Menopause

While primary care physicians are generally comfortable prescribing vaginal estrogen therapy for recurrent urinary tract infections (UTIs), other nonantibiotic prophylactic options remain significantly underutilized, according to new research that highlights a crucial gap in antibiotic stewardship practices among primary care physicians.

UTIs are the most common bacterial infection in women of all ages, and an estimated 30%-40% of women will experience reinfection within 6 months. Recurrent UTI is typically defined as two or more infections within 6 months or a greater number of infections within a year, according to the American Academy of Family Physicians.

Antibiotics are the first line of defense in preventing and treating recurrent UTIs, but repeated and prolonged use could lead to antibiotic resistance.

Researchers at the University of North Carolina surveyed 40 primary care physicians at one academic medical center and found that 96% of primary care physicians prescribe vaginal estrogen therapy for recurrent UTI prevention, with 58% doing so “often.” Estrogen deficiency and urinary retention are strong contributors to infection.

However, 78% of physicians surveyed said they had never prescribed methenamine hippurate, and 85% said they had never prescribed D-mannose.

Physicians with specialized training in menopausal care felt more at ease prescribing vaginal estrogen therapy to patients with complex medical histories, such as those with a family history of breast cancer or endometrial cancer. This suggests that enhanced education could play a vital role in increasing comfort levels among general practitioners, said Lauren Tholemeier, MD, a urogynecology fellow at the University of North Carolina at Chapel Hill.

“Primary care physicians are the front line of managing patients with recurrent UTI,” said Tholemeier.

“There’s an opportunity for further education on, and even awareness of, methenamine hippurate and D-mannose as an option that has data behind it and can be included as a tool” for patient care, she said.

Indeed, physicians who saw six or more recurrent patients with UTI each month were more likely to prescribe methenamine hippurate, the study found, suggesting that familiarity with recurrent UTI cases can lead to greater confidence in employing alternative prophylactic strategies.

Tholemeier presented her research at the American Urogynecologic Society’s PFD Week in Washington, DC.

Expanding physician knowledge and utilization of all available nonantibiotic therapies can help them better care for patients who don’t necessarily have access to a subspecialist, Tholemeier said.

According to the American Urogynecologic Society’s best practice guidelines, there is limited evidence supporting routine use of D-mannose to prevent recurrent UTI. Methenamine hippurate, however, may be effective for short-term UTI prevention, according to the group.

By broadening the use of vaginal estrogen therapy, methenamine hippurate, and D-mannose, primary care physicians can help reduce reliance on antibiotics for recurrent UTI prevention — a practice that may contribute to growing antibiotic resistance, said Tholemeier.

“The end goal isn’t going to be to say that we should never prescribe antibiotics for UTI infection,” said Tholemeier, adding that, in some cases, physicians can consider using these other medications in conjunction with antibiotics.

“But it’s knowing they [clinicians] have some other options in their toolbox,” she said.

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

While primary care physicians are generally comfortable prescribing vaginal estrogen therapy for recurrent urinary tract infections (UTIs), other nonantibiotic prophylactic options remain significantly underutilized, according to new research that highlights a crucial gap in antibiotic stewardship practices among primary care physicians.

UTIs are the most common bacterial infection in women of all ages, and an estimated 30%-40% of women will experience reinfection within 6 months. Recurrent UTI is typically defined as two or more infections within 6 months or a greater number of infections within a year, according to the American Academy of Family Physicians.

Antibiotics are the first line of defense in preventing and treating recurrent UTIs, but repeated and prolonged use could lead to antibiotic resistance.

Researchers at the University of North Carolina surveyed 40 primary care physicians at one academic medical center and found that 96% of primary care physicians prescribe vaginal estrogen therapy for recurrent UTI prevention, with 58% doing so “often.” Estrogen deficiency and urinary retention are strong contributors to infection.

However, 78% of physicians surveyed said they had never prescribed methenamine hippurate, and 85% said they had never prescribed D-mannose.

Physicians with specialized training in menopausal care felt more at ease prescribing vaginal estrogen therapy to patients with complex medical histories, such as those with a family history of breast cancer or endometrial cancer. This suggests that enhanced education could play a vital role in increasing comfort levels among general practitioners, said Lauren Tholemeier, MD, a urogynecology fellow at the University of North Carolina at Chapel Hill.

“Primary care physicians are the front line of managing patients with recurrent UTI,” said Tholemeier.

“There’s an opportunity for further education on, and even awareness of, methenamine hippurate and D-mannose as an option that has data behind it and can be included as a tool” for patient care, she said.

Indeed, physicians who saw six or more recurrent patients with UTI each month were more likely to prescribe methenamine hippurate, the study found, suggesting that familiarity with recurrent UTI cases can lead to greater confidence in employing alternative prophylactic strategies.

Tholemeier presented her research at the American Urogynecologic Society’s PFD Week in Washington, DC.

Expanding physician knowledge and utilization of all available nonantibiotic therapies can help them better care for patients who don’t necessarily have access to a subspecialist, Tholemeier said.

According to the American Urogynecologic Society’s best practice guidelines, there is limited evidence supporting routine use of D-mannose to prevent recurrent UTI. Methenamine hippurate, however, may be effective for short-term UTI prevention, according to the group.

By broadening the use of vaginal estrogen therapy, methenamine hippurate, and D-mannose, primary care physicians can help reduce reliance on antibiotics for recurrent UTI prevention — a practice that may contribute to growing antibiotic resistance, said Tholemeier.

“The end goal isn’t going to be to say that we should never prescribe antibiotics for UTI infection,” said Tholemeier, adding that, in some cases, physicians can consider using these other medications in conjunction with antibiotics.

“But it’s knowing they [clinicians] have some other options in their toolbox,” she said.

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

While primary care physicians are generally comfortable prescribing vaginal estrogen therapy for recurrent urinary tract infections (UTIs), other nonantibiotic prophylactic options remain significantly underutilized, according to new research that highlights a crucial gap in antibiotic stewardship practices among primary care physicians.

UTIs are the most common bacterial infection in women of all ages, and an estimated 30%-40% of women will experience reinfection within 6 months. Recurrent UTI is typically defined as two or more infections within 6 months or a greater number of infections within a year, according to the American Academy of Family Physicians.

Antibiotics are the first line of defense in preventing and treating recurrent UTIs, but repeated and prolonged use could lead to antibiotic resistance.

Researchers at the University of North Carolina surveyed 40 primary care physicians at one academic medical center and found that 96% of primary care physicians prescribe vaginal estrogen therapy for recurrent UTI prevention, with 58% doing so “often.” Estrogen deficiency and urinary retention are strong contributors to infection.

However, 78% of physicians surveyed said they had never prescribed methenamine hippurate, and 85% said they had never prescribed D-mannose.

Physicians with specialized training in menopausal care felt more at ease prescribing vaginal estrogen therapy to patients with complex medical histories, such as those with a family history of breast cancer or endometrial cancer. This suggests that enhanced education could play a vital role in increasing comfort levels among general practitioners, said Lauren Tholemeier, MD, a urogynecology fellow at the University of North Carolina at Chapel Hill.

“Primary care physicians are the front line of managing patients with recurrent UTI,” said Tholemeier.

“There’s an opportunity for further education on, and even awareness of, methenamine hippurate and D-mannose as an option that has data behind it and can be included as a tool” for patient care, she said.

Indeed, physicians who saw six or more recurrent patients with UTI each month were more likely to prescribe methenamine hippurate, the study found, suggesting that familiarity with recurrent UTI cases can lead to greater confidence in employing alternative prophylactic strategies.

Tholemeier presented her research at the American Urogynecologic Society’s PFD Week in Washington, DC.

Expanding physician knowledge and utilization of all available nonantibiotic therapies can help them better care for patients who don’t necessarily have access to a subspecialist, Tholemeier said.

According to the American Urogynecologic Society’s best practice guidelines, there is limited evidence supporting routine use of D-mannose to prevent recurrent UTI. Methenamine hippurate, however, may be effective for short-term UTI prevention, according to the group.

By broadening the use of vaginal estrogen therapy, methenamine hippurate, and D-mannose, primary care physicians can help reduce reliance on antibiotics for recurrent UTI prevention — a practice that may contribute to growing antibiotic resistance, said Tholemeier.

“The end goal isn’t going to be to say that we should never prescribe antibiotics for UTI infection,” said Tholemeier, adding that, in some cases, physicians can consider using these other medications in conjunction with antibiotics.

“But it’s knowing they [clinicians] have some other options in their toolbox,” she said.

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

The Food and Drug Administration (FDA) has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.

Uncomplicated UTIs are bladder infections that typically affect women who don’t have other issues like kidney disease or urinary tract abnormalities. These infections are common, affecting around half of all women at least once in their lives.

Treating UTIs can be difficult when standard antibiotics don’t work well, often because of antibiotic resistance or certain health conditions. Orlynvah offers a promising new option by combining two drugs, sulopenem etzadroxil and probenecid, in one oral tablet. This combination helps keep the antibiotic in the body longer, making it work better, especially against bacteria that resist traditional treatments. Orlynvah is specifically approved to target infections from bacteria like Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, which can be harder to treat.

Marjorie Golden, MD, an infectious disease specialist at Yale New Haven Hospital in Connecticut, described Orlynvah as a much-needed alternative for women struggling with difficult-to-treat UTIs. 

“Orlynvah has the potential to be an important treatment option for those who need it,” she said in a news release from Iterum Therapeutics, the drug’s maker.

The FDA approved Orlynvah based on two large clinical trials involving over 3,800 women. In these studies, Orlynvah worked as well as or better than antibiotics like ciprofloxacin and Augmentin. It was generally well-tolerated, though common side effects included diarrhea, nausea, yeast infections, and headaches.

The FDA advises people to discuss their medical history with their doctor before taking Orlynvah, especially if they have conditions like gout, kidney stones, or allergies to other antibiotics.

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

The Food and Drug Administration (FDA) has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.

Uncomplicated UTIs are bladder infections that typically affect women who don’t have other issues like kidney disease or urinary tract abnormalities. These infections are common, affecting around half of all women at least once in their lives.

Treating UTIs can be difficult when standard antibiotics don’t work well, often because of antibiotic resistance or certain health conditions. Orlynvah offers a promising new option by combining two drugs, sulopenem etzadroxil and probenecid, in one oral tablet. This combination helps keep the antibiotic in the body longer, making it work better, especially against bacteria that resist traditional treatments. Orlynvah is specifically approved to target infections from bacteria like Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, which can be harder to treat.

Marjorie Golden, MD, an infectious disease specialist at Yale New Haven Hospital in Connecticut, described Orlynvah as a much-needed alternative for women struggling with difficult-to-treat UTIs. 

“Orlynvah has the potential to be an important treatment option for those who need it,” she said in a news release from Iterum Therapeutics, the drug’s maker.

The FDA approved Orlynvah based on two large clinical trials involving over 3,800 women. In these studies, Orlynvah worked as well as or better than antibiotics like ciprofloxacin and Augmentin. It was generally well-tolerated, though common side effects included diarrhea, nausea, yeast infections, and headaches.

The FDA advises people to discuss their medical history with their doctor before taking Orlynvah, especially if they have conditions like gout, kidney stones, or allergies to other antibiotics.

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

The Food and Drug Administration (FDA) has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.

Uncomplicated UTIs are bladder infections that typically affect women who don’t have other issues like kidney disease or urinary tract abnormalities. These infections are common, affecting around half of all women at least once in their lives.

Treating UTIs can be difficult when standard antibiotics don’t work well, often because of antibiotic resistance or certain health conditions. Orlynvah offers a promising new option by combining two drugs, sulopenem etzadroxil and probenecid, in one oral tablet. This combination helps keep the antibiotic in the body longer, making it work better, especially against bacteria that resist traditional treatments. Orlynvah is specifically approved to target infections from bacteria like Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, which can be harder to treat.

Marjorie Golden, MD, an infectious disease specialist at Yale New Haven Hospital in Connecticut, described Orlynvah as a much-needed alternative for women struggling with difficult-to-treat UTIs. 

“Orlynvah has the potential to be an important treatment option for those who need it,” she said in a news release from Iterum Therapeutics, the drug’s maker.

The FDA approved Orlynvah based on two large clinical trials involving over 3,800 women. In these studies, Orlynvah worked as well as or better than antibiotics like ciprofloxacin and Augmentin. It was generally well-tolerated, though common side effects included diarrhea, nausea, yeast infections, and headaches.

The FDA advises people to discuss their medical history with their doctor before taking Orlynvah, especially if they have conditions like gout, kidney stones, or allergies to other antibiotics.

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

A novel biomaterial developed by researchers at the University of California, San Diego, may help treat commonly overlooked menopausal vaginal changes and discomfort experienced by many women.

As many as 84% of menopausal women experience genitourinary syndrome of menopause, a condition that can cause vaginal dryness, irritation, and pain during intercourse and significantly affect quality of life. Current treatments, mainly estrogen creams, help with surface issues but don’t address deeper tissue problems.

Marianna Alperin, MD, and researchers at her lab created a gel-like material derived from pig vaginal tissue designed to mimic the natural environment of the vagina and stimulate the body’s own healing processes.

“We used porcine vaginal tissue that was minced, decellularized by detergent, lyophilized, milled into powder, and enzymatically digested,” said Alperin, professor and vice chair for translational research in the Department of Obstetrics, Gynecology, and Reproductive Sciences and professor of urology at the University of California, San Diego.

Using the vaginal extracellular matrix biomaterial on rats — which have vaginal tissue similar to that of humans — improved vaginal epithelial thickness and health of the vaginal lining.

Three days after administering the biomaterial, the treatment group exhibited a mean epithelial thickness of 32.37 ± 6.29 µm, compared with 19.00 ± 1.59 µm in the saline control group (P < .0001). Rats treated with vaginal extracellular matrix biomaterial also showed a mean smooth muscle layer thickness of 54.02 ± 10.56 µm, significantly thicker than the saline group’s 35.07 ± 7.80 µm (P < .05), the study found.

“While [the biomaterial] did not restore the epithelial thickness all the way to the level of the healthy, unperturbed animals, it certainly was superior to the other groups, especially at the higher dose,” she said.

It also enhanced the underlying muscle layer, something current treatments don’t typically achieve, the researchers noted.

Alperin’s research was awarded best overall paper at the American Urogynecologic Society’s PFD Week conference in Washington, DC.

The material seems to work by interacting with immune cells to carry the healing material deeper into the vaginal tissues, potentially explaining its widespread effects.

“It looked like the cells are trafficking the biomaterial into the deeper tissues, which is very exciting,” said Alperin, adding that unlike existing treatments, this new approach may improve both the surface layer and deeper tissues of the vagina.

Also, the benefits appeared to increase with higher doses of the material, they found.

While the study shows promise, Alperin acknowledged that further research is needed, particularly in comparing their treatment with topical estrogen.

“We are repeating the experiment with the dose adjusted to the volume of the rat vagina,” Alperin said.
 

A version of this article appeared on Medscape.com.

A novel biomaterial developed by researchers at the University of California, San Diego, may help treat commonly overlooked menopausal vaginal changes and discomfort experienced by many women.

As many as 84% of menopausal women experience genitourinary syndrome of menopause, a condition that can cause vaginal dryness, irritation, and pain during intercourse and significantly affect quality of life. Current treatments, mainly estrogen creams, help with surface issues but don’t address deeper tissue problems.

Marianna Alperin, MD, and researchers at her lab created a gel-like material derived from pig vaginal tissue designed to mimic the natural environment of the vagina and stimulate the body’s own healing processes.

“We used porcine vaginal tissue that was minced, decellularized by detergent, lyophilized, milled into powder, and enzymatically digested,” said Alperin, professor and vice chair for translational research in the Department of Obstetrics, Gynecology, and Reproductive Sciences and professor of urology at the University of California, San Diego.

Using the vaginal extracellular matrix biomaterial on rats — which have vaginal tissue similar to that of humans — improved vaginal epithelial thickness and health of the vaginal lining.

