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Postmenopausal stress linked to mood, cognitive symptoms
PHILADELPHIA – , according to research presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).
“This work suggests that markers of hypothalamic-pituitary-axis activation that capture total cortisol secretion over multiple months, [such as] hair cortisol, strongly correlate with cognitive performance on attention and working memory tasks, whereas measures of more acute cortisol, [such as] salivary cortisol, may be more strongly associated with depression symptom severity and verbal learning,” Christina Metcalf, PhD, an assistant professor of psychiatry in the Colorado Center for Women’s Behavioral Health and Wellness at the University of Colorado at Denver, Aurora, told attendees. “Given the associations with chronic stress, there’s a lot of potential here to increase our knowledge about how women are doing and managing stress and life stressors during this life transition,” she said.
The study involved collecting hair and saliva samples from 43 healthy women in late perimenopause or early postmenopause with an average age of 51. The participants were predominantly white and college educated. The hair sample was taken within 2 cm of the scalp, and the saliva samples were collected the day after the hair sample collection, at the start and end of a 30-minute rest period that took place between 2:00 and 3:00 p.m. local time.
All the participants had an intact uterus and at least one ovary. None of the participants were current smokers or had recent alcohol or drug dependence, and none had used hormones within the previous 6 months. The study also excluded women who were pregnant or breastfeeding, who had bleached hair or no hair, who were taking steroids, beta blockers or opioid medication, and who had recently taken NSAIDS.
Measuring hair cortisol more feasible
The study was conducted remotely, with participants using video conferencing to communicate with the study personnel and then completing study procedures at home, including 2 days of cognitive testing with the California Verbal Learning Test – Third Edition and the n-back and continuous performance tasks. The participants also completed the Center for Epidemiologic Studies Depression Scale (CES-D).
Participants with higher levels of hair cortisol and salivary cortisol also had more severe depression symptoms (P < .001). Hair cortisol was also significantly associated with attention and working memory: Women with higher levels had fewer correct answers on the 0-back and 1-back trials (P < .01) and made more mistakes on the 2-back trial (P < .001). They also scored with less specificity on the continuous performance tasks (P = .022).
Although no association existed between hair cortisol levels and verbal learning or verbal memory (P > .05), participants with higher hair cortisol did score worse on the immediate recall trials (P = .034). Salivary cortisol levels, on the other hand, showed no association with memory recall trials, attention or working memory (P > .05).
Measuring cortisol from hair samples is more feasible than using saliva samples and may offer valuable insights regarding hypothalamic-pituitary-axis activity “to consider alongside the cognitive and mental health of late peri-/early postmenopausal women,” Dr. Metcalf told attendees. The next step is to find out whether the hypothalamic-pituitary-axis axis is a modifiable biomarker that can be used to improve executive function.
The study was limited by its small population, its cross-sectional design, and the lack of covariates in the current analyses.
Monitor symptoms in midlife
Hadine Joffe, MD, MSc, a professor of psychiatry and executive director of the Mary Horrigan Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said the study findings were not surprising given how common the complaints of stress and depressive symptoms are.
“Mood changes are linked with acute, immediate cortisol levels at the same point in time, and cognitive symptoms were linked to more chronically elevated cortisol levels,” Dr. Joffe said in an interview. “Women and their providers should monitor for these challenging brain symptoms in midlife as they affect performance and quality of life and are linked with changes in the HPA axis as stress biomarkers.”
Because the study is small and has a cross-sectional design, it’s not possible to determine the direction of the associations or to make any inferences about causation, Dr. Joffe said.
“We cannot make the conclusion that stress is adversely affecting mood and cognitive performance given the design limitations. It is possible that mood and cognitive issues contributed to these stress markers,” Dr. Joffe said.“However, it is known that the experience of stress is linked with vulnerability to mood and cognitive symptoms, and also that mood and cognitive symptoms induce significant stress.”
The research was funded by the Menopause Society, Colorado University, the Ludeman Family Center for Women’s Health Research, the National Institute of Mental Health, and the National Institute of Aging. Dr. Metcalf had no disclosures. Dr. Joffe has received grant support from Merck, Pfizer and Sage, and has been a consultant or advisor for Bayer, Merck and Hello Therapeutics.
PHILADELPHIA – , according to research presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).
“This work suggests that markers of hypothalamic-pituitary-axis activation that capture total cortisol secretion over multiple months, [such as] hair cortisol, strongly correlate with cognitive performance on attention and working memory tasks, whereas measures of more acute cortisol, [such as] salivary cortisol, may be more strongly associated with depression symptom severity and verbal learning,” Christina Metcalf, PhD, an assistant professor of psychiatry in the Colorado Center for Women’s Behavioral Health and Wellness at the University of Colorado at Denver, Aurora, told attendees. “Given the associations with chronic stress, there’s a lot of potential here to increase our knowledge about how women are doing and managing stress and life stressors during this life transition,” she said.
The study involved collecting hair and saliva samples from 43 healthy women in late perimenopause or early postmenopause with an average age of 51. The participants were predominantly white and college educated. The hair sample was taken within 2 cm of the scalp, and the saliva samples were collected the day after the hair sample collection, at the start and end of a 30-minute rest period that took place between 2:00 and 3:00 p.m. local time.
All the participants had an intact uterus and at least one ovary. None of the participants were current smokers or had recent alcohol or drug dependence, and none had used hormones within the previous 6 months. The study also excluded women who were pregnant or breastfeeding, who had bleached hair or no hair, who were taking steroids, beta blockers or opioid medication, and who had recently taken NSAIDS.
Measuring hair cortisol more feasible
The study was conducted remotely, with participants using video conferencing to communicate with the study personnel and then completing study procedures at home, including 2 days of cognitive testing with the California Verbal Learning Test – Third Edition and the n-back and continuous performance tasks. The participants also completed the Center for Epidemiologic Studies Depression Scale (CES-D).
Participants with higher levels of hair cortisol and salivary cortisol also had more severe depression symptoms (P < .001). Hair cortisol was also significantly associated with attention and working memory: Women with higher levels had fewer correct answers on the 0-back and 1-back trials (P < .01) and made more mistakes on the 2-back trial (P < .001). They also scored with less specificity on the continuous performance tasks (P = .022).
Although no association existed between hair cortisol levels and verbal learning or verbal memory (P > .05), participants with higher hair cortisol did score worse on the immediate recall trials (P = .034). Salivary cortisol levels, on the other hand, showed no association with memory recall trials, attention or working memory (P > .05).
Measuring cortisol from hair samples is more feasible than using saliva samples and may offer valuable insights regarding hypothalamic-pituitary-axis activity “to consider alongside the cognitive and mental health of late peri-/early postmenopausal women,” Dr. Metcalf told attendees. The next step is to find out whether the hypothalamic-pituitary-axis axis is a modifiable biomarker that can be used to improve executive function.
The study was limited by its small population, its cross-sectional design, and the lack of covariates in the current analyses.
Monitor symptoms in midlife
Hadine Joffe, MD, MSc, a professor of psychiatry and executive director of the Mary Horrigan Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said the study findings were not surprising given how common the complaints of stress and depressive symptoms are.
“Mood changes are linked with acute, immediate cortisol levels at the same point in time, and cognitive symptoms were linked to more chronically elevated cortisol levels,” Dr. Joffe said in an interview. “Women and their providers should monitor for these challenging brain symptoms in midlife as they affect performance and quality of life and are linked with changes in the HPA axis as stress biomarkers.”
Because the study is small and has a cross-sectional design, it’s not possible to determine the direction of the associations or to make any inferences about causation, Dr. Joffe said.
“We cannot make the conclusion that stress is adversely affecting mood and cognitive performance given the design limitations. It is possible that mood and cognitive issues contributed to these stress markers,” Dr. Joffe said.“However, it is known that the experience of stress is linked with vulnerability to mood and cognitive symptoms, and also that mood and cognitive symptoms induce significant stress.”
The research was funded by the Menopause Society, Colorado University, the Ludeman Family Center for Women’s Health Research, the National Institute of Mental Health, and the National Institute of Aging. Dr. Metcalf had no disclosures. Dr. Joffe has received grant support from Merck, Pfizer and Sage, and has been a consultant or advisor for Bayer, Merck and Hello Therapeutics.
PHILADELPHIA – , according to research presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).
“This work suggests that markers of hypothalamic-pituitary-axis activation that capture total cortisol secretion over multiple months, [such as] hair cortisol, strongly correlate with cognitive performance on attention and working memory tasks, whereas measures of more acute cortisol, [such as] salivary cortisol, may be more strongly associated with depression symptom severity and verbal learning,” Christina Metcalf, PhD, an assistant professor of psychiatry in the Colorado Center for Women’s Behavioral Health and Wellness at the University of Colorado at Denver, Aurora, told attendees. “Given the associations with chronic stress, there’s a lot of potential here to increase our knowledge about how women are doing and managing stress and life stressors during this life transition,” she said.
The study involved collecting hair and saliva samples from 43 healthy women in late perimenopause or early postmenopause with an average age of 51. The participants were predominantly white and college educated. The hair sample was taken within 2 cm of the scalp, and the saliva samples were collected the day after the hair sample collection, at the start and end of a 30-minute rest period that took place between 2:00 and 3:00 p.m. local time.
All the participants had an intact uterus and at least one ovary. None of the participants were current smokers or had recent alcohol or drug dependence, and none had used hormones within the previous 6 months. The study also excluded women who were pregnant or breastfeeding, who had bleached hair or no hair, who were taking steroids, beta blockers or opioid medication, and who had recently taken NSAIDS.
Measuring hair cortisol more feasible
The study was conducted remotely, with participants using video conferencing to communicate with the study personnel and then completing study procedures at home, including 2 days of cognitive testing with the California Verbal Learning Test – Third Edition and the n-back and continuous performance tasks. The participants also completed the Center for Epidemiologic Studies Depression Scale (CES-D).
Participants with higher levels of hair cortisol and salivary cortisol also had more severe depression symptoms (P < .001). Hair cortisol was also significantly associated with attention and working memory: Women with higher levels had fewer correct answers on the 0-back and 1-back trials (P < .01) and made more mistakes on the 2-back trial (P < .001). They also scored with less specificity on the continuous performance tasks (P = .022).
Although no association existed between hair cortisol levels and verbal learning or verbal memory (P > .05), participants with higher hair cortisol did score worse on the immediate recall trials (P = .034). Salivary cortisol levels, on the other hand, showed no association with memory recall trials, attention or working memory (P > .05).
Measuring cortisol from hair samples is more feasible than using saliva samples and may offer valuable insights regarding hypothalamic-pituitary-axis activity “to consider alongside the cognitive and mental health of late peri-/early postmenopausal women,” Dr. Metcalf told attendees. The next step is to find out whether the hypothalamic-pituitary-axis axis is a modifiable biomarker that can be used to improve executive function.
The study was limited by its small population, its cross-sectional design, and the lack of covariates in the current analyses.
Monitor symptoms in midlife
Hadine Joffe, MD, MSc, a professor of psychiatry and executive director of the Mary Horrigan Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said the study findings were not surprising given how common the complaints of stress and depressive symptoms are.
“Mood changes are linked with acute, immediate cortisol levels at the same point in time, and cognitive symptoms were linked to more chronically elevated cortisol levels,” Dr. Joffe said in an interview. “Women and their providers should monitor for these challenging brain symptoms in midlife as they affect performance and quality of life and are linked with changes in the HPA axis as stress biomarkers.”
Because the study is small and has a cross-sectional design, it’s not possible to determine the direction of the associations or to make any inferences about causation, Dr. Joffe said.
“We cannot make the conclusion that stress is adversely affecting mood and cognitive performance given the design limitations. It is possible that mood and cognitive issues contributed to these stress markers,” Dr. Joffe said.“However, it is known that the experience of stress is linked with vulnerability to mood and cognitive symptoms, and also that mood and cognitive symptoms induce significant stress.”
The research was funded by the Menopause Society, Colorado University, the Ludeman Family Center for Women’s Health Research, the National Institute of Mental Health, and the National Institute of Aging. Dr. Metcalf had no disclosures. Dr. Joffe has received grant support from Merck, Pfizer and Sage, and has been a consultant or advisor for Bayer, Merck and Hello Therapeutics.
AT NAMS 2023
Metabolic effects of estetrol are promising in postmenopausal women
PHILADELPHIA – presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
Participants taking estetrol experienced a decrease in hemoglobin A1c, fasting plasma glucose, total cholesterol, LDL and lipoprotein as well as an increase in HDL cholesterol, according to the findings presented by Wolf Utian, MD, PhD, DSC, a professor emeritus of reproductive biology at Case Western Reserve University, Cleveland, and medical director emeritus of the Menopause Society.
A separate poster at the conference from the same trial also reported significant improvements from estetrol in quality of life, including that related to vasomotor symptoms, and several psychosocial and sexual functioning areas.
E4 is already available as combination oral contraception and is now being considered for treating vasomotor symptoms, explained Chrisandra Shufelt, MD, professor and chair of general internal of medicine and associate director of the Women’s Health Research Center at Mayo Clinic Florida, who was not involved in the study.
Background on estetrol
E4 is a human fetal liver estrogen produced during pregnancy that’s synthesized from plants for pharmaceutical use, including as the oral contraceptive drospirenone, Dr. Utian told attendees. It’s classified as a native estrogen with selective tissue activity (NEST), he said.
“E4 is a completely different native estrogen with oral administration mimicking the benefits of transdermals and hence safe and effective,” Dr. Utian said in an interview. “It would be a significant new addition to the pharmaceutical armamentarium.”
Two phase 3 trials presented by Dr. Utian at the same conference last year found estetrol reduced the frequency and severity of moderate to severe vasomotor symptoms, and a previous phase 2 trial finding vasomotor and genitourinary symptom benefits suggested it had potential benefits for lipids, carbohydrate metabolism, and bone turnover.
“In summary, E4 at a daily dose of 15 mg exhibited estrogenic effects in the vagina, leading to improved vaginal health and reduced signs of atrophy, emerging as a promising treatment option not only for vasomotor symptoms but also for other significant menopausal symptoms,” Dr. Utian said. “E4 could offer comprehensive relief for women experiencing a range of menopause-related discomforts.”
Dr. Utian also referenced a 2017 trial in which estetrol positively impacted lipid profiles, “lowering low-density lipoprotein cholesterol, increasing high-density lipoprotein cholesterol, and showing minimal influence on triglycerides,” he said. “Importantly, estetrol was associated with a significant decrease in osteocalcin levels in the higher dose groups, suggesting a potential preventive effect on bone loss,” he added. A recent review of the overall evidence on estetrol suggests its use is “promising,” Dr. Utian noted.
Current trial
His current randomized controlled phase 3 trial included postmenopausal women ages 40-65 from 151 sites in 14 countries in Europe, Latin America, and North America, and Russia. Among the 640 participants in the trial, 213 women randomly received 15 mg of estetrol, 213 women received 20 mg of estetrol, and 214 women received a placebo every day for 3 months. All women without hysterectomies also received 200 mg of progesterone once daily for two weeks after completing the estetrol treatment to protect the endometrium.
Researchers took blood samples from the participants at baseline and week 12 to assess total cholesterol, LDL, HDL, the total cholesterol/HDL ratio, triglycerides, lipoprotein A, fasting plasma glucose, insulin, and A1c.
Compared with women in the placebo group, women in both the 15 mg and 20 mg groups saw a statistically significant decrease in lipoprotein A and in the ratio of total cholesterol to HDL, and a statistically significant increase in HDL. Only the women in the 15 mg group saw a statistically significant decrease in LDL and increase in triglycerides; an increase in triglycerides in the 20 mg group did not reach statistical significance.
Statistically significant decreases in fasting plasma glucose and A1c also occurred in both treatment groups, but a decrease in insulin levels and in the homeostasis model-assessment-estimated insulin resistance (HOMA-IR) seen in both treatment arms did not reach significance.
“While the mean changes after 12 weeks from baseline overall were small changes to the cholesterol and blood sugar profiles, they are clinically meaningful because it suggests that E4 does not have any adverse effects to these measures,” Dr. Shufelt said in an interview. “An advantage is that this gives us another hormone option for vasomotor symptoms since it is a native estrogen with selective tissue.”
It’s too early, however, to determine whether estetrol offers benefits in terms of its safety profile, compared with currently available therapies, Dr. Shufelt said.
”These findings of E4 are similar to how oral estradiol changes lipids, which finds an increase in high-density lipoprotein cholesterol, and decreases plasma concentrations of total and low-density lipoprotein cholesterol. an increase in HDL-C and triglycerides and decrease in LDL-C,” she said.
Poster findings also promising
For the findings reported in the poster, researchers assessed quality of life and the clinical meaningfulness of vasomotor symptoms’ reduction at baseline and 12 weeks using the Menopause-Specific Quality of Life (MENQOL) questionnaire and the Clinical Global Impression questionnaire, respectively. They also assessed women’s self-reported genitourinary symptoms, including vaginal dryness, pain during urination, vaginal pain and bleeding related to sex, and vaginal or vulvar irritation or itching. Most of these findings primarily confirmed previous positive effects from E4 in other trials.
Women in both the 15 mg and 20 mg estetrol groups reported a statistically significant improvement at 12 weeks, compared with placebo, in their total MENQOL score and in the vasomotor, psychosocial, and sexual functioning domain scores (P < .05). Those in the 20 mg group also had a statistically significant improvement in their physical domain score (P < .05).
