Women's Health

TOPLINE:

A 12-week low-fat vegan diet with soybeans led to significant changes in the gut microbiome that correlated with significant reductions in vasomotor symptoms in postmenopausal women.

METHODOLOGY:

• For this exploratory analysis, postmenopausal women with two or more moderate to severe hot flashes daily were randomly assigned in two successive cohorts to consume a low-fat vegan diet with cooked soybeans or their usual diet.
• Over a 12-week period, frequency and severity of hot flashes were recorded on a mobile application.
• Researchers used deep shotgun metagenomic sequencing to analyze the gut microbiome at baseline and 12 weeks in a subset of 11 women in the dietary intervention group.

TAKEAWAY:

• In the subset receiving microbiome analysis, total hot flashes decreased by 95%, moderate to severe hot flashes decreased by 96%, and severe hot flashes disappeared during the dietary intervention.
• The relative abundance of Porphyromonas and Prevotella corporis decreased in participants on the diet intervention, and this correlated with a reduction in severe daytime hot flashes.
• The relative abundance of Clostridium asparagiforme also decreased in participants on the low-fat vegan diet, and this change correlated with a reduction in total severe and severe nighttime hot flashes.
• However, after correction for multiple comparisons, these associations were no longer significant.

IN PRACTICE:

“The targeted and untargeted gut microbiome analysis was robust and revealed important changes in the gut microbiome composition in response to a low-fat vegan diet and large correlations with symptomatic changes,” the authors write. “Larger randomized clinical trials are needed to further investigate these findings.”

SOURCE:

The study, with first author Hana Kahleova, MD, PhD, with the Physicians Committee for Responsible Medicine, in Washington, DC, was published online  November 8 in Complementary Therapies in Medicine.

LIMITATIONS:

The gut microbiome analysis was only performed in a small subset of women on the diet intervention, with no control group. Although strong associations were noted between several gut bacteria and changes in hot flash frequency, and nominally statistically significant relative abundance changes were observed, robust statistical significance cannot be concluded for any of the reported gut microbiome assessments when the modestly large number of total comparisons is taken into account.

DISCLOSURES:

The study was funded by the Physicians Committee for Responsible Medicine. The authors report no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A 12-week low-fat vegan diet with soybeans led to significant changes in the gut microbiome that correlated with significant reductions in vasomotor symptoms in postmenopausal women.

METHODOLOGY:

• For this exploratory analysis, postmenopausal women with two or more moderate to severe hot flashes daily were randomly assigned in two successive cohorts to consume a low-fat vegan diet with cooked soybeans or their usual diet.
• Over a 12-week period, frequency and severity of hot flashes were recorded on a mobile application.
• Researchers used deep shotgun metagenomic sequencing to analyze the gut microbiome at baseline and 12 weeks in a subset of 11 women in the dietary intervention group.

TAKEAWAY:

• In the subset receiving microbiome analysis, total hot flashes decreased by 95%, moderate to severe hot flashes decreased by 96%, and severe hot flashes disappeared during the dietary intervention.
• The relative abundance of Porphyromonas and Prevotella corporis decreased in participants on the diet intervention, and this correlated with a reduction in severe daytime hot flashes.
• The relative abundance of Clostridium asparagiforme also decreased in participants on the low-fat vegan diet, and this change correlated with a reduction in total severe and severe nighttime hot flashes.
• However, after correction for multiple comparisons, these associations were no longer significant.

IN PRACTICE:

“The targeted and untargeted gut microbiome analysis was robust and revealed important changes in the gut microbiome composition in response to a low-fat vegan diet and large correlations with symptomatic changes,” the authors write. “Larger randomized clinical trials are needed to further investigate these findings.”

SOURCE:

The study, with first author Hana Kahleova, MD, PhD, with the Physicians Committee for Responsible Medicine, in Washington, DC, was published online  November 8 in Complementary Therapies in Medicine.

LIMITATIONS:

The gut microbiome analysis was only performed in a small subset of women on the diet intervention, with no control group. Although strong associations were noted between several gut bacteria and changes in hot flash frequency, and nominally statistically significant relative abundance changes were observed, robust statistical significance cannot be concluded for any of the reported gut microbiome assessments when the modestly large number of total comparisons is taken into account.

DISCLOSURES:

The study was funded by the Physicians Committee for Responsible Medicine. The authors report no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A 12-week low-fat vegan diet with soybeans led to significant changes in the gut microbiome that correlated with significant reductions in vasomotor symptoms in postmenopausal women.

METHODOLOGY:

• For this exploratory analysis, postmenopausal women with two or more moderate to severe hot flashes daily were randomly assigned in two successive cohorts to consume a low-fat vegan diet with cooked soybeans or their usual diet.
• Over a 12-week period, frequency and severity of hot flashes were recorded on a mobile application.
• Researchers used deep shotgun metagenomic sequencing to analyze the gut microbiome at baseline and 12 weeks in a subset of 11 women in the dietary intervention group.

TAKEAWAY:

• In the subset receiving microbiome analysis, total hot flashes decreased by 95%, moderate to severe hot flashes decreased by 96%, and severe hot flashes disappeared during the dietary intervention.
• The relative abundance of Porphyromonas and Prevotella corporis decreased in participants on the diet intervention, and this correlated with a reduction in severe daytime hot flashes.
• The relative abundance of Clostridium asparagiforme also decreased in participants on the low-fat vegan diet, and this change correlated with a reduction in total severe and severe nighttime hot flashes.
• However, after correction for multiple comparisons, these associations were no longer significant.

IN PRACTICE:

“The targeted and untargeted gut microbiome analysis was robust and revealed important changes in the gut microbiome composition in response to a low-fat vegan diet and large correlations with symptomatic changes,” the authors write. “Larger randomized clinical trials are needed to further investigate these findings.”

SOURCE:

The study, with first author Hana Kahleova, MD, PhD, with the Physicians Committee for Responsible Medicine, in Washington, DC, was published online  November 8 in Complementary Therapies in Medicine.

LIMITATIONS:

The gut microbiome analysis was only performed in a small subset of women on the diet intervention, with no control group. Although strong associations were noted between several gut bacteria and changes in hot flash frequency, and nominally statistically significant relative abundance changes were observed, robust statistical significance cannot be concluded for any of the reported gut microbiome assessments when the modestly large number of total comparisons is taken into account.

DISCLOSURES:

The study was funded by the Physicians Committee for Responsible Medicine. The authors report no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

Having a first menstrual period (menarche) at age 10 or younger was linked with a greater risk for type 2 diabetes and a greater risk of stroke in women with diabetes, a retrospective study of US women under age 65 found.

METHODOLOGY:

• Researchers analyzed data from 17,377 women who were aged 20-65 years when they participated in a National Health and Nutrition Examination Survey (NHANES) from 1999 to 2018 and reported their age at first menstruation, which was classified as ≤ 10, 11, 12, 13, 14, or ≥ 15 years of age.
• In total, 0.2% of the women (1773) had type 2 diabetes; of these, 11.5% (205) had cardiovascular disease (CVD), defined as coronary heart disease (CHD), myocardial infarction, or stroke.
• Compared with women who had their first menstrual period at age 13 (the mean age in this population), those who had their period at age ≤ 10 had a significantly greater risk of having type 2 diabetes, after adjustment for age, race/ethnicity, education, parity, menopause status, family history of diabetes, smoking status, physical activity, alcohol consumption, and body mass index (odds ratio, 1.32; 95% CI, 1.03-1.69; P trend = .03).
• Among the women with diabetes, compared with those who had their first menstrual period at age 13, those who had it at age ≤ 10 had a significantly greater risk of having stroke (OR, 2.66; 95% CI, 1.07-6.64; P trend = .02), but not CVD or CHD, after adjustment for these multiple variables.

TAKEAWAY:

• In a racially and ethnically diverse national sample of US women younger than 65, “extremely early” age at first menstrual period was associated with significantly increased risk for type 2 diabetes; among the women with type 2 diabetes, it was associated with significantly increased risk for stroke but not CVD or CHD, after adjustment for multiple variables.
• Early age at menarche may be an early indicator of the cardiometabolic disease trajectory in women.

IN PRACTICE:

“Women with early-life exposures such as early age at menarche need to be further examined for diabetes and prevention research and strategies for progression of diabetes complications,” the study authors write. 

SOURCE:

The authors, mainly from Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, and also from Harvard Medical School, Boston, Massachusetts, published their findings in BMJ Nutrition, Prevention & Health.

LIMITATIONS:

• The women who participated in NHANES may not be representative of all women in the United States (selection bias).
• The study only included women who reported the age when they had their first menstrual period (selection bias).
• This was a cross-sectional, observational study, so it cannot show causality.
• The women may have reported the wrong age at which they had their first period (recall bias and social desirability bias).
• The women may have inaccurately reported CVD and type 2 diabetes (recall bias and social desirability bias).

DISCLOSURES:

The researchers were supported by grants from the National Heart, Lung, and Blood Institute and from the National Institute of General Medical Sciences of the National Institutes of Health.

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

TOPLINE: 

Having a first menstrual period (menarche) at age 10 or younger was linked with a greater risk for type 2 diabetes and a greater risk of stroke in women with diabetes, a retrospective study of US women under age 65 found.

METHODOLOGY:

• Researchers analyzed data from 17,377 women who were aged 20-65 years when they participated in a National Health and Nutrition Examination Survey (NHANES) from 1999 to 2018 and reported their age at first menstruation, which was classified as ≤ 10, 11, 12, 13, 14, or ≥ 15 years of age.
• In total, 0.2% of the women (1773) had type 2 diabetes; of these, 11.5% (205) had cardiovascular disease (CVD), defined as coronary heart disease (CHD), myocardial infarction, or stroke.
• Compared with women who had their first menstrual period at age 13 (the mean age in this population), those who had their period at age ≤ 10 had a significantly greater risk of having type 2 diabetes, after adjustment for age, race/ethnicity, education, parity, menopause status, family history of diabetes, smoking status, physical activity, alcohol consumption, and body mass index (odds ratio, 1.32; 95% CI, 1.03-1.69; P trend = .03).
• Among the women with diabetes, compared with those who had their first menstrual period at age 13, those who had it at age ≤ 10 had a significantly greater risk of having stroke (OR, 2.66; 95% CI, 1.07-6.64; P trend = .02), but not CVD or CHD, after adjustment for these multiple variables.

TAKEAWAY:

• In a racially and ethnically diverse national sample of US women younger than 65, “extremely early” age at first menstrual period was associated with significantly increased risk for type 2 diabetes; among the women with type 2 diabetes, it was associated with significantly increased risk for stroke but not CVD or CHD, after adjustment for multiple variables.
• Early age at menarche may be an early indicator of the cardiometabolic disease trajectory in women.

IN PRACTICE:

“Women with early-life exposures such as early age at menarche need to be further examined for diabetes and prevention research and strategies for progression of diabetes complications,” the study authors write. 

SOURCE:

The authors, mainly from Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, and also from Harvard Medical School, Boston, Massachusetts, published their findings in BMJ Nutrition, Prevention & Health.

LIMITATIONS:

• The women who participated in NHANES may not be representative of all women in the United States (selection bias).
• The study only included women who reported the age when they had their first menstrual period (selection bias).
• This was a cross-sectional, observational study, so it cannot show causality.
• The women may have reported the wrong age at which they had their first period (recall bias and social desirability bias).
• The women may have inaccurately reported CVD and type 2 diabetes (recall bias and social desirability bias).

DISCLOSURES:

The researchers were supported by grants from the National Heart, Lung, and Blood Institute and from the National Institute of General Medical Sciences of the National Institutes of Health.

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

TOPLINE: 

Having a first menstrual period (menarche) at age 10 or younger was linked with a greater risk for type 2 diabetes and a greater risk of stroke in women with diabetes, a retrospective study of US women under age 65 found.

METHODOLOGY:

• Researchers analyzed data from 17,377 women who were aged 20-65 years when they participated in a National Health and Nutrition Examination Survey (NHANES) from 1999 to 2018 and reported their age at first menstruation, which was classified as ≤ 10, 11, 12, 13, 14, or ≥ 15 years of age.
• In total, 0.2% of the women (1773) had type 2 diabetes; of these, 11.5% (205) had cardiovascular disease (CVD), defined as coronary heart disease (CHD), myocardial infarction, or stroke.
• Compared with women who had their first menstrual period at age 13 (the mean age in this population), those who had their period at age ≤ 10 had a significantly greater risk of having type 2 diabetes, after adjustment for age, race/ethnicity, education, parity, menopause status, family history of diabetes, smoking status, physical activity, alcohol consumption, and body mass index (odds ratio, 1.32; 95% CI, 1.03-1.69; P trend = .03).
• Among the women with diabetes, compared with those who had their first menstrual period at age 13, those who had it at age ≤ 10 had a significantly greater risk of having stroke (OR, 2.66; 95% CI, 1.07-6.64; P trend = .02), but not CVD or CHD, after adjustment for these multiple variables.

TAKEAWAY:

• In a racially and ethnically diverse national sample of US women younger than 65, “extremely early” age at first menstrual period was associated with significantly increased risk for type 2 diabetes; among the women with type 2 diabetes, it was associated with significantly increased risk for stroke but not CVD or CHD, after adjustment for multiple variables.
• Early age at menarche may be an early indicator of the cardiometabolic disease trajectory in women.