Three days after administering the biomaterial, the treatment group exhibited a mean epithelial thickness of 32.37 ± 6.29 µm, compared with 19.00 ± 1.59 µm in the saline control group (P < .0001). Rats treated with vaginal extracellular matrix biomaterial also showed a mean smooth muscle layer thickness of 54.02 ± 10.56 µm, significantly thicker than the saline group’s 35.07 ± 7.80 µm (P < .05), the study found.

“While [the biomaterial] did not restore the epithelial thickness all the way to the level of the healthy, unperturbed animals, it certainly was superior to the other groups, especially at the higher dose,” she said.

It also enhanced the underlying muscle layer, something current treatments don’t typically achieve, the researchers noted.

Alperin’s research was awarded best overall paper at the American Urogynecologic Society’s PFD Week conference in Washington, DC.

The material seems to work by interacting with immune cells to carry the healing material deeper into the vaginal tissues, potentially explaining its widespread effects.

“It looked like the cells are trafficking the biomaterial into the deeper tissues, which is very exciting,” said Alperin, adding that unlike existing treatments, this new approach may improve both the surface layer and deeper tissues of the vagina.

Also, the benefits appeared to increase with higher doses of the material, they found.

While the study shows promise, Alperin acknowledged that further research is needed, particularly in comparing their treatment with topical estrogen.

“We are repeating the experiment with the dose adjusted to the volume of the rat vagina,” Alperin said.
 

A version of this article appeared on Medscape.com.

A novel biomaterial developed by researchers at the University of California, San Diego, may help treat commonly overlooked menopausal vaginal changes and discomfort experienced by many women.

As many as 84% of menopausal women experience genitourinary syndrome of menopause, a condition that can cause vaginal dryness, irritation, and pain during intercourse and significantly affect quality of life. Current treatments, mainly estrogen creams, help with surface issues but don’t address deeper tissue problems.

Marianna Alperin, MD, and researchers at her lab created a gel-like material derived from pig vaginal tissue designed to mimic the natural environment of the vagina and stimulate the body’s own healing processes.

“We used porcine vaginal tissue that was minced, decellularized by detergent, lyophilized, milled into powder, and enzymatically digested,” said Alperin, professor and vice chair for translational research in the Department of Obstetrics, Gynecology, and Reproductive Sciences and professor of urology at the University of California, San Diego.

Using the vaginal extracellular matrix biomaterial on rats — which have vaginal tissue similar to that of humans — improved vaginal epithelial thickness and health of the vaginal lining.

Three days after administering the biomaterial, the treatment group exhibited a mean epithelial thickness of 32.37 ± 6.29 µm, compared with 19.00 ± 1.59 µm in the saline control group (P < .0001). Rats treated with vaginal extracellular matrix biomaterial also showed a mean smooth muscle layer thickness of 54.02 ± 10.56 µm, significantly thicker than the saline group’s 35.07 ± 7.80 µm (P < .05), the study found.

“While [the biomaterial] did not restore the epithelial thickness all the way to the level of the healthy, unperturbed animals, it certainly was superior to the other groups, especially at the higher dose,” she said.

It also enhanced the underlying muscle layer, something current treatments don’t typically achieve, the researchers noted.

Alperin’s research was awarded best overall paper at the American Urogynecologic Society’s PFD Week conference in Washington, DC.

The material seems to work by interacting with immune cells to carry the healing material deeper into the vaginal tissues, potentially explaining its widespread effects.

“It looked like the cells are trafficking the biomaterial into the deeper tissues, which is very exciting,” said Alperin, adding that unlike existing treatments, this new approach may improve both the surface layer and deeper tissues of the vagina.

Also, the benefits appeared to increase with higher doses of the material, they found.

While the study shows promise, Alperin acknowledged that further research is needed, particularly in comparing their treatment with topical estrogen.

“We are repeating the experiment with the dose adjusted to the volume of the rat vagina,” Alperin said.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Excess body fat in postmenopausal women is linked to a higher risk for breast cancer, with the Clínica Universidad de Navarra-Body Adiposity Estimator (CUN-BAE) showing a stronger association than body mass index (BMI). Accurate body fat measures are crucial for effective cancer prevention.

METHODOLOGY:

• Researchers conducted a case-control study including 1033 breast cancer cases and 1143 postmenopausal population controls from the MCC-Spain study.
• Participants were aged 20-85 years. BMI was calculated as the ratio of weight to height squared and categorized using World Health Organization standards: < 25, 25-29.9, 30-34.9, and ≥ 35.
• CUN-BAE was calculated using a specific equation and categorized according to the estimated percentage of body fat: < 35%, 35%-39.9%, 40%-44.9%, and ≥ 45%.
• Odds ratios (ORs) were estimated with 95% CIs for both measures (BMI and CUN-BAE) for breast cancer cases using unconditional logistic regression.

TAKEAWAY:

• Excess body weight attributable to the risk for breast cancer was 23% when assessed using a BMI value > 30 and 38% when assessed using a CUN-BAE value > 40% body fat.
• Hormone receptor stratification showed that these differences in population-attributable fractions were only observed in hormone receptor–positive cases, with an estimated burden of 19.9% for BMI and 41.9% for CUN-BAE.
• The highest categories of CUN-BAE showed an increase in the risk for postmenopausal breast cancer (OR, 2.13 for body fat ≥ 45% compared with the reference category < 35%).
• No similar trend was observed for BMI, as the gradient declined after a BMI ≥ 35.

IN PRACTICE:

“The results of our study indicate that excess body fat is a significant risk factor for hormone receptor–positive breast cancer in postmenopausal women. Our findings suggest that the population impact could be underestimated when using traditional BMI estimates, and that more accurate measures of body fat, such as CUN-BAE, should be considered,” the authors of the study wrote.

SOURCE:

This study was led by Verónica Dávila-Batista, University of Las Palmas de Gran Canaria in Las Palmas de Gran Canaria, Spain. It was published online in Journal of Epidemiology and Community Health.

LIMITATIONS:

The case-control design of the study may have limited the ability to establish causal relationships. BMI was self-reported at the time of the interview for controls and 1 year before diagnosis for cancer cases, which may have introduced recall bias. The formula for CUN-BAE was calculated from a sedentary convenience sample, which may not have been representative of the general population. The small sample size of cases that did not express hormone receptors was another limitation. The study’s findings may not be generalizable to non-White populations as non-White participants were excluded.

DISCLOSURES:

Dávila-Batista disclosed receiving grants from the Carlos III Health Institute. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Excess body fat in postmenopausal women is linked to a higher risk for breast cancer, with the Clínica Universidad de Navarra-Body Adiposity Estimator (CUN-BAE) showing a stronger association than body mass index (BMI). Accurate body fat measures are crucial for effective cancer prevention.

METHODOLOGY:

• Researchers conducted a case-control study including 1033 breast cancer cases and 1143 postmenopausal population controls from the MCC-Spain study.
• Participants were aged 20-85 years. BMI was calculated as the ratio of weight to height squared and categorized using World Health Organization standards: < 25, 25-29.9, 30-34.9, and ≥ 35.
• CUN-BAE was calculated using a specific equation and categorized according to the estimated percentage of body fat: < 35%, 35%-39.9%, 40%-44.9%, and ≥ 45%.
• Odds ratios (ORs) were estimated with 95% CIs for both measures (BMI and CUN-BAE) for breast cancer cases using unconditional logistic regression.

TAKEAWAY:

• Excess body weight attributable to the risk for breast cancer was 23% when assessed using a BMI value > 30 and 38% when assessed using a CUN-BAE value > 40% body fat.
• Hormone receptor stratification showed that these differences in population-attributable fractions were only observed in hormone receptor–positive cases, with an estimated burden of 19.9% for BMI and 41.9% for CUN-BAE.
• The highest categories of CUN-BAE showed an increase in the risk for postmenopausal breast cancer (OR, 2.13 for body fat ≥ 45% compared with the reference category < 35%).
• No similar trend was observed for BMI, as the gradient declined after a BMI ≥ 35.

IN PRACTICE:

“The results of our study indicate that excess body fat is a significant risk factor for hormone receptor–positive breast cancer in postmenopausal women. Our findings suggest that the population impact could be underestimated when using traditional BMI estimates, and that more accurate measures of body fat, such as CUN-BAE, should be considered,” the authors of the study wrote.

SOURCE:

This study was led by Verónica Dávila-Batista, University of Las Palmas de Gran Canaria in Las Palmas de Gran Canaria, Spain. It was published online in Journal of Epidemiology and Community Health.

LIMITATIONS:

The case-control design of the study may have limited the ability to establish causal relationships. BMI was self-reported at the time of the interview for controls and 1 year before diagnosis for cancer cases, which may have introduced recall bias. The formula for CUN-BAE was calculated from a sedentary convenience sample, which may not have been representative of the general population. The small sample size of cases that did not express hormone receptors was another limitation. The study’s findings may not be generalizable to non-White populations as non-White participants were excluded.

DISCLOSURES:

Dávila-Batista disclosed receiving grants from the Carlos III Health Institute. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Excess body fat in postmenopausal women is linked to a higher risk for breast cancer, with the Clínica Universidad de Navarra-Body Adiposity Estimator (CUN-BAE) showing a stronger association than body mass index (BMI). Accurate body fat measures are crucial for effective cancer prevention.

METHODOLOGY:

• Researchers conducted a case-control study including 1033 breast cancer cases and 1143 postmenopausal population controls from the MCC-Spain study.
• Participants were aged 20-85 years. BMI was calculated as the ratio of weight to height squared and categorized using World Health Organization standards: < 25, 25-29.9, 30-34.9, and ≥ 35.
• CUN-BAE was calculated using a specific equation and categorized according to the estimated percentage of body fat: < 35%, 35%-39.9%, 40%-44.9%, and ≥ 45%.
• Odds ratios (ORs) were estimated with 95% CIs for both measures (BMI and CUN-BAE) for breast cancer cases using unconditional logistic regression.

TAKEAWAY:

• Excess body weight attributable to the risk for breast cancer was 23% when assessed using a BMI value > 30 and 38% when assessed using a CUN-BAE value > 40% body fat.
• Hormone receptor stratification showed that these differences in population-attributable fractions were only observed in hormone receptor–positive cases, with an estimated burden of 19.9% for BMI and 41.9% for CUN-BAE.
• The highest categories of CUN-BAE showed an increase in the risk for postmenopausal breast cancer (OR, 2.13 for body fat ≥ 45% compared with the reference category < 35%).
• No similar trend was observed for BMI, as the gradient declined after a BMI ≥ 35.

IN PRACTICE:

“The results of our study indicate that excess body fat is a significant risk factor for hormone receptor–positive breast cancer in postmenopausal women. Our findings suggest that the population impact could be underestimated when using traditional BMI estimates, and that more accurate measures of body fat, such as CUN-BAE, should be considered,” the authors of the study wrote.

SOURCE:

This study was led by Verónica Dávila-Batista, University of Las Palmas de Gran Canaria in Las Palmas de Gran Canaria, Spain. It was published online in Journal of Epidemiology and Community Health.

LIMITATIONS:

The case-control design of the study may have limited the ability to establish causal relationships. BMI was self-reported at the time of the interview for controls and 1 year before diagnosis for cancer cases, which may have introduced recall bias. The formula for CUN-BAE was calculated from a sedentary convenience sample, which may not have been representative of the general population. The small sample size of cases that did not express hormone receptors was another limitation. The study’s findings may not be generalizable to non-White populations as non-White participants were excluded.

DISCLOSURES:

Dávila-Batista disclosed receiving grants from the Carlos III Health Institute. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Women with hypothyroidism treated with levothyroxine show no significant cognitive decline across the menopausal transition compared with those without thyroid disease.

METHODOLOGY:

• Levothyroxine, the primary treatment for hypothyroidism, has been linked to perceived cognitive deficits, yet it is unclear whether this is due to the underlying condition being inadequately treated or other factors.
• Using data collected from the Study of Women’s Health Across the Nation, which encompasses five ethnic/racial groups from seven centers across the United States, researchers compared cognitive function over time between women with hypothyroidism treated with levothyroxine and those without thyroid disease.
• Participants underwent cognitive testing across three domains — processing speed, working memory, and episodic memory — which were assessed over a mean follow-up of 13 years.
• Further analyses assessed the impact of abnormal levels of thyroid-stimulating hormone on cognitive outcomes.

TAKEAWAY:

• Of 2033 women included, 227 (mean age, 49.8 years) had levothyroxine-treated hypothyroidism and 1806 (mean age, 50.0 years) did not have thyroid disease; the proportion of women with premenopausal or early perimenopausal status at baseline was higher in the hypothyroidism group (54.2% vs 49.8%; P = .010).
• At baseline, levothyroxine-treated women had higher scores for processing speed (mean score, 56.5 vs 54.4; P = .006) and working memory (mean score, 6.8 vs 6.4; P = .018) than those without thyroid disease; however, no difference in episodic memory was observed between the groups.
• Over the study period, there was no significant difference in cognitive decline between the groups.
• There was no significant effect of levothyroxine-treated hypothyroidism on working memory or episodic memory, although an annual decline in processing speed was observed (P < .001).
• Sensitivity analyses determined that abnormal levels of thyroid-stimulating hormone did not affect cognitive outcomes in women with hypothyroidism.

IN PRACTICE:

When cognitive decline is observed in these patients, the authors advised that “clinicians should resist anchoring on inadequate treatment of hypothyroidism as the cause of these symptoms and may investigate other disease processes (eg, iron deficiency, B12 deficiency, sleep apnea, celiac disease).”

SOURCE:

The study, led by Matthew D. Ettleson, Section of Endocrinology, Diabetes, and Metabolism, University of Chicago, was published online in Thyroid.

LIMITATIONS:

The cognitive assessments in the study were not designed to provide a thorough evaluation of all aspects of cognitive function. The study may not have been adequately powered to detect small effects of levothyroxine-treated hypothyroidism on cognitive outcomes. The higher levels of education attained by the study population may have acted as a protective factor against cognitive decline, potentially biasing the results.

DISCLOSURES:

The Study of Women’s Health Across the Nation was supported by grants from the National Institutes of Health (NIH), DHHS, through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Women with hypothyroidism treated with levothyroxine show no significant cognitive decline across the menopausal transition compared with those without thyroid disease.

METHODOLOGY:

• Levothyroxine, the primary treatment for hypothyroidism, has been linked to perceived cognitive deficits, yet it is unclear whether this is due to the underlying condition being inadequately treated or other factors.
• Using data collected from the Study of Women’s Health Across the Nation, which encompasses five ethnic/racial groups from seven centers across the United States, researchers compared cognitive function over time between women with hypothyroidism treated with levothyroxine and those without thyroid disease.
• Participants underwent cognitive testing across three domains — processing speed, working memory, and episodic memory — which were assessed over a mean follow-up of 13 years.
• Further analyses assessed the impact of abnormal levels of thyroid-stimulating hormone on cognitive outcomes.

TAKEAWAY:

• Of 2033 women included, 227 (mean age, 49.8 years) had levothyroxine-treated hypothyroidism and 1806 (mean age, 50.0 years) did not have thyroid disease; the proportion of women with premenopausal or early perimenopausal status at baseline was higher in the hypothyroidism group (54.2% vs 49.8%; P = .010).
• At baseline, levothyroxine-treated women had higher scores for processing speed (mean score, 56.5 vs 54.4; P = .006) and working memory (mean score, 6.8 vs 6.4; P = .018) than those without thyroid disease; however, no difference in episodic memory was observed between the groups.
• Over the study period, there was no significant difference in cognitive decline between the groups.
• There was no significant effect of levothyroxine-treated hypothyroidism on working memory or episodic memory, although an annual decline in processing speed was observed (P < .001).
• Sensitivity analyses determined that abnormal levels of thyroid-stimulating hormone did not affect cognitive outcomes in women with hypothyroidism.

IN PRACTICE:

When cognitive decline is observed in these patients, the authors advised that “clinicians should resist anchoring on inadequate treatment of hypothyroidism as the cause of these symptoms and may investigate other disease processes (eg, iron deficiency, B12 deficiency, sleep apnea, celiac disease).”

