to draw statistically significant conclusions. In particular, the data are not adequate to support the authors’ statement that Black people are more likely to experience the forms of described trauma generally.”

The authors and Dr. Shah reported no disclosures.

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Patients and providers alike support virtual prenatal care

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Obstetric patients and clinicians both overwhelmingly reported that telehealth was a safer way to receive ob.gyn. care and improve health care access during the COVID-19 pandemic, according to a survey at a single institution. The findings, from the Vanderbilt University Medical Center in Nashville, Tenn., were presented in a poster at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“The COVID-19 pandemic caused rapid and broad expansion of tele-obstetrics, warranting the need to assess patient and provider experiences and opinions about these services,” Karampreet Kaur, a 4th-year MD candidate at Vanderbilt University, and colleagues wrote in the poster. The group’s findings led them to conclude that virtual choices for prenatal care should be available independent of the pandemic.

Neel Shah, MD, assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, and founding director of the Delivery Decisions Initiative at Harvard’s Ariadne Labs, agreed that the study results supported continuation of telehealth even without COVID-19. Dr. Shah was not involved with the research.

“The fact that telehealth is broadly acceptable is not surprising but the magnitudes are striking,” Dr. Shah said in an interview. “Both providers and patients overwhelmingly see telehealth as a value-added fixture of obstetrical care that should be sustained beyond the pandemic.”

The researchers conducted an online survey of both obstetrical patients who received virtual prenatal care and ob.gyn. department providers, including MDs, DOs, advanced practice providers, genetic counselors, social workers, and registered dietitians.

Just over half (53%) of the 167 patients who completed the survey between June 2020 and April 2021 were between the ages 25 and 34. The remaining patients included 13% between ages 18 and 24 and 35% between ages 35 and 44. Most of these patients (84%) were at home for their telehealth appointment, but 16% were at a clinic for the telehealth appointment.

A quarter of the patients had a telehealth visit with a genetic counselor (26%) while 44% of patients saw an ob generalist and 28% saw a maternal fetal medicine specialist. Only 1% reported a social worker visit.

The majority of patients (75%) reported that they felt personally safer using telehealth rather than an in-person visit, and 18% said they would have forgone care if telehealth were not an option. Similarly, 74% of patients said the virtual care reduced their travel time, and 46% said they saved at least $35 in transportation, child care, or missed wages. More than half the patients surveyed were satisfied with their telehealth experience and believe Tennessee should have a tele-obstetrics program.

“The fact that a significant number of patients would have forgone care, and that nearly all providers observed improvements in access, makes widespread adoption of telehealth a moral imperative,” Dr. Shah said. “Telehealth and other forms of virtual care require rethinking our standard care models,” he added. “Traditional prenatal care for example is based on a model that is nearly a century old and may not meet the needs of many people. The experimentation with new ways of providing care that the pandemic forced should be an ongoing effort to ensure every person giving birth receives the care they deserve.”

Medical doctors (MD and DO) made up 53% of the 72 providers who completed the survey between June and August 2020, and a little over a third (36%) were advanced practice providers. Nearly all the providers (more than 95%) agreed with the statement that “telehealth was safer than in-clinic appointments for themselves, colleagues, and obstetrical patients.” Similar majorities felt telehealth was an acceptable way to provide health care (94%) and that virtual care improved access to health care (96%).

Most of the providers (85%) also felt that telehealth provided an opportunity for high-quality communication with their patients. More than half the providers said they would be willing to use telehealth outside of the pandemic, and a similar proportion felt that “Vanderbilt telehealth is a positive program for the state of Tennessee.”

Though not an author of the study, another Vanderbilt ob.gyn. also believes the findings support exploring continued telehealth options for the patients and providers interested in it.

“Health care providers and patients alike can attest to the benefits of telehealth utilization, Etoi A. Garrison, MD, PhD, associate professor of maternal-fetal medicine at Vanderbilt University, said in an interview. She was particularly struck by the savings reported by patients. “These costs are difficult to quantify but can have a significant impact on patients’ day-to-day quality of life,” she said.

A limitation of the study is the lack of information on how many were invited to complete it, so it’s not possible to know if the results are representative of the majority of people who used telehealth services, Dr. Garrison added. Dr. Shah agreed but didn’t think that limitation diminished the clinical implications of the study.

“A relatively small number of patients and providers are surveyed over a long period of time in which the context of the pandemic varied significantly,” he said. “Nonetheless, the findings show strong and internally consistent beliefs among those receiving and providing care that telehealth is valuable.”

The authors and Dr. Shah reported no disclosures. Dr. Garrison reported receiving a grant from the Tennessee Maternal Mortality Review committee to create an Unconscious Bias Faculty Train-the-Trainer program.

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Obstetric patients and clinicians both overwhelmingly reported that telehealth was a safer way to receive ob.gyn. care and improve health care access during the COVID-19 pandemic, according to a survey at a single institution. The findings, from the Vanderbilt University Medical Center in Nashville, Tenn., were presented in a poster at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“The COVID-19 pandemic caused rapid and broad expansion of tele-obstetrics, warranting the need to assess patient and provider experiences and opinions about these services,” Karampreet Kaur, a 4th-year MD candidate at Vanderbilt University, and colleagues wrote in the poster. The group’s findings led them to conclude that virtual choices for prenatal care should be available independent of the pandemic.

Neel Shah, MD, assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, and founding director of the Delivery Decisions Initiative at Harvard’s Ariadne Labs, agreed that the study results supported continuation of telehealth even without COVID-19. Dr. Shah was not involved with the research.

“The fact that telehealth is broadly acceptable is not surprising but the magnitudes are striking,” Dr. Shah said in an interview. “Both providers and patients overwhelmingly see telehealth as a value-added fixture of obstetrical care that should be sustained beyond the pandemic.”

The researchers conducted an online survey of both obstetrical patients who received virtual prenatal care and ob.gyn. department providers, including MDs, DOs, advanced practice providers, genetic counselors, social workers, and registered dietitians.

Just over half (53%) of the 167 patients who completed the survey between June 2020 and April 2021 were between the ages 25 and 34. The remaining patients included 13% between ages 18 and 24 and 35% between ages 35 and 44. Most of these patients (84%) were at home for their telehealth appointment, but 16% were at a clinic for the telehealth appointment.

A quarter of the patients had a telehealth visit with a genetic counselor (26%) while 44% of patients saw an ob generalist and 28% saw a maternal fetal medicine specialist. Only 1% reported a social worker visit.

The majority of patients (75%) reported that they felt personally safer using telehealth rather than an in-person visit, and 18% said they would have forgone care if telehealth were not an option. Similarly, 74% of patients said the virtual care reduced their travel time, and 46% said they saved at least $35 in transportation, child care, or missed wages. More than half the patients surveyed were satisfied with their telehealth experience and believe Tennessee should have a tele-obstetrics program.

“The fact that a significant number of patients would have forgone care, and that nearly all providers observed improvements in access, makes widespread adoption of telehealth a moral imperative,” Dr. Shah said. “Telehealth and other forms of virtual care require rethinking our standard care models,” he added. “Traditional prenatal care for example is based on a model that is nearly a century old and may not meet the needs of many people. The experimentation with new ways of providing care that the pandemic forced should be an ongoing effort to ensure every person giving birth receives the care they deserve.”

Medical doctors (MD and DO) made up 53% of the 72 providers who completed the survey between June and August 2020, and a little over a third (36%) were advanced practice providers. Nearly all the providers (more than 95%) agreed with the statement that “telehealth was safer than in-clinic appointments for themselves, colleagues, and obstetrical patients.” Similar majorities felt telehealth was an acceptable way to provide health care (94%) and that virtual care improved access to health care (96%).

Most of the providers (85%) also felt that telehealth provided an opportunity for high-quality communication with their patients. More than half the providers said they would be willing to use telehealth outside of the pandemic, and a similar proportion felt that “Vanderbilt telehealth is a positive program for the state of Tennessee.”

Though not an author of the study, another Vanderbilt ob.gyn. also believes the findings support exploring continued telehealth options for the patients and providers interested in it.

“Health care providers and patients alike can attest to the benefits of telehealth utilization, Etoi A. Garrison, MD, PhD, associate professor of maternal-fetal medicine at Vanderbilt University, said in an interview. She was particularly struck by the savings reported by patients. “These costs are difficult to quantify but can have a significant impact on patients’ day-to-day quality of life,” she said.

A limitation of the study is the lack of information on how many were invited to complete it, so it’s not possible to know if the results are representative of the majority of people who used telehealth services, Dr. Garrison added. Dr. Shah agreed but didn’t think that limitation diminished the clinical implications of the study.

“A relatively small number of patients and providers are surveyed over a long period of time in which the context of the pandemic varied significantly,” he said. “Nonetheless, the findings show strong and internally consistent beliefs among those receiving and providing care that telehealth is valuable.”

The authors and Dr. Shah reported no disclosures. Dr. Garrison reported receiving a grant from the Tennessee Maternal Mortality Review committee to create an Unconscious Bias Faculty Train-the-Trainer program.

 

Obstetric patients and clinicians both overwhelmingly reported that telehealth was a safer way to receive ob.gyn. care and improve health care access during the COVID-19 pandemic, according to a survey at a single institution. The findings, from the Vanderbilt University Medical Center in Nashville, Tenn., were presented in a poster at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“The COVID-19 pandemic caused rapid and broad expansion of tele-obstetrics, warranting the need to assess patient and provider experiences and opinions about these services,” Karampreet Kaur, a 4th-year MD candidate at Vanderbilt University, and colleagues wrote in the poster. The group’s findings led them to conclude that virtual choices for prenatal care should be available independent of the pandemic.

Neel Shah, MD, assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, and founding director of the Delivery Decisions Initiative at Harvard’s Ariadne Labs, agreed that the study results supported continuation of telehealth even without COVID-19. Dr. Shah was not involved with the research.

“The fact that telehealth is broadly acceptable is not surprising but the magnitudes are striking,” Dr. Shah said in an interview. “Both providers and patients overwhelmingly see telehealth as a value-added fixture of obstetrical care that should be sustained beyond the pandemic.”

The researchers conducted an online survey of both obstetrical patients who received virtual prenatal care and ob.gyn. department providers, including MDs, DOs, advanced practice providers, genetic counselors, social workers, and registered dietitians.

Just over half (53%) of the 167 patients who completed the survey between June 2020 and April 2021 were between the ages 25 and 34. The remaining patients included 13% between ages 18 and 24 and 35% between ages 35 and 44. Most of these patients (84%) were at home for their telehealth appointment, but 16% were at a clinic for the telehealth appointment.

A quarter of the patients had a telehealth visit with a genetic counselor (26%) while 44% of patients saw an ob generalist and 28% saw a maternal fetal medicine specialist. Only 1% reported a social worker visit.

The majority of patients (75%) reported that they felt personally safer using telehealth rather than an in-person visit, and 18% said they would have forgone care if telehealth were not an option. Similarly, 74% of patients said the virtual care reduced their travel time, and 46% said they saved at least $35 in transportation, child care, or missed wages. More than half the patients surveyed were satisfied with their telehealth experience and believe Tennessee should have a tele-obstetrics program.

“The fact that a significant number of patients would have forgone care, and that nearly all providers observed improvements in access, makes widespread adoption of telehealth a moral imperative,” Dr. Shah said. “Telehealth and other forms of virtual care require rethinking our standard care models,” he added. “Traditional prenatal care for example is based on a model that is nearly a century old and may not meet the needs of many people. The experimentation with new ways of providing care that the pandemic forced should be an ongoing effort to ensure every person giving birth receives the care they deserve.”

Medical doctors (MD and DO) made up 53% of the 72 providers who completed the survey between June and August 2020, and a little over a third (36%) were advanced practice providers. Nearly all the providers (more than 95%) agreed with the statement that “telehealth was safer than in-clinic appointments for themselves, colleagues, and obstetrical patients.” Similar majorities felt telehealth was an acceptable way to provide health care (94%) and that virtual care improved access to health care (96%).

Most of the providers (85%) also felt that telehealth provided an opportunity for high-quality communication with their patients. More than half the providers said they would be willing to use telehealth outside of the pandemic, and a similar proportion felt that “Vanderbilt telehealth is a positive program for the state of Tennessee.”

Though not an author of the study, another Vanderbilt ob.gyn. also believes the findings support exploring continued telehealth options for the patients and providers interested in it.

“Health care providers and patients alike can attest to the benefits of telehealth utilization, Etoi A. Garrison, MD, PhD, associate professor of maternal-fetal medicine at Vanderbilt University, said in an interview. She was particularly struck by the savings reported by patients. “These costs are difficult to quantify but can have a significant impact on patients’ day-to-day quality of life,” she said.

A limitation of the study is the lack of information on how many were invited to complete it, so it’s not possible to know if the results are representative of the majority of people who used telehealth services, Dr. Garrison added. Dr. Shah agreed but didn’t think that limitation diminished the clinical implications of the study.