IN PRACTICE:

“Women with early-life exposures such as early age at menarche need to be further examined for diabetes and prevention research and strategies for progression of diabetes complications,” the study authors write. 

SOURCE:

The authors, mainly from Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, and also from Harvard Medical School, Boston, Massachusetts, published their findings in BMJ Nutrition, Prevention & Health.

LIMITATIONS:

• The women who participated in NHANES may not be representative of all women in the United States (selection bias).
• The study only included women who reported the age when they had their first menstrual period (selection bias).
• This was a cross-sectional, observational study, so it cannot show causality.
• The women may have reported the wrong age at which they had their first period (recall bias and social desirability bias).
• The women may have inaccurately reported CVD and type 2 diabetes (recall bias and social desirability bias).

DISCLOSURES:

The researchers were supported by grants from the National Heart, Lung, and Blood Institute and from the National Institute of General Medical Sciences of the National Institutes of Health.

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

Compared with premenopausal women, postmenopausal women experienced greater improvement in pain following interventions such as physical therapy despite being prescribed fewer medications, a new study shows.

“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.

Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.   

For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.

According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.

Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.

“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.  

The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.

While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.

“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.  

Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”

Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”

Dr. Yu and Dr. Wenham report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Compared with premenopausal women, postmenopausal women experienced greater improvement in pain following interventions such as physical therapy despite being prescribed fewer medications, a new study shows.

“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.

Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.   

For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.

According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.

Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.

“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.  

The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.

While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.

“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.  

Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”

Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”

Dr. Yu and Dr. Wenham report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Compared with premenopausal women, postmenopausal women experienced greater improvement in pain following interventions such as physical therapy despite being prescribed fewer medications, a new study shows.

“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.

Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.   

For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.

According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.

Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.

“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.  

The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.

While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.

“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.  

Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”

Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”

Dr. Yu and Dr. Wenham report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Jerome J. Federspiel, MD, often cares for patients who are about to deliver a baby but who have untreated iron deficiency anemia (IDA). Often, these patients require a blood transfusion after giving birth.

“I am sad to hear commonly from patients we treat that they have had iron-deficient anemia symptoms for many years. Correcting these conditions makes birth safer and, oftentimes, makes people feel much better – sometimes better than they have in years,” Dr. Federspiel, maternal-fetal medicine physician and assistant professor of obstetrics and gynecology and population health sciences at Duke University, Durham, N.C., said.

Even patients he is able to diagnose earlier “will have difficulties catching up during pregnancy.”

The condition is the most common type of anemia among people who are pregnant. IDA increases a patient’s risk of delivering preterm and developing postpartum depression and puts their infants at a risk for perinatal mortality. Without proper treatment of IDA throughout pregnancy, the condition can also lead to low birth weights in infants or failing to meet weight goals later on.

But of all women with a new diagnosis of IDA from 2021 to 2022, 10% were pregnant, according to an analysis by Komodo Health, a health care analytics company.

While estimates of the prevalence of IDA vary, research from 2021 found 6.5% of nearly 1,500 patients who were pregnant during the first trimester had the condition, a figure the researchers said might underrepresent the problem.

“In severe cases [fetal outcomes can include] abnormal fetal oxygenation, nonreassuring fetal heart rate patterns, reduced amniotic fluid volume, fetal cerebral vasodilation, and fetal death,” Alianne S. Tilley, NP, family nurse practitioner at Women’s Care of Lake Cumberland, Somerset, Ky., said.

Research has shown that adequate levels of iron are an integral component in the development of the fetal brain. Some studies have reported that IDA during pregnancy increases an infant’s risk for poor neurodevelopmental outcomes.
 

Lack of screening protocol

Discrepancies in guidance for testing patients who are pregnant for IDA may add to late diagnosis and low treatment, according to Katelin Zahn, MD, assistant professor of general obstetrics, gynecology, and midwifery at University of North Carolina at Chapel Hill.

“There’s no consistency, which leads to a lot of variation in individual practice, which creates variation in outcomes, too,” Dr. Zahn said. “You can only do so much as one independent physician, and you need to be able to create change in a system that functions and provides standard of care even when you aren’t there.”

The American College of Obstetricians and Gynecologists recommends screening all patients who are pregnant with a complete blood count in the first trimester and again between 24 and 27 weeks of gestation.

Patients who meet criteria for IDA based on hematocrit levels less than 33% in the first and third trimesters, and less than 32% in the second trimester, should be evaluated to determine the cause. Those with IDA should be treated with supplemental iron, in addition to prenatal vitamins, ACOG says.

But the U.S. Preventive Services Task Force in 2015 found insufficient evidence to recommend for or against screening patients without symptoms or signs of the condition. The organization is in the process of updating the recommendation.
 

Prevention as best practice

The most effective way to address IDA in patients who are pregnant is prevention, according to Dr. Federspiel.

“Having a systematic approach to screening and treatment is really important, and this starts before pregnancy,” Dr. Federspiel said. “On average, a typical pregnancy requires an additional 1 g of iron.”

Dr. Federspiel recommends clinicians discuss the causes and the effects of IDA with patients who are planning to or could become pregnant. Clinicians might recommend iron- and folate-rich foods and vitamins B12 and C and ask patients if they face any barriers to access.

“Prenatal vitamins with iron are the gold standard in preventing IDA in the pregnant population,” Ms. Tilley said. “Education on the significant risk factors associated with IDA in early pregnancy is key.”

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

Jerome J. Federspiel, MD, often cares for patients who are about to deliver a baby but who have untreated iron deficiency anemia (IDA). Often, these patients require a blood transfusion after giving birth.

“I am sad to hear commonly from patients we treat that they have had iron-deficient anemia symptoms for many years. Correcting these conditions makes birth safer and, oftentimes, makes people feel much better – sometimes better than they have in years,” Dr. Federspiel, maternal-fetal medicine physician and assistant professor of obstetrics and gynecology and population health sciences at Duke University, Durham, N.C., said.

Even patients he is able to diagnose earlier “will have difficulties catching up during pregnancy.”

The condition is the most common type of anemia among people who are pregnant. IDA increases a patient’s risk of delivering preterm and developing postpartum depression and puts their infants at a risk for perinatal mortality. Without proper treatment of IDA throughout pregnancy, the condition can also lead to low birth weights in infants or failing to meet weight goals later on.

But of all women with a new diagnosis of IDA from 2021 to 2022, 10% were pregnant, according to an analysis by Komodo Health, a health care analytics company.

While estimates of the prevalence of IDA vary, research from 2021 found 6.5% of nearly 1,500 patients who were pregnant during the first trimester had the condition, a figure the researchers said might underrepresent the problem.

“In severe cases [fetal outcomes can include] abnormal fetal oxygenation, nonreassuring fetal heart rate patterns, reduced amniotic fluid volume, fetal cerebral vasodilation, and fetal death,” Alianne S. Tilley, NP, family nurse practitioner at Women’s Care of Lake Cumberland, Somerset, Ky., said.

Research has shown that adequate levels of iron are an integral component in the development of the fetal brain. Some studies have reported that IDA during pregnancy increases an infant’s risk for poor neurodevelopmental outcomes.
 

Lack of screening protocol

Discrepancies in guidance for testing patients who are pregnant for IDA may add to late diagnosis and low treatment, according to Katelin Zahn, MD, assistant professor of general obstetrics, gynecology, and midwifery at University of North Carolina at Chapel Hill.

“There’s no consistency, which leads to a lot of variation in individual practice, which creates variation in outcomes, too,” Dr. Zahn said. “You can only do so much as one independent physician, and you need to be able to create change in a system that functions and provides standard of care even when you aren’t there.”

The American College of Obstetricians and Gynecologists recommends screening all patients who are pregnant with a complete blood count in the first trimester and again between 24 and 27 weeks of gestation.

Patients who meet criteria for IDA based on hematocrit levels less than 33% in the first and third trimesters, and less than 32% in the second trimester, should be evaluated to determine the cause. Those with IDA should be treated with supplemental iron, in addition to prenatal vitamins, ACOG says.

But the U.S. Preventive Services Task Force in 2015 found insufficient evidence to recommend for or against screening patients without symptoms or signs of the condition. The organization is in the process of updating the recommendation.
 

Prevention as best practice

The most effective way to address IDA in patients who are pregnant is prevention, according to Dr. Federspiel.

“Having a systematic approach to screening and treatment is really important, and this starts before pregnancy,” Dr. Federspiel said. “On average, a typical pregnancy requires an additional 1 g of iron.”

Dr. Federspiel recommends clinicians discuss the causes and the effects of IDA with patients who are planning to or could become pregnant. Clinicians might recommend iron- and folate-rich foods and vitamins B12 and C and ask patients if they face any barriers to access.

“Prenatal vitamins with iron are the gold standard in preventing IDA in the pregnant population,” Ms. Tilley said. “Education on the significant risk factors associated with IDA in early pregnancy is key.”

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

Jerome J. Federspiel, MD, often cares for patients who are about to deliver a baby but who have untreated iron deficiency anemia (IDA). Often, these patients require a blood transfusion after giving birth.

“I am sad to hear commonly from patients we treat that they have had iron-deficient anemia symptoms for many years. Correcting these conditions makes birth safer and, oftentimes, makes people feel much better – sometimes better than they have in years,” Dr. Federspiel, maternal-fetal medicine physician and assistant professor of obstetrics and gynecology and population health sciences at Duke University, Durham, N.C., said.

Even patients he is able to diagnose earlier “will have difficulties catching up during pregnancy.”

The condition is the most common type of anemia among people who are pregnant. IDA increases a patient’s risk of delivering preterm and developing postpartum depression and puts their infants at a risk for perinatal mortality. Without proper treatment of IDA throughout pregnancy, the condition can also lead to low birth weights in infants or failing to meet weight goals later on.

But of all women with a new diagnosis of IDA from 2021 to 2022, 10% were pregnant, according to an analysis by Komodo Health, a health care analytics company.

While estimates of the prevalence of IDA vary, research from 2021 found 6.5% of nearly 1,500 patients who were pregnant during the first trimester had the condition, a figure the researchers said might underrepresent the problem.

“In severe cases [fetal outcomes can include] abnormal fetal oxygenation, nonreassuring fetal heart rate patterns, reduced amniotic fluid volume, fetal cerebral vasodilation, and fetal death,” Alianne S. Tilley, NP, family nurse practitioner at Women’s Care of Lake Cumberland, Somerset, Ky., said.

Research has shown that adequate levels of iron are an integral component in the development of the fetal brain. Some studies have reported that IDA during pregnancy increases an infant’s risk for poor neurodevelopmental outcomes.
 

Lack of screening protocol

Discrepancies in guidance for testing patients who are pregnant for IDA may add to late diagnosis and low treatment, according to Katelin Zahn, MD, assistant professor of general obstetrics, gynecology, and midwifery at University of North Carolina at Chapel Hill.

“There’s no consistency, which leads to a lot of variation in individual practice, which creates variation in outcomes, too,” Dr. Zahn said. “You can only do so much as one independent physician, and you need to be able to create change in a system that functions and provides standard of care even when you aren’t there.”

The American College of Obstetricians and Gynecologists recommends screening all patients who are pregnant with a complete blood count in the first trimester and again between 24 and 27 weeks of gestation.

Patients who meet criteria for IDA based on hematocrit levels less than 33% in the first and third trimesters, and less than 32% in the second trimester, should be evaluated to determine the cause. Those with IDA should be treated with supplemental iron, in addition to prenatal vitamins, ACOG says.

But the U.S. Preventive Services Task Force in 2015 found insufficient evidence to recommend for or against screening patients without symptoms or signs of the condition. The organization is in the process of updating the recommendation.
 

Prevention as best practice

The most effective way to address IDA in patients who are pregnant is prevention, according to Dr. Federspiel.

“Having a systematic approach to screening and treatment is really important, and this starts before pregnancy,” Dr. Federspiel said. “On average, a typical pregnancy requires an additional 1 g of iron.”

Dr. Federspiel recommends clinicians discuss the causes and the effects of IDA with patients who are planning to or could become pregnant. Clinicians might recommend iron- and folate-rich foods and vitamins B12 and C and ask patients if they face any barriers to access.

“Prenatal vitamins with iron are the gold standard in preventing IDA in the pregnant population,” Ms. Tilley said. “Education on the significant risk factors associated with IDA in early pregnancy is key.”

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

TOPLINE:

For pregnant women with breast cancer, exposure to HER2-targeted therapies increases the risk of severe adverse outcomes to the fetus or newborn, according to a recent analysis.

METHODOLOGY:

• Current guidelines do not recommend treating pregnant women with trastuzumab, given documented safety concerns. Other anti-HER2 agents are also discouraged in this setting because of a lack of safety data. However, when considering the efficacy of these drugs in HER2-positive breast cancer, having a better understanding of the potential toxicities in pregnant patients is important.
• In the current case-control analysis, the team explored the risk for adverse effects among pregnant women exposed to anti-HER2 agents vs other anticancer drugs.
• The researchers leveraged the World Health Organization’s pharmacovigilance database, VigiBase, to identify reports with at least one pregnancy-related complication and one suspected anticancer drug.
• The researchers classified exposure to the drugs as occurring before pregnancy, during pregnancy, or via breast milk, semen, or skin. The team then examined 30 maternal and fetal or neonatal adverse outcomes and grouped them into seven categories: abortions, stillbirths, congenital malformations, pregnancy complications, preterm birth, neonatal complications, and delivery complications.
• The most used anti-HER2 agent was trastuzumab (n = 302), followed by pertuzumab (n = 55), trastuzumab-emtansine (n = 20), and lapatinib (n = 18).