SOURCE:

The study, led by Matthew D. Ettleson, Section of Endocrinology, Diabetes, and Metabolism, University of Chicago, was published online in Thyroid.

LIMITATIONS:

The cognitive assessments in the study were not designed to provide a thorough evaluation of all aspects of cognitive function. The study may not have been adequately powered to detect small effects of levothyroxine-treated hypothyroidism on cognitive outcomes. The higher levels of education attained by the study population may have acted as a protective factor against cognitive decline, potentially biasing the results.

DISCLOSURES:

The Study of Women’s Health Across the Nation was supported by grants from the National Institutes of Health (NIH), DHHS, through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Women with hypothyroidism treated with levothyroxine show no significant cognitive decline across the menopausal transition compared with those without thyroid disease.

METHODOLOGY:

• Levothyroxine, the primary treatment for hypothyroidism, has been linked to perceived cognitive deficits, yet it is unclear whether this is due to the underlying condition being inadequately treated or other factors.
• Using data collected from the Study of Women’s Health Across the Nation, which encompasses five ethnic/racial groups from seven centers across the United States, researchers compared cognitive function over time between women with hypothyroidism treated with levothyroxine and those without thyroid disease.
• Participants underwent cognitive testing across three domains — processing speed, working memory, and episodic memory — which were assessed over a mean follow-up of 13 years.
• Further analyses assessed the impact of abnormal levels of thyroid-stimulating hormone on cognitive outcomes.

TAKEAWAY:

• Of 2033 women included, 227 (mean age, 49.8 years) had levothyroxine-treated hypothyroidism and 1806 (mean age, 50.0 years) did not have thyroid disease; the proportion of women with premenopausal or early perimenopausal status at baseline was higher in the hypothyroidism group (54.2% vs 49.8%; P = .010).
• At baseline, levothyroxine-treated women had higher scores for processing speed (mean score, 56.5 vs 54.4; P = .006) and working memory (mean score, 6.8 vs 6.4; P = .018) than those without thyroid disease; however, no difference in episodic memory was observed between the groups.
• Over the study period, there was no significant difference in cognitive decline between the groups.
• There was no significant effect of levothyroxine-treated hypothyroidism on working memory or episodic memory, although an annual decline in processing speed was observed (P < .001).
• Sensitivity analyses determined that abnormal levels of thyroid-stimulating hormone did not affect cognitive outcomes in women with hypothyroidism.

IN PRACTICE:

When cognitive decline is observed in these patients, the authors advised that “clinicians should resist anchoring on inadequate treatment of hypothyroidism as the cause of these symptoms and may investigate other disease processes (eg, iron deficiency, B12 deficiency, sleep apnea, celiac disease).”

SOURCE:

The study, led by Matthew D. Ettleson, Section of Endocrinology, Diabetes, and Metabolism, University of Chicago, was published online in Thyroid.

LIMITATIONS:

The cognitive assessments in the study were not designed to provide a thorough evaluation of all aspects of cognitive function. The study may not have been adequately powered to detect small effects of levothyroxine-treated hypothyroidism on cognitive outcomes. The higher levels of education attained by the study population may have acted as a protective factor against cognitive decline, potentially biasing the results.

DISCLOSURES:

The Study of Women’s Health Across the Nation was supported by grants from the National Institutes of Health (NIH), DHHS, through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

There’s an unexpected treatment for hot flashes and other menopause symptoms that’s getting more popular: clinical hypnosis. 

Hypnosis is a state of highly focused attention that works through disassociating, or putting aside your conscious awareness of things that would ordinarily be in your consciousness, said David Spiegel, MD, a psychiatrist with Stanford Medical School in Califonrnia. 

“It increases your cognitive flexibility – a way to approach an old problem from a new point of view and just let go of your older ways of thinking about it,” he said. 

Usually around age 50, women have menopause, which is the end of their menstrual cycles. Estrogen levels drop, and hot flashes can happen 12-15 times per day, said Gary Elkins, PhD, a psychology and neuroscience professor at Baylor University in Waco, Texas.

Both clinical hypnosis and cognitive-behavioral therapy, a common form of talk therapy, have been shown to work as non-hormonal treatments for hot flashes, particularly for women who are unable to take hormones for health reasons, such as having a history with an estrogen-sensitive cancer (like breast cancer), according to research published by the Menopause Society in 2023. 

A new review presented at the 2024 annual meeting of the Menopause Society in Chicago analyzed 23 studies from 1996 to 2022 and compared how well clinical hypnosis and cognitive behavioral therapy worked as treatments for hot flashes and other menopause symptoms. Researchers found that clinical hypnosis is better at helping make hot flashes less frequent and less intense, even reducing symptoms by 60%. Findings on cognitive-behavioral therapy, on the other hand, showed only slight hot flash reduction, though it helped reduce daily stress linked with hot flashes. 

Hypnosis can address the “perfect storm” of mental and physical issues that come with menopause symptoms, explained Dr. Spiegel, who created a popular self-hypnosis app called Reveri. “You’re having a reduction in your levels of estrogen and progesterone, but it’s also a reminder that you’re going into a different stage of life where you’re no longer fertile, you’re getting older,” he said. “[With hypnosis], you can disassociate pain and your awareness of things that ordinarily would impede your consciousness and make you miserable.”

A hypnosis session can help you separate psychological discomfort from physical discomfort, Dr. Spiegel said. “Typically, people in hypnosis dealing with menopause will imagine they’re floating in a lake, feeling cool, tingling, numbness. They can literally change how hot they feel. They can change the hot flash and imagine themselves cool, comfortable. If they’re worried about something, picture it on an imaginary screen. Just picture it, but not feel it.”
 

Hypnosis for Sleep

Hot flashes that happen at night are called night sweats and can hinder your sleep. Hypnotherapy can help reduce both hot flashes and night sweats, to the point where sleep is not interrupted, Dr. Elkins said. “While sleep improves with the hypnotherapy intervention, it also involves general relaxation,” said Dr. Elkins, who is the director of the Mind-Body Medicine Research Laboratory at Baylor University. “As women practice self-hypnosis at night, they’re entering a more calm and relaxed state, which also may facilitate good sleep or improve sleep duration and sleep quality.”

Our subconscious mind influences our sleep patterns largely through experiences vs. words or thoughts, according to Emilie Leyes, a certified hypnotherapist based in Philadelphia. This explains why simply reciting the words “I’m relaxed,” when you’re stressed, is often less effective than a few deep breaths or a warm hug from a family member or friend, said Ms. Leyes, who hosts a brain-training podcast for mindset transformation called How to Like Your Life.

“In a similar way, hypnosis, which directly accesses the subconscious, allows us to offer our minds new, powerful experiences to reduce our stress, improve our mood, and increase our access to positive emotions,” she said. “Repeatedly exposing ourselves to these positive experiences in our minds can increase our capacity to feel good, and impact how we feel in our everyday lives.”
 

Your First Hypnosis Session

A hypnosis session always begins with deep relaxation, which can help your mind and body grow accustomed to what it’s like to feel calm, said Ms. Leyes. “By giving the brain and body experiences of safety, relaxation, and inner peace, we can more easily let go of our stressful thoughts of the day and drift off to sleep with ease at night.”

You will often start by sitting or lying in a comfortable position, and then the hypnotic induction begins with a focus of attention, according to Dr. Elkins. The person concentrates, with their eyelids closed, and then are given suggestions for deepening their relaxed state. “Usually that’s a safe, pleasant place, such as walking through the mountains or being near a beach,” he said. “And within that, suggestions are given that target the mechanism that underlies the symptoms [such as hot flashes].”

Dr. Spiegel usually starts off with a neutral test that can help measure how hypnotizable a person is on a 0-to-10 scale. For example, instructing the client to imagine that their hand is floating in the air. If they pull their hand down and it floats back up, the client finds they can “actually dissociate the psychological from the physiological aspects of their experience – their left hand feels different from their right hand,” Dr. Spiegel said. “I use that as an example for them to say, ‘look how you can change how your body feels. Now, let’s use it to help you with your anxiety with your menopausal symptoms.’ ”

A version of this article appeared on WebMD.com.

There’s an unexpected treatment for hot flashes and other menopause symptoms that’s getting more popular: clinical hypnosis. 

Hypnosis is a state of highly focused attention that works through disassociating, or putting aside your conscious awareness of things that would ordinarily be in your consciousness, said David Spiegel, MD, a psychiatrist with Stanford Medical School in Califonrnia. 

“It increases your cognitive flexibility – a way to approach an old problem from a new point of view and just let go of your older ways of thinking about it,” he said. 

Usually around age 50, women have menopause, which is the end of their menstrual cycles. Estrogen levels drop, and hot flashes can happen 12-15 times per day, said Gary Elkins, PhD, a psychology and neuroscience professor at Baylor University in Waco, Texas.

Both clinical hypnosis and cognitive-behavioral therapy, a common form of talk therapy, have been shown to work as non-hormonal treatments for hot flashes, particularly for women who are unable to take hormones for health reasons, such as having a history with an estrogen-sensitive cancer (like breast cancer), according to research published by the Menopause Society in 2023. 

A new review presented at the 2024 annual meeting of the Menopause Society in Chicago analyzed 23 studies from 1996 to 2022 and compared how well clinical hypnosis and cognitive behavioral therapy worked as treatments for hot flashes and other menopause symptoms. Researchers found that clinical hypnosis is better at helping make hot flashes less frequent and less intense, even reducing symptoms by 60%. Findings on cognitive-behavioral therapy, on the other hand, showed only slight hot flash reduction, though it helped reduce daily stress linked with hot flashes. 

Hypnosis can address the “perfect storm” of mental and physical issues that come with menopause symptoms, explained Dr. Spiegel, who created a popular self-hypnosis app called Reveri. “You’re having a reduction in your levels of estrogen and progesterone, but it’s also a reminder that you’re going into a different stage of life where you’re no longer fertile, you’re getting older,” he said. “[With hypnosis], you can disassociate pain and your awareness of things that ordinarily would impede your consciousness and make you miserable.”

A hypnosis session can help you separate psychological discomfort from physical discomfort, Dr. Spiegel said. “Typically, people in hypnosis dealing with menopause will imagine they’re floating in a lake, feeling cool, tingling, numbness. They can literally change how hot they feel. They can change the hot flash and imagine themselves cool, comfortable. If they’re worried about something, picture it on an imaginary screen. Just picture it, but not feel it.”
 

Hypnosis for Sleep

Hot flashes that happen at night are called night sweats and can hinder your sleep. Hypnotherapy can help reduce both hot flashes and night sweats, to the point where sleep is not interrupted, Dr. Elkins said. “While sleep improves with the hypnotherapy intervention, it also involves general relaxation,” said Dr. Elkins, who is the director of the Mind-Body Medicine Research Laboratory at Baylor University. “As women practice self-hypnosis at night, they’re entering a more calm and relaxed state, which also may facilitate good sleep or improve sleep duration and sleep quality.”

Our subconscious mind influences our sleep patterns largely through experiences vs. words or thoughts, according to Emilie Leyes, a certified hypnotherapist based in Philadelphia. This explains why simply reciting the words “I’m relaxed,” when you’re stressed, is often less effective than a few deep breaths or a warm hug from a family member or friend, said Ms. Leyes, who hosts a brain-training podcast for mindset transformation called How to Like Your Life.

“In a similar way, hypnosis, which directly accesses the subconscious, allows us to offer our minds new, powerful experiences to reduce our stress, improve our mood, and increase our access to positive emotions,” she said. “Repeatedly exposing ourselves to these positive experiences in our minds can increase our capacity to feel good, and impact how we feel in our everyday lives.”
 

Your First Hypnosis Session

A hypnosis session always begins with deep relaxation, which can help your mind and body grow accustomed to what it’s like to feel calm, said Ms. Leyes. “By giving the brain and body experiences of safety, relaxation, and inner peace, we can more easily let go of our stressful thoughts of the day and drift off to sleep with ease at night.”

You will often start by sitting or lying in a comfortable position, and then the hypnotic induction begins with a focus of attention, according to Dr. Elkins. The person concentrates, with their eyelids closed, and then are given suggestions for deepening their relaxed state. “Usually that’s a safe, pleasant place, such as walking through the mountains or being near a beach,” he said. “And within that, suggestions are given that target the mechanism that underlies the symptoms [such as hot flashes].”

Dr. Spiegel usually starts off with a neutral test that can help measure how hypnotizable a person is on a 0-to-10 scale. For example, instructing the client to imagine that their hand is floating in the air. If they pull their hand down and it floats back up, the client finds they can “actually dissociate the psychological from the physiological aspects of their experience – their left hand feels different from their right hand,” Dr. Spiegel said. “I use that as an example for them to say, ‘look how you can change how your body feels. Now, let’s use it to help you with your anxiety with your menopausal symptoms.’ ”

A version of this article appeared on WebMD.com.

There’s an unexpected treatment for hot flashes and other menopause symptoms that’s getting more popular: clinical hypnosis. 

Hypnosis is a state of highly focused attention that works through disassociating, or putting aside your conscious awareness of things that would ordinarily be in your consciousness, said David Spiegel, MD, a psychiatrist with Stanford Medical School in Califonrnia. 

“It increases your cognitive flexibility – a way to approach an old problem from a new point of view and just let go of your older ways of thinking about it,” he said. 

Usually around age 50, women have menopause, which is the end of their menstrual cycles. Estrogen levels drop, and hot flashes can happen 12-15 times per day, said Gary Elkins, PhD, a psychology and neuroscience professor at Baylor University in Waco, Texas.

Both clinical hypnosis and cognitive-behavioral therapy, a common form of talk therapy, have been shown to work as non-hormonal treatments for hot flashes, particularly for women who are unable to take hormones for health reasons, such as having a history with an estrogen-sensitive cancer (like breast cancer), according to research published by the Menopause Society in 2023. 

A new review presented at the 2024 annual meeting of the Menopause Society in Chicago analyzed 23 studies from 1996 to 2022 and compared how well clinical hypnosis and cognitive behavioral therapy worked as treatments for hot flashes and other menopause symptoms. Researchers found that clinical hypnosis is better at helping make hot flashes less frequent and less intense, even reducing symptoms by 60%. Findings on cognitive-behavioral therapy, on the other hand, showed only slight hot flash reduction, though it helped reduce daily stress linked with hot flashes. 

Hypnosis can address the “perfect storm” of mental and physical issues that come with menopause symptoms, explained Dr. Spiegel, who created a popular self-hypnosis app called Reveri. “You’re having a reduction in your levels of estrogen and progesterone, but it’s also a reminder that you’re going into a different stage of life where you’re no longer fertile, you’re getting older,” he said. “[With hypnosis], you can disassociate pain and your awareness of things that ordinarily would impede your consciousness and make you miserable.”

A hypnosis session can help you separate psychological discomfort from physical discomfort, Dr. Spiegel said. “Typically, people in hypnosis dealing with menopause will imagine they’re floating in a lake, feeling cool, tingling, numbness. They can literally change how hot they feel. They can change the hot flash and imagine themselves cool, comfortable. If they’re worried about something, picture it on an imaginary screen. Just picture it, but not feel it.”
 

Hypnosis for Sleep

Hot flashes that happen at night are called night sweats and can hinder your sleep. Hypnotherapy can help reduce both hot flashes and night sweats, to the point where sleep is not interrupted, Dr. Elkins said. “While sleep improves with the hypnotherapy intervention, it also involves general relaxation,” said Dr. Elkins, who is the director of the Mind-Body Medicine Research Laboratory at Baylor University. “As women practice self-hypnosis at night, they’re entering a more calm and relaxed state, which also may facilitate good sleep or improve sleep duration and sleep quality.”

Our subconscious mind influences our sleep patterns largely through experiences vs. words or thoughts, according to Emilie Leyes, a certified hypnotherapist based in Philadelphia. This explains why simply reciting the words “I’m relaxed,” when you’re stressed, is often less effective than a few deep breaths or a warm hug from a family member or friend, said Ms. Leyes, who hosts a brain-training podcast for mindset transformation called How to Like Your Life.