“A relatively small number of patients and providers are surveyed over a long period of time in which the context of the pandemic varied significantly,” he said. “Nonetheless, the findings show strong and internally consistent beliefs among those receiving and providing care that telehealth is valuable.”

The authors and Dr. Shah reported no disclosures. Dr. Garrison reported receiving a grant from the Tennessee Maternal Mortality Review committee to create an Unconscious Bias Faculty Train-the-Trainer program.

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Language barrier may contribute to ob.gyn. pain management disparities

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Thu, 06/03/2021 - 10:15

 

Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m2, across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

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Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m2, across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

 

Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m2, across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

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Addressing today’s racial health inequities requires understanding their roots

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The health disparities seen in today’s high rates of Black infant and maternal morbidity and mortality are rooted in health inequities and generational stress dating back centuries in the United States, but today’s obstetricians can make changes in their own practices to address this inequity, according to Haywood L. Brown, MD, professor of ob.gyn. and associate dean of diversity at the Morsani College of Medicine and vice president of institutional equity at the University of South Florida, Tampa.

Dr. Brown delivered his remarks during the Benson and Pamela Harer Seminar on History at the annual meeting of the American College of Obstetricians and Gynecologists on May 2. His talk focused on the origins of perinatal and maternal health inequities and how those original factors play out today in increased maternal and neonatal morbidity and mortality among Black women and their babies.

“Racial and ethnic disparities and inequity in maternal and child health are prevalent and persistent. We have to move beyond the documentation,” Dr. Brown told attendees. “We have to adopt uniform care standards, recognizing our own biases and understanding that the contribution of social determinants of health are important in the care and outcome of women. And we have to work on decreasing the stress of women who give birth.”

Dr. Evelyn Nicole Mitchell is the faculty chair of OB/GYN Diversity &amp; Inclusion Committee at the University of Southern California, Los Angeles
Dr. Evelyn Nicole Mitchell

Evelyn Nicole Mitchell, MD, faculty chair of the ob.gyn. diversity and inclusion committee at the University of Southern California, found Dr. Brown’s talk compelling and hopes it opens the eyes of others who attended.

“You really have to understand the why behind the problems we have, and it really goes back to slavery and this historical distrust that’s been here from the beginning,” Dr. Mitchell said in an interview. “I hope this allows people to open their eyes and think about this situation from their patients’ shoes, to really put their guard down and explore, ‘how can I contribute to fixing this system that has been here from the beginning?’ I think a lot of people get defensive and think: ‘Oh, I’m not a racist. I just don’t want to talk about this,’ but it’s about a system being racist.” The question then, Dr. Mitchell said, is: “So how do I contribute to that system?”

Dr. Brown frequently returned to the theme of high stress levels in Black mothers contributing to poorer outcomes, such as preterm birth. That stress arises originally from the generational stress brought on by racism and oppression over the centuries but has been compounded by poverty, racial injustice, lack of access to adequate nutrition, lower education levels, environmental factors, and other determinants of health.

“The bottom line, as Dr. Brown said, is that we need to decrease the stress level of Black mothers giving birth,” Dr. Mitchell said. “How can I, as a provider, decrease the stress level of my patients? Well, No. 1, I can identify and eliminate implicit bias that I may harbor.”
 

 

 

Slavery husbandry laid the groundwork for today

The most surprising aspect of Dr. Brown’s lecture for Dr. Mitchell was the fact that enslaved women received a measure of protection that other enslaved people did not to “ensure that they were healthy and that they were able to reproduce in the future,” Dr. Mitchell said. “It was for the wrong reasons – to keep slavery going – but in a sense they were prioritizing Black women to take advantage of their reproductive capacity, compared to nowadays where Black women are facing severe disparities.”

To safeguard enslaved women’s fecundity, plantation owners attempted to reduce stressors in the women’s lives, such as allowing them to cohabitate with a husband and nuclear family, though sexual assault and abuse still occurred. The owners also tracked the enslaved girls’ menstrual cycles after menarche to maximize their “breeding” potential, especially between the ages of 15 and 24. Slave owners delegated older enslaved women as maternity caregivers and midwives, leading to the passing down of midwifery skills through generations of Black American women.

“Pregnant women received the best medical care on the plantation because of the premium placed on reproduction,” Dr. Brown said. Wealthier planters called in doctors for complicated deliveries, which provided J. Marian Sims the ability conduct surgical experiments on Betsey, Lucy, and Anarcha to treat vesicovaginal fistula since fistula “limited her ability to do the maximum work she could in the house or on the plantation,” Dr. Brown said.

After slavery ended, health care access did not improve for Black people. In 1920, there was approximately 1 Black physician for every 3,000 Black people, compared with 1 in 500 for the White population, and grannie midwives continued to be the primary birthing attendants for Black women. Over the next several decades, however, both maternal and infant mortality across all races began steeply dropping. Reasons for the drop included the incorporation of the American Board of Obstetrics and Gynecology in 1930, a shift from home births to hospital births, and the legalization of abortion, which led to an 89% decline in deaths from septic illegal abortions from 1950 to 1973.

Still, Black maternal and infant mortality remained higher than White, and the poverty gap further exacerbated outcomes.

“Substandard maternity care really is the origin of many of the Black maternal and infant morbidity and mortality” complications, such as low birth weight, small for gestational age, growth restriction, and intrauterine starvation, “which we now believe are the origin of things like hypertension, diabetes, and obesity,” Dr. Brown said.

Today, inequities persist because of the systemic racism throughout this history.

“As we talk about health disparities, prematurity, growth restriction, and maternal morbidity, the fetal origins for adult disease in diabetes and hypertension and obesity have generational implications over the last 400 years,” Dr. Brown said. “Generational stress and stresses in lack women from slavery to present times are some of the origins of the things that we see today, including segregation, economic inequities, eugenic sterilizations, the quality of education, and of course, systemic racism on health care access and quality.”

It is this long arc of history that Dr. Mitchell hopes attendees will begin to grasp.

“If you don’t understand all that and have that depth, there’s no way for you to truly understand the problems that are going on and how to solve them,” Dr. Mitchell said. She hopes that especially those who have been more “resistant to accepting these truths” can start to see the big picture. “Hopefully, they can look at it as a systemic problem and then focus on how they can change the system.”

Dr Brown is a contributor to UpToDate and the Merck Manual and serves on the advisory boards of Merck for Mothers Global Women’s Health and BabyScripts. Dr. Mitchell has no disclosures.

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The health disparities seen in today’s high rates of Black infant and maternal morbidity and mortality are rooted in health inequities and generational stress dating back centuries in the United States, but today’s obstetricians can make changes in their own practices to address this inequity, according to Haywood L. Brown, MD, professor of ob.gyn. and associate dean of diversity at the Morsani College of Medicine and vice president of institutional equity at the University of South Florida, Tampa.

Dr. Brown delivered his remarks during the Benson and Pamela Harer Seminar on History at the annual meeting of the American College of Obstetricians and Gynecologists on May 2. His talk focused on the origins of perinatal and maternal health inequities and how those original factors play out today in increased maternal and neonatal morbidity and mortality among Black women and their babies.

“Racial and ethnic disparities and inequity in maternal and child health are prevalent and persistent. We have to move beyond the documentation,” Dr. Brown told attendees. “We have to adopt uniform care standards, recognizing our own biases and understanding that the contribution of social determinants of health are important in the care and outcome of women. And we have to work on decreasing the stress of women who give birth.”

Dr. Evelyn Nicole Mitchell is the faculty chair of OB/GYN Diversity &amp; Inclusion Committee at the University of Southern California, Los Angeles
Dr. Evelyn Nicole Mitchell

Evelyn Nicole Mitchell, MD, faculty chair of the ob.gyn. diversity and inclusion committee at the University of Southern California, found Dr. Brown’s talk compelling and hopes it opens the eyes of others who attended.

“You really have to understand the why behind the problems we have, and it really goes back to slavery and this historical distrust that’s been here from the beginning,” Dr. Mitchell said in an interview. “I hope this allows people to open their eyes and think about this situation from their patients’ shoes, to really put their guard down and explore, ‘how can I contribute to fixing this system that has been here from the beginning?’ I think a lot of people get defensive and think: ‘Oh, I’m not a racist. I just don’t want to talk about this,’ but it’s about a system being racist.” The question then, Dr. Mitchell said, is: “So how do I contribute to that system?”

Dr. Brown frequently returned to the theme of high stress levels in Black mothers contributing to poorer outcomes, such as preterm birth. That stress arises originally from the generational stress brought on by racism and oppression over the centuries but has been compounded by poverty, racial injustice, lack of access to adequate nutrition, lower education levels, environmental factors, and other determinants of health.

“The bottom line, as Dr. Brown said, is that we need to decrease the stress level of Black mothers giving birth,” Dr. Mitchell said. “How can I, as a provider, decrease the stress level of my patients? Well, No. 1, I can identify and eliminate implicit bias that I may harbor.”
 

 

 

Slavery husbandry laid the groundwork for today

The most surprising aspect of Dr. Brown’s lecture for Dr. Mitchell was the fact that enslaved women received a measure of protection that other enslaved people did not to “ensure that they were healthy and that they were able to reproduce in the future,” Dr. Mitchell said. “It was for the wrong reasons – to keep slavery going – but in a sense they were prioritizing Black women to take advantage of their reproductive capacity, compared to nowadays where Black women are facing severe disparities.”

To safeguard enslaved women’s fecundity, plantation owners attempted to reduce stressors in the women’s lives, such as allowing them to cohabitate with a husband and nuclear family, though sexual assault and abuse still occurred. The owners also tracked the enslaved girls’ menstrual cycles after menarche to maximize their “breeding” potential, especially between the ages of 15 and 24. Slave owners delegated older enslaved women as maternity caregivers and midwives, leading to the passing down of midwifery skills through generations of Black American women.

“Pregnant women received the best medical care on the plantation because of the premium placed on reproduction,” Dr. Brown said. Wealthier planters called in doctors for complicated deliveries, which provided J. Marian Sims the ability conduct surgical experiments on Betsey, Lucy, and Anarcha to treat vesicovaginal fistula since fistula “limited her ability to do the maximum work she could in the house or on the plantation,” Dr. Brown said.

After slavery ended, health care access did not improve for Black people. In 1920, there was approximately 1 Black physician for every 3,000 Black people, compared with 1 in 500 for the White population, and grannie midwives continued to be the primary birthing attendants for Black women. Over the next several decades, however, both maternal and infant mortality across all races began steeply dropping. Reasons for the drop included the incorporation of the American Board of Obstetrics and Gynecology in 1930, a shift from home births to hospital births, and the legalization of abortion, which led to an 89% decline in deaths from septic illegal abortions from 1950 to 1973.

Still, Black maternal and infant mortality remained higher than White, and the poverty gap further exacerbated outcomes.

“Substandard maternity care really is the origin of many of the Black maternal and infant morbidity and mortality” complications, such as low birth weight, small for gestational age, growth restriction, and intrauterine starvation, “which we now believe are the origin of things like hypertension, diabetes, and obesity,” Dr. Brown said.

Today, inequities persist because of the systemic racism throughout this history.

“As we talk about health disparities, prematurity, growth restriction, and maternal morbidity, the fetal origins for adult disease in diabetes and hypertension and obesity have generational implications over the last 400 years,” Dr. Brown said. “Generational stress and stresses in lack women from slavery to present times are some of the origins of the things that we see today, including segregation, economic inequities, eugenic sterilizations, the quality of education, and of course, systemic racism on health care access and quality.”

It is this long arc of history that Dr. Mitchell hopes attendees will begin to grasp.

“If you don’t understand all that and have that depth, there’s no way for you to truly understand the problems that are going on and how to solve them,” Dr. Mitchell said. She hopes that especially those who have been more “resistant to accepting these truths” can start to see the big picture. “Hopefully, they can look at it as a systemic problem and then focus on how they can change the system.”

Dr Brown is a contributor to UpToDate and the Merck Manual and serves on the advisory boards of Merck for Mothers Global Women’s Health and BabyScripts. Dr. Mitchell has no disclosures.

 

The health disparities seen in today’s high rates of Black infant and maternal morbidity and mortality are rooted in health inequities and generational stress dating back centuries in the United States, but today’s obstetricians can make changes in their own practices to address this inequity, according to Haywood L. Brown, MD, professor of ob.gyn. and associate dean of diversity at the Morsani College of Medicine and vice president of institutional equity at the University of South Florida, Tampa.

Dr. Brown delivered his remarks during the Benson and Pamela Harer Seminar on History at the annual meeting of the American College of Obstetricians and Gynecologists on May 2. His talk focused on the origins of perinatal and maternal health inequities and how those original factors play out today in increased maternal and neonatal morbidity and mortality among Black women and their babies.

“Racial and ethnic disparities and inequity in maternal and child health are prevalent and persistent. We have to move beyond the documentation,” Dr. Brown told attendees. “We have to adopt uniform care standards, recognizing our own biases and understanding that the contribution of social determinants of health are important in the care and outcome of women. And we have to work on decreasing the stress of women who give birth.”