TAKEAWAY:

• Among 3,558 reports included in the analysis, 328 patients were exposed to anti-HER2 drugs compared with 3,230 patients who received other anticancer agents.
• Pregnancy, fetal, or newborn adverse outcomes were reported in 61.3% of women treated with anti-HER2 agents and 56.3% of those receiving other anticancer drugs.
• The five most frequently reported complications in the anti-HER2 group were oligohydramnios (23.8%), preterm birth (17.4%), intrauterine growth restriction (9.8%), neonatal respiratory disorder (7.3%), and spontaneous abortion (7.3%).
• Adverse outcomes overreported in women who received anti-HER2 agents included oligohydramnios (reporting odds ratio [ROR], 17.68), congenital tract disorders (ROR, 9.98), and neonatal kidney failure (ROR, 9.15). Cardiovascular malformations were also overreported among women receiving trastuzumab-emtansine (ROR, 4.46), as were intrauterine growth restrictions for those treated with lapatinib (ROR, 7.68).

IN PRACTICE:

Exposure to anti-HER2 agents was associated with “severe specific adverse pregnancy and fetal or newborn outcomes compared with exposure to other anticancer treatments,” with a “strong, highly significant overreporting of congenital respiratory tract disorders and neonatal kidney failure,” which can lead to oligohydramnios, the authors wrote. The authors also noted that when delaying anti-HER2 therapy is not possible, it’s imperative to monitor patients closely for oligohydramnios.

SOURCE:

The study, led by Paul Gougis, MD, Institut Curie Centre de Recherche, Paris, , was published online in JAMA Network Open.

LIMITATIONS:

Potential inconsistencies in the collection of pharmacovigilance data could limit the generalizability of the results in the general population. The group of women exposed to other anticancer therapies may also constitute a different patient population from that given anti-HER2 therapies.

DISCLOSURES:

Coauthor Jean-Philippe Spano, MD, PhD, declared relationships Gilead, AstraZeneca, Lilly, Pfizer, Novartis, Daiichi Sankyo, and GSK.
 

A version of this article appeared on Medscape.com.

TOPLINE:

For pregnant women with breast cancer, exposure to HER2-targeted therapies increases the risk of severe adverse outcomes to the fetus or newborn, according to a recent analysis.

METHODOLOGY:

• Current guidelines do not recommend treating pregnant women with trastuzumab, given documented safety concerns. Other anti-HER2 agents are also discouraged in this setting because of a lack of safety data. However, when considering the efficacy of these drugs in HER2-positive breast cancer, having a better understanding of the potential toxicities in pregnant patients is important.
• In the current case-control analysis, the team explored the risk for adverse effects among pregnant women exposed to anti-HER2 agents vs other anticancer drugs.
• The researchers leveraged the World Health Organization’s pharmacovigilance database, VigiBase, to identify reports with at least one pregnancy-related complication and one suspected anticancer drug.
• The researchers classified exposure to the drugs as occurring before pregnancy, during pregnancy, or via breast milk, semen, or skin. The team then examined 30 maternal and fetal or neonatal adverse outcomes and grouped them into seven categories: abortions, stillbirths, congenital malformations, pregnancy complications, preterm birth, neonatal complications, and delivery complications.
• The most used anti-HER2 agent was trastuzumab (n = 302), followed by pertuzumab (n = 55), trastuzumab-emtansine (n = 20), and lapatinib (n = 18).

TAKEAWAY:

• Among 3,558 reports included in the analysis, 328 patients were exposed to anti-HER2 drugs compared with 3,230 patients who received other anticancer agents.
• Pregnancy, fetal, or newborn adverse outcomes were reported in 61.3% of women treated with anti-HER2 agents and 56.3% of those receiving other anticancer drugs.
• The five most frequently reported complications in the anti-HER2 group were oligohydramnios (23.8%), preterm birth (17.4%), intrauterine growth restriction (9.8%), neonatal respiratory disorder (7.3%), and spontaneous abortion (7.3%).
• Adverse outcomes overreported in women who received anti-HER2 agents included oligohydramnios (reporting odds ratio [ROR], 17.68), congenital tract disorders (ROR, 9.98), and neonatal kidney failure (ROR, 9.15). Cardiovascular malformations were also overreported among women receiving trastuzumab-emtansine (ROR, 4.46), as were intrauterine growth restrictions for those treated with lapatinib (ROR, 7.68).

IN PRACTICE:

Exposure to anti-HER2 agents was associated with “severe specific adverse pregnancy and fetal or newborn outcomes compared with exposure to other anticancer treatments,” with a “strong, highly significant overreporting of congenital respiratory tract disorders and neonatal kidney failure,” which can lead to oligohydramnios, the authors wrote. The authors also noted that when delaying anti-HER2 therapy is not possible, it’s imperative to monitor patients closely for oligohydramnios.

SOURCE:

The study, led by Paul Gougis, MD, Institut Curie Centre de Recherche, Paris, , was published online in JAMA Network Open.

LIMITATIONS:

Potential inconsistencies in the collection of pharmacovigilance data could limit the generalizability of the results in the general population. The group of women exposed to other anticancer therapies may also constitute a different patient population from that given anti-HER2 therapies.

DISCLOSURES:

Coauthor Jean-Philippe Spano, MD, PhD, declared relationships Gilead, AstraZeneca, Lilly, Pfizer, Novartis, Daiichi Sankyo, and GSK.
 

A version of this article appeared on Medscape.com.

TOPLINE:

For pregnant women with breast cancer, exposure to HER2-targeted therapies increases the risk of severe adverse outcomes to the fetus or newborn, according to a recent analysis.

METHODOLOGY:

• Current guidelines do not recommend treating pregnant women with trastuzumab, given documented safety concerns. Other anti-HER2 agents are also discouraged in this setting because of a lack of safety data. However, when considering the efficacy of these drugs in HER2-positive breast cancer, having a better understanding of the potential toxicities in pregnant patients is important.
• In the current case-control analysis, the team explored the risk for adverse effects among pregnant women exposed to anti-HER2 agents vs other anticancer drugs.
• The researchers leveraged the World Health Organization’s pharmacovigilance database, VigiBase, to identify reports with at least one pregnancy-related complication and one suspected anticancer drug.
• The researchers classified exposure to the drugs as occurring before pregnancy, during pregnancy, or via breast milk, semen, or skin. The team then examined 30 maternal and fetal or neonatal adverse outcomes and grouped them into seven categories: abortions, stillbirths, congenital malformations, pregnancy complications, preterm birth, neonatal complications, and delivery complications.
• The most used anti-HER2 agent was trastuzumab (n = 302), followed by pertuzumab (n = 55), trastuzumab-emtansine (n = 20), and lapatinib (n = 18).

TAKEAWAY:

• Among 3,558 reports included in the analysis, 328 patients were exposed to anti-HER2 drugs compared with 3,230 patients who received other anticancer agents.
• Pregnancy, fetal, or newborn adverse outcomes were reported in 61.3% of women treated with anti-HER2 agents and 56.3% of those receiving other anticancer drugs.
• The five most frequently reported complications in the anti-HER2 group were oligohydramnios (23.8%), preterm birth (17.4%), intrauterine growth restriction (9.8%), neonatal respiratory disorder (7.3%), and spontaneous abortion (7.3%).
• Adverse outcomes overreported in women who received anti-HER2 agents included oligohydramnios (reporting odds ratio [ROR], 17.68), congenital tract disorders (ROR, 9.98), and neonatal kidney failure (ROR, 9.15). Cardiovascular malformations were also overreported among women receiving trastuzumab-emtansine (ROR, 4.46), as were intrauterine growth restrictions for those treated with lapatinib (ROR, 7.68).

IN PRACTICE:

Exposure to anti-HER2 agents was associated with “severe specific adverse pregnancy and fetal or newborn outcomes compared with exposure to other anticancer treatments,” with a “strong, highly significant overreporting of congenital respiratory tract disorders and neonatal kidney failure,” which can lead to oligohydramnios, the authors wrote. The authors also noted that when delaying anti-HER2 therapy is not possible, it’s imperative to monitor patients closely for oligohydramnios.

SOURCE:

The study, led by Paul Gougis, MD, Institut Curie Centre de Recherche, Paris, , was published online in JAMA Network Open.

LIMITATIONS:

Potential inconsistencies in the collection of pharmacovigilance data could limit the generalizability of the results in the general population. The group of women exposed to other anticancer therapies may also constitute a different patient population from that given anti-HER2 therapies.

DISCLOSURES:

Coauthor Jean-Philippe Spano, MD, PhD, declared relationships Gilead, AstraZeneca, Lilly, Pfizer, Novartis, Daiichi Sankyo, and GSK.
 

A version of this article appeared on Medscape.com.

Women, particularly those who are postmenopausal, who sleep less than the recommended 7 hours per night may have impaired insulin sensitivity regardless of their degree of adiposity, a randomized crossover trial reveals.

The research was published recently in Diabetes Care.

Nearly 40 women were randomly assigned to either restricted sleep or adequate sleep for 6 weeks, then crossed over to the other sleep condition. During sleep restriction, women slept an average of 6.2 hours per night versus 7-9 hours per night.

Both fasting insulin levels and insulin resistance were significantly increased during sleep restriction, with the effect on insulin resistance particularly notable in postmenopausal women. This was independent of adiposity and changes in adiposity.

“What we’re seeing is that more insulin is needed to normalize glucose levels in the women under conditions of sleep restriction,” said senior author Marie-Pierre St-Onge, PhD, director of the Center of Excellence for Sleep and Circadian Research at Columbia University Vagelos College of Physicians and Surgeons, New York, in a release.

“Even then, the insulin may not have been doing enough to counteract rising blood glucose levels of postmenopausal women,” she stated.
 

Prolonged lack of sleep may accelerate diabetes progression

Dr. St-Onge added, “If that’s sustained over time, it is possible that prolonged insufficient sleep among individuals with prediabetes could accelerate the progression to type 2 diabetes.”

Dr. St-Onge said in an interview that it was crucial to show the impact of sleep restriction in a randomized study, because “observational studies don’t provide information on causality.”

The study did not rely on people “living in our clinical research facility,” but instead enrolled individuals who were “living their lives,” and the reduction in sleep achieved was “similar to what is seen in the general population with sleep,” she said.

Dr. St-Onge therefore believes the findings indicate that sleep has been overlooked as a contributory factor in insulin sensitivity.

Robert Gabbay, MD, PhD, chief scientific and medical officer at the American Diabetes Association, said in an interview that this is an “important study [that] builds on what we have seen on the importance of sleep for metabolic outcomes and diabetes.”

Joslin Diabetes Center

A version of this article appeared on Medscape.com.

Women, particularly those who are postmenopausal, who sleep less than the recommended 7 hours per night may have impaired insulin sensitivity regardless of their degree of adiposity, a randomized crossover trial reveals.

The research was published recently in Diabetes Care.

Nearly 40 women were randomly assigned to either restricted sleep or adequate sleep for 6 weeks, then crossed over to the other sleep condition. During sleep restriction, women slept an average of 6.2 hours per night versus 7-9 hours per night.

Both fasting insulin levels and insulin resistance were significantly increased during sleep restriction, with the effect on insulin resistance particularly notable in postmenopausal women. This was independent of adiposity and changes in adiposity.

“What we’re seeing is that more insulin is needed to normalize glucose levels in the women under conditions of sleep restriction,” said senior author Marie-Pierre St-Onge, PhD, director of the Center of Excellence for Sleep and Circadian Research at Columbia University Vagelos College of Physicians and Surgeons, New York, in a release.

“Even then, the insulin may not have been doing enough to counteract rising blood glucose levels of postmenopausal women,” she stated.
 

Prolonged lack of sleep may accelerate diabetes progression

Dr. St-Onge added, “If that’s sustained over time, it is possible that prolonged insufficient sleep among individuals with prediabetes could accelerate the progression to type 2 diabetes.”

Dr. St-Onge said in an interview that it was crucial to show the impact of sleep restriction in a randomized study, because “observational studies don’t provide information on causality.”

The study did not rely on people “living in our clinical research facility,” but instead enrolled individuals who were “living their lives,” and the reduction in sleep achieved was “similar to what is seen in the general population with sleep,” she said.

Dr. St-Onge therefore believes the findings indicate that sleep has been overlooked as a contributory factor in insulin sensitivity.

Robert Gabbay, MD, PhD, chief scientific and medical officer at the American Diabetes Association, said in an interview that this is an “important study [that] builds on what we have seen on the importance of sleep for metabolic outcomes and diabetes.”

Joslin Diabetes Center

A version of this article appeared on Medscape.com.

Women, particularly those who are postmenopausal, who sleep less than the recommended 7 hours per night may have impaired insulin sensitivity regardless of their degree of adiposity, a randomized crossover trial reveals.