“In a similar way, hypnosis, which directly accesses the subconscious, allows us to offer our minds new, powerful experiences to reduce our stress, improve our mood, and increase our access to positive emotions,” she said. “Repeatedly exposing ourselves to these positive experiences in our minds can increase our capacity to feel good, and impact how we feel in our everyday lives.”
 

Your First Hypnosis Session

A hypnosis session always begins with deep relaxation, which can help your mind and body grow accustomed to what it’s like to feel calm, said Ms. Leyes. “By giving the brain and body experiences of safety, relaxation, and inner peace, we can more easily let go of our stressful thoughts of the day and drift off to sleep with ease at night.”

You will often start by sitting or lying in a comfortable position, and then the hypnotic induction begins with a focus of attention, according to Dr. Elkins. The person concentrates, with their eyelids closed, and then are given suggestions for deepening their relaxed state. “Usually that’s a safe, pleasant place, such as walking through the mountains or being near a beach,” he said. “And within that, suggestions are given that target the mechanism that underlies the symptoms [such as hot flashes].”

Dr. Spiegel usually starts off with a neutral test that can help measure how hypnotizable a person is on a 0-to-10 scale. For example, instructing the client to imagine that their hand is floating in the air. If they pull their hand down and it floats back up, the client finds they can “actually dissociate the psychological from the physiological aspects of their experience – their left hand feels different from their right hand,” Dr. Spiegel said. “I use that as an example for them to say, ‘look how you can change how your body feels. Now, let’s use it to help you with your anxiety with your menopausal symptoms.’ ”

A version of this article appeared on WebMD.com.

CHICAGO — The nonhormonal investigational drug elinzanetant led to significant improvement in hot flashes as well as sleep disturbance and quality of life, according to data from three randomized controlled trials presented at The Menopause Society 2024 Annual Meeting in Chicago. Two phase 3 trials, OASIS 1 and 2, were also published in JAMA, and the longer-term OASIS 3 trial was presented as a poster at the conference.

Elinzanetant is a selective neurokinin (NK) receptor antagonist, similar to fezolinetant, the first drug in this class approved by the US Food and Drug Administration (FDA) for vasomotor symptoms in May 2023. This class of medications targets the estrogen-sensitive kisspeptin/NK B/dynorphin (KNDy) neurons thought to play a role in thermoregulation and hot flashes during menopause. While fezolinetant targets only the NK-3 receptor, elinzanetant is a dual NK receptor antagonist that targets both NK-1 and NK-3. Bayer submitted a New Drug Application for elinzanetant to the FDA on August 1.

For those in whom hormone therapy is contraindicated, “it’s always been difficult for women with really severe symptoms to have a safe and effective therapy,” lead author JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, told this news organization. “The nonhormonal therapies we’ve used mostly off-label — the antidepressants, gabapentin, clonidine, oxybutynin — do help the hot flashes, but they don’t work nearly as effectively as these new NK receptor antagonists, and having one that looks like it might have a broader use for hot flashes, night sweats, mood, and sleep is just really exciting.”

Dr. Pinkerton said approximately 80% of the women in the OASIS 1 and 2 studies had at least a 50% reduction in hot flashes. “It was a very strong, dramatic positive finding, but the improvements in sleep and mood have really encouraged us to go further,” she said.

Declining estrogen levels during and after menopause can cause hypertrophy and hyperactivity of the KNDy neurons, which has been linked to thermoregulation disruptions that may trigger hot flashes, James Simon, MD, a clinical professor of ob.gyn. at The George Washington University School of Medicine & Health Sciences and medical director of IntimMedicine in Washington, DC, told attendees. He presented pooled data from OASIS 1 and 2. The NK-1 receptor, targeted by elinzanetant but not fezolinetant, is also thought to play a role in insomnia and possibly in mood.

“Oftentimes the focus on a lot of these drugs is hot flashes, hot flashes, hot flashes, but we know hot flashes do not occur in isolation,” Chrisandra Shufelt, MD, professor and chair of general internal medicine and associate director of the Women’s Health Research Center at Mayo Clinic in Jacksonville, Florida, told this news organization. Elinzanetant is “an interesting compound because it actually works on sleep, and that was critical because sleep disturbance precedes” many other menopausal symptoms, said Dr. Shufelt, who was not involved in the study.

“I think it is an outstanding option for women who don’t have the opportunity to get hormones,” Dr. Shufelt said, and she was particularly pleased to see there were no safety concerns for the liver in the trial data. The FDA issued a warning on September 12 about the risk for rare liver injury with fezolinetant, but the early signals that had been seen in fezolinetant data were not seen in these elinzanetant data.

The OASIS 1 and 2 trials enrolled postmenopausal women, aged 40-65 years, who had at least 50 moderate to severe vasomotor occurrences per week.

“A moderate hot flash is a hot flash that is also associated with sweating, and a severe hot flash is a moderate hot flash that stops a woman in her tracks,” Dr. Simon said. “Namely, it’s severe enough with sweating and central nervous system effects that she is interrupted in whatever it is that she’s doing at the time.”

Exclusion criteria for the trials included a history of arrhythmias, heart block, or QT prolongation; abnormal lab results; history of malignancy within the past 5 years; uncontrolled or treatment-resistant hypertension, hypothyroidism, or hyperthyroidism; unexplained postmenopausal bleeding; clinically relevant abnormal mammogram findings; or disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer.

The predominantly White (80%) women were an average 54 years old, with an average body mass index (BMI) of 27.8, and were an average 3.5 years from their last period. For the first 12 weeks of the trials, 399 women were assigned to receive 120 mg once daily of oral elinzanetant and 397 were assigned to once daily placebo. Then the women taking placebo switched to elinzanetant for the final 14 weeks of the study.

The endpoints included mean change in frequency and severity of vasomotor symptoms at weeks 1, 4, and 12 as well as change in sleep disturbance and quality of life at week 12. Sleep was assessed with the Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form score, which ranges from 28.9 to 76.5, with a higher number denoting greater sleep disturbance. The Menopause-Specific Quality-of-Life score ranges from 1 to 8, with a higher score indicating poorer quality of life.

Daily frequency of vasomotor symptoms was 14 per day at baseline in the elinzanetant group, decreasing by 4.8 per day at week 1, 8 per day at week 4, and 9.4 per day at week 12. In the placebo group, women had an average 15.2 occurrences per day at baseline, which decreased by 3.2 at week 1, 5.2 at week 4, and 6.4 at week 12. Comparing the groups at 12 weeks, those receiving elinzanetant had 3.2 fewer daily vasomotor symptoms than those receiving placebo (P < .0001).

The severity of vasomotor symptoms also improved more in the elinzanetant group than in the placebo group over 12 weeks, after which severity improved further in those who switched from placebo to elinzanetant (P < .0001).

Sleep disturbance scores, starting at a mean 61.5 in the elinzanetant group and 60.5 in the placebo group, fell 10.7 points in the elinzanetant group and 5.3 points in the placebo group at 12 weeks, for a difference of 4.9 points (P < .0001). Sleep then further improved in those who switched from placebo to elinzanetant. Quality-of-life scores improved 1.37 points (from 4.52 at baseline) in the elinzanetant group and 0.96 points (from 4.49 at baseline) in the placebo group, for a mean difference at 12 weeks of 0.36 (P < .0001).

Though no head-to-head data exist comparing elinzanetant and fezolinetant, Dr. Simon told this news organization the side effects with fezolinetant “tend to be gastrointestinal, whereas the side effects for elinzanetant tend to be central nervous system,” such as drowsiness and lethargy.

The women who are the best candidates for elinzanetant, Dr. Pinkerton told this news organization, include those who have had an estrogen-sensitive cancer, such as breast or endometrial cancer, or who have fear of it, a family history, or are otherwise high risk. Other ideal candidates include those with a history of venous thromboembolism, people who have migraine with aura (due to concerns about increased risk for stroke), and those who have endometriosis or large fibroids.

“Then the last group might be women who took hormone therapy in their 50s and want to continue, but they’re trying to go off, and they have a recurrence of their hot flashes or night sweats or sleep issues,” Dr. Pinkerton said. “This might be a great group to switch over.”

OASIS 3 assessed the drug for 1 year and “supported the results of OASIS 1 and 2, demonstrating efficacy over a longer study duration and in a population with a vasomotor symptom profile representative of that seen in clinical practice,” Nick Panay, BSc, MBBS, director of the Menopause & PMS Centre at Queen Charlotte’s Hospital & Imperial College London, London, England, and his colleague reported.

Among 628 postmenopausal women aged 40-65, the predominantly White (78.5%) women were an average 54 years old, with an average BMI of 27.6, and were an average 5 years past their last period. Half received 120 mg elinzanetant and half received a placebo for 52 weeks.

At 12 weeks, the women receiving elinzanetant reported an average 1.6 moderate to severe vasomotor symptoms per day, down from 6.7 at baseline. Daily average symptoms in the placebo group fell from 6.8 at baseline to 3.4 at 12 weeks, for a difference of 1.6 fewer occurrences per day in the elinzanetant group (P < .0001).

Sleep disturbances also improved, falling 9.4 points from a baseline 57.4 in the elinzanetant group and 5.7 points from a baseline 58 in the placebo group. Quality-of-life scores improved from 4.1 to 2.8 (−1.3 change) in the elinzanetant group and from 4.4 to 3.3 (−1.1 change) in the placebo group.

In addition to looking at treatment-emergent adverse events, the safety assessments also included endometrial biopsies; bone mineral density in the femoral neck, hip, and lumbar spine; weight; and labs. Adverse events related to the study drug occurred in 30.4% of those in the elinzanetant group and 14.6% of those in the placebo group. The most commonly reported adverse events were headache (9.6% elinzanetant vs 7% placebo), fatigue (7% vs 10.2%), and sleepiness (5.1% vs 1.3%). A higher proportion of women taking elinzanetant (12.5%) than those taking placebo (4.1%) discontinued the study.

No serious adverse events deemed to be treatment-related occurred in either group, and no endometrial hyperplasia or malignant neoplasm occurred in either group. Bone mineral density changes in both groups were within the expected range for the women’s age, and their weight remained stable over the 52 weeks.

Six women taking elinzanetant and four taking placebo met predefined criteria for close liver observation, but none showed hepatotoxicity or evidence of possible drug-induced liver injury.

The research was funded by Bayer. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Dr. Shufelt had no disclosures. Dr. Simon had grant/research support, consulting/advisory board participation, and/or speaking disclosures with AbbVie, Bayer Healthcare, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services, Covance, Daré Bioscience, DEKA M.E.L.A S.r.l., Femasys, Ipsen, KaNDy/NeRRe Therapeutics, Khyria, Madorra, Mayne Pharma, Mitsubishi Tanabe Pharma Development America, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Pfizer, Pharmavite, QUE Oncology, Scynexis, Sebela Pharmaceuticals, Sprout Pharmaceuticals, TherapeuticsMD, Vella Bioscience, and Viveve Medical, and he is a stockholder in Sermonix Pharmaceuticals.

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

CHICAGO — The nonhormonal investigational drug elinzanetant led to significant improvement in hot flashes as well as sleep disturbance and quality of life, according to data from three randomized controlled trials presented at The Menopause Society 2024 Annual Meeting in Chicago. Two phase 3 trials, OASIS 1 and 2, were also published in JAMA, and the longer-term OASIS 3 trial was presented as a poster at the conference.

Elinzanetant is a selective neurokinin (NK) receptor antagonist, similar to fezolinetant, the first drug in this class approved by the US Food and Drug Administration (FDA) for vasomotor symptoms in May 2023. This class of medications targets the estrogen-sensitive kisspeptin/NK B/dynorphin (KNDy) neurons thought to play a role in thermoregulation and hot flashes during menopause. While fezolinetant targets only the NK-3 receptor, elinzanetant is a dual NK receptor antagonist that targets both NK-1 and NK-3. Bayer submitted a New Drug Application for elinzanetant to the FDA on August 1.

For those in whom hormone therapy is contraindicated, “it’s always been difficult for women with really severe symptoms to have a safe and effective therapy,” lead author JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, told this news organization. “The nonhormonal therapies we’ve used mostly off-label — the antidepressants, gabapentin, clonidine, oxybutynin — do help the hot flashes, but they don’t work nearly as effectively as these new NK receptor antagonists, and having one that looks like it might have a broader use for hot flashes, night sweats, mood, and sleep is just really exciting.”

Dr. Pinkerton said approximately 80% of the women in the OASIS 1 and 2 studies had at least a 50% reduction in hot flashes. “It was a very strong, dramatic positive finding, but the improvements in sleep and mood have really encouraged us to go further,” she said.

Declining estrogen levels during and after menopause can cause hypertrophy and hyperactivity of the KNDy neurons, which has been linked to thermoregulation disruptions that may trigger hot flashes, James Simon, MD, a clinical professor of ob.gyn. at The George Washington University School of Medicine & Health Sciences and medical director of IntimMedicine in Washington, DC, told attendees. He presented pooled data from OASIS 1 and 2. The NK-1 receptor, targeted by elinzanetant but not fezolinetant, is also thought to play a role in insomnia and possibly in mood.

“Oftentimes the focus on a lot of these drugs is hot flashes, hot flashes, hot flashes, but we know hot flashes do not occur in isolation,” Chrisandra Shufelt, MD, professor and chair of general internal medicine and associate director of the Women’s Health Research Center at Mayo Clinic in Jacksonville, Florida, told this news organization. Elinzanetant is “an interesting compound because it actually works on sleep, and that was critical because sleep disturbance precedes” many other menopausal symptoms, said Dr. Shufelt, who was not involved in the study.

“I think it is an outstanding option for women who don’t have the opportunity to get hormones,” Dr. Shufelt said, and she was particularly pleased to see there were no safety concerns for the liver in the trial data. The FDA issued a warning on September 12 about the risk for rare liver injury with fezolinetant, but the early signals that had been seen in fezolinetant data were not seen in these elinzanetant data.

The OASIS 1 and 2 trials enrolled postmenopausal women, aged 40-65 years, who had at least 50 moderate to severe vasomotor occurrences per week.

“A moderate hot flash is a hot flash that is also associated with sweating, and a severe hot flash is a moderate hot flash that stops a woman in her tracks,” Dr. Simon said. “Namely, it’s severe enough with sweating and central nervous system effects that she is interrupted in whatever it is that she’s doing at the time.”

Exclusion criteria for the trials included a history of arrhythmias, heart block, or QT prolongation; abnormal lab results; history of malignancy within the past 5 years; uncontrolled or treatment-resistant hypertension, hypothyroidism, or hyperthyroidism; unexplained postmenopausal bleeding; clinically relevant abnormal mammogram findings; or disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer.

The predominantly White (80%) women were an average 54 years old, with an average body mass index (BMI) of 27.8, and were an average 3.5 years from their last period. For the first 12 weeks of the trials, 399 women were assigned to receive 120 mg once daily of oral elinzanetant and 397 were assigned to once daily placebo. Then the women taking placebo switched to elinzanetant for the final 14 weeks of the study.

The endpoints included mean change in frequency and severity of vasomotor symptoms at weeks 1, 4, and 12 as well as change in sleep disturbance and quality of life at week 12. Sleep was assessed with the Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form score, which ranges from 28.9 to 76.5, with a higher number denoting greater sleep disturbance. The Menopause-Specific Quality-of-Life score ranges from 1 to 8, with a higher score indicating poorer quality of life.

Daily frequency of vasomotor symptoms was 14 per day at baseline in the elinzanetant group, decreasing by 4.8 per day at week 1, 8 per day at week 4, and 9.4 per day at week 12. In the placebo group, women had an average 15.2 occurrences per day at baseline, which decreased by 3.2 at week 1, 5.2 at week 4, and 6.4 at week 12. Comparing the groups at 12 weeks, those receiving elinzanetant had 3.2 fewer daily vasomotor symptoms than those receiving placebo (P < .0001).

The severity of vasomotor symptoms also improved more in the elinzanetant group than in the placebo group over 12 weeks, after which severity improved further in those who switched from placebo to elinzanetant (P < .0001).