Although numerical improvements in genitourinary symptoms occurred at 12 weeks across all three groups, the only statistically significant difference from baseline occurred in patients taking 15 mg of estetrol, who experienced a decrease in vaginal dryness and vaginal pain during sex (P = .0142 and P = .003, respectively).
The Clinical Global Impression questionnaire asked women at 4 and 12 weeks to rate on a seven-item Likert scale their response to this question: “Rate the total improvement, whether or not in your judgment it is due entirely to drug treatment. Compared to your condition at admission to the study, how much has it changed?” Responses of “very much improved” and “much improved” counted as a clinically meaningful difference.
Compared with 27.9% of patients in the placebo group, 52.9% of patients in the 15 mg group and 59.8% of patients in the 20 mg group rated the weekly frequency of moderate to severe vasomotor symptoms as “much improved” or “very much improved” at 4 weeks (P < .0001). At 12 weeks, those numbers rose to 47% in the placebo group, 73.3% in the 15 mg group and 77.8% in the 20 mg group (P < .0001).
The trial’s primary limitation at this point is having only a 12-week follow-up, Dr. Shufelt said, though a few other questions remain.
“Because the two phase 3 RCTs included hysterectomized and nonhysterectomized women, it was unclear how many women in the study had E4 alone versus E4 with progesterone, as that might play a role in both cholesterol and carbohydrate metabolism,” Dr. Shufelt said. “While baseline data was not presented, it would also be important to know baseline values for the women and confirm that none were on lipid-lowering medications.”
The research was funded by Estetra SRL, an affiliate of Mithra Pharmaceuticals. Dr. Utian is a member of the Mithra and Elektra Scientific Advisory Boards. Dr. Shufelt has no disclosures.
PHILADELPHIA – presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
Participants taking estetrol experienced a decrease in hemoglobin A1c, fasting plasma glucose, total cholesterol, LDL and lipoprotein as well as an increase in HDL cholesterol, according to the findings presented by Wolf Utian, MD, PhD, DSC, a professor emeritus of reproductive biology at Case Western Reserve University, Cleveland, and medical director emeritus of the Menopause Society.
A separate poster at the conference from the same trial also reported significant improvements from estetrol in quality of life, including that related to vasomotor symptoms, and several psychosocial and sexual functioning areas.
E4 is already available as combination oral contraception and is now being considered for treating vasomotor symptoms, explained Chrisandra Shufelt, MD, professor and chair of general internal of medicine and associate director of the Women’s Health Research Center at Mayo Clinic Florida, who was not involved in the study.
Background on estetrol
E4 is a human fetal liver estrogen produced during pregnancy that’s synthesized from plants for pharmaceutical use, including as the oral contraceptive drospirenone, Dr. Utian told attendees. It’s classified as a native estrogen with selective tissue activity (NEST), he said.
“E4 is a completely different native estrogen with oral administration mimicking the benefits of transdermals and hence safe and effective,” Dr. Utian said in an interview. “It would be a significant new addition to the pharmaceutical armamentarium.”
Two phase 3 trials presented by Dr. Utian at the same conference last year found estetrol reduced the frequency and severity of moderate to severe vasomotor symptoms, and a previous phase 2 trial finding vasomotor and genitourinary symptom benefits suggested it had potential benefits for lipids, carbohydrate metabolism, and bone turnover.
“In summary, E4 at a daily dose of 15 mg exhibited estrogenic effects in the vagina, leading to improved vaginal health and reduced signs of atrophy, emerging as a promising treatment option not only for vasomotor symptoms but also for other significant menopausal symptoms,” Dr. Utian said. “E4 could offer comprehensive relief for women experiencing a range of menopause-related discomforts.”
Dr. Utian also referenced a 2017 trial in which estetrol positively impacted lipid profiles, “lowering low-density lipoprotein cholesterol, increasing high-density lipoprotein cholesterol, and showing minimal influence on triglycerides,” he said. “Importantly, estetrol was associated with a significant decrease in osteocalcin levels in the higher dose groups, suggesting a potential preventive effect on bone loss,” he added. A recent review of the overall evidence on estetrol suggests its use is “promising,” Dr. Utian noted.
Current trial
His current randomized controlled phase 3 trial included postmenopausal women ages 40-65 from 151 sites in 14 countries in Europe, Latin America, and North America, and Russia. Among the 640 participants in the trial, 213 women randomly received 15 mg of estetrol, 213 women received 20 mg of estetrol, and 214 women received a placebo every day for 3 months. All women without hysterectomies also received 200 mg of progesterone once daily for two weeks after completing the estetrol treatment to protect the endometrium.
Researchers took blood samples from the participants at baseline and week 12 to assess total cholesterol, LDL, HDL, the total cholesterol/HDL ratio, triglycerides, lipoprotein A, fasting plasma glucose, insulin, and A1c.
Compared with women in the placebo group, women in both the 15 mg and 20 mg groups saw a statistically significant decrease in lipoprotein A and in the ratio of total cholesterol to HDL, and a statistically significant increase in HDL. Only the women in the 15 mg group saw a statistically significant decrease in LDL and increase in triglycerides; an increase in triglycerides in the 20 mg group did not reach statistical significance.
Statistically significant decreases in fasting plasma glucose and A1c also occurred in both treatment groups, but a decrease in insulin levels and in the homeostasis model-assessment-estimated insulin resistance (HOMA-IR) seen in both treatment arms did not reach significance.
“While the mean changes after 12 weeks from baseline overall were small changes to the cholesterol and blood sugar profiles, they are clinically meaningful because it suggests that E4 does not have any adverse effects to these measures,” Dr. Shufelt said in an interview. “An advantage is that this gives us another hormone option for vasomotor symptoms since it is a native estrogen with selective tissue.”
It’s too early, however, to determine whether estetrol offers benefits in terms of its safety profile, compared with currently available therapies, Dr. Shufelt said.
”These findings of E4 are similar to how oral estradiol changes lipids, which finds an increase in high-density lipoprotein cholesterol, and decreases plasma concentrations of total and low-density lipoprotein cholesterol. an increase in HDL-C and triglycerides and decrease in LDL-C,” she said.
Poster findings also promising
For the findings reported in the poster, researchers assessed quality of life and the clinical meaningfulness of vasomotor symptoms’ reduction at baseline and 12 weeks using the Menopause-Specific Quality of Life (MENQOL) questionnaire and the Clinical Global Impression questionnaire, respectively. They also assessed women’s self-reported genitourinary symptoms, including vaginal dryness, pain during urination, vaginal pain and bleeding related to sex, and vaginal or vulvar irritation or itching. Most of these findings primarily confirmed previous positive effects from E4 in other trials.
Women in both the 15 mg and 20 mg estetrol groups reported a statistically significant improvement at 12 weeks, compared with placebo, in their total MENQOL score and in the vasomotor, psychosocial, and sexual functioning domain scores (P < .05). Those in the 20 mg group also had a statistically significant improvement in their physical domain score (P < .05).
Although numerical improvements in genitourinary symptoms occurred at 12 weeks across all three groups, the only statistically significant difference from baseline occurred in patients taking 15 mg of estetrol, who experienced a decrease in vaginal dryness and vaginal pain during sex (P = .0142 and P = .003, respectively).
The Clinical Global Impression questionnaire asked women at 4 and 12 weeks to rate on a seven-item Likert scale their response to this question: “Rate the total improvement, whether or not in your judgment it is due entirely to drug treatment. Compared to your condition at admission to the study, how much has it changed?” Responses of “very much improved” and “much improved” counted as a clinically meaningful difference.
Compared with 27.9% of patients in the placebo group, 52.9% of patients in the 15 mg group and 59.8% of patients in the 20 mg group rated the weekly frequency of moderate to severe vasomotor symptoms as “much improved” or “very much improved” at 4 weeks (P < .0001). At 12 weeks, those numbers rose to 47% in the placebo group, 73.3% in the 15 mg group and 77.8% in the 20 mg group (P < .0001).
The trial’s primary limitation at this point is having only a 12-week follow-up, Dr. Shufelt said, though a few other questions remain.
“Because the two phase 3 RCTs included hysterectomized and nonhysterectomized women, it was unclear how many women in the study had E4 alone versus E4 with progesterone, as that might play a role in both cholesterol and carbohydrate metabolism,” Dr. Shufelt said. “While baseline data was not presented, it would also be important to know baseline values for the women and confirm that none were on lipid-lowering medications.”
The research was funded by Estetra SRL, an affiliate of Mithra Pharmaceuticals. Dr. Utian is a member of the Mithra and Elektra Scientific Advisory Boards. Dr. Shufelt has no disclosures.
PHILADELPHIA – presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
Participants taking estetrol experienced a decrease in hemoglobin A1c, fasting plasma glucose, total cholesterol, LDL and lipoprotein as well as an increase in HDL cholesterol, according to the findings presented by Wolf Utian, MD, PhD, DSC, a professor emeritus of reproductive biology at Case Western Reserve University, Cleveland, and medical director emeritus of the Menopause Society.
A separate poster at the conference from the same trial also reported significant improvements from estetrol in quality of life, including that related to vasomotor symptoms, and several psychosocial and sexual functioning areas.
E4 is already available as combination oral contraception and is now being considered for treating vasomotor symptoms, explained Chrisandra Shufelt, MD, professor and chair of general internal of medicine and associate director of the Women’s Health Research Center at Mayo Clinic Florida, who was not involved in the study.
Background on estetrol
E4 is a human fetal liver estrogen produced during pregnancy that’s synthesized from plants for pharmaceutical use, including as the oral contraceptive drospirenone, Dr. Utian told attendees. It’s classified as a native estrogen with selective tissue activity (NEST), he said.
“E4 is a completely different native estrogen with oral administration mimicking the benefits of transdermals and hence safe and effective,” Dr. Utian said in an interview. “It would be a significant new addition to the pharmaceutical armamentarium.”
Two phase 3 trials presented by Dr. Utian at the same conference last year found estetrol reduced the frequency and severity of moderate to severe vasomotor symptoms, and a previous phase 2 trial finding vasomotor and genitourinary symptom benefits suggested it had potential benefits for lipids, carbohydrate metabolism, and bone turnover.
“In summary, E4 at a daily dose of 15 mg exhibited estrogenic effects in the vagina, leading to improved vaginal health and reduced signs of atrophy, emerging as a promising treatment option not only for vasomotor symptoms but also for other significant menopausal symptoms,” Dr. Utian said. “E4 could offer comprehensive relief for women experiencing a range of menopause-related discomforts.”
Dr. Utian also referenced a 2017 trial in which estetrol positively impacted lipid profiles, “lowering low-density lipoprotein cholesterol, increasing high-density lipoprotein cholesterol, and showing minimal influence on triglycerides,” he said. “Importantly, estetrol was associated with a significant decrease in osteocalcin levels in the higher dose groups, suggesting a potential preventive effect on bone loss,” he added. A recent review of the overall evidence on estetrol suggests its use is “promising,” Dr. Utian noted.
Current trial
His current randomized controlled phase 3 trial included postmenopausal women ages 40-65 from 151 sites in 14 countries in Europe, Latin America, and North America, and Russia. Among the 640 participants in the trial, 213 women randomly received 15 mg of estetrol, 213 women received 20 mg of estetrol, and 214 women received a placebo every day for 3 months. All women without hysterectomies also received 200 mg of progesterone once daily for two weeks after completing the estetrol treatment to protect the endometrium.
Researchers took blood samples from the participants at baseline and week 12 to assess total cholesterol, LDL, HDL, the total cholesterol/HDL ratio, triglycerides, lipoprotein A, fasting plasma glucose, insulin, and A1c.
Compared with women in the placebo group, women in both the 15 mg and 20 mg groups saw a statistically significant decrease in lipoprotein A and in the ratio of total cholesterol to HDL, and a statistically significant increase in HDL. Only the women in the 15 mg group saw a statistically significant decrease in LDL and increase in triglycerides; an increase in triglycerides in the 20 mg group did not reach statistical significance.
Statistically significant decreases in fasting plasma glucose and A1c also occurred in both treatment groups, but a decrease in insulin levels and in the homeostasis model-assessment-estimated insulin resistance (HOMA-IR) seen in both treatment arms did not reach significance.
“While the mean changes after 12 weeks from baseline overall were small changes to the cholesterol and blood sugar profiles, they are clinically meaningful because it suggests that E4 does not have any adverse effects to these measures,” Dr. Shufelt said in an interview. “An advantage is that this gives us another hormone option for vasomotor symptoms since it is a native estrogen with selective tissue.”
It’s too early, however, to determine whether estetrol offers benefits in terms of its safety profile, compared with currently available therapies, Dr. Shufelt said.
”These findings of E4 are similar to how oral estradiol changes lipids, which finds an increase in high-density lipoprotein cholesterol, and decreases plasma concentrations of total and low-density lipoprotein cholesterol. an increase in HDL-C and triglycerides and decrease in LDL-C,” she said.
Poster findings also promising
For the findings reported in the poster, researchers assessed quality of life and the clinical meaningfulness of vasomotor symptoms’ reduction at baseline and 12 weeks using the Menopause-Specific Quality of Life (MENQOL) questionnaire and the Clinical Global Impression questionnaire, respectively. They also assessed women’s self-reported genitourinary symptoms, including vaginal dryness, pain during urination, vaginal pain and bleeding related to sex, and vaginal or vulvar irritation or itching. Most of these findings primarily confirmed previous positive effects from E4 in other trials.
Women in both the 15 mg and 20 mg estetrol groups reported a statistically significant improvement at 12 weeks, compared with placebo, in their total MENQOL score and in the vasomotor, psychosocial, and sexual functioning domain scores (P < .05). Those in the 20 mg group also had a statistically significant improvement in their physical domain score (P < .05).
Although numerical improvements in genitourinary symptoms occurred at 12 weeks across all three groups, the only statistically significant difference from baseline occurred in patients taking 15 mg of estetrol, who experienced a decrease in vaginal dryness and vaginal pain during sex (P = .0142 and P = .003, respectively).
The Clinical Global Impression questionnaire asked women at 4 and 12 weeks to rate on a seven-item Likert scale their response to this question: “Rate the total improvement, whether or not in your judgment it is due entirely to drug treatment. Compared to your condition at admission to the study, how much has it changed?” Responses of “very much improved” and “much improved” counted as a clinically meaningful difference.
Compared with 27.9% of patients in the placebo group, 52.9% of patients in the 15 mg group and 59.8% of patients in the 20 mg group rated the weekly frequency of moderate to severe vasomotor symptoms as “much improved” or “very much improved” at 4 weeks (P < .0001). At 12 weeks, those numbers rose to 47% in the placebo group, 73.3% in the 15 mg group and 77.8% in the 20 mg group (P < .0001).
The trial’s primary limitation at this point is having only a 12-week follow-up, Dr. Shufelt said, though a few other questions remain.
“Because the two phase 3 RCTs included hysterectomized and nonhysterectomized women, it was unclear how many women in the study had E4 alone versus E4 with progesterone, as that might play a role in both cholesterol and carbohydrate metabolism,” Dr. Shufelt said. “While baseline data was not presented, it would also be important to know baseline values for the women and confirm that none were on lipid-lowering medications.”
The research was funded by Estetra SRL, an affiliate of Mithra Pharmaceuticals. Dr. Utian is a member of the Mithra and Elektra Scientific Advisory Boards. Dr. Shufelt has no disclosures.
AT NAMS 2023
Cannabis use growing among menopausal women
PHILADELPHIA – presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
Though most women reported using cannabis for recreational reasons, 13% used it only for medical reasons, most often for chronic pain, anxiety, sleep, and stress.
“These findings highlight the importance of recognizing and discussing cannabis use in the health care setting, and the need for additional research to evaluate the potential harms and/or benefits of use in this vulnerable population,” Carolyn J. Gibson, PhD, MPH, a staff psychologist in women’s health at the San Francisco VA Health Care System and an assistant professor of psychiatry and behavioral sciences at the University of California, San Francisco, told attendees.
As cannabis has become more accessible, with its use legalized in 38 states and Washington, D.C., the proportion of U.S. adults using it has doubled over about a decade, from 6% in 2007 to 12% in 2019, Dr. Gibson said. Further, women aged 50 and older are among the fastest-growing groups of users of cannabis, and it’s being increasingly used – and marketed – for treating menopause-related and aging-related symptoms, including insomnia, anxiety, and chronic pain, she said.
“With these decisions to use cannabis, medically or for these other purposes, there’s this perception that it’s harmless,” Dr. Gibson said. Yet potential health risks associated with cannabis include the usual health effects associated with any kind of smoking as well as dependence in those who use it more frequently and/or develop a tolerance for it. She noted that average THC potency has increased over time, and acute risks for using cannabis with high levels of THC – at least 15% or at least 10 mg – can include anxiety/panic, confusion, disturbing/intrusive thoughts, psychosis, and effects on coordination and cognition. She also acknowledged, however, that most of the data available on risks come from studies of men and younger adults rather than older women.
Given the growing normalization of cannabis use, Dr. Gibson’s team sought to better understand prevalence of use as well as types of use and reasons for use in perimenopasual and postmenopausal women. They analyzed data from a cross-sectional survey of women and gender-diverse members, aged 45-64, of Ipsos KnowledgePanel, an online panel with more than 60,000 participating members in the United States.
All the respondents identified themselves as female at birth and had not used gender-affirming therapy or undergone gender-affirming surgery. The survey included questions on sociodemographics, menopause status, frequency of cannabis use, types of cannabis used, reasons for using cannabis, and use of cannabis in the previous 30 days. The 5,174 respondents were an average 55 years old and predominantly non-Hispanic white (63%), with 13% non-Hispanic Black and 16% Hispanic. Two-thirds of the women reported working full- or part-time (67%) and two-thirds were postmenopausal (68%), with 64% reporting experiencing menopause symptoms.