The research was published recently in Diabetes Care.

Nearly 40 women were randomly assigned to either restricted sleep or adequate sleep for 6 weeks, then crossed over to the other sleep condition. During sleep restriction, women slept an average of 6.2 hours per night versus 7-9 hours per night.

Both fasting insulin levels and insulin resistance were significantly increased during sleep restriction, with the effect on insulin resistance particularly notable in postmenopausal women. This was independent of adiposity and changes in adiposity.

“What we’re seeing is that more insulin is needed to normalize glucose levels in the women under conditions of sleep restriction,” said senior author Marie-Pierre St-Onge, PhD, director of the Center of Excellence for Sleep and Circadian Research at Columbia University Vagelos College of Physicians and Surgeons, New York, in a release.

“Even then, the insulin may not have been doing enough to counteract rising blood glucose levels of postmenopausal women,” she stated.
 

Prolonged lack of sleep may accelerate diabetes progression

Dr. St-Onge added, “If that’s sustained over time, it is possible that prolonged insufficient sleep among individuals with prediabetes could accelerate the progression to type 2 diabetes.”

Dr. St-Onge said in an interview that it was crucial to show the impact of sleep restriction in a randomized study, because “observational studies don’t provide information on causality.”

The study did not rely on people “living in our clinical research facility,” but instead enrolled individuals who were “living their lives,” and the reduction in sleep achieved was “similar to what is seen in the general population with sleep,” she said.

Dr. St-Onge therefore believes the findings indicate that sleep has been overlooked as a contributory factor in insulin sensitivity.

Robert Gabbay, MD, PhD, chief scientific and medical officer at the American Diabetes Association, said in an interview that this is an “important study [that] builds on what we have seen on the importance of sleep for metabolic outcomes and diabetes.”

Joslin Diabetes Center

A version of this article appeared on Medscape.com.

In 2022, two colleagues from Johns Hopkins University, Baltimore, Bhuchitra Singh, MD, MPH, MS, MBA, and James Segars Jr., MD, reviewed the available literature to evaluate the effectiveness of newer minimally invasive therapies in reducing bleeding and improving the quality of life and control of symptoms linked to uterine fibroids. 

Their goal, according to Dr. Segars, a professor of obstetrics and gynecology and director of the division of women’s health research at Johns Hopkins, was to help guide clinicians and patients in making decisions about the use of the newer therapies, including radiofrequency ablation and ultrasound-guided removal of lesions. 

But he and Dr. Singh, the director of clinical research at the Howard W. and Georgeanna Seegar Jones Laboratory of Reproductive Sciences and Women’s Health Research, were surprised by their findings. “The outcomes were relatively the same,” Dr. Segars said. “All of the modalities lead to significant reduction in bleeding and other fibroid-related symptoms.” 

The data on long-term complications and risk for recurrence are sparse for some of the newer approaches, and not enough high-quality long-term studies have been conducted for the Food and Drug Administration to approve them as fertility-sparing treatments.

But perhaps, the biggest challenge now is to ensure that women can take advantage of these newer therapies, with large gaps in both the diagnosis of fibroids and geographic access to minimally invasive treatments.
 

A widespread condition widely underdiagnosed 

Uterine fibroids occur in most women (the incidence rises with age) and can be found in up to 70% of women by the time they reach menopause. Risk factors include family history, increasing interval since last birth, hypertension, and obesity. Increasing parity and use of oral contraceptives are protective.

But as many as 50% of cases go undiagnosed, and one reason for this is the failure of clinicians to dig deeply enough into women’s menstrual histories to diagnose fibroids. 

“The most common cause of anemia is heavy menstrual bleeding,” said Shannon Laughlin-Tommaso, MD, MPH, a professor of obstetrics and gynecology at Mayo Clinic in Rochester, Minn. She frequently sees patients who have already undergone colonoscopy to work-up the source of their anemia before anyone suspects that fibroids are the culprit. 

“When women tell us about their periods, what they’ve been told is normal [bleeding] – or what they’ve always had and considered normal – is actually kind of on the heavier spectrum,” she said. 

Ideally, treatment for uterine fibroids would fix abnormally prolonged or heavy menstrual bleeding, relieve pain, and ameliorate symptoms associated with an enlarged uterus, such as pelvic pressure, urinary frequency, and constipation. And the fibroids would never recur.

By those measures, hysterectomy fits the bill: Success rates in relieving symptoms are high, and the risk for recurrence is zero. But the procedure carries significant drawbacks: short-term complications of surgery, including infection, bleeding, and injury to the bowels and bladder along with potential long-term risks for cardiovascular disease, cancer, ovarian failure and premature menopause, depression, and decline in cognitive function. Those factors loom even larger for women who still hope to have children. 

For that reason, the American College of Obstetricians and Gynecologists recommends myomectomy, or surgical removal of individual fibroids, for women who desire uterine preservation or future pregnancy. And the literature here is solid, according to Dr. Singh, who found that 95% of myomectomy patients achieved control of their bleeding symptoms, whether it was via laparoscopy, hysteroscopy, or laparotomy. Up to 40% of women may develop new fibroids, or leiomyomas, within 3 years, although only 12.2% required a second surgery up to after 5 years. 

But myomectomy is invasive, requiring general anesthesia, incisions in the uterus, and stitches to close the organ. 

Newer techniques have emerged that can effectively treat symptoms of fibroids without requiring surgery. Uterine artery embolization (UAE), which involves passing a catheter into the femoral artery, or laparoscopic uterine artery occlusion can be used to cut off the blood supply of the fibroid. Other techniques, including focused ultrasound surgery and radiofrequency ablation (RFA), use various forms of energy to heat and ablate fibroids. The latter two can be performed in outpatient settings and often without general anesthesia.

Approved for use in 1994, UAE has the most data available, with reduction in the volume of fibroids and uterine tissue lasting up to 5 years, and rates of reintervention of 19%-38% between 2 and 5 years after the procedure. Dr. Singh’s review found that 79%-98.5% of recipients of the procedure reported declines in bleeding that persisted for several years, which is comparable to myomectomy. Quality of life and pain scores also showed good improvement, with follow-up in the different studies ranging from 12 months to over 5 years, the analysis showed.

UAE does have its drawbacks. In rare cases, embolization can deprive the entire uterus and ovaries of blood, which can cause ovarian dysfunction and potentially result in premature menopause, although this outcome is most common in women who are older than 45 years. The procedure can often also be painful enough that overnight hospitalization is required.

Focused ultrasound surgeries, which include magnetic resonance–guided focused ultrasound surgery (MRgFUS) and high-intensity focused ultrasound (HIFU), were approved by the FDA in 2004. Focused ultrasound waves pass through the abdominal wall and produce significant heating, causing a burn that destroys the targeted tissue without damaging surrounding tissue. As with UAE, improvements in fibroid-associated bleeding and measures of quality of life were similar to those after myomectomy up to 3 years later.

But Dr. Singh noted that both focused ultrasound and RFA can damage the skin or internal organs. “[As] always with the thermal interventions, there is the probability of skin as well as internal organs that might get the thermal energy if it’s not focused correctly on to the fibroid itself,” he said. In addition, MRgFUS is not an option for women who are not good candidates to undergo an MRI, such as those with claustrophobia or pacemakers.

Also, with focus ultrasound and RFA, “we do worry about that fibroid getting blood flow back,” which can lead to recurrence of heavy menstrual bleeding, Dr. Laughlin-Tommaso noted. 

Although data on RFA are limited to 12 months of follow-up, most women reported meaningful reductions in bleeding symptoms. Longer follow-up has been reported for bleeding symptoms after MRgFUS, with similar results up to 3 years later. 

For Leslie Hansen-Lindner, MD, chief of obstetrics and gynecology at Atrium Health in Charlotte, N.C., choosing the right procedure starts with a patient-centered conversation weighing the pros and cons of the options and the woman’s goals. 

“Is their goal to reduce the size and impact of their fibroid, bleed less, and have a better quality of life on their period?” Dr. Hansen-Lindner said. “Or is their goal to have the entire fibroid removed?” 

If the former, an RFA is appealing to many women. If the latter, laparoscopic or mini-laparotomy myomectomy might be a better choice. Although fewer than 10% of patients require surgical reintervention at 3 years of follow-up for RFA, myomectomy has more consistent long-term evidence showing that fewer women require re-intervention and preserve their fertility, she added. 

Age also plays a role in the decision: The closer a woman is to menopause, the less likely she is to experience a recurrence, so a less-invasive procedure is preferable. But for younger women hoping to become pregnant, the lower risk for recurrence and good prognosis for future fertility might sway the choice toward myomectomy.

The first laparoscopic RFA procedures were approved for uterine fibroids in 2012. Dr. Hansen-Lindner is a proponent of transcervical fibroid ablation (TFA), a newer RFA procedure that the FDA approved in 2018. Performed through the cervix, TFA requires no incisions and can generally be done without general anesthesia. Eligible candidates would be any woman with symptomatic fibroids, such as heavy menstrual bleeding, pain, or bulk symptoms. The contraindications are few.

“It’s going to come down to size and location of fibroids, and whether or not they would be accessible by the TFA,” Dr. Hansen-Lindner said. “I have to make sure that there isn’t a fibroid blocking their cervix and that the fibroids are accessible with this device.” 

TFA also is not suitable for removing most submucosal lesions, which typically must be removed by hysteroscopic myomectomy. Dr. Hansen-Lindner said that she often uses TFA in conjunction with hysteroscopic myomectomy for this scenario. Although data on pregnancy after RFA (including TFA), MRgFUS, and HIFU are lacking, Gynesonics, the manufacturer of the Sonata System (the device that delivers radiofrequency energy to shrink the fibroid) has documented 79 pregnancies among the 2,200 women who have undergone TFA in the United States since 2018.
 

Disparities hampering care

Uterine fibroids are a particular problem for Black women, whose symptoms are more likely to be ignored by clinicians, according to Jodie Katon, PhD, a core investigator at the Veterans Affairs Greater Los Angeles Center for the Study of Healthcare Innovation, Implementation and Policy. Dr. Katon cited studies in which Black women interviewed about their experiences reported a consistent theme: Clinicians dismissed their symptoms, told them these were nothing to worry about, and advised them to lose weight. Those interactions not only delayed diagnosis among Black women but also led many of them to mistrust clinicians and avoid the health care system altogether.

The failure of clinicians to take their complaints seriously is just one of the disparities affecting Black women. In reviewing the literature, Dr. Laughlin-Tommaso, who also serves as the associate dean for Education Diversity, Equity, and Inclusion at the Mayo Clinic, found that African American women experience two to three times the risk for fibroids, compared with White women, as well as earlier onset and more severe disease, as measured by number and size of the lesions. 

According to Dr. Katon, the etiology of fibroids is still poorly understood. “What we do know is that Black women are disproportionately exposed to a variety of factors that we have shown through observational studies are associated with increased risk of development of uterine fibroids.” 

The list includes factors like stress; interpersonal racism; early age at menarche; various indicators of poor diets, such as vitamin D deficiency; the use of certain beauty products, specifically hair straighteners; as well as exposure to air pollution and other environmental toxins.

Laughlin-Tommaso also pointed to historical disparities in management, citing a doubled risk for hysterectomy for Black women in a study published in 2007 despite survey data suggesting that Black women report being more interested in uterine-preserving therapies rather than a hysterectomy.
 

Breaking down barriers of access to new treatments

Dr. Laughlin-Tommaso looked at more recent trends in the management of fibroids using data from the multicenter COMPARE-UF study, which enrolled women between 2015 and 2020 undergoing fibroid treatment into a longitudinal registry to track their outcomes. She found that Black women underwent hysterectomies at a lower rate than did White women and were instead more likely to undergo myomectomy or UAE. 

Some of the change may reflect lack of approved minimally invasive procedures before 2000. “But now that we have expanded options, I think most women are opting not to have a hysterectomy,” Dr. Laughlin-Tommaso said.

Dr. Katon has research funding from the VA to look more closely at racial disparities in the treatment of fibroids. In a study published in April 2023, she reported some surprising trends. 

During the period from 2010 to 2018, she found that Black veterans diagnosed with fibroids were less likely than White veterans were to receive treatment, regardless of their age or the severity of their symptoms. This finding held even among women with anemia, which should have been a clear indication for treatment.

But, as in the COMPARE-UF study, the subset of Black veterans who received an interventional treatment were less likely than their White peers were to undergo hysterectomy in favor of a fertility-sparing treatment as their initial procedure. Dr. Katon called it a “welcome but unexpected finding.” 

But another significant barrier remains: The two newest types of procedures, RFA and guided focused ultrasound, are not commonly performed outside of tertiary care facilities. However, studies have found that all these procedures are cost effective (studies for myomectomy, UAE, MRgFUS, and TFA). The implementation of a category 1 billing code for laparoscopic RFA in 2017 has led more insurance companies to cover the service, and a category 1 code will be available for TFA effective January 2024. 

Although RFA does require investment in specialized equipment, which limits facilities from offering the procedure, any gynecologist who routinely performs hysteroscopy can easily learn to do TFA. And the VA, which is committed to eliminating disparities in women’s health, established a 2-year advanced fellowship in minimally invasive gynecologic surgery in 2022 to help expand their capacity to offer these procedures. 