Dr. Evelyn Nicole Mitchell is the faculty chair of OB/GYN Diversity &amp; Inclusion Committee at the University of Southern California, Los Angeles
Dr. Evelyn Nicole Mitchell

Evelyn Nicole Mitchell, MD, faculty chair of the ob.gyn. diversity and inclusion committee at the University of Southern California, found Dr. Brown’s talk compelling and hopes it opens the eyes of others who attended.

“You really have to understand the why behind the problems we have, and it really goes back to slavery and this historical distrust that’s been here from the beginning,” Dr. Mitchell said in an interview. “I hope this allows people to open their eyes and think about this situation from their patients’ shoes, to really put their guard down and explore, ‘how can I contribute to fixing this system that has been here from the beginning?’ I think a lot of people get defensive and think: ‘Oh, I’m not a racist. I just don’t want to talk about this,’ but it’s about a system being racist.” The question then, Dr. Mitchell said, is: “So how do I contribute to that system?”

Dr. Brown frequently returned to the theme of high stress levels in Black mothers contributing to poorer outcomes, such as preterm birth. That stress arises originally from the generational stress brought on by racism and oppression over the centuries but has been compounded by poverty, racial injustice, lack of access to adequate nutrition, lower education levels, environmental factors, and other determinants of health.

“The bottom line, as Dr. Brown said, is that we need to decrease the stress level of Black mothers giving birth,” Dr. Mitchell said. “How can I, as a provider, decrease the stress level of my patients? Well, No. 1, I can identify and eliminate implicit bias that I may harbor.”
 

 

 

Slavery husbandry laid the groundwork for today

The most surprising aspect of Dr. Brown’s lecture for Dr. Mitchell was the fact that enslaved women received a measure of protection that other enslaved people did not to “ensure that they were healthy and that they were able to reproduce in the future,” Dr. Mitchell said. “It was for the wrong reasons – to keep slavery going – but in a sense they were prioritizing Black women to take advantage of their reproductive capacity, compared to nowadays where Black women are facing severe disparities.”

To safeguard enslaved women’s fecundity, plantation owners attempted to reduce stressors in the women’s lives, such as allowing them to cohabitate with a husband and nuclear family, though sexual assault and abuse still occurred. The owners also tracked the enslaved girls’ menstrual cycles after menarche to maximize their “breeding” potential, especially between the ages of 15 and 24. Slave owners delegated older enslaved women as maternity caregivers and midwives, leading to the passing down of midwifery skills through generations of Black American women.

“Pregnant women received the best medical care on the plantation because of the premium placed on reproduction,” Dr. Brown said. Wealthier planters called in doctors for complicated deliveries, which provided J. Marian Sims the ability conduct surgical experiments on Betsey, Lucy, and Anarcha to treat vesicovaginal fistula since fistula “limited her ability to do the maximum work she could in the house or on the plantation,” Dr. Brown said.

After slavery ended, health care access did not improve for Black people. In 1920, there was approximately 1 Black physician for every 3,000 Black people, compared with 1 in 500 for the White population, and grannie midwives continued to be the primary birthing attendants for Black women. Over the next several decades, however, both maternal and infant mortality across all races began steeply dropping. Reasons for the drop included the incorporation of the American Board of Obstetrics and Gynecology in 1930, a shift from home births to hospital births, and the legalization of abortion, which led to an 89% decline in deaths from septic illegal abortions from 1950 to 1973.

Still, Black maternal and infant mortality remained higher than White, and the poverty gap further exacerbated outcomes.

“Substandard maternity care really is the origin of many of the Black maternal and infant morbidity and mortality” complications, such as low birth weight, small for gestational age, growth restriction, and intrauterine starvation, “which we now believe are the origin of things like hypertension, diabetes, and obesity,” Dr. Brown said.

Today, inequities persist because of the systemic racism throughout this history.

“As we talk about health disparities, prematurity, growth restriction, and maternal morbidity, the fetal origins for adult disease in diabetes and hypertension and obesity have generational implications over the last 400 years,” Dr. Brown said. “Generational stress and stresses in lack women from slavery to present times are some of the origins of the things that we see today, including segregation, economic inequities, eugenic sterilizations, the quality of education, and of course, systemic racism on health care access and quality.”

It is this long arc of history that Dr. Mitchell hopes attendees will begin to grasp.

“If you don’t understand all that and have that depth, there’s no way for you to truly understand the problems that are going on and how to solve them,” Dr. Mitchell said. She hopes that especially those who have been more “resistant to accepting these truths” can start to see the big picture. “Hopefully, they can look at it as a systemic problem and then focus on how they can change the system.”

Dr Brown is a contributor to UpToDate and the Merck Manual and serves on the advisory boards of Merck for Mothers Global Women’s Health and BabyScripts. Dr. Mitchell has no disclosures.

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Lesions in pelvis may be ‘tip of the iceberg’ in endometriosis

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Tue, 05/18/2021 - 14:42

Recognizing the systemic effects of endometriosis may help doctors better understand the experiences of patients with the disease and guide the approach to diagnosis and treatment, according to the president of the American Society for Reproductive Medicine (ASRM).

Dr. Hugh S. Taylor, Yale University, New Haven, Conn.
Dr. Hugh S. Taylor

Beyond lesions in the pelvis, endometriosis may underlie a range of co-occurring conditions, such as generalized inflammation, fatigue, bowel or bladder dysfunction, depression, and anxiety, Hugh S. Taylor, MD, said at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Its systemic manifestations may explain why women with endometriosis tend to have a lower body mass index, compared with women without the disease, Dr. Taylor said.

“Stem cells, microRNAs, and generalized inflammation are some of the mechanisms that mediate these long-range effects on distant organ systems,” he said.

Studies have indicated that lesions in the pelvis do not fully explain the disease, and investigators continue to elucidate how “endometriosis that we see in the pelvis is really just the tip of the iceberg,” said Dr. Taylor, chair of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn.

Pain, including dysmenorrhea, pelvic pain, and dyspareunia, “can be just as bad with ... stage 1 disease as it can be with stage 4 disease,” he said.

Some patients may not have pain, but have infertility. Other women are asymptomatic, and doctors find endometriosis incidentally.

One common definition of endometriosis – ectopic endometrial glands and stroma predominantly caused by retrograde menstruation – “probably overly simplifies this complex disease,” said Dr. Taylor, who reviewed the current understanding of endometriosis in an article in The Lancet. “The lesions in the pelvis are important. We see them. We treat them. But endometriosis has ... effects throughout the body.”

Dr. Taylor’s research group has shown that stem cells are a potential source of endometriosis. “There are cells from the endometriosis that can be found traveling in the circulation,” but their effects are unclear, he said.

Levels of several microRNAs may be increased or decreased in women with endometriosis, and these altered levels may induce the production of inflammatory cytokines. They also may serve as the basis of a blood test for endometriosis that could be ready for clinical use soon, Dr. Taylor said.

In a mouse model of endometriosis, the disease changes the electrophysiology of the brain and behavior. “We see changes in anxiety induced by endometriosis. We see changes in pain sensitivity induced by endometriosis. And we also see an increase in depression induced by endometriosis in this animal model,” Dr. Taylor said.

Although surgical therapy treats local disease, medical therapy may be needed to treat the systemic manifestations.

During a question-and-answer period after the presentation, Marcelle I. Cedars, MD, asked whether analgesic and hormonal management may be sufficient when a woman has suspected or laparoscopically diagnosed endometriosis and pain is the primary complaint.

“Given the understanding of endometriosis, how would you suggest approaching treatment?” asked Dr. Cedars, president elect of the ASRM and director of the division of reproductive endocrinology and infertility at the University of California, San Francisco.

Analgesic and hormonal therapies remain “the best treatments we have,” Dr. Taylor said. He starts treatment with an oral contraceptive and a nonsteroidal anti-inflammatory medication – “not only for pain relief but to tamp some of the inflammation associated with endometriosis,” he said. If an oral contraceptive does not work, a gonadotropin-releasing hormone antagonist typically is the next step.

Dr. Taylor has disclosed ties to Dot Lab and AbbVie. Dr. Cedars had no disclosures.

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Recognizing the systemic effects of endometriosis may help doctors better understand the experiences of patients with the disease and guide the approach to diagnosis and treatment, according to the president of the American Society for Reproductive Medicine (ASRM).

Dr. Hugh S. Taylor, Yale University, New Haven, Conn.
Dr. Hugh S. Taylor

Beyond lesions in the pelvis, endometriosis may underlie a range of co-occurring conditions, such as generalized inflammation, fatigue, bowel or bladder dysfunction, depression, and anxiety, Hugh S. Taylor, MD, said at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Its systemic manifestations may explain why women with endometriosis tend to have a lower body mass index, compared with women without the disease, Dr. Taylor said.

“Stem cells, microRNAs, and generalized inflammation are some of the mechanisms that mediate these long-range effects on distant organ systems,” he said.

Studies have indicated that lesions in the pelvis do not fully explain the disease, and investigators continue to elucidate how “endometriosis that we see in the pelvis is really just the tip of the iceberg,” said Dr. Taylor, chair of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn.

Pain, including dysmenorrhea, pelvic pain, and dyspareunia, “can be just as bad with ... stage 1 disease as it can be with stage 4 disease,” he said.

Some patients may not have pain, but have infertility. Other women are asymptomatic, and doctors find endometriosis incidentally.

One common definition of endometriosis – ectopic endometrial glands and stroma predominantly caused by retrograde menstruation – “probably overly simplifies this complex disease,” said Dr. Taylor, who reviewed the current understanding of endometriosis in an article in The Lancet. “The lesions in the pelvis are important. We see them. We treat them. But endometriosis has ... effects throughout the body.”

Dr. Taylor’s research group has shown that stem cells are a potential source of endometriosis. “There are cells from the endometriosis that can be found traveling in the circulation,” but their effects are unclear, he said.

Levels of several microRNAs may be increased or decreased in women with endometriosis, and these altered levels may induce the production of inflammatory cytokines. They also may serve as the basis of a blood test for endometriosis that could be ready for clinical use soon, Dr. Taylor said.

In a mouse model of endometriosis, the disease changes the electrophysiology of the brain and behavior. “We see changes in anxiety induced by endometriosis. We see changes in pain sensitivity induced by endometriosis. And we also see an increase in depression induced by endometriosis in this animal model,” Dr. Taylor said.

Although surgical therapy treats local disease, medical therapy may be needed to treat the systemic manifestations.

During a question-and-answer period after the presentation, Marcelle I. Cedars, MD, asked whether analgesic and hormonal management may be sufficient when a woman has suspected or laparoscopically diagnosed endometriosis and pain is the primary complaint.

“Given the understanding of endometriosis, how would you suggest approaching treatment?” asked Dr. Cedars, president elect of the ASRM and director of the division of reproductive endocrinology and infertility at the University of California, San Francisco.

Analgesic and hormonal therapies remain “the best treatments we have,” Dr. Taylor said. He starts treatment with an oral contraceptive and a nonsteroidal anti-inflammatory medication – “not only for pain relief but to tamp some of the inflammation associated with endometriosis,” he said. If an oral contraceptive does not work, a gonadotropin-releasing hormone antagonist typically is the next step.

Dr. Taylor has disclosed ties to Dot Lab and AbbVie. Dr. Cedars had no disclosures.

Recognizing the systemic effects of endometriosis may help doctors better understand the experiences of patients with the disease and guide the approach to diagnosis and treatment, according to the president of the American Society for Reproductive Medicine (ASRM).

Dr. Hugh S. Taylor, Yale University, New Haven, Conn.
Dr. Hugh S. Taylor

Beyond lesions in the pelvis, endometriosis may underlie a range of co-occurring conditions, such as generalized inflammation, fatigue, bowel or bladder dysfunction, depression, and anxiety, Hugh S. Taylor, MD, said at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Its systemic manifestations may explain why women with endometriosis tend to have a lower body mass index, compared with women without the disease, Dr. Taylor said.

“Stem cells, microRNAs, and generalized inflammation are some of the mechanisms that mediate these long-range effects on distant organ systems,” he said.

Studies have indicated that lesions in the pelvis do not fully explain the disease, and investigators continue to elucidate how “endometriosis that we see in the pelvis is really just the tip of the iceberg,” said Dr. Taylor, chair of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn.

Pain, including dysmenorrhea, pelvic pain, and dyspareunia, “can be just as bad with ... stage 1 disease as it can be with stage 4 disease,” he said.

Some patients may not have pain, but have infertility. Other women are asymptomatic, and doctors find endometriosis incidentally.

One common definition of endometriosis – ectopic endometrial glands and stroma predominantly caused by retrograde menstruation – “probably overly simplifies this complex disease,” said Dr. Taylor, who reviewed the current understanding of endometriosis in an article in The Lancet. “The lesions in the pelvis are important. We see them. We treat them. But endometriosis has ... effects throughout the body.”