About two in five respondents (42%) had ever used cannabis in any form, most often smoking it (83%) or consuming edibles (51%). Among those who had ever used it, 30% reported having smoked it daily or nearly daily for at least a year at some point.
Ten percent of respondents had used cannabis in the past month, again primarily smoking (56%) or edibles (52%), though 39% said they used it in more than one form, including vaping, dabbing, or topical use. Nearly half (46%) of the respondents who smoked cannabis recently did not know the THC potency of what they consumed, and just over 20% of those consuming edibles didn’t know the THC potency of what they used. However, about a third of those taking edibles used cannabis with less than 10 mg of THC, and a little over a quarter used edibles with 10 mg of THC.
Within the 10% who had used cannabis in the past month, nearly a third (31%) of respondents – or around 3.1% of the total sample – reported smoking cannabis daily or almost daily, and 19% (or 1.9% of the overall sample) consumed cannabis edibles daily or almost daily.
Most of the respondents who used cannabis said it was for recreational use (62%), but a quarter (25%) reported using it for both recreational and medical reasons, and 13% used it only for medical reasons. The most common reason women used cannabis was to treat chronic pain (28%), followed by nearly as many women reporting cannabis use for anxiety (24%), sleep (22%), and stress (22%). Six percent of women used cannabis specifically for menopause-related sleep and mood problems.
Given the growing use of cannabis in this population and the dearth of data on its effects in older women, Dr. Gibson highlighted the need for research examining the potential benefits and harms of cannabis for menopausal women.
Not risk-free
Susan D. Reed, MD, MPH, MSCP, a professor emeritus of ob.gyn. at the University of Washington, Seattle, and president of the Menopause Society, found the study well-executed and was not surprised by how many respondents had ever used cannabis.
“What did surprise me was that nearly a third reported daily use for at least 1 year and that 38% were medical marijuana users, not just recreational,” Dr. Reed said in an interview. The proportions of women using cannabis for menopausal symptoms or using it daily are concerning, she added.
“These individuals are at risk for dependence and health risks related to marijuana use,” Dr. Reed said. “Providers should always ask patients about OTC products, herbals, supplements, cannabis use, and alternative management of menopausal symptoms to better understand patient preferences for menopausal symptom therapies, so that treatment plans can be discussed with individual patient preferences in mind. We need to start with where the patient is coming from.”
Data presented throughout the conference has shown how people are “disillusioned with the care they are receiving for menopause,” Dr. Reed added. “It is so difficult to distinguish truth from myths based on information gained through social media, family, and friends, and that often is where most people are getting their information.”
Physicians often have not received adequate training on how to provide people with accurate information about menopause and managing menopausal symptoms, so she advises patients and physicians to visit reliable sites such as the Menopause Society, the Swan Study, and My Menoplan.
The research was funded by the Tobacco-Related Disease Research Program and the Veterans Administration. Dr. Gibson has provided unpaid consultation to Astellas Pharmaceuticals. Dr. Reed has received research support from Bayer and receives royalties from UpToDate.
PHILADELPHIA – presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
Though most women reported using cannabis for recreational reasons, 13% used it only for medical reasons, most often for chronic pain, anxiety, sleep, and stress.
“These findings highlight the importance of recognizing and discussing cannabis use in the health care setting, and the need for additional research to evaluate the potential harms and/or benefits of use in this vulnerable population,” Carolyn J. Gibson, PhD, MPH, a staff psychologist in women’s health at the San Francisco VA Health Care System and an assistant professor of psychiatry and behavioral sciences at the University of California, San Francisco, told attendees.
As cannabis has become more accessible, with its use legalized in 38 states and Washington, D.C., the proportion of U.S. adults using it has doubled over about a decade, from 6% in 2007 to 12% in 2019, Dr. Gibson said. Further, women aged 50 and older are among the fastest-growing groups of users of cannabis, and it’s being increasingly used – and marketed – for treating menopause-related and aging-related symptoms, including insomnia, anxiety, and chronic pain, she said.
“With these decisions to use cannabis, medically or for these other purposes, there’s this perception that it’s harmless,” Dr. Gibson said. Yet potential health risks associated with cannabis include the usual health effects associated with any kind of smoking as well as dependence in those who use it more frequently and/or develop a tolerance for it. She noted that average THC potency has increased over time, and acute risks for using cannabis with high levels of THC – at least 15% or at least 10 mg – can include anxiety/panic, confusion, disturbing/intrusive thoughts, psychosis, and effects on coordination and cognition. She also acknowledged, however, that most of the data available on risks come from studies of men and younger adults rather than older women.
Given the growing normalization of cannabis use, Dr. Gibson’s team sought to better understand prevalence of use as well as types of use and reasons for use in perimenopasual and postmenopausal women. They analyzed data from a cross-sectional survey of women and gender-diverse members, aged 45-64, of Ipsos KnowledgePanel, an online panel with more than 60,000 participating members in the United States.
All the respondents identified themselves as female at birth and had not used gender-affirming therapy or undergone gender-affirming surgery. The survey included questions on sociodemographics, menopause status, frequency of cannabis use, types of cannabis used, reasons for using cannabis, and use of cannabis in the previous 30 days. The 5,174 respondents were an average 55 years old and predominantly non-Hispanic white (63%), with 13% non-Hispanic Black and 16% Hispanic. Two-thirds of the women reported working full- or part-time (67%) and two-thirds were postmenopausal (68%), with 64% reporting experiencing menopause symptoms.
About two in five respondents (42%) had ever used cannabis in any form, most often smoking it (83%) or consuming edibles (51%). Among those who had ever used it, 30% reported having smoked it daily or nearly daily for at least a year at some point.
Ten percent of respondents had used cannabis in the past month, again primarily smoking (56%) or edibles (52%), though 39% said they used it in more than one form, including vaping, dabbing, or topical use. Nearly half (46%) of the respondents who smoked cannabis recently did not know the THC potency of what they consumed, and just over 20% of those consuming edibles didn’t know the THC potency of what they used. However, about a third of those taking edibles used cannabis with less than 10 mg of THC, and a little over a quarter used edibles with 10 mg of THC.
Within the 10% who had used cannabis in the past month, nearly a third (31%) of respondents – or around 3.1% of the total sample – reported smoking cannabis daily or almost daily, and 19% (or 1.9% of the overall sample) consumed cannabis edibles daily or almost daily.
Most of the respondents who used cannabis said it was for recreational use (62%), but a quarter (25%) reported using it for both recreational and medical reasons, and 13% used it only for medical reasons. The most common reason women used cannabis was to treat chronic pain (28%), followed by nearly as many women reporting cannabis use for anxiety (24%), sleep (22%), and stress (22%). Six percent of women used cannabis specifically for menopause-related sleep and mood problems.
Given the growing use of cannabis in this population and the dearth of data on its effects in older women, Dr. Gibson highlighted the need for research examining the potential benefits and harms of cannabis for menopausal women.
Not risk-free
Susan D. Reed, MD, MPH, MSCP, a professor emeritus of ob.gyn. at the University of Washington, Seattle, and president of the Menopause Society, found the study well-executed and was not surprised by how many respondents had ever used cannabis.
“What did surprise me was that nearly a third reported daily use for at least 1 year and that 38% were medical marijuana users, not just recreational,” Dr. Reed said in an interview. The proportions of women using cannabis for menopausal symptoms or using it daily are concerning, she added.
“These individuals are at risk for dependence and health risks related to marijuana use,” Dr. Reed said. “Providers should always ask patients about OTC products, herbals, supplements, cannabis use, and alternative management of menopausal symptoms to better understand patient preferences for menopausal symptom therapies, so that treatment plans can be discussed with individual patient preferences in mind. We need to start with where the patient is coming from.”
Data presented throughout the conference has shown how people are “disillusioned with the care they are receiving for menopause,” Dr. Reed added. “It is so difficult to distinguish truth from myths based on information gained through social media, family, and friends, and that often is where most people are getting their information.”
Physicians often have not received adequate training on how to provide people with accurate information about menopause and managing menopausal symptoms, so she advises patients and physicians to visit reliable sites such as the Menopause Society, the Swan Study, and My Menoplan.
The research was funded by the Tobacco-Related Disease Research Program and the Veterans Administration. Dr. Gibson has provided unpaid consultation to Astellas Pharmaceuticals. Dr. Reed has received research support from Bayer and receives royalties from UpToDate.
PHILADELPHIA – presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
Though most women reported using cannabis for recreational reasons, 13% used it only for medical reasons, most often for chronic pain, anxiety, sleep, and stress.
“These findings highlight the importance of recognizing and discussing cannabis use in the health care setting, and the need for additional research to evaluate the potential harms and/or benefits of use in this vulnerable population,” Carolyn J. Gibson, PhD, MPH, a staff psychologist in women’s health at the San Francisco VA Health Care System and an assistant professor of psychiatry and behavioral sciences at the University of California, San Francisco, told attendees.
As cannabis has become more accessible, with its use legalized in 38 states and Washington, D.C., the proportion of U.S. adults using it has doubled over about a decade, from 6% in 2007 to 12% in 2019, Dr. Gibson said. Further, women aged 50 and older are among the fastest-growing groups of users of cannabis, and it’s being increasingly used – and marketed – for treating menopause-related and aging-related symptoms, including insomnia, anxiety, and chronic pain, she said.
“With these decisions to use cannabis, medically or for these other purposes, there’s this perception that it’s harmless,” Dr. Gibson said. Yet potential health risks associated with cannabis include the usual health effects associated with any kind of smoking as well as dependence in those who use it more frequently and/or develop a tolerance for it. She noted that average THC potency has increased over time, and acute risks for using cannabis with high levels of THC – at least 15% or at least 10 mg – can include anxiety/panic, confusion, disturbing/intrusive thoughts, psychosis, and effects on coordination and cognition. She also acknowledged, however, that most of the data available on risks come from studies of men and younger adults rather than older women.
Given the growing normalization of cannabis use, Dr. Gibson’s team sought to better understand prevalence of use as well as types of use and reasons for use in perimenopasual and postmenopausal women. They analyzed data from a cross-sectional survey of women and gender-diverse members, aged 45-64, of Ipsos KnowledgePanel, an online panel with more than 60,000 participating members in the United States.
All the respondents identified themselves as female at birth and had not used gender-affirming therapy or undergone gender-affirming surgery. The survey included questions on sociodemographics, menopause status, frequency of cannabis use, types of cannabis used, reasons for using cannabis, and use of cannabis in the previous 30 days. The 5,174 respondents were an average 55 years old and predominantly non-Hispanic white (63%), with 13% non-Hispanic Black and 16% Hispanic. Two-thirds of the women reported working full- or part-time (67%) and two-thirds were postmenopausal (68%), with 64% reporting experiencing menopause symptoms.
About two in five respondents (42%) had ever used cannabis in any form, most often smoking it (83%) or consuming edibles (51%). Among those who had ever used it, 30% reported having smoked it daily or nearly daily for at least a year at some point.
Ten percent of respondents had used cannabis in the past month, again primarily smoking (56%) or edibles (52%), though 39% said they used it in more than one form, including vaping, dabbing, or topical use. Nearly half (46%) of the respondents who smoked cannabis recently did not know the THC potency of what they consumed, and just over 20% of those consuming edibles didn’t know the THC potency of what they used. However, about a third of those taking edibles used cannabis with less than 10 mg of THC, and a little over a quarter used edibles with 10 mg of THC.
Within the 10% who had used cannabis in the past month, nearly a third (31%) of respondents – or around 3.1% of the total sample – reported smoking cannabis daily or almost daily, and 19% (or 1.9% of the overall sample) consumed cannabis edibles daily or almost daily.
Most of the respondents who used cannabis said it was for recreational use (62%), but a quarter (25%) reported using it for both recreational and medical reasons, and 13% used it only for medical reasons. The most common reason women used cannabis was to treat chronic pain (28%), followed by nearly as many women reporting cannabis use for anxiety (24%), sleep (22%), and stress (22%). Six percent of women used cannabis specifically for menopause-related sleep and mood problems.
Given the growing use of cannabis in this population and the dearth of data on its effects in older women, Dr. Gibson highlighted the need for research examining the potential benefits and harms of cannabis for menopausal women.
Not risk-free
Susan D. Reed, MD, MPH, MSCP, a professor emeritus of ob.gyn. at the University of Washington, Seattle, and president of the Menopause Society, found the study well-executed and was not surprised by how many respondents had ever used cannabis.
“What did surprise me was that nearly a third reported daily use for at least 1 year and that 38% were medical marijuana users, not just recreational,” Dr. Reed said in an interview. The proportions of women using cannabis for menopausal symptoms or using it daily are concerning, she added.
“These individuals are at risk for dependence and health risks related to marijuana use,” Dr. Reed said. “Providers should always ask patients about OTC products, herbals, supplements, cannabis use, and alternative management of menopausal symptoms to better understand patient preferences for menopausal symptom therapies, so that treatment plans can be discussed with individual patient preferences in mind. We need to start with where the patient is coming from.”
Data presented throughout the conference has shown how people are “disillusioned with the care they are receiving for menopause,” Dr. Reed added. “It is so difficult to distinguish truth from myths based on information gained through social media, family, and friends, and that often is where most people are getting their information.”
Physicians often have not received adequate training on how to provide people with accurate information about menopause and managing menopausal symptoms, so she advises patients and physicians to visit reliable sites such as the Menopause Society, the Swan Study, and My Menoplan.
The research was funded by the Tobacco-Related Disease Research Program and the Veterans Administration. Dr. Gibson has provided unpaid consultation to Astellas Pharmaceuticals. Dr. Reed has received research support from Bayer and receives royalties from UpToDate.
AT NAMS 2023
Bone degradation measure can sway osteoporosis diagnosis
Assessing a key aspect of bone architecture, for which clinicians can now be reimbursed under Medicare, can significantly improve the ability to predict a patient’s risk for bone fracture.
Although bone mineral density (BMD) is traditionally used to identify patients with osteoporosis or low bone mass, some physicians have begun incorporating the trabecular bone score (TBS) into their exams.
At the Cleveland Clinic Center for Specialized Women’s Health, factoring in the TBS changed the diagnosis for 16% of 432 patients, according to Holly Thacker, MD, the center’s director.
“Importantly, 11% got worse diagnoses, and I use that in terms of prioritizing treatment,” Dr. Thacker said in an interview. The ability to determine how degraded the bone microarchitecture is through a software system “is a huge advance.”
Dr. Thacker described her center’s experience with the technology at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
While BMD captures the amount of minerals like calcium in the skeleton, TBS assesses the underlying microarchitecture by looking at the distribution of shades of gray on dual-energy x-ray absorptiometry (DXA) scans.
Based on the TBS, patients’ bones are classified as normal, partially degraded, or degraded. Among the 432 patients who received a TBS analysis in 2022, 3% shifted from a normal diagnosis to osteopenia, 8% worsened from osteopenia to osteoporosis, 4% went from osteopenia to normal, and 1.6% downgraded from osteoporosis to osteopenia, Dr. Thacker reported.
The new test may also provide some reassurance for female patients who have thinner bones, which may raise alarms based on BMD. TBS, however, may show that the structure of the bone looks normal.
“When you know that the microarchitecture is normal, you’re a lot less concerned that they actually have a bone disease of osteoporosis,” Dr. Thacker said.
Conversely, unexpectedly degraded bone raises questions.
“That makes you go back and say [to the patient]: ‘Have you been on steroids? Were you malnourished? Is there some other metabolic problem? Have you had some calcium disorder?’ ” Dr. Thacker said.
Dr. Thacker leverages the TBS to help patients obtain effective therapy, typically an anabolic agent followed by antiresorptive medication.
“When I see a patient who not only has osteoporosis on bone density but has completely degraded bone architecture, it’s a lot easier for me to make the argument to the insurance company that this patient is at grave risk for a low trauma fracture and bad outcome without the best treatment,” Dr. Thacker said.
10-year-old tech, recently covered
The Food and Drug Administration approved TBS software in 2012, but Medicare only recently started paying for it.
Medimaps Group, a company that markets imaging software to calculate TBS, announced in 2022 that reimbursement from the Centers for Medicare & Medicaid Services was available, at $41.53 on the Physician Fee Schedule and $82.61 on the Hospital Outpatient Prospective Payment Schedule.
“Reimbursement through CMS is an important endorsement of the clinical value of TBS for clinicians and their patients,” Didier Hans, PhD, MBA, the CEO of Medimaps, said in a statement at the time. He noted that more than 600,000 TBS procedures were being performed in the United States each year.
Nevertheless, the initial investment in purchasing the software may be a barrier for health systems.
“We are the first and only site in our health system to offer TBS, as this is an extra expense and not uniformly reimbursed by insurers,” Dr. Thacker reported at the meeting.
Potential drawbacks
The TBS software used in Dr. Thacker’s study has been validated only in Asian and White patients between certain ages and weights, meaning the system is not designed to be used for other populations. Other researchers have highlighted a need for trabecular bone scoring to be validated more broadly. The authors of a recent analysis, however, suggest that TBS can be used the same way no matter a patient’s race.
TBS “is going to be most helpful in those with osteopenia who are right near the threshold for treatment,” said Marcella Donovan Walker, MD, MS, in a presentation on bone quality at the meeting.