The VA has been rapidly expanding their gynecology services, and Katon said that she is confident that ultrasound-guided procedures and RFA will become more available within the system. “I would say we’re keeping pace. And in some ways, you know, as a national system we may be positioned to actually outpace the rest of the U.S.”

Dr. Segars reported prior research funding for clinical trials from BioSpecifics Technologies, Bayer, Allergan, AbbVie, and ObsEva and currently receives funding from Myovant Sciences. Dr. Hansen-Lindner reported personal fees from Gynesonics. Dr. Singh, Dr. Laughlin-Tommaso, and Dr. Katon reported no financial conflicts of interest. 

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

In 2022, two colleagues from Johns Hopkins University, Baltimore, Bhuchitra Singh, MD, MPH, MS, MBA, and James Segars Jr., MD, reviewed the available literature to evaluate the effectiveness of newer minimally invasive therapies in reducing bleeding and improving the quality of life and control of symptoms linked to uterine fibroids. 

Their goal, according to Dr. Segars, a professor of obstetrics and gynecology and director of the division of women’s health research at Johns Hopkins, was to help guide clinicians and patients in making decisions about the use of the newer therapies, including radiofrequency ablation and ultrasound-guided removal of lesions. 

But he and Dr. Singh, the director of clinical research at the Howard W. and Georgeanna Seegar Jones Laboratory of Reproductive Sciences and Women’s Health Research, were surprised by their findings. “The outcomes were relatively the same,” Dr. Segars said. “All of the modalities lead to significant reduction in bleeding and other fibroid-related symptoms.” 

The data on long-term complications and risk for recurrence are sparse for some of the newer approaches, and not enough high-quality long-term studies have been conducted for the Food and Drug Administration to approve them as fertility-sparing treatments.

But perhaps, the biggest challenge now is to ensure that women can take advantage of these newer therapies, with large gaps in both the diagnosis of fibroids and geographic access to minimally invasive treatments.
 

A widespread condition widely underdiagnosed 

Uterine fibroids occur in most women (the incidence rises with age) and can be found in up to 70% of women by the time they reach menopause. Risk factors include family history, increasing interval since last birth, hypertension, and obesity. Increasing parity and use of oral contraceptives are protective.

But as many as 50% of cases go undiagnosed, and one reason for this is the failure of clinicians to dig deeply enough into women’s menstrual histories to diagnose fibroids. 

“The most common cause of anemia is heavy menstrual bleeding,” said Shannon Laughlin-Tommaso, MD, MPH, a professor of obstetrics and gynecology at Mayo Clinic in Rochester, Minn. She frequently sees patients who have already undergone colonoscopy to work-up the source of their anemia before anyone suspects that fibroids are the culprit. 

“When women tell us about their periods, what they’ve been told is normal [bleeding] – or what they’ve always had and considered normal – is actually kind of on the heavier spectrum,” she said. 

Ideally, treatment for uterine fibroids would fix abnormally prolonged or heavy menstrual bleeding, relieve pain, and ameliorate symptoms associated with an enlarged uterus, such as pelvic pressure, urinary frequency, and constipation. And the fibroids would never recur.

By those measures, hysterectomy fits the bill: Success rates in relieving symptoms are high, and the risk for recurrence is zero. But the procedure carries significant drawbacks: short-term complications of surgery, including infection, bleeding, and injury to the bowels and bladder along with potential long-term risks for cardiovascular disease, cancer, ovarian failure and premature menopause, depression, and decline in cognitive function. Those factors loom even larger for women who still hope to have children. 

For that reason, the American College of Obstetricians and Gynecologists recommends myomectomy, or surgical removal of individual fibroids, for women who desire uterine preservation or future pregnancy. And the literature here is solid, according to Dr. Singh, who found that 95% of myomectomy patients achieved control of their bleeding symptoms, whether it was via laparoscopy, hysteroscopy, or laparotomy. Up to 40% of women may develop new fibroids, or leiomyomas, within 3 years, although only 12.2% required a second surgery up to after 5 years. 

But myomectomy is invasive, requiring general anesthesia, incisions in the uterus, and stitches to close the organ. 

Newer techniques have emerged that can effectively treat symptoms of fibroids without requiring surgery. Uterine artery embolization (UAE), which involves passing a catheter into the femoral artery, or laparoscopic uterine artery occlusion can be used to cut off the blood supply of the fibroid. Other techniques, including focused ultrasound surgery and radiofrequency ablation (RFA), use various forms of energy to heat and ablate fibroids. The latter two can be performed in outpatient settings and often without general anesthesia.

Approved for use in 1994, UAE has the most data available, with reduction in the volume of fibroids and uterine tissue lasting up to 5 years, and rates of reintervention of 19%-38% between 2 and 5 years after the procedure. Dr. Singh’s review found that 79%-98.5% of recipients of the procedure reported declines in bleeding that persisted for several years, which is comparable to myomectomy. Quality of life and pain scores also showed good improvement, with follow-up in the different studies ranging from 12 months to over 5 years, the analysis showed.

UAE does have its drawbacks. In rare cases, embolization can deprive the entire uterus and ovaries of blood, which can cause ovarian dysfunction and potentially result in premature menopause, although this outcome is most common in women who are older than 45 years. The procedure can often also be painful enough that overnight hospitalization is required.

Focused ultrasound surgeries, which include magnetic resonance–guided focused ultrasound surgery (MRgFUS) and high-intensity focused ultrasound (HIFU), were approved by the FDA in 2004. Focused ultrasound waves pass through the abdominal wall and produce significant heating, causing a burn that destroys the targeted tissue without damaging surrounding tissue. As with UAE, improvements in fibroid-associated bleeding and measures of quality of life were similar to those after myomectomy up to 3 years later.

But Dr. Singh noted that both focused ultrasound and RFA can damage the skin or internal organs. “[As] always with the thermal interventions, there is the probability of skin as well as internal organs that might get the thermal energy if it’s not focused correctly on to the fibroid itself,” he said. In addition, MRgFUS is not an option for women who are not good candidates to undergo an MRI, such as those with claustrophobia or pacemakers.

Also, with focus ultrasound and RFA, “we do worry about that fibroid getting blood flow back,” which can lead to recurrence of heavy menstrual bleeding, Dr. Laughlin-Tommaso noted. 

Although data on RFA are limited to 12 months of follow-up, most women reported meaningful reductions in bleeding symptoms. Longer follow-up has been reported for bleeding symptoms after MRgFUS, with similar results up to 3 years later. 

For Leslie Hansen-Lindner, MD, chief of obstetrics and gynecology at Atrium Health in Charlotte, N.C., choosing the right procedure starts with a patient-centered conversation weighing the pros and cons of the options and the woman’s goals. 

“Is their goal to reduce the size and impact of their fibroid, bleed less, and have a better quality of life on their period?” Dr. Hansen-Lindner said. “Or is their goal to have the entire fibroid removed?” 

If the former, an RFA is appealing to many women. If the latter, laparoscopic or mini-laparotomy myomectomy might be a better choice. Although fewer than 10% of patients require surgical reintervention at 3 years of follow-up for RFA, myomectomy has more consistent long-term evidence showing that fewer women require re-intervention and preserve their fertility, she added. 

Age also plays a role in the decision: The closer a woman is to menopause, the less likely she is to experience a recurrence, so a less-invasive procedure is preferable. But for younger women hoping to become pregnant, the lower risk for recurrence and good prognosis for future fertility might sway the choice toward myomectomy.

The first laparoscopic RFA procedures were approved for uterine fibroids in 2012. Dr. Hansen-Lindner is a proponent of transcervical fibroid ablation (TFA), a newer RFA procedure that the FDA approved in 2018. Performed through the cervix, TFA requires no incisions and can generally be done without general anesthesia. Eligible candidates would be any woman with symptomatic fibroids, such as heavy menstrual bleeding, pain, or bulk symptoms. The contraindications are few.

“It’s going to come down to size and location of fibroids, and whether or not they would be accessible by the TFA,” Dr. Hansen-Lindner said. “I have to make sure that there isn’t a fibroid blocking their cervix and that the fibroids are accessible with this device.” 

TFA also is not suitable for removing most submucosal lesions, which typically must be removed by hysteroscopic myomectomy. Dr. Hansen-Lindner said that she often uses TFA in conjunction with hysteroscopic myomectomy for this scenario. Although data on pregnancy after RFA (including TFA), MRgFUS, and HIFU are lacking, Gynesonics, the manufacturer of the Sonata System (the device that delivers radiofrequency energy to shrink the fibroid) has documented 79 pregnancies among the 2,200 women who have undergone TFA in the United States since 2018.
 

Disparities hampering care

Uterine fibroids are a particular problem for Black women, whose symptoms are more likely to be ignored by clinicians, according to Jodie Katon, PhD, a core investigator at the Veterans Affairs Greater Los Angeles Center for the Study of Healthcare Innovation, Implementation and Policy. Dr. Katon cited studies in which Black women interviewed about their experiences reported a consistent theme: Clinicians dismissed their symptoms, told them these were nothing to worry about, and advised them to lose weight. Those interactions not only delayed diagnosis among Black women but also led many of them to mistrust clinicians and avoid the health care system altogether.

The failure of clinicians to take their complaints seriously is just one of the disparities affecting Black women. In reviewing the literature, Dr. Laughlin-Tommaso, who also serves as the associate dean for Education Diversity, Equity, and Inclusion at the Mayo Clinic, found that African American women experience two to three times the risk for fibroids, compared with White women, as well as earlier onset and more severe disease, as measured by number and size of the lesions. 

According to Dr. Katon, the etiology of fibroids is still poorly understood. “What we do know is that Black women are disproportionately exposed to a variety of factors that we have shown through observational studies are associated with increased risk of development of uterine fibroids.” 

The list includes factors like stress; interpersonal racism; early age at menarche; various indicators of poor diets, such as vitamin D deficiency; the use of certain beauty products, specifically hair straighteners; as well as exposure to air pollution and other environmental toxins.

Laughlin-Tommaso also pointed to historical disparities in management, citing a doubled risk for hysterectomy for Black women in a study published in 2007 despite survey data suggesting that Black women report being more interested in uterine-preserving therapies rather than a hysterectomy.
 

Breaking down barriers of access to new treatments

Dr. Laughlin-Tommaso looked at more recent trends in the management of fibroids using data from the multicenter COMPARE-UF study, which enrolled women between 2015 and 2020 undergoing fibroid treatment into a longitudinal registry to track their outcomes. She found that Black women underwent hysterectomies at a lower rate than did White women and were instead more likely to undergo myomectomy or UAE. 

Some of the change may reflect lack of approved minimally invasive procedures before 2000. “But now that we have expanded options, I think most women are opting not to have a hysterectomy,” Dr. Laughlin-Tommaso said.

Dr. Katon has research funding from the VA to look more closely at racial disparities in the treatment of fibroids. In a study published in April 2023, she reported some surprising trends. 

During the period from 2010 to 2018, she found that Black veterans diagnosed with fibroids were less likely than White veterans were to receive treatment, regardless of their age or the severity of their symptoms. This finding held even among women with anemia, which should have been a clear indication for treatment.

But, as in the COMPARE-UF study, the subset of Black veterans who received an interventional treatment were less likely than their White peers were to undergo hysterectomy in favor of a fertility-sparing treatment as their initial procedure. Dr. Katon called it a “welcome but unexpected finding.” 

But another significant barrier remains: The two newest types of procedures, RFA and guided focused ultrasound, are not commonly performed outside of tertiary care facilities. However, studies have found that all these procedures are cost effective (studies for myomectomy, UAE, MRgFUS, and TFA). The implementation of a category 1 billing code for laparoscopic RFA in 2017 has led more insurance companies to cover the service, and a category 1 code will be available for TFA effective January 2024. 

Although RFA does require investment in specialized equipment, which limits facilities from offering the procedure, any gynecologist who routinely performs hysteroscopy can easily learn to do TFA. And the VA, which is committed to eliminating disparities in women’s health, established a 2-year advanced fellowship in minimally invasive gynecologic surgery in 2022 to help expand their capacity to offer these procedures. 

The VA has been rapidly expanding their gynecology services, and Katon said that she is confident that ultrasound-guided procedures and RFA will become more available within the system. “I would say we’re keeping pace. And in some ways, you know, as a national system we may be positioned to actually outpace the rest of the U.S.”

Dr. Segars reported prior research funding for clinical trials from BioSpecifics Technologies, Bayer, Allergan, AbbVie, and ObsEva and currently receives funding from Myovant Sciences. Dr. Hansen-Lindner reported personal fees from Gynesonics. Dr. Singh, Dr. Laughlin-Tommaso, and Dr. Katon reported no financial conflicts of interest. 

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

In 2022, two colleagues from Johns Hopkins University, Baltimore, Bhuchitra Singh, MD, MPH, MS, MBA, and James Segars Jr., MD, reviewed the available literature to evaluate the effectiveness of newer minimally invasive therapies in reducing bleeding and improving the quality of life and control of symptoms linked to uterine fibroids. 

Their goal, according to Dr. Segars, a professor of obstetrics and gynecology and director of the division of women’s health research at Johns Hopkins, was to help guide clinicians and patients in making decisions about the use of the newer therapies, including radiofrequency ablation and ultrasound-guided removal of lesions. 