Sleep disturbance scores, starting at a mean 61.5 in the elinzanetant group and 60.5 in the placebo group, fell 10.7 points in the elinzanetant group and 5.3 points in the placebo group at 12 weeks, for a difference of 4.9 points (P < .0001). Sleep then further improved in those who switched from placebo to elinzanetant. Quality-of-life scores improved 1.37 points (from 4.52 at baseline) in the elinzanetant group and 0.96 points (from 4.49 at baseline) in the placebo group, for a mean difference at 12 weeks of 0.36 (P < .0001).

Though no head-to-head data exist comparing elinzanetant and fezolinetant, Dr. Simon told this news organization the side effects with fezolinetant “tend to be gastrointestinal, whereas the side effects for elinzanetant tend to be central nervous system,” such as drowsiness and lethargy.

The women who are the best candidates for elinzanetant, Dr. Pinkerton told this news organization, include those who have had an estrogen-sensitive cancer, such as breast or endometrial cancer, or who have fear of it, a family history, or are otherwise high risk. Other ideal candidates include those with a history of venous thromboembolism, people who have migraine with aura (due to concerns about increased risk for stroke), and those who have endometriosis or large fibroids.

“Then the last group might be women who took hormone therapy in their 50s and want to continue, but they’re trying to go off, and they have a recurrence of their hot flashes or night sweats or sleep issues,” Dr. Pinkerton said. “This might be a great group to switch over.”

OASIS 3 assessed the drug for 1 year and “supported the results of OASIS 1 and 2, demonstrating efficacy over a longer study duration and in a population with a vasomotor symptom profile representative of that seen in clinical practice,” Nick Panay, BSc, MBBS, director of the Menopause & PMS Centre at Queen Charlotte’s Hospital & Imperial College London, London, England, and his colleague reported.

Among 628 postmenopausal women aged 40-65, the predominantly White (78.5%) women were an average 54 years old, with an average BMI of 27.6, and were an average 5 years past their last period. Half received 120 mg elinzanetant and half received a placebo for 52 weeks.

At 12 weeks, the women receiving elinzanetant reported an average 1.6 moderate to severe vasomotor symptoms per day, down from 6.7 at baseline. Daily average symptoms in the placebo group fell from 6.8 at baseline to 3.4 at 12 weeks, for a difference of 1.6 fewer occurrences per day in the elinzanetant group (P < .0001).

Sleep disturbances also improved, falling 9.4 points from a baseline 57.4 in the elinzanetant group and 5.7 points from a baseline 58 in the placebo group. Quality-of-life scores improved from 4.1 to 2.8 (−1.3 change) in the elinzanetant group and from 4.4 to 3.3 (−1.1 change) in the placebo group.

In addition to looking at treatment-emergent adverse events, the safety assessments also included endometrial biopsies; bone mineral density in the femoral neck, hip, and lumbar spine; weight; and labs. Adverse events related to the study drug occurred in 30.4% of those in the elinzanetant group and 14.6% of those in the placebo group. The most commonly reported adverse events were headache (9.6% elinzanetant vs 7% placebo), fatigue (7% vs 10.2%), and sleepiness (5.1% vs 1.3%). A higher proportion of women taking elinzanetant (12.5%) than those taking placebo (4.1%) discontinued the study.

No serious adverse events deemed to be treatment-related occurred in either group, and no endometrial hyperplasia or malignant neoplasm occurred in either group. Bone mineral density changes in both groups were within the expected range for the women’s age, and their weight remained stable over the 52 weeks.

Six women taking elinzanetant and four taking placebo met predefined criteria for close liver observation, but none showed hepatotoxicity or evidence of possible drug-induced liver injury.

The research was funded by Bayer. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Dr. Shufelt had no disclosures. Dr. Simon had grant/research support, consulting/advisory board participation, and/or speaking disclosures with AbbVie, Bayer Healthcare, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services, Covance, Daré Bioscience, DEKA M.E.L.A S.r.l., Femasys, Ipsen, KaNDy/NeRRe Therapeutics, Khyria, Madorra, Mayne Pharma, Mitsubishi Tanabe Pharma Development America, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Pfizer, Pharmavite, QUE Oncology, Scynexis, Sebela Pharmaceuticals, Sprout Pharmaceuticals, TherapeuticsMD, Vella Bioscience, and Viveve Medical, and he is a stockholder in Sermonix Pharmaceuticals.

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

CHICAGO — The nonhormonal investigational drug elinzanetant led to significant improvement in hot flashes as well as sleep disturbance and quality of life, according to data from three randomized controlled trials presented at The Menopause Society 2024 Annual Meeting in Chicago. Two phase 3 trials, OASIS 1 and 2, were also published in JAMA, and the longer-term OASIS 3 trial was presented as a poster at the conference.

Elinzanetant is a selective neurokinin (NK) receptor antagonist, similar to fezolinetant, the first drug in this class approved by the US Food and Drug Administration (FDA) for vasomotor symptoms in May 2023. This class of medications targets the estrogen-sensitive kisspeptin/NK B/dynorphin (KNDy) neurons thought to play a role in thermoregulation and hot flashes during menopause. While fezolinetant targets only the NK-3 receptor, elinzanetant is a dual NK receptor antagonist that targets both NK-1 and NK-3. Bayer submitted a New Drug Application for elinzanetant to the FDA on August 1.

For those in whom hormone therapy is contraindicated, “it’s always been difficult for women with really severe symptoms to have a safe and effective therapy,” lead author JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, told this news organization. “The nonhormonal therapies we’ve used mostly off-label — the antidepressants, gabapentin, clonidine, oxybutynin — do help the hot flashes, but they don’t work nearly as effectively as these new NK receptor antagonists, and having one that looks like it might have a broader use for hot flashes, night sweats, mood, and sleep is just really exciting.”

Dr. Pinkerton said approximately 80% of the women in the OASIS 1 and 2 studies had at least a 50% reduction in hot flashes. “It was a very strong, dramatic positive finding, but the improvements in sleep and mood have really encouraged us to go further,” she said.

Declining estrogen levels during and after menopause can cause hypertrophy and hyperactivity of the KNDy neurons, which has been linked to thermoregulation disruptions that may trigger hot flashes, James Simon, MD, a clinical professor of ob.gyn. at The George Washington University School of Medicine & Health Sciences and medical director of IntimMedicine in Washington, DC, told attendees. He presented pooled data from OASIS 1 and 2. The NK-1 receptor, targeted by elinzanetant but not fezolinetant, is also thought to play a role in insomnia and possibly in mood.

“Oftentimes the focus on a lot of these drugs is hot flashes, hot flashes, hot flashes, but we know hot flashes do not occur in isolation,” Chrisandra Shufelt, MD, professor and chair of general internal medicine and associate director of the Women’s Health Research Center at Mayo Clinic in Jacksonville, Florida, told this news organization. Elinzanetant is “an interesting compound because it actually works on sleep, and that was critical because sleep disturbance precedes” many other menopausal symptoms, said Dr. Shufelt, who was not involved in the study.

“I think it is an outstanding option for women who don’t have the opportunity to get hormones,” Dr. Shufelt said, and she was particularly pleased to see there were no safety concerns for the liver in the trial data. The FDA issued a warning on September 12 about the risk for rare liver injury with fezolinetant, but the early signals that had been seen in fezolinetant data were not seen in these elinzanetant data.

The OASIS 1 and 2 trials enrolled postmenopausal women, aged 40-65 years, who had at least 50 moderate to severe vasomotor occurrences per week.

“A moderate hot flash is a hot flash that is also associated with sweating, and a severe hot flash is a moderate hot flash that stops a woman in her tracks,” Dr. Simon said. “Namely, it’s severe enough with sweating and central nervous system effects that she is interrupted in whatever it is that she’s doing at the time.”

Exclusion criteria for the trials included a history of arrhythmias, heart block, or QT prolongation; abnormal lab results; history of malignancy within the past 5 years; uncontrolled or treatment-resistant hypertension, hypothyroidism, or hyperthyroidism; unexplained postmenopausal bleeding; clinically relevant abnormal mammogram findings; or disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer.

The predominantly White (80%) women were an average 54 years old, with an average body mass index (BMI) of 27.8, and were an average 3.5 years from their last period. For the first 12 weeks of the trials, 399 women were assigned to receive 120 mg once daily of oral elinzanetant and 397 were assigned to once daily placebo. Then the women taking placebo switched to elinzanetant for the final 14 weeks of the study.

The endpoints included mean change in frequency and severity of vasomotor symptoms at weeks 1, 4, and 12 as well as change in sleep disturbance and quality of life at week 12. Sleep was assessed with the Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form score, which ranges from 28.9 to 76.5, with a higher number denoting greater sleep disturbance. The Menopause-Specific Quality-of-Life score ranges from 1 to 8, with a higher score indicating poorer quality of life.

Daily frequency of vasomotor symptoms was 14 per day at baseline in the elinzanetant group, decreasing by 4.8 per day at week 1, 8 per day at week 4, and 9.4 per day at week 12. In the placebo group, women had an average 15.2 occurrences per day at baseline, which decreased by 3.2 at week 1, 5.2 at week 4, and 6.4 at week 12. Comparing the groups at 12 weeks, those receiving elinzanetant had 3.2 fewer daily vasomotor symptoms than those receiving placebo (P < .0001).

The severity of vasomotor symptoms also improved more in the elinzanetant group than in the placebo group over 12 weeks, after which severity improved further in those who switched from placebo to elinzanetant (P < .0001).

Sleep disturbance scores, starting at a mean 61.5 in the elinzanetant group and 60.5 in the placebo group, fell 10.7 points in the elinzanetant group and 5.3 points in the placebo group at 12 weeks, for a difference of 4.9 points (P < .0001). Sleep then further improved in those who switched from placebo to elinzanetant. Quality-of-life scores improved 1.37 points (from 4.52 at baseline) in the elinzanetant group and 0.96 points (from 4.49 at baseline) in the placebo group, for a mean difference at 12 weeks of 0.36 (P < .0001).

Though no head-to-head data exist comparing elinzanetant and fezolinetant, Dr. Simon told this news organization the side effects with fezolinetant “tend to be gastrointestinal, whereas the side effects for elinzanetant tend to be central nervous system,” such as drowsiness and lethargy.

The women who are the best candidates for elinzanetant, Dr. Pinkerton told this news organization, include those who have had an estrogen-sensitive cancer, such as breast or endometrial cancer, or who have fear of it, a family history, or are otherwise high risk. Other ideal candidates include those with a history of venous thromboembolism, people who have migraine with aura (due to concerns about increased risk for stroke), and those who have endometriosis or large fibroids.

“Then the last group might be women who took hormone therapy in their 50s and want to continue, but they’re trying to go off, and they have a recurrence of their hot flashes or night sweats or sleep issues,” Dr. Pinkerton said. “This might be a great group to switch over.”

OASIS 3 assessed the drug for 1 year and “supported the results of OASIS 1 and 2, demonstrating efficacy over a longer study duration and in a population with a vasomotor symptom profile representative of that seen in clinical practice,” Nick Panay, BSc, MBBS, director of the Menopause & PMS Centre at Queen Charlotte’s Hospital & Imperial College London, London, England, and his colleague reported.

Among 628 postmenopausal women aged 40-65, the predominantly White (78.5%) women were an average 54 years old, with an average BMI of 27.6, and were an average 5 years past their last period. Half received 120 mg elinzanetant and half received a placebo for 52 weeks.

At 12 weeks, the women receiving elinzanetant reported an average 1.6 moderate to severe vasomotor symptoms per day, down from 6.7 at baseline. Daily average symptoms in the placebo group fell from 6.8 at baseline to 3.4 at 12 weeks, for a difference of 1.6 fewer occurrences per day in the elinzanetant group (P < .0001).

Sleep disturbances also improved, falling 9.4 points from a baseline 57.4 in the elinzanetant group and 5.7 points from a baseline 58 in the placebo group. Quality-of-life scores improved from 4.1 to 2.8 (−1.3 change) in the elinzanetant group and from 4.4 to 3.3 (−1.1 change) in the placebo group.

In addition to looking at treatment-emergent adverse events, the safety assessments also included endometrial biopsies; bone mineral density in the femoral neck, hip, and lumbar spine; weight; and labs. Adverse events related to the study drug occurred in 30.4% of those in the elinzanetant group and 14.6% of those in the placebo group. The most commonly reported adverse events were headache (9.6% elinzanetant vs 7% placebo), fatigue (7% vs 10.2%), and sleepiness (5.1% vs 1.3%). A higher proportion of women taking elinzanetant (12.5%) than those taking placebo (4.1%) discontinued the study.

No serious adverse events deemed to be treatment-related occurred in either group, and no endometrial hyperplasia or malignant neoplasm occurred in either group. Bone mineral density changes in both groups were within the expected range for the women’s age, and their weight remained stable over the 52 weeks.

Six women taking elinzanetant and four taking placebo met predefined criteria for close liver observation, but none showed hepatotoxicity or evidence of possible drug-induced liver injury.

The research was funded by Bayer. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Dr. Shufelt had no disclosures. Dr. Simon had grant/research support, consulting/advisory board participation, and/or speaking disclosures with AbbVie, Bayer Healthcare, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services, Covance, Daré Bioscience, DEKA M.E.L.A S.r.l., Femasys, Ipsen, KaNDy/NeRRe Therapeutics, Khyria, Madorra, Mayne Pharma, Mitsubishi Tanabe Pharma Development America, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Pfizer, Pharmavite, QUE Oncology, Scynexis, Sebela Pharmaceuticals, Sprout Pharmaceuticals, TherapeuticsMD, Vella Bioscience, and Viveve Medical, and he is a stockholder in Sermonix Pharmaceuticals.

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

CHICAGO — The vast majority of women experiencing genitourinary syndrome of menopause (GSM) symptoms did not receive a prescription for hormonal vaginal therapies prior to seeking care at a specialized menopause clinic, according to research presented at the annual meeting of The Menopause Society.

“GSM symptoms are very common and affect women’s health and quality of life, often worsening without effective therapy,” Leticia Hernández Galán, PhD, of the Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada, and colleagues reported. “We have demonstrated that most women seeking specialty care in an urban center with GSM symptoms have not been given a trial of local vaginal therapies by referring providers despite guidelines about safety and lack of contraindications. Given very long wait times for menopause providers in Canada, improved education for both women and their providers is needed to reduce needless suffering and improve care.”

Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, was not involved with the study but agreed with the authors’ assessment of the findings.

“This study highlights the treatment gap for women with genitourinary syndrome of menopause,” Dr. Faubion told this news organization. “Clearly, there is underutilization of low-dose vaginal hormonal therapies, which are known to be safe and effective. We still have work to do in terms of educating both women and providers on established treatment options for this common concern in menopausal women.” 

The findings match previous ones that found a majority of women with GSM do not receive treatment. A 2017 study, which was cited in the 2020 Menopause Society position statement on the condition, found that half of women with GSM had never used any treatment.

GSM is the current term that replaces previously used “vulvovaginal atrophy” and “atrophic vaginitis” because it encompasses all the menopause symptoms and signs associated with menopause that affect the vagina, vulva, and urinary tract. Anywhere from 50% to 84% of postmenopausal women experience GSM, the authors noted, with symptoms that include “burning, itching, or irritation of the vulva” and “lack of lubrication and discomfort or pain with sexual activity as well as dysuria, increased frequency or urgency of urination, and increased risk for urinary tract infections.”

First-line treatment of mild GSM often includes nonhormonal vaginal lubricants and moisturizers, but vaginal estrogen is considered the most effective treatment for more severe or bothersome cases. Other treatments include systematic hormone therapy and ospemifene or other selective estrogen receptor modulators.
 

Increased Risk for Urinary Tract Infections (UTIs)

Untreated GSM is not simply a quality of life issue; it increases the risk of developing serious UTIs, explained JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia, Charlottesville, who was not involved in the study.