Dr. Taylor’s research group has shown that stem cells are a potential source of endometriosis. “There are cells from the endometriosis that can be found traveling in the circulation,” but their effects are unclear, he said.

Levels of several microRNAs may be increased or decreased in women with endometriosis, and these altered levels may induce the production of inflammatory cytokines. They also may serve as the basis of a blood test for endometriosis that could be ready for clinical use soon, Dr. Taylor said.

In a mouse model of endometriosis, the disease changes the electrophysiology of the brain and behavior. “We see changes in anxiety induced by endometriosis. We see changes in pain sensitivity induced by endometriosis. And we also see an increase in depression induced by endometriosis in this animal model,” Dr. Taylor said.

Although surgical therapy treats local disease, medical therapy may be needed to treat the systemic manifestations.

During a question-and-answer period after the presentation, Marcelle I. Cedars, MD, asked whether analgesic and hormonal management may be sufficient when a woman has suspected or laparoscopically diagnosed endometriosis and pain is the primary complaint.

“Given the understanding of endometriosis, how would you suggest approaching treatment?” asked Dr. Cedars, president elect of the ASRM and director of the division of reproductive endocrinology and infertility at the University of California, San Francisco.

Analgesic and hormonal therapies remain “the best treatments we have,” Dr. Taylor said. He starts treatment with an oral contraceptive and a nonsteroidal anti-inflammatory medication – “not only for pain relief but to tamp some of the inflammation associated with endometriosis,” he said. If an oral contraceptive does not work, a gonadotropin-releasing hormone antagonist typically is the next step.

Dr. Taylor has disclosed ties to Dot Lab and AbbVie. Dr. Cedars had no disclosures.

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Primary ovarian insufficiency requires long-term management of sequelae

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Tue, 06/08/2021 - 09:00

 

Primary ovarian insufficiency is not your mother’s early menopause, according to Laurie McKenzie, MD, a reproductive endocrinologist and associate professor of ob.gyn. at the University of Texas MD Anderson Cancer Center with a joint appointment at Baylor College of Medicine, both in Houston.

Known previously as primary ovarian failure, the syndrome of primary ovarian insufficiency (POI) no longer refers to a failure in part because of the term’s negative connotations but mostly because it’s not precisely accurate, Dr. McKenzie told attendees at the 2021 annual meeting of the American College of Obstetricians and Gynecologists on May 1.

“Many of these women, especially early on in diagnosis, may be experiencing some intermittent ovarian function, so it may not be a complete failure of the ovaries,” Dr. McKenzie said.

Although the condition is not common, affecting about 1% of the female population, “it’s the kind of thing that when a gynecologist has someone who has this walk into their office, you really need to know how to address it because these women are understandably very distressed.” Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University, Chicago, said in an interview after attending the talk.

Women who develop POI lose ovarian activity before age 40, characterized by menstrual disturbance with raised gonadotropins and low estradiol. Symptoms include the hot flushes and night sweats characteristic of estrogen deficiency as well as vaginal symptoms, including dyspareunia and dryness. Other symptoms can include sleep disturbance, mood changes, poor concentration, stiffness, dry eyes, altered urinary frequency, low libido, and lack of energy.

Dr. McKenzie urged doctors to ask women about their symptoms if they present with amenorrhea because young women with primary amenorrhea rarely experience symptoms at presentation, “implying that these symptoms are due to estrogen withdrawal rather than estrogen deficiency,” she said. Diagnosis involves confirmation of 4-6 months of amenorrhea or oligomenorrhea and two measurements of elevated follicle-stimulating hormone (FSH). Following this work-up, clinicians should seek the cause of the condition.
 

Etiology of POI and associated conditions

A wide range of conditions or genetic factors can cause POI or be more likely in patients with POI, Dr. McKenzie said. Many women diagnosed with POI have chromosomal abnormalities, and there is no cutoff for genetic testing, she said. Most of these genetic causes (94%) are X chromosome abnormalities, including Turners-associated dysmorphic features, gonadal dysgenesis, and FMR1 anomalies. Autosomal gene mutations could also play a role in POI.

Although women with the full FMR1 mutation (Fragile X syndrome) do not have an increased risk of POI, those with the premutation (55-200 repeats) have a 13%-26% increased risk of developing POI, albeit no increased risk of intellectual disability. About 0.8%-7.5% of women with sporadic POI and up to 13% of women with a family history of POI have this genetic anomaly.

Autoimmune conditions may also develop or be related to POI, including hypothyroidism and adrenal insufficiency, Dr. McKenzie said. About 20% of adults with POI will develop hypothyroidism, so testing every 1-2 years is reasonable, though no formal screening guidelines exist. In women whose cause of POI is unknown or in whom you suspect an immune disorder, clinicians may consider screening for 21OH-Ab or adrenocortical antibodies. Patients with a positive 21OH-Ab or adrenocortical antibodies test should be referred to an endocrinologist to test adrenal function and rule out Addison disease.

Though diabetes mellitus has been linked to POI, not enough evidence exists to recommend screening women with POI for diabetes. There’s similarly no indication for infection screening, but infections can cause POI. Mumps oophoritis, for example, accounts for 3%-7% of POI cases. Cancer therapy, including radiotherapy and chemotherapy, and surgical treatment for cancer can result in POI.

“Smoking, alcohol, nutrition, and exposure to endocrine disruptors are implicated as influencing the age of menopause but are not readily diagnosable causes of POI,” Dr. McKenzie said. “Although not proven to cause POI, cigarette smoking is toxic to the ovaries and has been linked to an earlier age at menopause.” Then there are many women whose cause of POI is unknown.

To take all these possibilities into account, Dr. McKenzie described the complete diagnostic work-up recommended by ACOG:

  • Menstrual irregularity for at least 3-4 months
  • Test FSH and estradiol
  • Test hCG, TSH, and prolactin
  • If diagnosis is confirmed, test karyotype, FMR1 premutation, adrenal antibodies, and a pelvic sonogram.

However, she added during the Q&A after her talk, she is not sure why a sonogram is recommended or what additional information it might provide.
 

Long-term consequences of POI

Dr McKenzie noted that one study found a 2-year reduction in life expectancy among women who developed menopause before age 40. The reduced life expectancy linked to untreated POI is primarily caused by cardiovascular disease, she said. Women who undergo menopause aged between 35 and 40 years have a 50% greater risk of death related to ischemic heart disease than those ages 49-51, after adjusting for other comorbidities and confounders.

“Women with primary ovarian insufficiency should be advised on how to reduce cardiovascular risk factors by not smoking, taking regular exercise, and maintaining a healthy weight,” Dr McKenzie said.
 

No interventions have been shown to increase ovarian activity

Though fertility is substantially reduced in women with POI, it may not be completely gone. Several studies have found pregnancy rates ranging from 1.5% to 4.8%, and one study found that 25% of women with idiopathic POI had some evidence of ovarian function. Clinicians should therefore recommend women with POI use contraception if they do not want to conceive. Egg donation is an option for preserving fertility in women with POI but only before POI is solidly established.

“No interventions have been reliably shown to increase ovarian activity and natural conception rates,” Dr. McKenzie said.

For women who survive childhood or adolescent cancer and become pregnant, no evidence has shown an increased risk of congenital anomalies, but risk of low birth weight is elevated in babies whose mothers received anthracyclines. Treatment with anthracyclines and mediastinal radiotherapy have also been linked with cardiomyopathy and heart failure, so an echocardiogram prior to pregnancy is indicated in women with exposure to these or high-dose cyclophosphamide.

Abdominopelvic radiotherapy, however, has been linked to poor uterine function with a greater risk of late miscarriage, prematurity, low birth weight, stillbirth, neonatal hemorrhage, and postpartum hemorrhage.

“Pregnancies in women with Turner syndrome are very high risk and may have a maternal mortality as high as 3.5%,” Dr. McKenzie said, so these pregnancies require involvement of a cardiologist.

Other sequelae of POI can include increased bone resorption, net loss of bone (2%-3% annually soon after menopause) and reduced bone mineral density. Women should be getting 1,000 mg/day of calcium and 800 IU/day of vitamin D, but bone screening remains controversial in the field. Finally, providers should not ignore psychosocial effects of POI, including grief, diminished self esteem, and sadness, even more so, potentially, among adolescents.
 

Treatment of POI

Managing POI involves a two-pronged strategy of providing enough estrogen (estradiol, ethinyl estradiol, or conjugated equine estrogens) to mimic normal physiology and enough progestogen (synthetic or progesterone) to protect the endometrium from the mitogenic effect of estrogen.

The two primary options are hormone therapy and combination oral contraceptives. Hormone therapy might allow ovulation and pregnancy in some women, but combination oral contraceptive may feel less stigmatized in those who are still young, albeit with a potential risk for venous thromboembolism.

Continuous treatment tends to be easier and can involve breakthrough bleeding in younger patients; in postmenopausal women, breast cancer risk is higher but endometrial cancer risk is lower. Cyclic treatment mimics the endometrium’s normal function, resulting in bleeding that may help some women feel more “normal” and aids in knowing about a pregnancy. Those wanting to avoid bleeds and use contraception can use the levonorgestrel IUD off label.

Dr. Streicher said in an interview, “Not only is it critically important to recognize [long-term consequences] in this small group of women, but the lessons learned from young women who go though menopause can absolutely be extrapolated to women who go through menopause at an appropriate time.”

Dr. McKenzie had no disclosures. Dr. Streicher has consulted for Astellas Pharma and Church & Dwight, and she owns investments in InControl Medical and Sermonix Pharmaceutical.

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Primary ovarian insufficiency is not your mother’s early menopause, according to Laurie McKenzie, MD, a reproductive endocrinologist and associate professor of ob.gyn. at the University of Texas MD Anderson Cancer Center with a joint appointment at Baylor College of Medicine, both in Houston.

Known previously as primary ovarian failure, the syndrome of primary ovarian insufficiency (POI) no longer refers to a failure in part because of the term’s negative connotations but mostly because it’s not precisely accurate, Dr. McKenzie told attendees at the 2021 annual meeting of the American College of Obstetricians and Gynecologists on May 1.

“Many of these women, especially early on in diagnosis, may be experiencing some intermittent ovarian function, so it may not be a complete failure of the ovaries,” Dr. McKenzie said.

Although the condition is not common, affecting about 1% of the female population, “it’s the kind of thing that when a gynecologist has someone who has this walk into their office, you really need to know how to address it because these women are understandably very distressed.” Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University, Chicago, said in an interview after attending the talk.

Women who develop POI lose ovarian activity before age 40, characterized by menstrual disturbance with raised gonadotropins and low estradiol. Symptoms include the hot flushes and night sweats characteristic of estrogen deficiency as well as vaginal symptoms, including dyspareunia and dryness. Other symptoms can include sleep disturbance, mood changes, poor concentration, stiffness, dry eyes, altered urinary frequency, low libido, and lack of energy.

Dr. McKenzie urged doctors to ask women about their symptoms if they present with amenorrhea because young women with primary amenorrhea rarely experience symptoms at presentation, “implying that these symptoms are due to estrogen withdrawal rather than estrogen deficiency,” she said. Diagnosis involves confirmation of 4-6 months of amenorrhea or oligomenorrhea and two measurements of elevated follicle-stimulating hormone (FSH). Following this work-up, clinicians should seek the cause of the condition.
 

Etiology of POI and associated conditions

A wide range of conditions or genetic factors can cause POI or be more likely in patients with POI, Dr. McKenzie said. Many women diagnosed with POI have chromosomal abnormalities, and there is no cutoff for genetic testing, she said. Most of these genetic causes (94%) are X chromosome abnormalities, including Turners-associated dysmorphic features, gonadal dysgenesis, and FMR1 anomalies. Autosomal gene mutations could also play a role in POI.

Although women with the full FMR1 mutation (Fragile X syndrome) do not have an increased risk of POI, those with the premutation (55-200 repeats) have a 13%-26% increased risk of developing POI, albeit no increased risk of intellectual disability. About 0.8%-7.5% of women with sporadic POI and up to 13% of women with a family history of POI have this genetic anomaly.

Autoimmune conditions may also develop or be related to POI, including hypothyroidism and adrenal insufficiency, Dr. McKenzie said. About 20% of adults with POI will develop hypothyroidism, so testing every 1-2 years is reasonable, though no formal screening guidelines exist. In women whose cause of POI is unknown or in whom you suspect an immune disorder, clinicians may consider screening for 21OH-Ab or adrenocortical antibodies. Patients with a positive 21OH-Ab or adrenocortical antibodies test should be referred to an endocrinologist to test adrenal function and rule out Addison disease.

Though diabetes mellitus has been linked to POI, not enough evidence exists to recommend screening women with POI for diabetes. There’s similarly no indication for infection screening, but infections can cause POI. Mumps oophoritis, for example, accounts for 3%-7% of POI cases. Cancer therapy, including radiotherapy and chemotherapy, and surgical treatment for cancer can result in POI.