But he and Dr. Singh, the director of clinical research at the Howard W. and Georgeanna Seegar Jones Laboratory of Reproductive Sciences and Women’s Health Research, were surprised by their findings. “The outcomes were relatively the same,” Dr. Segars said. “All of the modalities lead to significant reduction in bleeding and other fibroid-related symptoms.” 

The data on long-term complications and risk for recurrence are sparse for some of the newer approaches, and not enough high-quality long-term studies have been conducted for the Food and Drug Administration to approve them as fertility-sparing treatments.

But perhaps, the biggest challenge now is to ensure that women can take advantage of these newer therapies, with large gaps in both the diagnosis of fibroids and geographic access to minimally invasive treatments.
 

A widespread condition widely underdiagnosed 

Uterine fibroids occur in most women (the incidence rises with age) and can be found in up to 70% of women by the time they reach menopause. Risk factors include family history, increasing interval since last birth, hypertension, and obesity. Increasing parity and use of oral contraceptives are protective.

But as many as 50% of cases go undiagnosed, and one reason for this is the failure of clinicians to dig deeply enough into women’s menstrual histories to diagnose fibroids. 

“The most common cause of anemia is heavy menstrual bleeding,” said Shannon Laughlin-Tommaso, MD, MPH, a professor of obstetrics and gynecology at Mayo Clinic in Rochester, Minn. She frequently sees patients who have already undergone colonoscopy to work-up the source of their anemia before anyone suspects that fibroids are the culprit. 

“When women tell us about their periods, what they’ve been told is normal [bleeding] – or what they’ve always had and considered normal – is actually kind of on the heavier spectrum,” she said. 

Ideally, treatment for uterine fibroids would fix abnormally prolonged or heavy menstrual bleeding, relieve pain, and ameliorate symptoms associated with an enlarged uterus, such as pelvic pressure, urinary frequency, and constipation. And the fibroids would never recur.

By those measures, hysterectomy fits the bill: Success rates in relieving symptoms are high, and the risk for recurrence is zero. But the procedure carries significant drawbacks: short-term complications of surgery, including infection, bleeding, and injury to the bowels and bladder along with potential long-term risks for cardiovascular disease, cancer, ovarian failure and premature menopause, depression, and decline in cognitive function. Those factors loom even larger for women who still hope to have children. 

For that reason, the American College of Obstetricians and Gynecologists recommends myomectomy, or surgical removal of individual fibroids, for women who desire uterine preservation or future pregnancy. And the literature here is solid, according to Dr. Singh, who found that 95% of myomectomy patients achieved control of their bleeding symptoms, whether it was via laparoscopy, hysteroscopy, or laparotomy. Up to 40% of women may develop new fibroids, or leiomyomas, within 3 years, although only 12.2% required a second surgery up to after 5 years. 

But myomectomy is invasive, requiring general anesthesia, incisions in the uterus, and stitches to close the organ. 

Newer techniques have emerged that can effectively treat symptoms of fibroids without requiring surgery. Uterine artery embolization (UAE), which involves passing a catheter into the femoral artery, or laparoscopic uterine artery occlusion can be used to cut off the blood supply of the fibroid. Other techniques, including focused ultrasound surgery and radiofrequency ablation (RFA), use various forms of energy to heat and ablate fibroids. The latter two can be performed in outpatient settings and often without general anesthesia.

Approved for use in 1994, UAE has the most data available, with reduction in the volume of fibroids and uterine tissue lasting up to 5 years, and rates of reintervention of 19%-38% between 2 and 5 years after the procedure. Dr. Singh’s review found that 79%-98.5% of recipients of the procedure reported declines in bleeding that persisted for several years, which is comparable to myomectomy. Quality of life and pain scores also showed good improvement, with follow-up in the different studies ranging from 12 months to over 5 years, the analysis showed.

UAE does have its drawbacks. In rare cases, embolization can deprive the entire uterus and ovaries of blood, which can cause ovarian dysfunction and potentially result in premature menopause, although this outcome is most common in women who are older than 45 years. The procedure can often also be painful enough that overnight hospitalization is required.

Focused ultrasound surgeries, which include magnetic resonance–guided focused ultrasound surgery (MRgFUS) and high-intensity focused ultrasound (HIFU), were approved by the FDA in 2004. Focused ultrasound waves pass through the abdominal wall and produce significant heating, causing a burn that destroys the targeted tissue without damaging surrounding tissue. As with UAE, improvements in fibroid-associated bleeding and measures of quality of life were similar to those after myomectomy up to 3 years later.

But Dr. Singh noted that both focused ultrasound and RFA can damage the skin or internal organs. “[As] always with the thermal interventions, there is the probability of skin as well as internal organs that might get the thermal energy if it’s not focused correctly on to the fibroid itself,” he said. In addition, MRgFUS is not an option for women who are not good candidates to undergo an MRI, such as those with claustrophobia or pacemakers.

Also, with focus ultrasound and RFA, “we do worry about that fibroid getting blood flow back,” which can lead to recurrence of heavy menstrual bleeding, Dr. Laughlin-Tommaso noted. 

Although data on RFA are limited to 12 months of follow-up, most women reported meaningful reductions in bleeding symptoms. Longer follow-up has been reported for bleeding symptoms after MRgFUS, with similar results up to 3 years later. 

For Leslie Hansen-Lindner, MD, chief of obstetrics and gynecology at Atrium Health in Charlotte, N.C., choosing the right procedure starts with a patient-centered conversation weighing the pros and cons of the options and the woman’s goals. 

“Is their goal to reduce the size and impact of their fibroid, bleed less, and have a better quality of life on their period?” Dr. Hansen-Lindner said. “Or is their goal to have the entire fibroid removed?” 

If the former, an RFA is appealing to many women. If the latter, laparoscopic or mini-laparotomy myomectomy might be a better choice. Although fewer than 10% of patients require surgical reintervention at 3 years of follow-up for RFA, myomectomy has more consistent long-term evidence showing that fewer women require re-intervention and preserve their fertility, she added. 

Age also plays a role in the decision: The closer a woman is to menopause, the less likely she is to experience a recurrence, so a less-invasive procedure is preferable. But for younger women hoping to become pregnant, the lower risk for recurrence and good prognosis for future fertility might sway the choice toward myomectomy.

The first laparoscopic RFA procedures were approved for uterine fibroids in 2012. Dr. Hansen-Lindner is a proponent of transcervical fibroid ablation (TFA), a newer RFA procedure that the FDA approved in 2018. Performed through the cervix, TFA requires no incisions and can generally be done without general anesthesia. Eligible candidates would be any woman with symptomatic fibroids, such as heavy menstrual bleeding, pain, or bulk symptoms. The contraindications are few.

“It’s going to come down to size and location of fibroids, and whether or not they would be accessible by the TFA,” Dr. Hansen-Lindner said. “I have to make sure that there isn’t a fibroid blocking their cervix and that the fibroids are accessible with this device.” 

TFA also is not suitable for removing most submucosal lesions, which typically must be removed by hysteroscopic myomectomy. Dr. Hansen-Lindner said that she often uses TFA in conjunction with hysteroscopic myomectomy for this scenario. Although data on pregnancy after RFA (including TFA), MRgFUS, and HIFU are lacking, Gynesonics, the manufacturer of the Sonata System (the device that delivers radiofrequency energy to shrink the fibroid) has documented 79 pregnancies among the 2,200 women who have undergone TFA in the United States since 2018.
 

Disparities hampering care

Uterine fibroids are a particular problem for Black women, whose symptoms are more likely to be ignored by clinicians, according to Jodie Katon, PhD, a core investigator at the Veterans Affairs Greater Los Angeles Center for the Study of Healthcare Innovation, Implementation and Policy. Dr. Katon cited studies in which Black women interviewed about their experiences reported a consistent theme: Clinicians dismissed their symptoms, told them these were nothing to worry about, and advised them to lose weight. Those interactions not only delayed diagnosis among Black women but also led many of them to mistrust clinicians and avoid the health care system altogether.

The failure of clinicians to take their complaints seriously is just one of the disparities affecting Black women. In reviewing the literature, Dr. Laughlin-Tommaso, who also serves as the associate dean for Education Diversity, Equity, and Inclusion at the Mayo Clinic, found that African American women experience two to three times the risk for fibroids, compared with White women, as well as earlier onset and more severe disease, as measured by number and size of the lesions. 

According to Dr. Katon, the etiology of fibroids is still poorly understood. “What we do know is that Black women are disproportionately exposed to a variety of factors that we have shown through observational studies are associated with increased risk of development of uterine fibroids.” 

The list includes factors like stress; interpersonal racism; early age at menarche; various indicators of poor diets, such as vitamin D deficiency; the use of certain beauty products, specifically hair straighteners; as well as exposure to air pollution and other environmental toxins.

Laughlin-Tommaso also pointed to historical disparities in management, citing a doubled risk for hysterectomy for Black women in a study published in 2007 despite survey data suggesting that Black women report being more interested in uterine-preserving therapies rather than a hysterectomy.
 

Breaking down barriers of access to new treatments

Dr. Laughlin-Tommaso looked at more recent trends in the management of fibroids using data from the multicenter COMPARE-UF study, which enrolled women between 2015 and 2020 undergoing fibroid treatment into a longitudinal registry to track their outcomes. She found that Black women underwent hysterectomies at a lower rate than did White women and were instead more likely to undergo myomectomy or UAE. 

Some of the change may reflect lack of approved minimally invasive procedures before 2000. “But now that we have expanded options, I think most women are opting not to have a hysterectomy,” Dr. Laughlin-Tommaso said.

Dr. Katon has research funding from the VA to look more closely at racial disparities in the treatment of fibroids. In a study published in April 2023, she reported some surprising trends. 

During the period from 2010 to 2018, she found that Black veterans diagnosed with fibroids were less likely than White veterans were to receive treatment, regardless of their age or the severity of their symptoms. This finding held even among women with anemia, which should have been a clear indication for treatment.

But, as in the COMPARE-UF study, the subset of Black veterans who received an interventional treatment were less likely than their White peers were to undergo hysterectomy in favor of a fertility-sparing treatment as their initial procedure. Dr. Katon called it a “welcome but unexpected finding.” 

But another significant barrier remains: The two newest types of procedures, RFA and guided focused ultrasound, are not commonly performed outside of tertiary care facilities. However, studies have found that all these procedures are cost effective (studies for myomectomy, UAE, MRgFUS, and TFA). The implementation of a category 1 billing code for laparoscopic RFA in 2017 has led more insurance companies to cover the service, and a category 1 code will be available for TFA effective January 2024. 

Although RFA does require investment in specialized equipment, which limits facilities from offering the procedure, any gynecologist who routinely performs hysteroscopy can easily learn to do TFA. And the VA, which is committed to eliminating disparities in women’s health, established a 2-year advanced fellowship in minimally invasive gynecologic surgery in 2022 to help expand their capacity to offer these procedures. 

The VA has been rapidly expanding their gynecology services, and Katon said that she is confident that ultrasound-guided procedures and RFA will become more available within the system. “I would say we’re keeping pace. And in some ways, you know, as a national system we may be positioned to actually outpace the rest of the U.S.”

Dr. Segars reported prior research funding for clinical trials from BioSpecifics Technologies, Bayer, Allergan, AbbVie, and ObsEva and currently receives funding from Myovant Sciences. Dr. Hansen-Lindner reported personal fees from Gynesonics. Dr. Singh, Dr. Laughlin-Tommaso, and Dr. Katon reported no financial conflicts of interest. 

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

TOPLINE:

Posttraumatic stress disorder (PTSD) symptoms are associated with poorer cardiovascular and neurocognitive health among midlife women, particularly those who are APOEε4 carriers, new research suggests.

METHODOLOGY:

• Researchers conducted a cross-sectional study of 274 women (mean age, 59 years) participating in the MsBrain study of menopause and brain health.
• As part of the study, the women completed the PTSD Checklist–Civilian Version and underwent physical and neuropsychological testing, as well as carotid artery ultrasonography and brain MRI.
• Outcomes of interest were associations of PTSD symptoms with carotid intima media thickness (IMT), brain white matter hyperintensity volume (WMHV), and cognition, assessed in linear regression models.
• Interactions by APOEε4 were assessed; covariates included age, race/ethnicity, education, and CVD risk factors.

TAKEAWAY:

• Higher PTSD symptoms were associated with greater carotid IMT (P = .03); associations of PTSD symptoms with neurocognitive outcomes varied significantly by APOEε4 status.
• Among APOEε4 carriers, PTSD symptoms were associated with greater whole-brain WMHV (P = .009), periventricular WMHV (P = .02), deep WMHV (P = .01), and frontal WMHV (P = .04) in multivariable models.
• APOEε4 carriers with PTSD symptoms also had poorer cognition, specifically attention and working memory (P = .02), semantic fluency (P = .01), perceptual speed (P = .002) and processing speed (P = .002), in multivariable models.

IN PRACTICE:

“This study sheds important insight on the implications of PTSD symptoms to women’s cardiovascular and neurocognitive health. Our findings indicate that the APOEε4 genotype may identify a group of women with PTSD symptoms at particular risk for poor neurocognitive health,” the authors wrote.