Many studies have shown that TBS “provides additive information to bone density,” said Dr. Walker, a professor of medicine in the division of endocrinology at Columbia University, New York. For example, a large study of women in Manitoba found that, regardless of whether their bone density was normal, osteopenic, or osteoporotic, those with a low TBS had a much higher risk for fracture.
‘Opportunistic screening’ with CT?
TBS relies on the same DXA scans that are used to calculate bone mineral density, so obtaining the score does not add time or radiation to the scanning process, Dr. Thacker said.
But many patients who should receive DXA scans do not, which adds to the promise of “opportunistic screening” for osteoporosis, Dr. Walker said. With this approach, physicians would analyze a CT scan that a patient received for another purpose, such as to investigate abdominal pain or chest pain.
“In these images is information about the bone,” Dr. Walker said.
Researchers have used high-resolution peripheral quantitative CT to perform finite element analysis, where a computer program simulates compression of the bone to create a measure of bone stiffness and determine the load required for a break.
One study found that including those elements predicted fractures better than bone mineral density or the Fracture Risk Assessment Tool alone, Dr. Walker noted.
Other aspects of bone quality include how many cracks are in the bone, the amount of adipose in the marrow space, and the rate at which bone is broken down and rebuilt. But Dr. Walker suggested that the longstanding focus on bone mineral density in clinical practice makes sense.
“By far, bone mass is the most important bone quality,” Dr. Walker said.
Dr. Thacker is the executive director of the nonprofit Speaking of Women’s Health. Dr. Walker reported receiving funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and Amgen.
A version of this article first appeared on Medscape.com.
Assessing a key aspect of bone architecture, for which clinicians can now be reimbursed under Medicare, can significantly improve the ability to predict a patient’s risk for bone fracture.
Although bone mineral density (BMD) is traditionally used to identify patients with osteoporosis or low bone mass, some physicians have begun incorporating the trabecular bone score (TBS) into their exams.
At the Cleveland Clinic Center for Specialized Women’s Health, factoring in the TBS changed the diagnosis for 16% of 432 patients, according to Holly Thacker, MD, the center’s director.
“Importantly, 11% got worse diagnoses, and I use that in terms of prioritizing treatment,” Dr. Thacker said in an interview. The ability to determine how degraded the bone microarchitecture is through a software system “is a huge advance.”
Dr. Thacker described her center’s experience with the technology at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
While BMD captures the amount of minerals like calcium in the skeleton, TBS assesses the underlying microarchitecture by looking at the distribution of shades of gray on dual-energy x-ray absorptiometry (DXA) scans.
Based on the TBS, patients’ bones are classified as normal, partially degraded, or degraded. Among the 432 patients who received a TBS analysis in 2022, 3% shifted from a normal diagnosis to osteopenia, 8% worsened from osteopenia to osteoporosis, 4% went from osteopenia to normal, and 1.6% downgraded from osteoporosis to osteopenia, Dr. Thacker reported.
The new test may also provide some reassurance for female patients who have thinner bones, which may raise alarms based on BMD. TBS, however, may show that the structure of the bone looks normal.
“When you know that the microarchitecture is normal, you’re a lot less concerned that they actually have a bone disease of osteoporosis,” Dr. Thacker said.
Conversely, unexpectedly degraded bone raises questions.
“That makes you go back and say [to the patient]: ‘Have you been on steroids? Were you malnourished? Is there some other metabolic problem? Have you had some calcium disorder?’ ” Dr. Thacker said.
Dr. Thacker leverages the TBS to help patients obtain effective therapy, typically an anabolic agent followed by antiresorptive medication.
“When I see a patient who not only has osteoporosis on bone density but has completely degraded bone architecture, it’s a lot easier for me to make the argument to the insurance company that this patient is at grave risk for a low trauma fracture and bad outcome without the best treatment,” Dr. Thacker said.
10-year-old tech, recently covered
The Food and Drug Administration approved TBS software in 2012, but Medicare only recently started paying for it.
Medimaps Group, a company that markets imaging software to calculate TBS, announced in 2022 that reimbursement from the Centers for Medicare & Medicaid Services was available, at $41.53 on the Physician Fee Schedule and $82.61 on the Hospital Outpatient Prospective Payment Schedule.
“Reimbursement through CMS is an important endorsement of the clinical value of TBS for clinicians and their patients,” Didier Hans, PhD, MBA, the CEO of Medimaps, said in a statement at the time. He noted that more than 600,000 TBS procedures were being performed in the United States each year.
Nevertheless, the initial investment in purchasing the software may be a barrier for health systems.
“We are the first and only site in our health system to offer TBS, as this is an extra expense and not uniformly reimbursed by insurers,” Dr. Thacker reported at the meeting.
Potential drawbacks
The TBS software used in Dr. Thacker’s study has been validated only in Asian and White patients between certain ages and weights, meaning the system is not designed to be used for other populations. Other researchers have highlighted a need for trabecular bone scoring to be validated more broadly. The authors of a recent analysis, however, suggest that TBS can be used the same way no matter a patient’s race.
TBS “is going to be most helpful in those with osteopenia who are right near the threshold for treatment,” said Marcella Donovan Walker, MD, MS, in a presentation on bone quality at the meeting.
Many studies have shown that TBS “provides additive information to bone density,” said Dr. Walker, a professor of medicine in the division of endocrinology at Columbia University, New York. For example, a large study of women in Manitoba found that, regardless of whether their bone density was normal, osteopenic, or osteoporotic, those with a low TBS had a much higher risk for fracture.
‘Opportunistic screening’ with CT?
TBS relies on the same DXA scans that are used to calculate bone mineral density, so obtaining the score does not add time or radiation to the scanning process, Dr. Thacker said.
But many patients who should receive DXA scans do not, which adds to the promise of “opportunistic screening” for osteoporosis, Dr. Walker said. With this approach, physicians would analyze a CT scan that a patient received for another purpose, such as to investigate abdominal pain or chest pain.
“In these images is information about the bone,” Dr. Walker said.
Researchers have used high-resolution peripheral quantitative CT to perform finite element analysis, where a computer program simulates compression of the bone to create a measure of bone stiffness and determine the load required for a break.
One study found that including those elements predicted fractures better than bone mineral density or the Fracture Risk Assessment Tool alone, Dr. Walker noted.
Other aspects of bone quality include how many cracks are in the bone, the amount of adipose in the marrow space, and the rate at which bone is broken down and rebuilt. But Dr. Walker suggested that the longstanding focus on bone mineral density in clinical practice makes sense.
“By far, bone mass is the most important bone quality,” Dr. Walker said.
Dr. Thacker is the executive director of the nonprofit Speaking of Women’s Health. Dr. Walker reported receiving funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and Amgen.
A version of this article first appeared on Medscape.com.
Assessing a key aspect of bone architecture, for which clinicians can now be reimbursed under Medicare, can significantly improve the ability to predict a patient’s risk for bone fracture.
Although bone mineral density (BMD) is traditionally used to identify patients with osteoporosis or low bone mass, some physicians have begun incorporating the trabecular bone score (TBS) into their exams.
At the Cleveland Clinic Center for Specialized Women’s Health, factoring in the TBS changed the diagnosis for 16% of 432 patients, according to Holly Thacker, MD, the center’s director.
“Importantly, 11% got worse diagnoses, and I use that in terms of prioritizing treatment,” Dr. Thacker said in an interview. The ability to determine how degraded the bone microarchitecture is through a software system “is a huge advance.”
Dr. Thacker described her center’s experience with the technology at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
While BMD captures the amount of minerals like calcium in the skeleton, TBS assesses the underlying microarchitecture by looking at the distribution of shades of gray on dual-energy x-ray absorptiometry (DXA) scans.
Based on the TBS, patients’ bones are classified as normal, partially degraded, or degraded. Among the 432 patients who received a TBS analysis in 2022, 3% shifted from a normal diagnosis to osteopenia, 8% worsened from osteopenia to osteoporosis, 4% went from osteopenia to normal, and 1.6% downgraded from osteoporosis to osteopenia, Dr. Thacker reported.
The new test may also provide some reassurance for female patients who have thinner bones, which may raise alarms based on BMD. TBS, however, may show that the structure of the bone looks normal.
“When you know that the microarchitecture is normal, you’re a lot less concerned that they actually have a bone disease of osteoporosis,” Dr. Thacker said.
Conversely, unexpectedly degraded bone raises questions.
“That makes you go back and say [to the patient]: ‘Have you been on steroids? Were you malnourished? Is there some other metabolic problem? Have you had some calcium disorder?’ ” Dr. Thacker said.
Dr. Thacker leverages the TBS to help patients obtain effective therapy, typically an anabolic agent followed by antiresorptive medication.
“When I see a patient who not only has osteoporosis on bone density but has completely degraded bone architecture, it’s a lot easier for me to make the argument to the insurance company that this patient is at grave risk for a low trauma fracture and bad outcome without the best treatment,” Dr. Thacker said.
10-year-old tech, recently covered
The Food and Drug Administration approved TBS software in 2012, but Medicare only recently started paying for it.
Medimaps Group, a company that markets imaging software to calculate TBS, announced in 2022 that reimbursement from the Centers for Medicare & Medicaid Services was available, at $41.53 on the Physician Fee Schedule and $82.61 on the Hospital Outpatient Prospective Payment Schedule.
“Reimbursement through CMS is an important endorsement of the clinical value of TBS for clinicians and their patients,” Didier Hans, PhD, MBA, the CEO of Medimaps, said in a statement at the time. He noted that more than 600,000 TBS procedures were being performed in the United States each year.
Nevertheless, the initial investment in purchasing the software may be a barrier for health systems.
“We are the first and only site in our health system to offer TBS, as this is an extra expense and not uniformly reimbursed by insurers,” Dr. Thacker reported at the meeting.
Potential drawbacks
The TBS software used in Dr. Thacker’s study has been validated only in Asian and White patients between certain ages and weights, meaning the system is not designed to be used for other populations. Other researchers have highlighted a need for trabecular bone scoring to be validated more broadly. The authors of a recent analysis, however, suggest that TBS can be used the same way no matter a patient’s race.
TBS “is going to be most helpful in those with osteopenia who are right near the threshold for treatment,” said Marcella Donovan Walker, MD, MS, in a presentation on bone quality at the meeting.
Many studies have shown that TBS “provides additive information to bone density,” said Dr. Walker, a professor of medicine in the division of endocrinology at Columbia University, New York. For example, a large study of women in Manitoba found that, regardless of whether their bone density was normal, osteopenic, or osteoporotic, those with a low TBS had a much higher risk for fracture.
‘Opportunistic screening’ with CT?
TBS relies on the same DXA scans that are used to calculate bone mineral density, so obtaining the score does not add time or radiation to the scanning process, Dr. Thacker said.
But many patients who should receive DXA scans do not, which adds to the promise of “opportunistic screening” for osteoporosis, Dr. Walker said. With this approach, physicians would analyze a CT scan that a patient received for another purpose, such as to investigate abdominal pain or chest pain.
“In these images is information about the bone,” Dr. Walker said.
Researchers have used high-resolution peripheral quantitative CT to perform finite element analysis, where a computer program simulates compression of the bone to create a measure of bone stiffness and determine the load required for a break.
One study found that including those elements predicted fractures better than bone mineral density or the Fracture Risk Assessment Tool alone, Dr. Walker noted.
Other aspects of bone quality include how many cracks are in the bone, the amount of adipose in the marrow space, and the rate at which bone is broken down and rebuilt. But Dr. Walker suggested that the longstanding focus on bone mineral density in clinical practice makes sense.
“By far, bone mass is the most important bone quality,” Dr. Walker said.
Dr. Thacker is the executive director of the nonprofit Speaking of Women’s Health. Dr. Walker reported receiving funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and Amgen.
A version of this article first appeared on Medscape.com.
FROM NAMS 2023
Pelvic yoga, physical conditioning both improve urinary incontinence
PHILADELPHIA – Both a pelvic yoga program and a general physical conditioning program for incontinence led to improvements in women’s incontinence, according to a study presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
“As clinicians, we’re usually focused on treatments that we ourselves can prescribe, perform, or administer. We’re not as good as recommending or supporting treatment or management strategies that don’t rely on costly or intensive visits with clinical specialists,” lead author Alison Huang, MD, MAS, a professor of medicine at the University of California, San Francisco, said in an interview.
“But our findings suggest that women who try pelvic yoga as a complementary management strategy for genitourinary conditions like urinary incontinence that often emerge in midlife are likely to experience substantial improvement in their genitourinary symptoms and function,” Dr. Huang said. “Some of these improvements may be shared with other forms of low-impact physical movement or exercise.”
The 240 participants from communities around three Northern California sites ranged in age from 45 to 90 years old, with an average age of 62, and all had at least daily urgency, stress, or mixed-type urinary incontinence. While most were White women, 40% identified as racial/ethnic minorities, including 14% Hispanic, 6% Black, 16% Asian American, and 4% multiracial.
Participants needed to be able to walk two blocks on level ground and get from a supine to a standing position on their own, but they should not have recently participated in any organized yoga or physical conditioning exercise classes. They also needed to forgo behavioral, invasive, or pharmacologic treatments for urinary incontinence for at least 3 months. The trial ran from 2019 to 2022, with most women completing the 3-month program virtually once the pandemic began.
The 121 women randomly assigned to the pelvic yoga program had twice-weekly group instruction by trained yoga instructors and once-weekly individual practice. The practice focused on 16 standard Hatha yoga poses in standing, seated, supine, and prone positions with an emphasis on precise alignment of their postures during each pose. Yoga props, such as blocks, straps, or bolsters, were available to minimize risk of injury and to accommodate women with less flexibility.
The 119 women randomly assigned to the physical conditioning group spent the same amount of group and individual class time on skeletal muscle stretching and strengthening exercises. These exercises focused on strengthening and stretching exercises for the upper and lower extremities in standing, sitting, or supine positions. The only props needed were exercise straps and handles and an exercise mat, and the program was designed to be safe and feasible for women across all ages.
Both groups received standard self-management pamphlets describing pelvic floor muscle exercises and recommendations on timed urination and urging suppression. After early dropouts from both arms, 107 women remained for analysis in the pelvic yoga group, and 113 women remained for analysis in the physical conditioning group.
Researchers assessed participants’ genitourinary quality of life at baseline and after 3 months using the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire (IIQ), and Patient Perception of Bladder Condition (PPBC). At baseline, the women’s average scores were 38.8 on the UDI-6, 101 on the IIQ, and 3.4 on the PPBC.
About one-third of the women in both groups attended all 24 group classes, and 57% of women in both groups attended 20-23 classes. In addition, 65% of the women in the pelvic yoga group and 73% of the women in the physical conditioning group completed all of the recommended additional hours of individual practice. Only 15% of pelvic yoga participants and 9% of physical conditioning participants completed less than 80% of the recommended individual practice hours. No differences in participation between the groups were statistically significant.
“Over 3 months, scores on all genitourinary quality of life measures improved by more than the minimum important difference thresholds in the pelvic yoga group,” the researchers reported, but only the UDI-6 score improved significantly – albeit still modestly – in the pelvic yoga group, compared with the physical conditioning group. Average scores improved 18.9 points in the pelvic yoga group and 13.1 points in the physical conditioning group (5.8-point difference; P = .02).
The scores on the IIQ improved an average 38.5 points in the pelvic yoga group and 31.4 points in the physical conditioning group (P = .48). PPBC scores improved 0.7 points in both groups.
“While yoga may offer benefits for genitourinary quality of life, it may not offer superior benefits compared to equivalent-time practice of other activities that improve general physical function,” Dr. Huang told attendees.
“The bottom line is that physical activity toward incontinence is a helpful technique,” Stephanie Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health and medical director for the Menopause Society, said in an interview regarding the findings. Urinary incontinence is under-recognized, Dr. Faubion said, “because women are embarrassed, so they don’t bring it up, so it doesn’t get managed.” But it’s a common problem, so clinicians need to ask patients about it, she said.
“We should realize that, in midlife and older age, genitourinary health is often connected to overall health,” Dr. Huang said in an interview. “We shouldn’t focus exclusively on treatments that are directed solely at the genital or lower urinary tract organs or tissues. We should consider the ways in which women’s urinary and sexual function are influenced by other aspects of their physical and cognitive health.”
The research was funded by the National Institutes of Health. Dr. Huang and Dr. Faubion had no disclosures.
PHILADELPHIA – Both a pelvic yoga program and a general physical conditioning program for incontinence led to improvements in women’s incontinence, according to a study presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
“As clinicians, we’re usually focused on treatments that we ourselves can prescribe, perform, or administer. We’re not as good as recommending or supporting treatment or management strategies that don’t rely on costly or intensive visits with clinical specialists,” lead author Alison Huang, MD, MAS, a professor of medicine at the University of California, San Francisco, said in an interview.
“But our findings suggest that women who try pelvic yoga as a complementary management strategy for genitourinary conditions like urinary incontinence that often emerge in midlife are likely to experience substantial improvement in their genitourinary symptoms and function,” Dr. Huang said. “Some of these improvements may be shared with other forms of low-impact physical movement or exercise.”
The 240 participants from communities around three Northern California sites ranged in age from 45 to 90 years old, with an average age of 62, and all had at least daily urgency, stress, or mixed-type urinary incontinence. While most were White women, 40% identified as racial/ethnic minorities, including 14% Hispanic, 6% Black, 16% Asian American, and 4% multiracial.
Participants needed to be able to walk two blocks on level ground and get from a supine to a standing position on their own, but they should not have recently participated in any organized yoga or physical conditioning exercise classes. They also needed to forgo behavioral, invasive, or pharmacologic treatments for urinary incontinence for at least 3 months. The trial ran from 2019 to 2022, with most women completing the 3-month program virtually once the pandemic began.