“Smoking, alcohol, nutrition, and exposure to endocrine disruptors are implicated as influencing the age of menopause but are not readily diagnosable causes of POI,” Dr. McKenzie said. “Although not proven to cause POI, cigarette smoking is toxic to the ovaries and has been linked to an earlier age at menopause.” Then there are many women whose cause of POI is unknown.

To take all these possibilities into account, Dr. McKenzie described the complete diagnostic work-up recommended by ACOG:

  • Menstrual irregularity for at least 3-4 months
  • Test FSH and estradiol
  • Test hCG, TSH, and prolactin
  • If diagnosis is confirmed, test karyotype, FMR1 premutation, adrenal antibodies, and a pelvic sonogram.

However, she added during the Q&A after her talk, she is not sure why a sonogram is recommended or what additional information it might provide.
 

Long-term consequences of POI

Dr McKenzie noted that one study found a 2-year reduction in life expectancy among women who developed menopause before age 40. The reduced life expectancy linked to untreated POI is primarily caused by cardiovascular disease, she said. Women who undergo menopause aged between 35 and 40 years have a 50% greater risk of death related to ischemic heart disease than those ages 49-51, after adjusting for other comorbidities and confounders.

“Women with primary ovarian insufficiency should be advised on how to reduce cardiovascular risk factors by not smoking, taking regular exercise, and maintaining a healthy weight,” Dr McKenzie said.
 

No interventions have been shown to increase ovarian activity

Though fertility is substantially reduced in women with POI, it may not be completely gone. Several studies have found pregnancy rates ranging from 1.5% to 4.8%, and one study found that 25% of women with idiopathic POI had some evidence of ovarian function. Clinicians should therefore recommend women with POI use contraception if they do not want to conceive. Egg donation is an option for preserving fertility in women with POI but only before POI is solidly established.

“No interventions have been reliably shown to increase ovarian activity and natural conception rates,” Dr. McKenzie said.

For women who survive childhood or adolescent cancer and become pregnant, no evidence has shown an increased risk of congenital anomalies, but risk of low birth weight is elevated in babies whose mothers received anthracyclines. Treatment with anthracyclines and mediastinal radiotherapy have also been linked with cardiomyopathy and heart failure, so an echocardiogram prior to pregnancy is indicated in women with exposure to these or high-dose cyclophosphamide.

Abdominopelvic radiotherapy, however, has been linked to poor uterine function with a greater risk of late miscarriage, prematurity, low birth weight, stillbirth, neonatal hemorrhage, and postpartum hemorrhage.

“Pregnancies in women with Turner syndrome are very high risk and may have a maternal mortality as high as 3.5%,” Dr. McKenzie said, so these pregnancies require involvement of a cardiologist.

Other sequelae of POI can include increased bone resorption, net loss of bone (2%-3% annually soon after menopause) and reduced bone mineral density. Women should be getting 1,000 mg/day of calcium and 800 IU/day of vitamin D, but bone screening remains controversial in the field. Finally, providers should not ignore psychosocial effects of POI, including grief, diminished self esteem, and sadness, even more so, potentially, among adolescents.
 

Treatment of POI

Managing POI involves a two-pronged strategy of providing enough estrogen (estradiol, ethinyl estradiol, or conjugated equine estrogens) to mimic normal physiology and enough progestogen (synthetic or progesterone) to protect the endometrium from the mitogenic effect of estrogen.

The two primary options are hormone therapy and combination oral contraceptives. Hormone therapy might allow ovulation and pregnancy in some women, but combination oral contraceptive may feel less stigmatized in those who are still young, albeit with a potential risk for venous thromboembolism.

Continuous treatment tends to be easier and can involve breakthrough bleeding in younger patients; in postmenopausal women, breast cancer risk is higher but endometrial cancer risk is lower. Cyclic treatment mimics the endometrium’s normal function, resulting in bleeding that may help some women feel more “normal” and aids in knowing about a pregnancy. Those wanting to avoid bleeds and use contraception can use the levonorgestrel IUD off label.

Dr. Streicher said in an interview, “Not only is it critically important to recognize [long-term consequences] in this small group of women, but the lessons learned from young women who go though menopause can absolutely be extrapolated to women who go through menopause at an appropriate time.”

Dr. McKenzie had no disclosures. Dr. Streicher has consulted for Astellas Pharma and Church & Dwight, and she owns investments in InControl Medical and Sermonix Pharmaceutical.

 

Primary ovarian insufficiency is not your mother’s early menopause, according to Laurie McKenzie, MD, a reproductive endocrinologist and associate professor of ob.gyn. at the University of Texas MD Anderson Cancer Center with a joint appointment at Baylor College of Medicine, both in Houston.

Known previously as primary ovarian failure, the syndrome of primary ovarian insufficiency (POI) no longer refers to a failure in part because of the term’s negative connotations but mostly because it’s not precisely accurate, Dr. McKenzie told attendees at the 2021 annual meeting of the American College of Obstetricians and Gynecologists on May 1.

“Many of these women, especially early on in diagnosis, may be experiencing some intermittent ovarian function, so it may not be a complete failure of the ovaries,” Dr. McKenzie said.

Although the condition is not common, affecting about 1% of the female population, “it’s the kind of thing that when a gynecologist has someone who has this walk into their office, you really need to know how to address it because these women are understandably very distressed.” Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University, Chicago, said in an interview after attending the talk.

Women who develop POI lose ovarian activity before age 40, characterized by menstrual disturbance with raised gonadotropins and low estradiol. Symptoms include the hot flushes and night sweats characteristic of estrogen deficiency as well as vaginal symptoms, including dyspareunia and dryness. Other symptoms can include sleep disturbance, mood changes, poor concentration, stiffness, dry eyes, altered urinary frequency, low libido, and lack of energy.

Dr. McKenzie urged doctors to ask women about their symptoms if they present with amenorrhea because young women with primary amenorrhea rarely experience symptoms at presentation, “implying that these symptoms are due to estrogen withdrawal rather than estrogen deficiency,” she said. Diagnosis involves confirmation of 4-6 months of amenorrhea or oligomenorrhea and two measurements of elevated follicle-stimulating hormone (FSH). Following this work-up, clinicians should seek the cause of the condition.
 

Etiology of POI and associated conditions

A wide range of conditions or genetic factors can cause POI or be more likely in patients with POI, Dr. McKenzie said. Many women diagnosed with POI have chromosomal abnormalities, and there is no cutoff for genetic testing, she said. Most of these genetic causes (94%) are X chromosome abnormalities, including Turners-associated dysmorphic features, gonadal dysgenesis, and FMR1 anomalies. Autosomal gene mutations could also play a role in POI.

Although women with the full FMR1 mutation (Fragile X syndrome) do not have an increased risk of POI, those with the premutation (55-200 repeats) have a 13%-26% increased risk of developing POI, albeit no increased risk of intellectual disability. About 0.8%-7.5% of women with sporadic POI and up to 13% of women with a family history of POI have this genetic anomaly.

Autoimmune conditions may also develop or be related to POI, including hypothyroidism and adrenal insufficiency, Dr. McKenzie said. About 20% of adults with POI will develop hypothyroidism, so testing every 1-2 years is reasonable, though no formal screening guidelines exist. In women whose cause of POI is unknown or in whom you suspect an immune disorder, clinicians may consider screening for 21OH-Ab or adrenocortical antibodies. Patients with a positive 21OH-Ab or adrenocortical antibodies test should be referred to an endocrinologist to test adrenal function and rule out Addison disease.

Though diabetes mellitus has been linked to POI, not enough evidence exists to recommend screening women with POI for diabetes. There’s similarly no indication for infection screening, but infections can cause POI. Mumps oophoritis, for example, accounts for 3%-7% of POI cases. Cancer therapy, including radiotherapy and chemotherapy, and surgical treatment for cancer can result in POI.

“Smoking, alcohol, nutrition, and exposure to endocrine disruptors are implicated as influencing the age of menopause but are not readily diagnosable causes of POI,” Dr. McKenzie said. “Although not proven to cause POI, cigarette smoking is toxic to the ovaries and has been linked to an earlier age at menopause.” Then there are many women whose cause of POI is unknown.

To take all these possibilities into account, Dr. McKenzie described the complete diagnostic work-up recommended by ACOG:

  • Menstrual irregularity for at least 3-4 months
  • Test FSH and estradiol
  • Test hCG, TSH, and prolactin
  • If diagnosis is confirmed, test karyotype, FMR1 premutation, adrenal antibodies, and a pelvic sonogram.

However, she added during the Q&A after her talk, she is not sure why a sonogram is recommended or what additional information it might provide.
 

Long-term consequences of POI

Dr McKenzie noted that one study found a 2-year reduction in life expectancy among women who developed menopause before age 40. The reduced life expectancy linked to untreated POI is primarily caused by cardiovascular disease, she said. Women who undergo menopause aged between 35 and 40 years have a 50% greater risk of death related to ischemic heart disease than those ages 49-51, after adjusting for other comorbidities and confounders.

“Women with primary ovarian insufficiency should be advised on how to reduce cardiovascular risk factors by not smoking, taking regular exercise, and maintaining a healthy weight,” Dr McKenzie said.
 

No interventions have been shown to increase ovarian activity

Though fertility is substantially reduced in women with POI, it may not be completely gone. Several studies have found pregnancy rates ranging from 1.5% to 4.8%, and one study found that 25% of women with idiopathic POI had some evidence of ovarian function. Clinicians should therefore recommend women with POI use contraception if they do not want to conceive. Egg donation is an option for preserving fertility in women with POI but only before POI is solidly established.

“No interventions have been reliably shown to increase ovarian activity and natural conception rates,” Dr. McKenzie said.

For women who survive childhood or adolescent cancer and become pregnant, no evidence has shown an increased risk of congenital anomalies, but risk of low birth weight is elevated in babies whose mothers received anthracyclines. Treatment with anthracyclines and mediastinal radiotherapy have also been linked with cardiomyopathy and heart failure, so an echocardiogram prior to pregnancy is indicated in women with exposure to these or high-dose cyclophosphamide.

Abdominopelvic radiotherapy, however, has been linked to poor uterine function with a greater risk of late miscarriage, prematurity, low birth weight, stillbirth, neonatal hemorrhage, and postpartum hemorrhage.

“Pregnancies in women with Turner syndrome are very high risk and may have a maternal mortality as high as 3.5%,” Dr. McKenzie said, so these pregnancies require involvement of a cardiologist.

Other sequelae of POI can include increased bone resorption, net loss of bone (2%-3% annually soon after menopause) and reduced bone mineral density. Women should be getting 1,000 mg/day of calcium and 800 IU/day of vitamin D, but bone screening remains controversial in the field. Finally, providers should not ignore psychosocial effects of POI, including grief, diminished self esteem, and sadness, even more so, potentially, among adolescents.
 

Treatment of POI

Managing POI involves a two-pronged strategy of providing enough estrogen (estradiol, ethinyl estradiol, or conjugated equine estrogens) to mimic normal physiology and enough progestogen (synthetic or progesterone) to protect the endometrium from the mitogenic effect of estrogen.

The two primary options are hormone therapy and combination oral contraceptives. Hormone therapy might allow ovulation and pregnancy in some women, but combination oral contraceptive may feel less stigmatized in those who are still young, albeit with a potential risk for venous thromboembolism.

Continuous treatment tends to be easier and can involve breakthrough bleeding in younger patients; in postmenopausal women, breast cancer risk is higher but endometrial cancer risk is lower. Cyclic treatment mimics the endometrium’s normal function, resulting in bleeding that may help some women feel more “normal” and aids in knowing about a pregnancy. Those wanting to avoid bleeds and use contraception can use the levonorgestrel IUD off label.

Dr. Streicher said in an interview, “Not only is it critically important to recognize [long-term consequences] in this small group of women, but the lessons learned from young women who go though menopause can absolutely be extrapolated to women who go through menopause at an appropriate time.”

Dr. McKenzie had no disclosures. Dr. Streicher has consulted for Astellas Pharma and Church & Dwight, and she owns investments in InControl Medical and Sermonix Pharmaceutical.

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Self-harm is a leading cause of death for new moms

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Death by self-harm through suicide or overdose is a leading cause of death for women in the first year post partum, data indicate. Many of these deaths may be preventable, said Adrienne Griffen, MPP, executive director of the Maternal Mental Health Leadership Alliance.

Ms. Griffen discussed these findings and ways clinicians may be able to help at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Women “visit a health care provider an average of 25 times during a healthy pregnancy and first year of baby’s life,” she said. “Obstetric and primary care providers who serve pregnant and postpartum women are uniquely positioned to intervene effectively to screen and assess women for mental health disorders.”

To that end, clinicians should discuss mental health “early and often,” Ms. Griffen said.

“Asking about mental health issues and suicide will not cause women to think these thoughts,” she said. “We cannot wait for women to raise their hand and ask for help because by the time they do that, they needed help many weeks ago.”

Obstetric providers can explain to patients that they will check on their mental health every visit, just as they do with their weight and blood pressure, Ms. Griffen said.