SOURCE:

The study, with first author Rebecca Thurston, PhD, of the department of psychiatry, University of Pittsburgh, was published online  in JAMA Network Open.

LIMITATIONS:

No diagnostic clinical interviews were conducted, and PTSD treatment was not assessed. All participants identified as cisgender, and most were non-Hispanic Black or White. The study was observational and cross-sectional, precluding assertions about directionality or causality.

DISCLOSURES:

The study was funded by the National Institutes of Health, the University of Pittsburgh Clinical and Translational Science Institute, and the University of Pittsburgh Small Molecule Biomarker Core. Dr. Thurston reported receiving personal fees from Astellas Pharma, Bayer, Hello Therapeutics, Vira Health, and Happify Health outside the submitted work.

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

TOPLINE:

Posttraumatic stress disorder (PTSD) symptoms are associated with poorer cardiovascular and neurocognitive health among midlife women, particularly those who are APOEε4 carriers, new research suggests.

METHODOLOGY:

• Researchers conducted a cross-sectional study of 274 women (mean age, 59 years) participating in the MsBrain study of menopause and brain health.
• As part of the study, the women completed the PTSD Checklist–Civilian Version and underwent physical and neuropsychological testing, as well as carotid artery ultrasonography and brain MRI.
• Outcomes of interest were associations of PTSD symptoms with carotid intima media thickness (IMT), brain white matter hyperintensity volume (WMHV), and cognition, assessed in linear regression models.
• Interactions by APOEε4 were assessed; covariates included age, race/ethnicity, education, and CVD risk factors.

TAKEAWAY:

• Higher PTSD symptoms were associated with greater carotid IMT (P = .03); associations of PTSD symptoms with neurocognitive outcomes varied significantly by APOEε4 status.
• Among APOEε4 carriers, PTSD symptoms were associated with greater whole-brain WMHV (P = .009), periventricular WMHV (P = .02), deep WMHV (P = .01), and frontal WMHV (P = .04) in multivariable models.
• APOEε4 carriers with PTSD symptoms also had poorer cognition, specifically attention and working memory (P = .02), semantic fluency (P = .01), perceptual speed (P = .002) and processing speed (P = .002), in multivariable models.

IN PRACTICE:

“This study sheds important insight on the implications of PTSD symptoms to women’s cardiovascular and neurocognitive health. Our findings indicate that the APOEε4 genotype may identify a group of women with PTSD symptoms at particular risk for poor neurocognitive health,” the authors wrote.

SOURCE:

The study, with first author Rebecca Thurston, PhD, of the department of psychiatry, University of Pittsburgh, was published online  in JAMA Network Open.

LIMITATIONS:

No diagnostic clinical interviews were conducted, and PTSD treatment was not assessed. All participants identified as cisgender, and most were non-Hispanic Black or White. The study was observational and cross-sectional, precluding assertions about directionality or causality.

DISCLOSURES:

The study was funded by the National Institutes of Health, the University of Pittsburgh Clinical and Translational Science Institute, and the University of Pittsburgh Small Molecule Biomarker Core. Dr. Thurston reported receiving personal fees from Astellas Pharma, Bayer, Hello Therapeutics, Vira Health, and Happify Health outside the submitted work.

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

TOPLINE:

Posttraumatic stress disorder (PTSD) symptoms are associated with poorer cardiovascular and neurocognitive health among midlife women, particularly those who are APOEε4 carriers, new research suggests.

METHODOLOGY:

• Researchers conducted a cross-sectional study of 274 women (mean age, 59 years) participating in the MsBrain study of menopause and brain health.
• As part of the study, the women completed the PTSD Checklist–Civilian Version and underwent physical and neuropsychological testing, as well as carotid artery ultrasonography and brain MRI.
• Outcomes of interest were associations of PTSD symptoms with carotid intima media thickness (IMT), brain white matter hyperintensity volume (WMHV), and cognition, assessed in linear regression models.
• Interactions by APOEε4 were assessed; covariates included age, race/ethnicity, education, and CVD risk factors.

TAKEAWAY:

• Higher PTSD symptoms were associated with greater carotid IMT (P = .03); associations of PTSD symptoms with neurocognitive outcomes varied significantly by APOEε4 status.
• Among APOEε4 carriers, PTSD symptoms were associated with greater whole-brain WMHV (P = .009), periventricular WMHV (P = .02), deep WMHV (P = .01), and frontal WMHV (P = .04) in multivariable models.
• APOEε4 carriers with PTSD symptoms also had poorer cognition, specifically attention and working memory (P = .02), semantic fluency (P = .01), perceptual speed (P = .002) and processing speed (P = .002), in multivariable models.

IN PRACTICE:

“This study sheds important insight on the implications of PTSD symptoms to women’s cardiovascular and neurocognitive health. Our findings indicate that the APOEε4 genotype may identify a group of women with PTSD symptoms at particular risk for poor neurocognitive health,” the authors wrote.

SOURCE:

The study, with first author Rebecca Thurston, PhD, of the department of psychiatry, University of Pittsburgh, was published online  in JAMA Network Open.

LIMITATIONS:

No diagnostic clinical interviews were conducted, and PTSD treatment was not assessed. All participants identified as cisgender, and most were non-Hispanic Black or White. The study was observational and cross-sectional, precluding assertions about directionality or causality.

DISCLOSURES:

The study was funded by the National Institutes of Health, the University of Pittsburgh Clinical and Translational Science Institute, and the University of Pittsburgh Small Molecule Biomarker Core. Dr. Thurston reported receiving personal fees from Astellas Pharma, Bayer, Hello Therapeutics, Vira Health, and Happify Health outside the submitted work.

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

Use of low-dose aspirin to manage hypertension in pregnancy caused no increased flares in patients with inflammatory bowel disease, shows new research presented in October at the American College of Gastroenterology (ACG) Annual Scientific Meeting.

Low-dose aspirin is recommended for pregnant women who are at risk of hypertensive disorders, such as eclampsia, preeclampsia, and gestational diabetes, said Uma Mahadevan, MD, AGAF, a gastroenterologist and director of the University of California, San Francisco Colitis and Crohn’s Disease Center, who presented the research at the meeting. Regular nonsteroidal anti-inflammatory drug use has been associated with increased disease activity in patients with inflammatory bowel disease (IBD), but the impact of low-dose aspirin on IBD during pregnancy has not been well studied, she said.

The study, which was conducted between January 2013 and December 2022 at a single clinic, included 325 women (mean age 34 years) with IBD who had at least one pregnancy. Of these, 53% had ulcerative colitis and 47% had Crohn’s disease. The primary outcome was IBD flare during pregnancy or within 6 months postpartum. Flares were defined as an IBD-related hospitalization and/or surgery, new initiation of IBD therapy, elevated level of fecal calprotectin greater than 150 micrograms per milligram, or new active endoscopic disease.

A total of 95 patients (29%) used low-dose aspirin during pregnancy; 59 took 81 mg and 36 took 162 mg. The cumulative flare rate was similar between patients who took low-dose aspirin and those who did not (24% vs. 26%, P = .83). However, patients who took low-dose aspirin were significantly more likely than were those who did not to experience preterm birth, younger gestational age at delivery, and cesarean delivery (22.1% vs. 6.1%, 38 weeks vs. 39 weeks, 51% vs. 27%, respectively, P < .01 for all).

Overall rates of hypertensive disorders of pregnancy were similar between the low-dose aspirin and non–low-dose aspirin groups (22% vs. 19%, respectively, P = .59), but individuals on low-dose aspirin were more likely to experience preeclampsia than were those not on low-dose aspirin (11.6% vs 4.3%, P = .03).

The study findings support the benefits of aspirin for pregnant women at increased risk for these conditions. “Pregnant patients with IBD should be offered low-dose aspirin without concern for increased risk of flares,” Dr. Mahadevan said.

“This is a very practical study with high relevance in our everyday management of IBD patients,” Shannon Chang, MD, a specialist in IBD with NYU Langone Health, said in an interview. “Having this study helps us understand the risk of increased IBD activity in the setting of aspirin use during pregnancy.”

Dr. Chang was not surprised by the findings. “Since the [ACOG] guidelines changed several years ago, there have been more and more patients with IBD who have taken aspirin during their pregnancies and the results of this study seem to match what we see in clinical practice,” she said. “This study will help us counsel our patients on the safety of aspirin use during pregnancy, and the findings will also be useful for discussions with our obstetrics colleagues who may seek guidance on the safety of aspirin [use] in our pregnant IBD patients.”

The study received no outside funding. Dr. Mahadevan disclosed relationships with AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Gilead, Janssen, Pfizer, Prometheus Biosciences, Protagonist Therapeutics, Rani Therapeutics, Roivant, and Takeda. Dr. Chang disclosed serving as a consultant for Pfizer, AbbVie, and BMS.

Use of low-dose aspirin to manage hypertension in pregnancy caused no increased flares in patients with inflammatory bowel disease, shows new research presented in October at the American College of Gastroenterology (ACG) Annual Scientific Meeting.

Low-dose aspirin is recommended for pregnant women who are at risk of hypertensive disorders, such as eclampsia, preeclampsia, and gestational diabetes, said Uma Mahadevan, MD, AGAF, a gastroenterologist and director of the University of California, San Francisco Colitis and Crohn’s Disease Center, who presented the research at the meeting. Regular nonsteroidal anti-inflammatory drug use has been associated with increased disease activity in patients with inflammatory bowel disease (IBD), but the impact of low-dose aspirin on IBD during pregnancy has not been well studied, she said.

The study, which was conducted between January 2013 and December 2022 at a single clinic, included 325 women (mean age 34 years) with IBD who had at least one pregnancy. Of these, 53% had ulcerative colitis and 47% had Crohn’s disease. The primary outcome was IBD flare during pregnancy or within 6 months postpartum. Flares were defined as an IBD-related hospitalization and/or surgery, new initiation of IBD therapy, elevated level of fecal calprotectin greater than 150 micrograms per milligram, or new active endoscopic disease.

A total of 95 patients (29%) used low-dose aspirin during pregnancy; 59 took 81 mg and 36 took 162 mg. The cumulative flare rate was similar between patients who took low-dose aspirin and those who did not (24% vs. 26%, P = .83). However, patients who took low-dose aspirin were significantly more likely than were those who did not to experience preterm birth, younger gestational age at delivery, and cesarean delivery (22.1% vs. 6.1%, 38 weeks vs. 39 weeks, 51% vs. 27%, respectively, P < .01 for all).

Overall rates of hypertensive disorders of pregnancy were similar between the low-dose aspirin and non–low-dose aspirin groups (22% vs. 19%, respectively, P = .59), but individuals on low-dose aspirin were more likely to experience preeclampsia than were those not on low-dose aspirin (11.6% vs 4.3%, P = .03).

The study findings support the benefits of aspirin for pregnant women at increased risk for these conditions. “Pregnant patients with IBD should be offered low-dose aspirin without concern for increased risk of flares,” Dr. Mahadevan said.

“This is a very practical study with high relevance in our everyday management of IBD patients,” Shannon Chang, MD, a specialist in IBD with NYU Langone Health, said in an interview. “Having this study helps us understand the risk of increased IBD activity in the setting of aspirin use during pregnancy.”

Dr. Chang was not surprised by the findings. “Since the [ACOG] guidelines changed several years ago, there have been more and more patients with IBD who have taken aspirin during their pregnancies and the results of this study seem to match what we see in clinical practice,” she said. “This study will help us counsel our patients on the safety of aspirin use during pregnancy, and the findings will also be useful for discussions with our obstetrics colleagues who may seek guidance on the safety of aspirin [use] in our pregnant IBD patients.”

The study received no outside funding. Dr. Mahadevan disclosed relationships with AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Gilead, Janssen, Pfizer, Prometheus Biosciences, Protagonist Therapeutics, Rani Therapeutics, Roivant, and Takeda. Dr. Chang disclosed serving as a consultant for Pfizer, AbbVie, and BMS.

Use of low-dose aspirin to manage hypertension in pregnancy caused no increased flares in patients with inflammatory bowel disease, shows new research presented in October at the American College of Gastroenterology (ACG) Annual Scientific Meeting.

Low-dose aspirin is recommended for pregnant women who are at risk of hypertensive disorders, such as eclampsia, preeclampsia, and gestational diabetes, said Uma Mahadevan, MD, AGAF, a gastroenterologist and director of the University of California, San Francisco Colitis and Crohn’s Disease Center, who presented the research at the meeting. Regular nonsteroidal anti-inflammatory drug use has been associated with increased disease activity in patients with inflammatory bowel disease (IBD), but the impact of low-dose aspirin on IBD during pregnancy has not been well studied, she said.

The study, which was conducted between January 2013 and December 2022 at a single clinic, included 325 women (mean age 34 years) with IBD who had at least one pregnancy. Of these, 53% had ulcerative colitis and 47% had Crohn’s disease. The primary outcome was IBD flare during pregnancy or within 6 months postpartum. Flares were defined as an IBD-related hospitalization and/or surgery, new initiation of IBD therapy, elevated level of fecal calprotectin greater than 150 micrograms per milligram, or new active endoscopic disease.