The 121 women randomly assigned to the pelvic yoga program had twice-weekly group instruction by trained yoga instructors and once-weekly individual practice. The practice focused on 16 standard Hatha yoga poses in standing, seated, supine, and prone positions with an emphasis on precise alignment of their postures during each pose. Yoga props, such as blocks, straps, or bolsters, were available to minimize risk of injury and to accommodate women with less flexibility.
The 119 women randomly assigned to the physical conditioning group spent the same amount of group and individual class time on skeletal muscle stretching and strengthening exercises. These exercises focused on strengthening and stretching exercises for the upper and lower extremities in standing, sitting, or supine positions. The only props needed were exercise straps and handles and an exercise mat, and the program was designed to be safe and feasible for women across all ages.
Both groups received standard self-management pamphlets describing pelvic floor muscle exercises and recommendations on timed urination and urging suppression. After early dropouts from both arms, 107 women remained for analysis in the pelvic yoga group, and 113 women remained for analysis in the physical conditioning group.
Researchers assessed participants’ genitourinary quality of life at baseline and after 3 months using the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire (IIQ), and Patient Perception of Bladder Condition (PPBC). At baseline, the women’s average scores were 38.8 on the UDI-6, 101 on the IIQ, and 3.4 on the PPBC.
About one-third of the women in both groups attended all 24 group classes, and 57% of women in both groups attended 20-23 classes. In addition, 65% of the women in the pelvic yoga group and 73% of the women in the physical conditioning group completed all of the recommended additional hours of individual practice. Only 15% of pelvic yoga participants and 9% of physical conditioning participants completed less than 80% of the recommended individual practice hours. No differences in participation between the groups were statistically significant.
“Over 3 months, scores on all genitourinary quality of life measures improved by more than the minimum important difference thresholds in the pelvic yoga group,” the researchers reported, but only the UDI-6 score improved significantly – albeit still modestly – in the pelvic yoga group, compared with the physical conditioning group. Average scores improved 18.9 points in the pelvic yoga group and 13.1 points in the physical conditioning group (5.8-point difference; P = .02).
The scores on the IIQ improved an average 38.5 points in the pelvic yoga group and 31.4 points in the physical conditioning group (P = .48). PPBC scores improved 0.7 points in both groups.
“While yoga may offer benefits for genitourinary quality of life, it may not offer superior benefits compared to equivalent-time practice of other activities that improve general physical function,” Dr. Huang told attendees.
“The bottom line is that physical activity toward incontinence is a helpful technique,” Stephanie Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health and medical director for the Menopause Society, said in an interview regarding the findings. Urinary incontinence is under-recognized, Dr. Faubion said, “because women are embarrassed, so they don’t bring it up, so it doesn’t get managed.” But it’s a common problem, so clinicians need to ask patients about it, she said.
“We should realize that, in midlife and older age, genitourinary health is often connected to overall health,” Dr. Huang said in an interview. “We shouldn’t focus exclusively on treatments that are directed solely at the genital or lower urinary tract organs or tissues. We should consider the ways in which women’s urinary and sexual function are influenced by other aspects of their physical and cognitive health.”
The research was funded by the National Institutes of Health. Dr. Huang and Dr. Faubion had no disclosures.
PHILADELPHIA – Both a pelvic yoga program and a general physical conditioning program for incontinence led to improvements in women’s incontinence, according to a study presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
“As clinicians, we’re usually focused on treatments that we ourselves can prescribe, perform, or administer. We’re not as good as recommending or supporting treatment or management strategies that don’t rely on costly or intensive visits with clinical specialists,” lead author Alison Huang, MD, MAS, a professor of medicine at the University of California, San Francisco, said in an interview.
“But our findings suggest that women who try pelvic yoga as a complementary management strategy for genitourinary conditions like urinary incontinence that often emerge in midlife are likely to experience substantial improvement in their genitourinary symptoms and function,” Dr. Huang said. “Some of these improvements may be shared with other forms of low-impact physical movement or exercise.”
The 240 participants from communities around three Northern California sites ranged in age from 45 to 90 years old, with an average age of 62, and all had at least daily urgency, stress, or mixed-type urinary incontinence. While most were White women, 40% identified as racial/ethnic minorities, including 14% Hispanic, 6% Black, 16% Asian American, and 4% multiracial.
Participants needed to be able to walk two blocks on level ground and get from a supine to a standing position on their own, but they should not have recently participated in any organized yoga or physical conditioning exercise classes. They also needed to forgo behavioral, invasive, or pharmacologic treatments for urinary incontinence for at least 3 months. The trial ran from 2019 to 2022, with most women completing the 3-month program virtually once the pandemic began.
The 121 women randomly assigned to the pelvic yoga program had twice-weekly group instruction by trained yoga instructors and once-weekly individual practice. The practice focused on 16 standard Hatha yoga poses in standing, seated, supine, and prone positions with an emphasis on precise alignment of their postures during each pose. Yoga props, such as blocks, straps, or bolsters, were available to minimize risk of injury and to accommodate women with less flexibility.
The 119 women randomly assigned to the physical conditioning group spent the same amount of group and individual class time on skeletal muscle stretching and strengthening exercises. These exercises focused on strengthening and stretching exercises for the upper and lower extremities in standing, sitting, or supine positions. The only props needed were exercise straps and handles and an exercise mat, and the program was designed to be safe and feasible for women across all ages.
Both groups received standard self-management pamphlets describing pelvic floor muscle exercises and recommendations on timed urination and urging suppression. After early dropouts from both arms, 107 women remained for analysis in the pelvic yoga group, and 113 women remained for analysis in the physical conditioning group.
Researchers assessed participants’ genitourinary quality of life at baseline and after 3 months using the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire (IIQ), and Patient Perception of Bladder Condition (PPBC). At baseline, the women’s average scores were 38.8 on the UDI-6, 101 on the IIQ, and 3.4 on the PPBC.
About one-third of the women in both groups attended all 24 group classes, and 57% of women in both groups attended 20-23 classes. In addition, 65% of the women in the pelvic yoga group and 73% of the women in the physical conditioning group completed all of the recommended additional hours of individual practice. Only 15% of pelvic yoga participants and 9% of physical conditioning participants completed less than 80% of the recommended individual practice hours. No differences in participation between the groups were statistically significant.
“Over 3 months, scores on all genitourinary quality of life measures improved by more than the minimum important difference thresholds in the pelvic yoga group,” the researchers reported, but only the UDI-6 score improved significantly – albeit still modestly – in the pelvic yoga group, compared with the physical conditioning group. Average scores improved 18.9 points in the pelvic yoga group and 13.1 points in the physical conditioning group (5.8-point difference; P = .02).
The scores on the IIQ improved an average 38.5 points in the pelvic yoga group and 31.4 points in the physical conditioning group (P = .48). PPBC scores improved 0.7 points in both groups.
“While yoga may offer benefits for genitourinary quality of life, it may not offer superior benefits compared to equivalent-time practice of other activities that improve general physical function,” Dr. Huang told attendees.
“The bottom line is that physical activity toward incontinence is a helpful technique,” Stephanie Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health and medical director for the Menopause Society, said in an interview regarding the findings. Urinary incontinence is under-recognized, Dr. Faubion said, “because women are embarrassed, so they don’t bring it up, so it doesn’t get managed.” But it’s a common problem, so clinicians need to ask patients about it, she said.
“We should realize that, in midlife and older age, genitourinary health is often connected to overall health,” Dr. Huang said in an interview. “We shouldn’t focus exclusively on treatments that are directed solely at the genital or lower urinary tract organs or tissues. We should consider the ways in which women’s urinary and sexual function are influenced by other aspects of their physical and cognitive health.”
The research was funded by the National Institutes of Health. Dr. Huang and Dr. Faubion had no disclosures.
AT NAMS 2023
Hormone therapy less effective in menopausal women with obesity
PHILADELPHIA – , according to a small, retrospective study presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).
More than 40% of women over age 40 in the United States have obesity, presenter Anita Pershad, MD, an ob.gyn. medical resident at Eastern Virginia Medical School, Norfolk, told attendees. Yet most of the large-scale studies investigating perimenopausal and postmenopausal hormone therapy included participants without major medical comorbidities, so little data exist on how effectively HT works in women with these comorbidities, she said
“The main takeaway of our study is that obesity may worsen a woman’s menopausal symptoms and limit the amount of relief she gets from hormone therapy,” Dr. Pershad said in an interview. “It remains unclear if hormone therapy is less effective in women with obesity overall, or if the expected efficacy can be achieved with alternative design and administration routes. A potential mechanism of action for the observed decreased effect could be due to adipose tissue acting as a heat insulator, promoting the effects of vasomotor symptoms.”
Dr. Pershad and her colleagues conducted a retrospective review of the medical records of 119 patients who presented to a menopause clinic at a Midsouth urban academic medical center between July 2018 and December 2022. Obesity was defined as having a body mass index (BMI) of 30 kg/m2 or greater.
The patients with and without obesity were similar in terms of age, duration of menopause, use of hormone therapy, and therapy acceptance, but patients with obesity were more likely to identify themselves as Black (71% vs. 40%). Women with obesity were also significantly more likely than women without obesity to report vasomotor symptoms (74% vs. 45%, P = .002), genitourinary/vulvovaginal symptoms (60% vs. 21%, P < .001), mood disturbances (11% vs. 0%, P = .18), and decreased libido (29% vs. 11%, P = .017).
There were no significant differences in comorbidities between women with and without obesity, and among women who received systemic or localized HT, the same standard dosing was used for both groups.
Women with obesity were much less likely to see a satisfying reduction in their menopausal symptoms than women without obesity (odds ratio 0.07, 95% confidence interval, 0.01-0.64; P = .006), though the subgroups for each category of HT were small. Among the 20 women receiving systemic hormone therapy, only 1 of the 12 with obesity (8.3%) reported improvement in symptoms, compared with 7 of the 8 women without obesity (88%; P = .0004). Among 33 women using localized hormone therapy, 46% of the 24 women with obesity vs. 89% of the 9 women without obesity experienced symptom improvement (P = .026).
The proportions of women reporting relief from only lifestyle modifications or from nonhormonal medications, such as SSRIs/SNRIs, trazodone, and clonidine, were not statistically different. There were 33 women who relied only on lifestyle modifications, with 31% of the 16 women with obesity and 59% of the 17 women without obesity reporting improvement in their symptoms (P = .112). Similarly, among the 33 women using nonhormonal medications, 75% of the 20 women with obesity and 77% of the 13 women without obesity experienced relief (P = .9).
Women with obesity are undertreated
Dr. Pershad emphasized the need to improve care and counseling for diverse patients seeking treatment for menopausal symptoms.
“More research is needed to examine how women with medical comorbidities are uniquely impacted by menopause and respond to therapies,” Dr. Pershad said in an interview. “This can be achieved by actively including more diverse patient populations in women’s health studies, burdened by the social determinants of health and medical comorbidities such as obesity.”
Stephanie S. Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health, Rochester, Minn., and medical director for The Menopause Society, was not surprised by the findings, particularly given that women with obesity tend to have more hot flashes and night sweats as a result of their extra weight. However, dosage data was not adjusted for BMI in the study and data on hormone levels was unavailable, she said, so it’s difficult to determine from the data whether HT was less effective for women with obesity or whether they were underdosed.
“I think women with obesity are undertreated,” Dr. Faubion said in an interview. “My guess is people are afraid. Women with obesity also may have other comorbidities,” such as hypertension and diabetes, she said, and “the greater the number of cardiovascular risk factors, the higher risk hormone therapy is.” Providers may therefore be leery of prescribing HT or prescribing it at an appropriately high enough dose to treat menopausal symptoms.
Common practice is to start patients at the lowest dose and titrate up according to symptoms, but “if people are afraid of it, they’re going to start the lowest dose” and may not increase it, Dr. Faubion said. She noted that other nonhormonal options are available, though providers should be conscientious about selecting ones whose adverse events do not include weight gain.
Although the study focused on an understudied population within hormone therapy research, the study was limited by its small size, low overall use of hormone therapy, recall bias, and the researchers’ inability to control for other medications the participants may have been taking.
Dr. Pershad said she is continuing research to try to identify the mechanisms underlying the reduced efficacy in women with obesity.
The research did not use any external funding. Dr. Pershad had no industry disclosures, but her colleagues reported honoraria from or speaking for TherapeuticsMD, Astella Pharma, Scynexis, Pharmavite, and Pfizer. Dr. Faubion had no disclosures.
PHILADELPHIA – , according to a small, retrospective study presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).
More than 40% of women over age 40 in the United States have obesity, presenter Anita Pershad, MD, an ob.gyn. medical resident at Eastern Virginia Medical School, Norfolk, told attendees. Yet most of the large-scale studies investigating perimenopausal and postmenopausal hormone therapy included participants without major medical comorbidities, so little data exist on how effectively HT works in women with these comorbidities, she said
“The main takeaway of our study is that obesity may worsen a woman’s menopausal symptoms and limit the amount of relief she gets from hormone therapy,” Dr. Pershad said in an interview. “It remains unclear if hormone therapy is less effective in women with obesity overall, or if the expected efficacy can be achieved with alternative design and administration routes. A potential mechanism of action for the observed decreased effect could be due to adipose tissue acting as a heat insulator, promoting the effects of vasomotor symptoms.”
Dr. Pershad and her colleagues conducted a retrospective review of the medical records of 119 patients who presented to a menopause clinic at a Midsouth urban academic medical center between July 2018 and December 2022. Obesity was defined as having a body mass index (BMI) of 30 kg/m2 or greater.
The patients with and without obesity were similar in terms of age, duration of menopause, use of hormone therapy, and therapy acceptance, but patients with obesity were more likely to identify themselves as Black (71% vs. 40%). Women with obesity were also significantly more likely than women without obesity to report vasomotor symptoms (74% vs. 45%, P = .002), genitourinary/vulvovaginal symptoms (60% vs. 21%, P < .001), mood disturbances (11% vs. 0%, P = .18), and decreased libido (29% vs. 11%, P = .017).
There were no significant differences in comorbidities between women with and without obesity, and among women who received systemic or localized HT, the same standard dosing was used for both groups.
Women with obesity were much less likely to see a satisfying reduction in their menopausal symptoms than women without obesity (odds ratio 0.07, 95% confidence interval, 0.01-0.64; P = .006), though the subgroups for each category of HT were small. Among the 20 women receiving systemic hormone therapy, only 1 of the 12 with obesity (8.3%) reported improvement in symptoms, compared with 7 of the 8 women without obesity (88%; P = .0004). Among 33 women using localized hormone therapy, 46% of the 24 women with obesity vs. 89% of the 9 women without obesity experienced symptom improvement (P = .026).
The proportions of women reporting relief from only lifestyle modifications or from nonhormonal medications, such as SSRIs/SNRIs, trazodone, and clonidine, were not statistically different. There were 33 women who relied only on lifestyle modifications, with 31% of the 16 women with obesity and 59% of the 17 women without obesity reporting improvement in their symptoms (P = .112). Similarly, among the 33 women using nonhormonal medications, 75% of the 20 women with obesity and 77% of the 13 women without obesity experienced relief (P = .9).
Women with obesity are undertreated
Dr. Pershad emphasized the need to improve care and counseling for diverse patients seeking treatment for menopausal symptoms.
“More research is needed to examine how women with medical comorbidities are uniquely impacted by menopause and respond to therapies,” Dr. Pershad said in an interview. “This can be achieved by actively including more diverse patient populations in women’s health studies, burdened by the social determinants of health and medical comorbidities such as obesity.”
Stephanie S. Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health, Rochester, Minn., and medical director for The Menopause Society, was not surprised by the findings, particularly given that women with obesity tend to have more hot flashes and night sweats as a result of their extra weight. However, dosage data was not adjusted for BMI in the study and data on hormone levels was unavailable, she said, so it’s difficult to determine from the data whether HT was less effective for women with obesity or whether they were underdosed.
“I think women with obesity are undertreated,” Dr. Faubion said in an interview. “My guess is people are afraid. Women with obesity also may have other comorbidities,” such as hypertension and diabetes, she said, and “the greater the number of cardiovascular risk factors, the higher risk hormone therapy is.” Providers may therefore be leery of prescribing HT or prescribing it at an appropriately high enough dose to treat menopausal symptoms.
Common practice is to start patients at the lowest dose and titrate up according to symptoms, but “if people are afraid of it, they’re going to start the lowest dose” and may not increase it, Dr. Faubion said. She noted that other nonhormonal options are available, though providers should be conscientious about selecting ones whose adverse events do not include weight gain.
Although the study focused on an understudied population within hormone therapy research, the study was limited by its small size, low overall use of hormone therapy, recall bias, and the researchers’ inability to control for other medications the participants may have been taking.
Dr. Pershad said she is continuing research to try to identify the mechanisms underlying the reduced efficacy in women with obesity.
The research did not use any external funding. Dr. Pershad had no industry disclosures, but her colleagues reported honoraria from or speaking for TherapeuticsMD, Astella Pharma, Scynexis, Pharmavite, and Pfizer. Dr. Faubion had no disclosures.
PHILADELPHIA – , according to a small, retrospective study presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).