For example, a doctor might tell a patient: “Your mental health is just as important as your physical health, and anxiety and depression are the most common complications of pregnancy and childbirth,” Ms. Griffen suggested. “Every time I see you, I’m going to ask you how you are doing, and we’ll do a formal screening assessment periodically over the course of the pregnancy. … Your job is to answer us honestly so that we can connect you with resources as soon as possible to minimize the impact on you and your baby.”

Although the obstetric provider should introduce this topic, a nurse, lactation consultant, or social worker may conduct screenings and help patients who are experiencing distress, she said.

During the past decade, several medical associations have issued new guidance around screening new mothers for anxiety and depression. One recent ACOG committee opinion recommends screening for depression at least once during pregnancy and once post partum, and encourages doctors to initiate medical therapy if possible and provide resources and referrals.

Another committee opinion suggests that doctors should have contact with a patient between 2 and 3 weeks post partum, primarily to assess for mental health.
 

Limited data

In discussing maternal suicide statistics, Ms. Griffen focused on data from Maternal Mortality Review Committees (MMRCs).

Two other sources of data about maternal mortality – the National Vital Statistics System and the Pregnancy Mortality Surveillance System – do not include information about suicide, which may be a reason this cause of death is not discussed more often, Ms. Griffen noted.

MMRCs, on the other hand, include information about suicide and self-harm. About half of the states in the United States have these multidisciplinary committees. Committee members review deaths of all women during pregnancy or within 1 year of pregnancy. Members consider a range of clinical and nonclinical data, including reports from social services and police, to try to understand the circumstances of each death.

A report that examined pregnancy-related deaths using data from 14 U.S. MMRCs between 2008 and 2017 showed that mental health conditions were the leading cause of death for non-Hispanic White women. In all, 34% of pregnancy-related suicide deaths had a documented prior suicide attempt, and the majority of suicides happened in the late postpartum time frame (43-365 days post partum).

Some physicians cite a lack of education, time, reimbursement, or referral resources as barriers to maternal mental health screening and treatment, but there may be useful options available, Ms. Griffen said. Postpartum Support International provides resources for physicians, as well as mothers. The National Curriculum in Reproductive Psychiatry and the Seleni Institute also have educational resources.

Some states have psychiatry access programs, where psychiatrists educate obstetricians, family physicians, and pediatricians about how to assess for and treat maternal mental health issues, Ms. Griffen noted.

Self care, social support, and talk therapy may help patients. “Sometimes medication is needed, but a combination of all of these things … can help women recover from maternal mental health conditions,” Ms. Griffen said.
 

 

 

Need to intervene

Although medical societies have emphasized the importance of maternal mental health screening and treatment in recent years, the risk of self-harm has been a concern for obstetricians and gynecologists long before then, said Marc Alan Landsberg, MD, a member of the meeting’s scientific committee who moderated the session.

“We have been talking about this at ACOG for a long time,” Dr. Landsberg said in an interview.

The presentation highlighted why obstetricians, gynecologists, and other doctors who deliver babies and care for women post partum “have got to screen these people,” he said. The finding that 34% of pregnancy-related suicide deaths had a prior suicide attempt indicates that clinicians may be able to identify these patients, Dr. Landsberg said. Suicide and overdose are leading causes of death in the first year post partum and “probably 100% of these are preventable,” he said.

As a first step, screening may be relatively simple. The Edinburgh Postnatal Depression Scale, highlighted during the talk, is an easy and quick tool to use, Dr. Landsberg said. It contains 10 items and assesses for anxiety and depression. It also specifically asks about suicide.

Ms. Griffen and Dr. Landsberg had no conflicts of interest.

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Death by self-harm through suicide or overdose is a leading cause of death for women in the first year post partum, data indicate. Many of these deaths may be preventable, said Adrienne Griffen, MPP, executive director of the Maternal Mental Health Leadership Alliance.

Ms. Griffen discussed these findings and ways clinicians may be able to help at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Women “visit a health care provider an average of 25 times during a healthy pregnancy and first year of baby’s life,” she said. “Obstetric and primary care providers who serve pregnant and postpartum women are uniquely positioned to intervene effectively to screen and assess women for mental health disorders.”

To that end, clinicians should discuss mental health “early and often,” Ms. Griffen said.

“Asking about mental health issues and suicide will not cause women to think these thoughts,” she said. “We cannot wait for women to raise their hand and ask for help because by the time they do that, they needed help many weeks ago.”

Obstetric providers can explain to patients that they will check on their mental health every visit, just as they do with their weight and blood pressure, Ms. Griffen said.

For example, a doctor might tell a patient: “Your mental health is just as important as your physical health, and anxiety and depression are the most common complications of pregnancy and childbirth,” Ms. Griffen suggested. “Every time I see you, I’m going to ask you how you are doing, and we’ll do a formal screening assessment periodically over the course of the pregnancy. … Your job is to answer us honestly so that we can connect you with resources as soon as possible to minimize the impact on you and your baby.”

Although the obstetric provider should introduce this topic, a nurse, lactation consultant, or social worker may conduct screenings and help patients who are experiencing distress, she said.

During the past decade, several medical associations have issued new guidance around screening new mothers for anxiety and depression. One recent ACOG committee opinion recommends screening for depression at least once during pregnancy and once post partum, and encourages doctors to initiate medical therapy if possible and provide resources and referrals.

Another committee opinion suggests that doctors should have contact with a patient between 2 and 3 weeks post partum, primarily to assess for mental health.
 

Limited data

In discussing maternal suicide statistics, Ms. Griffen focused on data from Maternal Mortality Review Committees (MMRCs).

Two other sources of data about maternal mortality – the National Vital Statistics System and the Pregnancy Mortality Surveillance System – do not include information about suicide, which may be a reason this cause of death is not discussed more often, Ms. Griffen noted.

MMRCs, on the other hand, include information about suicide and self-harm. About half of the states in the United States have these multidisciplinary committees. Committee members review deaths of all women during pregnancy or within 1 year of pregnancy. Members consider a range of clinical and nonclinical data, including reports from social services and police, to try to understand the circumstances of each death.

A report that examined pregnancy-related deaths using data from 14 U.S. MMRCs between 2008 and 2017 showed that mental health conditions were the leading cause of death for non-Hispanic White women. In all, 34% of pregnancy-related suicide deaths had a documented prior suicide attempt, and the majority of suicides happened in the late postpartum time frame (43-365 days post partum).

Some physicians cite a lack of education, time, reimbursement, or referral resources as barriers to maternal mental health screening and treatment, but there may be useful options available, Ms. Griffen said. Postpartum Support International provides resources for physicians, as well as mothers. The National Curriculum in Reproductive Psychiatry and the Seleni Institute also have educational resources.

Some states have psychiatry access programs, where psychiatrists educate obstetricians, family physicians, and pediatricians about how to assess for and treat maternal mental health issues, Ms. Griffen noted.

Self care, social support, and talk therapy may help patients. “Sometimes medication is needed, but a combination of all of these things … can help women recover from maternal mental health conditions,” Ms. Griffen said.
 

 

 

Need to intervene

Although medical societies have emphasized the importance of maternal mental health screening and treatment in recent years, the risk of self-harm has been a concern for obstetricians and gynecologists long before then, said Marc Alan Landsberg, MD, a member of the meeting’s scientific committee who moderated the session.

“We have been talking about this at ACOG for a long time,” Dr. Landsberg said in an interview.

The presentation highlighted why obstetricians, gynecologists, and other doctors who deliver babies and care for women post partum “have got to screen these people,” he said. The finding that 34% of pregnancy-related suicide deaths had a prior suicide attempt indicates that clinicians may be able to identify these patients, Dr. Landsberg said. Suicide and overdose are leading causes of death in the first year post partum and “probably 100% of these are preventable,” he said.

As a first step, screening may be relatively simple. The Edinburgh Postnatal Depression Scale, highlighted during the talk, is an easy and quick tool to use, Dr. Landsberg said. It contains 10 items and assesses for anxiety and depression. It also specifically asks about suicide.

Ms. Griffen and Dr. Landsberg had no conflicts of interest.

 

Death by self-harm through suicide or overdose is a leading cause of death for women in the first year post partum, data indicate. Many of these deaths may be preventable, said Adrienne Griffen, MPP, executive director of the Maternal Mental Health Leadership Alliance.

Ms. Griffen discussed these findings and ways clinicians may be able to help at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Women “visit a health care provider an average of 25 times during a healthy pregnancy and first year of baby’s life,” she said. “Obstetric and primary care providers who serve pregnant and postpartum women are uniquely positioned to intervene effectively to screen and assess women for mental health disorders.”

To that end, clinicians should discuss mental health “early and often,” Ms. Griffen said.

“Asking about mental health issues and suicide will not cause women to think these thoughts,” she said. “We cannot wait for women to raise their hand and ask for help because by the time they do that, they needed help many weeks ago.”

Obstetric providers can explain to patients that they will check on their mental health every visit, just as they do with their weight and blood pressure, Ms. Griffen said.

For example, a doctor might tell a patient: “Your mental health is just as important as your physical health, and anxiety and depression are the most common complications of pregnancy and childbirth,” Ms. Griffen suggested. “Every time I see you, I’m going to ask you how you are doing, and we’ll do a formal screening assessment periodically over the course of the pregnancy. … Your job is to answer us honestly so that we can connect you with resources as soon as possible to minimize the impact on you and your baby.”

Although the obstetric provider should introduce this topic, a nurse, lactation consultant, or social worker may conduct screenings and help patients who are experiencing distress, she said.

During the past decade, several medical associations have issued new guidance around screening new mothers for anxiety and depression. One recent ACOG committee opinion recommends screening for depression at least once during pregnancy and once post partum, and encourages doctors to initiate medical therapy if possible and provide resources and referrals.

Another committee opinion suggests that doctors should have contact with a patient between 2 and 3 weeks post partum, primarily to assess for mental health.
 

Limited data

In discussing maternal suicide statistics, Ms. Griffen focused on data from Maternal Mortality Review Committees (MMRCs).

Two other sources of data about maternal mortality – the National Vital Statistics System and the Pregnancy Mortality Surveillance System – do not include information about suicide, which may be a reason this cause of death is not discussed more often, Ms. Griffen noted.

MMRCs, on the other hand, include information about suicide and self-harm. About half of the states in the United States have these multidisciplinary committees. Committee members review deaths of all women during pregnancy or within 1 year of pregnancy. Members consider a range of clinical and nonclinical data, including reports from social services and police, to try to understand the circumstances of each death.

A report that examined pregnancy-related deaths using data from 14 U.S. MMRCs between 2008 and 2017 showed that mental health conditions were the leading cause of death for non-Hispanic White women. In all, 34% of pregnancy-related suicide deaths had a documented prior suicide attempt, and the majority of suicides happened in the late postpartum time frame (43-365 days post partum).

Some physicians cite a lack of education, time, reimbursement, or referral resources as barriers to maternal mental health screening and treatment, but there may be useful options available, Ms. Griffen said. Postpartum Support International provides resources for physicians, as well as mothers. The National Curriculum in Reproductive Psychiatry and the Seleni Institute also have educational resources.

Some states have psychiatry access programs, where psychiatrists educate obstetricians, family physicians, and pediatricians about how to assess for and treat maternal mental health issues, Ms. Griffen noted.

Self care, social support, and talk therapy may help patients. “Sometimes medication is needed, but a combination of all of these things … can help women recover from maternal mental health conditions,” Ms. Griffen said.
 

 

 

Need to intervene

Although medical societies have emphasized the importance of maternal mental health screening and treatment in recent years, the risk of self-harm has been a concern for obstetricians and gynecologists long before then, said Marc Alan Landsberg, MD, a member of the meeting’s scientific committee who moderated the session.

“We have been talking about this at ACOG for a long time,” Dr. Landsberg said in an interview.

The presentation highlighted why obstetricians, gynecologists, and other doctors who deliver babies and care for women post partum “have got to screen these people,” he said. The finding that 34% of pregnancy-related suicide deaths had a prior suicide attempt indicates that clinicians may be able to identify these patients, Dr. Landsberg said. Suicide and overdose are leading causes of death in the first year post partum and “probably 100% of these are preventable,” he said.

As a first step, screening may be relatively simple. The Edinburgh Postnatal Depression Scale, highlighted during the talk, is an easy and quick tool to use, Dr. Landsberg said. It contains 10 items and assesses for anxiety and depression. It also specifically asks about suicide.

Ms. Griffen and Dr. Landsberg had no conflicts of interest.