“Estrogen depletion alters the vaginal epithelium, with distinct impairments in lubrication, elasticity, pH, and blood flow,” Dr. Pinkerton said. “The vaginal microbiome changes, with increasing pH following menopause and loss of lactobacillus predominance. These alterations allow a more hospitable environment for bacterial growth and increase the risk of UTI.”

Vaginal estrogen, meanwhile, reduces UTI risk because it “increases the presence of lactobacillus in the vagina due to improvements in vaginal pH, rebuilding superficial cells, elasticity, and connectivity,” she said.

The study assessed the incidence of GSM among patients at a single specialized Canadian institution, St. Joseph’s Healthcare Menopause Clinic in Hamilton, Ontario, between January 2021 and August 2024. Patients completed a Menopause Rating Scale that quantified two sets of GSM symptoms relating to “dryness of the vagina” and “bladder problems.” Patients also answered questions about the provider they had seen before coming to the specialized clinic and whether they had been prescribed local vaginal products before their visit.

Among 529 patients, the average age was 51, and the vast majority (88%) had some amount of tertiary education beyond high school. Only 21.5% were still menstruating, whereas the other respondents had stopped menstruating. The patient population was mostly White (85.6%), with Black, Hispanic, Asian, Middle Eastern, and Indigenous patients making up most of the other patient groups.

Among the 521 patients who answered the question on vaginal dryness, answers were similarly split between none (26%), mild (23%), moderate (21%), severe (15%), and very severe (15%). One third of the 526 women (34%) who answered the question on bladder problems said they had none, whereas the remainder reported their problems as mild (24%), moderate (24%), severe (11%), or very severe (7%).

Despite about half the participants reporting moderate to very severe vaginal dryness, 85% of them had not been prescribed local vaginal hormone therapies before their visit to the menopause clinic. Women were more likely to have been prescribed a localized therapy if they were older, were postmenopausal instead of perimenopausal, or had a female healthcare provider prior to this visit.

The survey also asked about the specialty and years in practice for the providers women had seen before visiting the clinic, but neither of these were predictors for receiving a hormone prescription. The patient’s education, partner status, and ethnicity were also not associated with the likelihood of a prescription.

Among 62 women who had been prescribed a vaginal hormone treatment, most were prescribed Vagifem (29%) or Premarin Vaginal cream (26%), followed by Intrarosa (19%), Estragyn cream (16%), Estring (3%), or something else (18%).
 

Serious Complications of GSM

Dr. Pinkerton described how GSM, particularly in older women, can run the risk of becoming life-threatening if untreated and unrecognized.

“For some women, UTIs can lead to urosepsis, as both the vaginal tissues and bladder tissues are thin with blood vessels close to the surface,” Dr. Pinkerton said. “What may have started as a UTI, can ascend to the kidneys or get into the bloodstream, which, in some, can develop into urosepsis, which can be life-threatening. The bacterial pathogen initiates the disease process, but host immune responses drive whether sepsis develops and its severity.”

The research by Dr. Hernández Galán was funded by the Canadian Institutes of Health Research, the Canadian Menopause Society, and Pfizer. Dr. Faubion had no disclosures, and Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer.

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

CHICAGO — The vast majority of women experiencing genitourinary syndrome of menopause (GSM) symptoms did not receive a prescription for hormonal vaginal therapies prior to seeking care at a specialized menopause clinic, according to research presented at the annual meeting of The Menopause Society.

“GSM symptoms are very common and affect women’s health and quality of life, often worsening without effective therapy,” Leticia Hernández Galán, PhD, of the Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada, and colleagues reported. “We have demonstrated that most women seeking specialty care in an urban center with GSM symptoms have not been given a trial of local vaginal therapies by referring providers despite guidelines about safety and lack of contraindications. Given very long wait times for menopause providers in Canada, improved education for both women and their providers is needed to reduce needless suffering and improve care.”

Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, was not involved with the study but agreed with the authors’ assessment of the findings.

“This study highlights the treatment gap for women with genitourinary syndrome of menopause,” Dr. Faubion told this news organization. “Clearly, there is underutilization of low-dose vaginal hormonal therapies, which are known to be safe and effective. We still have work to do in terms of educating both women and providers on established treatment options for this common concern in menopausal women.” 

The findings match previous ones that found a majority of women with GSM do not receive treatment. A 2017 study, which was cited in the 2020 Menopause Society position statement on the condition, found that half of women with GSM had never used any treatment.

GSM is the current term that replaces previously used “vulvovaginal atrophy” and “atrophic vaginitis” because it encompasses all the menopause symptoms and signs associated with menopause that affect the vagina, vulva, and urinary tract. Anywhere from 50% to 84% of postmenopausal women experience GSM, the authors noted, with symptoms that include “burning, itching, or irritation of the vulva” and “lack of lubrication and discomfort or pain with sexual activity as well as dysuria, increased frequency or urgency of urination, and increased risk for urinary tract infections.”

First-line treatment of mild GSM often includes nonhormonal vaginal lubricants and moisturizers, but vaginal estrogen is considered the most effective treatment for more severe or bothersome cases. Other treatments include systematic hormone therapy and ospemifene or other selective estrogen receptor modulators.
 

Increased Risk for Urinary Tract Infections (UTIs)

Untreated GSM is not simply a quality of life issue; it increases the risk of developing serious UTIs, explained JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia, Charlottesville, who was not involved in the study.

“Estrogen depletion alters the vaginal epithelium, with distinct impairments in lubrication, elasticity, pH, and blood flow,” Dr. Pinkerton said. “The vaginal microbiome changes, with increasing pH following menopause and loss of lactobacillus predominance. These alterations allow a more hospitable environment for bacterial growth and increase the risk of UTI.”

Vaginal estrogen, meanwhile, reduces UTI risk because it “increases the presence of lactobacillus in the vagina due to improvements in vaginal pH, rebuilding superficial cells, elasticity, and connectivity,” she said.

The study assessed the incidence of GSM among patients at a single specialized Canadian institution, St. Joseph’s Healthcare Menopause Clinic in Hamilton, Ontario, between January 2021 and August 2024. Patients completed a Menopause Rating Scale that quantified two sets of GSM symptoms relating to “dryness of the vagina” and “bladder problems.” Patients also answered questions about the provider they had seen before coming to the specialized clinic and whether they had been prescribed local vaginal products before their visit.

Among 529 patients, the average age was 51, and the vast majority (88%) had some amount of tertiary education beyond high school. Only 21.5% were still menstruating, whereas the other respondents had stopped menstruating. The patient population was mostly White (85.6%), with Black, Hispanic, Asian, Middle Eastern, and Indigenous patients making up most of the other patient groups.

Among the 521 patients who answered the question on vaginal dryness, answers were similarly split between none (26%), mild (23%), moderate (21%), severe (15%), and very severe (15%). One third of the 526 women (34%) who answered the question on bladder problems said they had none, whereas the remainder reported their problems as mild (24%), moderate (24%), severe (11%), or very severe (7%).

Despite about half the participants reporting moderate to very severe vaginal dryness, 85% of them had not been prescribed local vaginal hormone therapies before their visit to the menopause clinic. Women were more likely to have been prescribed a localized therapy if they were older, were postmenopausal instead of perimenopausal, or had a female healthcare provider prior to this visit.

The survey also asked about the specialty and years in practice for the providers women had seen before visiting the clinic, but neither of these were predictors for receiving a hormone prescription. The patient’s education, partner status, and ethnicity were also not associated with the likelihood of a prescription.

Among 62 women who had been prescribed a vaginal hormone treatment, most were prescribed Vagifem (29%) or Premarin Vaginal cream (26%), followed by Intrarosa (19%), Estragyn cream (16%), Estring (3%), or something else (18%).
 

Serious Complications of GSM

Dr. Pinkerton described how GSM, particularly in older women, can run the risk of becoming life-threatening if untreated and unrecognized.

“For some women, UTIs can lead to urosepsis, as both the vaginal tissues and bladder tissues are thin with blood vessels close to the surface,” Dr. Pinkerton said. “What may have started as a UTI, can ascend to the kidneys or get into the bloodstream, which, in some, can develop into urosepsis, which can be life-threatening. The bacterial pathogen initiates the disease process, but host immune responses drive whether sepsis develops and its severity.”

The research by Dr. Hernández Galán was funded by the Canadian Institutes of Health Research, the Canadian Menopause Society, and Pfizer. Dr. Faubion had no disclosures, and Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer.

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

CHICAGO — The vast majority of women experiencing genitourinary syndrome of menopause (GSM) symptoms did not receive a prescription for hormonal vaginal therapies prior to seeking care at a specialized menopause clinic, according to research presented at the annual meeting of The Menopause Society.

“GSM symptoms are very common and affect women’s health and quality of life, often worsening without effective therapy,” Leticia Hernández Galán, PhD, of the Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada, and colleagues reported. “We have demonstrated that most women seeking specialty care in an urban center with GSM symptoms have not been given a trial of local vaginal therapies by referring providers despite guidelines about safety and lack of contraindications. Given very long wait times for menopause providers in Canada, improved education for both women and their providers is needed to reduce needless suffering and improve care.”

Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, was not involved with the study but agreed with the authors’ assessment of the findings.

“This study highlights the treatment gap for women with genitourinary syndrome of menopause,” Dr. Faubion told this news organization. “Clearly, there is underutilization of low-dose vaginal hormonal therapies, which are known to be safe and effective. We still have work to do in terms of educating both women and providers on established treatment options for this common concern in menopausal women.” 

The findings match previous ones that found a majority of women with GSM do not receive treatment. A 2017 study, which was cited in the 2020 Menopause Society position statement on the condition, found that half of women with GSM had never used any treatment.

GSM is the current term that replaces previously used “vulvovaginal atrophy” and “atrophic vaginitis” because it encompasses all the menopause symptoms and signs associated with menopause that affect the vagina, vulva, and urinary tract. Anywhere from 50% to 84% of postmenopausal women experience GSM, the authors noted, with symptoms that include “burning, itching, or irritation of the vulva” and “lack of lubrication and discomfort or pain with sexual activity as well as dysuria, increased frequency or urgency of urination, and increased risk for urinary tract infections.”

First-line treatment of mild GSM often includes nonhormonal vaginal lubricants and moisturizers, but vaginal estrogen is considered the most effective treatment for more severe or bothersome cases. Other treatments include systematic hormone therapy and ospemifene or other selective estrogen receptor modulators.
 

Increased Risk for Urinary Tract Infections (UTIs)

Untreated GSM is not simply a quality of life issue; it increases the risk of developing serious UTIs, explained JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia, Charlottesville, who was not involved in the study.

“Estrogen depletion alters the vaginal epithelium, with distinct impairments in lubrication, elasticity, pH, and blood flow,” Dr. Pinkerton said. “The vaginal microbiome changes, with increasing pH following menopause and loss of lactobacillus predominance. These alterations allow a more hospitable environment for bacterial growth and increase the risk of UTI.”

Vaginal estrogen, meanwhile, reduces UTI risk because it “increases the presence of lactobacillus in the vagina due to improvements in vaginal pH, rebuilding superficial cells, elasticity, and connectivity,” she said.

The study assessed the incidence of GSM among patients at a single specialized Canadian institution, St. Joseph’s Healthcare Menopause Clinic in Hamilton, Ontario, between January 2021 and August 2024. Patients completed a Menopause Rating Scale that quantified two sets of GSM symptoms relating to “dryness of the vagina” and “bladder problems.” Patients also answered questions about the provider they had seen before coming to the specialized clinic and whether they had been prescribed local vaginal products before their visit.

Among 529 patients, the average age was 51, and the vast majority (88%) had some amount of tertiary education beyond high school. Only 21.5% were still menstruating, whereas the other respondents had stopped menstruating. The patient population was mostly White (85.6%), with Black, Hispanic, Asian, Middle Eastern, and Indigenous patients making up most of the other patient groups.

Among the 521 patients who answered the question on vaginal dryness, answers were similarly split between none (26%), mild (23%), moderate (21%), severe (15%), and very severe (15%). One third of the 526 women (34%) who answered the question on bladder problems said they had none, whereas the remainder reported their problems as mild (24%), moderate (24%), severe (11%), or very severe (7%).

Despite about half the participants reporting moderate to very severe vaginal dryness, 85% of them had not been prescribed local vaginal hormone therapies before their visit to the menopause clinic. Women were more likely to have been prescribed a localized therapy if they were older, were postmenopausal instead of perimenopausal, or had a female healthcare provider prior to this visit.

The survey also asked about the specialty and years in practice for the providers women had seen before visiting the clinic, but neither of these were predictors for receiving a hormone prescription. The patient’s education, partner status, and ethnicity were also not associated with the likelihood of a prescription.

Among 62 women who had been prescribed a vaginal hormone treatment, most were prescribed Vagifem (29%) or Premarin Vaginal cream (26%), followed by Intrarosa (19%), Estragyn cream (16%), Estring (3%), or something else (18%).
 

Serious Complications of GSM

Dr. Pinkerton described how GSM, particularly in older women, can run the risk of becoming life-threatening if untreated and unrecognized.

“For some women, UTIs can lead to urosepsis, as both the vaginal tissues and bladder tissues are thin with blood vessels close to the surface,” Dr. Pinkerton said. “What may have started as a UTI, can ascend to the kidneys or get into the bloodstream, which, in some, can develop into urosepsis, which can be life-threatening. The bacterial pathogen initiates the disease process, but host immune responses drive whether sepsis develops and its severity.”

The research by Dr. Hernández Galán was funded by the Canadian Institutes of Health Research, the Canadian Menopause Society, and Pfizer. Dr. Faubion had no disclosures, and Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer.

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

CHICAGO — Less than 4% of American women aged 50-59 years use hormone therapy (HT) to treat menopausal symptoms today, approximately 10 times lower than the peak use of HT before the publication of the 2002 Women’s Health Initiative (WHI) study that misguidedly cast doubt on the safety of HT. Though subsequent research has addressed the flaws of the WHI study and supports the use of HT in most menopausal women younger than 60 years, use of this therapy has never recovered, according to research presented at the annual meeting of The Menopause Society (formerly The North American Menopause Society).

“Despite evidence supporting the efficacy and safety of HT, usage rates of US Food and Drug Administration–approved HT remain low,” Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, told attendees. “Improved education of clinicians and patients is critically needed.”

Today, “there is more clarity on the risk/benefit ratio of HT use with the benefits typically outweighing the risks in women who initiate therapy under the age of 60 years and within 10 years of menopause onset.”

Using medical and pharmacy claims data from OptumLabs, Dr. Faubion and her colleagues examined utilization rates from 2007 to 2023 of transdermal vs oral estrogen and of conjugated estrogen vs estradiol in women aged 40 years or older. The data included more than 200 million people throughout the United States covered by commercial insurance or Medicare Advantage. The researchers defined annual rate of HT use as the proportion of women who had at least 180 days of a filled prescription for a systemic HT preparation with estrogen.

The study population increased from an estimated 2 million women in 2007 to 4.5 million women in 2023, and the average age of enrollees increased from 53 in 2007 to 66 in 2023. Starting at 4.6% in 2007, HT use steadily declined to a low of 1.8% in 2023 for the whole cohort of women aged 40 years or older.

Though rates remained highest in women aged 50-64 years, it still declined within each age group: From 6% in 2007 to 3.6% in 2023 among women aged 50-54 years, from 7.3% to 3.8% among women aged 55-59 years, and from 7.5% to 2.9% among women aged 60-64 years. It also declined in younger women, from 3.2% in 2007 to 1.5% in 2023 in those aged 45-50 years. Estradiol was the most common formulation used, and oral administration was the most common route.

The researchers also saw a gradual decline during the study period in the use of high-dose oral HT and an increase in the use of low-dose oral HT, whereas standard dosages remained fairly consistent as the most common dose prescribed. Similarly, the use of high transdermal doses declined, whereas low transdermal doses increased and surpassed the use of standard doses. Conjugated estrogen use plummeted during the study period across all age groups, from 2%-5% in most age groups to < 1% in all age groups by 2023.