More than 40% of women over age 40 in the United States have obesity, presenter Anita Pershad, MD, an ob.gyn. medical resident at Eastern Virginia Medical School, Norfolk, told attendees. Yet most of the large-scale studies investigating perimenopausal and postmenopausal hormone therapy included participants without major medical comorbidities, so little data exist on how effectively HT works in women with these comorbidities, she said
“The main takeaway of our study is that obesity may worsen a woman’s menopausal symptoms and limit the amount of relief she gets from hormone therapy,” Dr. Pershad said in an interview. “It remains unclear if hormone therapy is less effective in women with obesity overall, or if the expected efficacy can be achieved with alternative design and administration routes. A potential mechanism of action for the observed decreased effect could be due to adipose tissue acting as a heat insulator, promoting the effects of vasomotor symptoms.”
Dr. Pershad and her colleagues conducted a retrospective review of the medical records of 119 patients who presented to a menopause clinic at a Midsouth urban academic medical center between July 2018 and December 2022. Obesity was defined as having a body mass index (BMI) of 30 kg/m2 or greater.
The patients with and without obesity were similar in terms of age, duration of menopause, use of hormone therapy, and therapy acceptance, but patients with obesity were more likely to identify themselves as Black (71% vs. 40%). Women with obesity were also significantly more likely than women without obesity to report vasomotor symptoms (74% vs. 45%, P = .002), genitourinary/vulvovaginal symptoms (60% vs. 21%, P < .001), mood disturbances (11% vs. 0%, P = .18), and decreased libido (29% vs. 11%, P = .017).
There were no significant differences in comorbidities between women with and without obesity, and among women who received systemic or localized HT, the same standard dosing was used for both groups.
Women with obesity were much less likely to see a satisfying reduction in their menopausal symptoms than women without obesity (odds ratio 0.07, 95% confidence interval, 0.01-0.64; P = .006), though the subgroups for each category of HT were small. Among the 20 women receiving systemic hormone therapy, only 1 of the 12 with obesity (8.3%) reported improvement in symptoms, compared with 7 of the 8 women without obesity (88%; P = .0004). Among 33 women using localized hormone therapy, 46% of the 24 women with obesity vs. 89% of the 9 women without obesity experienced symptom improvement (P = .026).
The proportions of women reporting relief from only lifestyle modifications or from nonhormonal medications, such as SSRIs/SNRIs, trazodone, and clonidine, were not statistically different. There were 33 women who relied only on lifestyle modifications, with 31% of the 16 women with obesity and 59% of the 17 women without obesity reporting improvement in their symptoms (P = .112). Similarly, among the 33 women using nonhormonal medications, 75% of the 20 women with obesity and 77% of the 13 women without obesity experienced relief (P = .9).
Women with obesity are undertreated
Dr. Pershad emphasized the need to improve care and counseling for diverse patients seeking treatment for menopausal symptoms.
“More research is needed to examine how women with medical comorbidities are uniquely impacted by menopause and respond to therapies,” Dr. Pershad said in an interview. “This can be achieved by actively including more diverse patient populations in women’s health studies, burdened by the social determinants of health and medical comorbidities such as obesity.”
Stephanie S. Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health, Rochester, Minn., and medical director for The Menopause Society, was not surprised by the findings, particularly given that women with obesity tend to have more hot flashes and night sweats as a result of their extra weight. However, dosage data was not adjusted for BMI in the study and data on hormone levels was unavailable, she said, so it’s difficult to determine from the data whether HT was less effective for women with obesity or whether they were underdosed.
“I think women with obesity are undertreated,” Dr. Faubion said in an interview. “My guess is people are afraid. Women with obesity also may have other comorbidities,” such as hypertension and diabetes, she said, and “the greater the number of cardiovascular risk factors, the higher risk hormone therapy is.” Providers may therefore be leery of prescribing HT or prescribing it at an appropriately high enough dose to treat menopausal symptoms.
Common practice is to start patients at the lowest dose and titrate up according to symptoms, but “if people are afraid of it, they’re going to start the lowest dose” and may not increase it, Dr. Faubion said. She noted that other nonhormonal options are available, though providers should be conscientious about selecting ones whose adverse events do not include weight gain.
Although the study focused on an understudied population within hormone therapy research, the study was limited by its small size, low overall use of hormone therapy, recall bias, and the researchers’ inability to control for other medications the participants may have been taking.
Dr. Pershad said she is continuing research to try to identify the mechanisms underlying the reduced efficacy in women with obesity.
The research did not use any external funding. Dr. Pershad had no industry disclosures, but her colleagues reported honoraria from or speaking for TherapeuticsMD, Astella Pharma, Scynexis, Pharmavite, and Pfizer. Dr. Faubion had no disclosures.
AT THE MENOPAUSE SOCIETY ANNUAL MEETING
False-positive Pap smear may indicate genitourinary syndrome
TOPLINE:
, according to a poster presented at The Menopause Society 2023 annual meeting.
METHODOLOGY:
- Starting in 2010, researchers in Florida and Antigua saw an increase in the number of perimenopausal women with no history of cervical abnormalities and low risk for sexually transmitted infections (STIs) presenting with abnormal Pap smears at their clinics.
- They studied 1,500 women aged 30-70 from several clinics. The women had low risk for STIs, a maximum of two sexual partners, and the presence of cervical dysplasia over a period of 12 years.
TAKEAWAY:
- Nearly all (96.7%) of the women who received local estrogen treatment had a normal Pap smear following therapy.
- A high number of patients who initially presented with cervical dysplasia underwent interventions such as colposcopies, biopsies, LEEP excisions, cryotherapy, cone biopsies, and hysterectomies because of cervical atrophy.
- The researchers concluded that local estrogen treatment could save patients money spent on treatments for cervical atrophy.
- Some women who underwent cone biopsies and hysterectomies and did not receive local estrogen still had vaginal dysplasia.
IN PRACTICE:
“In this study, we report an early sign of genitourinary syndrome of menopause: false positive cervical dysplasia caused by cervicovaginal atrophy resulting from decreased estrogen levels during perimenopause,” say the investigators. “We also demonstrate how the use of local estrogen therapy can prevent a significant number of interventions and procedures, resulting in significant cost savings. This is particularly relevant as the number of Pap smears conducted in this population represents 50%-60% of all Pap smears performed on women.”
SOURCE:
The data were presented at The Menopause Society 2023 annual meeting. The study was led by Alberto Dominguez-Bali, MD, from the Miami Center for Obstetrics, Gynecology and Human Sexuality.
LIMITATIONS:
The study authors report no limitations.
DISCLOSURES:
The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, according to a poster presented at The Menopause Society 2023 annual meeting.
METHODOLOGY:
- Starting in 2010, researchers in Florida and Antigua saw an increase in the number of perimenopausal women with no history of cervical abnormalities and low risk for sexually transmitted infections (STIs) presenting with abnormal Pap smears at their clinics.
- They studied 1,500 women aged 30-70 from several clinics. The women had low risk for STIs, a maximum of two sexual partners, and the presence of cervical dysplasia over a period of 12 years.
TAKEAWAY:
- Nearly all (96.7%) of the women who received local estrogen treatment had a normal Pap smear following therapy.
- A high number of patients who initially presented with cervical dysplasia underwent interventions such as colposcopies, biopsies, LEEP excisions, cryotherapy, cone biopsies, and hysterectomies because of cervical atrophy.
- The researchers concluded that local estrogen treatment could save patients money spent on treatments for cervical atrophy.
- Some women who underwent cone biopsies and hysterectomies and did not receive local estrogen still had vaginal dysplasia.
IN PRACTICE:
“In this study, we report an early sign of genitourinary syndrome of menopause: false positive cervical dysplasia caused by cervicovaginal atrophy resulting from decreased estrogen levels during perimenopause,” say the investigators. “We also demonstrate how the use of local estrogen therapy can prevent a significant number of interventions and procedures, resulting in significant cost savings. This is particularly relevant as the number of Pap smears conducted in this population represents 50%-60% of all Pap smears performed on women.”
SOURCE:
The data were presented at The Menopause Society 2023 annual meeting. The study was led by Alberto Dominguez-Bali, MD, from the Miami Center for Obstetrics, Gynecology and Human Sexuality.
LIMITATIONS:
The study authors report no limitations.
DISCLOSURES:
The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, according to a poster presented at The Menopause Society 2023 annual meeting.
METHODOLOGY:
- Starting in 2010, researchers in Florida and Antigua saw an increase in the number of perimenopausal women with no history of cervical abnormalities and low risk for sexually transmitted infections (STIs) presenting with abnormal Pap smears at their clinics.
- They studied 1,500 women aged 30-70 from several clinics. The women had low risk for STIs, a maximum of two sexual partners, and the presence of cervical dysplasia over a period of 12 years.
TAKEAWAY:
- Nearly all (96.7%) of the women who received local estrogen treatment had a normal Pap smear following therapy.
- A high number of patients who initially presented with cervical dysplasia underwent interventions such as colposcopies, biopsies, LEEP excisions, cryotherapy, cone biopsies, and hysterectomies because of cervical atrophy.
- The researchers concluded that local estrogen treatment could save patients money spent on treatments for cervical atrophy.
- Some women who underwent cone biopsies and hysterectomies and did not receive local estrogen still had vaginal dysplasia.
IN PRACTICE:
“In this study, we report an early sign of genitourinary syndrome of menopause: false positive cervical dysplasia caused by cervicovaginal atrophy resulting from decreased estrogen levels during perimenopause,” say the investigators. “We also demonstrate how the use of local estrogen therapy can prevent a significant number of interventions and procedures, resulting in significant cost savings. This is particularly relevant as the number of Pap smears conducted in this population represents 50%-60% of all Pap smears performed on women.”
SOURCE:
The data were presented at The Menopause Society 2023 annual meeting. The study was led by Alberto Dominguez-Bali, MD, from the Miami Center for Obstetrics, Gynecology and Human Sexuality.
LIMITATIONS:
The study authors report no limitations.
DISCLOSURES:
The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE MENOPAUSE SOCIETY ANNUAL MEETING
CBT effectively treats sexual concerns in menopausal women
PHILADELPHIA – . Four CBT sessions specifically focused on sexual concerns resulted in decreased sexual distress and concern, reduced depressive and menopausal symptoms, and increased sexual desire and functioning, as well as improved body image and relationship satisfaction.
An estimated 68%-87% of perimenopausal and postmenopausal women report sexual concerns, Sheryl Green, PhD, CPsych, an associate professor of psychiatry and behavioral neurosciences at McMaster University and a psychologist at St. Joseph’s Healthcare’s Women’s Health Concerns Clinic, both in Hamilton, Ont., told attendees at the meeting.
“Sexual concerns over the menopausal transition are not just physical, but they’re also psychological and emotional,” Dr. Green said. “Three common challenges include decreased sexual desire, a reduction in physical arousal and ability to achieve an orgasm, and sexual pain and discomfort during intercourse.”
The reasons for these concerns are multifactorial, she said. Decreased sexual desire can stem from stress, medical problems, their relationship with their partner, or other causes. A woman’s difficulty with reduced physical arousal or ability to have an orgasm can result from changes in hormone levels and vaginal changes, such as vaginal atrophy, which can also contribute to the sexual pain or discomfort reported by 17%-45% of postmenopausal women.
Two pharmacologic treatments exist for sexual concerns: oral flibanserin (Addyi) and injectable bremelanotide (Vyleesi). But many women may be unable or unwilling to take medication for their concerns. Previous research from Lori Brotto has found cognitive behavioral therapy and mindfulness interventions to effectively improve sexual functioning in women treated for gynecologic cancer and in women without a history of cancer.
“Sexual function needs to be understood from a bio-psychosocial model, looking at the biologic factors, the psychological factors, the sociocultural factors, and the interpersonal factors,” Sheryl Kingsberg, PhD, a professor of psychiatry and reproductive biology at Case Western Reserve University and a psychologist at University Hospitals in Cleveland, said in an interview.
“They can all overlap, and the clinician can ask a few pointed questions that help identify what the source of the problem is,” said Dr. Kingsberg, who was not involved in this study. She noted that the International Society for the Study of Women’s Sexual Health has an algorithm that can help in determining the source of the problems.
“Sometimes it’s going to be a biologic condition for which pharmacologic options are nice, but even if it is primarily pharmacologic, psychotherapy is always useful,” Dr. Kingsberg said. “Once the problem is there, even if it’s biologically based, then you have all the things in terms of the cognitive distortion, anxiety,” and other issues that a cognitive behavioral approach can help address. “And access is now much wider because of telehealth,” she added.
‘Psychology of menopause’
The study led by Dr. Green focused on peri- and postmenopausal women, with an average age of 50, who were experiencing primary sexual concerns based on a score of at least 26 on the Female Sexual Function Index (FSFI). Among the 20 women recruited for the study, 6 had already been prescribed hormone therapy for sexual concerns.
All reported decreased sexual desire, 17 reported decreased sexual arousal, 14 had body image dissatisfaction related to sexual concerns, and 6 reported urogenital problems. Nine of the women were in full remission from major depressive disorder, one had post-traumatic stress syndrome, and one had subclinical generalized anxiety disorder.
After spending 4 weeks on a wait list as self-control group for the study, the 15 women who completed the trial underwent four individual CBT sessions focusing on sexual concerns. The first session focused on psychoeducation and thought monitoring, and the second focused on cognitive distortions, cognitive strategies, and unhelpful beliefs or expectations related to sexual concerns. The third session looked at the role of problematic behaviors and behavioral experiments, and the fourth focused on continuation of strategies, long-term goals, and maintaining gains.
The participants completed eight measures at baseline, after the 4 weeks on the wait list, and after the four CBT sessions to assess the following:
- Sexual satisfaction, distress, and desire, using the FSFI, the Female Sexual Distress Scale-Revised (FSDS-R), and the Female Sexual Desire Questionnaire (FSDQ).
- Menopause symptoms, using the Greene Climacteric Scale (GCS).
- Body image, using the Dresden Body Image Questionnaire (DBIQ).
- Relationship satisfaction, using the Couples Satisfaction Index (CSI).
- Depression, using the Beck Depression Inventory-II (BDI-II).
- Anxiety, using the Hamilton Anxiety Rating Scale (HAM-A).
The women did not experience any significant changes while on the wait list except a slight decrease on the FSDQ concern subscale. Following the CBT sessions, however, the women experienced a significant decrease in sexual distress and concern as well as an increase in sexual dyadic desire and sexual functioning (P = .003 for FSFI, P = .002 for FSDS-R, and P = .003 for FSDQ).
Participants also experienced a decrease in depression (P < .0001) and menopausal symptoms (P = .001) and an increase in body-image satisfaction (P = .018) and relationship satisfaction (P = .0011) after the CBT sessions. The researchers assessed participants’ satisfaction with the Client Satisfaction Questionnaire after the CBT sessions and reported some of the qualitative findings.
“The treatment program was able to assist me with recognizing that some of my sexual concerns were normal, emotional as well as physical and hormonal, and provided me the ability to delve more deeply into the psychology of menopause and how to work through symptoms and concerns in more manageable pieces,” one participant wrote. Another found helpful the “homework exercises of recognizing a thought/feeling/emotion surrounding how I feel about myself/body and working through. More positive thought pattern/restructuring a response the most helpful.”
The main complaint about the program was that it was too short, with women wanting more sessions to help continue their progress.
Not an ‘either-or’ approach
Dr. Kingsberg said ISSWSH has a variety of sexual medicine practitioners, including providers who can provide CBT for sexual concerns, and the American Association of Sexuality Educators, Counselors and Therapists has a referral directory.
“Keeping in mind the bio-psychosocial model, sometimes psychotherapy is going to be a really effective treatment for sexual concerns,” Dr. Kingsberg said. “Sometimes the pharmacologic option is going to be a really effective treatment for some concerns, and sometimes the combination is going to have a really nice treatment effect. So it’s not a one-size-fits-all, and it doesn’t have to be an either-or.”
The sexual concerns of women still do not get adequately addressed in medical schools and residencies, Dr. Kingsberg said, which is distinctly different from how male sexual concerns are addressed in health care.
“Erectile dysfunction is kind of in the norm, and women are still a little hesitant to bring up their sexual concerns,” Dr. Kingsberg said. “They don’t know if it’s appropriate and they’re hoping that their clinician will ask.”
One way clinicians can do that is with a global question for all their patients: “Most of my patients have sexual questions or concerns; what concerns do you have?”
“They don’t have to go through a checklist of 10 things,” Dr. Kingsberg said. If the patient does not bring anything up, providers can then ask a single follow up question: “Do you have any concerns with desire, arousal, orgasm, or pain?” That question, Dr. Kingsberg said, covers the four main areas of concern.
The study was funded by the Canadian Institute of Health Research. Dr. Green reported no disclosures. Dr. Kingsberg has consulted for or served on the advisory board for Alloy, Astellas, Bayer, Dare Bioscience, Freya, Reunion Neuroscience, Materna Medical, Madorra, Palatin, Pfizer, ReJoy, Sprout, Strategic Science Technologies, and MsMedicine.
PHILADELPHIA – . Four CBT sessions specifically focused on sexual concerns resulted in decreased sexual distress and concern, reduced depressive and menopausal symptoms, and increased sexual desire and functioning, as well as improved body image and relationship satisfaction.
An estimated 68%-87% of perimenopausal and postmenopausal women report sexual concerns, Sheryl Green, PhD, CPsych, an associate professor of psychiatry and behavioral neurosciences at McMaster University and a psychologist at St. Joseph’s Healthcare’s Women’s Health Concerns Clinic, both in Hamilton, Ont., told attendees at the meeting.
“Sexual concerns over the menopausal transition are not just physical, but they’re also psychological and emotional,” Dr. Green said. “Three common challenges include decreased sexual desire, a reduction in physical arousal and ability to achieve an orgasm, and sexual pain and discomfort during intercourse.”