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Breast cancer survivors have specific gynecological needs

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Sexual dysfunction is a common problem among breast cancer survivors, but it’s also an issue inadequately addressed by either ob.gyns. or hematologists and oncologists, according to Erin Keyser, MD, the program director of the San Antonio Uniformed Services Health Education Consortium. Dr. Keyser discussed management of sexual dysfunction and a variety of other issues frequently faced by women who have survived breast cancer at the at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“Despite the fact that no specialty is better qualified to render care for this consequence of cancer treatments, many obstetrician-gynecologists feel uncomfortable or ill-equipped to address sexual pain in women affected by cancer,” Dr. Keyser quoted from a 2016 article in Obstetrics & Gynecology about the sexual health of women affected by cancer. As a breast cancer survivor herself, Dr. Keyser said hematologists and oncologists are even less equipped to discuss sexual health, “so oftentimes patients get punted between their hem-onc and their gyn,” with each telling the patient to ask the other specialist.

“There’s plenty of data in chronic health disease that maintaining sexual function for women is an indicator of the overall quality of life and that many women really don’t want to bring this up,” Dr. Keyser told attendees, so the onus is on the ob.gyn. to bring it up.

The effects of breast cancer treatment can impact women’s body image, fertility, menopause, sexual function, osteoporosis, and cardiovascular disease, but the bulk of Dr. Keyser’s talk focused on sexual health and bilateral salpingo-oophorectomy (BSO).

Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University, Chicago, thought Dr. Keyser’s talk was useful for the general gynecologist but had some concerns about a few parts.

“She gave a very thoughtful analysis of whether someone should have their ovaries removed or not in a breast cancer diagnosis, ” Dr. Streicher said in an interview. “I would have liked to hear more about the consequences of an early menopause in women in terms of heart health, bone health, and cognitive function.”

Dr. Keyser noted that her talk pertained mostly to survivors of estrogen receptor (ER)–positive breast cancer since that population tends to struggle most with side effects of treatment. The most common medications used in this population are tamoxifen and aromatase inhibitors – such as anastrazole, letrozole, and exemestane – and these medications can affect management of different concerns.
 

Current guidance on ovarian removal

For women with a BRCA mutation, ACOG clinical guidance already exists regarding BSO. For other women, the complementary TEXT and SOFT trials changed the management of breast cancer treatment in premenopausal women, Dr. Keyser said.

Before these trials, postmenopausal hormone receptor–positive women began aromatase inhibitors and premenopausal HR-positive women began tamoxifen. These trials found that premenopausal women with HR-positive early breast cancer were less likely to experience recurrence when receiving adjuvant treatment with exemestane plus ovarian suppression compared to tamoxifen plus ovarian suppression. Ovarian suppression was achieved by either GnRH agonist injections, surgical removal of the ovaries, or radiation therapy to the ovaries.

The side effects of these treatments included hot flushes (92%), depression (87%), musculoskeletal symptoms (89%), vaginal dryness (52%), decreased libido (45%), dyspareunia (31%), osteoporosis (39%), insomnia (58%), and fatigue (61%). These are all quality of life concerns, Dr. Keyser said, and these findings raise questions about the consequences of long-term ovarian suppression. Findings from the Nurses’ Health Study showed that BSO before age 47.5 years resulted in lower mortality from ovarian cancer and breast cancer but was linked in women under 50 to increased all-cause mortality and mortality from coronary heart disease, lung cancer, and colorectal cancer, compared with ovarian conservation. Further, 74% of women who undergo risk-reducing BSO experience sexual dysfunction.

The bottom line, Dr. Keyser said, is that “premature removal of ovaries is not completely benign.” Her own recommendation is to follow ACOG guidance for women with BRCA mutations and, for women aged under 35 years, use ovarian suppression for 5-10 years, after which ovarian function may resume along with improved quality of life. In women aged over 40, remove ovaries since, after 5-10 years of treatment, there’s likely no benefit of retaining ovaries.
 

 

 

Addressing sexual health

Dyspareunia affects up to 45% of cancer survivors, Dr. Keyser said, and multiple treatment options exist for breast cancer survivors. The therapies she discussed included lubricants, moisturizers, local vaginal estrogen, DHEA, ospemifene, and CO2 laser therapy.

Though Dr. Keyser briefly touched on vaginal lubricants and moisturizers, Dr. Streicher was disappointed that Dr. Keyser did not clearly define and differentiate between lubricants and moisturizers or mention hyaluronic acid products. Dr. Streicher also disagreed with the way Dr. Keyser represented the benefits of coconut oil as a lubricant. “Oils are not condom compatible and are known to potentially increase the risk of infection, and not just from poor handwashing,” Dr. Streicher said.

Small retrospective studies support the safety of topical vaginal estrogen in breast cancer survivors, Dr. Keyser said, and the 10-mcg Vagifem tablet and vaginal estradiol ring appear to have the lowest systemic absorption. ACOG guidance recommends that women taking aromatase inhibitors who don’t respond to nonhormonal approaches may benefit from switching temporarily to tamoxifen with vaginal estrogen and then returning to aromatase inhibitors. However, Dr. Keyser said there’s plenty of data to support using vaginal estrogen in patients taking aromatase inhibitors.

“I do feel that it’s safe for patients, whether they’re on tamoxifen or aromatase inhibitors, to take vaginal estrogen,” Dr. Keyser said. “I usually stick with the estradiol vaginal ring or the estradiol tablet, and I base that on a patient’s comfort with placing and removing a ring.” She also, instead of asking the patient’s hematologist-oncologist, simply notifies them of the treatment since most hematologist-oncologists are less familiar with the data.

Another effective option is vaginal DHEA/prasterone, which can significantly improve sexual desire, arousal, pain, and overall sexual function. Although breast cancer patients were included in early studies on DHEA, Intrarosa manufacturers excluded breast cancer patients in their Food and Drug Administration application, resulting in a package stating that “use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer” and that “Intrarosa has not been studied in women with a history of breast cancer.” While that’s true for Intrarosa specifically, DHEA has been studied in breast cancer patients, Dr. Keyser said, so she expects to see more research in this area.

Ospemifene is another option for improving vulvovaginal atrophy but cannot be taken at the same time as tamoxifen. It has similar chemopreventive effects as tamoxifen in rat studies, but it’s not as effective. It’s a reasonable option in women with refractory genitourinary syndrome of menopause (GSM) who have completed their 5-10 years of adjuvant therapy and have no history of venous thromboembolism.

Dr. Keyser said CO2 laser therapy is still being studied for treating GSM, and current data have shown benefits for dyspareunia and vaginal dryness without documented harms. There have now been randomized, controlled trials; however, since it’s not FDA approved, it’s not covered by insurance and costs approximately $5,000 for three treatments.

Dr. Streicher was glad to see Dr. Keyser’s discussion of the safety and types of local vaginal estrogen, “although she neglected to mention the 4-mcg vaginal suppository, Imvexxy, which has the lowest systemic absorption,” Dr. Streicher said. Dr. Streicher also felt the inclusion of DHEA/prasterone and ospemifene were also important, especially since the latter is “underutilized in breast cancer patients.”

The information provided on CO2 laser therapy, however, was problematic, Dr. Streicher said, given that long-term and randomized, controlled studies have now been published. Dr. Streicher also noted that two of the devices listed on the presentation slide, Thermiva and Voltiva, are radiofrequency, not laser devices.

Aside from these treatment options, the most consistent predictor of satisfying sexual experiences in women with breast cancer is the quality of their relationships, Dr. Keyser said, so couples counseling is recommended, and treatments in general are more effective with regularly sexual activity.

In discussing nonhormonal options for treating vasomotor symptoms, Dr. Keyser recommended venlafaxine, gabapentin, and low-dose paroxetine (though SSRIs and tamoxifen are contraindicated since they may reduce tamoxifen’s efficacy).

These are all off label, Dr. Streicher said it was important to note, and she would have liked to have seen a mention of the development of KNdy neurokinin disrupters along with a more in-depth discussion about which lifestyle modifications and botanicals have been shown in randomized, controlled trials to mitigate vasomotor symptoms.

Dr. Keyser wrapped up with a few additional notes and takeaways:

  • The only safe reversible long-term option for contraception in HR-positive breast cancer survivors is the Paraguard IUD.
  • It’s important to discuss fertility with breast cancer patients and survivors since a majority report unmet needs in this area.
  • Patients taking tamoxifen need to be sure to report any vaginal spotting or bleeding since it increases risk of endometrial cancer in postmenopausal women.
  • Screen for depression and anxiety.
  • Ask women about sexual health and hot flashes.
  • Ensure that they’re getting bone screening.
  • A recommended resource is Living Beyond Breast Cancer.

Dr. Keyser had no disclosures. Dr. Streicher has consulted for Astellas Pharma and Church & Dwight, and she owns investments in InControl Medical and Sermonix Pharmaceuticals.

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Sexual dysfunction is a common problem among breast cancer survivors, but it’s also an issue inadequately addressed by either ob.gyns. or hematologists and oncologists, according to Erin Keyser, MD, the program director of the San Antonio Uniformed Services Health Education Consortium. Dr. Keyser discussed management of sexual dysfunction and a variety of other issues frequently faced by women who have survived breast cancer at the at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“Despite the fact that no specialty is better qualified to render care for this consequence of cancer treatments, many obstetrician-gynecologists feel uncomfortable or ill-equipped to address sexual pain in women affected by cancer,” Dr. Keyser quoted from a 2016 article in Obstetrics & Gynecology about the sexual health of women affected by cancer. As a breast cancer survivor herself, Dr. Keyser said hematologists and oncologists are even less equipped to discuss sexual health, “so oftentimes patients get punted between their hem-onc and their gyn,” with each telling the patient to ask the other specialist.

“There’s plenty of data in chronic health disease that maintaining sexual function for women is an indicator of the overall quality of life and that many women really don’t want to bring this up,” Dr. Keyser told attendees, so the onus is on the ob.gyn. to bring it up.

The effects of breast cancer treatment can impact women’s body image, fertility, menopause, sexual function, osteoporosis, and cardiovascular disease, but the bulk of Dr. Keyser’s talk focused on sexual health and bilateral salpingo-oophorectomy (BSO).

Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University, Chicago, thought Dr. Keyser’s talk was useful for the general gynecologist but had some concerns about a few parts.

“She gave a very thoughtful analysis of whether someone should have their ovaries removed or not in a breast cancer diagnosis, ” Dr. Streicher said in an interview. “I would have liked to hear more about the consequences of an early menopause in women in terms of heart health, bone health, and cognitive function.”

Dr. Keyser noted that her talk pertained mostly to survivors of estrogen receptor (ER)–positive breast cancer since that population tends to struggle most with side effects of treatment. The most common medications used in this population are tamoxifen and aromatase inhibitors – such as anastrazole, letrozole, and exemestane – and these medications can affect management of different concerns.
 

Current guidance on ovarian removal

For women with a BRCA mutation, ACOG clinical guidance already exists regarding BSO. For other women, the complementary TEXT and SOFT trials changed the management of breast cancer treatment in premenopausal women, Dr. Keyser said.

Before these trials, postmenopausal hormone receptor–positive women began aromatase inhibitors and premenopausal HR-positive women began tamoxifen. These trials found that premenopausal women with HR-positive early breast cancer were less likely to experience recurrence when receiving adjuvant treatment with exemestane plus ovarian suppression compared to tamoxifen plus ovarian suppression. Ovarian suppression was achieved by either GnRH agonist injections, surgical removal of the ovaries, or radiation therapy to the ovaries.

The side effects of these treatments included hot flushes (92%), depression (87%), musculoskeletal symptoms (89%), vaginal dryness (52%), decreased libido (45%), dyspareunia (31%), osteoporosis (39%), insomnia (58%), and fatigue (61%). These are all quality of life concerns, Dr. Keyser said, and these findings raise questions about the consequences of long-term ovarian suppression. Findings from the Nurses’ Health Study showed that BSO before age 47.5 years resulted in lower mortality from ovarian cancer and breast cancer but was linked in women under 50 to increased all-cause mortality and mortality from coronary heart disease, lung cancer, and colorectal cancer, compared with ovarian conservation. Further, 74% of women who undergo risk-reducing BSO experience sexual dysfunction.

The bottom line, Dr. Keyser said, is that “premature removal of ovaries is not completely benign.” Her own recommendation is to follow ACOG guidance for women with BRCA mutations and, for women aged under 35 years, use ovarian suppression for 5-10 years, after which ovarian function may resume along with improved quality of life. In women aged over 40, remove ovaries since, after 5-10 years of treatment, there’s likely no benefit of retaining ovaries.
 

 

 

Addressing sexual health

Dyspareunia affects up to 45% of cancer survivors, Dr. Keyser said, and multiple treatment options exist for breast cancer survivors. The therapies she discussed included lubricants, moisturizers, local vaginal estrogen, DHEA, ospemifene, and CO2 laser therapy.

Though Dr. Keyser briefly touched on vaginal lubricants and moisturizers, Dr. Streicher was disappointed that Dr. Keyser did not clearly define and differentiate between lubricants and moisturizers or mention hyaluronic acid products. Dr. Streicher also disagreed with the way Dr. Keyser represented the benefits of coconut oil as a lubricant. “Oils are not condom compatible and are known to potentially increase the risk of infection, and not just from poor handwashing,” Dr. Streicher said.