A total of 95 patients (29%) used low-dose aspirin during pregnancy; 59 took 81 mg and 36 took 162 mg. The cumulative flare rate was similar between patients who took low-dose aspirin and those who did not (24% vs. 26%, P = .83). However, patients who took low-dose aspirin were significantly more likely than were those who did not to experience preterm birth, younger gestational age at delivery, and cesarean delivery (22.1% vs. 6.1%, 38 weeks vs. 39 weeks, 51% vs. 27%, respectively, P < .01 for all).

Overall rates of hypertensive disorders of pregnancy were similar between the low-dose aspirin and non–low-dose aspirin groups (22% vs. 19%, respectively, P = .59), but individuals on low-dose aspirin were more likely to experience preeclampsia than were those not on low-dose aspirin (11.6% vs 4.3%, P = .03).

The study findings support the benefits of aspirin for pregnant women at increased risk for these conditions. “Pregnant patients with IBD should be offered low-dose aspirin without concern for increased risk of flares,” Dr. Mahadevan said.

“This is a very practical study with high relevance in our everyday management of IBD patients,” Shannon Chang, MD, a specialist in IBD with NYU Langone Health, said in an interview. “Having this study helps us understand the risk of increased IBD activity in the setting of aspirin use during pregnancy.”

Dr. Chang was not surprised by the findings. “Since the [ACOG] guidelines changed several years ago, there have been more and more patients with IBD who have taken aspirin during their pregnancies and the results of this study seem to match what we see in clinical practice,” she said. “This study will help us counsel our patients on the safety of aspirin use during pregnancy, and the findings will also be useful for discussions with our obstetrics colleagues who may seek guidance on the safety of aspirin [use] in our pregnant IBD patients.”

The study received no outside funding. Dr. Mahadevan disclosed relationships with AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Gilead, Janssen, Pfizer, Prometheus Biosciences, Protagonist Therapeutics, Rani Therapeutics, Roivant, and Takeda. Dr. Chang disclosed serving as a consultant for Pfizer, AbbVie, and BMS.

SAN DIEGO – In pregnant women with systemic lupus erythematosus (SLE), those with ill-timed pregnancies had poorer pregnancy outcomes, including preeclampsia and preterm birth.

Women with autoimmune conditions are at an increased risk for pregnancy complications, including pregnancy loss, preterm delivery, and increased need for cesarean delivery, said Catherine Sims, MD, a rheumatologist at Duke Health in Durham, N.C., who is focused on reproductive rheumatology. “The natural question, both clinically and from a research perspective, is: ‘What can we do in order to mitigate or minimize these complications?’ ” she said during a presentation at the annual meeting of the American College of Rheumatology.

Lucy Hicks/Medscape Medical News

While research suggests that patients who plan their pregnancies during times of well-controlled disease have the “best chances of improved pregnancy outcomes,” Dr. Sims and colleagues wanted to quantify how planning for pregnancy affected reproductive outcomes.

Dr. Sims recruited pregnant women with SLE and assessed if the women were medically optimized for pregnancy, if the pregnancy was intended, or both. Intended pregnancy was assessed by using a validated self-reported survey called the London Measure of Unplanned Pregnancy. Pregnant women were considered “medically optimized” for pregnancy if they were not on teratogenic medication, had continued pregnancy-compatible SLE medications, and had a urine protein-creatinine ratio of less than 1 gram in the 6 months prior to or during the first trimester. Intended pregnancies that were medically optimized were classified as “well timed.”

Of the 115 women enrolled in the study, about half had well-timed pregnancies, 20% were neither intended nor medically optimized, 17% were not intended but medically optimized, and 13% were intended but not medically optimized.

Women with ill-timed pregnancy – either not medically optimized and/or unintended – were generally younger and more likely to be single, on Medicare or Medicaid, and on income of less than $50,000 per year.

Ill-timed pregnancies had higher rates of mycophenolate exposure and higher physician-reported SLE disease activity. While patient-reported SLE activity was higher in patients who were not personally ready for pregnancy, in patients who had an intended pregnancy, there was no difference in self-reported SLE activity between those that were medically optimized and those not medically optimized.

“About a third of our patients are actually underestimating their true disease activity level when they are preparing for pregnancy,” Dr. Sims said. For example, while persistent proteinuria in a patient would drive up physician assessment of disease activity, the patient may not be experiencing any symptoms and is unaware of her condition.

In terms of pregnancy outcomes, women with unintended pregnancies had a 2.5 times higher incidence of preeclampsia, compared with those with intended pregnancies. Patients with unplanned pregnancies were also significantly more likely to experience stillbirth.

Women who were not medically optimized for pregnancy were three times as likely to experience preterm birth and preeclampsia compared with those with optimized pregnancies.

These outcomes drive home the importance of optimizing patients for pregnancy, Dr. Sims said, and effectively communicating this importance to patients, especially when they might not be perceiving their disease activity.

The study’s findings show providers “what we thought we knew, which is that there are some patients that are not as aware of their risk,” commented Lisa R. Sammaritano, MD, Hospital for Special Surgery, New York, who moderated the session where the research was presented. “It brings home the importance of counselling our patients about contraception [as well as] the importance of planning.”

Dr. Sims added that it is “crucial” to make this information easily accessible and digestible to patients. One important resource she mentioned is the HOP-STEP program, which stands for Healthy Outcomes in Pregnancy with SLE Through Education of Providers. The program, directed by researchers at Duke University, is designed to improve pregnancy planning in people with lupus. Direct-to-patient resources are key, she said, as patients can often be nervous to ask about pregnancy planning during appointments.

“They won’t want to bring a pregnancy with me in clinic because they’re afraid I’m just going to say, ‘don’t do it,’ ” Dr. Sims said. “But we are making decisions with the patient. Our patients are not asking for permission, but telling us what they want, and we need to meet them where they are at.”

A version of this article appeared on Medscape.com.

SAN DIEGO – In pregnant women with systemic lupus erythematosus (SLE), those with ill-timed pregnancies had poorer pregnancy outcomes, including preeclampsia and preterm birth.

Women with autoimmune conditions are at an increased risk for pregnancy complications, including pregnancy loss, preterm delivery, and increased need for cesarean delivery, said Catherine Sims, MD, a rheumatologist at Duke Health in Durham, N.C., who is focused on reproductive rheumatology. “The natural question, both clinically and from a research perspective, is: ‘What can we do in order to mitigate or minimize these complications?’ ” she said during a presentation at the annual meeting of the American College of Rheumatology.

Lucy Hicks/Medscape Medical News

While research suggests that patients who plan their pregnancies during times of well-controlled disease have the “best chances of improved pregnancy outcomes,” Dr. Sims and colleagues wanted to quantify how planning for pregnancy affected reproductive outcomes.

Dr. Sims recruited pregnant women with SLE and assessed if the women were medically optimized for pregnancy, if the pregnancy was intended, or both. Intended pregnancy was assessed by using a validated self-reported survey called the London Measure of Unplanned Pregnancy. Pregnant women were considered “medically optimized” for pregnancy if they were not on teratogenic medication, had continued pregnancy-compatible SLE medications, and had a urine protein-creatinine ratio of less than 1 gram in the 6 months prior to or during the first trimester. Intended pregnancies that were medically optimized were classified as “well timed.”

Of the 115 women enrolled in the study, about half had well-timed pregnancies, 20% were neither intended nor medically optimized, 17% were not intended but medically optimized, and 13% were intended but not medically optimized.

Women with ill-timed pregnancy – either not medically optimized and/or unintended – were generally younger and more likely to be single, on Medicare or Medicaid, and on income of less than $50,000 per year.

Ill-timed pregnancies had higher rates of mycophenolate exposure and higher physician-reported SLE disease activity. While patient-reported SLE activity was higher in patients who were not personally ready for pregnancy, in patients who had an intended pregnancy, there was no difference in self-reported SLE activity between those that were medically optimized and those not medically optimized.

“About a third of our patients are actually underestimating their true disease activity level when they are preparing for pregnancy,” Dr. Sims said. For example, while persistent proteinuria in a patient would drive up physician assessment of disease activity, the patient may not be experiencing any symptoms and is unaware of her condition.

In terms of pregnancy outcomes, women with unintended pregnancies had a 2.5 times higher incidence of preeclampsia, compared with those with intended pregnancies. Patients with unplanned pregnancies were also significantly more likely to experience stillbirth.

Women who were not medically optimized for pregnancy were three times as likely to experience preterm birth and preeclampsia compared with those with optimized pregnancies.

These outcomes drive home the importance of optimizing patients for pregnancy, Dr. Sims said, and effectively communicating this importance to patients, especially when they might not be perceiving their disease activity.

The study’s findings show providers “what we thought we knew, which is that there are some patients that are not as aware of their risk,” commented Lisa R. Sammaritano, MD, Hospital for Special Surgery, New York, who moderated the session where the research was presented. “It brings home the importance of counselling our patients about contraception [as well as] the importance of planning.”

Dr. Sims added that it is “crucial” to make this information easily accessible and digestible to patients. One important resource she mentioned is the HOP-STEP program, which stands for Healthy Outcomes in Pregnancy with SLE Through Education of Providers. The program, directed by researchers at Duke University, is designed to improve pregnancy planning in people with lupus. Direct-to-patient resources are key, she said, as patients can often be nervous to ask about pregnancy planning during appointments.

“They won’t want to bring a pregnancy with me in clinic because they’re afraid I’m just going to say, ‘don’t do it,’ ” Dr. Sims said. “But we are making decisions with the patient. Our patients are not asking for permission, but telling us what they want, and we need to meet them where they are at.”

A version of this article appeared on Medscape.com.

SAN DIEGO – In pregnant women with systemic lupus erythematosus (SLE), those with ill-timed pregnancies had poorer pregnancy outcomes, including preeclampsia and preterm birth.

Women with autoimmune conditions are at an increased risk for pregnancy complications, including pregnancy loss, preterm delivery, and increased need for cesarean delivery, said Catherine Sims, MD, a rheumatologist at Duke Health in Durham, N.C., who is focused on reproductive rheumatology. “The natural question, both clinically and from a research perspective, is: ‘What can we do in order to mitigate or minimize these complications?’ ” she said during a presentation at the annual meeting of the American College of Rheumatology.

Lucy Hicks/Medscape Medical News

While research suggests that patients who plan their pregnancies during times of well-controlled disease have the “best chances of improved pregnancy outcomes,” Dr. Sims and colleagues wanted to quantify how planning for pregnancy affected reproductive outcomes.

Dr. Sims recruited pregnant women with SLE and assessed if the women were medically optimized for pregnancy, if the pregnancy was intended, or both. Intended pregnancy was assessed by using a validated self-reported survey called the London Measure of Unplanned Pregnancy. Pregnant women were considered “medically optimized” for pregnancy if they were not on teratogenic medication, had continued pregnancy-compatible SLE medications, and had a urine protein-creatinine ratio of less than 1 gram in the 6 months prior to or during the first trimester. Intended pregnancies that were medically optimized were classified as “well timed.”

Of the 115 women enrolled in the study, about half had well-timed pregnancies, 20% were neither intended nor medically optimized, 17% were not intended but medically optimized, and 13% were intended but not medically optimized.

Women with ill-timed pregnancy – either not medically optimized and/or unintended – were generally younger and more likely to be single, on Medicare or Medicaid, and on income of less than $50,000 per year.

Ill-timed pregnancies had higher rates of mycophenolate exposure and higher physician-reported SLE disease activity. While patient-reported SLE activity was higher in patients who were not personally ready for pregnancy, in patients who had an intended pregnancy, there was no difference in self-reported SLE activity between those that were medically optimized and those not medically optimized.

“About a third of our patients are actually underestimating their true disease activity level when they are preparing for pregnancy,” Dr. Sims said. For example, while persistent proteinuria in a patient would drive up physician assessment of disease activity, the patient may not be experiencing any symptoms and is unaware of her condition.

In terms of pregnancy outcomes, women with unintended pregnancies had a 2.5 times higher incidence of preeclampsia, compared with those with intended pregnancies. Patients with unplanned pregnancies were also significantly more likely to experience stillbirth.

Women who were not medically optimized for pregnancy were three times as likely to experience preterm birth and preeclampsia compared with those with optimized pregnancies.

These outcomes drive home the importance of optimizing patients for pregnancy, Dr. Sims said, and effectively communicating this importance to patients, especially when they might not be perceiving their disease activity.

The study’s findings show providers “what we thought we knew, which is that there are some patients that are not as aware of their risk,” commented Lisa R. Sammaritano, MD, Hospital for Special Surgery, New York, who moderated the session where the research was presented. “It brings home the importance of counselling our patients about contraception [as well as] the importance of planning.”

Dr. Sims added that it is “crucial” to make this information easily accessible and digestible to patients. One important resource she mentioned is the HOP-STEP program, which stands for Healthy Outcomes in Pregnancy with SLE Through Education of Providers. The program, directed by researchers at Duke University, is designed to improve pregnancy planning in people with lupus. Direct-to-patient resources are key, she said, as patients can often be nervous to ask about pregnancy planning during appointments.

“They won’t want to bring a pregnancy with me in clinic because they’re afraid I’m just going to say, ‘don’t do it,’ ” Dr. Sims said. “But we are making decisions with the patient. Our patients are not asking for permission, but telling us what they want, and we need to meet them where they are at.”

A version of this article appeared on Medscape.com.