The reasons for these concerns are multifactorial, she said. Decreased sexual desire can stem from stress, medical problems, their relationship with their partner, or other causes. A woman’s difficulty with reduced physical arousal or ability to have an orgasm can result from changes in hormone levels and vaginal changes, such as vaginal atrophy, which can also contribute to the sexual pain or discomfort reported by 17%-45% of postmenopausal women.
Two pharmacologic treatments exist for sexual concerns: oral flibanserin (Addyi) and injectable bremelanotide (Vyleesi). But many women may be unable or unwilling to take medication for their concerns. Previous research from Lori Brotto has found cognitive behavioral therapy and mindfulness interventions to effectively improve sexual functioning in women treated for gynecologic cancer and in women without a history of cancer.
“Sexual function needs to be understood from a bio-psychosocial model, looking at the biologic factors, the psychological factors, the sociocultural factors, and the interpersonal factors,” Sheryl Kingsberg, PhD, a professor of psychiatry and reproductive biology at Case Western Reserve University and a psychologist at University Hospitals in Cleveland, said in an interview.
“They can all overlap, and the clinician can ask a few pointed questions that help identify what the source of the problem is,” said Dr. Kingsberg, who was not involved in this study. She noted that the International Society for the Study of Women’s Sexual Health has an algorithm that can help in determining the source of the problems.
“Sometimes it’s going to be a biologic condition for which pharmacologic options are nice, but even if it is primarily pharmacologic, psychotherapy is always useful,” Dr. Kingsberg said. “Once the problem is there, even if it’s biologically based, then you have all the things in terms of the cognitive distortion, anxiety,” and other issues that a cognitive behavioral approach can help address. “And access is now much wider because of telehealth,” she added.
‘Psychology of menopause’
The study led by Dr. Green focused on peri- and postmenopausal women, with an average age of 50, who were experiencing primary sexual concerns based on a score of at least 26 on the Female Sexual Function Index (FSFI). Among the 20 women recruited for the study, 6 had already been prescribed hormone therapy for sexual concerns.
All reported decreased sexual desire, 17 reported decreased sexual arousal, 14 had body image dissatisfaction related to sexual concerns, and 6 reported urogenital problems. Nine of the women were in full remission from major depressive disorder, one had post-traumatic stress syndrome, and one had subclinical generalized anxiety disorder.
After spending 4 weeks on a wait list as self-control group for the study, the 15 women who completed the trial underwent four individual CBT sessions focusing on sexual concerns. The first session focused on psychoeducation and thought monitoring, and the second focused on cognitive distortions, cognitive strategies, and unhelpful beliefs or expectations related to sexual concerns. The third session looked at the role of problematic behaviors and behavioral experiments, and the fourth focused on continuation of strategies, long-term goals, and maintaining gains.
The participants completed eight measures at baseline, after the 4 weeks on the wait list, and after the four CBT sessions to assess the following:
- Sexual satisfaction, distress, and desire, using the FSFI, the Female Sexual Distress Scale-Revised (FSDS-R), and the Female Sexual Desire Questionnaire (FSDQ).
- Menopause symptoms, using the Greene Climacteric Scale (GCS).
- Body image, using the Dresden Body Image Questionnaire (DBIQ).
- Relationship satisfaction, using the Couples Satisfaction Index (CSI).
- Depression, using the Beck Depression Inventory-II (BDI-II).
- Anxiety, using the Hamilton Anxiety Rating Scale (HAM-A).
The women did not experience any significant changes while on the wait list except a slight decrease on the FSDQ concern subscale. Following the CBT sessions, however, the women experienced a significant decrease in sexual distress and concern as well as an increase in sexual dyadic desire and sexual functioning (P = .003 for FSFI, P = .002 for FSDS-R, and P = .003 for FSDQ).
Participants also experienced a decrease in depression (P < .0001) and menopausal symptoms (P = .001) and an increase in body-image satisfaction (P = .018) and relationship satisfaction (P = .0011) after the CBT sessions. The researchers assessed participants’ satisfaction with the Client Satisfaction Questionnaire after the CBT sessions and reported some of the qualitative findings.
“The treatment program was able to assist me with recognizing that some of my sexual concerns were normal, emotional as well as physical and hormonal, and provided me the ability to delve more deeply into the psychology of menopause and how to work through symptoms and concerns in more manageable pieces,” one participant wrote. Another found helpful the “homework exercises of recognizing a thought/feeling/emotion surrounding how I feel about myself/body and working through. More positive thought pattern/restructuring a response the most helpful.”
The main complaint about the program was that it was too short, with women wanting more sessions to help continue their progress.
Not an ‘either-or’ approach
Dr. Kingsberg said ISSWSH has a variety of sexual medicine practitioners, including providers who can provide CBT for sexual concerns, and the American Association of Sexuality Educators, Counselors and Therapists has a referral directory.
“Keeping in mind the bio-psychosocial model, sometimes psychotherapy is going to be a really effective treatment for sexual concerns,” Dr. Kingsberg said. “Sometimes the pharmacologic option is going to be a really effective treatment for some concerns, and sometimes the combination is going to have a really nice treatment effect. So it’s not a one-size-fits-all, and it doesn’t have to be an either-or.”
The sexual concerns of women still do not get adequately addressed in medical schools and residencies, Dr. Kingsberg said, which is distinctly different from how male sexual concerns are addressed in health care.
“Erectile dysfunction is kind of in the norm, and women are still a little hesitant to bring up their sexual concerns,” Dr. Kingsberg said. “They don’t know if it’s appropriate and they’re hoping that their clinician will ask.”
One way clinicians can do that is with a global question for all their patients: “Most of my patients have sexual questions or concerns; what concerns do you have?”
“They don’t have to go through a checklist of 10 things,” Dr. Kingsberg said. If the patient does not bring anything up, providers can then ask a single follow up question: “Do you have any concerns with desire, arousal, orgasm, or pain?” That question, Dr. Kingsberg said, covers the four main areas of concern.
The study was funded by the Canadian Institute of Health Research. Dr. Green reported no disclosures. Dr. Kingsberg has consulted for or served on the advisory board for Alloy, Astellas, Bayer, Dare Bioscience, Freya, Reunion Neuroscience, Materna Medical, Madorra, Palatin, Pfizer, ReJoy, Sprout, Strategic Science Technologies, and MsMedicine.
PHILADELPHIA – . Four CBT sessions specifically focused on sexual concerns resulted in decreased sexual distress and concern, reduced depressive and menopausal symptoms, and increased sexual desire and functioning, as well as improved body image and relationship satisfaction.
An estimated 68%-87% of perimenopausal and postmenopausal women report sexual concerns, Sheryl Green, PhD, CPsych, an associate professor of psychiatry and behavioral neurosciences at McMaster University and a psychologist at St. Joseph’s Healthcare’s Women’s Health Concerns Clinic, both in Hamilton, Ont., told attendees at the meeting.
“Sexual concerns over the menopausal transition are not just physical, but they’re also psychological and emotional,” Dr. Green said. “Three common challenges include decreased sexual desire, a reduction in physical arousal and ability to achieve an orgasm, and sexual pain and discomfort during intercourse.”
The reasons for these concerns are multifactorial, she said. Decreased sexual desire can stem from stress, medical problems, their relationship with their partner, or other causes. A woman’s difficulty with reduced physical arousal or ability to have an orgasm can result from changes in hormone levels and vaginal changes, such as vaginal atrophy, which can also contribute to the sexual pain or discomfort reported by 17%-45% of postmenopausal women.
Two pharmacologic treatments exist for sexual concerns: oral flibanserin (Addyi) and injectable bremelanotide (Vyleesi). But many women may be unable or unwilling to take medication for their concerns. Previous research from Lori Brotto has found cognitive behavioral therapy and mindfulness interventions to effectively improve sexual functioning in women treated for gynecologic cancer and in women without a history of cancer.
“Sexual function needs to be understood from a bio-psychosocial model, looking at the biologic factors, the psychological factors, the sociocultural factors, and the interpersonal factors,” Sheryl Kingsberg, PhD, a professor of psychiatry and reproductive biology at Case Western Reserve University and a psychologist at University Hospitals in Cleveland, said in an interview.
“They can all overlap, and the clinician can ask a few pointed questions that help identify what the source of the problem is,” said Dr. Kingsberg, who was not involved in this study. She noted that the International Society for the Study of Women’s Sexual Health has an algorithm that can help in determining the source of the problems.
“Sometimes it’s going to be a biologic condition for which pharmacologic options are nice, but even if it is primarily pharmacologic, psychotherapy is always useful,” Dr. Kingsberg said. “Once the problem is there, even if it’s biologically based, then you have all the things in terms of the cognitive distortion, anxiety,” and other issues that a cognitive behavioral approach can help address. “And access is now much wider because of telehealth,” she added.
‘Psychology of menopause’
The study led by Dr. Green focused on peri- and postmenopausal women, with an average age of 50, who were experiencing primary sexual concerns based on a score of at least 26 on the Female Sexual Function Index (FSFI). Among the 20 women recruited for the study, 6 had already been prescribed hormone therapy for sexual concerns.
All reported decreased sexual desire, 17 reported decreased sexual arousal, 14 had body image dissatisfaction related to sexual concerns, and 6 reported urogenital problems. Nine of the women were in full remission from major depressive disorder, one had post-traumatic stress syndrome, and one had subclinical generalized anxiety disorder.
After spending 4 weeks on a wait list as self-control group for the study, the 15 women who completed the trial underwent four individual CBT sessions focusing on sexual concerns. The first session focused on psychoeducation and thought monitoring, and the second focused on cognitive distortions, cognitive strategies, and unhelpful beliefs or expectations related to sexual concerns. The third session looked at the role of problematic behaviors and behavioral experiments, and the fourth focused on continuation of strategies, long-term goals, and maintaining gains.
The participants completed eight measures at baseline, after the 4 weeks on the wait list, and after the four CBT sessions to assess the following:
- Sexual satisfaction, distress, and desire, using the FSFI, the Female Sexual Distress Scale-Revised (FSDS-R), and the Female Sexual Desire Questionnaire (FSDQ).
- Menopause symptoms, using the Greene Climacteric Scale (GCS).
- Body image, using the Dresden Body Image Questionnaire (DBIQ).
- Relationship satisfaction, using the Couples Satisfaction Index (CSI).
- Depression, using the Beck Depression Inventory-II (BDI-II).
- Anxiety, using the Hamilton Anxiety Rating Scale (HAM-A).
The women did not experience any significant changes while on the wait list except a slight decrease on the FSDQ concern subscale. Following the CBT sessions, however, the women experienced a significant decrease in sexual distress and concern as well as an increase in sexual dyadic desire and sexual functioning (P = .003 for FSFI, P = .002 for FSDS-R, and P = .003 for FSDQ).
Participants also experienced a decrease in depression (P < .0001) and menopausal symptoms (P = .001) and an increase in body-image satisfaction (P = .018) and relationship satisfaction (P = .0011) after the CBT sessions. The researchers assessed participants’ satisfaction with the Client Satisfaction Questionnaire after the CBT sessions and reported some of the qualitative findings.
“The treatment program was able to assist me with recognizing that some of my sexual concerns were normal, emotional as well as physical and hormonal, and provided me the ability to delve more deeply into the psychology of menopause and how to work through symptoms and concerns in more manageable pieces,” one participant wrote. Another found helpful the “homework exercises of recognizing a thought/feeling/emotion surrounding how I feel about myself/body and working through. More positive thought pattern/restructuring a response the most helpful.”
The main complaint about the program was that it was too short, with women wanting more sessions to help continue their progress.
Not an ‘either-or’ approach
Dr. Kingsberg said ISSWSH has a variety of sexual medicine practitioners, including providers who can provide CBT for sexual concerns, and the American Association of Sexuality Educators, Counselors and Therapists has a referral directory.
“Keeping in mind the bio-psychosocial model, sometimes psychotherapy is going to be a really effective treatment for sexual concerns,” Dr. Kingsberg said. “Sometimes the pharmacologic option is going to be a really effective treatment for some concerns, and sometimes the combination is going to have a really nice treatment effect. So it’s not a one-size-fits-all, and it doesn’t have to be an either-or.”
The sexual concerns of women still do not get adequately addressed in medical schools and residencies, Dr. Kingsberg said, which is distinctly different from how male sexual concerns are addressed in health care.
“Erectile dysfunction is kind of in the norm, and women are still a little hesitant to bring up their sexual concerns,” Dr. Kingsberg said. “They don’t know if it’s appropriate and they’re hoping that their clinician will ask.”
One way clinicians can do that is with a global question for all their patients: “Most of my patients have sexual questions or concerns; what concerns do you have?”
“They don’t have to go through a checklist of 10 things,” Dr. Kingsberg said. If the patient does not bring anything up, providers can then ask a single follow up question: “Do you have any concerns with desire, arousal, orgasm, or pain?” That question, Dr. Kingsberg said, covers the four main areas of concern.
The study was funded by the Canadian Institute of Health Research. Dr. Green reported no disclosures. Dr. Kingsberg has consulted for or served on the advisory board for Alloy, Astellas, Bayer, Dare Bioscience, Freya, Reunion Neuroscience, Materna Medical, Madorra, Palatin, Pfizer, ReJoy, Sprout, Strategic Science Technologies, and MsMedicine.
AT NAMS 2023
Hyaluronic acid suppository improves menopause symptoms
TOPLINE:
Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.
METHODOLOGY:
- Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
- The trial was conducted between September 2021 and August 2022.
TAKEAWAY:
- Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
- The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
- Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
- No treatment-related severe adverse events were reported.
IN PRACTICE:
“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”
SOURCE:
Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.
DISCLOSURES:
The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.
A version of this article appeared on Medscape.com.
TOPLINE:
Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.
METHODOLOGY:
- Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
- The trial was conducted between September 2021 and August 2022.
TAKEAWAY:
- Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
- The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
- Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
- No treatment-related severe adverse events were reported.
IN PRACTICE:
“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”
SOURCE:
Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.
DISCLOSURES:
The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.
A version of this article appeared on Medscape.com.
TOPLINE:
Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.
METHODOLOGY:
- Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
- The trial was conducted between September 2021 and August 2022.
TAKEAWAY:
- Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
- The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
- Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
- No treatment-related severe adverse events were reported.
IN PRACTICE:
“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”
SOURCE:
Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.
DISCLOSURES:
The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.
A version of this article appeared on Medscape.com.
Menopausal hormone therapy less prescribed for Black women
PHILADELPHIA – , according to a review of published studies presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
“Gaps in treatment can be used to inform health care providers about menopausal HT prescribing disparities, with the goal of improving equitable and advanced patient care among disadvantaged populations,” wrote Danette Conklin, PhD, an assistant professor of psychiatry and reproductive biology at Case Western Reserve University, Cleveland, and a psychologist at University Hospitals Cleveland Medical Center; Sally MacPhedran, MD, an associate professor of reproductive biology at Case Western Reserve University and an ob.gyn at MetroHealth Medical Center, also in Cleveland; and their colleagues.
The researchers combed through PubMed, CINAHL, Cochrane Library, Web of Science and PsychInfo databases to identify all studies conducted in the United States since 1940 that contained data on patient demographics and prescribing patterns for hormone therapy to treat menopausal symptoms. In addition to excluding men, children, teens, trans men, and women who had contraindications for HT, the investigators excluded randomized clinical trials so that prescribing patterns would not be based on protocols or RCT participatory criteria.
The researchers identified 20 studies, ranging from 1973 through 2015, including 9 national studies and the others across different U.S. regions. They then analyzed differences in HT prescribing according to age, race/ethnicity, education, income, insurance type, body mass index, and mental health, including alcohol or substance use.
Seven of the studies assessed HT use based on patient surveys, seven used medical or medication records showing an HT prescription, two studies used insurance claims to show an HT prescription, and one study surveyed patients about whether they received an HT prescription. Another four studies used surveys that asked patients whether they received HT counseling but did not indicate if the patients received a prescription.
Half of the studies showed racial disparities in HT prescribing. In all of them, Black women used or were prescribed or counseled on using HT less than white, Hispanic, or Asian women. White women had greater use, prescribing, or counseling than all other races/ethnicities except one study in which Hispanic women were prescribed vaginal estrogen more often than white women.
Six of the studies showed education disparities in which menopausal women with lower education levels used less HT or were prescribed or counseled on HT less than women with higher education.
Complex reasons
Monica Christmas, MD, an associate professor of obstetrics and gynecology at the University of Chicago and director of the Menopause Program and the Center for Women’s Integrated Health, said the study’s findings were not surprising, but the reasons for the racial disparities are likely complex.
Implicit bias in providers is likely one contributing factor, with some providers not thinking of offering HT to certain patients or not expecting the patients to be interested in it. Providers may also hesitate to prescribe HT to patients with more comorbidities because of concerns about HT risks, so if Black patients have more comorbidities, that could play a role in how many are offered or counseled on HT, she said.
“Probably the biggest take home is that it is important to be asking all of our patients about their symptoms and being proactive about talking about it,” Dr. Christmas said in an interview.
At the same time, in her anecdotal experience at a previous institution, Dr. Christmas noticed that her Black patients were less receptive to using hormone therapy than her White patients even though her Black patients tended to exhibit or report greater or more severe symptoms. But there’s been a “paradigm shift” more recently, Dr. Christmas said. With awareness about menopause growing in the media and particularly on social media, and with greater awareness about racial disparities in menopausal symptoms and care – including that shown in Dr. Christmas’s work in the SWAN Study – Dr. Christmas has had more Black patients asking about HT and other treatments for their menopausal symptoms more recently.