One limitation of the study was that it could not examine rates of compounded HT use because those would not be reflected in insurance claims, pointed out JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, who was not involved in the study. Dr. Pinkerton found it surprising that the numbers were so low, despite the fact that research estimates suggest less than 15% of menopausal women are receiving adequate treatment, she told this news organization. “You can see there’s a large unmet need to get treatment,” she said. “All major medical societies say the same thing: For healthy, symptomatic menopausal women, you can use hormone therapy safely and effectively.” 

The lack of education among providers is likely the biggest reason for the decline, Dr. Pinkerton says. “I think it’s because there’s a whole group of providers that did not receive any training, and that’s OB/GYNs, internal medicine, family practice, endocrinologists,” she said. “Now that people are starting to feel more confident that we can use it safely, we’re trying to get that training out to people about vasomotor symptoms, about hormone therapy, and now about new nonhormone therapies.”

Dr. Pinkerton noted that The Menopause Society has begun a new teaching program, Menopause Step-by-Step, aimed at providing short articles on the basics of menopause, HT, non-HT, and vaginal issues.

A separate poster presented at the conference provides insight into another potential factor contributing to low HT rates. A survey of 1050 American and Canadian women found that 90% discussed their symptoms with their healthcare providers, yet only 25% said their doctor identified the symptoms as likely due to perimenopause or menopause on their first visit — and only 10% of respondents said their doctor was the one to bring up perimenopause/menopause.

The respondents comprised a convenience sample of those who saw the survey on social media, in an email, or on the website of Morphus, a Toronto-based company aimed at providing support, information, and products related to menopause. Though the survey is ongoing, the analyzed responses are from March to May 2024.

Though 40% of the women said their provider attributed their symptoms to perimenopause or menopause on the second or third visit, 18% saw a provider four to five times, and 17% saw a provider more than five times before the provider considered menopause as a cause. About a third of the women (35%) brought it up to their doctor themselves and found their provider receptive, but 40% said the response was dismissive when they brought it up, and 15% said the topic was never broached at all.

Andrea Donsky, RHN, founder of Morphus who conducted the study, found these numbers surprising because she would have hoped that more doctors would have brought up perimenopause/menopause sooner. “We still have a lot of work to do to help educate women and healthcare providers,” Ms. Donsky told this news organization. “A lot of women spend years not knowing they’re in this phase of life, so they visit their doctors/HCPs [healthcare providers] many times because the connection isn’t made on the first visit.”

Danielle Meitiv, MS, a study co-author and health coach based in Silver Spring, Maryland, added, “Everyone wonders why we end up with Dr. Google; that’s the only doctor who’s talking to us about menopause.”

Dr. Pinkerton was less surprised by these survey findings. “As a menopause specialist, my most common new patient is a perimenopausal woman who feels like she hasn’t been listened to,” whether it’s her primary care doctor, her ob.gyn., or another clinician. “If the provider doesn’t ask or if the women doesn’t tell, then you don’t have the conversation,” Dr. Pinkerton said. “So many women in perimenopause are busy with work, families, partnerships, aging parents — all of the issues that they’re dealing with — that when they start to have sleep issues or mood issues or easy crying, they relate it to their life stressors, instead of recognizing that it’s fluctuating hormones.”

When Ms. Donsky examined the 1223 responses they had received through August 2024, the most common treatments advised for symptoms were antidepressants and HT, both recommended by 38% of providers. Other common recommendations were to “lose weight,” “eat less and exercise more,” supplements, or birth control pills.

Dr. Faubion had no disclosures, and her study used no external funding. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Ms. Donsky is the owner of Morphus. Ms. Meitiv had no disclosures. The poster on women’s experiences with providers was funded by Morphus Inc.

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

CHICAGO — Less than 4% of American women aged 50-59 years use hormone therapy (HT) to treat menopausal symptoms today, approximately 10 times lower than the peak use of HT before the publication of the 2002 Women’s Health Initiative (WHI) study that misguidedly cast doubt on the safety of HT. Though subsequent research has addressed the flaws of the WHI study and supports the use of HT in most menopausal women younger than 60 years, use of this therapy has never recovered, according to research presented at the annual meeting of The Menopause Society (formerly The North American Menopause Society).

“Despite evidence supporting the efficacy and safety of HT, usage rates of US Food and Drug Administration–approved HT remain low,” Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, told attendees. “Improved education of clinicians and patients is critically needed.”

Today, “there is more clarity on the risk/benefit ratio of HT use with the benefits typically outweighing the risks in women who initiate therapy under the age of 60 years and within 10 years of menopause onset.”

Using medical and pharmacy claims data from OptumLabs, Dr. Faubion and her colleagues examined utilization rates from 2007 to 2023 of transdermal vs oral estrogen and of conjugated estrogen vs estradiol in women aged 40 years or older. The data included more than 200 million people throughout the United States covered by commercial insurance or Medicare Advantage. The researchers defined annual rate of HT use as the proportion of women who had at least 180 days of a filled prescription for a systemic HT preparation with estrogen.

The study population increased from an estimated 2 million women in 2007 to 4.5 million women in 2023, and the average age of enrollees increased from 53 in 2007 to 66 in 2023. Starting at 4.6% in 2007, HT use steadily declined to a low of 1.8% in 2023 for the whole cohort of women aged 40 years or older.

Though rates remained highest in women aged 50-64 years, it still declined within each age group: From 6% in 2007 to 3.6% in 2023 among women aged 50-54 years, from 7.3% to 3.8% among women aged 55-59 years, and from 7.5% to 2.9% among women aged 60-64 years. It also declined in younger women, from 3.2% in 2007 to 1.5% in 2023 in those aged 45-50 years. Estradiol was the most common formulation used, and oral administration was the most common route.

The researchers also saw a gradual decline during the study period in the use of high-dose oral HT and an increase in the use of low-dose oral HT, whereas standard dosages remained fairly consistent as the most common dose prescribed. Similarly, the use of high transdermal doses declined, whereas low transdermal doses increased and surpassed the use of standard doses. Conjugated estrogen use plummeted during the study period across all age groups, from 2%-5% in most age groups to < 1% in all age groups by 2023.

One limitation of the study was that it could not examine rates of compounded HT use because those would not be reflected in insurance claims, pointed out JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, who was not involved in the study. Dr. Pinkerton found it surprising that the numbers were so low, despite the fact that research estimates suggest less than 15% of menopausal women are receiving adequate treatment, she told this news organization. “You can see there’s a large unmet need to get treatment,” she said. “All major medical societies say the same thing: For healthy, symptomatic menopausal women, you can use hormone therapy safely and effectively.” 

The lack of education among providers is likely the biggest reason for the decline, Dr. Pinkerton says. “I think it’s because there’s a whole group of providers that did not receive any training, and that’s OB/GYNs, internal medicine, family practice, endocrinologists,” she said. “Now that people are starting to feel more confident that we can use it safely, we’re trying to get that training out to people about vasomotor symptoms, about hormone therapy, and now about new nonhormone therapies.”

Dr. Pinkerton noted that The Menopause Society has begun a new teaching program, Menopause Step-by-Step, aimed at providing short articles on the basics of menopause, HT, non-HT, and vaginal issues.

A separate poster presented at the conference provides insight into another potential factor contributing to low HT rates. A survey of 1050 American and Canadian women found that 90% discussed their symptoms with their healthcare providers, yet only 25% said their doctor identified the symptoms as likely due to perimenopause or menopause on their first visit — and only 10% of respondents said their doctor was the one to bring up perimenopause/menopause.

The respondents comprised a convenience sample of those who saw the survey on social media, in an email, or on the website of Morphus, a Toronto-based company aimed at providing support, information, and products related to menopause. Though the survey is ongoing, the analyzed responses are from March to May 2024.

Though 40% of the women said their provider attributed their symptoms to perimenopause or menopause on the second or third visit, 18% saw a provider four to five times, and 17% saw a provider more than five times before the provider considered menopause as a cause. About a third of the women (35%) brought it up to their doctor themselves and found their provider receptive, but 40% said the response was dismissive when they brought it up, and 15% said the topic was never broached at all.

Andrea Donsky, RHN, founder of Morphus who conducted the study, found these numbers surprising because she would have hoped that more doctors would have brought up perimenopause/menopause sooner. “We still have a lot of work to do to help educate women and healthcare providers,” Ms. Donsky told this news organization. “A lot of women spend years not knowing they’re in this phase of life, so they visit their doctors/HCPs [healthcare providers] many times because the connection isn’t made on the first visit.”

Danielle Meitiv, MS, a study co-author and health coach based in Silver Spring, Maryland, added, “Everyone wonders why we end up with Dr. Google; that’s the only doctor who’s talking to us about menopause.”

Dr. Pinkerton was less surprised by these survey findings. “As a menopause specialist, my most common new patient is a perimenopausal woman who feels like she hasn’t been listened to,” whether it’s her primary care doctor, her ob.gyn., or another clinician. “If the provider doesn’t ask or if the women doesn’t tell, then you don’t have the conversation,” Dr. Pinkerton said. “So many women in perimenopause are busy with work, families, partnerships, aging parents — all of the issues that they’re dealing with — that when they start to have sleep issues or mood issues or easy crying, they relate it to their life stressors, instead of recognizing that it’s fluctuating hormones.”

When Ms. Donsky examined the 1223 responses they had received through August 2024, the most common treatments advised for symptoms were antidepressants and HT, both recommended by 38% of providers. Other common recommendations were to “lose weight,” “eat less and exercise more,” supplements, or birth control pills.

Dr. Faubion had no disclosures, and her study used no external funding. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Ms. Donsky is the owner of Morphus. Ms. Meitiv had no disclosures. The poster on women’s experiences with providers was funded by Morphus Inc.

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

CHICAGO — Less than 4% of American women aged 50-59 years use hormone therapy (HT) to treat menopausal symptoms today, approximately 10 times lower than the peak use of HT before the publication of the 2002 Women’s Health Initiative (WHI) study that misguidedly cast doubt on the safety of HT. Though subsequent research has addressed the flaws of the WHI study and supports the use of HT in most menopausal women younger than 60 years, use of this therapy has never recovered, according to research presented at the annual meeting of The Menopause Society (formerly The North American Menopause Society).

“Despite evidence supporting the efficacy and safety of HT, usage rates of US Food and Drug Administration–approved HT remain low,” Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health in Jacksonville, Florida, and medical director of The Menopause Society, told attendees. “Improved education of clinicians and patients is critically needed.”

Today, “there is more clarity on the risk/benefit ratio of HT use with the benefits typically outweighing the risks in women who initiate therapy under the age of 60 years and within 10 years of menopause onset.”

Using medical and pharmacy claims data from OptumLabs, Dr. Faubion and her colleagues examined utilization rates from 2007 to 2023 of transdermal vs oral estrogen and of conjugated estrogen vs estradiol in women aged 40 years or older. The data included more than 200 million people throughout the United States covered by commercial insurance or Medicare Advantage. The researchers defined annual rate of HT use as the proportion of women who had at least 180 days of a filled prescription for a systemic HT preparation with estrogen.

The study population increased from an estimated 2 million women in 2007 to 4.5 million women in 2023, and the average age of enrollees increased from 53 in 2007 to 66 in 2023. Starting at 4.6% in 2007, HT use steadily declined to a low of 1.8% in 2023 for the whole cohort of women aged 40 years or older.

Though rates remained highest in women aged 50-64 years, it still declined within each age group: From 6% in 2007 to 3.6% in 2023 among women aged 50-54 years, from 7.3% to 3.8% among women aged 55-59 years, and from 7.5% to 2.9% among women aged 60-64 years. It also declined in younger women, from 3.2% in 2007 to 1.5% in 2023 in those aged 45-50 years. Estradiol was the most common formulation used, and oral administration was the most common route.

The researchers also saw a gradual decline during the study period in the use of high-dose oral HT and an increase in the use of low-dose oral HT, whereas standard dosages remained fairly consistent as the most common dose prescribed. Similarly, the use of high transdermal doses declined, whereas low transdermal doses increased and surpassed the use of standard doses. Conjugated estrogen use plummeted during the study period across all age groups, from 2%-5% in most age groups to < 1% in all age groups by 2023.

One limitation of the study was that it could not examine rates of compounded HT use because those would not be reflected in insurance claims, pointed out JoAnn Pinkerton, MD, a professor of ob.gyn. at the University of Virginia in Charlottesville, Virginia, who was not involved in the study. Dr. Pinkerton found it surprising that the numbers were so low, despite the fact that research estimates suggest less than 15% of menopausal women are receiving adequate treatment, she told this news organization. “You can see there’s a large unmet need to get treatment,” she said. “All major medical societies say the same thing: For healthy, symptomatic menopausal women, you can use hormone therapy safely and effectively.” 

The lack of education among providers is likely the biggest reason for the decline, Dr. Pinkerton says. “I think it’s because there’s a whole group of providers that did not receive any training, and that’s OB/GYNs, internal medicine, family practice, endocrinologists,” she said. “Now that people are starting to feel more confident that we can use it safely, we’re trying to get that training out to people about vasomotor symptoms, about hormone therapy, and now about new nonhormone therapies.”

Dr. Pinkerton noted that The Menopause Society has begun a new teaching program, Menopause Step-by-Step, aimed at providing short articles on the basics of menopause, HT, non-HT, and vaginal issues.

A separate poster presented at the conference provides insight into another potential factor contributing to low HT rates. A survey of 1050 American and Canadian women found that 90% discussed their symptoms with their healthcare providers, yet only 25% said their doctor identified the symptoms as likely due to perimenopause or menopause on their first visit — and only 10% of respondents said their doctor was the one to bring up perimenopause/menopause.

The respondents comprised a convenience sample of those who saw the survey on social media, in an email, or on the website of Morphus, a Toronto-based company aimed at providing support, information, and products related to menopause. Though the survey is ongoing, the analyzed responses are from March to May 2024.

Though 40% of the women said their provider attributed their symptoms to perimenopause or menopause on the second or third visit, 18% saw a provider four to five times, and 17% saw a provider more than five times before the provider considered menopause as a cause. About a third of the women (35%) brought it up to their doctor themselves and found their provider receptive, but 40% said the response was dismissive when they brought it up, and 15% said the topic was never broached at all.

Andrea Donsky, RHN, founder of Morphus who conducted the study, found these numbers surprising because she would have hoped that more doctors would have brought up perimenopause/menopause sooner. “We still have a lot of work to do to help educate women and healthcare providers,” Ms. Donsky told this news organization. “A lot of women spend years not knowing they’re in this phase of life, so they visit their doctors/HCPs [healthcare providers] many times because the connection isn’t made on the first visit.”

Danielle Meitiv, MS, a study co-author and health coach based in Silver Spring, Maryland, added, “Everyone wonders why we end up with Dr. Google; that’s the only doctor who’s talking to us about menopause.”

Dr. Pinkerton was less surprised by these survey findings. “As a menopause specialist, my most common new patient is a perimenopausal woman who feels like she hasn’t been listened to,” whether it’s her primary care doctor, her ob.gyn., or another clinician. “If the provider doesn’t ask or if the women doesn’t tell, then you don’t have the conversation,” Dr. Pinkerton said. “So many women in perimenopause are busy with work, families, partnerships, aging parents — all of the issues that they’re dealing with — that when they start to have sleep issues or mood issues or easy crying, they relate it to their life stressors, instead of recognizing that it’s fluctuating hormones.”

When Ms. Donsky examined the 1223 responses they had received through August 2024, the most common treatments advised for symptoms were antidepressants and HT, both recommended by 38% of providers. Other common recommendations were to “lose weight,” “eat less and exercise more,” supplements, or birth control pills.

Dr. Faubion had no disclosures, and her study used no external funding. Dr. Pinkerton has run a trial funded by Bayer and is a consultant for Bayer and Pfizer. Ms. Donsky is the owner of Morphus. Ms. Meitiv had no disclosures. The poster on women’s experiences with providers was funded by Morphus Inc.

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

CHICAGO — Use of CO₂ lasers and similar “energy-based” treatments result in little to no benefit for genitourinary syndrome of menopause (GSM) symptoms, according to research presented at the The Menopause Society 2024 Annual Meeting in Chicago on September 12.