Small retrospective studies support the safety of topical vaginal estrogen in breast cancer survivors, Dr. Keyser said, and the 10-mcg Vagifem tablet and vaginal estradiol ring appear to have the lowest systemic absorption. ACOG guidance recommends that women taking aromatase inhibitors who don’t respond to nonhormonal approaches may benefit from switching temporarily to tamoxifen with vaginal estrogen and then returning to aromatase inhibitors. However, Dr. Keyser said there’s plenty of data to support using vaginal estrogen in patients taking aromatase inhibitors.

“I do feel that it’s safe for patients, whether they’re on tamoxifen or aromatase inhibitors, to take vaginal estrogen,” Dr. Keyser said. “I usually stick with the estradiol vaginal ring or the estradiol tablet, and I base that on a patient’s comfort with placing and removing a ring.” She also, instead of asking the patient’s hematologist-oncologist, simply notifies them of the treatment since most hematologist-oncologists are less familiar with the data.

Another effective option is vaginal DHEA/prasterone, which can significantly improve sexual desire, arousal, pain, and overall sexual function. Although breast cancer patients were included in early studies on DHEA, Intrarosa manufacturers excluded breast cancer patients in their Food and Drug Administration application, resulting in a package stating that “use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer” and that “Intrarosa has not been studied in women with a history of breast cancer.” While that’s true for Intrarosa specifically, DHEA has been studied in breast cancer patients, Dr. Keyser said, so she expects to see more research in this area.

Ospemifene is another option for improving vulvovaginal atrophy but cannot be taken at the same time as tamoxifen. It has similar chemopreventive effects as tamoxifen in rat studies, but it’s not as effective. It’s a reasonable option in women with refractory genitourinary syndrome of menopause (GSM) who have completed their 5-10 years of adjuvant therapy and have no history of venous thromboembolism.

Dr. Keyser said CO2 laser therapy is still being studied for treating GSM, and current data have shown benefits for dyspareunia and vaginal dryness without documented harms. There have now been randomized, controlled trials; however, since it’s not FDA approved, it’s not covered by insurance and costs approximately $5,000 for three treatments.

Dr. Streicher was glad to see Dr. Keyser’s discussion of the safety and types of local vaginal estrogen, “although she neglected to mention the 4-mcg vaginal suppository, Imvexxy, which has the lowest systemic absorption,” Dr. Streicher said. Dr. Streicher also felt the inclusion of DHEA/prasterone and ospemifene were also important, especially since the latter is “underutilized in breast cancer patients.”

The information provided on CO2 laser therapy, however, was problematic, Dr. Streicher said, given that long-term and randomized, controlled studies have now been published. Dr. Streicher also noted that two of the devices listed on the presentation slide, Thermiva and Voltiva, are radiofrequency, not laser devices.

Aside from these treatment options, the most consistent predictor of satisfying sexual experiences in women with breast cancer is the quality of their relationships, Dr. Keyser said, so couples counseling is recommended, and treatments in general are more effective with regularly sexual activity.

In discussing nonhormonal options for treating vasomotor symptoms, Dr. Keyser recommended venlafaxine, gabapentin, and low-dose paroxetine (though SSRIs and tamoxifen are contraindicated since they may reduce tamoxifen’s efficacy).

These are all off label, Dr. Streicher said it was important to note, and she would have liked to have seen a mention of the development of KNdy neurokinin disrupters along with a more in-depth discussion about which lifestyle modifications and botanicals have been shown in randomized, controlled trials to mitigate vasomotor symptoms.

Dr. Keyser wrapped up with a few additional notes and takeaways:

  • The only safe reversible long-term option for contraception in HR-positive breast cancer survivors is the Paraguard IUD.
  • It’s important to discuss fertility with breast cancer patients and survivors since a majority report unmet needs in this area.
  • Patients taking tamoxifen need to be sure to report any vaginal spotting or bleeding since it increases risk of endometrial cancer in postmenopausal women.
  • Screen for depression and anxiety.
  • Ask women about sexual health and hot flashes.
  • Ensure that they’re getting bone screening.
  • A recommended resource is Living Beyond Breast Cancer.

Dr. Keyser had no disclosures. Dr. Streicher has consulted for Astellas Pharma and Church & Dwight, and she owns investments in InControl Medical and Sermonix Pharmaceuticals.

Sexual dysfunction is a common problem among breast cancer survivors, but it’s also an issue inadequately addressed by either ob.gyns. or hematologists and oncologists, according to Erin Keyser, MD, the program director of the San Antonio Uniformed Services Health Education Consortium. Dr. Keyser discussed management of sexual dysfunction and a variety of other issues frequently faced by women who have survived breast cancer at the at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“Despite the fact that no specialty is better qualified to render care for this consequence of cancer treatments, many obstetrician-gynecologists feel uncomfortable or ill-equipped to address sexual pain in women affected by cancer,” Dr. Keyser quoted from a 2016 article in Obstetrics & Gynecology about the sexual health of women affected by cancer. As a breast cancer survivor herself, Dr. Keyser said hematologists and oncologists are even less equipped to discuss sexual health, “so oftentimes patients get punted between their hem-onc and their gyn,” with each telling the patient to ask the other specialist.

“There’s plenty of data in chronic health disease that maintaining sexual function for women is an indicator of the overall quality of life and that many women really don’t want to bring this up,” Dr. Keyser told attendees, so the onus is on the ob.gyn. to bring it up.

The effects of breast cancer treatment can impact women’s body image, fertility, menopause, sexual function, osteoporosis, and cardiovascular disease, but the bulk of Dr. Keyser’s talk focused on sexual health and bilateral salpingo-oophorectomy (BSO).

Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University, Chicago, thought Dr. Keyser’s talk was useful for the general gynecologist but had some concerns about a few parts.

“She gave a very thoughtful analysis of whether someone should have their ovaries removed or not in a breast cancer diagnosis, ” Dr. Streicher said in an interview. “I would have liked to hear more about the consequences of an early menopause in women in terms of heart health, bone health, and cognitive function.”

Dr. Keyser noted that her talk pertained mostly to survivors of estrogen receptor (ER)–positive breast cancer since that population tends to struggle most with side effects of treatment. The most common medications used in this population are tamoxifen and aromatase inhibitors – such as anastrazole, letrozole, and exemestane – and these medications can affect management of different concerns.
 

Current guidance on ovarian removal

For women with a BRCA mutation, ACOG clinical guidance already exists regarding BSO. For other women, the complementary TEXT and SOFT trials changed the management of breast cancer treatment in premenopausal women, Dr. Keyser said.

Before these trials, postmenopausal hormone receptor–positive women began aromatase inhibitors and premenopausal HR-positive women began tamoxifen. These trials found that premenopausal women with HR-positive early breast cancer were less likely to experience recurrence when receiving adjuvant treatment with exemestane plus ovarian suppression compared to tamoxifen plus ovarian suppression. Ovarian suppression was achieved by either GnRH agonist injections, surgical removal of the ovaries, or radiation therapy to the ovaries.

The side effects of these treatments included hot flushes (92%), depression (87%), musculoskeletal symptoms (89%), vaginal dryness (52%), decreased libido (45%), dyspareunia (31%), osteoporosis (39%), insomnia (58%), and fatigue (61%). These are all quality of life concerns, Dr. Keyser said, and these findings raise questions about the consequences of long-term ovarian suppression. Findings from the Nurses’ Health Study showed that BSO before age 47.5 years resulted in lower mortality from ovarian cancer and breast cancer but was linked in women under 50 to increased all-cause mortality and mortality from coronary heart disease, lung cancer, and colorectal cancer, compared with ovarian conservation. Further, 74% of women who undergo risk-reducing BSO experience sexual dysfunction.

The bottom line, Dr. Keyser said, is that “premature removal of ovaries is not completely benign.” Her own recommendation is to follow ACOG guidance for women with BRCA mutations and, for women aged under 35 years, use ovarian suppression for 5-10 years, after which ovarian function may resume along with improved quality of life. In women aged over 40, remove ovaries since, after 5-10 years of treatment, there’s likely no benefit of retaining ovaries.
 

 

 

Addressing sexual health

Dyspareunia affects up to 45% of cancer survivors, Dr. Keyser said, and multiple treatment options exist for breast cancer survivors. The therapies she discussed included lubricants, moisturizers, local vaginal estrogen, DHEA, ospemifene, and CO2 laser therapy.

Though Dr. Keyser briefly touched on vaginal lubricants and moisturizers, Dr. Streicher was disappointed that Dr. Keyser did not clearly define and differentiate between lubricants and moisturizers or mention hyaluronic acid products. Dr. Streicher also disagreed with the way Dr. Keyser represented the benefits of coconut oil as a lubricant. “Oils are not condom compatible and are known to potentially increase the risk of infection, and not just from poor handwashing,” Dr. Streicher said.

Small retrospective studies support the safety of topical vaginal estrogen in breast cancer survivors, Dr. Keyser said, and the 10-mcg Vagifem tablet and vaginal estradiol ring appear to have the lowest systemic absorption. ACOG guidance recommends that women taking aromatase inhibitors who don’t respond to nonhormonal approaches may benefit from switching temporarily to tamoxifen with vaginal estrogen and then returning to aromatase inhibitors. However, Dr. Keyser said there’s plenty of data to support using vaginal estrogen in patients taking aromatase inhibitors.

“I do feel that it’s safe for patients, whether they’re on tamoxifen or aromatase inhibitors, to take vaginal estrogen,” Dr. Keyser said. “I usually stick with the estradiol vaginal ring or the estradiol tablet, and I base that on a patient’s comfort with placing and removing a ring.” She also, instead of asking the patient’s hematologist-oncologist, simply notifies them of the treatment since most hematologist-oncologists are less familiar with the data.

Another effective option is vaginal DHEA/prasterone, which can significantly improve sexual desire, arousal, pain, and overall sexual function. Although breast cancer patients were included in early studies on DHEA, Intrarosa manufacturers excluded breast cancer patients in their Food and Drug Administration application, resulting in a package stating that “use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer” and that “Intrarosa has not been studied in women with a history of breast cancer.” While that’s true for Intrarosa specifically, DHEA has been studied in breast cancer patients, Dr. Keyser said, so she expects to see more research in this area.

Ospemifene is another option for improving vulvovaginal atrophy but cannot be taken at the same time as tamoxifen. It has similar chemopreventive effects as tamoxifen in rat studies, but it’s not as effective. It’s a reasonable option in women with refractory genitourinary syndrome of menopause (GSM) who have completed their 5-10 years of adjuvant therapy and have no history of venous thromboembolism.

Dr. Keyser said CO2 laser therapy is still being studied for treating GSM, and current data have shown benefits for dyspareunia and vaginal dryness without documented harms. There have now been randomized, controlled trials; however, since it’s not FDA approved, it’s not covered by insurance and costs approximately $5,000 for three treatments.

Dr. Streicher was glad to see Dr. Keyser’s discussion of the safety and types of local vaginal estrogen, “although she neglected to mention the 4-mcg vaginal suppository, Imvexxy, which has the lowest systemic absorption,” Dr. Streicher said. Dr. Streicher also felt the inclusion of DHEA/prasterone and ospemifene were also important, especially since the latter is “underutilized in breast cancer patients.”

The information provided on CO2 laser therapy, however, was problematic, Dr. Streicher said, given that long-term and randomized, controlled studies have now been published. Dr. Streicher also noted that two of the devices listed on the presentation slide, Thermiva and Voltiva, are radiofrequency, not laser devices.

Aside from these treatment options, the most consistent predictor of satisfying sexual experiences in women with breast cancer is the quality of their relationships, Dr. Keyser said, so couples counseling is recommended, and treatments in general are more effective with regularly sexual activity.

In discussing nonhormonal options for treating vasomotor symptoms, Dr. Keyser recommended venlafaxine, gabapentin, and low-dose paroxetine (though SSRIs and tamoxifen are contraindicated since they may reduce tamoxifen’s efficacy).

These are all off label, Dr. Streicher said it was important to note, and she would have liked to have seen a mention of the development of KNdy neurokinin disrupters along with a more in-depth discussion about which lifestyle modifications and botanicals have been shown in randomized, controlled trials to mitigate vasomotor symptoms.

Dr. Keyser wrapped up with a few additional notes and takeaways:

  • The only safe reversible long-term option for contraception in HR-positive breast cancer survivors is the Paraguard IUD.
  • It’s important to discuss fertility with breast cancer patients and survivors since a majority report unmet needs in this area.
  • Patients taking tamoxifen need to be sure to report any vaginal spotting or bleeding since it increases risk of endometrial cancer in postmenopausal women.
  • Screen for depression and anxiety.
  • Ask women about sexual health and hot flashes.
  • Ensure that they’re getting bone screening.
  • A recommended resource is Living Beyond Breast Cancer.

Dr. Keyser had no disclosures. Dr. Streicher has consulted for Astellas Pharma and Church & Dwight, and she owns investments in InControl Medical and Sermonix Pharmaceuticals.

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