“Just 10 years ago, I was trying to talk to people about hormones, and I’ve been giving them to people that need them for a long time, and I couldn’t,” Dr. Christmas said. “Now people are coming in, saying ‘no one’s ever talked to me about it’ or ‘I deserve this.’ It shows you the persuasion that social media and the Internet have on our thinking too, and I think that’s going to be interesting to look at, to see how that impacts people’s perception about wanting treatment.”
Dr. Conklin agreed that reasons for the disparities likely involve a combination of factors, including providers’ assumptions about different racial groups’ knowledge and receptiveness toward different treatments. One of the studies in their review also reported provider barriers to prescribing HT, which included lack of time, lack of adequate knowledge, and concern about risks to patients’ health.
“Medical providers tend to have less time with their patients compared to PhDs, and that time factor really makes a big difference in terms of what the focus is going to be in that [short] appointment,” Dr. Conklin said in an interview. “Perhaps from a provider point of view, they are prioritizing what they think is more important to their patient and not really listening deeply to what their patient is saying.”
Educating clinicians
Potentially supporting that possibility, Dr. Conklin and Dr. MacPhedran also had a poster at the conference that looked at prescribing of HT in both Black and White women with a diagnosis of depression, anxiety, or bipolar disorder.
“In a population with a high percentage of Black patients known to have more menopause symptoms, the data demonstrated a surprisingly low rate of documented menopause symptoms (11%) compared to prior reports of up to 80%,” the researchers reported. “This low rate may be related to patient reporting, physician inquiry, or physician documentation of menopause symptoms.” They further found that White women with menopause symptoms and one of those psychiatric diagnosis were 40% more likely to receive an HT prescription for menopausal symptoms than Black women with the same diagnoses and symptoms.
Dr. Conklin emphasized the importance of providers not overlooking women who have mental health disorders when it comes to treating menopausal symptoms, particularly since mental health conditions and menopausal symptoms can exacerbate each other.
“Their depression could worsen irritability, and anxiety can worsen during the transition, and it could be overlooked or thought of as another [psychiatric] episode,” Dr. Conklin said. Providers may need to “dig a little deeper,” especially if patients are reporting having hot flashes or brain fog.
A key way to help overcome the racial disparities – whether they result from systemic issues, implicit bias or assumptions, or patients’ own reticence – is education, Dr. Conklin said. She recommended that providers have educational material about menopause and treatments for menopausal symptoms in the waiting room and then ask patients about their symptoms and invite patients to ask questions.
Dr. MacPhedran added that education for clinicians is key as well.
“Now is a great time – menopause is hot, menopause is interesting, and it’s getting a little bit of a push in terms of research dollars,” Dr. MacPhedran said. “That will trickle down to more emphasis in medical education, whether that’s nurse practitioners, physicians, PAs, or midwives. Everybody needs more education on menopause so they can be more comfortable asking and answering these questions.”
Dr. Conklin said she would like to see expanded education on menopause for medical residents and in health psychology curricula as well.
Among the 13 studies that found disparities in prescribing patterns by age, seven studies showed that older women used or were prescribed or counseled on HT more often than younger women. Four studies found the opposite, with older women less likely to use or be prescribed or counseled about HT. One study had mixed results, and one study had expected prescribing patterns.
Five studies found income disparities and five studies found disparities by medical conditions in terms of HT use, prescribing, or counseling. Other disparities identified in smaller numbers of studies (four or fewer) included natural versus surgical menopause, insurance coverage, body mass index, geographic region, smoking and alcohol use.
The two biggest limitations of the research were its heterogeneity and the small number of studies included, which points to how scarce research on racial disparities in HT use really are, Dr. Conklin said.
The research did not use any external funding. The authors had no industry disclosures. Dr. Christmas has done an educational video for FertilityIQ.
PHILADELPHIA – , according to a review of published studies presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
“Gaps in treatment can be used to inform health care providers about menopausal HT prescribing disparities, with the goal of improving equitable and advanced patient care among disadvantaged populations,” wrote Danette Conklin, PhD, an assistant professor of psychiatry and reproductive biology at Case Western Reserve University, Cleveland, and a psychologist at University Hospitals Cleveland Medical Center; Sally MacPhedran, MD, an associate professor of reproductive biology at Case Western Reserve University and an ob.gyn at MetroHealth Medical Center, also in Cleveland; and their colleagues.
The researchers combed through PubMed, CINAHL, Cochrane Library, Web of Science and PsychInfo databases to identify all studies conducted in the United States since 1940 that contained data on patient demographics and prescribing patterns for hormone therapy to treat menopausal symptoms. In addition to excluding men, children, teens, trans men, and women who had contraindications for HT, the investigators excluded randomized clinical trials so that prescribing patterns would not be based on protocols or RCT participatory criteria.
The researchers identified 20 studies, ranging from 1973 through 2015, including 9 national studies and the others across different U.S. regions. They then analyzed differences in HT prescribing according to age, race/ethnicity, education, income, insurance type, body mass index, and mental health, including alcohol or substance use.
Seven of the studies assessed HT use based on patient surveys, seven used medical or medication records showing an HT prescription, two studies used insurance claims to show an HT prescription, and one study surveyed patients about whether they received an HT prescription. Another four studies used surveys that asked patients whether they received HT counseling but did not indicate if the patients received a prescription.
Half of the studies showed racial disparities in HT prescribing. In all of them, Black women used or were prescribed or counseled on using HT less than white, Hispanic, or Asian women. White women had greater use, prescribing, or counseling than all other races/ethnicities except one study in which Hispanic women were prescribed vaginal estrogen more often than white women.
Six of the studies showed education disparities in which menopausal women with lower education levels used less HT or were prescribed or counseled on HT less than women with higher education.
Complex reasons
Monica Christmas, MD, an associate professor of obstetrics and gynecology at the University of Chicago and director of the Menopause Program and the Center for Women’s Integrated Health, said the study’s findings were not surprising, but the reasons for the racial disparities are likely complex.
Implicit bias in providers is likely one contributing factor, with some providers not thinking of offering HT to certain patients or not expecting the patients to be interested in it. Providers may also hesitate to prescribe HT to patients with more comorbidities because of concerns about HT risks, so if Black patients have more comorbidities, that could play a role in how many are offered or counseled on HT, she said.
“Probably the biggest take home is that it is important to be asking all of our patients about their symptoms and being proactive about talking about it,” Dr. Christmas said in an interview.
At the same time, in her anecdotal experience at a previous institution, Dr. Christmas noticed that her Black patients were less receptive to using hormone therapy than her White patients even though her Black patients tended to exhibit or report greater or more severe symptoms. But there’s been a “paradigm shift” more recently, Dr. Christmas said. With awareness about menopause growing in the media and particularly on social media, and with greater awareness about racial disparities in menopausal symptoms and care – including that shown in Dr. Christmas’s work in the SWAN Study – Dr. Christmas has had more Black patients asking about HT and other treatments for their menopausal symptoms more recently.
“Just 10 years ago, I was trying to talk to people about hormones, and I’ve been giving them to people that need them for a long time, and I couldn’t,” Dr. Christmas said. “Now people are coming in, saying ‘no one’s ever talked to me about it’ or ‘I deserve this.’ It shows you the persuasion that social media and the Internet have on our thinking too, and I think that’s going to be interesting to look at, to see how that impacts people’s perception about wanting treatment.”
Dr. Conklin agreed that reasons for the disparities likely involve a combination of factors, including providers’ assumptions about different racial groups’ knowledge and receptiveness toward different treatments. One of the studies in their review also reported provider barriers to prescribing HT, which included lack of time, lack of adequate knowledge, and concern about risks to patients’ health.
“Medical providers tend to have less time with their patients compared to PhDs, and that time factor really makes a big difference in terms of what the focus is going to be in that [short] appointment,” Dr. Conklin said in an interview. “Perhaps from a provider point of view, they are prioritizing what they think is more important to their patient and not really listening deeply to what their patient is saying.”
Educating clinicians
Potentially supporting that possibility, Dr. Conklin and Dr. MacPhedran also had a poster at the conference that looked at prescribing of HT in both Black and White women with a diagnosis of depression, anxiety, or bipolar disorder.
“In a population with a high percentage of Black patients known to have more menopause symptoms, the data demonstrated a surprisingly low rate of documented menopause symptoms (11%) compared to prior reports of up to 80%,” the researchers reported. “This low rate may be related to patient reporting, physician inquiry, or physician documentation of menopause symptoms.” They further found that White women with menopause symptoms and one of those psychiatric diagnosis were 40% more likely to receive an HT prescription for menopausal symptoms than Black women with the same diagnoses and symptoms.
Dr. Conklin emphasized the importance of providers not overlooking women who have mental health disorders when it comes to treating menopausal symptoms, particularly since mental health conditions and menopausal symptoms can exacerbate each other.
“Their depression could worsen irritability, and anxiety can worsen during the transition, and it could be overlooked or thought of as another [psychiatric] episode,” Dr. Conklin said. Providers may need to “dig a little deeper,” especially if patients are reporting having hot flashes or brain fog.
A key way to help overcome the racial disparities – whether they result from systemic issues, implicit bias or assumptions, or patients’ own reticence – is education, Dr. Conklin said. She recommended that providers have educational material about menopause and treatments for menopausal symptoms in the waiting room and then ask patients about their symptoms and invite patients to ask questions.
Dr. MacPhedran added that education for clinicians is key as well.
“Now is a great time – menopause is hot, menopause is interesting, and it’s getting a little bit of a push in terms of research dollars,” Dr. MacPhedran said. “That will trickle down to more emphasis in medical education, whether that’s nurse practitioners, physicians, PAs, or midwives. Everybody needs more education on menopause so they can be more comfortable asking and answering these questions.”
Dr. Conklin said she would like to see expanded education on menopause for medical residents and in health psychology curricula as well.
Among the 13 studies that found disparities in prescribing patterns by age, seven studies showed that older women used or were prescribed or counseled on HT more often than younger women. Four studies found the opposite, with older women less likely to use or be prescribed or counseled about HT. One study had mixed results, and one study had expected prescribing patterns.
Five studies found income disparities and five studies found disparities by medical conditions in terms of HT use, prescribing, or counseling. Other disparities identified in smaller numbers of studies (four or fewer) included natural versus surgical menopause, insurance coverage, body mass index, geographic region, smoking and alcohol use.
The two biggest limitations of the research were its heterogeneity and the small number of studies included, which points to how scarce research on racial disparities in HT use really are, Dr. Conklin said.
The research did not use any external funding. The authors had no industry disclosures. Dr. Christmas has done an educational video for FertilityIQ.
PHILADELPHIA – , according to a review of published studies presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
“Gaps in treatment can be used to inform health care providers about menopausal HT prescribing disparities, with the goal of improving equitable and advanced patient care among disadvantaged populations,” wrote Danette Conklin, PhD, an assistant professor of psychiatry and reproductive biology at Case Western Reserve University, Cleveland, and a psychologist at University Hospitals Cleveland Medical Center; Sally MacPhedran, MD, an associate professor of reproductive biology at Case Western Reserve University and an ob.gyn at MetroHealth Medical Center, also in Cleveland; and their colleagues.
The researchers combed through PubMed, CINAHL, Cochrane Library, Web of Science and PsychInfo databases to identify all studies conducted in the United States since 1940 that contained data on patient demographics and prescribing patterns for hormone therapy to treat menopausal symptoms. In addition to excluding men, children, teens, trans men, and women who had contraindications for HT, the investigators excluded randomized clinical trials so that prescribing patterns would not be based on protocols or RCT participatory criteria.
The researchers identified 20 studies, ranging from 1973 through 2015, including 9 national studies and the others across different U.S. regions. They then analyzed differences in HT prescribing according to age, race/ethnicity, education, income, insurance type, body mass index, and mental health, including alcohol or substance use.
Seven of the studies assessed HT use based on patient surveys, seven used medical or medication records showing an HT prescription, two studies used insurance claims to show an HT prescription, and one study surveyed patients about whether they received an HT prescription. Another four studies used surveys that asked patients whether they received HT counseling but did not indicate if the patients received a prescription.
Half of the studies showed racial disparities in HT prescribing. In all of them, Black women used or were prescribed or counseled on using HT less than white, Hispanic, or Asian women. White women had greater use, prescribing, or counseling than all other races/ethnicities except one study in which Hispanic women were prescribed vaginal estrogen more often than white women.
Six of the studies showed education disparities in which menopausal women with lower education levels used less HT or were prescribed or counseled on HT less than women with higher education.
Complex reasons
Monica Christmas, MD, an associate professor of obstetrics and gynecology at the University of Chicago and director of the Menopause Program and the Center for Women’s Integrated Health, said the study’s findings were not surprising, but the reasons for the racial disparities are likely complex.
Implicit bias in providers is likely one contributing factor, with some providers not thinking of offering HT to certain patients or not expecting the patients to be interested in it. Providers may also hesitate to prescribe HT to patients with more comorbidities because of concerns about HT risks, so if Black patients have more comorbidities, that could play a role in how many are offered or counseled on HT, she said.
“Probably the biggest take home is that it is important to be asking all of our patients about their symptoms and being proactive about talking about it,” Dr. Christmas said in an interview.
At the same time, in her anecdotal experience at a previous institution, Dr. Christmas noticed that her Black patients were less receptive to using hormone therapy than her White patients even though her Black patients tended to exhibit or report greater or more severe symptoms. But there’s been a “paradigm shift” more recently, Dr. Christmas said. With awareness about menopause growing in the media and particularly on social media, and with greater awareness about racial disparities in menopausal symptoms and care – including that shown in Dr. Christmas’s work in the SWAN Study – Dr. Christmas has had more Black patients asking about HT and other treatments for their menopausal symptoms more recently.
“Just 10 years ago, I was trying to talk to people about hormones, and I’ve been giving them to people that need them for a long time, and I couldn’t,” Dr. Christmas said. “Now people are coming in, saying ‘no one’s ever talked to me about it’ or ‘I deserve this.’ It shows you the persuasion that social media and the Internet have on our thinking too, and I think that’s going to be interesting to look at, to see how that impacts people’s perception about wanting treatment.”
Dr. Conklin agreed that reasons for the disparities likely involve a combination of factors, including providers’ assumptions about different racial groups’ knowledge and receptiveness toward different treatments. One of the studies in their review also reported provider barriers to prescribing HT, which included lack of time, lack of adequate knowledge, and concern about risks to patients’ health.
“Medical providers tend to have less time with their patients compared to PhDs, and that time factor really makes a big difference in terms of what the focus is going to be in that [short] appointment,” Dr. Conklin said in an interview. “Perhaps from a provider point of view, they are prioritizing what they think is more important to their patient and not really listening deeply to what their patient is saying.”
Educating clinicians
Potentially supporting that possibility, Dr. Conklin and Dr. MacPhedran also had a poster at the conference that looked at prescribing of HT in both Black and White women with a diagnosis of depression, anxiety, or bipolar disorder.
“In a population with a high percentage of Black patients known to have more menopause symptoms, the data demonstrated a surprisingly low rate of documented menopause symptoms (11%) compared to prior reports of up to 80%,” the researchers reported. “This low rate may be related to patient reporting, physician inquiry, or physician documentation of menopause symptoms.” They further found that White women with menopause symptoms and one of those psychiatric diagnosis were 40% more likely to receive an HT prescription for menopausal symptoms than Black women with the same diagnoses and symptoms.
Dr. Conklin emphasized the importance of providers not overlooking women who have mental health disorders when it comes to treating menopausal symptoms, particularly since mental health conditions and menopausal symptoms can exacerbate each other.
“Their depression could worsen irritability, and anxiety can worsen during the transition, and it could be overlooked or thought of as another [psychiatric] episode,” Dr. Conklin said. Providers may need to “dig a little deeper,” especially if patients are reporting having hot flashes or brain fog.
A key way to help overcome the racial disparities – whether they result from systemic issues, implicit bias or assumptions, or patients’ own reticence – is education, Dr. Conklin said. She recommended that providers have educational material about menopause and treatments for menopausal symptoms in the waiting room and then ask patients about their symptoms and invite patients to ask questions.
Dr. MacPhedran added that education for clinicians is key as well.
“Now is a great time – menopause is hot, menopause is interesting, and it’s getting a little bit of a push in terms of research dollars,” Dr. MacPhedran said. “That will trickle down to more emphasis in medical education, whether that’s nurse practitioners, physicians, PAs, or midwives. Everybody needs more education on menopause so they can be more comfortable asking and answering these questions.”
Dr. Conklin said she would like to see expanded education on menopause for medical residents and in health psychology curricula as well.
Among the 13 studies that found disparities in prescribing patterns by age, seven studies showed that older women used or were prescribed or counseled on HT more often than younger women. Four studies found the opposite, with older women less likely to use or be prescribed or counseled about HT. One study had mixed results, and one study had expected prescribing patterns.
Five studies found income disparities and five studies found disparities by medical conditions in terms of HT use, prescribing, or counseling. Other disparities identified in smaller numbers of studies (four or fewer) included natural versus surgical menopause, insurance coverage, body mass index, geographic region, smoking and alcohol use.
The two biggest limitations of the research were its heterogeneity and the small number of studies included, which points to how scarce research on racial disparities in HT use really are, Dr. Conklin said.
The research did not use any external funding. The authors had no industry disclosures. Dr. Christmas has done an educational video for FertilityIQ.
AT NAMS 2023