“There was a concern that menopausal women are being targeted for treatments that may not have a lot of benefit and might have significant harms,” Elisheva Danan, MD, MPH, a physician at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, told this news organization. While she was not surprised to find little evidence of benefit, “we were a little bit surprised that we also didn’t find significant evidence of harms.”

The study was unable to evaluate the potential for financial harms, but Dr. Danan noted that these therapies are often expensive and not typically covered by insurance. The treatments appear to be used primarily in private practice, she said, while “most academic clinicians were not familiar with these and do not use these lasers.”

The American Urological Association had requested the review, Dr. Danan said, “to inform clinical guidelines that they could put out for practitioners about treating genital urinary syndrome from menopause.” Yet the evidence available remains slim. “There’s a lot of outcomes that were not looked at by most of these [trials], or they were looked at in a way that we couldn’t separate out,” she said.

Kamalini Das, MD, a professor of ob.gyn. at the University of Minnesota who was not involved in the research, was surprised by the findings because studies to date have been variable, “but since this looks at multiple studies and they find no benefits, I would take these results as more significant than any of the small studies,” she told this news organization.

Dr. Das said she has patients who ask about using these therapies and have had them done. “So far, I’ve told them the jury is out on whether it will help or not, that there are some studies that say they’re beneficial and some studies that they’re not,” Dr. Das said.

But this new review changes what she will tell patients going forward, she said. “This is a good study because it consolidates lots of little studies, so I think I would use this to say, looking at all the studies together, this treatment is not beneficial.”

GSM occurs due to the body’s reduced production of estrogen and affects anywhere from 27% to 84% of postmenopausal women. It can involve a constellation of symptoms ranging from vaginal discomfort and irritation to painful urination or intercourse. Typical recommended treatments for GSM include systemic hormone therapy, localized hormonal treatments such as vaginal estrogen or dehydroepiandrosterone, nonhormonal creams and moisturizers, and the prescription drug ospemifene.

Most of these have been found effective, according to a recent systematic review  Dr. Danan published in the Annals of Internal Medicine that this news organization covered. But recent years have also seen a rapid increase in interest and the availability of energy-based treatments for GSM, such as CO₂ laser and radiofrequency interventions, particularly for those who cannot or do not want to use hormonal treatments. The idea behind these newer therapies is that they “heat tissue to cause a denaturation of collagen fibers and induce a wound-healing response,” with the aim of “enhancement of vaginal elasticity, restoration of premenopausal epithelial function, and symptom improvement,” the authors wrote.

Evidence has been scant and uneven for the safety and effectiveness of these treatments, and they have not been evaluated by the US Food and Drug Administration. The agency issued a warning in 2018 with remarks from then Commissioner Scott Gottlieb that the “products have serious risks and don’t have adequate evidence to support their use for these purposes.”

Much of the evidence has focused on CO₂ lasers instead of other energy-based treatments, however, and a raft of new studies have been published on these interventions in the past 2 years. Dr. Danan and colleagues, therefore, assessed the most current state of the research with a systematic review of randomized controlled trials (RCTs) and prospective observational studies with control groups published through December 11, 2023.

Included studies needed to evaluate an energy-based treatment for at least 8 weeks in a minimum of 40 postmenopausal women (20 in each group) who had one or more GSM symptoms. The authors also included nonrandomized and uncontrolled studies with a follow-up of a year or more to assess possible adverse events. The studies also needed to assess at least one of eight core outcomes: Dyspareunia; vulvovaginal dryness; vulvovaginal discomfort/irritation; dysuria; change in most bothersome symptom; treatment satisfaction; adverse events; and distress, bother, or interference associated with genitourinary symptoms.

The authors identified 32 studies, including 16 RCTs, one quasi-RCT, and 15 nonrandomized studies. The researchers extracted and analyzed data from the 10 RCTs and one quasi-RCT that were rated as having low to moderate risk for bias.

Most of these studies assessed CO₂ lasers alone, while three assessed erbium:yttrium-aluminum-garnet (Er:YAG) laser, and one looked at CO₂ lasers vs radiofrequency treatments.

The average age of participants ranged from 56 to 64 years, and most trials were in the United States. Results showed that CO₂ lasers led to little or no difference in dysuria, dyspareunia, or quality of life when compared with sham lasers. The CO₂ laser therapy also showed little to no difference compared with vaginal estrogen creams for dyspareunia, dryness, discomfort/irritation, dysuria, or quality of life.

Most CO₂ laser studies reported on most outcomes, but the Er:YAG studies tended to report only on quality of life and/or one or two other outcomes. The radiofrequency study only assessed dyspareunia and quality of life.

“Treatment effects on other outcomes and effects of Er:YAG laser or radiofrequency on any outcomes are very uncertain,” the authors reported. Few adverse events and no serious adverse events were reported based on 15 studies, including the additional non-RCTs that had follow-up for at least a year.

“There are case reports and other types of studies that have shown some bad outcomes using laser therapies, and we really wanted to be expansive and include anything, especially because this is such a new treatment and all these trials were in the last couple of years,” Dr. Danan said. 

The review was limited by inconsistent or nonvalidated outcome reporting in the studies as well as small populations and short follow-up, typically less than 3 months.

The research was funded by the Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. Dr. Danan and Dr. Das had no disclosures.
 

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

CHICAGO — Use of CO₂ lasers and similar “energy-based” treatments result in little to no benefit for genitourinary syndrome of menopause (GSM) symptoms, according to research presented at the The Menopause Society 2024 Annual Meeting in Chicago on September 12.

“There was a concern that menopausal women are being targeted for treatments that may not have a lot of benefit and might have significant harms,” Elisheva Danan, MD, MPH, a physician at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, told this news organization. While she was not surprised to find little evidence of benefit, “we were a little bit surprised that we also didn’t find significant evidence of harms.”

The study was unable to evaluate the potential for financial harms, but Dr. Danan noted that these therapies are often expensive and not typically covered by insurance. The treatments appear to be used primarily in private practice, she said, while “most academic clinicians were not familiar with these and do not use these lasers.”

The American Urological Association had requested the review, Dr. Danan said, “to inform clinical guidelines that they could put out for practitioners about treating genital urinary syndrome from menopause.” Yet the evidence available remains slim. “There’s a lot of outcomes that were not looked at by most of these [trials], or they were looked at in a way that we couldn’t separate out,” she said.

Kamalini Das, MD, a professor of ob.gyn. at the University of Minnesota who was not involved in the research, was surprised by the findings because studies to date have been variable, “but since this looks at multiple studies and they find no benefits, I would take these results as more significant than any of the small studies,” she told this news organization.

Dr. Das said she has patients who ask about using these therapies and have had them done. “So far, I’ve told them the jury is out on whether it will help or not, that there are some studies that say they’re beneficial and some studies that they’re not,” Dr. Das said.

But this new review changes what she will tell patients going forward, she said. “This is a good study because it consolidates lots of little studies, so I think I would use this to say, looking at all the studies together, this treatment is not beneficial.”

GSM occurs due to the body’s reduced production of estrogen and affects anywhere from 27% to 84% of postmenopausal women. It can involve a constellation of symptoms ranging from vaginal discomfort and irritation to painful urination or intercourse. Typical recommended treatments for GSM include systemic hormone therapy, localized hormonal treatments such as vaginal estrogen or dehydroepiandrosterone, nonhormonal creams and moisturizers, and the prescription drug ospemifene.

Most of these have been found effective, according to a recent systematic review  Dr. Danan published in the Annals of Internal Medicine that this news organization covered. But recent years have also seen a rapid increase in interest and the availability of energy-based treatments for GSM, such as CO₂ laser and radiofrequency interventions, particularly for those who cannot or do not want to use hormonal treatments. The idea behind these newer therapies is that they “heat tissue to cause a denaturation of collagen fibers and induce a wound-healing response,” with the aim of “enhancement of vaginal elasticity, restoration of premenopausal epithelial function, and symptom improvement,” the authors wrote.

Evidence has been scant and uneven for the safety and effectiveness of these treatments, and they have not been evaluated by the US Food and Drug Administration. The agency issued a warning in 2018 with remarks from then Commissioner Scott Gottlieb that the “products have serious risks and don’t have adequate evidence to support their use for these purposes.”

Much of the evidence has focused on CO₂ lasers instead of other energy-based treatments, however, and a raft of new studies have been published on these interventions in the past 2 years. Dr. Danan and colleagues, therefore, assessed the most current state of the research with a systematic review of randomized controlled trials (RCTs) and prospective observational studies with control groups published through December 11, 2023.

Included studies needed to evaluate an energy-based treatment for at least 8 weeks in a minimum of 40 postmenopausal women (20 in each group) who had one or more GSM symptoms. The authors also included nonrandomized and uncontrolled studies with a follow-up of a year or more to assess possible adverse events. The studies also needed to assess at least one of eight core outcomes: Dyspareunia; vulvovaginal dryness; vulvovaginal discomfort/irritation; dysuria; change in most bothersome symptom; treatment satisfaction; adverse events; and distress, bother, or interference associated with genitourinary symptoms.

The authors identified 32 studies, including 16 RCTs, one quasi-RCT, and 15 nonrandomized studies. The researchers extracted and analyzed data from the 10 RCTs and one quasi-RCT that were rated as having low to moderate risk for bias.

Most of these studies assessed CO₂ lasers alone, while three assessed erbium:yttrium-aluminum-garnet (Er:YAG) laser, and one looked at CO₂ lasers vs radiofrequency treatments.

The average age of participants ranged from 56 to 64 years, and most trials were in the United States. Results showed that CO₂ lasers led to little or no difference in dysuria, dyspareunia, or quality of life when compared with sham lasers. The CO₂ laser therapy also showed little to no difference compared with vaginal estrogen creams for dyspareunia, dryness, discomfort/irritation, dysuria, or quality of life.

Most CO₂ laser studies reported on most outcomes, but the Er:YAG studies tended to report only on quality of life and/or one or two other outcomes. The radiofrequency study only assessed dyspareunia and quality of life.

“Treatment effects on other outcomes and effects of Er:YAG laser or radiofrequency on any outcomes are very uncertain,” the authors reported. Few adverse events and no serious adverse events were reported based on 15 studies, including the additional non-RCTs that had follow-up for at least a year.

“There are case reports and other types of studies that have shown some bad outcomes using laser therapies, and we really wanted to be expansive and include anything, especially because this is such a new treatment and all these trials were in the last couple of years,” Dr. Danan said. 

The review was limited by inconsistent or nonvalidated outcome reporting in the studies as well as small populations and short follow-up, typically less than 3 months.

The research was funded by the Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. Dr. Danan and Dr. Das had no disclosures.
 

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

CHICAGO — Use of CO₂ lasers and similar “energy-based” treatments result in little to no benefit for genitourinary syndrome of menopause (GSM) symptoms, according to research presented at the The Menopause Society 2024 Annual Meeting in Chicago on September 12.

“There was a concern that menopausal women are being targeted for treatments that may not have a lot of benefit and might have significant harms,” Elisheva Danan, MD, MPH, a physician at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, told this news organization. While she was not surprised to find little evidence of benefit, “we were a little bit surprised that we also didn’t find significant evidence of harms.”

The study was unable to evaluate the potential for financial harms, but Dr. Danan noted that these therapies are often expensive and not typically covered by insurance. The treatments appear to be used primarily in private practice, she said, while “most academic clinicians were not familiar with these and do not use these lasers.”

The American Urological Association had requested the review, Dr. Danan said, “to inform clinical guidelines that they could put out for practitioners about treating genital urinary syndrome from menopause.” Yet the evidence available remains slim. “There’s a lot of outcomes that were not looked at by most of these [trials], or they were looked at in a way that we couldn’t separate out,” she said.

Kamalini Das, MD, a professor of ob.gyn. at the University of Minnesota who was not involved in the research, was surprised by the findings because studies to date have been variable, “but since this looks at multiple studies and they find no benefits, I would take these results as more significant than any of the small studies,” she told this news organization.

Dr. Das said she has patients who ask about using these therapies and have had them done. “So far, I’ve told them the jury is out on whether it will help or not, that there are some studies that say they’re beneficial and some studies that they’re not,” Dr. Das said.

But this new review changes what she will tell patients going forward, she said. “This is a good study because it consolidates lots of little studies, so I think I would use this to say, looking at all the studies together, this treatment is not beneficial.”

GSM occurs due to the body’s reduced production of estrogen and affects anywhere from 27% to 84% of postmenopausal women. It can involve a constellation of symptoms ranging from vaginal discomfort and irritation to painful urination or intercourse. Typical recommended treatments for GSM include systemic hormone therapy, localized hormonal treatments such as vaginal estrogen or dehydroepiandrosterone, nonhormonal creams and moisturizers, and the prescription drug ospemifene.

Most of these have been found effective, according to a recent systematic review  Dr. Danan published in the Annals of Internal Medicine that this news organization covered. But recent years have also seen a rapid increase in interest and the availability of energy-based treatments for GSM, such as CO₂ laser and radiofrequency interventions, particularly for those who cannot or do not want to use hormonal treatments. The idea behind these newer therapies is that they “heat tissue to cause a denaturation of collagen fibers and induce a wound-healing response,” with the aim of “enhancement of vaginal elasticity, restoration of premenopausal epithelial function, and symptom improvement,” the authors wrote.

Evidence has been scant and uneven for the safety and effectiveness of these treatments, and they have not been evaluated by the US Food and Drug Administration. The agency issued a warning in 2018 with remarks from then Commissioner Scott Gottlieb that the “products have serious risks and don’t have adequate evidence to support their use for these purposes.”

Much of the evidence has focused on CO₂ lasers instead of other energy-based treatments, however, and a raft of new studies have been published on these interventions in the past 2 years. Dr. Danan and colleagues, therefore, assessed the most current state of the research with a systematic review of randomized controlled trials (RCTs) and prospective observational studies with control groups published through December 11, 2023.

Included studies needed to evaluate an energy-based treatment for at least 8 weeks in a minimum of 40 postmenopausal women (20 in each group) who had one or more GSM symptoms. The authors also included nonrandomized and uncontrolled studies with a follow-up of a year or more to assess possible adverse events. The studies also needed to assess at least one of eight core outcomes: Dyspareunia; vulvovaginal dryness; vulvovaginal discomfort/irritation; dysuria; change in most bothersome symptom; treatment satisfaction; adverse events; and distress, bother, or interference associated with genitourinary symptoms.

The authors identified 32 studies, including 16 RCTs, one quasi-RCT, and 15 nonrandomized studies. The researchers extracted and analyzed data from the 10 RCTs and one quasi-RCT that were rated as having low to moderate risk for bias.

Most of these studies assessed CO₂ lasers alone, while three assessed erbium:yttrium-aluminum-garnet (Er:YAG) laser, and one looked at CO₂ lasers vs radiofrequency treatments.

The average age of participants ranged from 56 to 64 years, and most trials were in the United States. Results showed that CO₂ lasers led to little or no difference in dysuria, dyspareunia, or quality of life when compared with sham lasers. The CO₂ laser therapy also showed little to no difference compared with vaginal estrogen creams for dyspareunia, dryness, discomfort/irritation, dysuria, or quality of life.

Most CO₂ laser studies reported on most outcomes, but the Er:YAG studies tended to report only on quality of life and/or one or two other outcomes. The radiofrequency study only assessed dyspareunia and quality of life.

“Treatment effects on other outcomes and effects of Er:YAG laser or radiofrequency on any outcomes are very uncertain,” the authors reported. Few adverse events and no serious adverse events were reported based on 15 studies, including the additional non-RCTs that had follow-up for at least a year.

“There are case reports and other types of studies that have shown some bad outcomes using laser therapies, and we really wanted to be expansive and include anything, especially because this is such a new treatment and all these trials were in the last couple of years,” Dr. Danan said. 

The review was limited by inconsistent or nonvalidated outcome reporting in the studies as well as small populations and short follow-up, typically less than 3 months.

The research was funded by the Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. Dr. Danan and Dr. Das had no disclosures.
 

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